GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Доступна з:

SANIS HEALTH INC

Код атс:

N06DA04

ІПН (Міжнародна Ім'я):

GALANTAMINE

Дозування:

16MG

Фармацевтична форма:

CAPSULE (EXTENDED RELEASE)

Склад:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0144660004; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2016-01-07

Характеристики продукта

Page 1 of 55
PRODUCT MONOGRAPH
PR
GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: June 22, 2017
Submission Control No: 206599
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
..............................................