TARO-PEMETREXED POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PEMETREXED (PEMETREXED DISODIUM)

Pieejams no:

TARO PHARMACEUTICALS INC

ATĶ kods:

L01BA04

SNN (starptautisko nepatentēto nosaukumu):

PEMETREXED

Deva:

1000MG

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

PEMETREXED (PEMETREXED DISODIUM) 1000MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

50ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-08-30

Produkta apraksts

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