ARA-CELL 4 G

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CYTARABINE

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

L01BC01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

CYTARABINE 4000 MG / 80 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

STADAPHARM GMBH, GERMANY

Therapeutic area:

CYTARABINE

Therapeutic indications:

ARA-cell® 4000 mg is indicated for induction and maintenance of clinical remission in patients with acute myeloid leukemia, acute non-lymphoblastic leukemias, acute lymphoblastic leukemias, blast crises of chronic myeloid leukemia, diffuse histiocytic lymphomas (non-Hodgkin's lymphomas of high malignancy).

Authorization date:

2016-03-07

Summary of Product characteristics

1
1. NAME OF THE MEDICINAL PRODUCT
ARA-cell
®
4 g solution for infusion
50 mg/ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of _ARA-cell_
_®_
_ _4 g _solution for infusion_ with 80 ml solution for infusion
contains 4 g
cytarabine (50 mg/ml)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clear, colourless to yellowish solution free of particles.
Solution for infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARA-cell® 4 g is indicated for induction and maintenance of clinical
remission in patients
with acute myeloid leukemia, acute non-lymphoblastic leukemias, acute
lymphoblastic
leukemias, blast crises of chronic myeloid leukemia, diffuse
histiocytic lymphomas (non-
Hodgkin's lymphomas of high malignancy).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Effective plasma levels are assumed to range between 0.01 and 0.15
g/ml. The dose must
be determined
exactly for each individual patient, ideally in relation to the body
surface area (BSA).
Unless otherwise specified for certain combinations, Ara-cell should
be administered in the
below indicated
dosages:
STANDARD DOSAGE
_Induction therapy in patients with acute leukaemia _
Intravenous injection 100-200 mg/m2 of body surface area, daily.
Intravenous infusion of 100 mg/m2 of body surface area, daily.
The above doses are suggested as a guideline and may be exceeded
during therapy.
The duration of therapy is dependent on the clinical and morphological
findings (bone
marrow).
The patient may receive a treatment course of up to 7 days, which is
followed by a treatment-
free interval
of 7-9 days to allow for sufficient recovery of the bone marrow;
consolidation courses (often
shorter) may
subsequently be undertaken until remission or toxicity occurs.
Alternatively, therapy may be continued until bone marrow hypoplasia
occurs, which is to be
regarded as
2
the tolerance limit.
Each consecutive treatment course (often shorter) must be preceded by
a therapy-free
interval of at least
14 days or until the bone mar