Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE
Teva Pharma B.V.
20 + 5
Eye Drops Solution
2010-07-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dortim 20mg/ml + 5mg/ml Eye Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre contains 20 mg of dorzolamide as dorzolamide hydrochloride and 5 mg of timolol as timolol maleate. _Excipients_ Each ml contains 0.075 mg benzalkonium chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Colourless, clear, viscous solution, free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is indicated in the treatment of elevated intra-ocular 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 The dose is one drop of Dortim in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic agent is being used, Dortim and 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 dispensing 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. _Usage instructions_ 1. Before using the medication for the first time, be sure the tamper seal is unbroken. 2. To open the bottle, unscrew the cap. 3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye. 4. Invert the bottle, and press lightly on the sides of the bottle until a sin read_full_document