VALORAN Powder for solution for injection or infusion Ref.[28262] Active ingredients: Cefotaxime

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Valoran 500mg powder for solution for injection/infusion.

Valoran 1g powder for solution for injection/infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

The powder is white to slightly creamy, and when reconstituted with water for injection gives a straw coloured solution. Any variation in the intensity of colour of the freshly prepared solution is not indicative of change in potency or safety.

Qualitative and quantitative composition

Valoran 500 mg contains 500 mg cefotaxime as cefotaxime sodium.

Valoran 1 g contains 1 g cefotaxime as cefotaxime sodium.

1 g cefotaxime contains approximately 2.09 mmol of sodium.

For a full list of excipients, see section 6.1.

Active Ingredient 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

Clear type I glass vials, sealed with a grey bromobutyl rubber stopper and aluminium cap. Vials are cartonned in packs of 10, 50 or 100 with an instruction leaflet. Valoran 1g is also available in packs of 1 vial.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Valoran 500mg powder for solution for injection or infusion: M. L. No. 12779
Valoran 1g powder for solution for injection or infusion: M. L. No. 12778

Valoran 500mg powder for solution for injection/infusion:

Date of first authorisation: 06/07/1990
Date of latest renewal: 21/08/2013

Valoran 1g powder for solution for injection/infusion:

Date of first authorisation: 06/07/1990
Date of latest renewal: 21/08/2013

Drugs

Drug Countries
VALORAN Cyprus, Estonia, Spain, Hong Kong, Malta

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