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<http://linked.opendata.cz/resource/sukl/spc/section/SPC158335_doc-5-3>	<http://salt.semanticauthoring.org/ontologies/sdo#hasText>	"Neklinick\u00E9 \u00FAdaje zalo\u017Een\u00E9 na studi\u00EDch toxicity opakovan\u00FDch d\u00E1vek a genotoxicity neodhalily \u017E\u00E1dn\u00E9 specifick\u00E9 riziko pro lidi.\nStudie na zv\u00ED\u0159atech uk\u00E1zaly, \u017Ee toxicita navozen\u00E1 imipenemem, jako jedinou l\u00E1tkou, byla omezena na ledviny. Sou\u010Dasn\u00E9 pod\u00E1v\u00E1n\u00ED cilastatinu s imipenemem v pom\u011Bru 1:1 zabr\u00E1nilo u kr\u00E1l\u00EDk\u016F a opic vzniku nefrotoxick\u00FDch \u00FA\u010Dink\u016F. Dostupn\u00E9 d\u016Fkazy nazna\u010Duj\u00ED, \u017Ee cilastatin blokuje nefrotoxicitu t\u00EDm, \u017Ee br\u00E1n\u00ED vstupu imipenemu do tubul\u00E1rn\u00EDch bun\u011Bk.\nTeratologick\u00E1 studie na b\u0159ez\u00EDch opic\u00EDch rodu cynomolgus, kter\u00FDm byla pod\u00E1v\u00E1na kombinace imipenem/sodn\u00E1 s\u016Fl cilastatinu v d\u00E1vk\u00E1ch 40\u00A0mg/kg/den (bolusov\u00E1 intraven\u00F3zn\u00ED injekce) vedla k\u00A0toxicit\u011B pro matku, v\u010Detn\u011B krv\u00E1cen\u00ED, nechutenstv\u00ED, \u00FAbytku na v\u00E1ze, pr\u016Fjmu a v n\u011Bkter\u00FDch p\u0159\u00EDpadech \u00FAhynu. Pokud byly b\u0159ez\u00EDm opic\u00EDm rodu cynomolgus pod\u00E1v\u00E1ny d\u00E1vky kombinace imipenem/sodn\u00E1 s\u016Fl cilastatinu (p\u0159ibli\u017En\u011B 100\u00A0mg/100\u00A0mg/kg/den neboli p\u0159ibli\u017En\u011B 3n\u00E1sobek obvykl\u00E9 doporu\u010Den\u00E9 denn\u00ED intraven\u00F3zn\u00ED d\u00E1vky u lid\u00ED) rychlost\u00ED intraven\u00F3zn\u00ED infuze, kter\u00E1 napodobovala klinick\u00E9 pou\u017Eit\u00ED u lid\u00ED, byla intolerance matek minim\u00E1ln\u00ED (ob\u010Dasn\u00E9 zvracen\u00ED), nedo\u0161lo k \u017E\u00E1dn\u00E9mu \u00FAhynu matek, nebyly \u017E\u00E1dn\u00E9 d\u016Fkazy teratogenity, ale v porovn\u00E1n\u00ED s kontroln\u00EDmi skupinami do\u0161lo ke zv\u00FD\u0161en\u00ED ztr\u00E1ty embry\u00ED (viz\u00A0bod\u00A04.6).\nDlouhodob\u00E9 studie na zv\u00ED\u0159atech s c\u00EDlem vyhodnotit karcinogenn\u00ED potenci\u00E1l kombinace imipenem/cilastatin nebyly provedeny.\n"@cs .