PENNSAID SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

PALADIN LABS INC.

Kod ATC:

M02AA15

INN (Nama Antarabangsa):

DICLOFENAC

Dos:

1.5%

Borang farmaseutikal:

SOLUTION

Komposisi:

DICLOFENAC SODIUM 1.5%

Laluan pentadbiran:

TOPICAL

Unit dalam pakej:

60ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0114417007; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2006-03-03

Ciri produk

_PENNSAID_
_®_
_ (diclofenac sodium) _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PENNSAID®
Diclofenac sodium solution
Solution, 1.5% w/w, Topical
ATC Code: M02AA15
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Paladin Labs Inc.
100 Alexis-Nihon Blvd., Suite 600
St-Laurent, Quebec
H4M 2P2
Date of Initial Authorization:
October 20, 2003
Date of Revision:
February 16, 2022
Version: 6.0
Submission Control Number: 255809
PENNSAID® is a registered trademark of NUVO PHARMACEUTICALS INC.
_ _
_PENNSAID_
_®_
_ (diclofenac sodium)_
_ _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions
02/2022
7 Warnings and Precautions
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (<18 years of age)
..............................................................................
4
1.2
Geriatrics (≥65 years of
age)...............................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
.......................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment......................................