MONOCRYL™
389976R04
LAB100413706v4
04/2021
For recognized legal manufacturer, refer to product label.
ETHICON, Inc.
1000 Route 202
Raritan, New Jersey 08869
USA
1-877-ETHICON
+1-513-337-6928
ETHICON, LLC
475 C Street
Los Frailes Industrial Park
Suite 401 Guaynabo, Puerto Rico 00969
USA
1-877-ETHICON
+1-513-337-6928
Johnson & Johnson INTERNATIONAL
c/o European Logistics Centre
Leonardo Da Vincilaan, 15
BE-1831 Diegem, Belgium
+1-513-337-6928
Johnson & Johnson Medical GmbH
Robert-Koch-Strasse 1
Norderstedt
22851
Germany
© Ethicon, Inc. 2017
ar
ﻲﺣا
ﻂﻴﺧ
ﺮﺟ
fr FIL DE SUTURE
bg КОНЕЦ hu VARRÓANYAG
cs ŠICÍ MATERIÁL it SUTURA
da SUTUR kk ТІГУ МАТЕРИАЛЫ
de NAHTMATERIAL ko 봉합사
pt FIO DE SUTURA
ro FIR DE SUTURĂ
ru ШОВНЫЙ МАТЕРИАЛ
sk CHIRURGICKÁ NIŤ sv
SUTUR
el ΡΑΜΜΑ lt SIŪLAS tr SÜTÜR
en SUTURE
es SUTURA
lv ĶIRURĢISKAIS DIEGS zh-cn 缝线nl
HECHTMATERIAAL zh-tw 縫合線
et ÕMBLUSMATERJAL no SUTUR
fi OMMELAINE pl NICI CHIRURGICZNE
La résorption est pratiquement complète au bout de 91 à 119 jours.
CONTRE-INDICATIONS
Comme il est résorbable, ce l de suture )coloré et incolore( ne doit pas être utilisé lorsqu’un
rapprochement prolongé des tissus soumis à un stress est nécessaire.
Le l de suture incolore MONOCRYL™, en particulier, ne doit pas être utilisé pour la fermeture
des tissus fasciaux.
AVERTISSEMENTS
L’innocuité et l’ecacité du l de suture MONOCRYL™ n’ont pas été établies dans les cas
suivants : tissus nerveux, tissus cardiovasculaires, microchirurgie et chirurgie ophtalmique.
L’utilisateur doit connaître les procédures et les techniques chirurgicales relatives
à l’utilisation de ls de suture résorbables avant d’utiliser le l de suture MONOCRYL™ pour
la fermeture d’une plaie ainsi que le risque de déhiscence de la plaie qui dépend du site
opératoire et de la nature du l de suture. Le choix du l de suture par les médecins est
fonction de ses propriétés in vivo )voir la rubrique MODE D’ACTION(.
Il convient de respecter les procédures chirurgicales habituelles nécessaires au contrôle de la
contamination ou de l’infection de la plaie.
Comme ce l de suture est résorbable, le chirurgien peut envisager d’utiliser en complément
des ls de suture non résorbables pour la fermeture de plaies susceptibles de subir une
expansion, un étirement ou une distension, ou exigeant un soutien supplémentaire.
Ne pas restériliser/réutiliser. La réutilisation de ce dispositif )ou de parties de ce dispositif(
peut créer un risque de dégradation du produit, susceptible d’entraîner une défaillance
du dispositif et/ou une contamination croisée, ce qui peut provoquer une infection ou la
transmission d’agents pathogènes transmissibles par le sang aux patients et aux utilisateurs.
Dans la mesure où le l de suture est un matériau résorbable, il peut se comporter
transitoirement comme un corps étranger. Comme tout corps étranger, ce produit peut
aggraver une infection existante.
PRÉCAUTIONS
Une attention particulière doit être portée à la manipulation de ce l et de tout autre matériel de
suture an de ne pas risquer de les détériorer. Ne pas écraser ou pincer le l lors de l’application
d’instruments chirurgicaux tels que des pinces ou des porte-aiguilles.
Les ls de suture cutanés restant en place pendant plus de 7 jours peuvent entraîner une
irritation localisée et doivent être coupés ou retirés selon les indications.
Dans certaines circonstances, notamment lors de procédures orthopédiques, une
immobilisation des articulations par soutien externe peut être utilisée à la discrétion
du chirurgien.
Il convient d’être prudent en cas d’utilisation de ls de suture résorbables au niveau de tissus
mal irrigués, car il existe alors un risque de rejet de la suture et de retard de la résorption.
PPE Specification
Labeling Specification
389976R04 Monocryl Suture Global CE Marked IFU
100413706 | Rev:4
Released: 18 Aug 2021
CO: 100889796
Release Level: 4. Production
-ar / bg-Неизползвайтеповторно/
cs-Projednorázovépoužití / da-Må ikke genbruges/
de-Nicht zur Wiederverwendung / el-Μην
επαναχρησιμοποιείτε/ en-Donotreuse/ es-Noreutilizar/
et-Ärgekasutagekorduvalt/ -Ei saa käyttää uudelleen/
fr-Ne pas réutiliser/ hu-Ne használja újra/ it-Non
riutilizzare/ kk-Қайта пайдаланбаңыз/
ko-재사용하지 마십시오/ lt-Tinka iki nurodytos
datos / lv-Nelietotatkārtoti/ nl-Niet opnieuw gebruiken/
no-Skalikkebrukespånytt/ pl-Nie używać powtórnie/
pt-Não reutilizar/ ro-Anusereutiliza/ ru-Не использовать
повторно/ sk-Nepoužívajte opakovane/ sv-Får ej
återanvändas/ tr-Tekrar kullanmayın/ zh-cn-不得重复
使用/ zh-tw-不得重複使用
-ar / bg-Да се употреби до/
cs-Datum použitelnosti/ da-Anvendes inden/
de-Verfallsdatum/ el-Ημερομηνία λήξης/ en-Use-by date/
es-Fecha de caducidad/ et-Viimane kasutuskuupäev/
-Viimeinen käyttöpäivä/ fr-Date de péremption/
hu-Felhasználhatóság dátuma/ it-Utilizzare entro il/
kk-Жарамдылық мерзімі/ ko-사용기한일/
lt-Tinka iki nurodytos datos/ lv-Izlietot līdz )datums(/
nl-Uiterste gebruiksdatum/ no-Utløpsdato/ pl-Wykorzystać
do dnia/ pt-Data de validade / ro-A se utiliza până la data
de/ ru-Использовать до )дата(/ sk-Spotrebujte do/
sv-Används före/ tr-Son kullanma tarihi/ zh-cn-使用有
效期/ zh-tw- 使 用有效日期
-ar / bg-Партиденкод/ cs-Číslošarže/
da-Batchkode/ de-Chargenbezeichnung/ el-Κωδικός
παρτίδας/ en-Batchcode/ es-Código de lote/
et-Partiikood/ -Eräkoodi/ fr-Codedelot/
hu-Gyártásikód/ it-Codicedilotto/ kk-Партия коды/
ko-배치 코드/ lt-Partijoskodas/ lv-Partijaskods/
nl-Batchcode/ no-Partikode/ pl-Kod serii/ pt-Código de
lote/ ro-Codullotului/ ru-Номер партии/ sk-Kódšarže/
sv-Satskod/ tr- Parti kodu/ zh-cn-批号/ zh-tw-批號
-ar / bg-Стерилизирано
сетиленов оксид/ cs-Sterilizováno ethylenoxidem/
da-Steriliseret med ethylenoxid/ de-Sterilisation mit
Ethylenoxid/ el-Αποστειρωμένο με οξείδιο αιθυλενίου/
en-Sterilized using ethylene oxide/es-Esterilizado usando
óxido de etileno / et-Steriliseeritud etüleenoksiidiga/
-Steriloitu etyleenioksidilla / fr-Stérilisé à l’oxyde
d’éthylène/ hu-Etilén-oxiddal sterilizált/ it-Sterilizzato
aossido di etilene/ kk-Этиленоксидпен
зарарсыздандырылған/
ko-에틸렌옥사이드로 멸균 처리됨/
lt-Sterilizuota etileno oksidu/ lv-Sterilizēts, izmantojot
etilēnoksīdu/ nl-Gesteriliseerd met ethyleenoxide/
no-Sterilisert med etylenoksid/ pl-Wysterylizowano
tlenkiem etylenu/ pt-Esterilizado utilizando óxido de
etileno/ ro-Sterilizat cu oxid de etilenă/ ru-Стерилизовано
этиленоксидом/ sk-Sterilizované etylénoxidom/
sv-Steriliserad med etylenoxid/ tr-Etilen oksit kullanılarak
sterilize edilmiştir/ zh-cn-使用环氧乙烷灭菌/
zh-tw-使用環氧乙烷滅菌
-ar / bg-Каталоженномер / cs-Katalogovéčíslo/
da-Varenummer/ de-Katalognummer/ el-Αριθμός
καταλόγου/ en-Cataloguenumber / es-Númerode
catálogo/ et-Katalooginumber / -Tuotenumero/
fr-Numéroderéférenceaucatalogue/ hu-Katalógusszám/
it-Numero di catalogo/ kk-Каталог бойынша
нөмірі / ko-카탈로그 번호/ lt-Katalogonumeris /
lv-Kataloganumurs / nl-Catalogusnummer/
no-Katalognummer/ pl-Numer katalogowy/ pt-Número de
catálogo/ ro-Numărdecatalog/ ru-Номер по каталогу/
sk-Katalógové číslo/ sv-Katalognummer/
tr-KatalogNumarası/ zh-cn-目录编号/
zh-tw-目錄型號
-ar / bg-Внимание/ cs-Upozornění/ da-Forsigtig/
de-Achtung/el-Προσοχή/ en-Caution/ es-Atención/
et-Ettevaatust / -Huomio/ fr-Attention/ hu-Vigyázat/
it-Attenzione/ kk-Назар аударыңыз/ ko-주의/
lt-Įspėjimas/ lv-Uzmanību/ nl-Letop/ no-Obs/
pl-Przestroga/ pt-Atenção/ ro-Atenție/ ru-Внимание/
sk-Upozornenie/ sv-Obs/ tr-Dikkat/ zh-cn-注意/
zh-tw-注意
-ar / bg-Производител/ cs-Výrobce/
da-Producent/ de-Hersteller/ el-Κατασκευαστής/
en-Manufacturer/ es-Fabricante/ et-Tootja/ -Valmistaja/
fr-Fabricant/ hu-Gyártó/ it-Fabbricante/
kk-Дайындаушы/ ko-제조자/ lt-Gamintojas/
lv-Ražotājs/ nl-Fabrikant/ no-Produsent/
pl-Producent/ pt-Fabricante/ ro-Producător/
ru-Производитель/ sk-Výrobca/ sv-Tillverkare/
tr-İmalatçı/ zh-cn-制造商/ zh-tw-製造廠
-ar / bg-Нестерилизирайтеповторно/
cs-Neresterilizujte/ da-Må ikke resteriliseres/
de-Nicht erneutsterilisieren/ el-Μην επαναποστειρώνετε/
en-Donotresterilize/ es-Noreesterilizar/ et-Mitte
resteriliseerida/ -Ei saa steriloida uudelleen/ fr-Ne pas
restériliser/ hu-Ne sterilizálja újra/ it-Non risterilizzare/
kk-Қайта зарарсыздандырмаңыз/
ko-재멸균하지 마십시오/ lt-Negalima sterilizuoti
pakartotinai/ lv-Nesterilizētatkārtoti/ nl-Niet opnieuw
steriliseren/ no-Skal ikke resteriliseres/ pl-Nie wyjaławiać
powtórnie/ pt-Não reesterilizar/ ro-Nuresterilizați/
ru-Не стерилизовать повторно/ sk-Nesterilizujte
opakovane/ sv-Får ej omsteriliseras/ tr-Tekrar steril etmeyin/
zh-cn-不得重复灭菌/ zh-tw-不得重複滅菌
-ar / bg-Упълномощен
представител за Европейската общност/ cs-Autorizovaný
zástupce v Evropském společenství/ da-Autoriseret
repræsentant i EU/ de-Bevollmächtigter in der Europäischen
Gemeinschaft/ el-Εξουσιοδοτημένος αντιπρόσωπος στην
Ευρωπαϊκή Κοινότητα/ en-Authorized Representative in the
European Community/ es-Representante autorizado en la
Comunidad Europea/ et-Ametlik esindaja Euroopa
Ühenduses/ -Valtuutettu edustaja Euroopan yhteisössä/
fr-Mandataire agréé dans la Communauté européenne/
hu-Engedéllyel rendelkező képviselet az Európai
Közösségben/ it-Rappresentante autorizzato nella Comunità
europea/ kk-ЕО ресми өкілі/ ko-유럽연합 공식
대리인/ lt-Įgaliotasis atstovas Europos Bendrijoje/
lv-Pilnvarotais pārstāvis Eiropas Kopienā/ nl-Gemachtigd
vertegenwoordiger in de Europese Unie/ no-Autorisert
representant i EU/ pl-Autoryzowany przedstawiciel we
Wspólnocie Europejskiej/ pt-Representante autorizado na
Comunidade Europeia/ ro-Reprezentant autorizat în
Comunitatea Europeană/
ru-Официальный представитель в ЕС/ sk-Autorizovaný
zástupca pre Európske spoločenstvo/ sv-Auktoriserad
representant i Europeiska gemenskapen/ tr-Avrupa
Topluluğu Yetkili Temsilcisi/ zh-cn-欧洲共同体授权
代理/ zh-tw-歐洲共同體授權代表
-ar / bg-Да не се използва,
ако опаковката е с нарушена цялост/ cs-Nepoužívejte,
je-li obal poškozený/ da-Må ikke anvendes, hvis pakningen
er beskadiget/ de-Bei beschädigter Verpackung nicht
verwenden/ el-Μην χρησιμοποιήσετε εάν η συσκευασία έχει
υποστεί ζημιά/ en-Do not use if package is damaged/
es-No usar si el envase está dañado/ et-Mitte kasutada,
kuipakend on kahjustatud/ -Ei saa käyttää, jos pakkaus
onvaurioitunut/ fr-Ne pas utiliser si l’emballage est
endommagé/ hu-Ne használja, ha a csomagolás megsérült/
it-Non utilizzare se l’imballaggio non è integro/ kk-Егер
қаптама зақымданған болса
пайдаланбаңыз/ ko-포장이 파손되어
있는 경우에는 사용하지 마십시오/
lt-Jei pakuotė pažeista, naudoti negalima/ lv-Nelietot, ja
iepakojums ir bojāts/ nl-Niet gebruiken als de verpakking
beschadigd is/ no-Må ikke brukes hvis pakningen er skadet/
pl-Nie używać, jeśli opakowanie jest uszkodzone/
pt-Não utilizar se a embalagem estiver danicada/
ro-Nu se utilizează dacă ambalajul este deteriorat/
ru-Не использовать, если упаковка повреждена/
sk-Nepoužívajte, ak je balenie poškodené/ sv-Får ej
användas om förpackningen är skadad/ tr-Ambalaj
hasarlıysa kullanmayın/ zh-cn-如 果 包 装 有 损 坏 ，请
勿使用/ zh-tw-如 果 包 裝 有 破 損，請 勿 使 用
-ar
/
.
EEC/93/42
bg-CE маркировка и идентификационен номер на
нотифицирания орган. Продуктът отговаря на основните
изисквания на директивата за медицинските устройства
93/42/ЕИО/ cs-Označení CE a identikační číslo notikované
osoby. Výrobek odpovídá základním požadavkům směrnice
93/42/EHS o zdravotnických prostředcích/
da-CE-mærkning og identikationsnummer for bemyndiget
organ. Produktet opfylder de væsentlige krav i Direktiv 93/42/
EØF om medicinsk udstyr/ de-CE-Kennzeichnung und
Kennnummer der Benannten Stelle. Das Produkt entspricht
den grundlegenden Anforderungen der Richtlinie 93/42/EWG
des Rates über Medizinprodukte/ el-Σήμανση CE και Αριθμός
Αναγνώρισης του Κοινοποιημένου Οργανισμού. Το προϊόν
πληροί τις ουσιώδεις απαιτήσεις της Οδηγίας 93/42/ΕΟΚ περί
ιατροτεχνολογικών προϊόντων/ en-CE-mark and Identication
number of Notied Body. The product meets the essential
requirements of Medical Device Directive 93/42/EEC/ es-Marca
CE + número de identicación del organismo noticado. Este
producto cumple los requisitos esenciales de la directiva de
productos sanitarios 93/42/CEE/ et-CE-märgis ja teavitatud
asutuse registreerimisnumber. Toode vastab
meditsiiniseadmete direktiivi 93/42/EMÜ põhinõuetele/
-CE-merkintä ja ilmoitetun laitoksen tunnusnumero. Tuote
noudattaa lääkinnällisistä laitteista annetun direktiivin
93/42/ETY olennaisia vaatimuksia/ fr-Marquage CE et numéro
d’identication de l’organisme notié. Ce produit est conforme
aux exigences essentielles de la Directive sur les dispositifs
médicaux 93/42/CEE / hu-CE-jel és a bejegyzett testület száma.
A termék megfelel az orvosi készülékekről szóló 93/42/EGK
számú irányelv előírásainak/ it-Marchio CE e numero di
identicazione dell’organismo noticato. Il prodotto è
conforme ai requisiti essenziali della direttiva 93/42/CEE sui
dispositivi medici/ kk-СЕ – белгі және құзыретті
органның бірегейлік нөмірі. Өнім 93/42/ЕЭС
медициналық бұйымдар туралы
Директивасының негізгі талаптарына
жауап береді/ ko-CE마크 및 인증기관의
식별번호. 제품은 의료기기규정 93/42/EEC의
해당 요구조건을 준수합니다/ lt-CE ženklas ir
notikuotosios įstaigos identikavimo numeris. Produktas
atitinka pagrindinius medicininių prietaisų 93/42/EEB
direktyvos reikalavimus / lv-CE zīme un sertikācijas iestādes
identikācijas numurs. Izstrādājums atbilst medicīnisko ierīču
direktīvā 93/42/EEK izvirzītajām pamatprasībām/
nl-CE-markering en identicatienummer van de aangemelde
instantie. Het product voldoet aan de essentiële eisen van de
Richtlijn voor medische hulpmiddelen 93/42/EEG /
no-CE-merke og ID-nummer for bemyndiget organ. Produktet
innfrir de vesentlige krav i direktivet 93/42/EØF for medisinsk
utstyr / pl-Znak CE i numer identykacyjny jednostki
notykowanej. Produkt spełnia wymagania zasadnicze
zawarte w dyrektywie 93/42/EWG dotyczącej wyrobów
medycznych / pt-Marca CE e número de identicação do
organismo noticado. O produto cumpre os principais
requisitos da diretiva sobre dispositivos médicos 93/42/CEE/
ro-Marcajul CE și numărul de identicare a organismului
noticat. Acest produs corespunde cerințelor esențiale ale
Directivei privind dispozitivele medicale 93/42/CEE/ ru-Знак
сертификации «СЕ» и идентификационный номер
уведомленного органа. Изделие отвечает основным
требованиям директивы о медицинском оборудовании
93/42/ЕЭС/ sk-Označenie CE a identikačné číslo
notikovaného orgánu. Tento produkt spĺňa základné
požiadavky smernice č.93/42/EHS ozdravotníckych
pomôckach/ sv-CE-märke och identieringsnummer för
anmält organ. Produkten uppfyller de väsentliga kraven i
direktivet för medicinsk utrustning 93/42/EEG/ tr-CE işareti ve
Onaylanmış Kuruluşun kimlik numarası. Ürün, 93/42/EEC sayılı
Tıbbi Cihazlar Direkti’nin başlıca gereklerine uygundur/
zh-cn-CE 标志和认证机构的识别号。产品符
合医疗设备指令 93/42/EEC 的基本要求/
zh-tw-CE 標誌和認證機構的識別號碼。產品
符合醫療設備指令 93/42/EEC 的基本要求
-ar / bg-Брой единици/ cs-Početkusů/
da-Antal enheder/ de-Stückzahl / el-Αριθμός μονάδων/
en-Number of Units/ es-Númerodeunidades/
et-Seadmetearv/ -Yksikköjen lukumäärä/ fr-Nombre
d’unités/ hu-Az egységek száma/ it-Numero diunità/
kk-Бірліктер саны/ ko-제품 개수/
lt-Vienetųskaičius/ lv-Vienībuskaits/ nl-Aantaleenheden/
no-Antall enheter/ pl-Liczba jednostek/ pt-Número de
unidades/ ro-Număr de unități/ ru-Число единиц/
sk-Početkusov/ sv-Antal enheter/ tr-Ünite sayısı/
zh-cn-件数/ zh-tw-數量
) =X( CONTROL RELEASE™-ar/
bg-CONTROL RELEASE™ )X=Брой снопове в една
опаковка(/ cs-CONTROL RELEASE™ )X=počet vláken
v jednom balení(/ da-CONTROL RELEASE™ )X=Antal tråde
pr. pakke( / de-CONTROL RELEASE™ )X=die Anzahl der
Stränge pro Paket(/ el-CONTROL RELEASE™ )X=Ο αριθμός
των νημάτων ανά πακέτο(/ en-CONTROL RELEASE™ )X=The
number of strands per packet(/ es-CONTROL RELEASE™
)X=número de hebras por envase(/ et-CONTROL RELEASE™
)X=niitide arv pakendis(/ -CONTROL RELEASE™
)X=lankojen määrä pakettia kohden(/ fr-CONTROL
RELEASE™ )X=nombre de brins par paquet(/ hu-CONTROL
RELEASE™ )X=A varrószálak száma csomagonként(/
it-CONTROL RELEASE™ )X=numero di li per confezione(/
kk-CONTROL RELEASE™ )X=Әр орауыштағы
түйіндер саны)/ ko-CONTROL RELEASE™
)X=패킷당 가닥 수(/ lt-CONTROL RELEASE™ )X=vijų
skaičius pakuotėje(/ lv-CONTROL RELEASE™ )X=šķiedru
skaits iepakojumā(/ nl-CONTROL RELEASE™ )X=het aantal
draden per verpakking(/ no-CONTROL RELEASE™ )X=antall
tråder i hver pakke(/ pl-CONTROL RELEASE™ )X=Liczba
pasm w opakowaniu(/ pt-CONTROL RELEASE™ )X=número
de lamentos por embalagem(/ ro-CONTROL RELEASE™
)X=numărul de lamente per pachet(/
ru-CONTROL RELEASE™ )X=число нитей в пакете(/
sk-CONTROL RELEASE™ )X=počet vlákien na balenie(/
sv-CONTROL RELEASE™ )X=antalet suturer per förpackning( /
tr-CONTROL RELEASE™ )X=Paket başına iplik sayısı(/
zh-cn-CONTROL RELEASE™ )X=每包股线的数目）/
zh-tw-CONTROL RELEASE™ （X=每包股數量）
) =X( -ar / bg-Множество
снопове )X=Брой снопове в една опаковка(/
cs-Multistrand )X=počet vláken v jednom balení(/
da-Multi-tråd )X=Antal tråde pr. pakke(/
de-Mehrfachstrang )X=die Anzahl der Stränge pro Paket(/
el-Πολλαπλά νήματα )X=O αριθμός των νημάτων ανά
πακέτο(/ en-Multistrand )X=The number of strands per
packet(/ es-Multihebra )X=número de hebras por envase(/
et-Multistrand )X=niitide arv pakendis(/ -Monilankainen
)X=lankojen määrä pakettia kohden(/ fr-Multibrin
)X=nombre de brins par paquet(/ hu-Többszálú )X=A szálak
száma csomagonként(/ it-Multilo )X=numero di li per
confezione(/ kk-Көп түйін (X=Әр орауыштағы
түйіндер саны)/ ko-다중 가닥(X=패킷당
가닥 수)/ lt-Daugiavijis )X=vijų skaičius pakuotėje(/
lv-Daudzšķiedru )X=šķiedru skaits iepakojumā(/
nl-Meerdere draden )X=het aantal draden per verpakking(/
no-Flertrådet )X=antall tråder i hver pakke(/
pl-Wielopasmowy )X=Liczba pasm wopakowaniu(/
pt-Multilamentos )X=número de lamentos por
embalagem(/ ro-Multilament )X=numărul de lamente
per pachet(/ ru-Многониточный )X=число нитей в
пакете(/ sk-Viacvláknová )X=počet vláken na balenie(/
sv-Multistrand )X=antalet suturer per förpackning( /
tr-Çok iplikli )X=Paket başına iplik sayısı(/
zh-cn-多 股（ X=每包股线的数目）/
zh-tw-多 股（ X=每包股數量）
-ar / bg-ОТЛЕПЕТЕ/ПОВДИГНЕТЕ/
//
ОТВОРЕТЕ ТУК/ cs-ZDE ODLOUPNĚTE/ZDVIHNĚTE/
OTEVŘETE/ da-TRÆK AF/LØFT/ÅBN HER/ de-HIER
ABZIEHEN/ANHEBEN/ÖFFNEN/ el-ΑΠΟΚΟΛΛΗΣΤΕ/
ΑΝΑΣΗΚΩΣΤΕ/ΑΝΟΙΞΤΕ ΕΔΩ/ en-PEEL/LIFT/OPEN HERE /
es-DESPRENDER/LEVANTAR/ABRIR AQUÍ/ et-TÕMBA/TÕSTA/
AVA SIIT/ -KUORI/NOSTA/AVAA TÄSTÄ/ fr-DÉTACHER/
SOULEVER/OUVRIR ICI/ hu-HÚZZA LE/EMELJE MEG/NYISSA
FEL ITT/ it-STRAPPARE/SOLLEVARE/APRIRE QUI/ kk-ОСЫ
ЖЕРДЕН СЫДЫРЫҢЫЗ/КӨТЕРІҢІЗ/
АШЫҢЫЗ/ ko-여기를 벗기십시오/들어
올리십시오/여십시오/ lt-NULUPTI/PAKELTI/
ATIDARYTI ČIA/ lv-NOPLĒST/PACELT/ATVĒRT ŠEIT/ nl-HIER
OPENTREKKEN/OMHOOGTREKKEN/OPENEN/ no-SKRELLES
AV/LØFTES/ÅPNES HER/ pl-ODERWAĆ/UNIEŚĆ/OTWIERAĆ
TUTAJ/ pt-PUXAR/LEVANTAR/ABRIR AQUI/ ro-DEZLIPIȚI/
RIDICAȚI/DESCHIDEȚI AICI/ ru-СНЯТЬ/ПРИПОДНЯТЬ/
ОТКРЫТЬ ЗДЕСЬ/ sk-TU ODLÚPNUŤ/NADVIHNÚŤ/OTVORIŤ/
sv-DRA AV/LYFT/ÖPPNA HÄR/ tr-BURADAN SOYUN/
KALDIRIN/AÇIN/ zh-cn-剥开/提起/此处开启/
zh-tw-剝開/提起/此處開啟
-ar / bg-СКЪСАЙТЕ ТУК/ cs-ZDE ODTRHNĚTE/
da-RIV HER/ de-HIER AUFREISSEN/ el-ΣΚΙΣΤΕ ΕΔΩ/
en-TEAR HERE/ es-RASGAR AQUÍ/ et-REBI SIIT/ -REVI
TÄSTÄ/ fr-DÉCHIRER ICI/ hu-SZAKÍTSA LE ITT/
it-ROMPERE QUI/ kk-ОСЫ ЖЕРДЕН
ЖЫРТЫҢЫЗ/ ko-여기를 찢으십시오/
lt-NUPLĖŠTI ČIA/ lv-NOPLĒST ŠEIT/ nl-HIER AFSCHEUREN/
no-RIVES HER/ pl-TU ROZERWAĆ/ pt-RASGAR AQUI/
ro-RUPEȚI AICI/ ru-ОТОРВАТЬ ЗДЕСЬ/ sk-TU ODTRHNÚŤ/
sv-RIV HÄR/ tr-BURADAN YIRTIN/ zh-cn-由此撕开/
zh-tw-在此撕開
enInstructions for use
MONOCRYL™
Poliglecaprone 25 )MONOFILAMENT(
STERILE SYNTHETIC ABSORBABLE SURGICAL SUTURE
DESCRIPTION
MONOCRYL™ Suture is a sterile, monolament, synthetic, absorbable surgical suture composed
of a copolymer of glycolide and )epsilon( ε-caprolactone. The empirical molecular formula of the
polymer is )C2H2O2(m )C6H10O2(n.
Poliglecaprone 25 copolymer has been found to be nonantigenic, nonpyrogenic and elicits only a
slight tissue reaction during absorption.
MONOCRYL™ Suture is available undyed and dyed with D&C Violet No. 2 )Color Index 60725( to
enhance visibility in the surgical eld.
MONOCRYL™ Suture is available in a range of gauge sizes and lengths, non-needled or attached to
needles of varying types and sizes as described in the HOW SUPPLIED section.
MONOCRYL™ Suture complies with the requirements of the European Pharmacopoeia )Ph.
Eur.( for Sterile Synthetic Absorbable Monolament Sutures and United States Pharmacopeia
)USP( for Absorbable Surgical Sutures except for a slight oversize in diameter for all gauges as
shown in the table below.
USP Suture Size Metric Suture Size Maximum Oversize
6-0 0.7 0.049 mm
5-0 10.033 mm
4-0 1.5 0.045 mm
3-0 20.067 mm
2-0 30.055 mm
03.5 0.088 mm
1 4 0.066 mm
The European Pharmacopoeia recognizes units of measure Metric and Ph. Eur. Sizes as equivalent,
which is reected on the labeling.
INDICATIONS
MONOCRYL™ Sutures are indicated for use in general soft tissue approximation and/or ligation,
but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
APPLICATIONS
Sutures should be selected and implanted depending on patient condition, surgical experience,
surgical technique and wound size.
PERFORMANCE / ACTIONS
MONOCRYL™ Suture elicits a minimal initial inammatory reaction in tissues and ingrowth of
brous connective tissue. Progressive loss of tensile strength and eventual absorption occurs by
means of hydrolysis, where the polymer degrades to adipic acid, which is subsequently absorbed
and metabolized in the body. Absorption begins as loss of tensile strength followed by a loss of
mass. Implantation studies in rats show the following prole:
DYED UNDYED
Post Implantation Approx. Original
Strength Remaining Post Implantation Approx. Original
Strength Remaining
7 days 60% to 70% 7 days 50% to 60%
14 days 30% to 40% 14 days 20% to 30%
All of the original tensile strength is
essentially lost by 28 days post-implantation. All of the original tensile strength is
essentially lost by 21 days post-implantation.
Absorption is essentially complete between 91 and 119 days.
CONTRAINDICATIONS
This suture )dyed and undyed(, being absorbable, should not be used where extended
approximation of tissues under stress is required.
Undyed MONOCRYL™ Sutures, in particular, should not be used to close fascial tissue.
WARNINGS
The safety and eectiveness of MONOCRYL™ Sutures has not been established in the
following areas – neural tissue, cardiovascular tissue, microsurgery and ophthalmic surgery.
Users should be familiar with surgical procedures and techniques involving absorbable
sutures before employing MONOCRYL™ Suture for wound closure, as risk of wound
dehiscence may vary with the site of application and the suture material used. Medical
professionals should consider the in vivo performance )under PERFORMANCE/ACTIONS
section( when selecting a suture.
Acceptable surgical practice should be followed for the management of contaminated
or infected wounds.
As this is an absorbable suture material, the use of supplemental nonabsorbable sutures
should be considered by the surgeon in the closure of sites which may undergo expansion,
stretching or distension, or that may require additional support.
Do not resterilize/reuse. Reuse of this device )or portions of this device( may create a risk of
product degradation, which may result in device failure and/or cross-contamination, which
may lead to infection or transmission of blood-borne pathogens to patients and users.
As an absorbable suture, this suture may act transiently as a foreign body. Like all foreign
bodies, this product may potentiate infection.
PRECAUTIONS
In handling this or any other suture material, care should be taken to avoid damage. Avoid crushing
or crimping damage due to application of surgical instruments such as forceps or needle holders.
Skin sutures which must remain in place longer than 7 days may cause localized irritation and
should be snipped o or removed as indicated.
Under some circumstances, notably orthopedic procedures, immobilization of joints by external
support may be employed at the discretion of the surgeon.
Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply
as suture extrusion and delayed absorption may occur.
Subcuticular sutures should be placed as deeply as possible to minimize the erythema and
induration normally associated with the absorption process.
This suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients
suering from conditions that may delay wound healing.
As with any suture material, adequate knot security requires the standard surgical technique of
at, square ties with additional throws as warranted by surgical circumstance and the experience
of the surgeon. The use of additional throws may be particularly appropriate when knotting
monolament sutures.
Care should be taken to avoid damage when handling surgical needles. Grasp the needle in an area
one-third )1/3( to one-half )1/2( of the distance from the attachment end to the point. Grasping
in the point area could impair the penetration performance and cause fracture of the needle.
Grasping at the attachment end could cause bending or breakage. Reshaping needles may cause
them to lose strength and be less resistant to bending and breaking.
Users should exercise caution when handling surgical needles to avoid inadvertent needle stick
injury. Broken needles may result in extended or additional surgeries or residual foreign bodies.
Inadvertent needle sticks with contaminated surgical needles may result in the transmission of
blood-borne pathogens. Discard used needles in “sharps” containers.
ADVERSE REACTIONS
Adverse reactions associated with the use of this device include wound dehiscence, calculi
formation in urinary or biliary tracts when prolonged contact with salt solutions such as urine or
bile occurs, transient inammatory tissue reaction, and transient local irritation at the wound site.
STERILITY
MONOCRYL™ Suture is sterilized by ethylene oxide gas. Do not resterilize. Do not use if package is
opened or damaged. Discard opened, unused sutures.
STORAGE
No special storage conditions required. Do not use after expiry date.
HOW SUPPLIED
Please note that not all sizes are available in all markets. Please contact your local sales
representative for size availability.
MONOCRYL™ Suture is available as sterile, monolament strands in sizes 6-0 through 1 )metric
sizes 0.7 - 4(, in a variety of lengths, with and without permanently attached needles.
MONOCRYL™ Suture is also available in sizes 3-0 through 1 )metric sizes 2 - 4( as sterile strands
attached to CONTROL RELEASE™ removable needles, which enable the needles to be pulled o
instead of being cut o.
MONOCRYL™ Suture is available in one, two or three dozen units per box.
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Gima 22351 Manualul proprietarului
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- français: Gima 22351 Le manuel du propriétaire
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