Optimum Medical optilube 1167 Mode D'emploi page 2

Pantone 5415
Page 1
GBR INSTRUCTIONS FOR USE
PRODUCT REF/CONTENTS
1167 OptiLube Active CHG Free 6ml Prefilled Syringe
1168 OptiLube Active CHG Free 11ml Prefilled Syringe
This is an OptiLube Active CHG Free product information leaflet for the user.
OptiLube Active CHG Free has been prescribed for you by a Healthcare Professional.
Do not share it with anyone else.
Read all of the product information leaflet prior to use and retain for your information.
If you are unsure about how to use this product, or whether it is suitable for you, please
seek medical advice.
PRODUCT DESCRIPTION
OptiLube Active CHG Free (with Lidocaine) is a sterile, single-use, pre-filled syringe
with water-soluble jelly available in 6ml and 11ml syringes.
INGREDIENTS
100g of OptiLube Active CHG Free contains:
Active Ingredient: • 2g Lidocaine Hydrochloride
Other Ingredients: • Purified Water; • Propylene Glycol; • Hydroxyethyl cellulose.
INTENDED PURPOSE
OptiLube Active CHG Free is a medical device that helps to prevent trauma being
caused to the patient during catheterisation procedures or other urethral procedures by
effective lubrication. Additionally, OptiLube Active CHG Free contains the following
ancillary medicinal substance; local anaesthetic (Lidocaine) to help reduce pain for the
patient.
INDICATION FOR USE
OptiLube Active CHG Free is designed to lubricate the urethra prior to insertion of a
urethral catheter and other urological medical devices including cystoscopes.
CONTRAINDICATIONS
OptiLube Active CHG Free must not be used in patients:
• With known allergies or hypersensitivity to any of the ingredients.
• Who have ever had a reaction to Lidocaine.
• Who have damaged or bleeding mucous membranes because of the risk of
systemic absorption of the Lidocaine.
Do not use in children below 2 years of age.
Do not use for intravenous (IV) or intramuscular (IM) injections.
Do not use orally. If swallowed, please seek medical advice.
Do not use in eyes. If it comes into contact with the eyes, please seek medical advice.
1167-1168-A0141-V1.0.indd 3-4 1167-1168-A0141-V1.0.indd 3-4
Pantone 5415
Page 2
WARNINGS AND PRECAUTIONS
OptiLube Active CHG Free must only be used under the supervision of Healthcare
Professionals in accordance with local guidelines, policies and procedures.
OptiLube Active CHG Free is not suitable if a patient:
• Has a damaged or bleeding urethra.
Care should be taken when using the jelly with patients who:
• Have heart problems or taking medication for treating irregular heartbeat;
• Have liver problems;
• Are epileptic.
OptiLube Active CHG Free must not be used at the same time as other medical devices
or medicines containing Lidocaine or other local anaesthetic.
Patients may experience a slight stinging on application of the jelly, but this usually
stops once the anaesthetic starts to work. Encourage patients to report any reaction to
the jelly.
Keep out of reach of children.
Ensure OptiLube Active CHG Free is suitable for the intended use and compatible with
other medical devices to be used in conjunction with it.
This is a single-use device. Re-use of this device may result in patient infection/
cross-contamination.
Re/sterilisation, reprocessing, cleaning and disinfection may also compromise the
product characteristics, resulting in trauma or infection to the patient.
OptiLube Active CHG Free is latex free.
PREGNANCY AND LACTATION
Only use during pregnancy and breast feeding under the direction of a doctor.
Always ask the patient if they are pregnant prior to using the jelly.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINERY
The ability to drive and operate machinery may be slightly impaired after the use of
lubricant jelly with Lidocaine. If affected, patients should be advised not to drive or use
machinery.
INTERACTIONS OF MEDICINAL SUBSTANCES
AND SUBSTANCES THAT ARE ABSORBED
Depending on the absorption of Lidocaine, these interactions can be seen when used
with the following medications:
Propranolol: Reduction in plasma clearance of Lidocaine;
Cimetidine: Reduction in plasma clearance of Lidocaine;
Antiarrhythmic products: Increase in the toxicity of Lidocaine;
Phenytoin or barbiturates: Reduction in plasma levels of Lidocaine.
Specified interactions can be seen in the long-term use and repeated high doses.
When administered as recommended, there is no clinically significant interactions
reported.
UNDESIRABLE SIDE EFFECTS
Like any medication, OptiLube Active CHG Free may cause side effects in some people.
6/28/2021 9:16:28 AM 6/28/2021 9:16:28 AM