Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
ROSUVASTATIN
G & A Licensing Limited
10 Milligram
Film Coated Tablet
2012-01-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Crestor 10mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Contains lactose monohydrate. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets _Product imported from Romania:_ Round, biconvex, pink coloured tablets, engraved with ‘ZD4522’ and ‘10’ on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF HYPERCHOLESTEROLAEMIA Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. PREVENTION OF CARDIOVASCULAR EVENTS Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines. Crestor may be given at any time of day, with or without food. TREATMENT OF HYPERCHOLESTEROLAEMIA The recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reduc Lees het volledige document