DONEPEZIL TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DONEPEZIL HYDROCHLORIDE

Disponibbli minn:

RANBAXY PHARMACEUTICALS CANADA INC.

Kodiċi ATC:

N06DA02

INN (Isem Internazzjonali):

DONEPEZIL

Dożaġġ:

5MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

DONEPEZIL HYDROCHLORIDE 5MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2022-08-19

Karatteristiċi tal-prodott

_ _
_DONEPEZIL (Donepezil Hydrochloride Tablets, USP) Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
DONEPEZIL
Donepezil Hydrochloride Tablets, USP
5 mg and 10 mg
CHOLINESTERASE INHIBITOR
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
DATE OF PREPARATION:
March 7, 2014
Submission Control No: 171793
Trademark owned by Ranbaxy Laboratories Limited
_ _
_DONEPEZIL (Donepezil Hydrochloride Tablets USP) Product Monograph _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL