VIDISIC 0.2% w/w Eye gel Ref.[49801] Active ingredients: Carbomer

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Vidisic 0.2% w/w Eye Gel.

Pharmaceutical Form

Eye gel.

Sterile, colourless, clear, aqueous eye gel, without visible particles.

Qualitative and quantitative composition

The product contains carbomer 0.2% w/w.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Carbomer

Polyacrylic acid is a hydrophilic, high molecular weight polymer of carboxyvinylic acid. The gel forms a transparent lubricating and moistening film on the surface of the eye. The preparation has a pH similar to that found in the normal tear film and is slightly hypotonic with respect to tears. Polyacrylic acid relieves the symptoms of irritation linked with dry eye syndromes and protects the cornea against drying out.

List of Excipients

Cetrimide
Sorbitol
Water for injections
Sodium hydroxide

Pack sizes and marketing

Polyfoil (HDPE-lined, aluminium, co-polymer layered) tube with HDPE cap.

Pack size: 10 g.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA22698/002/001

Date of first authorisation: 11th August 1993
Date of last renewal: 11th August 2008

Drugs

Drug Countries
VIDISIC Brazil, Germany, Ireland, Poland

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