FrancophonIA/ELRC3.0 huggingface dataset:
Dutch: c.442A>C of c.444T>A of c.444T>G
Croatian: c.442A>C ili c.444T>A ili c.444T>G
Dutch: c.139T>C of c.139T>A
Croatian: c.139T>C ili c.139T>A
Dutch: c.C207A of c.C207G
Croatian: c.C207A ili c.C207G
Dutch: NIET BEKEND (del Exon3 en 4?)
Croatian: NEPOZNATO (del Exon3 i 4?)
Dutch: c.1045T>C of c.1045T>A c.T1045C of c.T1045A
Croatian: c.1045T>C ili c.1045T>A c.T1045C ili c.T1045A
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.
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.
Dutch: c.611G>A of 612G>A
Croatian: c.611G>A ili 612G>A
Dutch: c.159C>G of c.159C>A
Croatian: c.159C>G ili c.159C>A
Dutch: In het onderzoek bij patiënten met ERT-ervaring bleef de nierfunctie stabiel gedurende 18 maanden behandeling met Galafold.
Croatian: U ispitivanju s bolesnicima koji su prethodno primali ERT, funkcija bubrega ostala je stabilna do 18 mjeseci terapije lijekom Galafold.
Dutch: Behandeling met Galafold in farmacodynamische fase 2-onderzoeken leidde tot toename van de endogene α-Gal A-activiteit in witte bloedcellen, alsmede in de huid en nieren bij de meerderheid van de patiënten.
Croatian: Liječenje lijekom Galafold u farmakodinamičkim ispitivanjima faze 2 u većine je bolesnika općenito dovelo do povećanja aktivnosti endogenog enzima α-Gal
Dutch: c.148T>C of c.150C>G of c.150C>A
Croatian: c.148T>C ili c.150C>G ili c.150C>A
Dutch: Als u of uw partner zwanger wil worden, neem dan contact op met uw arts, apotheker of verpleegkundige voor advies.
Croatian: Ako planirate imati dijete, obratite se za savjet svom liječniku, ljekarniku ili medicinskoj sestri.
Dutch: c.G801A (putatieve splicing locatie)
Croatian: c.G801A (pretpostavljeno mjesto prekrajanja)
Dutch: c.A124C of c.A124T
Croatian: c.A124C ili c.A124T
Dutch: Paresthesie Duizeligheid Hypo-esthesie
Croatian: Poremećaji živčanog sustava glavobolja parestezija omaglica hipoestezija
Dutch: c.G284A of c.G285A
Croatian: c.G284A ili c.G285A
Dutch: c.126G>A of c.126G>C of c.126G>T
Croatian: c.126G>A ili c.126G>C ili c.126G>T
Dutch: • Pijnlijke stijve nek
Croatian: • bolni ukočeni vrat (tortikolis)
Dutch: Hoofdpijn en duizeligheid waren de meest voorkomende bijwerkingen die werden gemeld in Galafold-doses tot respectievelijk 1250 mg en 2000 mg.
Croatian: Najčešća nuspojava zabilježena pri dozama lijeka Galafold od najviše 1250 mg bila je glavobolja, odnosno pri dozama od najviše 2000 mg omaglica.
Dutch: • Neusbloeding
Croatian: • krvarenje iz nosa
Dutch: c.1046G>A of c.1047G>A c.G1046A of c.G1047A
Croatian: c.1046G>A ili c.1047G>A c.G1046A ili c.G1047A
Dutch: De gemiddelde verandering van de LVMi ten opzichte van de uitgangswaarde was in maand 18 tot 24 bij patiënten met linkerventrikelhypertrofie bij de start van het onderzoek (vrouwen met een uitgangsLVMi > 95 g/m of mannen met een uitgangs-LVMi > 115 g/ m2) -18,6 (95%-BI: -38,2; 1,0; n=8).
Croatian: Srednja vrijednost promjene u odnosu na početnu vrijednost LVMi od 18. do 24. mjeseca u bolesnika s hipertrofijom lijevog ventrikula na početku (ženski bolesnici s početnom vrijednošću LVMi > 95 g/m ili muški bolesnici s početnom vrijednošću LVMi > 115 g/m2) iznosila je -18,6 (95 % CI: -38,2; 1,0; n = 8).
Dutch: c.1034C>G of c.1034C>A c.C1034G of c.C1034A
Croatian: c.1034C>G ili c.1034C>A c.C1034G ili c.C1034A
Dutch: c.G547A (putatieve splicing locatie)
Croatian: c.G547A (pretpostavljeno mjesto prekrajanja)
Dutch: c.140G>A of 141G>A
Croatian: c.140G>A ili 141G>A
Dutch: Constipatie Droge mond Defecatie-aandrang Dyspepsie
Croatian: Poremećaji probavnog sustava proljev mučnina bol u trbuhu zatvor suha usta urgencija za defekaciju dispepsija
Dutch: c.216G>A of c.216G>T of c.216G>C
Croatian: c.216G>A ili c.216G>T ili c.216G>C
Dutch: Noteer de datum op de doordrukverpakking op de eerste dag dat u dit geneesmiddel uit een nieuwe doordrukverpakking gebruikt.
Croatian: Prvog dana uzimanja lijeka iz nove blister kartice zabilježite datum na kartici.
Dutch: c.280T>A of c.281G>C
Croatian: c.280T>A ili c.281G>C
Dutch: c.T881G of c.T881A
Croatian: c.T881G ili c.T881A
Dutch: c.G639A (putatieve splicing locatie)
Croatian: c.G639A (pretpostavljeno mjesto prekrajanja)
Dutch: c.801G>A (putatieve splicing locatie)
Croatian: c.801G>A (pretpostavljeno mjesto prekrajanja)
Dutch: c.1147T>C of c.1149C>G of c.1149C>A
Croatian: c.1147T>C ili c.1149C>G ili c.1149C>A
Dutch: C]-migalastathydrochloride liet zien dat ongeveer 77% van de radioactief gelabelde dosis in de urine kon worden teruggevonden, waarvan 55% werd uitgescheiden als onveranderde migalastat en 4% als gecombineerde metabolieten M1, M2 en M3.
Croatian: Farmakokinetičko ispitivanje u zdravih muških dobrovoljaca s dozom od 150 mg C]-migalastatklorida pokazalo je da je otprilike 77 % radioaktivno označene doze pronađeno u urinu od kojih je 55% bilo izlučeno kao neizmijenjeni migalastat, a 4 % kao kombinirani metaboliti M1, M2 i M3. Otprilike 5 % ukupne radioaktivnosti uzorka bilo je od nedodijeljenih komponenata.
Dutch: c.G228C of c.G228A of c.G228T M76I
Croatian: c.G228C ili c.G228A ili c.G228T M76I
Dutch: c.G612T of c.G612C
Croatian: c.G612T ili c.G612C
Dutch: Ademhalingsstelsel-, borstkasen mediastinumaandoeningen
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja epistaksa
Dutch: c.T187A of c.G188C
Croatian: c.T187A ili c.G188C
Dutch: c.T139C of c.T139A
Croatian: c.T139C ili c.T139A
Dutch: Bij patiënten met behandelbare mutaties nam de GL-3-spiegel in de urine en in renale interstitiële capillairen vaak af.
Croatian: U bolesnika s mutacijama koje omogućavaju odgovor na liječenje, razine GL-3 imale su tendenciju smanjenja u urinu te u intersticijskim kapilarama bubrega.
Dutch: c.T241C of c.T241A
Croatian: c.T241C ili c.T241A
Dutch: c.C233G of c.C233A
Croatian: c.C233G ili c.C233A
Dutch: c.284G>A of c.285G>A
Croatian: c.284G>A ili c.285G>A
Dutch: c.G982A of c.G982C
Croatian: c.G982A ili c.G982C
Dutch: c.241T>C of c.241T>A
Croatian: c.241T>C ili c.241T>A
Dutch: g.941_5845del p.?
Croatian: g.941_5845del p.?(Exon1_2del)
Dutch: c.T166A of c.G167C
Croatian: c.T166A ili c.G167C
Dutch: c.G734A of c.G735A
Croatian: c.G734A ili c.G735A
Dutch: c.639G>A (putatieve splicing locatie)
Croatian: c.639G>A (pretpostavljeno mjesto prekrajanja)
Dutch: Bent u vergeten dit middel in te nemen?
Croatian: Ako ste zaboravili uzeti Galafold
Dutch: c.G285T of c.G285C
Croatian: c.G285T ili c.G285C
Dutch: c.G131A of c.G132A
Croatian: c.G131A ili c.G132A
Dutch: c.924A>T of c.924A>C
Croatian: c.924A>T ili c.924A>C
Dutch: c.G126A of c.G126C of c.G126T M42I
Croatian: c.G126A ili c.G126C ili c.G126T M42I
Dutch: c.G103C of c.G103A
Croatian: c.G103C ili c.G103A
Dutch: c.C279G of c.C279A
Croatian: c.C279G ili c.C279A
Dutch: c.817T>C of c.819T>A of c.819T>G
Croatian: c.817T>C ili c.819T>A ili c.819T>G
Dutch: c.G888A of c.G888T of c.G888C M296I
Croatian: c.G888A ili c.G888T ili c.G888C M296I
Dutch: c.471G>C of c.471G>T
Croatian: c.471G>C ili c.471G>T
Dutch: c.T552A of c.T552G
Croatian: c.T552A ili c.T552G
Dutch: c.261G>C of c.261G>T
Croatian: c.261G>C ili c.261G>T
Dutch: c.124A>C of c.124A>T
Croatian: c.124A>C ili c.124A>T
Dutch: c.G870A of c.G870C of c.G870T M290I
Croatian: c.G870A ili c.G870C ili c.G870T M290I
Dutch: c.C305G of c.C305A
Croatian: c.C305G ili c.C305A
Dutch: c.228G>C of c.228G>A of c.228G>T
Croatian: c.228G>C ili c.228G>A ili c.228G>T
Dutch: c.G261C of c.G261T
Croatian: c.G261C ili c.G261T
Dutch: c.412G>A of c.412G>C
Croatian: c.412G>A ili c.412G>C
Dutch: Vermoeidheid Pijn
Croatian: Supstrat bolesti
Dutch: c.G540C of c.G540T
Croatian: c.G540C ili c.G540T
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).
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).
Dutch: c.G140A of G141A
Croatian: c.G140A ili G141A
Dutch: c.C525G of c.C525A
Croatian: c.C525G ili c.C525A
Dutch: c.G471C of c.G471T
Croatian: c.G471C ili c.G471T
Dutch: HULS VOOR BLISTERVERPAKKING
Croatian: BLISTER KARTICA
Dutch: c.C747G of c.C747A
Croatian: c.C747G ili c.C747A
Dutch: c.T258G of c.T258A
Croatian: c.T258G ili c.T258A
Dutch: c.T514A of c.G515C
Croatian: c.T514A ili c.G515C
Dutch: c.547G>A (putatieve splicing locatie)
Croatian: c.547G>A (pretpostavljeno mjesto prekrajanja)
Dutch: c.540G>C of c.540G>T
Croatian: c.540G>C ili c.540G>T
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.
Croatian: Savjetuje se da se u bolesnika koji su počeli uzimati migalastat ili koji su prešli na lijek Galafold, periodično (svakih 6 mjeseci) prate bubrežna funkcija, ehokardiografski parametri i biokemijski markeri.
Dutch: c.T960G of c.T960A
Croatian: c.T960G ili c.T960A
Dutch: c.187T>A of c.188G>C
Croatian: c.187T>A ili c.188G>C
Dutch: c.552T>A of c.552T>G
Croatian: c.552T>A ili c.552T>G
Dutch: c.G1074T of c.G1074C
Croatian: c.G1074T ili c.G1074C
Dutch: c.G132T of c.G132C
Croatian: c.G132T ili c.G132C
Dutch: c.G242A of c.G243A
Croatian: c.G242A ili c.G243A
Dutch: c.153G>A of c.153G>T of c.153G>C
Croatian: c.153G>A ili c.153G>T ili c.153G>C
Dutch: c.C453G of c.C453A
Croatian: c.C453G ili c.C453A
Dutch: c.279C>G of c.279C>A
Croatian: c.279C>G ili c.279C>A
Dutch: c.103G>C of c.103G>A
Croatian: c.103G>C ili c.103G>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.
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.
Dutch: De GLA-mutaties die behandelbaar en niet behandelbaar zijn met Galafold worden opgesomd in respectievelijk tabel 2 en tabel 3 hieronder.
Croatian: Mutacije gena GLA koje omogućuju i koje isključuju odgovor na liječenje lijekom Galafold navedene su u tablici 2., odnosno tablici 3. u nastavku.
Dutch: c.285G>T of c.285G>C
Croatian: c.285G>T ili c.285G>C
Dutch: c.G243T of c.G243C
Croatian: c.G243T ili c.G243C
Dutch: c.A588T of c.A588C
Croatian: c.A588T ili c.A588C
Dutch: c.G609C of c.G609T
Croatian: c.G609C ili c.G609T
Dutch: c.519C>A of c.519C>G
Croatian: c.519C>A ili c.519C>G
Dutch: c.525C>G of c.525C>A
Croatian: c.525C>G ili c.525C>A
Dutch: c.561G>T of c.561G>A of c.561G>C
Croatian: c.561G>T ili c.561G>A ili c.561G>C
Dutch: c.612G>T of c.612G>C
Croatian: c.612G>T ili c.612G>C
Dutch: c.233C>G of c.233C>A
Croatian: c.233C>G ili c.233C>A
Dutch: c.G144T of c.G144C
Croatian: c.G144T ili c.G144C
Dutch: Verandering eiwitsequentie
Croatian: Promjena slijeda u proteinu
Dutch: c.131G>A of c.132G>A
Croatian: c.131G>A ili c.132G>A
Dutch: c.A840T of c.A840C
Croatian: c.A840T ili c.A840C
Dutch: c.243G>T of c.243G>C
Croatian: c.243G>T ili c.243G>C
Dutch: U moet alleen om de andere dag eenmaal Galafold innemen.
Croatian: Galafold smijete uzimati samo jedanput svaki drugi dan.
Dutch: • Het gevoel rond te tollen
Croatian: • osjećaj vrtnje
Dutch: c.141G>C of c.141G>T
Croatian: c.141G>C ili c.141G>T
Dutch: c.337T>C of c.339T>A of c.339T>G
Croatian: c.337T>C ili c.339T>A ili c.339T>G
Dutch: c.242G>A of c.243G>A
Croatian: c.242G>A ili c.243G>A
Dutch: c.982G>A of c.982G>C
Croatian: c.982G>A ili c.982G>C
Dutch: c.258T>G of c.258T>A
Croatian: c.258T>G ili c.258T>A
Dutch: c.G1081A of c.G1081C
Croatian: c.G1081A ili c.G1081C
Dutch: c.207C>A of c.207C>G
Croatian: c.207C>A ili c.207C>G
Dutch: NIET BEKEND (del Exon3?)
Croatian: NEPOZNATO (del Exon3?)
Dutch: c.G288A of c.G288T of c.G288C M96I
Croatian: c.G288A ili c.G288T ili c.G288C M96I
Dutch: c.G831T of c.G831C
Croatian: c.G831T ili c.G831C
Dutch: c.T859C of c.T859A
Croatian: c.T859C ili c.T859A
Dutch: c.G567C of c.G567T
Croatian: c.G567C ili c.G567T
Dutch: c.132G>T of c.132G>C
Croatian: c.132G>T ili c.132G>C
Dutch: c.453C>G of c.453C>A
Croatian: c.453C>G ili c.453C>A
Dutch: c.C897G of c.C897A
Croatian: c.C897G ili c.C897A
Dutch: c.1081G>A of c.1081G>C
Croatian: c.1081G>A ili c.1081G>C
Dutch: c.816C>A of c.816C>G
Croatian: c.816C>A ili c.816C>G
Dutch: c.T408A of c.T408G
Croatian: c.T408A ili c.T408G
Dutch: c.T369G of c.T369A
Croatian: c.T369G ili c.T369A
Dutch: c.166T>A of c.167G>C
Croatian: c.166T>A ili c.167G>C
Dutch: c.G830A of c.G831A
Croatian: c.G830A ili c.G831A
Dutch: c.G860A of c.G861A
Croatian: c.G860A ili c.G861A
Dutch: c.859T>C of c.859T>A
Croatian: c.859T>C ili c.859T>A
Dutch: c.870G>A of c.870G>C of c.870G>T
Croatian: c.870G>A ili c.870G>C ili c.870G>T
Dutch: c.T610C of c.T610A
Croatian: c.T610C ili c.T610A
Dutch: c.108G>C of c.108G>T
Croatian: c.108G>C ili c.108G>T
Dutch: c.T465A of c.T465G
Croatian: c.T465A ili c.T465G
Dutch: c.609G>C of c.609G>T
Croatian: c.609G>C ili c.609G>T
Dutch: c.C966A of c.C966G
Croatian: c.C966A ili c.C966G
Dutch: NIET BEKEND (del Exon5_7?)
Croatian: NEPOZNATO (del Exon5_7?)
Dutch: c.881T>G of c.881T>A
Croatian: c.881T>G ili c.881T>A
Dutch: c.G141C of c.G141T
Croatian: c.G141C ili c.G141T
Dutch: c.T280A of c.G281C
Croatian: c.T280A ili c.G281C
Dutch: c.1074G>T of c.1074G>C
Croatian: c.1074G>T ili c.1074G>C
Dutch: Het leeftijdseffect werd geëvalueerd in een populatiefarmacokinetische analyse van de plasmaklaring van migalastat bij de ERT-naïeve onderzoekspopulatie.
Croatian: U analizi populacijske farmakokinetike ocijenjen je učinak dobi na klirens migalastata iz plazme u populaciji bolesnika koji nisu prethodno primali ERT.
Dutch: c.G71A of c.G72A
Croatian: c.G71A ili c.G72A
Dutch: c.T154A of c.G155C
Croatian: c.T154A ili c.G155C
Dutch: NIET BEKEND (del Exon1_2?)
Croatian: NEPOZNATO (del Exon1_2?)
Dutch: c.C456A of c.C456G
Croatian: c.C456A ili c.C456G
Dutch: • Maagpijn
Croatian: • mučnina
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).
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).
Dutch: c.144G>T of c.144G>C
Croatian: c.144G>T ili c.144G>C
Dutch: c.305C>G of c.305C>A
Croatian: c.305C>G ili c.305C>A
Dutch: c.567G>C of c.567G>T
Croatian: c.567G>C ili c.567G>T
Dutch: c.610T>C of c.610T>A
Croatian: c.610T>C ili c.610T>A
Dutch: • Aanhoudende jeuk
Croatian: • ustrajan svrbež
Dutch: c.960T>G of c.960T>A
Croatian: c.960T>G ili c.960T>A
Dutch: c.G485A of c.G486A
Croatian: c.G485A ili c.G486A
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
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
Dutch: c.G439A of c.G439C
Croatian: c.G439A ili c.G439C
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%).
Croatian: 99 % radioaktivno označene doze nađene u plazmi sastojalo od neizmijenjenog migalastata (77 %) te od tri dehidrogenirana konjugirana metabolita O-glukuronida M1 do M3 (13 %).
Dutch: c.T676C of c.T676A
Croatian: c.T676C ili c.T676A
Dutch: Er was geen detecteerbare binding aan plasma-eiwitten na toediening van C]-migalastathydrochloride in het concentratiebereik tussen 1 en 100 M.
Croatian: Nije bilo primijećeno vezanje na proteine plazme nakon primjene [
Dutch: c.830G>A of c.831G>A
Croatian: c.830G>A ili c.831G>A
Dutch: c.707G>A of c.708G>A
Croatian: c.707G>A ili c.708G>A
Dutch: c.485G>A of c.486G>A
Croatian: c.485G>A ili c.486G>A
Dutch: c.70T>C of c.70T>A
Croatian: c.70T>C ili c.70T>A
Dutch: BLISTERFOLIE
Croatian: FOLIJA BLISTERA
Dutch: c.154T>A of c.155G>C
Croatian: c.154T>A ili c.155G>C
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
Croatian: Galafold nije ispitivan u bolesnika s Fabryjevom bolešću koji imaju GFR manji od 30 ml/min/1,73 m U ispitivanju koje je uključivalo davanje jedne doze Galafolda u ispitanika koji nisu imali Fabryjevu bolest s različitim stupnjevima bubrežne insuficijencije, izloženosti su se povećale 4,3 puta u ispitanika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73 m
Dutch: c.G861C of c.G861T
Croatian: c.G861C ili c.G861T
Dutch: c.T648A of c.T648G
Croatian: c.T648A ili c.T648G
Dutch: c.860G>A of c.861G>A
Croatian: c.860G>A ili c.861G>A
Dutch: c.897C>G of c.897C>A
Croatian: c.897C>G ili c.897C>A
Dutch: c.465T>A of c.465T>G
Croatian: c.465T>A ili c.465T>G
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).
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).
Dutch: c.A868C of c.A868T
Croatian: c.A868C ili c.A868T
Dutch: c.288G>A of c.288G>T of c.288G>C
Croatian: c.288G>A ili c.288G>T ili c.288G>C
Dutch: c.394G>A of c.394G>C
Croatian: c.394G>A ili c.394G>C
Dutch: c.966C>A of c.966C>G
Croatian: c.966C>A ili c.966C>G
Dutch: c.708G>C of c.708G>T
Croatian: c.708G>C ili c.708G>T
Dutch: c.T834G of c.T834A
Croatian: c.T834G ili c.T834A
Dutch: c.861G>C of c.861G>T
Croatian: c.861G>C ili c.861G>T
Dutch: c.T687A of c.T687G
Croatian: c.T687A ili c.T687G
Dutch: c.831G>T of c.831G>C
Croatian: c.831G>T ili c.831G>C
Dutch: c.G486C of c.G486T
Croatian: c.G486C ili c.G486T
Dutch: c.G837C of c.G837T
Croatian: c.G837C ili c.G837T
Dutch: c.G394A of c.G394C
Croatian: c.G394A ili c.G394C
Dutch: c.439G>A of c.439G>C
Croatian: c.439G>A ili c.439G>C
Dutch: c.T667A of c.G668C
Croatian: c.T667A ili c.G668C
Dutch: c.T894G of c.T894A
Croatian: c.T894G ili c.T894A
Dutch: c.C666A of c.C666G
Croatian: c.C666A ili c.C666G
Dutch: c.734G>A of c.735G>A
Croatian: c.734G>A ili c.735G>A
Dutch: c.676T>C of c.676T>A
Croatian: c.676T>C ili c.676T>A
Dutch: c.102T>G of c.102T>A
Croatian: c.102T>G ili c.102T>A
Dutch: c.486G>C of c.486G>T
Croatian: c.486G>C ili c.486G>T
Dutch: c.408T>A of c.408T>G
Croatian: c.408T>A ili c.408T>G
Dutch: c.514T>A of c.515G>C
Croatian: c.514T>A ili c.515G>C
Dutch: c.588A>T of c.588A>C
Croatian: c.588A>T ili c.588A>C
Dutch: c.456C>A of c.456C>G
Croatian: c.456C>A ili c.456C>G
Dutch: c.720G>C of c.720G>T
Croatian: c.720G>C ili c.720G>T
Dutch: c.888G>A of c.888G>T of c.888G>C
Croatian: c.888G>A ili c.888G>T ili c.888G>C
Dutch: c.G108C of c.G108T
Croatian: c.G108C ili c.G108T
Dutch: c.T102G of c.T102A
Croatian: c.T102G ili c.T102A
Dutch: c.837G>C of c.837G>T
Croatian: c.837G>C ili c.837G>T
Dutch: c.778G>C of c.778G>A
Croatian: c.778G>C ili c.778G>A
Dutch: c.G772C of c.G772A
Croatian: c.G772C ili c.G772A
Dutch: c.978G>C of c.978G>T
Croatian: c.978G>C ili c.978G>T
Dutch: Galafold is verkrijgbaar in de vorm van capsules (123 mg).
Croatian: Galafold je dostupan u obliku kapsula (123 mg).
Dutch: De aanbevolen dosis Galafold is één capsule om de andere dag, ingenomen via de mond ten minste 2 uur vóór of na de inname van voedsel.
Croatian: Preporučena doza lijeka Galafold jest jedna kapsula svaki drugi dan koja se uzima oralno najmanje 2 sata prije ili nakon obroka.
Dutch: De meest voorkomende bijwerking van Galafold (die bij maximaal 1 op de 10 personen kan optreden) is hoofdpijn.
Croatian: Najčešća nuspojava lijeka Galafold (može se javiti u otprilike 1 na 10 osoba) jest glavobolja.
Dutch: De voornaamste graadmeter voor de werkzaamheid was de verandering in de nierfunctie van de patiënten na 18 maanden behandeling.
Croatian: Glavno mjerilo učinkovitosti bila je promjena funkcije bubrega u bolesnika nakon 18 mjeseci liječenja.
Dutch: Daardoor kan GL-3 niet worden afgebroken en wordt het afgezet in verschillende cellen van het lichaam, waaronder in het hart en de nieren.
Croatian: Kao rezultat toga, GL-3 se ne može razgraditi te se nakuplja u raznim stanicama u tijelu, uključujući srce i bubrege.
Dutch: Hierdoor kan het enzym naar gebieden van de cel worden getransporteerd waar het GL-3 kan afbreken.
Croatian: To omogućuje prijenos enzima u dijelove stanice gdje može razgraditi GL-3.
Dutch: Overige informatie over Galafold
Croatian: Ostale informacije o lijeku Galafold
Dutch: Galafold is onderzocht in twee hoofdstudies onder in totaal 127 patiënten met de ziekte van Fabry.
Croatian: Galafold je istraživan u dvama glavnim ispitivanjima u kojima je sudjelovalo ukupno 127 bolesnika s Fabryjevom bolešću.
Dutch: Welke maatregelen worden er genomen om een veilig en doeltreffend gebruik van Galafold te waarborgen?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Galafold?
Dutch: Het Comité merkte op dat Galafold weliswaar bij een beperkt aantal patiënten was onderzocht, maar dat het beschikbare bewijs voldoende wordt geacht voor een dergelijke zeldzame aandoening.
Croatian: Odbor smatra da je Galafold ispitan na ograničenom broju bolesnika, međutim dostupni dokazi smatraju se dostatnima za liječenje tako rijetke bolesti.
Dutch: Waarom is Galafold goedgekeurd?
Croatian: Zašto je Galafold odobren?
Dutch: Het volledige EPAR voor Galafold is te vinden op de website van het Geneesmiddelenbureau: 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.
Dutch: Aangezien het aantal patiënten met de ziekte van Fabry klein is, wordt de ziekte als ‘zeldzaam' beschouwd en werd Galafold op 22 mei 2006 aangewezen als ‘weesgeneesmiddel' (een geneesmiddel voor zeldzame aandoeningen).
Croatian: Budući da postoji mali broj bolesnika koji boluju od Fabryjeve bolesti, bolest se smatra „rijetkom" te se Galafold označava kao lijek za liječenje rijetkih bolesti od 22. svibnja 2006.
Dutch: Dit document is een samenvatting van het Europees openbaar beoordelingsrapport (EPAR) voor Galafold.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Galafold.
Dutch: In de tweede studie, bij 60 patiënten, werd Galafold vergeleken met de geneesmiddelen agalsidasealfa of agalsidase-bèta, twee behandelingen die het ontbrekende enzym vervangen.
Croatian: Druga studija provedena na 60 bolesnika uspoređivala je Galafold s lijekovima agalzidaza alfa ili agalzidaza beta, dvama liječenjima koja zamjenjuju enzim koji nedostaje.
Dutch: Het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) van het Geneesmiddelenbureau heeft geconcludeerd dat de voordelen van Galafold groter zijn dan de risico's en heeft geadviseerd dit middel voor gebruik in de EU goed te keuren.
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.