PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Verfügbar ab:

ACCORD HEALTHCARE INC

ATC-Code:

L01BA04

INN (Internationale Bezeichnung):

PEMETREXED

Dosierung:

100MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

10ML

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2016-05-20

Fachinformation

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