ILUBE Eye drops, solution Ref.[2455] Active ingredients: Acetylcysteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Rayner Pharmaceuticals Ltd, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ, United Kingdom

Product name and form

ILUBE 5% w/v Eye Drops, Solution.

Pharmaceutical Form

Eye drops, solution.

A clear and colourless eye drops solution.

Qualitative and quantitative composition

Acetylcysteine 5.0% w/v.

Excipient(s) with known effect: Benzalkonium chloride 0.01% w/v.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Acetylcysteine

Acetylcysteine is N-acetyl derivative of cysteine. Used as a mucolytic agent to reduce the viscosity of mucous secretions.

List of Excipients

Disodium edetate
Hypromellose
Benzalkonium chloride
Sodium hydroxide
Purified water

Pack sizes and marketing

A lipped Type I amber glass bottle with a push-in closure (chlorobutyl bung) containing 10 ml of solution. The bung is held in place by a polypropylene and aluminium overseal. The bung and overseal form a single integral closure (“flipcap”). Immediately before use, the overseal and bung are removed and replaced with a polyvinyl chloride integral cap and dropper assembly, which fits over the lip of the bottle. The integral cap and dropper assembly has an aperture at the end for the delivery of the product, which is closed with a small high density polyethylene screw cap.

Marketing authorization holder

Rayner Pharmaceuticals Ltd, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ, United Kingdom

Marketing authorization dates and numbers

PL 47069/0002

Date of first authorisation: 17 December 1992
Date of last renewal: 25 June 2007

Drugs

Drug Countries
ILUBE United Kingdom

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