Optimum Medical optilube 1160 Mode D'emploi page 3

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There is also a risk of severe reactions including drop in blood pressure, dizziness, nausea,
shortness of breath, bradycardia, convulsions and anaphylactic shock. If this occurs, stop
using OptiLube Active and consult your Healthcare Professional.
Any serious incident or malfunction which may affect the safety of OptiLube Active
should be reported to the manufacturer and the Competent Authority of the Member
State in which the user and/or patient is established.
DOSAGE
Dosage recommendations:
FOR ADULTS: Max. 800 mg Lidocaine during a 24 hour period (x 3 syringe for 11 ml)
(x 6 syringe for 6 ml),
FOR CHILDREN (between 2 and 15 years): max. 0.3ml gel/kg B.W ( 6mg Lidocaine/kg)
is recommended per procedure and no more than four doses should be administered
within 24 hours.
In children below 2 years lubricant gel with Lidocaine must not be used.
OVERDOSE
Excessive dosage or short intervals between doses can result in high plasma levels and
serious adverse effects.
OptiLube Active must not be used at the same time as any other medical device or
medicines containing a local anaesthetic agent.
In the event of excessive absorption of Lidocaine into the bloodstream, symptoms may
include central nervous system effects and cardiovascular reactions.
In the event of excessive use or use outside of these guidelines please seek medical
advice.
HOW TO USE
The decision as to which size (6ml or 11ml) of OptiLube Active sterile lubricating jelly
pre-filled syringe to be used is taken by the Healthcare Professional. It is recommended
that this product is used as part of an aseptic technique.
• Cleanse the opening to the urethra and surrounding area prior to use;
• Evenly peel back the paper backing and remove the sterile syringe;
• Remove the cap from the end of syringe;
• Apply a drop of jelly to urethral opening to make initial insertion easier;
• Insert the nozzle into the urethral opening and press the plunger of the syringe slowly
to release the necessary amount of OptiLube Active.
NOTE: OptiLube Active should be applied to the urethra, not directly onto the device;
• The lubrication characteristics of the jelly start to take effect at the time of application.
The onset of anaesthetic effect takes 3-5 minutes.
Do not use if packaging is damaged or unintentionally opened prior to use.
STERILISATION
OptiLube Active is supplied sterile.
Sterilised with gamma radiation after the packaging process.
Do not resterilise.
STORAGE AND HANDLING
The scale on the syringe is for the orientation of the user.
1160-1161-A0140-V1.0.indd 5-6 1160-1161-A0140-V1.0.indd 5-6
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It does not have a measurement function.
Store between 5-30°C (41-86°F) until expiry date.
Keep dry and out of direct sunlight.
Unopened packs have a 3-year shelf life. Do not use after expiry date.
DISPOSAL
OptiLube Active must be disposed of according to local policies and procedures,
including any remaining fluid in the syringe.
FRA MODE D'EMPLOI
RÉF PRODUIT/CONTENU
Seringue préremplie 6 ml 1160 OptiLube Active
Seringue préremplie 11 ml 1161 OptiLube Active
Ceci est une notice d'information sur le produit OptiLube Active destinée à l'utilisateur.
OptiLube Active vous a été prescrit par un professionnel de santé. Ne le partagez pas
avec d'autres personnes.
Veuillez lire l'intégralité de la notice du produit avant l'utilisation et la conserver pour
votre information.
Si vous n' ê tes pas sûr de savoir comment utiliser ce produit et s'il est adapté à votre cas,
veuillez consulter un médecin.
DESCRIPTION DU PRODUIT
OptiLube Active (avec de la lidocaïne et de la chlorhexidine) est une seringue
préremplie stérile, à usage unique, contenant de la gelée hydrosoluble, disponible en
seringues de 6 et 11 ml.
INGRÉDIENTS
100 g d'OptiLube Active contient :
Ingrédients actifs
• 0,05 g de chlorhexidine gluconate ; • 2 g de chlorhydrate de lidocaïne
Autres ingrédients
• Eau purifiée ; • Propylène glycol ; • Hydroxyéthyl cellulose ;
• Hydroxybenzoate de méthyle ; • Hydroxybenzoate de propyle.
FINALITÉ PRÉVUE
OptiLube Active est un dispositif médical qui aide à prévenir les traumatismes causés
au patient pendant les procédures de cathétérisme ou autres procédures urétrales en
assurant une lubrification efficace. En outre, OptiLube Active contient les substances
thérapeutiques additionnelles suivantes : un antiseptique (chlorhexidine) et un
anesthésique local (lidocaïne) pour aider à réduire le risque d'infection et la douleur
pour le patient.
INDICATIONS D'EMPLOI
OptiLube Active est conçu pour lubrifier l'urètre avant l'insertion d'un cathéter urétral et
d'autres dispositifs médicaux urologiques, y compris les cystoscopes.
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