GIOTRIF TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-06-2019
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Active ingredient:
AFATINIB (AFATINIB DIMALEATE)
Available from:
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
ATC code:
L01EB03
INN (International Name):
AFATINIB
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
AFATINIB (AFATINIB DIMALEATE) 20MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0154930001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-11-01
Summary of Product characteristics
_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
............................................................
Read the complete document
