Clofarabine 20 mg/20 ml
Dilute before the intravenous use
THIS PRODUCT IS INCLUDED IN THE RISK MANAGMENT PLAN
Argentine Industry - Dispense under prescription
Each glass bottle contains:
Clofarabine 20.0 mg
Sodium chloride 180 mg
Water for injection qs 20 ml
Treatment of paediatric patients with relapsed or refractory acute lymphoblastic leukaemia (ALL) after receiving at least two regimes of prior treatment and for whom there is no other therapeutic option which a lasting response can be expected with. The safety and efficacy of this drug have been evaluated in patients ≤ 21 years old at the initial diagnose time (see Pharmacodynamic properties).
Do not freeze.
Store at room temperature between 15 and 30 °C.
Cartons with 1 and 4 glass bottles containing 20 mg clofarabine (1 mg/1 ml)
Keep in an appropriate place and out of the reach of children.
Information for the patient
"If any inconvenience is presented with the product, the patient can fill the sheet provided on the website of ANMAT: http://www.anmat.gov.ar/farmacovigilancia/Notificar.asp or call ANMAT, which responds to 0800-333 -1234 ".
Medicinal speciality authorised by the Ministry of Health
Certificate Nº 56678
Laboratorio DOSA S.A.
Girardot 1369 (C1427AKC) City of Buenos Aires, Argentina.
Pharmaceutical Director: María C. Terzo, Pharmacist.