Home
DirectAccess Online Tool
Contents
1. Manage Prescription ri E vous Ue Tomolatos r sroesona APPLESOLES smo Orders r3 36765441 CONNE AVED Active Order Histor E AVERY Acne sim sur r 27000045 ena azer Ade Crede tak B E T BARASHKOVA 2069 SERE pene WE 37069945 care Ache ERE 37060326 xmv CAT Active amane Patients Wno Are On Hola E scad r m Ace Patents Who Have Net Eb NIME TERRE Ache a nove de EXTRANEAL EL EN Please see Indicatons and 9 resulta found displaying 110 16 i 4 1121214151617 P Example 2 Click the check box next to the patient s name to assign that patient to the staff member whose information you are updating Click Save to save your information the system confirms that the information has been successfully saved MANAGE STAFF ASSIGN ESIGNING RIGHTS TO A STAFF MEMBER 1 To assign eSigning rights to a staff member click on the eSigning tab the system displays the eSigning screen SS TEST CLIN HomeCare Services Drectazcess Home Manage Stet Edit Stai Member HOME Salfi servas DT O estonia O rare in at LEN ISE patente Transfer Patient Emal Tongariron Marape Prescriptions Repent E mail CTA 1 Manage Pr
2. The pls container tubing set is fabricate trom polyvinyl chloride PL 1469 Plastic Exposure to temperatures above 25 C 77 F during transport and storage wil lead to minor losses in moisture content Higher temperature lead to greater losses Iis unlikely that these minor losses wil lead te clinically significant changes within the expiration period The amount of water that can permeate from inside the solution container into the overpouch is insufficient to affect the solution gniicanty Solutions in contact with the plastic container may leach out certain chemical components trom the plastic in very small amounts however biological testing was supportive of he safety of the plastic container materials Clinical Pharmacology Peritoneal dialysis is a procedure far removing toxic substances and metabolites normally excreted by the kidneys and for aiding in the regulation of uid and electrolyte balance The procedure is accomplished by instiling peritoneal dialysis fluid through a conduit into the peritoneal cavity Toxic substances and metabolites present in high concentration in the blood cross the peritoneal membrane into the dying flid Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma creating an osmotic gradient which facilites fluid removal rom the patient s plasma nto the peritoneal cavity After a period of time dwell time he uid is drained by gravity rom the cavity The solution
3. NDC 0911 0411 48 mm NDC 0941 041149 Canter io sm NDC 0911 0411 25 too Lie ooo usasa Fantoni 2 18 m Eb Dass as sco soe 30 3000 Solution with rg my a mg me 3000 3000 1588179 NOG 0941 041304 an Donoso Soo nsis NDC 0811 041307 pasa mo Canter se wo wm ito pmen amp mms meus e a l an n on 52 iwo 2000 Eom LEE ass dow mo as os os s 00 NDC 0941041345 a jm m mm 33 xo 30 17 MDC 0941041347 30 3000 NDC 0941041348 Meine Soo oo npccostostsso Smo 5000 LEM ME P02 feti is as me 207 sos a a mo as sw soo 35 Dextrose 2 55 Canter ooo nocoostasisos Peso is 18 Em Soon vim SE ma ng ms dot nel as os oo AM 425 Dextrose 5000 6000 1585195 NDG 0941 0415 07 Lon io mo iena Canter se ncm wm NDC 0041 041543 Das a 52 m Salon wit LEE ws dio mo as os so im 59 En i Canter m NDC 0041 041549 m NDC 0041 04
4. soluton ine Break solution frangible green by grasping the tabing above top ot the fangbl and puling forward and backward unti the frangible separates See gues 3 and 4 Hang the new soluton container Piace the drainage container below the o the perloneum Open transfers clamp to drain solution trom perkoneum Warning During solution drainage frin stands may become attached to the connector arable closure Manipulation ot the connector closure in the tubing may ee any bin obstruction that occurs 11 Close transfer set ie clam aer drainage i compie 12 Open soi ine clamp ard al new Solution tow into the drainage container tor 5 seconds to prime ine 19 Ciamp drain ine 14 Open vase set clamp and alow the to fow into the peritoneum 15 Glose transfer set camp when infusion s compite 16 Prepare a new disconnect cap Tolling directions accompanying the cap 17 Disconnect he patent anster set rom the and alach Pew disconnect cap to the transfer How Supplied Dianeal Low Calcium peritoneal dialysis solutions in UltraBag containers are available in nominal size fel containers as shown the tab n the DESCRIPTION secte All Dianeal Low Calcium peritoneal dialysis solutions have overfills which are declared on container Freezing of solutions may occur at temperatures below 0 C 32 F Allow to thaw naturally in ambient condition and through mix conten
5. DirectAccess HomeCare Online Tool NURSE REFERENCE GUIDE Baxter WELCOME from Baxter s HomeCare Services team Whether we are taking orders delivering products or answering your questions our job is to assist you and your patients with home dialysis needs We will work with you to set up new patients maintain patient prescriptions and order deliver your patient s dialysis supplies Baxter provides consistent high quality products and services to our home patients and health care professionals The cooperation between you and Baxter are key components of success There are several key interactions you will experience with Baxter s HomeCare Services team including the following New Home Patients Basic Services Other Patient Orders amp Changes Other Patient Services Center Professional Needs Because many of these interactions apply to both home patients and health care professionals you will find information applicable to both audiences in our Going Home with Confidence booklet For information specific to health care professionals we have the DirectAccess online tool which was designed to help you manage your patients more efficiently than ever before The sections in this guide provide step by step instructions on how to use the DirectAccess online tool This is the preferred vehicle for health care professionals to manage home patient transactions with Baxter We strive to deliver superior service that
6. and tey wil b orde in loda a Create Sta Enter paient comments to be sent to Barter Support Manage Averse Eveni Reone Patents ro Are on Ho E Patante Whe Have Net Example 2 Add comments as necessary and click Save the system sends the comments to Baxter 3 Click Home to return to the To Do list Annual Prescription Renewals Baxter will not accept any order for patients without a prescription signed and dated by a physician The prescription To Do list also identifies prescriptions requiring a renewal Bater Renal HomeCare Services Deeeteesee Home MARY MARIN 112542 AN rev peter Create New Patent Youbave iFendra Patents ciet itam Pecan Manage Patects 2 Voutas premi ea er ty mE aar enero Cc zo dip Example 1 Clickthe Click Here link on the Renewal Rx line to display the prescriptions requiring an annual renewal the system displays the prescriptions in a box below the link you just clicked Bate Renal Science Solutions Systems Support Home Care Services pem EVAR Las ta Dna To ere ate Tono ese fonte Ded 3 a bene Mese le apte pae Cente ei TELE Nectar a Crize pn Patent auras esa ending Renewal Presentan Paint n Raven order eye n e ec
7. needed Nursing mothers Caution should be exercised when Dianeal PD 2 peritoneal dialysis solution is administered to a nursing woman Podiatric use Safely and effectiveness in children have nat been established Adverse Reactions Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as he of contamination of equipment or improper technique in catheter placement Abdominal pan bleeding partons subcutaneous infection around the peritoneal catheter catheter site Infection catheter blockage fica in fuid removal and are among te complications the procedure Solution related adverse reactions may include peritonitis electrolyte and fluid imbalances hypovolemia hypervolemia hypotension hypertension disequilibrium syndrome alergie symptoms and muscle cramping Dosage and Administration Diansal PD 2 solutions are intended fr intraperitoneal administration Itis recommended that adult patients being placed on continuous ambulatory peritoneal dialysis should be appropriately trained in program which is under he supervision of physician Training materials are valable from Baxter Healthcare Corporation Deerfield IL 60015 USA o facta this training Parenteral drug products should be inspected visualy for particulate matter and discoloration prior to administration whenever solution and container permit The frequency of treatment formulation exc
8. Notes can be entered in the free form text box These notes will be sent to Baxter when clicking Next This field can be utilized at any time for any patient to send Baxter information The Additional Contacts tab displays You can select Save Patient to save with no additional contacts or Cancel Create to end the process To add additional contacts click Add additional contact Science Solutions Systems Support PFAQ LOGOFF Renal Passport sce s TEST CLINIC P DirectAccess Home Create Patient eI GM Basento Denographie nto Additional Contacts What Do INeed To Do Here Example KE Complete all fields To add multiple contacts click Add additional contact To delete a contact click Delete Contact Click Save Patient when you are finished adding additional contacts Science Solutions Systems Support praa LOGOFF Renal Passport rest Diecthccese Home gt Create Patient indicato required file L Phone Humber oo Additional phone info Pena typa or rei Primary Contact n Rolationship To Pationt rhone commenta Example The confirmation window displays You can choose to Create another patient Assign patients to staff or Create patient s prescription The patient will remain in your To Do list under Pending Patients until the prescription has bee
9. ra Rae GI What Dai Need to bo Here Last Name Fist Name DOR Effective Dato Expiration Dato Sion Status SEASHELL swa nano Verny Cresent Baxter Renal penai Product Baxter by checking his boxyou accapt Sour eStunauue e e came ae Yauriegar signere II Example 8 The Batch eSign confirmation window displays Click Close to return to the Home page E D review D Last name Firat Nome pon Hfectve pate proton Date estan status SEASHELL mario nani Approves pr estan naar s Example Scheduled Orders A 8 Services Scheduled Orders After logging on the system displays the DirectAccess online tool Home Page An item on the To Do list identifies the patients who have not placed their scheduled orders For each patient the system enables you to easily view that patient s calendar look at their order history and send a comment to Baxter if needed Welcome MARY MARTIN Last ogm 0 13 09 2 40 57 PM What Do Need Ta Do Here Vei nava S Pereng ciacreroto depay ou ave i Presepio i retira a pci sigue Click hec e disp 1 You nave 2 pater nho have no placed Peke screed order Cis ere o 9 Creato Now Pationt Manage Patients gt ou nave charges Lich nere Ma
10. Plasma levels of icodextrin and metabolites return to baseline es poli Letca folo of administration Metabolism lcodextrin is metabolized by alpha amylase into oligosaccharides with a lower degree of polymerization DP including maltose OP2 maltotriose DP3 maltotetraose and higher molecular weight species In single dose study DP2 and showed a progressive rise in plasma concentrations with a profile similar to that for total icodextrin with peak values reached by the end of the dwell and declining thereafter Only very small increases in blood levels of larger polymers were observed Steady state plasma levels of icodextrin metabolites were achieved within one week and stable plasma levels were observed during long term administration Some degree of metabolism of icodextrin occurs intraperitoneall with a progressive rise in the concentration of the smaller polymers the dialysate during the 12 hour dwell Elimination lcodextrin undergoes renal elimination direct proportion to the level of residual renal function Diffusion of the smaller icodextrin metabolites from plasma into the peritoneal cavity is also possible after systemic absorption and metabolism of icodextrin Special Populations Geriatrics The influence of age on the pharmacokinetics of icodextrin and its metabolites was not assessed Gender and Race The influence of gender and race on th
11. chronic CCPD patients Diaz Buxo et al 1983 have been observed to be somewhat lower than normal values the bicarbonate precursor lactate concentration of this formulation has been raised to 40 mEq L Serum bicarbonate levels should be monitored The osmolarities shown in Table 1 are calculated values As an example measured osmolarity by freezing point depression determination of DIANEAL PD 2 peritoneal dialysis solution with 1 5 dextrose is approximately 334 mOsmol L compared with measured values in normal human serum of 280 mOsmol L The plastic container is fabricated from a specially formulated polyvinyl chloride PL 146 Plastic The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period e g di 2 ethylhexyl phthalate DEHP up to 5 parts per million however the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies Clinical Pharmacology Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys and for aiding in the regulation of fluid and electrolyte balance The procedure is accomplished by instilling peritoneal dialysis fluid through
12. rent Patiente Whe On Hele Fotis Who Have Not sion Status Example 8 Click on the patient s name to select a new attending physician The system displays the Basic Info tab of the View Update Patient screen with that patient s information The note indicates the name of the patient you are editing wa TESO Ci ey roms im pae perm vato Pene otte pem Tronto Palloni maso name age str Manage Prescon tentes pe Care OF Post Box TO ci omano I ED Lr ite A Example 4 Select a new attending physician from the list in the drop down in the Attending Physician field and click the Save button The system updates the patient s information with the new attending physician and confirms that the information has been successfully saved 5 Click on HOME from the left navigation bar to return to the To Do list 6 Repeatthe steps above until all patients are assigned a new attending physician MANAGE STAFF You may also make staff changes monthly and as needed using the Manage Staff and Create Staff links in the Navigation bar on the left These changes include Updating staff information including staff type and staff details assigning patients by staff member and assigning eSigning rights Activating and deactivating staff You can also view a list o
13. 5 mEq L Average plasma magnesium levels have not been reported for chronic IPD and patients Serum magnesium levels should be monitored and if low oral magnesium supplements oral magnesium containing phosphate binders or peritoneal dialysis solutions containing higher magnesium concentrations may be used Because average serum bicarbonate levels in some chronic CAPD patients Nolph et al 1981 some chronic IPD patients La Greca et al 1980 and some chronic patients Diaz Buxo et al 1983 have been observed to be somewhat lower than normal values the bicarbonate precursor lactate concentration of this formulation has been raised to 40 mEq L Serum bicarbonate levels should be monitored Not for use in the treatment of lactic acidosis Potassium is omitted from DIANEAL PD 2 solutions because dialysis may be performed to correct hyperkalemia Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician The use of 5 or 6 liters of dialysis solution is not indicated in a single exchange Refer to manufacturers directions accompanying drugs to obtain full information on additives If the resealable rubber plug on the medication port is missing or partially removed do not use product if medication is to be added After the pull ring has been removed inspect connector of solution container for fluid flow A few drops of solution wi
14. Example 2 Click Print Calendar to print calendar as needed 3 To return to the To Do list click Home from the left navigation bar VIEW HISTORY 1 To view a patient s order history return to the To Do List and click to display the Pending Scheduled Order Patients box Click the View History link for the patient the system displays the Order Search Results window with the patient s orders listed Baxter Renal Science Solutions Systems Support PROFILE CONTACTUS LOGOFF HomeCare Services DrectAccsse Home Order Soarch Resulta HOME Order sea cesis Pane tame orerumber S Denverynae 5 Daa oi pacea e options Create New Patent KAREN 37055472 sonore seno sum vana Patients AE 27005472 pen nee Transfer Patent ara x sam amm p Wanags Prescitens su found dispasing allrasuts Bro Example 2 Selectthe desired order and click on the Order Number to View the order The system displays the Order Detail with the Shipping Address Order Quantity Product Code Product Name Pack Factor Status and Delivery Date Sate Renal Science Solutions Systems Support CHANGE CLIC MY PROFILE CONTACTUS HomeCare Services Droaaseeza Home tnx soaron gt Orgar Header Order detail What Do Need To Do Here mem cmm Manage Patients
15. PROFILE CONTACT US LOGOFF DIRECTACCESS TEST CLIC HomeCare Services Directaccess Home HOME Welcome MARY MARTIN Last 10 21 09 9 16 42 AN Patents E Croate How Patent Yeu hove 17 Prosorplore that require a physicaie aanatre Cicki Yeu have 0 paints who have rel paced ther scheduled order Manage Patients Yeu nave 2 Siart changes Cici nere Transtar Manage Prescriptions Manage Prescription Templates Example In the navigation bar on the left click Manage Patients the system displays the Search Patients screen CHANGE CLMIC EDIT MY PROFLE CONTACTUS HELPIFAQ LOGOFF DIRECTACCESS TEST CLINIC HomeCare Services rect ccess Home gt Manage Patients Search HONE Soarch Pationts Patients Enter search criteria and click Search Create New Patent Last lame sa Manage Patients Firet Mamo __ J Transfer Patient Staff Member Manage Preccristone ERG TEN Manage Prescription Templates Therapy LUNE Orders Order Histor Example 2 Enter the patient s last name make sure All is selected in the Status drop down and click Search The system displays the Patient Search Results screen CHANGECLINC EDITNIYPROFILE CONTACTUS HELPIFAQ DIRECTACCESS TEST CLINC 8 HomeCare Services Lirectaccess Home Manage Pants Search Results HOME Patient search results Patents Lostlemo HiretHamo MI Statue DOB
16. To Do Here Ursi roster O Mte Your erro a new reser tor panene rav mr ano Pan Trans Patt EEE News region CER I a E Templates ere recone a a a eases Dornei aie Became ase pan 2 EL Create Star au Example 5 The system also asks if you wish to save the prescription as a template so you can use it as a starting point for other prescriptions Click Yes to save as template Click No to return to the Home screen 6 The prescription you just renewed will now appear in the new Rx To Do list Click the Click here on the new Rx line to display the list Homecare Services tweeters ome 73 Wome MART HART O R zip aoe eta ie Paone Crete teo ter feat ere e e tod E 1 amafi epc ee air sn seo Marae Pao rent Drev Go teda arte patent TOI TTT ped nem resero rene cri 159 pianisian rar Pein Comments Manage Peer SE Pini oris IUE m 2 pum AGOTtONA 2 dee eiie ispum 9 ives n sma Pan am On Holt venimine Amel denari EI Em esae Motto RIDE n ton sen emos xeumum mace T p E Rene e ion ud imc T set 1 one Posso ie
17. WALKEGAN IL Tense roon cx a Co e Templates Delivery Date donne pu Orde Pad s san YET z E UNCAPOSCORECIOP OCA Manage Star Wo Example 3 To return to the To Do list click Home from the left navigation bar SEND COMMENTS 1 To send comments return to the To Do list and click to display the Pending Scheduled Order Patients box Click the Send Instructions link for the patient the system displays the Demographics Info tab Baxter Renal Science Solutions Systems Support ENTMYPRORLE CONTACTUS HELPFAO LOGOFF HomeCare Services Drssccoee Home Order Soarch gt Resulta HOME Orter search vests pasen tame orderiumber DetweryDate 2 Dare order Placed optiona Create New Patent APPLE KAREN 37085472 sns vanaya Patients APPLE KAREN 37993472 p ae Transfer Patent METE x sam sana p Menag Prescristons result found displaying ali resus 2 Add comments as necessary and click Save the system sends the comments to Baxter 3 To return to the To Do list click Home from the left navigation bar Patient On Hold HomeCare A 8 Services Patient Status Change How To Put a Patient On Hold The following steps will guide you through putting a patient on hold After logging on the system displays the DirectAccess online tool Home Page CHANGE CLINIC EDIT NY
18. a vein Itis not known if EXTRANEAL is safe and works in children Who should not use EXTRANEAL Do not use EXTRANEAL if you have a glycogen storage disease you do not tolerate maltose or isomaltose you have severe lactic acidosis you are allergic to cornstarch or icodextrin What should tell my doctor before using EXTRANEAL EXTRANEAL may not be right for you Before using EXTRANEAL tell your doctor about all your medical conditions including if you have a condition that affects your nutrition or you are not able to eat well have a lung or breathing problem have low potassium levels in your blood have high calcium levels in your blood have low magnesium levels in your blood have had recent aortic graft surgery have had stomach area abdomen surgery in the past 30 days tumors wounds infection have certain bowel conditions including a colostomy or ileostomy frequent episodes of diverticulitis inflammatory bowel disease pregnant or plan to become pregnant It is not known if EXTRANEAL will harm your unborn baby breast feeding It is not known if EXTRANEAL passes into your breast milk Tell your doctor about all the medicines you take including prescription and non prescription medicines vitamins and herbal supplements The dose of certain medicines may need to be changed when you use EXTRANEAL Especially tell your doctor if you take insulin blood pr
19. around the catheter fluid and electrolyte imbalance and pain were observed at a similar frequency with EXTRANEAL and Controls See PRECAUTIONS Changes in Alkaline Phosphatase and Serum Electrolytes An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receiving EXTRANEAL No associated increases in other liver chemistry tests were observed Serum alkaline phosphatase levels did not show progressive increase aver a 12 month study period Levels returned to normal approximately two weeks after discontinuation of EXTRANEAL Decreases in serum sodium and chloride have been observed in patients using EXTRANEAL The declines in serum sodium and chloride may be related to dilution resulting from the presence of icodextrin metabolites in plasma Although these decreases have been small and clinically unimportant monitoring of patients serum electrolyte levels as part of routine blood chemistry testing is recommended Post Marketing The following adverse reactions have been identified during post approval use of EXTRANEAL Because these reactions are reported voluntarily from a population of uncertain size itis not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure Adverse reactions are listed by MedDRA System Order Class SOC followed by Preferred Term in order of severity INFECTIONS AND INFESTATIONS Fungal peritonitis Peritonitis bact
20. diarrhea vomiting nausea vomiting anemia peripheral edema hypokalemia hyperphosphatemia hypoproteinemia hypervolemia arthralgia dizziness dyspnea skin disorder pruritis Additional adverse events occurring at an incidence of lt 5 and that may or may not have been related to EXTRANEAL include pain on infusion abdominal enlargement cloudy effluent ultrafiltration decrease postural hypotension heart failure hyponatremia hypochloremia hypercalcemia hypoglycemia alkaline phosphatase increase SGPT increase SGOT increase cramping confusion lung edema facial edema exfoliative dermatitis eczema vesicobullous rash maculopapular rash erythema multiforme All reported events are included in the list except those already listed in Table 1 or the following two paragraphs those not plausibly associated with EXTRANEAL and those that were associated with the condition being treated or related to the dialysis procedure EXTRANEAL was additionally studied in a subpopulation of 92 high average high transporter APD patients in a two week controlled clinical trial where patients received a single daily exchange of EXTRANEAL n 47 or dextrose control n 45 the long dwell 14 2 hours Consistent with the data reported in the original trials of EXTRANEAL rash was the most frequently occurring event GNE Peritoneal Dialysis Related Adverse events common to the peritoneal dialysis including peritonitis infection
21. does not contain potassium In situations n which there is a normal serum potassium evel or hypokalemia the addition of potassium chloride up to a concentration of 4 mEq L may be Indicated to prevent severe hypokalemia Addition a potassium chloride should be made after careful evaluation vf serum and total body potassium and only under the direction of a physician Clinical studies have demonstrated the use of this solution resulted in significant increases in serum CO and decreases serum magnesium levels The decrease in magnesium levels did not cause ica significant hypomagnesemia Indications and Usage Dianeal PD 2 peritoneal dialysis solutions in UltraBag containers are indicated for use in chronic rea lure patents beng maintained continuous ambulatory peritoneal when nend ic medical therapy is judged to be inadequate Contraindications None known Not tor intravenous Injection Use aseptic technique Contamination Luer lock connector may result in peritonitis An improper camping sequence may result in infusion o air into the peritoneum Peritoneal dialysis shouldbe done with great care it at al in patients with a number of conditions including disruption of the peritoneal membrane or diaphragm by surgery or trauma extensive adhesions bowel distention undiagnosed abdominal disease abdominal wall infection hernias or Dus fecal fistula or colostomy tense ascites obesity large polycystic Kidneys
22. following the directions accompanying the cap 17 Disconnect the patient transfer set connection rom the and attach new disconnect op to the transfer set How Supplied Dianeal PD 2 peritoneal dialysis solutions in UltraBag containers are avail lecti containers as Shown in the Table n the DESCRIPTION secon Ali Dianeal PD 2 peritoneal dialysis solutions have overfills which are declared on container Freezing of solution may occur at temperatures below 0 C 32 F Allow to thaw naturally in ambient conditions and throught mix contents by shaking Exposure ot pharmaceutical products to heat should be minimized Avoid excessive heat Itis recommended the product be stored at room temperature 25 C 77 P Figure 3 Figure 4 ion Ee E mol Lue gt wine cor w A sel Break Blue Frangible T fano ai i SEN Dan Pime 3 Disconnect p s San p ru Cu m ns 2 Ss zl Baxter Healthcare Copyright 1992 1994 Baxter Healthcare Corporation All rights reserve Deerfield IL 60015 USA 07 19 26 994 Printed in USA 200202 BAR CODE POSITION ONLY 071926994 07 19 59 178 DIANEAL PD 2 Peritoneal Dialysis Solution AMBU FLEX Container For Peritoneal Dialysis For intraperitoneal administration only Description DIANEAL PD 2 peritone
23. gt Aeseuntlo Edit Croato Now Fationt ABBOTT GNA acs WUST 36800674 VieviLIncaie Caencar Asian statt Manage Patents One resultfound Transrer Patent Example 3 Click the View Update link the system displays the Basic Info tab of the View Update Patient screen The note indicates the name of the patient you are editing CHANGE CLING EDIT MY PRO DIRECTACCESS TEST CLINIC B HomeCare Services DirectAccess Home 9 Manage Patients Search Resulis View Update Patient HOME tesic into Denoaone nio coniac Wat Do neea Do Patents Mote You are exling patient ADDOTT GNA Create New Patient Manage Patents Transfer Patient Manage Presenptans requires fle Last name Phone Number pgo ore tame E Mode z Manage Presciption freiem oe Templates Care OF Fost Attending B Physician Orders delivery GAS 3010 ROSENARY LN Patent sito ORECTACCESS TESTO order ist a Ser are statue Create Statt Stato X N asceunttumber Manage Sta ro imt Example 4 Select Hold from the Status drop down and click Save The system displays the Hold Reason dialog HomeCare Services Drec
24. in pediatric patients have not been established Geriatric Use No formal studies were specifically carried out in the geriatric population However 140 of the patients in clinical studies of EXTRANEAL were age 65 or older with 28 of the patients age 75 or older No overall differences in safety or effectiveness were observed between these patients and patients under age 65 Although clinical experience has not identified differences in responses between the elderly and younger patients greater sensitivity of some older individuals cannot be ruled out 07 19 65 351 ADVERSE REACTIONS Clinical Trials Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The adverse reaction information from clinical trials does however provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates EXTRANEAL was originally studied in controlled clinical trials of 493 patients with end stage renal disease who received a single daily exchange of EXTRANEAL for the long dwell 840 16 hours There were 215 patients exposed for at least 6 months and 155 patients exposed for at least one year The population was 18 83 years of age 56 male and 449 female 73 Caucasian 18 Black 4 Asian 3 Hispanic and
25. information is needed ss mo r Example gt If you wish to add contacts click the Add Additonal Contacts button the system displays the Additional Contact screen Enter the additional contact information CHANGE CLIC EDITMY PROFILE CONTACTUS WELPIFAO ETT HomeCare Services HOME Pellets Croato Now Patent Manage Patents Transfer Patert pm Manage Prescription Templates Orders omar ctor Sem Grete cor Stat Meise Event Example Information in the Phone Comments field is for clinic use only and is not accessible to Baxter KH 5 When you are done adding additional contacts click on Save Patient The system displays a confirmation window with a message telling you that your information has been successfully saved and that the patient has been created successfully ou has heen Manage Patente p rr rent Oana raso Example 6 Click the Create Patient s Prescription link to continue if prescription information is also required for that patient this will take you to the Prescriptions section of the system You can also get to it from the left hand navigation bar under Manage Prescriptions Also the patient s name will remain in the pending patient To Do list until the prescription is complete CREATE UPDATE PRESCRIPTION SCREEN The Creat
26. interaction between the dialysis treatment and therapy directed at other existing lesse For Example rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs digitalis toxicity may be masked by elevated potassium or magnesium or by hypocalcemia Correction of electrolytes by dialysis may precipitate signs and symptoms of digitais excess Conversely toxicity may occur at suboptimal dosages of digitali f potassium is low or calcium high Azotemie diabetics require careul monitoring of insulin requirements during and following dialysis with dextrose containing solutions Laboratory tests Serum elactroiytes magnesium bicarbonate and fuid balance shouid be periodically monitored Carcinogenesis mutagenesis impairment of fertility Studies to evaluate the carcinogenic or mutagenic potential af this product or its potential o affect fertility adversely have not been performed Pregnancy Teratogenic Effects Pregnancy Category Animal reproduction studies have not been conducted with Dianeal Low Calcium Contraindications pertoneal dialysis Solution Its aso not known whether Dianeal Low Calcium peritoneal dialysis solution None known cause fetal harm when administered to a pregnant woman or can affect reproduction capaciy Dianel Low Calcium peritoneal dialysis solution should be given to a pregnant woman i cary Warnings needed Not for Intravenous Injection Use asept
27. into the screens of the DirectAccess online tool 1 Drectaccess Home Create Update Prescription Example s Create New Patient Prescription What Do Need To Do 3 Prescrotion information Prescription tems Review Prescrpton _ 4 ot o are creating a new presrpton or patent LINGE AMT 1 The Breadcrumb shows you where in the system you are in relation to the Home screen 2 The Steps show you how you re progressing through a set of tabs on a screen 3 The Tabs show the types of information and the Icons on the tabs show whether the information is complete green checkmark or requires work red exclamation 4 The Note indicates specific information like the name of the patient you are working on and the related activity 5 The What Do I Need To Do Here link is provided on most pages Click on this link for a demonstration of how to complete the tasks on that page The link will be located in the upper right corner of the screen BUTTONS Please use the buttons on the screen to navigate rather than the buttons on the browser Example Error fields are identified in light red with an error message in red text Prescription Information indicates required field eee 1 sl PN Ries ZINKER DR TROY E eo Den EVERY 28 DAYS E oeysresene Liters Day is mandatory LitersiDay Example B CONFIRMATION M
28. it pul ring is not attached o the connector Inspect tubing and drin container for presence o solution If solution is noted discard units NOTE Small water droplets are acceptable Squeeze container to check fer leaks and broken solution frangible Note solution flow past the rangle Discard if container or solution frangible leaks because stri may be impaired Figure 2 Administration Procedure for the The Steps Refer to the Corresponding Administration Steps E M Supplemental Medication is Prescribed 1 Inspect container to ensure resealable rubber medication port isin pace Discard i rubber injection not attached to container Put on a mask Prepare medication port according to aseptic technique Using a syringe with a 1 inch long 19 to 25 gauge neede puncture resealable medication port and inject medication Position container with medication port facing upward Squeeze and tap medication port to empty solution Mix solution by vigorously agtatng container Administrator Pat on mask and wash ands Insure patent anse set ts closed Break connector range Blue by grasping the tuting above the top of the anil and puling forvard and backyard n the frangible separates trom base See Figures 1 and 2 Remove pul ing fom patient connector Remove desonnect cap frm patient transfer set mediately atach patient anster set connector to the patent connector by sth the connector un fy Secured
29. na re la 246 moe P a Faton ia Hoe at Crt JOY SEASON wiewundsie MOIO rain cs Sion Status Example Names appearing in Red have orders that will be delayed until a signed prescription is received From this screen you can View or Update the prescription Viewthe order Selecta physician to provide an eSignature for the prescription and forward the prescription to that physician View or Print the prescription Send Comments to Baxter VIEW UPDATE PRESCRIPTION 1 From the new changed prescriptions box in the To Do list click on the patient s View Update link in the Manage Prescriptions column the system displays the Create Update Prescription screen Baxter Renal Science Solutions Systems Support HomeCare Services Dre Crete te str UIT aS tne cca ni tia res rev rain TENNGTESTNO Manage Pressipiione MS iii Sow Rive em p ansam Treu riae esi ecd EXIT SD ees E gru Carina B E ee ee Sr CRC rin sta nano Du oir Remindar Cinio undergoing Luer Converrion Please tt completed Training CerfirmalionR Changs form to 14003888487 in orderfo Luer codas to be TE Example 2 Use the tabs o
30. osmosis and diffusion across the peritoneal membrane between the patient s plasma and the dialysis fluid Toxic substances and metabolites present in high concentrations in the blood cross the peritoneal membrane into the dialyzing fluid Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma creating an osmotic gradient which facilitates fluid removal from the patient s plasma into the peritoneal cavity After a period of time dwell time the fluid is drained from the cavity Indications and Usage DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis Contraindications None known Warnings Peritoneal dialysis should be done with great care if at all in patients with a number of abdominal conditions including disruption of the peritoneal membrane or diaphragm by surgery or trauma extensive adhesions bowel distention undiagnosed abdominal disease abdominal wall infection hernias or burns fecal fistula or colostomy tense ascites obesity and large polycystic kidneys Vaamonde and Perez 1977 Other conditions include recent aortic graft replacement and severe pulmonary disease When assessing peritoneal dialysis as the mode of therapy in such extreme situations the benefits to the patient must be weighed against the possible complications An accurate fluid balance record must be kept and the weight of
31. period the access device is opened the solution drained and fresh solution instilled The procedure is repeated 3 to 5 times per day 6 to 7 days per week Solution exchange volumes and frequency of exchanges should be individualized for adequate biochemical and fluid volume control Moncrief et al 1982 Twardowski et al 1983 The majority of exchanges will utilize 1 5 or 2 5 dextrose containing peritoneal dialysis solutions with 3 5 or 4 25 dextrose containing solutions being used when extra fluid removal is required Patient weight is used as the indicator of the need for fluid removal Popovich et al 1978 In the patient receives or 4 dialysis exchanges during the night which range from 2 1 2 to hours dwell duration Typically 1 5 to 2 0 liters of dialysis solution depending upon patient size are delivered each cycle by an automatic peritoneal dialysis cycler machine After the last outflow during the night an additional exchange is infused by the cycler machine into the peritoneum The equipment is then disconnected from the patient and the dialysate remains in the peritoneum for 14 to 15 hours during the day unti the next nocturnal cycle Diaz Buxo et al 1981 Combinations of 1 5 or 2 5 dextrose containing peritoneal dialysis solutions are usually used for the nighttime exchanges while 3 5 or 4 25 dextrose is used when extra fluid removal is required such as during the daytime exchange Patient Weight is used
32. recent aortic grat replacement lactic acidosis and severe pulmonary disease When assessing peritoneal dialysis as he mode of therapy in such extreme situations the benefits to the patient must be weighed against the possible complications Av accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration wth severe consequences including congestive heart failure volume depletion and shock Ater the pul ring has been removed from the out check for broken connector frangible seal evidenced by continuous fluid rom port ew drops of solution within the connector or protector cap may be present If a continuous stream or droplets of ful are noted discard solution because steriity may be impaired During solution drainage fibrin strands may be observed in the solution and may become attached to the connector frangible closure In occasional instances partial or complete obstruction of draining may occur Manipulation of the connector frangible closure in th tubing may free the fibrin obstruction Precautions General Do not administer unless solution is chear Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection Significant losses of protein amino acids and water soluble vitamins may occur during peritoneal dialysis Replacement therapy should be provided as necessary When prescribing t
33. related to treatment Drug Interactions General No clinical drug interaction studies were performed No evaluation of EXTRANEAL s effects on the cytochrome P450 system was conducted As with other dialysis solutions blood concentrations of dialyzable drugs may be reduced by dialysis Dosage adjustment of concomitant medications may be necessary In patients using cardiac glycosides digoxin and others plasma levels of calcium potassium and magnesium must be carefully monitored Insulin A clinical study in 6 insulin dependent diabetic patients demonstrated no effect of EXTRANEAL on insulin absorption from the peritoneal cavity or on insulin s ability to control blood glucose when insulin was administered intraperitoneally with EXTRANEAL However appropriate monitoring See PRECAUTIONS Drug Laboratory Test Interactions of blood glucose should be performed when Initiating EXTRANEAL in diabetic patients and insulin dosage should be adjusted if needed See PRECAUTIONS Heparin No human drug interaction studies with heparin were conducted In viro studies demonstrated no evidence of incompatibility of heparin with EXTRANEAL Antibiotics No human drug interaction studies with antibiotics were conducted In vitro studies evaluating the minimum inhibitory concentration MIC of vancomycin cefazolin ampicillin ampicilin fiucoxaciln ceftazidime gentamicin and amphotericin demonstrated no evidence of incompatibility of these antibio
34. requiring a prescriber s review and signature Annual Renewals requiring updates and a prescriber s review and signature To see the Prescriptions list click the Click Here link to display the system displays lines identifying the number of new and changed prescriptions and those requiring a renewal each with a Click Here link HomeCare Services Welcome MARY MARTI Last gin 11542 AM CiD eed Ta Here Sume dolo Cro Now rater LSM Gere agro iso dy 9 You have 14 new Re Slo hero aay Teste Pat Example NEW AND CHANGED PRESCRIPTIONS 1 Click the Click Here link to display the new or the changed prescriptions the system displays the prescriptions in a box below the link you just clicked xt Renal ns Systems Support prere p Wacome MARY ARI ton 02609 ast an snai Panis Cres neu ratent Tan bare Pana nt tre i ene ira srt ctr apy liu 2 Viu have i new Re ic fed day birra Pending Prescnptons Patents in RED have an order that will be delayed until we receve the signed prescription usage rear Fein Bafile MEDS Vie Creme d o Sie Pair ea me vci sN ie so Ven oneris MEM eme onm Summi sur m desinis o cum crea Sat emen uiarepe sor cum Sees Rar pm in me movere venama o emm ONS crm S Patents
35. services provided by Baxter New patient introduction driver introduces self explains ordering inventory count process reviews intro packet Supplies are brought to correct area of home Rotation of patients stock by Baxter Service Specialist upon request Call to patient prior to delivery indicating 3 hour delivery time window If short lead delivery 5 business days is required there may be multiple delivery shipments and the probability of having the delivery made by a Baxter Service Specialist decreases Please remember that while we strive to have commercial carriers meet our delivery requirements we cannot guarantee their delivery schedule DID YOU KNOW In 2008 almost 90 of our customers ranked willingness to have this driver or other carrier make future Baxter deliveries in the top two box satisfaction levels on a 9 point scale through our automated telephone surveys INITIAL ORDER PLACEMENT Several orders may be placed at the time of initial set up Initial Order to the patient containing solution ancillaries i e gauze and supporting product i e caps or lines Starter Kit to the patient or unit i e IV pole scale or BP cuff Training supplies to the patient or unit following your established contract Hardware to the unit i e HomeChoice APD system Templates are available in the DirectAccess online tool to customize prescriptions based on your clinic s needs DID YOU KNOW If you are plac
36. solution by vigorously agitating container Administration Put on mask and wash hands Insure patent transfer st i closed Break connector frangible bue by grasping the tubing above he top of the frangible and puling forward and backward unti the frangible separates from base See Figures 1 and 2 Remove pul ring the patient connector Remove disconnect cap from patient transfer set Immediately attach patient transfer set connector to the patient connector by twisting the connector until firmly secured amp solution lire Break solution frangible green by grasping the tubing above the top of the frangible and puling forward and backward unti the frangible separates See Figures and 4 Hang the new solution container Place the drainage container below the level of the peritoneum Open transfer set clamp to drain solution from peritoneum Warming During solution drainage fibrin strands may become attached to the connector frangible closure Manipulation of the connector frangible closure in the tubing may free any fibrin obstruction that occurs 11 Close transfer set ine camp after drainage is complete 12 Open solution ine cam tne new Soliton to into the drainage container for 5 seconds to prime line 13 Camp drain ine 14 Open transter set clamp and allow the solution to flow into the peritoneum 15 Close transfer set camp when infusion is complete 16 Prepare a new disconnect cap
37. the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure volume depletion and shock Excessive use of DIANEAL Low Calcium peritoneal dialysis solution with 3 5 or 4 25 dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors as well as other indicators of patient status In some patients calcium carbonate is used as a phosphate binder Because serum calcium levels have been observed to be elevated in these patients Slatopolsky et al 1986 the calcium concentration of DIANEAL Low Calcium peritoneal dialysis solutions has been reduced to 2 5 mEq L Serum calcium levels should be monitored and if low the amount of oral calcium carbonate phosphate binder may be increased or peritoneal dialysis solutions containing higher calcium concentrations may be used If serum calcium levels rise adjustments to the dosage of the calcium carbonate phosphate binder and or vitamin D analogs should be considered by the physician Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated Nolph et al 1981 the magnesium concentration of this formulation has been reduced to 0 5 mEq L Average plasma magnesium levels have not been reported for chronic
38. the primary phone number contact provided to Baxter s Services should be called Selecting Call clinic indicates the cycler was brought to the dialysis unit and you d like to be contacted for pickup arrangements Selecting Other indicates you would like to make other arrangements Use the text box to enter the appropriate information such as contact name e g in the event the patient is deceased or alternate phone numbers e g nursing home number spouse family cell phone numbers etc The text box can only be used when the Other radio button is selected 2 If you are providing information in the Contact Details box you do not need to provide an explanation or reason for the hardware pickup APD PATIENT DISPOSABLES PICKUP Next the system displays the Disposables Pickup Confirmation dialog Disposable Pickup Confirmation this fee select cancel There is a 95 fee to accept this fee select continue to decline 1 Click either Continue or Cancel By selecting Continue you agree to the 95 00 pickup fee and request Baxter s HomeCare Services to contact the patient or family and make appropriate arrangements By selecting Cancel you tell the system that you ve made prior arrangements with the patient to dispose of remaining disposable products If you click Cancel no arrangements will be made by Baxter HomeCare Services If you click Continue meaning that you agre
39. work surface where you set your PD supplies before starting your exchange use the technique that you were shown in your peritoneal dialysis training to prevent contamination with bacteria aseptic technique when making connections It you use a manual method of peritoneal dialysis infuse EXTRANEAL over 10 to 20 minutes at a rate that is comfortable for you When you drain the fluid after the dwell check the drained fluid for cloudiness or fibrin Fibrin looks like clumps or stringy material in the drained solution Cloudy drained fluid or fibrin may mean that you have an infection Call your doctor if your drained fluid is cloudy or contains fibrin Regularly check and write down your fluid balance and weight to avoid having too much or too litte fluid in your body over hydration or dehydration This can help lessen the chance of serious side effects such as heart failure and shock Call your dialysis center or doctor if you need more help or have any questions Ifyou infuse too much EXTRANEAL your stomach area abdomen may look large and you may feel full or feel short of breath If this happens drain the EXTRANEAL solution from your peritoneal cavity Talk to your doctor before adding any other medicines to EXTRANEAL Throw away any unused EXTRANEAL Do not use your EXTRANEAL solution more than one time BAR CODE POSITION ONLY 071960827 What are possible side effects of E
40. 10 HomeCare Services DrectAecoss ome Welcome MARYMARTH Lastlogin 14409 2157 17 PA Wii Do oed To Da Hare Patents DE Crese New Patent ste 1 pena Cis ato day Manage Parts ve pais Ine ace e cheie n BEA o display e Sart oronge i hats toata Maraoo Presenmons Manage Preserinton Tomsiies 21 1 see list of deactivated physicians whose patients need to be reassigned click the Click Here link to display the system displays the physicians i e Inactive Prescribers in a box below the link you just clicked HomeCare Services omo come MUR MANI Lasting V A Z6 E Who Nen To Do Hore ciere Hew Paten ose anna serre Cheb eno Manage Patents Transfer Patent nape Presenter erage Praetor Temple ars ser manere stan Example 2 Click on the physician name to update Prescriber the system displays the list of patients requiring a new attending physician HomeCare Services View Unite Pint Hone Wacom Paten MARTI Clase Manage Pales cau ay Transtar Pon Manage Pongo nr ten ManageFrescrplon Temple Orders Chi pr Manage Stat een SE mar m Resots Na rave antes cosine st the pie cube KPI number see RP bare in the NPI database Pesce der n reco this mall
41. 15 25 m too NDC 0041 0415 28 cron o on on Ho Baxter Dianeal Ambu Flex and PL 146 are trademarks of Baxter Healthcare Corporation Deertield IL 60015 USA Dextrose Hydrous USP Copyright 1981 1982 1983 1984 1989 2008 0 Glucopyranose monohydrate Baxter Healthcare Corporation Printed in USA All rights reserved 07 19 59 178 2008 11 BAR CODE POSITION ONLY 071959178 07 19 60 956 DIANEAL Low Calcium Peritoneal Dialysis Solution AMBU FLEX Container For Peritoneal Dialysis For intraperitoneal administration only Description DIANEAL Low Calcium peritoneal dialysis solutions in AMBU FLEX containers are sterile nonpyrogenic solutions for intraperitoneal administration only They contain no bacteriostatic or antimicrobial agents or added buffers Composition calculated osmolarity pH and ionic concentrations are shown in Table 1 Potassium is omitted from peritoneal dialysis solutions because dialysis may be performed to correct hyperkalemia In situations in which there is a normal serum potassium level or hypokalemia the addition of potassium chloride up to a concentration of 4 mEq L may be indicated to prevent severe hypokalemia Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician Frequent monitoring of serum electrolytes is indicated In some patients calcium carbonate is used as
42. 1981 Continuous ambulatory peritoneal dialysis in pediatrics J 8 11 13 44 Kim D et al 1984 Continuous ambulatory peritoneal dialysis with three liter exchanges a prospective study Peritoneal Dial Bull 4 82 85 La Greca G et al 1980 Acid base balance on peritoneal dialysis Clinical Nephrology 16 1 1 6 Mattocks A M and El Bassiouni 1971 Peritoneal dialysis a review 1 Pharm Sci 60 1767 1782 Moncrif J W et al 1982 CAPD Are three exchanges per day adequate J 9 39 43 Nolph K D etal 1981 Considerations for dialysis solution modifications In Peritoneal Dialysis eds Robert Atkins et al Chapter 25 New York Churchill Livingston Popovich R P et al 1978 Continuous ambulatory peritoneal dialysis inn Intern Med 8 449 456 Potter DE et al 1981 Continuous ambulatory dialysis CAPD in children Trans Am Soc Artit intern Organs 27 64 67 bot S etal 1966 Complications of peritoneal dialysis Am Med Sel 252505 Slatopolsky E et al 1986 Calcium carbonate as a phosphate binder in patients with chronic renal failure undergoing dialysis NEJM 3 315 157 160 Twardowski 2 1 and Janicka L 1981 Three exchanges with a 2 5 liter volume for Continuous ambulatory peritoneal dialysis Kidney Int 20 281 284 Twardowski 7 1 et al 1983 High volume low frequency continuous ambulatory peritoneal dialysis Kidney Int 23 64 70 Twardowski 2 1 and Burrows L 1984 Two year experien
43. 5505D and 55505E only 34 Dialysis Facility Total Year to Date Total Dialysis Facility dollars for year to date YTD on reports 55505A 555050 and 55505E only 35 Dialysis Facility Total Current Month Total Dialysis Facility dollars for current month on reports 555050 and E APPENDIX SIMPLE Report A2 Baxter 3 SSSOSA SIMPLE Report Date 1 11 08 Home Patient Customer Service 4 November 2007 5 Time 13 17 58 2 1 800 284 4060 Pagos d Patient Detail 7 Facility ie 12345678 8 Facility Name Kidney Dialysis Unit 3 Phone 123 456 7890 10 Teritory 1111 11 HPSR Name Molly Representative 38 Phone EXT 0000 48 Patient Name Annerp Mary Active Date 00 13 2007 19 SB Max 99 CA Patient Number 87654321 17 Inactive Date 15 Mode APD Hosp Center SO RX Expiration Dale 1025 2008 2 24 26 20 20 Product Descipiongs On SO Order Extended Actual Order Invoice Summary Quanitico VID Code SO RX Price Ship Dale 427 a DecbNovCOa 2007 RX Date 20072007 2007 2007 Dollars 559876 2S PD2UB2L2LDNL SCA CA 99999 99992007 22222222 99990007 99 99 99 999CA 939599 559896 425 PD2UB2LALDNL 99CA CA 99999 99992007 22222222 99992007 99 99 99 999CA 999999 Dec B Total mer YTD 5B 999 CA SCAWGP wmacarpisconsecrwove 9CA SCA 99999 99 99 2007 22222222 99 99 2007 lIIII 9 99 99 CA 999999 5K7792 GLYLATEX
44. 9 99 999 CA 999 5 4466 MINICAP DISCONNECT WPVE 60CA CA 999 99 999 CA 9999 7792 GLV LATEXNISLG FA 100 PK 9 EA 99999 999 EA p SK8070 MASK YELLOW ELASTIC lt S0 BX 999 EA 99999 999 EA 999 25 Facility Total 999999 999 999 APPENDIX RN Patient Training Checklist B Patient Inventory Management Emphasize the importance of good inventory management with the patient Establish that the patient is expected to work with Baxter and the unit to maintain appropriate supply levels in their home Review inventory management procedure with patient Onor near the date of order placement the patient must take an ACCURATE and complete inventory of all UNOPENED boxes including reserve boxes and document the count on the inventory form During order placement the patient must provide the information from the completed inventory to their HOSR During order placement the patient also must provide their Baxter HCSR with their daily solution usage and any variations which can also be captured on the inventory form Review proper product stocking levels with patient Upon delivery the patient should have enough product to get them to their next scheduled delivery date plus a reserve stock to compensate for usage changes and or other emergencies patient thinks they may not have enough product to get them to their next delivery date they should call their HCSR immediately Instruct the patient to call their
45. ESSAGES When you complete a process the system provides a confirmation window telling you the results of your action e g that your information has been successfully saved The system may also provide you with links to additional system functions Baxter Renal Science Solutions Systems Support ESS Hema Mavs Paint Example ar information hes en saved Patent Paier Bam o Create Nem Part are metre Marace Patents pum Tender sint A CANCELS The system allows you to cancel a process prior to a Save by clicking the Cancel button For additional assistance at any time please feel free to contact the DirectAccess technical support team at 1 800 284 4060 Create New Patient A 8 Services Create New Patient THE FOLLOWING STEPS WILL GUIDE YOU IN CREATING A NEW PATIENT Log on to the DirectAccess online tool From the left navigation bar select Create New Patient ale Renal E EUTMYPRUTLE CONTACTUS HELPFAQ LOGOFF EE ICI Solutions Systems Support HomeCare Services Tirechecess Home HOME Welcome TESTERFOUR failed login attempts since 7290 125539 PM What Do Need To Do Here 223 m Create New Patent n You have ieri gue a sone Cc ae od whe hove net piedi shedied ore 28 rte ds Ck recto Transfer Patent n You have 1 Fens dirne Ser Cc arto M
46. Example Cite superi Luci Donon Please fas capete Tani Cenfmalio Rs henge 10 tiled ty pater 11 Review the prescription and return to the Prescription Items tab by clicking Previous if you need to make a correction When you are done click Save HomoCaro Services HOME Create New Patent Manage Patients Transfer Pationt Manage Prescriptions Manage Preccnpton Templates Orders Ordor Hictoy Create star Menage Stafi odes tr TESTING TESTING pe Onder Query Loca tea ue NEAL scat masoticomier CAP Piane order enough spes to get tne pain hunt ne echeted very ee Please send the following order lo deliver to the patients home by tha 23 o the month want delivery on tho Baxtor trucks Thanks Chris Jones RN Example CREATE UPDATE PRESCRIPTION SCREEN INITIAL ORDER SCREEN The system displays the Initial Order screen HomeCare Services ere creser Ponton Patients Sainte has cash eat o prezent ce LOUIE pectin regis e pese signo Clot nere to qo to mero Torno Temolates Saas template su activa praseripten Rame can be savad ae revr po gt 22 Example 12 Enter instructions for HomeCare Services what to send for the patient s firs
47. HCSR whenever their prescription changes or when their solution strength usage changes significantly to help avoid potential stockout situations Communicate the importance of adhering to the order and delivery schedule that Baxter supplies to each home patient Emphasize the importance of keeping supplies as close together in the home as possible The drivers need to see all the supplies to ensure optimal inventory levels are maintained Success of this program requires commitment from Baxter the dialysis unit staff and the patient APPENDIX Home Patient Inventory Form B La er The Original HOME PATIENT INVENTORY FORM Date Supplies Are Counted Next Count Date Please count and enter in the appropriate space below the number of full cases on hand and usage Be sure to include your reserve stock in your count and to notify Baxter of any usage changes OPES On On On On On On Dialysis Solution Hand Usage Hand Usage Hand Usage Hand Usage Hand Usage Hand Usage Hand Usage On Yellow 1 5 Green 2 5 Red 4 25 Purple 7 5 Other Supplies Caps Cassettes Cycler Tubing Drain Line Patient Extensions Y Sets Supplies should be stored in the Notes following manner Atroom temperature Avoid excessive heat or freezing Avoid insect rodent infestation Avoid liquid contamination Store
48. IPD and CCPD patients Serum magnesium levels should be monitored and if low oral magnesium supplements oral magnesium containing phosphate binders or peritoneal dialysis solutions containing higher magnesium concentrations may be used Because average serum bicarbonate levels in some chronic CAPD patients et al 1981 some chronic IPD patients La Greca et al 1980 and some chronic CCPD patients Diaz Buxo et al 1983 have been observed to be somewhat lower than normal values the bicarbonate precursor lactate concentration of DIANEAL Low Calcium peritoneal dialysis solutions has been raised to 40 mEq L Serum bicarbonate levels should be monitored Not for use in the treatment of lactic acidosis Potassium is omitted from DIANEAL Low Calcium peritoneal dialysis solutions because dialysis may be performed to correct hyperkalemia Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician The use of 5 or 6 liters of dialysis solution is not indicated in a single exchange Refer to manufacturer s directions accompanying drugs to obtain fll information additives If the resealable rubber plug on the medication port is missing or partially removed do not use product if medication is to be added After the pull ring has been removed inspect connector of solution container or fluid flow A few drops of solution within the connector or pul
49. NEAL or icodextrin have not been conducted Icodextrin is derived from maltodextrin a common food ingredient A fertility study in rats where males and females were treated for four and two weeks respectively prior to mating and until day 17 of gestation at up to 1 5 O ko day 1 3 the human exposure on a mg m basis revealed slightly low epididymal weights in parental males in the high dose group as compared to Control Toxicological significance of this finding was not evident as no other reproductive organs were affected and all males were of proven fertility The study demonstrated no effects of treatment with icodextrin on mating performance fertility response embryo fetal survival fetal growth and development Pregnancy Pregnancy Category Complete animal reproduction studies including in utero embryofetal development at appreciable multiples of human exposure have not been conducted with EXTRANEAL or icodextrin Thus it is not known whether icodextrin or EXTRANEAL solution can cause fetal harm when administered to a pregnant woman or affect reproductive capacity EXTRANEAL should only be utilized in pregnant women when the need outweighs the potential risks Nursing Mothers Itis not known whether icodextrin or its metabolites are excreted in human milk Because many drugs are excreted in human milk caution should be exercised when EXTRANEAL 15 administered to a nursing woman Pediatric Use Safety and effectiveness
50. NSLGEA M 9EA 99999 99992007 22222222 9999200711111 999 999 999 9999 999999 SKS070 FACEMASRVEILOVELASTIE OEA 0 0 99 999 EA 999999 Patient Total Current Month Dollars 999999 39 Patient Total YTD Dollars 9999999 Baxter 1 585058 SIMPLE Report Date 1 11 08 Home Patent Customer Service November 2007 5 Time 13 178 2 1 800 284 4060 11 01 07 11 31 07 m Patient Summary 7 Facility 12345678 8 Facility Name Kidney Dialysis Unit 9 Phone 123 456 7890 10 Territory 111 16 17 n Dollars Invoiced a 13 Patient Active Inactive gg Dee Nov Qi e Qi YID 14 NameNbr Date Date 2007 2007 2007 2007 2007 2007 2007 2007 ANNERP MARY 999999 99939 9 99999 99 999 90 999 87654321 02 13 2007 SMITH BRIAN 239090 999999 9 99999 D o D 99 999 99 999 55544433 05 18 2007 ASCOT STEVE oo 00 9 999 99 D 9999 9 999 22233344 02 05 2007 11 0 2007 35 Facility Toul 9999900 9999999 9929909 D o o 999 999 34 990 999 1 sssosA SIMPLE Report Date 1 11 08 Home Patient Customer Service 4 November 2007 8 Time 13 17 58 2 1 800 284 4060 4a 11 01 07 11 31 07 Pages d Product Summary 7 Facility 4 12345678 8 Facility Name Kidney Dialysis Unit 9 Phone 123 486 7800 10 Territory 1111 December vm Product Description 21 Pack Esa 5 2 Code Factor 30a Quantity 33 Dollars Invoiced Quantity Dollars Invoiced 589876 255 PDUB2L2LDNL 6 99 CA 9929 999 CA 9 999 589896 225 02 UBIL2L DNL CA 99 CA 99
51. XTRANEAL EXTRANEAL can cause serious side effects including See What is the most important information should know about EXTRANEAL Serious allergic reactions Tell your doctor or get medical help Tight away if you get any of these symptoms of a serious allergic reaction during treatment with EXTRANEAL swelling of your face eyes lips tongue or mouth trouble swallowing or breathing skin rash hives sores in your mouth on your eyelids or in your eyes your skin blisters and peels Common side effects of EXTRANEAL include infection in the peritoneal cavity peritonitis Peritonitis is common in people on peritoneal dialysis Tell your doctor right away if you have any pain redness fever or cloudy drained fluid high blood pressure nausea headache swelling stomach area abdomen pain gt chest pain increased cough upset stomach flu like symptoms high blood sugar These are not all the possible side effects of EXTRANEAL For more information ask your doctor or dialysis center Call your doctor for medical advice about side effects You may report side effects to FDA at 1 800 FDA 1088 How should store EXTRANEAL Store EXTRANEAL at 68 F to 77 F 20 to 25 Keep EXTRANEAL in the moisture barrier overpouch in the carton until ready to use Do not warm EXTRANEAL above 104 F 40 Do not freeze EXTRANEAL General information about EXTRANEAL Medicines are so
52. a conduit into the peritoneal cavity With the exception of lactate present as a bicarbonate precursor electrolyte concentrations in the fluid have been formulated to attempt to normalize plasma electrolyte concentrations resulting from osmosis and diffusion across the peritoneal membrane between the plasma of the patient and the dialysis fluid Toxic substances and metabolites present in high concentrations in the blood cross the peritoneal membrane into the dialyzing fluid Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma creating an osmotic gradient which facilitates fluid removal from the patient s plasma into the peritoneal cavity After a period of time dwell time the fluid is drained from the cavity Indications and Usage Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate Vaamonde and Perez 1977 It may also be indicated in the treatment of certain fluid and electrolyte disturbances and for patients intoxicated with certain poisons and drugs Knepshield et al 1977 However for many substances other methods of detoxification have been reported to be more effective than peritoneal dialysis Vaamonde and Perez 1977 Chang 1977 Contraindications None known Warnings Peritoneal dialysis should be done with great if at all in patients with a number of abdominal conditions inc
53. a Manage Prescription E Unassionea 118096 55 95 AM Ries JAMESON Unassigned hache pu asta Orders cen suse Physician Ade 2 nesca Order History menm Many Ste administrator Ade 102000175851 4M Deactivate w rzn Unasigned Hase T4818 701 40 AM ss ROGERS ani p Physician Actie Eit Manage Stafi 1 Aeresuls found disolaring aljresuts Example 2 To change the status click on Activate or Deactivate in the Options column 3 The system asks you to confirm the change click YES to continue or NO to cancel 4 When you activate a staff member you must also assign their role within the center After you activate the staff member the system displays the Edit Staff Member screen 5 Click the radio buttons to assign the staff member to another role and click Save the system assigns the new role of the activated staff member Note that the current status is displayed in red or green in the Status column VIEW A LIST OF PATIENTS ASSIGNED TO A STAFF MEMBER 1 To view a list of patients assigned to a particular staff member click on Manage Patients in the navigation bar on the left the system displays the Search Patients box OFILE CONTACTUS HELPIFAQ LO EST CLINIC B HomeCare Services DiectAccess Home Manage Patien
54. a phosphate binder Because serum calcium levels have been observed to be elevated in these patients Slatopolsky etal 1986 the calcium concentration of DIANEAL Low Calcium peritoneal dialysis solutions has been reduced to 2 5 mEq L Serum calcium levels should be monitored and if low the amount of oral calcium carbonate phosphate binder may be increased or peritoneal dialysis solutions containing higher calcium concentrations may be used If serum calcium levels rise adjustments to the dosage of the calcium carbonate phosphate binder and or vitamin D analogs should be considered by the physician Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated Nolph etal 1981 the magnesium concentration ofthis formulation has been reduced to 0 5 mEq L Average plasma magnesium levels have not bean reported for chronic IPD and CCPD patients Serum magnesium levels should be monitored and if low oral magnesium supplements oral magnesium containing phosphate binders or peritoneal dialysis solutions containing higher magnesium concentrations may be used Because average serum bicarbonate levels in some chronic patients Nolph et al 1981 some chronic IPD patients La Greca et al 1980 and some chronic patients Diaz Buxo et al 1983 have been observed to be somewhat lower than normal values the bicarbonate precursor lactate concentration of DIANEAL Low Calcium peritoneal dialy
55. agnesium levels The decrease In magnesum levels did not cause nica Sint hypomagnesemia Indications and Usage Dianeal Low Calcium peritoneal dialysis solutions in UltraBag containers are indicated for use in chronic renal failure patients being maintained continuous ambulatory peritoneal dialysis when nondiaytc medical therapy is judged be inadequate Ater the pul ring has been removed from the outlet check for broken connector frangible seal evidenced by continuous fluid low from port A few drops of solution within the connector or protector cap may be present continuous stream or droplets of fuid are noted discard solution because sterility may be impaired During solution drainage fibrin stands may be observed in the solution and may become attached to the connector frangible closure In occasional instances partial or complete obstruction of draining may occur Manipulation of the connector frangible closure in the tubing may fre the frin obstruction Precautions General Do not administer unless solution is clear Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibly of infection Significant losses of protein amino acids and water soluble vitamins may occur during peritoneal dialysis Replacement therapy should be provided as necessary When prescribing the solution to be used far an individual patient consideration should be given to the potential
56. ainer If continuous fluid flow from connector is observed discard solution container 4 Remove tip protector from tubing set and immediately attach to connector of the solution container 5 Continue with therapy set up as instructed in user manual or directions accompanying tubing sets 6 Upon completion of therapy discard unused portion References Diaz Buxo JA at al 1981 Continuous cyclic peritoneal dialysis a preliminary report Int Soc Artif Organs 81 157 161 Diaz Buxo JA at al 1983 Observations on inadequate base buffer concentrations in peritoneal dialysis solutions ASAIO Abstracts 43 Furman et al 1978 Activity of intraperitoneal heparin during peritoneal dialysis Clinical Nephrology 9 15 18 Irwin et al 1981 Continuous ambulatory peritoneal dialysis in pediatrics J 8 11 13 44 Kim D et al 1984 Continuous ambulatory peritoneal dialysis with three Iter exchanges a prospective study Peritoneal Dial Bull 4 82 85 La Greca G et al 1980 Acid base balance on peritoneal dialysis Clinical Nephrology 16 1 1 8 Mattocks and El Bassiouni E A 1971 Peritoneal dialysis a review 1767 1782 dt 1982 CAPD Are thre exchanges per day adeguate Nolph K D et al 1981 Considerations for dialysis solution modifications In Peritoneal Dialysis eds Robert Atkins et al Chapter 25 New York Churchill Livingston Popovich R P et al 1978 Continuous ambulatory
57. al dialysis solutions in AMBU FLEX containers are sterile solutions for intraperitoneal administration only They contain bacteriostatic or antimicrobial agents or added buffers Composition calculated osmolarity pH and ionic concentrations are shown in Table 1 Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia In situations in which there is a normal serum potassium level or hypokalemia the addition of potassium chloride up to a concentration of 4 mEq L may be indicated to prevent severe hypokalemia Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician Frequent monitoring of serum electrolytes is indicated Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated Nolph et al 1981 the magnesium concentration of this formulation has been reduced to 0 5 mEq L Average plasma magnesium levels have not been reported for chronic IPD and patients Serum magnesium levels should be monitored and if low oral magnesium supplements oral magnesium containing phosphate binders or peritoneal dialysis solutions containing higher magnesium concentrations may be used Because average serum bicarbonate levels in some chronic CAPD patients Nolph et al 1981 some chronic IPD patients La Greca et al 1980 and some
58. alable rubber plug on the medication portis missing or partially removed do not use product After removing overpouch check for minute leaks by squeezing container firmly leaks are found discard th solution because the sterility may be impaired aE Conese i 5 Hi Sp ESTS 2 il Biel ib ndisse vi 8 i ig 1 B i isa 2183 53 42 81 3 3 8 3 pem m mm a as sa a tas ao tse 2s os ao RE IB set Wien RN 25 EM Roms I ENE NE IB nouta pm m CS a as soa ma soe ao ue 2s os fos ao Sore ic m wm Da m mu Bs em ENE Bost Dana Lo a m ai seems a soa no sos a re 2s os fos o S Be Soe BES m wm Pa 25 2 SR mn E Se aie EX ROSE The plastic container tubing set is fabricated from polyinyl chloride PL 146 Plastic Exposure to temperatures above 25 C 77 F during transport and storage will lead to minor losses in moisture content Higher temperatures lad to greater losses It s unlikely that these minor losses wil ead to clinically significant changes within the expiration period The amount of water that can permeate from inside the Solu
59. also clear your intemetbrowser cache ater out Renalinte Dexter Renal Renel Product Baxter Example Enter your user name and password and click LOGON NOTE Remember that your user name and password are case sensitive NAVIGATION The system displays the Home Page of the DirectAccess online tool Baxter Renal Science Solutions Systems Support nance cumc promte CONTACTUS Losorr ORECTACCESSTEST HomeCare Services 1 HOME Welcome MARY MARTH Lastiogin 40 4100 1 5404 PM What o ined ToDo Here Patents RS Create Nen Patent You ave 1 Penda Fere Cici here o dep You have 17 Preserptions that require physicians signature Click here to display You nave 1 patents who have not placed ther scheduled erder to display Transter Patent Vou have 2 Steff changes Clik here to display Manage Patents Manage Presciptions Roporte Manage Prescription compie Templates Pease review the reports rom your Left Hand Navigation to ensure accuracy orders Order Histon ser Example Create St 3 Manage Staff E Adverse Event Repers Patients Who Are On Held Patients Who Have Not Placed An Order eign Status EXTRANEAL SCREEN LAYOUT 1 Basic Menu Options At the top are basic menu options This includes a Change Clinic option which is only available if you have access to multiple clinics The name of the clin
60. amus esiste rt Rs ute m pm ce m 5 m 5 a Transfer Patent PR 20 N E Fendi Vanago Prestan HN NI que estates Vanaje Preston P LOS FER Mc aaae an or ve ent orders EE diras ncm anu 2 FE Order Hai CON NEM NC NN pm ES E 3 a Vento te ers E Em reso 6 Vonage af Example 2 Click the View Update for the patient whose modality you wish to change the system displays the Prescription Information tab of the Create Update Prescription screen maton 8 Perm rre eve cio OD L fair ti mapa po TESTING TESTING De es Tesi Er ur me Tees 208 Preserigiion Information 00 m sce 7 no Beaw eese lisse essa ame mate TT EXTRANEAL ecc eric NU DDR added fa pallens pasion Example e Change the Therapy Mode using the Therapy Mode drop down the Therapy Change window appears with a message stating Changing the therapy will inactivate the current prescription and a new prescription will need to be created gt aS M Palome Prescription Information Prescinisctiems Review Prescription E rile MO sa e Manage Prescriptions me
61. anage Freserigtions Manage Frescicion Templates Example There are only three steps to setting up a new patient The Basic Info tab displays first Complete all of the fields and click Next to continue or Cancel Create to end the process Science Solutions Systems Support Praa LOGOFF Rena Passport Select Ej eme p DrectAccess Home gt Create Patient Basic into Denoarephic nto GQ Actitional Contacts j Hote Please enter the patient indicates required feld gary 1 01 57 date tame E Pane pe Firot Therapy Mode cacorirostto as TT mer ras TT TT lemn ete LEASE SELECT state Example Click on What Do I Need To Do Here for additional help This help option is located on each tab The Demographic Info tab displays Complete all of the fields and click Next to continue or Cancel Create to end the process The note tells you what patient you are entering Science Solutions Systems Support Iena Rena Passport TEST Demographic into conie _ What Do Need To Do Here 279 whe information tor pati vvv Gender Mole Female Diabetic statue TT E Example
62. are Services Drect ccess Home Manage Patients Search Resuts View Update Patient HOME Basic info Demograpricinfo Additonal Contacts 4 What Do Need To Do Pavenis Note You are eating pater MASTERS DENNIS Create New Patent naetesrecurea fes Manage Patiente Phone number ics Tem Co 174 2 55 55 Manage Prescriptions Firetilame EEE Therapy Mode a Manage Prescription geni Care Of Post Attending Template nding E Orders Delivery ratent pil io ORECTACCESS TESTE z order Histor Address Sta au se AIME ACTIVE Create Stat mx E Accouninumbor Manage Stan Averse Event Example 4 Select Inactive from the Status drop down and click Save The system displays the Loss Reason dialog HomeCare Services Lireethocsea Home gt Manage Patiente Search Roeulte HOME Patient search results Patients Lastilame Firstilame MI Status DOB Aecountile Edit Create New Patient MASTERS 3 Acive 90920925 View Update Calendar Assign Sar Manage Patients One result feund LEKEI Transfer Patient Manage Frescriptons Example 5 Select the appropriate Loss Reason from the list and click Save The system confirms the change click Ok UNSIGNED PRESCRIPTION In the situation where the patient you are inactivating has an u
63. as the indicator of the need for fluid removal Popovich et al 1978 so therapy should be individualized according to the patient s need for ultrafiltration Itis recommended that adult patients being placed on chronic peritoneal dialysis or in the case of pediatric patients the selected caretaker as well as the patient when suitable should be appropriately trained in a program which is under the supervision of a physician Training materials are available from Baxter Healthcare Corporation Deerfield IL 60015 USA to facilitate this training How Supplied DIANEAL PD 2 peritoneal dialysis solutions in AMBU FLEX Il and AMBU FLEX II containers are available in nominal size flexible containers with fill volumes and dextrose concentrations as indicated in Table 1 Ali DIANEAL PD 2 peritoneal dialysis solutions have overfils which are declared on container labeling Exposure of pharmaceutical products to heat should be minimized Avoid excessive heat It is recommended the product be stored at room temperature briet exposure up to 40 C 104 does not adversely affect the product Directions for Use Use aseptic technique For complete system preparation see directions accompanying ancillary equipment Peritoneal dialysis solutions may be warmed in the overpouch to 37 C 98 6 F to enhance patient comfort However only dry heat for example heating pad should be used Solutions should not be heated in water due to an increa
64. ation process may be observed This does not affect the solution quality or safety and often leave a slight amount of moisture within the overwrap Inspect for Container Integrity Inspect the container for signs of leakage and check for minute leaks by squeezing the container firmly Adding Medications Some drug additives may be incompatible with EXTRANEAL See DOSAGE AND ADMINISTRATION section for additional information If the Te sealable rubber plug on the medication port is missing or partly removed do not use the product if medication is to be added 1 Put on mask Clean and or disinfect hands 2 Prepare medication port site using aseptic technique 3 Using a syringe with a 1 inch long 25 to 19 gauge needle puncture the medication port and inject additive 4 Reposition container with container ports up and evacuate medication port by squeezing and tapping it 5 Mix solution and additive thoroughly Preparation for Administration 1 Put on mask Clean and or disinfect hands 2 Place EXTRANEAL on work surface 3 Remove pull ring from connector of solution container If continuous fluid flow from connector is observed discard solution container 4 Remove tip protector from tubing set and immediately attach to connector of solution container 5 Continue with therapy set up as instructed in user manual or directions accompanying tubing sets 6 Upon completion of therapy discard any unused por
65. away from chemicals Name To place your order call 1 800 284 4060 Ea Baxter Renal PD Solutions Ambuflex Luer Lock SYS Bag Codes PD Solutions LITER DIANEAL DIANEAL EXTRANEAL SIZE PD 2 LOW CAL icodextrin Refer to Appendix E for Baxter s PD Solution package inserts Luer Disposable Set Codes DESCRIPTION LUER CODE NUMBER 3 Prong Integrated Set L5C4531 4 Prong APD Set R5C4479C Low Recirculation APD Set N5C8305C 5 Prong Manifold Set 200 mm L5C4446 UltraSet Disposable Disconnect Y Set L5C4366 Baxter PD Solution Package Inserts EXTRANEAL icodextrin Peritoneal Dialysis Solution Dangerous Drug Device Interaction Only use glucose specific monitors and test strips to measure blood glucose leves in patients using EXTRANEAL icodextrin Peritoneal Dialysis Solution Blood glucose monitoring devices using glucose dehydrogenase pytolquiolnequnone GOH POQ or gucose dye oxidoeductas GDO ased methods must not be used In addition some blood glucose monitoring systems using glucose dehydrogenase flavn adenine dinucleotide GDH FAD based methods must not be used Use of GDH PQQ GDO and GDH FAD based glucose monitors and test strips has resulted in falsely elevated glucose readings due to the presence of maltose see PRECAUTIONS Drug Laboratory Test Interactions Falsely elevated glucose readings have lod patients or health care providers to withhold treatment of hypoglyc
66. cation Additives may be incompatible If the resealable rubber plug on the medication port is missing or partially removed do not use product if medication is to be added 1 Put on mask Clean and or disinfect hands 2 Prepare medication site using aseptic technique 3 Using a syringe with a 1 inch long 19 to 25 gauge needle puncture resealable medication port and inject medication 4 Position container with ports up and evacuate the medication port by squeezing and tapping it 5 Mix solution and medication thoroughly Preparation for Administration 1 Put on mask Clean and or disinfect hands 2 Place solution container on work surface 3 Remove pull ring from connector of the solution container continuous fluid flow from connector is observed discard solution container 4 Remove tip protector from tubing set and immediately attach to connector of the solution container 5 Continue with therapy set up as instructed in user manual or directions accompanying tubing sets 6 Upon completion of therapy discard unused portion References Diaz Buxo JA et al 1981 Continuous cyclic peritoneal dialysis a preliminary report Int Soc Artif Organs 81 157 161 Diaz Buxo JA et al 1983 Observations on inadequate base buffer concentrations in peritoneal dialysis solutions ASAIO Abstracts 43 Furman et al 1978 Activity of intraperitoneal heparin during peritoneal dialysis Clinical Nephrology 9 15 18 Irwin M A et al
67. ce with high volume low frequency continuous ambulatory peritoneal dialysis Peritoneal Dial Bull 4 567 Vaamonde and Perez 6 0 1977 Peritoneal dialysis today Kidney 10 Table 1 LE Ho agi a ae lila a 8 Fill Container ii E lis volume Ser 15 FEE HIP mL Code noe z 55 3 EH ds 8 11 mm SE m sum mo E ie AZ 1 5 Dextrose 65 5000 6000 1584826 ND 0941 0409 07 rums FEM 1500 2000 589715 NDC 0941 0409 45 2 m SR VENE E pos men m E m mnt Ex qs wies fae diss E B E ROSI 25 Dextrose 65 5000 6000 1585202 NDC 0941 0457 05 Er S m 1500 2000 589726 NDC 0941 0457 45 5 2 ERE BS Eo diss EIS x Mera 58 5000 5000 585202 NDC 0841 0457 25 6000 6000 589771 NDC 0941 0457 28 pies rom i tion as ou foa me sos os fos scorse 35 Dextrose 9 mm 65 sE gms 4 25 Dextrose 65 5000 6000 NDC 0941 0459 05 ir EER H ap DAMEN 1500 2000 589745 NDC 0941 0459 45 Hiis 5 ES E B ejajajs eds mS m Loc 425 Dee sa 5000 5000 585008 NDC 0841 0458 25 6000 6000 589772 NDC 0941 0459 28 M Dextrose Hydrou
68. d discoloration prior to administration whenever solution and container permit The mode of therapy Intermittent Peritoneal Dialysis IPD Continuous Ambulatory Peritoneal Dialysis CAPD or Continuous Cyclic Peritoneal Dialysis CCPD frequency of treatment formulation exchange volume duration of dwell and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange Peritoneal dialysis solutions may be warmed in the overpouch to 37 C 98 6 F to enhance patient comfort However only dry heat for example heating pad should be used See Directions for Use The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis or when the solution drainage contains fibrinous or proteinaceous material Ribot et al 1966 1000 to 2000 USP units of heparin per liter of solution has been recommended adults Furman et al 1978 For children 50 units of heparin per 100 mL of dialysis fluid has been recommended Irwin etal 1981 Additives may be incompatible Complete information is not available Those additives known to be incompatible shoul
69. d not be used Consult with pharmacist if available in the informed judgement of the physician it is deemed advisable to introduce additives use aseptic technique Mix thoroughly when additives have been introduced Do not store solutions containing additives Intermittent Peritoneal Dialysis IPD For maintenance dialysis of chronic renal failure patients The cycle of instillation dwell and removal of dialysis fluid is repeated sequentially over a period of hours 8 to 36 hours as many times per week as indicated by the condition of the patient For chronic renal failure patients maintenance dialysis is often accomplished by periodic dialysis 3 to 5 times weekly for shorter time periods 8 to 14 hours per session Mattocks and El Bassiouni 1971 Continuous Ambulatory Peritoneal Dialysis CAPD and Continuous Cyclic Peritoneal Dialysis CCPD For maintenance dialysis of chronic renal failure patients In 1 5 to 3 0 liters of dialysis solution depending upon patient size are instilled into the peritoneal cavity of adults and the peritoneal access device is then clamped Kim et al 1984 Twardowsk and Janicka 1981 Twardowski and Burrows 1984 For children 30 to 50 mL kg body weight with a maximum of 2 liters has been recommended Potter et al 1981 Irwin et al 1981 The solution remains in the cavity for dwell times of 4 to 8 hours during the day and 8 to 12 hours overnight At the conclusion of each dwell
70. ding Physician Name PRESCRIPTION REQUIREMENTS Baxter will not accept any order for patients without a prescription signed and dated by a physician THE INFORMATION REQUIRED FOR PRESCRIPTIONS INCLUDES 1 Product codes and quantities Utilize your product catalog to determine codes 2 5B max and 5B Line maxes Utilize the 5B solution grid to help set 5B maxes Page 62 3 Allowable refill period not to exceed one year 4 Prescriptions should be managed and e signed through the DirectAccess online tool Refer to Section 5 for more details DID YOU KNOW Baxter s product catalog can be accessed at http www ecomm baxter com ecatalog browseCatalog do NEW PATIENT LEAD TIME GUIDELINES Baxter requires a five business day lead time This lead time Will increase the likelihood that the delivery will be made by a Baxter Service Specialist Ensures patient receives introductory packet from Baxter before delivery Facilitates a minimum number of order shipments Ensures hardware machines shipped separately from solutions are received on or near the date of solutions delivery Orders must be placed no later than 12 noon local time in the time zone of your local distribution center to be counted for a particular business day Orders placed after 12 noon local time will be counted on the following business day for purposes of calculating lead time BENEFITS OF BAXTER TRUCK DELIVERY The following exemplify the delivery
71. ding congestive heart failure volume depletion and hypovolemic shock An accurate fluid balance record must be kept and the patient s body weight monitored Significant losses of protein amino acids water soluble vitamins and other medicines may occur during peritoneal dialysis The patients nutritional status should be monitored and replacement therapy should be provided as necessary In patients with hypercalcemia particularly in those on low calcium peritoneal dialysis solutions consideration should be given to the fact that EXTRANEAL is not provided in a low calcium electrolyte solution Solutions that are cloudy contain particulate matter or show evidence of leakage should not be used 07 19 65 351 Insulin dependent diabetes mellitus Patients with insulin dependent diabetes may require modification of Insulin dosage following initiation of treatment with EXTRANEAL Appropriate monitoring of blood glucose should be performed and insulin dosage adjusted if needed See WARNINGS PRECAUTIONS Drug Laboratory Test Interactions Information for Patients Patients should be instructed not to use solutions if they are cloudy discolored contain visible particulate matter if they show evidence of leaking containers Aseptic technique should be employed throughout the procedure To reduce possible discomfort during administration patients should be instructed that solutions may be warmed to 37 C 98 F prior to use Only dry h
72. e Gis is o ern tense acum fs EP PR ow M Sm eed ne ss 1 Example 4 Click Yes to create the new prescription The system creates the new prescription and returns you to the Prescription Information tab of the Create Update Prescription screen 5 Change the following fields to reflect the patient s new therapy Liters Day using the drop down Quantity To figure out a 28 day Max Quantity supply with five day reserve use this grid 5B MAX GRID 5 DAY Reserve Quantities per a 28 day cycle Number of bags used per day Pack Factor 1 day 2xday 3 4xday Sxday 2 5 17 33 50 66 83 4 5 9 17 25 33 42 5 CS 7 14 20 27 33 6 CS 6 11 17 22 28 8 CS 5 9 13 17 21 12 CS 3 6 9 11 14 From this point forward the prescription is treated as a new prescription and follows the procedure as described in the Prescriptions User Guide please consult that document for guidance on working prescriptions that appear in the Prescription To Do list Managing Staff Changes A 8 Services Managing Staff Changes Site Administrators Only After logging on the system displays the DirectAccess online tool Home Page The To Do List may contain a Staff changes note which will list deactivated physicians whose patients need to be reassigned The following steps will guide you through this process OFLE CONTACTS
73. e Update Prescription screen has three tabs Prescription Information Prescription Items Review Prescription CREATE UPDATE PRESCRIPTION SCREEN PRESCRIPTION INFORMATION TAB The system displays the Prescription Information tab if this information is needed Baxter Renal HomeCare Services sk _ Patente Creat New Patent em raven memor _ ESTRO STAI Marge Patents dine tare TEST CLIC a desee aman prece das 5 VOR V eua ma P COMINO Fatlens ve On oid _ W Have Hot eq EXIRANEAL Remind nt undergoing Luer Conversion Please tax completed Training Cantirnation Fx Change form fo 1 800 866 8467 erdertar Luer codesta Da 2005910 patient prestatia di 2 Example 7 Enter all required fields on the Prescription Information tab a next to the field name indicates that it is a required field When you are done entering the information click Next CREATE UPDATE PRESCRIPTION SCREEN PRESCRIPTION ITEMS TAB The system displays the Prescription Items tab if this information is needed Baxter Renal Science Solutions Systems Support CEE pc a a ee e m p CRA ition Nate You ening rea rapine patant TESTNGIESTING Marge Patents even meno
74. e overpouch to 37 C 98 6 F to enhance patient comfort However only dry heat for example heating pad should be used See Directions for Use The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis or when the solution drainage contains fibrinous or proteinaceous material Ribot et al 1986 1000 to 2000 USP units of heparin per liter of solution has been recommended for adults Furman et al 1978 For children 50 units of heparin per 100 mL of dialysis fluid has been recommended Irwin et al 1981 Additives may be incompatible Complete information is not available Those additives known to be incompatible should not be used Consult with pharmacist if available I in the informed judgment of the physician itis deemed advisable to introduce additives use aseptic technique Mix thoroughly when additives have been introduced Do not store solutions containing additives Intermittent Peritoneal Dialysis IPD For maintenance dialysis of chronic renal failure patients The cycle of instillation dwell and removal of dialysis fluid is repeated sequentially over a period of hours 8 to 36 hours as many times per week as indicated by the condition of the patient For chronic renal failure patients maintenance dialysis is often accomplished by periodic dialysis 3 to 5 times weekly for shorter time periods 8 to 14 hours per session Mattocks and El Ba
75. e pharmacokinetics of icodextrin and its metabolites was not assessed trials of approximately 480 patients studied with end stage renal disease ESRD Uttafitration Urea and Creatinine Clearance In the active controlled trials of one to six months in duration described below EXTRANEAL used once daily for the long dwell in either continuous ambulatory peritoneal dialysis CAPD or automated peritoneal dialysis APD therapy resulted in higher net ultrafiltration than 1 5 and 2 5 dextrose solutions and higher creatinine and urea nitrogen clearances than 2 5 dextrose Net ultrafitration was similar to 4 25 dextrose across all patients in these studies Effects BE 78 generally similar in CAPD and APD In an additional randomized multicenter active controlled two week study in high average high transporter APD patients EXTRANEAL used once dally for the ong dwell produced higher net ultrafiltration compared to 4 25 dextrose Mean Creatinine and urea nitrogen clearances were also greater with EXTRANEAL and ultrafiltration efficiency was improved In 175 CAPD patients randomized to EXTRANEAL N 90 or 2 5 dextrose solution N 85 for the 8 15 hour overnight dwell for one month mean net ultrafiltration for the overnight dwell was significantly greater in the EXTRANEAL group at weeks 2 and 4 Figure 1 Mean creatinine and urea nitrogen clearances were also greater with EXTRANEAL Figure 2 Figure 1 Mean Net Ultrafiltratio
76. e related to dilution resulting from the presence of icodextrin metabolites in plasma Although these decreases have been small and clinically unimportant monitoring of the patients serum electrolyte levels as part of routine blood chemistry testing is recommended EXTRANEAL does not contain potassium Evaluate serum potassium prior to administering potassium chloride to the patient In situations where there is a mormal serum potassium level or hypokalemia addition of potassium chloride up to a concentration of 4 mEQ L to the solution may be necessary to prevent severe hypokalemia This should be made under careful evaluation of serum and total body potassium and only under the direction of a physician Fluid hematology blood chemistry electrolyte concentrations and bicarbonate should be monitored periodically If serum magnesium levels are low magnesium supplements may be used Alkaline Phosphatase An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receiving EXTRANEAL No associated increases in liver function tests were observed Serum alkaline phosphatase levels did not show evidence of progressive increase over a 12 month study period Levels returned to normal approximately two weeks after discontinuation of EXTRANEAL There were individual cases where increased alkaline phosphatase was associated with elevated AST SGOT but neither elevation was considered causally
77. e to the 95 00 pickup fee and request Baxter s HomeCare Services to contact the patient or family and make appropriate arrangements the system displays the Disposables Pickup screen En e pum HomeCare Services Trece Home Vene Paes Serch View Update Patient Home Disposable Pickup Paone Mote Disposable Pichup far MASTERS DMS Create Patient Manage Paints v Trantor Patent Manage Prescriptions ame Contact Manage Presciption e CO Gd pet primer coni Cater Temelaes ua a reer H stony Ser Create Manage Evan zi mem EEC Example 1 Inthe Authorization Number field optional enter an Authorization Number This is used if your dialysis center requires an additional authorization BES 2 Inthe Title and Authorization Name fields enter the title and name of the person authorizing the 95 00 pickup fee This may be authorized by any person title at your dialysis center Entering a person s name and title establishes that the person identified has authority to approve charges on the dialysis center s behalf 8 Choose the Contact Type by clicking the radio button to identify who should be contacted to make arrangements for the pickup of the patient s disposables Selecting Call patient s primary contact indicates the primary phone number contact provided to Baxter s HomeCare Services should be called Selectin
78. eat should be used It is best to warm solutions within the overwrap using a heating pad To avoid contamination solutions should not be immersed in water for warming Do not use a microwave oven to warm EXTRANEAL Heating the solution above 40 C 104 F may be detrimental to the solution See DOSAGE AND ADMINISTRATION Directions for Use Because the use of EXTRANEAL interferes with glucose dehydrogenase pyrroloquinolinequinone GDH POQ glucose dye oxidoreductase GDO and some GDH FAD based blood glucose measurements patients must be instructed to use only glucose specific glucose monitors and test strips See WARNINGS PRECAUTIONS Drug Laboratory Test Interactions A Patient Medication Guide is provided in each carton of EXTRANEAL Laboratory Tests Serum Electrolytes Decreases in sarum sodium and chloride have been observed in patients using EXTRANEAL The mean change in serum sodium from baseline to the last study visit was 2 8 mmol L for patients on EXTRANEAL and 0 3 mmol L for patients on control solution Four EXTRANEAL patients and two contro patients developed serum sodium lt 125 mmol L The mean change in serum chloride from baseline to ast study visit was 2 0 mmol L for EXTRANEAL patients and 0 6 mmoVL for control patients Similar changes in serum chemistries were observed in an additional clinical study in a subpopulation of high average high transporter patients The declines in serum sodium and chloride may b
79. ed in Table 1 AI DIANEAL Low Calcium peritoneal dialysis solutions have overfil which are declared on container labeling Exposure of pharmaceutical products to heat should be minimized Avoid excessive heat Itis recommended the product be stored at room temperatura 25 C 77 F brief exposure up to 40 C 104 F does not adversely affect the product Directions for Use Use aseptic technique For complete system preparation see directions accompanying ancillary equipment Peritoneal dialysis solutions may be warmed in the overpouch to 37 C 98 6 F to enhance patient comfort However only dry heat for example heating pad should be used Solutions should not be heated in water due to an increased risk of infection Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container Moreover microwave oven heating may potentially cause overheating and or non uniform heating of the solution that may result in patient injury or discomfort To Open Tear overpouch down side at slit and remove solution container Some opacity of the plastic due to moisture absorption during the sterilization process may be observed This is normal and does not affect the solution quality or safety The opacity will diminish gradually f supplemental medication is desired follow directions below before preparing for administration Check for minute leaks by squeezing container firmly To Add Medi
80. emia or to administer insulin inappropriately Both of these situations have resulted in unrecognized hypoglycemia which has led to loss of consciousness coma permanent neurological damage and death Plasma levels of EXTRANEAL sodextrin and its metabolites retum to baseline within approximately 14 days following cessation of EXTRANEAL icodexrin administration Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of EXTRANEAL icodextrin therapy when GDH PQ0 GDO and GDH FAD based blood glucose monitors and test strips are used Because GDH PQ0 GDO and GDH FAD based blood glucose monitors may be used in hospital settings itis important that the health care providers of peritoneal dialysis patients using EXTRANEAL icodextrin carefully review the product information of the blood glucose testing system including that of test strips to determine if the system is appropriate for use with EXTRANEAL icodextrn To avoid improper insulin administration educate patients to alert health care providers of this interaction whenever they are admitted to the hospital The manufacturer s of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference falsely elevated glucose readings Fora list of toll free numbers for glucose monitor and test strip manufacturers please contact the Baxter Renal Clinical Help Line 1 888 RENAL HELP or visit www qlucosesafety c
81. erial Catheter site infection Catheter related infection BLOOD AND LYMPHATIC SYSTEM DISORDERS Thrombocytopenia Leukopenia IMMUNE SYSTEM DISORDERS Leukocytoclastic vasculitis Serum sickness Hypersensitivity METABOLISM AND NUTRITION DISORDERS Shock hypoglycemia Fluid overload Dehydration Fluid imbalance NERVOUS SYSTEM DISORDERS Hypoglycemic coma Burning sensation EYE DISORDERS Vision blurred RESPIRATORY THORACIC AND MEDIASTINAL DISORDERS Bronchospasm Stridor GASTROINTESTINAL DISORDERS Sclerosing encapsulating peritonitis Aseptic peritonitis Peritoneal cloudy effluent Ileus Ascites Inguinal hernia Abdominal discomfort SKIN AND SUBCUTANEOUS DISORDERS Toxic epidermal necrolysis Erythema multiforme Angioedema Urticaria generalized Toxic skin eruption Swelling face Periorbital edema Exfoliative rash Skin exfoliation Prurigo Rash including macular papular erythematous exfoliative Dermatitis including allergic and contact Drug eruption Erythema Onychomadesis Dry skin Skin chapped Blister MUSCULOSKELETAL CONNECTIVE TISSUE DISORDERS Arthralgia Back pain Musculoskeletal pain REPRODUCTIVE SYSTEM AND BREAST DISORDERS Penile edema Scrotal edema GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS Discomfort Pyrexia Chills Malaise Drug effect decreased Drug ineffective Catheter site erythema Catheter site inflammation Infusion related reaction including Infusion sita pain Insti
82. ers invoice numbers and dates are provided for reference Details for the current month along with summary information for the two prior months are listed 24 Order Qty Quantity ordered on each specific order Quantities are reported in the unit of measure indicated 25 Extended Price The sum of the order quantity multiplied by the current contract price per item reports 55505A 55505D and 55505E only 26 Actual Ship Date Date the product was actually shipped to the patient 27 Order Order number for that specific product 28 Invoice Date Date the product is invoiced 29 Invoice amp Invoice number for that specific product 30 Summary Quantities Shown for current active products Current month One month prior c Two months r E Naro dato order quantity YTD Pack factor designator cases CA or each EA 1 Year to date dollars on reports 55505A 555050 and 55505 only Dollar amounts do not include tax Totals reflect credits issued during the specified time frame Specific questions regarding credits can be addressed to your Account Business Services Representative ABS 31 PD Solution Totals 58 5B PD solutions total quantity for current month 58 PD solutions total quantity year to date 82 Patient Total Year to Date Dollars Total patient quantity for year to date YTD 33_Patient Total Current Month Dollars Total patient dollars for current month reports 55505A 5
83. ers as well as by tissue culture toxicity studies CLINICAL PHARMACOLOGY Mechanism of Action EXTRANEAL is an isosmotic peritoneal dialysis solution containing glucose polymers icodextrin as the primary osmotic agent lcodextrin functions as a colloid osmotic agent to achieve ultrafitration during long peritoneal dialysis dwells Icodextrn acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapilary ultrafitration throughout the dwell Like other peritoneal dialysis solutions EXTRANEAL also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid base status Pharmacokinetics of Icodextrin Abs Absorption of icodextrin from the peritoneal cavity follows zero order kinetics consistent with convective transport peritoneal lymphatic pathways In a single dose pharmacokinetic study using EXTRANEAL icodextrin a median of 40 60 9 of the instilled icodextrin was absorbed from the peritoneal solution during a 12 hour dwell Plasma levels of icodextrn rose during the dwell and declined after the dwell was drained Peak plasma levels of icodextrin plus its metabolites median C 2 20 L were observed at the end of the long dwell exchange median T 13 hours At steady state the mean plasma level of icodextrin plus its metabolites was about 5 01 In multidose stes steady state levels of icodextrin wer achieved one week
84. escripton signing Rights n Tese Granted EE costo Example 2 Click the eSigning Rights check box make sure that the staff member s email has been entered in both fields and select the staff member s title from the drop down these are required for eSigning 3 Click Save to save your information the system confirms that the information has been successfully saved A Site Administrator for each clinic is designated by Baxter and is responsible for providing user access rights depending on user role Baxter makes no warranties or guarantees as to the identity of users utilizing DirectAccess online tool You agree to use DirectAccess online tool for lawful and ethical purposes only MANAGE STAFF ACTIVATE AND DEACTIVATE 1 Click on Manage Staff in the left navigation bar the system displays the Staff Search Results window CHANGE CLINC EDIT MY PROFILE CONTACTUS HELPFAQ LOGOFF ESSTEST HomeCare Services Directkcoess Home Manage Staff Search Results Patients User leme LastName First lame Staff Type Status Lest Login Create New Patent Not vale Physician System Generated hace TASB TOL AM e WAI PrysicaniSystem Generaed nace TIISUSTOLIS A acte Transter Patent Sta ministro 2000102600 40 GADALEON Physician Active Esi Pesci
85. essure medicine digoxin Lanoxicaps Lanoxin Lanoxin Pediatric Know the medicines you take Keep a list of them and show your doctor and pharmacist when you get a new medicine How should use EXTRANEAL Use EXTRANEAL exactly as prescribed by your doctor Use EXTRANEAL only for your long dwell exchange and not more than 1 exchange in 24 hours Follow the steps that you learned in your peritoneal dialysis training to do your EXTRANEAL exchange To open EXTRANEAL tear the overwrap at the slit and remove the bag of solution Before using EXTRANEAL always check to make sure the bag does not leak A small amount of moisture inside the averwrap is normal Firmly squeeze the bag to check for small leaks the expiration date has not passed Do not use EXTRANEAL after the expiration date shown on the carton and product label Look at the bag to make sure the solution is clear and does not contain particles Do not use a bag of EXTRANEAL if it is cloudy or contains particles Before using EXTRANEAL you may warm the bag in the overpouch to make it more comfortable Only use dry heat such as a heating pad to warm the EXTRANEAL solution to 98 6 F 37 not microwave EXTRANEAL You can damage the solution if it gets hotter than 104 F 40 C avoid an increased risk of infection do not put EXTRANEAL in water to heat the bag To prevent a serious infection you must clean disinfect your
86. f patients assigned to a particular staff member 1 Click on Manage Staff in the left navigation bar the system displays the Staff Search Results window NANGE CLINIC EDIT Locorr TEST cumcp Ras TUN Patients liserilame LastName FirstName Stafi Type Status 2 Last Login ee ss ER Ia cet ETA een ere BRIT e gadalet GADALEON FLORINE Physican Acte E E SO panne JAMESON WICHA Unassigned macie 8127 08 8 5005 PM Orders lewsust SUSIE Physician Active 8 3 03 2 10 03 PM Order History MARTIN MARY Site Administrator 10 20 00 11 58 51 AM Create Staff rogers ROGERS ANN Nurse Ed VORNE NEN 5 sa ENS 12 results und dispiaving allesuts N 411 Example 2 make changes on a staff member s account click the Edit link in the second column from the right This will allow you to Update staff type Update staff details Assign patients by staff member Assign eSigning rights At the beginning of every month the system will send you a reminder on the To Do List asking you to review your staff members profiles and update if necessary MANAGE STAFF UPDATE STAFF TYPE The system displays the Edit Staff Member screen CHANGE CLINIC EDITA mm HomeCare Services Drceticcess Home gt Menage Edit Staff Member HOME suntwoe sar veas rates sane Wiha Do Need To Do Heres Patients Choose a staf type a
87. g Other indicates you would like to make other arrangements Use the text box to enter the appropriate information such as contact name e g in the event the patient is deceased or alternate phone numbers e g nursing home number spouse family cell phone numbers etc The text box can only be used when the Other radio button is selected 4 If you are providing information in the Contact Details box you do not need to provide an explanation or reason for the disposables pickup 5 Click Ok The system confirms that your information has been successfully saved Click Ok Your inactivation is now complete Modality Changes HomeCare A 8 Services Modality Changes The following steps will guide you in changing a patient s therapy After logging on the system displays the DirectAccess online tool Home Page HomeCare Services Hone HOME Nome WARY MARTI Last login 1071303 0245 PM Creste New tini 2 Vate Dy eng Patente ici arto dep 2 vane 1 Fei Pi recu phi iu Cid bere odi Sete ptr o are nt pics laid sri te TrarcterPalient vene Dy Sri Ela eet dy Example 1 In the navigation bar on the left click Manage Prescriptions the system displays the Manage Prescriptions screen with a patient listing HomeCare O HOME Lum CR RR NR Patente E Lo 00407 eo 2 FE Create New Patent ame toue 55 ues eno
88. g the prescription click on Approve to eSignature List To cancel the process at anytime click on Cancel eSignature Drect ccens Home T GIL cunas ir you are unabto to the orange Do Lise To Do Here soetan 7 ANDERSON ROBERT no rana 2 moore aL arama Roviow Proscription Now Lino on tho Proscription are Mahliahtod in vollow Max Quantity 22 LitorsDay Product Pack order No Description Quantity YOM Factor Frequency PT CLAMP 21 Example 3 When Approve to eSignature is selected the next prescription displays To reject a presciption click on Reject for eSignature List 2879 Prescription New Line reme on tho ProscHptian ars m yottow pa oscription Example 4 When Reject for eSignature List is selected comments will be required These comments will display on the Site Administrators eSign Status report for further follow up After entering the comments click Send Review sarate db What Do Led To Do Heret unable t tho orando hiahli rted une ploase down Lost Hlame F etHame DOD Effective Date Expiration Date Sign Status Commente setecr an SEASHELL nano inam Aopreved For eSian ANDERSON E Er Pro comments tor roj
89. gt 0 70 and 4 hour D De ratio lt 0 34 as defined by the peritoneal equilibration test PET comparing EXTRANEAL n 47 to 4 25 dextrose n 45 after adjusting for baseline the mean net ultrafiltration achieved during 214 2 hour dwell was significantly greater in the EXTRANEAL group than the 4 25 dextrose group at weeks 1 and 2 p lt 0 001 see Figure 3 Consistent with increases in net ultrafiltration thera were also significantly greater creatinine and urea nitrogen clearances and ultrafiltration efficiency in the EXTRANEAL group p lt 0 001 see Figure 3 07 19 65 351 Figure 3 Mean Net Ultrafiltration Creatinine and Urea Nitrogen Clearances and Ultrafiltration Efficiency for the Long Dwell in High Average High Transporter Patients sm m m p lt 0 001 EXTRANEAL vs 4 25 dextrose adjusted for baseline p lt 0 001 EXTRANEAL vs 4 25 dextrose adjusted for baseline Hun jus i is im in i5 ix 200 a 000 mire Ma Mea p lt 0 001 EXTRANEAL vs 4 25 dextrose p0 001 EXTRANEAL vs 4 25 dextrose adjusted for baseline adjusted for baseline Peritoneal Membrane Transport Characteristics After one year of treatment with EXTRANEAL during the long dwell exchange there were no differences in membrane transport characteristics for urea and creatinine The mass transfer area coefficients MTAC for urea creatin
90. h the current expiration date eSigning Prescriptions A 8 Services The Following Steps Will Guide You With eSigning 1 Log in to the DirectAccess online tool The Home page displays the To Do List Click on the Click here link to view prescriptions that need to be reviewed and signed EDIT MY PROFILE CONTACTUS MELPTAQ LOGOFF 0 3 TEST CLINIC P HomeCare Services DirectAccess Home HOME Welcome sam kop Last login 7 90 10 12 50 32 PM Wiat Do Need To Do Here tse reni Em rt Okie esin Please see ratore and or EXTRANEAL PO Scion Example There are two tabs when signing a prescription electronically The Review tab displays the patient information You can view all of the prescriptions by clicking on Select All or click on only the ones you want to review ELT n m maini esos rona ran meore a sons vera Prescription Mew Line omo on the Progenption are Hugged n yellow Example Click on What Do Need To Do Here for additional help This help option is located on each tab 2 each prescription is being reviewed the patient s name will be highlighted in orange The prescription items will display in the Review Prescription window The items highlighted in yellow indicate they need a physician signature After reviewin
91. hange volume duration o dwell and length o dialysis shouldbe selected by the physician responsible for and supervising the treatment of the individual patent To avoid the risk of severe dehydration and hypovolemia and to minimize the oss of protein itis advisable to select the peritoneal dialysis solution with the lowest evel of osmolarity consistent with the flid removal requirements for that exchange Heating the dialysis solution to 37 C 98 8 F may decrease discomfort Additives may be incompatible Do not store solution containing additives Two Iers of dialysis solution are instiled into the peritoneal cavity of adults and the peritoneal access device en clamped The solution remains in the cavi for duel times f 4 to 8 hours during the day and 8 to 12 hours overnight At the conclusion of each dwell period the access device is opened the solution drained and fresh solution The procedure repeated 3 to 5 times per day 6 to 7 days per week Solution exchange frequency shouid be individualized for adequate biochemical and fuid volume control The maori of exchanges wil ui 15 or 2 5 dextrose containing peritoneal dialysis solutions with 425 dextrose containing solutions being used when extra fluid removal is required Patient weight is used as the indicator of the need for fuid removal Directions for Use Use aseptic technique For complete system preparation se directions accompanying ancilary equipment Prepara
92. he solution to be used for an individual patient consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing nesses For example rapid potassium removal may create arrhythmias in cardiac patients using or similar drugs digitalis toxicity may be masked by elevated potassium or magnesium or by hypocalcemia Correction of electrolytes by dialysis may precipitate signs and symptoms ot digitalis excess Conversely tonicity may occu at suboptimal dosages of digitalis 1 potassium is low or calcium high Jzotemic diabetics require careful monitoring of insulin requirements during and following dialysis with dextrose containing solutions Laboratory tests Serm electrolytes magnesium bicarbonate levels and fluid balance shouldbe periodically monitored Carcinogenesis mutagenesis impairment o eril Long term animal studies with ianeal PD 2 peritoneal dialysis solution have not been performed to evaluate the carcinogenic potential mutagenic potential or effect on fert Pregnancy Teratogenic Effects Pregnancy Category Animal reproduction studies have not been conducted with Dianeal PD 2 pentonea dialysis solution Is also not known whether Dianeal PD 2 peritoneal dialysis solution cause fetal harm when administered to pregnant woman or can affect reproduction capac Dianeal PD 2 peritoneal dialysis solution should be given to a pregnant woman if
93. hie palin ram to palet et Teme Patent veri Manage Manage Presson fou harre zeita phi cna Sisk Hare 10 Example 2 To complete the pending work on a patient click the patient s name in the box The system will start you at one of the following tabs of the View Update Patient Screen or at the Create Update Prescription Screen explained below depending on what is required to complete the pending patient set up VIEW UPDATE PATIENT SCREEN The View Update Patient Screen has three tabs Basic Info tab Demographics Info tab Additional Contacts tab You will not be directed to the Basic Info tab of the View Update Patient Screen because that information will be complete But you can view it if you wish by clicking on the tab VIEW UPDATE PATIENT SCREEN DEMOGRAPHICS INFO TAB The system displays the Demographics Info tab if this information is needed The Note indicates the patient you are working on s Car fo ____ ji rende wron sun Create Stat 5 22 2 p p Example Complete all required fields and add any additional comments or information as desired and click Next VIEW UPDATE PATIENT SCREEN ADDITIONAL CONTACTS TAB The system displays the Demographics Info tab if this
94. i me prese rene View Print one easton tearm sa di my ode nla sit um a Vou have ci pate fo have pc etii Ceto Ou bee item Tisch 2 Example Prescription renewals appear on the To Do list with the prescription expiration date noted Patient names appearing in Red have an order that will be delayed until a signed prescription is received From this screen you can Renew the prescription to obtain a physician s eSignature Printthe Prescription to obtain a handwritten signature RENEW TO OBTAIN ESIGNATURE 1 From the prescriptions box in the To Do list click on Renew the Prescription to obtain a physician s eSignature the system displays the Renew Prescription screen This screen is just like the Create Update Prescription screen Use the tabs on this screen to view or update the prescription For additional information please see the Pending Patients User Guide 2 Review the prescription information on each of the tabs and make any changes if necessary Reviewing and saving a prescription requiring renewal creates the new prescription 3 When you are done click Save 4 Prescription Note appears telling you that the prescription will now display as a New Prescription where you will be able to forward it to your physician Click Ok co Em Now Patient Croato How Prescription Wiat Do Need
95. ic technique Contamination of Luer lack connector may result in peritonitis An improper clamping sequence result in intusion of air into peritoneum Nursing mothers Caution should be exercised when Dianeal Low Calcium peritoneal dialysis solution is administered to a nursing woman Pediatric use Peritoneal dialysis should be done with great care itat al in patients with a number of conditions y ness in cidren have not been estab including disruption of the peritoneal membrane or diaphragm by surgery or trauma extensive adhesions oi 40 Most a bowel distention undiagnosed abdominal disease abdominal wall infection hernias or bums fecal fua Adverse Reactions colostomy tense ascites obesity large polycystic kidneys recent aortic graft replacement lactic acidosis and severe pulmonary disease When assessing peritoneal dialysis as the mode of therapy in Such extreme situations the benefits to the patient must be weighed against possible complications An accurate fluid balance record must be kept and the weight o the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure volume depletion and shock Advers reactions to peritoneal dialysis include mechanical and solution related problems as well as the resuls of contamination of equipment or improper technique in catheter placement Abdominal pain bleeding peritonitis subcutaneous infection aro
96. ic you are currently viewing is listed on the far right If you have this option click on it and a pop up window will allow you to switch between the Clinics to which you have access Additional menu options include access to your User Profile Contact Information Help FAQ and the Log Off option 2 To Do List The To Do list provides a constantly updated queue of matters requiring your attention For example it includes a list of patients whose information or prescriptions are incomplete a list prescriptions that are new updated or need to be renewed and a list of patients who have not placed their scheduled orders Each staff member s To Do list is unique and changes constantly based on their actions and the actions of other staff members For example if you have a prescription for one of your patients that requires renewal it will show up on your To Do list Once you renew the prescription and send it for a physician s signature it will show up on the physician s To Do list 3 Navigation Bar The navigation bar on the left of each screen allows you access to all the functions in the system This includes a link to return to the Home screen and links to manage patients prescriptions orders staff adverse affects and reports It also includes links to important information about Extraneal icodextrin PD solution HELPFUL SCREEN TIPS The following screen tips will help you take advantage of the information and navigation aids built
97. ically 1 5 to 2 0 liters of dialysis solution depending upon patient size are delivered each cycle by an automatic peritoneal dialysis cycler machine After the last outflow during the night an additional exchange is infused by the cycler machine into the peritoneum The equipment is then disconnected from the patient and the dialysate remains in the peritoneum for 14 to 15 hours during the day until the next nocturnal cycle Diaz Buxo et al 1981 Combinations of 1 5 or 2 5 dextrose containing peritoneal dialysis solutions are usually used for the nighttime exchanges while 3 5 or 4 25 dextrose containing solution is used when extra fluid removal is required such as during the daytime exchange Patient weight is used as the indicator of the need for fluid removal Popovich et al 1978 so therapy should be individualized according to the patient s need for ultrafiltration It is recommended that adult patients being placed on peritoneal dialysis or n the case of pediatric patients the selected caretaker as well as the patient when suitable should be appropriately trained in a program which is under the supervision of a physician Training materials are available from Baxter Healthcare Corporation Deerfield IL 60015 USA to facilitato this training How Supplied DIANEAL Low Calcium peritoneal dialysis solutions in AMBU FLEX II and AMBU FLEX Il containers are available in nominal size flexible containers with fi Volumes as indicat
98. ine and glucose at one year were not different in patients receiving treatment with EXTRANEAL or 2 5 dextrose solution for the long dwell INDICATIONS AND USAGE EXTRANEAL is indicated for a single dally exchange for the long B to 16 hour dwell during continuous ambulatory peritoneal dialysis CAPD or automated peritoneal dialysis APD for the management of end stage renal disease EXTRANEAL is also indicated to improve compared to 4 25 dextrose long dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics as defined using the peritoneal equilibration test PET See CLINICAL PHARMACOLOGY Clinical Studies EXTRANEAL icodextrin is contraindicated in patients with a known allergy to Cornstarch or icodextrin in patients with maltose or isomaltose intolerance in patients with glycogen storage disease and in patients with pre existing severe Tactic acidosis WARNINGS Dangerous Drug Device Interaction See BOXED WARNING Only use glucose specific monitors and test strips to measure blood glucose levels in patients using EXTRANEAL icodextrin Peritoneal Dialysis Solution Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone GDH PQQ or glucose dye oxidoreductase GDO based methods must not be used In addition some blood glucose monitoring systems using glucose dehydrogenase flavin adenine dinucleotide GDH FAD based me
99. ing an order mid cycle you may need to increase or de crease the order quantities to get the patient on a scheduled delivery route Together with your HCSR we can ensure your new patient s first experience with Baxter is with a Baxter driver whenever possible Your Baxter HCSR can provide with information regarding when the next Baxter truck is in your new patient s area THE NEW PATIENT INTRODUCTORY PACKET When your new home patient is set up with Baxter an introductory packet will be mailed to the patient This packet includes the following materials intended to help the patient understand how to place orders manage inventory and interact with Baxter Going Home with Confidence Global Destinations Postcard Home Patient Inventory Form Emergency Preparedness Brochure Home Patient Order and Delivery Schedule A sample of the Home Patient Inventory Form is available in this booklet See Appendix C You can request a copy of the Going Home with Confidence booklet from your Baxter Account Executive or Clinical Educator OTHER TOOLS AVAILABLE TO HELP YOU Utilizing the following order placement tools will assist in making ordering and processing times more efficient and will improve order accuracy Product Catalog Please use Baxter product codes whenever possible when placing orders The Baxter product catalog can be accessed at http Avww ecomm baxter com ecatalog browseCatalog do 5B Max Grid Page 62 The Maximum Solut
100. ion Case or 5B Max Quantity found in the upper right hand corner of the Baxter Ordering Grid refers to the overall maximum number of solution cases a patient is allowed to receive in his or her delivery cycle An optimal 5B Max assists in managing the home patient s inventory while allowing the patient to vary ratios without exceeding the total number of allowed cases within the cycle The 5B Max grid was designed to help the facility calculate how much solution a patient may need for a 28 day cycle Baxter Ordering Grid Appendix D Pending Patients A 8 Services Pending Patients After logging on the system displays the DirectAccess online tool Home Page Pending Patients are defined as incomplete patient setup and the To Do item indicates actions required to complete patient setup Baxter Renal Science Solutions Systems Support aura Wane MARTH TOTI Save o oi Pes tae ey 1 Taurere o eoten a pisa me at n di mini aia 8 Yeu Fave COnarierte whe have ror placed teir schedules order ick here to Lum LEO an samant Hierbas doy Freins Example To see a list of these patients click the Click Here link to display the system displays the patients in a box below the link you just clicked HomeCare Services aue Raison MARY MARTIN Last ua 10 1308 CRUS FM c
101. it included patients with the following comorbid conditions 27 diabetes 49 hypertension and 23 hypertensive nephropathy Rash was the most frequently occurring EXTRANEAL related adverse event 6 5 EXTRANEAL 1 7 Control Seven patients on EXTRANEAL discontinued treatment due to rash and one patient on EXTRANEAL discontinued due to exfoliative dermatitis The rash typically appeared within the first three weeks of treatment and resolved with treatment discontinuation or in some patients with continued treatment Famale patients reported a higher incidence of skin events including rash in both EXTRANEAL and dextrose control treatment groups Table 1 shows the adverse events reported in these clinical studies regardless of causality occurring in gt 5 of patients and more common on EXTRANEAL than control Table 1 Adverse Experiences In of Patients and More Common on EXTRANEAL EXRANEAL Control Nan N 7 Paitone 26 7 Upper respiratory infection 18 18 Hypertension 13 E Rash 10 E Headache 9 7 Abdominal ar 8 6 Flu syndrome 7 GA Nausea 7 E Cough meroase 7 4 Edema GA 5 Acc denial injury 6 4 Chest pain 5 4 Dyspepsia 5 4 5 4 Adverse reactions reported with an incidence of gt 5 and at least as common on dextrose control included pain asthenia exit site infection infection back pain hypotension
102. l ring may be present due to condensation of water resulting from the sterilization process If continuous stream of fluid is noted discard solution because sterility may be impaired Aer removing overpouch check for minut leaks by squeezing container rly leaks are found discard the solution because the sterility may be impaired Freezing of solution may occur at temperatures below 0 C 32 F Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking Za Precautions Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibilty of infection If peritonitis occurs the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organisms when possible Prior to Identification of the involved organism s broad spectrum antibiotios may be indicated Peritoneal dialysis solutions may be warmed in the overpouch to 37 C 98 6 F to enhance patient comfort However only dry heat for example heating pad should be used Solutions should not be heated in water due to an increased risk of infection Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container Moreover microwave oven heating may potentially cause overheating and or non uniform heating of the solution that may result in patient injury or discomfort Significant losses
103. ltion site pain DRUG ABUSE AND DEPENDENCE There has been no observed potential of drug abuse or dependence with EXTRANEAL OVERDOSAGE No data are available on experiences of overdosage with EXTRANEAL Overdosage of EXTRANEAL would be expected to result in higher levels of serum icodextrin and metabolites but it is not known what signs or symptoms might be caused by exposure in excess of the exposures used in clinical trials In the event of overdosage with EXTRANEAL continued peritoneal dialysis with glucosa based solutions should be provided 07 19 65 351 DOSAGE AND ADMINISTRATION EXTRANEAL is intended for intraperitoneal administration only It should be administered only as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis The recommended dwell time is 8 10 16 hours Not for intravenous injection Patients should be carefully monitored to avoid under or over hydration An accurate fluid balance record must be kept and the patient s body weight monitored to avoid potentially severe consequences including congestive heart failure volume depletion and hypovolemic shock Aseptic technique should be used throughout the peritoneal dialysis procedure To reduce possible discomfort during administration solutions may be warmed prior to use See DOSAGE AND ADMINISTRATION Directions for Use EXTRANEAL should be administered over a period of 10 20 minutes a
104. luding disruption of the peritoneal membrane diaphragm by surgery or trauma extensive adhesions bowel distention undiagnosed abdominal disease abdominal wall infection hernias or burns fecal fistula or colostomy tense ascites obesity and large polycystic kidneys Vaamonde and Perez 1977 Other conditions include recent aortic graft replacement and severe pulmonary disease When assessing peritoneal dialysis as the mode of therapy in such extreme situations the benefits to the patient must be weighed against the possible complications An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure volume depletion and shock Excessive use of DIANEAL PD 2 peritoneal dialysis solution with 3 5 or 4 25 dextrose during a peritoneal dialysis treatment can result significant removal of water from the patient In acute renal failure patients plasma electrolyte concentrations should be monitored periodically during the procedure Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors as well as other indicators of patient status Because average plasma magnesium levels in chronic CAPD patients have been observed to be elevated Nolph et al 1981 the magnesium concentration of this formulation has been reduced to 0
105. me LEW SUSIE Create New Patent C site Administrator They uil have permission to view modify stat and patients for their clinic Manage Patients ey wil have permission to view modifyidelete Protected Health Inforinaton They can Hm They wit have perm iewimodifyidelete Protected Health information They Transfer Patent bo required to sign proscriptione to which they are cosigned arae Cs rane Tese se cepe presarton Cares Trey ut ave permise mode Pret etern E Any other employees as deemed appropriate by the Site Administrator They wil have gt nic Employee permission to View Modify Delete Protected Health Information They wil have permission to viewimodity delete Protected Healt Information In some tates they car have the ability to eign prescriptions ce Creato Sat Example Ordor History C Physicien Assistant 1 If not displayed click on the Staff Type tab This allows you to change a staff member s role at the clinic 2 Click the radio buttons to assign this staff member to another role and click Save the system changes the role of the staff member MANAGE STAFF UPDATE STAFF DETAILS 1 Click on the Staff Details tab the system displays the Staff Details screen PROFILE CONTACTUS HELPIFAQ LOGOFF HomeCare Services Dreciaccess Hone WanegeStatt ton Start member HOME Settiyse stat
106. metimes prescribed for purposes other than those listed in a Medication Guide Do not use EXTRANEAL for a condition for which it was not prescribed Do not give EXTRANEAL to other people even if they have the same symptoms you have It may harm them This Medication Guide summarizes the most important information about EXTRANEAL If you would like more information talk with your doctor You can ask your doctor for information about EXTRANEAL that is written for healthcare professionals You can also find out more about EXTRANEAL by calling your doctor or visiting the website www renalinfo com Baxter and Extraneal are trademarks of Baxter International Inc Baxter Healthcare Corporation Deerfield IL 60015 USA November 2010 Printed in USA This Medication Guide has been approved by the U S Food and Drug Administration 07 19 60 827 2010 10 Dianeal PD 2 Peritoneal Dialysis Solution UltraBag System For Continuous Ambulatory Peritoneal Dialysis CAPD For intraperitoneal administration only Description Dianeal PD 2 peritoneal dialysis solutions are sterile nonpyrogenc solutions in Containers for intraperitoneal administration They contain no bacteriostatic or antimicrobial agents UtraBag containers are designed with an integrated Y set and drain container for infusion and of Danes PD 2 when dsonecion of bs set rom the waster set during duel is Excessive use of Daneal PD 2 peri
107. n completed PIFAQ LOGOFF Directaccess Home Create Patient Your information has been successfully saved Patient has been created successfully Create another patient Assi t Create patient s prescription Example You can access the Renal Product Catalog by clicking the link located at the bottom of the DirectAccess online tool HOME page For additional assistance at any time please feel free to contact the DirectAccess technical support team at 1 800 284 4060 New Home Patients NEW PATIENT SETUP Please provide the following information when contacting Baxter to establish a new patient Patient first and last name Patient address boxes are acceptable for mailings only Boxes are not acceptable for supply deliveries Please supply physical street address If none available please include cross streets and detailed directions Patient phone number and back up phone number Gender Special Handling requests i e wheelchair blind child or Spanish speaking Gain Reason 072 prior mode 012 Chronic ICH 022 Acute ICH 08Z Transplant Failed 13Z Other Modality CAPD APD Hemo Diabetic Status U Unknown 1 Insulin dep 2 Non Insulin dep Type2 Insulin dep D Undisclosed Sold To Option Method 1 Method 2 Baxter Supplied BSS Purchase Order if applicable Atten
108. n for the Overnight Dwell p lt 0 001 EXTRANEAL vs 2 5 dextrose adjusted for baseline Figure 2 Mean Creatinine and Urea Nitrogen Clearance for the Overnight Dwell s nom cu BEI n ao Bestar 250 Crore Clearance m min res Nitrogen Clearance 20 madre Lal p lt 0 001 EXTRANEAL vs 2 5 dextrose adjusted for baseline pc 001 EXTRANEAL vs 2 5 dextrose adjusted for baseline In another study of 39 APD patients randomized to EXTRANEAL or 2 5 dextrose solution for the long daytime dwell 10 17 hours for three months the net ultrafiltration reported during the treatment period was mean SD 278 192 mL for the EXTRANEAL group and 138 352 mL for the dextrose group p 0 001 Mean creatinine and urea nitrogen clearances were significantly greater Tor EXTRANEAL than 2 5 dextrose at weeks 6 and 12 p lt 0 001 In a six month study in CAPD patients comparing EXTRANEAL n 28 with 4 25 dextrose n 31 net ultrafiltration achieved during an 8 hour dwell averaged 510 ml for EXTRANEAL and 556 mL for 4 25 dextrose For 12 hour dwells net ultrafiltration averaged 575 mL for EXTRANEAL n 29 and 476 mL for 4 25 dextrose n 31 There was no significant difference between the two groups with respect to ultrafiltration a two week study in high average high transporter APD patients 4 hour D P Creatinine ratio
109. n this screen to view or update the prescription For additional information please see the Pending Patients User Guide VIEW PRINT PRESCRIPTION 1 To view or print the prescription from the prescriptions box in the Do list click the View Print Rx for that patient the system displays a separate window with a PDF of the prescription 5 ora genere er 23 Day isat ds se nt priest abo Example 2 Click on the Print icon at upper left to print the prescription 3 Click Home to return to the To Do list SEND COMMENTS TO BAXTER 1 To send comments to Baxter concerning the prescription from the prescriptions box in the To Do list click the Send Comments link for that patient the system displays the Demographics Info tab Eat Renal Science Solutions Systems Support EDT MYPROPLE COMACTUS Le cu HomeCare Services lore Vin Update Patient What De Need To Do Here Patents aro editing rion CLARK Create New Patent Arrests cui a Manage Parts condor rena Transfer Patient Diabet statue ra ZI Ei Manage fv Bound doaf Enter patient comments Manage Preston Templates
110. na oo Festina Example Find the prescription and use the Select Physician for eSignatue drop down to select the physician Click on the Forward to Physician link to forward the prescription to the physician for eSignature The system displays the Remind Physician Confirmation message Click Ok HomeCare Services recta ee Welcome 101008 52615 PN Wal id To Da Hat Vos ta range ciaoo Shen sens ee pane sane ii Re ree p endi in Desde Ps n E ao mr ht es dea it oo i ig uen Manage Preseriptnn Patient Hame Mew comenta eM p Soloct Physician for Commenta Prescription Order reminder c Ar etie dor m to baner Tees n Orders 7 Physician Confirmation preme Temi Wenn Forwarded to Physician for Approval ET EC REI N pesa vit ml cessi css visus 9 vara n ze menta ere Example TO PRINT PRESCRIPTION FOR YOUR FILES 1 Click the Print the Prescription link in the To Do list box for renewals the system displays separate window with a PDF of the prescription vu GRO A ee o a ED Example 2 Click on the Print icon at upper left to print the prescription Prescription renewals print wit
111. nage Presciipions Reports Presenpion Templates orders nter Histor Hence esteso reports rom Your Lem Hand aecton o ensure accuracy Example To see a list of these patients click the Click Here link to display the system displays Pending Scheduled Order Patients in a box below the link you just clicked CHANGE CLINIC EDITMYPROFILE CONTACTUS LOGOFF DIRECTACEESS TEST emen HomeCare Services DirectAccess Nome Home Welcome MARY Last togi 0 13 09 2 55 10 What Do Hee To Do Here Patients Sale Create New Patent 2 Vouhave i Pending Patients Clckchere to e outes 14 Pressione thet require physician s signature Cic ber ops TRA outas 2 whe have no place ter setesi order CL si o dila Transfer Palin Pena Scheduled Order Pacte Pieergtera Paier name Revew _ Manage Prescrgton GMARBEOIT view Calor Vi tone Templates View calendor pom FATA Youtove 1 tt changes eter e ei TER Reports creats siat Peer marepate m your Let Hand len tenere cee Manage tt Adverse Eront Example 2 You can then use the system to view the patient s calendar look at order history or send a comment to Baxter by clicking on the appropriate link for that patient VIEW CALENDAR 1 To view a patient s calendar click on the View Calendar link for that patient the system displays the calenda
112. nsigned prescription the system will not confirm the change Instead the system displays the following message which tells you that there are outstanding prescriptions for the patient and that all patient prescriptions must be signed before the patient can be inactivated Active Prescriptions There are outstanding prescriptions for thiis patient AN patient prescriptions must be signed before this patient can be activated If you receive this message click Ok and work your unsigned prescriptions from your To Do list AUTOMATED PERITONEAL DIALYSIS APD PATIENT In the situation where the patient you are inactivating is an APD patient the system will continue the process in order to manage the return of APD hardware and disposables APD PATIENT HARDWARE PICKUP The system displays the Hardware Pickup screen HomeCare Services DrectaccessHome Patents Search View Update Patient HOME Hardware Pickup Patients ote Hardware Pickup for MASTERS DERMIS Create Nen Patent CortactType Cal patients primary contact C cal sinc oter Manage Patents B Transter Patent Manage Prescriptions Contact Manage Presciption Details 2 orcertistoy E Example Choose the Contact Type by clicking the radio button to identify who should be contacted to make arrangements for the pickup of the patient s cycler Selecting Call patient s primary contact indicates
113. octing praseription Prescription Quantity Mo Product Cox Example 5 Once prescriptions have been reviewed the current status is displayed in the eSign Status column In the Comments column it s indicated that comments were entered for the rejected prescription To apply the eSignature to prescriptions Approved for eSign click on Proceed to eSignature Rev sero What bal Need To Do Here Lastilame Firstiiame DOB Effective Dato Expiration Dato estan Statue Comments sereetan IT SEASHELL po nana aam Approved For eSign n Review Prescription New Line tems onthe Prescription are highlighted in yellow Max Quantity aa LitersDay 10 Product Pack pescupten Rove cusan Factor Example z 6 The eSignature tab displays with the prescription s that are approved for eSignature Click on Apply eSignature What Do iNeed To Do He Last name DOB Emecnve Date Expiration Date stans SEASHELL nano nam Approved ror Example 7 The Verify Credentials window displays Enter the User Name and Password that was used to log in to DirectAccess online tool Physician Assistants and Nurse Practitioners will be required to select a physician from the On Behalf Of drop down box Click the eSignature terms check box and click Authorize
114. of protein amino acids and water soluble vitamins may occur during peritoneal dialysis Replacement therapy should be provided as necessary Pregnancy Teratogenic Effects Pregnancy Category Animal reproduction studies have not been conducted with DIANEAL Low Calcium peritoneal dialysis solutions It is also not known whether DIANEAL Low Calcium peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity DIANEAL Low Calcium peritoneal dialysis solutions should be given to a pregnant woman oniy if clearly needed Do not administer unless solution is clear and seal is intact Adverse Reactions Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement Abdominal pain bleeding peritonitis subcutaneous infection around a chronic peritoneal catheter catheter blockage difficulty in fluid removal and ileus are among the complications of the procedure Solution related adverse reactions may include electrolyte and fluid Imbalances hypovolemia hypervolemia hypertension hypotension disequilibrium syndrome and muscle cramping When prescribing the solution to be used for an individual patient consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing lnesses For example rapid potas
115. om DESCRIPTION EXTRANEAL icodextrin Peritoneal Dialysis Solution is peritoneal dialysis solution containing the colloid osmotic agent icodextrin Icodextrin is starch derived water soluble glucose polymer linked by alpha 1 4 and less than 10 alpha 1 6 glucosidic bonds with a weight average molecular weight between 13 000 and 19 000 Daltons and a number average molecular weight between 5 000 and 6 500 Daltons The representative structural formula of icodextrin ES 150 535 mg 448 mg Calcium Chloride USP 257 mg Magnesium Chloride USP amp 08mg Electrolyte content per liter Sodium 132 mEg L Calcium 35 Magnesium 05 mEg L Chloride 96 lactate Water for Injection USP qs HCUNaOH may have been used to adjust pH EXTRANEAL contains no bacteriostatic or antimicrobial agents Calculated osmolarity 282 286 mOSm L pH 5 0 6 0 EXTRANEAL is available for intraperitoneal administration only as sterile nonpyrogenic clear solution in AMBU FLEX II AMBU FLEX Il and ULTRABAG containers The container systems are composed of polyvinyl chloride Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period ethylhexyl phthalate DEHP up to 5 parts per milion however the Safety of the plastic has been confirmed in tests in animals according to USP biological tests tor plastic contain
116. peritoneal dialysis Ann Intern Med 8 449 456 Potter D E et al 1981 Continuous ambulatory dialysis CAPD in children Trans Am Soc Artif Intern Organs 27 64 67 Ribot S et al 1966 Complications of peritoneal dialysis Am J Med Sel 252 50 Twardowski 2 1 and Janicka L 1981 Three exchanges with a 2 5 liter volume for continuous ambulatory peritoneal dialysis Kidney Int 20 281 284 Twardowski Z J et al 1983 High volume low frequency continuous ambulatory peritoneal dialysis Kidney Int 23 64 70 Twardowski 2 and Burrows 1 1984 Two year experience with high volume low frequency continuous ambulatory peritoneal dialysis Peritoneal Dial Bull 4 567 Vaamonde and Perez G O 1977 Peritoneal dialysis today Kidney 10 31 38 Table 1 compio s 8g Iu MERE 88 mb conaner sli d i we oe a 5 A m Code s ililili 2 35 88 3200 eo nocosstasitos E Am 50 tesies Vom ma ing mo 9 hme as os 15 Doe J Som resia mo Canter Sm io i i P02 P EB Sio win omm ma moe Aem as os m f s Em Nog oot oa ae 15 Dots E
117. play You have 8 patents who have not place ther schedule order isk here to display You ave 2 Staff changes Cick hare to Manage Patients Transfer Patient Menage Prescnptons Manage erescnpton Example 1 In the navigation bar on the left click Manage Patients the system displays the Search Patients screen HomeCare Services Diecthecess Home Manage Patients Search HOME Search Pationts AIA RE gt a dd em Templates Am _ on Example 2 Enterthe patient s last name make sure All is selected in the Status drop down and select the patient s therapy from the Therapy drop down Click Search The system displays the Patient Search Results screen HomeCare Services Cirscthecsea Home Manage Patiente Search gt Ros HOME Patient search results Patients Lastilame Firstilame Mi Staue DOB AccountMo Edit Create New Patient MASTERS View Update Calendar Assign Sar Manage Fatlents One resuitfeund KERES Transfer Patient Manage Fresciptons Example 8 Click the View Update link the system displays the Basic Info tab of the View Update Patient screen The note indicates the name of the patient you are inactivating CHANGE CME aace HomeC
118. plete healing abdominal tumors abdominal wall infections hernias fecal fistula colostomies or ilaostomies frequent episodes of diverticulitis inflammatory or ischemic bowel disease large polycystic kidneys or other conditions that compromise the integrity of the abdominal wall abdominal surface or intra abdominal cavity such as documented loss of peritoneal function or extensive adhesions that compromise peritoneal function Conditions that preclude normal nutrition impaired respiratory function recent aortic graft placement and potassium deficiency may also predispose to complications of peritoneal dialysis Aseptic technique should be employed throughout the peritoneal dialysis procedure to reduce the possibility of infection Following use the drained fluid should be inspected for the presence of fibrin or cloudiness which may indicate the presence of peritonitis Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention feeling of fullness and or shortness of breath Treatment of overinfusion is to drain the peritoneal dialysis solution from the peritoneal cavity Need for Trained Physician Treatment should be initiated and monitored under the supervision of a physician knowledgeable in the management of patients with renal failure A patient s volume status should be carefully monitored to avoid hyper hypovolemia and potentially severe consequences inclu
119. promotes value and makes a meaningful difference in our customer s lives TABLE OF CONTENTS Logon and Navigation Create New Patient Pending Patients Prescriptions eSigning Prescriptions Scheduled Orders Patient Status Change How To Put a Patient on Hold Patient Status Change How To Inactivate a Patient Modality Changes Managing Staff Changes Site Admin Only Appendices Logon and Navigation A 8 Services DirectAccess Online Tool Logon and Navigation LOGON Use your browser Internet Explorer 6 0 and above and Firefox 1 5 and above to go to the login page of the DirectAccess online tool using the link you receive from Baxter s HomeCare Services Baxter Renal Science Solutions Systems Support contactus Welcome to DirectAccess HomeCare Services Please log in Direct ccess supports Microsof Internet Explorer 6 0 and above and Firefox 1 5 end above This system is for authorized business use only Unauthorized access or may a violation of law This organzaton has the abili and reserves righi to monitor system in accordance wih applicable law tor purposes of securi and ensuring compliance law the company s policies regarding the use ot rs computer systems This site contains contcential patent deta You must aways ext ihe site using the LOGOFF button You should
120. r HomeCare Services DrectAoccoo Homo gt Pationt Calendar ome Paterts 3010 ROSEMARY Ul Create New Patient Manage Patents Transfer Patient ot me ven e svety nn Manage Prescriptions Manage Presciption a Renal Dsbn Account unter J p Order Scheduled ship scheduled Deliver Order Scheduled ship Scheduled Delver Order History Date Date DIS tee bate sur Croato stan nne Dr on Cn Manage Stat manes over prm COE were 12070 suono EET Repons Den wise HH CEI IEZI m weno Patients Who Have Not vote LI Placed An Order esign staus EXTRANEAL Deny bemos Please see Indicalions ind To piece your creer please call your representative HILDA GALLARDO at 1 200 784 4060 Risk formation To ensure a complete delivery on your scheduled day please place your order on your Order Date fitis necessary to make Tor EXTRANZAL codetin changes to your order please not us no ter han ive 5 working days prior to he scheduled Ship Date PO senton your delivery happens to on one of the above holidays your revised delivery date wil be communiceted atime of order Please see Prescibing placement Information for EXTRANEAL a ieodentin PO Solution
121. r DI Template dine use 73 CLIC a amo orti peoos E osi E ai a lesi ee E SERI ero E T Talis me Ae On Hid utei LU C Eus Femin tar me eurertyinderoing Luer Conversion Please tac Confirmation Change frm fo 1 800 006 8467 in order ur Luer cesto n Piesa as Indistione and S068 te pater presenter Example 8 You can create the prescription either by using a template or creating it by adding the items from the List of Items on the left to the Prescription Cart like a shopping cart on the right Template To use a template select the template from the drop down list in the Apply Template box and click Apply the system adds the items in the template to the Prescription Cart SlandardTemplae List of Products by Category To populate the List of Products select a category of products from the Category dropdown this adds all the items in the category to the List of Products You can also add products to the list by entering a search term in the Search Products box under the drop down category ax search zm mede APD Acceasorea Aro icone CAPO Accessi Product ranae Ganea Accessories FO Anci omer Haraware Seuore 9 With the List of Products populated you can move items from it to the Prescrip
122. rogenase pyrroloquinolinequinone GDH PQQ or glucose dye oxidoreductase GDO Some blood glucose monitors or test strips that use glucose dehydrogenase flavin adenine dinucleotide GDH FAD also must not be used You or your nurse or doctor should call the manufacturer of your blood glucose monitor and test strips to make sure that the maltose in EXTRANEAL icodextrin will not affect your blood sugar test results are hospitalized or go to an emergency room tell the hospital staff that you use EXTRANEAL so that they use the right kind of blood sugar monitor and test strips for you You can get information on glucose monitor and test strip methods from their manufacturers For a list of toll free numbers for glucose monitor and test strip manufacturers you can ask your doctor or go to www glucosesafety com What is EXTRANEAL EXTRANEAL is a prescription peritoneal dialysis solution EXTRANEAL draws fluid and wastes from your bloodstream into your peritoneal cavity the space inside your abdomen The fluids and wastes are removed from your body when the EXTRANEAL solution is drained EXTRANEAL is for the long dwell exchange 8 hours to 16 hours in peritoneal dialysis The long dwell is the exchange that lasts 8 hours or more the nighttime exchange if you are on continuous ambulatory peritoneal dialysis CAPD the daytime exchange if you are using a cycler EXTRANEAL is not for intravenous injection injection into
123. rt d rtves may be incompatible Do not store solution containing additives Approximately two liters of dialysis solution are instiled into the peritoneal cavity of adults and the peritoneal access device is then clamped The solution remains in the cavity for dwell times of 4 to 8 hours ring the day and 8 to 12 hours overnight At the conclusion of each duel period the access device is opened the solution drained and fresh solution instiled The procedure is repeated 3 to 5 times per day 6 107 days per week Solution exchange frequency should be individualized for adequate biochemical and fuid volume control The majority of exchanges utlize 1 5 or 2 5 dextrose containing peritoneal dialysis solutions with 4 25 dextrose containing solutions being used when extra fluid removal is Tequired Patent weight is used as the indicator at the need for fluid removal Directions for Use Use aseptic technique For complete system preparation se directions accompanying ancilary equipment Preparation tor Administration 1 Gather supplies 2 Tear the container overpouch firmly dm the side from top slit and remove Some opacity of the plastic due to moisture absorption during the sterilization process may be observed This is normal and does not affect the soluton quality or safety The opacity should diminish gradually Place container on work station Unco tubing Inspect the patient connector to ensure the pul ring is attached Do not use
124. s USP 0 Glucopyranose monohydrate Baxter Dianeal Ambu Flex and PL 146 are trademarks of Copyright 1981 1982 1983 1984 1989 2008 Baxter Healthcare Corporation Baxter International Inc All rights reserved 07 19 60 956 Baxter Healthcare Corporation 2009 08 Deerfield IL 60015 USA Printed in USA BAR CODE POSITION ONLY 071960956 Dianeal Low Calcium Peritoneal Dialysis Solution UltraBag System For Continuous Ambulatory Peritoneal Dialysis CAPD For intraperitoneal administration only Description Dianeal Low Calcium peritoneal dialysis solutions are sterile nonpyrogenic solutions in UltraBag containers for intapertoneal administration ony They contain bacteriostatic antimicrobial agents containers are designed with an integrated Y set and drain container or infusion and drainage of Dianeal Low Calcium when disconnection of the Y set from the transfer set during dwell is desired Composition calculated osmolarity pH and ionic concentrations are shown in the following table Excessive use of Daneal Low Calcium pertonea dialysis solution with 425 dextrose during a peritoneal treatment result in significant removal of water from the patient Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors as well as other indicators patient status It the rese
125. sed risk of infection Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container Moreover microwave oven heating may potentially cause overheating and or non uniform heating of the solution that may result in patient injury or discomfort To Open Tear overwrap down side at slit and remove solution container Some opacity of the plastic due to moisture absorption during the sterilization process may be observed This is normal and does not affect the solution quality or safety The opacity will diminish gradually If supplemental medication Is desired follow directions below before preparing for administration Check for minute leaks by squeezing container firmly To Add Medication Additives may be incompatible If the resealable rubber plug on the medication port is missing or partially removed do not use product if medication is to be added 1 Put on mask Clean and or disinfect hands 2 Prepare medication site using aseptic technique 3 Using a syringe with a 1 inch long 19 to 25 gauge needle puncture resealable medication port and inject medication 4 Position container with ports up and evacuate the medication port by squeezing and tapping it 5 Mix solution and medication thoroughly Preparation for Administration 1 Put on mask Clean and or disinfect hands 2 Place solution container on work surface 3 Remove pull ring from connector of the solution cont
126. sis Facility 10 Territory Baxter assigned sales territory 11 HCSR Name The name of the primary HomeCare Service Representative HCSR Their telephone number is displayed 2 and their extension is 12 12 Phone The HCSR telephone extension Patient Information 13 Patient Name Patient name 14 Patient number Patient number assigned by Baxter different than the account number for the dialysis center 15 Mode Current therapy 16 Active Date The date the patient started with the specified Dialysis Facility Patients that are active with he Dialysis Facilty will appear at the beginning of the report 17 Inactive Date Patients that are NOT active with the Dialysis Facility and have year to date values wil be moved Prescription Information SO Fix Expiration Date The expiration date of the Standing Order Prescription SO Rx 19 5B Max The prescribed monthly PD solution maximum denoted in the prescription as 58 Max 20 Product Code Baxter assigned product code number LEASED HARDWARE is indicated by an L suffix on the product code ex 5C4471L 21 Description Baxter product name description 22 On SO Rx letter Y yes in the On SO Rx column indicates a product currently on the patients prescription All products that are not currently active on the Rx but have had activity during the current year will appear on the report 23 SORxQy Quantity prescribed ORDER INFORMATION Order numb
127. sis solutions has been raised to 40 mEg L Serum bicarbonate levels should be monitored The osmolarties shown in Table 1 are calculated values Calculated osmolarity of DIANEAL Low Calcium peritoneal dialysis solution with 1 5 dextrose is 344 mOsmol L compared with measured values in normal human serum of 280 mOsmol L The pase container is fabricated rom specialy formulated poly chloride PL 146 Plastic The amount of water that can permeate from inside the Container into the overpouch is insufficient to affect the solution significantly Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period 0 di 2 ethyihexyi phthalate DEHP up to 5 parts per million however the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies Clinical Pharmacology Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys and for aiding in the regulation of fluid and electrolyte balance The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the peritoneal cavity With the exception of lactate present as a bicarbonate precursor electrolyte concentrations in the fluid have been formulated in an attempt to normalize plasma electrolyte concentrations resulting from
128. sium removal may create arrhythmias in cardiac patients using digitalis or similar drugs digitalis toxicity may be masked by elevated potassium or magnesium or by hypocalcemia Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess Conversely toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high Azotemic diabetics require careful monitoring of insulin requirements during and folowing dialysis with dextrose containing solutions Dosage and Administration DIANEAL Low Calcium peritoneal dialysis solutions are intended for intraperitoneal administration only Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit The mode of therapy Intermittent Peritoneal Dialysis IPD Continuous Ambulatory Peritoneal Dialysis CAPD or Continuous Cyclic Peritoneal Dialysis CCPD frequency of treatment formulation exchange volume duration of dwell and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange Peritoneal dialysis solutions may be warmed in th
129. spital The manufacturer s of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose readings For a list of toll free numbers for glucose monitor and test strip manufacturers please contact the Baxter Renal Clinical Help Line 1 888 RENAL HELP or visit www glucosesafety com EXTRANEAL is intended for intraperitoneal administration only Not for intravenous injection Encapsulating peritoneal sclerosis EPS is a known rare complication of peritoneal dialysis therapy EPS has been reported in patients using peritoneal dialysis solutions including EXTRANEAL icodextrin Infrequent but fatal outcomes have been reported It peritonitis occurs the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism s when possible Prior to the identification of the involved organism s broad spectrum antibiotics may be indicated Rarely serious hypersensitivity reactions to EXTRANEAL have been reported such as toxic epidermal necrolysis angioedema serum sickness erythema multiforme and leukocytoclastic vasculitis If a serious reaction is suspected discontinue EXTRANEAL and institute appropriate treatment as clinically indicated Patients with severe lactic acidosis should not be treated with lactate based peritoneal dialysis solutions See CONTRAINDICATIONS It is recommended tha
130. ssiouni 1971 Continuous Ambulatory Peritoneal Dialysis CAPD and Continuous Cyclic Peritoneal Dialysis For maintenance dialysis of chronic renal failure patients In CAPD typically 1 5 to 3 0 liters of dialysis solution depending upon patient size are instilled into the peritoneal cavity of adults and the peritoneal access device is then clamped Kim et al 1984 Twardowski and Janicka 1981 Twardowski and Burrows 1984 For children 30 to 50 mL Kg body weight with a maximum of 2 liters has been recommended Potter at al 1981 Irwin et al 1981 The solution remains in the cavity for dwell times of 4 to 8 hours during the day and 8 to 12 hours overnight At the conclusion of each dwell period the access device is opened the solution drained and fresh solution instilled The procedure is repeated 3 to 5 times per day 6 to 7 days per week Solution exchange volumes and frequency of exchanges should be individualized for adequate biochemical and fluid volume control Moncrief et al 1982 Twardowski et al 1983 The majority of exchanges will utilize 1 5 or 2 5 dextrose containing peritoneal dialysis solutions with 3 5 or 4 25 dextrose containing solutions being used when extra fluid removal is required Patient weight is used as the indicator of the need for fluid removal Popovich et al 1978 CCPD the patient receives 3 or 4 dialysis exchanges during the night which range from 2 1 2 to 3 hours dwell duration Typ
131. t Demis O Pater asenn Wat Do Need Do Here Pationts oe ame LEW SUSE Create New Patent naretes requrea Tet Business 2 Manage Patients castiame s alia Transfer Patient FretWame 90 T nosienumbe M Manage Prescriptions iom Fax Number Manage Presciption Aadress REN CENTER GEO WASHNGTON EH 018 upinumber 500002000 orders Order History 527 EE Ste DE z Create Stat Zo Manage Statt jose en 2 Make any necessary changes and click Save the system confirms the changes Example 3 If a Staff Member forgets their password verify the e mail address and click on the Generate New Password button to send a new temporary password to the user s e mail address the system confirms that the password was sent MANAGE STAFF ASSIGN PATIENTS BY STAFF MEMBER 1 To assign patients to a staff member click on the Patients tab the system displays the Patients screen which contains a list of all patients at the clinic EDIT my PROALE CONTACTUS HomeCare Services Direct ccess Home Manage Staff Edit Staff Member statt statt betats Patents eso Patients motez amc LEW SUSIE Create New Patient Account First leme MiddleName Manage Patients 37067780 ARDA Trensler Patient rj cina ner Manage Prescripicne r
132. t a rate that is comfortable for the patient Do not use EXTRANEAL if it is cloudy or discolored if it contains particulate matter or if the container is leaky Following use the drained fluid should be inspected for the presence of fibrin or cloudiness which may indicate the presence of peritonitis For single use only Discard unused portion Addition of Potassium Potassium is omitted from EXTRANEAL solutions because dialysis may be performed to hyperkalemia In situations where there is normal serum potassium level or hypokalemia the addition of potassium chloride up to a concentration of 4 mEG L may be indicated to prevent severe hypokalemia The decision to add potassium chloride should be made by the physician after careful evaluation of serum potassium Addition of Insulin Addition of insulin to EXTRANEAL was evaluated in 6 insulin dependent diabetic patients undergoing CAPD for end stage renal disease No interference of EXTRANEAL with insulin absorption from the peritoneal cavity or with insulin s ability to control blood glucose was observed See PRECAUTIONS Drug Laboratory Test Interactions Appropriate monitoring of blood glucose should be performed when initiating EXTRANEAL in diabetic patients and insulin dosage adjusted if needed See PRECAUTIONS Addition of Heparin No human drug interaction studies with heparin were conducted In vitro studies demonstrated no evidence of incompatibility of heparin
133. t home delivery and click Send Order The system displays the Confirmation screen The system tells you that your information has been successfully saved and the prescription has been created The prescription now requires a prescriber s signature either esignature or handwritten signature on printed prescription is acceptable The system also asks if you wish to save the prescription as a template you select Yes you can use it as a starting point for other prescriptions E signing within DirectAccess online tool allows physicians to attach e signatures to prescriptions This is the preferred method for signing prescriptions Refer to Section 5 for more details To return to the To Do list click Home from the left navigation bar HomeCare 272 Services Prescriptions Prescriptions After logging on the system displays the DirectAccess online tool Home Page An item on the To Do list identifies the prescriptions that require attention HomeCare Services Home Malone MARY MASTIN Lae lei 30 1208 sas PM pem 2 Yau hava E onding Pees Clit baneta o You ave m Perito ere yi signature parto wiw laced thir ached onder er do A EN cer Li tesse aly Example Prescription To Dos may consist of Recent prescription changes requiring a prescriber s review and signature New patient prescriptions
134. t patients with conditions known to increase the risk of lactic acidosis e g acute renal failure inborn errors of metabolism treatment with drugs such as metformin and nucleoside nucleotide reverse transcriptase Inhibitors NRTIS must be monitored for occurrence of lactic acidosis before the start of treatment and during treatment with lactate based peritoneal dialysis solutions When prescribing the solution to be used for an individual patient consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses Serum potassium levels should be monitored carefully in patients treated with cardiac glycosides For example rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs digitalis toxicity may be masked by hyperkalemia hypermagnesemia hypocalcemia Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess Conversely toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high PRECAUTIONS General Peritoneal Dialysis Related The following conditions may predispose to adverse reactions to peritoneal dialysis procedures abdominal conditions including uncorrectable mechanical defects that prevent effective PD or increase the risk of infection disruption of the peritoneal membrane and diaphragm by surgery congenital anomalies or trauma prior to com
135. tains maltose which can react with certain blood glucose blood sugar monitors and test strips Using EXTRANEAL may cause a false incorrect high blood sugar reading or may hide a blood sugar reading that is actually very low This can happen if you use a glucose monitor or test strips with glucose dehydrogenase pyrroloquinolinequinone GDH PQQ glucose dye oxidoreductase GDO or glucose dehydrogenase flavin adenine dinucleotide GDH FAD at any time during treatment or within approximately 2 weeks 14 days after you stop treatment with EXTRANEAL This kind of false reading means that your blood sugar may really be too low even though the test says that itis normal or high This can lead to dangerous side effects You could accidentally wait too long to treat your low blood sugar if you have low blood sugar and do not use the right kind of monitor and test strips You could accidentally take too much insulin if you have a false high blood sugar reading Taking too much insulin or waiting too long to treat low blood sugar can cause you to have serious reactions including loss of consciousness passing out coma permanent neurological problems or death Ifyou have high blood sugar or diabetes and monitor your blood glucose you must use a specific glucose monitor and test strips during treatment with EXTRANEAL and up to 2 weeks after stopping EXTRANEAL Do not use blood glucose monitors or test strips that use glucose dehyd
136. thccess Manage Patents Search View Update Patient HOME J sasie into Coraes Do I Neea To Do Here Patents Note Vou are editing patient ABBOTT GINA Create New Patient iaia retire Manage Fallen ast ame Told Reason Transter Patent ra Please select tne reason this patient is being put on ho Janage Presciptans Tisi ame ac Manage Presciipton CENTER HENO Templates Care Orr Post Orders delivery Order History Mmm ESI ay Create star state Manage staf T TRANSFERRING UNITS ee PATIENT TRANSPLANTED PATENT FOR TRANSPLANT Repons Example 5 Select the appropriate Hold Reason from the list and click Save The system confirms the save click Ok The patient s status has been changed Inactivate A Patient A 8 Services Patient Status Change How To Inactivate a Patient The following steps will guide you in changing a patient s status from an Active or Hold status to Inactive After logging on the system displays the DirectAccess online tool Home Page CLINIC EDIT MY PROFILE CONTACTUS NELP FAQ LOGOFF DRECTACCESS TEST HomeCare Services Birectaceess Home BONE Welcome MARY MARTIN Last login 10210004642 AM What Do need To Do Patents abd Create New Patient Yeu have 17 Preserpons that recure physisiar s signature Click here to dis
137. ther staff member by clicking the appropriate links HomeCare 272 Services Appendices SIMPLE Report Guide APPENDIX A1 This list reflects all of the terms displayed in the three sections of the SIMPLE Report Patient Detail Patient Summary and Product Summary All reports do not contain all the data fields listed here All of the terms defined here are used in one or more reports and the number of the data field is on the report samples attached to the end of the report The patient will remain on the report for the calendar year if activity has occurred 1 _550555 Number identifies report used internal Baxter 2 Home Patient Customer Service The 800 telephone number for placing product orders and making delivery inquires 3 The Report Name name of the report 4 Date For the most recent months information displayed 4a Range The range of the dates for the included in this specific report 5 DateandTime Date and time the report is printed generated Page Number Page number located in upper right hand corner can be helpful it discussing report 6 Patient Detail The name of the specific section of the SIMPLE Report ex Patient Detail Product Detail or Product Summary 7 Baxter assigned account number for Dialysis Facility B Facility Name The name of the Dialysis Facility 8 Phone telephone number for the Dialy
138. thin the connector or pull ring may be present due to condensation of water resulting from the sterilization process If a continuous stream of fluid is noted discard solution because sterility may be impaired After removing overwrap check for minute leaks by squeezing container firmly If leaks are found discard the solution because the sterility may be impaired Freezing of solution may occur at temperatures below 0 C 32 F Do not flex or manipulate container when frozen Allow container to thaw naturally in ambient Conditions and thoroughly mix contents by shaking Precautions Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection If peritonitis occurs the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism s when possible Prior to identification of the involved organism s broad spectrum antibiotics may be indicat Peritoneal dialysis solutions may be warmed in the overpouch to 37 C 98 6 F to enhance patient comfort However only dry heat for example heating pad should be used Solutions should not be heated in water due to an increased risk of infection Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container Moreover microwave oven heating may potentially cause overheating and or non uniform hea
139. thods must not be used Use of GDH PQO GDO and GDH FAD based glucose monitors and test strips has resulted in falsely elevated glucose readings due to the presence of maltose see PRECAUTIONS Drug Laboratory Test Interactions Falsely elevated glucose readings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately Both of these situations have resulted in unrecognized hypoglycemia which has led to loss of consciousness coma permanent neurological damage and death Plasma levels of EXTRANEAL icodextrin and its metabolites return to baseline within approximately 14 days following cessation of EXTRANEAL icodextrin administration Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of EXTRANEAL icodextrin therapy when GDH POQ GDO and GDH FAD based blood glucose monitors and test strips are used Because GDH POO GDO and GDH FAD based blood glucose monitors may be used in hospital settings it is important that the health care providers of peritoneal dialysis patients using EXTRANEAL icodextrin carefully review the product information of the blood glucose testing system including that test strips to determine if the system is appropriate for use with EXTRANEAL icodextrin To avoid improper insulin administration educate patients to alert health care providers of this interaction whenever they are admitted to the ho
140. tics with EXTRANEAL See DOSAGE AND ADMINISTRATION Drug Laboratory Test Interactions Blood Glucose Blood glucose measurement must be done with a glucose specific method to prevent maltose interference with test results Falsely elevated glucose levels have been observed with blood glucose monitoring devices and test strips that use glucose dehydrogenase pyrroloquinolinequinone 60 00 glucose dye oxidoreductase GDO and some glucose dehydrogenase flavin adenine nucleotide GDH FAD based methods GDH POQ glucose dye oxidoreductase and some GDH FAD based methods must not be used to measure glucose levels patients administered EXTRANEAL See WARNINGS Serum Amylase apparent decrease in serum amylase activity has been observed in patients administered EXTRANEAL Preliminary investigations indicate that icodextrin and its metabolites interfere with enzymatic based amylase assays resulting in inaccurately low values This should be taken into account when evaluating serum amylase levels for diagnosis or monitoring of pancreatitis in patients using EXTRANEAL Carcinogenesis Mutagenesis Impairment of Fertility Icodextrin did not demonstrate evidence of genotoxicity potential in in vitro bacterial cell reverse mutation assay Ames test in vitro mammalian cell chromosomal aberration assay CHO cell assay and in the in vivo micronucleus assay in rats Long term animal studies to evaluate the carcinogenic potential of EXTRA
141. ting of the solution that may result in patient injury or discomfort Significant losses of protein amino acids and water soluble vitamins may occur during peritoneal dialysis Replacement therapy should be provided as necessary Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with DIANEAL peritoneal dialysis solutions it is also not known whether DIANEAL peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity DIANEAL peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed Do not administer unless solution is clear and seal is intact Adverse Reactions Adverse reactions to peritoneal dss include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement Abdominal pain bleeding peritonitis subcutaneous infection around a chronic peritoneal catheter catheter blockage difficulty in fluid removal and ileus are among the complications of the procedure Solution related adverse reactions may include electrolyte and fluid imbalances hypovolemia hypervolemia hypertension hypotension disequilibrium syndrome and muscle cramping Dosage and Administration DIANEAL PD 2 solutions are intended for intraperitoneal administration only Parenteral drug products should be inspected visually for particulate matter an
142. tion Baxter Extraneal UltraBag and Ambu Flex are trademarks of Baxter International Inc Baxter Healthcare Corporation Deerfield IL 60015 USA Printed in USA 07 19 65 351 2010 10 071965351 07 19 65 351 HOW SUPPLIED EXTRANEAL icodextrin Peritoneal Dialysis Solution is available in the following containers and fill volumes Container Fill Volume ULTRABAG 151 NDC 0941 0679 51 ULTRABAG 20L NDC 0941 0679 52 ULTRABAG 251 NDC 0941 0679 53 AMBU FLEX III 15L NDC 0941 0679 45 AMBU FLEX III 20L NDC 0941 0679 47 AMBU FLEX III 25L NDC 0941 0679 48 AMBU FLEX II 20L NDC 0941 0679 06 AMBU FLEX II 25L NDC 0941 0679 05 Each 100 mL of EXTRANEAL contains 7 5 grams of icodextrin an electrolyte solution with 40 mEq L lactate Store at 20 25 68 77 F Excursions permitted to 15 30 59 86 F See USP Controlled Room Temperature Store in moisture barrier overwrap in carton until ready to use Protect from freezing Rx Only 07 827 MEDICATION GUIDE EXTRANEAL X tra neel icodextrin Peritoneal Dialysis Solution Read the Medication Guide that comes with EXTRANEAL before you begin treatment and each time you receive a carton of EXTRANEAL There may be new information This information does not take the place of talking with your doctor about your medical condition or your treatment What is the most important information should know about EXTRANEAL EXTRANEAL icodextrin con
143. tion Cart You can also remove items from the Cart Wi eda atm Pate Tavra nenea restore na 87 uae 80476 EFFLUENT SAMPLE BAG TET EK I e maraga ar osup sad eine E mm EET TUER TIPI Rear 7272 77 7 Resort mers seran UPON fe et E ie Linea denti Deira Pato soo aon ans Fenici iene te ci Snyder Luer Conversion ese a an cnm hanger BRE B457 ea Example To move an item from the List of Products to the Prescription Cart click on the symbol the system will move the item to the Prescription Cart To remove an item from the Prescription Cart click the X symbol in the Remove column the system removes the item Click View Update to change the line quantity on an item Click Calculate to calculate how many boxes a patient will need for their delivery cycle based on how many bags per day they will be using 10 When you are done click Save CREATE UPDATE PRESCRIPTION SCREEN REVIEW PRESCRIPTION TAB The system displays the Review Prescription tab for your review HomeCare Services main Date 60 quc Ben ras line re perii bee i um s
144. tion container into the overpouch is insufficient to affect the solution significantiy Solutons in contact With the plastic container may leach out certain chemical components from th plastic in very small amounts however biological testing was supportive of the safety of be plastic container materia Clinical Pharmacology Peritoneal dialysis is a procedure for removing tre substances and metaboltes normaly excreted by the Kidneys and Tor aising n e regulation of fd and decr te ance The procedure is accomplished by sting peritoneal dialysis fud tough a conduit into the peritoneal caii Td substances and present im hi concentration i te blood cross the peroneal membrane into tne dalyng fuid Dextrose in the dang fud used to produce a solution hyperosmolar to the plasma creating an emot gradient wich facitates fud removal rm the patents plasma into the peritonea Afer a period of time duell ime the udis drained by graviy cai The solution does not contain potassium n situations in wich there is norma serum possum level or hypokalemia the adition of potassium chloride up to a concentration of 4 mg may be indicated to prevent severe Addition of potassium chloride should be made afler careful evaluation ot Serum and total Body potassium and oniy under tne direction ot a physician Cina studies have demonstrated the use of ttis solution resulted in sigan increases in serum CO amd decreases in serum m
145. tion tor Administration 1 Gather supplies 2 Tear the container overpouch firmly down the side from top slit and remove Some opacity of the plastic due to moisture absorption during the sterilization process may be observed This is normal and does not affect the solution quality safety The opaci should diminish gradually Place container on work surface tubing Inspect the patient connector to ensure the pull ring is attached Do not use if pull ring is not attached to the connector Inspect tubing and drain container for presence of solution It solution is noted discard units NOTE Smal water droplets are acceptable Squeeze container to check for leaks and broken solution frangible Note solution flow past the frangible Discard if container or solution frangible leaks because sterility may be impaired Administration Procedure for the UltraBag Container Exchange The Steps Refer to the Corresponding Administration Steps It Supplemental Medication is Prescribed 1 Inspect container to ensure resealable rubber medication portis in place Discard i rubber injection port is not attached to container port Put on a mask Prepare medication port according to aseptic technique Using a syringe with a 1 inch long 19 to 25 gauge needle puncture resealable medication port and inject medication Position container with medication port facing upward Squeeze and tap medication port to empty solution
146. toneal dialysis solution with 425 dextrose during a peritoneal dialysis treatment can result in significant removal af water from the patient Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation f blood chemistries and hematologie factors as wel as other indicators of patient status If the resealable rubber plug on the medication portis missing or partially removed do not use product fter removing averpouch check for minute leaks by squeezing container firmy If leaks are found Conpostin cule oli nd concertone hon ho folowing t TS cao e cit ny betas Tac a Compost mi Csa Tow Spied a 5 18 F 2 lg HF ili s 4 H a vie Sie a Fi GEE e ls ilg M me is Sodium Lactate 2 8383 88 33 BR x 3 3 Dianeal PD 2 52 Pete mm zm ens a as son aw 257 son 12 os se De do oo 7 Dre ERE NE IN Dianeal PD 2 52 sm mo mes Wo Vestro E as sos aw 257 soe a0 m as os se m mmm mms FX mo mo ng se Eie E m mo soos meos t n am soa 257 508 uo 12 a5 os ao seen Siimu Seo Mme Eros
147. ts Scarch HOME Search Patients Patents Enter search criterio and click Search Croato New Pationt Last Name i Manage Patents First Name 0 4 Transter Patient stati Mombor Manage Prescriptions ERIS Manage Prescription Templates m zm Example 2 To search by staff member name click on Staff Member drop down select a Staff Member from the list provided and click Search The system will display a list of patients assigned to that particular staff member ACCESS TEST CLI HomeCare Services DirestAccea Home Manage Patiente Search gt Results HOME Patient search results Patients Lestame Firstlame Status DOB AccountNo Edit Creste New Patent Active 56 37087730 Calendar Assion Sati ra ABBOTT Calendar Assion Sati ALTERBERG sono Active eme Calendar Assien Sai Transfer Patient anez vows 11 37089328 Calendar Assion Sati MEINES EIN APPLEBEES AFPLESBEES Active SI7IDE 3708084 Viswlindats Calendar Aasian Sai manage aveo come Active Viu nds Calendar Assion Staff en AVERY dov Active Calendar Assien Orders p oma Adie 37080343 Calencer Assien Order History BARASHKOVA OLGA Active 20810 37060822 Example 8 From this screen you can View Update the patient view the patient s Calendar or assign the patient to ano
148. ts by shaking Exposure of pharmaceutical products to heat should be minimized Avoid excessive heat Itis recommended the product be stored at room temperature 25 C 77 F m Bem np ma pra UitraBag Container Exchange Container ink Groen ree exer re Om ATO ae i d Gate a ge VET 9 Disconnect Dan Steps dan Steps Gand sento Pine pr Supe and a Sap Baxter Healthcare lon Deerfield IL 60015 USA Printed in USA BAR CODE POSITION ONLY 071926995 Copyright 1992 Baxter Healthcare Corporation rights reserved 07 19 26 905 2002 02 Baxter Baxter Healthcare Corporation Renal Division One Baxter Parkway Deerfield IL 60015 Baxter Dianeal DirectAccess Extraneal and HomeChoice are trademarks of Baxter International Inc AL10405A 5 11
149. und te peritoneal catheter catheter ste infection catheter blockage difficult uid removal and les are among the complications of the procedure Solution related adverse reactions may include peritonitis electrolyte and imbalances hypovolemia hypervolermia hypotension hypertension disequilibrium syndrome allergic symptoms and muscle cramping Dosage and Administration Dianeal Low Calcium solutions are intended fo intraperitoneal administration Itis recommended that adult patients being placed on continuous ambulatory peritoneal dialysis should be appropriately trained in program which is under supervision of a physician Training materials are available trom Baxter Healthcare Corporation Deerfield IL 60015 USA to facilitate this training Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit The frequency of treatment formulation exchange volume duration of dwell and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein it is advisable to select the peritoneal dialysis solution with he lowest level of osmolarity consistent with the fluid removal requirements tor that exchange Heating the dialysis solution to 37 88698 may decrease discomfo
150. with EXTRANEAL Addition of Antibiotics No formal clinical drug interaction studies have been performed In vitro compatibility studies with EXTRANEAL icodextrin and the following antibiotics have demonstrated no effects with regard to minimum inhibitory concentration MIC vancomycin cefazolin ampicillin ampicillin flucoxacillin ceftazidime gentamicin and amphotericin However aminoglycosides should not be mixed with penicilins due to chemical incompatibility Patients undergoing peritoneal dialysis should be under careful supervision of a physician experienced in the treatment of end stage renal disease with peritoneal dialysis Itis recommended that patients being placed on peritoneal dialysis should be appropriately trained in a program that is under supervision of a physician Directions for Use For complete CAPD and APD system preparation see directions accompanying ancillary equipment Aseptic technique should be used Warming For patient comfort EXTRANEAL can be warmed to 37 C 98 F Only dry heat should be used It is best to warm solutions within the overwrap using a heating pad Do not immerse EXTRANEAL in water for warming Do not use a microwave oven to warm EXTRANEAL Heating above 40 C 104 F may be detrimental 10 the solution To Open To open tear the overwrap down atthe slit and remove the solution container Some opacity of the plastic due to moisture absorption during the steriliz
Download Pdf Manuals
Related Search
Related Contents
Manual de Instruções - Servidor não encontrado Samsung VM-M2100 User Manual Case Logic VNC218 Notice d`instructions et d`assemblage IXP20 Web Interface User Manual SpeedMarking-Laser - Weidmüller Interface GmbH & Co. KG Manual do utilizador Installation Guide Guía de Instalación Guide d`installation Bordbar CDF-11 STATIC CONE PENETROMETER Copyright © All rights reserved.
Failed to retrieve file