Страна: Канада
Язык: английский
Источник: Health Canada
DONEPEZIL HYDROCHLORIDE
PFIZER CANADA ULC
N06DA02
DONEPEZIL
5MG
TABLET (ORALLY DISINTEGRATING)
DONEPEZIL HYDROCHLORIDE 5MG
ORAL
28
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0131548001; AHFS:
CANCELLED POST MARKET
2022-03-30
_ARICEPT_ _®_ _/ARICEPT_ _®_ _ RDT (donepezil hydrochloride) Product Monograph _ _Page 1 of 53 _ PRODUCT MONOGRAPH Pr ARICEPT ® (donepezil hydrochloride) Tablets 5 and 10 mg Pr ARICEPT ® RDT (donepezil hydrochloride) Rapidly Disintegrating Tablets 5 and 10 mg CHOLINESTERASE INHIBITOR Pfizer Canada Inc. 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 www.pfizer.ca ® ARICEPT is a registered trademark of Eisai Co. Ltd., Tokyo, Japan/used under license 2014 Pfizer Canada Inc. Submission Control No: 177353 Date of Revision: December 18, 2014 _ARICEPT_ _®_ _/ARICEPT_ _®_ _ RDT (donepezil hydrochloride) Product Monograph _ _Page 2 of 53 _ 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 ....................................................................................................9 DRUG INTERACTIONS ..................................................................................................17 DOSAGE AND ADMINISTRATION ..............................................................................18 OVERDOSAGE ................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ............................................................20 STORAGE AND STABILITY ..........................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................22 PART II: SCIENTIFIC INFORMATION ..................................... Прочитать полный документ