INSTILLAGEL, 10X11 ml

Instructions for use of Instillagel®

Instillagel® is a sterile gel with local anesthetic and disinfectant effects that is used for instillation.No prescription is required for this product.

Areas of application

Instillagel® is used for mucous membrane disinfection and local anesthesia in various medical procedures.These include catheterizations, probing, endoscopies, changing fistula catheters, intubations, and preventing iatrogenic injuries to the rectum and colon.It is also used in pediatrics.

Contraindications

Instillagel® must not be used in cases of known hypersensitivity to lidocaine and other local anesthetics of the amide type, in patients with significant disorders of the conduction system, as well as in cases of hypersensitivity to methyl and propyl-4-hydroxybenzoate, chlorhexidine or other components of the gel.

Use during pregnancy and breastfeeding

Lidocaine should only be used in the first three months of pregnancy if absolutely necessary.It is not known whether lidocaine passes into breast milk.Breastfeeding should therefore not be carried out for up to approximately 12 hours after administration.

Composition

11 ml of gel contains: Lidocaine hydrochloride 1H2O 230.00 mg, chlorhexidine digluconate 5.75 mg, methyl 4-hydroxybenzoate 6.90 mg, propyl 4-hydroxybenzoate 2.87 mg.Other ingredients include hyetellosis, propylene glycol, sodium hydroxide and purified water.

Dosage instructions, type and duration of application

Unless otherwise prescribed, Instillagel® is used as follows:

During catheterization, 11 ml of Instillagel® are slowly instilled into the urethra.For cystoscopy and endoscopies, 11 ml, possibly an additional 6 ml or 11 ml, can be instilled.For urethral strictures, 11 ml, possibly an additional 6 ml or 11 ml, is also instilled.For disinfection, 11 ml of gel is distributed evenly on the mucous membrane.For other applications, 11 ml are slowly instilled into the respective body opening and/or the gel is distributed onto the catheter or instrument to be inserted.

The full local anesthetic and disinfectant effect occurs after 5 - 10 minutes.

Side effects

Despite the wide range of safety of Instillagel®, undesirable effects of the local anesthetic lidocaine can occur in severe urethral injuries.In very rare cases, allergic reactions to an amide-type local anesthetic may occur.Chlorhexidine and/or methyl or propyl 4-hydroxybenzoate can also cause hypersensitivity reactions in very rare cases.

Notes on durability

The expiry date of this packaging is printed on the folding box and container.Do not use medicine after the expiry date has expired.After opening, use the individual syringe immediately and discard the remaining gel.Keep out of the reach of children!

Active ingredients / ingredients / ingredients

3.14 mg chlorhexidine digluconate, 1.77 mg chlorhexidine, 125.4 mg lidocaine hydrochloride 1-water, 101.75 mg lidocaine, 117.58 mg lidocaine hydrochloride, 3.76 mg methyl 4-hydroxybenzoate, 1.57 mg propyl 4-hydroxybenzoate.Excipients include hyetellosis, sodium hydroxide, propylene glycol and purified water.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacist.

Manufacturer: Farco-Pharma GmbH, Gereonsmühlengasse 1-11, 50670 Cologne