METOJECT SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHOTREXATE (METHOTREXATE SODIUM)

Available from:

MEDEXUS PHARMACEUTICALS INC.

ATC code:

L01BA01

INN (International Name):

METHOTREXATE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

METHOTREXATE (METHOTREXATE SODIUM) 10MG

Administration route:

INTRA-ARTERIAL

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-04-23

Summary of Product characteristics

_ _
_Page 1 of _50_ _
PRODUCT MONOGRAPH
Pr
METOJECT
®
methotrexate sodium solution for injection
methotrexate 10 mg/mL
Single-Use Pre-Filled Syringes
Sterile
THERAPEUTIC CLASSIFICATION
Antimetabolite and Antirheumatic
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Submission Control No.: 231322
Date of Revision:
December 10, 2019
_ _
_Page 2 of _50_ _
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 ................................................
ERROR! BOOKMARK NOT DEFINED.
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
.................................................