. . . . . . . . . . . . "Nej\u010Dast\u011Bji (>1/10) hl\u00E1\u0161en\u00FDmi ne\u017E\u00E1douc\u00EDmi \u00FA\u010Dinky jsou bolest hlavy, bolest b\u0159icha, pr\u016Fjem, nauzea, zvracen\u00ED, zv\u00FD\u0161en\u00E1 hladina alaninaminotransfer\u00E1zy, zv\u00FD\u0161en\u00E1 hladina aspart\u00E1taminotransfer\u00E1zy, zv\u00FD\u0161en\u00E1 hladina alkalick\u00E9 fosfat\u00E1zy v krvi a vyr\u00E1\u017Eka. \nN\u00ED\u017Ee uveden\u00E9 ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky byly pozorov\u00E1ny a hl\u00E1\u0161eny b\u011Bhem l\u00E9\u010Dby p\u0159\u00EDpravkem Apo-Fluconazol s n\u00E1sleduj\u00EDc\u00ED \u010Detnost\u00ED v\u00FDskytu: velmi \u010Dast\u00E9 (\u22651/10); \u010Dast\u00E9 (\u22651/100 a\u017E <1/10); m\u00E9n\u011B \u010Dast\u00E9 (\u22651/1000 a\u017E <1/100); vz\u00E1cn\u00E9 (\u22651/10 000 a\u017E <1/1000); velmi vz\u00E1cn\u00E9 (<1/10 000) a nen\u00ED zn\u00E1mo (nelze stanovit z dostupn\u00FDch \u00FAdaj\u016F).\n\tOrg\u00E1nov\u00FD syst\u00E9m \n\t\u010Cast\u00E9 \n\tM\u00E9n\u011B \u010Dast\u00E9 \n\tVz\u00E1cn\u00E9 \n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\n\tAnemie \n\tAgranulocyt\u00F3za, leukopenie, trombocytopenie a neutropenie \n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\t\n\t\n\tAnafylaxe\n\tPoruchy metabolismu a v\u00FD\u017Eivy\n\t\n\tSn\u00ED\u017Een\u00ED chuti k j\u00EDdlu \n\tHypertriglyceridemie, hypercholesterolemie, hypokalemie \n\tPsychiatrick\u00E9 poruchy\n\t\n\tSomnolence, insomnie\n\t\n\tPoruchy nervov\u00E9ho syst\u00E9mu \n\tBolest hlavy \n\tZ\u00E1chvaty, parest\u00E9zie, z\u00E1vrat\u011B, odchylky ve vn\u00EDm\u00E1n\u00ED chuti \n\tT\u0159es \n\tPoruchy ucha a labyrintu\n\t\n\tVertigo \n\t\n\tSrde\u010Dn\u00ED poruchy\n\t\n\t\n\tTorsades de pointes (viz bod 4.4), prodlou\u017Een\u00ED intervalu QT(viz bod 4.4) \n\tGastrointestin\u00E1ln\u00ED poruchy \n\tBolest b\u0159icha, zvracen\u00ED, pr\u016Fjem, nauzea \n \n\tZ\u00E1cpa, dyspepsie, flatulence, sucho v \u00FAstech \n \n\t\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest \n\tZv\u00FD\u0161en\u00E1 hladina alaninaminotransfer\u00E1zy (viz bod 4.4) a aspart\u00E1taminotransfer\u00E1zy \n(viz bod 4.4), zv\u00FD\u0161en\u00E1 hladina alkalick\u00E9 fosfat\u00E1zy v krvi (viz bod 4.4) \n\tCholest\u00E1za (viz bod 4.4), \u017Eloutenka (viz bod 4.4), zv\u00FD\u0161en\u00FD bilirubin \n(viz bod 4.4) \n\tJatern\u00ED selh\u00E1n\u00ED (viz bod 4.4), hepatocelul\u00E1rn\u00ED nekr\u00F3za (viz bod 4.4), hepatitida (viz bod \n4.4), hepatocelul\u00E1rn\u00ED po\u0161kozen\u00ED (viz bod 4.4) \n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B \n\tVyr\u00E1\u017Eka (viz bod 4.4) \n\tVyr\u00E1\u017Eka po pod\u00E1n\u00ED l\u00E9ku (viz bod 4.4), urtikarie (viz bod 4.4), pruritus, zv\u00FD\u0161en\u00E9 pocen\u00ED \n\tToxick\u00E1 epiderm\u00E1ln\u00ED nekrol\u00FDza, (viz bod 4.4), Stevens-Johnson\u016Fv syndrom (viz bod 4.4), akutn\u00ED generalizovana exantemat\u00F3zn\u00ED pustul\u00F3za (viz bod 4.4), exfoliativn\u00ED dermatitida, angioed\u00E9m, otoky v obli\u010Deji, alopecie \n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B \n\t\n\tMyalgie \n\t\n\tCelkov\u00E9 poruchy a reakce v m\u00EDst\u011B aplikace \n\t\n\tVy\u010Derp\u00E1n\u00ED, mal\u00E1tnost, astenie, hore\u010Dka \n\t\nPediatrick\u00E1 populace: \nCharakter a v\u00FDskyt ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F a labolatortn\u00EDch abnormalit zaznamenan\u00FDch v pr\u016Fb\u011Bhu klinick\u00FDch studi\u00ED u d\u011Bt\u00ED, s v\u00FDjimkou indikace kandid\u00F3zy genit\u00E1lu, je srovnateln\u00FD s v\u00FDskytem ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F u dosp\u011Bl\u00FDch.\n"@cs . . . "4.8 \tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . "004.008" .