Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Latanoprost
Imbat Limited
S01EE; S01EE01
Latanoprost
50 microgram(s)/millilitre
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Prostaglandin analogues1); latanoprost
Authorised
2008-10-24
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER XALATAN ® 50 MICROGRAMS/ML EYE DROPS, SOLUTION latanoprost Your medicine is available using the above name but will be referred to as Xalatan throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. EVEN IF YOU HAVE ALREADY USED XALATAN OR A SIMILAR MEDICINE BEFORE, WE ADVISE YOU TO READ THIS TEXT CAREFULLY. THE INFORMATION MAY HAVE BEEN CHANGED. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or the doctor treating your child or pharmacist. This medicine has been prescribed for you or for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or the doctor treating your child or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT XALATAN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XALATAN 3. HOW TO USE XALATAN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE XALATAN 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT XALATAN IS AND WHAT IT IS USED FOR Xalatan belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream. Xalatan is used to treat conditions known as OPEN ANGLE GLAUCOMA and OCULAR HYPERTENSION in adults. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight. Xalatan is also used to treat increased eye pressure and glaucoma in all ages of children and babies. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XALATAN Xalatan can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Xalatan has not been investigated in prematurely born infants (less than 36 weeks gestation). DO NOT USE XAL Прочитать полный документ
Health Products Regulatory Authority 25 January 2019 CRN008QF7 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xalatan 50 micrograms/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 100ml eye drops solution contains 5mg latanoprost One drop contains approximately 1.5 micrograms latanoprost. Excipient with known effect: Benzalkonium chloride 0.02% w/v is included as a preservative. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution _Product imported from: Italy & UK (as Latanoprost and as Xalatan)_ The solution is a clear colourless liquid. 4 CLINICAL PARTICULARS As per PA0822/140/001 5 PHARMACOLOGICAL PROPERTIES As per PA0822/140/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium chloride Benzalkonium chloride Sodium dihydrogen phosphate monohydrate (E339a) Anhydrous disodium phosphate (E339b) Water for injections 6.2 INCOMPATIBILITIES In vitro studies have shown that precipitation occurs when eye drops containing thiomersal are mixed with Xalatan. If such medicinal products are used, the eye drops should be administered with an interval of at least five minutes. Health Products Regulatory Authority 25 January 2019 CRN008QF7 Page 2 of 3 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Shelf life after opening of container: 4 weeks. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Product imported from Italy (as Xalatan) and UK (as Latanoprost) Store in a refrigerator (2°C - 8°C) Keep the bottle in the outer carton in order to protect from light. After first opening the bottle: do not store above 25°C and use within four weeks. Product imported from UK (as Xalatan) Store at room temperature (below 25°C) Keep the bottle in the outer carton in order to protect from light. Use within four weeks of opening. 6.5 NATURE AND CONTENTS OF CONTAINER Dropper container with either a screw cap and tamper evident ove Прочитать полный документ