PMS-ERLOTINIB TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

L01EB02

INN (International Adı):

ERLOTINIB

Doz:

100MG

Farmasötik formu:

TABLET

Kompozisyon:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0151203002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2016-05-02

Ürün özellikleri

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