PMS-ERLOTINIB TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
27-11-2018
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Aktivní složka:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Dostupné s:
PHARMASCIENCE INC
ATC kód:
L01EB02
INN (Mezinárodní Name):
ERLOTINIB
Dávkování:
100MG
Léková forma:
TABLET
Složení:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG
Podání:
ORAL
Jednotky v balení:
30/100
Druh předpisu:
Prescription
Terapeutické oblasti:
ANTINEOPLASTIC AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0151203002; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2016-05-02
Charakteristika produktu
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
.............................................................
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