DIANEAL Peritoneal Dialysis Solution
Contents
1. Break the connector Y set frangible 4 Remove the tip protector from the connector of solution container Do not reuse the solution or container once the tip protector is removed 5 Clamp solution line and then break frangible near solution bag Hang solution container and place the drainage container below the level of the abdomen 6 Open transfer set to drain the solution from abdomen If drainage cannot be established contact your clinician When drainage complete close transfer set T Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line Clamp drain line after flush complete 8 Open transfer set to fill When fill complete close transfer set 9 Disconnect ULTRABAG from transfer set and apply MINICAP 10 Upon completion of therapy discard any unused portion Administration instructions for APD therapy using containers with pull rings or blue pull tips Products listed in Tables 3 5 Put on mask Clean and or disinfect hands Using aseptic technique T Remove the tip protector from the connector of solution container Do not reuse the solution or container once the tip protector is removed 2 Immediately attach the solution container to an appropriate automated peritoneal dialysis set 3 Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis 4 Upon completion of therapy discard any unused2. show evidence of leakage should not be used 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 It is recommended that patients being placed on peritoneal dialysis and or their caretaker s should be appropriately trained Addition of Potassium Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia In situations where 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 The decision to add potassium chloride should be made by the physician after careful evaluation of serum potassium Addition of Insulin Patients with insulin dependent diabetes may require modification of insulin dosage following initiation of treatment with DIANEAL Appropriate monitoring of blood glucose should be performed when initiating DIANEAL in diabetic patients and insulin dosage adjusted if needed see Warnings Addition of Heparin No human drug interaction studies with heparin were conducted n vitro studies demonstrated no evidence of incompatibility of heparin with DIANEAL Addition of Antibiotics No formal clinical drug interaction studies have been performed n vitro studies of the following medications have demonstrated stability with DIANEAL amp
3. 00 2000 5B9765 0941 0424 51 c aa 15g 538mg 448mg 183mg 508mg 344 oto 132 25 05 95 40 aot aH dein e AT with 1 5 Dextrose 5 3000 5000 5B9757 0941 0424 55 DIANEAL Low Calcium 25 1500 2000 5B9775 0941 0430 51 Duende T 25g 538mg 448mg 183mg 508mg 395 oto 132 25 05 95 40 p m REA he D with 2 5 Dextrose 6 5 3000 5000 5B9758 0941 0430 55 DIANEAL Low Calcium 52 1500 2000 5B9795 0941 0433 51 ander T 425g 538mg 448mg 183mg 508mg 483 oto 132 25 05 95 40 m po pati ree 2s with 4 25 Dextrose 5 3000 5000 5B9759 0941 0433 55 Table 3 DIANEAL PD 2 Peritoneal Dialysis Solution AMBU FLEX CONTAINER with pull ring for APD therapy Composition 100 mL lonic Concentration mEq L How Supplied 5 zu G E T 3 8 ae l zef z2 T 5 Ej E S Ea 3 Fill Container 55 Ea s E Volume Size Code NDC 3 e E mL mL 5 8 E 2 E E 8 3 5 5 E 5 E E g a E E g m z 2 2 8 5 E 3 3 E 5 E p E 3 8 E 8 amp E 8 i 5 E 1000 1000 L5B5163 0941 0411 05 peices ie 52 2000 3000 L5B5166 0941 0411 06 15g 538mg 448mg 257mg 508mg 346 40to 132 35 05 96 40 3000 3000 L585169 0941 0411 04 with 1 5 Dextrose pe A CONTAINER 6 5 5000 6000 L5B5193 0941 0411 07 6000 6000 L5B9710 0941 0411 11 1000 1000 LsB5173 0941 0413 05 Hee ne 52 20
4. 00 3000 L5B5177 0941 0413 06 y 25g 538mg 448mg 257mg 508mg 396 40to 132 35 05 96 40 3000 3000 L5B5179 0941 0413 04 with 2 5 Dextrose NN AER 65 5000 6000 L5B5194 0941 0413 07 6000 6000 L5B9711 0941 0413 01 1000 1000 LsB5183 0941 0415 05 A ae d enda 52 2000 3000 L5B5187 0941 0415 06 y 425g 538mg 448mg 257mg 508mg 485 ot 132 35 05 96 40 3000 3000 L5B5189 0941 0415 04 wini 4 25 Dextrose 6 000 6000 B5195 0941 0415 0 AMBU FLEX II CONTAINER 5 3 Ten OHO 6000 6000 L5B9712 0941 0415 01 Table 4 DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis Solution Composition 100 mL lonic Concentration mEq L How Supplied 5 bud S a E T 3 8 gt zm S 2 S a 5 E3 S S 8 E Fill Container 55 amp m E Volume Size Code NDC 3 c mL mL 5 S g 5 E E 2 E g 5 3 5 E 5 E E S 8 3 E E g z188 amp 8 253 2 8 a 3 3 S 3 8 E 3 amp 5 s DIANEAL Low Calcium i L5B4825 0941 0409 06 2 5 mEq L Peritoneal L5B9901 0941 0409 05 Dialysis Solution 15g 5B4826 0941 0409 07 WINS Dextrose L589770 0941 0409 01 AMBU FLEX II CONTAINER L DEEN Tow GC L5B9727 0941 0457 08 2 5 mEq L Peritoneal ae Md 2 L589902 0941 0457 02 wii eio M i L5B5202 0941 0457 05 AMBU FLEX II CONTAINER No THp ig ae 2000 3000 L589747 0941 0459 08 Dialysis Solution 425g 538mg 448mg 183mg 508mg 483 ot 132 25 05 95 40 m 3000 L5B9903 0941 0459 0
5. 2 alysis So 5000 6000 L585203 0941 0459 05 With 4 257 Dextrose 6 5 6000 6000 589772 0941 0459 01 AMBU FLEX Il CONTAINER L Table 5 DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis Solution Made in Ireland Plastic container with blue pull tip for APD therapy Composition 100 mL lonic Concentration mEq L How Supplied S x S zx S 8 S 3 2 GA E zt E Fill Container 3 amp gt Ea s 8 Volume Size Code NDC 8 mE E a 5 E mL mL 5 3 g S2 2 E 8 5 2 E z 5 S 5 5 E 5 E E E 8 a E E g 2 E 3 3 2 3 3 E E 9 3 E gt s 9 3 gt E 9 e B B 2 eo a B 5 o 5 DIANEAL Low 50 Calcium 2 5 mEq L i 5 s j Peritoneal Dialysis Solution 159g 538mg 448mg 18 4mg 5 08 mg 344 32 25 0 5 95 40 5000 5000 EZPB5245R 0941 0484 0 with 1 5 Dextrose DIANEAL Low 50 Calcium 2 5 mEq L s D SRART Peritoneal Dialysis Solution 259g 538mg 448mg 18 4mg 5 08 mg 395 e 32 25 0 5 95 40 5000 5000 EZPB5255R 0941 0487 0 with 2 5 Dextrose DIANEAL Low Calcium 2 5 mEq L 50 x PI l l Peritoneal Dialysis Solution 4 259 538mg 448mg 18 4mg 5 08 mg 483 ho 32 25 0 5 95 40 5000 5000 EZPB5265R 0941 0490 0 with 4 2596 Dextrose j Table 6 DIANEAL Low Calcium 2 5 mEg L Peritoneal Dialysis Solution Made in Mexico Composition 100 mL lonic Concentration mE
6. DIANEAL Peritoneal Dialysis Solution For intraperitoneal administration only DIANEAL PD 2 Peritoneal Dialysis DIANEAL PD 2 Peritoneal Dialysis Solution With 2 596 Dextrose DIANEAL PD 2 Peritoneal Dialysis Solution With 4 2596 Dextrose Solution With 1 596 Dextrose DESCRIPTION DIANEAL Peritoneal Dialysis Solutions are sterile nonpyrogenic solutions in flexible containers for intraperitoneal administration only The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents Composition calculated osmolarity pH and ionic concentrations are shown in Tables 1 6 DIANEAL is a hyperosmolar solution The plastic container is fabricated from polyvinyl 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 lead to greater losses It is unlikely that these minor losses will lead to clinically significant changes within the expiration period The amount of water that can permeate from inside the solution 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 t
7. apy Composition 100 mL lonic Concentration mEq L How Supplied 5 5 G E 8 3 S9 E g a S S S a E Fill Container 55 Ea s E Volume Size Code NDC E 3 g F E t mL mL Ez k g a 5 8 E 2 E s 5 5 5 5 5 5 5 S g 8 E 5 8 8 8 8 8 B amp 8 8 2 amp 3 DIANEAL PD 2 52 2000 2000 5B9866 0941 0426 52 Peritoneal Dialysis Solution 159g 538mg 448mg 25 7 mg 5 08 mg 346 4 0 to 132 3 5 0 5 96 40 2500 3000 5B9868 0941 0426 53 with 1 5 Dextrose 6 5 3000 5000 5B9857 0941 0426 55 DIANEAL PD 2 Peritoneal 52 2000 2000 589876 0941 0427 52 Dialysis Solution 25g 538mg 448mg 257mg 5 08mg 396 40to 132 35 0 5 96 40 2500 3000 589878 0941 0427 53 with 2 5 Dextrose 6 5 3000 5000 5B9858 0941 0427 55 DIANEAL PD 2 Peritoneal 5 2 2000 2000 5B9896 0941 0429 52 Dialysis Solution 425g 538mg 448mg 25 7mg 508mg 485 40to 132 3 5 0 5 96 40 2500 3000 5B9898 0941 0429 53 with 4 25 Dextrose 6 5 3000 5000 5B9859 0941 0429 55 Table 2 DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis Solution Composition 100 mL lonic Concentration mEq L How Supplied amp f zu as g g gt ei 3 5 s 3 Ss Ea Fill Container 2 55 E 5 s E Volume Size Code NDC d E E g Ei 5 t mL mL 2 5 E E z E 2 3 8 E S 8 t E E 3 E E B 2 g E E 8 a s 2 8 3 5 5 8 8 8 E Ej z 8 8 E 5 3 DIANEAL Low Calcium 85 15
8. assium 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 Patients receiving DIANEAL solutions should have their calcium levels monitored for the development of hypocalcemia or hypercalcemia In these circumstances adjustments to the dosage of the phosphate binders vitamin D analogs and or calcimimetics should be considered by the physician DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis solution should be considered for use in patients with hypercalcemia Carcinogenesis Mutagenesis Impairment of Fertility Studies to evaluate the carcinogenic or mutagenic potential of this product or its potential to affect fertility adversely have not been performed Drug Interactions No clinical drug interaction studies were performed 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 see Warnings Use in Specific Population Pregnancy Pregnancy Category C DIANEAL is a peritoneal dialysis solution of electrolytes lactate and dextrose and is pharmacologically inactive Animal reproduction studies have not been conduc
9. e their frequency or establish a causal relationship during drug exposure Adverse reactions are listed by MedDRA System Organ Class SOC then by Preferred Term in order of severity INFECTIONS AND INFESTATIONS Fungal peritonitis Peritonitis bacterial Catheter related infection METABOLISM AND NUTRITION DISORDERS Hypovolemia Hypervolemia Fluid retention Hypokalemia Hyponatremia Dehydration Hypochloremia VASCULAR DISORDERS Hypotension Hypertension RESPIRATORY THORACIC AND MEDIASTINAL DISORDERS Dyspnea GASTROINTESTINAL DISORDERS Sclerosing encapsulating peritonitis Peritonitis Peritoneal cloudy effluent Vomiting Diarrhea Nausea Constipation Abdominal pain Abdominal distension Abdominal discomfort SKIN AND SUBCUTANEOUS DISORDERS Stevens Johnson syndrome Urticaria Rash including pruritic erythematous and generalized Pruritus MUSCULOSKELETAL CONNECTIVE TISSUE DISORDERS Myalgia Muscle spasms Musculoskeletal pain GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Generalized edema Pyrexia Malaise Infusion site pain Catheter related complication DRUG ABUSE AND DEPENDENCE There has been no observed potential of drug abuse or dependence with DIANEAL solution OVERDOSAGE There is a potential for overdose resulting in hypervolemia hypovolemia electrolyte disturbances or hyperglycemia Excessive use of DIANEAL peritoneal dialysis solution with 4 25 dextrose during a peritoneal dialysis treatment ca
10. ests for plastic containers as well as by cell culture toxicity studies CLINICAL PHARMACOLOGY Mechanism of Action DIANEAL is a hypertonic peritoneal dialysis solution containing dextrose a monosaccharide as the primary osmotic agent An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur The hypertonic concentration of glucose in DIANEAL exerts an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration Like other peritoneal dialysis solutions DIANEAL contains electrolytes to facilitate the correction of electrolyte abnormalities DIANEAL contains a buffer lactate to help normalize acid base abnormalities Pharmacokinetics of DIANEAL Glucose content in DIANEAL is expressed as dextrose monohydrate and is available in three concentrations 1 5 2 5 and 4 25 Glucose is rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to the high glucose concentration gradient between DIANEAL compared to blood capillary glucose level Absorption per unit time will be the highest at the start of an exchange and decreases over time The rate of glucose absorption will be dependent upon the transport characteristics of the patient s peritoneal membrane as determined by a peritoneal equilibration test PET Glucose absorption will also depend upon the concentration of glucose used for the excha
11. hotericin B ampicillin cefazolin cefepime cefotaxime ceftazidime ceftriaxone ciprofloxacin clindamycin deferoxamine erythromycin gentamicin linezolid mezlocillin miconazole moxifloxacin nafcillin ofloxacin penicillin G piperacillin sulfamethoxazole trimethoprim ticarcillin tobramycin and vancomycin However aminoglycosides should not be mixed with penicillins due to chemical incompatibility Directions for Use For complete CAPD and APD system preparation see directions accompanying ancillary equipment Aseptic technique must be used throughout the peritoneal dialysis procedure Warming For patient comfort DIANEAL 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 DIANEAL in water for warming Do not use a microwave oven to warm DIANEAL To Open To open tear the overwrap down at the slit and remove the solution container Some opacity of the plastic due to moisture absorption during the sterilization process may be observed This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap The opacity should diminish gradually Inspect for Container Integrity Inspect the bag connector to ensure the tip protector pull ring blue pull tip or blue twist off tip is attached Do not use if the tip protector is not attached to the connector Inspect the DIANEAL conta
12. iner for signs of leakage and check for minute leaks by squeezing the container firmly If the container has frangible s inspect that they are positioned correctly and are not broken Do not use DIANEAL if the frangible s are broken or leaks are suspected as sterility may be impaired For DIANEAL in ULTRABAG inspect the tubing and drain container for presence of solution Small droplets are acceptable but if solution flows past the frangible prior to use do not use and discard the units Adding Medications Some drug additives may be incompatible with DIANEAL See DOSAGE AND ADMINISTRATION section for additional information If the resealable rubber plug on the medication port is missing or partly removed do not use the product if medication is to be added ils Put on mask Clean and or disinfect hands Prepare medication port site using aseptic technique 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 Administration instructions for CAPD therapy using ULTRABAG containers Products listed in Tables 1 2 Put on mask Clean and or disinfect hands Using aseptic technique 1 Uncoil tubing and drain bag ensuring that the transfer set is closed 2 Immediately attach the solution container to patient connector transfer set 3
13. is 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 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 indicated 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 or hypovolemia and potentially severe consequences including congestive heart failure volume depletion and hypovolemic shock An accurate fluid balance record must be kept and the patient s body weight monitored Excessive use of DIANEAL peritoneal dialysis solution with higher dextrose concentration during a peritoneal dialysis treatment may result in significant removal of water from the patient see Dosage and Administration Significant losses of protein amino acids
14. n result in significant removal of water from the patient DOSAGE AND ADMINISTRATION DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only The mode of therapy 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 DIANEAL should be administered at a rate that is comfortable for the patient generally over a period of 10 20 minutes for a single exchange Patients on continuous ambulatory peritoneal dialysis CAPD typically perform 4 cycles per day 24 hours Patients on automated peritoneal dialysis APD typically perform 4 5 cycles at night and up to 2 cycles during the day The fill volume depends on body size usually from 2 0 to 2 5 liters per 1 73m 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 As the patient s body weight becomes closer to the ideal dry weight lowering the dextrose concentration of DIANEAL is recommended DIANEAL 4 25 dextrose containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration Solutions that are cloudy discolored contain visible particulate matter or
15. nge and the length of the dwell Glucose is metabolized by normal cellular pathways e g glycolysis and provides a source of calories and may elevate blood glucose levels Transport of other molecules across the peritoneal membrane such as lactate will occur by diffusion Metabolism of lactate occurs in the liver and results in the generation of the bicarbonate Transport of other molecules will be dependent upon the molecular size of the solute the concentration gradient and the effective peritoneal surface area as determined by the PET DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis Solution With 1 5 Dextrose DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis Solution With 2 5 Dextrose DIANEAL Low Calcium 2 5 mEq L Peritoneal Dialysis Solution With 4 25 Dextrose INDICATIONS AND USAGE DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate CONTRAINDICATIONS DIANEAL is contraindicated in patients with pre existing severe lactic acidosis WARNINGS Encapsulating Peritoneal Sclerosis EPS is considered to be a known rare complication of peritoneal dialysis therapy EPS has been reported in patients using peritoneal dialysis solutions including DIANEAL Infrequently fatal outcomes of EPS have been reported with DIANEAL Because DIANEAL is a dextrose based solution patients with allergy to co
16. portion Administration instructions for APD therapy using containers with with twist off tips Products listed in Tables 6 Put on mask Clean and or disinfect hands Using aseptic technique 1 Place and fasten blue outlet port clamp on solution bag administration port between the blue connector and the solution container 2 Remove the blue twist off tip from connector of solution container Do not reuse the solution or container once the blue twist off tip is removed 3 Immediately insert the spike of the automated peritoneal dialysis set into the solution bag port 4 Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis 5 Upon completion of therapy discard any unused portion HOW SUPPLIED DIANEAL peritoneal dialysis solutions are available in nominal size flexible containers as shown in Tables 1 6 All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling 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 Exposure of pharmaceutical products to heat should be minimized Avoid excessive heat It is recommended the product be stored at room temperature 25 C 77 F brief exposure up to 40 C 104 F does not adversely affect the product Table 1 DIANEAL PD 2 Peritoneal Dialysis Solution ULTRABAG CONTAINER for CAPD ther
17. q L How Supplied S x amp Y ET N eo 3 8 S 2 i 2 25 z E E E E Fill Container 5 E 5 F Volume Size Code NDC 8 E E E E mL mL 5 S g 5 8 3 z E Ps 56 5 5 5 5 e pue ow pom E a s gs 2 8 g 8 8 8 53 83 8B8 s3 58 3 58 3 DIANEAL Low Calcium 2 5 mEq L Peritoneal 5 0 Aleit 1 59 538mg 448mg 18 3mg 5 08 mg 344 to 132 25 0 5 95 40 6000 6000 VBB4928US 0941 0472 01 Dialysis Solution 56 with 1 5 Dextrose DIANEAL Low Calcium 2 5 mEq L Peritoneal 5 0 aa a 2 59 538mg 448mg 18 3mg 5 08 mg 395 to 132 25 0 5 95 40 6000 6000 VBB4931US 0941 0475 01 Dialysis Solution 56 with 2 5 Dextrose i CH OH o OH H O OH HO OH Dextrose Hydrous USP D Glucopyranose monohydrate BAXTER DIANEAL AMBU FLEX ULTRABAG MINICAP and PL 146 are trademarks of Baxter International Inc Baxter Healthcare Corporation Deerfield IL 60015 USA Printed in USA 08 2015 07 19 75 233 USMP 76 15 0001 1 10 15
18. rn or corn products are at increased risk for allergic reaction which may include anaphylactic anaphylactoid reactions Stop the infusion immediately drain the solution from the peritoneal cavity and treat appropriately if any signs or symptoms of a suspected hypersensitivity reaction develop Patients with severe lactic acidosis should not be treated with lactate based peritoneal dialysis solutions See Contraindications Patients with conditions known to increase the risk of lactic acidosis e g severe hypotension or sepsis that can be associated with acute renal failure hepatic failure inborn errors of metabolism and treatment with drugs such as nucleoside nucleotide reverse transcriptase inhibitors NRTIs must be monitored for the 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 or hypocalcemia Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis e
19. ted with DIANEAL dialysis solution While there are no adequate and well controlled studies in pregnant women appropriate administration of DIANEAL with monitoring of fluid electrolyte acid base and glucose balance is not expected to cause fetal harm or affect reproductive capacity Maintenance of normal acid base balance is important for fetal well being Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing DIANEAL Nursing Mothers DIANEAL is a dialysis solution of electrolytes lactate and dextrose and is pharmacologically inactive The components of DIANEAL are excreted in human milk Appropriate administration of DIANEAL with monitoring of fluid electrolyte acid base and glucose balance is not expected to harm a nursing infant Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing DIANEAL Pediatric Use Safety and effectiveness have been established based on published clinical data No adequate and well controlled studies have been conducted with DIANEAL solutions in pediatric patients Geriatric Use Safety and effectiveness have been established based on published clinical data ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of DIANEAL Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimat
20. water soluble vitamins and other medicines may occur during peritoneal dialysis The patient s nutritional status should be monitored and replacement therapy should be provided as necessary Information for Patients Patients should be instructed not to use solutions if they are cloudy discolored contain visible particulate matter or if they show evidence of leaking containers see Dosage and Administration Aseptic technique must be employed throughout the procedure An improper clamping sequence may result in infusion of air into the peritoneum see Dosage and Administration Directions for Use 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 heat 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 the solution see Dosage and Administration Directions for Use Laboratory Tests Serum Electrolytes DIANEAL does not contain potassium Evaluate serum potassium prior to administering potassium chloride to the patient In situations where there is a normal 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 pot
21. xcess Conversely toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium is high Diabetics require careful monitoring of insulin requirements and other treatments for hyperglycemia during and following dialysis with dextrose containing solutions PRECAUTIONS General Peritoneal Dialysis Related DIANEAL is intended for intraperitoneal administration only Not for intravenous administration The following conditions may predispose to adverse reactions to peritoneal dialysis procedures abdominal conditions including uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase the risk of infection disruption of the peritoneal membrane and diaphragm by surgery congenital anomalies or trauma prior to complete healing abdominal tumors abdominal wall infections hernias fecal fistula colostomies or ileostomies 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 must be employed throughout the peritoneal dialys
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