ARA-CELL 5 G

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

CYTARABINE

Доступно од:

MBI PHARMA LTD., ISRAEL

АТЦ код:

L01BC01

Фармацеутски облик:

CONCENTRATE FOR SOLUTION FOR INFUSION

Састав:

CYTARABINE 5 G / 50 ML

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

STADAPHARM GMBH, GERMANY

Терапеутска област:

CYTARABINE

Терапеутске индикације:

ARA-cell® 100 mg/ml is used in combination with other cytostatic agents in high-dose therapy for:• refractory non-Hodgkin’s lymphoma• refractory acute non-lymphocytic leukaemia• refractory acute lymphoblastic leukaemia• recurrent cases of acute leukaemia• types of leukaemia with special risk: – secondary leukaemia following previous chemotherapy and/or radiation treatment – manifest leukaemia following transformation of pre-leukaemia• consolidation of the remission of acute non-lymphocytic leukaemia in patients under 60 years of age.

Датум одобрења:

2021-02-28

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCTS
ARA-cell
®
5 g concentrate for solution for intravenous infusion
Active substance: cytarabine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with 50 ml concentrate for solution for infusion contains 5,000
mg cytarabine
Excipient with known effect
1 vial with 50 ml concentrate for solution for infusion contains 11.15
mmol (256.5 mg)
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to yellowish solution free of particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARA-cell
®
5 g is used in combination with other cytostatic agents in high-dose
therapy for:
•
refractory non-Hodgkin’s lymphoma
•
refractory acute non-lymphocytic leukaemia
•
refractory acute lymphoblastic leukaemia
•
recurrent cases of acute leukaemia
•
types of leukaemia with special risk:
– secondary leukaemia following previous chemotherapy and/or
radiation treatment
– manifest leukaemia following transformation of pre-leukaemia
•
consolidation of the remission of acute non-lymphocytic leukaemia in
patients under 60
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ARA-cell
®
5 g is applied in combination with other cytostatic substances during
complex
treatment protocols in high-dose treatment.
High-dose treatments are usually carried out with 1 to 3 g
cytarabine/m
2
body surface as
intravenous infusion over 1 to 3 hours at 12-hour intervals for 4 to 6
days.
The exact dosages can be obtained from treatment protocols in
specialist literature.
_ _
Since ARA-cell
®
5 g is a hypertonic solution, ARA-cell
®
5 g concentrate for solution for
intravenous infusion must therefore not be administered intrathecally
and should not be
administered undiluted.
The increased risk of complications pertaining to the central nervous
system should be
observed when determining dosages for high-dose treatment.
Cytarabine is haemodialisable. ARA-cell
_®_
_ _should therefore no