RATIO-METHOTREXATE SODIUM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-06-2013
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Active ingredient:
METHOTREXATE (METHOTREXATE SODIUM)
Available from:
TEVA CANADA LIMITED
ATC code:
L01BA01
INN (International Name):
METHOTREXATE
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
METHOTREXATE (METHOTREXATE SODIUM) 2.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0107545001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-05-07
Summary of Product characteristics
PRODUCT
MONOGRAPH
PR
RATIO-METHOTREXATE SODIUM
Methotrexate
sodium
Tablets 2.5 mg USP
Antimetabolite
Teva Canada Limited Date of Preparation:
30 Novopharm Court June 17, 2013
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165513
_Product Monograph - ratio-METHOTREXATE SODIUM_
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT
INFORMATION.....................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
.................................................................................................4
ADVERSE
REACTIONS................................................................................................15
DRUG
INTERACTIONS
................................................................................................17
DOSAGE AND ADMINISTRATION
...........................................................................20
OVERDOSAGE
...............................................................................................................26
ACTION AND CLINICAL
PHARMACOLOGY
........................................................27
STORAGE AND
STABILITY........................................................................................29
SPECIAL HANDLING
INSTRUCTIONS....................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................30
PART II: SCIENTIFIC INFORMATION
................................................................................32
PHARMACEUTICAL
INFORMATION......................................................................32
TOXICOLOGY
...............................................................................................................35
REFERENCES...............................................................................................................
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