FLUDARA Powder for solution for injection or infusion Ref.[8137] Active ingredients: Fludarabine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Product name and form

Fludara 50 mg powder for solution for injection or infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

White lyophilisate for reconstitution.

Qualitative and quantitative composition

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
Sodium hydroxide (to adjust the pH to 7.7)

Pack sizes and marketing

10 ml colourless Type I glass vials containing 50 mg fludarabine phosphate.

Pack size: 5 vials per carton.

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization dates and numbers

PL 12375/0039

Date of first authorisation: 11 August 1994
Date of last renewal: 07 August 2009

Drugs

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

© 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.