País: Canadá
Idioma: inglés
Fuente: Health Canada
DICLOFENAC SODIUM
NOVARTIS PHARMACEUTICALS CANADA INC
M01AB05
DICLOFENAC
50MG
SUPPOSITORY
DICLOFENAC SODIUM 50MG
RECTAL
30
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417002; AHFS:
APPROVED
1997-05-07
_VOLTAREN_ _ _ _and VOLTAREN SR diclofenac sodium _ _ Page 1 of 50_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VOLTAREN ® PR VOLTAREN ® SR (Diclofenac sodium suppositories) (Diclofenac sodium slow-release tablets) Slow-Release Tablets, 100 mg, for oral use Suppositories, 50 mg, for rectal use Mfr. Std. Non-Steroidal Anti-Inflammatory Drug (NSAID) Novartis Pharmaceuticals Canada Inc. Date of Initial Authorization: 385 Bouchard Blvd., July 5, 1989 Dorval, Quebec H9S 1A9 www.novartis.ca Date of Revision: JUN 08, 2022 Control no. 260554 VOLTAREN and VOLTAREN SR are registered trademark. _ _ _VOLTAREN_ _ _ _and VOLTAREN SR diclofenac sodium _ _ Page 2 of 50_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX- Risk in Pregnancy 10/2021 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, _Pregnancy_ 10/2021 7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions _ 10/2021 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 10/2021 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 ............................................................................................................4 1.2 Geriatrics.............................................................................................................5 2 CONTRAINDICATIONS ...................................................................................................5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................. Leer el documento completo