PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Tillgänglig från:

ACCORD HEALTHCARE INC

ATC-kod:

L01BA04

INN (International namn):

PEMETREXED

Dos:

100MG

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

10ML

Receptbelagda typ:

Prescription

Terapiområde:

ANTINEOPLASTIC AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2016-05-20

Produktens egenskaper

_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
................................................