Država: Kanada
Jezik: angleščina
Source: Health Canada
DICLOFENAC SODIUM; MISOPROSTOL
ABRI PHARMACEUTICALS INC
M01AB55
DICLOFENAC, COMBINATIONS
50MG; 200MCG
TABLET (ENTERIC-COATED)
DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG
ORAL
100/250/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0222885003; AHFS:
CANCELLED PRE MARKET
2017-09-12
_ _ _ _ _Page 1 of 48_ PRODUCT MONOGRAPH _PR_ DICLOFENAC MISOPROSTOL Diclofenac sodium and Misoprostol Enteric-coated Tablets 50 mg diclofenac/200 µg misoprostol and 75 mg diclofenac/ 200 µg misoprostol NSAID with a Mucosal Protective Agent Abri Pharmaceuticals Inc. 6500 Kitimat Road Mississauga, ON Canada, L5N 2B8 Date of Preparation: April 18, 2013 Submission Control No: 163906 _ _ _ _ _Page 2 of 48_ 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 ................................................................................................. 19 DOSAGE AND ADMINISTRATION ............................................................................. 22 OVERDOSAGE ............................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 24 STORAGE AND STABILITY ......................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 26 PART II: SCIENTIFIC INFORMATION .............................................................................. 28 PHARMACEUTICAL INFORMATION ......................................................................... 28 CLINICAL TRIALS ................................................................................ Preberite celoten dokument