JAMP-DONEPEZIL TABLETS

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DONEPEZIL HYDROCHLORIDE

זמין מ:

JAMP PHARMA CORPORATION

קוד ATC:

N06DA02

INN (שם בינלאומי):

DONEPEZIL

כמות:

5MG

טופס פרצבטיות:

TABLET

הרכב:

DONEPEZIL HYDROCHLORIDE 5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

28/30/250

סוג מרשם:

Prescription

איזור תרפויטי:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2013-12-27

מאפייני מוצר

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
.........................................................................