PEMETREXED FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEMETREXED (PEMETREXED DISODIUM)

Available from:

DR REDDY'S LABORATORIES LTD

ATC code:

L01BA04

INN (International Name):

PEMETREXED

Dosage:

100MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PEMETREXED (PEMETREXED DISODIUM) 100MG

Administration route:

INTRAVENOUS

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-05-04

Summary of Product characteristics

1
PRODUCT MONOGRAPH
Pr
PEMETREXED FOR INJECTION, USP
100 mg or 500 mg pemetrexed (as pemetrexed disodium)
per vial
Sterile Lyophilized
Powder
Antineoplastic Agent
Manufactured by:
DATE OF INITIAL APPROVAL:
DR. REDDY’S LABORATORIES
LTD.,
April 12, 2017
Bachupally–500 090 India
Imported and Distributed by: DATE OF REVISION:
DR. REDDY’S LABORATORIES CANADA INC.,
May 3, 2022
Mississauga, ON L4W 4Y1 Canada
CONTROL NO: 259095
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFO R MATI ON ...................................................... 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
.................................................................................................................24
ACTION
AND
CLINICAL
PHARMACOLOGY
.................................................................25
STORAGE
AND
STABILITY
............................................................................................27
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................27
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................27
PART II: SCIENTIFIC
INFO R MATI ON ..........................................................................
29
PHARMACEUTICAL
INFORMATION
........