Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DICLOFENAC SODIUM
SANDOZ CANADA INCORPORATED
M01AB05
DICLOFENAC
50MG
TABLET (DELAYED-RELEASE)
DICLOFENAC SODIUM 50MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417002; AHFS:
CANCELLED POST MARKET
2021-02-04
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _ _ _ _Page 1 of 42 _ PRODUCT MONOGRAPH PR SANDOZ-DICLOFENAC PR SANDOZ-DICLOFENAC SR (diclofenac sodium) 50 mg Enteric-Coated Tablets 75 and 100 mg Slow-Release Tablets 50 mg Suppositories Acetic Acid Derivatives and Related Substances Sandoz Canada Inc. Date of revision: 110 Rue de Lauzon June 6, 2022 Boucherville, Quebec J4B 1E6 Control no. 259798 _Sandoz-Diclofenac and Sandoz-Diclofenac SR _ _ _ _Page 2 of 42 _ 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....................................................................................................19 DOSAGE AND ADMINISTRATION.................................................................................22 OVERDOSAGE .................................................................................................................24 ACTION AND CLINICAL PHARMACOLOGY ................................................................25 STORAGE AND STABILITY............................................................................................27 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................27 PART II: SCIENTIFIC INFORMATION ...........................................................................28 PHARMACEUTICAL INFORMATION.............................................................................28 CLINICAL TRIALS ....... Přečtěte si celý dokument