GIOTRIF TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

AFATINIB (AFATINIB DIMALEATE)

可用日期:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC代码:

L01EB03

INN（国际名称）:

AFATINIB

剂量:

20MG

药物剂型:

TABLET

组成:

AFATINIB (AFATINIB DIMALEATE) 20MG

给药途径:

ORAL

每包单位数:

28

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

Active ingredient group (AIG) number: 0154930001; AHFS:

授权状态:

APPROVED

授权日期:

2013-11-01

产品特点

_Pr_
_GIOTRIF® Product Monograph _
_ Page 1 of 44 _
PRODUCT MONOGRAPH
PR
GIOTRIF
®
Afatinib Tablets
20, 30 and 40 mg afatinib (as afatinib dimaleate)
Protein Kinase Inhibitor
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
www.boehringer-ingelheim.ca
Date of Revision:
June 6, 2019
Submission Control No: 225731
Giotrif
®
is a registered trademark and used under license from Boehringer
Ingelheim
International GmbH
BICL 0281-09
_Pr_
_GIOTRIF® Product Monograph _
_ Page 2 of 44 _
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II : SCIENTIFIC INFORMATION
............................................................