Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Fludara oral 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. Salmon-pink, capsule-shaped tablet marked with ‘LN’ in a regular hexagon on one side. |
Each film-coated tablet contains 10mg fludarabine phosphate.
Excipients: Lactose monohydrate 74.75 mg.
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 |
|---|
|
Tablet core: Cellulose, microcrystalline Film-coat: Hypromellose |
Blisters of 5 tablets each, comprising polyamide/aluminium/polypropylene thermoformable foil with a lidding foil of aluminium. The blisters are packed in a polyethylene tablet container with a child-resistant polypropylene screw cap.
Pack sizes: 15 or 20 film-coated tablets per tablet container.
Not all pack sizes may be marketed.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
PL 12375/0040
Date of first authorisation: 24 October 2000
Date of last renewal: 11 October 2010
| 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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