POLYGYNAX Vaginal capsule Ref.[28309] Active ingredients: Neomycin Nystatin Polymyxin B

Revision Year: 2020  Publisher: LABORATOIRE INNOTECH INTERNATIONAL, 22 AVENUE ARISTIDE BRIAND, 94110 ARCUEIL

Product name and form

POLYGYNAX, vaginal capsule.

Pharmaceutical Form

Vaginal capsule.

Qualitative and quantitative composition

Neomycin sulfate 35 000 I.U.

Polymyxin B sulfate 35 000 I.U.

Nystatin 100 000 I.U.

For one vaginal capsule.

Excipient with known effect: Hydrogenated soybean oil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Neomycin

Neomycin is an aminoglycoside antibiotic and acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.

Nystatin

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

Polymyxin B

Polymixin B is bactericidal against a wide range of gram negative bacilli. It exerts a bactericidal effect by binding to acid phospholipids in the cell wall and membranes of the bacterium, thereby rendering ineffective the osmotic barrier normally provided by the cell membrane.

List of Excipients

PEG-6 stearate and glycol stearate and PEG-32 stearate (Tefose 63), hydrogenated soybean oil, dimeticone 1000.

Composition of the shell soft capsule: gelatine, glycerol, dimeticone 1000.

Pack sizes and marketing

Box of 1 or 2 blisters (PVC/PVDC/Aluminium) of 6 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

LABORATOIRE INNOTECH INTERNATIONAL, 22 AVENUE ARISTIDE BRIAND, 94110 ARCUEIL

Marketing authorization dates and numbers

MA093/00401

02nd January 2007 / 22nd November 2018

Drugs

Drug Countries
POLYGYNAX Cyprus, Ecuador, Estonia, France, Hong Kong, Croatia, Lithuania, Malta, Mexico, Nigeria, Romania, Singapore, Tunisia

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