. . . . . . . . . . . . . . "004.008" . . . . "4.8. Ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky"@cs . . . . . . . . . . "Dosp\u011Bl\u00ED\nNej\u010Dast\u011Bji hl\u00E1\u0161en\u00FDmi (pozorovan\u00E9 u \u22651\u00A0% pacient\u016F) ne\u017E\u00E1douc\u00EDmi \u00FA\u010Dinky spojen\u00FDmi s\u00A0u\u017E\u00EDv\u00E1n\u00EDm olanzapinu v\u00A0klinick\u00FDch studi\u00EDch byla ospalost, p\u0159ib\u00FDv\u00E1n\u00ED na v\u00E1ze, eozinofilie, zv\u00FD\u0161en\u00E9 hladiny prolaktinu, cholesterolu, glukosy a triglycerid\u016F (viz bod 4.4), glykosurie, zv\u00FD\u0161en\u00E1 chu\u0165 k\u00A0j\u00EDdlu, z\u00E1vrat\u011B, akatizie, parkinsonismus (viz bod 4.4), dyskineze, ortostatick\u00E1 hypotenze, anticholinergn\u00ED \u00FA\u010Dinky, p\u0159echodn\u00E9 asymptomatick\u00E9 zv\u00FD\u0161en\u00ED jatern\u00EDch transamin\u00E1z (viz bod 4.4), vyr\u00E1\u017Eka, astenie, \u00FAnava a otoky.\nN\u00E1sleduj\u00EDc\u00ED tabulka pod\u00E1v\u00E1 seznam ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F a laboratorn\u00EDch n\u00E1lez\u016F pozorovan\u00FDch ve spont\u00E1nn\u00EDch hl\u00E1\u0161en\u00EDch a v\u00A0klinick\u00FDch hodnocen\u00EDch. V\u00A0ka\u017Ed\u00E9 skupin\u011B \u010Detnost\u00ED jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se\u0159azeny podle klesaj\u00EDc\u00ED z\u00E1va\u017Enosti.\nOhodnocen\u00ED \u010Detnosti v\u00FDskytu: velmi \u010Dast\u00E9 (\u226510\u00A0%), \u010Dast\u00E9 (\u22651\u00A0% a\u017E <10\u00A0%), m\u00E9n\u011B \u010Dast\u00E9 (\u22650,1\u00A0% a\u017E <1\u00A0%), vz\u00E1cn\u00E9 (\u22650,01\u00A0% a\u017E <0,1\u00A0%), velmi vz\u00E1cn\u00E9 (<0,01\u00A0%) a nen\u00ED zn\u00E1mo (z\u00A0dostupn\u00FDch \u00FAdaj\u016F nelze ur\u010Dit).\n\tVelmi \u010Dast\u00E9 \n\t\u010Cast\u00E9 \n\tM\u00E9n\u011B \u010Dast\u00E9 \n\tNen\u00ED zn\u00E1mo \n\tPoruchy krve a lymfatick\u00E9ho syst\u00E9mu\n\t\n\t\n\t\n\tEozinofilie \n\tLeukopenie Neutropenie \n\tTrombocytopenie \n\tPoruchy imunitn\u00EDho syst\u00E9mu \n\t\n\t\n\t\n\t\n\t\n\tAlergick\u00E1 reakce \n\tPoruchy metabolismu a v\u00FD\u017Eivy \n\t\n\t\n\tP\u0159ib\u00FDv\u00E1n\u00ED na v\u00E1ze 1\n\tZv\u00FD\u0161en\u00E9 hladiny cholesterolu2,3 \nZv\u00FD\u0161en\u00E9 hladiny glukosy4 \nZv\u00FD\u0161en\u00E9 hladiny triglycerid\u016F2,5 Glykosurie \nZv\u00FD\u0161en\u00E1 chu\u0165 k\u00A0j\u00EDdlu \n\t\n\tVznik nebo exacerbace diabetu, spojen\u00E9 p\u0159\u00EDle\u017Eitostn\u011B s\u00A0ketoacid\u00F3zou nebo komatem, v\u010Detn\u011B n\u011Bkolika fat\u00E1ln\u00EDch p\u0159\u00EDpad\u016F (viz bod 4.4) Hypotermie \n\tPoruchy nervov\u00E9ho syst\u00E9mu \n\t\n\t\n\tOspalost \n\tZ\u00E1vrat\u011B \nAkatizie6 Parkinsonismus6 Dyskineze6\n\t\n\tK\u0159e\u010De, kdy ve v\u011Bt\u0161in\u011B p\u0159\u00EDpad\u016F byly hl\u00E1\u0161eny k\u0159e\u010De v\u00A0anamn\u00E9ze \u010Di jin\u00E9 rizikov\u00E9 faktory pro vznik k\u0159e\u010D\u00ED Neuroleptick\u00FD malign\u00ED syndrom (viz bod 4.4) Dystonie (v\u010Detn\u011B okulogyrick\u00E9 krize) Tardivn\u00ED dyskineze P\u0159\u00EDznaky z\u00A0vysazen\u00ED7 \n\tSrde\u010Dn\u00ED poruchy \n\t\n\t\n\t\n\t\n\tBradykardie Prodlou\u017Een\u00ED QTc intervalu (viz bod 4.4) \n\tVentrikul\u00E1rn\u00ED tachykardie/fibrilace, n\u00E1hl\u00E1 smrt (viz bod 4.4) \n\tC\u00E9vn\u00ED poruchy \n\t\n\t\n\t\n\tOrtostatick\u00E1 hypotenze \n\t\n\tTromboembolismus (v\u010Detn\u011B pulmon\u00E1ln\u00ED embolie a hlubok\u00E9 \u017Eiln\u00ED tromb\u00F3zy) \n\tGastrointestin\u00E1ln\u00ED poruchy \n\t\n\t\n\t\n\tM\u00EDrn\u00E9 p\u0159echodn\u00E9 anticholinergn\u00ED \u00FA\u010Dinky v\u010Detn\u011B obstipace a such\u00E9 \u00FAstn\u00ED sliznice \n\t\n\tPankreatitida \n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest \n\t\n\t\n\t\n\tP\u0159echodn\u00E9 asymptomatick\u00E9 zv\u00FD\u0161en\u00ED hladiny jatern\u00EDch transamin\u00E1z (ALT, AST) obzvl\u00E1\u0161\u0165 na po\u010D\u00E1tku l\u00E9\u010Dby (viz bod 4.4) \n\t\n\tHepatitida (v\u010Detn\u011B hepatocelul\u00E1rn\u00EDho, cholestatick\u00E9ho nebo kombinovan\u00E9ho po\u0161kozen\u00ED jater) \n\tPoruchy k\u016F\u017Ee a podko\u017En\u00ED tk\u00E1n\u011B\n\t\n\tKo\u017En\u00ED vyr\u00E1\u017Eka \n\tFotosenzitivn\u00ED reakce Alopecie \n\t\n\tPoruchy svalov\u00E9 a kostern\u00ED soustavy a pojivov\u00E9 tk\u00E1n\u011B \n\t\n\t\n\t\n\tRhabdomyol\u00FDza \n\tPoruchy ledvin a mo\u010Dov\u00FDch cest \n\t\n\t\n\tInkontinence mo\u010Di\n\tRetardace startu mo\u010Den\u00ED \n\tPoruchy reproduk\u010Dn\u00EDho syst\u00E9mu a prsu \n\t\n\t\n\t\n\tPriapismus \n\tCelkov\u00E9 poruchy a reakce v m\u00EDst\u011B aplikace \n\t\n\tAstenie \n\u00DAnava \nOtok \n\t\n\t\n\tV\u00EDcen\u00E1sobn\u00E1 vy\u0161et\u0159en\u00ED \n\tZv\u00FD\u0161en\u00E9 plazmatick\u00E9 hladiny prolaktinu8\n\t\n\tVysok\u00E1 hladina kreatinfosfokin\u00E1zy Zv\u00FD\u0161en\u00E1 hodnota celkov\u00E9ho bilirubinu\n\tZv\u00FD\u0161en\u00E9 hodnoty alkalick\u00E9 fosfat\u00E1zy\n(1) Klinicky v\u00FDznamn\u00E9 zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti bylo pozorov\u00E1no nap\u0159\u00ED\u010D v\u0161emi z\u00E1kladn\u00EDmi kategoriemi dle BMI (Body Mass Index). Po kr\u00E1tkodob\u00E9 l\u00E9\u010Db\u011B (pr\u016Fm\u011Brn\u00E1 d\u00E9lka trv\u00E1n\u00ED 47\u00A0dn\u016F) bylo zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti o \u22657\u00A0% velmi \u010Dast\u00E9 (22,2\u00A0%), o \u226515\u00A0% \u010Dast\u00E9 (4,2\u00A0%) a o \u226525\u00A0% bylo m\u00E9n\u011B \u010Dast\u00E9 (0,8\u00A0%). P\u0159i dlouhodob\u00E9m u\u017E\u00EDv\u00E1n\u00ED (nejm\u00E9n\u011B 48\u00A0t\u00FDdn\u016F) bylo u pacient\u016F zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti o \u22657\u00A0%, \u226515\u00A0% a \u226525\u00A0% velmi \u010Dast\u00E9 (64,4\u00A0%, 31,7\u00A0% resp. 12,3\u00A0%).\n(2) Pr\u016Fm\u011Brn\u00E9 zv\u00FD\u0161en\u00ED hodnot lipid\u016F nala\u010Dno (celkov\u00FD cholesterol, LDL cholesterol a triglyceridy) bylo vy\u0161\u0161\u00ED u pacient\u016F bez prok\u00E1zan\u00E9 poruchy regulace tuk\u016F na za\u010D\u00E1tku l\u00E9\u010Dby.\n(3) Pozorov\u00E1no pro norm\u00E1ln\u00ED po\u010D\u00E1te\u010Dn\u00ED hladiny nala\u010Dno (<5,17\u00A0mmol/l), kdy do\u0161lo ke zv\u00FD\u0161en\u00ED hladin na vysok\u00E9 (\u22656,2\u00A0mmol/l). Zm\u011Bny po\u010D\u00E1te\u010Dn\u00EDch hodnot celkov\u00E9ho cholesterolu nala\u010Dno z\u00A0hrani\u010Dn\u00EDch (\u22655,17-<6,2\u00A0mmol/l) na vysok\u00E9 (\u22656,2\u00A0mmol/l) byly velmi \u010Dast\u00E9. \n(4) Pozorov\u00E1no pro norm\u00E1ln\u00ED po\u010D\u00E1te\u010Dn\u00ED hladiny glukosy nala\u010Dno (<5,56\u00A0mmol/l), kdy do\u0161lo ke zv\u00FD\u0161en\u00ED hladin na vysok\u00E9 (\u22657\u00A0mmol/l). Zm\u011Bny po\u010D\u00E1te\u010Dn\u00EDch hodnot glukosy nala\u010Dno z\u00A0hrani\u010Dn\u00EDch (\u22655,56-<7\u00A0mmol/l) na vysok\u00E9 (\u22657\u00A0mmol/l) byly velmi \u010Dast\u00E9.\n(5) Pozorov\u00E1no pro norm\u00E1ln\u00ED po\u010D\u00E1te\u010Dn\u00ED hladiny nala\u010Dno (<1,69\u00A0mmol/l), kter\u00E9 vzrostly na vysok\u00E9 (\u22652,26\u00A0mmol/l). Zm\u011Bny po\u010D\u00E1te\u010Dn\u00EDch hladin triglycerid\u016F nala\u010Dno z\u00A0hrani\u010Dn\u00EDch hodnot (\u22651,69\u00A0mmol/l-<2,26\u00A0mmol/l) na vysok\u00E9 (\u22652,26\u00A0mmol/l) byly velmi \u010Dast\u00E9.\n(6) V klinick\u00FDch studi\u00EDch byl v\u00FDskyt parkinsonismu a dystonie u pacient\u016F l\u00E9\u010Den\u00FDch olanzapinem \u010D\u00EDseln\u011B vy\u0161\u0161\u00ED, ale statisticky se signifikantn\u011B neli\u0161il od placeba. Parkinsonismus, akathisie a dystonie se vyskytly vz\u00E1cn\u011Bji p\u0159i u\u017E\u00EDv\u00E1n\u00ED olanzapinu ne\u017E p\u0159i u\u017E\u00EDv\u00E1n\u00ED titrovan\u00FDch d\u00E1vek haloperidolu. Vzhledem k\u00A0nedostatku podrobn\u00FDch informac\u00ED o akutn\u00EDch a pozdn\u00EDch extrapyramidov\u00FDch p\u0159\u00EDznac\u00EDch v\u00A0anamn\u00E9ze nen\u00ED mo\u017En\u00E9 rozhodnout, zda olanzapin zp\u016Fsobuje tardivn\u00ED dyskinezi a/nebo dal\u0161\u00ED pozdn\u00ED extrapyramidov\u00E9 p\u0159\u00EDznaky m\u00E9n\u011B \u010Dasto. \n(7) P\u0159i n\u00E1hl\u00E9m p\u0159eru\u0161en\u00ED l\u00E9\u010Dby olanzapinem byly hl\u00E1\u0161eny akutn\u00ED p\u0159\u00EDznaky jako pocen\u00ED, nespavost, t\u0159es, \u00FAzkost, nevolnost a zvracen\u00ED. \n(8) V\u00A0klinick\u00FDch studi\u00EDch trvaj\u00EDc\u00EDch a\u017E 12\u00A0t\u00FDdn\u016F p\u0159ekro\u010Dily plazmatick\u00E9 koncentrace prolaktinu horn\u00ED limit norm\u00E1ln\u00EDho rozmez\u00ED p\u0159ibli\u017En\u011B u 30\u00A0% pacient\u016F l\u00E9\u010Den\u00FDch olanzapinem s\u00A0norm\u00E1ln\u00ED v\u00FDchoz\u00ED hodnotou prolaktinu. U v\u011Bt\u0161iny t\u011Bchto pacient\u016F bylo zv\u00FD\u0161en\u00ED obecn\u011B m\u00EDrn\u00E9 a z\u016Fstalo pod dvojn\u00E1sobkem horn\u00ED hranice norm\u00E1ln\u00EDho rozmez\u00ED. U pacient\u016F se schizofreni\u00ED poklesly v\u00A0pr\u016Fb\u011Bhu l\u00E9\u010Dby pr\u016Fm\u011Brn\u00E9 zm\u011Bny hladiny prolaktinu, zat\u00EDmco pr\u016Fm\u011Brn\u00E9 zv\u00FD\u0161en\u00ED bylo pozorov\u00E1no u pacient\u016F s\u00A0jin\u00FDmi diagn\u00F3zami. Pr\u016Fm\u011Brn\u00E9 zm\u011Bny byly m\u00EDrn\u00E9. Potenci\u00E1ln\u011B souvisej\u00EDc\u00ED klinick\u00E9 projevy u pacient\u016F l\u00E9\u010Den\u00FDch olanzapinem (nap\u0159. amenorea, zv\u011Bt\u0161en\u00ED prs\u016F / galaktorea u \u017Een, gynekomastie / zv\u011Bt\u0161en\u00ED prs\u016F u mu\u017E\u016F), byly obvykle m\u00E9n\u011B \u010Dast\u00E9. Potenci\u00E1ln\u011B souvisej\u00EDc\u00ED ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky na sexu\u00E1ln\u00ED funkce (nap\u0159. poruchy erekce u mu\u017E\u016F a sn\u00ED\u017Een\u00E1 libido u obou pohlav\u00ED) byly pozorov\u00E1ny \u010Dasto.\nDlouhodob\u00E9 u\u017E\u00EDv\u00E1n\u00ED (nejm\u00E9n\u011B 48\u00A0t\u00FDdn\u016F)\nProcento pacient\u016F, u kter\u00FDch se projevily ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky - klinicky v\u00FDznamn\u00FD vzestup t\u011Blesn\u00E9 hmotnosti, glukosy, celkov\u00E9ho /LDL/HDL cholesterolu nebo triglycerid\u016F - se v\u00A0pr\u016Fb\u011Bhu \u010Dasu zvy\u0161uje. U dosp\u011Bl\u00FDch pacient\u016F, kte\u0159\u00ED dokon\u010Dili l\u00E9\u010Dbu v\u00A0d\u00E9lce 9-12\u00A0m\u011Bs\u00EDc\u016F, se stupe\u0148 n\u00E1r\u016Fstu hladiny glukosy v\u00A0krvi zpomalil p\u0159ibli\u017En\u011B po 6\u00A0m\u011Bs\u00EDc\u00EDch.\nDal\u0161\u00ED informace t\u00FDkaj\u00EDc\u00ED se specifick\u00FDch populac\u00ED\nV\u00A0klinick\u00FDch studi\u00EDch u star\u0161\u00EDch pacient\u016F s\u00A0demenc\u00ED byla l\u00E9\u010Dba olanzapinem spojena s\u00A0vy\u0161\u0161\u00ED incidenc\u00ED \u00FAmrt\u00ED a cerebrovaskul\u00E1rn\u00EDch ne\u017E\u00E1douc\u00EDch p\u0159\u00EDhod ve srovn\u00E1n\u00ED s\u00A0placebem (viz tak\u00E9 4.4). Velmi \u010Dast\u00E9 ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky spojen\u00E9 s\u00A0u\u017E\u00EDv\u00E1n\u00EDm olanzapinu u t\u00E9to skupiny pacient\u016F byly abnorm\u00E1ln\u00ED ch\u016Fze a p\u00E1dy. \u010Casto byly pozorov\u00E1ny pneumonie, zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 teploty, letargie, eryt\u00E9m, zrakov\u00E9 halucinace a inkontinence mo\u010Di.\nV\u00A0klinick\u00FDch studi\u00EDch u pacient\u016F s\u00A0Parkinsonovou chorobou s\u00A0psych\u00F3zou souvisej\u00EDc\u00ED s\u00A0pod\u00E1v\u00E1n\u00EDm dopaminov\u00E9ho agonisty bylo velmi \u010Dasto a s\u00A0vy\u0161\u0161\u00ED frekvenc\u00ED ne\u017E u placeba zaznamen\u00E1no zhor\u0161en\u00ED parkinsonsk\u00E9 symptomatiky a halucinace.\nV\u00A0jedn\u00E9 klinick\u00E9 studii u pacient\u016F v\u00A0manick\u00E9 f\u00E1zi bipol\u00E1rn\u00ED afektivn\u00ED poruchy m\u011Bla l\u00E9\u010Dba valpro\u00E1tem v\u00A0kombinaci s\u00A0olanzapinem za n\u00E1sledek 4,1% incidenci neutropenie; potenci\u00E1ln\u011B p\u0159isp\u00EDvaj\u00EDc\u00EDm faktorem by mohly b\u00FDt vysok\u00E9 plazmatick\u00E9 hladiny valpro\u00E1tu. Sou\u010Dasn\u00E9 pod\u00E1n\u00ED olanzapinu s\u00A0lithiem nebo valpro\u00E1tem vedlo ke zv\u00FD\u0161en\u00ED v\u00FDskytu (\u226510\u00A0%) tremoru, sucha v\u00A0\u00FAstech, zv\u00FD\u0161en\u00E9 chuti k\u00A0j\u00EDdlu a p\u0159ib\u00FDv\u00E1n\u00ED na v\u00E1ze. Poruchy \u0159e\u010Di byly tak\u00E9 hl\u00E1\u0161eny \u010Dasto. P\u0159i l\u00E9\u010Db\u011B olanzapinem v\u00A0kombinaci s\u00A0lithiem nebo divalproexem do\u0161lo v\u00A0akutn\u00ED f\u00E1zi l\u00E9\u010Dby (trvaj\u00EDc\u00ED max. 6\u00A0t\u00FDdn\u016F) ke zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti o \u22657\u00A0% u 17,4\u00A0% pacient\u016F. Dlouhodob\u00E1 l\u00E9\u010Dba olanzapinem (a\u017E 12\u00A0m\u011Bs\u00EDc\u016F) pro prevenci recidivy u pacient\u016F s\u00A0bipol\u00E1rn\u00ED afektivn\u00ED poruchou byla doprov\u00E1zena zv\u00FD\u0161en\u00EDm t\u011Blesn\u00E9 hmotnosti o \u22657\u00A0% u 39,9\u00A0% pacient\u016F.\nD\u011Bti a dosp\u00EDvaj\u00EDc\u00ED\nOlanzapin nen\u00ED indikov\u00E1n k\u00A0l\u00E9\u010Db\u011B d\u011Bt\u00ED a dosp\u00EDvaj\u00EDc\u00EDch mlad\u0161\u00EDch 18\u00A0let. A\u010Dkoli nebyly provedeny studie navr\u017Een\u00E9 pro porovn\u00E1n\u00ED dosp\u00EDvaj\u00EDc\u00EDch a dosp\u011Bl\u00FDch pacient\u016F, data z\u00A0klinick\u00FDch hodnocen\u00ED dosp\u00EDvaj\u00EDc\u00EDch byla srovn\u00E1na s\u00A0\u00FAdaji z\u00EDskan\u00FDmi ze studi\u00ED u dosp\u011Bl\u00FDch.\nN\u00E1sleduj\u00EDc\u00ED tabulka shrnuje ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky hl\u00E1\u0161en\u00E9 s\u00A0vy\u0161\u0161\u00ED \u010Detnost\u00ED v\u00FDskytu u dosp\u00EDvaj\u00EDc\u00EDch pacient\u016F (ve v\u011Bku 13-17\u00A0let) oproti dosp\u011Bl\u00FDm pacient\u016Fm, nebo ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky identifikovan\u00E9 pouze v\u00A0pr\u016Fb\u011Bhu kr\u00E1tkodob\u00FDch klinick\u00FDch hodnocen\u00ED u dosp\u00EDvaj\u00EDc\u00EDch pacient\u016F. Zd\u00E1 se, \u017Ee se klinicky v\u00FDznamn\u00E9 zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti (\u22657\u00A0%) ve srovn\u00E1n\u00ED s\u00A0dosp\u011Blou populac\u00ED vyskytuje u dosp\u00EDvaj\u00EDc\u00EDch pacient\u016F s\u00A0vy\u0161\u0161\u00ED frekvenc\u00ED. Velikost v\u00E1hov\u00E9ho p\u0159\u00EDr\u016Fstku a procento dosp\u00EDvaj\u00EDc\u00EDch, u kter\u00FDch do\u0161lo ke klinicky v\u00FDznamn\u00E9mu n\u00E1r\u016Fstu t\u011Blesn\u00E9 hmotnosti, byly vy\u0161\u0161\u00ED p\u0159i dlouhodob\u00E9m u\u017E\u00EDv\u00E1n\u00ED (nejm\u00E9n\u011B 24\u00A0t\u00FDdn\u016F) ve srovn\u00E1n\u00ED s\u00A0kr\u00E1tkodob\u00FDm u\u017E\u00EDv\u00E1n\u00EDm.\nV\u00A0ka\u017Ed\u00E9 skupin\u011B \u010Detnost\u00ED jsou ne\u017E\u00E1douc\u00ED \u00FA\u010Dinky se\u0159azeny podle klesaj\u00EDc\u00ED z\u00E1va\u017Enosti. Ohodnocen\u00ED \u010Detnosti v\u00FDskytu: velmi \u010Dast\u00E9 (\u226510\u00A0%), \u010Dast\u00E9 (\u22651\u00A0% a\u017E <10\u00A0%).\n\tPoruchy metabolismu a v\u00FD\u017Eivy \nVelmi \u010Dast\u00E9: P\u0159ib\u00FDv\u00E1n\u00ED na v\u00E1ze9, zv\u00FD\u0161en\u00E9 hladiny triglycerid\u016F10, zv\u00FD\u0161en\u00E1 chu\u0165 k\u00A0j\u00EDdlu. \n\u010Cast\u00E9: zv\u00FD\u0161en\u00E9 hladiny cholesterolu11 \n\tPoruchy nervov\u00E9ho syst\u00E9mu \nVelmi \u010Dast\u00E9: Sedace (zahrnuj\u00EDc\u00ED: hypersomnii, letargii, ospalost). \n\tGastrointestin\u00E1ln\u00ED poruchy \n\u010Cast\u00E9: Sucho v\u00A0\u00FAstech \n\tPoruchy jater a \u017Elu\u010Dov\u00FDch cest \nVelmi \u010Dast\u00E9: Zv\u00FD\u0161en\u00ED hladiny jatern\u00EDch transamin\u00E1z (ALT/AST; viz bod 4.4). \n\tVy\u0161et\u0159en\u00ED \nVelmi \u010Dast\u00E9: Sn\u00ED\u017Een\u00E9 hodnoty celkov\u00E9ho bilirubinu, zv\u00FD\u0161en\u00ED hodnoty GMT, zv\u00FD\u0161en\u00ED plazmatick\u00FDch hladin prolaktinu12 . \n9 Po kr\u00E1tkodob\u00E9 studii (pr\u016Fm\u011Brn\u00E1 d\u00E9lka trv\u00E1n\u00ED 22\u00A0dn\u016F) bylo zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti o \u22657\u00A0% z\u00A0v\u00FDchoz\u00ED t\u011Blesn\u00E9 hmotnosti (kg) velmi \u010Dast\u00E9 (40,6\u00A0%), zv\u00FD\u0161en\u00ED t\u011Blesn\u00E9 hmotnosti o \u226515\u00A0% z\u00A0v\u00FDchoz\u00ED t\u011Blesn\u00E9 hmotnosti bylo \u010Dast\u00E9 (7,1\u00A0%) a \u226525\u00A0% bylo m\u00E9n\u011B \u010Dast\u00E9 (2,5\u00A0%). P\u0159i dlouhodob\u00E9m u\u017E\u00EDv\u00E1n\u00ED (nejm\u00E9n\u011B 24\u00A0t\u00FDdn\u016F), 89,4\u00A0% n\u00E1r\u016Fst o \u22657\u00A0%, 55,3\u00A0% n\u00E1r\u016Fst o \u226515\u00A0% a 29,1\u00A0% n\u00E1r\u016Fst o \u226525\u00A0% z\u00A0v\u00FDchoz\u00ED t\u011Blesn\u00E9 hmotnosti.\n10Pozorov\u00E1no pro norm\u00E1ln\u00ED po\u010D\u00E1te\u010Dn\u00ED hladiny nala\u010Dno (<1,016\u00A0mmol/l), kter\u00E9 vzrostly na vysok\u00E9 (\u22651,467\u00A0mmol/l) a zm\u011Bny po\u010D\u00E1te\u010Dn\u00EDch hladin triglycerid\u016F nala\u010Dno z\u00A0hrani\u010Dn\u00EDch hodnot (\u22651,016\u00A0mmol/l-<1,467\u00A0mmol/l) na vysok\u00E9 (\u22651,467\u00A0mmol/l).\n11Zm\u011Bny po\u010D\u00E1te\u010Dn\u00EDch hodnot celkov\u00E9ho cholesterolu nala\u010Dno, kdy do\u0161lo ke zv\u00FD\u0161en\u00ED hladin z\u00A0norm\u00E1ln\u00EDch (<4,39\u00A0mmol/l) na vysok\u00E9 (\u22655,17\u00A0mmol/l), byly pozorov\u00E1ny \u010Dasto. Zm\u011Bny po\u010D\u00E1te\u010Dn\u00EDch hodnot celkov\u00E9ho cholesterolu nala\u010Dno z\u00A0hrani\u010Dn\u00EDch (\u22654,39-<5,17\u00A0mmol/l) na vysok\u00E9 (\u22655,17\u00A0mmol/l) byly velmi \u010Dast\u00E9.\n12Zv\u00FD\u0161en\u00ED plazmatick\u00E9 hladiny prolaktinu bylo hl\u00E1\u0161eno u 47,4\u00A0% dosp\u00EDvaj\u00EDc\u00EDch pacient\u016F.\n"@cs . . . . . . .