ARICEPT RDT TABLET (ORALLY DISINTEGRATING)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DONEPEZIL HYDROCHLORIDE

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

N06DA02

INN (International Adı):

DONEPEZIL

Doz:

5MG

Farmasötik formu:

TABLET (ORALLY DISINTEGRATING)

Kompozisyon:

DONEPEZIL HYDROCHLORIDE 5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

28

Reçete türü:

Prescription

Terapötik alanı:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2022-03-30

Ürün özellikleri

_ARICEPT_
_®_
_/ARICEPT_
_®_
_ RDT (donepezil hydrochloride) Product Monograph _
_Page 1 of 53 _
PRODUCT MONOGRAPH
Pr
ARICEPT
®
(donepezil hydrochloride)
Tablets 5 and 10 mg
Pr
ARICEPT
® RDT
(donepezil hydrochloride)
Rapidly Disintegrating Tablets 5 and 10 mg
CHOLINESTERASE INHIBITOR
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
www.pfizer.ca
®
ARICEPT is a registered trademark of Eisai Co. Ltd., Tokyo,
Japan/used under license
2014 Pfizer Canada Inc.
Submission Control No: 177353
Date of Revision:
December 18, 2014
_ARICEPT_
_®_
_/ARICEPT_
_®_
_ RDT (donepezil hydrochloride) Product Monograph _
_Page 2 of 53 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
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
.....................................