VALPROIC ACID ORAL SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

VALPROIC ACID (SODIUM VALPROATE)

Предлага се от:

APOTEX INC

АТС код:

N03AG01

INN (Международно Name):

VALPROIC ACID

дозиране:

250MG

Лекарствена форма:

SOLUTION

Композиция:

VALPROIC ACID (SODIUM VALPROATE) 250MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS ANTICONVULSANTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-11-20

Данни за продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VALPROIC ACID
Valproic Acid Capsules
Capsules, 250 mg, Oral
USP
Pr
VALPROIC ACID ORAL SOLUTION
Valproic Acid Oral Solution
Oral solution, 250 mg / 5 mL valproic acid (as sodium valproate), Oral
USP
Antiepileptic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
November 20, 2020
Date of Revision:
February 7, 2023
Submission Control Number: 267284
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
02/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or
Fatal Hepatotoxicity
02/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
02/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
02/2023
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
......................................................................
4
1
INDICATIONS....................................................................................................................
4
1.1
Pediatrics.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................................
5
4
DOSAGE AND ADMINISTRATION
...........