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Doribax 500mg powder for solution for infusion (2012)

Active ingredients: Doripenem

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.

Chemical substance
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
Authorization dates

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

Date of first authorisation: 25 July 2008

Marketing authorization number:

EU/1/08/467/001