AZADINE (Azacitidine Powder for Suspension for Injection 100mg/vial)

Manufacturer
INTAS PHARMACEUTICALS LIMITED(INDIA)

Registraction Number
MAL19086009AZ

Content:
Each vial contains 100 mg of Azacitidine and excipients.
Indications:
AZADINE is used to treat:

• Intermediate-2 and high-risk myelodysplastic syndromes (MDS)
• Chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
• Acute myeloid leukemia (AML) with 20-30% blasts and multi-lineage dysplasia

1. Reconstitution: Reconstitute each vial with 4 mL of water for injection to form a white homogeneous cloudy suspension.
2. Administration: Administer by subcutaneous injection or intravenous infusion as directed by your healthcare provider.
3. Dosage: Follow the dosing regimen prescribed by your healthcare provider.
4. Precautions: Inform your doctor if you have a history of severe congestive heart failure, clinically unstable cardiac disease, or pulmonary disease. Monitor for signs of necrotizing fasciitis and tumour lysis syndrome.
5. Storage: Store below 30°C. Keep out of reach of children.