RATIO-GALANTAMINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Доступно од:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

АТЦ код:

N06DA04

INN (Међународно име):

GALANTAMINE

Дозирање:

12MG

Фармацеутски облик:

TABLET

Састав:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 12MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0144660003; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2015-10-16

Карактеристике производа

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