Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TAFLUPROST
Merck Sharp & Dohme Ireland (Human Health) Limited
15 Microgram/ML
Eye Drops Solution
2011-02-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Saflutan 15 micrograms/ml, eye drops solution, single-dose container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of eye drops, solution, contains 15 micrograms of tafluprost. One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution, single-dose container (eye drops). A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. As monotherapy in patients: o who would benefit from preservative free eye drops o insufficiently responsive to first line therapy o intolerant or contra-indicated to first line therapy. As adjunctive therapy to beta-blockers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one drop of Saflutan in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect. For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use. Use in elderly: No dosage alteration in elderly patients is necessary. Use in children and adolescents: Tafluprost is not recommended for use in children or adolescents below age 18 due to a lack of data on safety and efficacy. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/02/2011_ _CRN 2088606_ _page number: 1_ Use in renal/hepatic impairment Tafluprost has not been studied in patients with renal/hepatic impairment and shoul Read the complete document