FrancophonIA/ELRC3.0 huggingface dataset:
English: No reduction in proteinuria was observed in patients treated with Galafold.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Galafold, zmanjšanje proteinurije ni bilo ugotovljeno.
English: c.T817C or c.T819A or c.T819G F273L
Slovenian: c.T817C ali c.T819A ali c.T819G F273L
English: c.G153A or c.G153T or c.G153C M51I
Slovenian: c.G153A ali c.G153T ali c.G153C M51I
English: How to take Galafold
Slovenian: Kako jemati zdravilo Galafold
English: Fertility in women It is not yet known if this medicine affects fertility in women.
Slovenian: Ni še znano, ali to zdravilo vpliva na plodnost pri ženskah.
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
Slovenian: Ena kapsula vsebuje migalastatijevega klorida v količini, ki ustreza 123 mg migalastata.
English: It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on or switched to Galafold.
Slovenian: Pri bolnikih, ki so začeli ali prešli na zdravljenje z zdravilom Galafold, se priporoča periodično spremljanje ledvične funkcije, ehokardiografskih parametrov in biokemičnih markerjev (vsakih 6 mesecev).
English: c.A712C or c.T714A or c.T714G S238R
Slovenian: c.A712C ali c.T714A ali c.T714G S238R
English: It is not known whether Galafold is secreted in human milk.
Slovenian: Ni znano, ali se zdravilo Galafold izloča v materino mleko.
English: c.T1147C or c.C1149G or c.C1149A
Slovenian: c.T1147C ali c.C1149G ali c.C1149A
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).
Slovenian: Pri bolnikih, ki so bili v fazi 1 randomizirani na zdravilo Galafold, se je srednje odlaganje GL-3 v intersticijskih kapilarah v 6. mesecu v primerjavi s placebom (+0,07 ± 0,13; +14 %) statistično značilno bolj zmanjšalo (±SEM) (-0,25 ± 0,10; -39 %) (p = 0,008).
English: c.A504C or c.A504T
Slovenian: c.A504C ali c.A504T
English: While taking Galafold you should use effective birth control.
Slovenian: Med jemanjem zdravila Galafold morate uporabljati učinkovito kontracepcijo.
English: c.G611A or G612A
Slovenian: c.G611A ali G612A
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj pruritus
English: c.A924T or c.A924C
Slovenian: c.A924T ali c.A924C
English: Protein Sequence change c.1A>C or c.1A>T
Slovenian: Sprememba proteinskega zapaliedja c.1A>C ali c.1A>T
English: c.A442C or c.T444A or c.T444G S148R
Slovenian: c.A442C ali c.T444A ali c.T444G S148R
English: Hepatic impairment No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka zdravila Galafold ni potrebna (glejte razdelek 5.2).
English: (torticollis)
Slovenian: (tortikolis)
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
Slovenian: V študiji s enkratnim odmerkom zdravila Galafold pri bolnikih, ki nimajo Fabryjeve bolezni in imajo različno stopnjo ledvične insuficience, se je pri osebah s hudo okvaro ledvic (GFR > 30 ml/min/1,73 m2) izpostavljenost povečala za 4,3-krat.
English: Based upon in vivo data, migalastat is a substrate for UGT, being a minor elimination pathway.
Slovenian: Po podatkih raziskav in vivo je migalastat substrat za encim UGT.
English: Blood Creatine Phosphokinase increased
Slovenian: Preiskave zvišana raven kreatin fosfokinaze v krvi povečana telesna masa
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).
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).
English: c.611G>A or 612G>A
Slovenian: c.611G>A ali 612G>A
English: c.140G>A or 141G>A
Slovenian: c.140G>A ali 141G>A
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Slovenian: c.1095T>A ali c.1095T>G c.T1095A ali c.T1095G
English: c.504A>C or c.504A>T
Slovenian: c.504A>C ali c.504A>T
English: c.712A>C or c.714T>A or c.714T>G
Slovenian: c.712A>C ali c.714T>A ali c.714T>G
English: Paraesthesia Dizziness Hypoaesthesia
Slovenian: Bolezni živčevja glavobol parestezije omotica hipestezija
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).
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).
English: c.1045T>C or c.1045T>A c.T1045C or c.T1045A
Slovenian: c.1045T>C ali c.1045T>A c.T1045C ali c.T1045A
English: Alternate daily between taking the capsule on odd numbered days and punching out the perforated white circles on even numbered days, up to and including day 28.
Slovenian: Po 2. dnevu se pomikajte v desno po pretisnem omotu in do vključno 28. dne nadaljujte tako, da na lihe dneve vzamete kapsulo, na sode dneve pa preluknjate bel krogec.
English: Do not eat food at least 2 hours before and 2 hours after taking your medicine to give a minimum 4 hours fast.
Slovenian: Vsaj 2 uri pred jemanjem in 2 uri po jemanju zdravila ne jejte, tako da skupno vsaj 4 ure ne pojeste ničesar.
English: • are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions
Slovenian: Ne jemljite zdravila Galafold: • če ste alergični na migalastat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: c.G412A or c.G412C
Slovenian: c.G412A ali c.G412C
English: c.T139C or c.T139A
Slovenian: c.T139C ali c.T139A
English: c.G126A or c.G126C or c.G126T M42I
Slovenian: c.G126A ali c.G126C ali c.G126T M42I
English: c.1147T>C or c.1149C>G or c.1149C>A
Slovenian: c.1147T>C ali c.1149C>G ali c.1149C>A
English: c.C816A or c.C816G
Slovenian: c.C816A ali c.C816G
English: c.1046G>A or c.1047G>A c.G1046A or c.G1047A
Slovenian: c.1046G>A ali c.1047G>A c.G1046A ali c.G1047A
English: Galafold is to be taken every other day.
Slovenian: Zdravilo Galafold vzemite vsak drugi dan.
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Slovenian: c.1034C>G ali c.1034C>A c.C1034G ali c.C1034A
English: c.C519A or c.C519G
Slovenian: c.C519A ali c.C519G
English: c.369+3_639+954del3129insT UNKNOWN (del Exon3 and 4?)
Slovenian: c.369+3_639+954del3129insT NEZNANO (del Exon3 in g.6009_9741del
English: c.216G>A or c.216G>T or c.216G>C
Slovenian: c.216G>A ali c.216G>T ali c.216G>C
English: c.C159G or c.C159A
Slovenian: c.C159G ali c.C159A
English: c.G216A or c.G216T or c.G216C M72I
Slovenian: c.G216A ali c.G216T ali c.G216C M72I
English: This is a common spontaneous tumour in ad libitum-fed male rats.
Slovenian: To je pri ad libitum hranjenih podganjih samcih pogost spontani tumor.
English: c.C207A or c.C207G
Slovenian: c.C207A ali c.C207G
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Slovenian: c.1065C>A ali c.1065C>G c.C1065A ali c.C1065G
English: Following ascending single oral doses (25-675 mg migalastat hydrochloride), no trends were found for clearance, CL/F).
Slovenian: Pri očistku (CL/F) ni bil po dajanju enkratnih naraščajočih peroralnih odmerkov (25-675 mg migalastatijevega klorida) prepoznan noben trend.
English: c.G284A or c.G285A
Slovenian: c.G284A ali c.G285A
English: c.924A>T or c.924A>C
Slovenian: c.924A>T ali c.924A>C
English: c.442A>C or c.444T>A or c.444T>G
Slovenian: c.442A>C ali c.444T>A ali c.444T>G
English: c.G140A or G141A
Slovenian: c.G140A ali G141A
English: c.280T>A or c.281G>C
Slovenian: c.280T>A ali c.281G>C
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Slovenian: c.3G>A ali c.3G>T ali c.3G>C c.G3A ali c.G3T ali c.G3C
English: c.159C>G or c.159C>A
Slovenian: c.159C>G ali c.159C>A
English: c.A124C or c.A124T
Slovenian: c.A124C ali c.A124T
English: c.139T>C or c.139T>A
Slovenian: c.139T>C ali c.139T>A
English: c.T187A or c.G188C
Slovenian: c.T187A ali c.G188C
English: c.T241C or c.T241A
Slovenian: c.T241C ali c.T241A
English: c.G870A or c.G870C or c.G870T M290I
Slovenian: c.G870A ali c.G870C ali c.G870T M290I
English: c.G982A or c.G982C
Slovenian: c.G982A ali c.G982C
English: c.148T>C or c.150C>G or c.150C>A
Slovenian: c.148T>C ali c.150C>G ali c.150C>A
English: c.G228C or c.G228A or c.G228T M76I
Slovenian: c.G228C ali c.G228A ali c.G228T M76I
English: • Stomach ache
Slovenian: • Suha usta
English: c.T881G or c.T881A
Slovenian: c.T881G ali c.T881A
English: c.G285T or c.G285C
Slovenian: c.G285T ali c.G285C
English: c.G103C or c.G103A
Slovenian: c.G103C ali c.G103A
English: c.187T>A or c.188G>C
Slovenian: c.187T>A ali c.188G>C
English: c.T166A or c.G167C
Slovenian: c.T166A ali c.G167C
English: c.284G>A or c.285G>A
Slovenian: c.284G>A ali c.285G>A
English: c.C279G or c.C279A
Slovenian: c.C279G ali c.C279A
English: c.412G>A or c.412G>C
Slovenian: c.412G>A ali c.412G>C
English: c.561G>T or c.561G>A or c.561G>C
Slovenian: c.561G>T ali c.561G>A ali c.561G>C
English: Protein Sequence change
Slovenian: Sprememba proteinskega zapaliedja
English: c.153G>A or c.153G>T or c.153G>C
Slovenian: c.153G>A ali c.153G>T ali c.153G>C
English: c.T552A or c.T552G
Slovenian: c.T552A ali c.T552G
English: c.G261C or c.G261T
Slovenian: c.G261C ali c.G261T
English: • Tiredness
Slovenian: • Driska
English: c.G242A or c.G243A
Slovenian: c.G242A ali c.G243A
English: UNKNOWN (del Exon3?)
Slovenian: NEZNANO (del Exon3?)
English: c.241T>C or c.241T>A
Slovenian: c.241T>C ali c.241T>A
English: In the ERT- naïve trial, Galafold showed statistically significant reductions in plasma lyso-Gb3 concentrations and kidney interstitial capillary GL-3 inclusions in patients with amenable mutations.
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.
English: c.124A>C or c.124A>T
Slovenian: c.124A>C ali c.124A>T
English: c.C525G or c.C525A
Slovenian: c.C525G ali c.C525A
English: Galafold has not been studied in patients with Fabry disease who have a GFR less than 30 mL/min/1.73 m2.
Slovenian: Zdravilo Galafold ni bilo raziskano pri bolnikih s Fabryjevo boleznijo, pri katerih je GFR nižja od 30 ml/min/1,73 m2.
English: c.261G>C or c.261G>T
Slovenian: c.261G>C ali c.261G>T
English: c.285G>T or c.285G>C
Slovenian: c.285G>T ali c.285G>C
English: BLISTER FOIL
Slovenian: PRETISNA FOLIJA
English: c.G888A or c.G888T or c.G888C M296I
Slovenian: c.G888A ali c.G888T ali c.G888C M296I
English: c.G471C or c.G471T
Slovenian: c.G471C ali c.G471T
English: c.G131A or c.G132A
Slovenian: c.G131A ali c.G132A
English: c.G734A or c.G735A
Slovenian: c.G734A ali c.G735A
English: c.817T>C or c.819T>A or c.819T>G
Slovenian: c.817T>C ali c.819T>A ali c.819T>G
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Slovenian: Indeks mase levega prekata (LVMi, Left Ventricular Mass index) V preskušanju s predhodnim ERT se je po 18-mesečnem zdravljenju z zdravilom Galafold LVMi statistično značilno zmanjšal (p < 0,05).
English: c.G540C or c.G540T
Slovenian: c.G540C ali c.G540T
English: c.337T>C or c.339T>A or c.339T>G
Slovenian: c.337T>C ali c.339T>A ali c.339T>G
English: c.552T>A or c.552T>G
Slovenian: c.552T>A ali c.552T>G
English: Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m
Slovenian: Uporaba zdravila Galafold ni priporočljiva pri bolnikih s hudo ledvično insuficienco, opredeljeno z ocenjeno GFR pod 30 ml/min/1,73 m
English: c.471G>C or c.471G>T
Slovenian: c.471G>C ali c.471G>T
English: c.G1081A or c.G1081C
Slovenian: c.G1081A ali c.G1081C
English: c.C233G or c.C233A
Slovenian: c.C233G ali c.C233A
English: c.G612T or c.G612C
Slovenian: c.G612T ali c.G612C
English: c.T258G or c.T258A
Slovenian: c.T258G ali c.T258A
English: c.G243T or c.G243C
Slovenian: c.G243T ali c.G243C
English: c.982G>A or c.982G>C
Slovenian: c.982G>A ali c.982G>C
English: c.G1074T or c.G1074C
Slovenian: c.G1074T ali c.G1074C
English: c.C305G or c.C305A
Slovenian: c.C305G ali c.C305A
English: The difference in clearance between Fabry patients ≥ 65 years and those < 65 years was 20%, which was not considered clinically significant.
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.
English: In the ERT-experienced trial, plasma lyso-Gb3 levels slightly increased but remained low in patients with amenable mutations treated with Galafold for the 30 month duration of the study.
Slovenian: Pri preskušanju s predhodnim ERT se je pri bolnikih z odzivnimi mutacijami, ki so bili med izvajanjem študije 30 mesecev zdravljeni z zdravilom Galafold, plazemska koncentracija lizo-Gb3 nekoliko povečala, a je ostala nizka.
English: c.C897G or c.C897A
Slovenian: c.C897G ali c.C897A
English: c.132G>T or c.132G>C
Slovenian: c.132G>T ali c.132G>C
English: c.279C>G or c.279C>A
Slovenian: c.279C>G ali c.279C>A
English: c.1074G>T or c.1074G>C
Slovenian: c.1074G>T ali c.1074G>C
English: c.519C>A or c.519C>G
Slovenian: c.519C>A ali c.519C>G
English: c.228G>C or c.228G>A or c.228G>T
Slovenian: c.228G>C ali c.228G>A ali c.228G>T
English: No studies have been carried out in subjects with impaired hepatic function.
Slovenian: Pri osebah z oslabljenim delovanjem jeter študije niso bile izvedene.
English: c.242G>A or c.243G>A
Slovenian: c.242G>A ali c.243G>A
English: c.612G>T or c.612G>C
Slovenian: c.612G>T ali c.612G>C
English: c.G132T or c.G132C
Slovenian: c.G132T ali c.G132C
English: c.C453G or c.C453A
Slovenian: c.C453G ali c.C453A
English: UNKNOWN (del Exon1_2?)
Slovenian: NEZNANO (del Exon1_2?)
English: c.A840T or c.A840C
Slovenian: c.A840T ali c.A840C
English: c.816C>A or c.816C>G
Slovenian: c.816C>A ali c.816C>G
English: c.A588T or c.A588C
Slovenian: c.A588T ali c.A588C
English: c.207C>A or c.207C>G
Slovenian: c.207C>A ali c.207C>G
English: Migalastat is not a substrate for P-glycoprotein (P-gP) in vitro and it is considered unlikely that migalastat would be subject to drug-drug interactions with cytochrome P450s.
Slovenian: Malo verjetno je, da bi bil migalastat udeležen v interakcijah med zdravili v povezavi s citokromom P450.
English: c.G144T or c.G144C
Slovenian: c.G144T ali c.G144C
English: c.243G>T or c.243G>C
Slovenian: c.243G>T ali c.243G>C
English: c.525C>G or c.525C>A
Slovenian: c.525C>G ali c.525C>A
English: c.T859C or c.T859A
Slovenian: c.T859C ali c.T859A
English: c.T960G or c.T960A
Slovenian: c.T960G ali c.T960A
English: c.C747G or c.C747A
Slovenian: c.C747G ali c.C747A
English: c.G567C or c.G567T
Slovenian: c.G567C ali c.G567T
English: c.T514A or c.G515C
Slovenian: c.T514A ali c.G515C
English: c.T154A or c.G155C
Slovenian: c.T154A ali c.G155C
English: c.131G>A or c.132G>A
Slovenian: c.131G>A ali c.132G>A
English: UNKNOWN (del Exon5_7?)
Slovenian: NEZNANO (del Exon5_7?)
English: c.G609C or c.G609T
Slovenian: c.G609C ali c.G609T
English: c.G288A or c.G288T or c.G288C M96I
Slovenian: c.G288A ali c.G288T ali c.G288C M96I
English: c.609G>C or c.609G>T
Slovenian: c.609G>C ali c.609G>T
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.
Slovenian: V 18. mesecu je povprečna sprememba indeksa LVMi od začetka zdravljenja za zdravilo Galafold znašala -6,6 (95-% CI: -11,0, -2,1; n = 31), za zdravljenje ERT pa -2,0 (95-% CI: -11,0, 7,0; n = 13).
English: c.144G>T or c.144G>C
Slovenian: c.144G>T ali c.144G>C
English: c.1081G>A or c.1081G>C
Slovenian: c.1081G>A ali c.1081G>C
English: The GLA mutations amenable and not amenable to treatment with Galafold are listed in Table 2 and Table 3 respectively below.
Slovenian: Na zdravljenje z zdravilom Galafold odzivne in neodzivne mutacije gena GLA so navedene v preglednicah 2 in 3.
English: c.166T>A or c.167G>C
Slovenian: c.166T>A ali c.167G>C
English: c.258T>G or c.258T>A
Slovenian: c.258T>G ali c.258T>A
English: c.T408A or c.T408G
Slovenian: c.T408A ali c.T408G
English: c.540G>C or c.540G>T
Slovenian: c.540G>C ali c.540G>T
English: c.233C>G or c.233C>A
Slovenian: c.233C>G ali c.233C>A
English: c.103G>C or c.103G>A
Slovenian: c.103G>C ali c.103G>A
English: c.707G>A or c.708G>A
Slovenian: c.707G>A ali c.708G>A
English: c.T369G or c.T369A
Slovenian: c.T369G ali c.T369A
English: c.G830A or c.G831A
Slovenian: c.G830A ali c.G831A
English: c.G485A or c.G486A
Slovenian: c.G485A ali c.G486A
English: c.G831T or c.G831C
Slovenian: c.G831T ali c.G831C
English: c.G141C or c.G141T
Slovenian: c.G141C ali c.G141T
English: c.567G>C or c.567G>T
Slovenian: c.567G>C ali c.567G>T
English: c.G860A or c.G861A
Slovenian: c.G860A ali c.G861A
English: c.141G>C or c.141G>T
Slovenian: c.141G>C ali c.141G>T
English: c.T610C or c.T610A
Slovenian: c.T610C ali c.T610A
English: c.881T>G or c.881T>A
Slovenian: c.881T>G ali c.881T>A
English: c.610T>C or c.610T>A
Slovenian: c.610T>C ali c.610T>A
English: c.G71A or c.G72A
Slovenian: c.G71A ali c.G72A
English: c.870G>A or c.870G>C or c.870G>T
Slovenian: c.870G>A ali c.870G>C ali c.870G>T
English: c.453C>G or c.453C>A
Slovenian: c.453C>G ali c.453C>A
English: c.T280A or c.G281C
Slovenian: c.T280A ali c.G281C
English: c.831G>T or c.831G>C
Slovenian: c.831G>T ali c.831G>C
English: c.G861C or c.G861T
Slovenian: c.G861C ali c.G861T
English: c.C456A or c.C456G
Slovenian: c.C456A ali c.C456G
English: c.305C>G or c.305C>A
Slovenian: c.305C>G ali c.305C>A
English: c.C966A or c.C966G
Slovenian: c.C966A ali c.C966G
English: c.T465A or c.T465G
Slovenian: c.T465A ali c.T465G
English: c.960T>G or c.960T>A
Slovenian: c.960T>G ali c.960T>A
English: c.860G>A or c.861G>A
Slovenian: c.860G>A ali c.861G>A
English: Psychiatric disorders
Slovenian: Psihiatrične motnje depresija
English: c.859T>C or c.859T>A
Slovenian: c.859T>C ali c.859T>A
English: c.514T>A or c.515G>C
Slovenian: c.514T>A ali c.515G>C
English: • Constipation
Slovenian: • Utrujenost
English: c.288G>A or c.288G>T or c.288G>C
Slovenian: c.288G>A ali c.288G>T ali c.288G>C
English: c.108G>C or c.108G>T
Slovenian: c.108G>C ali c.108G>T
English: c.T676C or c.T676A
Slovenian: c.T676C ali c.T676A
English: c.G439A or c.G439C
Slovenian: c.G439A ali c.G439C
English: c.888G>A or c.888G>T or c.888G>C
Slovenian: c.888G>A ali c.888G>T ali c.888G>C
English: c.897C>G or c.897C>A
Slovenian: c.897C>G ali c.897C>A
English: c.830G>A or c.831G>A
Slovenian: c.830G>A ali c.831G>A
English: c.394G>A or c.394G>C
Slovenian: c.394G>A ali c.394G>C
English: Abdominal pain Constipation Dry mouth
Slovenian: Bolezni prebavil driska navzea bolečine v trebuhu zaprtje suha usta tiščanje na blato dispepsija
English: c.G108C or c.G108T
Slovenian: c.G108C ali c.G108T
English: c.485G>A or c.486G>A
Slovenian: c.485G>A ali c.486G>A
English: c.465T>A or c.465T>G
Slovenian: c.465T>A ali c.465T>G
English: c.154T>A or c.155G>C
Slovenian: c.154T>A ali c.155G>C
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični krči mialgija tortikolis bolečina v okončinah
English: How to store Galafold
Slovenian: Shranjevanje zdravila Galafold
English: c.T648A or c.T648G
Slovenian: c.T648A ali c.T648G
English: Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Slovenian: Najpogostejša neželena učinka pri odmerkih zdravila Galafold do 1.250 oz. 2.000 mg sta bila glavobol in omotica.
English: c.734G>A or c.735G>A
Slovenian: c.734G>A ali c.735G>A
English: c.A868C or c.A868T
Slovenian: c.A868C ali c.A868T
English: c.439G>A or c.439G>C
Slovenian: c.439G>A ali c.439G>C
English: • Muscle pain (myalgia)
Slovenian: • Mravljinčenje v okončinah (parestezija)
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).
Slovenian: Pri bolnikih s hipertrofijo levega prekata (ženske z izhodiščnim LVMi > 95 g/m in moški z izhodiščnim LVMi > 115 g/m2) se je LVMi (g/m2) od začetka zdravljenja do 18. meseca pri migalastatu spremenil za -8,4 (95-% CI: -15,7, 2,6; n = 13) in pri ERT za 4,5 (95-% CI: -10,7, 18,4; n = 5).
English: c.588A>T or c.588A>C
Slovenian: c.588A>T ali c.588A>C
English: c.G394A or c.G394C
Slovenian: c.G394A ali c.G394C
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
Slovenian: Po sledenju v odprtem podaljšanem preskušanju je bila srednja sprememba od izhodiščnega LVMi pri bolnikih s hipertrofijo levega prekata v izhodišču v 36. mesecu -30,0 (95-% CI: -57,9, -2,2; n = 4), v 48. mesecu pa -33,1 (CI: -60,9, -5,4; n = 4).
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
Slovenian: Uporaba zdravila Galafold ni priporočljiva pri bolnikih s Fabryjevo boleznijo, pri katerih je ocenjena stopnja glomerulne filtracije (GFR) manjša kot 30 ml/min/1,73 m
English: C]-migalastat hydrochloride in the concentration range between 1 and
Slovenian: C]-migalastatijevega klorida v koncentracijskem razponu od 1 do 100 M ni bilo zaznavne vezave na plazemske proteine.
English: c.T70C or c.T70A
Slovenian: c.T70C ali c.T70A
English: c.T484C or c.T484A
Slovenian: c.T484C ali c.T484A
English: c.G486C or c.G486T
Slovenian: c.G486C ali c.G486T
English: c.840A>T or c.840A>C
Slovenian: c.840A>T ali c.840A>C
English: c.T834G or c.T834A
Slovenian: c.T834G ali c.T834A
English: c.966C>A or c.966C>G
Slovenian: c.966C>A ali c.966C>G
English: c.456C>A or c.456C>G
Slovenian: c.456C>A ali c.456C>G
English: c.T667A or c.G668C
Slovenian: c.T667A ali c.G668C
English: c.T687A or c.T687G
Slovenian: c.T687A ali c.T687G
English: c.G707A or c.G708A
Slovenian: c.G707A ali c.G708A
English: c.708G>C or c.708G>T
Slovenian: c.708G>C ali c.708G>T
English: UNKNOWN (del Exon3_7?)
Slovenian: NEZNANO (del Exon3_7?)
English: • Indigestion (dyspepsia)
Slovenian: • Kratka sapa (dispneja)
English: c.408T>A or c.408T>G
Slovenian: c.408T>A ali c.408T>G
English: c.486G>C or c.486G>T
Slovenian: c.486G>C ali c.486G>T
English: c.G837C or c.G837T
Slovenian: c.G837C ali c.G837T
English: c.T894G or c.T894A
Slovenian: c.T894G ali c.T894A
English: c.369T>G or c.369T>A
Slovenian: c.369T>G ali c.369T>A
English: c.837G>C or c.837G>T
Slovenian: c.837G>C ali c.837G>T
English: c.676T>C or c.676T>A
Slovenian: c.676T>C ali c.676T>A
English: • Dizziness
Slovenian: • Izpuščaj
English: c.C666A or c.C666G
Slovenian: c.C666A ali c.C666G
English: c.784T>A or c.784T>C
Slovenian: c.784T>A ali c.784T>C
English: c.102T>G or c.102T>A
Slovenian: c.102T>G ali c.102T>A
English: c.70T>C or c.70T>A
Slovenian: c.70T>C ali c.70T>A
English: c.71G>A or c.72G>A
Slovenian: c.71G>A ali c.72G>A
English: Mean annualised rate of change in eGFRCKD-EPI was -0.40 mL/min/1.73 m
Slovenian: Srednja letna stopnja spremembe eGFRCKD-EPI je bila v skupini, zdravljeni z zdravilom Galafold, -0,40 ml/min/1,73 m
English: c.T102G or c.T102A
Slovenian: c.T102G ali c.T102A
English: c.T402G or c.T402A
Slovenian: c.T402G ali c.T402A