. . . "T\u011Bhotenstv\u00ED\nDostate\u010Dn\u00E9 \u00FAdaje o pod\u00E1v\u00E1n\u00ED l\u00E9\u010Div\u00E9 l\u00E1tky t\u011Bhotn\u00FDm \u017Een\u00E1m a dob\u0159e kontrolovan\u00E9 studie u t\u011Bhotn\u00FDch \u017Een nejsou k\u00A0dispozici. Po uveden\u00ED p\u0159\u00EDpravku na trh byl hl\u00E1\u0161en jen omezen\u00FD po\u010Det p\u0159\u00EDpad\u016F expozice t\u011Bhotn\u00FDch \u017Een s\u00A0akromegali\u00ED a u p\u0159ibli\u017En\u011B poloviny hl\u00E1\u0161en\u00FDch p\u0159\u00EDpad\u016F t\u011Bhotenstv\u00ED nen\u00ED zn\u00E1m v\u00FDsledek. V\u011Bt\u0161ina \u017Een byla vystavena p\u016Fsoben\u00ED oktreotidu b\u011Bhem prvn\u00EDho trimestru t\u011Bhotenstv\u00ED v\u00A0d\u00E1vk\u00E1ch v\u00A0rozmez\u00ED 100\u00A0a\u017E\u00A0300\u00A0\u00B5g/den s.c. pod\u00E1van\u00E9ho Sandostatinu nebo 20-30\u00A0mg/m\u011Bs\u00EDc Sandostatinu LAR. P\u0159ibli\u017En\u011B ve dvou t\u0159etin\u00E1ch p\u0159\u00EDpad\u016F se zn\u00E1m\u00FDm v\u00FDsledkem t\u011Bhotenstv\u00ED se pacientky samy rozhodly, \u017Ee budou v\u00A0l\u00E9\u010Db\u011B oktreotidem v\u00A0pr\u016Fb\u011Bhu t\u011Bhotenstv\u00ED pokra\u010Dovat. Ve v\u011Bt\u0161in\u011B p\u0159\u00EDpad\u016F se zn\u00E1m\u00FDm v\u00FDsledkem do\u0161lo k narozen\u00ED norm\u00E1ln\u00EDho novorozence, rovn\u011B\u017E v\u0161ak bylo v\u00A0pr\u016Fb\u011Bhu prvn\u00EDho trimestru hl\u00E1\u0161eno n\u011Bkolik p\u0159\u00EDpad\u016F spont\u00E1nn\u00EDch potrat\u016F a indukovan\u00FDch p\u0159eru\u0161en\u00ED t\u011Bhotenstv\u00ED.\nV\u00A0p\u0159\u00EDpadech, kdy byl zn\u00E1m v\u00FDsledek t\u011Bhotenstv\u00ED p\u0159i u\u017E\u00EDv\u00E1n\u00ED oktreotidu, se nevyskytly \u017E\u00E1dn\u00E9 kongenit\u00E1ln\u00ED anom\u00E1lie nebo malformace.\nStudie na zv\u00ED\u0159atech neuk\u00E1zaly \u017E\u00E1dn\u00E9 p\u0159\u00EDm\u00E9 nebo nep\u0159\u00EDm\u00E9 \u0161kodliv\u00E9 \u00FA\u010Dinky z\u00A0hlediska posouzen\u00ED pr\u016Fb\u011Bhu t\u011Bhotenstv\u00ED, embryo/fet\u00E1ln\u00EDho v\u00FDvoje, porodu nebo postnat\u00E1ln\u00EDho v\u00FDvoje, nehled\u011B na n\u011Bkter\u00E9 p\u0159echodn\u00E9 retardace fyziologick\u00E9ho r\u016Fstu (viz bod 5.3 P\u0159edklinick\u00E9 \u00FAdaje vztahuj\u00EDc\u00ED se k\u00A0bezpe\u010Dnosti).\nSandostatin by m\u011Bl b\u00FDt p\u0159edeps\u00E1n t\u011Bhotn\u00FDm \u017Een\u00E1m pouze v\u00A0krajn\u011B nal\u00E9hav\u00FDch p\u0159\u00EDpadech (viz bod 4.4 Zvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED).\nKojen\u00ED\nNen\u00ED zn\u00E1mo, zda je oktreotid vylu\u010Dov\u00E1n do mate\u0159sk\u00E9ho ml\u00E9ka lid\u00ED. Ve studi\u00EDch na zv\u00ED\u0159atech byl oktreotid nalezen v\u00A0ml\u00E9ce zv\u00ED\u0159at. Pacientky u\u017E\u00EDvaj\u00EDc\u00ED Sandostatin by nem\u011Bly kojit.\n"@cs . . "004.006" . . . . . "4.6\tT\u011Bhotenstv\u00ED a kojen\u00ED"@cs .