ACULAR Eye drops, solution Ref.[7563] Active ingredients: Ketorolac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Therapeutic indications

ACULAR is indicated for the prophylaxis and reduction of inflammation and associated symptoms following ocular surgery.

ACULAR is indicated in adults.

Posology and method of administration

Posology

Post-operative inflammation

One drop instilled into the eye three times daily starting 24 hours pre-operatively and continuing for up to three weeks post-operatively.

Paediatric population

There is no relevant use of ACULAR in the paediatric population in the indication: For the prophylaxis and reduction of inflammation following cataract surgery.

Method of administration

Ocular use.

Instil one drop of the solution into the inferior conjunctival sac of the eye to be treated, while pulling the lower eyelid gently downwards and looking upwards.

If ACULAR is used concomitantly with other topical eye medications there must be an interval of at least 5 minutes between the two medications.

Overdose

No case of overdose has been reported. Overdose is unlikely to occur via the recommended method of administration.

If accidentally ingested, drink fluids to dilute.

Shelf life

Unopened: 2 years.

Use within 28 days of first opening.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Low density polyethylene dropper bottles (with LDPE dropper tips) containing 3 ml, 5 ml or 10 ml of solution. The drop size is 35 microlitres. Each bottle has a medium impact polystyrene (MIPS) screw-cap.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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