FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: En el ensayo en pacientes no expuestos previamente a TSE, Galafold produjo un descenso estadísticamente significativo del IMVI (p< 0,05); el cambio promedio desde el periodo basal en el IMVI en los meses de 18 a 24 fue de -7,7 (IC del 95 %: -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).
Spanish: Migalastat no es un sustrato de la P-glicoproteína in vitro y se considera poco probable que migalastat estuviera sujeto a interacciones entre fármacos con citocromo P450s.
Slovenian: Malo verjetno je, da bi bil migalastat udeležen v interakcijah med zdravili v povezavi s citokromom P450.
Spanish: c.T817C o c.T819A o c.T819G F273L
Slovenian: c.T817C ali c.T819A ali c.T819G F273L
Spanish: Alterne los días tomando la cápsula los días impares y perforando los círculos blancos los días pares, hasta el día 28, incluido este último.
Slovenian: Po 2. dnevu se pomikajte v desno po pretisnem omotu in do vključno 28. dne nadaljujte tako, da na lihe dneve vzamete kapsulo, na sode dneve pa preluknjate bel krogec.
Spanish: En pacientes con mutaciones susceptibles de responder al tratamiento, los niveles de GL-3 tendían a disminuir en la orina y en los capilares intersticiales renales.
Slovenian: Pri bolnikih z odzivnimi mutacijami so se ravni GL-3 v urinu in ledvičnih intersticijskih kapilarah večinoma znižale.
Spanish: (IC del 95 %: -3,636, 1,575; n=18) en el grupo de TSE.
Slovenian: (95-% CI: -3,636, 1,575; n = 18).
Spanish: Fertilidad en mujeres No se sabe si este medicamento afecta a la fertilidad femenina.
Slovenian: Ni še znano, ali to zdravilo vpliva na plodnost pri ženskah.
Spanish: Secuencia proteica modificada c.[253G>A; 254G>T; 255T>G] c.G253A/G254T/T255G
Slovenian: c.[253G>A; 254G>T; 255T>G] c.G253A/G254T/T255G
Spanish: No se recomienda utilizar Galafold durante el embarazo.
Slovenian: Zdravilo Galafold v nosečnosti ni priporočljivo.
Spanish: c.A712C o c.T714A o c.T714G S238R
Slovenian: c.A712C ali c.T714A ali c.T714G S238R
Spanish: (IC del 95 %: -2,653, -0,782;
Slovenian: (95-% CI: -2,653, -0,782; n = 31).
Spanish: c.G611A o G612A
Slovenian: c.G611A ali G612A
Spanish: Después de una única dosis oral de 150 mg de solución de clorhidrato de migalastat, el tiempo hasta la concentración plasmática máxima fue de aproximadamente 3 horas.
Slovenian: Čas do najvišje plazemske koncentracije po enkratnem peroralnem odmerku 150 mg raztopine migalastatijevega klorida je bil približno 3 ure.
Spanish: Insuficiencia hepática No se requiere un ajuste de dosis de Galafold en pacientes con insuficiencia hepática (ver sección 5.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka zdravila Galafold ni potrebna (glejte razdelek 5.2).
Spanish: c.1046G>A o c.1047G>A c.G1046A o c.G1047A
Slovenian: c.1046G>A ali c.1047G>A c.G1046A ali c.G1047A
Spanish: • Aumento de peso
Slovenian: • Povečanje telesne mase
Spanish: En un estudio de dosis única con Galafold en sujetos sin la enfermedad de Fabry con diferentes grados de insuficiencia renal, las exposiciones aumentaron de 4,3 veces en sujetos con insuficiencia renal grave (TFG< 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.
Spanish: Trastornos respiratorios, torácicos y mediastínicos
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja epistaksa
Spanish: Secuencia proteica modificada g.6736_11545del c.370-533_c.1290+277del
Slovenian: NEZNANO (del Exon3 in g.6736_11545del c.370-533_c.1290+277del
Spanish: Las mutaciones de GLA susceptibles y no susceptibles al tratamiento con Galafold figuran en las tablas 2 y 3 respectivamente a continuación.
Slovenian: Na zdravljenje z zdravilom Galafold odzivne in neodzivne mutacije gena GLA so navedene v preglednicah 2 in 3.
Spanish: Tabla 1: Reacciones adversas con Galafold en ensayos clínicos
Slovenian: Preglednica 1: Neželeni učinki zdravila Galafold, o katerih so poročali v kliničnih preskušanjih Organski sistem
Spanish: Tragar las cápsulas enteras.
Slovenian: Kapsulo pogoltnite celo.
Spanish: c.T1147C o c.C1149G o c.C1149A
Slovenian: c.T1147C ali c.C1149G ali c.C1149A
Spanish: Este medicamento no ha sido estudiado en niños menores de 16 años.
Slovenian: Tega zdravila pri otrocih in mladostnikih, mlajših od 16 let, niso raziskovali, zato varnost in učinkovitost zdravila pri tej starostni skupini nista bili dokazani.
Spanish: En el ensayo de extensión abierto con pacientes no expuestos previamente a TSE, la función renal permaneció estable durante un máximo de 5 años de tratamiento con Galafold.
Slovenian: Pri preskušanju brez predhodnega ERT in odprtem podaljšanem preskušanju je delovanje ledvic ostalo stabilno do 5 let od začetka zdravljenja z zdravilom Galafold.
Spanish: c.611G>A o 612G>A
Slovenian: c.611G>A ali 612G>A
Spanish: c.140G>A o 141G>A
Slovenian: c.140G>A ali 141G>A
Spanish: Si se olvida una dosis durante todo un día, el paciente debe tomar la dosis olvidada de Galafold solamente en el plazo de 12 horas siguientes a la hora habitual a la que se toma la dosis.
Slovenian: Če bolnik v celoti izpusti odmerek za posamezen dan, naj vzame zamujeni odmerek zdravila Galafold le, če ni preteklo več kot 12 ur od običajnega časa, ko bi moral vzeti odmerek.
Spanish: c.A924T o c.A924C
Slovenian: c.A924T ali c.A924C
Spanish: c.A442C o c.T444A o c.T444G S148R
Slovenian: c.A442C ali c.T444A ali c.T444G S148R
Spanish: Trastornos de la piel y del tejido subcutáneo
Slovenian: Bolezni kože in podkožja izpuščaj pruritus
Spanish: La diferencia de aclaramiento entre pacientes con Fabry de 65 años o mayores y menores de 65 años fue del 20%, lo cual no se consideró como clínicamente significativo.
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.
Spanish: c.A504C o c.A504T
Slovenian: c.A504C ali c.A504T
Spanish: En el ensayo en pacientes previamente tratados con TSE, la función renal permaneció estable hasta los 18 meses de tratamiento con Galafold.
Slovenian: Pri preskušanju s predhodnim ERT je delovanje ledvic ostalo stabilno do 18 mesecev od začetka zdravljenja z zdravilom Galafold.
Spanish: c.T139C o c.T139A
Slovenian: c.T139C ali c.T139A
Spanish: c.712A>C o c.714T>A o c.714T>G
Slovenian: c.712A>C ali c.714T>A ali c.714T>G
Spanish: c.G801A (Sitio probable de splicing)
Slovenian: c.G801A (domnevno mesto spajanja)
Spanish: Tras una media de 3,4 años de tratamiento, la tasa de cambio medio anualizada de la TFG estimada CKD-EPI fue de -0,74 ml/min/1,73 m
Slovenian: Po povprečno 3,4 letih zdravljenja je bila srednja letna stopnja spremembe eGFRCKD-EPI -0,74 ml/min/1,73 m
Spanish: Tras seguimiento en el ensayo de extensión abierto, el cambio promedio desde el periodo basal en el IMVI en el mes 36 fue de -8,3 (IC del 95 %: -17,1, 0,4; n=25) y en el mes 48 fue de -9,1 (IC del 95 %: -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).
Spanish: c.C816A o c.C816G
Slovenian: c.C816A ali c.C816G
Spanish: c.G140A o G141A
Slovenian: c.G140A ali G141A
Spanish: c.G216A o c.G216T o c.G216C M72I
Slovenian: c.G216A ali c.G216T ali c.G216C M72I
Spanish: c.126G>A o c.126G>C o c.126G>T
Slovenian: c.126G>A ali c.126G>C ali c.126G>T
Spanish: c.504A>C o c.504A>T
Slovenian: c.504A>C ali c.504A>T
Spanish: Tras dosis orales únicas en aumento (25-675 mg de clorhidrato de migalastat), no se hallaron tendencias para el aclaramiento, CL/F).
Slovenian: Pri očistku (CL/F) ni bil po dajanju enkratnih naraščajočih peroralnih odmerkov (25-675 mg migalastatijevega klorida) prepoznan noben trend.
Spanish: No comer ningún alimento al menos 2 horas antes y 2 horas después de tomar el medicamento para permitir un ayuno mínimo de 4 horas.
Slovenian: Vsaj 2 uri pred jemanjem in 2 uri po jemanju zdravila ne jejte, tako da skupno vsaj 4 ure ne pojeste ničesar.
Spanish: c.216G>A o c.216G>T o c.216G>C
Slovenian: c.216G>A ali c.216G>T ali c.216G>C
Spanish: Tras 30 meses de tratamiento con Galafold, el cambio medio desde el periodo basal en el IMVI fue de -3,8 (IC del 95 %: -8,9, 1,3; n=28) y el cambio medio desde el periodo basal en el IMVI en los pacientes con hipertrofia ventricular izquierda en el inicio fue de -10,0 (IC del 95 %: -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).
Spanish: c.G126A o c.G126C o c.G126T M42I
Slovenian: c.G126A ali c.G126C ali c.G126T M42I
Spanish: c.1147T>C o c.1149C>G o c.1149C>A
Slovenian: c.1147T>C ali c.1149C>G ali c.1149C>A
Spanish: c.C207A o c.C207G
Slovenian: c.C207A ali c.C207G
Spanish: c.3G>A o c.3G>T o c.3G>C c.G3A o c.G3T o c.G3C
Slovenian: c.3G>A ali c.3G>T ali c.3G>C c.G3A ali c.G3T ali c.G3C
Spanish: c.C159G o c.C159A
Slovenian: c.C159G ali c.C159A
Spanish: c.139T>C o c.139T>A
Slovenian: c.139T>C ali c.139T>A
Spanish: c.369+3_639+954del3129insT DESCONOCIDO (del Exon3 y 4?)
Slovenian: c.369+3_639+954del3129insT NEZNANO (del Exon3 in g.6009_9741del
Spanish: c.C519A o c.C519G
Slovenian: c.C519A ali c.C519G
Spanish: c.801G>A (Sitio probable de splicing)
Slovenian: c.801G>A (domnevno mesto spajanja)
Spanish: c.924A>T o c.924A>C
Slovenian: c.924A>T ali c.924A>C
Spanish: Los pacientes elegidos al azar para el uso de Galafold en la fase 1 demostraron una mayor reducción estadísticamente significativa (±SEM) en la deposición de GL-3 por capilar intersticial promedio (-0,25±0,10; -39 %) en el mes 6 comparado con el 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).
Spanish: c.G639A (Sitio probable de splicing)
Slovenian: c.G639A (domnevno mesto spajanja)
Spanish: c.G412A o c.G412C
Slovenian: c.G412A ali c.G412C
Spanish: c.148T>C o c.150C>G o c.150C>A
Slovenian: c.148T>C ali c.150C>G ali c.150C>A
Spanish: c.G284A o c.G285A
Slovenian: c.G284A ali c.G285A
Spanish: En el ensayo en pacientes previamente tratados con TSE, después de 18 meses de tratamiento con Galafold se produjo una reducción estadísticamente significativa del IMVI (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).
Spanish: c.T187A o c.G188C
Slovenian: c.T187A ali c.G188C
Spanish: c.280T>A o c.281G>C
Slovenian: c.280T>A ali c.281G>C
Spanish: c.159C>G o c.159C>A
Slovenian: c.159C>G ali c.159C>A
Spanish: Trastornos cardíacos
Slovenian: Srčne bolezni palpitacije
Spanish: c.442A>C o c.444T>A o c.444T>G
Slovenian: c.442A>C ali c.444T>A ali c.444T>G
Spanish: c.A124C o c.A124T
Slovenian: c.A124C ali c.A124T
Spanish: c.G547A (Sitio probable de splicing)
Slovenian: c.G547A (domnevno mesto spajanja)
Spanish: c.639G>A (Sitio probable de splicing)
Slovenian: c.639G>A (domnevno mesto spajanja)
Spanish: c.284G>A o c.285G>A
Slovenian: c.284G>A ali c.285G>A
Spanish: c.T241C o c.T241A
Slovenian: c.T241C ali c.T241A
Spanish: c.187T>A o c.188G>C
Slovenian: c.187T>A ali c.188G>C
Spanish: c.G870A o c.G870C o c.G870T M290I
Slovenian: c.G870A ali c.G870C ali c.G870T M290I
Spanish: c.G982A o c.G982C
Slovenian: c.G982A ali c.G982C
Spanish: c.T166A o c.G167C
Slovenian: c.T166A ali c.G167C
Spanish: c.817T>C o c.819T>A o c.819T>G
Slovenian: c.817T>C ali c.819T>A ali c.819T>G
Spanish: En el ensayo con pacientes no expuestos previamente a TSE, Galafold mostró reducciones estadísticamente significativas en las concentraciones plasmáticas de lyso-Gb3 y en las inclusiones de GL-3 por capilar intersticial renal en pacientes con mutaciones susceptibles de responder al tratamiento.
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.
Spanish: LÁMINA DE BLÍSTER
Slovenian: Okvara ledvic
Spanish: c.241T>C o c.241T>A
Slovenian: c.241T>C ali c.241T>A
Spanish: c.G228C o c.G228A o c.G228T M76I
Slovenian: c.G228C ali c.G228A ali c.G228T M76I
Spanish: c.T881G o c.T881A
Slovenian: c.T881G ali c.T881A
Spanish: c.153G>A o c.153G>T o c.153G>C
Slovenian: c.153G>A ali c.153G>T ali c.153G>C
Spanish: De acuerdo con datos in vivo, migalastat es un sustrato de UGT, por lo tanto, una vía de eliminación menor.
Slovenian: Po podatkih raziskav in vivo je migalastat substrat za encim UGT.
Spanish: El cambio promedio desde el periodo basal del IMVI en los meses de 18 a 24 en pacientes con hipertrofia ventricular izquierda en el periodo basal (mujeres con IMVI basal > 95 g/m o varones con IMVI basal
Slovenian: 2, moški z izhodiščnim hipertrofijo levega prekata v izhodišču (ženske z izhodiščnim LVMi > 95 g/m
Spanish: c.412G>A o c.412G>C
Slovenian: c.412G>A ali c.412G>C
Spanish: Tras seguimiento en el ensayo de extensión abierto, el cambio promedio desde el periodo basal hasta el mes 36 en el IMVI en pacientes con hipertrofia ventricular izquierda en el periodo basal fue de -30,0 (IC del 95 %: -57,9, -2,2; n=4) y en el mes 48 fue de -33,1 (IC: -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).
Spanish: c.124A>C o c.124A>T
Slovenian: c.124A>C ali c.124A>T
Spanish: c.G261C o c.G261T
Slovenian: c.G261C ali c.G261T
Spanish: c.C525G o c.C525A
Slovenian: c.C525G ali c.C525A
Spanish: c.261G>C o c.261G>T
Slovenian: c.261G>C ali c.261G>T
Spanish: c.T552A o c.T552G
Slovenian: c.T552A ali c.T552G
Spanish: • Mareos
Slovenian: • Driska
Spanish: c.C279G o c.C279A
Slovenian: c.C279G ali c.C279A
Spanish: • Picor persistente
Slovenian: • Trdovratna srbečica
Spanish: c.561G>T o c.561G>A o c.561G>C
Slovenian: c.561G>T ali c.561G>A ali c.561G>C
Spanish: Sequedad de boca Necesidad urgente de defecar Dispepsia
Slovenian: Bolezni prebavil driska navzea bolečine v trebuhu zaprtje suha usta tiščanje na blato dispepsija
Spanish: c.G888A o c.G888T o c.G888C M296I
Slovenian: c.G888A ali c.G888T ali c.G888C M296I
Spanish: c.G734A o c.G735A
Slovenian: c.G734A ali c.G735A
Spanish: c.337T>C o c.339T>A o c.339T>G
Slovenian: c.337T>C ali c.339T>A ali c.339T>G
Spanish: c.471G>C o c.471G>T
Slovenian: c.471G>C ali c.471G>T
Spanish: c.G242A o c.G243A
Slovenian: c.G242A ali c.G243A
Spanish: c.G285T o c.G285C
Slovenian: c.G285T ali c.G285C
Spanish: Secuencia proteica modificada c.931dupC
Slovenian: Sprememba proteinskega zapaliedja c.1202dupC
Spanish: Migalastat no afectó a la fertilidad en ratas hembra.
Slovenian: Pri podganjih samicah migalastat na plodnost ni vplival.
Spanish: c.G471C o c.G471T
Slovenian: c.G471C ali c.G471T
Spanish: (IC del 95 %: -2,272, 1,478; n=34) en el grupo de Galafold comparado con -1,03 ml/min/1,73 m
Slovenian: (95-% CI: -2,272, 1,478; n = 34), v skupini,
Spanish: c.228G>C o c.228G>A o c.228G>T
Slovenian: c.228G>C ali c.228G>A ali c.228G>T
Spanish: c.285G>T o c.285G>C
Slovenian: c.285G>T ali c.285G>C
Spanish: c.G612T o c.G612C
Slovenian: c.G612T ali c.G612C
Spanish: c.982G>A o c.982G>C
Slovenian: c.982G>A ali c.982G>C
Spanish: c.552T>A o c.552T>G
Slovenian: c.552T>A ali c.552T>G
Spanish: Criterios de valoración clínicos combinados
Slovenian: Sestavljeni klinični izidi
Spanish: c.131G>A o c.132G>A
Slovenian: c.131G>A ali c.132G>A
Spanish: c.G131A o c.G132A
Slovenian: c.G131A ali c.G132A
Spanish: Composición de Galafold - El principio activo es migalastat.
Slovenian: Kaj vsebuje zdravilo Galafold - Zdravilna učinkovina je migalastat.
Spanish: c.C233G o c.C233A
Slovenian: c.C233G ali c.C233A
Spanish: Aumento de la creatinfosfoquinasa en sangre Peso aumentado
Slovenian: Preiskave zvišana raven kreatin fosfokinaze v krvi povečana telesna masa
Spanish: DESCONOCIDO (del Exon1_2?)
Slovenian: NEZNANO (del Exon1_2?)
Spanish: c.547G>A (Sitio probable de splicing)
Slovenian: c.547G>A (domnevno mesto spajanja)
Spanish: c.G1081A o c.G1081C
Slovenian: c.G1081A ali c.G1081C
Spanish: c.G103C o c.G103A
Slovenian: c.G103C ali c.G103A
Spanish: c.519C>A o c.519C>G
Slovenian: c.519C>A ali c.519C>G
Spanish: DESCONOCIDO (del Exon3?)
Slovenian: NEZNANO (del Exon3?)
Spanish: c.T258G o c.T258A
Slovenian: c.T258G ali c.T258A
Spanish: c.G540C o c.G540T
Slovenian: c.G540C ali c.G540T
Spanish: c.816C>A o c.816C>G
Slovenian: c.816C>A ali c.816C>G
Spanish: c.A588T o c.A588C
Slovenian: c.A588T ali c.A588C
Spanish: c.C305G o c.C305A
Slovenian: c.C305G ali c.C305A
Spanish: c.279C>G o c.279C>A
Slovenian: c.279C>G ali c.279C>A
Spanish: Galafold no está recomendado en pacientes con la enfermedad de Fabry portadores de una tasa de filtración glomerular (TFG) estimada inferior a 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
Spanish: c.T154A o c.G155C
Slovenian: c.T154A ali c.G155C
Spanish: c.242G>A o c.243G>A
Slovenian: c.242G>A ali c.243G>A
Spanish: c.G132T o c.G132C
Slovenian: c.G132T ali c.G132C
Spanish: c.C897G o c.C897A
Slovenian: c.C897G ali c.C897A
Spanish: c.207C>A o c.207C>G
Slovenian: c.207C>A ali c.207C>G
Spanish: c.609G>C o c.609G>T
Slovenian: c.609G>C ali c.609G>T
Spanish: DESCONOCIDO (del Exon5_7?)
Slovenian: NEZNANO (del Exon5_7?)
Spanish: c.G288A o c.G288T o c.G288C M96I
Slovenian: c.G288A ali c.G288T ali c.G288C M96I
Spanish: c.G1074T o c.G1074C
Slovenian: c.G1074T ali c.G1074C
Spanish: El cambio desde el periodo basal hasta el mes 18 en el IMVI en pacientes con hipertrofia ventricular izquierda (mujeres con IMVI basal > 95 g/m y hombres con IMVI basal > 115 g/m2) fue de -8,4 (IC del 95 %: -15,7, 2,6; n=13) para migalastat y de 4,5 (IC del 95 %: -10,7, 18,4; n=5) para TSE.
Slovenian: Pri bolnikih s hipertrofijo levega prekata (ženske z izhodiščnim LVMi > 95 g/m in moški z izhodiščnim LVMi > 115 g/m2) se je LVMi (g/m2) od začetka zdravljenja do 18. meseca pri migalastatu spremenil za -8,4 (95-% CI: -15,7, 2,6; n = 13) in pri ERT za 4,5 (95-% CI: -10,7, 18,4; n = 5).
Spanish: c.G243T o c.G243C
Slovenian: c.G243T ali c.G243C
Spanish: c.243G>T o c.243G>C
Slovenian: c.243G>T ali c.243G>C
Spanish: Se recomienda supervisar periódicamente la función renal, los parámetros ecocardiográficos y los marcadores bioquímicos (cada 6 meses) en pacientes que han iniciado un tratamiento con Galafold o han cambiado a este último.
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).
Spanish: c.1074G>T o c.1074G>C
Slovenian: c.1074G>T ali c.1074G>C
Spanish: Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
Spanish: c.T859C o c.T859A
Slovenian: c.T859C ali c.T859A
Spanish: c.166T>A o c.167G>C
Slovenian: c.166T>A ali c.167G>C
Spanish: c.T960G o c.T960A
Slovenian: c.T960G ali c.T960A
Spanish: c.G609C o c.G609T
Slovenian: c.G609C ali c.G609T
Spanish: c.525C>G o c.525C>A
Slovenian: c.525C>G ali c.525C>A
Spanish: c.T610C o c.T610A
Slovenian: c.T610C ali c.T610A
Spanish: c.141G>C o c.141G>T
Slovenian: c.141G>C ali c.141G>T
Spanish: c.C747G o c.C747A
Slovenian: c.C747G ali c.C747A
Spanish: c.G144T o c.G144C
Slovenian: c.G144T ali c.G144C
Spanish: c.T514A o c.G515C
Slovenian: c.T514A ali c.G515C
Spanish: En los pacientes tratados con Galafold durante 30 meses, la tasa de cambio medio anualizada de la TFG estimada CKD-EPI desde el periodo basal fue de -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
Spanish: c.A840T o c.A840C
Slovenian: c.A840T ali c.A840C
Spanish: c.540G>C o c.540G>T
Slovenian: c.540G>C ali c.540G>T
Spanish: c.707G>A o c.708G>A
Slovenian: c.707G>A ali c.708G>A
Spanish: c.1081G>A o c.1081G>C
Slovenian: c.1081G>A ali c.1081G>C
Spanish: c.144G>T o c.144G>C
Slovenian: c.144G>T ali c.144G>C
Spanish: c.258T>G o c.258T>A
Slovenian: c.258T>G ali c.258T>A
Spanish: c.G567C o c.G567T
Slovenian: c.G567C ali c.G567T
Spanish: En el ensayo en pacientes previamente tratados con TSE, los niveles plasmáticos de lyso-Gb3 aumentaron ligeramente pero permanecieron bajos en los pacientes con mutaciones susceptibles de responder al tratamiento tratados con Galafold durante los 30 meses que duró el estudio.
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.
Spanish: c.610T>C o c.610T>A
Slovenian: c.610T>C ali c.610T>A
Spanish: c.G71A o c.G72A
Slovenian: c.G71A ali c.G72A
Spanish: c.T408A o c.T408G
Slovenian: c.T408A ali c.T408G
Spanish: c.C453G o c.C453A
Slovenian: c.C453G ali c.C453A
Spanish: c.T70C o c.T70A
Slovenian: c.T70C ali c.T70A
Spanish: c.G830A o c.G831A
Slovenian: c.G830A ali c.G831A
Spanish: c.859T>C o c.859T>A
Slovenian: c.859T>C ali c.859T>A
Spanish: c.T280A o c.G281C
Slovenian: c.T280A ali c.G281C
Spanish: c.567G>C o c.567G>T
Slovenian: c.567G>C ali c.567G>T
Spanish: c.C1202G o c.C1202A
Slovenian: c.1202C>G ali c.1202C>A c.C1202G ali c.C1202A
Spanish: c.T369G o c.T369A
Slovenian: c.T369G ali c.T369A
Spanish: c.G485A o c.G486A
Slovenian: c.G485A ali c.G486A
Spanish: c.870G>A o c.870G>C o c.870G>T
Slovenian: c.870G>A ali c.870G>C ali c.870G>T
Spanish: c.881T>G o c.881T>A
Slovenian: c.881T>G ali c.881T>A
Spanish: c.G141C o c.G141T
Slovenian: c.G141C ali c.G141T
Spanish: c.G831T o c.G831C
Slovenian: c.G831T ali c.G831C
Spanish: c.G860A o c.G861A
Slovenian: c.G860A ali c.G861A
Spanish: c.860G>A o c.861G>A
Slovenian: c.860G>A ali c.861G>A
Spanish: c.103G>C o c.103G>A
Slovenian: c.103G>C ali c.103G>A
Spanish: c.G861C o c.G861T
Slovenian: c.G861C ali c.G861T
Spanish: c.305C>G o c.305C>A
Slovenian: c.305C>G ali c.305C>A
Spanish: c.453C>G o c.453C>A
Slovenian: c.453C>G ali c.453C>A
Spanish: c.960T>G o c.960T>A
Slovenian: c.960T>G ali c.960T>A
Spanish: c.C966A o c.C966G
Slovenian: c.C966A ali c.C966G
Spanish: C]-migalastat en el rango de concentración entre 1 y 100 M.
Slovenian: C]-migalastatijevega klorida v koncentracijskem razponu od 1 do 100 M ni bilo zaznavne vezave na plazemske proteine.
Spanish: c.831G>T o c.831G>C
Slovenian: c.831G>T ali c.831G>C
Spanish: c.T465A o c.T465G
Slovenian: c.T465A ali c.T465G
Spanish: • Falta de aliento (disnea)
Slovenian: • Kratka sapa (dispneja)
Spanish: c.485G>A o c.486G>A
Slovenian: c.485G>A ali c.486G>A
Spanish: c.108G>C o c.108G>T
Slovenian: c.108G>C ali c.108G>T
Spanish: • Estreñimiento
Slovenian: • Zaprtje
Spanish: c.897C>G o c.897C>A
Slovenian: c.897C>G ali c.897C>A
Spanish: c.288G>A o c.288G>T o c.288G>C
Slovenian: c.288G>A ali c.288G>T ali c.288G>C
Spanish: c.514T>A o c.515G>C
Slovenian: c.514T>A ali c.515G>C
Spanish: c.830G>A o c.831G>A
Slovenian: c.830G>A ali c.831G>A
Spanish: Galafold no ha sido estudiado en pacientes con la enfermedad de Fabry portadores de una TFG estimada inferior a 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.