{"id":126,"date":"2020-01-20T14:51:42","date_gmt":"2020-01-20T13:51:42","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=126"},"modified":"2025-11-18T10:52:08","modified_gmt":"2025-11-18T09:52:08","slug":"veterinari-lekari-a-chovatelia","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=126","title":{"rendered":"VETERIN\u00c1RNE LIEKY\u00a0 &#8211;\u00a0 Hl\u00e1senie podozren\u00ed na ne\u017eiaducu\u00a0 udalos\u0165 (NU)"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\"><strong>\u010co je potrebn\u00e9 hl\u00e1si\u0165<\/strong><\/mark><\/h3>\n\n\n\n<p>V&nbsp;zmysle nariadenia 2019\/6 o&nbsp;veterin\u00e1rnych liekoch je potrebn\u00e9 hl\u00e1si\u0165 v\u0161etky ne\u017eiaduce udalosti, u&nbsp;ktor\u00fdch je podozrenie, \u017ee s\u00favisia s&nbsp;pou\u017eit\u00edm dan\u00e9ho lieku (vr\u00e1tane autog\u00e9nnych vakc\u00edn), hlavne ak ide o:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ak\u00fako\u013evek \u0161kodliv\u00fa a nechcen\u00fa reakciu ak\u00e9hoko\u013evek zviera\u0165a na veterin\u00e1rny liek;<\/li>\n\n\n\n<li>ak\u00e9ko\u013evek pozorovanie na nedostato\u010dn\u00fa \u00fa\u010dinnos\u0165 veterin\u00e1rneho lieku po jeho podan\u00ed zviera\u0165u, \u010di u\u017e podanie bolo alebo nebolo vykonan\u00e9 v s\u00falade so s\u00fahrnom charakteristick\u00fdch vlastnost\u00ed lieku resp. p\u00edsomnou inform\u00e1ciou pre pou\u017e\u00edvate\u013ea;<\/li>\n\n\n\n<li>ak\u00e9ko\u013evek pozorovan\u00e9 environment\u00e1lne nehody po podan\u00ed veterin\u00e1rneho lieku zviera\u0165u;<\/li>\n\n\n\n<li>ak\u00fako\u013evek nepriazniv\u00fa reakciu u \u013eud\u00ed vystaven\u00fdch veterin\u00e1rnemu lieku;<\/li>\n\n\n\n<li>ak\u00e9ko\u013evek zistenie farmakologicky \u00fa\u010dinnej l\u00e1tky alebo mark\u00e9ru rez\u00eddua v produkte \u017eivo\u010d\u00ed\u0161neho p\u00f4vodu v mno\u017estve presahuj\u00facom maxim\u00e1lne hladiny rez\u00eddu\u00ed ur\u010den\u00e9 v s\u00falade s nariaden\u00edm (ES) \u010d. 470\/2009 po dodr\u017ean\u00ed stanovenej ochrannej lehoty;<\/li>\n\n\n\n<li>ak\u00e9ko\u013evek podozrenie na prenos infek\u010dn\u00e9ho agensu prostredn\u00edctvom veterin\u00e1rneho lieku;<\/li>\n\n\n\n<li>ak\u00fako\u013evek \u0161kodliv\u00fa a nechcen\u00fa reakciu zviera\u0165a na liek na hum\u00e1nne pou\u017eitie.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\"><strong>Kto a komu m\u00e1 hl\u00e1si\u0165 podozrenie na NU<\/strong><\/mark><\/h3>\n\n\n\n<p>Povinnos\u0165 hl\u00e1si\u0165 NU je nasledovn\u00e1:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Kto m\u00e1 hl\u00e1si\u0165<\/strong><\/td><td><strong>Komu hl\u00e1si\u0165<\/strong><\/td><\/tr><tr><td>Veterin\u00e1rny lek\u00e1r<\/td><td>Bu\u010f dr\u017eite\u013eovi rozhodnutia o registr\u00e1cii alebo \u00da\u0160KVBL (pod\u013ea \u00a7 122 ods.18)*<\/td><\/tr><tr><td>Chovate\u013e zvierat \/Pou\u017e\u00edvate\u013e veterin\u00e1rneho lieku<\/td><td>Prioritne o\u0161etruj\u00facemu veterin\u00e1rnemu lek\u00e1rovi (pod\u013ea \u00a7 102 ods.12)*; v&nbsp;pr\u00edpade potreby m\u00f4\u017ee hl\u00e1si\u0165 priamo na \u00da\u0160KVBL<\/td><\/tr><tr><td>Dr\u017eite\u013e povolenia na v\u00fdrobu veterin\u00e1rneho lieku<\/td><td>\u00da\u0160KVBL (pod\u013ea \u00a7 15 ods.1 p\u00edsm. f) bod 2)*<\/td><\/tr><tr><td>Dr\u017eitelia povolenia na ve\u013ekodistrib\u00faciu liekov&nbsp;<\/td><td>U\u0160KVBL (pod\u013ea \u00a7 18 ods.1 p\u00edsm. j)*<\/td><\/tr><tr><td>Dr\u017eite\u013e povolenia na s\u00fabe\u017en\u00fd obchod<\/td><td>Dr\u017eite\u013eovi rozhodnutia o registr\u00e1cii (\u010dl. 102 ods. 6, p\u00edsm. e) &nbsp;Nariadenia 2019\/6)<\/td><\/tr><tr><td>Dr\u017eite\u013e povolenia na poskytovanie lek\u00e1renskej starostlivosti<\/td><td>\u00da\u0160KVBL (pod\u013ea \u00a7 23 ods.1 p\u00edsm. p)*<\/td><\/tr><tr><td>Dr\u017eite\u013e povolenia na maloobchodn\u00fd predaj&nbsp;<\/td><td>\u00da\u0160KVBL (\u00a7 124a ods.4 p\u00edsm. e)*<\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\">*Z\u00e1kon 362\/2011 Z.z. o&nbsp;liekoch a&nbsp;zdravotn\u00edckych pom\u00f4ckach<\/figcaption><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Ako treba hl\u00e1si\u0165<\/mark><\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>&#8211; dr\u017eite\u013eovi rozhodnutia o&nbsp;registr\u00e1cii<\/strong><\/h4>\n\n\n\n<p>Kontaktn\u00e9 \u00fadaje osoby dr\u017eite\u013ea rozhodnutia o&nbsp;registr\u00e1cii veterin\u00e1rneho lieku zodpovednej za farmakovigilanciu s\u00fa uveden\u00e9 v&nbsp;poslednej \u010dasti p\u00edsomnej inform\u00e1cie pre pou\u017e\u00edvate\u013ea veterin\u00e1rneho lieku<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>&#8211; na \u00da\u0160KVBL<\/strong><\/h4>\n\n\n\n<p>Hl\u00e1senie o&nbsp;podozren\u00ed na NU sa zasiela na formul\u00e1ri (vzor na stiahnutie vi\u010f ni\u017e\u0161ie) a&nbsp;to bu\u010f elektronicky na email <a href=\"mailto:neziaduce_ucinky@uskvbl.sk\">neziaduce_ucinky@uskvbl.sk<\/a> alebo po\u0161tou na adresu:&nbsp; \u00dastav \u0161t\u00e1tnej kontroly veterin\u00e1rnych bioprepar\u00e1tov a lie\u010div Nitra, Biovetsk\u00e1 34, 94901 Nitra, Slovensk\u00e1 republika.<\/p>\n\n\n\n<p>Minim\u00e1lne inform\u00e1cie potrebn\u00e9 k&nbsp;tomu, aby bolo hl\u00e1senie pova\u017eovan\u00e9 za platn\u00e9:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Identifikovan\u00fd prim\u00e1rny zdroj&nbsp; (napr. veterin\u00e1rny lek\u00e1r, lek\u00e1rnik, chovate\u013e);<\/li>\n\n\n\n<li>Podrobnosti&nbsp; o postihnutom zvierati \/\u010dloveku; druh, vek, pohlavie;<\/li>\n\n\n\n<li>Podrobnosti o v\u0161etk\u00fdch liekoch, ktor\u00fdm bolo zviera, \u010dlovek alebo \u017eivotn\u00e9 prostredie vystaven\u00e9 (n\u00e1zov veterin\u00e1rnych liekov,&nbsp; registra\u010dn\u00e9 \u010d\u00edsla) <\/li>\n\n\n\n<li>Podrobnosti oh\u013eadom podozrenia ne ne\u017eiaducu udalos\u0165 ( klinick\u00e9 pr\u00edznaky, popis pr\u00edpadu)<\/li>\n<\/ul>\n\n\n\n<p>Formul\u00e1re na hl\u00e1senie NU<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-7fa09f2f-1e38-424b-8173-b34504f3b195\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f_92b_pre_veterinarov_a_zdravotnikov_na_nu.doc\">F 92b EU formul\u00e1r pre veterin\u00e1rnych lek\u00e1rov a zdravotn\u00edckych pracovn\u00edkov na hl\u00e1senie ne\u017eiaducich \u00fa\u010dinkov<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-91b5ba9a-af63-426c-9097-5c8189b0678e\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/f_92c_pre_chovatelov_na_nu.doc\">F 92c Formul\u00e1r pre chovate\u013eov na hl\u00e1senie ne\u017eiaducich \u00fa\u010dinkov<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p>Agent\u00fara EMA spr\u00edstupnila hl\u00e1senia o&nbsp;podozreniach na ne\u017eiaduce udalosti liekov (\u00fadaje z&nbsp;EVVet) v&nbsp;Eur\u00f3pskej datab\u00e1ze hl\u00e1sen\u00ed o&nbsp;podozreniach na ne\u017eiaduce udalosti liekov pre n\u00e1rodn\u00e9 liekov\u00e9 autority v&nbsp;EHP, Eur\u00f3psku komisiu, pre zdravotn\u00edckych pracovn\u00edkov, chovate\u013eov, spotrebite\u013eov farmaceutick\u00fd priemysel a&nbsp;v\u00fdskumn\u00e9 organiz\u00e1cie<\/p>\n\n\n\n<p><a href=\"https:\/\/www.adrreports.eu\/sk\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">hl\u00e1senia o&nbsp;podozreniach na ne\u017eiaduce udalosti liekov <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u010co je potrebn\u00e9 hl\u00e1si\u0165 V&nbsp;zmysle nariadenia 2019\/6 o&nbsp;veterin\u00e1rnych liekoch je potrebn\u00e9 hl\u00e1si\u0165 v\u0161etky ne\u017eiaduce udalosti, u&nbsp;ktor\u00fdch je podozrenie, \u017ee s\u00favisia s&nbsp;pou\u017eit\u00edm dan\u00e9ho lieku (vr\u00e1tane autog\u00e9nnych vakc\u00edn), hlavne ak ide o: Kto a komu m\u00e1 hl\u00e1si\u0165 podozrenie na NU Povinnos\u0165 hl\u00e1si\u0165 &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=126\">Pokra\u010dova\u0165 v \u010d\u00edtan\u00ed <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-126","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/126","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=126"}],"version-history":[{"count":25,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/126\/revisions"}],"predecessor-version":[{"id":9367,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/126\/revisions\/9367"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}