מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
timolol (timolol maleate)
S.C. Rompharm Company S.R.L.
S01ED01
timolol (timolol maleate)
5mg/ml
drops eye
5ml plastic vial-dropper
Prescription
Registered
2021-12-20
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Timolol 5 mg/ml, eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains timolol 5.0 mg (as timolol maleate). Excipients with known effect: One ml of solution contains: benzalkonium chloride 0.1 mg disodium phosphate dodecahydrate 8.00 mg sodium dihydrogen phosphate monohydrate 2.00 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution, practically free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Timolol is a beta-adrenoceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including following: - Patients with ocular hypertension; - Patients with chronic open-angle glaucoma including aphakic patients; - Some patient with secondary glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults:_ Posology: Recommended therapy is one drop of Timolol 0.5% eye drops, solution in the affected eye(s) twice a day. Timolol 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 also section 4.4). Intraocular pressure should be reassessed approximately four weeks after starting treatment because response to Timolol 0.5% eye drops may take a few weeks to stabilise. Provided that the intraocular pressure is maintained at satisfactory levels, many patients can then be placed on once a day therapy. 2 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 Timolol 0.5% eye drops the next day, with one drop in each affected eye twice a day. When transferring a patient from a single anti-glaucoma agent other than a topical beta- blocking agent continue the agent and add one drop of Timolol 0.5% eye drops in each affected eye twice a day. On the following day, discontinue the previous age קרא את המסמך השלם