VOLTAREN OPHTHA SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

DICLOFENAC SODIUM

Доступна с:

NOVARTIS PHARMACEUTICALS CANADA INC

код АТС:

S01BC03

ИНН (Международная Имя):

DICLOFENAC

дозировка:

0.1%

Фармацевтическая форма:

SOLUTION

состав:

DICLOFENAC SODIUM 0.1%

Администрация маршрут:

OPHTHALMIC

Штук в упаковке:

0.3/2.5/5/10ML

Тип рецепта:

Prescription

Терапевтические области:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0114417004; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2008-04-04

Характеристики продукта

_VOLTAREN_
®
_ OPHTHA Diclofenac Sodium _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VOLTAREN® OPHTHA
Diclofenac Sodium Ophthalmic Solution
Ophthalmic solution, 0.1% w/v for Topical use
Anti-inflammatory agents, non-steroids
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St.,Suite 100
Montreal, Quebec
H2Y0C1
www.novartis.ca
Date of Initial Authorization:
SEPT 13, 1991
Date of Revision:
APR 11, 2023
Submission Control Number: 269518
VOLTAREN is a registered trademark.
_ _
_VOLTAREN_
®
_ OPHTHA Diclofenac Sodium _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
04/2023
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
....................................................... 4
4.4 Administration
........................................................................................