METOJECT SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

METHOTREXATE (METHOTREXATE SODIUM)

Доступна з:

MEDEXUS PHARMACEUTICALS INC.

Код атс:

L01BA01

ІПН (Міжнародна Ім'я):

METHOTREXATE

Дозування:

7.5MG

Фармацевтична форма:

SOLUTION

Склад:

METHOTREXATE (METHOTREXATE SODIUM) 7.5MG

Адміністрація маршрут:

INTRA-ARTERIAL

Одиниць в упаковці:

0.75ML

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2022-06-29

Характеристики продукта

_ _
_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 .................................................
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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
.........................................