Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
TIMOLOL MALEATE
Pharmathen S.A.
S01ED01
TIMOLOL MALEATE
2.5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may be renewed (B)
timolol
Not Marketed
2016-09-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vizioblok 2.5 mg/ml Eye Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Vizioblok 2.5 mg/ml solution contains 3.417 mg of timolol maleate (equivalent to 2.5 mg of timolol). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless, eye drops pH: 6.5-7.5 Osmolality: 270-330 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Visioblok Eye Drops Solution is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intra- ocular pressure in various conditions. Visioblok is indicated in adult patients with ocular hypertension; adult patients with chronic open-angle glaucoma including aphakic patients; some adult patients with secondary glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: _Posology:_ Recommended therapy is one drop of 2.5 mg/ml solution in the affected eye, once or twice (morning and evening) 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 of 5 mg/ml solution in each affected eye, once or twice (morning and evening) a day. If needed, Visioblok may be used with other agent(s) for lowering intra-ocular pressure. The use of two topical beta-adrenergic blocking agents is not recommended (see 4.4). Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to Visioblok may take a few weeks to stabilise. Provided that the intra-ocular pressure is maintained at satisfactory levels, many patients can then be placed on once-a- day therapy of Visioblok. _Transfer from other agents_ When another topical beta-blocking agent is being used, discontinue its use after a full day of therapy and start treatment with Visioblok the next day with one drop of 2.5 mg/ml Visio Đọc toàn bộ tài liệu