JAMP-DONEPEZIL TABLETS

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DONEPEZIL HYDROCHLORIDE

Dostupno od:

JAMP PHARMA CORPORATION

ATC koda:

N06DA02

INN (International ime):

DONEPEZIL

Doziranje:

5MG

Farmaceutski oblik:

TABLET

Sastav:

DONEPEZIL HYDROCHLORIDE 5MG

Administracija rute:

ORAL

Jedinice u paketu:

28/30/250

Tip recepta:

Prescription

Područje terapije:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2013-12-27

Svojstava lijeka

JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride) Product Monograph
Page 1 of 51
PRODUCT MONOGRAPH
PR
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride)
Tablets 5 and 10 mg
CHOLINESTERASE INHIBITOR
JAMP PHARMA CORPORATION
1380-203 NEWTON STREET
BOUCHERVILLE, QUEBEC
J4B 5H2
DATE OF REVISION:
MARCH 12, 2015
Submission Control No: 182041
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride) Product Monograph
Page 2 of 51
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
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
.........................................................................