{"id":67,"date":"2023-05-03T15:55:34","date_gmt":"2023-05-03T15:55:34","guid":{"rendered":"http:\/\/www.mdx.cz\/?page_id=67"},"modified":"2025-09-24T07:52:36","modified_gmt":"2025-09-24T07:52:36","slug":"vpois","status":"publish","type":"page","link":"https:\/\/www.mdx.cz\/?page_id=67","title":{"rendered":"VPOIS"},"content":{"rendered":"\n

Ve\u0159ejn\u011b p\u0159\u00edstupn\u00e1 odborn\u00e1 informa\u010dn\u00ed slu\u017eba (VPOIS)<\/strong><\/p>\n\n\n\n

Aktu\u00e1ln\u00ed informace o p\u0159\u00edpravc\u00edch distribuovan\u00fdch spole\u010dnost\u00ed Medindex, spol. s r.o. najdete na str\u00e1nk\u00e1ch St\u00e1tn\u00edho \u00fastavu pro kontrolu l\u00e9\u010div<\/a><\/p>\n\n\n\n

Odborn\u00edk\u016fm ve zdravotnictv\u00ed jsou ur\u010deny informace ze souhrnu informac\u00ed o p\u0159\u00edpravku (SPC) a laick\u00e9 ve\u0159ejnosti informace z p\u0159\u00edbalov\u00e9 informace (PIL).<\/p>\n\n\n\n

P\u0159\u00edpravky, kter\u00e9 maj\u00ed stanovenu \u00fahradu ze zdravotn\u00edho poji\u0161t\u011bn\u00ed jsou barevn\u011b ozna\u010deny a maj\u00ed symbol \u2013 \u017elut\u00e9 mince.<\/p>\n\n\n\n

P\u0159\u00edpravky s aktivn\u00edm v\u00fdskytem na \u010desk\u00e9m trhu dle pravideln\u00e9ho hl\u00e1\u0161en\u00ed dod\u00e1vek distributor\u016f v obdob\u00ed p\u0159edchoz\u00edch t\u0159\u00ed m\u011bs\u00edc\u016f (s m\u011bs\u00ed\u010dn\u00edm odstupem) jsou uvedeny tu\u010dn\u011b a ozna\u010deny symbolem \u2013 zelen\u00e1 fajfka.<\/p>\n\n\n\n

V p\u0159\u00edpad\u011b dotaz\u016f na konkr\u00e9tn\u00ed p\u0159\u00edpravek distribuovan\u00fd spole\u010dnost\u00ed Medindex, spol. s r.o. n\u00e1s kontaktujte na adrese medindex@mdx.cz<\/a> nebo na tel.: + 420 777 785 228<\/a><\/p>\n\n\n\n

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\u2022 Nitro POHL 1MG\/ML INF SOL 10x10ML SUKL k\u00f3d: 0004307 ( 1.10.2018- za\u010d\u00e1tek distribuce spole\u010dnost\u00ed Medindex)<\/p>\n\n\n\n

\u2022 Trachisan 8mg pastilky proti bolesti v krku (od 1.12.2017 ukon\u010dena distribuce spole\u010dnost\u00ed Medindex)<\/p>\n\n\n\n

\u2022 PROSPAN Sirup 7mg\/ml (od 1.12.2017 ukon\u010dena distribuce spole\u010dnost\u00ed Medindex)<\/p>\n\n\n\n

\u2022 PK-Merz, potahovan\u00e9 tablety (od 1.1.2018 ukon\u010dena distribuce spole\u010dnost\u00ed Medindex)<\/p>\n\n\n\n

\u2022 PK-Merz Infusion Inf\u00fazn\u00ed roztok (od 1.1.2018 ukon\u010dena distribuce spole\u010dnost\u00ed Medindex)<\/p>\n\n\n\n

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\u2022 Viru-Merz od 1.9.2015 ukon\u010den\u00ed distribuce spole\u010dnost\u00ed Medindex.<\/p>\n\n\n\n

HL\u00c1\u0160EN\u00cd PODEZ\u0158EN\u00cd NA NE\u017d\u00c1DOUC\u00cd \u00da\u010cINKY L\u00c9\u010cIV\u00c9HO P\u0158\u00cdPRAVKU<\/strong><\/p>\n\n\n\n

KDO HL\u00c1S\u00cd? Nejd\u016fle\u017eit\u011bj\u0161\u00edm zdrojem informac\u00ed o l\u00e9\u010div\u00e9m p\u0159\u00edpravku po jeho uveden\u00ed na trh jsou zdravotni\u010dt\u00ed pracovn\u00edci a pacienti. Povinnost nahl\u00e1sit S\u00daKL z\u00e1va\u017en\u00fd nebo neo\u010dek\u00e1van\u00fd ne\u017e\u00e1douc\u00ed \u00fa\u010dinek danou z\u00e1konem o l\u00e9\u010divech maj\u00ed krom\u011b zdravotnick\u00fdch pracovn\u00edk\u016f (l\u00e9ka\u0159\u016f, l\u00e9k\u00e1rn\u00edk\u016f, zdravotn\u00edch sester atd.) tak\u00e9 dr\u017eitel\u00e9 rozhodnut\u00ed o registraci a dal\u0161\u00ed provozovatel\u00e9.<\/p>\n\n\n\n

CO HL\u00c1SIT? Pros\u00edme V\u00e1s o hl\u00e1\u0161en\u00ed jak\u00e9hokoliv podez\u0159en\u00ed na z\u00e1va\u017en\u00fd nebo neo\u010dek\u00e1van\u00fd ne\u017e\u00e1douc\u00ed \u00fa\u010dinek l\u00e9\u010div\u00e9ho p\u0159\u00edpravku ODKAZ<\/a>. Pros\u00edme, hlaste i zneu\u017eit\u00ed nebo nespr\u00e1vn\u00e9 pou\u017eit\u00ed l\u00e9\u010div\u00e9ho p\u0159\u00edpravku, p\u0159ed\u00e1vkov\u00e1n\u00ed, nebo m\u00e1te-li podez\u0159en\u00ed na l\u00e9kovou interakci, teratogenn\u00ed efekt nebo ne\u00fa\u010dinnost p\u0159\u00edpravku.<\/p>\n\n\n\n

JAK HL\u00c1SIT? Nahl\u00e1sit podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek l\u00e9\u010div\u00e9ho p\u0159\u00edpravku je mo\u017en\u00e9 n\u011bkolika zp\u016fsoby. Nejl\u00e9pe vypln\u011bn\u00edm elektronick\u00e9ho formul\u00e1\u0159e pro hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edho \u00fa\u010dinku, d\u00e1le je mo\u017en\u00e9 pou\u017e\u00edt formul\u00e1\u0159e ve form\u00e1tu PDF, zaslat e-mail s popisem ne\u017e\u00e1douc\u00edho \u00fa\u010dinku, p\u0159\u00edpadn\u011b jej nahl\u00e1sit telefonicky (e-mailov\u00fd kontakt i telefon uvedeny n\u00ed\u017ee).<\/p>\n\n\n\n

Formul\u00e1\u0159 pro hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edho \u00fa\u010dinku naleznete na www.sukl.cz. Po vypln\u011bn\u00ed je formul\u00e1\u0159 automaticky p\u0159ed\u00e1n na Odd\u011blen\u00ed farmakovigilance. Pokud se V\u00e1m elektronick\u00fd formul\u00e1\u0159 neotev\u0159e, p\u0159ekontrolujte pros\u00edm nastaven\u00ed Va\u0161eho po\u010d\u00edta\u010de ODKAZ<\/a>.<\/p>\n\n\n\n

St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div zpracuje poskytnut\u00e9 \u00fadaje za \u00fa\u010delem evidence a zpracov\u00e1n\u00ed hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f, a to na z\u00e1klad\u011b \u00a7 93a a 93b z\u00e1kona \u010d. 378\/2007 Sb., o l\u00e9\u010divech. Osobn\u00ed \u00fadaje nejsou ukl\u00e1d\u00e1ny dlouhodob\u011b a bezprost\u0159edn\u011b po p\u0159ijet\u00ed hl\u00e1\u0161en\u00ed jsou anonymizov\u00e1ny. Bli\u017e\u0161\u00ed informace o zpracov\u00e1n\u00ed osobn\u00edch \u00fadaj\u016f, zejm\u00e9na o va\u0161ich pr\u00e1vech, jako je pr\u00e1vo na p\u0159\u00edstup, najdete na webu www.sukl.gov.cz<\/a> v sekci Ochrana osobn\u00edch \u00fadaj\u016f nebo si je m\u016f\u017eete vy\u017e\u00e1dat na adrese S\u00daKL, \u0160rob\u00e1rova 48, 100 41 Praha 10.<\/p>\n\n\n\n

KAM HL\u00c1SIT? Adresa pro zasl\u00e1n\u00ed ti\u0161t\u011bn\u00e9ho formul\u00e1\u0159e:<\/p>\n\n\n\n

e-mailov\u00e1 adresa: farmakovigilance@sukl.gov.cz<\/a><\/p>\n\n\n\n

po\u0161tovn\u00ed adresa: St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div Odd\u011blen\u00ed farmakovigilance \u0160rob\u00e1rova 48 100 41 Praha<\/p>\n\n\n\n

V p\u0159\u00edpad\u011b dotaz\u016f n\u00e1s kontaktujte na:<\/p>\n\n\n\n

e-mailov\u00e1 adresa: farmakovigilance@sukl.gov.cz<\/a><\/p>\n\n\n\n

telefon – sekretari\u00e1t Odd\u011blen\u00ed farmakovigilance: 272 185 322<\/a>, 272 185 274<\/a><\/p>\n\n\n\n

PRO\u010c HL\u00c1SIT? Hl\u00e1sit je t\u0159eba i podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek, proto\u017ee rozhodnout, zda existuje kauz\u00e1ln\u00ed vztah mezi ne\u017e\u00e1douc\u00edm \u00fa\u010dinkem a pod\u00e1n\u00edm l\u00e9\u010div\u00e9ho p\u0159\u00edpravku je v mnoha p\u0159\u00edpadech (s ohledem na konkomitantn\u00ed terapii, pr\u016fb\u011bh onemocn\u011bn\u00ed, sou\u010dasn\u011b prob\u00edhaj\u00edc\u00ed onemocn\u011bn\u00ed atd.) velmi obt\u00ed\u017en\u00e9. Je mo\u017en\u00e9, \u017ee se se stejnou reakc\u00ed setkali i jin\u00ed zdravotni\u010dt\u00ed pracovn\u00edci a poslali hl\u00e1\u0161en\u00ed, a pr\u00e1v\u011b kumulace po\u010d\u00e1te\u010dn\u00edch \u201epodez\u0159en\u00ed\u201c d\u00e1v\u00e1 v \u010dase vzniknout farmakovigilan\u010dn\u00edmu sign\u00e1lu.<\/p>\n\n\n\n

Pokud dal\u0161\u00ed ov\u011b\u0159en\u00ed farmakovigilan\u010dn\u00edho sign\u00e1lu uk\u00e1\u017ee, \u017ee byl objeven mo\u017en\u00fd nov\u00fd ne\u017e\u00e1douc\u00ed \u00fa\u010dinek l\u00e9\u010div\u00e9ho p\u0159\u00edpravku nebo \u017ee zn\u00e1m\u00fd ne\u017e\u00e1douc\u00ed \u00fa\u010dinek je z\u00e1va\u017en\u011bj\u0161\u00ed \u010di \u010dast\u011bj\u0161\u00ed ne\u017e bylo dosud zn\u00e1mo, jsou aktualizov\u00e1ny texty doprov\u00e1zej\u00edc\u00ed p\u0159\u00edpravek (SPC a p\u0159\u00edbalov\u00e1 informace). Aktualizovan\u00e9 texty jsou dostupn\u00e9 v datab\u00e1zi l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f. Nejv\u00fdznamn\u011bj\u0161\u00ed bezpe\u010dnostn\u00ed informace jsou tak\u00e9 uvedeny v informa\u010dn\u00edm zpravodaji S\u00daKL „Ne\u017e\u00e1douc\u00ed \u00fa\u010dinky l\u00e9\u010div“.<\/p>\n\n\n\n

V\u00edce informac\u00ed o farmakovigilanci naleznete ODKAZ<\/a>.<\/p>\n\n\n\n

Pros\u00edme, hlaste v\u0161echno, co pova\u017eujete za neobvykl\u00e9 nebo odli\u0161n\u00e9. P\u0159i hl\u00e1\u0161en\u00ed podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinek nemus\u00edte b\u00fdt p\u0159esv\u011bd\u010deni o tom, \u017ee ne\u017e\u00e1douc\u00ed \u00fa\u010dinek byl zp\u016fsoben l\u00e9kem.<\/p>\n\n\n\n

Pokud budete hl\u00e1sit podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinky l\u00e9ku, pros\u00edm informujte n\u00e1s o tom (viz kontakty).<\/p>\n\n\n\n

Distribuci l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f s p\u0159\u00edznakem „omezen\u00e1 dostupnost“<\/strong> zaji\u0161\u0165uj\u00ed pro dr\u017eitele rozhodnut\u00ed o registraci spole\u010dnosti: Phoenix l\u00e9k\u00e1rensk\u00fd velkoobchod, s.r.o., Alliance Healthcare s.r.o., ViaPharma spol. s.r.o., Movianto \u010cesk\u00e1 republika s.r.o., PHARMOS, a.s. a Pharmawell a.s.<\/p>\n\n\n\n

Z\u00e1vady v\u00a0jakosti \u2013 nep\u0159etr\u017eit\u00e1 slu\u017eba pro hl\u00e1\u0161en\u00ed z\u00e1vad mimo pracovn\u00ed dobu<\/strong>*<\/p>\n\n\n\n

Pond\u011bl\u00ed a\u017e p\u00e1tek 16:30 \u2013 8:00, o v\u00edkendech nep\u0159etr\u017eit\u011b
tel.: 272 185 777<\/a>
e-mail: zavady@sukl.gov.cz<\/a><\/p>\n\n\n\n

Hl\u00e1\u0161en\u00ed podez\u0159en\u00ed na z\u00e1va\u017enou ne\u017e\u00e1douc\u00ed p\u0159\u00edhodu pacientem<\/strong><\/p>\n\n\n\n

Hl\u00e1\u0161en\u00ed jsou nejd\u016fle\u017eit\u011bj\u0161\u00edm zdrojem informac\u00ed o\u00a0zdravotnick\u00fdch prost\u0159edc\u00edch po\u00a0jejich dod\u00e1n\u00ed na trh. Na z\u00e1klad\u011b t\u011bchto hl\u00e1\u0161en\u00ed lze odstranit nedostatky v\u00a0souvislosti s\u00a0n\u00e1vrhem, v\u00fdrobou nebo jejich pou\u017e\u00edv\u00e1n\u00edm a\u00a0t\u00edm minimalizovat opakov\u00e1n\u00ed z\u00e1va\u017en\u00fdch ne\u017e\u00e1douc\u00edch p\u0159\u00edhod. Dal\u0161\u00ed informace najdete na: Hl\u00e1\u0161en\u00ed podez\u0159en\u00ed na z\u00e1va\u017enou ne\u017e\u00e1douc\u00ed p\u0159\u00edhodu pacientem \u2013 S\u00daKL<\/a><\/p>\n\n\n\n

Zdravotnick\u00e9 prost\u0159edky \u2013 nep\u0159etr\u017eit\u00e1 slu\u017eba pro vigilan\u010dn\u00ed hl\u00e1\u0161en\u00ed mimo pracovn\u00ed dobu<\/strong>*
Pond\u011bl\u00ed a\u017e p\u00e1tek 16:30\u00a0\u2013 8:00, o\u00a0v\u00edkendech nep\u0159etr\u017eit\u011b
tel.:\u00a0272\u00a0185\u00a0999<\/a>
e-mail:\u00a0urgent@sukl.gov.cz<\/a><\/p>\n\n\n\n

*Nep\u0159etr\u017eit\u00e1 slu\u017eba zaji\u0161\u0165uje, aby v S\u00daKL byly neprodlen\u011b \u0159e\u0161eny krizov\u00e9 situace, kter\u00e9 nastanou zejm\u00e9na v d\u016fsledku zji\u0161t\u011bn\u00ed z\u00e1vad v jakosti l\u00e9\u010div a v d\u016fsledku ohl\u00e1\u0161en\u00fdch z\u00e1va\u017en\u00fdch ne\u017e\u00e1douc\u00edch p\u0159\u00edhod zdravotnick\u00fdch prost\u0159edk\u016f a diagnostick\u00fdch zdravotnick\u00fdch prost\u0159edk\u016f in vitro, p\u0159\u00edpadn\u011b podez\u0159en\u00ed na n\u011b, kter\u00e9 mohou ohrozit \u017eivot nebo zp\u016fsobit z\u00e1va\u017en\u00e9 ohro\u017een\u00ed ve\u0159ejn\u00e9ho zdrav\u00ed.<\/p>\n\n\n\n

Posledn\u00ed aktualizace 24.09.2025<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Ve\u0159ejn\u011b p\u0159\u00edstupn\u00e1 odborn\u00e1 informa\u010dn\u00ed slu\u017eba (VPOIS) Aktu\u00e1ln\u00ed informace o p\u0159\u00edpravc\u00edch distribuovan\u00fdch spole\u010dnost\u00ed Medindex, spol. s r.o. najdete na str\u00e1nk\u00e1ch St\u00e1tn\u00edho \u00fastavu pro kontrolu l\u00e9\u010div Odborn\u00edk\u016fm ve zdravotnictv\u00ed jsou ur\u010deny informace ze souhrnu informac\u00ed o p\u0159\u00edpravku (SPC) a laick\u00e9 ve\u0159ejnosti informace z p\u0159\u00edbalov\u00e9 informace (PIL). P\u0159\u00edpravky, kter\u00e9 maj\u00ed stanovenu \u00fahradu ze zdravotn\u00edho poji\u0161t\u011bn\u00ed jsou barevn\u011b ozna\u010deny a […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-67","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.mdx.cz\/index.php?rest_route=\/wp\/v2\/pages\/67","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mdx.cz\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.mdx.cz\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.mdx.cz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mdx.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=67"}],"version-history":[{"count":16,"href":"https:\/\/www.mdx.cz\/index.php?rest_route=\/wp\/v2\/pages\/67\/revisions"}],"predecessor-version":[{"id":125,"href":"https:\/\/www.mdx.cz\/index.php?rest_route=\/wp\/v2\/pages\/67\/revisions\/125"}],"wp:attachment":[{"href":"https:\/\/www.mdx.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=67"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}