METHOTREXATE TABLETS, USP
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
12-09-2019
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ingredients actius:
METHOTREXATE
Disponible des:
PFIZER CANADA ULC
Codi ATC:
L01BA01
Designació comuna internacional (DCI):
METHOTREXATE
Dosis:
10MG
formulario farmacéutico:
TABLET
Composición:
METHOTREXATE 10MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
ANTINEOPLASTIC AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0107545004; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2003-12-05
Fitxa tècnica
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
................................................................
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