PMS-DICLOFENAC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC SODIUM

Available from:

PHARMASCIENCE INC

ATC code:

M02AA15

INN (International Name):

DICLOFENAC

Dosage:

1.5%

Pharmaceutical form:

SOLUTION

Composition:

DICLOFENAC SODIUM 1.5%

Administration route:

TOPICAL

Units in package:

15/30/60/120ML

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2010-09-24

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-DICLOFENAC
Diclofenac sodium solution
Solution, 1.5% w/w, Topical
ATC Code: M02AA15
Non-Steroidal Anti-Inflammatory Drug (NSAID)
PHARMASCIENCE INC
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Initial Authorization:
September 24, 2010
Date of Revision:
July 12, 2022
Submission Control Number: 261768
2
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions
07/2022
7 Warnings and Precautions
07/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE 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
............................................................ 6
4.4
Administration
.................................................................