TARO-PEMETREXED POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PEMETREXED (PEMETREXED DISODIUM)

Tilgjengelig fra:

TARO PHARMACEUTICALS INC

ATC-kode:

L01BA04

INN (International Name):

PEMETREXED

Dosering :

1000MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

PEMETREXED (PEMETREXED DISODIUM) 1000MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

50ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-08-30

Preparatomtale

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