PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

L01BA04

INN (International Name):

PEMETREXED

Dosering:

100MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

10ML

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0150104002; AHFS:

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2019-08-01

Produktets egenskaber

_ _
_Pemetrexed Disodium for Injection _
_Page 1 of 66_
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
_ _
_Pemetrexed Disodium for Injection _
_Page 2 of 66_
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
..........................................................