PMS-ERLOTINIB TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Saadav alates:

PHARMASCIENCE INC

ATC kood:

L01EB02

INN (Rahvusvaheline Nimetus):

ERLOTINIB

Annus:

150MG

Ravimvorm:

TABLET

Koostis:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANTINEOPLASTIC AGENTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0151203003; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2016-05-02

Toote omadused

PRODUCT MONOGRAPH
Pr
PMS-ERLOTINIB
Erlotinib Hydrochloride Tablets
100 mg and 150 mg erlotinib
EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) TYROSINE KINASE
INHIBITOR
PROTEIN KINASE INHIBITOR (L01XE03)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION
:
November 27, 2018
Submission Control No: 221860
_ _
_pms-ERLOTINIB Product Monograph _
_Page 2 of 45_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
.............................................................