Each lyophilized powder vial contains:
Fludarabine phosphate …………………………… 100 mg
Excipients q.s. to ………………………………………. 1 vial
Each solvent ampoule contains:
Water for injection ………………………………………. 2 ml
Lyophilized powder
Box of 1 vial of the lyophilized powder and 1 solvent ampoule
– 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.
Tight, at 2 – 8°C
– 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).
Please read carefully the leaflet before using
