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<http://linked.opendata.cz/resource/sukl/spc/section/SPC160893_doc-4-8>	<http://salt.semanticauthoring.org/ontologies/sdo#hasOrderNumber>	"004.008" .
<http://linked.opendata.cz/resource/sukl/spc/section/SPC160893_doc-4-8>	<http://salt.semanticauthoring.org/ontologies/sdo#hasParagraph>	<http://linked.opendata.cz/resource/sukl/spc/paragraph/SPC160893_doc-4-8-6> .
<http://linked.opendata.cz/resource/sukl/spc/section/SPC160893_doc-4-8>	<http://salt.semanticauthoring.org/ontologies/sdo#hasParagraph>	<http://linked.opendata.cz/resource/sukl/spc/paragraph/SPC160893_doc-4-8-8> .
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<http://linked.opendata.cz/resource/sukl/spc/section/SPC160893_doc-4-8>	<http://salt.semanticauthoring.org/ontologies/sdo#hasSectionTitle>	"4.8 \tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs .
<http://linked.opendata.cz/resource/sukl/spc/section/SPC160893_doc-4-8>	<http://salt.semanticauthoring.org/ontologies/sdo#hasText>	"Nej\u010Dast\u011Bj\u0161\u00EDmi ne\u017E\u00E1douc\u00EDmi \u00FA\u010Dinky (1-10 % pacient\u016F) jsou bolest hlavy, bolest b\u0159icha, z\u00E1cpa, pr\u016Fjem, plynatost a nevolnost/zvracen\u00ED.\nN\u00E1sleduj\u00EDc\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky byly zaznamen\u00E1ny v pr\u016Fb\u011Bhu klinick\u00E9ho hodnocen\u00ED s omeprazolem a v poregistra\u010Dn\u00EDm obdob\u00ED. \u017D\u00E1dn\u00FD ne\u017E\u00E1douc\u00ED \u00FA\u010Dinek nen\u00ED z\u00E1visl\u00FD na d\u00E1vce.\nV ka\u017Ed\u00E9 skupin\u011B \u010Detnost\u00ED jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se\u0159azeny podle \u010Detnost\u00ED a t\u0159\u00EDdy org\u00E1nov\u00FDch syst\u00E9m\u016F (SOC). Frekvence jsou definov\u00E1ny podle n\u00E1sleduj\u00EDc\u00ED konvence: velmi \u010Dast\u00E9 (\u2265 10), \u010Dast\u00E9 (\u2265 1/100 a\u017E < 1/10), m\u00E9n\u011B \u010Dast\u00E9 (\u2265 1/1000 a\u017E < 1/100), vz\u00E1cn\u00E9 (\u2265 1/10000 a\u017E < 1/1000), velmi vz\u00E1cn\u00E9 (< 1/10000), nen\u00ED zn\u00E1mo (z dostupn\u00FDch \u00FAdaj\u016F nelze ur\u010Dit).\n\tSOC/frekvence\n\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinek\n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\tVz\u00E1cn\u00E9: \n\tLeukopenie, trombocytopenie\n\tVelmi vz\u00E1cn\u00E9: \n\tAgranulocyt\u00F3za, pancytopenie\n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\tVz\u00E1cn\u00E9: \n\tHypersenzitivn\u00ED reakce, tj. hore\u010Dka, angioed\u00E9m a anafylaktick\u00E1 reakce/\u0161ok Poruchy metabolismu a v\u00FD\u017Eivy\n\tVz\u00E1cn\u00E9: \n\tHyponatr\u00E9mie\n\tNen\u00ED zn\u00E1mo: \n\tHypomagnesemie [viz bod zvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED (4.4)]\n\tPsychiatrick\u00E9 poruchy\n\tM\u00E9n\u011B \u010Dast\u00E9: \n\tNespavost\n\tVz\u00E1cn\u00E9: \n\tAgitovanost, zmatenost, deprese\n\tVelmi vz\u00E1cn\u00E9: \n\tAgrese, halucinace\n\tPoruchy nervov\u00E9ho syst\u00E9mu\n\t\u010Cast\u00E9: \n\tBolest hlavy\n\tM\u00E9n\u011B \u010Dast\u00E9: \n\tZ\u00E1vrat\u011B, parest\u00E9zie, ospalost\n\tVz\u00E1cn\u00E9: \n\tPoruchy chuti\n\tPoruchy oka\n\tVz\u00E1cn\u00E9: \n\tNeostr\u00E9 vid\u011Bn\u00ED\n\tPoruchy ucha a labyrintu\n\tM\u00E9n\u011B \u010Dast\u00E9: \n\tVertigo\n\tRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy\n\tVz\u00E1cn\u00E9: \n\tBronchospasmus\n\tGastrointestin\u00E1ln\u00ED poruchy\n\t\u010Cast\u00E9: \n\tBolest b\u0159icha, z\u00E1cpa, pr\u016Fjem, plynatost, nausea/zvracen\u00ED\n\tVz\u00E1cn\u00E9: \n\tSucho v \u00FAstech, stomatitida, gastrointestin\u00E1ln\u00ED kandid\u00F3za\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest\n\tM\u00E9n\u011B \u010Dast\u00E9: \n\tZv\u00FD\u0161en\u00E9 jatern\u00ED enzymy\n\tVz\u00E1cn\u00E9: \n\tHepatitida se \u017Eloutenkou nebo bez n\u00ED\n\tVelmi vz\u00E1cn\u00E9: \n\tSelh\u00E1n\u00ED jater, encefalopatie u pacient\u016F s ji\u017E existuj\u00EDc\u00ED poruchou jater\n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\tM\u00E9n\u011B \u010Dast\u00E9: \n\tDermatitida, sv\u011Bd\u011Bn\u00ED, rash, kop\u0159ivka\n\tVz\u00E1cn\u00E9: \n\tAlopecie, fotosenzitivita\n\tVelmi vz\u00E1cn\u00E9: \n\tMultiformn\u00ED eryt\u00E9m, Stevens-Johnson syndrom, toxick\u00E1 nekrol\u00FDza epidermis (TEN)\n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B\n\tVz\u00E1cn\u00E9: \n\tBolest kloub\u016F, bolest sval\u016F\n\tVelmi vz\u00E1cn\u00E9: \n\tSvalov\u00E1 slabost\n\tM\u00E9n\u011B \u010Dast\u00E9:\n\tFraktury proxim\u00E1ln\u00EDho konce femuru, dist\u00E1ln\u00EDho konce p\u0159edlokt\u00ED a obratl\u016F  (viz bod 4.4)\n\tPoruchy ledvin a mo\u010Dov\u00FDch cest\n\tVz\u00E1cn\u00E9: \n\tInterstici\u00E1ln\u00ED nefritida\n\tPoruchy reproduk\u010Dn\u00EDho syst\u00E9mu a prsu\n\tVelmi vz\u00E1cn\u00E9: \n\tGynekomastie\n\tCelkov\u00E9 poruchy a reakce v m\u00EDst\u011B aplikace\n\tM\u00E9n\u011B \u010Dast\u00E9: \n\tNevolnost, perifern\u00ED ed\u00E9my\n\tVz\u00E1cn\u00E9: \n\tZv\u00FD\u0161en\u00E9 pocen\u00ED\nD\u011Bti\nBezpe\u010Dnost omeprazolu byla hodnocena na celkem 310 d\u011Btech ve v\u011Bku 0 a\u017E 16 let s poruchou kysel\u00E9 \u017Ealude\u010Dn\u00ED sekrece. Existuj\u00ED pouze omezen\u00E9 bezpe\u010Dnostn\u00ED \u00FAdaje p\u0159i dlouhodob\u00E9m u\u017E\u00EDv\u00E1n\u00ED u 46 d\u011Bt\u00ED, kter\u00FDm byl v klinick\u00E9m hodnocen\u00ED dlouhodob\u011B pod\u00E1v\u00E1n omeprazol k l\u00E9\u010Db\u011B t\u011B\u017Ek\u00E9 erozivn\u00ED ezofagitidy po dobu a\u017E 749 dn\u016F. Profil ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F byl obecn\u011B stejn\u00FD jako u dosp\u011Bl\u00FDch p\u0159i kr\u00E1tkodob\u00E9 i dlouhodob\u00E9 l\u00E9\u010Db\u011B. Neexistuj\u00ED dlouhodob\u00E9 \u00FAdaje o vlivu pod\u00E1v\u00E1n\u00ED omeprazolu na pr\u016Fb\u011Bh puberty a r\u016Fst.\n"@cs .