INSTILLAGEL Gel Ref.[28230] Active ingredients: Chlorhexidine Lidocaine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Farco-Pharma GmbH, Gereonsmühlengasse 1‑11, 50670 Köln, Germany, Tel: ++49 221 594061, Fax: ++49 221 593614

Product name and form

Instillagel.

Pharmaceutical Form

Gel.

Qualitative and quantitative composition

One syringe of 6 ml gel contains:

Lidocaine hydrochloride: 125.40 mg
Chlorhexidine digluconate: 3.14 mg
Methyl parahydroxybenzoate (E 218): 3.76 mg
Propyl parahydroxybenzoate (E 216): 1.57 mg

One syringe 11 ml gel contains:

Lidocaine hydrochloride: 230.00 mg
Chlorhexidine digluconate: 5.75 mg
Methyl parahydroxybenzoate (E 218): 6.90 mg
Propyl parahydroxybenzoate (E 216): 2.87 mg

Excipients with known effect: This medicine contains 3.14 g propylene glycol in each syringe of 6 ml and 5.75 g propylenglycol in each syringe of 11 ml. This is equivalent to 522.5 mg/ml.

Propylenglycol may cause skin irritation.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Chlorhexidine

Chlorhexidine is an antimicrobial agent, active against a broad spectrum of Gram-positive and Gram-negative organisms, yeasts, fungi, opportunistic anaerobes and aerobes. Chlorhexidine is mainly a “membrane-acting” agent that destroys the outer membrane of the bacteria. It is inactive on bacterial spores unless the temperatures are high.

Lidocaine

Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. Local anaesthetics of the amide-type are thought to act within the sodium channels of the nerve membrane.

List of Excipients

Hydroxyethylcellulose
Sodium hydroxide
Propylene glycol
Purified water

Pack sizes and marketing

The disposable syringe is made of polypropylene with butyl rubber stopper and containing 6 or 11 ml of gel. The syringes are packed in boxes of 10 × 6/11 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Farco-Pharma GmbH, Gereonsmühlengasse 1‑11, 50670 Köln, Germany, Tel: ++49 221 594061, Fax: ++49 221 593614

Marketing authorization dates and numbers

19988

29th Dec. 2005

Drugs

Drug Countries
INSTILLAGEL Austria, Canada, Cyprus, France, Hong Kong, Ireland, Israel, Netherlands, New Zealand, United Kingdom

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