DICLOFENAC SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DICLOFENAC SODIUM

Tersedia dari:

PHARMA STULLN INC.

Kode ATC:

S01BC03

INN (Nama Internasional):

DICLOFENAC

Dosis:

0.1%

Bentuk farmasi:

SOLUTION

Komposisi:

DICLOFENAC SODIUM 0.1%

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

0.3MLX10 X20 X50

Jenis Resep:

Prescription

Area terapi:

ANTIALLERGIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-06-19

Karakteristik produk

_Diclofenac Sodium Ophthalmic Solution _
_Page 1 of 26 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DICLOFENAC
Diclofenac Sodium Ophthalmic Solution
Ophthalmic solution, 0.1% w/v for Topical use
Anti-inflammatory agents, non-steroids
Pharma Stulln Inc
6500 Transcanada Highway, Suite 400
Pointe-Claire
Quebec
H9R0A5
Date of Initial Authorization:
JUN 19, 2018
Date of Revision:
November 16, 2023
Submission Control Number: 275190
_Diclofenac Sodium Ophthalmic Solution _
_ _
_Page 3 of 26 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
11/2023
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................................................................
3
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................................................................
5
1
INDICATIONS
..................................................................................................................................................................
5
1.1
P
EDIATRICS
.......................................................................................................................................................................
5
1.2
G
ERIATRICS
.......................................................................................................................................................................
5
2
CONTRAINDICATIONS
.....................................................................................................................................................
5
4
DOSAGE AND ADMINISTRATION
....................................................................................................................................
5
4.2
R
ECOMMENDED
D
OSE AND
D
OSAGE
A
DJUSTM