METHOTREXATE TABLETS, USP

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

METHOTREXATE

MAH:

PFIZER CANADA ULC

ATC_code:

L01BA01

INN:

METHOTREXATE

dosage:

10MG

pharmaceutical_form:

TABLET

composition:

METHOTREXATE 10MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2003-12-05

SPC

PRODUCT MONOGRAPH
PR
METHOTREXATE TABLETS, USP
10 mg (as methotrexate)
Antimetabolite and Antirheumatic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
SUBMISSION CONTROL NO.: 224778
Date of Revision:
September 12, 2019
_Product Monograph - _
_Pr_
_Methotrexate Tablets, USP _
_ _
_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL INFORMATION
..........................................................................29
CLINICAL TRIALS
................................................................