FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: NEPOZNATO IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T NEPOZNATO
Maltese: MHUX MAGĦRUF IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T MHUX MAGĦRUF
Croatian: c.207_369+651del814ins231 NEPOZNATO (del Exon2?)
Maltese: c.207_369+651del814ins231 MHUX MAGĦRUF (del Exon2?)
Croatian: c.G790T/G805A
Maltese: G790T/G805A
Croatian: Prethodno geliran škrob (kukuruzni) Magnezijev stearat
Maltese: Kontenut tal-kapsula Pregelatinised starch (qamħirrum) Magnesium stearate
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Croatian: NEPOZNATO (E66_Y123del; del Exon2?)
Maltese: MHUX MAGĦRUF (E66_Y123del; del Exon2?)
Croatian: c.1196G>A ili c.1197G>A c.G1196A ili c.G1197A
Maltese: c.1196G>A jew c.1197G>A c.G1196A jew c.G1197A
Croatian: Promjena slijeda u proteinu c.1A>C ili c.1A>T
Maltese: Bidla fis-Sekwenza tal-Proteina c.1A>C jew c.1A>T
Croatian: FOLIJA BLISTERA
Maltese: FOLJA (BLISTER)
Croatian: c.T280A/G281C
Maltese: T280A/G281C
Croatian: c.A644G/G811A
Maltese: A644G/G811A
Croatian: c.1019G>A ili c.1020G>A c.G1019A ili c.G1020A
Maltese: c.1019G>A jew c.1020G>A c.G1019A jew c.G1020A
Croatian: (pruritus)
Maltese: (prurite)
Croatian: g.2594_10904dup c.195-2500_999+197dup g.2934_6378del
Maltese: g.2594_10904dup c.195-2500_999+197dup
Croatian: Izloženost migalastatu u plazmi (AUC0-∞) i Cmax pokazali su povećanje proporcionalno dozi pri oralnim dozama migalastatklorida od 50 mg do 1250 mg.
Maltese: L-esponiment fil-plażma ta' migalastat hydrochloride (AUC0-∞) u Cmax wrew żidiet proporzjonali mad-doża f'dożi orali ta' migalastat minn 50 mg sa 1,250 mg.
Croatian: Učestalost se određuje kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
Croatian: Farmakokinetičko ispitivanje u zdravih muških dobrovoljaca s dozom od 150 mg [
Maltese: Prova farmakokinetika f'voluntiera rġiel f'saħħithom b'150 mg [
Croatian: c.A504C ili c.A504T
Maltese: A504C jew c.A504T
Croatian: NEPOZNATO (E66_Y123del; del Exon2)
Maltese: MHUX MAGĦRUF (E66_Y123del; del Exon2)
Croatian: c.712A>C ili c.714T>A ili c.714T>G
Maltese: c.712A>C jew c.714T>A jew c.714T>G
Croatian: Na temelju in vitro podataka, utvrđeno je da migalastat nije induktor enzima CYP1A2, 2B6 ili 3A4.
Maltese: Abbażi ta' data in vitro, migalastat mhuwiex induttur ta' CYP1A2, 2B6, jew 3A4.
Croatian: c.504A>C ili c.504A>T
Maltese: c.504A>C jew c.504A>T
Croatian: c.A924T ili c.A924C
Maltese: A924T jew c.A924C
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 %).
Maltese: C]-migalastat HC żvelat li 99% tad-doża radjutikkettata rkuprata fil-plażma kienet komposta minn migalastat mhux mibdul (77%) u minn 3 metaboliti konġugati ta dehydrogenated O-glucuronide, M1 sa M3 (13%).
Croatian: g.10237_11932del/11933_12083i nv/12084_12097del g.>5.5kbdel to 3UTR
Maltese: g.10237_11932del/11933_12083i nv/12084_12097del
Croatian: c.C816A ili c.C816G
Maltese: c.C816A jew c.C816G
Croatian: Tablica 1.: Nuspojave lijeka Galafold zabilježene u kliničkim ispitivanjima Klasifikacija organskih sustava
Maltese: Tabella 1: Reazzjonijiet avversi b'Galafold rraportati fi provi kliniċi Klassi tas-Sistema tal
Croatian: c.A374T/G383A
Maltese: A374T/G383A
Croatian: Nema dostupnih podataka.
Maltese: L-ebda data ma hi disponibbli.
Croatian: Tijekom uzimanja lijeka Galafold trebate koristiti učinkovitu kontracepciju.
Maltese: Waqt li qed tieħu Galafold għandek tuża kontraċettiv effettiv.
Croatian: c.T139C ili c.T139A
Maltese: T139C jew c.T139A
Croatian: • grčevi u mišićima
Maltese: • Spażmi fil-muskoli
Croatian: c.G611A ili G612A
Maltese: G611A jew G612A
Croatian: c.140G>A ili 141G>A
Maltese: c.140G>A jew 141G>A
Croatian: c.1095T>A ili c.1095T>G c.T1095A ili c.T1095G
Maltese: c.1095T>A jew c.1095T>G c.T1095A jew c.T1095G
Croatian: • proteini u urinu
Maltese: • Proteina fl-awrina
Croatian: c.T1147C ili c.C1149G ili c.C1149A
Maltese: T1147C jew c.C1149G jew c.C1149A
Croatian: - Drugi sastojci su: Sadržaj kapsule: prethodno geliran kukuruzni škrob i magnezijev stearat Ovojnica kapsule: želatina, titanijev dioksid i indigotin Tinta za označavanje: šelak, crni željezov oksid i kalijev hidroksid
Maltese: Pregelatinised maize starch u magnesium stearate Qoxra tal-kapsula: Gelatin, titanium dioxide, u indigotine Linka ta' stampar:
Croatian: c.G412A ili c.G412C
Maltese: c.G412A jew c.G412C
Croatian: c.1065C>A ili c.1065C>G c.C1065A ili c.C1065G
Maltese: c.1065C>A jew c.1065C>G c.C1065A jew c.C1065G
Croatian: c.C159G ili c.C159A
Maltese: c.C159G jew c.C159A
Croatian: Mutacije gena GLA dostupne su također za zdravstvene radnike na adresi: www.galafoldamenabilitytable.com.
Maltese: Il-mutazzjonijiet GLA huma wkoll aċċessibbli mill-fornituri tal-kura tas-saħħa f'www.galafoldamenabilitytable.com.
Croatian: c.611G>A ili 612G>A
Maltese: c.611G>A jew 612G>A
Croatian: c.1045T>C ili c.1045T>A c.T1045C ili c.T1045A
Maltese: c.1045T>C jew c.1045T>A c.T1045C jew c.T1045A
Croatian: c.1147T>C ili c.1149C>G ili c.1149C>A
Maltese: c.1147T>C jew c.1149C>G jew c.1149C>A
Croatian: c.1046G>A ili c.1047G>A c.G1046A ili c.G1047A
Maltese: c.1046G>A jew c.1047G>A c.G1046A jew c.G1047A
Croatian: Migalastat nije supstrat za P-glikoprotein (P-gP) in vitro i ne smatra se vjerojatnim da bi migalastat bio podložan interakciji lijekova s citokromima P450.
Maltese: Migalastat mhuwiex sottostrat ta' P-glycoprotein (P-gP) in vitro u huwa meqjus improbabbli li migalastat għamdu ikun soġġett għal interazzjonijiet bejn mediċina u ohra maċ- cytochrome P450s.
Croatian: Bolesnici koji su bili randomizirani u skupinu koja je primala placebo u 1. fazi te koji su prešli na Galafold u 6. mjesecu (2.faza) također su pokazali statistički značajno smanjenje inkluzija GL-3 u intersticijskim kapilarama u 12. mjesecu (-0,33 ± 0,15; -58 %) (p = 0,014).
Maltese: Pazjenti randomizzati għall-plaċebo fi Stadju 1 u li bdew jingħataw Galafold f'xahar 6 (Stadju 2) ukoll urew tnaqqis statistikament sinifikanti f'inklużjonijiet GL-3 fil-kapillari interstizjali f'xahar 12 (-0.33±0.15; -58%) (p=0.014).
Croatian: c.C519A ili c.C519G
Maltese: c.C519A jew c.C519G
Croatian: c.A124C ili c.A124T
Maltese: A124C jew c.A124T
Croatian: c.C207A ili c.C207G
Maltese: c.C207A jew c.C207G
Croatian: c.159C>G ili c.159C>A
Maltese: c.159C>G jew c.159C>A
Croatian: c.442A>C ili c.444T>A ili c.444T>G
Maltese: 442A>C jew c.444T>A jew c.444T>G
Croatian: c.1034C>G ili c.1034C>A c.C1034G ili c.C1034A
Maltese: c.1034C>G jew c.1034C>A c.C1034G jew c.C1034A
Croatian: c.280T>A ili c.281G>C
Maltese: 280T>A jew c.281G>C
Croatian: • bol u mišićima (mialgija)
Maltese: • Uġigħ fil-muskoli (mijalġja)
Croatian: c.139T>C ili c.139T>A
Maltese: 139T>C jew c.139T>A
Croatian: Učestalost događaja u bolesnika liječenih lijekom Galafold tijekom 30 mjeseci (32 %) bila je slična 18-mjesečnom razdoblju.
Maltese: Il-frekwenza ta' avvenimenti f'pazjenti kkurati b'Galafold fuq perjodu ta' 30 xahar (32%) kienet simili għall-perjodu ta' 18-il xahar.
Croatian: c.924A>T ili c.924A>C
Maltese: c.924A>T jew c.924A>C
Croatian: Galafold nije namijenjen za istodobnu primjenu s enzimskom nadomjesnom terapijom (vidjeti dio 4.4).
Maltese: Galafold mhuwiex intiż għall-użu fl-istess ħinma'terapija ta' sostituzzjoni tal-enzima (ara sezzjoni 4.4).
Croatian: U zdravih dobrovoljaca volumen distribucije (Vz/F) migalastata nakon povećavanja jednokratne oralne doze (25 - 675 mg migalastat HCl) kretao se u rasponu od 77 do 133 l, što je pokazalo dobru distribuciju lijeka u tkiva, te prelazi ukupnu količinu vode u tijelu (42 litre).
Maltese: F'voluntiera f'saħħithom, il-volum tad-distribuzzjoni (Vz/F) ta' migalastat wara dożi orali waħdanin li jiżdiedu (25-675 mg migalastat HCl) varja minn 77 sa 133 L, u dan jindika li huwa mqassam tajjeb fit-tessuti u akbar mit-total tal-ilma fil-ġisem (42 litru).
Croatian: c.124A>C ili c.124A>T
Maltese: c.124A>C jew c.124A>T
Croatian: c.G284A ili c.G285A
Maltese: G284A jew c.G285A
Croatian: c.G103C ili c.G103A
Maltese: c.G103C jew c.G103A
Croatian: c.T241C ili c.T241A
Maltese: T241C jew c.T241A
Croatian: c.412G>A ili c.412G>C
Maltese: c.412G>A jew c.412G>C
Croatian: c.148T>C ili c.150C>G ili c.150C>A
Maltese: c.148T>C jew c.150C>G jew c.150C>A
Croatian: Tablica 2.: Tablica mutacija koje omogućuju odgovili na lijek Galafold (migalastat) Promjena nukleotida
Maltese: Tabella 2: Tabella ta' mutazzjonijiet li jirrispondu għal Galafold (migalastat) Bidla fin-nukleotidi
Croatian: c.T806G/G937T
Maltese: T806G/G937T
Croatian: c.C233G ili c.C233A
Maltese: C233G jew c.C233A
Croatian: c.G982A ili c.G982C
Maltese: c.G982A jew c.G982C
Croatian: Netfang: MedInfo@amicusrx.com
Maltese: MedInfo@amicusrx.com
Croatian: c.284G>A ili c.285G>A
Maltese: c.284G>A jew c.285G>A
Croatian: c.817T>C ili c.819T>A ili c.819T>G
Maltese: c.817T>C jew c.819T>A jew c.819T>G
Croatian: c.C279G ili c.C279A
Maltese: c.C279G jew c.C279A
Croatian: c.T552A ili c.T552G
Maltese: c.T552A jew c.T552G
Croatian: Promjena nukleotida
Maltese: Bidla fin-nukleotidi
Croatian: c.187T>A ili c.188G>C
Maltese: c.187T>A jew c.188G>C
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u popisu referentnih datuma Unije (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
Croatian: c.T166A ili c.G167C
Maltese: c.T166A jew c.G167C
Croatian: c.G285T ili c.G285C
Maltese: c.G285T jew c.G285C
Croatian: Fabryjevu bolest uzrokuje nedostatak ili oštećenje enzima naziva alfa-galaktozidaza A (α-Gal A).
Maltese: Il-marda ta' Fabry hija kkawżata min-nuqqas ta' jew enzima difettuża li tissejjaħ alpha-galactosidase A (α-Gal A).
Croatian: c.T187A ili c.G188C
Maltese: T187A jew c.G188C
Croatian: c.216G>A ili c.216G>T ili c.216G>C
Maltese: c.216G>A jew c.216G>T jew c.216G>C
Croatian: c.552T>A ili c.552T>G
Maltese: c.552T>A jew c.552T>G
Croatian: c.T148C ili c.C150G ili c.C150A F50L
Maltese: T148C jew c.C150G jew c.C150A
Croatian: c.T881G ili c.T881A
Maltese: T881G jew c.T881A
Croatian: c.471G>C ili c.471G>T
Maltese: c.471G>C jew c.471G>T
Croatian: c.241T>C ili c.241T>A
Maltese: 241T>C jew c.241T>A
Croatian: c.C525G ili c.C525A
Maltese: c.C525G jew c.C525A
Croatian: c.519C>A ili c.519C>G
Maltese: c.519C>A jew c.519C>G
Croatian: NEPOZNATO (M267I)
Maltese: MHUX MAGĦRUF (M267I)
Croatian: c.261G>C ili c.261G>T
Maltese: c.261G>C jew c.261G>T
Croatian: c.G140A ili G141A
Maltese: c.G140A jew G141A
Croatian: c.G734A ili c.G735A
Maltese: G734A jew c.G735A
Croatian: c.337T>C ili c.339T>A ili c.339T>G
Maltese: c.337T>C jew c.339T>A jew c.339T>G
Croatian: c.242G>A ili c.243G>A
Maltese: c.242G>A jew c.243G>A
Croatian: c.207C>A ili c.207C>G
Maltese: c.207C>A jew c.207C>G
Croatian: c.C305G ili c.C305A
Maltese: c.C305G jew c.C305A
Croatian: c.G471C ili c.G471T
Maltese: G471C jew c.G471T
Croatian: c.279C>G ili c.279C>A
Maltese: c.279C>G jew c.279C>A
Croatian: c.T514A ili c.G515C
Maltese: c.T514A jew c.G515C
Croatian: c.A644G/G937T
Maltese: A644G/G937T
Croatian: c.A588T ili c.A588C
Maltese: A588T jew c.A588C
Croatian: c.816C>A ili c.816C>G
Maltese: c.816C>A jew c.816C>G
Croatian: c.285G>T ili c.285G>C
Maltese: c.285G>T jew c.285G>C
Croatian: c.228G>C ili c.228G>A ili c.228G>T
Maltese: c.228G>C jew c.228G>A jew c.228G>T
Croatian: c.G609C ili c.G609T
Maltese: c.G609C jew c.G609T
Croatian: c.G261C ili c.G261T
Maltese: G261C jew c.G261T
Croatian: c.G540C ili c.G540T
Maltese: c.G540C jew c.G540T
Croatian: Migalastat nije supstrat za MDR1 ili BCRP, niti je inhibitor humanih efluksnih transportera BCRP, MDR1 ili BSEP.
Maltese: Migalastat mhuwiex sottostrat ta' MDR1 jew BCRP, lanqas ma huwa inibitur ta' BCRP, MDR1 jew trasportaturi tal-effluss umani (human efflux transporters) BSEP.
Croatian: Ovojnica kapsule Želatina
Maltese: Il-qoxra tal-kapsula Ġelatina
Croatian: c.A840T ili c.A840C
Maltese: A840T jew c.A840C
Croatian: c.G131A ili c.G132A
Maltese: G131A jew c.G132A
Croatian: c.T960G ili c.T960A
Maltese: c.T960G jew c.T960A
Croatian: c.561G>T ili c.561G>A ili c.561G>C
Maltese: c.561G>T jew c.561G>A jew c.561G>C
Croatian: c.G132T ili c.G132C
Maltese: c.G132T jew c.G132C
Croatian: c.612G>T ili c.612G>C
Maltese: c.612G>T jew c.612G>C
Croatian: c.982G>A ili c.982G>C
Maltese: c.982G>A jew c.982G>C
Croatian: c.C747G ili c.C747A
Maltese: C747G jew c.C747A
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
Croatian: c.525C>G ili c.525C>A
Maltese: c.525C>G jew c.525C>A
Croatian: c.103G>C ili c.103G>A
Maltese: c.103G>C jew c.103G>A
Croatian: c.T258G ili c.T258A
Maltese: T258G jew c.T258A
Croatian: c.C897G ili c.C897A
Maltese: c.C897G jew c.C897A
Croatian: Drugi otvoreni nastavak ispitivanja (AT1001-042) uključuje i bolesnike koji su prešli iz nastavka ispitivanja AT1001-041 i one koji su prešli izravno iz ispitivanja faze 3, ATTRACT, i još uvijek je u tijeku.
Maltese: It-tieni prova OLE (AT1001-042) kient tinkludi pazjenti li kienu ġew ittrasferiti minn studju OLE AT1001-041 u direttament minn studju ta' Fażi 3 ATTRACT, u din għadha għaddejja.
Croatian: c.153G>A ili c.153G>T ili c.153G>C
Maltese: c.153G>A jew c.153G>T jew c.153G>C
Croatian: c.T859C ili c.T859A
Maltese: c.T859C jew c.T859A
Croatian: NEPOZNATO (del Exon1_2?)
Maltese: MHUX MAGĦRUF (del Exon1_2?)
Croatian: c.G612T ili c.G612C
Maltese: G612T jew c.G612C
Croatian: c.126G>A ili c.126G>C ili c.126G>T
Maltese: c.126G>A jew c.126G>C jew c.126G>T
Croatian: c.243G>T ili c.243G>C
Maltese: c.243G>T jew c.243G>C
Croatian: Srčani poremećaji palpitacije
Maltese: Disturbi gastro-intestinali
Croatian: c.T280A ili c.G281C
Maltese: c.T280A jew c.G281C
Croatian: c.G242A ili c.G243A
Maltese: G242A jew c.G243A
Croatian: c.830G>A ili c.831G>A
Maltese: c.830G>A jew c.831G>A
Croatian: c.G567C ili c.G567T
Maltese: c.G567C jew c.G567T
Croatian: c.G144T ili c.G144C
Maltese: c.G144T jew c.G144C
Croatian: c.131G>A ili c.132G>A
Maltese: c.131G>A jew c.132G>A
Croatian: c.863delC
Maltese: 863delC
Croatian: c.258T>G ili c.258T>A
Maltese: c.258T>G jew c.258T>A
Croatian: c.166T>A ili c.167G>C
Maltese: c.166T>A jew c.167G>C
Croatian: c.C453G ili c.C453A
Maltese: C453G jew c.C453A
Croatian: U ispitivanju s bolesnicima koji nisu prethodno primali ERT, Galafold je pokazao statistički značajna smanjenja koncentracija lyso-Gb3 u plazmi te inkluzija GL-3 u intersticijskim bubrežnim kapilarama u bolesnika s mutacijama koje omogućuju odgovor na liječenje.
Maltese: Fil-prova mingħajr esperjenza tal-ERT, Galafold wera tnaqqis statistikament sinifikanti f'konċentrazzjonijiet tal-plażma ta' lyso-Gb3 u ta' inklużjonijiet GL-3 tal-kapillari interstizjali tal-kliewi f'pazjenti b'mutazzjonijiet li jirrispondu ghal Galafold.
Croatian: c.G216A ili c.G216T ili c.G216C M72I
Maltese: c.G216A jew c.G216T jew c.G216C
Croatian: c.T465A ili c.T465G
Maltese: c.T465A jew c.T465G
Croatian: c.540G>C ili c.540G>T
Maltese: c.540G>C jew c.540G>T
Croatian: c.707G>A ili c.708G>A
Maltese: c.707G>A jew c.708G>A
Croatian: c.363delT
Maltese: 363delT
Croatian: c.609G>C ili c.609G>T
Maltese: c.609G>C jew c.609G>T
Croatian: c.G801A (pretpostavljeno mjesto prekrajanja)
Maltese: c.G801A (sit probabbli ta' tagħqid)
Croatian: c.141G>C ili c.141G>T
Maltese: c.141G>C jew c.141G>T
Croatian: Jedna blister kartica lijeka Galafold = 14 tvrdih kapsula = 28 dana terapije
Maltese: Folja (Blister) waħda ta' Galafold = 14-il kapusla iebsa = 28 jum ta' kura
Croatian: c.132G>T ili c.132G>C
Maltese: c.132G>T jew c.132G>C
Croatian: Što sadrži Galafold - Djelatna tvar je migalastat.
Maltese: X'fih Galafold - Is-sustanza attiva hija migalastat.
Croatian: c.233C>G ili c.233C>A
Maltese: 233C>G jew c.233C>A
Croatian: c.T610C ili c.T610A
Maltese: c.T610C jew c.T610A
Croatian: c.G243T ili c.G243C
Maltese: G243T jew c.G243C
Croatian: c.G71A ili c.G72A
Maltese: G71A jew c.G72A
Croatian: c.144G>T ili c.144G>C
Maltese: c.144G>T jew c.144G>C
Croatian: c.881T>G ili c.881T>A
Maltese: c.881T>G jew c.881T>A
Croatian: Migalastat primijenjen uz obrok s visokim udjelom masti ili sat vremena prije obroka s visokim udjelom masti ili laganog obroka ili sat vremena nakon laganog obroka doveo je do značajnih smanjenja srednje ukupne izloženosti migalastatu (AUC0-∞) od 37 % do 42 %, te do smanjenja srednje maksimalne izloženosti migalastatu (Cmax) od 15 do 40 % u usporedbi s primjenom natašte.
Maltese: Migalastat mogħti ma' ikla b'kontenut għoli ta' xaħam, jew siegħa qabel ikla b'kontenut għoli ta' xaħam jew inkella ikla ħafifa, jew siegħa wara ikla ħafifa, irriżulta fi tnaqqis sinifikanti ta' 37% sa 43% fil-medja tal-esponiment totali ta' migalastat (AUC0-∞) u tnaqqis ta' 15% sa 40% fil-medja tal-esponiment massimuta' migalastat (Cmax) meta mqabbel ma' stat ta' sawm.
Croatian: U ispitivanju s bolesnicima koji su prethodno primali ERT, a nakon 18-mjesečnog liječenja lijekom Galafold, došlo je do statistički značajnog smanjenja LVMi (p < 0,05).
Maltese: Fil-prova b' esperjenza tal-ERT, wara 18-il xahar ta' kura b'Galafold, kien hemm tnaqqis statistikament sinifikanti fil-LVMi (p< 0.05).
Croatian: Klinička ispitivanja lijeka Galafold obuhvatila su mali broj bolesnika u dobi od 65 godina i starijih.
Maltese: Studji kliniċi ta' Galafold inkludew numru żgħir ta' pazjenti mill-età ta' 65 sena u aktar.
Croatian: België/Belgique/Belgien Amicus Therapeutics Europe Limited Tél/Tel: 0800 79245 e-mail: MedInfo@amicusrx.com
Maltese: België/Belgique/Belgien Amicus Therapeutics Europe Limited Tél/Tel: 0800 79245 e-mail:
Croatian: c.859T>C ili c.859T>A
Maltese: c.859T>C jew c.859T>A
Croatian: Srednja vrijednost duljine izloženosti dozi lijeka Galafold od 123 mg (koja se nalazi na tržištu) svakog drugog dana u bolesnika koji su završili ispitivanje AT1001-041 bila je 3,57 (±1,23) godina (n = 85).
Maltese: Ilkobor medju tal-esponiment tad-doża mqiegħda fis-suq ta' Galafold 123 mg QOD f'pazjenti li kienu qed ilestu studju AT1001-041 kien ta' 3.57 (±1.23) snin (n=85).
Croatian: • trnci u udovima (parestezija)
Maltese: • Tnemnim flestremitajiet (paresteżija)
Croatian: c.734G>A ili c.735G>A
Maltese: c.734G>A jew c.735G>A
Croatian: Kvalitativna smanjenja razina GL-3 primijećena su u više vrsta bubrežnih stanica: podocitima, mezangijalnim stanicama, glomerularnim endotelnim stanicama, tijekom 12 mjeseci liječenja lijekom Galafold.
Maltese: GL-3 kien osservat f'diversi tipi ta' ċelloli tal-kliewi: podoċiti (podocytes), ċelloli meżanġjali (mesangial cells), u ċelloli glomerulari endoteljali, rispettivament, fuq 12-il xahar ta' kura b'Galafold.
Croatian: c.T154A ili c.G155C
Maltese: T154A jew c.G155C
Croatian: c.G830A ili c.G831A
Maltese: c.G830A jew c.G831A
Croatian: c.960T>G ili c.960T>A
Maltese: c.960T>G jew c.960T>A
Croatian: c.T408A ili c.T408G
Maltese: T408A jew c.T408G
Croatian: c.305C>G ili c.305C>A
Maltese: c.305C>G jew c.305C>A
Croatian: Nakon povećavanja jednokratnih oralnih doza (25 - 675 mg migalastatklorida) nije primijećen nikakav trend za klirens CL/F.
Maltese: Wara d-dożi orali waħdanin li jiżdiedu, (25-675 mg migalastat hydrochloride), ma nstabux xejriet għat-tneħħija (clearance), CL/F).
Croatian: c.G547A (pretpostavljeno mjesto prekrajanja)
Maltese: c.G547A (sit probabbli ta' tagħqid)
Croatian: c.C456A ili c.C456G
Maltese: c.C456A jew c.C456G
Croatian: c.946delG
Maltese: 946delG
Croatian: Riječ je o čestom spontanom tumoru u mužjaka štakora hranjenih ad libitum.
Maltese: Dan huwa tumur spontanju komuni f'firien irġiel mitmugħin ad libitum.
Croatian: c.567G>C ili c.567G>T
Maltese: c.567G>C jew c.567G>T
Croatian: c.T369G ili c.T369A
Maltese: T369G jew c.T369A
Croatian: c.831G>T ili c.831G>C
Maltese: c.831G>T jew c.831G>C
Croatian: c.T70C ili c.T70A
Maltese: c.T70C jew c.T70A
Croatian: c.610T>C ili c.610T>A
Maltese: c.610T>C jew c.610T>A
Croatian: Svaka kapsula sadrži migalastatklorid koji odgovara 123 mg migalastata.
Maltese: Kull kapsula fiha migalastat hydrochloride ekwivalenti għal 123 mg migalastat.
Croatian: c.801G>A (pretpostavljeno mjesto prekrajanja)
Maltese: c.801G>A (sit probabbli ta' tagħqid)
Croatian: c.154T>A ili c.155G>C
Maltese: c.154T>A jew c.155G>C
Croatian: c.108G>C ili c.108G>T
Maltese: c.108G>C jew c.108G>T
Croatian: c.860G>A ili c.861G>A
Maltese: c.860G>A jew c.861G>A
Croatian: c.G141C ili c.G141T
Maltese: G141C jew c.G141T
Croatian: c.485G>A ili c.486G>A
Maltese: c.485G>A jew c.486G>A
Croatian: c.453C>G ili c.453C>A
Maltese: c.453C>G jew c.453C>A
Croatian: c.C966A ili c.C966G
Maltese: c.C966A jew c.C966G
Croatian: c.G485A ili c.G486A
Maltese: c.G485A jew c.G486A
Croatian: Galafold je indiciran za dugotrajno liječenje odraslih i adolescenata u dobi od 16 godina i starijih s potvrđenom dijagnozom Fabryjeve bolesti (nedostatak α-galaktozidaze A) i koji imaju mutacije koje omogućuju odgovor na liječenje (vidjeti tablice u dijelu 5.1).
Maltese: Galafold huwa indikat għal kura fit-tul ta' adulti u adolexxenti fl-età ta' 16-il sena u aktar b'dijanjożi kkonfermata tal-marda ta' Fabry (defiċjenza ta' α-galactosidase A) u li għandhom mutazzjoni li tirrispondi għal Galafold (ara t-tabelli fis-sezzjoni 5.1).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
Maltese: Tnaqqis kwalitattiv fil-livelli
Croatian: NEPOZNATO (del Exon2_3?)
Maltese: MHUX MAGĦRUF (del Exon2_3?)
Croatian: c.897C>G ili c.897C>A
Maltese: c.897C>G jew c.897C>A
Croatian: c.870G>A ili c.870G>C ili c.870G>T
Maltese: c.870G>A jew c.870G>C jew c.870G>T
Croatian: U ispitivanju s bolesnicima koji su prethodno primali ERT, analiza kompozitnog kliničkog ishoda koji se sastojao od bubrežnih, srčanih i cerebrovaskularnih događaja ili smrti, je pokazala kako je učestalost događaja primijećenih u skupini koja je primala Galafold iznosila 29 %, u usporedbi s 44 % u skupini koja je primala ERT tijekom 18 mjeseci.
Maltese: Fil-prova b'' esperjenza tal-ERT analiżi ta' riżultat kliniku kompost magħmul minn avvenimenti tal-kliewi, tal-qalb, ċerebrovaskulari, jew mewt, il-frekwenza tal-avvenimenti osservati fil-grupp tal-kura ta' Galafold kienet ta' 29% imqabbla ma' 44% fil-grupp ERT fuq 18-il xahar.
Croatian: c.A868C ili c.A868T
Maltese: A868C jew c.A868T
Croatian: c.514T>A ili c.515G>C
Maltese: c.514T>A jew c.515G>C
Croatian: c.840A>T ili c.840A>C
Maltese: c.840A>T jew c.840A>C
Croatian: c.T402G ili c.T402A
Maltese: c.T402G jew c.T402A
Croatian: c.T337C ili c.T339A ili c.T339G F113L
Maltese: T337C jew c.T339A jew c.T339G
Croatian: c.456C>A ili c.456C>G
Maltese: c.456C>A jew c.456C>G
Croatian: c.439G>A ili c.439G>C
Maltese: c.439G>A jew c.439G>C
Croatian: c.70T>C ili c.70T>A
Maltese: c.70T>C jew c.70T>A
Croatian: c.G108C ili c.G108T
Maltese: c.G108C jew c.G108T
Croatian: c.G861C ili c.G861T
Maltese: c.G861C jew c.G861T
Croatian: c.413dupG
Maltese: 413dupG
Croatian: c.G831T ili c.G831C
Maltese: G831T jew c.G831C
Croatian: c.966C>A ili c.966C>G
Maltese: c.966C>A jew c.966C>G
Croatian: c.T676C ili c.T676A
Maltese: T676C jew c.T676A
Croatian: c.71G>A ili c.72G>A
Maltese: c.71G>A jew c.72G>A
Croatian: NEPOZNATO (G183S)
Maltese: MHUX MAGĦRUF (G183S)
Croatian: c.T648A ili c.T648G
Maltese: T648A jew c.T648G
Croatian: c.G860A ili c.G861A
Maltese: c.G860A jew c.G861A