METHOTREXATE INJECTION, BP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-11-2019
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Active ingredient:
METHOTREXATE (METHOTREXATE SODIUM)
Available from:
PHARMASCIENCE INC
ATC code:
L01BA01
INN (International Name):
METHOTREXATE
Dosage:
20MG
Pharmaceutical form:
SOLUTION
Composition:
METHOTREXATE (METHOTREXATE SODIUM) 20MG
Administration route:
INTRA-ARTERIAL
Units in package:
0.8ML
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0107545002; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-03-10
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION, BP
25 mg/mL methotrexate (as methotrexate sodium)
Single-Use Pre-Filled Syringes
Sterile
ANTIMETABOLITE AND ANTIRHEUMATIC
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite # 100
November 28, 2019
Montréal, Québec
H4P 2T4
Submission Control No.: 231323
_METHOTREXATE INJECTION, BP Product Monograph _
_Page 2 of 50 _
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
.......................................................................................................................................
13
DRUG
INTERACTIONS
.......................................................................................................................................
17
DOSAGE
AND
ADMINISTRATION....................................................................................................................
21
OVERDOSAGE
.....................................................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
31
STORAGE
AND
STABILITY
...............................................................................................................................
34
SPECIAL
HANDLING
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