দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)
ACTAVIS PHARMA COMPANY
N06DA02
DONEPEZIL
10MG
TABLET
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 10MG
ORAL
30/100
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0131548002; AHFS:
CANCELLED POST MARKET
2018-06-12
_ _ 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 .......................................................................... সম্পূর্ণ নথি পড়ুন