DEPAKENE SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VALPROIC ACID (SODIUM VALPROATE)

Доступна з:

BGP PHARMA ULC

Код атс:

N03AG01

ІПН (Міжнародна Ім'я):

VALPROIC ACID

Дозування:

250MG

Фармацевтична форма:

SOLUTION

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:

APPROVED

Дата Авторизація:

2015-01-07

Характеристики продукта

_ _
_ _
_ _
_ _
_DEPAKENE®, valproic acid Product Monograph_
_ _
_Page 1 of 60_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DEPAKENE®
valproic acid
Oral solution, 250 mg/5 mL valproic acid (as sodium valproate), Oral
USP
Antiepileptic
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
DEC 22, 2014
Date of Revision:
FEB 06, 2023
Submission Control Number: 266468
_ _
_ _
_ _
_DEPAKENE®, valproic acid Product Monograph _
_ _
_Page 2 of 60_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity
02/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
07/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Hyperammonemia
02/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Patients at Risk of Hypocarnitinemia
02/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic:
Serious or Fatal Hepatotoxicity
02/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
11/2021
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
05/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women,
Pregnancy Exposure Risk related to Valproate
02/2023
_ _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................5
1
INDICATIONS
................................................................................................................5
1.1
Pediatrics
............................................................................................................5
1.2
Geriatrics
......................................................................