Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Mupirocin
PCO Manufacturing Ltd.
D06AX; D06AX09
Mupirocin
2.0 percent weight/weight
Nasal ointment
Product subject to prescription which may not be renewed (A)
Other antibiotics for topical use; mupirocin
Authorised
2013-07-26
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER BACTROBAN ® 2.0% W/W NASAL OINTMENT mupirocin 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, nurse or pharmacist. • 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, nurse or pharmacist. This includes any possible side-effects not listed in this leaflet. See section 4. • In this leaflet, Bactroban 2.0% w/w Nasal Ointment will be called Bactroban. WHAT IS IN THIS LEAFLET: 1. What Bactroban is and what it is used for 2. What you need to know before you use Bactroban 3. How to use Bactroban 4. Possible side effects 5. How to store Bactroban 6. Contents of the pack and other information 1 s and what it is used for 1. WHAT BACTROBAN IS AND WHAT IT IS USED FOR Bactroban contains the active substance mupirocin as mupirocin calcium. Bactroban is an antibiotic ointment. It is used: • to kill a group of bacteria in the nose called ‘Staphylococci’ • this group includes MRSA (Methicillin Resistant _Staphylococcus aureus_) • this ointment is for use in your nose only. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BACTROBAN DO NOT USE BACTROBAN IF: • you are allergic to mupirocin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Bactroban • Do not put Bactroban into your mouth or swallow it. • Do not put Bactroban in your eyes. If you get it in your eyes, wash it out immediately. • If you develop a severe skin reaction or allergy wipe off the ointment, stop using it and tell your doctor as soon as possible. • Prolonged use of Bactroban may result in overgrowth of non-susceptible organisms. OTHER MEDICINES AND BACTROBAN Tell your doctor Lugege kogu dokumenti
Health Products Regulatory Authority 10 June 2022 CRN00CZ6V Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bactroban 2% w/w Nasal Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of nasal ointment contains 20 mg mupirocin (2.0% w/w) as mupirocin calcium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal ointment. _Product sourced from Spain and Greece:_ An off white smooth ointment. 4 CLINICAL PARTICULARS As per PA1077/094/002 5 PHARMACOLOGICAL PROPERTIES As per PA1077/094/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS White soft paraffin Mixed diglycerin ester of fatty acids (softisan 649) 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. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. 6.5 NATURE AND CONTENTS OF CONTAINER Lacquered aluminium tube fitted with a nozzle and screw cap containing 3 g white ointment. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any product remaining at the end of treatment should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Wash your hands after application. Health Products Regulatory Authority 10 June 2022 CRN00CZ6V Page 2 of 2 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/312/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 th July 2013 Last updated: December 2016 10 DATE OF REVISION OF THE TEXT June 2022 Lugege kogu dokumenti