PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

L01BA04

INN (International Name):

PEMETREXED

Dosage:

1000MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 1000MG

Administration route:

INTRAVENOUS

Units in package:

100ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0150104003; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2019-08-01

Summary of Product characteristics

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_Pemetrexed Disodium for Injection _
_Page 1 of 66_
PRODUCT MONOGRAPH
PR
PEMETREXED DISODIUM FOR INJECTION
100 mg, 500 mg, 1000 mg pemetrexed (as pemetrexed disodium
hemipentahydrate) per vial
Sterile Lyophilized Powder
Antineoplastic Agent
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC J4B 7K8
Date of Revision:
May 4, 2016
Submission Control No: 176560
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_Pemetrexed Disodium for Injection _
_Page 2 of 66_
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
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
..........................................................................31
DETAILED PHARMACOLOGY
..........................................................