ACH-DONEPEZIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DONEPEZIL HYDROCHLORIDE

Tilgjengelig fra:

ACCORD HEALTHCARE INC

ATC-kode:

N06DA02

INN (International Name):

DONEPEZIL

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

DONEPEZIL HYDROCHLORIDE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-12-01

Preparatomtale

_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