{"id":18159,"date":"2014-10-30T19:03:28","date_gmt":"2014-10-30T18:03:28","guid":{"rendered":"http:\/\/www.invarena.cz\/?p=18159"},"modified":"2014-10-30T19:03:28","modified_gmt":"2014-10-30T18:03:28","slug":"z-trhu-se-stahuje-ibuberl-pro-deti-jsou-v-nem-kvasinky","status":"publish","type":"post","link":"https:\/\/www.invarena.cz\/?p=18159","title":{"rendered":"Z trhu se stahuje Ibuberl pro d\u011bti, jsou v n\u011bm kvasinky"},"content":{"rendered":"

St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div (S\u00daKL) stahuje od pacient\u016f v\u0161echny \u0161ar\u017ee suspenze Ibuberl pro d\u011bti 100 mg\/5ml, kter\u00fd se u\u017e\u00edv\u00e1 na sn\u00ed\u017een\u00ed hore\u010dky a tlumen\u00ed bolest\u00ed nap\u0159\u00edklad hlavy, zub\u016f \u010di sval\u016f. Stahuj\u00ed se v\u0161echny \u0161ar\u017ee p\u0159\u00edtomn\u00e9 na trhu, kontrola prok\u00e1zala p\u0159ekro\u010den\u00ed povolen\u00e9ho obsahu kvasinek.<\/strong> <\/p>\n

P\u0159\u00edpravek je ur\u010den k pou\u017eit\u00ed u d\u011bt\u00ed od hmotnosti p\u011bt a\u017e 29 kilogram\u016f, co\u017e odpov\u00edd\u00e1 v\u011bku od \u0161esti m\u011bs\u00edc\u016f do dev\u00edti let.<\/p>\n

„Peror\u00e1ln\u00ed suspenze se stahuje na z\u00e1klad\u011b v\u00fdsledk\u016f kontroly kvality, kter\u00e9 prok\u00e1zaly, \u017ee \u0161ar\u017ee \u010d\u00edslo 21003, 22009 a 23013 nevyhovuj\u00ed po\u017eadavk\u016fm na mikrobiologickou jakost – byla p\u0159ekro\u010dena povolen\u00e1 \u00farove\u0148 obsahu mikroorganism\u016f (kvasinek Yarrowia lipolytica). \u0160ar\u017ee 23015 se stahuje z preventivn\u00edch d\u016fvod\u016f,“ up\u0159esnila mluv\u010d\u00ed \u00fastavu Lucie \u0160ustkov\u00e1.<\/p>\n

Kvasinky Yarrowia lipolytica jsou pou\u017e\u00edv\u00e1ny ve farmaceutick\u00e9m pr\u016fmyslu a v potravin\u00e1\u0159stv\u00ed. Americk\u00fd \u00fa\u0159ad pro potraviny a l\u00e9ky (FDA) je \u0159ad\u00ed do kategorie v\u0161eobecn\u011b bezpe\u010dn\u00fdch, po po\u017eit\u00ed je b\u011b\u017en\u011b rozlo\u017e\u00ed \u017ealude\u010dn\u00ed kyseliny a tr\u00e1vic\u00ed enzymy.<\/p>\n

P\u0159ekro\u010den\u00ed povolen\u00e9 \u00farovn\u011b obsahu kvasinek by podle mluv\u010d\u00ed mohlo znamenat nepravd\u011bpodobn\u00e9, ale p\u0159esto ur\u010dit\u00e9 riziko pro pacienty s velmi z\u00e1va\u017en\u00fdmi onemocn\u011bn\u00edmi, u kter\u00fdch je v\u00e1\u017en\u011b naru\u0161en imunitn\u00ed syst\u00e9m nebo vstupn\u00ed st\u0159evn\u00ed bari\u00e9ra, nap\u0159\u00edklad u pacient\u016f s akutn\u00ed leuk\u00e9mi\u00ed u\u017e\u00edvaj\u00edc\u00edch l\u00e9ky nitro\u017eiln\u00ed cestou nebo u pacient\u016f s akutn\u00edm z\u00e1n\u011btem slinivky b\u0159i\u0161n\u00ed.<\/p>\n

Pacienti, kte\u0159\u00ed maj\u00ed doma tento p\u0159\u00edpravek, by ho m\u011bli p\u0159estat u\u017e\u00edvat a vr\u00e1tit ho v jak\u00e9koli l\u00e9k\u00e1rn\u011b, nejl\u00e9pe v t\u00e9, kde ho zakoupili. Vr\u00e1tit lze i na\u010dat\u00e9 balen\u00ed s platnou dobou pou\u017eitelnosti, a to do 30. listopadu 2014.<\/p>\n

Za p\u0159\u00edpravek s platnou dobou pou\u017eitelnosti, na\u010dat\u00e9 i nena\u010dat\u00e9 balen\u00ed, dostanou pen\u00edze zp\u011bt. P\u0159i p\u0159edlo\u017een\u00ed \u00fa\u010detn\u00edho dokladu o zaplacen\u00ed jim bude vr\u00e1cena uveden\u00e1 \u010d\u00e1stka, bez \u00fa\u010detn\u00edho dokladu 85 korun.<\/p>\n

N\u00e1hradou za stahovan\u00fd l\u00e9\u010div\u00fd p\u0159\u00edpravek lze podat jin\u00fd l\u00e9k se stejnou \u00fa\u010dinnou l\u00e1tkou ibuprofen, radu poskytne l\u00e9ka\u0159 \u010di l\u00e9k\u00e1rn\u00edk.
\nV p\u0159\u00edpad\u011b pot\u00ed\u017e\u00ed doporu\u010duje l\u00e9kov\u00fd \u00fastav obr\u00e1tit se na zastoupen\u00ed dr\u017eitele rozhodnut\u00ed o registraci stahovan\u00e9ho l\u00e9ku v \u010cR, spole\u010dnost Berlin-Chemie\/A.Menarini \u010cesk\u00e1 republika s.r.o.<\/p>\n","protected":false},"excerpt":{"rendered":"

St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div (S\u00daKL) stahuje od pacient\u016f v\u0161echny \u0161ar\u017ee suspenze Ibuberl pro d\u011bti 100 mg\/5ml, kter\u00fd se u\u017e\u00edv\u00e1 na sn\u00ed\u017een\u00ed hore\u010dky a tlumen\u00ed […]<\/a><\/p>\n<\/div>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-18159","post","type-post","status-publish","format-standard","hentry","category-zpravy"],"_links":{"self":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts\/18159","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=18159"}],"version-history":[{"count":0,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts\/18159\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18159"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18159"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18159"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}