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BDF-FDACELL 50


Composition: 
Each lyophilized powder vial contains:
        Fludarabine phosphate ................................. 100 mg
        Excipients q.s. to .............................................. 1 vial
Each solvent ampoule contains:
        Water for injection .............................................. 2 ml

Dosage form: Lyophilized powder

Packaging: Box of 1 vial of the lyophilized powder and 1 solvent ampoule 

Pharmacodynamics: 
Fludarabine phosphate is a fluorinated nucleotide. It works as a drug antagonizing purine metabolism. Fludarabine is a cancer drug which is used treatment of chronic lymphocytic leukemia.

Pharmacokinetics:
Following IV infusion, Fludarabine phosphate is rapidly dephosphorylated in serum to fludarabine (2-fluoro-ara-adenosin, 2-fluoro-ara-A), which penetrates into intracellular via intermediate channel, then is modified by deoxycytidine kinase to link triphospho nucleotide (FATP, 2-fluorobarabinofuranosyladenin triphosphate, 2-fluoro-ara-ATP). 2-fluoro-ara-ATP is active drug. Peak concentration of triphosphate fludarabine in intercellular obtains in 4 hours after IV one dose. The half-life is about 20 hour. 60% of drug is excreted in urine.

Indications:
- B-cell chronic lymphocytic leukemia.
- Fludarabine is used as the second-line therapy to treat lymphocytic leukemia when the initial AND alkylating therapy is not successful.

Dosage and administration:
- Fludarabine phosphate injection is given 25 mg/m² administered intravenously over a period of approximately 30 minutes daily for five consecutive days. Each 5 days course of treatment should commence every 28 days. Each course of treatment is about 6 cycles.
- Dissolve lyophilized components in 2 ml of water and should be used within 8 hours of reconstitution.
- Fludarabine phosphate is diluted un 100 ml or 125 ml Dextrose 5% or NaCl 0,9% to intravenous infusion. Or diluted in 10 ml NaCl 0,9% to slow intravenous injection.
- The dosage of Fludarabine phosphate is based on the clinical response and the tolerance of drug.
- The patients with moderate impairment of renal function (Creatinine clearance: 30-70 ml/min) should have a half dose reduction.
Fludarabine phosphate injection should not be administered to patients with severely impaired renal function ( Creatinine clearance less than 30 ml/min).

Contraindications: Please read carefully the leaflet before using

Storage: Tight, at 2 – 8°C

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