BIO-DONEPEZIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DONEPEZIL HYDROCHLORIDE

Tersedia dari:

BIOMED PHARMA

Kode ATC:

N06DA02

INN (Nama Internasional):

DONEPEZIL

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

DONEPEZIL HYDROCHLORIDE 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:

APPROVED

Tanggal Otorisasi:

2013-12-27

Karakteristik produk

Page 1 of 50
PRODUCT MONOGRAPH
Pr
BIO-DONEPEZIL
Donepezil Hydrochloride Tablets, House Std
5 and 10 mg
CHOLINESTERASE INHIBITOR
CONTROL
# 241442
H1P 3H8
Montreal, Quebec
1B-9450 Boulevard Langelier, August 12, 2020
Biomed Pharma Date of Revision:
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
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
....................................................................................
32
TOXICO