M-DONEPEZIL TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
24-03-2020
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有効成分:
DONEPEZIL HYDROCHLORIDE
から入手可能:
MANTRA PHARMA INC
ATCコード:
N06DA02
INN（国際名）:
DONEPEZIL
投薬量:
10MG
医薬品形態:
TABLET
構図:
DONEPEZIL HYDROCHLORIDE 10MG
投与経路:
ORAL
パッケージ内のユニット:
100
処方タイプ:
Prescription
治療領域:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
製品概要:
Active ingredient group (AIG) number: 0131548002; AHFS:
認証ステータス:
APPROVED
承認日:
2017-08-17
製品の特徴
PRODUCT MONOGRAPH
Pr
M-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
J4Y 0E3
Brossard, Quebec
9150 Boulevard Leduc, Suite 201
Mantra Pharma
Inc.
March
24,
2020
Date of Revision:
Submission Control No.:
236845
Pr
M-DONEPEZIL (Donepezil Hydrochloride Tablets) Product Monograph
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
..................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 22
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
..................................................................................
24
CLINICAL TRIALS
..................................................................................................................
25
DETAILED PHARMACOLOGY
....................................
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