FLUDARABIN EBEWE 50 MG2 ML

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

FLUDARABINE PHOSPHATE

זמין מ:

NOVARTIS ISRAEL LTD

קוד ATC:

L01BB05

טופס פרצבטיות:

CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION

הרכב:

FLUDARABINE PHOSPHATE 50 MG/DOSE

מסלול נתינה (של תרופות):

I.V

סוג מרשם:

Required

תוצרת:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

קבוצה תרפויטית:

FLUDARABINE

איזור תרפויטי:

FLUDARABINE

סממני תרפויטית:

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.

תאריך אישור:

2023-04-30

מאפייני מוצר

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