Description
Manufacturer
Shilpa Medicare Limited (Unit IV)(INDIA)
Registraction Number
MAL24086008AZ
Contents
Active Ingredient: Decitabine, 50 mg per vial.
Formulation: Lyophilized powder for reconstitution.
Indications
Leudibine is used for:
Treatment of myelodysplastic syndromes (MDS), including:
Previously treated and untreated cases.
De novo and secondary MDS of all French-American-British (FAB) subtypes.
Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups.
Treatment of acute myeloid leukemia (AML) in adults aged 65 and above who are not candidates for standard induction chemotherapy.
Instructions
Preparation: Reconstitute with sterile water for injection. The reconstituted solution must be further diluted with compatible infusion fluids (e.g., 0.9% Sodium Chloride or 5% Dextrose Injection).
Administration: Administered via intravenous infusion under the supervision of a healthcare professional.
Typical regimens include:
15 mg/m² every 8 hours for 3 days (repeated every 6 weeks).
20 mg/m² daily for 5 days (repeated every 4 weeks).
Precautions:
Regular monitoring of blood counts and organ function is required.
Avoid use if allergic to decitabine or other ingredients.
Consult a doctor if pregnant, breastfeeding, or taking other medications.
Storage: Store unopened vials below 30°C. After reconstitution, use within 15 minutes or store at 2–8°C for up to 4 hours.
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