RATIO-RIVASTIGMINE CAPSULE

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Доступна с:

TEVA CANADA LIMITED

код АТС:

N06DA03

ИНН (Международная Имя):

RIVASTIGMINE

дозировка:

6MG

Фармацевтическая форма:

CAPSULE

состав:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 6MG

Администрация маршрут:

ORAL

Штук в упаковке:

60/100/500

Тип рецепта:

Prescription

Терапевтические области:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0140521004; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2018-05-18

Характеристики продукта

_ _
_ratio-RIVASTIGMINE Capsules _
_Page 1 of 54_
PRODUCT MONOGRAPH
Pr
ratio-RIVASTIGMINE
1.5 mg, 3 mg, 4.5 mg and 6 mg rivastigmine
(as rivastigmine hydrogen tartrate)
Capsules
Cholinesterase Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
November 08, 2016
Submission Control No: 199189
_ _
_ratio-RIVASTIGMINE Capsules _
_Page 2 of 54_
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
.............................................................................