LARACIT 100 mg INJECTION

البلد: جنوب أفريقيا

اللغة: الإنجليزية

المصدر: South African Health Products Regulatory Authority (SAHPRA)

متاح من:

Teva Pharmaceuticals (Pty) Ltd

جرعة:

See ingredients

الشكل الصيدلاني:

INJECTION

تركيب:

EACH VIAL CONTAINS CYTARABINE 100,0 mg

الوضع إذن:

Registered

تاريخ الترخيص:

2007-05-07

خصائص المنتج

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SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM:
LARACIT 100 MG (injection)
LARACIT 500 MG (injection)
PHARMACOLOGICAL CLASSIFICATION:
A26 Cytostatics
COMPOSITION:
Each vial contains 100 mg per 2 ml solution.
Each 5 ml vial of LARACIT 100 MG contains 100 mg cytarabine.
Each 14 ml vial of LARACIT 500 MG contains 500 mg cytarabine.
PHARMACOLOGICAL ACTION:
Cytarabine is an antimetabolite of the series of pyrimidine
antagonists and inhibits the
formation of desoxycytidine triphosphate, and thus DNA synthesis, by
blocking the reduction
of cytidine phosphate to desoxycytidine phosphate.
INDICATIONS:
LARACIT 100 MG is indicated in the treatment of adults and children
with:
Acute non-lymphocytic leukaemia
Acute lymphocytic leukaemia. Blast crisis in chronic myeloid leukaemia
(CML).
In combination with other agents, for the treatment of Non- Hodgkin
Lymphomas of high
malignancy in adults and children.
LARACIT 500 MG is indicated in the treatment of adults and children
with:
S4
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Refractory acute non-lymphocytic leukaemias Refractory acute
lymphocytic leukaemias
Blast crisis of chronic myeloid leukaemia (CML) High risk leukaemias
such as
acute leukaemias as second malignancies after preceding chemotherapy
and/or
radiation.
transformation of preleukaemias.
Refractory Non-Hodgkin's lymphomas.
CONTRAINDICATIONS:
LARACIT is contraindicated in:
Patients with hypersensitivity to cytarabine.
Patients with drug-induced bone marrow suppression.
WARNINGS AND SPECIAL PRECAUTIONS:
LARACIT should be administered only under the supervision of medical
specialists in
oncology and the use of antineoplastic chemotherapeutic agents.
For induction therapy, patients should be treated in a facility with
laboratory and supportive
resources sufficient to monitor medicine tolerance and protect and
maintain a patient
compromised by medicine toxicity.
Anaphylaxis that resulted in acute cardiopulmonary arrest and required
resuscitation, has
been reported.
The main toxic effect of LARACIT is bone marrow suppression, possibly