Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
DORZOLAMIDE TIMOLOL
Merck Sharp & Dohme Ireland (Human Health) Limited
20/5 Mg/Ml
Eye Drops Solution
2006-09-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT COSOPT Preservative-Free 20 mg/ml + 5 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 dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol. 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 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 Preservative-Free in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic agent is being used, COSOPT Preservative-Free and the other agent should be administered at least ten minutes apart. COSOPT Preservative-Free is a sterile solution that does not contain a preservative. The solution from one individual single dose container is to be used immediately after opening for administration to the affected eye (s). Since sterility cannot be maintained after the individual single dose container is opened, any remaining contents must be discarded immediately after administration. 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 visio Leggi il documento completo