DONEPEZIL HYDROCHLORIDE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DONEPEZIL HYDROCHLORIDE

Fáanlegur frá:

JUBILANT GENERICS LIMITED

ATC númer:

N06DA02

INN (Alþjóðlegt nafn):

DONEPEZIL

Skammtar:

5MG

Lyfjaform:

TABLET

Samsetning:

DONEPEZIL HYDROCHLORIDE 5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30/100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2013-12-24

Vara einkenni

_ _
_ Donepezil Hydrochloride Product Monograph _
_Page 1 of 43 _
_ _
PRODUCT MONOGRAPH
PR DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 AND 10 MG
CHOLINESTERASE INHIBITOR
MANUFACTURED BY:
Jubilant Generics Limited
Date of Revision:
Village Sikandarpur Bhainswal,
June 7, 2016
Roorkee Dehradun highway,
Bhagwanpur, Roorkee.
Distt. – Haridwar
Uttarakhand – 247661, India
DISTRIBUTED BY:
Jubilant Draximage Incorporation
16751 Trans Canada Highway,
Kirkland, Quebec, Canada
H9H 4J4
Submission Control No: 191309
_ _
_ Donepezil Hydrochloride Product Monograph _
_Page 2 of 43 _
_ _
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.............................................................................................................7
DRUG
INTERACTIONS……………………............................................................................15
DOSAGE AND
ADMINISTRATION........................................................................................16
OVERDOSAGE..........................................................................................................................17
ACTION AND CLINICAL
PHARMACOLOGY......................................................................17
STORAGE AND
STABILITY...................................................................................................19
DOSAGE FORMS, COMPOSITION AND
PACKAGING.......................................................20
PART II: SCIENTIFIC
INFORMATION......