TEVA-ERLOTINIB TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

มีจำหน่ายจาก:

TEVA CANADA LIMITED

รหัส ATC:

L01EB02

INN (ชื่อสากล):

ERLOTINIB

ปริมาณ:

100MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

ANTINEOPLASTIC AGENTS

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2014-12-08

สรุปลักษณะสินค้า

1
PRODUCT MONOGRAPH
PR
TEVA-ERLOTINIB
Erlotinib Hydrochloride Tablets
25 mg, 100 mg, 150 mg Erlotinib
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Protein Kinase Inhibitor (L01XE03)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No. 223095
Date of Revision:
January 16, 2019
2
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
.........................................................................................................
9
DRUG
INTERACTIONS
.......................................................................................................
16
DOSAGE
AND
ADMINISTRATION
...................................................................................
18
OVERDOSAGE
......................................................................................................................
19
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 20
STORAGE
AND
STABILITY
...............................................................................................
22
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................
22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION
.........................................................