Страна: Израиль
Язык: английский
Источник: Ministry of Health
CYTARABINE
MBI PHARMA LTD., ISRAEL
L01BC01
CONCENTRATE FOR SOLUTION FOR INFUSION
CYTARABINE 5 G / 50 ML
I.V
Required
STADAPHARM GMBH, GERMANY
CYTARABINE
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.
2021-02-28
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 Прочитать полный документ