DACOGEN (Decitabine) 50 mg Powder for Concentrate for Solution for Infusion

Manufacturer
BSP Pharmaceuticals S.p.A.(ITALY)

Registraction Number
MAL19126024ACRSZ

Content:
Dacogen (Decitabine) 50 mg Powder for Concentrate for Solution for Infusion contains the active ingredient decitabine. Each vial contains 50 mg of decitabine.
Indications:
Dacogen is used for the treatment of:
Myelodysplastic Syndromes (MDS): Including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia).
Acute Myeloid Leukemia (AML): In patients who are not eligible for standard induction chemotherapy.
Instructions:
Reconstitution: Reconstitute each vial containing 50 mg decitabine with 10 mL of sterile water for injection. Shake vigorously until a uniform suspension is obtained.
Administration:
For intravenous infusion: Reconstitute the suspension further with 50-100 mL of 0.9% sodium chloride solution and administer as an intravenous infusion over 1 hour.