Pays: Canada
Langue: anglais
Source: Health Canada
DICLOFENAC SODIUM
PALADIN LABS INC.
M02AA15
DICLOFENAC
1.5%
SOLUTION
DICLOFENAC SODIUM 1.5%
TOPICAL
60ML
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417007; AHFS:
APPROVED
2006-03-03
_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...................................... Lire le document complet