ACT DONEPEZIL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Dostępny od:

ACTAVIS PHARMA COMPANY

Kod ATC:

N06DA02

INN (International Nazwa):

DONEPEZIL

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2018-06-12

Charakterystyka produktu

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DONEPEZIL
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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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DONEPEZIL
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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
..........................................................................