"5.3\tP\u0159edklinick\u00E9 \u00FAdaje vztahuj\u00EDc\u00ED se k bezpe\u010Dnosti "@cs . . . . . "005.003" . "Preklinick\u00E1 data bezpe\u010Dnosti ziprasidonu nevyk\u00E1zala na z\u00E1klad\u011B konven\u010Dn\u00EDch zkou\u0161ek farmakologick\u00E9 bezpe\u010Dnosti, genotoxicity a karcinogenn\u00EDho potenci\u00E1lu \u017E\u00E1dn\u00E1 zvl\u00E1\u0161tn\u00ED rizika pro \u010Dlov\u011Bka. V reproduk\u010Dn\u00EDch studi\u00EDch ziprasidonu u potkan\u016F a kr\u00E1l\u00EDk\u016F nebyly z\u00EDsk\u00E1ny \u017E\u00E1dn\u00E9 pr\u016Fkazy teratogenity. Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky na fertilitu a sn\u00ED\u017Een\u00E1 hmotnost ml\u00E1\u010Fat byly pozorov\u00E1ny p\u0159i d\u00E1vk\u00E1ch, kter\u00E9 zp\u016Fsobovaly mate\u0159skou toxicitu (nap\u0159. sn\u00ED\u017Een\u00FD p\u0159\u00EDr\u016Fstek t\u011Blesn\u00E9 hmotnosti). Zv\u00FD\u0161en\u00E1 perinat\u00E1ln\u00ED mortalita a opo\u017Ed\u011Bn\u00FD funk\u010Dn\u00ED v\u00FDvoj ml\u00E1\u010Fat se objevily p\u0159i mate\u0159sk\u00FDch plazmatick\u00FDch koncentrac\u00EDch extrapolovan\u00FDch tak, aby byly podobn\u00E9 maxim\u00E1ln\u00EDm koncentrac\u00EDm u \u010Dlov\u011Bka, u\u017E\u00EDvaj\u00EDc\u00EDho terapeutickou d\u00E1vku.\nStudie parenter\u00E1ln\u011B pod\u00E1van\u00E9ho ziprasidonu nep\u0159inesly \u017E\u00E1dn\u00E1 negativn\u00ED zji\u0161t\u011Bn\u00ED pro pou\u017Eit\u00ED p\u0159\u00EDpravku v klinick\u00E9 praxi.\nV teratologick\u00E9 studii s\u00A0kr\u00E1l\u00EDky s\u00A0pomocnou l\u00E1tkou SBECD (sodnou sol\u00ED sulfobutoxybetadexu) byly pozorov\u00E1ny skelet\u00E1ln\u00ED zm\u011Bny, nikoliv v\u0161ak malformace.\n"@cs .