Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
atorvastatin (atorvastatin calcium)
KRKA d.d.
C10AA05
atorvastatin (atorvastatin calcium)
40mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2020-07-04
1.3.1 Atorvastatin calcium SPC, Labeling and Package Leaflet AM SmPCPIL152388_1 03.07.2020 – Updated: 03.07.2020 Page 1 of 22 1. NAME OF THE MEDICINAL PRODUCT Atoris ® 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg atorvastatin as 41.44 mg atorvastatin calcium. Excipient: lactose monohydrate Lactose 189,53 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round, slightly convex. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atoris is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL- cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atoris is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Prevention of cardiovascular events in adult patients 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 Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Atoris and should continue on this diet during treatment with Atoris. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. CONFIDENTIAL MODULE 1 VOL: 1; P: 13 / 41 1.3.1 Atorvastatin calcium SPC, Labeling and Package Leaflet AM SmPCPIL152388_1 03.07.2020 – Updated: 03.07.2020 Page 2 of 22 The usual starting dose is 10 mg once a day Прочитать полный документ