Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
FENOFIBRATE
LABORATOIRES FOURNIER S.A.S.
C10AB05
FENOFIBRATE
100MG
TABLET
FENOFIBRATE 100MG
ORAL
30
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895002; AHFS:
CANCELLED POST MARKET
2014-01-29
1 PRODUCT MONOGRAPH PR LIPIDIL SUPRA ® fenofibrate, microcoated formulation film-coated tablets (160 mg) LIPID METABOLISM REGULATOR Laboratoires Fournier SAS 42 rue Rouget de Lisle 92150 Suresnes, France Distributed by: Fournier Pharma Inc. 8401 Trans-Canada Highway Saint-Laurent, Quebec H4S 1Z1 Date of Preparation: February 28, 2000 Date of Previous Revision: November 13, 2013 Date of Revision: February 5, 2014 Submission Control No.:165706 ® Lipidil Supra: Registered Trademark Fournier Industrie et Santé Suresnes France; Licensed use by Fournier Pharma Inc., Saint-Laurent, Quebec, H4S 1Z1 2 PRODUCT MONOGRAPH PR LIPIDIL SUPRA ® fenofibrate, microcoated formulation THERAPEUTIC CLASSIFICATION Lipid Metabolism Regulator ACTIONS AND CLINICAL PHARMACOLOGY LIPIDIL SUPRA ® (fenofibrate, microcoated formulation) lowers elevated serum lipids by decreasing the low density lipoprotein (LDL) fraction rich in cholesterol and the very low density lipoprotein (VLDL) fraction rich in triglycerides. In addition, fenofibrate increases the high density lipoprotein (HDL) cholesterol fraction. Fenofibrate appears to have a greater depressant effect on the VLDL than on the low density lipoproteins (LDL). Therapeutic doses of fenofibrate produce elevations of HDL cholesterol, a reduction in the content of the low density lipoproteins cholesterol, and a substantial reduction in the triglyceride content of VLDL. Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated by the activation of a specific nuclear receptor called peroxisome proliferator activated receptor alpha (PPAR α ), which produces: • a reduction in apo C-III, and therefore a reduction in the level of dense atherogenic LDL particles; • a stimulation of mitochondrial beta-oxidation, and therefore a reduction in triglyceride secretion; • a rise in lipoprotein lipase production, and therefore an acceleration of triglyceride rich lipoprotein breakdown; • a rise in apo A-I and apo A-II production. Metabolism and Excret Perskaitykite visą dokumentą