MINT-DONEPEZIL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DONEPEZIL HYDROCHLORIDE

متاح من:

MINT PHARMACEUTICALS INC

ATC رمز:

N06DA02

INN (الاسم الدولي):

DONEPEZIL

جرعة:

5MG

الشكل الصيدلاني:

TABLET

تركيب:

DONEPEZIL HYDROCHLORIDE 5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2013-12-24

خصائص المنتج

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Page 1 of 51
F
PRODUCT MONOGRAPH
PR
MINT-DONEPEZIL
(donepezil hydrochloride USP as donepezil hydrochloride monohydrate)
5 mg and 10 mg tablets
In-House
CHOLINESTERASE INHIBITOR
MINT Pharmaceuticals Inc.
Date of Revision:
1093 Meyerside Drive, Unit 1
March 05, 2015
Mississauga, Ontario
Canada L5T 1J6
Submission Control No: 182010
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Page 2 of 51
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
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
...................................................................................
23
PHARMACEUTICAL INFORMATION
..............................................................................
23
CLINICAL TRIALS
.......................................