PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Disponível em:

ACCORD HEALTHCARE INC

Código ATC:

L01BA04

DCI (Denominação Comum Internacional):

PEMETREXED

Dosagem:

100MG

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

10ML

Tipo de prescrição:

Prescription

Área terapêutica:

ANTINEOPLASTIC AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0150104002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2016-05-20

Características técnicas

_Pemetrexed disodium for Injection - Product Monograph _
_Page 1 of 61_
PRODUCT MONOGRAPH
PR
PEMETREXED DISODIUM FOR INJECTION
100 mg or 500 mg pemetrexed per vial (as Pemetrexed Disodium
hemipentahydrate)
Antineoplastic Agent
Accord Healthcare Inc.
3535 Boul St. Charles, Suite 704, Kirkland, QC,
H9H 5B9, Canada
Date of Preparation:
March 12, 2015
Submission Control No: 176618
_Pemetrexed disodium for Injection - Product Monograph _
_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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................19
PREPARATION AND ADMINISTRATION PRECAUTIONS:
.....................................23
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................