AJ-CYTARABINE SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CYTARABINE

Mevcut itibaren:

AGILA JAMP CANADA INC

ATC kodu:

L01BC01

INN (International Adı):

CYTARABINE

Doz:

100MG

Farmasötik formu:

SOLUTION

Kompozisyon:

CYTARABINE 100MG

Uygulama yolu:

INTRATHECAL

Paketteki üniteler:

20ML

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2015-11-03

Ürün özellikleri

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