DOM-VALPROIC ACID E.C. CAPSULE (ENTERIC-COATED)

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

VALPROIC ACID

Доступна с:

DOMINION PHARMACAL

код АТС:

N03AG01

ИНН (Международная Имя):

VALPROIC ACID

дозировка:

500MG

Фармацевтическая форма:

CAPSULE (ENTERIC-COATED)

состав:

VALPROIC ACID 500MG

Администрация маршрут:

ORAL

Штук в упаковке:

150

Тип рецепта:

Prescription

Терапевтические области:

MISCELLANEOUS ANTICONVULSANTS

Обзор продуктов:

Active ingredient group (AIG) number: 0112996003; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

1997-04-24

Характеристики продукта

PRODUCT MONOGRAPH
PR
DOM-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
DOM-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
DOM-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg /5 mL
ANTIEPILEPTIC
DOMINION PHARMACAL DATE OF REVISION:
6111 Royalmount Avenue, suite 100 May 12, 2017
Montréal, Quebec
H4P 2T4
SUBMISSION CONTROL NO.: 204664
_ _
_Monographie de produit Dom-VALPROIC ACID & Dom-VALPROIC ACID E.C. _
_Page 2 de 61 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
21
DRUG INTERACTIONS
.................................................................................................
26
DOSAGE AND ADMINISTRATION
.............................................................................
34
OVERDOSAGE
................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 37
STORAGE AND STABILITY
.........................................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
............................