国家: 马耳他
语言: 英文
来源: Medicines Authority
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
J01DC02
CEFUROXIME 500 mg
FILM-COATED TABLET
CEFUROXIME 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-09-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ZINNAT 125 MG FILM-COATED TABLETS ZINNAT 250 MG FILM-COATED TABLETS ZINNAT 500 MG FILM-COATED TABLETS cefuroxime READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Zinnat is and what it is used for 2. What you need to know before you take Zinnat 3. How to take Zinnat 4. Possible side effects 5. How to store Zinnat 6. Contents of the pack and other further information 1. WHAT ZINNAT IS AND WHAT IT IS USED FOR Zinnat is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called _cephalosporins_ . Zinnat is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. Zinnat can also be used: • to treat Lyme disease (an infection spread by parasites called ticks). Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Zinnat during your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZINNAT DO NOT TAKE ZINNAT: • IF YOU ARE ALLERGIC to cefuroxime axetil or ANY CEPHALOSPORIN ANTIBIOTICS or any of the other ingredients of Zinnat (listed in section 6). • if you have ever had a severe allergic (hypersensitive) reaction to any other type of beta-lactam antibiotic (penicillins, monobactams and carbapenems). • if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after treatment wi 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zinnat 250 mg film-coated tablets Zinnat 500 mg film-coated tablets Zinnat 125 mg/5 ml granules for oral suspension Zinnat 250 mg/5 ml granules for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zinnat 250 mg film-coated tablets Each tablet contains 250 mg cefuroxime (as cefuroxime axetil). Zinnat 500 mg film-coated tablets Each tablet contains 500 mg cefuroxime (as cefuroxime axetil). Zinnat 125 mg/5 ml granules for oral suspension 125 mg cefuroxime per 5 ml (as 150 mg cefuroxime axetil). Zinnat 250 mg/5 ml granules for oral suspension 250 mg cefuroxime per 5 ml (as 300 mg cefuroxime axetil). Excipient(s) with known effect: Zinnat 250 mg film-coated tablets Each tablet contains 0.00203 mg sodium benzoate (E211) Each tablet contains 0.07 mg methyl parahydroxybenzoate (E218) and 0.06 mg propyl parahydroxybenzoate (E216) Zinnat 500 mg film-coated tablets Each tablet contains 0.00506 mg sodium benzoate (E211) Each tablet contains 0.18 mg methyl parahydroxybenzoate (E218) and 0.15 mg propyl parahydroxybenzoate (E216) Zinnat 125 mg/5 ml granules for oral suspension Contains 0.021 g aspartame (E951) per 5 ml dose Contains 3.1 g of sucrose per 5 ml dose Contains 6 mg of propylene glycol (E1520) per 5 ml dose Contains 4.5 mg benzyl alcohol (E1519) per 5 ml dose Zinnat 250 mg/5 ml granules for oral suspension Contains 0.045 g aspartame (E951) per 5 ml dose Contains 2.3 g of sucrose per 5 ml dose Contains 4.6 mg benzyl alcohol (E1519) per 5 ml dose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 250 mg, 500 mg film-coated tablets Film-coated tablet (tablet) 2 125 mg/5 ml, 250 mg/5 ml granules for oral suspension Granules for oral suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zinnat 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. 阅读完整的文件