Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Pierre Fabre Médicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France
Busilvex 6 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient | Description | |
|---|---|---|
| Busulfan |
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 |
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
EU/1/03/254/002
Date of first authorisation: 09 July, 2003
Date of latest renewal: 08 July, 2008
| Drug | Countries | |
|---|---|---|
| BUSILVEX | Austria, Brazil, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Turkey, United Kingdom, South Africa |
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