Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: ORPHELIA Pharma, 85 boulevard Saint-Michel, 75005 PARIS, France
Ivozall 1 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l, free from visible particles. |
Each ml of concentrate contains 1 mg of clofarabine.
Each 20 ml vial contains 20 mg of clofarabine.
Excipient with known effect: Each 20 ml vial contains 70.77 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Clofarabine |
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. |
| List of Excipients |
|---|
|
Sodium chloride |
Type I glass vial with grey chlorobutyl fluoropolymer coated 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 vial.
ORPHELIA Pharma, 85 boulevard Saint-Michel, 75005 PARIS, France
EU/1/19/1396/001
Date of first authorisation: 14 November 2019
| Drug | Countries | |
|---|---|---|
| IVOZALL | Austria, Estonia, France, Ireland, Lithuania, Poland |
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