Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
timolol (timolol maleate), dorzolamide (dorzolamide hydrochloride)
Diamond Pharma
S01ED51
timolol (timolol maleate), dorzolamide (dorzolamide hydrochloride)
20mg/ml+ 5mg/ml
drops eye
10ml bottle-dropper with 5ml drops
Prescription
Registered
2020-12-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Timodor eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 20 mg dorzolamide (as dorzolamide hydrochloride) and 5 mg timolol (as timolol maleate). Preservative: Benzalkonium chloride 0.075 mg/mL 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, slightly viscous, colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Timodor eye drops, solution is indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is one drop of Timodor eye drops, solution in the (conjunctival sac of the) affected eye(s) two times daily . If another topical ophthalmic medicinal product is being used, the other agent should be administered at least ten minutes apart . Patients should be instructed to wash their hands before use and 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 vision may result from using contaminated solutions . Patients should be informed of the correct handling of the ophthalmic Timodor bottles. Paediatric population Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of two years has not been established. Method of administration 1. The tamperproof seal on the bottle neck must be unbroken before the product is being used for the first time. A gap between the bottle and the cap is normal for an unopened bottle . 2. The cap of the bottle should be taken off . 3. The patient's head must be tilted back and the lower eyelid must be pulled gently down to form a small pocket between the eyelid and the Прочитать полный документ