RATIO-GALANTAMINE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

זמין מ:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

קוד ATC:

N06DA04

INN (שם בינלאומי):

GALANTAMINE

כמות:

8MG

טופס פרצבטיות:

TABLET

הרכב:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0144660002; AHFS:

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2015-10-16

מאפייני מוצר

ratio-GALANTAMINE
Page 1 of 53
PRODUCT MONOGRAPH
Pr
RATIO-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
ratiopharm inc.
17 800 Rue Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Control #096316
Date of Preparation:
December 1, 2009
ratio-GALANTAMINE
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................3
SUMMARY PRODUCT INFORMATION
...............................................................3
INDICATIONS AND CLINICAL USE
.....................................................................3
CONTRAINDICATIONS
..........................................................................................4
WARNINGS AND PRECAUTIONS
........................................................................4
ADVERSE REACTIONS
..........................................................................................8
DRUG INTERACTIONS
.........................................................................................14
DOSAGE AND ADMINISTRATION
.....................................................................16
OVERDOSAGE
.......................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
...................................................19
STORAGE AND STABILITY
................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................24
PART II SCIENTIFIC INFORMATION
........................................................................25
PHARMACEUTICAL INFORMATION
................................................................25
CLINICAL TRIALS
.................................................................................................26
DETAILED PHARMACOLOGY
............................................................................34
TOXICOLOGY
.....................................................................................