Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LATANOPROST
UPJOHN (MALAYSIA) SDN. BHD.
LATANOPROST
2.5 ml mL
PFIZER MANUFACTURING BELGIUM NV,
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ XALATAN EYE DROPS Latanoprost (50 mcg/ml) 1 WHAT IS IN THIS LEAFLET 1. What XALATAN is used for 2. How XALATAN works 3. Before you use XALATAN 4. How to use XALATAN 5. While you are using it 6. Side effects 7. Storage and Disposal of XALATAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT XALATAN IS USED FOR XALATAN is used to treat eye conditions that are linked to an increase in the pressure within the eye (glaucoma, ocular hypertension), that can eventually affect your eyesight. XALATAN is also used in all ages of children and babies. Data in the age group <1 year is limited. HOW XALATAN WORKS XALATAN works by increasing the natural outflow of fluid from inside the eye into the bloodstream and thus reducing the eye pressure. BEFORE YOU USE XALATAN _When you must not use it_ Do not start using XALATAN if you or your child is allergic (hypersensitive) to latanoprost or any of the other ingredients of XALATAN eye drops (see Section on ‘Product Description’). _Pregnancy and lactation_ Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant. Your doctor will discuss the possible risks and benefits of using XALATAN during pregnancy. XALATAN should be used with caution if you are breastfeeding. Ask your doctor or pharmacist for advice before using XALATAN if you are breastfeeding. _Before you start to use it_ Check with your doctor or pharmacist before using XALATAN if you think any of the following applies to you. The same applies if your child has been prescribed XALATAN. If you or your child suffer from eye problem (such as absence of the lens in the eye, or presence of artificial lens) If you or your child have severe asthma or if the asthma is not well controlled If you or your child wear contact lenses. You can still use XALATAN, but follow the instruction for contact lens wearers in Section ‘Th Olvassa el a teljes dokumentumot
PFIZER CONFIDENTIAL 1 1. NAME OF THE MEDICINAL PRODUCT XALATAN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 50 mcg of latanoprost and benzalkonium chloride 0.2 mg/mL. One drop contains approximately 1.5 mcg of latanoprost. Each bottle contains 2.5 mL eye drops corresponding to approximately 80 drops of solution. 3. PHARMACEUTICAL FORM Ophthalmic solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, chronic angle closure glaucoma, and ocular hypertension. 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). PFIZER CONFIDENTIAL 2 Pediatric Population Latanoprost 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 increase the brown pigment of the iris. The eye color change is du Olvassa el a teljes dokumentumot