Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
atorvastatin (atorvastatin calcium)
KRKA d.d.
C10AA05
atorvastatin (atorvastatin calcium)
10mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2016-05-24
1.3.1 Atorvastatin calcium SPC, Labeling and Package Leaflet AM SmPCPIL156614_1 25.09.2020 – Updated: 25.09.2020 Page 1 of 22 1. NAME OF THE MEDICINAL PRODUCT Atoris ® 10 mg film-coated tablets Atoris ® 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg or 20 mg atorvastatin as atorvastatin calcium. Excipient: lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets of 10 mg and 20 mg are white, round and biconvex tablets. 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 Atoris film-coated tablets 10 mg, 20 mg VOL: 1; P: 18 / 51 1.3.1 Atorvastatin calcium SPC, Labeling and Package Leafle Прочитать полный документ