AURO-DONEPEZIL TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
14-04-2015
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Aktiv bestanddel:
DONEPEZIL HYDROCHLORIDE
Tilgængelig fra:
AURO PHARMA INC
ATC-kode:
N06DA02
INN (International Name):
DONEPEZIL
Dosering:
5MG
Lægemiddelform:
TABLET
Sammensætning:
DONEPEZIL HYDROCHLORIDE 5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
2*14/3*10/30/100/250/500/1000
Recept type:
Prescription
Terapeutisk område:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0131548001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2013-12-24
Produktets egenskaber
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
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