{"id":5918,"date":"2026-02-27T06:05:09","date_gmt":"2026-02-27T06:05:09","guid":{"rendered":"https:\/\/www.europesays.com\/sk\/5918\/"},"modified":"2026-02-27T06:05:09","modified_gmt":"2026-02-27T06:05:09","slug":"sukl-stiahol-dolezity-liek-ma-vazny-kvalitativny-nedostatok","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/sk\/5918\/","title":{"rendered":"\u0160\u00daKL stiahol d\u00f4le\u017eit\u00fd liek. M\u00e1 v\u00e1\u017eny kvalitat\u00edvny nedostatok"},"content":{"rendered":"

\u010cL\u00c1NOK POKRA\u010cUJE POD REKLAMOU<\/p>\n

\u0160t\u00e1tny \u00fastav pre kontrolu lie\u010div<\/a> (\u0160\u00daKL) informuje o stiahnut\u00ed lieku<\/a> Urog*afin 76 %, sol inj 10\u00d720 ml (\u0160\u00daKL k\u00f3d 25162) z trhu. Opatrenie sa t\u00fdka v\u0161etk\u00fdch \u0161ar\u017e\u00ed.<\/p>\n

Pod\u013ea zverejnenej inform\u00e1cie sa s\u0165ahovanie realizuje z \u00farovne distribu\u010dn\u00fdch spolo\u010dnost\u00ed, lek\u00e1rn\u00ed aj zdravotn\u00edckych zariaden\u00ed. Ide teda o plo\u0161n\u00e9 opatrenie naprie\u010d dod\u00e1vate\u013esk\u00fdm re\u0165azcom.<\/p>\n

D\u00f4vodom je kvalitat\u00edvny nedostatok<\/p>\n

\u0160\u00daKL uv\u00e1dza, \u017ee d\u00f4vodom stiahnutia v\u0161etk\u00fdch \u0161ar\u017e\u00ed je zisten\u00fd nedostatok v kvalite lieku. Konkr\u00e9tne ide o pr\u00edtomnos\u0165 nitrozoam\u00ednovej ne\u010distoty v \u00fa\u010dinnej l\u00e1tke nad povolen\u00fd limit. Ako p\u00ed\u0161e port\u00e1l Regi\u00f3ny.sk<\/a>, ne\u010distoty nitrozoam\u00ednu vyvol\u00e1vaj\u00fa obavy. Je toti\u017e pravdepodobn\u00e9, \u017ee u \u013eud\u00ed sp\u00f4sobuje rakovinu. \u00a0<\/p>\n

Regul\u00e1tor z\u00e1rove\u0148 zd\u00f4raz\u0148uje, \u017ee stiahnutie m\u00e1 prevent\u00edvny charakter v z\u00e1ujme ochrany bezpe\u010dnosti a zdravia pacientov. Opatrenie tak prich\u00e1dza ako prevent\u00edvny krok po zisten\u00ed prekro\u010denia stanoven\u00fdch limitov.<\/p>\n

\"lek\u00e1r\"\"lek\u00e1r\"zdroj: Ilustra\u010dn\u00e1 fotka\/FreepikNa \u010do sa Urog*afin 76 % pou\u017e\u00edval<\/p>\n

Uro*rafin 76 % injek\u010dn\u00fd roztok patr\u00ed medzi diagnostik\u00e1 \u2013 konkr\u00e9tne medzi kontrastn\u00e9 l\u00e1tky pou\u017e\u00edvan\u00e9 v r\u00e1diol\u00f3gii. Ide o liek ur\u010den\u00fd v\u00fdlu\u010dne na diagnostick\u00e9 \u00fa\u010dely.<\/p>\n

\u201e\u00da\u010dinn\u00fdmi zlo\u017ekami lieku s\u00fa soli kyseliny amidotrizoovej (diatrizoovej), ktor\u00e9 obsahuj\u00fa j\u00f3d viazan\u00fd stabilnou chemickou v\u00e4zbou, umo\u017e\u0148uj\u00faci zobrazenie telesn\u00fdch \u0161trukt\u00far pomocou r\u00f6ntgenov\u00e9ho \u017eiarenia,\u201c p\u00ed\u0161e \u0160\u00daKL. Pr\u00e1ve v\u010faka tejto vlastnosti sa l\u00e1tka vyu\u017e\u00edva pri r\u00f4znych zobrazovac\u00edch vy\u0161etreniach. Liek je ur\u010den\u00fd pre dospel\u00fdch aj deti v ka\u017edom veku.<\/p>\n

Pod\u013ea port\u00e1lu ADC sa Urog*afin pou\u017e\u00edva<\/a> na vn\u00fatro\u017eilov\u00fa a retrogr\u00e1dnu urografiu, \u010di\u017ee r\u00f6ntgenov\u00e9 vy\u0161etrenie mo\u010dov\u00fdch ciest po podan\u00ed kontrastnej l\u00e1tky do \u017eily alebo cez mo\u010dov\u00fa r\u00faru.<\/p>\n

Vyu\u017eitie lieku<\/p>\n

Urogr*fin 76 % sa pou\u017e\u00edva najm\u00e4 pri:<\/p>\n

intraven\u00f3znej a retrogr\u00e1dnej urografii,
\nangiografick\u00fdch vy\u0161etreniach,
\nartrografii,
\nintraopera\u010dnej cholangiografii,
\nendoskopickej retrogr\u00e1dnej cholangiopankreatografii (ERCP),
\nsialografii,
\nfistulografii,
\nhysterosalpingografii.<\/p>\n

Vo v\u0161etk\u00fdch pr\u00edpadoch ide o zobrazovacie met\u00f3dy, pri ktor\u00fdch je potrebn\u00e9 zv\u00fdrazni\u0165 konkr\u00e9tne \u0161trukt\u00fary v tele pacienta pomocou kontrastnej l\u00e1tky.<\/p>\n

Kto liek u\u017e\u00edva\u0165 nemohol<\/p>\n

V pr\u00edbalovom let\u00e1ku sa p\u00ed\u0161e, \u017ee \u013eudia alergick\u00ed na amidotrizo\u00e1t sodn\u00fd alebo meglum\u00ednium-amidotrizo\u00e1t alebo na ktor\u00fako\u013evek z \u010fal\u0161\u00edch zlo\u017eiek tohto lieku ho u\u017ei\u0165 nem\u00f4\u017eu.\u00a0<\/p>\n

Urog*afin sa vyslovene nesmel pou\u017e\u00edva\u0165 na:<\/p>\n

myelografiu (r\u00f6ntgenov\u00e9 vy\u0161etrenie miechy po podan\u00ed kontrastnej l\u00e1tky),
\nventrikulografiu (r\u00f6ntgenov\u00e9 vy\u0161etrenie srdcov\u00fdch alebo mozgov\u00fdch kom\u00f4r po podan\u00ed kontrastnej l\u00e1tky),
\ncisternografiu (r\u00f6ntgenov\u00e9 vy\u0161etrenie likvorov\u00fdch priestorov v centr\u00e1lnom nervovom syst\u00e9me po podan\u00ed kontrastnej l\u00e1tky).<\/p>\n

Pri t\u00fdchto vy\u0161etreniach m\u00f4\u017ee toti\u017e vyvola\u0165 neurotoxick\u00e9 prejavy ako bolesti, k\u0155\u010de, k\u00f3mu, \u010dasto kon\u010diacu smr\u0165ou.<\/p>\n

Diagnostika pacientov ohrozen\u00e1 nie je<\/p>\n

\u0160\u00daKL z\u00e1rove\u0148 informuje, \u017ee dostupnos\u0165 diagnostiky na Slovensku nebude t\u00fdmto krokom ohrozen\u00e1. Na trhu s\u00fa toti\u017e dostupn\u00e9 in\u00e9 kontrastn\u00e9 l\u00e1tky, ktor\u00e9 m\u00f4\u017eu by\u0165 pou\u017eit\u00e9 ako alternat\u00edva.<\/p>\n

Rozhodnutie o tom, ak\u00fa kontrastn\u00fa l\u00e1tku pou\u017ei\u0165, je v kompetencii zodpovedn\u00e9ho lek\u00e1ra alebo r\u00e1diol\u00f3ga. Ten vyber\u00e1 vhodn\u00fd pr\u00edpravok na z\u00e1klade konkr\u00e9tneho vy\u0161etrenia a zdravotn\u00e9ho stavu pacienta.<\/p>\n

\u010co to znamen\u00e1 v praxi<\/p>\n

Stiahnutie sa t\u00fdka v\u0161etk\u00fdch \u0161ar\u017e\u00ed lieku Ur*grafin 76 %, sol inj 10\u00d720 ml s k\u00f3dom 25162. Ke\u010f\u017ee opatrenie prebieha na \u00farovni distribu\u010dn\u00fdch spolo\u010dnost\u00ed, lek\u00e1rn\u00ed a zdravotn\u00edckych zariaden\u00ed, liek by sa u\u017e nemal \u010falej pou\u017e\u00edva\u0165 ani vyd\u00e1va\u0165.<\/p>\n

Z poh\u013eadu pacientov je d\u00f4le\u017eit\u00e9 najm\u00e4 to, \u017ee ide o prevent\u00edvne opatrenie a \u017ee existuj\u00fa dostupn\u00e9 alternat\u00edvy. Samotn\u00fd regula\u010dn\u00fd org\u00e1n zd\u00f4raz\u0148uje ochranu bezpe\u010dnosti a zdravia ako hlavn\u00fd d\u00f4vod z\u00e1sahu.<\/p>\n

\u0160\u00daKL ako n\u00e1rodn\u00fd regul\u00e1tor liekov dohliada na kvalitu, bezpe\u010dnos\u0165 a \u00fa\u010dinnos\u0165 liekov na slovenskom trhu. V pr\u00edpade zistenia nedostatkov m\u00f4\u017ee prist\u00fapi\u0165 k obmedzeniam, pozastaveniu alebo \u00fapln\u00e9mu stiahnutiu lieku z trhu.<\/p>\n

V tomto pr\u00edpade ide o reakciu na prekro\u010den\u00fd limit nitrozoam\u00ednovej ne\u010distoty v \u00fa\u010dinnej l\u00e1tke. Tak\u00e9to limity s\u00fa stanoven\u00e9 s cie\u013eom minimalizova\u0165 rizik\u00e1 pre pacientov.<\/p>\n

\n \u010c\u00edtaj viac z kateg\u00f3rie: Hlavn\u00e9 spr\u00e1vy a aktuality<\/a>\n <\/p>\n

\n \u010eakujeme, \u017ee \u010d\u00edta\u0161 Startitup. V pr\u00edpade, \u017ee m\u00e1\u0161 postreh alebo si na\u0161iel v \u010dl\u00e1nku chybu, nap\u00ed\u0161 n\u00e1m na redakcia@startitup.sk<\/a>.\n <\/p>\n

Zdroje: \u0160\u00daKL<\/a>, ADC<\/a>, Regi\u00f3ny.sk<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"\u010cL\u00c1NOK POKRA\u010cUJE POD REKLAMOU \u0160t\u00e1tny \u00fastav pre kontrolu lie\u010div (\u0160\u00daKL) informuje o stiahnut\u00ed lieku Urog*afin 76 %, sol…\n","protected":false},"author":2,"featured_media":5919,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[3500,43,40,44,39,42,45,41,1029,3501,3502],"class_list":{"0":"post-5918","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-slovensko","8":"tag-liek","9":"tag-sk","10":"tag-slovak","11":"tag-slovak-republic","12":"tag-slovakia","13":"tag-slovencina","14":"tag-slovenska-republika","15":"tag-slovensko","16":"tag-sukl","17":"tag-urografin","18":"tag-urografin-76"},"share_on_mastodon":{"url":"","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/posts\/5918","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/comments?post=5918"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/posts\/5918\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/media\/5919"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/media?parent=5918"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/categories?post=5918"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/sk\/wp-json\/wp\/v2\/tags?post=5918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}