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ichthopaste™ ichthopaste™ ichthopaste
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1. perilesionale Tali pazienti devono essere inviati allo specialista per l esecuzione di patch test a fini diagnostici Una delle funzioni del bendaggio occlusivo aumentare l assorbimento Si deve dunque fare attenzione qualora si decida di applicare sotto il bendaggio preparazioni topiche a base di steroidi anestetici o retinoidi dal momento che il loro assorbimento pu aumentare notevolmente Ci pu ridurre la durata dell effetto degli anestetici locali oltre che aumentare il rischio di sensibilizzazione a tali preparazioni Solo per uso topico Istruzioni per l uso Una volta estratto dal sacchetto sigillato e dall involucro il prodotto amp pronto per l uso Il bendaggio si pu applicare in due modi 1 Partendo dalla base delle dita de piede awolgere senza stringere la benda attorno al piede al tallone e alla gamba procedendo a spirale fin sotto il ginocchio Una volta applicata fare aderire e modellare la benda attorno alla gamba 2 Partendo dalla base delle dita de piede awolgere senza stringere la benda attorno al piede e al tallone e quindi mentre si procede dalla caviglia a ogni giro ripiegare la benda su se stessa sul lato anteriore della gamba Ripetere per tutta la gamba fin sotto il ginocchioo In seguito si pu applicare un bendaggio compressivo Una volta applicato ICHTHOPASTE coprire la gamba con una benda o una medicazione per evitare di sporcare gli indumenti Durata d impiego raccoma
2. Solothurn Tel 32 624 5660 TAIWAN R O C Smith amp Nephew Overseas Ltd Taiwan Branch 9F 4 No 6 Lane 28 Long an Rd Xizhi City Taipei County 221 Tel 886 2 2649 2206 THAILAND Smith amp Nephew LTD 344 3 Soi Rongrien Yepun Rama IX Road Kwang Bangapi Khet Huay Kwang Bangkok 10310 Tel 2 719 6221 27 TURKEY Interfarma KS Mithatpasa C No 24 7 Yenisehir Ankara UNITED STATES Smith amp Nephew Inc Wound Management Division 970 Lake Carillon Drive Suite 110 St Petersburg FL 33716 Customer Care Center 1800 876 1261 or 727 392 1261 VENEZUELA Eurociencia C A Laboratorios Ball C A Marcas Asociadas Marcasa SA Calle Santa Ana Edificio Centro Penafiel Piso 3 Urb Boleita Sur Caracas Tel 2 234 8802 amp ICHTHOPASTE Zinc Paste and Ichthammol Bandage BP X smith amp nephew Single use Do not use if pouch is opened or damaged Store in a dry place 25 C 77 F Description ICHTHOPASTE is a bandage made of open wove cloth impregnated with a paste containing 6 32 Zinc Oxide BP and 2 Ichthammol BP rolled onto a plastic core It also contains Purified water BP Glycerine BP Gelatin BP Emulsifying wax BP Phenoxyethanol BP Each bandage is presented in a wrapper and sealed in a polythene bag contained in a cardboard carton Mode of action ICHTHOPASTE provides topical treatment It provides a moist wound healing environment over a venous leg ulcer helps to reduce skin i
3. 1 00 EASTERN EUROPE Smith amp Nephew Service GmbH Max Planck Strasse 1 3 D 34253 Lohfelden Tel 49 561 9514 0 FRANCE Smith amp Nephew SAS 25 bd Alexandre Oyon 72019 LE MANS Cedex 2 T l 02 43 83 23 23 FINLAND Smith amp Nephew Oy yritie 12 C 01510 Vantaa 0 10 218 7300 GERMANY Smith amp Nephew GmbH Wound Management Max Planck Str 1 3 D 34253 Lohfelden Tel 0 561 9514 0 GREECE Costas A Papaellinas Hellas SA 26th km Paeanias Markopoulou Ave PO Box 182 19400 Koropi Tel 662 6201 7 HONG KONG Smith amp Nephew Ltd Unit 813 816 8 F Delta House 3 On Yiu Street Shatin N T Tel 852 2648 7700 INDIA Smith amp Nephew Healthcare Limited 361 Solitaire Corporate Park Andheri Kurla Road Andheri East Mumbai 400 093 Tel 22 2826 6406 INDONESIA PT Smith amp Nephew Healthcare Total Building 5th Floor J1 Let Jend S Parman Kav 106A Jakarta 11440 Tel 21 5680521 IRELAND Smith amp Nephew Limited Carraig Court George s Avenue Blackrock Co Dublin Tel 01 217 0444 ITALY Smith amp Nephew S r l Via De Capitani 2A 20041 Agrate Brianza Milano Tel 39 039 60941 JAPAN Smith amp Nephew KK 2 4 1 Shiba Park Minato ku Tokyo 105 0011 Japan Tel 03 5403 8930 KOREA Smith amp Nephew Ltd 6th Floor Kwangmyung Building 237 2 Neung dong Kwangjin ku Seoul Korea 143 180 Tel 2343 60460 MALAYSIA Smith amp Nephew Healthcare Sdn Bdh Menara Merais 9t
4. Smith amp Nephew Record ITEM Ichthopaste PIL Global 4xlanguagel ADAMS DESIGN Record TT PAS 01 00 210 x 42mm x 10pp Colours Match to coated stock PMS Co ICHTHOPASTE Bande impr gn e de p te de zinc et d ichthyolammonium BP usage unique Ne pas utiliser en cas de rupture ou de d gradation du sachet protecteur conserver dans un endroit sec 25 C Description ICHTHOPASTE est une bande tiss e la structure a r e impr gn e d une p te contenant de l oxyde de zinc BP 6 32 et de l ichthyolammonium BP 2 96 enroul e autour d un support en mati re plastique ICHTHOPASTE contient galement de l eau purifi e BP de la glyc rine BP de la g latine BP de la cire mulsifiante BP et du ph noxy thanol BP Chaque boite en carton contient une bande sous enveloppe protectrice dans un sachet herm tique en poly thyl ne Mode d action ICHTHOPASTE est un traitement usage topique Il permet la cicatrisation en milieu humide des ulc res veineux de la jambe aide soulager les irritations cutan es et calme et prot ge les tissus cutan s environnants Ne s che pas une fois en place Indications ICHTHOPASTE est indiqu dans la prise en charge des ulc res de jambe En cas d insuffisance veineuse la bande impr gn e sera accompagn e d une bande de contention progressive ICHTHOPASTE est galement adapt dans la prise en charge de l ecz ma dermatite chronique lo
5. en omgivende hud S danne patienter skal overlades til diagnosticering med patch test hos en specialist En af okklusionsbandagens funktioner er at ge absorptionen Der skal derfor udvises forsigtighed hvis det besluttes at anvende topiske steroider an stetika eller retinoide pr parater under bandagen da disse midlers absorption kan blive get markant Dette kan f re til kortere varighed af virkningen af et topisk an stetikum udover at det ger risikoen for sensibilisering over for disse pr parater Kun til topisk anvendelse Instruktioner vedr rende anvendelsen Dette produkt er klar til brug n r det er fjernet fra den forseglede pose og omslaget Bandagen kan p f res p to m der 1 Med start ved basis af t erne skal bandagen omvikles l st omkring fod h l og ben i et spiralm nster til lige under kn et N r bandagen er p f rt skal den udglattes og formes omkring benet 2 Med start ved basis af t erne skal bandagen omvikles l st omkring fod og h l Derefter skal bandagen mens den omvikles fra anklen bukkes tilbage p sig selv i en fold foran p benet for hver drejning Dette gentages op ad benet indtil bandagen n r til lige under kn et Bandagering med kompression kan foretages derefter N r ICHTHOPASTE er blevet p f rt skal benet d kkes af en bandage eller forbinding for at forhindre at t jet bliver snavset Anbefalet varighed af brug til voksne og b rn Bandagen skifte
6. eroids heparin and chloramphenicol through the skin Ichthammol has also been shown to synergise the activity of oxytetracycline and antagonise the activity of ampicillin when present together in various ointment bases Product Availability Code Size Availability 4959 7 5cm x 6m Carton of 1 Manufacturer Made in England by Smith amp Nephew Medical Limited Hull HU3 2BN England Trade Mark of Smith amp Nephew OSmith amp Nephew 2008 NPN 01948466 1887 4131 0086 11725
7. h Floor 1 Jalan 9 13 Petaling Jaya 46300 Selangor Tel 03 7958 7103 MALTA V J Salamone Ltd PO Box 55 Valletta MEXICO Smith amp Nephew SA de CV Patricio Sanz No 442 Colonia del Valle C P 03100 M xico D F Tel 53 40 22 60 MIDDLE EAST Smith amp Nephew FZE Level 7 Convention Tower Dubai International Exhibition Complex P O Box 9715 Dubai United Arab Emirates Tel 971 4 3116 300 NETHERLANDS Smith amp Nephew BV Kruisweg 659 2132 NG Hoofddorp Tel 0031 020 6543999 NEW ZEALAND Smith amp Nephew Ltd PO Box 442 621 Rosebank Road Avondale Auckland Tel 9 828 4059 NORWAY Smith amp Nephew A S PO Box 224 Nye Vakas vei 64 1379 Nesbru Tel 66842020 PAKISTAN Smith amp Nephew Pakistan Private Ltd A 69 SITE Manghopir Road SITE PO Box 3659 Karachi 75700 Tel 21 2561176 PORTUGAL Smith amp Nephew Lda Lagoas Park Edificio 7 2740 299 Porto Salvo Tel 21 446 06 50 SINGAPORE Smith amp Nephew Pte Ltd 1 Jalan Kilang Timor 4 08 03 05 Pacific Tech Centre 159303 Tel 270 0552 SOUTH AFRICA Smith amp Nephew Pharmaceuticals Pty Limited 30 The Boulevard West End Office Park Westville 3629 Tel 031 7108111 SPAIN Smith amp Nephew SAU Fructu s Gelabert 2 4 08970 Sant Joan Despi Barcelona Tel 93 373 73 01 SWEDEN Smith amp Nephew AB Box 143 Kr ketorpsgatan 20 43122 M lndal Tel 031 746 58 00 SWITZERLAND Smith amp Nephew AG Glutz Blotzheim Str CH 4502
8. icost roides de l h parine et du chloramph nicol On a galement montr que l ichthyolammonium exerce un effet synergique sur l activit de l oxyt tracycline ainsi qu un effet antagoniste sur l activit de l ampicilline lorsque ces deux composants sont tous deux utilis s en tant qu excipients Pr sentation du produit Code Taille Pr sentation 4959 75cmx6 m Boite de1 bande Fabricant Fabriqu en Angleterre par Smith amp Nephew Medical Limited Hull HU3 2BN Angleterre Marque de commerce de Smith amp Nephew OSmith amp Nephew 2008 NPN 01948466 ICHTHOPASTE Benda all ossido di zinco e ittiolo BP 7X smith amp nephew Monouso Non utilizzare se la confezione aperta o danneggiata Conservare in un luogo asciutto 25 C Descrizione ICHTHOPASTE una benda costituita da tessuto a trama aperta impregnato con una pasta contenente ossido di zinco BP 6 32 e ittiolo BP 2 avvolto su un rocchetto in plastica Contiene inoltre acqua purificata BP glicerina BP gelatina BP cera emulsionante BP fenossietanolo BP Ogni benda confezionata singolarmente in un involucro e sigillata in un sacchetto di polietilene contenuto all interno di una scatola di cartone Meccanismo d azione ICHTHOPASTE costituisce un trattamento locale Fornisce un ambiente umido per la cicatrizzazione della ferita in corrispondenza dell ulcera venosa dell arto inferiore amp utile nella riduzione delle manifestazioni ir
9. ld be aken therefore if it is decided to apply opical steroid anaesthetic or retinoid preparations under the bandage as their absorption may be significantly increased his may lead to a shorter duration of effect of a topical anaesthetic product in addition to increasing the risk of sensitisation to these preparations For opical use only Instructions for use his product is ready for use upon removal from the sealed pouch and wrapper There are two ways that the bandage can be applied 1 Beginning at the base of the toes the bandage should be loosely wrapped around the foot heel and around the leg in a spiral fashion to just below the knee Once applied the bandage should then be smoothed and moulded around the leg 2 Beginning at the base of the toes the bandage should be loosely wrapped around the foot and heel and then whilst wrapping from the ankle with every turn the bandage should be folded back on itself in a pleat at the front of the leg This should be repeated up the leg until just below the knee Compression bandaging may follow Once ICHTHOPASTE has been applied the leg should be covered by a bandage or dressing to prevent soiling to clothes Recommended duration of use adults and children Change bandage as required can be worn up to 7 days Additional information Ichthammol of itself not related to the occlusive nature of the product may increase the absorption of corticost
10. ndata per adulti e bambini Il bendaggio va cambiato secondo le necessit pu rimanere in sede fino a 7 giorni Ulteriori informazioni L ittiolo di per s e non in relazione alla natura occlusiva del prodotto pu aumentare l assorbimento transcutaneo dei corticosteroidi dell eparina e del cloramfenicolo E stata dimostrata anche un attivit sinergica tra ittiolo e ossitetraciclina e un antagonismo tra ittiolo e ampicillina quando queste sostanze sono entrambe presenti nelle basi per unguenti Confezioni disponibili Codice Dimensioni Confezione 4959 75cmx m Scatola da1 bendaggio Fabbricante Prodotto in Inghilterra da Smith amp Nephew Medical Limited Hull HU3 2BN Inghilterra Marchio di Smith amp Nephew 9Smith amp Nephew 2008 x smith amp nephew ICHTHOPASTE Zinkpasta og ichthammol bandage BP Engangsbrug Produktet m ikke anvendes hvis posen har v ret bnet eller er beskadiget Opbevares p et t rt sted lt 25 C Beskrivelse ICHTHOPASTE er en bandage der er fremstillet af l rred med ben v vning og som er impr gneret med en pasta der indeholder 6 32 zinkoxid BP og 2 ichthammol BP som er rullet p en kerne af plast Den indeholder desuden renset vand BP glycerin BP gelatine BP emulgeret voks BP phenoxyethanol BP Hver bandage leveres i et omslag og er forseglet i en polythenpose i en papkarton Virkem de ICHTHOPASTE anvendes til topisk behandling Den giver et fugtig
11. ous la bande car il est possible que leur absorption en soit consid rablement accrue L effet du produit anesth sique pourra alors tre court et le risque de sensibilisation de telles pr parations accru A usage topique uniquement Mode d emploi Une fois retir de son sachet herm tique et de son enveloppe protectrice ce produit est pr t l emploi Deux m thodes d application sont possibles 1 En partant de la base des orteils appliquer la bande en spirale sans serrer autour du pied du talon et de la jambe jusqu au dessous du genou Une fois pos e lisser la surface de la bande pour qu elle moule parfaitement la jambe 2 En partant de la base des orteils appliquer la bande sans serrer autour du pied et du talon puis partir de la cheville replier la bande sur elle m me sur le devant de la jambe chaque spire R p ter ce geste jusqu atteindre le dessous du genou Faire suivre d une bande de contention si n cessaire Une fois l application d ICHTHOPASTE termin e recouvrir la jambe d une bande ou d un pansement afin de ne pas tacher les v tements Dur e d utilisation recommand e chez les adultes et les enfants Changer le bandage si n cessaire peut rester en place jusqu 7 jours au maximum smith amp nephew Autres informations l ichthyolammonium en soi sans gard la nature occlusive du produit est susceptible d accroitre l absorption cutan e des cort
12. ritative decongestiona e protegge la cute perilesionale Non si secca durante l uso Indicazioni ICHTHOPASTE indicato come coadiuvante nel trattamento delle ulcere degli arti inferiori In presenza di insufficienza venosa la benda con pasta dovrebbe essere impiegata effettuando un bendaggio a compressione graduale ICHTHOPASTE adatto anche nella gestione di eczemi o dermatiti croniche nei casi in cui sia indicata l occlusione Controindicazioni Non utilizzare nei casi accertati di sensibilit o allergia a uno qualsiasi dei componenti Precauzioni In presenza di insufficienza venosa applicare ICHTHOPASTE effettuando un bendaggio a compressione graduale dopo avere esaminato il paziente per escludere ur arteriopatia A tale scopo si raccomanda l impiego di ultrasonografia Doppler Non effettuare il bendaggio compressivo in pazienti con arteriopatia ABPI lt 0 8 se ne sconsiglia l uso nei pazienti diabetici con microvasculopatia in stadio avanzato La mancata diagnosi di un ridotto flusso arterioso pu portare alla necrosi da pressione all amputazione e persino alla morte Il rischio di un arteriopatia in associazione alla patologia venosa aumenta con l et del paziente La cute dei pazienti affetti da ulcere degli arti inferiori particolarmente sensibile ai trattamenti topici compresi i conservanti Si deve sospettare la sensibilizzazione soprattutto nei pazienti che presentano un deterioramento della cute
13. rritation and soothes and protects surrounding skin It will not dry out in use Indications ICHTHOPASTE is indicated to assist the management of leg ulcers Where venous insufficiency exists the paste bandage should be used under graduated compression bandaging ICHTHOPASTE is also suitable for use in the management of chronic eczema dermatitis where occlusion is indicated Contra indications Do not use in known cases of sensitivity or allergy to any of the ingredients Precautions Where venous insufficiency exists ICHTHOPASTE should be used under graduated compression bandaging after first assessing the patient to exclude arterial disease The use of Doppler ultrasound is recommended for this purpose Compression bandaging should not be used on patients who have arterial disease ABPI 0 8 and is not recommended for use on diabetic patients with advanced small vessel disease Failure to detect reduced arterial flow can result in pressure necrosis amputation or even death The risk of a patient having arterial as well as venous disease rises with age he skin of leg ulcer patients is easily sensitised to topical medicaments including preservatives Sensitisation should be suspected in patients particularly where there is deterioration of he surrounding skin Such patients should be referred for specialist diagnosis including patch testing One of he functions of occlusive bandages is to increase absorption Care shou
14. rsque l occlusion s impose Contre indications Ne pas utiliser en cas de sensibilit ou d allergie connue l un des composants Pr cautions d emploi En cas d insuffisance veineuse utiliser ICHTHOPASTE sous une bande de contention progressive apr s avoir cart toute art riopathie l examen du patient A cette fin l examen Doppler est recommand La bande de contention ne devra pas tre utilis e chez le patient atteint d art riopathie IPS 0 8 Elle n est pas non plus recommand e chez le patient diab tique atteint de microangiopathie au stade avanc L absence de d tection d un d bit art riel faible peut avoir des cons quences s rieuses n croses de compression amputation voire d c s Le risque d atteinte mixte la fois veineuse et art rielle augmente avec l ge La peau des patients souffrant d ulc re de jambe r agit facilement aux m dicaments topiques y compris aux agents de conservation On soupconnera tout particuli rement une sensibilisation chez le patient pr sentant une d gradation des tissus cutan s environnants Dans ce cas le patient devra tre orient vers un service adapt pour y subir un examen sp cialis notamment un test picutan Les pansements occlusifs ont entre autres pour fonction d augmenter l absorption Une attention particuli re devra donc tre port e en cas d application topique de pr parations base de st roides d anesth siques ou de r tinoides s
15. s efter behov kan b res i op til 7 dage Yderligere oplysninger Ichthammol i sig selv og ikke p grund af produktets okklusion kan ge absorptionen af kortikosteroider heparin og chloramphenicol gennem huden Ichthammol har desuden vist sig at potensere aktiviteten af oxytetracyclin og antagonisere aktiviteten af ampicillin n r disse er samlet i forskellige salvebaser Produkt pakningsst rrelser Kode Produktstr Pakningsstr 4959 75cmx m Karton med 1 Fremstiller Fremstillet i England af Smith amp Nephew Medical Limited Hull HU3 2BN England Varemaerke tilh rende Smith amp Nephew O Smith amp Nephew 2008 st smith amp nephew UK Smith amp Nephew Healthcare Limited Healthcare House Goulton Street Hull HU3 4DJ Tel 01482 222200 AUSTRALIA Smith amp Nephew Pty Ltd 315 Ferntree Gully Road Mount Waverley PO Box 242 Victoria 3149 Tel 03 8540 6777 AUSTRIA Smith amp Nephew GmbH Concorde Business Park C3 A 2320 Schwechat Tel 1 707 9102 BELGIUM Smith amp Nephew SA NV Av du Four Briques 3b 1140 Bruxelle Kareelovenlaan 3b 1140 Brussels Tel 02 702 29 11 CANADA Smith amp Nephew Inc 2250 Alfred Nobel St Laurent Qu bec H4S 2C9 Tel 1 514 956 1010 CHINA Smith amp Nephew Limited 19F Harbour Ring Hiang Pu Centre No 98 Liu He Road Shanghai 200001 Tel 21 6350 3100 DENMARK Smith amp Nephew A S Slotsmarken 14 2970 H rsholm Tel 45 45 80 6
16. t s rhelingsmiljg over et venest bens r er med til at reducere hudirritation og dulmer og beskytter den omgivende hud Bandagen t rrer ikke ud under brug Indikationer ICHTHOPASTE er indiceret til anvendelse i behandlingen af bens r I tilf lde af vengs insufficiens skal pastabandagen anvendes under gradueret bandagering med kompression ICHTHOPASTE er ogs egnet til anvendelse i behandlingen af kronisk eksem dermatitis hvor okklusion er indiceret Kontraindikationer M ikke anvendes i tilf lde af kendt overf lsomhed eller allergi over for et eller flere af indholdsstofferne Forsigtighedsregler I tilf lde af ven s insufficiens skal ICHTHOPASTE anvendes under gradueret bandagering med kompression efter at patienten er unders gt for at udelukke arteriel sygdom Anvendelse af Doppler ultralyd anbefales til dette form l Bandagering med kompression b r ikke anvendes til patienter med arteriel sygdom ABPI 0 8 og anbefales ikke til anvendelse til diabetespatienter med fremskreden sm karssygdom Hvis nedsat arteriel gennemstr mning ikke opdages kan det medf re tryknekrose amputation eller endda d dsfald Risikoen for at en patient b de har arteriel og ven s sygdom stiger i takt med alderen Huden p patienter med bens r sensibiliseres nemt over for topiske pr parater herunder konserveringsmidler Muligheden for sensibilisering hos patienterne skal overvejes is r i tilf lde af forringelse af d
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