ACH-DONEPEZIL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DONEPEZIL HYDROCHLORIDE

متاح من:

ACCORD HEALTHCARE INC

ATC رمز:

N06DA02

INN (الاسم الدولي):

DONEPEZIL

جرعة:

10MG

الشكل الصيدلاني:

TABLET

تركيب:

DONEPEZIL HYDROCHLORIDE 10MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2020-12-01

خصائص المنتج

_Donepezil Hydrochloride Product Monograph _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
ACH-DONEPEZIL
Donepezil Hydrochloride Tablets
5 mg and 10 mg
USP
CHOLINESTERASE INHIBITOR
Accord Healthcare Inc.
Date of Revision:
3535 boul. St. Charles suite 704
November 27, 2020
Kirkland, QC, H9H 5B9
Canada
Submission Control No: 241736
_ ACH-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
......................................................................................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