Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pitavastatin (pitavastatin calcium)
Recordati Industria Chimica e Farmaceutica S.p.A.
C10AA08
pitavastatin (pitavastatin calcium)
2mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2019-03-25
Recordati Ireland Ltd. Livarzo 2r]rg iiltn-coatcd tablcls tJ l{,'l l/ I 5 5 i;0 l,l)c SLIMMARY OF PRODUCT CHAI{ACTERISTICS I. NAME OF THE MEDICINAL PRODUCT Livazo 2nrg film-coated tabl€ts. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coatetl tablet contai|ls pitavastatin calcium eqLrivalent to 2mg pitavastatin. Excipient(s) include 126.I7mg Lactose rllor'rolrydrate For a full list of excipients see section 6- L. 3, PHARMACEUTICAL FORM Filur-coated tablet. Rorlnd white film-coated tablets enrbossed'l(C' on otre face and'2' on the reverse 4. CLINICALPAITTICULARS 4.1 Therapeuticindications Livazo is inclicated for'the reduction of elevatecl total cholesterol (TC) and I"DL-C. in aduits adolescents and chilciren aged 6 years oI older ivith primary hypercholesterolaemia. including heterozygoLrs familiat hypercholesterolaernia, and cornbined (mixed) dyslipidaenria, when response to diet and other ron-pharntacological measures is inadequate' 4.2 Posology ancl methotl of administration Posol_qgy Paticnts shouLd be on a choleslcrol lowcring diet before trcatnlent. lt is important that all patients coltinue dietary control dulil1g keatment The usual startiirg dose is lmg ollce daily. Adiustmerlt ofdose shoutd be made at intervals of4 weeks or more. Dosesihould be individualized according to ["DL-C levels. the goal of therapy and patient response. The maxirlum claily dose is 4mg. Elderly No dose adjustrnent necessary in patients older tlran ?0 yeals (see 5gq[94-i! and Sectio[j-?l Pacdiatric oopu lation Chiltlren and adole.scents aged 6 yeats .ucl ot'er: Livazo use in childr.en should only be carricd out by physicians experienced ir the lreatrr]etrt ol hyperlipidaenr ia and progress should be regttlatll' reviewed Iu children and adolescents with heterozygous farnilial hypercholesterolaemia tile usttal starting dose ic lnrc nnee rtaitv Adirrsfment ofdose siJuld be nade at intervals of4 weeks or more Doses shottld is Inrg oncc daily. Adjtrstment of dosc be inciividLralized according to LDL-C levels' 9 years ofage the Прочитать полный документ