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STOPAREN (2012)

Active ingredients: Cefotaxime

Product Name and Form

STOPAREN.

Pharmaceutical form

Dry powder and solvent for solution for injection.

Qualitative and Quantitative Composition

STOPAREN 0.5g/VIAL (IV+IM): Each vial contains 0.524g of cefotaxime sodium equivalent to 500mg of cefotaxime.

STOPAREN 1g/VIAL (IV): Each vial contains 1.048g of cefotaxime sodium equivalent to 1g of cefotaxime.

STOPAREN 1g/VIAL (IM): Each vial contains 1.048g of cefotaxime sodium equivalent to 1g of cefotaxime.

For a full list of excipients, see section 5.1.

Chemical substance
Description
Cefotaxime

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

Cefotaxime is supplied in Type III glass vials, closed with a rubber stopper.

STOPAREN 500mg (IM+IV): BTx1 vial + 1 ampoule solvent (2ml).

STOPAREN 1g (IV): BTx 1 vial + 1 ampoule solvent (4ml).

STOPAREN 1g (IM): BTx 1 vial + 1 ampoule solvent (4ml).

Marketing authorization holder
Authorization dates

ANFARM HELLAS SA
53-57 Perikleous str.
153 44
Gerakas
Athens
Greece

Tel.: (210) 6831632
Fax: (210) 6836540

28-4-1987 / 9-6-2008

Marketing authorization number:

STOPAREN 500mg (IV+IM): 42877/9-6-2008

STOPAREN 1g (IV): 69858/10/12-5-2011

STOPAREN 1g (IM): 69859/10/12-5-2011