BROLENE Eye drops Ref.[27603] Active ingredients: Propamidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Product name and form

Brolene Eye Drops.

Pharmaceutical Form

Eye drops.

Qualitative and quantitative composition

Propamidine isetionate 0.1% w/v.

Active Ingredient Description
Propamidine

Propamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of organisms. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli, the activity of the diamidines being retained in the presence of organic matter such as tissue fluids, pus and serum.

List of Excipients

Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.

Pack sizes and marketing

10 ml plastic dropper bottle and tamper-proof cap, or 10 ml plastic dropper bottle and tamper-proof cap together with an autodrop device as a separate item.

Marketing authorization holder

Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Marketing authorization dates and numbers

PL 04425/0197

07 November 2002

Drugs

Drug Countries
BROLENE Estonia, Ireland, New Zealand, United Kingdom

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