. . . "5.3.\tP\u0159edklinick\u00E9 \u00FAdaje vztahuj\u00EDc\u00ED se k\u00A0bezpe\u010Dnosti"@cs . . "Studie na my\u0161\u00EDch a potkanech nezjistily karcinogenn\u00ED potenci\u00E1l carvedilolu p\u0159i d\u00E1vk\u00E1ch 75\u00A0mg/kg a 200\u00A0mg/kg (38-100kr\u00E1t vy\u0161\u0161\u00ED ne\u017E maxim\u00E1ln\u00ED denn\u00ED d\u00E1vka u lid\u00ED).\nVe studi\u00EDch na savc\u00EDch a jin\u00FDch \u017Eivo\u010Di\u0161\u00EDch in vitro nebo in vivo nebyl zji\u0161t\u011Bn \u017E\u00E1dn\u00FD mutagenn\u00ED potenci\u00E1l carvedilolu.\nP\u0159i pod\u00E1v\u00E1n\u00ED vysok\u00FDch d\u00E1vek carvedilolu b\u0159ez\u00EDm potkan\u016Fm ((\u00A0200\u00A0mg/kg = (\u00A0100n\u00E1sobek maxim\u00E1ln\u00ED denn\u00ED d\u00E1vky u lid\u00ED) byly pozorov\u00E1ny ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky na t\u011Bhotenstv\u00ED a fertilitu. Fyzick\u00FD r\u016Fst a v\u00FDvoj plodu byly p\u0159i d\u00E1vk\u00E1ch (\u00A060\u00A0mg/kg ((\u00A030n\u00E1sobek maxim\u00E1ln\u00ED denn\u00ED d\u00E1vky u lid\u00ED) zpo\u017Ed\u011Bny. Byla pozorov\u00E1na embryotoxicita (zv\u00FD\u0161en\u00E1 mortalita po implantaci embrya), ani u potkan\u016F ani u kr\u00E1l\u00EDk\u016F v\u0161ak nebyly p\u0159i d\u00E1vk\u00E1ch 200\u00A0mg/kg a 75\u00A0mg/kg pozorov\u00E1ny deformace (38-100n\u00E1sobek maxim\u00E1ln\u00ED denn\u00ED d\u00E1vky u lid\u00ED).\n"@cs . "005.003" .