TARO-PEMETREXED POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEMETREXED (PEMETREXED DISODIUM)

Available from:

TARO PHARMACEUTICALS INC

ATC code:

L01BA04

INN (International Name):

PEMETREXED

Dosage:

1000MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PEMETREXED (PEMETREXED DISODIUM) 1000MG

Administration route:

INTRAVENOUS

Units in package:

50ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-08-30

Summary of Product characteristics

_Taro-Pemetrexed (_Pemetrexed Disodium for Injection_) _
_ Page 1 of 64 _
_Product Monograph_
PRODUCT MONOGRAPH
PR
TARO-PEMETREXED
(Pemetrexed Disodium for Injection)
100 mg, 500 mg, or 1,000 mg pemetrexed (as pemetrexed disodium) per
vial
Antineoplastic Agent
Taro Pharmaceuticals Inc.
DATE OF REVISION: August 30, 2018
130 East Drive, Brampton
Ontario, L6T 1C1 SUBMISSION CONTROL NO.: 212887
_Taro-Pemetrexed (_Pemetrexed Disodium for Injection_) _
_ Page 2 of 64 _
_Product Monograph_
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
OVERDOSAGE
.................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
.............................................................25
STORAGE AND
STABILITY...........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................27
PART II: SCIENTIFIC INFORMATION
.....................................................................29
PHARMACEUTICAL
INFORMATION...........................................................................29
CLINICAL
TRIALS..............................