STOPAREN Powder and solvent for solution for injection

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.

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

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

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

Marketing authorization dates and numbers

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

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

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

28-4-1987 / 9-6-2008

Drugs

Drug
Countries
Lithuania