Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Bristol-Myers Squibb Pharmaceuticals Ltd
PRAVASTATIN SODIUM
20 Milligram
Tablets
Withdrawn
2008-04-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin Sodium 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Pravastatin Sodium 20 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, capsule shaped biconvex scored tablet, with a ‘20’ engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERCHOLESTEROLAEMIA Treatment of 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. PRIMARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolaemia and at a high risk of a first cardiovascular event, as an adjunct to diet (see section 5.1). SECONDARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors (see section 5.1). POST TRANSPLANTATION Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation (see sections 4.2, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Prior to initiating PRAVASTATIN, secondary causes of hypercholesterolaemia should be excluded and patients should placed on a standard lipid-lowering diet which should be continued during treatment. PRAVASTATIN is administered orally once daily preferably in the evening with or without food. HYPERCHOLESTEROLAEMIA: the recommended dose range is 10-40mg once daily. The therapeutic response is seen within a week and the full effect of a given dose occurs within four weeks, theref Lue koko asiakirja