The lubricant effect of the gel helps prevent trauma that can occur between the urethral mucosa and the catheter/other medical devices.
Lidocaine hydrochloride is a local anesthetic agent used to prevent pain during the insertion of a catheter or medical device.
This relaxes the patient, minimizing iatrogenic injuries due to spasticity or discomfort. It also reduces the risk of infection thanks to its antiseptic properties and has a local anesthetic effect for painless application.
Instructions for use are only formulated for this gel and are not valid for other lubricants. -
What is this medicine used for? Lubrication of catheters and other medical devices during urethral applications such as urethral catheterization, endoscopy, and cystoscopy. Can also be used as a lubricant for rectal and colonic applications.
Directions for use Dosage suggestions: For adults; Max. 800mg Lidocaine over a period of 24 hours (4 x accordion tube of 12.5g) (3 x syringes of 11ml) (6 x syringes of 6ml) For children (between the ages of 2-15); Max. 0.3g gel/kg BW (6mg lidocaine/kg) is recommended for the procedure and no more than four doses should be administered in any 24 hour period.
Do not use the gel containing lidocaine in children under the age of 2. The decision on how much LUBRAGEL Lidocaine containing gel to use is made by the doctor. • Remove the syringe (6ml/11ml) from the sterile packaging by tearing open the tab • Remove the cap located on the end of the syringe. • Apply a drop of gel at the opening of the meatus. To facilitate application. • Insert the tip of the syringe into the urethral opening and gently apply pressure to the syringe plunger to inject the required amount of gel.
Contraindications Do not use in patients with a known allergy or hypersensitivity to any active ingredients or excipients contained in this product. Do not use if the mucous membranes are bleeding or damaged due to the risk of systemic absorption of licodaine hydrochloride.
Do not use in children under 2 years of age.
Ingredients The contents of 100 grams of gel are given below;
• Pure water
• Propylene Glycol Hydroxyethylcellulose (lubricant)
• 2g Lidocaine Hydrochloride (Local Anesthetic)
• 0.250g Chlorhexidine Gluconate - %20 concentration (Antiseptic),
• 0.060g Methyl Hydroxybenzoate (Antiseptic)
• 0.025g Propyl Hydroxybenzoate (Antiseptic)
Warnings LubraGel should only be used under the supervision of a healthcare professional. The conditions that are not suitable for the use of the gel; - If a reaction occurs to local anesthetics,
- If you have a known allergy or hypersensitivity to parabens, chlorhexidine gluconate or to the other agents, - In case of damaged or bleeding membranes.
The conditions that must be observed when using Lubragel; - If you have heart problems or are taking medication to treat an irregular heartbeat - If you have liver problems - If you are epileptic - If you are pregnant or breastfeeding When you first use Lubragel, you may experience a slight stinging sensation, however, as the anaesthetic effect of the gel works, this sensation will disappear after a short time. If you experience an adverse reaction while applying the gel, please contact your doctor as soon as possible. If a serious side effect or a side effect not mentioned in the instructions for use occurs, please contact your doctor, pharmacist or the manufacturer. If you feel drowsy after using the gel, it is advisable not to drive a car or operate machinery.
The gel cannot be used orally. If the gel has been used orally (inserted into your mouth), caution is advised when chewing or swallowing, as you may unconsciously bite your tongue due to the numbing sensation. Avoid contact with eyes, as numbness in the eyes may make you unaware of getting something in your eye.
Keep away from sunlight and store in a dry place. Do not use if packaging is damaged. Do not use the expiration date For single use only. Remove/dispose of any remaining lubricant in the syringe after use according to (hospital) protocol. Not for use in IV or IM injections. Keep out of reach of children.
Side effects The use of lidocaine and chlorhexidine can cause side effects in some people. Despite LUBRAGEL's proven broad safety record, adverse effects from the local anesthetic can occur. Lidocaine can also potentially cause serious damage to the mucous membrane and absorption.
Local hypersensitivity reactions, such as redness, irritation, itching, or hives, and/or systemic reactions to lidocaine and/or chlorhexidine, may occur rarely. There is also a risk of serious reactions: decreased blood pressure, dizziness, nausea, difficulty breathing, bradycardia, convulsions, and anaphylactic shock.
Storage advice Store at 5-30°C until expiration date. The expiration date is stated on the label.
Other information OVERDOSE
Symptoms: Do not use this gel with other medications containing local anesthetic properties or with a medical device. Excessive absorption of lidocaine into the bloodstream may cause central nervous system and cardiovascular symptoms.
If signs of overdose occur, consult a doctor immediately. If you have any further questions about using this product, please contact your doctor or pharmacist.
Treatment: Management of a patient suffering from systemic lidocaine toxicity consists of stopping any convulsion and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (breathing). Medical device. Read the instructions for use before use.
Manufacturer / Distributor OmniMedical BV ,
Weaver Street 28,
4061 AP, Ophemert,
The Netherlands