PMS-ERLOTINIB TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

L01EB02

INN (Tên quốc tế):

ERLOTINIB

Liều dùng:

150MG

Dạng dược phẩm:

TABLET

Thành phần:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-05-02

Đặc tính sản phẩm

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