RATIO-METHOTREXATE SODIUM TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

METHOTREXATE (METHOTREXATE SODIUM)

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

L01BA01

Designación común internacional (DCI):

METHOTREXATE

Dosis:

2.5MG

formulario farmacéutico:

TABLET

Composición:

METHOTREXATE (METHOTREXATE SODIUM) 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0107545001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-05-07

Ficha técnica

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...............................................................................................................