{"id":151075,"date":"2019-01-24T20:34:52","date_gmt":"2019-01-24T19:34:52","guid":{"rendered":"http:\/\/zakrasnejsivimperk.cz\/?p=151075"},"modified":"2019-01-24T20:44:18","modified_gmt":"2019-01-24T19:44:18","slug":"aktualne-dulezite-statni-ustav-pro-kontrolu-leciv-informuje-o-stahovani-nosniho-spreje-olynth-ha-01-od-pacientu","status":"publish","type":"post","link":"https:\/\/zakrasnejsivimperk.cz\/?p=151075","title":{"rendered":"AKTU\u00c1LN\u011a – D\u016eLE\u017dIT\u00c9: St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div informuje o stahov\u00e1n\u00ed nosn\u00edho spreje OLYNTH HA 0,1% od pacient\u016f"},"content":{"rendered":"
V\u011bnujte pozornost informaci St\u00e1tn\u00edho \u00fastavu pro kontrolu l\u00e9\u010div o stahov\u00e1n\u00ed\u00a0nosn\u00edho spreje OLYNTH HA 0,1% \u0161ar\u017ee F145560A, F145590A a F145600A od pacient\u016f z\u00a0d\u016fvodu rizika mikrobi\u00e1ln\u00ed kontaminace.<\/h6>\n
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\"\"St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div (S\u00daKL) informuje o stahov\u00e1n\u00ed nosn\u00edho spreje OLYNTH HA 0,1% \u0161ar\u017ee F145560A, F145590A a F145600A od pacient\u016f z\u00a0d\u016fvodu rizika mikrobi\u00e1ln\u00ed kontaminace. L\u00e9k se pou\u017e\u00edv\u00e1 u d\u011bt\u00ed od 7 let v\u011bku a dosp\u011bl\u00fdch ke zm\u00edrn\u011bn\u00ed otoku nosn\u00ed sliznice a tvorby hlenu p\u0159i akutn\u00ed infek\u010dn\u00ed a alergick\u00e9 r\u00fdm\u011b, p\u0159i z\u00e1n\u011btu vedlej\u0161\u00edch nosn\u00edch dutin a Eustachovy trubice. S\u00daKL vyz\u00fdv\u00e1 ve\u0159ejnost, aby stahovan\u00fd p\u0159\u00edpravek nepou\u017e\u00edvala a vr\u00e1tila jej do kter\u00e9koliv l\u00e9k\u00e1rny, p\u0159ednostn\u011b do t\u00e9, ve kter\u00e9 byl zakoupen.<\/strong><\/p>\n

S\u00daKL informuje o podez\u0159en\u00ed na z\u00e1vadu v\u00a0jakosti p\u0159\u00edpravku Olynth HA 0,1% \u0161ar\u017ee F145560A, F145590A a F145600A. Uveden\u00e9 \u0161ar\u017ee jsou stahov\u00e1ny z d\u016fvodu rizika mikrobi\u00e1ln\u00ed kontaminace a je pot\u0159eba vr\u00e1tit balen\u00ed dot\u010den\u00fdch \u0161ar\u017e\u00ed p\u0159\u00edpravku do l\u00e9k\u00e1rny.<\/p>\n

Riziko, \u017ee by mohlo b\u00fdt ohro\u017eeno zdrav\u00ed pacient\u016f, nelze jednozna\u010dn\u011b vylou\u010dit. P\u0159esto\u017ee dr\u017eitel\u00a0rozhodnut\u00ed o registraci k t\u011bmto \u0161ar\u017e\u00edm neeviduje \u017e\u00e1dn\u00e9 ne\u017e\u00e1douc\u00ed \u00fa\u010dinky, p\u0159istoupil ke stahov\u00e1n\u00ed v\u00fd\u0161e uveden\u00fdch \u0161ar\u017e\u00ed a\u017e z \u00farovn\u011b pacient\u016f, aby eliminoval i to nejmen\u0161\u00ed riziko pro pacienta. Dot\u010den\u00e9 \u0161ar\u017ee jsou v \u010cR dostupn\u00e9 od 28. 11. 2018 a dosud nebyla hl\u00e1\u0161ena \u017e\u00e1dn\u00e1 podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek spojen\u00fd s jejich pou\u017eit\u00edm.<\/p>\n<\/div>\n

Jedn\u00e1 se o p\u0159\u00edpravek:<\/strong><\/p>\n\n\n\n\n\n\n
K\u00f3d S\u00daKL<\/strong><\/td>\nN\u00e1zev LP<\/strong><\/td>\nDopln\u011bk n\u00e1zvu<\/strong><\/td>\nVelikost balen\u00ed<\/strong><\/td>\n\u0160ar\u017ee<\/strong><\/td>\nPou\u017eitelnost do<\/strong><\/td>\n<\/tr>\n
0040542<\/td>\nOLYNTH HA 0,1%<\/td>\n1MG\/ML NAS SPR SOL<\/td>\n10 ML<\/td>\nF145560A<\/td>\n09\/2020<\/td>\n<\/tr>\n
0040542<\/td>\nOLYNTH HA 0,1%<\/td>\n1MG\/ML NAS SPR SOL<\/td>\n10 ML<\/td>\nF145590A<\/td>\n09\/2020<\/td>\n<\/tr>\n
0040542<\/td>\nOLYNTH HA 0,1%<\/td>\n1MG\/ML NAS SPR SOL<\/td>\n10 ML<\/td>\nF145600A<\/td>\n09\/2020<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u00a0<\/strong><\/p>\n

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Postup pro ve\u0159ejnost:<\/strong><\/h6>\n
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  1. Zkontrolujte si \u010d\u00edslo \u0161ar\u017ee<\/strong>\u00a0l\u00e9\u010div\u00e9ho p\u0159\u00edpravku\u00a0OLYNTH HA 0,1% nosn\u00ed sprej<\/strong>, kter\u00e9 najdete na vn\u011bj\u0161\u00edm obalu l\u00e9ku. Stahov\u00e1n\u00ed se t\u00fdk\u00e1\u00a0pouze<\/strong>\u00a0\u0161ar\u017e\u00ed \u010d\u00edslo\u00a0F145560A, F145590A a F145600A.<\/strong><\/li>\n
  2. Pokud se \u010d\u00edslo \u0161ar\u017ee shoduje s\u00a0v\u00fd\u0161e uveden\u00fdm,\u00a0p\u0159\u00edpravek nepou\u017e\u00edvejte a vra\u0165te jej v\u00a0l\u00e9k\u00e1rn\u011b, nejl\u00e9pe v\u00a0t\u00e9, ve kter\u00e9 byl zakoupen.<\/li>\n
  3. L\u00e9k\u00e1rna vr\u00e1cen\u00e1 balen\u00ed vym\u011bn\u00ed za nez\u00e1vadnou \u0161ar\u017ei tohoto p\u0159\u00edpravku, nebo pokud nebude m\u00edt k\u00a0dispozici jinou \u0161ar\u017ei, vr\u00e1t\u00ed finan\u010dn\u00ed \u010d\u00e1stku\u00a0105\u00a0K\u010d za jedno balen\u00ed<\/strong>.<\/li>\n
  4. Stahov\u00e1n\u00ed se t\u00fdk\u00e1 na\u010dat\u00fdch i dosud nepou\u017eit\u00fdch balen\u00ed p\u0159\u00edpravku, kter\u00e9 je mo\u017en\u00e9 vracet zp\u011bt do l\u00e9k\u00e1ren\u00a0a\u017e do 30. 4. 2019<\/strong>.<\/li>\n
  5. V p\u0159\u00edpad\u011b v\u00fdskytu ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f po pou\u017e\u00edv\u00e1n\u00ed stahovan\u00fdch \u0161ar\u017e\u00ed tohoto l\u00e9\u010div\u00e9ho p\u0159\u00edpravku doporu\u010dujeme n\u00e1v\u0161t\u011bvu o\u0161et\u0159uj\u00edc\u00edho l\u00e9ka\u0159e. V\u00fdskyt ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f je pot\u0159eba nahl\u00e1sit na adresu:\u00a0dotazy@its.jnj.com<\/strong><\/a><\/span>\u00a0a St\u00e1tn\u00edmu \u00fastavu pro kontrolu l\u00e9\u010div, viz\u00a0http:\/\/www.sukl.cz\/nahlasit-nezadouci-ucinek<\/a>.<\/strong><\/li>\n
  6. V\u00a0p\u0159\u00edpad\u011b dodate\u010dn\u00fdch dotaz\u016f kontaktujte z\u00e1stupce dr\u017eitele rozhodnut\u00ed o registraci na
    \ne-mailov\u00e9 adrese\u00a0    dotazy@its.jnj.com<\/strong><\/a><\/span>\u00a0nebo telefonn\u00edm \u010d\u00edsle 00800 555\u00a0220 00.<\/li>\n<\/ol>\n

    Ot\u00e1zky a odpov\u011bdi pro ve\u0159ejnost:<\/strong><\/p>\n