AURO-DONEPEZIL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DONEPEZIL HYDROCHLORIDE

Disponible des:

AURO PHARMA INC

Codi ATC:

N06DA02

Designació comuna internacional (DCI):

DONEPEZIL

Dosis:

5MG

formulario farmacéutico:

TABLET

Composición:

DONEPEZIL HYDROCHLORIDE 5MG

Vía de administración:

ORAL

Unidades en paquete:

2*14/3*10/30/100/250/500/1000

tipo de receta:

Prescription

Área terapéutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-12-24

Fitxa tècnica

Page 1 of 49
PRODUCT MONOGRAPH
PR
AURO-DONEPEZIL
Donepezil Hydrochloride Tablets
5 mg & 10 mg
House Standard CHOLINESTERASE INHIBITOR
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
SUBMISSION CONTROL NO: 181605
Date of Revision:
March 12, 2015
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………………………………………
4
ADVERSE
REACTIONS…………………………………………………..
8
DRUG
INTERACTIONS…………………………………………………...
16
DOSAGE AND ADMINISTRATION……………………………………..
17
OVERDOSAGE…………………………………………………………….
18
ACTION AND CLINICAL PHARMACOLOGY………………………...
19
STORAGE AND
STABILITY……………………………………………..
21
DOSAGE FORMS, COMPOSITION AND PACKAGING……………….. 21
PART II:
SCIENTIFIC
INFORMATION…………………………………..………
22
PHARMACEUTICAL INFORMATION………………………………….. 22
CLINICAL
TRIALS………………………………………………………..
23
DETAILED PHARMACOLOGY………………………………………….
32
TOXICOLOGY……………………………………………………………..
32
REFERENCES……………………………………………………………...
44
PART III:
CONSUMER INFORMATION…………………………………………..
47
Page 3 of 49
PR
AURO-DONEPEZIL
(Donepezil Hydrochloride Tablets 5 mg & 10 mg)
House Standard
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NONMEDICINAL INGREDIENTS
oral
Tablets 5 mg & 10 mg
Cell