Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Latanoprost
IMED Healthcare Ltd.
S01EE; S01EE01
Latanoprost
50 microgram(s)/millilitre
Eye drops, solution in single-dose container
Prostaglandin analogues1); latanoprost
2021-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER MONOPOST ® UNIDOSE 50 MICROGRAMS/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER latanoprost READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, or pharmacist or nurse. - This medicine has been prescribed for you 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 pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What MONOPOST UNIDOSE is and what it is used for 2. What you need to know before you use MONOPOST UNIDOSE 3. How to use MONOPOST UNIDOSE 4. Possible side effects 5. How to store MONOPOST UNIDOSE 6. Contents of the pack and other information 1. WHAT MONOPOST UNIDOSE IS AND WHAT IT IS USED FOR MONOPOST UNIDOSE belongs to a group of medicines known as prostaglandins. It lowers the pressure within your eye by increasing the natural outflow of fluid from inside the eye into the bloodstream. MONOPOST UNIDOSE is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MONOPOST UNIDOSE DO NOT USE MONOPOST UNIDOSE • If you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6). 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 se Læs hele dokumentet
Health Products Regulatory Authority 30 September 2022 CRN00D50Y 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: polyethylene glycol glycerol hydroxystearate 40 (castor oil polyoxyl hydrogenated). 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 Sorbitol Carbomer 974P Polyethylene glycol 4000 Ethylenediaminetetraacetate disodium salt 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 30 September 2022 CRN00D50Y Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25 °C. For storage after first opening of the medicinal product, see section 6.3. 6.5 NATURE AND CONTENTS OF CONTAINER 5 or 10 single-dose containers containing 0.2 ml of eye drops solution are packed in sachet. Pack size: 30 single-dose containers. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycooli Læs hele dokumentet