Ország: Kanada
Nyelv: angol
Forrás: Health Canada
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
TORRENT PHARMACEUTICALS LIMITED
A10BG03
PIOGLITAZONE
45MG
TABLET
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45MG
ORAL
100
Prescription
THIAZOLIDINEDIONES
Active ingredient group (AIG) number: 0141541003; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2021-12-20
_ _ _ _ _Page 1 of 39_ PRODUCT MONOGRAPH PR TORRENT-PIOGLITAZONE Pioglitazone Tablets USP 15 mg, 30 mg and 45 mg (pioglitazone as pioglitazone hydrochloride) Anti-Diabetic Agent Manufacturer: Torrent Pharmaceuticals Ltd. Indrad – 382 721 Dist. Mehsana India Distributor: Torrent Pharma Canada Inc. Woodbridge, ON L4H 2K4 Submission Control: 163888 Date of Revision: December 04, 2013 _ _ _ _ _Page 2 of 39_ 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 ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................11 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL INFORMATION ..........................................................................20 CLINICAL TRIALS .............................................................................. Olvassa el a teljes dokumentumot