BUSILVEX Concentrate for solution

Active ingredients: Busulfan

Product name and form

Busilvex 6 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless solution.

Qualitative and quantitative composition

One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).

After dilution: 1 ml of solution contains 0.5 mg of busulfan.

For the full list of excipients see section 6.1.

Active Ingredient
Description

Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent. In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.

List of Excipients

Dimethylacetamide
Macrogol 400

Pack sizes and marketing

10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.

Multipack containing 8 (2 packs of 4) vials.

Marketing authorization holder

Pierre Fabre M├ędicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France

Marketing authorization dates and numbers

EU/1/03/254/002

Date of first authorisation: 09 July, 2003
Date of latest renewal: 08 July, 2008

Drugs

Drug
Countries
Austria, Brazil, Spain, France, Ireland, Lithuania, Netherlands, United Kingdom