DORIBAX Powder for solution for infusion Ref.[9837] Active ingredients: Doripenem

Source: European Medicines Agency (EU)  Revision Year: 2014  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Product name and form

Doribax 500 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion (powder for infusion).

White to slightly yellowish off-white crystalline powder.

Qualitative and quantitative composition

Each vial contains doripenem monohydrate equivalent to 500 mg doripenem.

Active Ingredient Description
Doripenem

Doripenem is a synthetic carbapenem antibacterial agent. Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis. Doripenem inactivates multiple essential penicillin-binding proteins (PBPs) resulting in inhibition of cell wall synthesis with subsequent cell death.

List of Excipients

None.

Pack sizes and marketing

Clear 20 ml Type I glass vial.

The medicinal product is supplied in cartons containing 10 vials.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization dates and numbers

EU/1/08/467/001

Date of first authorisation: 25 July 2008

Drugs

Drug Countries
DORIBAX Estonia, Singapore, South Africa

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