Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CEFOTAXIME
Sandoz GmbH
2 Grams
Solution for Inj/Inf
2002-12-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefotaxime 2 g Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 g vial contains 2 g cefotaxime (as cefotaxime sodium). Sodium content: 96 mg/vial. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. Description: Sterile, crystalline, white to slightly yellow powder for solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefotaxime is indicated for the treatment of the following severe infections when known or thought very likely to be due to bacteria that are susceptible to cefotaxime (_see section 5.1, Pharmacodynamic properties):_ o Bacterial pneumonia; cefotaxime is not active against bacteria that cause atypical pneumonia or against several other bacterial species that may cause pneumonia, including _P. aeruginosa _(_see section 5.1, Pharmacodynamic_ _properties)._ o Complicated infections of the kidneys and upper urinary tract. o Severe infections of the skin and soft tissue. o Genital infections caused by gonococci, particularly when penicillin has failed or is unsuitable. o Intra-abdominal infections (Such as peritonitis). Cefotaxime should be used in combination with an antibiotic that is active against anaerobes in the treatment of intra-abdominal infections. o Acute bacterial meningitis (particularly if due to _H. influenzae, N. meningitides, S. pneumoniae, E. coli, Kebsiella_ _spp._) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefotaxime may be administered by intravenous bolus injection, by intravenous infusion, or by intramuscular injection, after reconstitution of the solution according to the directions given below. Dosage and mode Belgenin tamamını okuyun