Land: Canada
Språk: engelsk
Kilde: Health Canada
ROSIGLITAZONE (ROSIGLITAZONE MALEATE)
PHARMEL INC
A10BG02
ROSIGLITAZONE
8MG
TABLET
ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 8MG
ORAL
100
Prescription
THIAZOLIDINEDIONES
Active ingredient group (AIG) number: 0138802004; AHFS:
CANCELLED PRE MARKET
2017-09-12
PRODUCT MONOGRAPH PR PHL-ROSIGLITAZONE Rosiglitazone (as Rosiglitazone Maleate) 2 mg, 4 mg and 8 mg Tablets Professed Standard Antidiabetic Agent Insulin Resistance Reducing Agent PHARMEL INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 DATE OF PREPARATION: November 25, 2011 _ _ Submission Control No: 120553, 151179_ _ _ _ _ _ _phl-ROSIGLITAZONE Product Monograph_ _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 .......................................................................................................................... 4 ADVERSE REACTIONS ............................................................................................................................................ 9 DRUG INTERACTIONS........................................................................................................................................... 14 DOSAGE AND ADMINISTRATION....................................................................................................................... 16 OVERDOSAGE......................................................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................................... 18 STORAGE AND STABILITY .......................................................................................................... read_full_document