Land: Kanada
Tungumál: enska
Heimild: Health Canada
DONEPEZIL HYDROCHLORIDE
JUBILANT GENERICS LIMITED
N06DA02
DONEPEZIL
10MG
TABLET
DONEPEZIL HYDROCHLORIDE 10MG
ORAL
30/100/500
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0131548002; AHFS:
APPROVED
2013-12-24
_ _ _ Donepezil Hydrochloride Product Monograph _ _Page 1 of 43 _ _ _ PRODUCT MONOGRAPH PR DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLETS USP 5 AND 10 MG CHOLINESTERASE INHIBITOR MANUFACTURED BY: Jubilant Generics Limited Date of Revision: Village Sikandarpur Bhainswal, June 7, 2016 Roorkee Dehradun highway, Bhagwanpur, Roorkee. Distt. – Haridwar Uttarakhand – 247661, India DISTRIBUTED BY: Jubilant Draximage Incorporation 16751 Trans Canada Highway, Kirkland, Quebec, Canada H9H 4J4 Submission Control No: 191309 _ _ _ Donepezil Hydrochloride Product Monograph _ _Page 2 of 43 _ _ _ 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.............................................................................................................7 DRUG INTERACTIONS……………………............................................................................15 DOSAGE AND ADMINISTRATION........................................................................................16 OVERDOSAGE..........................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY......................................................................17 STORAGE AND STABILITY...................................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING.......................................................20 PART II: SCIENTIFIC INFORMATION...... Lestu allt skjalið