البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
TIMOLOL
Novartis Pharmaceuticals UK Ltd
0.1 %w/w
Eyegel
2002-03-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nyogel 0.1% w/w eye gel. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g gel contains 1.37 mg timolol maleate, corresponding to 1 mg of timolol. Excipients: benzalkonium chloride (0.05mg/g) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye gel. Colourless, opalescent, odourless gel, free of visible particulate matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nyogel eye gel is used to reduce elevated intraocular pressure in the following conditions: - Ocular hypertension - Chronic open-angle glaucoma 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over the age of 12 years The recommended dosage is one drop of Nyogel eye gel in the affected eye(s) daily, preferably in the morning. Elderly The above dosage can be used for the elderly. Children under the age of 12 years Paediatric use is not recommended. All age goups Intraocular pressure should be reassessed 2 to 4 weeks after starting treatment, because response to treatment may take a few weeks to stabilize. If necessary, Nyogel eye gel can be used concomitantly with miotics, epinephrine and/or carbonic anhydrase inhibitors. To prevent the active substance from being washed out from the eye, an interval of at least 5 minutes between application of different drugs is required, and Nyogel eye gel should be the last one to be administered. In case of transfer from other topical beta blocking agents: discontinue their use after a full day of therapy and start treatment with Nyogel eye gel the next day. Instill one drop in each affected eye once a day, preferably in the morning. In case of transfer from a single antiglaucoma agent other than topical beta blocking agent: Continue the agent and add one drop اقرأ الوثيقة كاملة