ACT DONEPEZIL ODT TABLET (ORALLY DISINTEGRATING)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

N06DA02

Designació comuna internacional (DCI):

DONEPEZIL

Dosis:

5MG

formulario farmacéutico:

TABLET (ORALLY DISINTEGRATING)

Composición:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Vía de administración:

ORAL

Unidades en paquete:

28

tipo de receta:

Prescription

Área terapéutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2022-05-30

Fitxa tècnica

ACT_ _DONEPEZIL ODT _ _
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PRODUCT MONOGRAPH
Pr
ACT_ _DONEPEZIL ODT
(donepezil hydrochloride as donepezil hydrochloride monohydrate)
Donepezil Hydrochloride Orally Disintegrating Tablets USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Submission Control No.: 212186
Date of Revision:
January 22, 2018
ACT_ _DONEPEZIL ODT _ _
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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
......................................................................