Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
DICLOFENAC SODIUM
NOVARTIS PHARMACEUTICALS CANADA INC
M01AB05
DICLOFENAC
100MG
SUPPOSITORY
DICLOFENAC SODIUM 100MG
RECTAL
30
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417001; AHFS:
CANCELLED POST MARKET
2021-11-08
Page 1 of 43 PRODUCT MONOGRAPH PR VOLTAREN ® PR VOLTAREN ® SR (diclofenac sodium) 50 mg Enteric-Coated Tablets 75 and 100 mg Slow-Release Tablets 50 and 100 mg Suppositories Acetic Acid Derivatives and Related Substances Novartis Pharmaceuticals Canada Inc. Date of Preparation: 385 Bouchard Blvd., July 5, 1989 Dorval, Quebec H9S 1A9 Date of Revision: October 20, 2021 Control no. 253534 VOLTAREN and VOLTAREN SR are registered trademarks. Page 2 of 43 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION .......................................................................... 3 INDICATIONS AND CLINICAL USE................................................................................ 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................... 5 ADVERSE REACTIONS ...................................................................................................16 DRUG INTERACTIONS....................................................................................................20 DOSAGE AND ADMINISTRATION.................................................................................23 OVERDOSAGE .................................................................................................................25 ACTION AND CLINICAL PHARMACOLOGY ................................................................26 STORAGE AND STABILITY............................................................................................28 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................28 PART II: SCIENTIFIC INFORMATION ...........................................................................29 PHARMACEUTICAL INFORMATION.............................................................................29 CLINICAL TRIALS ............. Baca dokumen lengkapnya