PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

L01BA04

INN (International Nazwa):

PEMETREXED

Dawkowanie:

1000MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 1000MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

100ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2019-08-01

Charakterystyka 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
..........................................................