LUMIGAN Eye drops, solution Ref.[6528] Active ingredients: Bimatoprost

Posology

The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily, as more frequent administration may lessen the intraocular pressure lowering effect.

Paediatric population

The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established.

Patients with hepatic and renal impairment

LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/ml eye drops, solution had no adverse effect on liver function over 24 months.

Method of administration

If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

No case of overdose has been reported, and is unlikely to occur after ocular administration.

If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m² is at least 210 times higher than the accidental dose of one bottle of LUMIGAN 0.1 mg/ml eye drops, solution in a 10 kg child.

2 years.

4 weeks after first opening.

This medicinal product does not require any special storage conditions.

White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution. Not all pack sizes may be marketed.

No special requirements for disposal.