CYTOSAR 500 mg INJECTION

Pajjiż: Afrika t’Isfel

Lingwa: Ingliż

Sors: South African Health Products Regulatory Authority (SAHPRA)

Disponibbli minn:

Pfizer Laboratories (Pty) Ltd

Dożaġġ:

See ingredients

Għamla farmaċewtika:

INJECTION

Kompożizzjoni:

EACH VIAL CONTAINS CYTARABINE 500 mg

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

1988-06-11

Karatteristiċi tal-prodott

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APPROVED PACKAGE INSERT
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
CYTOSAR
TM
100 mg (Powder for Injection)
CYTOSAR
TM
500 mg (Powder for Injection)
Water For Injection with benzyl alcohol 0,9 % m/v
COMPOSITION:
CYTOSAR
TM
100 mg contains 100 mg Cytarabine per vial.
CYTOSAR
TM
500 mg contains 500 mg Cytarabine per vial.
Cytosar 100 mg and 500 mg must be reconstituted with Water for
Injection containing 0,9 %
m/v benzyl alcohol. (Do not use this diluent for intrathecal use or
for high dose therapy -
SEE WARNINGS).
PHARMACOLOGICAL CLASSIFICATION:
A 26 Cytostatic agents
PHARMACOLOGICAL ACTION:
TISSUE CULTURE STUDIES
CYTOSAR (cytarabine) is cytotoxic to a variety of mammalian cell lines
in culture. Although
inhibitory to growing mammalian cells, CYTOSAR is inactive at high
concentrations against
resting KB cells. Deoxycytidine delays or prevents the cytotoxic
action of CYSTOSAR into
DNA and RNA. Studies on the mechanism of cytotoxicity in-vitro suggest
that the primary
action of CYTOSAR is inhibition of deoxycytidine synthesis, although
inhibition of cytidylic
acid kinases and incorporation of the compound into nucleic acids may
also play a role in its
cytostatic and cytocidal actions. CYTOSAR has been reported to cause
chromosome
breaks in human leukocytes _in-vitro_. It inhibits DNA synthesis in
mammalian cell cultures.
CYTOSAR is immunosuppressive as demonstrated by inhibition of
hemaglutinin synthesis in
mice.
DRUG FATE AND METABOLISM
There is in human liver and kidney an enzyme which deaminates CYTOSAR
(cytarabine) to
arabinofuranosyl uracil, an inactive metabolite. After intravenous
administration of
CYTOSAR to humans, only 5-8 % of the administered dose is excreted
unaltered in the
urine within 12 -24 hours; approximately 90 % of the dose is excreted
as the deamination
product, arabinofuranosyl uracil. CYTOSAR appears to be metabolized
rapidly, primarily by
the liver and perhaps by the kidney and to be excreted mainly as the
deamination product.
After single high intravenous doses, blo