FrancophonIA/ELRC3.0 huggingface dataset:
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
Romanian: Modificarea anuală medie a RFGeCKD-EPI de la momentul inițial, la pacienții tratați timp de 30 luni cu Galafold, a fost de -1,72 ml/min/1,73 m
Dutch: Galafold is niet geïndiceerd voor gebruik bij patiënten met niet-behandelbare mutaties (zie rubriek 5.1).
Romanian: Galafold este contraindicat la pacienții cu mutații non-sensibile (vezi pct. 5.1).
Dutch: Een farmacokinetisch onderzoek bij gezonde mannelijke vrijwilligers met 150 mg C]-migalastat-HCl liet zien dat 99% van de radioactief gelabelde dosis die in het plasma werd teruggevonden, bestond uit onveranderde migalastat (77%) en 3 gedehydrogeneerde, aan O-glucuronide geconjugeerde metabolieten, M1 tot M3 (13%).
Romanian: C] administrat unor voluntari sănătoși, de sex masculin, a evidențiat că 99% din doza marcată radioactiv recuperată din plasmă a constat din migalastat nemodificat (77%) și din trei metaboliți O-glucuronoconjugați dehidrogenați, de la M1 la M3 (13%).
Dutch: c.1196G>A of c.1197G>A c.G1196A of c.G1197A
Romanian: c.1196G>A sau c.1197G>A c.G1196A sau c.G1197A
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.
Romanian: În studiul cu tratament anterior TSE, nivelurile plasmatice ale lyso-Gb3 au crescut ușor, dau au rămas scăzute la pacienții cu mutații sensibile tratați cu Galafold pe durata de 30 de luni a studiului.
Dutch: p.M42Tfs*74 c.134_138delTGCACinsGCTCG c.134_138delTGCACinsGCTCG L45R/H46S c.147_148insCCC
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice c.134_138delTGCACinsGCTCG c.134_138delTGCACinsGCTCG L45R/H46S c.147_148insCCC
Dutch: Verandering eiwitsequentie
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice
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
Romanian: Într-un studiu cu Galafold administrat în doză unică la subiecți care nu aveau boala Fabry, dar care prezentau diferite grade de insuficiență renală, expunerile au fost de 4,3 ori mai mari la subiecții cu insuficiență renală severă (RFG < 30 ml/min/1,73 m
Dutch: Bij mannelijke ratten was tijdelijke en volledig reversibele onvruchtbaarheid geassocieerd met migalastat-behandeling in alle beoordeelde doses.
Romanian: La masculii de șobolan, tratamentul cu migalastat în toate dozele evaluate a fost asociat cu infertilitate tranzitorie și complet reversibilă.
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).
Romanian: După 18 luni de tratament cu Galafold, în studiul cu tratament anterior cu TSE s-a observat o scădere semnificativă din punct de vedere statistic a IMVS (p< 0,05).
Dutch: Overleg met uw arts voordat u Galafold gaat gebruiken als u momenteel een enzymvervangende behandeling krijgt.
Romanian: Înainte să luați Galafold adresați-vă medicului dumneavoastră dacă vă aflați sub terapie de substituție enzimatică.
Dutch: Gepregelatineerd zetmeel (maïs) Magnesiumstearaat
Romanian: Conținutul capsulei Amidon pregelatinizat (porumb) Stearat de magneziu
Dutch: Als u of uw partner zwanger wil worden, neem dan contact op met uw arts, apotheker of verpleegkundige voor advies.
Romanian: Dacă intenționați să rămâneți gravidă, adresați-vă medicului dumneavoastră, farmacistului sau asistentei medicale pentru recomandări.
Dutch: Als er meer dan 12 uur is verstreken, moet de patiënt Galafold hervatten op de volgende geplande toedieningsdag en -tijd volgens het ‘om de andere dag'-toedieningsschema.
Romanian: Dacă au trecut mai mult de 12 ore, pacientul trebuie să reia administrarea Galafold în următoarea zi și la următoarea oră de administrare programată, conform schemei de administrare o dată la două zile.
Dutch: c.1019G>A of c.1020G>A c.G1019A of c.G1020A
Romanian: c.1019G>A sau c.1020G>A c.G1019A sau c.G1020A
Dutch: Verenering eiwitsequentie g.6736_11545del c.370-533_c.1290+277del
Romanian: g.6736_11545del c.370-533_c.1290+277del
Dutch: Verenering eiwitsequentie c.1A>C of c.1A>T
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice c.1A>C sau c.1A>T
Dutch: Verhoging van creatininefosfokinase in het bloed Toegenomen gewicht
Romanian: Creșterea valorilor plasmatice ale creatinfosfokinazei Creștere ponderală
Dutch: c.A504C of c.A504T
Romanian: c.A504C sau c.A504T
Dutch: g.10237_11932del/11933_12083i nv/12084_12097del
Romanian: g.10237_11932del/11933_12083i nv/12084_12097del g.>5.5kbdel până la 3UTR
Dutch: Verminderde leverfunctie Er is geen dosisaanpassing nodig voor patiënten met een leverfunctiestoornis (zie rubriek 5.2).
Romanian: Insuficiență hepatică Nu este necesară ajustarea dozei de Galafold la pacienții cu insuficiență hepatică (vezi pct. 5.2).
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).
Romanian: În luna 6, pacienții randomizați pentru tratamentul cu Galafold în faza 1 au demonstrat o reducere semnificativ mai mare din punct de vedere statistic (±ESM) a depunerii medii de GL-3 în capilarele interstițiale (-0,25±0,10; -39%) comparativ cu placebo (+0,07 ± 0,13; +14%) (p=0,008).
Dutch: Samengestelde klinische uitkomsten
Romanian: Criterii clinice compuse
Dutch: In het onderzoek bij patiënten met ERT-ervaring bleef de nierfunctie stabiel gedurende 18 maanden behandeling met Galafold.
Romanian: În studiul cu tratament anterior cu TSE, funcția renală a rămas stabilă pe parcursul celor 18 luni de tratament cu Galafold.
Dutch: Tabel 2: Tabel behandelbare mutaties met Galafold (migalastat)
Romanian: Tabelul 2: Tabelul mutațiilsau sensibile la Galafold (migalastat) Modificarea unei nucleotide
Dutch: c.G611A of G612A
Romanian: c.G611A sau G612A
Dutch: Kwalitatieve afnames van de GL-3-spiegels werden in meerdere typen niercellen gezien: respectievelijk podocyten, mesangiale cellen en glomerulaire endotheelcellen, gedurende 12 maanden behandeling met Galafold.
Romanian: Pe parcursul celor 12 luni de tratament cu Galafold au fost observate reduceri calitative ale concentrațiilor GL-3 în mai multe tipuri de celule renale: podocite, celule mezangiale și, respectiv, celule endoteliale glomerulare.
Dutch: Neemt u nog andere geneesmiddelen in?
Romanian: Galafold împreună cu alte medicamente
Dutch: Er zijn geen onderzoeken verricht bij proefpersonen met een leverfunctiestoornis.
Romanian: Nu s-au efectuat studii pe subiecți cu insuficiență hepatică.
Dutch: Elke capsule bevat migalastathydrochloride gelijk aan 123 mg migalastat
Romanian: Fiecare capsulă conține clorhidrat de migalastat, echivalentul a 123 mg migalastat
Dutch: c.T1147C of c.C1149G of c.C1149A
Romanian: c.T1147C sau c.C1149G sau c.C1149A
Dutch: g.2594_10904dup c.195-2500_999+197dup
Romanian: g.2594_10904dup c.195-2500_999+197dup g.2934_6378del
Dutch: U moet alleen om de andere dag eenmaal Galafold innemen.
Romanian: Trebuie să luați Galafold doar o dată la două zile.
Dutch: c.A924T of c.A924C
Romanian: c.A924T sau c.A924C
Dutch: Slik de capsules in hun geheel door.
Romanian: Înghițiți capsula întreagă.
Dutch: c.1095T>A of c.1095T>G c.T1095A of c.T1095G
Romanian: c.1095T>A sau c.1095T>G c.T1095A sau c.T1095G
Dutch: g.[10237_11932del; 11933_12083inv; 12084_12097del]
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice g.[10237_11932del; 11933_12083inv; 12084_12097del]
Dutch: Neem Galafold niet twee dagen achter elkaar in.
Romanian: Nu luați Galafold în două zile consecutive.
Dutch: 14 capsules per verpakking.
Romanian: Mărime a ambalajului de 14 capsule.
Dutch: c.140G>A of 141G>A
Romanian: c.140G>A sau 141G>A
Dutch: c.712A>C of c.714T>A of c.714T>G
Romanian: c.712A>C sau c.714T>A sau c.714T>G
Dutch: U mag Galafold niet gebruiken als u ook een enzymvervangende behandeling krijgt.
Romanian: Nu trebuie să luați Galafold dacă vi se administrează și terapie de substituție enzimatică.
Dutch: c.611G>A of 612G>A
Romanian: c.611G>A sau 612G>A
Dutch: Bepaalde GLA-mutaties kunnen leiden tot de productie van abnormaal gevouwen en instabiele mutantvormen van α-Gal A. Migalastat is een farmacologische chaperon die is bedoeld om selectief en reversibel met hoge affiniteit te binden aan de actieve plaatsen van bepaalde mutantvormen van -Gal A, de genotypen die behandelbare mutaties worden genoemd.
Romanian: Migalastatul este un șaperon farmacologic conceput pentru a se lega selectiv și reversibil, cu afinitate crescută, de situsurile active ale anumitor forme mutante ale genei -Gal A, ale căror genotipuri sunt denumite mutații sensibile.
Dutch: c.1065C>A of c.1065C>G c.C1065A of c.C1065G
Romanian: c.1065C>A sau c.1065C>G c.C1065A sau c.C1065G
Dutch: c.504A>C of c.504A>T
Romanian: c.504A>C sau c.504A>T
Dutch: c.G412A of c.G412C
Romanian: c.G412A sau c.G412C
Dutch: PARTIJ:
Romanian: LOT:
Dutch: c.C816A of c.C816G
Romanian: c.C816A sau c.C816G
Dutch: (pruritus)
Romanian: (prurit)
Dutch: c.280T>A of c.281G>C
Romanian: c.280T>A sau c.281G>C
Dutch: • Tintelingen in de ledematen (paresthesie)
Romanian: • Furnicături în extremități (parestezie)
Dutch: c.442A>C of c.444T>A of c.444T>G
Romanian: c.442A>C sau c.444T>A sau c.444T>G
Dutch: • Spierpijn (myalgie)
Romanian: • Dureri musculare (mialgie)
Dutch: c.1045T>C of c.1045T>A c.T1045C of c.T1045A
Romanian: c.1045T>C sau c.1045T>A c.T1045C sau c.T1045A
Dutch: c.C519A of c.C519G
Romanian: c.C519A sau c.C519G
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).
Romanian: În studiul fără tratament anterior cu TSE, tratamentul cu Galafold a avut drept rezultat o scădere semnificativă din punct de vedere statistic a IMVS (p< 0,05); modificarea medie a IMVS de la momentul inițial până în lunile 18-24 a fost de -7,7 (IÎ 95%: -15,4, -0,01; n=27).
Dutch: c.G140A of G141A
Romanian: c.G140A sau G141A
Dutch: Paresthesie Duizeligheid Hypo-esthesie
Romanian: Parestezie Amețeli Hipoestezie
Dutch: c.139T>C of c.139T>A
Romanian: c.139T>C sau c.139T>A
Dutch: c.A124C of c.A124T
Romanian: c.A124C sau c.A124T
Dutch: c.1034C>G of c.1034C>A c.C1034G of c.C1034A
Romanian: c.1034C>G sau c.1034C>A c.C1034G sau c.C1034A
Dutch: Na oplopende, enkelvoudige, orale doses (25-675 mg migalastathydrochloride) werden geen trends gevonden voor de klaring, CL/F).
Romanian: Nu au fost evidențiate tendințe pentru clearance, CL/F, în urma creșterii dozelor unice orale (25-675 mg clorhidrat de migalastat).
Dutch: NIET BEKEND (del Exon3 en 4?)
Romanian: NECUNOSCUTĂ (del Exon3 și 4?)
Dutch: c.159C>G of c.159C>A
Romanian: c.159C>G sau c.159C>A
Dutch: c.C159G of c.C159A
Romanian: c.C159G sau c.C159A
Dutch: Galafold dient om de andere dag op hetzelfde tijdstip van de dag te worden ingenomen, om zeker te zijn van optimale voordelen voor de patiënt.
Romanian: Pentru asigurarea unor beneficii optime pentru pacient, Galafold trebuie luat o dată la două zile, la aceeași oră.
Dutch: c.817T>C of c.819T>A of c.819T>G
Romanian: c.817T>C sau c.819T>A sau c.819T>G
Dutch: c.126G>A of c.126G>C of c.126G>T
Romanian: c.126G>A sau c.126G>C sau c.126G>T
Dutch: c.C279G of c.C279A
Romanian: c.C279G sau c.C279A
Dutch: c.G284A of c.G285A
Romanian: c.G284A sau c.G285A
Dutch: c.C207A of c.C207G
Romanian: c.C207A sau c.C207G
Dutch: c.216G>A of c.216G>T of c.216G>C
Romanian: c.216G>A sau c.216G>T sau c.216G>C
Dutch: c.148T>C of c.150C>G of c.150C>A
Romanian: c.148T>C sau c.150C>G sau c.150C>A
Dutch: c.412G>A of c.412G>C
Romanian: c.412G>A sau c.412G>C
Dutch: c.C233G of c.C233A
Romanian: c.C233G sau c.C233A
Dutch: c.1147T>C of c.1149C>G of c.1149C>A
Romanian: c.1147T>C sau c.1149C>G sau c.1149C>A
Dutch: c.T881G of c.T881A
Romanian: c.T881G sau c.T881A
Dutch: c.801G>A (putatieve splicing locatie)
Romanian: c.801G>A (sit putativ de splice) c.G801A (sit putativ de splice)
Dutch: c.T139C of c.T139A
Romanian: c.T139C sau c.T139A
Dutch: c.1046G>A of c.1047G>A c.G1046A of c.G1047A
Romanian: c.1046G>A sau c.1047G>A c.G1046A sau c.G1047A
Dutch: c.924A>T of c.924A>C
Romanian: c.924A>T sau c.924A>C
Dutch: De baselinewaarden waren 95,3 g/m voor de Galafold-groep en 92,9 g/m voor de ERT-groep, en de gemiddelde verandering in LVMi ten opzichte van baseline was bij maand 18 -6,6 (95%-BI: -11,0;2,1; n=31) voor Galafold en -2,0 (95%-BI: -11,0; 7,0; n=13) voor ERT.
Romanian: Valorile de la momentul inițial au fost de 95,3 g/m pentru grupul de tratament cu Galafold și de 92,9 g/m pentru grupul de tratament cu TSE, iar modificarea medie în Luna 18 față de momentul inițial a IMVS a fost de -6,6 (IÎ 95%: -11,0, -2,1; n=31) pentru grupul de tratament cu Galafold și de -2,0 (IÎ 95%: 11,0, 7,0; n=13) pentru grupul de tratament cu TSE.
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.
Romanian: Galafold nu a fost studiat la pacienți cu boală Fabry prezentând un RFG mai mic de 30 ml/min/1,73 m2.
Dutch: c.471G>C of c.471G>T
Romanian: c.471G>C sau c.471G>T
Dutch: c.187T>A of c.188G>C
Romanian: c.187T>A sau c.188G>C
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).
Romanian: După 30 luni de tratament cu Galafold, modificarea medie a IMVS față de momentul inițial a fost de -3,8 (IÎ 95%: -8,9, 1,3; n=28) și modificarea medie a IMVS față de momentul inițial la pacienții cu hipertrofie ventriculară stângă la momentul inițial a fost de -10,0 (IÎ 95%: -16,6, -3,3; n=10).
Dutch: c.T187A of c.G188C
Romanian: c.T187A sau c.G188C
Dutch: Gebruik dit geneesmiddel niet als u borstvoeding geeft totdat u met uw arts, apotheker of verpleegkundige hebt overlegd.
Romanian: Dacă alăptați, nu luați acest medicament înainte de a discuta cu medicul dumneavoastră, cu farmacistul sau cu asistenta medicală.
Dutch: c.C305G of c.C305A
Romanian: c.C305G sau c.C305A
Dutch: c.G285T of c.G285C
Romanian: c.G285T sau c.G285C
Dutch: c.G103C of c.G103A
Romanian: c.G103C sau c.G103A
Dutch: Noteer de datum op de doordrukverpakking op de eerste dag dat u dit geneesmiddel uit een nieuwe doordrukverpakking gebruikt.
Romanian: În prima zi în care luați medicamentul dintr-un blister nou, treceți data pe blister.
Dutch: g.941_5845del p.?
Romanian: g.941_5845del p.?(Exon1_2del)
Dutch: c.228G>C of c.228G>A of c.228G>T
Romanian: c.228G>C sau c.228G>A sau c.228G>T
Dutch: c.G982A of c.G982C
Romanian: c.G982A sau c.G982C
Dutch: c.284G>A of c.285G>A
Romanian: c.284G>A sau c.285G>A
Dutch: c.519C>A of c.519C>G
Romanian: c.519C>A sau c.519C>G
Dutch: c.T241C of c.T241A
Romanian: c.T241C sau c.T241A
Dutch: c.G612T of c.G612C
Romanian: c.G612T sau c.G612C
Dutch: c.261G>C of c.261G>T
Romanian: c.261G>C sau c.261G>T
Dutch: c.G540C of c.G540T
Romanian: c.G540C sau c.G540T
Dutch: c.T166A of c.G167C
Romanian: c.T166A sau c.G167C
Dutch: c.241T>C of c.241T>A
Romanian: c.241T>C sau c.241T>A
Dutch: c.C747G of c.C747A
Romanian: c.C747G sau c.C747A
Dutch: c.G471C of c.G471T
Romanian: c.G471C sau c.G471T
Dutch: c.T148C of c.C150G of c.C150A F50L
Romanian: c.T148C sau c.C150G sau c.C150A
Dutch: c.G734A of c.G735A
Romanian: c.G734A sau c.G735A
Dutch: c.C525G of c.C525A
Romanian: c.C525G sau c.C525A
Dutch: c.982G>A of c.982G>C
Romanian: c.982G>A sau c.982G>C
Dutch: c.G261C of c.G261T
Romanian: c.G261C sau c.G261T
Dutch: c.G242A of c.G243A
Romanian: c.G242A sau c.G243A
Dutch: c.207C>A of c.207C>G
Romanian: c.207C>A sau c.207C>G
Dutch: c.561G>T of c.561G>A of c.561G>C
Romanian: c.561G>T sau c.561G>A sau c.561G>C
Dutch: c.552T>A of c.552T>G
Romanian: c.552T>A sau c.552T>G
Dutch: c.337T>C of c.339T>A of c.339T>G
Romanian: c.337T>C sau c.339T>A sau c.339T>G
Dutch: c.124A>C of c.124A>T
Romanian: c.124A>C sau c.124A>T
Dutch: c.T514A of c.G515C
Romanian: c.T514A sau c.G515C
Dutch: c.131G>A of c.132G>A
Romanian: c.131G>A sau c.132G>A
Dutch: • Plotseling moeten stoelgang maken
Romanian: • Necesitate bruscă de a elimina materii fecale
Dutch: c.103G>C of c.103G>A
Romanian: c.103G>C sau c.103G>A
Dutch: c.540G>C of c.540G>T
Romanian: c.540G>C sau c.540G>T
Dutch: c.T960G of c.T960A
Romanian: c.T960G sau c.T960A
Dutch: c.T552A of c.T552G
Romanian: c.T552A sau c.T552G
Dutch: c.C453G of c.C453A
Romanian: c.C453G sau c.C453A
Dutch: c.816C>A of c.816C>G
Romanian: c.816C>A sau c.816C>G
Dutch: c.G131A of c.G132A
Romanian: c.G131A sau c.G132A
Dutch: c.285G>T of c.285G>C
Romanian: c.285G>T sau c.285G>C
Dutch: HULS VOOR BLISTERVERPAKKING
Romanian: Cerneală pentru inscripționare Șelac
Dutch: c.T258G of c.T258A
Romanian: c.T258G sau c.T258A
Dutch: c.G132T of c.G132C
Romanian: c.G132T sau c.G132C
Dutch: c.547G>A (putatieve splicing locatie)
Romanian: c.547G>A (sit putativ de splice) c.G547A (sit putativ de splice)
Dutch: BLISTERFOLIE
Romanian: BLISTER
Dutch: c.639G>A (putatieve splicing locatie)
Romanian: c.639G>A (sit putativ de splice) c.G639A (sit putativ de splice)
Dutch: c.C897G of c.C897A
Romanian: c.C897G sau c.C897A
Dutch: c.G243T of c.G243C
Romanian: c.G243T sau c.G243C
Dutch: c.153G>A of c.153G>T of c.153G>C
Romanian: c.153G>A sau c.153G>T sau c.153G>C
Dutch: c.G609C of c.G609T
Romanian: c.G609C sau c.G609T
Dutch: c.G144T of c.G144C
Romanian: c.G144T sau c.G144C
Dutch: c.279C>G of c.279C>A
Romanian: c.279C>G sau c.279C>A
Dutch: c.612G>T of c.612G>C
Romanian: c.612G>T sau c.612G>C
Dutch: c.A588T of c.A588C
Romanian: c.A588T sau c.A588C
Dutch: c.870G>A of c.870G>C of c.870G>T
Romanian: c.870G>A sau c.870G>C sau c.870G>T
Dutch: NIET BEKEND (del Exon5_7?)
Romanian: NECUNOSCUTĂ (del Exon5_7?)
Dutch: De gemiddelde, op jaarbasis berekende verandering van de eGFRCKD-EPI was -0,40 ml/min/1,73 m
Romanian: După o perioadă medie de 3,4 ani de tratament, modificarea anuală medie a RFGeCKD-EPI a fost de -0,74 ml/min/1,73 m
Dutch: c.A840T of c.A840C
Romanian: c.A840T sau c.A840C
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).
Romanian: După studiul de urmărire din faza de extensie deschisă, modificarea medie a IMVS de la momentul inițial până în luna 30 a fost de -8,3 (IÎ 95%: - 17,1, 0,4; n=25), iar până în luna 48 a fost de -9,1 (IÎ 95%: -20,3, 2,0; n=18).
Dutch: c.525C>G of c.525C>A
Romanian: c.525C>G sau c.525C>A
Dutch: c.141G>C of c.141G>T
Romanian: c.141G>C sau c.141G>T
Dutch: c.132G>T of c.132G>C
Romanian: c.132G>T sau c.132G>C
Dutch: c.258T>G of c.258T>A
Romanian: c.258T>G sau c.258T>A
Dutch: Een farmacokinetisch onderzoek bij gezonde mannelijke vrijwilligers met 150 mg
Romanian: Un studiu famacocinetic cu 150 mg clorhidrat de migalastat [
Dutch: c.243G>T of c.243G>C
Romanian: c.243G>T sau c.243G>C
Dutch: c.233C>G of c.233C>A
Romanian: c.233C>G sau c.233C>A
Dutch: c.G830A of c.G831A
Romanian: c.G830A sau c.G831A
Dutch: c.T369G of c.T369A
Romanian: c.T369G sau c.T369A
Dutch: c.881T>G of c.881T>A
Romanian: c.881T>G sau c.881T>A
Dutch: c.G860A of c.G861A
Romanian: c.G860A sau c.G861A
Dutch: Zie de bijsluiter voor meer informatie.
Romanian: Pentru instrucțiuni suplimentare, vezi prospectul.
Dutch: c.G567C of c.G567T
Romanian: c.G567C sau c.G567T
Dutch: c.108G>C of c.108G>T
Romanian: c.108G>C sau c.108G>T
Dutch: • Aanhoudende jeuk
Romanian: • Mâncărime persistentă
Dutch: c.T859C of c.T859A
Romanian: c.T859C sau c.T859A
Dutch: NIET BEKEND (del Exon1_2?)
Romanian: NECUNOSCUTĂ (del Exon1_2?)
Dutch: c.144G>T of c.144G>C
Romanian: c.144G>T sau c.144G>C
Dutch: c.830G>A of c.831G>A
Romanian: c.830G>A sau c.831G>A
Dutch: c.T465A of c.T465G
Romanian: c.T465A sau c.T465G
Dutch: c.707G>A of c.708G>A
Romanian: c.707G>A sau c.708G>A
Dutch: c.T610C of c.T610A
Romanian: c.T610C sau c.T610A
Dutch: c.G831T of c.G831C
Romanian: c.G831T sau c.G831C
Dutch: constipatie)
Romanian: • Constipație
Dutch: c.T154A of c.G155C
Romanian: c.T154A sau c.G155C
Dutch: c.G71A of c.G72A
Romanian: c.G71A sau c.G72A
Dutch: (dyspepsie)
Romanian: (dispnee)
Dutch: c.166T>A of c.167G>C
Romanian: c.166T>A sau c.167G>C
Dutch: c.734G>A of c.735G>A
Romanian: c.734G>A sau c.735G>A
Dutch: c.859T>C of c.859T>A
Romanian: c.859T>C sau c.859T>A
Dutch: c.453C>G of c.453C>A
Romanian: c.453C>G sau c.453C>A
Dutch: c.610T>C of c.610T>A
Romanian: c.610T>C sau c.610T>A
Dutch: c.609G>C of c.609G>T
Romanian: c.609G>C sau c.609G>T
Dutch: c.T408A of c.T408G
Romanian: c.T408A sau c.T408G
Dutch: c.T280A of c.G281C
Romanian: c.T280A sau c.G281C
Dutch: c.567G>C of c.567G>T
Romanian: c.567G>C sau c.567G>T
Dutch: c.G141C of c.G141T
Romanian: c.G141C sau c.G141T
Dutch: c.305C>G of c.305C>A
Romanian: c.305C>G sau c.305C>A
Dutch: c.3G>A of c.3G>T of c.3G>C c.G3A of c.G3T of c.G3C
Romanian: M1R c.3G>A sau c.3G>T sau c.3G>C c.G3A sau c.G3T sau c.G3C M1I c.19G>T
Dutch: NIET BEKEND (del Exon3?)
Romanian: NECUNOSCUTĂ (del Exon3?)
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
Romanian: Galafold este contraindicat la pacienții cu insuficiență renală severă, definită ca rată de filtrare glomerulară estimată mai mică de 30 ml/min/1,73m
Dutch: Bent u vergeten dit middel in te nemen?
Romanian: Dacă uitați să luați Galafold
Dutch: c.G485A of c.G486A
Romanian: c.G485A sau c.G486A
Dutch: c.860G>A of c.861G>A
Romanian: c.860G>A sau c.861G>A
Dutch: c.C966A of c.C966G
Romanian: c.C966A sau c.C966G
Dutch: c.C456A of c.C456G
Romanian: c.C456A sau c.C456G
Dutch: c.897C>G of c.897C>A
Romanian: c.897C>G sau c.897C>A
Dutch: c.960T>G of c.960T>A
Romanian: c.960T>G sau c.960T>A
Dutch: c.394G>A of c.394G>C
Romanian: c.394G>A sau c.394G>C
Dutch: c.831G>T of c.831G>C
Romanian: c.831G>T sau c.831G>C
Dutch: c.439G>A of c.439G>C
Romanian: c.439G>A sau c.439G>C
Dutch: c.T676C of c.T676A
Romanian: c.T676C sau c.T676A
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
Romanian: Galafold este contraindicat la pacienții cu boală Fabry care prezintă o rată de filtrare glomerulară estimată mai mică de 30 ml/min/1,73 m
Dutch: c.154T>A of c.155G>C
Romanian: c.154T>A sau c.155G>C
Dutch: c.G216A of c.G216T of c.G216C M72I
Romanian: c.G216A sau c.G216T sau c.G216C
Dutch: c.888G>A of c.888G>T of c.888G>C
Romanian: c.888G>A sau c.888G>T sau c.888G>C
Dutch: c.G439A of c.G439C
Romanian: c.G439A sau c.G439C
Dutch: c.G861C of c.G861T
Romanian: c.G861C sau c.G861T
Dutch: c.408T>A of c.408T>G
Romanian: c.408T>A sau c.408T>G
Dutch: c.966C>A of c.966C>G
Romanian: c.966C>A sau c.966C>G
Dutch: c.485G>A of c.486G>A
Romanian: c.485G>A sau c.486G>A
Dutch: c.G837C of c.G837T
Romanian: c.G837C sau c.G837T
Dutch: c.70T>C of c.70T>A
Romanian: c.70T>C sau c.70T>A
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).
Romanian: După studiul de urmărire din faza de extensie deschisă, modificarea medie a IMVS de la momentul inițial până în luna 36 a fost de -30,0 (IÎ 95%: -57,9, -2,2; n=4), iar la luna 48 a fost de -33,1 (IÎ:-60,9, -5,4; n=4).
Dutch: c.71G>A of c.72G>A
Romanian: c.71G>A sau c.72G>A
Dutch: c.708G>C of c.708G>T
Romanian: c.708G>C sau c.708G>T
Dutch: c.288G>A of c.288G>T of c.288G>C
Romanian: c.288G>A sau c.288G>T sau c.288G>C
Dutch: c.514T>A of c.515G>C
Romanian: c.514T>A sau c.515G>C
Dutch: c.T648A of c.T648G
Romanian: c.T648A sau c.T648G