Doribax 500mg powder for solution for infusion

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.

Active Ingredient
Description

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

Drugs

Drug
Countries
Singapore