Negara: Armenia
Bahasa: Inggris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fenofibrate
Alkaloid AD Skopje
C10AB05
fenofibrate
145mg
tablets
(30/3x10/) in blister
Prescription
Registered
2023-03-10
Ziglip ® 145 mg tablets Summary of Product Characteristics 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ZIGLIP ® 145 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 145 mg fenofibrate (nanoparticles). Excipients with known effect: Lactose anhydrous 444.1 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white biconvex oblong tablets, debossed with “F” on one side and “145” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziglip 145 mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dietary measures initiated before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered. Ziglip ® 145 mg tablets Summary of Product Characteristics 2 _Posology: _ Adults: The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Special populations Elderly patients (≥ 65 years old) No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 (see Patients with renal impairment). Patients with renal impairment: Fenofibrate should not be used if severe renal impairment, defined as eGFR <30 mL/min per 1.73 m 2 , is present. If eGFR is between 30 and 59 mL/min per 1.73 m 2 , the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized on Baca dokumen lengkapnya