PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Prieinama:

ACCORD HEALTHCARE INC

ATC kodas:

L01BA04

INN (Tarptautinis Pavadinimas):

PEMETREXED

Dozė:

100MG

Vaisto forma:

POWDER FOR SOLUTION

Sudėtis:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

10ML

Recepto tipas:

Prescription

Gydymo sritis:

ANTINEOPLASTIC AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2016-05-20

Prekės savybės

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