ประเทศ: มอลตา
ภาษา: อังกฤษ
แหล่งที่มา: Malta Medicines Authority
CEFUROXIME
Villerton Invest S.A. Rue Edward Steichen 14, 2540, Luxembourg
J01DC02
CEFUROXIME 250 mg
POWDER FOR SOLUTION FOR INJECTION POWDER FOR SUSPENSION FOR INJECTION
CEFUROXIME 250 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2019-09-02
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME 250MG POWDER FOR INJECTION CEFUROXIME SODIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your 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 your pharmacist. IN THIS LEAFLET: 1. What Cefuroxime Injection is and what it is used for 2. Before you are given Cefuroxime Injection 3. How Cefuroxime Injection is given 4. Possible side effects 5. How to store Cefuroxime Injection 6. Further information 1. WHAT CEFUROXIME INJECTION IS AND WHAT IT IS USED FOR Your medicine contains the active substance Cefuroxime, which is one of a group of medicines called antibiotics. These are used to kill the bacteria or ‘germs’ that cause infections. Your doctor has decided to give you Cefuroxime Injection because you have an infection, or to protect you from infection before an operation. 2. BEFORE YOU ARE GIVEN CEFUROXIME INJECTION DO NOT TAKE CEFUROXIME INJECTION: • If you are allergic (hypersensitive) to cefuroxime or other similar antibiotics (called “cephalosporins”) • If you have had a severe allergic reaction to penicillin or other similar antibiotics (called “beta-lactams”) • If you had an immediate allergic reaction when given penicillin or similar antibiotics. If you are unsure about any of these, ask your doctor. TAKE SPECIAL CARE WITH CEFUROXIME INJECTION If you have been told that your kidneys are not working as well as they should be. Talk to your doctor if this applies to you. If you have previously had an allergic reaction to penicillin or other similar antibiotics, you should tell your doctor. It may be alright for you to be given this medicine. If the allergic reaction was s อ่านเอกสารฉบับเต็ม
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefuroxime 250mg Powder for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each vial contains 250mg cefuroxime (as sodium salt) 3. PHARMACEUTICAL FORM Powder for solution for injection Powder for suspension for injection Vial containing white or almost white sterile powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime 250mg Powder for Injection is indicated for the treatment of the infections listed below in adults and children including neonates (from birth) (see sections 4.4 and 5.1). • Community acquired pneumonia. • Acute exacerbations of chronic bronchitis. • Complicated urinary tract infections, including pyelonephritis. • Soft-tissue infections: cellulitis, erysipelas and wound infections. • Intra-abdominal infections (see section 4.4). • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section). In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Table 1. Adults and children ≥ 40 kg _ INDICATION DOSAGE Community acquired pneumonia and acute 750 mg every 8 hours 2 exacerbations of chronic bronchitis (intravenously or intramuscularly) Soft-tissue infections: cellulitis, erysipelas and wound infections. Intra-abdominal infections Complicated urinary tract infections, including pyelonephritis 1.5 g every 8 hours (intravenously or intramuscularly) Severe infections 750 mg every 6 hours (intravenously) 1.5 g every 8 hours (intravenously) Surgical prophylaxis for gastrointestinal, gynaecological surgery (including caesarean section) and orthopaedic operations 1.5 g with the induction of anaesthesia. This อ่านเอกสารฉบับเต็ม