MYLAN-PREGABALIN CAPSULE

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

PREGABALIN

Доступна с:

MYLAN PHARMACEUTICALS ULC

код АТС:

N02BF02

ИНН (Международная Имя):

PREGABALIN

дозировка:

75MG

Фармацевтическая форма:

CAPSULE

состав:

PREGABALIN 75MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

MISCELLANEOUS ANTICONVULSANTS

Обзор продуктов:

Active ingredient group (AIG) number: 0151121003; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2018-07-12

Характеристики продукта

_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 1 _
_OF 81_
PRODUCT MONOGRAPH
PR
MYLAN-PREGABALIN
PREGABALIN CAPSULES
25 MG, 50 MG, 75 MG, 150 MG, 225 MG, 300 MG
ANALGESIC AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: March 1, 2017
_SUBMISSION CONTROL NO: _202862
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 2 _
_OF 81_
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
......................................................... 19
DRUG
INTERACTIONS
......................................................... 41
DOSAGE
AND
ADMINISTRATION
................................................. 44
OVERDOSAGE
................................................................ 48
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................... 49
STORAGE
AND
STABILITY
..................................................... 54
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................... 54
PART II: SCIENTIFIC INFORMATION ............................................ 56
PHARMACEUTICAL
INFORMATION
................................................ 56
CLINICAL
TRIALS
........................................................... 57
DETAILED
PHARMACOLOGY
..................................................... 68
TOXICOLOGY
................................................................ 71
REFERENCES
................................................................ 75
PART III: CONSUMER INFORMATION ............................................. 78
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 3 _
_OF 81_
PR MYLAN-PREGABALIN
P
REGABALIN CAPSULES
PART I: HEALTH PROFESSIONAL IN