Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Ketorolac trometamol
PCO Manufacturing Ltd.
S01BC; S01BC05
Ketorolac trometamol
0.5 percent weight/volume
Eye drops, solution
Product subject to prescription which may be renewed (B)
Antiinflammatory agents, non-steroids; ketorolac
Authorised
2012-07-20
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER ACULAR 0.5% W/V EYE DROPS, SOLUTION (Ketorolac trometamol) 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 ACULAR is and what it is used for 2. What you need to know before you use ACULAR 3. How to use ACULAR 4. Possible side effects 5. How to store ACULAR 6. Contents of the pack and other information 1. WHAT ACULAR IS AND WHAT IT IS USED FOR Acular is used to prevent and reduce eye inflammation following cataract surgery in adults. Acular belongs to a group of medicines known as non-steroidal anti- inflammatory drugs (NSAIDS). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACULAR DO NOT USE ACULAR If you are allergic to ketorolac trometamol or any of the other ingredients of this medicine (listed in section 6). If you are allergic to aspirin or any other similar drugs, such as other non-steroidal anti-inflammatory drugs. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before using ACULAR. If you suffer from, or have in the past suffered from: viral or bacterial infections of the eye bleeding tendencies (for example, anaemia) or stomach ulcers diabetes rheumatoid arthritis dry eye syndrome asthma after using non-steroidal anti-inflammatories if you have had recent eye surgery if you have lost sensitivity in the cornea (the clear surface covering the pupil and iris) or if the normally smooth surface of the cornea is damaged. CHILDREN ACULAR should not be prescribed for use in Belgenin tamamını okuyun
Health Products Regulatory Authority 07 June 2022 CRN00CZ0D Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACULAR 0.5% w/v Eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketorolac trometamol 5 mg/ml. Excipient(s) with known effect: Benzalkonium chloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution _Product imported from France_ Clear, colourless to pale yellow aqueous solution. 4 CLINICAL PARTICULARS As per PA1824/015/001 5 PHARMACOLOGICAL PROPERTIES As per PA1824/015/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium chloride Benzalkonium chloride 50% solution Sodium Edetate Octoxinol Sodium hydroxide 1N or hydrochloric acid 1N Purified water 6.2 INCOMPATIBILITIES Not applicable. 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. Use within 15 days of first opening. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25°C. 6.5 NATURE AND CONTENTS OF CONTAINER 5ml of solution in a dropper bottle (PE) with a screw cap 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Health Products Regulatory Authority 07 June 2022 CRN00CZ0D Page 2 of 2 No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/287/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20th July 2012 10 DATE OF REVISION OF THE TEXT June 2022 Belgenin tamamını okuyun