PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Dostępny od:

ACCORD HEALTHCARE INC

Kod ATC:

L01BA04

INN (International Nazwa):

PEMETREXED

Dawkowanie:

100MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

10ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2016-05-20

Charakterystyka produktu

_Pemetrexed disodium for Injection - Product Monograph _
_Page 1 of 61_
PRODUCT MONOGRAPH
PR
PEMETREXED DISODIUM FOR INJECTION
100 mg or 500 mg pemetrexed per vial (as Pemetrexed Disodium
hemipentahydrate)
Antineoplastic Agent
Accord Healthcare Inc.
3535 Boul St. Charles, Suite 704, Kirkland, QC,
H9H 5B9, Canada
Date of Preparation:
March 12, 2015
Submission Control No: 176618
_Pemetrexed disodium for Injection - Product Monograph _
_Page 2 of 61_
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
PREPARATION AND ADMINISTRATION PRECAUTIONS:
.....................................23
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................