ACT PEMETREXED POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PEMETREXED (PEMETREXED DISODIUM)

可用日期:

ACTAVIS PHARMA COMPANY

ATC代码:

L01BA04

INN（国际名称）:

PEMETREXED

剂量:

1000MG

药物剂型:

POWDER FOR SOLUTION

组成:

PEMETREXED (PEMETREXED DISODIUM) 1000MG

给药途径:

INTRAVENOUS

每包单位数:

100

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

Active ingredient group (AIG) number: 0150104003; AHFS:

授权状态:

CANCELLED PRE MARKET

授权日期:

2018-07-24

产品特点

_ACT Pemetrexed (pemetrexed disodium for injection) 100 mg/vial, 500
mg/vial and 1000 mg/vial _
_Page 1 of 62_
PRODUCT MONOGRAPH
PR
ACT PEMETREXED
(pemetrexed disodium for injection)
100 mg, 500 mg, 1000 mg
pemetrexed per
vial
Antineoplastic Agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Preparation:
July 22, 2014
Submission Control No: 169453
_ACT Pemetrexed (pemetrexed disodium for injection) 100 mg/vial, 500
mg/vial and 1000 mg/vial _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRADICTIONS
..........................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTION
....................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS COMPOSITION AND PACKAGING
..............................................28
PART II: SCIENTIFIC INFORMATION
.......................................................................