CEFOTAXIME 1g Powder for solution for injection or infusion

Active ingredients: Cefotaxime

Product name and form

Cefotaxime Sodium for Injection.

Pharmaceutical Form

Powder for solution for injection or infusion.

Vials containing a white to slightly yellow powder, which when dissolved in Water for Injections forms a straw coloured solution. The intensity of the colour of the solution may vary but this does not indicate differences in potency or safety.

Qualitative and quantitative composition

Cefotaxime (as cefotaxime sodium) per vialDiluent to be addedFinal concentration of solution
500 mg2 ml500 mg/2.2 ml
1 g4 ml1 g/4.4 ml

A quantity of cefotaxime sodium equivalent to 1 g cefotaxime contains approximately 50 mg (2.2 mmol) of sodium.

For excipients see 6.1.

Active Ingredient
Description

Cefotaxime exerts its action by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thereby inhibiting cell wall synthesis.

List of Excipients

None.

Pack sizes and marketing

500 mg and 1 g presentations in 10 ml glass vials closed with rubber stoppers and sealed with aluminium caps.

Packaged singly or in cartons of 10, 25 or 50.

Marketing authorization holder

Villerton Invest SA, Rue Edward Steichen 14, 2540 Luxembourg

Marketing authorization dates and numbers

PL 24780/0008

10/10/2011