DETAVI

Lyophilised injection

Argentine Industry - Dispense under prescription

Each glass bottle contains:

Decitabine 50 mg, monobasic potassium phosphate, and sodium hydroxide.

Therapeutic action:

Antineoplastic agent.

Indications:

DETAVI is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anaemia, refractory anaemia with ringed sideroblasts, refractory anaemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukaemia) and intermediate-1, intermediate- 2, and high-risk International Prognostic Scoring System groups.

Information for patients:

Patients should inform their physician about any underlying hepatic or renal disease.

Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with DATEVI.

Men should be advised not to father a child while receiving treatment with DATEVI, and for 2 months after the treatment.

Storage:

Store the glass bottles at a temperature between 15° and 30°C.

Reconstituted solution: unless used within 15 minutes from reconstitution, the diluted solution must be prepared using cold fluids for infusions (2° - 8°C) and stored at a temperature between 2°C and 8°C up to a maximum of 7 hours prior to the administration.

How supplied:

Packing containing 1 glass bottle.

Medicinal speciality authorised by the Ministry of Health

Certificate Nº 54891

Laboratorio DOSA S.A. - Girardot 1369 - (C1427AKC) Buenos Aires - Argentina

Pharmaceutical Director: María C. Terzo, Pharmacist