FrancophonIA/ELRC3.0 huggingface dataset:
Dutch: Tabel 1: Bijwerkingen die zijn gemeld in klinische onderzoeken met Galafold Systeem/orgaanklasse
Slovenian: Preglednica 1: Neželeni učinki zdravila Galafold, o katerih so poročali v kliničnih preskušanjih Organski sistem
Dutch: Verhoging van creatininefosfokinase in het bloed Toegenomen gewicht
Slovenian: Preiskave zvišana raven kreatin fosfokinaze v krvi povečana telesna masa
Dutch: Verandering eiwitsequentie
Slovenian: Sprememba proteinskega zapaliedja
Dutch: Om de bijsluiter in te zien, scan onderstaande code.
Slovenian: Za dostop do navodila za uporabo odčitajte spodnjo kodo.
Dutch: c.A712C of c.T714A of c.T714G S238R
Slovenian: c.A712C ali c.T714A ali c.T714G S238R
Dutch: 14 capsules per verpakking.
Slovenian: Velikost pakiranja: 14 kapsul.
Dutch: c.T817C of c.T819A of c.T819G F273L
Slovenian: c.T817C ali c.T819A ali c.T819G F273L
Dutch: c.G611A of G612A
Slovenian: c.G611A ali G612A
Dutch: Noteer de datum op de doordrukverpakking op de eerste dag dat u dit geneesmiddel uit een nieuwe doordrukverpakking gebruikt.
Slovenian: Prvi dan, ko vzamete zdravilo iz novega pretisnega omota, zabeležite datum na pretisni omot.
Dutch: Elke capsule bevat migalastathydrochloride equivalent aan 123 mg migalastat.
Slovenian: Ena kapsula vsebuje migalastatijevega klorida v količini, ki ustreza 123 mg migalastata.
Dutch: Migalastat had geen negatieve invloed op de vruchtbaarheid van vrouwelijke ratten.
Slovenian: Pri podganjih samicah migalastat na plodnost ni vplival.
Dutch: • Het gevoel rond te tollen
Slovenian: • Občutek vrtenja
Dutch: c.T1147C of c.C1149G of c.C1149A
Slovenian: c.T1147C ali c.C1149G ali c.C1149A
Dutch: (epistaxis)
Slovenian: (epistaksa)
Dutch: Er zijn geen onderzoeken verricht bij proefpersonen met een leverfunctiestoornis.
Slovenian: Pri osebah z oslabljenim delovanjem jeter študije niso bile izvedene.
Dutch: c.A504C of c.A504T
Slovenian: c.A504C ali c.A504T
Dutch: c.A924T of c.A924C
Slovenian: c.A924T ali c.A924C
Dutch: Ademhalingsstelsel-, borstkasen mediastinumaandoeningen
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja epistaksa
Dutch: In het onderzoek met ERT-naïeve patiënten leidde Galafold tot een statistisch significante afname van de LVMi (p < 0,05); de gemiddelde verandering van de LVMi ten opzichte van de uitgangswaarde was in maand 18 tot 24 -7,7 (95%-BI: -15,4; -0,01; n=27).
Slovenian: Pri preskušanju brez predhodnega ERT je zdravilo Galafold povzročilo statistično značilno zmanjšanje LVMi (p < 0,05); srednja sprememba od izhodiščnega LVMi v 18. do 24. mesecu je bila -7,7 (95-% CI: -15,4, -0,01; n = 27).
Dutch: c.A442C of c.T444A of c.T444G S148R
Slovenian: c.A442C ali c.T444A ali c.T444G S148R
Dutch: Na een enkelvoudige orale dosis van 150 mg migalastathydrochloride-oplossing bedroeg de tijd tot de piekconcentratie in het plasma ongeveer 3 uur.
Slovenian: Čas do najvišje plazemske koncentracije po enkratnem peroralnem odmerku 150 mg raztopine migalastatijevega klorida je bil približno 3 ure.
Dutch: c.1095T>A of c.1095T>G c.T1095A of c.T1095G
Slovenian: c.1095T>A ali c.1095T>G c.T1095A ali c.T1095G
Dutch: c.504A>C of c.504A>T
Slovenian: c.504A>C ali c.504A>T
Dutch: In een onderzoek met een enkelvoudige dosis Galafold bij proefpersonen zonder de ziekte de Fabry met verschillende graden van nierinsufficiëntie was de blootstelling 4,3 keer hoger bij proefpersonen met een ernstige nierfunctiestoornis (GFR < 30 ml/min/1,73 m
Slovenian: V študiji s enkratnim odmerkom zdravila Galafold pri bolnikih, ki nimajo Fabryjeve bolezni in imajo različno stopnjo ledvične insuficience, se je pri osebah s hudo okvaro ledvic (GFR > 30 ml/min/1,73 m2) izpostavljenost povečala za 4,3-krat.
Dutch: c.G216A of c.G216T of c.G216C M72I
Slovenian: c.G216A ali c.G216T ali c.G216C M72I
Dutch: c.G412A of c.G412C
Slovenian: c.G412A ali c.G412C
Dutch: c.C816A of c.C816G
Slovenian: c.C816A ali c.C816G
Dutch: • Plotseling moeten stoelgang maken
Slovenian: • Nenadno siljenje na blato
Dutch: c.139T>C of c.139T>A
Slovenian: c.139T>C ali c.139T>A
Dutch: c.G801A (putatieve splicing locatie)
Slovenian: c.G801A (domnevno mesto spajanja)
Dutch: In het onderzoek bij patiënten die eerder met ERT waren behandeld was er na 18 maanden behandeling met Galafold een statistisch significante afname van de LVMi (p < 0,05).
Slovenian: Indeks mase levega prekata (LVMi, Left Ventricular Mass index) V preskušanju s predhodnim ERT se je po 18-mesečnem zdravljenju z zdravilom Galafold LVMi statistično značilno zmanjšal (p < 0,05).
Dutch: Patiënten die in fase 1 naar Galafold waren gerandomiseerd lieten een statistisch significant grotere afname (± SEM) in de gemiddelde GL-3-depositie in interstitiële capillairen zien (-0,25 ± 0,10; -39%) in maand 6 in vergelijking met placebo (+0,07 ± 0,13; +14%) (p = 0,008).
Slovenian: Pri bolnikih, ki so bili v fazi 1 randomizirani na zdravilo Galafold, se je srednje odlaganje GL-3 v intersticijskih kapilarah v 6. mesecu v primerjavi s placebom (+0,07 ± 0,13; +14 %) statistično značilno bolj zmanjšalo (±SEM) (-0,25 ± 0,10; -39 %) (p = 0,008).
Dutch: c.1065C>A of c.1065C>G c.C1065A of c.C1065G
Slovenian: c.1065C>A ali c.1065C>G c.C1065A ali c.C1065G
Dutch: Zie de bijsluiter voor meer informatie.
Slovenian: Za dodatna navodila glejte navodilo za uporabo.
Dutch: c.G126A of c.G126C of c.G126T M42I
Slovenian: c.G126A ali c.G126C ali c.G126T M42I
Dutch: Het verschil in klaring tussen patiënten met de ziekte van Fabry van ≥ 65 jaar en degenen < 65 jaar was 20%; dit werd niet als klinisch significant beschouwd.
Slovenian: Učinek starosti so vrednotili s populacijsko farmakokinetično analizo plazemskega očistka migalastata pri populaciji, ki še ni prejemala ERT. Razlika v očistku pri bolnikih s Fabryjevo boleznijo, starih 65 let ali več, in mlajših od 65 let, je znašala 20 %, kar ni klinično pomembno.
Dutch: Na oplopende, enkelvoudige, orale doses (25-675 mg migalastathydrochloride) werden geen trends gevonden voor de klaring, CL/F).
Slovenian: Pri očistku (CL/F) ni bil po dajanju enkratnih naraščajočih peroralnih odmerkov (25-675 mg migalastatijevega klorida) prepoznan noben trend.
Dutch: c.C519A of c.C519G
Slovenian: c.C519A ali c.C519G
Dutch: c.1045T>C of c.1045T>A c.T1045C of c.T1045A
Slovenian: c.1045T>C ali c.1045T>A c.T1045C ali c.T1045A
Dutch: c.G140A of G141A
Slovenian: c.G140A ali G141A
Dutch: c.1034C>G of c.1034C>A c.C1034G of c.C1034A
Slovenian: c.1034C>G ali c.1034C>A c.C1034G ali c.C1034A
Dutch: c.712A>C of c.714T>A of c.714T>G
Slovenian: c.712A>C ali c.714T>A ali c.714T>G
Dutch: c.3G>A of c.3G>T of c.3G>C c.G3A of c.G3T of c.G3C
Slovenian: c.3G>A ali c.3G>T ali c.3G>C c.G3A ali c.G3T ali c.G3C
Dutch: c.1147T>C of c.1149C>G of c.1149C>A
Slovenian: c.1147T>C ali c.1149C>G ali c.1149C>A
Dutch: c.C207A of c.C207G
Slovenian: c.C207A ali c.C207G
Dutch: Paresthesie Duizeligheid Hypo-esthesie
Slovenian: Bolezni živčevja glavobol parestezije omotica hipestezija
Dutch: c.801G>A (putatieve splicing locatie)
Slovenian: c.801G>A (domnevno mesto spajanja)
Dutch: c.159C>G of c.159C>A
Slovenian: c.159C>G ali c.159C>A
Dutch: c.C159G of c.C159A
Slovenian: c.C159G ali c.C159A
Dutch: c.216G>A of c.216G>T of c.216G>C
Slovenian: c.216G>A ali c.216G>T ali c.216G>C
Dutch: c.611G>A of 612G>A
Slovenian: c.611G>A ali 612G>A
Dutch: In het onderzoek bij ERT-naïeve patiënten liet Galafold statistisch significante verlagingen zien van de plasmaconcentraties van lyso-Gb3 en van GL-3-inclusies in renale interstitiële capillairen bij patiënten met behandelbare mutaties.
Slovenian: Pri preskušanju brez predhodnega ERT se je pri bolnikih z odzivnimi mutacijami ob uporabi zdravila Galafold plazemska koncentracija lizo-Gb3 statistično značilno zmanjšala, prav tako je bilo manj vključkov GL-3 v intersticijskih kapilarah ledvic.
Dutch: c.G639A (putatieve splicing locatie)
Slovenian: c.G639A (domnevno mesto spajanja)
Dutch: c.369+3_639+954del3129insT NIET BEKEND (del Exon3 en 4?)
Slovenian: c.369+3_639+954del3129insT NEZNANO (del Exon3 in g.6009_9741del
Dutch: • Als u allergisch bent voor migalastat of een van de stoffen in dit geneesmiddel.
Slovenian: Ne jemljite zdravila Galafold: • če ste alergični na migalastat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Dutch: c.1046G>A of c.1047G>A c.G1046A of c.G1047A
Slovenian: c.1046G>A ali c.1047G>A c.G1046A ali c.G1047A
Dutch: c.280T>A of c.281G>C
Slovenian: c.280T>A ali c.281G>C
Dutch: c.G284A of c.G285A
Slovenian: c.G284A ali c.G285A
Dutch: c.126G>A of c.126G>C of c.126G>T
Slovenian: c.126G>A ali c.126G>C ali c.126G>T
Dutch: c.T187A of c.G188C
Slovenian: c.T187A ali c.G188C
Dutch: c.148T>C of c.150C>G of c.150C>A
Slovenian: c.148T>C ali c.150C>G ali c.150C>A
Dutch: c.G547A (putatieve splicing locatie)
Slovenian: c.G547A (domnevno mesto spajanja)
Dutch: Na de follow-up in de OLE was de gemiddelde verandering van de LVMi ten opzichte van de uitgangswaarde in maand 36 -8,3 (95%-BI: -17,1; 0,4; n=25) en in maand 48 -9,1 (95%-BI: -20,3; 2,0; n=18).
Slovenian: Po sledenju v odprtem podaljšanem preskušanju je bila srednja sprememba od izhodiščnega LVMi v 36. mesecu -8,3 (95-% CI: -17,1, 0,4; n = 25), v 48. mesecu pa -9,1 (95-% CI: -20,3, 2,0; n = 18).
Dutch: c.G870A of c.G870C of c.G870T M290I
Slovenian: c.G870A ali c.G870C ali c.G870T M290I
Dutch: c.G982A of c.G982C
Slovenian: c.G982A ali c.G982C
Dutch: c.140G>A of 141G>A
Slovenian: c.140G>A ali 141G>A
Dutch: c.924A>T of c.924A>C
Slovenian: c.924A>T ali c.924A>C
Dutch: c.639G>A (putatieve splicing locatie)
Slovenian: c.639G>A (domnevno mesto spajanja)
Dutch: Galafold is niet onderzocht bij patiënten met de ziekte van Fabry die een GFR hebben van minder dan 30 ml/min/1,73 m2.
Slovenian: Zdravilo Galafold ni bilo raziskano pri bolnikih s Fabryjevo boleznijo, pri katerih je GFR nižja od 30 ml/min/1,73 m2.
Dutch: Na 30 maanden behandeling met Galafold was de gemiddelde verandering in LVMi ten opzichte van baseline -3,8 (95%-BI: -8,9; 1,3; n=28) en was de gemiddelde verandering in LVMi ten opzichte van baseline bij patiënten met linkerkamerhypertrofie op baseline -10,0 (95%-BI: -16,6; -3,3; n=10).
Slovenian: Po 30-mesečnem zdravljenju z zdravilom Galafold je bila srednja sprememba od izhodiščnega LVMi -3,8 (95-% CI: -8,9, 1,3; n = 28), pri bolnikih z hipertrofijo levega prekata pa je bila srednja sprememba od izhodiščnega LVMi -10,00 (95-% CI: -16,6, -3,3; n = 10).
Dutch: c.241T>C of c.241T>A
Slovenian: c.241T>C ali c.241T>A
Dutch: c.442A>C of c.444T>A of c.444T>G
Slovenian: c.442A>C ali c.444T>A ali c.444T>G
Dutch: c.T139C of c.T139A
Slovenian: c.T139C ali c.T139A
Dutch: c.A124C of c.A124T
Slovenian: c.A124C ali c.A124T
Dutch: c.T881G of c.T881A
Slovenian: c.T881G ali c.T881A
Dutch: c.T166A of c.G167C
Slovenian: c.T166A ali c.G167C
Dutch: c.G228C of c.G228A of c.G228T M76I
Slovenian: c.G228C ali c.G228A ali c.G228T M76I
Dutch: c.T552A of c.T552G
Slovenian: c.T552A ali c.T552G
Dutch: (95%-BI: -2,272; 1,478; n=34) in de Galafold-groep in vergelijking met -1,03 ml/min/1,73 m
Slovenian: (95-% CI: -2,272, 1,478; n = 34), v skupini,
Dutch: c.261G>C of c.261G>T
Slovenian: c.261G>C ali c.261G>T
Dutch: c.G285T of c.G285C
Slovenian: c.G285T ali c.G285C
Dutch: c.124A>C of c.124A>T
Slovenian: c.124A>C ali c.124A>T
Dutch: c.T241C of c.T241A
Slovenian: c.T241C ali c.T241A
Dutch: c.284G>A of c.285G>A
Slovenian: c.284G>A ali c.285G>A
Dutch: c.G131A of c.G132A
Slovenian: c.G131A ali c.G132A
Dutch: c.G888A of c.G888T of c.G888C M296I
Slovenian: c.G888A ali c.G888T ali c.G888C M296I
Dutch: c.471G>C of c.471G>T
Slovenian: c.471G>C ali c.471G>T
Dutch: c.817T>C of c.819T>A of c.819T>G
Slovenian: c.817T>C ali c.819T>A ali c.819T>G
Dutch: c.G612T of c.G612C
Slovenian: c.G612T ali c.G612C
Dutch: c.C279G of c.C279A
Slovenian: c.C279G ali c.C279A
Dutch: c.412G>A of c.412G>C
Slovenian: c.412G>A ali c.412G>C
Dutch: Ziekte-substraat
Slovenian: Substrat bolezni
Dutch: c.G734A of c.G735A
Slovenian: c.G734A ali c.G735A
Dutch: c.G242A of c.G243A
Slovenian: c.G242A ali c.G243A
Dutch: c.187T>A of c.188G>C
Slovenian: c.187T>A ali c.188G>C
Dutch: In het onderzoek bij patiënten met ERT-ervaring bleef de nierfunctie stabiel gedurende 18 maanden behandeling met Galafold.
Slovenian: Pri preskušanju s predhodnim ERT je delovanje ledvic ostalo stabilno do 18 mesecev od začetka zdravljenja z zdravilom Galafold.
Dutch: DD maand JJJJ
Slovenian: DD. mesec LLLL
Dutch: c.C233G of c.C233A
Slovenian: c.C233G ali c.C233A
Dutch: Na de follow-up in de OLE was de gemiddelde verandering van de LVMi ten opzichte van de uitgangswaarde bij patiënten met linkerventrikelhypertrofie bij de start van het onderzoek in maand 36 -30,0 (95%-BI: -57,9; -2,2; n=4) en in maand 48 -33,1 (95%-BI: -60,9; -5,4; n=4).
Slovenian: Po sledenju v odprtem podaljšanem preskušanju je bila srednja sprememba od izhodiščnega LVMi pri bolnikih s hipertrofijo levega prekata v izhodišču v 36. mesecu -30,0 (95-% CI: -57,9, -2,2; n = 4), v 48. mesecu pa -33,1 (CI: -60,9, -5,4; n = 4).
Dutch: Op basis van in-vivo-gegevens is migalastat een substraat voor UGT; dit is een onbelangrijke eliminatieroute.
Slovenian: Po podatkih raziskav in vivo je migalastat substrat za encim UGT.
Dutch: c.153G>A of c.153G>T of c.153G>C
Slovenian: c.153G>A ali c.153G>T ali c.153G>C
Dutch: c.G261C of c.G261T
Slovenian: c.G261C ali c.G261T
Dutch: c.547G>A (putatieve splicing locatie)
Slovenian: c.547G>A (domnevno mesto spajanja)
Dutch: c.C525G of c.C525A
Slovenian: c.C525G ali c.C525A
Dutch: c.540G>C of c.540G>T
Slovenian: c.540G>C ali c.540G>T
Dutch: c.G471C of c.G471T
Slovenian: c.G471C ali c.G471T
Dutch: c.C305G of c.C305A
Slovenian: c.C305G ali c.C305A
Dutch: c.285G>T of c.285G>C
Slovenian: c.285G>T ali c.285G>C
Dutch: c.G103C of c.G103A
Slovenian: c.G103C ali c.G103A
Dutch: c.279C>G of c.279C>A
Slovenian: c.279C>G ali c.279C>A
Dutch: c.103G>C of c.103G>A
Slovenian: c.103G>C ali c.103G>A
Dutch: c.T258G of c.T258A
Slovenian: c.T258G ali c.T258A
Dutch: c.A588T of c.A588C
Slovenian: c.A588T ali c.A588C
Dutch: c.T514A of c.G515C
Slovenian: c.T514A ali c.G515C
Dutch: c.G1074T of c.G1074C
Slovenian: c.G1074T ali c.G1074C
Dutch: c.G132T of c.G132C
Slovenian: c.G132T ali c.G132C
Dutch: c.G243T of c.G243C
Slovenian: c.G243T ali c.G243C
Dutch: (torticollis)
Slovenian: (tortikolis)
Dutch: c.243G>T of c.243G>C
Slovenian: c.243G>T ali c.243G>C
Dutch: c.228G>C of c.228G>A of c.228G>T
Slovenian: c.228G>C ali c.228G>A ali c.228G>T
Dutch: c.A840T of c.A840C
Slovenian: c.A840T ali c.A840C
Dutch: c.G540C of c.G540T
Slovenian: c.G540C ali c.G540T
Dutch: c.132G>T of c.132G>C
Slovenian: c.132G>T ali c.132G>C
Dutch: c.519C>A of c.519C>G
Slovenian: c.519C>A ali c.519C>G
Dutch: c.T960G of c.T960A
Slovenian: c.T960G ali c.T960A
Dutch: c.C453G of c.C453A
Slovenian: c.C453G ali c.C453A
Dutch: c.552T>A of c.552T>G
Slovenian: c.552T>A ali c.552T>G
Dutch: c.525C>G of c.525C>A
Slovenian: c.525C>G ali c.525C>A
Dutch: Galafold wordt niet aanbevolen voor gebruik bij patiënten met de ziekte van Fabry die een geschatte glomerulaire filtratiesnelheid (GFR) hebben van minder dan 30 ml/min/1,73 m
Slovenian: Uporaba zdravila Galafold ni priporočljiva pri bolnikih s Fabryjevo boleznijo, pri katerih je ocenjena stopnja glomerulne filtracije (GFR) manjša kot 30 ml/min/1,73 m
Dutch: c.141G>C of c.141G>T
Slovenian: c.141G>C ali c.141G>T
Dutch: NIET BEKEND (del Exon3?)
Slovenian: NEZNANO (del Exon3?)
Dutch: c.C747G of c.C747A
Slovenian: c.C747G ali c.C747A
Dutch: c.G1081A of c.G1081C
Slovenian: c.G1081A ali c.G1081C
Dutch: c.816C>A of c.816C>G
Slovenian: c.816C>A ali c.816C>G
Dutch: c.982G>A of c.982G>C
Slovenian: c.982G>A ali c.982G>C
Dutch: Hoofdpijn en duizeligheid waren de meest voorkomende bijwerkingen die werden gemeld in Galafold-doses tot respectievelijk 1250 mg en 2000 mg.
Slovenian: Najpogostejša neželena učinka pri odmerkih zdravila Galafold do 1.250 oz. 2.000 mg sta bila glavobol in omotica.
Dutch: c.G144T of c.G144C
Slovenian: c.G144T ali c.G144C
Dutch: c.G609C of c.G609T
Slovenian: c.G609C ali c.G609T
Dutch: NIET BEKEND (del Exon5_7?)
Slovenian: NEZNANO (del Exon5_7?)
Dutch: Migalastat is in vitro geen substraat voor P-glycoproteïne (P-gP) en het wordt onwaarschijnlijk geacht dat migalastat geneesmiddelinteracties zou kunnen hebben met cytochroom P450's.
Slovenian: Malo verjetno je, da bi bil migalastat udeležen v interakcijah med zdravili v povezavi s citokromom P450.
Dutch: c.612G>T of c.612G>C
Slovenian: c.612G>T ali c.612G>C
Dutch: NIET BEKEND (del Exon1_2?)
Slovenian: NEZNANO (del Exon1_2?)
Dutch: c.131G>A of c.132G>A
Slovenian: c.131G>A ali c.132G>A
Dutch: c.1074G>T of c.1074G>C
Slovenian: c.1074G>T ali c.1074G>C
Dutch: c.561G>T of c.561G>A of c.561G>C
Slovenian: c.561G>T ali c.561G>A ali c.561G>C
Dutch: c.337T>C of c.339T>A of c.339T>G
Slovenian: c.337T>C ali c.339T>A ali c.339T>G
Dutch: c.T859C of c.T859A
Slovenian: c.T859C ali c.T859A
Dutch: c.859T>C of c.859T>A
Slovenian: c.859T>C ali c.859T>A
Dutch: c.G288A of c.G288T of c.G288C M96I
Slovenian: c.G288A ali c.G288T ali c.G288C M96I
Dutch: Bent u vergeten dit middel in te nemen?
Slovenian: Če ste pozabili vzeti zdravilo Galafold
Dutch: c.G860A of c.G861A
Slovenian: c.G860A ali c.G861A
Dutch: c.609G>C of c.609G>T
Slovenian: c.609G>C ali c.609G>T
Dutch: c.166T>A of c.167G>C
Slovenian: c.166T>A ali c.167G>C
Dutch: c.T154A of c.G155C
Slovenian: c.T154A ali c.G155C
Dutch: c.G830A of c.G831A
Slovenian: c.G830A ali c.G831A
Dutch: c.1081G>A of c.1081G>C
Slovenian: c.1081G>A ali c.1081G>C
Dutch: c.G831T of c.G831C
Slovenian: c.G831T ali c.G831C
Dutch: c.233C>G of c.233C>A
Slovenian: c.233C>G ali c.233C>A
Dutch: c.G567C of c.G567T
Slovenian: c.G567C ali c.G567T
Dutch: c.258T>G of c.258T>A
Slovenian: c.258T>G ali c.258T>A
Dutch: c.242G>A of c.243G>A
Slovenian: c.242G>A ali c.243G>A
Dutch: c.C897G of c.C897A
Slovenian: c.C897G ali c.C897A
Dutch: c.207C>A of c.207C>G
Slovenian: c.207C>A ali c.207C>G
Dutch: c.453C>G of c.453C>A
Slovenian: c.453C>G ali c.453C>A
Dutch: In het onderzoek bij patiënten die eerder met ERT werden behandeld namen de plasmaspiegels van lyso-Gb3 iets toe, maar bleven laag bij patiënten met behandelbare mutaties die met Galafold waren behandeld gedurende de 30 maanden van het onderzoek.
Slovenian: Pri preskušanju s predhodnim ERT se je pri bolnikih z odzivnimi mutacijami, ki so bili med izvajanjem študije 30 mesecev zdravljeni z zdravilom Galafold, plazemska koncentracija lizo-Gb3 nekoliko povečala, a je ostala nizka.
Dutch: Als meer dan 12 uur is verstreken, moet u Galafold hervatten op de volgende geplande toedieningsdag en -tijd volgens uw ‘om de andere dag'-toedieningsschema.
Slovenian: Če je preteklo več kot 12 ur, morate nadaljevati z jemanjem zdravila Galafold ob naslednjem načrtovanem dnevu in uri za odmerek, skladno z urnikom odmerjanja vsak drugi dan. Ne vzemite dveh kapsul, če ste pozabili vzeti prejšnji odmerek.
Dutch: c.881T>G of c.881T>A
Slovenian: c.881T>G ali c.881T>A
Dutch: c.T369G of c.T369A
Slovenian: c.T369G ali c.T369A
Dutch: c.870G>A of c.870G>C of c.870G>T
Slovenian: c.870G>A ali c.870G>C ali c.870G>T
Dutch: c.G485A of c.G486A
Slovenian: c.G485A ali c.G486A
Dutch: c.108G>C of c.108G>T
Slovenian: c.108G>C ali c.108G>T
Dutch: c.567G>C of c.567G>T
Slovenian: c.567G>C ali c.567G>T
Dutch: Galafold wordt niet aanbevolen voor gebruik bij patiënten met ernstige nierinsufficiëntie, gedefinieerd als een geschatte GFR van minder dan 30 ml/min/1,73 m
Slovenian: Uporaba zdravila Galafold ni priporočljiva pri bolnikih s hudo ledvično insuficienco, opredeljeno z ocenjeno GFR pod 30 ml/min/1,73 m
Dutch: c.T280A of c.G281C
Slovenian: c.T280A ali c.G281C
Dutch: c.144G>T of c.144G>C
Slovenian: c.144G>T ali c.144G>C
Dutch: c.T408A of c.T408G
Slovenian: c.T408A ali c.T408G
Dutch: c.G71A of c.G72A
Slovenian: c.G71A ali c.G72A
Dutch: Psychische stoornissen
Slovenian: • Prebavne motnje
Dutch: De gemiddelde verandering op jaarbasis ten opzichte van de baseline in eGFRCKD-EPI bij patiënten die gedurende 30 maanden met Galafold waren behandeld, was -1,72 ml/min/1,73 m
Slovenian: Pri bolnikih, ki so bili 30 mesecev zdravljeni z zdravilom Galafold, je bila srednja letna stopnja spremembe eGFRCKD-EPI -1,72 ml/min/1.73 m
Dutch: Drukinkt Schellak
Slovenian: PRETISNA FOLIJA
Dutch: Er was geen detecteerbare binding aan plasma-eiwitten na toediening van C]-migalastathydrochloride in het concentratiebereik tussen 1 en 100 M.
Slovenian: C]-migalastatijevega klorida v koncentracijskem razponu od 1 do 100 M ni bilo zaznavne vezave na plazemske proteine.
Dutch: c.610T>C of c.610T>A
Slovenian: c.610T>C ali c.610T>A
Dutch: c.T465A of c.T465G
Slovenian: c.T465A ali c.T465G
Dutch: Het is raadzaam om periodiek (om de 6 maanden) de nierfunctie, echocardiografische parameters en biochemische markers te controleren bij patiënten die zijn begonnen of zijn overgeschakeld op Galafold.
Slovenian: Pri bolnikih, ki so začeli ali prešli na zdravljenje z zdravilom Galafold, se priporoča periodično spremljanje ledvične funkcije, ehokardiografskih parametrov in biokemičnih markerjev (vsakih 6 mesecev).
Dutch: c.C456A of c.C456G
Slovenian: c.C456A ali c.C456G
Dutch: c.G861C of c.G861T
Slovenian: c.G861C ali c.G861T
Dutch: c.C966A of c.C966G
Slovenian: c.C966A ali c.C966G
Dutch: • Neusbloeding
Slovenian: • Krvavitev iz nosu
Dutch: c.305C>G of c.305C>A
Slovenian: c.305C>G ali c.305C>A
Dutch: Hoe ziet Galafold eruit en hoeveel zit er in een verpakking?
Slovenian: Izgled zdravila Galafold in vsebina pakiranja
Dutch: c.G141C of c.G141T
Slovenian: c.G141C ali c.G141T
Dutch: De GLA-mutaties die behandelbaar en niet behandelbaar zijn met Galafold worden opgesomd in respectievelijk tabel 2 en tabel 3 hieronder.
Slovenian: Na zdravljenje z zdravilom Galafold odzivne in neodzivne mutacije gena GLA so navedene v preglednicah 2 in 3.
Dutch: c.831G>T of c.831G>C
Slovenian: c.831G>T ali c.831G>C
Dutch: c.707G>A of c.708G>A
Slovenian: c.707G>A ali c.708G>A
Dutch: c.960T>G of c.960T>A
Slovenian: c.960T>G ali c.960T>A
Dutch: c.T610C of c.T610A
Slovenian: c.T610C ali c.T610A
Dutch: c.897C>G of c.897C>A
Slovenian: c.897C>G ali c.897C>A
Dutch: c.860G>A of c.861G>A
Slovenian: c.860G>A ali c.861G>A
Dutch: c.G439A of c.G439C
Slovenian: c.G439A ali c.G439C
Dutch: Als u of uw partner zwanger wil worden, neem dan contact op met uw arts, apotheker of verpleegkundige voor advies.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
Dutch: c.T648A of c.T648G
Slovenian: c.T648A ali c.T648G
Dutch: c.T676C of c.T676A
Slovenian: c.T676C ali c.T676A
Dutch: c.465T>A of c.465T>G
Slovenian: c.465T>A ali c.465T>G
Dutch: Verminderde leverfunctie Er is geen dosisaanpassing nodig voor patiënten met een leverfunctiestoornis (zie rubriek 5.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka zdravila Galafold ni potrebna (glejte razdelek 5.2).
Dutch: • Spierpijn (myalgie)
Slovenian: • Kratka sapa (dispneja)
Dutch: c.485G>A of c.486G>A
Slovenian: c.485G>A ali c.486G>A
Dutch: c.A868C of c.A868T
Slovenian: c.A868C ali c.A868T
Dutch: c.830G>A of c.831G>A
Slovenian: c.830G>A ali c.831G>A
Dutch: c.G837C of c.G837T
Slovenian: c.G837C ali c.G837T
Dutch: c.154T>A of c.155G>C
Slovenian: c.154T>A ali c.155G>C
Dutch: c.G394A of c.G394C
Slovenian: c.G394A ali c.G394C
Dutch: c.T667A of c.G668C
Slovenian: c.T667A ali c.G668C
Dutch: U moet alleen om de andere dag eenmaal Galafold innemen.
Slovenian: Zdravilo Galafold lahko vzamete samo enkrat vsak drugi dan.
Dutch: c.70T>C of c.70T>A
Slovenian: c.70T>C ali c.70T>A
Dutch: c.288G>A of c.288G>T of c.288G>C
Slovenian: c.288G>A ali c.288G>T ali c.288G>C
Dutch: c.394G>A of c.394G>C
Slovenian: c.394G>A ali c.394G>C
Dutch: c.514T>A of c.515G>C
Slovenian: c.514T>A ali c.515G>C
Dutch: c.486G>C of c.486G>T
Slovenian: c.486G>C ali c.486G>T
Dutch: c.840A>T of c.840A>C
Slovenian: c.840A>T ali c.840A>C
Dutch: c.676T>C of c.676T>A
Slovenian: c.676T>C ali c.676T>A
Dutch: c.888G>A of c.888G>T of c.888G>C
Slovenian: c.888G>A ali c.888G>T ali c.888G>C
Dutch: c.T687A of c.T687G
Slovenian: c.T687A ali c.T687G
Dutch: c.439G>A of c.439G>C
Slovenian: c.439G>A ali c.439G>C
Dutch: c.102T>G of c.102T>A
Slovenian: c.102T>G ali c.102T>A
Dutch: c.966C>A of c.966C>G
Slovenian: c.966C>A ali c.966C>G
Dutch: c.G108C of c.G108T
Slovenian: c.G108C ali c.G108T
Dutch: c.708G>C of c.708G>T
Slovenian: c.708G>C ali c.708G>T
Dutch: NIET BEKEND (del Exon3_7?)
Slovenian: NEZNANO (del Exon3_7?)