Kraj: Kanada
Język: angielski
Źródło: Health Canada
FENOFIBRATE
SANDOZ CANADA INCORPORATED
C10AB05
FENOFIBRATE
145.0MG
TABLET
FENOFIBRATE 145.0MG
ORAL
30
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895006; AHFS:
APPROVED
2012-08-02
_Sandoz Fenofibrate E Page 1 of 43_ PRODUCT MONOGRAPH PR SANDOZ FENOFIBRATE E Fenofibrate tablets 48 mg and 145 mg Manufacturer’s standard Lipid Metabolism Regulator Sandoz Canada Inc. Date of Revision: November 17, 2017 145 Jules-Léger Boucherville, QC, Canada J4B 7K8 Submission Control No: 204109 _ _ _Sandoz Fenofibrate E Page 2 of 43_ TABLE OF CONTENTS PART 1: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................9 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................18 STORAGE AND STABILITY ..........................................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................20 PART II: SCIENTIFIC INFORMATION ................................................................................22 PHARMACEUTICAL INFORMATION ..........................................................................22 CLINICAL TRIALS ..........................................................................................................23 DETAILED PHARMACOLOGY ............ Przeczytaj cały dokument