Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
BRIMONIDINE TARTRATE
G & A Licensing Limited
0.2 %w/v
Eye Drops Solution
2010-12-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alphagan 0.2% _w/v _(2 _mg/ml) _eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Excipient(s): Contains benzalkonium chloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from Greece_ Clear, greenish-yellow to light greenish-yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. As monotherapy in patients in whom topical beta-blocker therapy is contraindicated. As adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single agent (see Section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Recommended dosage in adults (including the elderly)_ The recommended dose is one drop of Alphagan in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop. If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart. _Use in renal and hepatic impairment_ Alphagan has not been studied in patients with hepatic or renal impairment (see section 4.4). _Use in paediatric subjects_ No clinical studies have been performed in adolescents (12 to 17 years). Alphagan is not recommended for use in children below 12 ye Pročitajte cijeli dokument