Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
LEVOBUNOLOL HYDROCHLORIDE
B & S Healthcare
LEVOBUNOLOL HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betagan 0.5% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 5mg levobunolol hydrochloride. Excipient(s): Contains benzalkonium chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from UK_ A clear, colourless to light yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the control of intraocular pressure in chronic open angle glaucoma and ocular hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly): The recommended dosage is one drop of Betagan in the affected eye(s) once or twice daily. Betagan is not recommended for use in children due to lack of safety and efficacy data (see section 5.1). Method of administration: topical into the conjunctival sac. If required, Betagan may be used with other agents to lower intra-ocular pressure. The use of two topical beta- adrenergic blocking agents is not recommended (see section 4.4). Intraocular pressure should be measured approximately four weeks after starting treatment with Betagan as a return to normal ocular pressure can take a few weeks. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac is compressed at the medial canthus (punctual occlusion) for one minute. This should be performed immediately following the instillation of each drop. Transfer from other beta-blocking treatment When another beta blocking agent is being used treatment must be discontinued after a full day of therapy. Start treatment with Betagan the next day with one drop of Betagan topically applied into the conjunctival sac in the affected eye(s) once or twice a day. If Betagan Läs hela dokumentet