DONEPEZIL HYDROCHLORIDE TABLETS USP

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Dostupné s:

DR REDDY'S LABORATORIES LTD

ATC kód:

N06DA02

INN (Mezinárodní Name):

DONEPEZIL

Dávkování:

5MG

Léková forma:

TABLET

Složení:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Podání:

ORAL

Jednotky v balení:

7/14/30/90/500/1000/9000

Druh předpisu:

Prescription

Terapeutické oblasti:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0131548001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2013-12-27

Charakteristika produktu

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..........