SABRIL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VIGABATRIN

Доступна з:

LUNDBECK PHARMACEUTICALS LLC

Код атс:

N03AG04

ІПН (Міжнародна Ім'я):

VIGABATRIN

Дозування:

500MG

Фармацевтична форма:

TABLET

Склад:

VIGABATRIN 500MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS ANTICONVULSANTS

Огляд продуктів:

Active ingredient group (AIG) number: 0125421003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2000-09-01

Характеристики продукта

_Vigabatrin Product Monograph Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SABRIL®
vigabatrin
Tablets, 500 mg
Sachets, 500 mg
Antiepileptic
® Trademark of Lundbeck
Manufactured by:
Lundbeck
Six Parkway North
Deerfield, IL 60015
U.S.A.
Imported and distributed by:
Lundbeck Canada Inc., Saint-Laurent, QC H4S 0A9
Submission Control No: 244467
Date of Preparation:
October 6, 2009
Date of Revision:
February 9, 2021
TABLE OF CONTENTS
_ _
_Vigabatrin Product Monograph Page 2 of 44_
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................29
SPECIAL HANDLING INSTRUCTIONS
.......................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTI