PEMETREXED FOR INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Available from:

ACCORD HEALTHCARE INC

ATC code:

L01BA04

INN (International Name):

PEMETREXED

Dosage:

25MG

Pharmaceutical form:

SOLUTION

Composition:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 25MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0150104004; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-04-29

Summary of Product characteristics

PRODUCT MONOGRAPH
Pemetrexed for Injection
Solution:
25 mg / mL pemetrexed (as pemetrexed disodium hemipentahydrate)
House Std.
Antineoplastic Agent
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC H9H 5B9, Canada
Date of Preparation:
October 7, 2020
Date of Revision:
April 26, 2021
CONTROL NUMBER: 235879
Pemetrexed for Injection - Product Monograph_ _
Page 2 of 60_ _
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..............................................................................................
......18
DOSAGE AND
ADMINISTRATION................................................................................19
OVERDOSAGE.................................................................................................................
23
ACTION AND CLINICAL
PHARMACOLOGY..............................................................24
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING
INSTRUCTIONS........................................................................26
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................26
PART II: SCIENTIFIC
INFORMATION..................................................................................28
PHARMACEUTICAL INFORMATION
..........................................................................2