Evoltra 1mg/ml concentrate for solution for infusion (2011)
Active ingredients: Clofarabine
Product Name and Form
Evoltra 1 mg/ml concentrate for solution for infusion.
Concentrate for solution for infusion.
Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.
Qualitative and Quantitative Composition
Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine.
Excipient: Each 20 ml vial contains 180 mg of sodium chloride.
For a full list of excipients, see section 6.1.
Clofarabine is a purine nucleoside anti-metabolite. Its antitumour activity is believed to be due to 3 mechanisms. Clofarabine produces DNA polymerase inhibition resulting in termination of DNA chain elongation and/or DNA synthesis/repair and ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools. Clofarabine also produces disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes.
Sodium chloride
Water for injections
Pack sizes and Marketing
Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal. The vials contain 20 ml concentrate for solution for infusion and are packaged in a box. Each box contains 1, 3, 4, 10 or 20 vials.
Not all pack sizes may be marketed.
Genzyme Europe BV
Gooimeer 10
1411DD Naarden
The Netherlands
Tel: +31 (0)35 699 12 00
Fax: +31 (0) 35 694 32 14
Date of first authorisation: 29 May 2006
Date of latest renewal: 24 March 2011
EU/1/06/334/001 3 vials
EU/1/06/334/002 4 vials
EU/1/06/334/003 10 vials
EU/1/06/334/004 20 vials
EU/1/06/334/005 1 vial