"B\u011Bhem klinick\u00FDch studi\u00ED p\u0159\u00EDpravku Clobex 500 mikrogram\u016F/g \u0161ampon prov\u00E1d\u011Bn\u00FDch celkem na 558 pacientech pou\u017E\u00EDvaj\u00EDc\u00EDch tento p\u0159\u00EDpravek byly nej\u010Dast\u011Bji ud\u00E1vanou reakc\u00ED na p\u0159\u00EDpravek ko\u017En\u00ED obt\u00ED\u017Ee. Jejich v\u00FDskyt byl zhruba 5 %. V\u011Bt\u0161ina nep\u0159\u00EDzniv\u00FDch reakc\u00ED se hodnotila jako m\u00EDrn\u00E9 a\u017E st\u0159edn\u00ED a nebyly ovlivn\u011Bny rasou \u010Di pohlav\u00EDm. Klinick\u00E9 zn\u00E1mky iritace byly m\u00E9n\u011B \u010Dast\u00E9 (0,5 %) V\u00A0pr\u016Fb\u011Bhu \u017E\u00E1dn\u00E9 klinick\u00E9 studie nebyly hl\u00E1\u0161eny z\u00E1va\u017En\u00E9 ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky vztahuj\u00EDc\u00ED se k\u00A0p\u0159\u00EDpravku. \nPokud se objev\u00ED zn\u00E1mky lok\u00E1ln\u00ED intolerance, je t\u0159eba aplikaci pozastavit do jejich vymizen\u00ED. Pokud se objev\u00ED zn\u00E1mky p\u0159ecitliv\u011Blosti, je t\u0159eba aplikaci zastavit ihned. \nTabulka n\u00ED\u017Ee uv\u00E1d\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky vztahuj\u00EDc\u00ED se k\u00A0l\u00E9\u010Db\u011B podle org\u00E1nov\u00FDch syst\u00E9m\u016F a absolutn\u00ED frekvence:\n\tOrg\u00E1nov\u00FD syst\u00E9m\n\tV\u00FDskyt \n\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky\n\tPoruchy k\u016F\u017Ee a podko\u017E\u00ED \nO\u010Dn\u00ED poruchy\n\t\u010Cast\u00E9 \n\u22651/100,<1/10\nM\u00E9n\u011B \u010Dast\u00E9 \n(\u22651/1000,<1/100)\n\u010Cast\u00E9\n(\u22651/100,<1/10)\n\tKo\u017En\u00ED obt\u00ED\u017Ee\nAkn\u00E9/folikulitida \nLok\u00E1ln\u00ED zn\u00E1mky podr\u00E1\u017Ed\u011Bn\u00ED \nPruritus\nKop\u0159ivka\nTelangiekt\u00E1zie \nAtrofie k\u016F\u017Ee \nBod\u00E1n\u00ED nebo p\u00E1len\u00ED v o\u010D\u00EDch\n \nVlastnost\u00ED dan\u00E9 l\u00E9kov\u00E9 skupiny je, \u017Ee dlouhodob\u00E9 u\u017E\u00EDv\u00E1n\u00ED lok\u00E1ln\u00EDch kortikosteroid\u016F, l\u00E9\u010Dba rozs\u00E1hl\u00FDch oblast\u00ED k\u016F\u017Ee nebo u\u017E\u00EDv\u00E1n\u00ED velk\u00FDch mno\u017Estv\u00ED m\u016F\u017Ee v\u00E9st k\u00A0syst\u00E9mov\u00E9 absorpci, kter\u00E1 posta\u010Duje k\u00A0vyvol\u00E1n\u00ED zn\u00E1mek hyperkortizolismu (Cushing\u016Fv syndrom) nebo potla\u010Den\u00ED osy hypotalamus-hypof\u00FDza-nadledviny (HPA). Potla\u010Den\u00ED osy HPA, pokud se vyskytne, je zpravidla p\u0159echodn\u00E9 s\u00A0rychl\u00FDm n\u00E1vratem k\u00A0norm\u00E1ln\u00EDm hodnot\u00E1m. Av\u0161ak jeliko\u017E se m\u00E1 p\u0159\u00EDpravek Clobex 500 mikrogram\u016F/g \u0161ampon ponechat na m\u00EDst\u011B aplikace po dobu pouh\u00FDch 15 min, ne\u017E se opl\u00E1chne, lze syst\u00E9movou absorpci pozorovat z\u0159\u00EDdka (viz bod 5.2), a proto je riziko potla\u010Den\u00ED osy HPA ve srovn\u00E1n\u00ED s\u00A0kortikosteroidn\u00EDmi p\u0159\u00EDpravky, kter\u00E9 se neoplachuj\u00ED, velice n\u00EDzk\u00E9. V\u00A0pr\u016Fb\u011Bhu klinick\u00FDch zkou\u0161ek s\u00A0p\u0159\u00EDpravkem Clobex 500 mikrogram\u016F/g \u0161ampon nebylo pozorov\u00E1no \u017E\u00E1dn\u00E9 potla\u010Den\u00ED osy HPA. \nDlouhodob\u00E1 a/nebo intenzivn\u00ED l\u00E9\u010Dba n\u011Bkter\u00FDmi kortikosteroidn\u00EDmi p\u0159\u00EDpravky m\u016F\u017Ee zp\u016Fsobovat m\u00EDstn\u00ED atrofick\u00E9 zm\u011Bny, jako je lok\u00E1ln\u00ED atrofie k\u016F\u017Ee, strie, teleangiekt\u00E1zie, eryt\u00E9m, purpura, kontaktn\u00ED dermatitida. P\u0159i aplikaci na obli\u010Dej mohou vysoce \u00FA\u010Dinn\u00E9 kortikosteroidy vyvol\u00E1vat peror\u00E1ln\u00ED dermatitidu, atrofii k\u016F\u017Ee nebo zhor\u0161ovat r\u016F\u017Eovku. B\u011Bhem v\u00FDvoje p\u0159\u00EDpravku Clobex 500 mikrogram\u016F/g \u0161ampon byla hodnocena atrofie k\u016F\u017Ee s\u00A0pou\u017Eit\u00EDm ultrazvukov\u00E9ho m\u011B\u0159en\u00ED tlou\u0161\u0165ky k\u016F\u017Ee ve specifick\u00E9 klinick\u00E9 studii zahrnuj\u00EDc\u00ED 13 pacient\u016F. Po 4 t\u00FDdnech l\u00E9\u010Dby p\u0159\u00EDpravkem Clobex 500 mikrogram\u016F/g \u0161ampon nebylo pozorov\u00E1no \u017E\u00E1dn\u00E9 zmen\u0161en\u00ED tlou\u0161\u0165ky k\u016F\u017Ee. \nV\u00A0souvislosti s pod\u00E1v\u00E1n\u00EDm lok\u00E1ln\u00EDch kortikosteroid\u016F byly hl\u00E1\u0161eny zm\u011Bny pigmentace, akn\u00E9, pustul\u00E1rn\u00ED v\u00FDsevy a hypertrich\u00F3za. \n"@cs . "004.008" . . . . . . . . "4.8\tNe\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs .