LEUCOVORIN CALCIUM INJECTION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LEUCOVORIN (LEUCOVORIN CALCIUM)

Предлага се от:

SANDOZ CANADA INCORPORATED

АТС код:

V03AF03

INN (Международно Name):

CALCIUM FOLINATE

дозиране:

10MG

Лекарствена форма:

SOLUTION

Композиция:

LEUCOVORIN (LEUCOVORIN CALCIUM) 10MG

Начин на приложение:

INTRAMUSCULAR

Броя в опаковка:

50ML/100ML

Вид предписание :

Prescription

Терапевтична област:

ANTIDOTES

Каталог на резюме:

Active ingredient group (AIG) number: 0108436002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2013-03-26

Данни за продукта

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_Leucovorin Calcium Injection_
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_Page 1 of 15_
PRODUCT MONOGRAPH
PR
LEUCOVORIN CALCIUM INJECTION
(Calcium Folinate Injection BP)
Folinic acid 10 mg/mL
Sterile Solution
Folic Acid Derivative
Sandoz Canada Inc.
145 Jules-Léger
Boucherville (QC)
J4B 7K8
Date of Preparation:
March 22, 2013
Submission Control No: 137634
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_Leucovorin Calcium Injection_
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_Page 2 of 15_
PRESCRIBING INFORMATION
PR LEUCOVORIN CALCIUM INJECTION
(Calcium Folinate Injection BP)
Folinic acid 10 mg/mL
Sterile Solution
Therapeutic Classification
Folic Acid Derivative
CAUTION: DO
NOT
ADMINISTER CALCIUM FOLINATE INJECTION INTRATHECALLY.
ACTION AND CLINICAL PHARMACOLOGY
Calcium folinate is the calcium salt of folinic acid (citrovorum
factor). It is a mixture of the
diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid.
The (-)-L stereoisomer is the
biologically active component of the mixture. It is a metabolite of
folic acid and an essential
coenzyme for nucleic acid synthesis. Folinic acid acts as an antidote
to folic acid antagonists,
such as methotrexate, which block the conversion of folic acid to
tetra-hydrofolate by binding to
the enzyme dihydrofolate reductase.
Folinic acid is readily converted to other reduced folic acid
derivatives such as tetrahydrofolate.
Folinic acid does not require reduction by dihydrofolate reductases,
therefore, it is not affected
by blockage of this enzyme by folic acid antagonists (dihydrofolate
reductase inhibitors). This
allows purine and thymidine synthesis, and thus DNA, RNA, and protein
synthesis to occur.
Folinic acid probably acts by competing with methotrexate for the same
transport processes into
the cell thus limiting the action of methotrexate on normal cells.
Folinic acid rescues bone marrow and gastrointestinal cells from
methotrexate toxicity, but does
not appear to have an effect on pre-existing methotrexate
nephrotoxicity.
Folinic acid enhances the cytotoxicity of fluoropirimidines such as
5-fluorouracil (5-FU) by the
metabolites,