Powder lyophilized for preparing solution
For injection 50 mg
Trade name: Fludarabine- Belmed.
International nonproprietary name: Fludarabine.
Description: white powder or porous mass compressed as a tablet.
Composition: each ampoule contains:
Active substance: fludarabine phosphate – 50 mg.
Excipients: mannitol, 1M sodium hydroxide solution.
Pharmaceutical form: lyophilized powder for solution for injection 50 mg.
ATC code: L01BB05.
Indications for use:
B- Cell chronic lymphocytic leukemia (CLL) in patients with sufficient bone marrow reserve. The therapy with the drug product as the essential one should be administered in patients with progressing disease of Rai stage lll/lV (Binet C) or Rai stage l/ll (Binet A/B) when the patient has the symptoms connected with the disease or attribute of progressing disease.