Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
DICLOFENAC SODIUM; MISOPROSTOL
ACTAVIS PHARMA COMPANY
M01AB55
DICLOFENAC, COMBINATIONS
75MG; 200MCG
TABLET (ENTERIC-COATED)
DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG
ORAL
100/250/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0222885004; AHFS:
CANCELLED POST MARKET
2019-08-08
_ _ _ _ _Page 1 of 54_ PRODUCT MONOGRAPH PR ACT_ _DICLO-MISO Diclofenac sodium and Misoprostol Enteric-coated Tablets, USP 50 mg diclofenac/200 mcg misoprostol and 75 mg diclofenac/200 mcg misoprostol NSAID with a Mucosal Protective Agent Actavis Pharma Company 6733 Mississauga Road, Suite 400 Mississauga, ON Canada, L5N 6J5 Date of Revision: December 09, 2015 Submission Control No: 190014 _ _ _ _ _Page 2 of 54_ 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 ................................................................................................. 17 DRUG INTERACTIONS ................................................................................................. 21 DOSAGE AND ADMINISTRATION ............................................................................. 25 OVERDOSAGE ............................................................................................................... 26 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 27 STORAGE AND STABILITY ......................................................................................... 30 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 30 PART II: SCIENTIFIC INFORMATION .............................................................................. 32 PHARMACEUTICAL INFORMATION ......................................................................... 32 CLINICAL TRIALS ........................................................................ Izlasiet visu dokumentu