FrancophonIA/ELRC3.0 huggingface dataset:
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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).
Slovenian: C]-migalastat HCl pri zdravih moških prostovoljcih je pokazalo, da so 99 % radioaktivno označenega odmerka v plazmi predstavljali nespremenjen migalastat (77 %) in trije dehidrogenirani z O-glukuronidom konjugirani presnovki, 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%).
Slovenian: c.T280A/G281C
Maltese: T280A/G281C
Slovenian: c.1196G>A ali c.1197G>A c.G1196A ali c.G1197A
Maltese: c.1196G>A jew c.1197G>A c.G1196A jew c.G1197A
Slovenian: Imetnik dovoljenja za promet z zdravilom 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
Slovenian: En pretisni omot zdravila Galafold = 14 trdih kapsul = 28 dni zdravljenja
Maltese: Folja (Blister) waħda ta' Galafold = 14-il kapusla iebsa = 28 jum ta' kura
Slovenian: c.A644G/G811A
Maltese: A644G/G811A
Slovenian: Na podlagi podatkov in vitro migalastat ni induktor encimov CYP1A2, 2B6 in 3A4.
Maltese: Abbażi ta' data in vitro, migalastat mhuwiex induttur ta' CYP1A2, 2B6, jew 3A4.
Slovenian: Plazemska izpostavljenost migalastatu (AUC0-∞) in Cmax sta pri peroralnih odmerkih migalastatijevega klorida od 50 mg do 1 250 mg pokazala odmerku sorazmeren porast.
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.
Slovenian: c.1019G>A ali c.1020G>A c.G1019A ali c.G1020A
Maltese: c.1019G>A jew c.1020G>A c.G1019A jew c.G1020A
Slovenian: NEZNANO (E66_Y123del; del Exon2)
Maltese: MHUX MAGĦRUF (E66_Y123del; del Exon2)
Slovenian: c.712A>C ali c.714T>A ali c.714T>G
Maltese: c.712A>C jew c.714T>A jew c.714T>G
Slovenian: (pruritus)
Maltese: (prurite)
Slovenian: c.504A>C ali c.504A>T
Maltese: c.504A>C jew c.504A>T
Slovenian: Sestavljeni klinični izidi
Maltese: Riżultati Kliniċi Komposti
Slovenian: Podatkov ni na voljo.
Maltese: L-ebda data ma hi disponibbli.
Slovenian: Sprememba proteinskega zapaliedja c.1A>C ali c.1A>T
Maltese: Bidla fis-Sekwenza tal-Proteina c.1A>C jew c.1A>T
Slovenian: c.A374T/G383A
Maltese: A374T/G383A
Slovenian: c.140G>A ali 141G>A
Maltese: c.140G>A jew 141G>A
Slovenian: c.1095T>A ali c.1095T>G c.T1095A ali c.T1095G
Maltese: c.1095T>A jew c.1095T>G c.T1095A jew c.T1095G
Slovenian: c.A504C ali c.A504T
Maltese: A504C jew c.A504T
Slovenian: c.611G>A ali 612G>A
Maltese: c.611G>A jew 612G>A
Slovenian: c.C816A ali c.C816G
Maltese: c.C816A jew c.C816G
Slovenian: (95-% CI: -2,272, 1,478; n = 34), v skupini,
Maltese: (95% CI: -2.272, 1.478;
Slovenian: c.A924T ali c.A924C
Maltese: A924T jew c.A924C
Slovenian: c.1147T>C ali c.1149C>G ali c.1149C>A
Maltese: c.1147T>C jew c.1149C>G jew c.1149C>A
Slovenian: NEZNANO (G183S)
Maltese: MHUX MAGĦRUF (G183S)
Slovenian: c.G412A ali c.G412C
Maltese: c.G412A jew c.G412C
Slovenian: Preglednica 1: Neželeni učinki zdravila Galafold, o katerih so poročali v kliničnih preskušanjih Organski sistem
Maltese: Tabella 1: Reazzjonijiet avversi b'Galafold rraportati fi provi kliniċi Klassi tas-Sistema tal
Slovenian: c.1065C>A ali c.1065C>G c.C1065A ali c.C1065G
Maltese: c.1065C>A jew c.1065C>G c.C1065A jew c.C1065G
Slovenian: - Druge sestavine zdravila so: Vsebina kapsule: predgelirani koruzni škrob in magnezijev stearat Ovoj kapsule: želatina, titanov dioksid in indigotin Črnilo: šelak, črni železov oksid in kalijev hidroksid
Maltese: Pregelatinised maize starch u magnesium stearate Qoxra tal-kapsula: Gelatin, titanium dioxide, u indigotine Linka ta' stampar:
Slovenian: c.442A>C ali c.444T>A ali c.444T>G
Maltese: 442A>C jew c.444T>A jew c.444T>G
Slovenian: c.G140A ali G141A
Maltese: c.G140A jew G141A
Slovenian: EXP:
Maltese: LOTT:
Slovenian: Mutacije gena GLA so izvajalcem zdravstvenih dejavnosti dostopne tudi na spletnem naslovu www.galafoldamenabilitytable.com.
Maltese: Il-mutazzjonijiet GLA huma wkoll aċċessibbli mill-fornituri tal-kura tas-saħħa f'www.galafoldamenabilitytable.com.
Slovenian: c.1034C>G ali c.1034C>A c.C1034G ali c.C1034A
Maltese: c.1034C>G jew c.1034C>A c.C1034G jew c.C1034A
Slovenian: g.941_5845del p.?
Maltese: g.941_5845del p.?(Exon1_2del)
Slovenian: c.139T>C ali c.139T>A
Maltese: 139T>C jew c.139T>A
Slovenian: c.T139C ali c.T139A
Maltese: T139C jew c.T139A
Slovenian: c.1045T>C ali c.1045T>A c.T1045C ali c.T1045A
Maltese: c.1045T>C jew c.1045T>A c.T1045C jew c.T1045A
Slovenian: c.C207A ali c.C207G
Maltese: c.C207A jew c.C207G
Slovenian: c.924A>T ali c.924A>C
Maltese: c.924A>T jew c.924A>C
Slovenian: c.C519A ali c.C519G
Maltese: c.C519A jew c.C519G
Slovenian: c.1046G>A ali c.1047G>A c.G1046A ali c.G1047A
Maltese: c.1046G>A jew c.1047G>A c.G1046A jew c.G1047A
Slovenian: c.159C>G ali c.159C>A
Maltese: c.159C>G jew c.159C>A
Slovenian: c.412G>A ali c.412G>C
Maltese: c.412G>A jew c.412G>C
Slovenian: c.216G>A ali c.216G>T ali c.216G>C
Maltese: c.216G>A jew c.216G>T jew c.216G>C
Slovenian: Približno 5 % celotne radioaktivnosti se je izločilo kot nepripisane sestavine.
Maltese: Madwar 5% tar-radjuattività totali tal-kampjun kienet komponenti mhux assenjati.
Slovenian: c.817T>C ali c.819T>A ali c.819T>G
Maltese: c.817T>C jew c.819T>A jew c.819T>G
Slovenian: c.148T>C ali c.150C>G ali c.150C>A
Maltese: c.148T>C jew c.150C>G jew c.150C>A
Slovenian: c.552T>A ali c.552T>G
Maltese: c.552T>A jew c.552T>G
Slovenian: NEZNANO (M267I)
Maltese: MHUX MAGĦRUF (M267I)
Slovenian: c.G611A ali G612A
Maltese: G611A jew G612A
Slovenian: c.C159G ali c.C159A
Maltese: c.C159G jew c.C159A
Slovenian: c.G982A ali c.G982C
Maltese: c.G982A jew c.G982C
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila 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.
Slovenian: c.G285T ali c.G285C
Maltese: c.G285T jew c.G285C
Slovenian: c.T1147C ali c.C1149G ali c.C1149A
Maltese: T1147C jew c.C1149G jew c.C1149A
Slovenian: c.280T>A ali c.281G>C
Maltese: 280T>A jew c.281G>C
Slovenian: c.T806G/G937T
Maltese: T806G/G937T
Slovenian: c.369+3_639+954del3129insT NEZNANO (del Exon3 in g.6009_9741del
Maltese: c.369+3_639+954del3129insT MHUX MAGĦRUF (del Exon3 u 4?)
Slovenian: c.284G>A ali c.285G>A
Maltese: c.284G>A jew c.285G>A
Slovenian: C]-migalastatijevega klorida v koncentracijskem razponu od 1 do 100 M ni bilo zaznavne vezave na plazemske proteine.
Maltese: C]-migalastat hydrochloride fil-firxa ta' konċentrazzjoni bejn 1 u 100 M.
Slovenian: c.T552A ali c.T552G
Maltese: c.T552A jew c.T552G
Slovenian: c.124A>C ali c.124A>T
Maltese: c.124A>C jew c.124A>T
Slovenian: Pri bolnikih, ki so bili v fazi 1 randomizirani na placebo in so na zdravilo Galafold prešli v 6. mesecu (faza 2), je bilo vključkov GL-3 v ntersticijskih kapilarah v 12. mesecu prav tako statistično značilno manj (-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).
Slovenian: c.A124C ali c.A124T
Maltese: A124C jew c.A124T
Slovenian: c.337T>C ali c.339T>A ali c.339T>G
Maltese: c.337T>C jew c.339T>A jew c.339T>G
Slovenian: c.T166A ali c.G167C
Maltese: c.T166A jew c.G167C
Slovenian: c.187T>A ali c.188G>C
Maltese: c.187T>A jew c.188G>C
Slovenian: c.241T>C ali c.241T>A
Maltese: 241T>C jew c.241T>A
Slovenian: c.228G>C ali c.228G>A ali c.228G>T
Maltese: c.228G>C jew c.228G>A jew c.228G>T
Slovenian: c.519C>A ali c.519C>G
Maltese: c.519C>A jew c.519C>G
Slovenian: c.471G>C ali c.471G>T
Maltese: c.471G>C jew c.471G>T
Slovenian: c.153G>A ali c.153G>T ali c.153G>C
Maltese: c.153G>A jew c.153G>T jew c.153G>C
Slovenian: c.T241C ali c.T241A
Maltese: T241C jew c.T241A
Slovenian: Kako jemati zdravilo Galafold
Maltese: Mediċini oħra u Galafold
Slovenian: • Beljakovine v urinu
Maltese: • Proteina fl-awrina
Slovenian: c.561G>T ali c.561G>A ali c.561G>C
Maltese: c.561G>T jew c.561G>A jew c.561G>C
Slovenian: c.261G>C ali c.261G>T
Maltese: c.261G>C jew c.261G>T
Slovenian: c.816C>A ali c.816C>G
Maltese: c.816C>A jew c.816C>G
Slovenian: c.T187A ali c.G188C
Maltese: T187A jew c.G188C
Slovenian: c.285G>T ali c.285G>C
Maltese: c.285G>T jew c.285G>C
Slovenian: c.G132T ali c.G132C
Maltese: c.G132T jew c.G132C
Slovenian: c.A588T ali c.A588C
Maltese: A588T jew c.A588C
Slovenian: c.A644G/G937T
Maltese: A644G/G937T
Slovenian: c.A840T ali c.A840C
Maltese: A840T jew c.A840C
Slovenian: c.279C>G ali c.279C>A
Maltese: c.279C>G jew c.279C>A
Slovenian: c.C279G ali c.C279A
Maltese: c.C279G jew c.C279A
Slovenian: c.242G>A ali c.243G>A
Maltese: c.242G>A jew c.243G>A
Slovenian: c.982G>A ali c.982G>C
Maltese: c.982G>A jew c.982G>C
Slovenian: c.207C>A ali c.207C>G
Maltese: c.207C>A jew c.207C>G
Slovenian: Shranjevanje zdravila Galafold 6.
Maltese: Kif taħżen Galafold 6.
Slovenian: c.126G>A ali c.126G>C ali c.126G>T
Maltese: c.126G>A jew c.126G>C jew c.126G>T
Slovenian: • Bolečine v mišicah
Maltese: • Spażmi fil-muskoli
Slovenian: c.C305G ali c.C305A
Maltese: c.C305G jew c.C305A
Slovenian: c.C233G ali c.C233A
Maltese: C233G jew c.C233A
Slovenian: c.243G>T ali c.243G>C
Maltese: c.243G>T jew c.243G>C
Slovenian: c.G103C ali c.G103A
Maltese: c.G103C jew c.G103A
Slovenian: Pri preskušanju brez predhodnega ERT je zdravilo Galafold povzročilo statistično značilno zmanjšanje LVMi (p < 0,05); srednja sprememba od izhodiščnega LVMi v 18. do 24. mesecu je bila -7,7 (95-% CI: -15,4, -0,01; n = 27).
Maltese: Fil-prova mingħajr esperjenza tal-ERT, Galafold irriżulta fi tnaqqis statistikament sinifikanti fil-LVMi (p< 0.05); il-bidla medja mil-linja bażi fil-LVMi għal Xahar 18 sa 24 kienet ta' -7.7 (95% CI: -15.4, -0.01; n=27).
Slovenian: c.103G>C ali c.103G>A
Maltese: c.103G>C jew c.103G>A
Slovenian: NEZNANO (del Exon1_2?)
Maltese: MHUX MAGĦRUF (del Exon1_2?)
Slovenian: c.C525G ali c.C525A
Maltese: c.C525G jew c.C525A
Slovenian: c.G284A ali c.G285A
Maltese: G284A jew c.G285A
Slovenian: c.612G>T ali c.612G>C
Maltese: c.612G>T jew c.612G>C
Slovenian: c.T859C ali c.T859A
Maltese: c.T859C jew c.T859A
Slovenian: c.C897G ali c.C897A
Maltese: c.C897G jew c.C897A
Slovenian: Sprememba nukleotida
Maltese: Bidla fin-nukleotidi
Slovenian: c.T881G ali c.T881A
Maltese: T881G jew c.T881A
Slovenian: Migalastat ni substrat humanih izločevalnih prenašalcev MDR1 in BCRP ali inhibitor humanih izločevalnih prenašalcev BCRP, MDR1 in 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.
Slovenian: c.G261C ali c.G261T
Maltese: G261C jew c.G261T
Slovenian: Drugo odprto podaljšano preskušanje (AT1001-042) je vključevalo bolnike, ki so bili preusmerjeni tako iz odprte podaljšane študije AT1001-041, kot tudi neposredno iz študije 3. faze ATTRACT, in še vedno poteka.
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.
Slovenian: c.T280A ali c.G281C
Maltese: c.T280A jew c.G281C
Slovenian: Pri preskušanju brez predhodnega ERT se je pri bolnikih z odzivnimi mutacijami ob uporabi zdravila Galafold plazemska koncentracija lizo-Gb3 statistično značilno zmanjšala, prav tako je bilo manj vključkov GL-3 v intersticijskih kapilarah ledvic.
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.
Slovenian: c.G609C ali c.G609T
Maltese: c.G609C jew c.G609T
Slovenian: c.G471C ali c.G471T
Maltese: G471C jew c.G471T
Slovenian: c.G801A (domnevno mesto spajanja)
Maltese: c.G801A (sit probabbli ta' tagħqid)
Slovenian: c.131G>A ali c.132G>A
Maltese: c.131G>A jew c.132G>A
Slovenian: c.T148C ali c.C150G ali c.C150A F50L
Maltese: T148C jew c.C150G jew c.C150A
Slovenian: c.G131A ali c.G132A
Maltese: G131A jew c.G132A
Slovenian: c.T960G ali c.T960A
Maltese: c.T960G jew c.T960A
Slovenian: c.863delC
Maltese: 863delC
Slovenian: c.525C>G ali c.525C>A
Maltese: c.525C>G jew c.525C>A
Slovenian: c.G144T ali c.G144C
Maltese: c.G144T jew c.G144C
Slovenian: c.G540C ali c.G540T
Maltese: c.G540C jew c.G540T
Slovenian: c.T514A ali c.G515C
Maltese: c.T514A jew c.G515C
Slovenian: c.707G>A ali c.708G>A
Maltese: c.707G>A jew c.708G>A
Slovenian: c.G216A ali c.G216T ali c.G216C M72I
Maltese: c.G216A jew c.G216T jew c.G216C
Slovenian: c.166T>A ali c.167G>C
Maltese: c.166T>A jew c.167G>C
Slovenian: c.G567C ali c.G567T
Maltese: c.G567C jew c.G567T
Slovenian: Trda kapsula velikosti 2 (6,4 x 18,0 mm) z neprozornim modrim pokrovčkom in neprozornim belim telesom s črno oznako „A1001", ki vsebuje bel do bledo rjav prašek.
Maltese: Kapsula iebsa tad-daqs 2 (6.4x18.0 mm) b'għatu blu opak u l-parti l-oħra bajda opaka b' 'A1001' stampat bl-iswed, li fiha trab abjad sa kannella ċar.
Slovenian: c.363delT
Maltese: 363delT
Slovenian: c.609G>C ali c.609G>T
Maltese: c.609G>C jew c.609G>T
Slovenian: c.132G>T ali c.132G>C
Maltese: c.132G>T jew c.132G>C
Slovenian: c.144G>T ali c.144G>C
Maltese: c.144G>T jew c.144G>C
Slovenian: c.258T>G ali c.258T>A
Maltese: c.258T>G jew c.258T>A
Slovenian: c.G734A ali c.G735A
Maltese: G734A jew c.G735A
Slovenian: c.G547A (domnevno mesto spajanja)
Maltese: c.G547A (sit probabbli ta' tagħqid)
Slovenian: c.540G>C ali c.540G>T
Maltese: c.540G>C jew c.540G>T
Slovenian: c.G612T ali c.G612C
Maltese: G612T jew c.G612C
Slovenian: c.831G>T ali c.831G>C
Maltese: c.831G>T jew c.831G>C
Slovenian: Povprečen obseg izpostavljenosti odmerku zdravila Galafold, ki je bil dan v promet, torej 123 mg vsak drugi dan, je bil pri bolnikih, ki so zaključili študijo AT1001-041, 3,57 (± 1,23) let (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).
Slovenian: c.881T>G ali c.881T>A
Maltese: c.881T>G jew c.881T>A
Slovenian: c.T465A ali c.T465G
Maltese: c.T465A jew c.T465G
Slovenian: Netfang: MedInfo@amicusrx.com
Maltese: MedInfo@amicusrx.com
Slovenian: NEZNANO (S65T)
Maltese: MHUX MAGĦRUF (S65T)
Slovenian: • Mravljinčenje v okončinah (parestezija)
Maltese: • Tnemnim flestremitajiet (paresteżija)
Slovenian: 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:
Slovenian: c.G830A ali c.G831A
Maltese: c.G830A jew c.G831A
Slovenian: c.141G>C ali c.141G>T
Maltese: c.141G>C jew c.141G>T
Slovenian: c.860G>A ali c.861G>A
Maltese: c.860G>A jew c.861G>A
Slovenian: Pri zdravih prostovoljcih je volumen porazdelitve migalastata (Vz/F) po naraščajočih enkratnih peroralnih odmerkih (25-675 mg migalastatijevega klorida) segal od 77 do 133 litrov, kar presega celotno količino vode v telesu (42 litrov) in pomeni, da se je zdravilo dobro razporedilo v tkivih.
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).
Slovenian: • Kratka sapa (dispneja)
Maltese: • Tinfaraġ (epistassi)
Slovenian: c.859T>C ali c.859T>A
Maltese: c.859T>C jew c.859T>A
Slovenian: c.G243T ali c.G243C
Maltese: G243T jew c.G243C
Slovenian: Pri migalastatu, vzetem z maščobno bogatim obrokom ali 1 uro pred maščobno bogatim ali lahkim obrokom ali 1 uro po lahkem obroku, sta se v primerjavi z jemanjem na prazen želodec pomembno zmanjšali srednja celotna izpostavljenost migalastatu (AUC0-∞), in sicer za 37 do 42 %, ter srednja najvišja izpostavljenost migalastatu (Cmax), in sicer za 15 do 40 %.
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.
Slovenian: c.453C>G ali c.453C>A
Maltese: c.453C>G jew c.453C>A
Slovenian: c.T610C ali c.T610A
Maltese: c.T610C jew c.T610A
Slovenian: c.946delG
Maltese: 946delG
Slovenian: c.830G>A ali c.831G>A
Maltese: c.830G>A jew c.831G>A
Slovenian: c.567G>C ali c.567G>T
Maltese: c.567G>C jew c.567G>T
Slovenian: c.T258G ali c.T258A
Maltese: T258G jew c.T258A
Slovenian: c.960T>G ali c.960T>A
Maltese: c.960T>G jew c.960T>A
Slovenian: Približno 20 % celotnega radioaktivno označenega odmerka se je izločilo z blatom, pri čemer je bil nespremenjeni migalastat edina izmerjena sestavina.
Maltese: Bejn wieħed u ieħor 20% tad-doża totali radjutikkettata kienet imneħħija (excreted) fl-ippurgar, b'migalastat mhux mibdul ikun l-unika komponent imkejjel.
Slovenian: c.233C>G ali c.233C>A
Maltese: 233C>G jew c.233C>A
Slovenian: Zdravilo Galafold ni namenjeno uporabi ob sočasnem encimskem nadomestnem zdravljenju (glejte poglavje 4.4).
Maltese: Galafold mhuwiex intiż għall-użu fl-istess ħinma'terapija ta' sostituzzjoni tal-enzima (ara sezzjoni 4.4).
Slovenian: c.734G>A ali c.735G>A
Maltese: c.734G>A jew c.735G>A
Slovenian: c.C456A ali c.C456G
Maltese: c.C456A jew c.C456G
Slovenian: c.C966A ali c.C966G
Maltese: c.C966A jew c.C966G
Slovenian: NEZNANO (del Exon2_3?)
Maltese: MHUX MAGĦRUF (del Exon2_3?)
Slovenian: c.801G>A (domnevno mesto spajanja)
Maltese: c.801G>A (sit probabbli ta' tagħqid)
Slovenian: c.305C>G ali c.305C>A
Maltese: c.305C>G jew c.305C>A
Slovenian: c.G242A ali c.G243A
Maltese: G242A jew c.G243A
Slovenian: C]-migalastatijevega klorida pri zdravih moških prostovoljcih je pokazalo, da se je približno 77 % radioaktivno označenega odmerka izločilo v urinu, od tega se je 55 % izločilo kot nespremenjeni migalastat, 4 % pa kot kombinacija presnovkov M1, M2 in M3.
Maltese: C]-migalastat hydrochloride żvelat li bejn wieħed u ieħor 77% tad-doża radjutikkettata kienet irkuprata fl-awrina li minnha, 55% kienet imneħħija (excreted) bħala migalastat mhux mibdul u 4% bħala metaboliti kombinati M1, M2 u M3.
Slovenian: c.439G>A ali c.439G>C
Maltese: c.439G>A jew c.439G>C
Slovenian: c.897C>G ali c.897C>A
Maltese: c.897C>G jew c.897C>A
Slovenian: c.456C>A ali c.456C>G
Maltese: c.456C>A jew c.456C>G
Slovenian: c.T154A ali c.G155C
Maltese: T154A jew c.G155C
Slovenian: c.G485A ali c.G486A
Maltese: c.G485A jew c.G486A
Slovenian: c.108G>C ali c.108G>T
Maltese: c.108G>C jew c.108G>T
Slovenian: c.610T>C ali c.610T>A
Maltese: c.610T>C jew c.610T>A
Slovenian: Učinek starosti so vrednotili s populacijsko farmakokinetično analizo plazemskega očistka migalastata pri populaciji, ki še ni prejemala ERT. Razlika v očistku pri bolnikih s Fabryjevo boleznijo, starih 65 let ali več, in mlajših od 65 let, je znašala 20 %, kar ni klinično pomembno.
Maltese: L-effett tal-età kien evalwat f'analiżi farmakokinetika tal-popolazzjoni dwar it-tneħħija ta' migalastat mill-plażma fil-popolazzjoni tal-istudju mingħajr esperjenza tal-ERT. Id-differenza fit-tneħħija(clearance) bejn il-pazjenti ta' Fabry ≥ 65 sena u dawk < 65 sena kienet ta' 20%, li ma kinitx meqjusa klinikament sinifikanti.
Slovenian: Po povprečno 3,4 letih zdravljenja je bila srednja letna stopnja spremembe eGFRCKD-EPI -0,74 ml/min/1,73 m
Maltese: Wara medja ta' 3.4 snin ta' kura, ir-rata medja annwali ta' bidla f'eGFRCKD-EPI kienet ta' -0.74 mL/min/1.73 m
Slovenian: c.C453G ali c.C453A
Maltese: C453G jew c.C453A
Slovenian: NEZNANO (del Exon3 in g.6736_11545del c.370-533_c.1290+277del
Maltese: Bidla fis-Sekwenza tal-Proteina g.6736_11545del c.370-533_c.
Slovenian: c.514T>A ali c.515G>C
Maltese: c.514T>A jew c.515G>C
Slovenian: Okvara ledvic
Maltese: Għeja Uġigħ
Slovenian: c.485G>A ali c.486G>A
Maltese: c.485G>A jew c.486G>A
Slovenian: c.T408A ali c.T408G
Maltese: T408A jew c.T408G
Slovenian: c.840A>T ali c.840A>C
Maltese: c.840A>T jew c.840A>C
Slovenian: c.870G>A ali c.870G>C ali c.870G>T
Maltese: c.870G>A jew c.870G>C jew c.870G>T
Slovenian: c.T369G ali c.T369A
Maltese: T369G jew c.T369A
Slovenian: c.G861C ali c.G861T
Maltese: c.G861C jew c.G861T
Slovenian: c.G394A ali c.G394C
Maltese: c.G394A jew c.G394C
Slovenian: Po sledenju v odprtem podaljšanem preskušanju je bila srednja sprememba od izhodiščnega LVMi v 36. mesecu -8,3 (95-% CI: -17,1, 0,4; n = 25), v 48. mesecu pa -9,1 (95-% CI: -20,3, 2,0; n = 18).
Maltese: Wara segwitu fl-OLE, il-bidla medja mil-linja bażi fil-LVMi f'Xahar 36 kienet ta' -8.3 (95% CI: -17.1, 0.4; n=25) u f'Xahar 48 kienet ta' -9.1 (95% CI: -20.3, 2.0; n=18).
Slovenian: Klinične študije zdravila Galafold so vključile majhno število bolnikov, starih 65 let ali več.
Maltese: Studji kliniċi ta' Galafold inkludew numru żgħir ta' pazjenti mill-età ta' 65 sena u aktar.
Slovenian: c.154T>A ali c.155G>C
Maltese: c.154T>A jew c.155G>C
Slovenian: c.288G>A ali c.288G>T ali c.288G>C
Maltese: c.288G>A jew c.288G>T jew c.288G>C
Slovenian: V lizosomih nato disociacija migalastata obnovi aktivnost -Gal A, kar omogoči katabolizem GL-3 in sorodnih substratov.
Maltese: Ġaladarba fil-liżożomi, id-diżassoċjazzjoni ta' migalastat ġġib lura l-attività -Gal A, u dan iwassal għal kataboliżmu ta' GL-3 u sottostrati relatati.
Slovenian: c.G71A ali c.G72A
Maltese: G71A jew c.G72A
Slovenian: c.T667A ali c.G668C
Maltese: c.T667A jew c.G668C
Slovenian: c.547G>A (domnevno mesto spajanja)
Maltese: c.547G>A (sit probabbli ta' tagħqid)
Slovenian: c.T337C ali c.T339A ali c.T339G F113L
Maltese: T337C jew c.T339A jew c.T339G
Slovenian: c.966C>A ali c.966C>G
Maltese: c.966C>A jew c.966C>G
Slovenian: c.465T>A ali c.465T>G
Maltese: 465T>A jew c.465T>G
Slovenian: c.413dupG
Maltese: 413dupG
Slovenian: c.T70C ali c.T70A
Maltese: c.T70C jew c.T70A
Slovenian: • Palpitacije (občutek razbijanja srca)
Maltese: • Palpitazzjonijiet (is sensazzjoni ta' qalb tħabbat)
Slovenian: Ena kapsula vsebuje migalastatijev klorid v količini, ki ustreza123 mg migalastata.
Maltese: Kull kapsula fiha migalastat hydrochloride ekwivalenti għal 123 mg migalastat.
Slovenian: c.G639A (domnevno mesto spajanja)
Maltese: G639A (sit probabbli ta' tagħqid)
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
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.
Slovenian: • Zvišane ravni kreatin fosfokinaze v krvnih testih
Maltese: • żieda fil-livelli ta' kreatina phosphokinase fit-testijiet tad-demm
Slovenian: c.T648A ali c.T648G
Maltese: T648A jew c.T648G
Slovenian: c.428dupC
Maltese: 428dupC
Slovenian: c.T402G ali c.T402A
Maltese: c.T402G jew c.T402A
Slovenian: c.588A>T ali c.588A>C
Maltese: c.588A>T jew c.588A>C
Slovenian: c.G831T ali c.G831C
Maltese: G831T jew c.G831C
Slovenian: c.71G>A ali c.72G>A
Maltese: c.71G>A jew c.72G>A
Slovenian: c.A868C ali c.A868T
Maltese: A868C jew c.A868T