País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
DORZOLAMIDE TIMOLOL
Merck Sharp & Dohme Ireland (Human Health) Limited
20/5 Milligram
Eye Drops Solution
2009-10-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT COSOPT 20mg/ml + 5mg/ml eye drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol. Excipients: Benzalkonium chloride 0.075 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless to nearly colourless, slightly viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose is one drop of COSOPT in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic agent is being used, COSOPT 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 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 OCUMETER PLUS bottles. _Usage Instructions_ 1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle. 2. Tear off the Safety Strip to break the seal. 3. To open the b Leia o documento completo