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)
4mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2019-03-25
Recofdati Ireland Ltd. I.ivazo 4mg filnr-coated rablels uK/ll/ I 55-5102./DC SUMMARY OF PRODUCT CHARACT IIRISTICS 1. NAMtr OF THE MEDICINAL PRODUCT Livazo 4rng filrrr-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tilm coated tablet contains pitavastatin calcium eqLrivalent to 4mg pitavastatin. Exc jpient(s) include 252.34nrg Lactose monohyd|ate. For a full list ofexcipients see section 6. l. J. PHARMACNUTICAL FORM Film-coated tablet. Round whitc film-coated tablets eirbossed'KC on one face nnd '4'on the reverse. 4. CLINICAL PARTICI-ILAIIS 4,1 Therapeuticirdications Livaz..o is indicated tbl tlre reduction ol' clcvatcd total cholestcrol (TC) and LDL-C, in adu lts, adolescents and children aged 6 years ol older with prirnary hypercho lestero laem ia, including heterozygous farnilial hypercholesterolaemia, and conrbined (mixed) dyslipidaemia, when response to diet and other non-pharnracological measures is inadequate. 4,2 Posology and method of administmtion Posolosv Patients sirould be on a clroleste|ol lowering diet befbre rreatr)ler'rl. lt is irnporlaDl {ha1 all paticnls continue dietary control during fteattnent. 'fhe Lrsual stalling dose is lnrg once daily. Ad.iustrnent oidose should be made a1 intervals ol 4 wecks or more. Doses should be individualized according to LDL-Cl levels, the goal r:rf'therapl and patierrt responsc. Thc maxinum daily dose is 4rng. Elderlv No dose adjustment nccessary in patients older Paediatlic population Expert / Ila Chilrlren arzd atlolesccnts aged 6 years and ,{ppiicent i ilat.e f cnf of Livaz-o use in children should only be hyperlipidaemia and progress should be reguiarly reviewed. ln chilclreu and adolesceuts with heterozygous lanrilial hypercholesletolretrtir lhe usual sLaltrrrB d(\sc is lmgoncedaily. Adjustrnent ofdose shoLild he nradeat intervals o1',1 weeks or tttore. I)oses shoulcl be individualized accordiug to [.DL-C lcvels, the goal oftlrerapy and patient response. In children 6 to 9 years ofage the maxitnutn daily dose is 2mg ln children l0 )'ears ol Прочитать полный документ