METHOTREXATE SODIUM INJECTION SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-11-2019
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Active ingredient:
METHOTREXATE (METHOTREXATE SODIUM)
Available from:
TEVA CANADA LIMITED
ATC code:
L01BA01
INN (International Name):
METHOTREXATE
Dosage:
25MG
Pharmaceutical form:
SOLUTION
Composition:
METHOTREXATE (METHOTREXATE SODIUM) 25MG
Administration route:
INTRACEREBROVENTRICULAR
Units in package:
2/20/40ML
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0107545002; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-05-02
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
METHOTREXATE SODIUM INJECTION
25 MG/ML
Sterile Solution
USP
Antimetabolite and Antirheumatic
Teva Canada Limited
DATE OF REVISION:
30 Novopharm Court
November 21, 2019
Toronto, Ontario
M1B 2K9
Submission Control No: 231327
_Page 2_
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
...................................................................................................
15
DRUG INTERACTIONS
....................................................................................................
18
DOSAGE AND ADMINISTRATION
................................................................................
23
OVERDOSAGE
..................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 34
STORAGE AND
STABILITY............................................................................................
37
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 38
PART II: SCIENTIFIC INFORMATION
.................................................................................
40
PHARMACEUTICAL INFORMATION
...........................................................................
40
DETAILED PHARMACOLOGY
....................................................................................
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