METHOTREXATE INJECTION BP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHOTREXATE (METHOTREXATE SODIUM)

Available from:

ACCORD HEALTHCARE INC

ATC code:

L01BA01

INN (International Name):

METHOTREXATE

Dosage:

25MG

Pharmaceutical form:

SOLUTION

Composition:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Administration route:

INTRAVENOUS

Units in package:

40ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0107545002; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-04-12

Summary of Product characteristics

Page 1 of 55
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PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION BP
25 MG / ML METHOTREXATE (AS METHOTREXATE SODIUM)
FORMULATION WITHOUT PRESERVATIVE
PR
METHOTREXATE INJECTION BP
25 MG / ML METHOTREXATE (AS METHOTREXATE SODIUM)
FORMULATION WITH PRESERVATIVE
Sterile Solution
Antimetabolite and Antirheumatic
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
October 30, 2019
Control No. 231320
Page 2 of 55
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_Pr_
_Methotrexate Injection BP, Product Monograph, Accord Healthcare Inc.
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
.......................................................................................................
14
DRUG INTERACTIONS
.......................................................................................................
19
DOSAGE AND ADMINISTRATION
...................................................................................
23
OVERDOSAGE
.....................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 35
STORAGE AND STABILITY
...............................................................................................
37
SPECIAL HANDLING INSTRUCTIONS
............................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 39
PART