"004.008" . . "Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky hl\u00E1\u0161en\u00E9 v klinick\u00FDch hodnocen\u00EDch a laboratorn\u00ED n\u00E1lezy vyskytuj\u00EDc\u00ED se \u010Dast\u011Bji p\u0159i l\u00E9\u010Db\u011B kombinac\u00ED valsartan a hydrochlorothiazid ve srovn\u00E1n\u00ED s placebem a individu\u00E1ln\u00ED postmarketingov\u00E1 hl\u00E1\u0161en\u00ED jsou prezentov\u00E1ny v tabulce dle org\u00E1nov\u00FDch syst\u00E9m\u016F. Ne\u017E\u00E1douc\u00ED reakce zn\u00E1m\u00E9 pro jednotliv\u00E9 slo\u017Eky, kter\u00E9 nebyly pozorov\u00E1ny v klinick\u00FDch studi\u00EDch, se mohou vyskytnout p\u0159i l\u00E9\u010Db\u011B kombinac\u00ED valsartanu a hydrochlorothiazidu.\nNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky jsou \u0159azeny podle \u010Detnosti, nej\u010Detn\u011Bj\u0161\u00ED prvn\u00ED, a podle n\u00E1sleduj\u00EDc\u00ED konvence: velmi \u010Dast\u00E9 (\u22651/10); \u010Dast\u00E9 (\u22651/100 a\u017E <1/10); m\u00E9n\u011B \u010Dast\u00E9 (\u22651/1\u00A0000 a\u017E <1/100); vz\u00E1cn\u00E9 (\u22651/10\u00A0000 a\u017E <1/1\u00A0000); velmi vz\u00E1cn\u00E9 (<1/10\u00A0000), nen\u00ED zn\u00E1mo (z dostupn\u00FDch \u00FAdaj\u016F nelze ur\u010Dit). V ka\u017Ed\u00E9 skupin\u011B \u010Detnost\u00ED jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se\u0159azeny podle klesaj\u00EDc\u00ED z\u00E1va\u017Enosti.\nTabulka 1: \u010Cetnost ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F valsartanu/hydrochlorothiazidu\nPoruchy metabolismu a v\u00FD\u017Eivy\nM\u00E9n\u011B \u010Dast\u00E9 \tDehydratace\nPoruchy nervov\u00E9ho syst\u00E9mu\nVelmi vz\u00E1cn\u00E9 \tZ\u00E1vra\u0165\nM\u00E9n\u011B \u010Dast\u00E9 \tParestezie\nNen\u00ED zn\u00E1mo \tSynkopa\nPoruchy oka\nM\u00E9n\u011B \u010Dast\u00E9 \tRozmazan\u00E9 vid\u011Bn\u00ED\nPoruchy ucha a labyrintu\nM\u00E9n\u011B \u010Dast\u00E9 \tTinnitus\nC\u00E9vn\u00ED poruchy\nM\u00E9n\u011B \u010Dast\u00E9 \tHypotenze\nRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy\nM\u00E9n\u011B \u010Dast\u00E9 \tKa\u0161el\nNen\u00ED zn\u00E1mo \tNekardiogenn\u00ED plicn\u00ED ed\u00E9m\nGastrointestin\u00E1ln\u00ED poruchy\nVelmi vz\u00E1cn\u00E9 \tPr\u016Fjem\nPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B\nM\u00E9n\u011B \u010Dast\u00E9 \tMyalgie\nVelmi vz\u00E1cn\u00E9 \tArtralgie\nPoruchy ledvin a mo\u010Dov\u00FDch cest\nNen\u00ED zn\u00E1mo \tZhor\u0161en\u00ED ren\u00E1ln\u00EDch funkc\u00ED\nCelkov\u00E9 poruchy a reakce v m\u00EDst\u011B aplikace\nM\u00E9n\u011B \u010Dast\u00E9 \t\u00DAnava\nVy\u0161et\u0159en\u00ED\nNen\u00ED zn\u00E1mo \tZv\u00FD\u0161en\u00ED hladin kyseliny mo\u010Dov\u00E9, zv\u00FD\u0161en\u00ED s\u00E9rov\u00E9ho bilirubinu a kreatininu, hypokalemie, hyponatremie, zv\u00FD\u0161en\u00ED krevn\u00ED urey, neutropenie\nDal\u0161\u00ED informace o jednotliv\u00FDch slo\u017Ek\u00E1ch\nNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky d\u0159\u00EDve hl\u00E1\u0161en\u00E9 u jednotliv\u00FDch slo\u017Eek mohou b\u00FDt potenci\u00E1ln\u011B ne\u017E\u00E1douc\u00EDmi \u00FA\u010Dinky i u p\u0159\u00EDpravku Blessin\u00A0Plus\u00A0H, i kdy\u017E nebyly pozorov\u00E1ny v klinick\u00FDch studi\u00EDch \u010Di b\u011Bhem postmarketingov\u00E9ho obdob\u00ED.\nTabulka 2: \u010Cetnost ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F valsartanu\nPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\nNen\u00ED zn\u00E1mo \tSn\u00ED\u017Een\u00ED hladiny hemoglobinu, sn\u00ED\u017Een\u00ED hematokritu, trombocytopenie\nPoruchy imunitn\u00EDho syst\u00E9mu\nNen\u00ED zn\u00E1mo \tJin\u00E1 p\u0159ecitliv\u011Blost / alergie v\u010Detn\u011B s\u00E9rov\u00E9 nemoci\nPoruchy metabolismu a v\u00FD\u017Eivy\nNen\u00ED zn\u00E1mo \tZv\u00FD\u0161en\u00ED s\u00E9rov\u00E9 hladiny drasl\u00EDku\nPoruchy ucha a labyrintu\nM\u00E9n\u011B \u010Dast\u00E9 \tVertigo\nC\u00E9vn\u00ED poruchy\nNen\u00ED zn\u00E1mo \tVaskulitida\nGastrointestin\u00E1ln\u00ED poruchy\nM\u00E9n\u011B \u010Dast\u00E9 \tBolesti b\u0159icha\nPoruchy jater a \u017Elu\u010Dov\u00FDch cest\nNen\u00ED zn\u00E1mo \tElevace jatern\u00EDch enzym\u016F\nPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\nNen\u00ED zn\u00E1mo \tAngioed\u00E9m, vyr\u00E1\u017Eka, pruritus\nPoruchy ledvin a mo\u010Dov\u00FDch cest\nNen\u00ED zn\u00E1mo \tSelh\u00E1n\u00ED ledvin\nTabulka 3: \u010Cetnost ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F hydrochlorothiazidu\nHydrochlorothiazid byl pe\u010Dliv\u011B studov\u00E1n po mnoho let, \u010Dasto ve vy\u0161\u0161\u00EDch d\u00E1vk\u00E1ch, ne\u017E jsou ty pod\u00E1van\u00E9 jako sou\u010D\u00E1st p\u0159\u00EDpravku Blessin\u00A0Plus\u00A0H. N\u00E1sleduj\u00EDc\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky byly hl\u00E1\u0161eny u pacient\u016F l\u00E9\u010Den\u00FDch monoterapi\u00ED thiazidov\u00FDmi diuretiky, v\u010Detn\u011B hydrochlorothiazidu:\nPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\nVz\u00E1cn\u00E9 \tTrombocytopenie n\u011Bkdy s purpurou\nVelmi vz\u00E1cn\u00E9 \tAgranulocyt\u00F3za, leukopenie, hemolytick\u00E1 anemie, \u00FAtlum kostn\u00ED d\u0159en\u011B\nPoruchy imunitn\u00EDho syst\u00E9mu\nVelmi vz\u00E1cn\u00E9 \tReakce p\u0159ecitliv\u011Blosti\nPsychiatrick\u00E9 poruchy\nVz\u00E1cn\u00E9 \tDeprese, poruchy sp\u00E1nku\nPoruchy nervov\u00E9ho syst\u00E9mu\nVz\u00E1cn\u00E9 \tBolesti hlavy\nSrde\u010Dn\u00ED poruchy\nVz\u00E1cn\u00E9 \tSrde\u010Dn\u00ED arytmie\nC\u00E9vn\u00ED poruchy\n\u010Cast\u00E9 \tPostur\u00E1ln\u00ED hypotenze\nRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy\nVelmi vz\u00E1cn\u00E9 \tRespira\u010Dn\u00ED \u00FAzkost v\u010Detn\u011B pneumonitis a plicn\u00EDho ed\u00E9mu\nGastrointestin\u00E1ln\u00ED poruchy\n\u010Cast\u00E9 \tZtr\u00E1ta chuti k j\u00EDdlu, m\u00EDrn\u00E1 nevolnost a zvracen\u00ED \nVz\u00E1cn\u00E9 \tZ\u00E1cpa, gastrointestin\u00E1ln\u00ED dyskomfort\nVelmi vz\u00E1cn\u00E9 \tPankreatitis\nPoruchy jater a \u017Elu\u010Dov\u00FDch cest\nVz\u00E1cn\u00E9 \tIntrahepat\u00E1ln\u00ED cholest\u00E1za nebo \u017Eloutenka\nPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\u010Cast\u00E9 \tKop\u0159ivka a jin\u00E9 formy vyr\u00E1\u017Eky\nVz\u00E1cn\u00E9 \tFotosenzitizace\nVelmi vz\u00E1cn\u00E9 \tNekrotizuj\u00EDc\u00ED vaskulitida a toxick\u00E1 epiderm\u00E1ln\u00ED nekrol\u00FDza, ko\u017En\u00ED reakce podobn\u00E9 lupus erytematodes, reaktivace ko\u017En\u00EDho lupus erytematodes\nPoruchy reproduk\u010Dn\u00EDho syst\u00E9mu a prsu\n\u010Cast\u00E9 \tImpotence\n"@cs . . "4.8 \tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . . . . . . . . . . . . .