METOJECT SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

METHOTREXATE (METHOTREXATE SODIUM)

Предлага се от:

MEDEXUS PHARMACEUTICALS INC.

АТС код:

L01BA01

INN (Международно Name):

METHOTREXATE

дозиране:

7.5MG

Лекарствена форма:

SOLUTION

Композиция:

METHOTREXATE (METHOTREXATE SODIUM) 7.5MG

Начин на приложение:

INTRA-ARTERIAL

Броя в опаковка:

0.75ML

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2022-06-29

Данни за 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
.........................................