PEMETREXED DISODIUM FOR INJECTION Poudre pour solution

País: Canadá

Idioma: francés

Fuente: Health Canada

Ingredientes activos:

Pémétrexed (Hémipentahydrate de pémétrexed disodique)

Disponible desde:

MARCAN PHARMACEUTICALS INC

Código ATC:

L01BA04

Designación común internacional (DCI):

PEMETREXED

Dosis:

500MG

formulario farmacéutico:

Poudre pour solution

Composición:

Pémétrexed (Hémipentahydrate de pémétrexed disodique) 500MG

Vía de administración:

Intraveineuse

Unidades en paquete:

50ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Numéro de groupe d'ingrédients actifs (GIA) :0150104001; AHFS:

Estado de Autorización:

APPROUVÉ

Fecha de autorización:

2018-02-02

Ficha técnica

Page 1 of 61
PRODUCT MONOGRAPH
PR
PEMETREXED DISODIUM FOR INJECTION
Mfr. Std.
500 mg pemetrexed per vial (as pemetrexed disodium hemipentahydrate)
Sterile Lyophilized Powder
Antineoplastic Agent
Marcan Pharmaceuticals Inc.
Date of Preparation:
2 Gurdwara Road, Suite #112
August 24, 2018
Ottawa, ON, K2E 1A2
Control # 218069
Page 2 of 61
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
...................................................................................................
7
DRUG
INTERACTIONS..................................................................................................
20
DOSAGE AND
ADMINISTRATION..............................................................................
19
OVERDOSAGE
................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 25
STORAGE AND STABILITY
.........................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 27
PART II: SCIENTIFIC
INFORMATION...............................................................................
28
PHARMACEUTICAL INFORMATION
.........................................................................
28
CLINICAL TRIALS
......................................