FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not eat food at least 2 hours before and 2 hours after taking your medicine to give a minimum 4 hours fast.
Dutch: Minstens 2 uur voor en 2 uur na het innemen van uw geneesmiddel niet eten, om minimaal 4 uur lang te vasten.
English: In a single dose study with Galafold in non-Fabry subjects with varying degrees of renal insufficiency, exposures were increased by 4.3-fold in subjects with severe renal impairment (GFR < 30 mL/min/1.73 m
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
English: See package leaflet for further instructions.
Dutch: Zie de bijsluiter voor meer informatie.
English: Paraesthesia Dizziness Hypoaesthesia
Dutch: Paresthesie Duizeligheid Hypo-esthesie
English: c.1018T>C or c.1018T>A c.T1018C or c.T1018A
Dutch: c.1018T>C of c.1018T>A c.T1018C of c.T1018A
English: p.D315_Q321del c.946_954dup c.946_954dup p.V316_A318dup p.V316_D322del c.946delG
Dutch: Verenering eiwitsequentie p.D315_Q321del c.946_954dup c.946_954dup p.V316_A318dup p.V316_D322del c.946delG
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Dutch: In het onderzoek bij patiënten die eerder met ERT waren behandeld was er na 18 maanden behandeling met Galafold een statistisch significante afname van de LVMi (p < 0,05).
English: The second OLE trial (AT1001-042) included patients that both transferred from OLE study AT1001-041 and directly from Phase 3 study ATTRACT, and is ongoing.Renal Function
Dutch: In de tweede OLE-studie (AT1001-042) werden zowel patiënten die overgebracht werden van OLEstudie AT1001-041 als patiënten direct uit fase 3-studie ATTRACT opgenomen.
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
Dutch: De gemiddelde verandering op jaarbasis ten opzichte van de baseline in eGFRCKD-EPI bij patiënten die gedurende 30 maanden met Galafold waren behandeld, was -1,72 ml/min/1,73 m
English: You should not take Galafold if you are also receiving enzyme replacement therapy.
Dutch: U mag Galafold niet gebruiken als u ook een enzymvervangende behandeling krijgt.
English: Protein Sequence change
Dutch: Verandering eiwitsequentie
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Dutch: In het onderzoek bij patiënten met ERT-ervaring bleef de nierfunctie stabiel gedurende 18 maanden behandeling met Galafold.
English: (95% CI: -2.653, -0.782; n=31).
Dutch: (95%-BI: -2,653; -0,782;
English: Torticollis Pain in extremity
Dutch: Torticollis Pijn in de ledematen
English: Patients randomised to Galafold in Stage 1 demonstrated statistically significant greater reduction (±SEM) in mean interstitial capillary GL-3 deposition (-0.25±0.10; -39%) at month 6 compared to placebo (+0.07 ± 0.13; +14%) (p=0.008).
Dutch: Patiënten die in fase 1 naar Galafold waren gerandomiseerd lieten een statistisch significant grotere afname (± SEM) in de gemiddelde GL-3-depositie in interstitiële capillairen zien (-0,25 ± 0,10; -39%) in maand 6 in vergelijking met placebo (+0,07 ± 0,13; +14%) (p = 0,008).
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Dutch: c.1196G>A of c.1197G>A c.G1196A of c.G1197A
English: c.A1C or c.A1T
Dutch: c.A1C of c.A1T
English: c.A1023C or c.A1023T
Dutch: c.A1023C of c.A1023T
English: c.G561T or c.G561A or c.G561C M187I
Dutch: c.G561T of c.G561A of c.G561C M187I
English: c.T148C or c.C150G or c.C150A F50L
Dutch: c.T148C of c.C150G of c.C150A F50L
English: Protein Sequence change c.1A>C or c.1A>T
Dutch: Verenering eiwitsequentie c.1A>C of c.1A>T
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Dutch: c.1202C>G of c.1202C>A c.C1202G of c.C1202A
English: Do not take Galafold on two consecutive days.
Dutch: Neem Galafold niet twee dagen achter elkaar in.
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Dutch: c.1019G>A of c.1020G>A c.G1019A of c.G1020A
English: c.G153A or c.G153T or c.G153C M51I
Dutch: c.G153A of c.G153T of c.G153C M51I
English: g.6736_11545del c.370-533_c.1290+277del
Dutch: Verenering eiwitsequentie g.6736_11545del c.370-533_c.1290+277del
English: Mean annualised rate of change in eGFRCKD-EPI was -0.40 mL/min/1.73 m
Dutch: De gemiddelde, op jaarbasis berekende verandering van de eGFRCKD-EPI was -0,40 ml/min/1,73 m
English: c.A712C or c.T714A or c.T714G S238R
Dutch: c.A712C of c.T714A of c.T714G S238R
English: c.T817C or c.T819A or c.T819G F273L
Dutch: c.T817C of c.T819A of c.T819G F273L
English: c.T337C or c.T339A or c.T339G F113L
Dutch: c.T337C of c.T339A of c.T339G F113L
English: • are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions
Dutch: • Als u allergisch bent voor migalastat of een van de stoffen in dit geneesmiddel.
English: c.A504C or c.A504T
Dutch: c.A504C of c.A504T
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Dutch: c.3G>A of c.3G>T of c.3G>C c.G3A of c.G3T of c.G3C
English: (proteinuria)
Dutch: (proteïnurie)
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Dutch: Als u of uw partner zwanger wil worden, neem dan contact op met uw arts, apotheker of verpleegkundige voor advies.
English: c.A924T or c.A924C
Dutch: c.A924T of c.A924C
English: c.T1147C or c.C1149G or c.C1149A
Dutch: c.T1147C of c.C1149G of c.C1149A
English: c.G611A or G612A
Dutch: c.G611A of G612A
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Dutch: (95%-BI: -2,272; 1,478; n=34) in de Galafold-groep in vergelijking met -1,03 ml/min/1,73 m
English: c.1023A >C or c.1023A>T
Dutch: c.1023A >C of c.1023A>T
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Dutch: c.1095T>A of c.1095T>G c.T1095A of c.T1095G
English: c.140G>A or 141G>A
Dutch: c.140G>A of 141G>A
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Dutch: c.1065C>A of c.1065C>G c.C1065A of c.C1065G
English: Galafold has not been studied in patients with Fabry disease who have a GFR less than 30 mL/min/1.73 m2.
Dutch: Galafold is niet onderzocht bij patiënten met de ziekte van Fabry die een GFR hebben van minder dan 30 ml/min/1,73 m2.
English: c.A442C or c.T444A or c.T444G S148R
Dutch: c.A442C of c.T444A of c.T444G S148R
English: c.504A>C or c.504A>T
Dutch: c.504A>C of c.504A>T
English: c.G412A or c.G412C
Dutch: c.G412A of c.G412C
English: c.712A>C or c.714T>A or c.714T>G
Dutch: c.712A>C of c.714T>A of c.714T>G
English: c.611G>A or 612G>A
Dutch: c.611G>A of 612G>A
English: c.G216A or c.G216T or c.G216C M72I
Dutch: c.G216A of c.G216T of c.G216C M72I
English: c.C816A or c.C816G
Dutch: c.C816A of c.C816G
English: c.442A>C or c.444T>A or c.444T>G
Dutch: c.442A>C of c.444T>A of c.444T>G
English: c.G126A or c.G126C or c.G126T M42I
Dutch: c.G126A of c.G126C of c.G126T M42I
English: Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m
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
English: c.C519A or c.C519G
Dutch: c.C519A of c.C519G
English: C]-migalastat HCl revealed that 99% of the radiolabeled dose recovered in plasma was comprised of unchanged migalastat (77%) and 3 dehydrogenated O-glucuronide conjugated metabolites, M1to M3 (13%).
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%).
English: c.1045T>C or c.1045T>A c.T1045C or c.T1045A
Dutch: c.1045T>C of c.1045T>A c.T1045C of c.T1045A
English: c.C159G or c.C159A
Dutch: c.C159G of c.C159A
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).
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).
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Dutch: c.1034C>G of c.1034C>A c.C1034G of c.C1034A
English: c.G140A or G141A
Dutch: c.G140A of G141A
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.
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.
English: c.A124C or c.A124T
Dutch: c.A124C of c.A124T
English: c.139T>C or c.139T>A
Dutch: c.139T>C of c.139T>A
English: c.1046G>A or c.1047G>A c.G1046A or c.G1047A
Dutch: c.1046G>A of c.1047G>A c.G1046A of c.G1047A
English: c.G284A or c.G285A
Dutch: c.G284A of c.G285A
English: UNKNOWN (del Exon3 and 4?)
Dutch: NIET BEKEND (del Exon3 en 4?)
English: c.280T>A or c.281G>C
Dutch: c.280T>A of c.281G>C
English: Hepatic impairment No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Dutch: Verminderde leverfunctie Er is geen dosisaanpassing nodig voor patiënten met een leverfunctiestoornis (zie rubriek 5.2).
English: c.159C>G or c.159C>A
Dutch: c.159C>G of c.159C>A
English: c.T139C or c.T139A
Dutch: c.T139C of c.T139A
English: c.C207A or c.C207G
Dutch: c.C207A of c.C207G
English: c.T881G or c.T881A
Dutch: c.T881G of c.T881A
English: BLISTER SLEEVE
Dutch: Drukinkt Schellak
English: Protein sequence change
Dutch: Verenering eiwitsequentie
English: c.G103C or c.G103A
Dutch: c.G103C of c.G103A
English: c.G870A or c.G870C or c.G870T M290I
Dutch: c.G870A of c.G870C of c.G870T M290I
English: LOT:
Dutch: PARTIJ:
English: Dyspnoea Epistaxis
Dutch: Dyspneu Epistaxis
English: c.G228C or c.G228A or c.G228T M76I
Dutch: c.G228C of c.G228A of c.G228T M76I
English: c.C279G or c.C279A
Dutch: c.C279G of c.C279A
English: c.G888A or c.G888T or c.G888C M296I
Dutch: c.G888A of c.G888T of c.G888C M296I
English: After follow up in the OLE, the mean change from baseline in LVMi at Month 36 was -8.3 (95% CI: -17.1, 0.4; n=25) and at Month 48 was -9.1 (95% CI: -20.3, 2.0; n=18).
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).
English: c.412G>A or c.412G>C
Dutch: c.412G>A of c.412G>C
English: c.G540C or c.G540T
Dutch: c.G540C of c.G540T
English: c.1147T>C or c.1149C>G or c.1149C>A
Dutch: c.1147T>C of c.1149C>G of c.1149C>A
English: c.216G>A or c.216G>T or c.216G>C
Dutch: c.216G>A of c.216G>T of c.216G>C
English: c.T187A or c.G188C
Dutch: c.T187A of c.G188C
English: c.228G>C or c.228G>A or c.228G>T
Dutch: c.228G>C of c.228G>A of c.228G>T
English: c.C233G or c.C233A
Dutch: c.C233G of c.C233A
English: c.G982A or c.G982C
Dutch: c.G982A of c.G982C
English: c.G285T or c.G285C
Dutch: c.G285T of c.G285C
English: c.924A>T or c.924A>C
Dutch: c.924A>T of c.924A>C
English: c.T241C or c.T241A
Dutch: c.T241C of c.T241A
English: c.148T>C or c.150C>G or c.150C>A
Dutch: c.148T>C of c.150C>G of c.150C>A
English: c.241T>C or c.241T>A
Dutch: c.241T>C of c.241T>A
English: c.G612T or c.G612C
Dutch: c.G612T of c.G612C
English: c.C305G or c.C305A
Dutch: c.C305G of c.C305A
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.
Dutch: De baselinewaarden waren 95,3 g/m voor de Galafold-groep en 92,9 g/m voor de ERT-groep, en de gemiddelde verandering in LVMi ten opzichte van baseline was bij maand 18 -6,6 (95%-BI: -11,0;2,1; n=31) voor Galafold en -2,0 (95%-BI: -11,0; 7,0; n=13) voor ERT.
English: c.T166A or c.G167C
Dutch: c.T166A of c.G167C
English: c.G261C or c.G261T
Dutch: c.G261C of c.G261T
English: c.187T>A or c.188G>C
Dutch: c.187T>A of c.188G>C
English: (dyspnoea)
Dutch: (dyspepsie)
English: c.C525G or c.C525A
Dutch: c.C525G of c.C525A
English: c.G734A or c.G735A
Dutch: c.G734A of c.G735A
English: c.G471C or c.G471T
Dutch: c.G471C of c.G471T
English: c.T514A or c.G515C
Dutch: c.T514A of c.G515C
English: c.817T>C or c.819T>A or c.819T>G
Dutch: c.817T>C of c.819T>A of c.819T>G
English: c.284G>A or c.285G>A
Dutch: c.284G>A of c.285G>A
English: c.519C>A or c.519C>G
Dutch: c.519C>A of c.519C>G
English: c.261G>C or c.261G>T
Dutch: c.261G>C of c.261G>T
English: c.G242A or c.G243A
Dutch: c.G242A of c.G243A
English: c.G131A or c.G132A
Dutch: c.G131A of c.G132A
English: c.124A>C or c.124A>T
Dutch: c.124A>C of c.124A>T
English: c.T552A or c.T552G
Dutch: c.T552A of c.T552G
English: c.471G>C or c.471G>T
Dutch: c.471G>C of c.471G>T
English: c.540G>C or c.540G>T
Dutch: c.540G>C of c.540G>T
English: c.552T>A or c.552T>G
Dutch: c.552T>A of c.552T>G
English: c.103G>C or c.103G>A
Dutch: c.103G>C of c.103G>A
English: c.C747G or c.C747A
Dutch: c.C747G of c.C747A
English: c.G1074T or c.G1074C
Dutch: c.G1074T of c.G1074C
English: c.T258G or c.T258A
Dutch: c.T258G of c.T258A
English: c.242G>A or c.243G>A
Dutch: c.242G>A of c.243G>A
English: c.T960G or c.T960A
Dutch: c.T960G of c.T960A
English: c.561G>T or c.561G>A or c.561G>C
Dutch: c.561G>T of c.561G>A of c.561G>C
English: c.131G>A or c.132G>A
Dutch: c.131G>A of c.132G>A
English: Swallow the capsule whole.
Dutch: Slik de capsules in hun geheel door.
English: • Constipation
Dutch: constipatie)
English: c.207C>A or c.207C>G
Dutch: c.207C>A of c.207C>G
English: c.982G>A or c.982G>C
Dutch: c.982G>A of c.982G>C
English: c.G132T or c.G132C
Dutch: c.G132T of c.G132C
English: c.612G>T or c.612G>C
Dutch: c.612G>T of c.612G>C
English: c.G243T or c.G243C
Dutch: c.G243T of c.G243C
English: c.G609C or c.G609T
Dutch: c.G609C of c.G609T
English: c.C453G or c.C453A
Dutch: c.C453G of c.C453A
English: Pack size of 14 capsules.
Dutch: 14 capsules per verpakking.
English: c.A840T or c.A840C
Dutch: c.A840T of c.A840C
English: c.816C>A or c.816C>G
Dutch: c.816C>A of c.816C>G
English: c.G144T or c.G144C
Dutch: c.G144T of c.G144C
English: c.285G>T or c.285G>C
Dutch: c.285G>T of c.285G>C
English: c.G288A or c.G288T or c.G288C M96I
Dutch: c.G288A of c.G288T of c.G288C M96I
English: c.337T>C or c.339T>A or c.339T>G
Dutch: c.337T>C of c.339T>A of c.339T>G
English: c.279C>G or c.279C>A
Dutch: c.279C>G of c.279C>A
English: c.525C>G or c.525C>A
Dutch: c.525C>G of c.525C>A
English: On your first day of taking this medicine from a new blister sleeve, record the date on the blister sleeve.
Dutch: Noteer de datum op de doordrukverpakking op de eerste dag dat u dit geneesmiddel uit een nieuwe doordrukverpakking gebruikt.
English: c.153G>A or c.153G>T or c.153G>C
Dutch: c.153G>A of c.153G>T of c.153G>C
English: c.1081G>A or c.1081G>C
Dutch: c.1081G>A of c.1081G>C
English: c.G830A or c.G831A
Dutch: c.G830A of c.G831A
English: c.141G>C or c.141G>T
Dutch: c.141G>C of c.141G>T
English: c.G567C or c.G567T
Dutch: c.G567C of c.G567T
English: c.G1081A or c.G1081C
Dutch: c.G1081A of c.G1081C
English: c.233C>G or c.233C>A
Dutch: c.233C>G of c.233C>A
English: c.243G>T or c.243G>C
Dutch: c.243G>T of c.243G>C
English: c.132G>T or c.132G>C
Dutch: c.132G>T of c.132G>C
English: c.A588T or c.A588C
Dutch: c.A588T of c.A588C
English: UNKNOWN (del Exon3?)
Dutch: NIET BEKEND (del Exon3?)
English: c.T154A or c.G155C
Dutch: c.T154A of c.G155C
English: c.T859C or c.T859A
Dutch: c.T859C of c.T859A
English: c.G831T or c.G831C
Dutch: c.G831T of c.G831C
English: c.C897G or c.C897A
Dutch: c.C897G of c.C897A
English: c.870G>A or c.870G>C or c.870G>T
Dutch: c.870G>A of c.870G>C of c.870G>T
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP.
Dutch: Die is te vinden op de doos en de blisterverpakking na EXP.
English: c.881T>G or c.881T>A
Dutch: c.881T>G of c.881T>A
English: c.G860A or c.G861A
Dutch: c.G860A of c.G861A
English: Table 2: Galafold (migalastat) amenability table
Dutch: Tabel 2: Tabel behandelbare mutaties met Galafold (migalastat)
English: c.258T>G or c.258T>A
Dutch: c.258T>G of c.258T>A
English: c.T465A or c.T465G
Dutch: c.T465A of c.T465G
English: c.T369G or c.T369A
Dutch: c.T369G of c.T369A
English: c.1074G>T or c.1074G>C
Dutch: c.1074G>T of c.1074G>C
English: c.859T>C or c.859T>A
Dutch: c.859T>C of c.859T>A
English: c.108G>C or c.108G>T
Dutch: c.108G>C of c.108G>T
English: c.610T>C or c.610T>A
Dutch: c.610T>C of c.610T>A
English: Muscle spasms Myalgia
Dutch: Spierspasmen Myalgie
English: c.G141C or c.G141T
Dutch: c.G141C of c.G141T
English: c.T610C or c.T610A
Dutch: c.T610C of c.T610A
English: c.T280A or c.G281C
Dutch: c.T280A of c.G281C
English: UNKNOWN (del Exon1_2?)
Dutch: NIET BEKEND (del Exon1_2?)
English: c.830G>A or c.831G>A
Dutch: c.830G>A of c.831G>A
English: c.567G>C or c.567G>T
Dutch: c.567G>C of c.567G>T
English: c.453C>G or c.453C>A
Dutch: c.453C>G of c.453C>A
English: c.166T>A or c.167G>C
Dutch: c.166T>A of c.167G>C
English: c.T408A or c.T408G
Dutch: c.T408A of c.T408G
English: c.609G>C or c.609G>T
Dutch: c.609G>C of c.609G>T
English: c.305C>G or c.305C>A
Dutch: c.305C>G of c.305C>A
English: Protein Sequence change c.290delC
Dutch: Verenering eiwitsequentie c.123delC
English: c.G71A or c.G72A
Dutch: c.G71A of c.G72A
English: UNKNOWN (del Exon5_7?)
Dutch: NIET BEKEND (del Exon5_7?)
English: c.144G>T or c.144G>C
Dutch: c.144G>T of c.144G>C
English: c.707G>A or c.708G>A
Dutch: c.707G>A of c.708G>A
English: c.C966A or c.C966G
Dutch: c.C966A of c.C966G
English: c.G485A or c.G486A
Dutch: c.G485A of c.G486A
English: c.860G>A or c.861G>A
Dutch: c.860G>A of c.861G>A
English: c.734G>A or c.735G>A
Dutch: c.734G>A of c.735G>A
English: c.C456A or c.C456G
Dutch: c.C456A of c.C456G
English: c.439G>A or c.439G>C
Dutch: c.439G>A of c.439G>C
English: c.T676C or c.T676A
Dutch: c.T676C of c.T676A
English: c.G439A or c.G439C
Dutch: c.G439A of c.G439C
English: • Reduced sense of touch or sensation
Dutch: • Verminderde tastzin of gevoel (hypo-esthesie)
English: c.960T>G or c.960T>A
Dutch: c.960T>G of c.960T>A
English: BLISTER FOIL
Dutch: BLISTERFOLIE
English: c.G861C or c.G861T
Dutch: c.G861C of c.G861T
English: c.897C>G or c.897C>A
Dutch: c.897C>G of c.897C>A
English: c.154T>A or c.155G>C
Dutch: c.154T>A of c.155G>C
English: c.394G>A or c.394G>C
Dutch: c.394G>A of c.394G>C
English: Check with your doctor, pharmacist, or nurse if you are not sure.
Dutch: Neem dan contact op met uw arts, apotheker of verpleegkundige voordat u dit geneesmiddel gebruikt.
English: The mean change from baseline in LVMi at Month 18 to 24 in patients with left ventricular hypertrophy at baseline (females with baseline LVMi > 95 g/m or males with baseline LVMi > 115 g/m 2) was -18.6 (95% CI: -38.2, 1.0; n=8).
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).
English: c.A868C or c.A868T
Dutch: c.A868C of c.A868T
English: c.70T>C or c.70T>A
Dutch: c.70T>C of c.70T>A
English: c.G486C or c.G486T
Dutch: c.G486C of c.G486T
English: c.888G>A or c.888G>T or c.888G>C
Dutch: c.888G>A of c.888G>T of c.888G>C
English: c.G108C or c.G108T
Dutch: c.G108C of c.G108T
English: c.408T>A or c.408T>G
Dutch: c.408T>A of c.408T>G
English: c.T648A or c.T648G
Dutch: c.T648A of c.T648G
English: c.708G>C or c.708G>T
Dutch: c.708G>C of c.708G>T
English: c.G837C or c.G837T
Dutch: c.G837C of c.G837T
English: c.465T>A or c.465T>G
Dutch: c.465T>A of c.465T>G
English: c.966C>A or c.966C>G
Dutch: c.966C>A of c.966C>G
English: c.861G>C or c.861G>T
Dutch: c.861G>C of c.861G>T
English: c.831G>T or c.831G>C
Dutch: c.831G>T of c.831G>C
English: What Galafold contains - The active substance is migalastat.
Dutch: - De werkzame stof in dit middel is migalastat.
English: c.102T>G or c.102T>A
Dutch: c.102T>G of c.102T>A
English: c.T687A or c.T687G
Dutch: c.T687A of c.T687G
English: c.T667A or c.G668C
Dutch: c.T667A of c.G668C
English: c.514T>A or c.515G>C
Dutch: c.514T>A of c.515G>C
English: c.T894G or c.T894A
Dutch: c.T894G of c.T894A
English: c.485G>A or c.486G>A
Dutch: c.485G>A of c.486G>A
English: c.T102G or c.T102A
Dutch: c.T102G of c.T102A
English: Disease Substrate
Dutch: Ziekte-substraat
English: c.71G>A or c.72G>A
Dutch: c.71G>A of c.72G>A
English: c.T834G or c.T834A
Dutch: c.T834G of c.T834A
English: c.456C>A or c.456C>G
Dutch: c.456C>A of c.456C>G
English: c.C666A or c.C666G
Dutch: c.C666A of c.C666G
English: c.837G>C or c.837G>T
Dutch: c.837G>C of c.837G>T
English: c.G394A or c.G394C
Dutch: c.G394A of c.G394C
English: c.G707A or c.G708A
Dutch: c.G707A of c.G708A
English: c.T70C or c.T70A
Dutch: c.T70C of c.T70A
English: c.G720C or c.G720T
Dutch: c.G720C of c.G720T
English: c.978G>C or c.978G>T
Dutch: c.978G>C of c.978G>T
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).
Dutch: Na 30 maanden behandeling met Galafold was de gemiddelde verandering in LVMi ten opzichte van baseline -3,8 (95%-BI: -8,9; 1,3; n=28) en was de gemiddelde verandering in LVMi ten opzichte van baseline bij patiënten met linkerkamerhypertrofie op baseline -10,0 (95%-BI: -16,6; -3,3; n=10).
English: c.486G>C or c.486G>T
Dutch: c.486G>C of c.486G>T
English: Abdominal pain Constipation Dry mouth
Dutch: Constipatie Droge mond Defecatie-aandrang Dyspepsie
English: c.676T>C or c.676T>A
Dutch: c.676T>C of c.676T>A
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
Dutch: Galafold wordt niet aanbevolen voor gebruik bij patiënten met de ziekte van Fabry die een geschatte glomerulaire filtratiesnelheid (GFR) hebben van minder dan 30 ml/min/1,73 m
English: c.T484C or c.T484A
Dutch: c.T484C of c.T484A
English: c.G778C or c.G778A
Dutch: c.G778C of c.G778A
English: c.G708C or c.G708T
Dutch: c.G708C of c.G708T
English: c.720G>C or c.720G>T
Dutch: c.720G>C of c.720G>T
English: c.G963C or c.G963T
Dutch: c.G963C of c.G963T
English: UNKNOWN (del Exon3_7?)
Dutch: NIET BEKEND (del Exon3_7?)
English: c.G772C or c.G772A
Dutch: c.G772C of c.G772A
English: c.784T>A or c.784T>C
Dutch: c.784T>A of c.784T>C
English: c.588A>T or c.588A>C
Dutch: c.588A>T of c.588A>C
English: c.T402G or c.T402A
Dutch: c.T402G of c.T402A
English: c.963G>C or c.963G>T
Dutch: c.963G>C of c.963G>T
English: c.G785A or c.G786A
Dutch: c.G785A of c.G786A
English: c.G729C or c.G729T
Dutch: c.G729C of c.G729T
English: c.288G>A or c.288G>T or c.288G>C
Dutch: c.288G>A of c.288G>T of c.288G>C
English: c.G978C or c.G978T
Dutch: c.G978C of c.G978T
English: c.834T>G or c.834T>A
Dutch: c.834T>G of c.834T>A
English: c.T706C or c.T706A
Dutch: c.T706C of c.T706A
English: c.894T>G or c.894T>A
Dutch: c.894T>G of c.894T>A
English: c.772G>C or c.772G>A
Dutch: c.772G>C of c.772G>A
English: c.840A>T or c.840A>C
Dutch: c.840A>T of c.840A>C
English: UNKNOWN (del Exon2_3?)
Dutch: NIET BEKEND (del Exon2_3?)
English: c.778G>C or c.778G>A
Dutch: c.778G>C of c.778G>A
English: c.G936T or c.G936C
Dutch: c.G936T of c.G936C
English: c.T784A or c.T784C
Dutch: c.T784A of c.T784C