"Pacienti l\u00E9\u010Den\u00ED imunosupresivy v\u010Detn\u011B kombinac\u00ED l\u00E9\u010Div\u00FDch p\u0159\u00EDpravk\u016F zahrnuj\u00EDc\u00EDch Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta jsou vystaveni zv\u00FD\u0161en\u00E9mu riziku v\u00FDskytu lymfom\u016F a dal\u0161\u00EDch malignit, p\u0159edev\u0161\u00EDm na k\u016F\u017Ei (viz bod 4.8). M\u00EDra tohoto rizika je z\u0159ejm\u011B sp\u00ED\u0161e ve vztahu k intenzit\u011B a trv\u00E1n\u00ED imunosuprese, ne\u017E k typu pou\u017Eit\u00E9ho p\u0159\u00EDpravku. V\u00A0souladu s\u00A0obecn\u00FDmi doporu\u010Den\u00EDmi k\u00A0minimalizaci rizika vzniku rakoviny k\u016F\u017Ee se doporu\u010Duje omezit expozici slune\u010Dn\u00EDmu a UV-z\u00E1\u0159en\u00ED no\u0161en\u00EDm ochrann\u00FDch od\u011Bv\u016F a pou\u017E\u00EDv\u00E1n\u00EDm opalovac\u00EDch kr\u00E9m\u016F s vysok\u00FDm ochrann\u00FDm faktorem.\nPacienti u\u017E\u00EDvaj\u00EDc\u00ED Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta mus\u00ED b\u00FDt upozorn\u011Bni, \u017Ee je t\u0159eba okam\u017Eit\u011B hl\u00E1sit l\u00E9ka\u0159i, pokud se objev\u00ED zn\u00E1mky infekce, ne\u010Dekan\u00E9 hematomy, krv\u00E1cen\u00ED nebo jak\u00E9koli dal\u0161\u00ED p\u0159\u00EDznaky \u00FAtlumu kostn\u00ED d\u0159en\u011B.\nPacienti l\u00E9\u010Den\u00ED imunosupresivy, v\u010Detn\u011B p\u0159\u00EDpravku Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta, maj\u00ED vy\u0161\u0161\u00ED riziko vzniku oportunn\u00EDch infekc\u00ED (bakteri\u00E1ln\u00EDch, mykotick\u00FDch, virov\u00FDch a protozo\u00E1ln\u00EDch), fat\u00E1ln\u00EDch infekc\u00ED a sepse (viz bod 4.8). Mezi oportunn\u00ED infekce pat\u0159\u00ED virem BK asociovan\u00E1 nefropatie a JC virem asociovan\u00E1 progresivn\u00ED multifok\u00E1ln\u00ED leukoencefalopatie (PML). Tyto infekce jsou \u010Dasto spojen\u00E9 s vy\u0161\u0161\u00ED celkovou imunosupresivn\u00ED z\u00E1t\u011B\u017E\u00ED a mohou v\u00E9st k z\u00E1va\u017En\u00FDm, nebo fat\u00E1ln\u00EDm stav\u016Fm, kter\u00E9 by m\u011Bl l\u00E9ka\u0159 zva\u017Eovat v diferenci\u00E1ln\u00ED diagn\u00F3ze u imunosuprimovan\u00FDch pacient\u016F s poruchou ren\u00E1ln\u00EDch funkc\u00ED nebo neurologick\u00FDmi symptomy.\nU pacient\u016F l\u00E9\u010Den\u00FDch p\u0159\u00EDpravkem Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta je t\u0159eba monitorovat po\u010Det neutrofil\u016F. Rozvoj neutropenie m\u016F\u017Ee b\u00FDt d\u016Fsledkem pod\u00E1v\u00E1n\u00ED mykofenol\u00E1t mofetilu samotn\u00E9ho, dal\u0161\u00ED soub\u011B\u017En\u00E9 medikace, virov\u00FDch infekc\u00ED nebo kombinac\u00ED t\u011Bchto vliv\u016F. Pacient\u016Fm u\u017E\u00EDvaj\u00EDc\u00EDm Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta je t\u0159eba vy\u0161et\u0159it kompletn\u00ED krevn\u00ED obraz jednou t\u00FDdn\u011B v pr\u016Fb\u011Bhu prvn\u00EDho m\u011Bs\u00EDce, dvakr\u00E1t za m\u011Bs\u00EDc ve druh\u00E9m a t\u0159et\u00EDm m\u011Bs\u00EDci l\u00E9\u010Dby a d\u00E1le jednou za m\u011Bs\u00EDc b\u011Bhem prvn\u00EDho roku. Pokud dojde k rozvoji neutropenie (absolutn\u00ED po\u010Det neutrofil\u016F < 1,3 x 103/\u03BCl), m\u016F\u017Ee b\u00FDt vhodn\u00E9 p\u0159eru\u0161en\u00ED nebo ukon\u010Den\u00ED l\u00E9\u010Dby p\u0159\u00EDpravkem Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta .\nU pacient\u016F l\u00E9\u010Den\u00FDch p\u0159\u00EDpravkem Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta v kombinaci s dal\u0161\u00EDmi imunosupresivn\u00EDmi l\u00E1tkami byly zaznamen\u00E1ny p\u0159\u00EDpady \u010Dist\u00E9 aplazie \u010Derven\u00E9 krevn\u00ED \u0159ady (PRCA). Mechanismus, jak\u00FDm mykofenol\u00E1t mofetil indukuje PRCA, nen\u00ED zn\u00E1m\u00FD. PRCA m\u016F\u017Ee b\u00FDt upravena sn\u00ED\u017Een\u00EDm d\u00E1vek nebo p\u0159eru\u0161en\u00EDm terapie mykofenol\u00E1t mofetilem. Zm\u011Bny v l\u00E9\u010Db\u011B p\u0159\u00EDpravkem Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta by u pacient\u016F po transplantaci m\u011Bly b\u00FDt prov\u00E1d\u011Bny pouze pod dohledem l\u00E9ka\u0159e, kter\u00FD m\u00E1 zku\u0161enosti s l\u00E9\u010Dbou takov\u00FDchto pacient\u016F, aby se minimalizovalo riziko odlou\u010Den\u00ED \u0161t\u011Bpu (viz bod 4.8).\nPacienti maj\u00ED b\u00FDt pou\u010Deni, \u017Ee v pr\u016Fb\u011Bhu l\u00E9\u010Dby p\u0159\u00EDpravkem Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta m\u016F\u017Ee b\u00FDt vakcinace m\u00E9n\u011B \u00FA\u010Dinn\u00E1 a \u017Ee by nem\u011Blo b\u00FDt prov\u00E1d\u011Bno o\u010Dkov\u00E1n\u00ED \u017Eiv\u00FDmi oslaben\u00FDmi vakc\u00EDnami (viz bod 4.5). O\u010Dkov\u00E1n\u00ED proti ch\u0159ipce se m\u016F\u017Ee prov\u00E1d\u011Bt. L\u00E9ka\u0159 by se m\u011Bl \u0159\u00EDdit n\u00E1rodn\u00EDmi sm\u011Brnicemi vakcinace proti ch\u0159ipce.\nProto\u017Ee pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta je spojeno se zv\u00FD\u0161en\u00EDm incidence v\u00FDskytu ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F v gastrointestin\u00E1ln\u00EDm traktu, v\u010Detn\u011B velmi vz\u00E1cn\u00FDch p\u0159\u00EDpad\u016F ulcerace, krv\u00E1cen\u00ED a perforace, je nutno pod\u00E1vat Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta velmi opatrn\u011B pacient\u016Fm s v\u00E1\u017En\u00FDm aktivn\u00EDm onemocn\u011Bn\u00EDm gastrointestin\u00E1ln\u00EDho traktu.\nMykofenol\u00E1t mofetil je inhibitor inosin monofosf\u00E1tdehydrogen\u00E1zy (IMPDH). Nem\u011Bl by b\u00FDt proto teoreticky pod\u00E1v\u00E1n pacient\u016Fm se vz\u00E1cn\u00FDm d\u011Bdi\u010Dn\u00FDm deficitem hypoxantin-guanin-fosforibosyltransfer\u00E1zy (HGPRT), jako je Lesh-Nyhan\u016Fv syndrom a Kelley-Seegmiller\u016Fv syndrom.\nDoporu\u010Duje se, aby Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta nebyl pod\u00E1v\u00E1n sou\u010Dasn\u011B s azathioprinem, proto\u017Ee tato kombinace dosud nebyla studov\u00E1na.\nS ohledem na signifikantn\u00ED sn\u00ED\u017Een\u00ED hodnot AUC MPA cholestyraminem, je t\u0159eba d\u00E1vat pozor p\u0159i soub\u011B\u017En\u00E9m pod\u00E1n\u00ED p\u0159\u00EDpravku Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta s l\u00E9\u010Div\u00FDmi p\u0159\u00EDpravky, kter\u00E9 interferuj\u00ED s enterohepatickou recirkulac\u00ED, pro mo\u017En\u00E9 sn\u00ED\u017Een\u00ED \u00FA\u010Dinnosti p\u0159\u00EDpravku. Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta.\nPom\u011Br rizika k prosp\u011Bchu sou\u010Dasn\u00E9ho pod\u00E1v\u00E1n\u00ED mykofenol\u00E1t mofetilu s takrolimem nebo sirolimem Mycophenolate mofetil Stada 500 mg potahovan\u00E1 tableta nebyl stanoven (viz t\u00E9\u017E bod 4.5).\n"@cs . . . . "004.004" . . . . . . . "4.4 Zvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED"@cs . . . .