FLUOROURACIL INJECTION SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

FLUOROURACIL

Доступна с:

GENERIC MEDICAL PARTNERS INC

код АТС:

L01BC02

ИНН (Международная Имя):

FLUOROURACIL

дозировка:

5000MG

Фармацевтическая форма:

SOLUTION

состав:

FLUOROURACIL 5000MG

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

100ML

Тип рецепта:

Prescription

Терапевтические области:

ANTINEOPLASTIC AGENTS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2018-05-31

Характеристики продукта

PRODUCT MONOGRAPH
PR
FLUOROURACIL INJECTION
50 MG/ML
(250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL, 5 g/100 mL)
Sterile Solution
Manufacturer’s Standard
Antineoplastic Agent
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 406
Toronto, Ontario
M3B 3K4
Date of Preparation:
March 12, 2020
Control No.: 236632
Page 2 of 22
PRODUCT MONOGRAPH
PR
FLUOROURACIL INJECTION
50 MG/ML
(250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL, 5 g/100 mL)
Sterile Solution
Antineoplastic agent
CAUTION
FLUOROURACIL IS A POTENT DRUG AND SHOULD BE ADMINISTERED BY, OR
UNDER SUPERVISION OF A PHYSICIAN, WHO IS EXPERIENCED IN CANCER
CHEMOTHERAPY.
ACTIONS AND CLINICAL PHARMACOLOGY
There appears to be two mechanisms of action of fluorouracil which
result in cytotoxic effects.
One is the competitive inhibition of thymidylate synthetase, the
enzyme catalyzing the
methylation of deoxyuridylic acid to thymidylic acid. The consequent
thymidine deficiency
results in inhibition of deoxyribonucleic acid (DNA) synthesis, thus
inducing cell death. A
second mechanism of action is evidenced by the moderate inhibition of
ribonucleic acid (RNA)
and incorporation of fluorouracil into RNA. The predominant mechanism
of antitumour action
appears to be dependent, at least in part, on individual tumour
intracellular metabolism.
The effects of DNA and RNA deprivation are most significant on those
cells which are most
rapidly proliferating.
Following intravenous injection, fluorouracil is cleared rapidly from
the plasma (half-life about
10 to 20 minutes), and distributed throughout body tissues including
the cerebrospinal fluid and
malignant effusions, exhibiting a volume of distribution equivalent to
the total body water.
Plasma concentrations fall below measurable levels within 3 hours.
Oral administration of
fluorouracil has shown marked variability in its bioavailability, from
28% to 100%. Constant
intravenous infusion for 96 hours showed constant plasma drug levels
and significantly less drug
(50- to 1000-fold) in the bone marrow.
Fluorouracil is converted to active nucle