ACT DONEPEZIL ODT TABLET (ORALLY DISINTEGRATING)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
22-01-2018
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Aktiv bestanddel:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
N06DA02
INN (International Name):
DONEPEZIL
Dosering:
5MG
Lægemiddelform:
TABLET (ORALLY DISINTEGRATING)
Sammensætning:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
28
Recept type:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0131548001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2022-05-30
Produktets egenskaber
ACT_ _DONEPEZIL ODT _ _
_ Page 1 of 49_
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 _ _
_ 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
......................................................................
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