DONEPEZIL TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DONEPEZIL HYDROCHLORIDE

Saadav alates:

LABORATOIRE RIVA INC.

ATC kood:

N06DA02

INN (Rahvusvaheline Nimetus):

DONEPEZIL

Annus:

5MG

Ravimvorm:

TABLET

Koostis:

DONEPEZIL HYDROCHLORIDE 5MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2018-05-02

Toote omadused

_Product Monograph _
_–_
_ DONEPEZIL _
_Page 1 of 47 _
PRODUCT MONOGRAPH
PR
DONEPEZIL
Donepezil Hydrochloride Tablets USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No: 247667
Date of revision:
January 25, 2021
_Product Monograph _
_–_
_ DONEPEZIL _
_Page 2 of 47 _
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
..................................................................................................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
...............................................................................
21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETA