Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ABBOTT INDONESIA - Indonesia
135 MG
KAPSUL LEPAS TUNDA
DUS, 3 BLISTER @ 10 KAPSUL LEPAS TUNDA
MYLAN LABORATORIES SAS, MAILLARD - France
2019-08-16
TRILIPIX ® CHOLINE FENOFIBRATE 135 MG DELAYED RELEASE CAPSULE 1. NAME OF THE MEDICINAL PRODUCT Trilipix ® 45 mg delayed release capsule Trilipix ® 135 mg delayed release capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delayed release capsule contains choline fenofibrate equivalent to 45 or 135 mg of fenofibric acid. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard, delayed release capsule, with 45 mg and 135 mg choline fenofibrate, respectively. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trilipix ® is indicated for mixed dyslipidemia in addition to lifestyle modification and statin, in patients with high cardiovascular risk dyslipidemia (Frederickson type IIb): Triglyceride ≥ 150 mg/dL (≥1.69 mmol/L), High Density Lipoprotein-C < 40 mg/dL (< 1.02 mmol/L) in males or < 50 mg/dL (< 1.28 mmol/L) in females, and Low Density Lipoprotein-C ≥130 mg/dL (≥ 3.37 mmol/L); obesity (BMI > 25 kg/m 2 ), diabetes mellitus, coronary heart disease) when triglyceride is not adequately controlled. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix ® as co- administered with a statin, and should continue this diet during treatment. Trilipix ® delayed release capsule can be taken without regard to meals. Serum lipids should be monitored periodically. The maximum dose is 135 mg once daily. Adults Co-administration therapy with statins for the treatment of mixed dyslipidemia: Trilipix ® 135 mg may be co-administered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of Trilipix ® may be taken at the same time as a statin, according to the dosing recommendations for each medication. Co-administration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks. Elderly Dose selection for the elderly should be made on the basis of renal function. Leggi il documento completo