CHLOROMYCETIN Eye drops, solution Ref.[50418] Active ingredients: Chloramphenicol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Product name and form

Chloromycetin 0.5% w/v Redidrops eye drops, solution.

Pharmaceutical Form

Eye drops, solution.

A clear, colourless, sterile, aqueous solution.

Qualitative and quantitative composition

Each 1ml of the drops contains 5mg of chloramphenicol (0.5% w/v).

Excipient with known effect:

Phenylmercuric nitrate: 0.002% w/v
Boric Acid: 1.5% w/v
Borax: 0.4% w/v

For the full list of excipients, see section 6.1.

Active Ingredient Description
Chloramphenicol

Chloramphenicol is a broad spectrum antibiotic which has activity against many types of Gram-positive and Gram-negative bacteria. It acts by interfering with bacterial protein synthesis. Chloramphenicol is widely distributed in body tissues and fluids and enters the cerebrospinal fluid.

List of Excipients

Borax
Boric acid
Phenylmercuric nitrate
Water for injections

Pack sizes and marketing

A flexible polyethylene bottle incorporating a polyethylene plug and cap assembly containing 10 ml of solution.

Marketing authorization holder

Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

Marketing authorization dates and numbers

PA1142/021/001

Date of first authorisation: 20 December 1974
Date of last renewal: 20 December 2009

Drugs

Drug Countries
CHLOROMYCETIN Ireland, Japan, New Zealand

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