Држава: Израел
Језик: Енглески
Извор: Ministry of Health
CEFUROXIME AS SODIUM
VITAMED LTD, ISRAEL
J01DC02
POWDER FOR SOLUTION OR SUSPENSION FOR INJECTION OR INFUSION
CEFUROXIME AS SODIUM 750 MG
I.M, I.V
Required
ACS DOBFAR S.P. A, ITALY
CEFUROXIME
CEFUROXIME – VIT is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth):• 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• Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section)• nose infections for example, sinusitis• septic arthritis
2023-11-30
Page 1 of 14 Cefuroxime - Vit SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefuroxime - Vit 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 750 mg of cefuroxime (as 789 mg cefuroxime sodium). Excipients with known effects: Each vial contains approximately 42 mg sodium (1.8 mmol). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution or suspension for injection or infusion. Vials containing a white or almost white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Cefuroxime – Vit is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth): • 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. • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section). • Nose infections for example, sinusitis. • Septic arthritis. 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 exacerbations of chronic bronchitis 750 mg every 8 hours (intravenously or intramuscularly) Soft-tissue infections: cellulitis, erysipelas and wound infections. Page 2 of 14 Intra-abdominal infections Sinusitis, septic arthritis 750 mg every 8 hours (intravenously or intramuscularly). For more severe infections, this dose should be increased to 1.5 g every 8 hours i.v. The frequency of i.m. or i.v. injections can Прочитајте комплетан документ