Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FLUVASTATIN SODIUM
Actavis Group PTC ehf
40 Milligram
Capsules Hard
2009-05-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Luvinsta 40 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule of Luvinsta contains 42.12 mg fluvastatin sodium equivalent to 40 mg fluvastatin free acid. Excipients: Luvinsta contains soya lecithin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Capsule cap: orange, opaque marked with white imprint ”40” Capsule body: yellow, opaque marked with brown imprint ”FST” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dyslipidaemia Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Secondary prevention in coronary heart disease Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary intervention (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Dyslipidaemia Prior to initiating with Luvinsta, patients should be placed on a standard cholesterol-lowering diet, which should be continued during treatment. Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished. The recommended dosing range is 20 to 80 mg/day. For patients requiring LDL-C reduction to a goal of < 25% a starting dose of 20 mg may be used as one capsule in the evening. For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening. The dose may be uptitrated to 80 mg daily, administered as a single dose (one fluvastatin prolonged-release tablet) at any time of the day or one 40 mg capsule given twice daily ( Perskaitykite visą dokumentą