VOLTAREN OPHTHA SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DICLOFENAC SODIUM

Disponible depuis:

NOVARTIS PHARMACEUTICALS CANADA INC

Code ATC:

S01BC03

DCI (Dénomination commune internationale):

DICLOFENAC

Dosage:

0.1%

forme pharmaceutique:

SOLUTION

Composition:

DICLOFENAC SODIUM 0.1%

Mode d'administration:

OPHTHALMIC

Unités en paquet:

0.3/2.5/5/10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2008-04-04

Résumé des caractéristiques du produit

_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
...............................................................................................................
4
1.2 Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
....................................................... 4
4.4 Administration
........................................................................................