APO-DONEPEZIL TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

N06DA02

INN (আন্তর্জাতিক নাম):

DONEPEZIL

ডোজ:

10MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 10MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

30/100/500

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0131548002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2013-12-24

পণ্য বৈশিষ্ট্য

_APO-DONEPEZIL Tablets Product Monograph_
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
APO-DONEPEZIL
Donepezil Hydrochloride Tablets
Tablets, 5 mg and 10 mg
(as donepezil hydrochloride monohydrate)
USP
Cholinesterase Inhibitor
APOTEX INC.
Date of Revision:
150 Signet Drive
January 17, 2023
Weston, Ontario
M9L 1T9
Submission Control No.: 266376
_APO-DONEPEZIL Tablets Product Monograph_
_Page 2 of 46_
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
........................................................................
21
PHARMACEUTICAL INFORMATION
..........................................................................
21
CLINICAL TRIALS
................................................................................................