{"id":40,"date":"2025-11-24T08:16:01","date_gmt":"2025-11-24T06:16:01","guid":{"rendered":"https:\/\/www.ipsen.com\/czc\/?page_id=40"},"modified":"2026-02-24T18:03:30","modified_gmt":"2026-02-24T16:03:30","slug":"farmakovigilance","status":"publish","type":"page","link":"https:\/\/www.ipsen.com\/czc\/nase-produkty\/farmakovigilance\/","title":{"rendered":"Farmakovigilance"},"content":{"rendered":"    <section class=\"sub-page-banner bg-img-enabled  banner-no-filter\" style=\"background-image:url(https:\/\/www.ipsen.com\/czc\/wp-content\/uploads\/sites\/23\/2026\/01\/Health-Medicines-300x44-1.jpg)\">\n                <div class=\"container content-sec\">\n            <nav aria-label=\"breadcrumb\">\n            <ol class=\"breadcrumb\">\n                <li class=\"breadcrumb-item\"><a href=\"https:\/\/www.ipsen.com\/czc\">Dom\u016f<\/a><\/li><li class=\"breadcrumb-item active\"><a class=\"link-pointer-events-none\" href=\"#\" aria-current=\"page\">Farmakovigilance<\/a><\/li><\/ol>\n            <\/nav>            <h1 class=\"visible banner-font-color-white\">Farmakovigilance<\/h1>\n            <p class=\"visible banner-font-color-white\">Odd\u011blen\u00ed farmakovigilance spole\u010dnosti Ipsen hraje d\u016fle\u017eitou roli t\u00edm, \u017ee neust\u00e1le hodnot\u00ed pom\u011br mezi p\u0159\u00ednosy a riziky na\u0161ich l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f prost\u0159ednictv\u00edm anal\u00fdzy informac\u00ed z\u00edskan\u00fdch od pacient\u016f a zdravotnick\u00fdch odborn\u00edk\u016f.<\/p>\n        <\/div>\n    <\/section>\n\n\n\n\n    <!--Accordion Cards Start Here-->\n    <section class=\"accordion bg-color-disabled\"  data-according-id=\"1924016075\">\n        <div class=\"container\">\n            <div class=\"row\">\n                <!--Accordion info section-->\n                <div class=\"column-1 col-xl-12 col-md-12 col-sm-12\">\n                    <div class=\"accordian-info\">\n                        <h3 class=\"accordian-heading hidden heading-three\" role=\"heading\" aria-level=\"2\">\n                                                    <\/h3>\n                        <p class=\"accordian-summary hidden\"><\/p>\n                    <\/div>\n                <\/div><!--Accordion info section over here -->\n\n                <div class=\"col-xl-12 col-lg-12 col-md-12 col-sm-12\">\n                    <div class=\"accordion accor-group\" id=\"accordionExample1924016075\">\n                         \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p  role=\"heading\" aria-level=\"3\" class=\"accordion-header accor-head-para\" id=\"expHeading0\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading19240160750\" aria-expanded=\"false\" aria-controls=\"expHeading19240160750\">\n                                                CO JE TO FARMAKOVIGILANCE?                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading19240160750\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading0\" data-bs-parent=\"#accordionExample1924016075\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Farmakovigilance je dohled nad bezpe\u010dnost\u00ed l\u00e9\u010div.<br \/>\nJe to v\u011bdn\u00ed obor, kter\u00fd zahrnuje \u010dinnosti zam\u011b\u0159en\u00e9 na zji\u0161\u0165ov\u00e1n\u00ed, hodnocen\u00ed, porozum\u011bn\u00ed a prevenci ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f l\u00e9\u010div nebo jak\u00fdchkoli jin\u00fdch probl\u00e9m\u016f souvisej\u00edc\u00edch s l\u00e9\u010divy.<br \/>\nJej\u00edm c\u00edlem je zlep\u0161en\u00ed p\u00e9\u010de o pacienty a zaji\u0161t\u011bn\u00ed bezpe\u010dnosti pacient\u016f a ve\u0159ejn\u00e9ho zdrav\u00ed v souvislosti s pou\u017e\u00edv\u00e1n\u00edm l\u00e9\u010div.<br \/>\n<br \/>\nProst\u0159ednictv\u00edm kontinu\u00e1ln\u00edho sb\u011bru a vyhodnocov\u00e1n\u00ed informac\u00ed:<br \/>\n<br \/><\/br><\/p>\n<ul>\n<li>se sleduje bezpe\u010dnostn\u00ed profil l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f<\/li>\n<li>hodnot\u00ed se pom\u011br p\u0159\u00ednos\u016f a rizik<\/li>\n<li>identifikuj\u00ed se nov\u00e9 informace o rizic\u00edch a ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch nebo o zm\u011bn\u00e1ch jejich charakteru<\/li>\n<li>podporuje se bezpe\u010dn\u00e9 a efektivn\u00ed u\u017e\u00edv\u00e1n\u00ed l\u00e9\u010div<\/li>\n<li>poskytuj\u00ed se d\u016fle\u017eit\u00e9 bezpe\u010dnostn\u00ed informace pacient\u016fm i zdravotnick\u00fdm pracovn\u00edk\u016fm<\/li>\n<li>zav\u00e1d\u011bj\u00ed se opat\u0159en\u00ed ke sn\u00ed\u017een\u00ed rizik a sleduje se jejich \u00fa\u010dinnost<\/li>\n<\/ul>\n<p>Farmakovigilance tak p\u0159isp\u00edv\u00e1 k ochran\u011b zdrav\u00ed pacient\u016f i cel\u00e9 ve\u0159ejnosti.<br \/>\n<br \/>\nZ\u00e1kony a p\u0159edpisy v jednotliv\u00fdch zem\u00edch ukl\u00e1daj\u00ed v\u00fdrobc\u016fm l\u00e9\u010div povinnost hl\u00e1sit ne\u017e\u00e1douc\u00ed \u00fa\u010dinky p\u0159\u00edslu\u0161n\u00fdm org\u00e1n\u016fm. St\u00e1tn\u00ed org\u00e1ny pravideln\u011b kontroluj\u00ed v\u00fdrobce l\u00e9\u010div, aby zajistily pln\u011bn\u00ed z\u00e1konn\u00fdch povinnost\u00ed.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p  role=\"heading\" aria-level=\"3\" class=\"accordion-header accor-head-para\" id=\"expHeading1\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading19240160751\" aria-expanded=\"false\" aria-controls=\"expHeading19240160751\">\n                                                JAK\u00c9 TYPY INFORMAC\u00cd SE SHROMA\u017d\u010eUJ\u00cd V R\u00c1MCI FARMAKOVIGILANCE?                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading19240160751\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading1\" data-bs-parent=\"#accordionExample1924016075\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>P\u0159i uveden\u00ed l\u00e9ku na trh jsou informace o jeho bezpe\u010dnosti omezen\u00e9, proto\u017ee klinick\u00e9 studie prob\u00edhaj\u00ed na men\u0161\u00edm po\u010dtu pacient\u016f a za specifick\u00fdch podm\u00ednek.<br \/>\nPodm\u00ednky, za kter\u00fdch jsou pacienti a l\u00e9ky studov\u00e1ny, nemus\u00ed nutn\u011b odpov\u00eddat zp\u016fsobu, kter\u00fdm jsou l\u00e9ky pou\u017e\u00edv\u00e1ny v nemocnic\u00edch \u010di ambulantn\u00ed praxi po uveden\u00ed na trh. N\u011bkter\u00e9 ne\u017e\u00e1douc\u00ed \u00fa\u010dinky se proto mohou projevit a\u017e p\u0159i b\u011b\u017en\u00e9m pou\u017e\u00edv\u00e1n\u00ed u \u0161ir\u0161\u00ed populace. Tak\u00e9 informace ohledn\u011b pou\u017eit\u00ed u t\u011bhotn\u00fdch \u017een, pediatrick\u00e9 a geriatrick\u00e9 populace nebo u jin\u00e9 zvl\u00e1\u0161tn\u00ed populace (nap\u0159. pacienti se sn\u00ed\u017eenou funkc\u00ed jater \u010di ledvin,\u2026) jsou omezen\u00e9, proto je d\u016fle\u017eit\u00e9 je sb\u00edrat.<br \/>\n<br \/>\nFarmakovigilance zaji\u0161\u0165uje dal\u0161\u00ed sledov\u00e1n\u00ed bezpe\u010dnosti l\u00e9k\u016f po jejich uveden\u00ed na trh, aby bylo mo\u017en\u00e9 v\u010das rozpoznat rizika a chr\u00e1nit pacienty.<br \/>\n<br \/>\nShroma\u017e\u010fujeme nejen informace o podez\u0159en\u00edch na ne\u017e\u00e1douc\u00ed \u00fa\u010dinky, ale tak\u00e9 \u00fadaje o dal\u0161\u00edch bezpe\u010dnostn\u011b relevantn\u00edch situac\u00edch (nap\u0159. u\u017eit\u00ed p\u0159\u00edpravku b\u011bhem t\u011bhotenstv\u00ed nebo kojen\u00ed, p\u0159ed\u00e1vkov\u00e1n\u00ed, chyb\u00e1ch v medikaci apod.) a to i v p\u0159\u00edpad\u011b, \u017ee nebyla pozorov\u00e1na ne\u017e\u00e1douc\u00ed reakce.<br \/>\n<br \/>\nMezi informace, kter\u00e9 shroma\u017e\u010fujeme pat\u0159\u00ed:<br \/>\n<br \/><\/br><\/p>\n<ul>\n<li>ne\u017e\u00e1douc\u00ed p\u0159\u00edhody\/\u00fa\u010dinky v\u010detn\u011b podez\u0159en\u00ed (nep\u0159\u00edzniv\u00e9 a nezam\u00fd\u0161len\u00e9 reakce po pod\u00e1n\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku)<\/li>\n<li>pou\u017e\u00edv\u00e1n\u00ed p\u0159\u00edpravku b\u011bhem t\u011bhotenstv\u00ed a kojen\u00ed (v\u010detn\u011b vystaven\u00ed l\u00e9ku prost\u0159ednictv\u00edm otce)<\/li>\n<li>abnorm\u00e1ln\u00ed laboratorn\u00ed hodnoty<\/li>\n<li>chyby v medikaci (v\u010detn\u011b zachycen\u00fdch nebo potenci\u00e1ln\u00edch chyb v medikaci), kter\u00e9 vedly, mohly nebo mohou v\u00e9st k po\u0161kozen\u00ed pacienta, jako nap\u0159\u00edklad chyby v pod\u00e1n\u00ed, p\u0159\u00edprav\u011b, p\u0159edepisov\u00e1n\u00ed, vyd\u00e1v\u00e1n\u00ed nebo skladov\u00e1n\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku<\/li>\n<li>pou\u017eit\u00ed p\u0159\u00edpravku v pediatrick\u00e9 a geriatrick\u00e9 populaci a jin\u00e9 ne\u017e c\u00edlov\u00e9 populaci nebo u zvl\u00e1\u0161tn\u00ed populace (nap\u0159. u pacient\u016f se sn\u00ed\u017eenou funkc\u00ed jater\/ledvin\u2026)<\/li>\n<li>profesn\u00ed expozice (expozice p\u0159\u00edpravku p\u0159i vykon\u00e1v\u00e1n\u00ed povol\u00e1n\u00ed)<\/li>\n<li>p\u0159ed\u00e1vkov\u00e1n\u00ed<\/li>\n<li>nespr\u00e1vn\u00e9 pou\u017eit\u00ed<\/li>\n<li>zneu\u017eit\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku<\/li>\n<li>kvalitativn\u00ed z\u00e1vady p\u0159\u00edpravku a pad\u011bl\u00e1n\u00ed l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f (v\u010detn\u011b potvrzen\u00e9ho u\u017eit\u00ed nebo podez\u0159en\u00ed na u\u017eit\u00ed takov\u00e9hoto p\u0159\u00edpravku)<\/li>\n<li>podez\u0159en\u00ed na p\u0159enos infek\u010dn\u00edho agens prost\u0159ednictv\u00edm p\u0159\u00edpravku<\/li>\n<li>neo\u010dek\u00e1van\u00fd terapeutick\u00fd a klinick\u00fd p\u0159\u00ednos<\/li>\n<li>nedostate\u010dn\u00e1 \u00fa\u010dinnost<\/li>\n<li>zhor\u0161en\u00ed onemocn\u011bn\u00ed po pod\u00e1n\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku<\/li>\n<li>\u00famrt\u00ed, hospitalizace b\u011bhem pou\u017e\u00edv\u00e1n\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku<\/li>\n<li>l\u00e9kov\u00e9 interakce, interakce mezi potravinami a l\u00e9\u010divem<\/li>\n<li>pou\u017eit\u00ed p\u0159\u00edpravku mimo schv\u00e1len\u00e9 podm\u00ednky registrace (mimo schv\u00e1lenou indikaci, mimo schv\u00e1lenou populaci, mimo schv\u00e1len\u00e9 d\u00e1vkovac\u00ed sch\u00e9ma,\u2026)<\/li>\n<\/ul>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p  role=\"heading\" aria-level=\"3\" class=\"accordion-header accor-head-para\" id=\"expHeading2\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading19240160752\" aria-expanded=\"false\" aria-controls=\"expHeading19240160752\">\n                                                D\u016fle\u017eit\u00e9 upozorn\u011bn\u00ed:                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading19240160752\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading2\" data-bs-parent=\"#accordionExample1924016075\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Pokud se b\u011bhem u\u017e\u00edv\u00e1n\u00ed l\u00e9ku ob\u00e1v\u00e1te o sv\u00e9 zdrav\u00ed, v\u017edy se nejprve obra\u0165te na sv\u00e9ho l\u00e9ka\u0159e, l\u00e9k\u00e1rn\u00edka nebo zdravotn\u00ed sestru. V\u017edy si p\u0159e\u010dt\u011bte p\u0159\u00edbalov\u00fd let\u00e1k nebo n\u00e1vod p\u0159ilo\u017een\u00fd k l\u00e9ku. Tyto dokumenty obsahuj\u00ed seznam zn\u00e1m\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f nebo probl\u00e9m\u016f a poskytuj\u00ed rady, jak postupovat. Ne\u017e\u00e1douc\u00ed \u00fa\u010dinky m\u016f\u017eete nahl\u00e1sit sv\u00e9mu l\u00e9ka\u0159i, zdravotn\u00ed sest\u0159e nebo l\u00e9k\u00e1rn\u00edkovi. Podrobnosti o hl\u00e1\u0161en\u00ed najdete v p\u0159\u00edbalov\u00e9m let\u00e1ku nebo n\u00e1vodu p\u0159ilo\u017een\u00e9m k l\u00e9ku.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                <\/div>\n                <\/div> \n            <\/div>\n        <\/div>\n    <\/section>\n    <!--Accordion Cards End Here-->\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":38,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-40","page","type-page","status-publish","hentry","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Farmakovigilance - Czech Republic<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ipsen.com\/czc\/nase-produkty\/farmakovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Farmakovigilance - Czech Republic\" \/>\n<meta property=\"og:url\" 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