দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
DORZOLAMIDE
Merck Sharp & Dohme Ireland (Human Health) Limited
DORZOLAMIDE
20 Micromol
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 TRUSOPT Preservative-Free 20 mg/ml eye drops, solution, single-dose container. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg of dorzolamide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution, single-dose container. Clear, colourless to nearly colourless, slightly viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRUSOPT Preservative-Free 20 mg/ml is indicated: • as adjunctive therapy to beta-blockers, • as monotherapy in patients unresponsive to beta-blockers or in whom beta-blockers are contraindicated, in the treatment of elevated intra-ocular pressure in: • ocular hypertension, • open-angle glaucoma, • pseudoexfoliative glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), three times daily. When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s) two times daily. When substituting dorzolamide for another ophthalmic anti-glaucoma agent, discontinue the other agent after proper dosing on one day, and start dorzolamide on the next day. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Patients should be instructed to avoid allowing the tip of the container to come into contact with the eye or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of সম্পূর্ণ নথি পড়ুন