Cytosar powder lyophilized for solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cytarabine

Available from:

Corden Pharma Latina S.p.A

ATC code:

L01BC01

INN (International Name):

cytarabine

Dosage:

100mg

Pharmaceutical form:

powder lyophilized for solution for injection

Units in package:

glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-01-13

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CYTOSAR
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution for injection, containing cytarabine 20 mg and 100 mg per mL.
Concentrate for solution for infusion, containing cytarabine 100 mg
per mL.
Powder freeze dried, containing cytarabine 20 mg, 40 mg, 100 mg and
500 mg.
Powder freeze dried for solution for injection, containing cytarabine
100 mg, 500 mg, 1 g,
and 2 g.
3. PHARMACEUTICAL FORM
Lyophilisate: white to off-white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
. acute lymphocytic and/or nonlymphocytic leukemia (for induction and
maintenance of
remission);
•
for prophylaxis or treatment of meningeal leukemia (as intrathecal
injections, alone or
in combination with other antineoplastic drugs);
•
treatment of non-Hodgkin’s lymphoma;
•
treatment of chronic myelocytic leukemia (blast phase).
High dose cytarabine treatment:
•
refractory non-Hodgkin’s lymphoma;
•
refractory acute lymphocytic and/or nonlymphocytic leukemia, as well
as poor-risk
leukemias;
•
relapsed acute leukemia;
•
secondary leukemia following previous chemo- and/or radiotherapy;
•
manifest leukemia following preleukemia transformation:
•
acute nonlymphocytic leukemia in patients under 60 years of age (for
consolidation of
remission);
•
chronic myelocytic leukemia (blast phase).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The schedule and method of administration varies with the program of
therapy to be used.
In every individual case, special literature should be consulted.
Cytosar
®
may be given by intravenous infusion or injection, subcutaneously
(usually as
maintenance therapy), or intrathecally.
Mean daily dose is 100-200 mg/m
2
. For elderly patients or those with low bone marrow
reserves, the dose should be 50-70 mg/m
2
.
Induction of remission in acute leukemia: in combination with other
antineoplastic agents,
100 mg/m
2
/day as continuous intravenous infusion during 7 days or 100 mg/m
2
i.v. every
12 hours over 7 consecuti