Leudibine - Decitabine powder for concentrate for solution for infusion 50 mg/via

Manufacturer
Shilpa Medicare Limited (Unit IV)(INDIA)

Registraction Number
MAL24086008AZ

Content:
Leudibine (Decitabine) 50 mg/vial Powder for Concentrate for Solution for Infusion contains 50 mg of decitabine. Decitabine is a hypomethylating agent used in the treatment of certain types of blood cancers.
Indications:
Leudibine is indicated for:

• Myelodysplastic Syndromes (MDS): Including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) 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): For adult patients aged 65 and above with newly diagnosed de novo or secondary AML who are not candidates for standard induction chemotherapy.

1. Reconstitution:
   • Withdraw the entire contents of the vial containing the suspension into a syringe.
   • Add the entire contents of the syringe into the vial containing the powder.
   • Gently swirl until the powder is completely dissolved.
2. Administration:
   • Administer the reconstituted solution via intravenous infusion.
   • Use a 0.2-0.22 micron in-line filter.
3. Timing:
   • The reconstituted solution should be used promptly.
   • If not used within 4 hours, it should be discarded.
4. Storage:
   • Store the reconstituted vaccine in the refrigerator (2°C – 8°C) or at room temperature up to 25°C.