{"id":2515,"date":"2021-06-14T06:39:10","date_gmt":"2021-06-14T04:39:10","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=2515"},"modified":"2021-06-14T06:39:10","modified_gmt":"2021-06-14T04:39:10","slug":"ema-varuje-pred-novymi-vedlejsimi-ucinky-pripravku-astrazeneca","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2021\/06\/14\/ema-varuje-pred-novymi-vedlejsimi-ucinky-pripravku-astrazeneca\/","title":{"rendered":"EMA varuje p\u0159ed nov\u00fdmi vedlej\u0161\u00edmi \u00fa\u010dinky p\u0159\u00edpravku AstraZeneca"},"content":{"rendered":"
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Po p\u0159ezkoum\u00e1n\u00ed bezpe\u010dnosti V\u00fdbor pro farmakovigilan\u010dn\u00ed hodnocen\u00ed rizik (PRAC)\u00a0<\/span>Evropsk\u00e9 agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMA)<\/span><\/strong><\/a>\u00a0doporu\u010dil, aby se vakc\u00edna Vaxzevria COVID-19 spole\u010dnosti AstraZeneca nepou\u017e\u00edvala u lid\u00ed se syndromem \u00faniku kapil\u00e1r.<\/span><\/p>\n

Syndrom kapil\u00e1rn\u00edho \u00faniku se do informa\u010dn\u00edho listu produktu p\u0159id\u00e1v\u00e1 jako nov\u00fd vedlej\u0161\u00ed \u00fa\u010dinek vakc\u00edny s nezn\u00e1mou frekvenc\u00ed, \u201cuv\u00e1d\u00ed EMA.<\/span><\/p>\n

Syndrom kapil\u00e1rn\u00edho \u00faniku je velmi vz\u00e1cn\u00fd, ale z\u00e1va\u017en\u00fd stav, p\u0159i kter\u00e9m z kapil\u00e1r unik\u00e1 tekutina, kter\u00e1 zp\u016fsobuje otoky pa\u017e\u00ed a nohou, n\u00edzk\u00fd krevn\u00ed tlak, zes\u00edlen\u00ed krve a n\u00edzkou hladinu albuminu v krvi.<\/span><\/p>\n

Na sv\u00e9m dubnov\u00e9m zased\u00e1n\u00ed v\u00fdbor PRAC ozn\u00e1mil, \u017ee zahajuje kontrolu bezpe\u010dnostn\u00edho sign\u00e1lu, kter\u00fd m\u00e1 posoudit zpr\u00e1vy o syndromu \u00faniku kapil\u00e1r u lid\u00ed u\u017e\u00edvaj\u00edc\u00edch p\u0159\u00edpravek Vaxzevria, jak uv\u00e1d\u00ed Medscape Medical News.<\/span><\/p>\n

Agentura p\u0159ezkoumala celkem 14 hl\u00e1\u0161en\u00ed syndromu \u00faniku kapil\u00e1r.\u00a0M\u011bla dostatek informac\u00ed k d\u016fkladn\u00e9mu pro\u0161et\u0159en\u00ed \u0161esti p\u0159\u00edpad\u016f syndromu kapil\u00e1rn\u00edho \u00faniku u lid\u00ed, kte\u0159\u00ed dostali vakc\u00ednu.<\/span><\/p>\n

V\u011bt\u0161ina p\u0159\u00edpad\u016f se vyskytla u \u017een a do 4 dn\u016f po o\u010dkov\u00e1n\u00ed.\u00a0T\u0159i z posti\u017een\u00fdch m\u011bli v anamn\u00e9ze syndrom \u00faniku kapil\u00e1r a jeden z nich pozd\u011bji zem\u0159el.<\/span><\/p>\n

K 27. kv\u011btnu 2021 bylo podle agentury EMA v Evropsk\u00e9 unii, Lichten\u0161tejnsku, na Islandu, v Norsku a ve Velk\u00e9 Brit\u00e1nii pod\u00e1no v\u00edce ne\u017e 78 milion\u016f d\u00e1vek vakc\u00edny.<\/span><\/p>\n

Zdravotni\u010dt\u00ed pracovn\u00edci si podle EMA mus\u00ed b\u00fdt v\u011bdomi zn\u00e1mek a p\u0159\u00edznak\u016f syndromu kapil\u00e1rn\u00edho \u00faniku a rizika jeho opakov\u00e1n\u00ed u lid\u00ed, kte\u0159\u00ed ji\u017e tento stav diagnostikovali.<\/span><\/p>\n

Lid\u00e9, kte\u0159\u00ed byli o\u010dkov\u00e1ni vakc\u00ednou Vaxzevria, by m\u011bli b\u00fdt pou\u010deni, aby okam\u017eit\u011b vyhledali l\u00e9ka\u0159e, pokud si v\u0161imnou rychl\u00e9ho otoku pa\u017e\u00ed a nohou nebo n\u00e1hl\u00e9ho p\u0159\u00edr\u016fstku hmotnosti ve dnech n\u00e1sleduj\u00edc\u00edch po o\u010dkov\u00e1n\u00ed.\u00a0Tyto p\u0159\u00edznaky jsou \u010dasto spojeny s mdlobami kv\u016fli n\u00edzk\u00e9mu krevn\u00edmu tlaku.<\/span><\/strong><\/p>\n

\u201ePacienti s akutn\u00ed epizodou syndromu kapil\u00e1rn\u00edho \u00faniku po o\u010dkov\u00e1n\u00ed mus\u00ed b\u00fdt okam\u017eit\u011b l\u00e9\u010deni a mohou vy\u017eadovat pr\u016fb\u011b\u017en\u00e9 sledov\u00e1n\u00ed specialist\u016f a intenzivn\u00ed podp\u016frnou l\u00e9\u010dbu,\u201c uv\u00e1d\u00ed EMA.<\/span><\/p>\n

PRAC bude i nad\u00e1le hledat dal\u0161\u00ed p\u0159\u00edpady syndromu kapil\u00e1rn\u00edho \u00faniku souvisej\u00edc\u00edho s vakc\u00ednou a podle pot\u0159eby podnikne dal\u0161\u00ed kroky, uv\u00e1d\u00ed se ve sd\u011blen\u00ed.<\/span><\/p>\n

V\u00fdbor PRAC rovn\u011b\u017e po\u017e\u00e1dal spole\u010dnost AstraZeneca, aby poskytla informace o mo\u017en\u00e9m mechanismu rozvoje syndromu \u00faniku kapil\u00e1r po o\u010dkov\u00e1n\u00ed.<\/span><\/p>\n

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Po p\u0159ezkoum\u00e1n\u00ed bezpe\u010dnosti V\u00fdbor pro farmakovigilan\u010dn\u00ed hodnocen\u00ed rizik (PRAC)\u00a0Evropsk\u00e9 agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMA)\u00a0doporu\u010dil, aby…<\/p>\n","protected":false},"author":2,"featured_media":856,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[136,23,213,21],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/2515"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=2515"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/2515\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/856"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=2515"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=2515"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=2515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}