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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
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