PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

L01BA04

INN (Mezinárodní Name):

PEMETREXED

Dávkování:

1000MG

Léková forma:

POWDER FOR SOLUTION

Složení:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 1000MG

Podání:

INTRAVENOUS

Jednotky v balení:

100ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2019-08-01

Charakteristika produktu

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_Pemetrexed Disodium for Injection _
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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 _
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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
..........................................................