. . . . "005.003" . . "5.3 P\u0159edklinick\u00E9 \u00FAdaje vztahuj\u00EDc\u00ED se k bezpe\u010Dnosti"@cs . . . . . . . "Ethinylestradiol\nToxikologick\u00FD profil ethinylestradiolu je dob\u0159e zn\u00E1m. Neexistuj\u00ED \u017E\u00E1dn\u00E9 p\u0159edklinick\u00E9 \u00FAdaje relevantn\u00ED pro\np\u0159edepisuj\u00EDc\u00EDho l\u00E9ka\u0159e, kter\u00E9 by poskytly dal\u0161\u00ED informace o bezpe\u010Dnosti p\u0159\u00EDpravku, ne\u017E kter\u00E9 jsou uvedeny\nv jin\u00FDch \u010D\u00E1stech tohoto textu.\nCyproteron acet\u00E1t\nSyst\u00E9mov\u00E1 toxicita\nP\u0159edklinick\u00E1 data zalo\u017Een\u00E1 na konven\u010Dn\u00EDch studi\u00EDch toxicity po opakovan\u00FDch d\u00E1vk\u00E1ch neodhalila \u017E\u00E1dn\u00E9 zvl\u00E1\u0161tn\u00ED\nriziko pro \u010Dlov\u011Bka\nEmbryotoxicita/teratogenicita\nHodnocen\u00ED embryotoxicity u\u017E\u00EDv\u00E1n\u00ED p\u0159\u00EDpravku obsahuj\u00EDc\u00EDho zm\u00EDn\u011Bn\u00E9 dv\u011B \u00FA\u010Dinn\u00E9 l\u00E1tky neprok\u00E1zalo \u017E\u00E1dn\u00FD\nteratogenn\u00ED vliv, je-li p\u0159\u00EDpravek pod\u00E1v\u00E1n b\u011Bhem organogeneze p\u0159ed v\u00FDvojem vn\u011Bj\u0161\u00EDch pohlavn\u00EDch org\u00E1n\u016F.\nPod\u00E1v\u00E1n\u00ED cyproteron acet\u00E1tu ve vy\u0161\u0161\u00EDch d\u00E1vk\u00E1ch b\u011Bhem hormon-sensitivn\u00ED f\u00E1ze diferenciace pohlavn\u00EDch org\u00E1n\u016F\nvedlo ke vzniku zn\u00E1mek feminizace u plod\u016F mu\u017Esk\u00E9ho pohlav\u00ED. Sledov\u00E1n\u00ED novorozen\u00FDch chlapc\u016F, kte\u0159\u00ED byli in\nutero vystaveni vlivu cyproteron acet\u00E1tu, v\u0161ak \u017E\u00E1dn\u00E9 zn\u00E1mky feminizace nezachytilo. Plat\u00ED v\u0161ak, \u017Ee t\u011Bhotenstv\u00ED\np\u0159edstavuje kontraindikaci u\u017E\u00EDv\u00E1n\u00ED Diane-35.\nGenotoxicita a karcinogenicita\nUzn\u00E1van\u00E9 testy genotoxicity prvn\u00ED linie prov\u00E1d\u011Bn\u00E9 s cyproteron acet\u00E1tem poskytly negativn\u00ED v\u00FDsledky. Dal\u0161\u00ED\ntesty v\u0161ak prok\u00E1zaly, \u017Ee cyproteron acet\u00E1t indukuje tvorbu DNA-adduct\u016F (zv\u00FD\u0161en\u00E1 repara\u010Dn\u00ED aktivita DNA)\nv jatern\u00EDch bu\u0148k\u00E1ch krys a opic a tak\u00E9 u \u010Derstv\u011B izolovan\u00FDch lidsk\u00FDch hepatocyt\u016F, hladina DNA adduct\u016F\nv jatern\u00EDch bu\u0148k\u00E1ch ps\u016F byla extr\u00E9mn\u011B n\u00EDzk\u00E1.\nTato DNA-adduct formace se vyskytla p\u0159i syst\u00E9mov\u00FDch expozic\u00EDch, kter\u00E9 by se daly o\u010Dek\u00E1vat p\u0159i doporu\u010Den\u00E9m\nd\u00E1vkovac\u00EDch sch\u00E9matu pro cyproteron acet\u00E1t. D\u016Fsledek l\u00E9\u010Dby cyproteron acet\u00E1tem in vivo byla zv\u00FD\u0161en\u00E1\nincidence fok\u00E1ln\u00EDch, mo\u017En\u00E1 pre-neoplastick\u00FDch, jatern\u00EDch l\u00E9z\u00ED u krys\u00EDch samic, ve kter\u00FDch byly alterovan\u00E9\ncelul\u00E1rn\u00ED enzymy a zv\u00FD\u0161en\u00ED frekvence mutac\u00ED u krys nesouc\u00EDch bakteri\u00E1ln\u00ED gen jako c\u00EDl pro mutace.\nKlinick\u00E1 zku\u0161enost a dob\u0159e veden\u00E9 epidemiologick\u00E9 studie do t\u00E9to doby nepotvrdily zv\u00FD\u0161enou incidenci jatern\u00EDch\ntumor\u016F u \u010Dlov\u011Bka. Ani testov\u00E1n\u00ED tumorigenicity cyproteron acet\u00E1tu na hlodavc\u00EDch neprok\u00E1zalo zn\u00E1mky\nspecifick\u00E9ho tumorigenn\u00EDho potenci\u00E1lu. Je t\u0159eba m\u00EDt v\u0161ak neust\u00E1le na pam\u011Bti, \u017Ee sexu\u00E1ln\u00ED steroidy mohou\npodporovat r\u016Fst n\u011Bkter\u00FDch hormon-dependentn\u00EDch tk\u00E1n\u00ED a tumor\u016F.\nObecn\u011B lze \u0159\u00EDci, \u017Ee dosavadn\u00ED v\u00FDsledky neposkytuj\u00ED d\u016Fvod proti pou\u017Eit\u00ED Diane-35 u lid\u00ED v souladu s dan\u00FDmi\nindikacemi a v doporu\u010Den\u00FDch d\u00E1vk\u00E1ch.\n"@cs . . . . .