Riik: Kanada
keel: inglise
Allikas: Health Canada
DICLOFENAC SODIUM
SANDOZ CANADA INCORPORATED
M01AB05
DICLOFENAC
100MG
SUPPOSITORY
DICLOFENAC SODIUM 100MG
RECTAL
30
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417001; AHFS:
CANCELLED POST MARKET
2021-01-25
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _ _ _ _Page 1 of 40 _ PRODUCT MONOGRAPH PR SANDOZ-DICLOFENAC PR SANDOZ-DICLOFENAC 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 Sandoz Canada Inc. Date of revision: 110 Rue de Lauzon, January 6, 2020 Boucherville, Quebec J4B 1E6 Control no. 233855 _Sandoz-Diclofenac and Sandoz-Diclofenac SR _ _ _ _Page 2 of 40 _ 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 ......................................................................................................... 15 DRUG INTERACTIONS ......................................................................................................... 17 DOSAGE AND ADMINISTRATION ..................................................................................... 21 OVERDOSAGE ....................................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 23 STORAGE AND STABILITY ................................................................................................. 25 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 25 PART II: SCIENTIFIC INFORMATION ............................................................................... 27 PHARMACEUTICAL INFORMATION ................. Lugege kogu dokumenti