SEPTA 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:

SEPTA PHARMACEUTICALS 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:

30/100 AND 10X10

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:

2014-08-15

製品の特徴

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_Septa Donepezil _
_Page 1 of 43_
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PRODUCT MONOGRAPH
PR SEPTA DONEPEZIL
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 AND 10 MG
CHOLINESTERASE INHIBITOR
Septa Pharmaceuticals, Inc.
Date of Preparation
7490 Pacific Circle, # 1
August 7, 2014
Mississauga ON L5T 2A3
Canada
Submission Control No: 176168
_ _
_Septa Donepezil _
_Page 2 of 43_
_ _
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……………………............................................................................14
DOSAGE AND
ADMINISTRATION........................................................................................16
OVERDOSAGE..........................................................................................................................16
ACTION AND CLINICAL
PHARMACOLOGY......................................................................17
STORAGE AND
STABILITY...................................................................................................19
DOSAGE FORMS, COMPOSITION AND
PACKAGING.......................................................19
PART II: SCIENTIFIC
INFORMATION.................................................................................20
PHARMACEUTICAL
INFORMATION...................................................................................20
CLINICAL
TRIALS.....................................................