. . . . . "4.8\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . "004.008" . "N\u00ED\u017Ee uveden\u00E1 tabulka obsahuje ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky zji\u0161t\u011Bn\u00E9 b\u011Bhem pou\u017E\u00EDv\u00E1n\u00ED v klinick\u00FDch hodnocen\u00EDch a po uveden\u00ED p\u0159\u00EDpravku na trh, set\u0159\u00EDd\u011Bn\u00E9 podle t\u0159\u00EDdy org\u00E1nov\u00FDch syst\u00E9m\u016F a \u010Detnosti. Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky zji\u0161t\u011Bn\u00E9 po uveden\u00ED na trh jsou uvedeny kurz\u00EDvou. Seskupen\u00ED dle \u010Detnosti je definov\u00E1no pomoc\u00ED n\u00E1sleduj\u00EDc\u00ED konvence: velmi \u010Dast\u00E9 (\u2265 1/10); \u010Dast\u00E9 (\u2265 1/100 a\u017E < 1/10); m\u00E9n\u011B \u010Dast\u00E9 (\u2265 1/1\u00A0000 a\u017E <\u00A01/100); vz\u00E1cn\u00E9 (\u2265 1/10\u00A0000 a\u017E <\u00A01/1\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 \u010Detnosti jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se\u0159azeny dle klesaj\u00EDc\u00ED z\u00E1va\u017Enosti.\nNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky p\u0159\u00EDpadn\u011B nebo pravd\u011Bpodobn\u011B souvisej\u00EDc\u00ED s azithromycinen zalo\u017Een\u00E9 na zku\u0161enostech v klinick\u00FDch hodnocen\u00EDch a po uveden\u00ED p\u0159\u00EDpravku na trh.\n\tT\u0159\u00EDda org\u00E1novv\u00FDch syst\u00E9m\u016F\n\t\u010Cetnost\n\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinek\n\tInfekce a infestace\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tKandid\u00F3za, or\u00E1ln\u00ED kandid\u00F3za, vagin\u00E1ln\u00ED infekce\n\t\n\tNen\u00ED zn\u00E1mo\n\tPseudomembran\u00F3zn\u00ED kolitida (viz bod 4.4)\n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\u010Cast\u00E9\n\tPokles po\u010Dtu lymfocyt\u016F, zv\u00FD\u0161en\u00FD po\u010Det eozinofil\u016F\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tLeukopenie, neutropenie\n\t\n\tVz\u00E1cn\u00E9\n\tThrombocytopenie, hemolytick\u00E1 an\u00E9mie\n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tAngioed\u00E9m, hypersenzitivita\n\t\n\tNen\u00ED zn\u00E1mo\n\tAnafylaktick\u00E1 reakce (viz bod 4.4)\n\tPoruchy metabolismu a v\u00FD\u017Eivy\n\t\u010Cast\u00E9\n\tAnorexie\n\tPsychiatrick\u00E9 poruchy\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tNervozita\n\t\n\tVz\u00E1cn\u00E9\n\tAgitovanost, depersonalizace\n\t\n\tNen\u00ED zn\u00E1mo\n\tAgrese,\u00FAzkost\n\tPoruchy nervov\u00E9ho syst\u00E9mu\n\t\u010Cast\u00E9\n\tZ\u00E1vra\u0165, bolesti hlavy, parestezie, dysgeuzie\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tHypoestezie, ospalost, nespavost\n\t\n\tNen\u00ED zn\u00E1mo\n\tSynkopa, k\u0159e\u010De, psychomotorick\u00E1 hyperaktivita, anosmia, ageuzie, parosmie, Myasthenia gravis (viz bod 4.4) .\n\tPoruchy oka\n\t\u010Cast\u00E9\n\tPoruchy zraku\n\tPoruchy ucha a labyrintu\n\t\u010Cast\u00E9\n\tHluchota\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tPorucha sluchu, tinnitus\n\t\n\tVz\u00E1cn\u00E9\n\tVertigo\n\t\n\t\n\t\n\tSrde\u010Dn\u00ED poruchy\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tPalpitace\n\t\n\tNen\u00ED zn\u00E1mo\n\tTorsade de pointes ( viz bod 4.4), arytmie (viz bod 4.4) v\u010Detn\u011B komorov\u00E9 tachykardie, prodlou\u017Een\u00ED intervalu QT na EKG (viz bod 4.4)\n\tC\u00E9vn\u00ED poruchy\n\tNen\u00ED zn\u00E1mo\n\tHypotenze\n\tGastrointesti-n\u00E1ln\u00ED poruchy\n\tVelmi \u010Dast\u00E9\n\tPr\u016Fjem, bolesti b\u0159icha, nauzea, flatulence\n\t\n\t\u010Cast\u00E9\n\tZvracen\u00ED, dyspepsie\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tGastritida, z\u00E1cpa\n\t\n\tNen\u00ED zn\u00E1mo\n\tPanreatitida, zm\u011Bna barvy jazyka\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tHepatitida, zv\u00FD\u0161en\u00ED aspart\u00E1taminotransfer\u00E1zy, zv\u00FD\u0161en\u00ED alaninaminotransfer\u00E1zy, zv\u00FD\u0161en\u00ED bilirubinu v krvi,\n\t\n\tVz\u00E1cn\u00E9\n\tabnorm\u00E1ln\u00ED funkce jater\n\t\n\tNen\u00ED zn\u00E1mo\n\tSelh\u00E1n\u00ED jater (viz bod 4.4 *), fulminantn\u00ED hepatitida, nekr\u00F3za jater, cholestatick\u00E1 \u017Eloutenka\n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\t\u010Cast\u00E9\n\tVyr\u00E1\u017Eka, sv\u011Bd\u011Bn\u00ED\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tSteven-Johnson\u016Fv syndrom, fotosenzitivn\u00ED reakce, kop\u0159ivka\n\t\n\tNen\u00ED zn\u00E1mo\n\tToxick\u00E1 epiderm\u00E1ln\u00ED nekrol\u00FDza, erythema multiforme\n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B\n\t\u010Cast\u00E9\n\tArtralgie\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tZv\u00FD\u0161en\u00ED mo\u010Doviny v krvi\n\t\n\tVz\u00E1cn\u00E9\n\tAkutn\u00ED selh\u00E1n\u00ED ledvin, interstici\u00E1ln\u00ED nefritida\n\tCelkov\u00E9 poruchy a reakce v m\u00EDst\u011B aplikace\n\t\u010Cast\u00E9\n\t\u00DAnava\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tBolesti na hrudi, otok, mal\u00E1tnost, astenie\n\tVy\u0161et\u0159en\u00ED\n\t\u010Cast\u00E9\n\tSn\u00ED\u017Een\u00FD bikarbon\u00E1t v krvi\n\t\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tAbnorm\u00E1ln\u00ED hladiny drasl\u00EDku v krvi\n* co\u017E vz\u00E1cn\u011B vedlo a\u017E k \u00FAmrt\u00ED\n"@cs . . . . .