Maa: Kanada
Kieli: englanti
Lähde: Health Canada
FLURBIPROFEN
TEVA CANADA LIMITED
M01AE09
FLURBIPROFEN
50MG
TABLET
FLURBIPROFEN 50MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0115998002; AHFS:
CANCELLED POST MARKET
2019-08-08
PRODUCT MONOGRAPH PR TEVA-FLURBIPROFEN (Flurbiprofen tablets BP) 50 mg and 100 mg Tablets Nonsteroidal anti-inflammatory drug (NSAID) Teva Canada Limited Date of Revision: 30 Novopharm Court July 14, 2015 Toronto, Ontario M1B 2K9 www.tevacanada.com Control No.: 184835 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 INDICATIONS AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS .............................................................................. 5 ADVERSE REACTIONS ............................................................................................... 16 DRUG INTERACTIONS ............................................................................................... 19 DOSAGE AND ADMINISTRATION .......................................................................... 22 OVERDOSAGE .............................................................................................................. 23 ACTION AND CLINICAL PHARMACOLOGY ....................................................... 23 STORAGE AND STABILITY....................................................................................... 25 DOSAGE FORMS, COMPOSITION AND PACKAGING ....................................... 25 PART II: SCIENTIFIC INFORMATION .............................................................................. 27 PHARMACEUTICAL INFORMATION ..................................................................... 27 CLINICAL TRIALS ....................................................................................................... 28 DETAILED PHARMACOLOGY ................................................................................. 30 TOXICOLOGY .............................................................................................................. 30 REFERENCES . Lue koko asiakirja