PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

Pieejams no:

ACCORD HEALTHCARE INC

ATĶ kods:

L01BA04

SNN (starptautisko nepatentēto nosaukumu):

PEMETREXED

Deva:

500MG

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 500MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

50ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0150104001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2016-05-20

Produkta apraksts

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