FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: Disnea Epistaxis
Croatian: Prijavljivanje nuspojava
Spanish: c.216G>A o c.216G>T o c.216G>C
Croatian: c.216G>A ili c.216G>T ili c.216G>C
Spanish: Los valores iniciales fueron de 95,3 g/m en el grupo de Galafold y 92,9 g/m en el grupo de TSE y el cambio medio respecto al periodo basal en el IMVI en el mes 18 fue de -6,6 (IC del 95 %: -11,0, -2.1; n=31) para Galafold y -2,0 (IC del 95 %: -11,0, 7,0; n=13) para TSE.
Croatian: 95,3 g/m za skupinu koja je primala Galafold i 92,9 g/m za skupinu koja je primala ERT, a srednja vrijednost promjene od početne vrijednosti u LVMi u 18. mjesecu bila je -6,6 (95 % Cl: -11,0; -2,1; n = 31) za Galafold i -2,0 (95 % Cl: -11,0; 7,0; n = 13) za ERT.
Spanish: Las mutaciones no susceptibles al tratamiento con Galafold figuran en la tabla 3, a continuación.
Croatian: Mutacije koje isključuju odgovor na liječenje lijekom Galafold navedene su u tablici 3. u nastavku.
Spanish: c.148T>C o c.150C>G o c.150C>A
Croatian: c.148T>C ili c.150C>G ili c.150C>A
Spanish: DESCONOCIDO (del Exon3 y 4?)
Croatian: NEPOZNATO (del Exon3 i 4?)
Spanish: c.140G>A o 141G>A
Croatian: c.140G>A ili 141G>A
Spanish: c.504A>C o c.504A>T
Croatian: c.504A>C ili c.504A>T
Spanish: Si han transcurrido más de 12 horas, el paciente debe volver a tomar Galafold el día correspondiente a la siguiente dosis y a la hora habitual, de acuerdo con la pauta posológica de días alternos.
Croatian: Ako je prošlo više od 12 sati, bolesnik treba nastaviti uzimati Galafold onog dana i u ono doba za koje je predviđena sljedeća doza u skladu s rasporedom doziranja svakog drugog dana.
Spanish: Resultados reportados por los pacientes - Escala de evaluación de síntomas gastrointestinales En el ensayo en pacientes no expuestos previamente a TSE, los análisis de la escala de evaluación de síntomas gastrointestinales demostraron que el tratamiento con Galafold estaba asociado a mejoras estadísticamente significativas (p<0,05) comparado con el placebo desde el periodo basal hasta el mes 6 en el ámbito de la diarrea, y del reflujo en pacientes con síntomas en el periodo basal.
Croatian: U ispitivanju s bolesnicima koji prethodno nisu primali ERT, analize ljestvice za ocjenu gastrointestinalnih simptoma pokazale su da je liječenje lijekom Galafold bilo povezano sa statistički značajnim (p < 0,05) poboljšanjima u odnosu na skupinu koja je primala placebo od početka ispitivanja do 6. mjeseca u području proljeva te refluksa za bolesnike koji su imali simptome na početku ispitivanja.
Spanish: c.C816A o c.C816G
Croatian: c.C816A ili c.C816G
Spanish: c.G126A o c.G126C o c.G126T M42I
Croatian: c.G126A ili c.G126C ili c.G126T M42I
Spanish: c.C207A o c.C207G
Croatian: c.C207A ili c.C207G
Spanish: c.139T>C o c.139T>A
Croatian: c.139T>C ili c.139T>A
Spanish: c.1147T>C o c.1149C>G o c.1149C>A
Croatian: c.1147T>C ili c.1149C>G ili c.1149C>A
Spanish: c.C159G o c.C159A
Croatian: c.C159G ili c.C159A
Spanish: c.G801A (Sitio probable de splicing)
Croatian: c.G801A (pretpostavljeno mjesto prekrajanja)
Spanish: c.126G>A o c.126G>C o c.126G>T
Croatian: c.126G>A ili c.126G>C ili c.126G>T
Spanish: c.G216A o c.G216T o c.G216C M72I
Croatian: c.G216A ili c.G216T ili c.G216C M72I
Spanish: c.A124C o c.A124T
Croatian: c.A124C ili c.A124T
Spanish: c.561G>T o c.561G>A o c.561G>C
Croatian: c.561G>T ili c.561G>A ili c.561G>C
Spanish: c.G639A (Sitio probable de splicing)
Croatian: c.G639A (pretpostavljeno mjesto prekrajanja)
Spanish: Algunas mutaciones del gen GLA pueden resultar en la producción de formas mutantes o mal plegadas de la α-Gal A. Migalastat es una chaperona farmacológica diseñada para unirse de forma selectiva y reversible con alta afinidad a los sitios activos de algunas formas mutantes de la -Gal A, cuyos genotipos se denominan mutaciones susceptibles de responder al tratamiento.
Croatian: Migalastat je farmakološki šaperon koji je osmišljen kako bi se selektivno i reverzibilno te s visokim afinitetom vezao za aktivna mjesta određenih mutiranih oblika enzima -Gal A čiji genotipovi imaju mutacije koje omogućuju odgovor na liječenje.
Spanish: c.280T>A o c.281G>C
Croatian: c.280T>A ili c.281G>C
Spanish: c.C519A o c.C519G
Croatian: c.C519A ili c.C519G
Spanish: C]-migalastat en el rango de concentración entre 1 y 100 M.
Croatian: C]-migalastatklorida u rasponu koncentracija između
Spanish: c.G284A o c.G285A
Croatian: c.G284A ili c.G285A
Spanish: c.G412A o c.G412C
Croatian: c.G412A ili c.G412C
Spanish: c.T187A o c.G188C
Croatian: c.T187A ili c.G188C
Spanish: c.C279G o c.C279A
Croatian: c.C279G ili c.C279A
Spanish: c.817T>C o c.819T>A o c.819T>G
Croatian: c.817T>C ili c.819T>A ili c.819T>G
Spanish: c.801G>A (Sitio probable de splicing)
Croatian: c.801G>A (pretpostavljeno mjesto prekrajanja)
Spanish: c.G228C o c.G228A o c.G228T M76I
Croatian: c.G228C ili c.G228A ili c.G228T M76I
Spanish: c.T241C o c.T241A
Croatian: c.T241C ili c.T241A
Spanish: c.G547A (Sitio probable de splicing)
Croatian: c.G547A (pretpostavljeno mjesto prekrajanja)
Spanish: c.159C>G o c.159C>A
Croatian: c.159C>G ili c.159C>A
Spanish: c.153G>A o c.153G>T o c.153G>C
Croatian: c.153G>A ili c.153G>T ili c.153G>C
Spanish: c.284G>A o c.285G>A
Croatian: c.284G>A ili c.285G>A
Spanish: c.412G>A o c.412G>C
Croatian: c.412G>A ili c.412G>C
Spanish: c.924A>T o c.924A>C
Croatian: c.924A>T ili c.924A>C
Spanish: c.639G>A (Sitio probable de splicing)
Croatian: c.639G>A (pretpostavljeno mjesto prekrajanja)
Spanish: c.T881G o c.T881A
Croatian: c.T881G ili c.T881A
Spanish: Lote
Croatian: Louth
Spanish: c.G982A o c.G982C
Croatian: c.G982A ili c.G982C
Spanish: c.337T>C o c.339T>A o c.339T>G
Croatian: c.337T>C ili c.339T>A ili c.339T>G
Spanish: c.C525G o c.C525A
Croatian: c.C525G ili c.C525A
Spanish: Si han transcurrido más de 12 horas, deberá volver a tomar Galafold el día correspondiente a la siguiente dosis y a la hora habitual, de acuerdo con la pauta posológica de días alternos.
Croatian: Ako je prošlo više od 12 sati, trebate nastaviti uzimati Galafold onog dana i u ono doba za koje je predviđena sljedeća doza u skladu s rasporedom doziranja svakog drugog dana.
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).
Croatian: Nakon praćenja u otvorenom nastavku ispitivanju, srednja vrijednost promjene u odnosu na početnu vrijednost LVMi u bolesnika s hipertrofijom lijevog ventrikula na početku u 36. mjesecu iznosila je -30,0 (95 % CI: -57,9; -2,2; n = 4), a u 48. mjesecu iznosila je -33,1 (95 % CI: -60,9; -5,4; n = 4).
Spanish: c.T166A o c.G167C
Croatian: c.T166A ili c.G167C
Spanish: c.G261C o c.G261T
Croatian: c.G261C ili c.G261T
Spanish: c.187T>A o c.188G>C
Croatian: c.187T>A ili c.188G>C
Spanish: FUNDA DE BLÍSTER
Croatian: FOLIJA BLISTERA
Spanish: c.G734A o c.G735A
Croatian: c.G734A ili c.G735A
Spanish: c.228G>C o c.228G>A o c.228G>T
Croatian: c.228G>C ili c.228G>A ili c.228G>T
Spanish: c.241T>C o c.241T>A
Croatian: c.241T>C ili c.241T>A
Spanish: c.G103C o c.G103A
Croatian: c.G103C ili c.G103A
Spanish: c.552T>A o c.552T>G
Croatian: c.552T>A ili c.552T>G
Spanish: c.T552A o c.T552G
Croatian: c.T552A ili c.T552G
Spanish: No se ha observado ninguna reducción de la proteinuria en pacientes tratados con Galafold.
Croatian: U bolesnika liječenih lijekom Galafold nije uočeno smanjenje proteinurije.
Spanish: c.124A>C o c.124A>T
Croatian: c.124A>C ili c.124A>T
Spanish: c.G870A o c.G870C o c.G870T M290I
Croatian: c.G870A ili c.G870C ili c.G870T M290I
Spanish: c.G140A o G141A
Croatian: c.G140A ili G141A
Spanish: c.G612T o c.G612C
Croatian: c.G612T ili c.G612C
Spanish: c.G131A o c.G132A
Croatian: c.G131A ili c.G132A
Spanish: c.G471C o c.G471T
Croatian: c.G471C ili c.G471T
Spanish: c.261G>C o c.261G>T
Croatian: c.261G>C ili c.261G>T
Spanish: c.G285T o c.G285C
Croatian: c.G285T ili c.G285C
Spanish: Sequedad de boca Necesidad urgente de defecar Dispepsia
Croatian: • iznenadna potreba za pražnjenjem crijeva
Spanish: c.G242A o c.G243A
Croatian: c.G242A ili c.G243A
Spanish: Insuficiencia hepática No se requiere un ajuste de dosis de Galafold en pacientes con insuficiencia hepática (ver sección 5.2).
Croatian: U bolesnika s oštećenjem jetre nije potrebna prilagodba doze lijeka Galafold (vidjeti dio 5.2).
Spanish: Las mutaciones de GLA susceptibles y no susceptibles al tratamiento con Galafold figuran en las tablas 2 y 3 respectivamente a continuación.
Croatian: Mutacije gena GLA koje omogućuju i koje isključuju odgovor na liječenje lijekom Galafold navedene su u tablici 2., odnosno tablici 3. u nastavku.
Spanish: c.G540C o c.G540T
Croatian: c.G540C ili c.G540T
Spanish: g.941_5845del p.?
Croatian: g.941_5845del p.?(Exon1_2del)
Spanish: c.131G>A o c.132G>A
Croatian: c.131G>A ili c.132G>A
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).
Croatian: U ispitivanju s bolesnicima koji nisu prethodno primali ERT, Galafold je doveo do statistički značajnog smanjenja LVMi (p < 0,05); srednja vrijednost promjene u odnosu na početnu vrijednost LVMi od 18. do 24. mjeseca iznosila je -7,7 (95 % CI: -15,4; -0,01; n = 27).
Spanish: c.T514A o c.G515C
Croatian: c.T514A ili c.G515C
Spanish: c.C747G o c.C747A
Croatian: c.C747G ili c.C747A
Spanish: Este medicamento no ha sido estudiado en niños menores de 16 años.
Croatian: Lijek nije ispitan u djece i adolescenata mlađih od 16 godina, stoga nisu utvrđene sigurnost i djelotvornost u toj dobnoj skupini.
Spanish: c.519C>A o c.519C>G
Croatian: c.519C>A ili c.519C>G
Spanish: c.C305G o c.C305A
Croatian: c.C305G ili c.C305A
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).
Croatian: Nakon 30 mjeseci liječenja lijekom Galafold, srednja vrijednost promjene od početne vrijednosti u LVMi bila je -3,8 (95 % CI: -8,9; 1,3; n = 28), a srednja vrijednost promjene od početne vrijednosti u LVMi u bolesnika s hipertrofijom lijevog ventrikula na početku bila je -10,0 (95 % CI: -16,6; -3,3; n = 10).
Spanish: c.471G>C o c.471G>T
Croatian: c.471G>C ili c.471G>T
Spanish: c.242G>A o c.243G>A
Croatian: c.242G>A ili c.243G>A
Spanish: c.C233G o c.C233A
Croatian: c.C233G ili c.C233A
Spanish: c.547G>A (Sitio probable de splicing)
Croatian: c.547G>A (pretpostavljeno mjesto prekrajanja)
Spanish: c.T258G o c.T258A
Croatian: c.T258G ili c.T258A
Spanish: No tome este medicamento si está dando el pecho a su hijo hasta que haya consultado con su médico, farmacéutico o enfermero.
Croatian: Ne uzimajte lijek ako dojite prije nego što se savjetujete sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
Spanish: c.G132T o c.G132C
Croatian: c.G132T ili c.G132C
Spanish: c.982G>A o c.982G>C
Croatian: c.982G>A ili c.982G>C
Spanish: c.207C>A o c.207C>G
Croatian: c.207C>A ili c.207C>G
Spanish: La dosis recomendada es una cápsula cada dos días a la misma hora del día.
Croatian: Uzmite jednu kapsulu lijeka Galafold svaki drugi dan u isto vrijeme.
Spanish: Trastornos del sistema nervioso Cefalea
Croatian: Poremećaji živčanog sustava glavobolja parestezija omaglica hipoestezija
Spanish: c.279C>G o c.279C>A
Croatian: c.279C>G ili c.279C>A
Spanish: c.T960G o c.T960A
Croatian: c.T960G ili c.T960A
Spanish: c.T610C o c.T610A
Croatian: c.T610C ili c.T610A
Spanish: c.243G>T o c.243G>C
Croatian: c.243G>T ili c.243G>C
Spanish: c.G1074T o c.G1074C
Croatian: c.G1074T ili c.G1074C
Spanish: Trastornos respiratorios, torácicos y mediastínicos
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja epistaksa
Spanish: c.G1081A o c.G1081C
Croatian: c.G1081A ili c.G1081C
Spanish: c.540G>C o c.540G>T
Croatian: c.540G>C ili c.540G>T
Spanish: c.285G>T o c.285G>C
Croatian: c.285G>T ili c.285G>C
Spanish: c.G888A o c.G888T o c.G888C M296I
Croatian: c.G888A ili c.G888T ili c.G888C M296I
Spanish: c.G609C o c.G609T
Croatian: c.G609C ili c.G609T
Spanish: Mientras esté tomando Galafold, su médico debe valorar su estado y si su medicamento está funcionando cada 6 meses.
Croatian: Vaš liječnik će nadzirati Vaše stanje i provjeravati djeluje li lijek svakih 6 mjeseci tijekom terapije lijekom Galafold.
Spanish: DESCONOCIDO (del Exon1_2?)
Croatian: NEPOZNATO (del Exon1_2?)
Spanish: c.525C>G o c.525C>A
Croatian: c.525C>G ili c.525C>A
Spanish: c.A840T o c.A840C
Croatian: c.A840T ili c.A840C
Spanish: c.G243T o c.G243C
Croatian: c.G243T ili c.G243C
Spanish: c.G144T o c.G144C
Croatian: c.G144T ili c.G144C
Spanish: c.A588T o c.A588C
Croatian: c.A588T ili c.A588C
Spanish: c.G288A o c.G288T o c.G288C M96I
Croatian: c.G288A ili c.G288T ili c.G288C M96I
Spanish: c.166T>A o c.167G>C
Croatian: c.166T>A ili c.167G>C
Spanish: c.T280A o c.G281C
Croatian: c.T280A ili c.G281C
Spanish: c.816C>A o c.816C>G
Croatian: c.816C>A ili c.816C>G
Spanish: DESCONOCIDO (del Exon5_7?)
Croatian: NEPOZNATO (del Exon5_7?)
Spanish: c.T154A o c.G155C
Croatian: c.T154A ili c.G155C
Spanish: c.T859C o c.T859A
Croatian: c.T859C ili c.T859A
Spanish: c.1081G>A o c.1081G>C
Croatian: c.1081G>A ili c.1081G>C
Spanish: c.G567C o c.G567T
Croatian: c.G567C ili c.G567T
Spanish: c.609G>C o c.609G>T
Croatian: c.609G>C ili c.609G>T
Spanish: c.258T>G o c.258T>A
Croatian: c.258T>G ili c.258T>A
Spanish: c.1074G>T o c.1074G>C
Croatian: c.1074G>T ili c.1074G>C
Spanish: c.C453G o c.C453A
Croatian: c.C453G ili c.C453A
Spanish: c.141G>C o c.141G>T
Croatian: c.141G>C ili c.141G>T
Spanish: c.C897G o c.C897A
Croatian: c.C897G ili c.C897A
Spanish: Tabla 3: Tabla de no susceptibilidad a Galafold (migalastat)
Croatian: Tablica 3.: Mutacije koje isključuju odgovili na lijek Galafold (migalastat)
Spanish: c.707G>A o c.708G>A
Croatian: c.707G>A ili c.708G>A
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).
Croatian: Nakon praćenja u otvorenom nastavku ispitivanja, srednja vrijednost promjene u odnosu na početnu vrijednost LVMi u 36. mjesecu iznosila je -8,3 (95 % CI: -17,1; 0,4; n = 25), a u 48. mjesecu iznosila je -9,1 (95 % CI: -20,3; 2,0; n = 18).
Spanish: Las cefaleas y los mareos fueron las reacciones adversas más comunes notificadas con dosis de Galafold de hasta 1250 mg y 2000 mg, respectivamente.
Croatian: Najčešća nuspojava zabilježena pri dozama lijeka Galafold od najviše 1250 mg bila je glavobolja, odnosno pri dozama od najviše 2000 mg omaglica.
Spanish: c.T408A o c.T408G
Croatian: c.T408A ili c.T408G
Spanish: c.960T>G o c.960T>A
Croatian: c.960T>G ili c.960T>A
Spanish: c.T70C o c.T70A
Croatian: c.T70C ili c.T70A
Spanish: c.144G>T o c.144G>C
Croatian: c.144G>T ili c.144G>C
Spanish: c.108G>C o c.108G>T
Croatian: c.108G>C ili c.108G>T
Spanish: DESCONOCIDO (del Exon3?)
Croatian: NEPOZNATO (del Exon3?)
Spanish: c.610T>C o c.610T>A
Croatian: c.610T>C ili c.610T>A
Spanish: c.870G>A o c.870G>C o c.870G>T
Croatian: c.870G>A ili c.870G>C ili c.870G>T
Spanish: c.G141C o c.G141T
Croatian: c.G141C ili c.G141T
Spanish: Galafold se debe tomar en días alternos.
Croatian: Galafold je potrebno uzimati svaki drugi dan.
Spanish: c.T369G o c.T369A
Croatian: c.T369G ili c.T369A
Spanish: c.305C>G o c.305C>A
Croatian: c.305C>G ili c.305C>A
Spanish: c.881T>G o c.881T>A
Croatian: c.881T>G ili c.881T>A
Spanish: c.T465A o c.T465G
Croatian: c.T465A ili c.T465G
Spanish: c.103G>C o c.103G>A
Croatian: c.103G>C ili c.103G>A
Spanish: c.453C>G o c.453C>A
Croatian: c.453C>G ili c.453C>A
Spanish: c.G831T o c.G831C
Croatian: c.G831T ili c.G831C
Spanish: c.G71A o c.G72A
Croatian: c.G71A ili c.G72A
Spanish: c.G860A o c.G861A
Croatian: c.G860A ili c.G861A
Spanish: c.G830A o c.G831A
Croatian: c.G830A ili c.G831A
Spanish: c.567G>C o c.567G>T
Croatian: c.567G>C ili c.567G>T
Spanish: c.830G>A o c.831G>A
Croatian: c.830G>A ili c.831G>A
Spanish: Si tiene previsto quedarse embarazada, consulte con su médico, farmacéutico o enfermero.
Croatian: Ako planirate imati dijete, obratite se za savjet svom liječniku, ljekarniku ili medicinskoj sestri.
Spanish: • Sequedad de boca
Croatian: Primjena kroz usta.
Spanish: g.?_?dup c.?_?dup
Croatian: Promjena slijeda u proteinu g.?_?dup c.?_?dup
Spanish: c.C966A o c.C966G
Croatian: c.C966A ili c.C966G
Spanish: c.859T>C o c.859T>A
Croatian: c.859T>C ili c.859T>A
Spanish: c.G485A o c.G486A
Croatian: c.G485A ili c.G486A
Spanish: c.288G>A o c.288G>T o c.288G>C
Croatian: c.288G>A ili c.288G>T ili c.288G>C
Spanish: c.485G>A o c.486G>A
Croatian: c.485G>A ili c.486G>A
Spanish: c.C1202G o c.C1202A
Croatian: c.1202C>G ili c.1202C>A c.C1202G ili c.C1202A
Spanish: c.G861C o c.G861T
Croatian: c.G861C ili c.G861T
Spanish: c.860G>A o c.861G>A
Croatian: c.860G>A ili c.861G>A
Spanish: c.G439A o c.G439C
Croatian: c.G439A ili c.G439C
Spanish: c.T676C o c.T676A
Croatian: c.T676C ili c.T676A
Spanish: c.888G>A o c.888G>T o c.888G>C
Croatian: c.888G>A ili c.888G>T ili c.888G>C
Spanish: Fecha de la última revisión de este prospecto
Croatian: Ova je uputa zadnji put revidirana u
Spanish: c.G108C o c.G108T
Croatian: c.G108C ili c.G108T
Spanish: c.G394A o c.G394C
Croatian: c.G394A ili c.G394C
Spanish: c.514T>A o c.515G>C
Croatian: c.514T>A ili c.515G>C
Spanish: c.C456A o c.C456G
Croatian: c.C456A ili c.C456G
Spanish: c.154T>A o c.155G>C
Croatian: c.154T>A ili c.155G>C
Spanish: c.831G>T o c.831G>C
Croatian: c.831G>T ili c.831G>C
Spanish: c.897C>G o c.897C>A
Croatian: c.897C>G ili c.897C>A
Spanish: c.394G>A o c.394G>C
Croatian: c.394G>A ili c.394G>C
Spanish: Tabla 2: Tabla de susceptibilidad a Galafold (migalastat)
Croatian: Tablica 2.: Tablica mutacija koje omogućuju odgovili na lijek Galafold (migalastat) Promjena nukleotida
Spanish: c.70T>C o c.70T>A
Croatian: c.70T>C ili c.70T>A
Spanish: c.439G>A o c.439G>C
Croatian: c.439G>A ili c.439G>C
Spanish: c.T484C o c.T484A
Croatian: c.T484C ili c.T484A
Spanish: c.588A>T o c.588A>C
Croatian: c.588A>T ili c.588A>C
Spanish: Trastornos musculoesqueléticos y del tejido conjuntivo
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija
Spanish: c.465T>A o c.465T>G
Croatian: c.465T>A ili c.465T>G
Spanish: c.708G>C o c.708G>T
Croatian: c.708G>C ili c.708G>T
Spanish: c.G486C o c.G486T
Croatian: c.G486C ili c.G486T
Spanish: c.966C>A o c.966C>G
Croatian: c.966C>A ili c.966C>G
Spanish: c.T648A o c.T648G
Croatian: c.T648A ili c.T648G
Spanish: c.71G>A o c.72G>A
Croatian: c.71G>A ili c.72G>A
Spanish: Galafold no está recomendado en pacientes con insuficiencia renal grave, con una TFG estimada inferior a 30 ml/min/1,73m
Croatian: Ne preporučuje se primjena lijeka Galafold u bolesnika s teškom bubrežnom insuficijencijom, definiranom procijenjenom vrijednosti GFR-a manjom od 30 mL/min/1,73m
Spanish: c.T834G o c.T834A
Croatian: c.T834G ili c.T834A
Spanish: • Cansancio
Croatian: • mučnina
Spanish: c.A868C o c.A868T
Croatian: c.A868C ili c.A868T
Spanish: c.T667A o c.G668C
Croatian: c.T667A ili c.G668C
Spanish: c.G837C o c.G837T
Croatian: c.G837C ili c.G837T
Spanish: c.408T>A o c.408T>G
Croatian: c.408T>A ili c.408T>G
Spanish: Secuencia proteica modificada c.614delC
Croatian: Promjena slijeda u proteinu c.256delT
Spanish: c.861G>C o c.861G>T
Croatian: c.861G>C ili c.861G>T
Spanish: DESCONOCIDO (del Exon3_7?)
Croatian: NEPOZNATO (del Exon3_7?)
Spanish: c.T102G o c.T102A
Croatian: c.T102G ili c.T102A
Spanish: c.T894G o c.T894A
Croatian: c.T894G ili c.T894A
Spanish: c.C666A o c.C666G
Croatian: c.C666A ili c.C666G
Spanish: c.T687A o c.T687G
Croatian: c.T687A ili c.T687G
Spanish: El efecto adverso más frecuente con Galafold (que puede afectar a alrededor de 1 de cada 10 personas) es el dolor de cabeza.
Croatian: Najčešća nuspojava lijeka Galafold (može se javiti u otprilike 1 na 10 osoba) jest glavobolja.
Spanish: Galafold se presenta en forma de cápsulas (123 mg).
Croatian: Galafold je dostupan u obliku kapsula (123 mg).
Spanish: Esto permite que la enzima se transporte a zonas de la célula en la que puede descomponer la GL-3.
Croatian: To omogućuje prijenos enzima u dijelove stanice gdje može razgraditi GL-3.
Spanish: La dosis recomendada de Galafold es de una cápsula un día sí y un día no, que se toma por vía oral al menos 2 horas antes o después de la comida.
Croatian: Preporučena doza lijeka Galafold jest jedna kapsula svaki drugi dan koja se uzima oralno najmanje 2 sata prije ili nakon obroka.
Spanish: En consecuencia, la GL-3 no se puede descomponer y se acumula en diversas células del organismo, incluyendo el corazón y los riñones.
Croatian: Kao rezultat toga, GL-3 se ne može razgraditi te se nakuplja u raznim stanicama u tijelu, uključujući srce i bubrege.
Spanish: ¿Qué es Galafold y para qué se utiliza?
Croatian: Što je Galafold i za što se koristi?
Spanish: El criterio de valoración principal de eficacia fue el cambio en la función renal de los pacientes después de 18 meses de tratamiento.
Croatian: Glavno mjerilo učinkovitosti bila je promjena funkcije bubrega u bolesnika nakon 18 mjeseci liječenja.
Spanish: Galafold se ha investigado en dos estudios principales en los que participaron en total 127 pacientes con enfermedad de Fabry.
Croatian: Galafold je istraživan u dvama glavnim ispitivanjima u kojima je sudjelovalo ukupno 127 bolesnika s Fabryjevom bolešću.
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Galafold?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Galafold?
Spanish: El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia decidió que los beneficios de Galafold son mayores que sus riesgos y recomendó autorizar su uso en la UE.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Galafold nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
Spanish: El segundo estudio, en 60 pacientes, comparó Galafold con los medicamentos agalsidasa alfa o agalsidasa beta, dos tratamientos que sustituyen a la enzima que falta.
Croatian: Druga studija provedena na 60 bolesnika uspoređivala je Galafold s lijekovima agalzidaza alfa ili agalzidaza beta, dvama liječenjima koja zamjenjuju enzim koji nedostaje.
Spanish: El Comité señaló que Galafold se estudió en un número reducido de pacientes, sin embargo se considera que las pruebas disponibles son suficientes para esta enfermedad rara.
Croatian: Odbor smatra da je Galafold ispitan na ograničenom broju bolesnika, međutim dostupni dokazi smatraju se dostatnima za liječenje tako rijetke bolesti.
Spanish: Galafold solo se podrá dispensar con receta médica y el tratamiento solo debe ser iniciado y supervisado por un médico con experiencia en el diagnóstico y el tratamiento de la enfermedad de Fabry.
Croatian: Galafold se izdaje samo na liječnički recept, a liječenje bi trebao započeti i nadzirati samo liječnik iskusan u dijagnosticiranju i liječenju Fabryjeve bolesti.
Spanish: El EPAR completo de Galafold puede consultarse en el sitio web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Galafold nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: El CHMP también señaló que Galafold se toma por vía oral y esto podría ser una ventaja en comparación con otros tratamientos autorizados como la sustitución enzimática que se administran mediante perfusión intravenosa (goteo).
Croatian: CHMP je također uočio da se Galafold uzima oralno te bi to moglo predstavljati prednost u usporedbi s drugim odobrenim liječenjima, kao što je nadomještanje enzima, koja se primjenjuju infuzijom (drip) u venu.
Spanish: ¿Por qué se ha aprobado Galafold?
Croatian: Zašto je Galafold odobren?