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 |
|---|
|
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.