Brolene Eye Ointment.

Dibrompropamidine isetionate 0.15% w/w.

Ointment.

Dibrompropamidine isetionate is an aromatic diamidine which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.

Adults, elderly persons and children: for the treatment of minor eye infections.

Apply topically once or twice daily. Medical advice should be obtained if there has been no significant improvement after two days.

Hypersensitivity to dibrompropamidine or any component of the preparation.

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days' therapy, discontinue use and consult a physician.

The eye ointment is unsuitable for use with hard or soft contact lenses.

None known.

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

Eye ointment will cause blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

Hypersensitivity may occur, in which case treatment should be discontinued immediately.

Topical overdose not applicable. Oral ingestion of a full 5g tube is unlikely to cause any toxic effects.

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.

No data available.

No relevant data.

Paraffin soft yellow, Paraffin liquid, Lanolin anhydrous, Phenylethanol,Water for injections.

None known.

36 months. Use within 4 weeks of first opening

Store below 25^oC.

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

No relevant instructions.

sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

PL 04425/0198

22 July 2002

November 2006

P