Optimum Medical optilube 1167 Mode D'emploi page 3

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Side effects to this product must be documented in patient records.
In rare cases local hypersensitivity reactions may occur, such as redness, stinging,
blistering or itching and/or systemic reactions to Lidocaine. 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 CHG Free and consult your Healthcare Professional.
Any serious incident or malfunction which may affect the safety of OptiLube Active
CHG Free 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 CHG Free 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 CHG Free sterile lubricat-
ing 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 CHG Free.
NOTE: OptiLube Active CHG Free 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 CHG Free is supplied sterile.
1167-1168-A0141-V1.0.indd 5-6 1167-1168-A0141-V1.0.indd 5-6
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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. 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 CHG Free must be disposed of according to local policies and
procedures, including any remaining fluid in the syringe.
FRA
MODE D'EMPLOI
RÉF. PRODUIT/CONTENU
1167 OptiLube Active CHG Free sans gluconate de chlorhexidine 6 ml Seringue préremplie
1168 OptiLube Active CHG CHG Free sans gluconate de chlorhexidine 11 ml Seringue
préremplie
Cette notice contient les informations sur le produit OptiLube Active CHG Free sans gluco-
nate de chlorhexidine. OptiLube Active CHG Free sans gluconate de chlorhexidine vous
a été prescrit par un professionnel de santé. Ne le partagez pas avec quelqu'un d'autre.
Veuillez lire l'intégralité de la notice du produit avant toute utilisation et la conservez-la.
Si vous avez un doute sur la manière d'utiliser ce produit ou si celui-ci est adapté à votre
cas, veuillez consulter un médecin.
DESCRIPTION DU PRODUIT
OptiLube Active CHG Free sans gluconate de chlorhexidine (avec Lidocaïne) est une
seringue préremplie stérile, à usage unique, contenant un gel hydrosoluble, disponible
en seringues de 6 et 11 ml.
INGRÉDIENTS
100 g d'OptiLube Active CHG Free sans gluconate de chlorhexidine contiennent :
Ingrédient actif : • 2 g de chlorhydrate de lidocaïne
Autres ingrédients : • Eau purifiée ; • Propylène glycol ; • Hydroxyéthylcellulose.
FINALITÉ PRÉVUE
OptiLube Active CHG Free sans gluconate de chlorhexidine est un dispositif médical qui
aide à prévenir les traumatismes causés au patient pendant les procédures de cathé-
térisme ou autres procédures urétrales en assurant une lubrification efficace. En outre,
OptiLube Active CHG Free sans gluconate de chlorhexidine contient un anesthétique
local, la Lidocaïne, servant à réduire la douleur du patient.
MODE D'EMPLOI
OptiLube Active CHG Free sans gluconate de chlorhexidine est conçu pour lubrifier
l'urètre avant l'insertion d'un cathéter urétral ou tout autre dispositif médical, dont le
cystoscope.
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