PEMETREXED DISODIUM FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE)

제공처:

ACCORD HEALTHCARE INC

ATC 코드:

L01BA04

INN (International Name):

PEMETREXED

복용량:

100MG

약제 형태:

POWDER FOR SOLUTION

구성:

PEMETREXED (PEMETREXED DISODIUM HEMIPENTAHYDRATE) 100MG

관리 경로:

INTRAVENOUS

패키지 단위:

10ML

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2016-05-20

제품 특성 요약

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