CYTOSAR 1 G.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CYTARABINE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

L01BC01

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CYTARABINE 1 G/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic group:

CYTARABINE

Therapeutic area:

CYTARABINE

Therapeutic indications:

Induction and maintenance of remission in acute myelocytic leukemia of adults and children. Treatment of other leukemias.

Authorization date:

2022-07-31

Summary of Product characteristics

Cytosar LPD CC 310122
2020-0061980
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cytosar
®
1G.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cytarabine 1 G/Vial
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Induction and maintenance of remission in acute myelocytic leukemia of
adults and children.
Treatment of other leukemias.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cytarabine is not active orally. The schedule and method of
administration vary with the
program of therapy to be used. Cytarabine may be given by intravenous
infusion or injection
Thrombophlebitis has occurred at the site of drug infusion in some
patients. In most instances,
however, the drug has been well tolerated.
Patients can tolerate higher total doses when they receive the drug by
rapid intravenous
injection as compared with slow infusion. This phenomenon is related
to the drug’s rapid
inactivation and brief exposure of susceptible normal and neoplastic
cells to significant levels
after rapid injection. Normal and neoplastic cells seem to respond in
somewhat parallel
fashion to these different modes of administration and no clear-cut
clinical advantage has
been demonstrated for either.
If high dose therapy is used, do not use a diluent containing benzyl
alcohol.
Conventional dose: In the induction therapy of acute non-lymphocytic
leukemia, the usual
cytarabine dose in combination with other anti-cancer drugs is 100
mg/m2/day by continuous
I.V. infusion (Days 1-7) or 100 mg/m2 I.V. every 12 hours (Days 1-7).
High dose: 2-3 g/m2 as an I.V. infusion over 1-3 hours given every 12
hours for 2-6 days with
or without additional cancer chemotherapeutic agents.
The literature should be consulted for the current recommendations for
use in leukemia and
pediatric non-Hodgkin’s lymphoma.
Drug compatibilities
Cytosar LPD CC 310122
2020-0061980
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Cytarabine is compatible with the follow