METOJECT SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

METHOTREXATE (METHOTREXATE SODIUM)

Sẵn có từ:

MEDEXUS PHARMACEUTICALS INC.

Mã ATC:

L01BA01

INN (Tên quốc tế):

METHOTREXATE

Liều dùng:

20MG

Dạng dược phẩm:

SOLUTION

Thành phần:

METHOTREXATE (METHOTREXATE SODIUM) 20MG

Tuyến hành chính:

INTRA-ARTERIAL

Các đơn vị trong gói:

2ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0107545004; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2017-05-19

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
METOJECT
®
methotrexate sodium
Solution for Injection 10 mg/mL
Single-Use Pre-Filled Syringes
Sterile
THERAPEUTIC CLASSIFICATION
Antimetabolite and Antirheumatic
Medexus Inc.
DATE OF PREPARATION
:
7895 Tranmere Drive, Unit 4
JANUARY 08, 2008
Mississauga, Ontario
L5S 1V9
CONTROL NUMBER: 107035
2
Pr
METOJECT
®
methotrexate sodium
Solution for Injection 10 mg/mL
Single-Use Pre-Filled Syringes
Sterile
THERAPEUTIC CLASSIFICATION
Antimetabolite and Antirheumatic
CAUTION
METOJECT (METHOTREXATE SODIUM) SHOULD BE USED ONLY BY
PHYSICIANS WHOSE KNOWLEDGE AND EXPERIENCE INCLUDES THE USE OF
ANTIMETABOLITE THERAPY
.
ACTIONS AND CLINICAL PHARMACOLOGY
Methotrexate is a folate antagonist.
Methotrexate inhibits dihydrofolate reductase (DHFR), the enzyme that
reduces folic acid to
tetrahydrofolic acid. Tetrahydrofolate must be regenerated via the
DHFR-catalyzed reaction in
order to maintain the intracellular pool of tetrahydrofolate
one-carbon derivatives for both
thymidylate and purine nucleotide biosynthesis. The inhibition of DHFR
by folate antagonists
(Methotrexate) results in a deficiency in the cellular pools of
thymidylate and purines and thus in
a decrease in nucleic acid synthesis. Therefore, methotrexate
interferes with DNA synthesis,
repair, and cellular replication.
Methotrexate is most active against rapidly multiplying cells, because
its cytotoxic effects occur
primarily during the S phase of the cell cycle. Since cellular
proliferation in malignant tissues is
3
greater than in most normal tissues, methotrexate may impair malignant
growth without
irreversible damage to normal tissues. As a result, actively
proliferating tissues such as malignant
cells, bone marrow, fetal cells, buccal and intestinal mucosa, and
cells of the urinary bladder are
in general more sensitive to DHFR inhibition effects of methotrexate.
The cytotoxicity of methotrexate results from three important actions:
inhibition of DHFR,
inhibition of thymidylate synthase, and alteration of the transport of
reduced folates. The aff