BROLENE Eye ointment Ref.[27605] Active ingredients: Dibrompropamidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Sanofi-Aventis Ireland Ltd. T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Brolene 0.15% w/w Eye Ointment.

Pharmaceutical Form

Eye ointment.

A pale yellow, smooth, sterile ointment.

Qualitative and quantitative composition

Dibrompropamidine Isetionate 0.15% w/w.

Excipients: contains Wool fat 9.7% w/w.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Dibrompropamidine

Dibrompropamidine is a member of the aromatic diamidine group of compounds, which possess bacteriostatic properties against a wide range of fungi and bacteria. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some gram-negative bacilli. The activity of the diamidines is retained in the presence of organic matter such as pus and blood.

List of Excipients

Paraffin, white soft
Paraffin liquid
Wool fat
Phenyl ethanol
Purified water

Pack sizes and marketing

Printed, internally lacquered aluminium tube with screw capped nozzle fitted with a polythene cap, containing 5g of ointment.

Marketing authorization holder

Sanofi-Aventis Ireland Ltd. T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/094/002

Date of first authorisation: 01 April 1983
Date of last renewal: 01 April 2008

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