ACT DONEPEZIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Tersedia dari:

ACTAVIS PHARMA COMPANY

Kode ATC:

N06DA02

INN (Nama Internasional):

DONEPEZIL

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-06-12

Karakteristik produk

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ACT
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DONEPEZIL
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_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
ACT_ _DONEPEZIL
(donepezil hydrochloride as donepezil hydrochloride monohydrate)
Donepezil Hydrochloride Tablets USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Submission Control No: 181946
Date of Revision:
February 26, 2015
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ACT
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DONEPEZIL
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_Page 2 of 49_
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
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
..........................................................................