Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
FLUDARABINE PHOSPHATE
NOVARTIS ISRAEL LTD
L01BB05
CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION
FLUDARABINE PHOSPHATE 50 MG/DOSE
I.V
Required
EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA
FLUDARABINE
FLUDARABINE
Palliative treatment of patients with CLL refractory to other therapy. Treatment of less malignant Non-Hodgkin lymphoma of stage 3 to 4 in patients who have not responded to standard therapy with at least one alkylating agent or in whom the disease progressed during or after standard therapy. Fludarabine is indicated for the initial treatment of patients with B- cell chronic lymphocytic leukaemia (CLL) or after first line therapy, in patients with sufficient bone marrow reserves.
2023-04-30
Flu API Jun 2021 1. NAME OF THE MEDICINAL PRODUCT Fludarabin "Ebewe" 50 mg/2 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml vial contain 50 mg fludarabine phosphate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for injection or infusion. A clear, colourless to almost colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palliative treatment of patients with CLL refractory to other therapy. Treatment of less malignant Non-Hodgkin lymphoma of stage 3 to 4 in patients who have not responded to standard therapy with at least one alkylating agent or in whom the disease progressed during or after standard therapy. Fludarabine is indicated for the initial treatment of patients with B- cell chronic lymphocytic leukaemia (CLL) or after first line therapy, in patients with sufficient bone marrow reserves. First line treatment with fludarabine should only be initiated in patients with advanced disease, Rai stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology • Adults The recommended dose of fludarabine is 25 mg/m 2 body surface given daily for 5 consecutive days (= one cycle) every 28 days by the intravenous route. The required dose (calculated on the basis of the patient's body surface) is drawn up into a syringe. For intravenous bolus injection this dose is further diluted in10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. Alternatively, for infusion, the required dose may be diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or in 100 to 125 ml of glucose 5% solution and infused intravenously over a period of approximately 30 minutes (see also section 6.6). The optimal duration of treatment has not been clearly established. The duration of treatment depends on the treatment success and the tolerability of the medicinal product. It is recommended to admin Lue koko asiakirja