Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Timolol Maleate
Santen OY
S01ED51
Timolol Maleate
0.25 %w/v
Eye drops, solution
via the ocular route
single bottles containing 2.5 ml of solution
Product subject to prescription which may be renewed (B)
Reduction of elevated intra-ocular pressure in various conditions including the following: patients with ocular hypertension; patients with chronic open-angle glaucoma including aphakic patients; some patients with secondary glaucoma.
Authorised
2015-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Timoptol LA 0.25 % w/v Gel Forming Eye Drops Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of 0.25 % w/v solution contains an amount of timolol maleate equivalent to 2.5mg/ml timolol. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Sterile slightly opalescent, nearly colourless, gel-forming eye drops solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intra-ocular pressure in various conditions including the following: patients with ocular hypertension; patients with chronic open-angle glaucoma including aphakic patients; some patients with secondary glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Recommended therapy is one drop 0.25% solution in the affected eye once a day. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. If clinical response is not adequate, dosage may be changed to one drop 0.5% solution in each affected eye once a day. If needed, ‘Timoptol’-LA may be used with other agent(s) for lowering intra-ocular pressure. Other topically applied medication should be administered at least 10 minutes before ‘Timoptol’-LA. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.4 ‘Special warnings and precautions for use’). Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to ‘Timoptol’-LA may take a few weeks to stabilise. _Transfer from Прочетете целия документ