Active ingredients: Busulfan
Busilvex 6 mg/ml concentrate for solution for infusion.
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless solution.
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.
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.
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.
Pierre Fabre Médicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France
Date of first authorisation: 09 July, 2003
Date of latest renewal: 08 July, 2008