MAR-DONEPEZIL TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DONEPEZIL HYDROCHLORIDE

Доступно од:

MARCAN PHARMACEUTICALS INC

АТЦ код:

N06DA02

INN (Међународно име):

DONEPEZIL

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

DONEPEZIL HYDROCHLORIDE 10MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2013-12-27

Карактеристике производа

Page 1 of 50
PRODUCT MONOGRAPH
Pr
MAR-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
Marcan Pharmaceuticals Inc. Date of Revision:
2 Gurdwara Road, Suite 112
February 10, 2020
Ottawa, Ontario
K2E 1A2
Submission Control No.: 235582
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
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
...................................................................