PHL-VALPROIC ACID SYRUP

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VALPROIC ACID (SODIUM VALPROATE)

Доступна з:

PHARMEL INC

Код атс:

N03AG01

ІПН (Міжнародна Ім'я):

VALPROIC ACID

Дозування:

250MG

Фармацевтична форма:

SYRUP

Склад:

VALPROIC ACID (SODIUM VALPROATE) 250MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

450ML

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS ANTICONVULSANTS

Огляд продуктів:

Active ingredient group (AIG) number: 0112996002; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2012-01-28

Характеристики продукта

PRODUCT MONOGRAPH
PR
PHL-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
PHL-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
PHL-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg/5 mL
ANTIEPILEPTIC
PHARMEL INC.
DATE OF REVISION:
6111 Royalmount Avenue, suite 100
January 27, 2012
Montreal, Canada
H4P 2T4
SUBMISSION CONTROL NO: 152317
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
29
OVERDOSAGE................................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY............................................................
32
STORAGE AND STABILITY
.........................................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 35
PART II: SCIENTIFIC INFORMATION
.............................................................................
36
PHARMACEUTICAL INFORMATION
.........................................................................
36
CLINICAL TRIALS
.........................................................................................................
37
DETAILED PHARMACOLOGY
....................................................................................
43
TOXICOLOGY..