FLUOROURACIL INJECTION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

FLUOROURACIL

Предлага се от:

SANDOZ CANADA INCORPORATED

АТС код:

L01BC02

INN (Международно Name):

FLUOROURACIL

дозиране:

50MG

Лекарствена форма:

SOLUTION

Композиция:

FLUOROURACIL 50MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

10ML

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0107505001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2005-06-01

Данни за продукта

_Fluorouracil Injection _
_Page 1 of 19 _
_ _
PRODUCT MONOGRAPH
FLUOROURACIL INJECTION
5-fluorouracil Ph.Eur.
50 mg/mL Injection USP
Antineoplastic Agent
Sandoz Canada Inc.
Date of Revision: April 3, 2012
145 Jules-Léger
Boucherville, QC
J4B 7K8
Submission Control No: 145218
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_Fluorouracil Injection _
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Fluorouracil Injection
(5-fluorouracil Ph.Eur.)
THERAPEUTIC CLASSIFICATION
Antineoplastic
CAUTION:
FLUOROURACIL (5-FLUOROURACIL) IS A POTENT DRUG AND SHOULD
BE PRESCRIBED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER
CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD
COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE
PERFORMED REGULARLY. DISCONTINUE THE DRUG IF THERE IS SIGNIFICANT
LEUKOPENIA (UNDER 3 000/mm
3
) OR GRANULOCYTOPENIA (UNDER 1 500/mm
3
).
ACTIONS AND CLINICAL PHARMACOLOGY
Fluorouracil (5-fluorouracil) is a fluorinated pyrimidine
antimetabolite which is structurally
similar to uracil, one of the necessary building blocks in cellular
division and growth.
Figure 1
Its usefulness is based on uracil being utilized preferentially for
nucleic acid biosynthesis in
some tumors. 5-fluorouracil is metabolized to 5-fluorouridine
triphosphate (F-UTP),
2-deoxyfluorouridine monophosphate (Fd-UMP), and 2-deoxyfluorouridine
triphosphate
(Fd-UTP) in cells to concentrations that result in both DNA-directed
and RNA-directed
cytotoxicities (see Figure 1). Fd-UMP is the intracellular cytotoxic
form of 5-fluorouracil. It
competes with the natural substrate d-UMP (deoxyuridine monophosphate)
for the catalytic site
_ _
_Fluorouracil Injection _
_Page 3 of 19 _
on thymidylate synthetase (a key enzyme in DNA synthesis), forming a
covalent complex with
the enzyme that is unable to undergo the normal catalytic reaction of
converting d-UMP to
d-TMP. The presence of a reduced folate cofactor is required for tight
binding of Fd-UMP to
thymidylate synthetase. Folinic acid (leucovorin), which is
metabolized to 5,10-methylene-
tetrahydropteroylglutamine (a reduced folate), is able to modulate the
ant