Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
LATANOPROST
VIATRIS PRIVATE LIMITED
S01EE01
50 mcg/ml
SOLUTION
LATANOPROST 50 mcg/ml
OPHTHALMIC
Prescription Only
Pfizer Manufacturing Belgium N.V.
ACTIVE
1997-11-21
XALATAN ® LATANOPROST 0.005% SOLUTION 1. NAME OF THE MEDICINAL PRODUCT XALATAN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 50 mcg of latanoprost. One drop contains approximately 1.5 mcg of latanoprost. 3. PHARMACEUTICAL FORM Ophthalmic solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. It may also be used for the reduction of elevated intraocular pressure as an adjunct medical therapy in patients with primary chronic angle closure glaucoma. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Use in adults (including the elderly): One drop in the affected eye(s) once daily. Optimal effect is obtained if latanoprost is administered in the evening. The dosage of latanoprost 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. Latanoprost may be used concomitantly with other classes of topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. XAL-SIN-0913/1 Date of last revision: Jan 2014 1 of 11 XAL-SIN-0913/1 Date of last revision: Jan 2014 2 of 11 Contact lenses should be removed before instillation of the eye drops and may be reinserted after fifteen minutes (see section 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE – GENERAL). Pediatric Population Xalatan eye drops may be used in paediatric patients at the same posology as in adults. N Přečtěte si celý dokument
Page 1 of 11 XALATAN LATANOPROST 0.005% SOLUTION 1. NAME OF THE MEDICINAL PRODUCT XALATAN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 50 mcg of latanoprost. One drop contains approximately 1.5 mcg of latanoprost. Excipient with known effect: benzalkonium chloride. 3. PHARMACEUTICAL FORM Ophthalmic solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. It may also be used for the reduction of elevated intraocular pressure as an adjunct medical therapy in patients with primary chronic angle closure glaucoma. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Use in adults (including the elderly) One drop in the affected eye(s) once daily. Optimal effect is obtained if latanoprost is administered in the evening. The dosage of latanoprost should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect. If one dose is missed, treatment should continue with the next dose as normal. Latanoprost may be used concomitantly with other classes of topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Contact lenses should be removed before instillation of the eye drops and may be reinserted after fifteen minutes (see section 4.4 ). Page 2 of 11 Paediatric population Xalatan eye drops may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group <1 year (4 patients) are limited (see section 5.1 ). 4.3 CONTRAINDICATIONS Known hypersensitivity to latanoprost or any other component of the product. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE _Iris pigmentation changes_ Latanoprost may gradually chan Přečtěte si celý dokument