ACCEL-DONEPEZIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DONEPEZIL HYDROCHLORIDE

Tilgjengelig fra:

ACCEL PHARMA INC

ATC-kode:

N06DA02

INN (International Name):

DONEPEZIL

Dosering :

5MG

Legemiddelform:

TABLET

Sammensetning:

DONEPEZIL HYDROCHLORIDE 5MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100

Resept typen:

Prescription

Terapeutisk område:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2019-10-28

Preparatomtale

_ _
_ _
_ _
_ _
_ _
_ _
Page 1 of 51
PRODUCT MONOGRAPH
PR
ACCEL-DONEPEZIL
(donepezil hydrochloride USP as donepezil hydrochloride monohydrate)
5 mg and 10 mg tablets
In-House
CHOLINESTERASE INHIBITOR
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
Date of Revision:
March 19, 2015
Submission Control No: 182956
_ _
_ _
_ _
_ _
_ _
_ _
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
................................................................