NAT-DONEPEZIL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DONEPEZIL HYDROCHLORIDE

から入手可能:

NATCO PHARMA (CANADA) INC

ATCコード:

N06DA02

INN（国際名）:

DONEPEZIL

投薬量:

5MG

医薬品形態:

TABLET

構図:

DONEPEZIL HYDROCHLORIDE 5MG

投与経路:

ORAL

パッケージ内のユニット:

7/14/28/30/100

処方タイプ:

Prescription

治療領域:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

製品概要:

Active ingredient group (AIG) number: 0131548001; AHFS:

認証ステータス:

APPROVED

承認日:

2015-05-27

製品の特徴

_NAT-Donepezil Product Monograph _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
NAT-DONEPEZIL
Donepezil Hydrochloride Tablets
5 mg and 10 mg
USP
CHOLINESTERASE INHIBITOR
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, suite 200
Mississauga, Ontario
L5N 1P7
Date of Revision:
February 17, 2021
Submission Control No.: 248208
_ NAT-Donepezil Product Monograph _
_ _
_ _
_ _
_ Page_
_2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
...........................................................................................................3
WARNINGS AND PRECAUTIONS
..........................................................................................3
ADVERSE REACTIONS
............................................................................................................7
DRUG INTERACTIONS
..........................................................................................................15
DOSAGE AND ADMINISTRATION
......................................................................................17
OVERDOSAGE
........................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
..................................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
..................................................................................22
CLINICAL TRIAL