SANDOZ DICLOFENAC OPHTHA SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DICLOFENAC SODIUM

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

S01BC03

INN (Kansainvälinen yleisnimi):

DICLOFENAC

Annos:

0.1%

Lääkemuoto:

SOLUTION

Koostumus:

DICLOFENAC SODIUM 0.1%

Antoreitti:

OPHTHALMIC

Kpl paketissa:

5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-05-12

Valmisteyhteenveto

_Page 1 of 27_
_Sandoz Diclofenac Ophtha (Diclofenac Sodium)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ DICLOFENAC OPHTHA
Diclofenac Sodium Ophthalmic Solution
Ophthalmic solution, 0.1% w/v for Topical use
Anti-inflammatory agents, non-steroids
Sandoz Canada Inc.
110, de Lauzon Street
Boucherville, QC J4B 1E6
Canada
Submission Control Number: 276264
Date of Initial Authorization:
MAY 12, 2016
Date of Revision:
JUL
13, 2023
_ _
_Sandoz Diclofenac Ophtha (Diclofenac Sodium) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
07/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
07/2023
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
.........................................................................................................
5
4.5 Missed Dose
..........................