EXOCIN Eye drops, solution Ref.[7845] Active ingredients: Ofloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Allergan Ltd, Marlow International, The Parkway, Marlow, Bucks SL7 1YL, United Kingdom

Product name and form

EXOCIN 3 mg/ml Eye Drops, Solution.

Pharmaceutical Form

Eye drops, solution.

Clear, pale to light yellow-green solution, practically free from visible particles.

Qualitative and quantitative composition

One millilitre contains 3 mg ofloxacin.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ofloxacin

Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both Gram-negative and Gram-positive organisms. The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination.

List of Excipients

Benzalkonium chloride (EP) 0.005% w/v
Sodium chloride (EP) 0.9% w/v
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Purified water (EP)

Pack sizes and marketing

A bottle and an applicator tip of low density polyethylene (LDPE) and medium or high impact polystyrene cap.

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

Marketing authorization holder

Allergan Ltd, Marlow International, The Parkway, Marlow, Bucks SL7 1YL, United Kingdom

Marketing authorization dates and numbers

PL 00426/0070

Date of first authorisation: 26th October 1992
Date of last renewal: 8th November 2004

Drugs

Drug Countries
EXOCIN Spain, Finland, Ireland, Turkey, United Kingdom, South Africa

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