FrancophonIA/ELRC3.0 huggingface dataset:
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Icelandic: Stöðull fyrir massa vinstri slegils (left ventricular mass index, LVMi) Eftir 18 mánaða meðferð með Galafold í rannsókn hjá sjúklingum með reynslu af ensímuppbótarmeðferð kom fram tölfræðilega marktæk lækkun á LVMi (p <0,05).
English: Amicus Therapeutics SAS Tél: 0800 906 788 e-mail: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics SAS Tél: 0800 906 788 e-mail:
English: c.412G>A or c.412G>C
Icelandic: c.412G>A eða c.412G>C
English: c.T187A or c.G188C
Icelandic: c.T187A eða c.G188C
English: c.G982A or c.G982C
Icelandic: c.G982A eða c.G982C
English: c.261G>C or c.261G>T
Icelandic: c.261G>C eða c.261G>T
English: c.G540C or c.G540T
Icelandic: c.G540C eða c.G540T
English: Protein Sequence change c.1A>C or c.1A>T
Icelandic: Breyting á próteinröð c.1A>C eða c.1A>T
English: c.C233G or c.C233A
Icelandic: c.C233G eða c.C233A
English: c.C159G or c.C159A
Icelandic: c.C159G eða c.C159A
English: c.T241C or c.T241A
Icelandic: c.T241C eða c.T241A
English: c.G471C or c.G471T
Icelandic: c.G471C eða c.G471T
English: c.817T>C or c.819T>A or c.819T>G
Icelandic: c.817T>C eða c.819T>A eða c.819T>G
English: c.153G>A or c.153G>T or c.153G>C
Icelandic: c.153G>A eða c.153G>T eða c.153G>C
English: c.207C>A or c.207C>G
Icelandic: c.207C>A eða c.207C>G
English: c.G285T or c.G285C
Icelandic: c.G285T eða c.G285C
English: Take at the same time each day.
Icelandic: Takið lyfið á sama tíma hverju sinni.
English: c.612G>T or c.612G>C
Icelandic: c.612G>T eða c.612G>C
English: c.C305G or c.C305A
Icelandic: c.C305G eða c.C305A
English: c.285G>T or c.285G>C
Icelandic: c.285G>T eða c.285G>C
English: c.228G>C or c.228G>A or c.228G>T
Icelandic: c.228G>C eða c.228G>A eða c.228G>T
English: c.148T>C or c.150C>G or c.150C>A
Icelandic: c.148T>C eða c.150C>G eða c.150C>A
English: Galafold is not intended for concomitant use with enzyme replacement therapy.
Icelandic: Galafold er ekki ætlað til samhliða notkunar með ensímuppbótarmeðferð.
English: c.G734A or c.G735A
Icelandic: c.G734A eða c.G735A
English: c.552T>A or c.552T>G
Icelandic: c.552T>A eða c.552T>G
English: Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Icelandic: Aukaverkanir með Galafold í klínískum rannsóknum
English: c.G567C or c.G567T
Icelandic: c.G567C eða c.G567T
English: c.284G>A or c.285G>A
Icelandic: c.284G>A eða c.285G>A
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Icelandic: (95% CI: -2,272, 1,478; n=34) í Galafold hópnum samanborið við -1,03 ml/mín./1,73 m
English: c.T166A or c.G167C
Icelandic: c.T166A eða c.G167C
English: c.187T>A or c.188G>C
Icelandic: c.187T>A eða c.188G>C
English: In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Icelandic: Í rannsókninni hjá sjúklingum sem ekki hafa fengið ensímuppbótarmeðferð (ERT-naive) og opinni framhaldsrannsókn hélst nýrnastarfsemi stöðug meðan á allt að 5 ára meðferð með Galafold stóð.
English: The effect of age was evaluated in a population pharmacokinetic analysis on plasma migalastat clearance in the ERT-naïve study population.
Icelandic: Áhrif aldurs voru metin með þýðisgreiningu á lyfjahvörfum á úthreinsun migalastats úr plasma í rannsókninni hjá sjúklingum sem ekki hafa fengið ERT-meðferð.
English: c.471G>C or c.471G>T
Icelandic: c.471G>C eða c.471G>T
English: c.T552A or c.T552G
Icelandic: c.T552A eða c.T552G
English: Amicus Therapeutics Europe Limited Tel.: 0808 034 288 / 877 309 5040 e-mail: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tel.: 0808 034 288 / 877 309 5040 e-mail:
English: c.337T>C or c.339T>A or c.339T>G
Icelandic: c.337T>C eða c.339T>A eða c.339T>G
English: UNKNOWN (del Exon1_2?)
Icelandic: ÓÞEKKT (del Exon1_2?)
English: c.G131A or c.G132A
Icelandic: c.G131A eða c.G132A
English: A377_P380dup c.1139delC
Icelandic: A377_P380dup
English: c.C747G or c.C747A
Icelandic: c.C747G eða c.C747A
English: During the open-label extension, statistically significant (p<0.05) improvements from baseline were observed in the diarrhoea and indigestion domains, with a trend of improvement in the constipation domain.
Icelandic: Í opnu framhaldsrannsókninni kom fram tölfræðilega marktæk (p <0,05) hækkun frá upphafsgildi hvað varðar niðurgang og meltingartruflanir með tilhneigingu til framfarar hvað varðar hægðatregðu.
English: c.242G>A or c.243G>A
Icelandic: c.242G>A eða c.243G>A
English: c.T258G or c.T258A
Icelandic: c.T258G eða c.T258A
English: c.124A>C or c.124A>T
Icelandic: c.124A>C eða c.124A>T
English: c.C525G or c.C525A
Icelandic: c.C525G eða c.C525A
English: c.241T>C or c.241T>A
Icelandic: c.241T>C eða c.241T>A
English: c.G132T or c.G132C
Icelandic: c.G132T eða c.G132C
English: In patients with amenable mutations, GL-3 levels tended to decrease in urine and in kidney interstitial capillaries.
Icelandic: Hjá sjúklingum með móttækilegar stökkbreytingar var tilhneiging til lækkunar á magni GL-3 í þvagi og millivefsháræðum í nýrum.
English: c.233C>G or c.233C>A
Icelandic: c.233C>G eða c.233C>A
English: c.T148C or c.C150G or c.C150A F50L
Icelandic: c.T148C eða c.C150G eða c.C150A
English: c.T610C or c.T610A
Icelandic: c.T610C eða c.T610A
English: c.982G>A or c.982G>C
Icelandic: c.982G>A eða c.982G>C
English: c.A840T or c.A840C
Icelandic: c.A840T eða c.A840C
English: c.G140A or G141A
Icelandic: G140A eða G141A
English: c.816C>A or c.816C>G
Icelandic: c.816C>A eða c.816C>G
English: UNKNOWN (del Exon3?)
Icelandic: ÓÞEKKT (del Exon3?)
English: UNKNOWN (del Exon5_7?)
Icelandic: ÓÞEKKT (del Exon5_7?)
English: c.T960G or c.T960A
Icelandic: c.T960G eða c.T960A
English: c.519C>A or c.519C>G
Icelandic: c.519C>A eða c.519C>G
English: c.243G>T or c.243G>C
Icelandic: c.243G>T eða c.243G>C
English: c.279C>G or c.279C>A
Icelandic: c.279C>G eða c.279C>A
English: c.131G>A or c.132G>A
Icelandic: c.131G>A eða c.132G>A
English: c.G243T or c.G243C
Icelandic: c.G243T eða c.G243C
English: c.G609C or c.G609T
Icelandic: c.G609C eða c.G609T
English: c.G144T or c.G144C
Icelandic: c.G144T eða c.G144C
English: Disease Substrate
Icelandic: Hvarfefni sjúkdómsins
English: c.A588T or c.A588C
Icelandic: c.A588T eða c.A588C
English: c.G612T or c.G612C
Icelandic: c.G612T eða c.G612C
English: c.T369G or c.T369A
Icelandic: c.T369G eða c.T369A
English: Galafold is not recommended during pregnancy.
Icelandic: Galafold er ekki ætlað til notkunar á meðgöngu.
English: c.G831T or c.G831C
Icelandic: c.G831T eða c.G831C
English: c.525C>G or c.525C>A
Icelandic: c.525C>G eða c.525C>A
English: A decision must be made whether to discontinue breast-feeding or to discontinue Galafold, taking into account the benefit of breast-feeding for the child relative to the benefit of therapy for the mother.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta meðferð með Galafold.
English: c.T280A or c.G281C
Icelandic: c.T280A eða c.G281C
English: Elderly population No dosage adjustment is required based on age (see section 5.2).
Icelandic: Ekki er þörf á skammtaaðlögun vegna aldurs (sjá kafla 5.2).
English: c.610T>C or c.610T>A
Icelandic: c.610T>C eða c.610T>A
English: 92.9 g/m for the ERT arm and the mean change from baseline in LVMi at Month 18 was -6.6 (95% CI: -11.0, -2.1; n=31) for Galafold and -2.0 (95% CI: -11.0, 7.0; n=13) for ERT.
Icelandic: Grunngildin voru 95,3 g/m fyrir Galafold hlutann og 92,9 g/m fyrir ERT hlutann og meðalbreyting frá grunngildi í LVMi í 18. mánuði var -6,6 (95% CI: -11,0, -2,1; n=31) hjá Galafold og -2,0 (95% CI: -11,0, 7,0; n=13) hjá ERT.
English: c.305C>G or c.305C>A
Icelandic: c.305C>G eða c.305C>A
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Icelandic: Í rannsókninni hjá sjúklingum með reynslu af ensímuppbótarmeðferð hélst nýrnastarfsemi stöðug í allt að 18 mánuði meðan á meðferð með Galafold stóð.
English: You should not take Galafold if you are also receiving enzyme replacement therapy.
Icelandic: Þú skalt ekki taka Galafold ef þú ert í ensímuppbótarmeðferð.
English: c.144G>T or c.144G>C
Icelandic: c.144G>T eða c.144G>C
English: c.132G>T or c.132G>C
Icelandic: c.132G>T eða c.132G>C
English: c.C453G or c.C453A
Icelandic: c.C453G eða c.C453A
English: c.G242A or c.G243A
Icelandic: c.G242A eða c.G243A
English: c.881T>G or c.881T>A
Icelandic: c.881T>G eða c.881T>A
English: c.609G>C or c.609G>T
Icelandic: c.609G>C eða c.609G>T
English: Transient and fully reversible infertility in male rats was associated with migalastat treatment at all doses assessed.
Icelandic: Skammvinn ófrjósemi, sem varð hjá karlkyns rottum í tengslum við meðferð með migalastati í öllum skömmtum sem metnir voru, gekk til baka að fullu.
English: c.707G>A or c.708G>A
Icelandic: c.707G>A eða c.708G>A
English: c.258T>G or c.258T>A
Icelandic: c.258T>G eða c.258T>A
English: c.830G>A or c.831G>A
Icelandic: c.830G>A eða c.831G>A
English: c.G141C or c.G141T
Icelandic: c.G141C eða c.G141T
English: c.166T>A or c.167G>C
Icelandic: c.166T>A eða c.167G>C
English: • are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions
Icelandic: ef um er að ræða ofnæmi fyrir migalastati eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6)
English: c.T465A or c.T465G
Icelandic: c.T465A eða c.T465G
English: Amicus Therapeutics Europe Limited Tfn: 020 795 493 e-post: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tfn: 020 795 493 e-post:
English: Nervous system disorders
Icelandic: Samsettar klínískar niðurstöður
English: c.108G>C or c.108G>T
Icelandic: c.108G>C eða c.108G>T
English: c.G860A or c.G861A
Icelandic: c.G860A eða c.G861A
English: c.960T>G or c.960T>A
Icelandic: c.960T>G eða c.960T>A
English: c.141G>C or c.141G>T
Icelandic: c.141G>C eða c.141G>T
English: c.453C>G or c.453C>A
Icelandic: c.453C>G eða c.453C>A
English: c.859T>C or c.859T>A
Icelandic: c.859T>C eða c.859T>A
English: See package leaflet for further instructions.
Icelandic: Sjá frekari upplýsingar í fylgiseðli.
English: c.T408A or c.T408G
Icelandic: c.T408A eða c.T408G
English: c.540G>C or c.540G>T
Icelandic: c.540G>C eða c.540G>T
English: c.T514A or c.G515C
Icelandic: c.T514A eða c.G515C
English: c.G216A or c.G216T or c.G216C M72I
Icelandic: c.G216A eða c.G216T eða c.G216C
English: c.897C>G or c.897C>A
Icelandic: c.897C>G eða c.897C>A
English: c.C897G or c.C897A
Icelandic: c.C897G eða c.C897A
English: c.734G>A or c.735G>A
Icelandic: c.734G>A eða c.735G>A
English: c.T154A or c.G155C
Icelandic: c.T154A eða c.G155C
English: c.T648A or c.T648G
Icelandic: c.T648A eða c.T648G
English: c.103G>C or c.103G>A
Icelandic: c.103G>C eða c.103G>A
English: c.C966A or c.C966G
Icelandic: c.C966A eða c.C966G
English: c.G830A or c.G831A
Icelandic: c.G830A eða c.G831A
English: c.860G>A or c.861G>A
Icelandic: c.860G>A eða c.861G>A
English: Amicus Therapeutics, UK Limited Tel: +44 175 3888 567 / 08 0823 46864 e-mail: MedInfo@amicusrx.com
Icelandic: +44 175 3888 567 / 08 0823 46864 e-mail:
English: UNKNOWN (del Exon3_7?)
Icelandic: ÓÞEKKT (del Exon3_7?)
English: c.C456A or c.C456G
Icelandic: c.C456A eða c.C456G
English: c.T676C or c.T676A
Icelandic: c.T676C eða c.T676A
English: c.G108C or c.G108T
Icelandic: c.G108C eða c.G108T
English: c.71G>A or c.72G>A
Icelandic: c.71G>A eða c.72G>A
English: The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi > 95 g/m and males with baseline LVMi > 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10).
Icelandic: Breytingin á LVMi (g/m2) frá grunngildi að 18. mánuði hjá sjúklingum með þykknun vinstri slegils (konum með LVMi > 95 g/m við grunngildi og körlum með LVMi > 115 g/m2) við grunngildi var -8,4 (95% CI: -15,7, 2,6; n=13) fyrir migalastat og 4,5 (95% CI: -10,7, 18,4; n=5) fyrir ERT.
English: c.G485A or c.G486A
Icelandic: c.G485A eða c.G486A
English: c.966C>A or c.966C>G
Icelandic: c.966C>A eða c.966C>G
English: Amicus Therapeutics BV Tel: + 31 20 235 8510 / 0800 022 8399 e-mail: MedInfo@amicusrx.com
Icelandic: + 31 20 235 8510 / 0800 022 8399 e-mail:
English: c.G71A or c.G72A
Icelandic: c.G71A eða c.G72A
English: c.G394A or c.G394C
Icelandic: c.G394A eða c.G394C
English: c.G486C or c.G486T
Icelandic: c.G486C eða c.G486T
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti Galafold og pakkningastærðir
English: All patients received the recommended dosage of 123 mg Galafold every other day.
Icelandic: 123 mg af Galafold annan hvern dag.
English: c.T337C or c.T339A or c.T339G F113L
Icelandic: c.T337C eða c.T339A eða c.T339G
English: c.888G>A or c.888G>T or c.888G>C
Icelandic: c.888G>A eða c.888G>T eða c.888G>C
English: The amino acid mutation (protein sequence change) is most relevant when determining amenability.
Icelandic: Stökkbreyting í amínósýrunni (raðbreyting í próteini) á helst við þegar ákvarða þarf móttækileika.
English: c.102T>G or c.102T>A
Icelandic: c.102T>G eða c.102T>A
English: c.465T>A or c.465T>G
Icelandic: c.465T>A eða c.465T>G
English: c.485G>A or c.486G>A
Icelandic: c.485G>A eða c.486G>A
English: c.588A>T or c.588A>C
Icelandic: c.588A>T eða c.588A>C
English: c.861G>C or c.861G>T
Icelandic: c.861G>C eða c.861G>T
English: c.T70C or c.T70A
Icelandic: c.T70C eða c.T70A
English: c.514T>A or c.515G>C
Icelandic: c.514T>A eða c.515G>C
English: c.708G>C or c.708G>T
Icelandic: c.708G>C eða c.708G>T
English: c.154T>A or c.155G>C
Icelandic: c.154T>A eða c.155G>C
English: c.439G>A or c.439G>C
Icelandic: c.439G>A eða c.439G>C
English: c.T667A or c.G668C
Icelandic: c.T667A eða c.G668C
English: The mean annualised rate of change from baseline in eGFRCKD-EPI in patients treated for 30 months with Galafold was -1.72 mL/min/1.73 m
Icelandic: 30 mánaða meðferð með Galafold var -1,72 ml/mín./1,73 m
English: Pharmacotherapeutic group: Various alimentary tract and metabolism products ATC code: A16AX14
Icelandic: {Ýmis efni fyrir meltingarveg og efnaskiptalyf}, ATC-flokkur:
English: c.T817C or c.T819A or c.T819G F273L
Icelandic: c.T817C eða c.T819A eða c.T819G
English: c.747C>G or c.747C>A
Icelandic: c.747C>G eða c.747C>A
English: c.A868C or c.A868T
Icelandic: c.A868C eða c.A868T
English: c.394G>A or c.394G>C
Icelandic: c.394G>A eða c.394G>C
English: c.G861C or c.G861T
Icelandic: c.G861C eða c.G861T
English: c.G439A or c.G439C
Icelandic: c.G439A eða c.G439C
English: c.408T>A or c.408T>G
Icelandic: c.408T>A eða c.408T>G
English: c.369T>G or c.369T>A
Icelandic: c.369T>G eða c.369T>A
English: c.870G>A or c.870G>C or c.870G>T
Icelandic: c.870G>A eða c.870G>C eða c.870G>T
English: c.T894G or c.T894A
Icelandic: c.T894G eða c.T894A
English: Blood Creatine Phosphokinase increased
Icelandic: Aukinn kreatínkínasi í blóði, þyngdaraukning
English: c.T784A or c.T784C
Icelandic: c.T784A eða c.T784C
English: Certain GLA mutations can result in the production of abnormally folded and unstable mutant forms of α-Gal A. Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of -Gal A, the genotypes of which are referred to as amenable mutations.
Icelandic: Ákveðnar GLA stökkbreytingar geta valdið framleiðslu á óstöðugum stökkbreyttum gerðum af α-Gal A með óeðlilega svipmótun (abnormally folded).
English: c.837G>C or c.837G>T
Icelandic: c.837G>C eða c.837G>T
English: c.456C>A or c.456C>G
Icelandic: c.456C>A eða c.456C>G
English: c.G707A or c.G708A
Icelandic: c.G707A eða c.G708A
English: c.784T>A or c.784T>C
Icelandic: c.784T>A eða c.784T>C
English: c.T484C or c.T484A
Icelandic: c.T484C eða c.T484A
English: c.T834G or c.T834A
Icelandic: c.T834G eða c.T834A
English: c.G720C or c.G720T
Icelandic: c.G720C eða c.G720T
English: c.676T>C or c.676T>A
Icelandic: c.676T>C eða c.676T>A
English: c.A712C or c.T714A or c.T714G S238R
Icelandic: c.A712C eða c.T714A eða c.T714G
English: c.G978C or c.G978T
Icelandic: c.G978C eða c.G978T
English: c.G837C or c.G837T
Icelandic: c.G837C eða c.G837T
English: c.288G>A or c.288G>T or c.288G>C
Icelandic: c.288G>A eða c.288G>T eða c.288G>C
English: c.402T>G or c.402T>A
Icelandic: c.402T>G eða c.402T>A
English: c.834T>G or c.834T>A
Icelandic: c.834T>G eða c.834T>A
English: c.720G>C or c.720G>T
Icelandic: c.720G>C eða c.720G>T
English: c.C666A or c.C666G
Icelandic: c.C666A eða c.C666G
English: c.G126A or c.G126C or c.G126T M42I
Icelandic: c.G126A eða c.G126C eða c.G126T
English: c.G963C or c.G963T
Icelandic: c.G963C eða c.G963T
English: c.677G>A or c.678G>A
Icelandic: c.677G>A eða c.678G>A
English: c.729G>C or c.729G>T
Icelandic: c.729G>C eða c.729G>T
English: c.G708C or c.G708T
Icelandic: c.G708C eða c.G708T
English: c.894T>G or c.894T>A
Icelandic: c.894T>G eða c.894T>A
English: c.486G>C or c.486G>T
Icelandic: c.486G>C eða c.486G>T
English: c.T402G or c.T402A
Icelandic: c.T402G eða c.T402A
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
Icelandic: Ekki er mælt með notkun Galafold hjá sjúklingum með Fabry-sjúkdóm sem eru með áætlaðan gauklasíunarhraða minni en 30 ml/mín./1,73 m
English: c.G153A or c.G153T or c.G153C M51I
Icelandic: c.G153A eða c.G153T eða c.G153C
English: c.840A>T or c.840A>C
Icelandic: c.840A>T eða c.840A>C
English: c.70T>C or c.70T>A
Icelandic: c.70T>C eða c.70T>A
English: c.G228C or c.G228A or c.G228T M76I
Icelandic: c.G228C eða c.G228A eða c.G228T
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Icelandic: Ef ekki er ljóst hvernig nota á lyfið skal leita upplýsinga hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum.
English: c.G785A or c.G786A
Icelandic: c.G785A eða c.G786A
English: What you need to know before you take Galafold 3.
Icelandic: Áður en byrjað er að nota Galafold 3. Hvernig nota á Galafold
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Icelandic: M1R c.3G>A eða c.3G>T eða c.3G>C c.G3A eða c.G3T eða c.G3C M1I c.19G>T
English: What Galafold contains - The active substance is migalastat.
Icelandic: - Virka innihaldsefnið er migalastat.
English: c.G729C or c.G729T
Icelandic: c.G729C eða c.G729T
English: c.648T>A or c.648T>G
Icelandic: c.648T>A eða c.648T>G
English: Galafold 123 mg hard capsules Migalastat
Icelandic: Galafold 123 mg hörð hylki migalastat
English: c.T102G or c.T102A
Icelandic: c.T102G eða c.T102A
English: c.G778C or c.G778A
Icelandic: c.G778C eða c.G778A
English: c.G936T or c.G936C
Icelandic: c.G936T eða c.G936C
English: c.666C>A or c.666C>G
Icelandic: c.666C>A eða c.666C>G
English: UNKNOWN (del Exon2_3?)
Icelandic: ÓÞEKKT (del Exon2_3?)
English: c.T706C or c.T706A
Icelandic: c.T706C eða c.T706A
English: c.978G>C or c.978G>T
Icelandic: c.978G>C eða c.978G>T
English: c.A1023C or c.A1023T
Icelandic: c.1023A >C eða c.1023A>T c.A1023C eða c.A1023T
English: BLISTER SLEEVE
Icelandic: Innihald hylkis
English: c.G772C or c.G772A
Icelandic: c.G772C eða c.G772A
English: c.A886T or c.A886C
Icelandic: c.A886T eða c.A886C
English: c.G72C or c.G72T
Icelandic: c.G72C eða c.G72T
English: c.702T>G or c.702T>A
Icelandic: c.702T>G eða c.702T>A
English: c.868A>C or c.868A>T
Icelandic: c.868A>C eða c.868A>T
English: c.785G>A or c.786G>A
Icelandic: c.785G>A eða c.786G>A
English: Amicus Therapeutics Europe Limited Tel.: 06 800 21202 e-mail: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tel.: 06 800 21202 e-mail:
English: c.T702G or c.T702A
Icelandic: c.T702G eða c.T702A
English: After follow up in the OLE, the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline at Month 36 was -30.0 (95%) CI: -57.9, -2.2; n=4) and at Month 48
Icelandic: Við eftirfylgni í opnu framhaldsrannsókninni var meðalbreyting frá grunngildi á LVMi hjá sjúklingum með stækkun vinstri slegils við grunngildi í 36. mánuði -30,0 (95%) CI: -57.9, -2.2; n=4) og í 48. mánuði -33,1 (CI:-60.9,5.4).
English: In the ERT-naïve trial, Galafold resulted in a statistically significant decrease in LVMi (p< 0.05); the mean change from baseline in LVMi at Month 18 to 24 was -7.7 (95% CI: -15.4, -0.01; n=27).
Icelandic: Í rannsókninni hjá sjúklingum sem ekki hafa fengið ensímuppbótarmeðferð olli Galafold tölfræðilega marktækri lækkun á LVMi (p<0,05); meðalbreyting á LVMi frá grunngildi í 18.til 24. mánuði var -7,7 (95% CI: -15,4, -0,01; n=27).
English: Slovenská republika Amicus Therapeutics Europe Limited Tel.: 0800 002 437 e-mail: MedInfo@amicusrx.com
Icelandic: Slovenská republika Amicus Therapeutics Europe Limited Tel.: 0800 002 437 e-mail:
English: c.772G>C or c.772G>A
Icelandic: c.772G>C eða c.772G>A
English: Galafold contains the active substance migalastat.
Icelandic: Galafold inniheldur virka efnið migalastat.
English: c.706T>C or c.706T>A
Icelandic: c.706T>C eða c.706T>A
English: c.72G>C or c.72G>T
Icelandic: c.72G>C eða c.72G>T
English: c.678G>T or c.678G>C
Icelandic: c.678G>T eða c.678G>C
English: c.936G>T or c.936G>C
Icelandic: c.936G>T eða c.936G>C
English: c.G561T or c.G561A or c.G561C M187I
Icelandic: c.G561T eða c.G561A eða c.G561C
English: c.A442C or c.T444A or c.T444G S148R
Icelandic: c.A442C eða c.T444A eða c.T444G
English: c.484T>C or c.484T>A
Icelandic: c.484T>C eða c.484T>A
English: g.2934_6378del
Icelandic: Breyting á próteinröð g.2934_6378del
English: c.687T>A or c.687T>G
Icelandic: c.687T>A eða c.687T>G
English: c.G786C or c.G786T
Icelandic: c.G786C eða c.G786T
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
Icelandic: Ef þungun er fyrirhuguð skal leita ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum.
English: Amicus Therapeutics Europe Limited Tel.: 0080 012 15475 e-mail: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tel.: 0080 012 15475 e-mail:
English: c.778G>C or c.778G>A
Icelandic: c.778G>C eða c.778G>A
English: c.886A>T or c.886A>C
Icelandic: c.886A>T eða c.886A>C
English: Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m
Icelandic: Ekki er mælt með notkun Galafold hjá sjúklingum með alvarlega skerta nýrnastarfsemi sem skilgreind er sem áætlaður gauklasíunarhraði minni en 30 ml/mín./1,73 m
English: Protein sequence change
Icelandic: Breyting á próteinröð
English: Protein Sequence change p.T412Sfs*37
Icelandic: p.T412Sfs*37
English: If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule.. Do not take two capsules to make up for your missed dose.
Icelandic: Ef meira en 12 klst. eru liðnar ættir að halda áfram að taka Galafold á næsta fyrirhuguðum skammtadegi og -tíma í samræmi við skammta annan hvern dag.
English: c.667T>A or c.668G>C
Icelandic: c.667T>A eða c.668G>C
English: c.G288A or c.G288T or c.G288C M96I
Icelandic: c.G288A eða c.G288T eða c.G288C
English: (torticollis)
Icelandic: (meltingartruflun)
English: c.G678T or c.G678C
Icelandic: c.G678T eða c.G678C
English: c.G677A or c.G678A
Icelandic: c.G677A eða c.G678A
English: Following a single oral dose of 150 mg migalastat hydrochloride solution, the time to peak plasma concentration was approximately 3 hours.
Icelandic: Eftir stakan 150 mg skammt af migalastat hýdróklóríð lausn til inntöku náðist hámarksplasmaþéttni eftir u.þ.b. 3 klst.
English: c.963G>C or c.963G>T
Icelandic: c.963G>C eða c.963G>T
English: c.798T>A or c.798T>G
Icelandic: c.798T>A eða c.798T>G
English: Left Ventricular Mass Index (LVMi)
Icelandic: Forhleypt sterkja (maís) Magnesíumsterat
English: c.786G>C or c.786G>T
Icelandic: c.786G>C eða c.786G>T
English: Amicus Therapeutics Europe Limited Tel.: 0800 81794 e-pošta: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tel.: 0800 81794 e-pošta:
English: c.T798A or c.T798G
Icelandic: c.T798A eða c.T798G
English: Amicus Therapeutics Europe Limited Teл.
Icelandic: Amicus Therapeutics Europe Limited Tel.: