Instructions for use
Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
The entire prescribed Busilvex dose should be delivered over two hours.
Small volumes may be administered over 2 hours using electric syringes. In this case infusion sets with minimal priming space should be used (i.e. 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Busilvex must not be infused concomitantly with another intravenous solution.
Polycarbonate syringes must not be used with Busilvex.
For single use only. Only a clear solution without any particles should be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
7. Marketing authorisation holder
 Pierre Fabre Médicament
45, Place Abel Gance
F-92654 Boulogne Billancourt Cedex
France
8. Marketing authorisation number(s)
 EU/1/03/254/002
9. Date of first authorisation/renewal of the authorisation
 Date of first authorisation: 09 July, 2003
Date of latest renewal: 08 July, 2008
10. Date of revision of the text
 11/2012
Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
More information about this product
•Patient Information Leaflets (PILs):
Busilvex 6 mg/ml concentrate for solution for infusion
•Alternative format Patient Information Leaflets (X-PILs):
Busilvex 6 mg/ml concentrate for solution for infusion
•Medicine Guides: