. . "004.008" . . . . . . "Sou\u010D\u00E1st\u00ED bezpe\u010Dnostn\u00EDho profilu ramiprilu je v\u00FDskyt p\u0159etrv\u00E1vaj\u00EDc\u00EDho such\u00E9ho ka\u0161le a reakc\u00ED souvisej\u00EDc\u00EDch s\u00A0hypotenz\u00ED. K\u00A0z\u00E1va\u017En\u00FDm ne\u017E\u00E1douc\u00EDm \u00FA\u010Dink\u016Fm pat\u0159\u00ED angioed\u00E9m, hyperkal\u00E9mie, zhor\u0161en\u00ED funkce ledvin nebo jater, pankreatitida, z\u00E1va\u017En\u00E9 ko\u017En\u00ED reakce a neutrop\u00E9nie/agranulocyt\u00F3za.\nFrekvence ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F jsou definov\u00E1ny podle n\u00E1sleduj\u00EDc\u00ED konvence:\nVelmi \u010Dast\u00E9 (\u2265\u00A01/10)\n\u010Cast\u00E9 (\u2265\u00A01/100 a\u017E <\u00A01/10)\nM\u00E9n\u011B \u010Dast\u00E9 (\u2265\u00A01/1\u00A0000 a\u017E <\u00A01/100)\nVz\u00E1cn\u00E9 (\u2265\u00A01/10\u00A0000 a\u017E <\u00A01/1\u00A0000)\nVelmi vz\u00E1cn\u00E9 (<\u00A01/10\u00A0000)\nNen\u00ED zn\u00E1mo (z dostupn\u00FDch \u00FAdaj\u016F nelze zjistit)\nV\u00A0ka\u017Ed\u00E9 skupin\u011B \u010Detnost\u00ED jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se\u0159azeny podle klesaj\u00EDc\u00ED z\u00E1va\u017Enosti.\n\t\n\t\u010Cast\u00E9\n\tM\u00E9n\u011B \u010Dast\u00E9\n\tVz\u00E1cn\u00E9\n\tVelmi vz\u00E1cn\u00E9\n\tNen\u00ED zn\u00E1mo\n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\n\tEozinofilie\n\tSn\u00ED\u017Een\u00FD po\u010Det b\u00EDl\u00FDch krvinek (v\u010Detn\u011B neutrop\u00E9nie anebo agranulocyt\u00F3-zy), sn\u00ED\u017Een\u00FD po\u010Det \u010Derven\u00FDch krvinek, pokles hemoglobinu, sn\u00ED\u017Een\u00FD po\u010Det krevn\u00EDch desti\u010Dek\n\t\n\tSelh\u00E1n\u00ED kostn\u00ED d\u0159en\u011B, pancytop\u00E9nie, hemolytick\u00E1 an\u00E9mie\n\tPoruchy imunitn\u00EDho syst\u00E9mu\n\t\n\t\n\t\n\t\n\tAnafylaktick\u00E9 nebo anafylaktoidn\u00ED reakce, zv\u00FD\u0161en\u00E9 antinukle\u00E1rn\u00ED protil\u00E1tky\n\tPoruchy metabolismu a v\u00FD\u017Eivy\n\tZv\u00FD\u0161en\u00E1 hladina drasl\u00EDku v krvi\n\tAnorexie, sn\u00ED\u017Een\u00E1 chu\u0165 k\u00A0j\u00EDdlu\n\t\n\t\n\tSn\u00ED\u017Een\u00E1 hladina sod\u00EDku v krvi\n\tPsychiatrick\u00E9 poruchy\n\t\n\tZhor\u0161en\u00E1 n\u00E1lada, \u00FAzkost, nervozita, neklid, poruchy sp\u00E1nku v\u010Detn\u011B somnolence\n\tStav zmatenosti\n\t\n\tPoruchy pozornosti\n\tPoruchy nervov\u00E9ho syst\u00E9mu\n\tBolest hlavy, z\u00E1vra\u0165\n\tVertigo, parest\u00E9zie, ageuzie, dysgeuzie\n\tT\u0159es, poruchy rovnov\u00E1hy\n\t\n\tMozkov\u00E1 isch\u00E9mie v\u010Detn\u011B mozkov\u00E9 p\u0159\u00EDhody a tranzitorn\u00ED ischemick\u00E9 ataky, zhor\u0161en\u00E9 psychomoto-rick\u00E9 schopnosti, pocit p\u00E1len\u00ED, parosmie\n\tPoruchy oka\n\t\n\tPoruchy zraku v\u010Detn\u011B zaml\u017Een\u00E9ho vid\u011Bn\u00ED \n\tKonjunktiviti-da\n\t\n\t\n\tPoruchy ucha a labyrintu\n\t\n\t\n\tZhor\u0161en\u00FD sluch, tinitus\n\t\n\t\n\tSrde\u010Dn\u00ED poruchy \n\t\n\tIsch\u00E9mie myokardu v\u010Detn\u011B anginy pectoris anebo infarktu myokardu, tachykardie, arytmie, palpitace, perifern\u00ED ed\u00E9m\n\t\n\t\n\t\n\tC\u00E9vn\u00ED poruchy \n\tHypotenze, sn\u00ED\u017Een\u00FD ortostatick\u00FD krevn\u00ED tlak, synkopa\n\tZ\u010Derven\u00E1n\u00ED \n\tVaskul\u00E1rn\u00ED sten\u00F3za, hypoperf\u00FAze, vaskulitida\n\t\n\tRaynaud\u016Fv fenom\u00E9n\n\tRespira\u010Dn\u00ED, hrudn\u00ED a mediastin\u00E1ln\u00ED poruchy \n\tNeproduktivn\u00ED dr\u00E1\u017Ediv\u00FD ka\u0161el, bronchitida, sinusitida, dyspnoe\n\tBroncho-spasmus v\u010Detn\u011B zhor\u0161en\u00ED astmatu, nepr\u016Fchodn\u00FD nos\n\t\n\t\n\t\n\tGastrointestin\u00E1ln\u00ED poruchy\n\tZ\u00E1n\u011Bt gastrointestin\u00E1ln\u00ED-ho traktu, poruchy tr\u00E1ven\u00ED, b\u0159i\u0161n\u00ED diskomfort, dyspepsie, pr\u016Fjem, nausea, zvracen\u00ED\n\tPankreatitida (p\u0159i u\u017E\u00EDv\u00E1n\u00ED ACE inhibitor\u016F byly velmi v\u00FDjime\u010Dn\u011B hl\u00E1\u0161eny p\u0159\u00EDpady s\u00A0fat\u00E1ln\u00EDm pr\u016Fb\u011Bhem), zv\u00FD\u0161en\u00E9 pankreatick\u00E9 enzymy, angioed\u00E9m tenk\u00E9ho st\u0159eva, bolest v horn\u00ED \u010Dasti b\u0159icha v\u010Detn\u011B gastritidy, z\u00E1cpa, sucho v\u00A0\u00FAstech\n\tGlositida\n\t\n\tAft\u00F3zn\u00ED stomatitida\n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest\n\t\n\tZv\u00FD\u0161en\u00E9 hladiny jatern\u00EDch enzym\u016F a/nebo konjugovan\u00E9ho bilirubinu\n\tCholestatick\u00E1 \u017Eloutenka, hepatocelul\u00E1rn\u00ED po\u0161kozen\u00ED\n\t\n\tAkutn\u00ED selh\u00E1n\u00ED jater, cholestatick\u00E1 nebo cytolytick\u00E1 hepatitida (velmi v\u00FDjime\u010Dn\u011B s\u00A0fat\u00E1ln\u00EDm pr\u016Fb\u011Bhem)\n\tPoruchy k\u016F\u017Ee a\u00A0podko\u017En\u00ED tk\u00E1n\u011B \n\tVyr\u00E1\u017Eka, hlavn\u011B makulopapul\u00E1rn\u00ED\n\tAngioed\u00E9m; velmi v\u00FDjime\u010Dn\u011B m\u016F\u017Ee b\u00FDt obstrukce d\u00FDchac\u00EDch cest v\u00A0d\u016Fsledku angioed\u00E9mu fat\u00E1ln\u00ED; pruritus, hyperhidr\u00F3za\n\tExfoliativn\u00ED dermatitida, kop\u0159ivka, onychol\u00FDza\n\tFotosenzitivn\u00ED reakce\n\tToxick\u00E1 epiderm\u00E1ln\u00ED nekrol\u00FDza, Stevens-Johnson\u016Fv syndrom, multiformn\u00ED eryt\u00E9m, pemfigus, zhor\u0161en\u00E1 psori\u00E1za, psoriatiformn\u00ED dermatitida, pemfigoidn\u00ED nebo lichenoidn\u00ED exant\u00E9m nebo enant\u00E9m, alopecie\n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B\n\tSvalov\u00FD spasmus, myalgie\n\tArtralgie\n\t\n\t\n\t\n\tPoruchy ledvin a\u00A0mo\u010Dov\u00FDch cest\n\t\n\tPorucha funkce ledvin v\u010Detn\u011B akutn\u00EDho selh\u00E1n\u00ED ledvin, zv\u00FD\u0161en\u00E9 vylu\u010Dov\u00E1n\u00ED mo\u010Di, zhor\u0161en\u00ED preexistuj\u00EDc\u00ED proteinurie, zv\u00FD\u0161en\u00E1 hladina mo\u010Doviny v krvi, zv\u00FD\u0161en\u00E1 hladina kreatininu v krvi\n\t\n\t\n\t\n\tPoruchy reproduk\u010Dn\u00EDho syst\u00E9mu a prs\u016F\n\t\n\tP\u0159echodn\u00E1 erektiln\u00ED impotence, sn\u00ED\u017Een\u00E9 libido \n\t\n\t\n\tGynekomastie\n\tCelkov\u00E9 poruchy a reakce v\u00A0m\u00EDst\u011B aplikace\n\tBolest na hrudi, \u00FAnava\n\tPyrexie\n\tAst\u00E9nie\n\t\n\t\nPediatrick\u00E1 populace\nBezpe\u010Dnost pou\u017Eit\u00ED ramiprilu byla sledov\u00E1na ve dvou klinick\u00FDch studi\u00EDch, u 325 d\u011Bt\u00ED a dosp\u00EDvaj\u00EDc\u00EDch ve v\u011Bku mezi 2-16 lety. Zat\u00EDmco podstata a z\u00E1va\u017Enost ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F byly podobn\u00E9 jako u dosp\u011Bl\u00FDch, \u010Detnost n\u00E1sleduj\u00EDc\u00EDch ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F byla u d\u011Bt\u00ED vy\u0161\u0161\u00ED:\nTachykardie, ucp\u00E1n\u00ED nosu a r\u00FDma \u201E\u010Dast\u00E9\u201C (\u2265 1/100 a\u017E < 1/10) u d\u011Bt\u00ED a \u201Em\u00E9n\u011B \u010Dast\u00E9\u201C (\u2265 1/1 000 a\u017E < 1/100) u dosp\u011Bl\u00FDch. \nZ\u00E1n\u011Bty spojivek \u201E\u010Dast\u00E9\u201C (\u2265 1/100 a\u017E < 1/10) u d\u011Bt\u00ED, zat\u00EDmco \u201Evz\u00E1cn\u00E9\u201C (\u2265 1/10 000 a\u017E < 1/1 000) u dosp\u011Bl\u00FDch. \nT\u0159es a kop\u0159ivka \u201Em\u00E9n\u011B \u010Dast\u00E9\u201C (\u2265 1/1 000 a\u017E < 1/100) u d\u011Bt\u00ED, zat\u00EDmco \u201Evz\u00E1cn\u00E9\u201C (\u2265 1/10 000 a\u017E < 1/1 000) u dosp\u011Bl\u00FDch. \nCelkov\u00FD bezpe\u010Dnostn\u00ED profil ramiprilu u pediatrick\u00FDch pacient\u016F se v\u00FDznamn\u011B neli\u0161\u00ED od bezpe\u010Dnostn\u00EDho profilu u dosp\u011Bl\u00FDch.\n"@cs . . . . . . . . . . . . . . . . . "4.8\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . . . . .