Cytosar powder lyophilized for solution for injection

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

cytarabine

Dostupné s:

Corden Pharma Latina S.p.A

ATC kód:

L01BC01

INN (Mezinárodní Name):

cytarabine

Dávkování:

500mg

Léková forma:

powder lyophilized for solution for injection

Jednotky v balení:

glass vial

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2022-01-13

Charakteristika produktu

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