ACT DONEPEZIL ODT TABLET (ORALLY DISINTEGRATING)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

N06DA02

INN (국제 이름):

DONEPEZIL

복용량:

5MG

약제 형태:

TABLET (ORALLY DISINTEGRATING)

구성:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

관리 경로:

ORAL

패키지 단위:

28

처방전 유형:

Prescription

치료 영역:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2022-05-30

제품 특성 요약

ACT_ _DONEPEZIL ODT _ _
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PRODUCT MONOGRAPH
Pr
ACT_ _DONEPEZIL ODT
(donepezil hydrochloride as donepezil hydrochloride monohydrate)
Donepezil Hydrochloride Orally Disintegrating Tablets USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Submission Control No.: 212186
Date of Revision:
January 22, 2018
ACT_ _DONEPEZIL ODT _ _
_ Page 2 of 49_
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
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
16
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 TRIALS
......................................................................