Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL
Actavis Group PTC ehf
J01DC02
CEFUROXIME AXETIL
500 Base Milligrams
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins
Authorised
2010-03-31
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME ACTAVIS 250 MG FILM-COATED TABLETS CEFUROXIME ACTAVIS 500 MG FILM-COATED TABLETS Cefuroxime 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 symptoms 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 Actavis is and what it is used for 2. Before you take Cefuroxime Actavis 3. How to take Cefuroxime Actavis 4. Possible side effects 5. How to store Cefuroxime Actavis 6. Further information 1. WHAT CEFUROXIME ACTAVIS IS AND WHAT IT IS USED FOR Cefuroxime Actavis is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotics are similar to penicillin. Cefuroxime Actavis kills bacteria and it can be used against various sorts of infections. Like all antibiotics Cefuroxime Actavis is only effective against some types of bacteria. So, it is only suitable for treating some types of infection. Cefuroxime Actavis can be used to treat: • ear, sinus and throat infections • chest infections such as bronchitis • infections of the bladder • infections in the skin and the layers just under the skin (such as furuncles, impetigo-an infection on the surface of the skin) • early Lyme disease (from a tick bite) and to prevent late complications in adults and children above the age of 12. 2. BEFORE YOU TAKE CEFUR Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Actavis 500 mg Film -coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg cefuroxime as cefuroxime axetil For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 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 Actavis is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). • Acute streptococcal tonsillitis and pharyngitis. • Acute bacterial sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual course of therapy is seven days (may range from five to ten days). _Table 1. Adults and children ( 40 kg)_ INDICATION DOSAGE Acute tonsillitis and pharyngitis, acute bacterial sinusitis 250 mg twice daily Acute otitis media 500 mg twice daily Acute exacerbations of chronic bronchitis 500 mg twice daily Cystitis 250 mg twice daily Pyelonephritis 250 mg twice daily Uncomplicated skin and soft tissue infections 250 mg twice daily Lyme disease 500 mg twice daily for 14 days (range of 10 to 21 days) HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 13/11/2015_ _CRN 2166939_ _page number: 1_ _Table 2. Children (<40 kg)_ There is no experience of using C Przeczytaj cały dokument