Doribax 500mg powder for solution for infusion Ref.[2763] Active ingredients: Doripenem

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  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.

The medicinal product does not contain any excipients.

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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