Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
FLUVASTATIN
Clonmel Healthcare Ltd
40 Milligram
Capsules Hard
2009-06-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lochol 40 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg of Fluvastatin corresponding to 42.12 mg of Fluvastatin Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Capsule size #1, green cap and white body hard shell capsules without imprints 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 interventions (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults_ Dyslipidaemia Prior to initiating treatment with Lochol, 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 one 40 mg capsule given twice daily (one in the morning and one in the evening). The maximum lipid-lowering effect with a given dose is achieved within 4 weeks. Dose adjustments should be made at intervals Прочитајте комплетан документ