TARO-DONEPEZIL TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
06-03-2020
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유효 성분:
DONEPEZIL HYDROCHLORIDE
제공처:
SUN PHARMA CANADA INC
ATC 코드:
N06DA02
INN (국제 이름):
DONEPEZIL
복용량:
10MG
약제 형태:
TABLET
구성:
DONEPEZIL HYDROCHLORIDE 10MG
관리 경로:
ORAL
패키지 단위:
100/500
처방전 유형:
Prescription
치료 영역:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
제품 요약:
Active ingredient group (AIG) number: 0131548002; AHFS:
승인 상태:
APPROVED
승인 날짜:
2020-03-10
제품 특성 요약
Page 1 of 52
PRODUCT MONOGRAPH
PR
TARO-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
Sun Pharma Canada Inc.
Date of Revision: March 6, 2020
126 East Drive
Brampton, Ontario
L6T 1C1
Submission Control No.: 236591
Page 2 of 52
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
.......................................................................................................
17
DOSAGE AND ADMINISTRATION
...................................................................................
18
OVERDOSAGE
......................................................................................................................
19
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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