ACT DONEPEZIL TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
27-02-2015
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)
Beschikbaar vanaf:
ACTAVIS PHARMA COMPANY
ATC-code:
N06DA02
INN (Algemene Internationale Benaming):
DONEPEZIL
Dosering:
5MG
farmaceutische vorm:
TABLET
Samenstelling:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0131548001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2018-06-12
Productkenmerken
_ _
ACT
_ _
DONEPEZIL
_ _
_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
_ _
ACT
_ _
DONEPEZIL
_ _
_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
..........................................................................
Lees het volledige document
