AJ-CYTARABINE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CYTARABINE

Disponible depuis:

AGILA JAMP CANADA INC

Code ATC:

L01BC01

DCI (Dénomination commune internationale):

CYTARABINE

Dosage:

100MG

forme pharmaceutique:

SOLUTION

Composition:

CYTARABINE 100MG

Mode d'administration:

INTRATHECAL

Unités en paquet:

20ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0108854005; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-11-03

Résumé des caractéristiques du produit

1
PRODUCT MONOGRAPH
PR
AJ-CYTARABINE
(cytarabine)
100 mg/mL
(2 g/ 20 mL)
HOUSE STANDARD
ANTILEUKEMIC AGENT
AGILA-JAMP CANADA INC.
1380-203 Newton
Boucherville, Québec
Canada J4B 5H2
DATE OF PREPARATION: April 4, 2013
CONTROL NO.: 163253
2
PRODUCT MONOGRAPH
PR
AJ-CYTARABINE
HOUSE STANDARD
ANTILEUKEMIC AGENT
CAUTION: AJ-CYTARABINE SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED
WITH CANCER THERAPY DRUGS (SEE WARNINGS AND PRECAUTIONS). HEMATOLOGIC,
RENAL, AND HEPATIC EVALUATIONS MUST BE DONE AT REGULAR INTERVALS.
ACTION AND CLINICAL PHARMACOLOGY
Cytarabine is metabolized by deoxycytidine kinase and other nucleotide
kinases to the nucleotide
triphosphate, an effective inhibitor of DNA polymerase; it is
inactivated by pyrimidine nucleoside
deaminase which converts it to the non-toxic uracil derivative. It
appears that the balance of kinase and
deaminase levels may be an important factor in determining sensitivity
or resistance of the cell to
cytarabine.
Cytarabine is rapidly metabolized and is not effective orally; less
than 20% of the orally administered
dose is absorbed from the gastrointestinal tract.
Following rapid intravenous injection of cytarabine, the disappearance
from plasma is biphasic. There is
an initial distributive phase with a half-life of about 10 minutes,
followed by a second elimination phase
with a half-life of about 1 to 3 hours. After the distributive phase,
over 80% of plasma radioactivity can
be accounted for by the inactive metabolite
1-β-Darabinofuranosyluraci (ara-U). Within 24 hours about
80% of the administered radioactivity can be recovered in the urine,
approximately 90% of which is
excreted as ara-U.
After subcutaneous or intramuscular administration of cytarabine, peak
plasma levels of radioactivity are
achieved about 20 to 60 minutes after injection and are considerably
lower than those after intravenous
administration.
Cerebrospinal fluid levels of cytarabine are low in comparison to
plasma levels after single intravenous
injection. However, in one patient in whom cerebrospinal leve