METHOTREXATE INJECTION BP SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

METHOTREXATE (METHOTREXATE SODIUM)

Disponible desde:

UMAN PHARMA INC

Código ATC:

L01BA01

Designación común internacional (DCI):

METHOTREXATE

Dosis:

25MG

formulario farmacéutico:

SOLUTION

Composición:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Vía de administración:

INTRA-ARTERIAL

Unidades en paquete:

2ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0107545002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2009-09-16

Ficha técnica

_PRODUCT MONOGRAPH; Methotrexate Injection BP – Uman Pharma Inc. _
_Page 1 of 43_
_ _
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION, BP 25 MG/ML
Sterile
Antimetabolite and Antirheumatic
Uman Pharma Inc.
Date of Preparation: September 2, 2009
100, boul. de l’Industrie
Candiac, QC, J5R 1J1
Canada
Control No. 132325
_PRODUCT MONOGRAPH; Methotrexate Injection BP – Uman Pharma Inc. _
_Page 2 of 43_
_ _
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
.......................................................................................................
12
DRUG
INTERACTIONS
........................................................................................................
14
DOSAGE
AND
ADMINISTRATION
....................................................................................
17
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
...............................................................................
31
PHARMACEUTICAL
INFORMATION
.