GIOTRIF TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AFATINIB (AFATINIB DIMALEATE)

Disponibil de la:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Codul ATC:

L01EB03

INN (nume internaţional):

AFATINIB

Dozare:

40MG

Forma farmaceutică:

TABLET

Compoziție:

AFATINIB (AFATINIB DIMALEATE) 40MG

Calea de administrare:

ORAL

Unități în pachet:

14/28

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0154930003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-11-01

Caracteristicilor produsului

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