VOLTAREN OPHTHA SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DICLOFENAC SODIUM

Commercializzato da:

NOVARTIS PHARMACEUTICALS CANADA INC

Codice ATC:

S01BC03

INN (Nome Internazionale):

DICLOFENAC

Dosaggio:

0.1%

Forma farmaceutica:

SOLUTION

Composizione:

DICLOFENAC SODIUM 0.1%

Via di somministrazione:

OPHTHALMIC

Confezione:

0.3/2.5/5/10ML

Tipo di ricetta:

Prescription

Area terapeutica:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2008-04-04

Scheda tecnica

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.2 Recommended Dose and Dosage Adjustment
....................................................... 4
4.4 Administration
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