"004.004" . . . . . . . . . . . . . . . . . . . "Hyperkalemie \nSoub\u011B\u017En\u00E9 pou\u017Eit\u00ED s dopl\u0148ky obsahuj\u00EDc\u00EDmi drasl\u00EDk, diuretiky \u0161et\u0159\u00EDc\u00EDmi drasl\u00EDk, n\u00E1hradami soli obsahuj\u00EDc\u00EDmi drasl\u00EDk nebo jin\u00FDmi l\u00E1tkami, kter\u00E9 mohou zv\u00FD\u0161it hladiny drasl\u00EDku (heparin apod.) se nedoporu\u010Duje. Monitorov\u00E1n\u00ED hladin drasl\u00EDku by m\u011Blo b\u00FDt prov\u00E1d\u011Bno podle pot\u0159eby. \nPacienti s deplec\u00ED sod\u00EDku a/nebo s deplec\u00ED tekutin \nU pacient\u016F se z\u00E1va\u017Enou deplec\u00ED sod\u00EDku a/nebo deplec\u00ED tekutin, jako jsou pacienti u\u017E\u00EDvaj\u00EDc\u00ED vysok\u00E9 d\u00E1vky diuretik, se m\u016F\u017Ee ve vz\u00E1cn\u00FDch p\u0159\u00EDpadech vyskytnout symptomatick\u00E1 hypotenze po zah\u00E1jen\u00ED l\u00E9\u010Dby p\u0159\u00EDpravkem Valsartan Orion. P\u0159ed zah\u00E1jen\u00EDm l\u00E9\u010Dby Valsartanem Orion je t\u0159eba depleci sod\u00EDku a/nebo tekutin korigovat, nap\u0159\u00EDklad sn\u00ED\u017Een\u00EDm d\u00E1vky diuretika. \nSten\u00F3za ren\u00E1ln\u00EDch art\u00E9ri\u00ED \nU pacient\u016F s bilater\u00E1ln\u00ED sten\u00F3zou ren\u00E1ln\u00EDch art\u00E9ri\u00ED nebo sten\u00F3zou art\u00E9rie jedin\u00E9 ledviny nebylo prok\u00E1z\u00E1no bezpe\u010Dn\u00E9 pou\u017Eit\u00ED p\u0159\u00EDpravku Valsartan Orion. \nKr\u00E1tkodob\u00E9 pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Valsartan Orion dvan\u00E1cti pacient\u016Fm se sekund\u00E1rn\u00ED renovaskul\u00E1rn\u00ED hypertenz\u00ED p\u0159i unilater\u00E1ln\u00ED sten\u00F3ze ren\u00E1ln\u00ED art\u00E9rie nevyvolalo \u017E\u00E1dn\u00E9 v\u00FDznamn\u00E9 zm\u011Bny v ren\u00E1ln\u00ED hemodynamice, hladin\u011B kreatininu v s\u00E9ru ani hladin\u011B dus\u00EDku mo\u010Doviny v krvi (BUN). P\u0159esto mohou jin\u00E9 l\u00E1tky, kter\u00E9 ovliv\u0148uj\u00ED renin-angiotensinov\u00FD syst\u00E9m, zv\u00FD\u0161it hladinu mo\u010Doviny v krvi a hladinu kreatininu v s\u00E9ru u pacient\u016F s unilater\u00E1ln\u00ED sten\u00F3zou ren\u00E1ln\u00ED art\u00E9rie, proto se doporu\u010Duje monitorov\u00E1n\u00ED funkce ledvin u pacient\u016F l\u00E9\u010Den\u00FDch valsartanem. \nTransplantace ledvin \nV sou\u010Dasnosti nejsou zku\u0161enosti s bezpe\u010Dn\u00FDm pou\u017E\u00EDv\u00E1n\u00EDm p\u0159\u00EDpravku Valsartan Orion u pacient\u016F, kte\u0159\u00ED ned\u00E1vno podstoupili transplantaci ledvin. \nPrim\u00E1rn\u00ED hyperaldosteronismus \nPacienti s prim\u00E1rn\u00EDm hyperaldosteronismem by nem\u011Bli b\u00FDt l\u00E9\u010Deni Valsartanem Orion, proto\u017Ee jejich renin-angiotensinov\u00FD syst\u00E9m nen\u00ED aktivov\u00E1n. \nSten\u00F3za aort\u00E1ln\u00ED a mitr\u00E1ln\u00ED chlopn\u011B, obstruk\u010Dn\u00ED hypertrofick\u00E1 kardiomyopatie \nStejn\u011B jako p\u0159i l\u00E9\u010Db\u011B jin\u00FDmi vazodilatancii je u pacient\u016F trp\u00EDc\u00EDch sten\u00F3zou aort\u00E1ln\u00ED a mitr\u00E1ln\u00ED chlopn\u011B nebo obstruk\u010Dn\u00ED hypertrofickou kardiomyopati\u00ED (HOCM) nutn\u00E1 zvl\u00E1\u0161tn\u00ED opatrnost. \nPo\u0161kozen\u00E1 funkce ledvin \n\u00DAprava d\u00E1vkov\u00E1n\u00ED u pacient\u016F s clearance kreatininu >10 ml/min nen\u00ED nutn\u00E1. V sou\u010Dasnosti nejsou zku\u0161enosti s bezpe\u010Dn\u00FDm pou\u017Eit\u00EDm u pacient\u016F s clearance kreatininu <10 ml/min a u pacient\u016F podstupuj\u00EDc\u00EDch dial\u00FDzu, proto by valsartan m\u011Bl b\u00FDt u t\u011Bchto pacient\u016F pou\u017E\u00EDv\u00E1n s opatrnost\u00ED (viz body 4.2 a 5.2).\nPo\u0161kozen\u00ED jater \nU pacient\u016F s m\u00EDrn\u00FDm a\u017E st\u0159edn\u011B z\u00E1va\u017En\u00FDm po\u0161kozen\u00EDm jater bez cholest\u00E1zy by m\u011Bl b\u00FDt Valsartan Orion pou\u017E\u00EDv\u00E1n s opatrnost\u00ED (viz body 4.2 a 5.2). \nT\u011Bhotenstv\u00ED \nL\u00E9\u010Dba inhibitory receptor\u016F angiotensinu II (AIIRA) nesm\u00ED b\u00FDt b\u011Bhem t\u011Bhotenstv\u00ED zah\u00E1jena. Pokud nen\u00ED pokra\u010Dov\u00E1n\u00ED v l\u00E9\u010Db\u011B AIIRA pova\u017Eov\u00E1no za nezbytn\u00E9, pacientky pl\u00E1nuj\u00EDc\u00ED t\u011Bhotenstv\u00ED mus\u00ED b\u00FDt p\u0159evedeny na jinou antihypertenzn\u00ED l\u00E9\u010Dbu s prok\u00E1zan\u00FDm bezpe\u010Dnostn\u00EDm profilem pro pod\u00E1v\u00E1n\u00ED v t\u011Bhotenstv\u00ED. Jestli\u017Ee je zji\u0161t\u011Bno t\u011Bhotenstv\u00ED, l\u00E9\u010Dba AIIRA mus\u00ED b\u00FDt ihned ukon\u010Dena, a pokud je to vhodn\u00E9, je nutno nasadit alternativn\u00ED l\u00E9\u010Dbu (viz body 4.3 a 4.6). \nNed\u00E1vno prod\u011Blan\u00FD infarkt myokardu (pouze 40 mg, 80 mg a 160 mg) \nU kombinace kaptoprilu a valsartanu nebyl pozorov\u00E1n p\u0159\u00EDdavn\u00FD klinick\u00FD p\u0159\u00EDnos, ale naopak bylo zv\u00FD\u0161eno riziko ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F v porovn\u00E1n\u00ED s l\u00E9\u010Dbou jednotliv\u00FDmi p\u0159\u00EDpravky (viz body 4.2 a 5.1). Proto nen\u00ED kombinace valsartanu s inhibitory ACE doporu\u010Dov\u00E1na. \nP\u0159i zah\u00E1jen\u00ED l\u00E9\u010Dby u pacient\u016F po infarktu myokardu je zapot\u0159eb\u00ED opatrnost. Zhodnocen\u00ED stavu pacient\u016F po infarktu myokardu by m\u011Blo v\u017Edy zahrnovat vy\u0161et\u0159en\u00ED funkce ledvin (viz bod 4.2). \nPod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Valsartan Orion u pacient\u016F po infarktu myokardu \u010Dasto vede k ur\u010Dit\u00E9mu sn\u00ED\u017Een\u00ED krevn\u00EDho tlaku, ale p\u0159eru\u0161en\u00ED l\u00E9\u010Dby z d\u016Fvodu pokra\u010Duj\u00EDc\u00ED symptomatick\u00E9 hypotenze nen\u00ED obvykle nutn\u00E9, pokud jsou dodr\u017Eov\u00E1ny pokyny o d\u00E1vkov\u00E1n\u00ED (viz bod 4.2). \nSrde\u010Dn\u00ED selh\u00E1n\u00ED (pouze 40 mg, 80 mg a 160 mg) \nU pacient\u016F se srde\u010Dn\u00EDm selh\u00E1n\u00EDm nebyl pozorov\u00E1n \u017E\u00E1dn\u00FD klinick\u00FD p\u0159\u00EDnos pou\u017Eit\u00ED trojkombinace inhibitoru ACE, beta-blok\u00E1toru a p\u0159\u00EDpravku Valsartan Orion (viz bod 5.1). Tato kombinace z\u0159ejm\u011B zvy\u0161uje riziko ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F, a proto se nedoporu\u010Duje. \nP\u0159i zah\u00E1jen\u00ED l\u00E9\u010Dby u pacient\u016F se srde\u010Dn\u00EDm selh\u00E1n\u00EDm je zapot\u0159eb\u00ED opatrnost. Zhodnocen\u00ED stavu pacient\u016F se srde\u010Dn\u00EDm selh\u00E1n\u00EDm by m\u011Blo v\u017Edy zahrnovat vy\u0161et\u0159en\u00ED funkce ledvin (viz bod 4.2). \nPod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Valsartan Orion u pacient\u016F se srde\u010Dn\u00EDm selh\u00E1n\u00EDm \u010Dasto vede k ur\u010Dit\u00E9mu sn\u00ED\u017Een\u00ED krevn\u00EDho tlaku, ale p\u0159eru\u0161en\u00ED l\u00E9\u010Dby z d\u016Fvodu pokra\u010Duj\u00EDc\u00ED symptomatick\u00E9 hypotenze nen\u00ED obvykle nutn\u00E9, pokud jsou dodr\u017Eov\u00E1ny pokyny o d\u00E1vkov\u00E1n\u00ED (viz bod 4.2).\nU pacient\u016F, jejich\u017E funkce ledvin m\u016F\u017Ee b\u00FDt z\u00E1visl\u00E1 na aktivit\u011B renin-angiotensinov\u00E9ho syst\u00E9mu (nap\u0159\u00EDklad pacienti se z\u00E1va\u017En\u00FDm m\u011Bstnav\u00FDm srde\u010Dn\u00EDm selh\u00E1n\u00EDm) byla l\u00E9\u010Dba inhibitory enzymu konvertuj\u00EDc\u00EDho angiotensin spojena s oliguri\u00ED a/nebo progresivn\u00ED azotemi\u00ED a ve vz\u00E1cn\u00FDch p\u0159\u00EDpadech s akutn\u00EDm selh\u00E1n\u00EDm ledvin a/nebo smrt\u00ED. Proto\u017Ee valsartan je antagonistou angiotensinu II, nelze vylou\u010Dit mo\u017Enost, \u017Ee pou\u017Eit\u00ED p\u0159\u00EDpravku Valsartan Orion m\u016F\u017Ee b\u00FDt spojeno s po\u0161kozen\u00EDm funkce ledvin. \n"@cs . . . "4.4 Zvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED "@cs . . . . .