. . . . . "U nejz\u00E1va\u017En\u011Bj\u0161\u00EDch p\u0159\u00EDpad\u016F pneumokokov\u00E9 pneumonie nemus\u00ED Levofloxacin Actavis p\u0159edstavovat optim\u00E1ln\u00ED l\u00E9\u010Dbu.\nNozokomi\u00E1ln\u00ED infekce vyvolan\u00E9 P. aeruginosa mohou vy\u017Eadovat kombinovanou l\u00E9\u010Dbu.\nD\u00E9lka infuze\nM\u00E1 se dodr\u017Eet doporu\u010Den\u00E1 d\u00E9lka infuze alespo\u0148 30 minut pro 250 mg p\u0159\u00EDpravku Levofloxacin Actavis nebo 60 minut pro 500 mg p\u0159\u00EDpravku Levofloxacin Actavis. U ofloxacinu je zn\u00E1mo, \u017Ee v\u00A0pr\u016Fb\u011Bhu infuze m\u016F\u017Ee vzniknout tachykardie a p\u0159echodn\u00FD pokles krevn\u00EDho tlaku. Ve vz\u00E1cn\u00FDch p\u0159\u00EDpadech, jako n\u00E1sledek v\u00FDrazn\u00E9ho poklesu krevn\u00EDho tlaku, m\u016F\u017Ee doj\u00EDt k\u00A0ob\u011Bhov\u00E9mu kolapsu. Dojde-li k\u00A0n\u00E1padn\u00E9mu poklesu krevn\u00EDho tlaku v\u00A0pr\u016Fb\u011Bhu infuze levofloxacinu (l-izomeru ofloxacinu), mus\u00ED b\u00FDt infuze okam\u017Eit\u011B p\u0159eru\u0161ena.\nMethicilin rezistentn\u00ED Staphylococcus aureus (MRSA)\nMethicilin rezistentn\u00ED Staphylococcus aureus je velmi pravd\u011Bpodobn\u011B rezistentn\u00ED i na fluorochinolony, v\u010Detn\u011B levofloxacinu. Levofloxacin se proto nedoporu\u010Duje v\u00A0l\u00E9\u010Db\u011B suspektn\u00EDch nebo zn\u00E1m\u00FDch infekc\u00ED vyvolan\u00FDch MRSA, pokud laboratorn\u00ED v\u00FDsledky nepotvrdily citlivost mikroorganizmu na levofloxacin (viz bod 5.1).\nTendinitida a ruptura \u0161lachy\nTendinitida, kter\u00E1 je vz\u00E1cn\u011B pozorov\u00E1na, postihuje zejm\u00E9na Achillovu \u0161lachu a m\u016F\u017Ee n\u011Bkdy v\u00E9st a\u017E k\u00A0jej\u00ED ruptu\u0159e. Riziko tenditidy a ruptury \u0161lachy je zv\u00FD\u0161eno u star\u0161\u00EDch pacient\u016F a sou\u010Dasn\u00FDm pod\u00E1v\u00E1n\u00EDm kortikosteroid\u016F. Pe\u010Dliv\u00E9 monitorov\u00E1n\u00ED t\u011Bchto pacient\u016F je proto nezbytn\u00E9, je-li u nich p\u0159edeps\u00E1n Levofloxacin Actavis. V\u0161ichni pacienti maj\u00ED b\u00FDt informovat l\u00E9ka\u0159e, jestli\u017Ee se objev\u00ED p\u0159\u00EDznaky tendinitidy. P\u0159i podez\u0159en\u00ED na tendinitidu, je nutno okam\u017Eit\u011B zastavit pod\u00E1v\u00E1n\u00ED levofloxacinu a zah\u00E1jit p\u0159\u00EDslu\u0161nou l\u00E9\u010Dbu posti\u017Een\u00E9 \u0161lachy (nap\u0159. jej\u00ED imobilizac\u00ED).\n\t\nOnemocn\u011Bn\u00ED zp\u016Fsoben\u00E1 Clostridium difficile\nPr\u016Fjem, zejm\u00E9na t\u011B\u017Ek\u00FD, p\u0159etrv\u00E1vaj\u00EDc\u00ED a/nebo s\u00A0p\u0159\u00EDm\u011Bs\u00ED krve, kter\u00FD se objev\u00ED v\u00A0pr\u016Fb\u011Bhu nebo po ukon\u010Den\u00ED l\u00E9\u010Dby p\u0159\u00EDpravkem Levofloxacin Actavis, m\u016F\u017Ee b\u00FDt zn\u00E1mkou kolitidy vyvolan\u00E9 patogenem Clostridium difficile, jej\u00ED\u017E nejz\u00E1va\u017En\u011Bj\u0161\u00ED formou je pseudomembran\u00F3zn\u00ED kolitida. Je-li podez\u0159en\u00ED na pseudomembran\u00F3zn\u00ED kolitidu, je nutno ihned ukon\u010Dit pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Levofloxacin Actavis a bez prodlen\u00ED poskytnout pacientovi vhodnou podp\u016Frnou l\u00E9\u010Dbu a specifickou terapii (nap\u0159. metronidazol nebo vankomycin peror\u00E1ln\u011B). P\u0159\u00EDpravky inhibuj\u00EDc\u00ED peristaltiku jsou v\u00A0tomto stavu p\u0159\u00EDsn\u011B kontraindikov\u00E1ny.\nPacienti s predispozic\u00ED k z\u00E1chvat\u016Fm\nLevofloxacin Actavis je kontraindikov\u00E1n u pacient\u016F s\u00A0anamn\u00E9zou epilepsie a u pacient\u016F s\u00A0predispozic\u00ED k z\u00E1chvat\u016Fm by m\u011Bl b\u00FDt, stejn\u011B jako ostatn\u00ED chinolony, u\u017E\u00EDv\u00E1n s\u00A0mimo\u0159\u00E1dnou opatrnost\u00ED. Jedn\u00E1 se nap\u0159\u00EDklad o pacienty s\u00A0l\u00E9z\u00ED CNS, pacienty l\u00E9\u010Den\u00E9 sou\u010Dasn\u011B fenbufenem a obdobn\u00FDmi nesteroidn\u00EDmi protiz\u00E1n\u011Btliv\u00FDmi l\u00E9ky sni\u017Euj\u00EDc\u00EDmi pr\u00E1h mozkov\u00FDch z\u00E1chvat\u016F, nap\u0159. theofylin (viz tak\u00E9 bod 4.5). V\u00A0p\u0159\u00EDpad\u011B rozvoje epileptick\u00E9ho z\u00E1chvatu je nutn\u00E9 l\u00E9\u010Dbu levofloxacinem ukon\u010Dit.\nPacienti s\u00A0deficienc\u00ED G-6-fosf\u00E1t dehydrogen\u00E1zy\nPacienti s\u00A0latentn\u00ED nebo zjevnou poruchou gluk\u00F3za-6-fosf\u00E1t-dehydrogen\u00E1zov\u00E9 aktivity mohou b\u00FDt n\u00E1chyln\u00ED k\u00A0hemolytick\u00FDm reakc\u00EDm, jsou-li l\u00E9\u010Deni chinolonov\u00FDmi antibakteri\u00E1ln\u00EDmi l\u00E1tkami, a proto je p\u0159i l\u00E9\u010Db\u011B levofloxacinem zapot\u0159eb\u00ED opatrnosti.\nPacienti s\u00A0poruchou funkce ledvin\nProto\u017Ee je levofloxacin vylu\u010Dov\u00E1n p\u0159ev\u00E1\u017En\u011B ledvinami, je vhodn\u00E9 d\u00E1vky p\u0159\u00EDpravku Levofloxacin Actavis u pacient\u016F s\u00A0poruchou funkce ledvin upravit (viz bod 4.2).\nReakce z\u00A0p\u0159ecitliv\u011Blosti\nLevofloxacin m\u016F\u017Ee zp\u016Fsobovat z\u00E1va\u017En\u00E9, potencion\u00E1ln\u011B fat\u00E1ln\u00ED reakce z\u00A0p\u0159ecitliv\u011Blosti (nap\u0159\u00EDklad angioed\u00E9m a\u017E anafylaktick\u00FD \u0161ok), n\u011Bkdy i po pod\u00E1n\u00ED \u00FAvodn\u00ED d\u00E1vky (viz bod 4.8). Pacienti maj\u00ED okam\u017Eit\u011B p\u0159eru\u0161it l\u00E9\u010Dbu a kontaktovat sv\u00E9ho l\u00E9ka\u0159e nebo l\u00E9ka\u0159skou pohotovostn\u00ED slu\u017Ebu, aby mohla b\u00FDt p\u0159ijata vhodn\u00E1 urgentn\u00ED opat\u0159en\u00ED.\nHypoglykemie\nStejn\u011B jako u v\u0161ech chinolin\u016F, m\u016F\u017Ee i u p\u0159\u00EDpravku Levofloxacin Actavis doj\u00EDt k\u00A0rozvoji hypoglykemie, obvykle u diabetick\u00FDch pacient\u016F sou\u010Dasn\u011B l\u00E9\u010Den\u00FDch peror\u00E1ln\u00EDmi antidiabetiky (nap\u0159\u00EDklad glibenklamidem) nebo inzulinem. U t\u011Bchto diabetik\u016F se doporu\u010Duje pe\u010Dliv\u011B monitorovat hladinu gluk\u00F3zy v\u00A0krvi (viz bod 4.8).\nPrevence fotosenzibilizace \nP\u0159esto\u017Ee se fotosenzibilizace objevuje u l\u00E9\u010Dby levofloxacinem velmi vz\u00E1cn\u011B, doporu\u010Duje se pacient\u016Fm nevystavovat se siln\u00E9mu slune\u010Dn\u00EDmu z\u00E1\u0159en\u00ED nebo um\u011Bl\u00FDm UV paprsk\u016Fm (nap\u0159. horsk\u00E9 slunce, sol\u00E1rium), aby fotosenzibilizaci p\u0159ede\u0161li.\nPacienti l\u00E9\u010Den\u00ED antagonisty vitaminu K\nVzhledem k mo\u017En\u00FDm zv\u00FD\u0161en\u00FDm hodnot\u00E1m koagula\u010Dn\u00EDch parametr\u016F (protrombinov\u00FD \u010Das (Quick\u016Fv test)/INR) a/nebo krv\u00E1cen\u00ED u pacient\u016F l\u00E9\u010Den\u00FDch levofloxacinem v kombinaci s antagonisty vitaminu K (nap\u0159. warfarin) mus\u00ED b\u00FDt sledov\u00E1ny i koagula\u010Dn\u00ED parametry, pokud jsou tyto p\u0159\u00EDpravky u\u017E\u00EDv\u00E1ny soub\u011B\u017En\u011B (viz bod 4.5). \nPsychotick\u00E9 reakce\nU pacient\u016F l\u00E9\u010Den\u00FDch chinolony, v\u010Detn\u011B levofloxacinu, byly pozorov\u00E1ny psychotick\u00E9 reakce. Ve velmi vz\u00E1cn\u00FDch p\u0159\u00EDpadech vedly tyto stavy k\u00A0sebevra\u017Eedn\u00FDm my\u0161lenk\u00E1m a sebepo\u0161kozuj\u00EDc\u00EDmu chov\u00E1n\u00ED, n\u011Bkdy i v\u00A0d\u016Fsledku pod\u00E1n\u00ED jedin\u00E9 d\u00E1vky levofloxacinu (viz bod 4.8). V\u00A0p\u0159\u00EDpad\u011B rozvoje takov\u00E9to rekce je nutn\u00E9 p\u0159eru\u0161it l\u00E9\u010Dbu a p\u0159ijmout p\u0159\u00EDslu\u0161n\u00E1 opat\u0159en\u00ED. U pacient\u016F s\u00A0psychotick\u00FDmi poruchami a u pacient\u016F s\u00A0anamn\u00E9zou psychiatrick\u00E9ho onemocn\u011Bn\u00ED je t\u0159eba db\u00E1t p\u0159i l\u00E9\u010Db\u011B opatrnosti.\nProdlou\u017Een\u00ED intervalu QT\nP\u0159i pou\u017E\u00EDv\u00E1n\u00ED fluorochinolonu v\u010Detn\u011B levofloxacinu, je t\u0159eba db\u00E1t opatrnosti u pacient\u016F s\u00A0rizikov\u00FDmi faktory pro prodlou\u017Een\u00ED intervalu QT, jako jsou nap\u0159\u00EDklad:\nsyndrom vrozen\u00E9ho prodlou\u017Een\u00ED intervalu QT\nsou\u010Dasn\u00E1 l\u00E9\u010Dba p\u0159\u00EDpravky prodlu\u017Euj\u00EDc\u00EDmi interval QT (nap\u0159\u00EDklad IA a III. t\u0159\u00EDda antiarytmik, tricyklick\u00E1 antidepresiva, makrolidy)\nnekorigovan\u00E1 nerovnov\u00E1ha miner\u00E1l\u016F (nap\u0159\u00EDklad hypokalemie, hypomagnesemie)\nvy\u0161\u0161\u00ED v\u011Bk\nsrde\u010Dn\u00ED onemocn\u011Bn\u00ED (nap\u0159\u00EDklad srde\u010Dn\u00ED selh\u00E1n\u00ED, infarkt myokardu, bradykardie) (viz body 4.2 D\u00E1vkov\u00E1n\u00ED u star\u0161\u00EDch pacient\u016F , 4.5, 4.8, 4.9).\nPerifern\u00ED neuropatie\nU pacient\u016F l\u00E9\u010Den\u00FDch fluorochinolony, v\u010Detn\u011B levofloxacinu, byla hl\u00E1\u0161ena senzorick\u00E1 nebo senzoricko-motorick\u00E1 perifern\u00ED neuropatie. Jej\u00ED n\u00E1stup m\u016F\u017Ee b\u00FDt rychl\u00FD. Pokud u pacienta dojde k\u00A0projev\u016Fm neuropatie, je t\u0159eba l\u00E9\u010Dbu ukon\u010Dit, aby nedo\u0161lo k\u00A0ireverzibiln\u00EDmu po\u0161kozen\u00ED.\nOpi\u00E1ty\nU pacient\u016F l\u00E9\u010Den\u00FDch levofloxacinem m\u016F\u017Ee p\u0159i testu na p\u0159\u00EDtomnost opi\u00E1t\u016F v\u00A0mo\u010Di doj\u00EDt k\u00A0fale\u0161n\u011B pozitivn\u00EDmu v\u00FDsledku. M\u016F\u017Ee b\u00FDt nezbytn\u00E9 pou\u017E\u00EDt v\u00EDce specifickou metodu.\nPosti\u017Een\u00ED jater a \u017Elu\u010Dov\u00FDch cest\nU pacient\u016F l\u00E9\u010Den\u00FDch levofloxacinem byly hl\u00E1\u0161eny p\u0159\u00EDpady jatern\u00ED nekr\u00F3zy a\u017E \u017Eivot ohro\u017Euj\u00EDc\u00EDho jatern\u00EDho selh\u00E1n\u00ED, zejm\u00E9na pak u pacient\u016F s\u00A0jin\u00FDm z\u00E1kladn\u00EDm onemocn\u011Bn\u00EDm, nap\u0159\u00EDklad seps\u00ED (viz bod 4.8). Pacienty je t\u0159eba upozornit, aby p\u0159eru\u0161ili l\u00E9\u010Dbu a kontaktovali l\u00E9ka\u0159e v\u00A0p\u0159\u00EDpad\u011B rozvoje projev\u016F jatern\u00EDho posti\u017Een\u00ED, nap\u0159\u00EDklad anorexie, \u017Eloutenky, tmav\u00E9 mo\u010Di, sv\u011Bd\u011Bn\u00ED nebo bolesti b\u0159icha.\nTento l\u00E9\u010Div\u00FD p\u0159\u00EDpravek obsahuje 7,70 mmol (177,10 mg) sod\u00EDku na 50 ml, 15,40 mmol (354,20 mg) sod\u00EDku na 100 ml roztoku. Tuto skute\u010Dnost je t\u0159eba br\u00E1t v\u00A0\u00FAvahu u pacient\u016F s\u00A0kontrolovan\u00FDm obsahem sod\u00EDku v\u00A0diet\u011B a u pacient\u016F, kde je nutn\u00E9 omezen\u00ED tekutin.\n"@cs . . . . . . . . . . . . . . . . . . . . . . "4.4. Zvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED"@cs . . . . . "004.004" . .