{"id":1734,"date":"2022-06-18T19:07:00","date_gmt":"2022-06-18T17:07:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1734"},"modified":"2024-03-23T12:54:11","modified_gmt":"2024-03-23T11:54:11","slug":"1734-2","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/1734-2\/","title":{"rendered":"4: Alfaoktokog (Advate) na profylaxiu a lie\u010dbu krv\u00e1cav\u00fdch stavov sp\u00f4soben\u00fdch vroden\u00fdm nedostatkom faktoru VIII (okrem von Willebrandovej choroby)"},"content":{"rendered":"
    \n
  1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Liek Advate obsahuje \u0161pecifick\u00fa bliekovinu, ktor\u00e1 je biologicky rovnocenn\u00e1 s bielkovinou obsiahnutej v \u013eudskej plazme. Z\u00edskava sa bez pridania zlo\u017eiek \u013eudskej alebo zvieracej plazmy.<\/p>\n\n\n\n

    Liek Advate sa pacientovi pod\u00e1va inf\u00faziou. Je zaraden\u00fd v zozname kategorizovan\u00fdch (hraden\u00fdch zdravotn\u00fdmi pois\u0165ov\u0148ami) liekov v injek\u010dn\u00fdch liekovk\u00e1ch s obsahom 250 IU (IU – medzin\u00e1rodn\u00fdch jednotiek), 500 IU, 1000 IU a 1500 IU.<\/p>\n\n\n\n

    Liek Advate je registrovan\u00fd (uznan\u00fd za vhodn\u00fd na pou\u017eitie) od roku 2004 vo v\u0161etk\u00fdch vekov\u00fdch skupin\u00e1ch na indik\u00e1ciu lie\u010dba a prevencia krv\u00e1cania u pacientov s hemof\u00edliou A.<\/p>\n\n\n\n

      \n
    1. \u010co je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako je z\u00e1sadn\u00e9?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Hemof\u00edlia A je nevylie\u010dite\u013en\u00e1, vroden\u00e1 choroba, ktor\u00e1 m\u00e1 za n\u00e1sledok zhor\u0161en\u00fa zr\u00e1\u017eanlivos\u0165 krvi a pred\u013a\u017een\u00fd \u010das krv\u00e1cania v pr\u00edpade aj drobn\u00e9ho poranenia, pri extrakcii zubov a po oper\u00e1ci\u00e1ch. Jedn\u00e1 sa o genetick\u00fa poruchu, d\u00f4sledkom ktorej je nedostato\u010dn\u00e1 tvorba funk\u010dn\u00e9ho faktora VIII (FVIII). Hemof\u00edlia A, postihuje 1 z 5 000 mu\u017eov. Hemof\u00edlia A postihuje najm\u00e4 mu\u017eov, pod\u013ea prieskumu WFH z roku 2020 bolo zast\u00fapenie mu\u017eov 90 %. Ide o celo\u017eivotn\u00e9 ochorenie, pri ktorom je zvy\u010dajne potrebn\u00e1 lie\u010dba u\u017e od narodenia.<\/p>\n\n\n\n

      Dva z\u00e1kladn\u00e9 pr\u00edstupy k lie\u010dbe hemof\u00edlie A s\u00fa: 1) lie\u010dba on-demand a 2) prevencia. Lie\u010dba on-demand znamen\u00e1 pod\u00e1vanie koncentr\u00e1tov FVIII v reakcii na krv\u00e1canie. Cie\u013eom prevencie je dosiahnu\u0165 a udr\u017ea\u0165 kontinu\u00e1lne hladiny FVIII porovnate\u013en\u00e9 s hladinami u pacientov so stredne \u0165a\u017ekou hemof\u00edliou.<\/p>\n\n\n\n

        \n
      1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

        Dr\u017eite\u013e registr\u00e1cie (spolo\u010dnos\u0165, ktor\u00e1 vlastn\u00ed pr\u00e1va na predaj lieku) \u017eiada o kategorizovanie nov\u00fdch s\u00edl lieku Advate (2000 IU a 3000 IU). Nako\u013eko na Slovensku u\u017e ni\u017e\u0161ie sily s\u00fa kategorizovan\u00e9, neprebehlo \u0161tandardn\u00e9 hodnotenie klinick\u00e9ho pr\u00ednosu, ke\u010f\u017ee dr\u017eite\u013e registr\u00e1cie u\u017e d\u00f4kaz o klinickom pr\u00ednose predkladal pri svojom predo\u0161lom zaraden\u00ed ni\u017e\u0161\u00edch s\u00edl.<\/p>\n\n\n\n

        Nako\u013eko pr\u00edchod nov\u00fdch s\u00edl (2000 IU a 3000 IU) nepredstavuje nov\u00e9 n\u00e1klady pre verejn\u00e9 zdravotn\u00e9 poistenie a zjednodu\u0161uje pod\u00e1vanie lie\u010dby pacientom, ktor\u00ed potrebuj\u00fa d\u00e1vku 2000 IU alebo 3000 IU, NIHO, pod\u013ea \u00a7 3 z\u00e1kona 358\/2021 Z.z, odpor\u00fa\u010da vyhovie\u0165<\/strong> \u017eiadosti dr\u017eite\u013ea registr\u00e1cie o zaradenie lieku Advate v predmetn\u00fdch sil\u00e1ch a v predmetnej indik\u00e1ci\u00ed.<\/p>\n\n\n\n

        <\/p>\n\n\n\n

        <\/p>","protected":false},"excerpt":{"rendered":"

        Nako\u013eko pr\u00edchod nov\u00fdch s\u00edl (2000 IU a 3000 IU) nepredstavuje nov\u00e9 n\u00e1klady pre verejn\u00e9 zdravotn\u00e9 poistenie a zjednodu\u0161uje pod\u00e1vanie lie\u010dby pacientom, ktor\u00ed potrebuj\u00fa d\u00e1vku 2000 IU alebo 3000 IU, NIHO, pod\u013ea \u00a7 3 z\u00e1kona 358\/2021 Z.z, odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti dr\u017eite\u013ea registr\u00e1cie<\/p>","protected":false},"author":3,"featured_media":1735,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[18,19],"class_list":["post-1734","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-advate","tag-alfaoktokog"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1734"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1734\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1735"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1734"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1734"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}