. . . . . . . . . . . . . . . "004.002" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . "4.2 D\u00E1vkov\u00E1n\u00ED a zp\u016Fsob pod\u00E1n\u00ED"@cs . . . . . . . . . . . "Tablety p\u0159\u00EDpravku Lamictal se maj\u00ED polykat cel\u00E9 a nem\u011Bly by se \u017Ev\u00FDkat, nebo drtit. \n\u017Dv\u00FDkac\u00ED/dispergovateln\u00E9 tablety p\u0159\u00EDpravku Lamictal se mohou \u017Ev\u00FDkat, rozpou\u0161t\u011Bt v mal\u00E9m objemu vody (alespo\u0148 v mno\u017Estv\u00ED dosta\u010Duj\u00EDc\u00EDm k pono\u0159en\u00ED cel\u00E9 tablety), nebo se mohou polykat cel\u00E9 a zap\u00EDjet mal\u00FDm mno\u017Estv\u00EDm vody.\nJestli\u017Ee se vypo\u010Dten\u00E1 d\u00E1vka lamotriginu (nap\u0159. k l\u00E9\u010Db\u011B d\u011Bt\u00ED s\u00A0epilepsi\u00ED, nebo pacient\u016F s\u00A0hepat\u00E1ln\u00ED dysfunkc\u00ED) nerovn\u00E1 ur\u010Dit\u00E9mu po\u010Dtu cel\u00FDch tablet, m\u00E1 se pod\u00E1vat d\u00E1vka zaokrouhlen\u00E1 na nejbli\u017E\u0161\u00ED ni\u017E\u0161\u00ED po\u010Det cel\u00FDch tablet.\nZnovuzah\u00E1jen\u00ED l\u00E9\u010Dby\nP\u0159i znovuzah\u00E1jen\u00ED l\u00E9\u010Dby u pacient\u016F, kte\u0159\u00ED z\u00A0jak\u00E9hokoliv d\u016Fvodu p\u0159estali u\u017E\u00EDvat Lamictal, by m\u011Bl p\u0159edepisuj\u00EDc\u00ED l\u00E9ka\u0159 posoudit pot\u0159ebu zvy\u0161ov\u00E1n\u00ED d\u00E1vky a\u017E po d\u00E1vku udr\u017Eovac\u00ED, proto\u017Ee s\u00A0vysok\u00FDmi \u00FAvodn\u00EDmi d\u00E1vkami a s p\u0159ekro\u010Den\u00EDm doporu\u010Den\u00E9ho postupn\u00E9ho zvy\u0161ov\u00E1n\u00ED d\u00E1vek lamotriginu je spojeno riziko z\u00E1va\u017En\u00E9 vyr\u00E1\u017Eky (viz bod 4.4). \u010C\u00EDm del\u0161\u00ED je \u010Dasov\u00FD interval od posledn\u00ED d\u00E1vky, t\u00EDm opatrn\u011Bji by m\u011Blo prob\u00EDhat zvy\u0161ov\u00E1n\u00ED d\u00E1vek k\u00A0d\u00E1vce udr\u017Eovac\u00ED. Pokud je interval od ukon\u010Den\u00ED pod\u00E1v\u00E1n\u00ED lamotriginu del\u0161\u00ED ne\u017E p\u011Bt polo\u010Das\u016F (viz bod 5.2), m\u011Bla by b\u00FDt d\u00E1vka p\u0159\u00EDpravku Lamictal zvy\u0161ov\u00E1na na udr\u017Eovac\u00ED d\u00E1vku podle p\u0159\u00EDslu\u0161n\u00E9ho sch\u00E9matu.\nJestli\u017Ee o\u010Dek\u00E1van\u00FD p\u0159\u00EDnos l\u00E9\u010Dby jasn\u011B nep\u0159ev\u00E1\u017E\u00ED mo\u017En\u00E9 riziko, doporu\u010Duje se, aby Lamictal nebyl znovu pod\u00E1v\u00E1n pacient\u016Fm, kter\u00FDm byla l\u00E9\u010Dba ukon\u010Dena z\u00A0d\u016Fvodu vyr\u00E1\u017Eky spojen\u00E9 s\u00A0l\u00E9\u010Dbou lamotriginem. \nEpilepsie\nDoporu\u010Den\u00E1 stup\u0148uj\u00EDc\u00ED se d\u00E1vka a udr\u017Eovac\u00ED d\u00E1vky pro dosp\u011Bl\u00E9 a dosp\u00EDvaj\u00EDc\u00ED od 13 let (tabulka 1) a pro d\u011Bti a dosp\u00EDvaj\u00EDc\u00ED od 2 do 12 let (tabulka 2) jsou uvedeny n\u00ED\u017Ee. V\u00A0d\u016Fsledku rizika vzniku vyr\u00E1\u017Eky by nem\u011Bla b\u00FDt p\u0159ekro\u010Dena \u00FAvodn\u00ED d\u00E1vka ani jej\u00ED n\u00E1sledn\u00E9 zvy\u0161ov\u00E1n\u00ED (viz bod 4.4).\nPokud jsou soub\u011B\u017En\u00E9 AED vysazeny, nebo jin\u00E9 AED/l\u00E9\u010Div\u00E9 p\u0159\u00EDpravky dod\u00E1ny do l\u00E9\u010Debn\u00E9ho re\u017Eimu obsahuj\u00EDc\u00EDho lamotrigin, je t\u0159eba zv\u00E1\u017Eit mo\u017En\u00FD \u00FA\u010Dinek na farmakokinetiku lamotriginu (viz bod 4.5). \n Tabulka 1: dosp\u011Bl\u00ED a dosp\u00EDvaj\u00EDc\u00ED nad 13 let \u2013 doporu\u010Den\u00FD l\u00E9\u010Debn\u00FD re\u017Eim u epilepsie\n\tL\u00E9\u010Debn\u00FD re\u017Eim\n\t1. a 2. t\u00FDden\n\t3. a 4. t\u00FDden\n\tObvykl\u00E1 udr\u017Eovac\u00ED d\u00E1vka\n\tMonoterapie:\n\t25 mg/den\n(jednou denn\u011B)\n\t50 mg/den\n(jednou denn\u011B)\n\t100 \u2013 200 mg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky lze denn\u00ED d\u00E1vku postupn\u011B zvy\u0161ovat ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny nejv\u00FD\u0161e o 50 a\u017E 100 mg, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi.\nN\u011Bkte\u0159\u00ED pacienti vy\u017Eaduj\u00ED k\u00A0dosa\u017Een\u00ED po\u017Eadovan\u00E9 odpov\u011Bdi denn\u00ED d\u00E1vku 500 mg.\n\tP\u0159\u00EDdatn\u00E1 terapie S\u00A0valpro\u00E1tem (inhibitor lamotriginov\u00E9 glukuronidace \u2013 viz bod 4.5)\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit s\u00A0valpro\u00E1tem bez ohledu na dal\u0161\u00ED sou\u010Dasn\u011B pod\u00E1vanou l\u00E9\u010Dbu. \n\t12,5 mg/den\n(pod\u00E1v\u00E1 se 25 mg obden)\n\t25 mg/den\n(jednou denn\u011B)\n\t100 \u2013 200 mg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky lze denn\u00ED d\u00E1vku postupn\u011B zvy\u0161ovat ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny nejv\u00FD\u0161e o 25 a\u017E 50 mg, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi.\n\tP\u0159\u00EDdatn\u00E1 terapie BEZ\u00A0valpro\u00E1tu a S\u00A0induktory lamotriginov\u00E9 glukuronidace (viz bod 4.5)\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit bez valpro\u00E1tu, ale s:\nfenytoinem\nkarbamazepinem\nfenobarbitalem\nprimidonem\nrifampicinem\nlopinavirem/ritonavirem\n\t50 mg/den\n(jednou denn\u011B)\n\t100 mg/den\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t200 \u2013 400 mg/den\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky lze denn\u00ED d\u00E1vku postupn\u011B zvy\u0161ovat ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny nejv\u00FD\u0161e o 100 mg, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi.\nN\u011Bkte\u0159\u00ED pacienti vy\u017Eaduj\u00ED k\u00A0dosa\u017Een\u00ED po\u017Eadovan\u00E9 odpov\u011Bdi denn\u00ED d\u00E1vku 700 mg.\n\tP\u0159\u00EDdatn\u00E1 terapie BEZ\u00A0valpro\u00E1tu a BEZ\u00A0induktor\u016F lamotriginov\u00E9 glukuronidace (viz bod 4.5)\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit s\u00A0jin\u00FDmi p\u0159\u00EDpravky, kter\u00E9 v\u00FDrazn\u011B neinhibuj\u00ED, nebo neindukuj\u00ED \nlamotriginovou glukuronidaci.\n\t25 mg/den\n(jednou denn\u011B)\n\t50 mg/den\n(jednou denn\u011B)\n\t100 \u2013 200 mg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky lze denn\u00ED d\u00E1vku postupn\u011B zvy\u0161ovat ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny nejv\u00FD\u0161e o 50 a\u017E 100 mg, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi.\n\tU pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch l\u00E9\u010Div\u00E9 p\u0159\u00EDpravky, u kter\u00FDch farmakokinetick\u00E1 interakce s\u00A0lamotriginem v\u00A0sou\u010Dasnosti nen\u00ED zn\u00E1m\u00E1 (viz bod 4.5), m\u00E1 b\u00FDt pou\u017Eit l\u00E9\u010Debn\u00FD re\u017Eim doporu\u010Den\u00FD pro kombinaci lamotriginu s\u00A0valpro\u00E1tem.\nTabulka 2: d\u011Bti a dosp\u00EDvaj\u00EDc\u00ED ve v\u011Bku od 2 do 12 let \u2013 doporu\u010Den\u00FD l\u00E9\u010Debn\u00FD re\u017Eim u epilepsie (vyj\u00E1d\u0159en\u00FD jako celkov\u00E9 denn\u00ED d\u00E1vky v\u00A0mg/kg t\u011Blesn\u00E9 hmotnosti/den):\n\tL\u00E9\u010Debn\u00FD re\u017Eim\n\t1. a 2. t\u00FDden\n\t3. a 4. t\u00FDden\n\tObvykl\u00E1 udr\u017Eovac\u00ED d\u00E1vka\n\tMonoterapie u z\u00E1chvat\u016F typick\u00FDch absenc\u00ED \n\t0,3 mg/kg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t0,6 mg/kg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t1 \u2013 15 mg/kg/den \n(jednou denn\u011B nebo rozd\u011Blen\u011B do dvou denn\u00EDch d\u00E1vek)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky mohou b\u00FDt d\u00E1vky zv\u00FD\u0161en\u00E9 nejv\u00FD\u0161e o 0,6 mg/kg/den \nka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi. Maxim\u00E1ln\u00ED udr\u017Eovac\u00ED d\u00E1vka je 200 mg /den. \n\tP\u0159\u00EDdatn\u00E1 terapie S\u00A0valpro\u00E1tem (inhibitor lamotriginov\u00E9 glukuronidace \u2013 viz bod 4.5)\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit s\u00A0valpro\u00E1tem bez ohledu na dal\u0161\u00ED sou\u010Dasn\u011B pod\u00E1vanou l\u00E9\u010Dbu. \n\t0,15 mg/kg/den*\n(jednou denn\u011B) \n\t0,3 mg/kg/den\n(jednou denn\u011B)\n\t1 \u2013 5 mg/kg/den \n(jednou denn\u011B nebo rozd\u011Blen\u011B do dvou denn\u00EDch d\u00E1vek)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky mohou b\u00FDt d\u00E1vky zv\u00FD\u0161en\u00E9 nejv\u00FD\u0161e o 0,3 mg/kg ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi. Maxim\u00E1ln\u00ED udr\u017Eovac\u00ED d\u00E1vka je 200 mg/den.\n\tP\u0159\u00EDdatn\u00E1 terapie BEZ\u00A0valpro\u00E1tu a S\u00A0induktory lamotriginov\u00E9 glukuronidace (viz bod 4.5)\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit bez valpro\u00E1tu, ale s:\nfenytoinem\nkarbamazepinem\nfenobarbitalem\nprimidonem\nrifampicinem\nlopinavirem/ritonavirem\n\t0,6 mg/kg/den\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t1,2 mg/kg/den\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t5 - 15 mg/kg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B do dvou denn\u00EDch d\u00E1vek)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky mohou b\u00FDt d\u00E1vky zv\u00FD\u0161en\u00E9 nejv\u00FD\u0161e o 1,2 mg/kg ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi. Maxim\u00E1ln\u00ED udr\u017Eovac\u00ED d\u00E1vka je 400 mg/den.\n\tP\u0159\u00EDdatn\u00E1 terapie BEZ\u00A0valpro\u00E1tu a BEZ\u00A0induktor\u016F lamotriginov\u00E9 glukuronidace (viz bod 4.5)\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit s\u00A0jin\u00FDmi p\u0159\u00EDpravky, kter\u00E9 v\u00FDrazn\u011B neinhibuj\u00ED, nebo neindukuj\u00ED \nlamotriginovou glukuronidaci.\n\t0,3 mg/kg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t0,6 mg/kg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t1 - 10 mg/kg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B do dvou denn\u00EDch d\u00E1vek)\nK\u00A0dosa\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky mohou b\u00FDt d\u00E1vky zv\u00FD\u0161en\u00E9 nejv\u00FD\u0161e o 0,6 mg/kg ka\u017Ed\u00FD t\u00FDden a\u017E ka\u017Ed\u00E9 dva t\u00FDdny, dokud nen\u00ED dosa\u017Eeno optim\u00E1ln\u00ED odpov\u011Bdi. Maxim\u00E1ln\u00ED udr\u017Eovac\u00ED d\u00E1vka je 200 mg/den.\n\tU pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch l\u00E9\u010Div\u00E9 p\u0159\u00EDpravky, u kter\u00FDch farmakokinetick\u00E1 interakce s\u00A0lamotriginem v\u00A0sou\u010Dasnosti nen\u00ED zn\u00E1m\u00E1 (viz bod 4.5), m\u00E1 b\u00FDt pou\u017Eit l\u00E9\u010Debn\u00FD re\u017Eim doporu\u010Den\u00FD pro kombinaci lamotriginu s\u00A0valpro\u00E1tem.\n\t* Pokud je vypo\u010Dten\u00E1 denn\u00ED d\u00E1vka u pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch valpro\u00E1t 2,5 mg a v\u00EDce, ale m\u00E9n\u011B ne\u017E 5 mg, lze p\u0159\u00EDpravek Lamictal 5 mg \u017Ev\u00FDkac\u00ED / dispergovateln\u00E9 tablety v\u00A0prvn\u00EDch dvou t\u00FDdnech u\u017E\u00EDvat obden. Pokud je vypo\u010Dten\u00E1 denn\u00ED d\u00E1vka u pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch valpro\u00E1t men\u0161\u00ED ne\u017E 2,5 mg, Lamictal se nem\u00E1 pod\u00E1vat.\nAby se u d\u011Bt\u00ED zajistily p\u0159esn\u00E9 terapeutick\u00E9 d\u00E1vky, je nutn\u00E9 pr\u016Fb\u011B\u017En\u011B sledovat t\u011Blesnou hmotnost a p\u0159i jej\u00ED zm\u011Bn\u011B revidovat d\u00E1vkov\u00E1n\u00ED. Je pravd\u011Bpodobn\u00E9, \u017Ee pacienti ve v\u011Bku dvou a\u017E \u0161esti let budou pot\u0159ebovat udr\u017Eovac\u00ED d\u00E1vky na horn\u00ED hranici doporu\u010Den\u00E9ho d\u00E1vkov\u00E9ho rozmez\u00ED.\nJe-li p\u0159i p\u0159\u00EDdatn\u00E9 l\u00E9\u010Db\u011B dosa\u017Eeno kontroly epilepsie, sou\u010Dasn\u00E9 u\u017E\u00EDv\u00E1n\u00ED antiepileptik m\u016F\u017Ee b\u00FDt ukon\u010Deno a pacienti mohou pokra\u010Dovat v\u00A0monoterapii p\u0159\u00EDpravkem Lamictal.\nJe t\u0159eba vz\u00EDt na v\u011Bdom\u00ED, \u017Ee vzhledem k\u00A0tomu, \u017Ee nejni\u017E\u0161\u00ED dostupn\u00E1 s\u00EDla \u017Ev\u00FDkac\u00EDch/dispergovateln\u00FDch tablet p\u0159\u00EDpravku Lamictal je 5 mg, nen\u00ED mo\u017En\u00E9 zah\u00E1jit l\u00E9\u010Dbu lamotriginem p\u0159esn\u011B podle doporu\u010Den\u00FDch instrukc\u00ED k\u00A0d\u00E1vkov\u00E1n\u00ED u pediatrick\u00FDch pacient\u016F s\u00A0t\u011Blesnou hmotnost\u00ED ni\u017E\u0161\u00ED ne\u017E 17 kg. \nD\u011Bti ve v\u011Bku do 2 let\n\u00DAdaje o \u00FA\u010Dinnosti a bezpe\u010Dnosti pod\u00E1v\u00E1n\u00ED lamotriginu jako p\u0159\u00EDdatn\u00E9 l\u00E9\u010Dby epilepsie s parci\u00E1ln\u00EDmi z\u00E1chvaty d\u011Btem ve v\u011Bku od 1 m\u011Bs\u00EDce do 2 let jsou omezen\u00E9 (viz bod 4.4). Nejsou \u017E\u00E1dn\u00E1 data o\u00A0pod\u00E1v\u00E1n\u00ED u d\u011Bt\u00ED do 1 m\u011Bs\u00EDce. Lamictal se tedy nedoporu\u010Duje pod\u00E1vat d\u011Btem do 2 let. Pokud je na z\u00E1klad\u011B klinick\u00E9 pot\u0159eby p\u0159esto rozhodnuto p\u0159\u00EDpravek podat, viz body 4.4, 5.1 a 5.2.\nBipol\u00E1rn\u00ED porucha\nDoporu\u010Den\u00E9 zvy\u0161ov\u00E1n\u00ED d\u00E1vek a udr\u017Eovac\u00ED d\u00E1vky u dosp\u011Bl\u00FDch pacient\u016F od 18 let jsou uvedeny n\u00ED\u017Ee v\u00A0tabulk\u00E1ch. P\u0159echodn\u00FD re\u017Eim zahrnuje zvy\u0161ov\u00E1n\u00ED d\u00E1vek lamotriginu k\u00A0udr\u017Eovac\u00ED stabilizuj\u00EDc\u00ED d\u00E1vce za v\u00EDce ne\u017E \u0161est t\u00FDdn\u016F (viz tabulka 3), po kter\u00E9 jin\u00E9 psychotropn\u00ED p\u0159\u00EDpravky a/nebo antiepileptika mohou b\u00FDt vysazeny, je-li to z\u00A0klinick\u00E9ho hlediska indikov\u00E1no (viz tabulka 4). \u00DAprava d\u00E1vky n\u00E1sleduj\u00EDc\u00ED po p\u0159id\u00E1n\u00ED dal\u0161\u00EDch psychotropn\u00EDch p\u0159\u00EDpravk\u016F a/nebo antiepileptik je rovn\u011B\u017E uvedena n\u00ED\u017Ee (viz tabulka 5). Vzhledem k\u00A0riziku v\u00FDskytu vyr\u00E1\u017Eky by nem\u011Bla b\u00FDt p\u0159ekro\u010Dena \u00FAvodn\u00ED d\u00E1vka ani jej\u00ED n\u00E1sledn\u00E9 zvy\u0161ov\u00E1n\u00ED (viz bod 4.4).\nTabulka 3: dosp\u011Bl\u00ED od 18 let - doporu\u010Den\u00E9 zvy\u0161ov\u00E1n\u00ED d\u00E1vek a\u017E po udr\u017Eovac\u00ED celkovou denn\u00ED stabilizuj\u00EDc\u00ED d\u00E1vku p\u0159i l\u00E9\u010Db\u011B bipol\u00E1rn\u00ED poruchy\n\tL\u00E9\u010Debn\u00FD re\u017Eim\n\t1. a 2. t\u00FDden\n\t3. a 4. t\u00FDden\n\t5. t\u00FDden\n\tStabilizuj\u00EDc\u00ED d\u00E1vka \n(6. t\u00FDden)*\n\tMonoterapie s\u00A0lamotriginem, NEBO p\u0159\u00EDdatn\u00E1 terapie BEZ valpro\u00E1tu a BEZ induktor\u016F lamotriginov\u00E9 glukuronidace (viz bod 4.5):\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit s\u00A0jin\u00FDmi p\u0159\u00EDpravky, kter\u00E9 v\u00FDrazn\u011B neinhibuj\u00ED, nebo neindukuj\u00ED \nlamotriginovou glukuronidaci.\n\t25 mg/den\n(jednou denn\u011B)\n\t50 mg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t100 mg/den\n(jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t200 mg/den \u2013 obvykl\u00E1 c\u00EDlov\u00E1 d\u00E1vka pro optim\u00E1ln\u00ED odpov\u011B\u010F (jednou denn\u011B nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\nV\u00A0klinick\u00FDch studi\u00EDch byly u\u017E\u00EDv\u00E1ny d\u00E1vky v rozmez\u00ED 100 a\u017E 400 mg/den.\n\tP\u0159\u00EDdatn\u00E1 terapie S\u00A0valpro\u00E1tem (inhibitor lamotriginov\u00E9 glukuronidace \u2013 viz bod 4.5) :\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit s\u00A0valpro\u00E1tem bez ohledu na jinou podp\u016Frnou l\u00E9\u010Dbu.\n\t12,5 mg/den\n(pod\u00E1v\u00E1 se 25 mg obden)\n\t25 mg/den\n(jednou denn\u011B)\n\t50 mg/den\n(jednou denn\u011B, nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t100 mg/den - obvykl\u00E1 c\u00EDlov\u00E1 d\u00E1vka pro optim\u00E1ln\u00ED odpov\u011B\u010F\n(jednou denn\u011B, nebo rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\nMaxim\u00E1ln\u00ED denn\u00ED d\u00E1vka 200 mg m\u016F\u017Ee b\u00FDt pod\u00E1na v\u00A0z\u00E1vislosti na klinick\u00E9 odpov\u011Bdi.\n\tP\u0159\u00EDdatn\u00E1 terapie BEZ\u00A0valpro\u00E1tu a S\u00A0induktory lamotriginov\u00E9 glukuronidace \u2013 viz bod 4.5):\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit bez valpro\u00E1tu, ale s:\nfenytoinem\nkarbamazepinem\nfenobarbitalem\nprimidonem\nrifampicinem\nlopinavirem/ritonavirem\n\t50 mg/den\n(jednou denn\u011B)\n\t100 mg/den\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t200 mg/den\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\tV 6. t\u00FDdnu 300 mg/den a je-li pot\u0159eba, d\u00E1vka se zv\u00FD\u0161\u00ED v 7. t\u00FDdnu na obvyklou c\u00EDlovou d\u00E1vku 400 mg/den k\u00A0dosa\u017Een\u00ED optim\u00E1ln\u00ED odpov\u011Bdi\n(rozd\u011Blen\u00E9 ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch).\n\tU pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch l\u00E9\u010Div\u00E9 p\u0159\u00EDpravky, u kter\u00FDch farmakokinetick\u00E1 interakce s\u00A0lamotriginem v\u00A0sou\u010Dasnosti nen\u00ED zn\u00E1ma (viz bod 4.5), m\u00E1 b\u00FDt pou\u017Eito zvy\u0161ov\u00E1n\u00ED d\u00E1vkov\u00E1n\u00ED lamotriginu doporu\u010Den\u00E9 pro kombinaci lamotriginu s\u00A0valpro\u00E1tem.\n*C\u00EDlov\u00E1 stabilizuj\u00EDc\u00ED d\u00E1vka se m\u011Bn\u00ED v z\u00E1vislosti na klinick\u00E9 odpov\u011Bdi.\nTabulka 4: dosp\u011Bl\u00ED od 18 let - udr\u017Eovac\u00ED stabilizuj\u00EDc\u00ED celkov\u00E1 denn\u00ED d\u00E1vka u bipol\u00E1rn\u00ED poruchy po vysazen\u00ED soub\u011B\u017En\u00E9 l\u00E9\u010Dby \nJakmile je dosa\u017Eena c\u00EDlov\u00E1 udr\u017Eovac\u00ED stabilizuj\u00EDc\u00ED denn\u00ED d\u00E1vka, ostatn\u00ED p\u0159\u00EDpravky mohou b\u00FDt vysazeny, jak je uk\u00E1z\u00E1no n\u00ED\u017Ee.\n\tL\u00E9\u010Debn\u00FD re\u017Eim\n\tSou\u010Dasn\u00E1 stabilizuj\u00EDc\u00ED d\u00E1vka lamotriginu\n(p\u0159ed vysazen\u00EDm)\n\t1. t\u00FDden\n(za\u010D\u00E1tek vysazov\u00E1n\u00ED l\u00E9\u010Dby)\n\t2. t\u00FDden\n\t3. t\u00FDden\n(a dal\u0161\u00ED)*\n\tVysazov\u00E1n\u00ED l\u00E9\u010Dby valpro\u00E1tem (inhibitor lamotriginov\u00E9 glukuronidace - viz bod 4.5), v\u00A0z\u00E1vislosti na p\u016Fvodn\u00ED d\u00E1vce lamotriginu:\n\tKdy\u017E je valpro\u00E1t vysazen, zdvojn\u00E1sob\u00ED se stabilizuj\u00EDc\u00ED d\u00E1vka, nep\u0159ekra\u010Duje se zv\u00FD\u0161en\u00ED o v\u00EDce ne\u017E 100 mg/t\u00FDden\n\t100 mg/den\n\t200 mg/den\n\tUdr\u017Eovat tuto d\u00E1vku (200 mg/den)\n(rozd\u011Blen\u011B ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch)\n\t\n\t200 mg/den\n\t300 mg/den\n\t400 mg/den\n\tUdr\u017Eovat tuto d\u00E1vku \uFFFD(400 mg/den)\n\tVysazov\u00E1n\u00ED induktor\u016F lamotriginov\u00E9 glukuronidace (viz bod 4.5), v\u00A0z\u00E1vislosti na p\u016Fvodn\u00ED d\u00E1vce lamotriginu:\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit p\u0159i vysazen\u00ED n\u00E1sleduj\u00EDc\u00EDch p\u0159\u00EDpravk\u016F:\nfenytoinu\t\nkarbamazepinu\nfenobarbitalu\nprimidonu\nrifampicinu\nlopinaviru/ritonaviru\n\t400 mg/den\n\t400 mg/den\n\t300 mg/den\n\t200 mg/den\n\t\n\t300 mg/den\n\t300 mg/den\n\t225 mg/den\n\t150 mg/den\n\t\n\t200 mg/den\n\t200 mg/den\n\t150 mg/den\n\t100 mg/den\n\tVysazov\u00E1n\u00ED p\u0159\u00EDpravk\u016F, kter\u00E9 v\u00FDznamn\u011B NEinhibuj\u00ED ani NEindukuj\u00ED lamotriginovou glukuronidaci (viz bod 4.5) :\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit p\u0159i vysazen\u00ED p\u0159\u00EDpravk\u016F, kter\u00E9 v\u00FDrazn\u011B neinhibuj\u00ED ani neindukuj\u00ED \nlamotriginovou glukuronidaci.\n\tUdr\u017Eovat c\u00EDlovou d\u00E1vku dosa\u017Eenou p\u0159i eskalaci d\u00E1vky (d\u00E1vka 200 mg/den rozd\u011Blen\u00E1 ve dvou d\u00EDl\u010D\u00EDch d\u00E1vk\u00E1ch), \n(d\u00E1vkovac\u00ED rozmez\u00ED 100 a\u017E 400 mg/den).\n\tU pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch l\u00E9\u010Div\u00E9 p\u0159\u00EDpravky, u kter\u00FDch farmakokinetick\u00E1 interakce s lamotriginem v sou\u010Dasnosti nen\u00ED zn\u00E1m\u00E1 (viz bod 4.5), je doporu\u010Den\u00FD re\u017Eim l\u00E9\u010Dby lamotriginem tento: zpo\u010D\u00E1tku udr\u017Eovat st\u00E1vaj\u00EDc\u00ED d\u00E1vku a l\u00E9\u010Dbu lamotriginem upravovat v\u00A0z\u00E1vislosti na klinick\u00E9 odpov\u011Bdi.\n* Je-li t\u0159eba, m\u016F\u017Ee b\u00FDt d\u00E1vka zv\u00FD\u0161ena a\u017E na 400 mg/den.\nTabulka 5: dosp\u011Bl\u00ED od 18 let \u2013 nastaven\u00ED denn\u00ED d\u00E1vky lamotriginu po p\u0159id\u00E1n\u00ED jin\u00FDch p\u0159\u00EDpravk\u016F u bipol\u00E1rn\u00ED poruchy:\nS nastaven\u00EDm denn\u00ED d\u00E1vky lamotriginu p\u0159i p\u0159id\u00E1n\u00ED jin\u00FDch p\u0159\u00EDpravk\u016F nejsou klinick\u00E9 zku\u0161enosti. Nicm\u00E9n\u011B, na z\u00E1klad\u011B interak\u010Dn\u00EDch studi\u00ED s jin\u00FDmi p\u0159\u00EDpravky, byla vytvo\u0159ena n\u00E1sleduj\u00EDc\u00ED doporu\u010Den\u00ED: \n\tL\u00E9\u010Debn\u00FD re\u017Eim\n\tSou\u010Dasn\u00E1 stabilizuj\u00EDc\u00ED d\u00E1vka lamotriginu (p\u0159ed nasazen\u00EDm p\u0159\u00EDdatn\u00E9 l\u00E9\u010Dby)\n\t1. t\u00FDden\n(za\u010D\u00E1tek s p\u0159\u00EDdatnou l\u00E9\u010Dbou)\n\t2. t\u00FDden\n\t3. t\u00FDden a dal\u0161\u00ED\n\tP\u0159id\u00E1n\u00ED valpro\u00E1tu (inhibitor lamotriginov\u00E9 glukuronidace \u2013 viz bod 4.5), v z\u00E1vislosti na p\u016Fvodn\u00ED d\u00E1vce lamotriginu:\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit \n\t200 mg/den\n\t100 mg/den\n\tUdr\u017Eovat tuto d\u00E1vku (100 mg/den)\n\ts\u00A0valpro\u00E1tem bez ohledu na dal\u0161\u00ED\n\t300 mg/den\n\t150 mg/den\n\tUdr\u017Eovat tuto d\u00E1vku (150 mg/den)\n\tsou\u010Dasn\u011B pod\u00E1vanou l\u00E9\u010Dbu.\n\t400 mg/den\n\t200 mg/den\n\tUdr\u017Eovat tuto d\u00E1vku (200 mg/den)\n\tP\u0159id\u00E1n\u00ED induktor\u016F lamotriginov\u00E9 glukuronidace pacient\u016Fm NEu\u017E\u00EDvaj\u00EDc\u00EDm valpro\u00E1t (viz bod 4.5), v z\u00E1vislosti na p\u016Fvodn\u00ED d\u00E1vce lamotriginu:\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit, p\u0159i p\u0159id\u00E1n\u00ED \nn\u00E1sleduj\u00EDc\u00EDch p\u0159\u00EDpravk\u016F bez valpro\u00E1tu: \nfenytoinu karbamazepinu\nfenobarbitalu\nprimidonu\nrifampicinu\nlopinaviru/ritonaviru\n\t200 mg/den\n\t200 mg/den\n\t300 mg/den\n\t400 mg/den\n\t\n\t150 mg/den\n\t150 mg/den\n\t225 mg/den\n\t300 mg/den\n\t\n\t100 mg/den\n\t100 mg/den\n\t150 mg/den\n\t200 mg/den\n\tP\u0159id\u00E1n\u00ED p\u0159\u00EDpravk\u016F BEZ signifikantn\u00ED inhibice, nebo indukce lamotriginov\u00E9 glukuronidace (viz bod 4.5):\n\tTento d\u00E1vkovac\u00ED re\u017Eim m\u00E1 b\u00FDt pou\u017Eit, p\u0159i p\u0159id\u00E1n\u00ED jin\u00FDch p\u0159\u00EDpravk\u016F bez signifikantn\u00ED inhibice, nebo indukce \nlamotriginov\u00E9 glukuronidace.\n\tUdr\u017Eovat c\u00EDlovou d\u00E1vku dosa\u017Eenou p\u0159i eskalaci d\u00E1vky (200 mg/den; d\u00E1vkovac\u00ED rozmez\u00ED 100 - 400 mg/den).\n\tU pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch l\u00E9\u010Div\u00E9 p\u0159\u00EDpravky, u kter\u00FDch farmakokinetick\u00E1 interakce s lamotriginem v sou\u010Dasnosti nen\u00ED zn\u00E1m\u00E1 (viz bod 4.5), m\u00E1 b\u00FDt pou\u017Eit l\u00E9\u010Debn\u00FD re\u017Eim lamotriginu doporu\u010Den\u00FD pro kombinaci s valpro\u00E1tem.\nUkon\u010Den\u00ED pod\u00E1v\u00E1n\u00ED lamotriginu pacient\u016Fm s bipol\u00E1rn\u00ED poruchou\nP\u0159i n\u00E1hl\u00E9m vysazen\u00ED lamotriginu se v klinick\u00FDch studi\u00EDch v porovn\u00E1n\u00ED s placebem neprok\u00E1zalo zv\u00FD\u0161en\u00ED incidence, z\u00E1va\u017Enosti ani typu ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F. Proto pacienti mohou ukon\u010Dit l\u00E9\u010Dbu p\u0159\u00EDpravkem Lamictal bez postupn\u00E9ho sni\u017Eov\u00E1n\u00ED d\u00E1vek.\nD\u011Bti a dosp\u00EDvaj\u00EDc\u00ED do 18 let\nVzhledem k nedostate\u010Dn\u00FDm \u00FAdaj\u016Fm o bezpe\u010Dnosti a \u00FA\u010Dinnosti se nedoporu\u010Duje pod\u00E1vat Lamictal d\u011Btem do 18 let (viz bod 4.4).\nObecn\u00E1 doporu\u010Den\u00ED pro d\u00E1vkov\u00E1n\u00ED p\u0159\u00EDpravku Lamictal u zvl\u00E1\u0161tn\u00EDch skupin pacient\u016F\n\u017Deny u\u017E\u00EDvaj\u00EDc\u00ED hormon\u00E1ln\u00ED antikoncepci\nU kombinace ethinylestradiol/levonorgestrel (30 \u00B5g/150 \u00B5g) bylo prok\u00E1z\u00E1no p\u0159ibli\u017En\u011B dvojn\u00E1sobn\u00E9 zv\u00FD\u0161en\u00ED clearance lamotriginu vedouc\u00ED ke sn\u00ED\u017Een\u00FDm hladin\u00E1m lamotriginu. Po titraci m\u016F\u017Ee b\u00FDt pot\u0159eba vy\u0161\u0161\u00ED udr\u017Eovac\u00ED d\u00E1vka lamotriginu (a\u017E dvojn\u00E1sobn\u011B) k doc\u00EDlen\u00ED maxim\u00E1ln\u00ED terapeutick\u00E9 odpov\u011Bdi. V\u00A0pr\u016Fb\u011Bhu t\u00FDdne bez medikace (\u201Et\u00FDden bez tablet\u201C) bylo pozorov\u00E1no dvojn\u00E1sobn\u00E9 zv\u00FD\u0161en\u00ED hladiny lamotriginu. Nen\u00ED mo\u017En\u00E9 vylou\u010Dit v\u00FDskyt ne\u017E\u00E1douc\u00EDch \u00FA\u010Dink\u016F souvisej\u00EDc\u00EDch s\u00A0d\u00E1vkou, proto by se m\u011Blo zva\u017Eovat u\u017E\u00EDv\u00E1n\u00ED antikoncepce, jejich\u017E re\u017Eim nezahrnuje t\u00FDden bez medikace, jako l\u00E9\u010Dba prvn\u00ED volby (nap\u0159. kontinu\u00E1ln\u00ED hormon\u00E1ln\u00ED antikoncepce nebo nehormon\u00E1ln\u00ED metody antikoncepce; viz body 4.4 a 4.5).\nZa\u010D\u00E1tek u\u017E\u00EDv\u00E1n\u00ED hormon\u00E1ln\u00ED antikoncepce u pacientek, kter\u00E9 ji\u017E u\u017E\u00EDvaj\u00ED udr\u017Eovac\u00ED d\u00E1vky lamotriginu a NEu\u017E\u00EDvaj\u00ED induktory lamotriginov\u00E9 glukuronidace\nVe v\u011Bt\u0161in\u011B p\u0159\u00EDpad\u016F je t\u0159eba udr\u017Eovac\u00ED d\u00E1vku lamotriginu zv\u00FD\u0161it a\u017E na dvojn\u00E1sobek (viz body 4.4 a 4.5). Doporu\u010Duje se, aby se od doby zah\u00E1jen\u00ED pod\u00E1v\u00E1n\u00ED hormon\u00E1ln\u00ED antikoncepce d\u00E1vka lamotriginu zv\u00FD\u0161ila ka\u017Ed\u00FD t\u00FDden o 50 a\u017E 100 mg/den, podle individu\u00E1ln\u00ED klinick\u00E9 odpov\u011Bdi. Zv\u00FD\u0161en\u00ED d\u00E1vky by nem\u011Blo p\u0159ekro\u010Dit toto rozmez\u00ED, pokud klinick\u00E1 odpov\u011B\u010F nepodpo\u0159\u00ED v\u00FDrazn\u011Bj\u0161\u00ED zv\u00FD\u0161en\u00ED. M\u011B\u0159en\u00ED plazmatick\u00FDch koncentrac\u00ED lamotriginu p\u0159ed a po zah\u00E1jen\u00ED u\u017E\u00EDv\u00E1n\u00ED hormon\u00E1ln\u00ED antikoncepce mohou b\u00FDt br\u00E1na jako potvrzen\u00ED, \u017Ee je p\u016Fvodn\u00ED koncentrace lamotriginu udr\u017Eov\u00E1na. Je-li to nutn\u00E9, d\u00E1vka by m\u011Bla b\u00FDt upravena. \u017Den\u00E1m u\u017E\u00EDvaj\u00EDc\u00EDm hormon\u00E1ln\u00ED antikoncepci, jejich\u017E re\u017Eim zahrnuje jeden t\u00FDden bez medikace (\u201Et\u00FDden bez tablet\u201C), by monitorov\u00E1n\u00ED plazmatick\u00E9 hladiny lamotriginu m\u011Blo b\u00FDt provedeno b\u011Bhem 3. t\u00FDdne aktivn\u00ED l\u00E9\u010Dby, tj. v 15. a\u017E 21. den cyklu antikoncepce. Proto by jako l\u00E9k prvn\u00ED volby m\u011Bla b\u00FDt zva\u017Eov\u00E1na antikoncepce bez t\u00FDdne bez medikace (nap\u0159. kontinu\u00E1ln\u00ED hormon\u00E1ln\u00ED antikoncepce nebo nehormon\u00E1ln\u00ED metody antikoncepce; viz body 4.4 a 4.5).\nUkon\u010Den\u00ED u\u017E\u00EDv\u00E1n\u00ED hormon\u00E1ln\u00ED antikoncepce u pacientek, kter\u00E9 ji\u017E u\u017E\u00EDvaj\u00ED udr\u017Eovac\u00ED d\u00E1vky lamotriginu a NEu\u017E\u00EDvaj\u00ED induktory lamotriginov\u00E9 glukuronidace\nVe v\u011Bt\u0161in\u011B p\u0159\u00EDpad\u016F je t\u0159eba udr\u017Eovac\u00ED d\u00E1vku lamotriginu sn\u00ED\u017Eit a\u017E o 50 % (viz body 4.4 a 4.5). Doporu\u010Duje se postupn\u00E9 sni\u017Eov\u00E1n\u00ED denn\u00ED d\u00E1vky lamotriginu o 50 \u2013 100 mg ka\u017Ed\u00FD t\u00FDden (rychlost\u00ED nep\u0159esahuj\u00EDc\u00ED 25 % celkov\u00E9 denn\u00ED d\u00E1vky t\u00FDdn\u011B) b\u011Bhem t\u0159\u00EDt\u00FDdenn\u00EDho obdob\u00ED, jestli\u017Ee klinick\u00E1 odpov\u011B\u010F nenazna\u010Duje jinak. M\u011B\u0159en\u00ED plazmatick\u00FDch koncentrac\u00ED lamotriginu p\u0159ed a po ukon\u010Den\u00ED u\u017E\u00EDv\u00E1n\u00ED hormon\u00E1ln\u00ED antikoncepce m\u016F\u017Ee b\u00FDt br\u00E1no jako potvrzen\u00ED udr\u017Een\u00ED p\u016Fvodn\u00ED koncentrace lamotriginu. \u017Den\u00E1m, kter\u00E9 si p\u0159ej\u00ED ukon\u010Dit u\u017E\u00EDv\u00E1n\u00ED hormon\u00E1ln\u00ED antikoncepce zahrnuj\u00EDc\u00ED jeden t\u00FDden bez l\u00E9\u010Dby (\u201Et\u00FDden bez tablet\u201C), by m\u011Blo b\u00FDt provedeno monitorov\u00E1n\u00ED plazmatick\u00E9 hladiny lamotriginu b\u011Bhem 3. t\u00FDdne aktivn\u00ED l\u00E9\u010Dby, tj. v 15. a\u017E 21. den cyklu antikoncepce. Vzorky pro posouzen\u00ED hladin lamotriginu po trval\u00E9m ukon\u010Den\u00ED u\u017E\u00EDv\u00E1n\u00ED antikoncep\u010Dn\u00EDch tablet by nem\u011Bly b\u00FDt odeb\u00EDr\u00E1ny v\u00A0pr\u016Fb\u011Bhu prvn\u00EDho t\u00FDdne po ukon\u010Den\u00ED antikoncepce.\nZa\u010D\u00E1tek l\u00E9\u010Dby lamotriginem u pacientek, kter\u00E9 ji\u017E u\u017E\u00EDvaj\u00ED hormon\u00E1ln\u00ED antikoncepci\nZvy\u0161ov\u00E1n\u00ED d\u00E1vky by m\u011Blo sledovat norm\u00E1ln\u00ED doporu\u010Den\u00E9 d\u00E1vkov\u00E1n\u00ED popsan\u00E9 v\u00A0tabulk\u00E1ch. \nZah\u00E1jen\u00ED a ukon\u010Den\u00ED l\u00E9\u010Dby hormon\u00E1ln\u00ED antikoncepc\u00ED u pacientek, kter\u00E9 ji\u017E u\u017E\u00EDvaj\u00ED udr\u017Eovac\u00ED d\u00E1vky lamotriginu a U\u017D\u00CDVAJ\u00CD induktory lamotriginov\u00E9 glukuronidace\nP\u0159izp\u016Fsoben\u00ED doporu\u010Den\u00E9 udr\u017Eovac\u00ED d\u00E1vky lamotriginu nemus\u00ED b\u00FDt pot\u0159ebn\u00E9. \nU\u017E\u00EDv\u00E1n\u00ED s\u00A0atazanavirem/ritonavirem\nPokud se lamotrigin p\u0159id\u00E1v\u00E1 k\u00A0zaveden\u00E9 l\u00E9\u010Db\u011B atazanavirem/ritonavirem, nen\u00ED nutn\u00E1 \u017E\u00E1dn\u00E1 \u00FAprava doporu\u010Den\u00E9ho postupn\u00E9ho zvy\u0161ov\u00E1n\u00ED d\u00E1vky lamotriginu.\nU pacient\u016F, kte\u0159\u00ED ji\u017E dost\u00E1vaj\u00ED udr\u017Eovac\u00ED d\u00E1vky lamotriginu a neu\u017E\u00EDvaj\u00ED induktory glukuronidizace, m\u016F\u017Ee b\u00FDt nutn\u00E9 d\u00E1vku lamotriginu zv\u00FD\u0161it, pokud se k\u00A0l\u00E9\u010Db\u011B p\u0159id\u00E1v\u00E1 atazanavir/ritonavir, nebo sn\u00ED\u017Eit, pokud se atazanavir/ritonavir vysazuje. P\u0159ed a v\u00A0pr\u016Fb\u011Bhu 2 t\u00FDdn\u016F po zah\u00E1jen\u00ED nebo ukon\u010Den\u00ED l\u00E9\u010Dby atazanavirem/ritonavirem je t\u0159eba prov\u00E1d\u011Bt kontroly hladiny lamotriginu v plazm\u011B, aby bylo mo\u017En\u00E9 sledovat, zda nen\u00ED nutn\u00E9 d\u00E1vku lamotriginu upravit (viz bod 4.5).\nU\u017E\u00EDv\u00E1n\u00ED s\u00A0lopinavirem/ritonavirem\nPokud se lamotrigin p\u0159id\u00E1v\u00E1 k\u00A0zaveden\u00E9 l\u00E9\u010Db\u011B lopinavirem/ritonavirem, nen\u00ED nutn\u00E1 \u017E\u00E1dn\u00E1 \u00FAprava doporu\u010Den\u00E9ho postupn\u00E9ho zvy\u0161ov\u00E1n\u00ED d\u00E1vky lamotriginu.\nU pacient\u016F, kte\u0159\u00ED ji\u017E dost\u00E1vaj\u00ED udr\u017Eovac\u00ED d\u00E1vky lamotriginu a neu\u017E\u00EDvaj\u00ED induktory glukuronidizace, m\u016F\u017Ee b\u00FDt nutn\u00E9 d\u00E1vku lamotriginu zv\u00FD\u0161it, pokud se k\u00A0l\u00E9\u010Db\u011B p\u0159id\u00E1v\u00E1 lopinavir/ritonavir, nebo sn\u00ED\u017Eit, pokud se lopinavir/ritonavir vysazuje. P\u0159ed a v\u00A0pr\u016Fb\u011Bhu 2 t\u00FDdn\u016F po zah\u00E1jen\u00ED nebo ukon\u010Den\u00ED l\u00E9\u010Dby lopinavirem/ritonavirem je t\u0159eba prov\u00E1d\u011Bt kontroly hladiny lamotriginu v plazm\u011B, aby bylo mo\u017En\u00E9 sledovat, zda nen\u00ED nutn\u00E9 d\u00E1vku lamotriginu upravit (viz bod 4.5).\nPacienti nad 65 let\nT\u011Bmto pacient\u016Fm nen\u00ED zapot\u0159eb\u00ED upravovat doporu\u010Den\u00E9 d\u00E1vkov\u00E1n\u00ED. Farmakokinetika lamotriginu nen\u00ED v\u00A0t\u00E9to v\u011Bkov\u00E9 skupin\u011B v\u00FDznamn\u011B odli\u0161n\u00E1 od farmakokinetiky mlad\u0161\u00EDch dosp\u011Bl\u00FDch (viz bod 5.2).\nPacienti s ren\u00E1ln\u00ED dysfunkc\u00ED\nP\u0159i pod\u00E1v\u00E1n\u00ED p\u0159\u00EDpravku Lamictal pacient\u016Fm s ren\u00E1ln\u00EDm selh\u00E1n\u00EDm je t\u0159eba zv\u00FD\u0161en\u00E1 obez\u0159etnost. \uFFFDU pacient\u016F s\u00A0termin\u00E1ln\u00EDm st\u00E1diem ren\u00E1ln\u00EDho selh\u00E1n\u00ED se \u00FAvodn\u00ED d\u00E1vky lamotriginu maj\u00ED \u0159\u00EDdit pr\u016Fvodn\u00ED medikac\u00ED. Sn\u00ED\u017Een\u00ED udr\u017Eovac\u00ED d\u00E1vky je zapot\u0159eb\u00ED u pacient\u016F s v\u00FDrazn\u00FDm sn\u00ED\u017Een\u00EDm ren\u00E1ln\u00EDch funkc\u00ED (viz body 4.4 a 5.2).\nPacienti s\u00A0hepat\u00E1ln\u00ED dysfunkc\u00ED\nObecn\u011B maj\u00ED b\u00FDt \u00FAvodn\u00ED, postupn\u011B zvy\u0161ovan\u00E9 i udr\u017Eovac\u00ED d\u00E1vky sn\u00ED\u017Eeny u pacient\u016F se st\u0159edn\u011B t\u011B\u017Ekou hepat\u00E1ln\u00ED dysfunkc\u00ED (stupn\u011B B podle Child-Pughovy klasifikace) p\u0159ibli\u017En\u011B o 50 % a u pacient\u016F s\u00A0t\u011B\u017Ekou hepat\u00E1ln\u00ED dysfunkc\u00ED (stupn\u011B C podle Child-Pughovy klasifikace) p\u0159ibli\u017En\u011B o 75 %. Zvy\u0161ovan\u00E9 a udr\u017Eovac\u00ED d\u00E1vky maj\u00ED b\u00FDt upraveny podle klinick\u00E9 odezvy (viz bod 5.2).\n"@cs . . . . . . . .