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

4.1. Therapeutic indications

Propamidine isetionate is an aromatic diamidine disinfectant 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.

4.2. Posology and method of administration

One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.9. Overdose

Topical overdosage not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.

6.3. Shelf life

24 months.

Once opened the drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, 7 days after first opening.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

None stated.

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