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:

7.5MG

Dạng dược phẩm:

SOLUTION

Thành phần:

METHOTREXATE (METHOTREXATE SODIUM) 7.5MG

Tuyến hành chính:

INTRA-ARTERIAL

Các đơn vị trong gói:

0.75ML

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:

2022-06-29

Đặc tính sản phẩm

_ _
_Page 1 of _38_ _
PRODUCT MONOGRAPH
Pr
METOJECT
®
methotrexate sodium solution for injection
methotrexate 10 mg/mL
Single-Use Pre-Filled Syringes
Sterile
THERAPEUTIC CLASSIFICATION
Antirheumatic
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Submission Control No.: 237592
Date of Revision:
May 22, 2020
_ _
_Page 2 of _38_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ........... Error! Bookmark
not defined.
SUMMARY PRODUCT INFORMATION ...................... ERROR! BOOKMARK NOT
DEFINED.
INDICATIONS AND CLINICAL USE ............................ ERROR!
BOOKMARK NOT DEFINED.
CONTRAINDICATIONS .................................................
ERROR! BOOKMARK NOT DEFINED.
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS ..................................................
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DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................33
SPECIAL HANDLING INSTRUCTIONS
.......................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
DETAILED PHARMACOLOGY
.....................................................................................36
TOXICOLOGY
.........................................