国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Latanoprost
Lexon (UK) Ltd
S01EE; S01EE01
Latanoprost
50 microgram(s)/millilitre
Eye drops, solution in single-dose container
Prostaglandin analogues1); latanoprost
2020-07-10
WHAT MONOPOST UNIDOSE LOOKS LIKE AND CONTENTS OF THE PACK This medicine is an eye drops, solution in single-dose container. The solution looks slightly yellow and cloudy. It contains no preservative. The single-dose containers are packed in a sachet of 10 units, each single-dose container holding 0.2 ml of solution. Each pack contains 30 (3 sachets of 10) single dose containers. Product procured from within the EU, repackaged and distributed by the PARALLEL PRODUCT AUTHORISATION HOLDER: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK. Manufacturer LABORATOIRE UNITHER ZI de la Guérie 50211 Coutances Cedex France Monopost is a registered trademark of Laboratoires Théa PPA1097/071/001 THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Estonia, Germany, Greece, Iceland, Italy, Latvia, Luxembourg, The Netherlands, Norway, Poland, Portugal, Spain, Sweden ..........................................MONOPROST Ireland ..............................MONOPOST UNIDOSE Austria, Czech Republic, Lithuania, Romania, Slovak Republic, Slovenia, United Kingdom ................................MONOPOST THIS LEAFLET WAS LAST REVISED IN JANUARY 2021 Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: +44 (0)1527 505414 for help. WARNINGS AND PRECAUTIONS Talk to your doctor, or pharmacist or nurse before using MONOPOST UNIDOSE if you think any of the following apply to you: • If you are about to have or have had eye surgery (including cataract surgery). • If you suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision). • If you know that you suffer from dry eyes. • If you have severe asthma or your asthma is not well controlled. • If you wear contact lenses. You can still use MONOPOST UNIDOSE, but follow the instruction for contact lens wearers in Section 3. • If you have suffered or are currently sufferin 阅读完整的文件
Health Products Regulatory Authority 03 February 2021 CRN00C04K Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml eye drops solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms of latanoprost. Excipient with known effect Macrogolglycerol hydroxystearate 40 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution in single-dose container. _ _ _Product imported from Greece_ The solution is a slightly yellow and opalescent solution. pH: 6.5 – 7.5 Osmolality: 250-310 mosmol/kg 4 CLINICAL PARTICULARS As per PA1107/007/001 5 PHARMACOLOGICAL PROPERTIES As per PA1107/007/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Macrogolglycerol hydroxystearate 40 Sorbitol Carbomer 974P Macrogol 4000 Disodium edetate Sodium hydroxide (for pH-adjustment) Water for injections 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. After first opening of the sachet: use the single-dose containers within 10 days. After first opening of the single-dose container: use immediately and discard the single-dose container after use. Health Products Regulatory Authority 03 February 2021 CRN00C04K Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25°C. 6.5 NATURE AND CONTENTS OF CONTAINER 10 single-dose containers containing 0.2 ml of eye drops solution packed in a sachet. Each pack contains 30 single-dose containers. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon (UK) Limited Unit 18, Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1097/071/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATIO 阅读完整的文件