AURO-DONEPEZIL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DONEPEZIL HYDROCHLORIDE

제공처:

AURO PHARMA INC

ATC 코드:

N06DA02

INN (국제 이름):

DONEPEZIL

복용량:

10MG

약제 형태:

TABLET

구성:

DONEPEZIL HYDROCHLORIDE 10MG

관리 경로:

ORAL

패키지 단위:

2*14/3*10/30/100/250/500/1000

처방전 유형:

Prescription

치료 영역:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

제품 요약:

Active ingredient group (AIG) number: 0131548002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-12-24

제품 특성 요약

Page 1 of 49
PRODUCT MONOGRAPH
PR
AURO-DONEPEZIL
Donepezil Hydrochloride Tablets
5 mg & 10 mg
House Standard CHOLINESTERASE INHIBITOR
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
SUBMISSION CONTROL NO: 181605
Date of Revision:
March 12, 2015
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………………………………………
4
ADVERSE
REACTIONS…………………………………………………..
8
DRUG
INTERACTIONS…………………………………………………...
16
DOSAGE AND ADMINISTRATION……………………………………..
17
OVERDOSAGE…………………………………………………………….
18
ACTION AND CLINICAL PHARMACOLOGY………………………...
19
STORAGE AND
STABILITY……………………………………………..
21
DOSAGE FORMS, COMPOSITION AND PACKAGING……………….. 21
PART II:
SCIENTIFIC
INFORMATION…………………………………..………
22
PHARMACEUTICAL INFORMATION………………………………….. 22
CLINICAL
TRIALS………………………………………………………..
23
DETAILED PHARMACOLOGY………………………………………….
32
TOXICOLOGY……………………………………………………………..
32
REFERENCES……………………………………………………………...
44
PART III:
CONSUMER INFORMATION…………………………………………..
47
Page 3 of 49
PR
AURO-DONEPEZIL
(Donepezil Hydrochloride Tablets 5 mg & 10 mg)
House Standard
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NONMEDICINAL INGREDIENTS
oral
Tablets 5 mg & 10 mg
Cell