PMS-ERLOTINIB TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Dostupno od:

PHARMASCIENCE INC

ATC koda:

L01EB02

INN (International ime):

ERLOTINIB

Doziranje:

150MG

Farmaceutski oblik:

TABLET

Sastav:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2016-05-02

Svojstava lijeka

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
.............................................................