DONEPEZIL HYDROCHLORIDE TABLETS USP
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
31-10-2022
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Viambatanisho vya kazi:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)
Inapatikana kutoka:
DR REDDY'S LABORATORIES LTD
ATC kanuni:
N06DA02
INN (Jina la Kimataifa):
DONEPEZIL
Kipimo:
5MG
Dawa fomu:
TABLET
Tungo:
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
7/14/30/90/500/1000/9000
Dawa ya aina:
Prescription
Eneo la matibabu:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0131548001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2013-12-27
Tabia za bidhaa
1
PRODUCT MONOGRAPH
Pr
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 mg and 10 mg
donepezil hydrochloride (as donepezil hydrochloride monohydrate)
CHOLINESTERASE INHIBITOR
Manufactured by:
DR. REDDY’S LABORATORIES LTD.,
Bachupally – 500 090
India
Imported and Distributed by:
Date of Revision:
DR. REDDY’S LABORATORIES CANADA INC.,
October 31, 2022
Mississauga, ON L4W 4Y1
Canada
Submission
Control Number: 264379
2
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
....................................................................................17
OVERDOSAGE.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
...............................................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................21
PART II: SCIENTIFIC INFORMATION
...........................................................................22
PHARMACEUTICAL INFORMATION
................................................................................22
CLINICAL
TRIALS..........
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