Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Fludara 50 mg powder for solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection or infusion. White lyophilisate for reconstitution. |
Each vial contains 50 mg fludarabine phosphate.
One ml of reconstituted solution contains 25 mg fludarabine phosphate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fludarabine |
Fludarabine is a water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Fludarabine phosphate is rapidly dephosphorylated to 2F-ara-A which is taken up by cells and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2F-ara-ATP. This metabolite has been shown to inhibit ribonucleotide reductase, DNA polymerase α/δ and ε, DNA primase and DNA ligase thereby inhibiting DNA synthesis. |
| List of Excipients |
|---|
|
Mannitol |
10 ml colourless Type I glass vials containing 50 mg fludarabine phosphate.
Pack size: 5 vials per carton.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
PL 12375/0039
Date of first authorisation: 11 August 1994
Date of last renewal: 07 August 2009
| Drug | Countries | |
|---|---|---|
| FLUDARA | Australia, Canada, Cyprus, Estonia, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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