Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
LATANOPROST TIMOLOL MALEATE
Aziende Chimiche Riunite Angelini Francesco
50/5
Eye Drops Solution
2011-05-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codalux 50 microgram/ml + 5 mg/ml Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains latanoprost 50 micrograms and timolol maleate 6.83 mg equivalent to 5 mg timolol. It contains 0.412 mg/ml of benzalkonium chloride solution 50%. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution The solution is a clear colourless liquid. pH 5.5 - 6.5. Osmolality 260-320 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended dosage for adults (including the elderly): Recommended therapy is one eye drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. Administration: Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. Use in children and adolescents Safety and effectiveness in children and adolescents has not been established. 4.3 CONTRAINDICATIONS IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/01/2012_ _CR Pročitajte cijeli dokument