Land: Canada
Taal: Engels
Bron: Health Canada
URSODIOL
PHARMEL INC
A05AA02
URSODEOXYCHOLIC ACID
500MG
TABLET
URSODIOL 500MG
ORAL
100
Prescription
CHOLELITHOLYTIC AGENTS
Active ingredient group (AIG) number: 0122789002; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH PR PHL-URSODIOL C Ursodiol Tablets USP 250 mg & 500 mg CHOLESTATIC LIVER DISEASES PHARMEL INC. DATE OF REVISION: 6111 Royalmount Avenue, Suite 100 April 23, 2013 Montreal, Quebec H4P 2T2 CONTROL NUMBER: 163335 _ _ _phl-URSODIOL C Product Monograph _ _Page 2 of 29_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................... 3 CONTRAINDICATIONS ......................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................ 4 ADVERSE REACTIONS.......................................................................................................... 5 DRUG INTERACTIONS ........................................................................................................ 10 DOSAGE AND ADMINISTRATION .................................................................................... 11 OVERDOSAGE ...................................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY .................................................................. 11 STORAGE AND STABILITY ................................................................................................ 13 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................... 13 PART II: SCIENTIFIC INFORMATION ..................................................................................... 14 PHARMACEUTICAL INFORMATION ................................................................................ 14 CLINICAL TRIALS ........................................................................................................... Lees het volledige document