Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
CEFUROXIME
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
J01DC02
CEFUROXIME 250 mg
FILM-COATED TABLET
CEFUROXIME 250 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2011-02-21
dimensions: pharmacode: date sent: TECHNICAL APPROVAL min pt size: awstudio@actavis.co.uk print proof no: origination date: originated by: revision date: supplier: technically app. date*: * Please note the technical approval is provided by the supplier and is valid on the date indicated. Any technical changes made by the supplier after approval are not the responsibility of the Artwork Studi Non Printing Colours colours/plates revised by: 1. 2. 3. 4. 5. 6. black 4 7pt 250x480 26.01.2012 26.01.2012 08.02.2012 K. Mutafchieva K. Mutafchieva 22.02.2012 Orchid, India AAAD2370 Cefuroxime Axetil, All Strengths, PIL, Malta & Cyprus READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symp- toms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Cefuroxime axetil Actavis is and what it is used for 2. Before you take Cefuroxime axetil Actavis 3. How to take Cefuroxime axetil Actavis 4. Possible side effects 5. How to store Cefuroxime axetil Actavis 6. Further information 1. WHAT CEFUROXIME AXETIL ACTAVIS IS AND WHAT IT IS USED FOR Cefuroxime axetil Actavis is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotics are similar to penicillin. Cefuroxime axetil Actavis kills bacteria and it can be used against various sorts of infections. Like all antibiotics Cefuroxime axetil Actavis is only effective against some types of bacteria. So, it is only suitable for treating some types of infection. Cefuroxime axetil Actavis can be used to treat: • ear, sinus and throat infections • chest infections such as bronchitis • infectio Đọc toàn bộ tài liệu
Page 1 of 9 SUMMARY OF PRODCUT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefuroxime Axetil Actavis 250 mg film-coated tablets Cefuroxime Axetil Actavis 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg cefuroxime as cefuroxime axetil Each tablet contains 500 mg cefuroxime as cefuroxime axetil For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _250 mg:_ Light blue-coloured film-coated, capsule shaped tablets marked “250” on one side and “P125” on the other side. _500 mg:_ Light blue coloured film-coated capsule shaped tablets marked “500” on one side and “P126” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Axetil Actavis is indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as: - upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis - acute bronchitis, acute exacerbations of chronic bronchitis - lower uncomplicated urinary tract infections: cystitis - skin and soft tissue infections: furunculosis, pyoderma and impetigo - treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For an individual dosage, Cefuroxime Axetil Actavis 250 mg and 500 mg film-coated tablets are available. General dosage recommendations for cefuroxime depend on the sensitivity of the respective pathogen and on the site of infection. Cefuroxime Axetil Actavis tablets are coated to mask their taste: they should not be broken, crushed or chewed. The usual duration of therapy is 7 days (ran Đọc toàn bộ tài liệu