Lubragel Lubricant lidocaine gel 6ml

Lubragel Lubricant lidocaine gel 6ml

LUBRAGEL is a sterile water-soluble lubricant.

The lubricating 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 ingredient used to prevent pain during the insertion of a catheter or medical devices.

The patient is relaxed, which minimizes iatrogenic injuries due to spasticity or complaints. It also reduces the risk of infection due to its antiseptic properties and has a local anesthetic property for a painless application.

The instructions for use are only valid for this gel and are not applicable to other lubricants.
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What this product is 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.

Instructions for use
Dosage suggestions: For adults; Max. 800mg Lidocaine over a period of 24 hours (4 x accordion tube of 12.5 g) (3 x syringes of 11 ml) (6 x syringes of 6 ml). For children (aged 2-15); Max. 0.3g gel/kg B.W (6mg lidocaine/kg) is recommended for the procedure, and no more than four doses may be administered within 24 hours.

Do not use the lidocaine-containing gel in children under the age of 2.
The decision on how much LUBRAGEL Lidocaine-containing gel should be used is given by the doctor.
• Remove the syringe (6ml/11ml) from the sterile packaging by tearing open the tab.
• Remove the cap located at the end of the syringe.
• Apply a drop of gel to the opening of the meatus to facilitate application.
• Insert the tip of the syringe into the urethral opening and gently apply pressure to the plunger of the syringe to introduce the required amount of gel.

Contraindications
Do not use in patients who have a known allergy or hypersensitivity to any active/excipients contained in it. Do not use in bleeding or damaged mucous membrane membranes due to the risk of systemic absorption of the lidocaine hydrochloride.

Do not use in children under 2 years.

Ingredients
The content of 100 grams of gel is given below; • Purified water • Propylene Glycol Hydroxyethylcellulose (lubricating) • 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 healthcare personnel.
The conditions that are not suitable for the use of the gel;
- If there is a reaction 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 to be considered when using Lubragel; - If you have heart problems or are taking medication for the treatment of an irregular heartbeat - If you have liver problems - If you are epileptic - If you are pregnant or breastfeeding Upon first use of Lubragel, a slight stinging sensation may occur; however, when the anesthetic effect of the gel takes effect, this sensation will end shortly. If you feel an unwanted reaction during the application of the gel, please contact your doctor as soon as possible. If a serious side effect or a side effect occurs that is not mentioned in the instructions for use, please contact your doctor, pharmacist, or manufacturer. If you feel drowsy after using the gel, it is advised not to drive a car or operate machinery.

The gel cannot be used orally. If the gel is used orally (inserted in your mouth), caution is advised when chewing or swallowing as you may bite your tongue without awareness due to the numbing sensation.
Avoid contact with the eyes, as numbness in the eyes may cause you to be unaware that something gets into your eye.

Keep away from sunlight and store dry.
Do not use if the packaging is damaged.
Do not use after the expiry date.
For single use only.
Remove/dispose of any remaining lubricant in the syringe after use according to (hospital) protocol. Not to be used for IV and IM injection. Keep out of reach of children.

Side effects
The use of lidocaine and chlorhexidine may cause side effects in some people. Despite the proven broad safety range of LUBRAGEL, unwanted effects of the local anesthetic may occur. The use of lidocaine may also cause serious damage to the mucous membrane and absorption may occur.

Local hypersensitivity reactions occur in rare cases, such as redness, irritation, itching, or hives and/or systemic reactions to lidocaine and/or chlorhexidine. There is also a risk of severe reactions: blood pressure drop, dizziness, nausea, respiratory difficulties, bradycardia, convulsions, and anaphylactic shock.

Storage advice
Store at 5-30°C until the expiry date. The expiry date is indicated on the label.

Additional information
OVERDOSE
Symptoms: Do not use this gel together with other medications that contain a local anesthetic property or with a medical device. With excessive absorption of lidocaine into the blood, symptoms of central nervous system and cardiovascular reactions may occur.

If there are signs of an overdose, consult a doctor immediately. If there are any questions about the use of this product, contact the doctor or pharmacist.

Treatment: treatment of a patient suffering from systemic toxicity of lidocaine consists of stopping any convulsions and ensuring adequate ventilation with oxygen, if necessary through assisted or controlled ventilation (breathing).
Medical device. Read the instructions for use before use.

Manufacturer / Distributor
OmniMedical B.V. , Weverstraat 28, 4061 AP, Ophemert, Netherlands