. "004.002" . . . . . . "Zp\u016Fsob pod\u00E1v\u00E1n\u00ED\n1 g pr\u00E1\u0161ek pro injek\u010Dn\u00ED nebo infuzn\u00ED roztok:\nintraven\u00F3zn\u00ED pod\u00E1n\u00ED\nintramuskul\u00E1rn\u00ED pod\u00E1n\u00ED (ve v\u00FDjime\u010Dn\u00FDch klinick\u00FDch situac\u00EDch)\n2 g pr\u00E1\u0161ek pro injek\u010Dn\u00ED nebo infuzn\u00ED roztok:\nintraven\u00F3zn\u00ED pod\u00E1n\u00ED\nD\u00E1vkov\u00E1n\u00ED\n\tTabulka 1: Dosp\u011Bl\u00ED a d\u011Bti \u2265 40 kg \nIntermitentn\u00ED pod\u00E1v\u00E1n\u00ED\nInfekce \nD\u00E1vka, kterou je t\u0159eba aplikovat \nBronchopulmon\u00E1ln\u00ED infekce u cystick\u00E9 fibr\u00F3zy \n100 a\u017E 150 mg/kg/den ka\u017Ed\u00FDch 8 hodin; maxim\u00E1ln\u00ED d\u00E1vka 9 g/den1 \nFebriln\u00ED neutropenie\n2 g ka\u017Ed\u00FDch 8 hodin \nNozokomi\u00E1ln\u00ED pneumonie \nBakteri\u00E1ln\u00ED meningitida \nBakteriemie* \nInfekce kost\u00ED a kloub\u016F \n1-2 g ka\u017Ed\u00FDch 8 hodin\nKomplikovan\u00E9 infekce k\u016F\u017Ee a m\u011Bkk\u00FDch tk\u00E1n\u00ED \nKomplikovan\u00E9 intraabdomin\u00E1ln\u00ED infekce\nPeritonitida souvisej\u00EDc\u00ED s dial\u00FDzou u pacient\u016F na CAPD\nKomplikovan\u00E9 infekce mo\u010Dov\u00FDch cest \n1-2 g ka\u017Ed\u00FDch 8 nebo 12 hodin \nPeropera\u010Dn\u00ED profylaxe u transuretr\u00E1ln\u00ED resekce prostaty (TURP) \n1 g p\u0159i \u00FAvodu do anestezie a druh\u00E1 d\u00E1vka p\u0159i odstran\u011Bn\u00ED katetru \nChronick\u00FD hnisav\u00FD z\u00E1n\u011Bt st\u0159edou\u0161\u00ED \n1 g a\u017E 2 g ka\u017Ed\u00FDch 8 hodin\nOtitis externa maligna \nKontinu\u00E1ln\u00ED infuze\nInfekce \nD\u00E1vka, kterou je t\u0159eba aplikovat \nFebriln\u00ED neutropenie \nNasycovac\u00ED d\u00E1vka 2 g n\u00E1sledovan\u00E1 kontinu\u00E1ln\u00ED infuz\u00ED s d\u00E1vkou 4 a\u017E 6 g ka\u017Ed\u00FDch 24 hodin1\nNozokomi\u00E1ln\u00ED pneumonie \nBronchopulmon\u00E1ln\u00ED infekce u cystick\u00E9 fibr\u00F3zy \nBakteri\u00E1ln\u00ED meningitida \nBakteriemie* \nInfekce kost\u00ED a kloub\u016F \nKomplikovan\u00E9 infekce k\u016F\u017Ee a m\u011Bkk\u00FDch tk\u00E1n\u00ED \nKomplikovan\u00E9 intraabdomin\u00E1ln\u00ED infekce \nPeritonitida souvisej\u00EDc\u00ED s dial\u00FDzou u pacient\u016F na CAPD \n1U dosp\u011Bl\u00FDch pacient\u016F s norm\u00E1ln\u00EDmi ren\u00E1ln\u00EDmi funkcemi byla pou\u017Eita d\u00E1vka 9 g/den bez ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F. \n*Souvis\u00ED-li s jakoukoli z infekc\u00ED shrnut\u00FDch v bod\u011B 4.1, nebo je-li podez\u0159en\u00ED, \u017Ee m\u016F\u017Ee m\u00EDt souvislost s jakoukoli z t\u011Bchto infekc\u00ED. \nTabulka 2: D\u011Bti < 40 kg \n\tKojenci a batolata > 2 m\u011Bs\u00EDce a d\u011Bti < 40 kg\n\tIntermitentn\u00ED pod\u00E1v\u00E1n\u00ED\n\tInfekce \n\tObvykl\u00E1 d\u00E1vka \n\tKomplikovan\u00E9 infekce mo\u010Dov\u00FDch cest\n\t100-150 mg/kg/den ve t\u0159ech rozd\u011Blen\u00FDch d\u00E1vk\u00E1ch, maxim\u00E1ln\u00ED d\u00E1vka 6 g/den\n\tChronick\u00FD hnisav\u00FD z\u00E1n\u011Bt st\u0159edou\u0161\u00ED \n\t\n\tOtitis externa maligna \n\t\n\tD\u011Bti s neutropeni\u00ED\n\t150 mg/kg/den ve t\u0159ech rozd\u011Blen\u00FDch d\u00E1vk\u00E1ch; maxim\u00E1ln\u00ED d\u00E1vka 6 g/den\n\tBronchopulmon\u00E1ln\u00ED infekce u cystick\u00E9 fibr\u00F3zy \n\t\n\tBakteri\u00E1ln\u00ED meningitida \n\t\n\tBakteriemie* \n\t\n\tInfekce kost\u00ED a kloub\u016F\n\t100-150 mg/kg/den ve t\u0159ech rozd\u011Blen\u00FDch d\u00E1vk\u00E1ch, maxim\u00E1ln\u00ED d\u00E1vka 6 g/den\n\tKomplikovan\u00E9 infekce k\u016F\u017Ee a m\u011Bkk\u00FDch tk\u00E1n\u00ED \n\t\n\tKomplikovan\u00E9 intraabdomin\u00E1ln\u00ED infekce \n\t\n\tPeritonitida souvisej\u00EDc\u00ED s dial\u00FDzou u pacient\u016F na CAPD \n\t\n\t\n\t\n\tKontinu\u00E1ln\u00ED infuze\n\tInfekce \n\tObvykl\u00E1 d\u00E1vka \n\tFebriln\u00ED neutropenie\n\tNasycovac\u00ED d\u00E1vka 60-100 mg/kg, pot\u00E9 infuze s d\u00E1vkou 100-200 mg/kg/den, maxim\u00E1ln\u00ED d\u00E1vka 6 g/den\n\tNozokomi\u00E1ln\u00ED pneumonie \n\t\n\tBronchopulmon\u00E1ln\u00ED infekce u cystick\u00E9 fibr\u00F3zy \n\t\n\tBakteri\u00E1ln\u00ED meningitida \n\t\n\tBakteriemie* \n\t\n\tInfekce kloub\u016F a kost\u00ED \n\t\n\tKomplikovan\u00E9 infekce k\u016F\u017Ee a m\u011Bkk\u00FDch tk\u00E1n\u00ED \n\t\n\tKomplikovan\u00E9 intraabdomin\u00E1ln\u00ED infekce \n\t\n\tPeritonitida souvisej\u00EDc\u00ED s dial\u00FDzou u pacient\u016F na CAPD \n\t\n\t\n\t\n\tNovorozenci a kojenci \u2264 2 m\u011Bs\u00EDce\n\tIntermitentn\u00ED pod\u00E1v\u00E1n\u00ED\n\tInfekce \n\tObvykl\u00E1 d\u00E1vka \n\tV\u011Bt\u0161ina infekc\u00ED\n\t25-60 mg/kg/den ve dvou rozd\u011Blen\u00FDch d\u00E1vk\u00E1ch1\n\t1U novorozenc\u016F a kojenc\u016F \u2264 2 m\u011Bs\u00EDce m\u016F\u017Ee b\u00FDt s\u00E9rov\u00FD polo\u010Das ceftazidimu 3-4n\u00E1sobn\u011B del\u0161\u00ED ne\u017E u dosp\u011Bl\u00FDch pacient\u016F. \n*Souvis\u00ED-li s jakoukoli z infekc\u00ED shrnut\u00FDch v bod\u011B 4.1, nebo je-li podez\u0159en\u00ED, \u017Ee m\u016F\u017Ee m\u00EDt souvislost s jakoukoli z t\u011Bchto infekc\u00ED.\nPediatrick\u00E1 populace \nBezpe\u010Dnost a \u00FA\u010Dinnost p\u0159\u00EDpravku Ceftazidim Stragen pod\u00E1van\u00E9ho ve form\u011B kontinu\u00E1ln\u00ED infuze novorozenc\u016Fm a kojenc\u016Fm \u2264 2 m\u011Bs\u00EDc\u016F nebyla zat\u00EDm stanovena. \nStar\u0161\u00ED pacienti \nVzhledem k tomu, \u017Ee u star\u0161\u00EDch pacient\u016F doch\u00E1z\u00ED v souvislosti s v\u011Bkem ke sn\u00ED\u017Een\u00ED clearance ceftazidimu, nem\u00E1 jeho denn\u00ED d\u00E1vka u pacient\u016F star\u0161\u00EDch 80 let obvykle p\u0159es\u00E1hnout 3 g. \nPorucha jatern\u00EDch funkc\u00ED \nDostupn\u00E9 \u00FAdaje neukazuj\u00ED na nutnost \u00FApravy d\u00E1vky u pacient\u016F s m\u00EDrnou a\u017E st\u0159edn\u011B t\u011B\u017Ekou poruchou jatern\u00EDch funkc\u00ED. U pacient\u016F s t\u011B\u017Ekou poruchou jatern\u00EDch funkc\u00ED nejsou k dispozici \u017E\u00E1dn\u00E9 studijn\u00ED \u00FAdaje (viz rovn\u011B\u017E bod 5.2). Doporu\u010Duje se pe\u010Dliv\u00E9 klinick\u00E9 sledov\u00E1n\u00ED bezpe\u010Dnosti a \u00FA\u010Dinnosti. \nPorucha ren\u00E1ln\u00EDch funkc\u00ED \nCeftazidim se vylu\u010Duje v nezm\u011Bn\u011Bn\u00E9 form\u011B ledvinami. Proto je t\u0159eba u pacient\u016F s poruchou ren\u00E1ln\u00EDch funkc\u00ED d\u00E1vkov\u00E1n\u00ED sn\u00ED\u017Eit (viz rovn\u011B\u017E bod 4.4). \nJe t\u0159eba podat \u00FAvodn\u00ED nasycovac\u00ED d\u00E1vku 1 g. Udr\u017Eovac\u00ED d\u00E1vka m\u00E1 b\u00FDt zalo\u017Eena na clearance kreatininu: \nTabulka 3: Doporu\u010Den\u00E9 udr\u017Eovac\u00ED d\u00E1vky p\u0159\u00EDpravku Ceftazidim Stragen u pacient\u016F s poruchou ren\u00E1ln\u00EDch funkc\u00ED - intermitentn\u00ED infuze\nDosp\u011Bl\u00ED a d\u011Bti \u2265 40 kg\n\tClearance kreatininu (ml/min)\n\tP\u0159ibli\u017En\u00E1 hodnota kreatininu v s\u00E9ru \u03BCmol/l (mg/dl)\n\tDoporu\u010Den\u00E1 jednotliv\u00E1 d\u00E1vka p\u0159\u00EDpravku Ceftazidim Stragen (g)\n\tFrekvence d\u00E1vkov\u00E1n\u00ED (hodinov\u00FD interval)\n\t50-31 \n\t150-200 (1,7-2,3) \n\t1 \n\t12 \n\t30-16 \n\t200-350 (2,3-4,0)\n\t1 \n\t24 \n\t15-6 \n\t350-500 (4,0-5,6)\n\t0,5 \n\t24 \n\t<5 \n\t>500 (>5,6) \n\t0,5 \n\t48 \nU pacient\u016F s t\u011B\u017Ekou infekc\u00ED je t\u0159eba zv\u00FD\u0161it jednotlivou d\u00E1vku o 50 % nebo je pot\u0159eba zv\u00FD\u0161it frekvenci d\u00E1vkov\u00E1n\u00ED.\nU d\u011Bt\u00ED je t\u0159eba clearance kreatininu upravit podle t\u011Blesn\u00E9ho povrchu nebo ide\u00E1ln\u00ED t\u011Blesn\u00E9 hmotnosti (LBM, lean body mass).\nD\u011Bti < 40 kg\n\tClearance kreatininu (ml/min)**\n\tP\u0159ibli\u017En\u00E1 hodnota kreatininu v s\u00E9ru* \u03BCmol/l (mg/dl)\n\tDoporu\u010Den\u00E1 jednotliv\u00E1 d\u00E1vka v mg/kg t\u011Blesn\u00E9 hmotnosti\n\tFrekvence d\u00E1vkov\u00E1n\u00ED (hodinov\u00FD interval)\n\t50-31 \n\t150-200 (1,7-2,3) \n\t25 \n\t12 \n\t30-16 \n\t200-350 (2,3-4,0) \n\t25 \n\t24 \n\t15-6 \n\t350-500 (4,0-5,6) \n\t12,5 \n\t24 \n\t< 5 \n\t> 500 (> 5,6) \n\t12,5 \n\t48 \n\t*Hodnoty kreatininu v s\u00E9ru jsou pomocn\u00E9 hodnoty, kter\u00E9 nemus\u00ED v\u017Edy ur\u010Dovat p\u0159esn\u011B stejn\u00FD stupe\u0148 sn\u00ED\u017Een\u00ED funkce u v\u0161ech pacient\u016F se sn\u00ED\u017Eenou funkc\u00ED ledvin. \n**Odhadnut\u00E1 na z\u00E1klad\u011B t\u011Blesn\u00E9ho povrchu nebo nam\u011B\u0159en\u00E1.\nDoporu\u010Duje se pe\u010Dliv\u00E9 klinick\u00E9 sledov\u00E1n\u00ED bezpe\u010Dnosti a \u00FA\u010Dinnosti\nTabulka 4: Doporu\u010Den\u00E9 udr\u017Eovac\u00ED d\u00E1vky p\u0159\u00EDpravku Ceftazidim Stragen u poruchy ren\u00E1ln\u00EDch funkc\u00ED - kontinu\u00E1ln\u00ED infuze\nDosp\u011Bl\u00ED a d\u011Bti \u2265 40 kg\n\tClearance kreatininu (ml/min)\n\tP\u0159ibli\u017En\u00E1 hodnota kreatininu v s\u00E9ru \u03BCmol/l (mg/dl)\n\tObvykl\u00E1 d\u00E1vka\n\t50-31 \n\t150-200 (1,7-2,3) \n\tNasycovac\u00ED d\u00E1vka 2 g n\u00E1sledovan\u00E1 1 g a\u017E 3 g /24 hodin \n\t30-16 \n\t200-350 (2,3-4,0) \n\tNasycovac\u00ED d\u00E1vka 2 g n\u00E1sledovan\u00E1 1 g/24 hodin \n\t\u226415 \n\t>350 (>4,0) \n\tNebylo hodnoceno \nV\u00FDb\u011Bru d\u00E1vky je t\u0159eba v\u011Bnovat pozornost. Doporu\u010Duje se pe\u010Dliv\u00E9 klinick\u00E9 sledov\u00E1n\u00ED bezpe\u010Dnosti a \u00FA\u010Dinnosti.\nD\u011Bti < 40 kg\nBezpe\u010Dnost a \u00FA\u010Dinnost p\u0159\u00EDpravku Ceftazidim Stragen pod\u00E1van\u00E9ho ve form\u011B kontinu\u00E1ln\u00ED infuze d\u011Btem s poruchou ren\u00E1ln\u00EDch funkc\u00ED a s hmotnost\u00ED < 40 kg nebyla zat\u00EDm stanovena. Doporu\u010Duje se pe\u010Dliv\u00E9 klinick\u00E9 sledov\u00E1n\u00ED bezpe\u010Dnosti a \u00FA\u010Dinnosti. \nPokud se d\u011Btem s poruchou ren\u00E1ln\u00EDch funkc\u00ED pod\u00E1v\u00E1 kontinu\u00E1ln\u00ED infuze, je t\u0159eba clearance kreatininu upravit podle t\u011Blesn\u00E9ho povrchu nebo ide\u00E1ln\u00ED t\u011Blesn\u00E9 hmotnosti (lean body mass).\nHaemodial\u00FDza \nS\u00E9rov\u00FD polo\u010Das se b\u011Bhem hemodial\u00FDzy pohybuje v rozmez\u00ED 3 a\u017E 5 hodin. \nPo ka\u017Ed\u00E9 hemodial\u00FDze je t\u0159eba znovu podat udr\u017Eovac\u00ED d\u00E1vku ceftazidimu, jak je doporu\u010Deno v tabulce n\u00ED\u017Ee. \nPeritone\u00E1ln\u00ED dial\u00FDza \nCeftazidim lze pou\u017E\u00EDt u pacient\u016F na peritone\u00E1ln\u00ED dial\u00FDze a na kontinu\u00E1ln\u00ED ambulantn\u00ED peritone\u00E1ln\u00ED dial\u00FDze (CAPD).\nKrom\u011B intraven\u00F3zn\u00EDho pod\u00E1n\u00ED m\u016F\u017Ee b\u00FDt ceftazidim p\u0159id\u00E1n i p\u0159\u00EDmo do dialyza\u010Dn\u00EDho roztoku (obvykle 125 a\u017E 250 mg do 2 litr\u016F dialyza\u010Dn\u00EDho roztoku).\nPacienti s ren\u00E1ln\u00EDm selh\u00E1n\u00EDm na kontinu\u00E1ln\u00ED arterio-ven\u00F3zn\u00ED hemodial\u00FDze nebo vysokopr\u016Ftokov\u00E9 (high-flux) hemofiltraci na jednotk\u00E1ch intenzivn\u00ED p\u00E9\u010De: 1 g bu\u010F jako jednotliv\u00E1 d\u00E1vka nebo v rozd\u011Blen\u00FDch d\u00E1vk\u00E1ch. P\u0159i n\u00EDzkopr\u016Ftokov\u00E9 (low-flux) hemofiltraci je t\u0159eba postupovat podle doporu\u010Den\u00ED pro poruchu ren\u00E1ln\u00EDch funkc\u00ED. \nU pacient\u016F na veno-ven\u00F3zn\u00ED hemofiltraci a veno-ven\u00F3zn\u00ED hemodial\u00FDze se postupuje podle doporu\u010Den\u00E9ho d\u00E1vkov\u00E1n\u00ED v tabulce n\u00ED\u017Ee.\nTabulka 5: Doporu\u010Den\u00E9 d\u00E1vkov\u00E1n\u00ED u kontinu\u00E1ln\u00ED veno-ven\u00F3zn\u00ED hemofiltrace\n\tRezidu\u00E1ln\u00ED ren\u00E1ln\u00ED funkce (clearance kreatininu ml/min)\n\tUdr\u017Eovac\u00ED d\u00E1vka (mg) pro rychlost ultrafiltrace (ml/min)1:\n\t\n\t5 \n\t16,7 \n\t33,3 \n\t50 \n\t0 \n\t250 \n\t250 \n\t500 \n\t500 \n\t5 \n\t250 \n\t250 \n\t500 \n\t500 \n\t10 \n\t250 \n\t500 \n\t500 \n\t750 \n\t15 \n\t250 \n\t500 \n\t500 \n\t750 \n\t20 \n\t500 \n\t500 \n\t500 \n\t750 \n\t1Udr\u017Eovac\u00ED d\u00E1vku je t\u0159eba pod\u00E1vat ka\u017Ed\u00FDch 12 hodin. \nTabulka 6: Pokyny pro d\u00E1vkov\u00E1n\u00ED u kontinu\u00E1ln\u00ED veno-ven\u00F3zn\u00ED hemodial\u00FDzy\n\tRezidu\u00E1ln\u00ED ren\u00E1ln\u00ED funkce (clearance kreatininu ml/min)\n\tUdr\u017Eovac\u00ED d\u00E1vka (mg) p\u0159i rychlosti p\u0159\u00EDtoku dialyz\u00E1tu1:\n\t\n\t1,0 litru/h\n\t2,0 litru/h\n\t\n\tRychlost ultrafiltrace (litr/h)\n\tRychlost ultrafiltrace (litr/h)\n\t\n\t0,5 \n\t1,0 \n\t2,0 \n\t0,5 \n\t1,0 \n\t2,0 \n\t0 \n\t500 \n\t500 \n\t500 \n\t500 \n\t500 \n\t750 \n\t5 \n\t500 \n\t500 \n\t750 \n\t500 \n\t500 \n\t750 \n\t10 \n\t500 \n\t500 \n\t750 \n\t500 \n\t750 \n\t1000 \n\t15 \n\t500 \n\t750 \n\t750 \n\t750 \n\t750 \n\t1000 \n\t20 \n\t750 \n\t750 \n\t1000 \n\t750 \n\t750 \n\t1000 \n\t1Udr\u017Eovac\u00ED d\u00E1vku je t\u0159eba pod\u00E1vat ka\u017Ed\u00FDch 12 hodin. \nZp\u016Fsob pod\u00E1n\u00ED\nP\u0159\u00EDpravek Ceftazidim Stragen se pod\u00E1v\u00E1 intraven\u00F3zn\u011B (injek\u010Dn\u00EDm bolusem nebo infuz\u00ED), nebo hlubokou intramuskul\u00E1rn\u00ED injekc\u00ED. Doporu\u010Den\u00E1 m\u00EDsta pro intramuskul\u00E1rn\u00ED aplikaci jsou zevn\u00ED horn\u00ED kvadrant m.glutei maximi nebo later\u00E1ln\u00ED \u010D\u00E1st stehna. P\u0159\u00EDpravek Ceftazidim Stragen se m\u016F\u017Ee pod\u00E1vat p\u0159\u00EDmo do \u017E\u00EDly nebo prost\u0159ednictv\u00EDm kanyly intraven\u00F3zn\u00ED linky, pokud pacient dost\u00E1v\u00E1 parenter\u00E1ln\u00ED roztoky. \nStandardn\u00ED doporu\u010Den\u00FD zp\u016Fsob pod\u00E1n\u00ED je pomoc\u00ED intraven\u00F3zn\u00ED intermitentn\u00ED injekce nebo kontinu\u00E1ln\u00ED infuze. Intramuskul\u00E1rn\u00ED pod\u00E1n\u00ED je t\u0159eba zv\u00E1\u017Eit pouze v p\u0159\u00EDpad\u011B, kdy intraven\u00F3zn\u00ED cesta nen\u00ED mo\u017En\u00E1 nebo je pro pacienta m\u00E9n\u011B vhodn\u00E1. \nD\u00E1vka z\u00E1vis\u00ED na z\u00E1va\u017Enosti, citlivosti, m\u00EDst\u011B a typu infekce a na v\u011Bku a ren\u00E1ln\u00EDch funkc\u00EDch pacienta. \nN\u00E1vod k rekonstituci tohoto l\u00E9\u010Div\u00E9ho p\u0159\u00EDpravku p\u0159ed jeho pod\u00E1n\u00EDm je uveden v\u00A0bod\u011B 6.6.\n"@cs . . . . . . "4.2. D\u00E1vkov\u00E1n\u00ED a zp\u016Fsob pod\u00E1v\u00E1n\u00ED"@cs . . . . . . . . . . . . . . . . . . .