PMS-ERLOTINIB TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

থেকে পাওয়া:

PHARMASCIENCE INC

এটিসি কোড:

L01EB02

INN (আন্তর্জাতিক নাম):

ERLOTINIB

ডোজ:

100MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

30/100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

ANTINEOPLASTIC AGENTS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2016-05-02

পণ্য বৈশিষ্ট্য

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