Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
LATANOPROST
Arrow Generics Limited
50 Microgram/ML
Eye Drops Solution
2009-05-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Proxal 50 micrograms/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of eye drop contains 50 micrograms of latanoprost. 2.5 ml bottle of eye drops contains 125 micrograms of latanoprost. Excipient: 0.2 mg benzalkonium chloride/ml eye drops. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution (eye drops). A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Ocular use _Recommended dosage for adults (including the elderly):_ Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Proxal 50 micrograms/ml eye drops is administered in the evening. The dosage of Proxal 50 micrograms/ml eye drops should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect. If one dose is missed, treatment should continue with the next dose as normal. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the installation of each drop. Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ Baca dokumen lengkap