Страна: Мальта
Язык: английский
Источник: Medicines Authority
CEFACLOR
Alta Care Laboratoires Piazza di Spagna 6, 00187 Roma, Italy
J01DC04
CEFACLOR 250 mg/5ml
GRANULES FOR ORAL SUSPENSION
CEFACLOR 250 mg/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2007-10-10
PACKAGE LEAFLET: INFORMATION FOR THE USER EUROCEFIX 500 MG HARD CAPSULES EUROCEFIX 250 MG / 5ML GRANULES FOR ORAL SUSPENSION Cefaclor 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. 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. IN THIS LEAFLET: 1. What EUROCEFIX is and what it is used for 2. Before you take EUROCEFIX 3. How to take EUROCEFIX 4. Possible side effects 5. How to store EUROCEFIX 6. Further information 1. WHAT EUROCEFIX IS AND WHAT IT IS USED FOR Cefaclor is a semisynthetic 2nd generation cephalosporin antibiotic, orally administered. EUROCEFIX is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: • Respiratory infections: such as pneumonia, bronchitis, re-acutisation of chronic bronchitis, pharyngitis and tonsillitis. • Otitis media (inflammatory processes of bacterial origin on the otitis media). • Skin infections and soft tissues. • Urinary tract infections, including phelonephritis and cystitis. • Sinusitis. Your doctor will be able to explain and tell you more. It is used to treat many different sorts of infection. Your doctor can tell you about your infection. 2. BEFORE YOU TAKE EUROCEFIX DO NOT TAKE EUROCEFIX - if you are allergic to it’s active substance (cefaclor and other cephalosporins), any of the other ingredients, or with history of allergic reaction to penicillin. TAKE SPECIAL CARE AND LET YOUR DOCTOR KNOW - Before starting treatment with cefaclor, inform your doctor of any know hypersensi Прочитать полный документ
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME EUROCEFIX – hard capsules EUROCEFIX - granules for oral suspension ATC CODE J01DA08 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EUROCEFIX 500 MG HARD CAPSULES Each capsule contains: Active Ingredient: cefaclor monohydrate equivalent to 500mg cefaclor. Excipients: starch 62.1mg, dimethicone 350 6.9mg, magnesium stearate 8mg. Capsule Constituents: gelatine 9.6mg, titanium dioxide 2mg. EUROCEFIX 250 MG/5 ML GRANULES FOR ORAL SUSPENSION 5 ml of suspension contain: Active Ingredient: cefaclor monohydrate equivalent to 250mg cefaclor. Excipients: modified starch 10mg, dimethicone 350 1mg, methylcellulose 15 3mg, saccharose 2.87g, sodium laurylsulfate 0.75mg, strawberry flavour 15mg, polysaccharide gum 7.5mg, erythrosine E127 2.4mg. 3. PHARMACEUTICAL FORM Hard capsules. Granules for oral suspension. 4. CLINICAL INFORMATION 4.1. THERAPEUTIC INDICATIONS Treatment of the following infections when caused by susceptible strains: • Respiratory infections: such as pneumonia, bronchitis, re-acutisation of chronic bronchitis, pharyngitis and tonsillitis. • Otitis media (inflammatory processes of bacterial origin on the otitis media). • Skin infections and soft tissues. • Urinary tract infections, including phelonephritis and cystitis. • Sinusitis. 4.2. DOSES, DIRECTIONS AND ADMINISTRATION EUROCEFIX is administered orally and can be administered independently without meals. ADULTS: 250mg every 8 hours. For more severe infections doses may be increased. The maximum recommended dose is of 2g a day. Page 2 of 6 CHILDREN: 20 mg/kg/day in divided doses every 8 hours: In more serious infections, otitis media, 40 mg/kg/day are recommended, with Прочитать полный документ