FrancophonIA/ELRC3.0 huggingface dataset:
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Slovak: E398A c.1196G>A alepo c.1197G>A c.G1196A alepo c.G1197A
English: Hepatic impairment No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Slovak: U pacientov s poruchou funkcie pečene nie je potrebná úprava dávkovania lieku Galafold (pozri časť 5.2).
English: How to take Galafold
Slovak: Ako užívať Galafold
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat - The other ingredients are: Capsule contents: Pregelatinised maize starch and magnesium stearate Capsule shell: Gelatin, titanium dioxide, and indigotine Printing ink: Shellac, black iron oxide, and potassium hydroxide
Slovak: Každá kapsula obsahuje migalastátumchlorid, čo zodpovedá 123 mg migalastátu - Ďalšie zložky sú: Obsah kapsuly: predželatínovaný kukuričný škrob a magnéziumstearát
English: c.A924T or c.A924C
Slovak: c.A924T alepo c.A924C
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.
Slovak: Po zvážení prínosu dojčenia pre dieťa a prínosu liečby pre matku sa musí prijať rozhodnutie o tom, či sa má prerušiť dojčenie alebo liečba liekom Galafold.
English: You should only take Galafold once every other day.
Slovak: Liek Galafold by ste mali užívať len každý druhý deň.
English: Patients randomised to placebo in Stage 1 and switched to Galafold at month 6 (Stage 2) also demonstrated statistically significant decreases in interstitial capillary GL-3 inclusions at month 12 (-0.33±0.15; -58%) (p=0.014).
Slovak: Pacienti randomizovaní na liečbu placebom v 1. štádiu, ktorí prešli na liek Galafold v šiestom mesiaci (2. štádium) tiež preukázali štatisticky významné zníženia inklúzií GL-3 v intersticiálnej oblasti kapilár v 12. mesiaci (-0,33 ±
English: Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse.
Slovak: Ak dojčíte, neužívajte tento liek, kým sa neporadíte s lekárom, lekárnikom alebo zdravotnou sestrou.
English: Galafold has not been studied in patients with Fabry disease who have a GFR less than 30 mL/min/1.73 m2.
Slovak: Galafold sa neskúmal u pacientov s Fabryho chorobou, ktorí majú odhadnutú hodnotu GFR nižšiu ako 30 ml/min/1,73 m2.
English: c.T1147C or c.C1149G or c.C1149A
Slovak: c.T1147C alepo c.C1149G alepo c.C1149A
English: c.C816A or c.C816G
Slovak: c.C816A alepo c.C816G
English: c.504A>C or c.504A>T
Slovak: c.504A>C alepo c.504A>T
English: c.712A>C or c.714T>A or c.714T>G
Slovak: c.712A>C alepo c.714T>A alepo c.714T>G
English: c.442A>C or c.444T>A or c.444T>G
Slovak: c.442A>C alepo c.444T>A alepo c.444T>G
English: c.207_369+651del814ins231 UNKNOWN (del Exon2?)
Slovak: c.207_369+651del814ins231
English: Table 2: Galafold (migalastat) amenability table
Slovak: Tabuľka 2: Tabuľka senzibility lieku Galafold (migalastát)
English: Do not take Galafold on two consecutive days.
Slovak: Galafold dva po sebe nasledujúce dni.
English: c.924A>T or c.924A>C
Slovak: c.924A>T alepo c.924A>C
English: c.611G>A or 612G>A
Slovak: c.611G>A alepo 612G>A
English: c.A124C or c.A124T
Slovak: c.A124C alepo c.A124T
English: c.369+3_639+954del3129insT UNKNOWN (del Exon3 and 4?)
Slovak: c.369+3_639+954del3129insT
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).
Slovak: Po sledovaní v OLE bola priemerná zmena LVMi od začiatku do 36. mesiaca -8,3 (95 % IS: -17,1; 0,4; n=25) a do 48. mesiaca -9,1 (95%
English: c.C525G or c.C525A
Slovak: c.C525G alepo c.C525A
English: c.1147T>C or c.1149C>G or c.1149C>A
Slovak: c.1147T>C alepo c.1149C>G alepo c.1149C>A
English: c.T187A or c.G188C
Slovak: c.T187A alepo c.G188C
English: Amicus Therapeutics Europe Limited Sími: 800 7634
Slovak: Limited Sími: 800 7634
English: c.G261C or c.G261T
Slovak: c.G261C alepo c.G261T
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.
Slovak: U pacientov, v prípade ktorých sa začala liečba liekom Galafold alebo ktorí prešli na liečbu liekom Galafold, sa odporúča pravidelne sledovať funkciu obličiek, echokardiografické parametre a biochemické markery (každých šesť mesiacov).
English: What you need to know before you take Galafold 3.
Slovak: 1. Čo je Galafold a na čo sa používa 2. Čo potrebujete vedieť predtým, ako užijete Galafold 3. Ako užívať Galafold
English: c.G982A or c.G982C
Slovak: c.G982A alepo c.G982C
English: c.C305G or c.C305A
Slovak: c.C305G alepo c.C305A
English: c.187T>A or c.188G>C
Slovak: c.187T>A alepo c.188G>C
English: c.G285T or c.G285C
Slovak: c.G285T alepo c.G285C
English: c.285G>T or c.285G>C
Slovak: c.285G>T alepo c.285G>C
English: Lot
Slovak: Louth
English: c.216G>A or c.216G>T or c.216G>C
Slovak: c.216G>A alepo c.216G>T alepo c.216G>C
English: c.T166A or c.G167C
Slovak: c.T166A alepo c.G167C
English: c.261G>C or c.261G>T
Slovak: c.261G>C alepo c.261G>T
English: c.G540C or c.G540T
Slovak: c.G540C alepo c.G540T
English: c.280T>A or c.281G>C
Slovak: c.280T>A alepo c.281G>C
English: c.305C>G or c.305C>A
Slovak: c.305C>G alepo c.305C>A
English: c.G132T or c.G132C
Slovak: c.G132T alepo c.G132C
English: c.T258G or c.T258A
Slovak: c.T258G alepo c.T258A
English: Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Slovak: Limited Block 1, Blanchardstown Corporate
English: c.148T>C or c.150C>G or c.150C>A
Slovak: c.148T>C alepo c.150C>G alepo c.150C>A
English: c.140G>A or 141G>A
Slovak: c.140G>A alepo 141G>A
English: UNKNOWN (del Exon3?)
Slovak: NEZNÁME (del Exon3?)
English: c.G471C or c.G471T
Slovak: c.G471C alepo c.G471T
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Slovak: V skúšaní u pacientov, ktorí mali skúsenosti s ERT, sa po 18 mesiacoch liečby liekom Galafold pozorovalo štatisticky významné zníženie LVMi (p <
English: c.1074G>T or c.1074G>C
Slovak: c.1074G>T alepo c.1074G>C
English: c.T881G or c.T881A
Slovak: c.T881G alepo c.T881A
English: c.243G>T or c.243G>C
Slovak: c.243G>T alepo c.243G>C
English: c.561G>T or c.561G>A or c.561G>C
Slovak: c.561G>T alepo c.561G>A alepo c.561G>C
English: c.132G>T or c.132G>C
Slovak: c.132G>T alepo c.132G>C
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.
Slovak: 18. mesiaci predstavovala -6,6 (95 % interval spoľahlivosti: -11,0; -2,1; n=31) pre Galafold a -2,0 (95 % interval spoľahlivosti: -11,0; 7,0; n=13) pre ERT.
English: c.471G>C or c.471G>T
Slovak: c.471G>C alepo c.471G>T
English: c.124A>C or c.124A>T
Slovak: c.124A>C alepo c.124A>T
English: c.T514A or c.G515C
Slovak: c.T514A alepo c.G515C
English: c.G611A or G612A
Slovak: c.G611A alepo G612A
English: c.C747G or c.C747A
Slovak: c.C747G alepo c.C747A
English: c.612G>T or c.612G>C
Slovak: c.612G>T alepo c.612G>C
English: c.T148C or c.C150G or c.C150A F50L
Slovak: c.T148C alepo c.C150G alepo c.C150A
English: c.228G>C or c.228G>A or c.228G>T
Slovak: c.228G>C alepo c.228G>A alepo c.228G>T
English: c.166T>A or c.167G>C
Slovak: c.166T>A alepo c.167G>C
English: c.960T>G or c.960T>A
Slovak: c.960T>G alepo c.960T>A
English: c.A840T or c.A840C
Slovak: c.A840T alepo c.A840C
English: UNKNOWN (del Exon1_2?)
Slovak: NEZNÁME (del Exon1_2?)
English: Galafold 123 mg hard capsules Migalastat
Slovak: Galafold 123 mg tvrdé kapsuly migalastát
English: c.982G>A or c.982G>C
Slovak: c.982G>A alepo c.982G>C
English: c.337T>C or c.339T>A or c.339T>G
Slovak: c.337T>C alepo c.339T>A alepo c.339T>G
English: c.[138C>G; 153G>T; 167G>T] c.C138G/G153T/G167T
Slovak: c.[138C>G; 153G>T; 167G>T]
English: c.G612T or c.G612C
Slovak: c.G612T alepo c.G612C
English: c.817T>C or c.819T>A or c.819T>G
Slovak: c.817T>C alepo c.819T>A alepo c.819T>G
English: c.T960G or c.T960A
Slovak: c.T960G alepo c.T960A
English: UNKNOWN (del Exon5_7?)
Slovak: NEZNÁME (del Exon5_7?)
English: Galafold 123 mg hard capsules
Slovak: Galafold 123 mg tvrdé kapsuly
English: c.C897G or c.C897A
Slovak: c.C897G alepo c.C897A
English: c.G1074T or c.G1074C
Slovak: c.G1074T alepo c.G1074C
English: c.G567C or c.G567T
Slovak: c.G567C alepo c.G567T
English: c.G144T or c.G144C
Slovak: c.G144T alepo c.G144C
English: Paraesthesia Dizziness Hypoaesthesia
Slovak: Poruchy nervového systému bolesť hlavy parestézia závraty hypoestézia
English: c.816C>A or c.816C>G
Slovak: c.816C>A alepo c.816C>G
English: c.G1081A or c.G1081C
Slovak: c.G1081A alepo c.G1081C
English: c.A588T or c.A588C
Slovak: c.A588T alepo c.A588C
English: c.G243T or c.G243C
Slovak: c.G243T alepo c.G243C
English: c.G103C or c.G103A
Slovak: c.G103C alepo c.G103A
English: The first Phase 3 trial (ATTRACT) was a randomised open-label active comparator trial that evaluated the efficacy and safety of Galafold compared to enzyme replacement therapy (ERT) (agalsidase beta, agalsidase alfa) in 52 male and female patients with Fabry disease who were receiving ERT prior to trial entry and who have amenable mutations (ERT-experienced trial).
Slovak: Prvé skúšanie fázy 3 (ATTRACT) bolo randomizované otvorené skúšanie s aktívnym porovnávacím liekom, v ktorom sa hodnotila účinnosť a bezpečnosť lieku Galafold v porovnaní s enzýmovou substitučnou liečbou (ERT)
English: c.881T>G or c.881T>A
Slovak: c.881T>G alepo c.881T>A
English: c.153G>A or c.153G>T or c.153G>C
Slovak: c.153G>A alepo c.153G>T alepo c.153G>C
English: c.T784A or c.T784C
Slovak: c.T784A alepo c.T784C
English: LOT:
Slovak: Tel.:
English: c.T154A or c.G155C
Slovak: c.T154A alepo c.G155C
English: c.144G>T or c.144G>C
Slovak: c.144G>T alepo c.144G>C
English: c.258T>G or c.258T>A
Slovak: c.258T>G alepo c.258T>A
English: c.707G>A or c.708G>A
Slovak: c.707G>A alepo c.708G>A
English: c.G734A or c.G735A
Slovak: c.G734A alepo c.G735A
English: c.1081G>A or c.1081G>C
Slovak: c.1081G>A alepo c.1081G>C
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%).
Slovak: %) a z troch dehydrogenovaných metabolitov konjugovaných s O-glukuronidom, M1 až M3 (13
English: c.394G>A or c.394G>C
Slovak: c.394G>A alepo c.394G>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
Slovak: Galafold sa neodporúča používať u pacientov so závažnou renálnou insuficienciou definovanou ako odhadnutá hodnota GFR nižšia ako 30 ml/min/1,73 m2 (pozri časť 5.2).
English: c.G216A or c.G216T or c.G216C M72I
Slovak: c.G216A alepo c.G216T alepo c.G216C
English: c.G831T or c.G831C
Slovak: c.G831T alepo c.G831C
English: c.G830A or c.G831A
Slovak: c.G830A alepo c.G831A
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).
Slovak: Priemerná zmena LVMi od začiatku do 18. - 24. mesiaca u pacientov s hypertrofiou ľavej komory na začiatku (ženy s LVMi na začiatku > 95 g/m2 alebo muži s LVMi na začiatku > 115 g/m2) bola -18,6
English: c.G140A or G141A
Slovak: c.G140A alepo G141A
English: Protein Sequence change c.744delT
Slovak: Zmena sekvencie proteínov c.214delA
English: c.897C>G or c.897C>A
Slovak: c.897C>G alepo c.897C>A
English: c.141G>C or c.141G>T
Slovak: c.141G>C alepo c.141G>T
English: c.G609C or c.G609T
Slovak: c.G609C alepo c.G609T
English: Blood Creatine Phosphokinase increased
Slovak: Laboratórne a funkčné vyšetrenia zvýšená hladina kreatínfosfokinázy v krvi zvýšená telesná hmotnosť
English: c.G71A or c.G72A
Slovak: c.G71A alepo c.G72A
English: c.860G>A or c.861G>A
Slovak: c.860G>A alepo c.861G>A
English: Amicus Therapeutics Europe Limited Tel.: 0808 034 288 / 877 309 5040 e-mail: MedInfo@amicusrx.com
Slovak: Limited Tel.: 0808 034 288 / 877 309 5040 e-mail: MedInfo@amicusrx.com
English: c.540G>C or c.540G>T
Slovak: c.540G>C alepo c.540G>T
English: c.103G>C or c.103G>A
Slovak: c.103G>C alepo c.103G>A
English: c.567G>C or c.567G>T
Slovak: c.567G>C alepo c.567G>T
English: c.609G>C or c.609G>T
Slovak: c.609G>C alepo c.609G>T
English: c.G141C or c.G141T
Slovak: c.G141C alepo c.G141T
English: c.830G>A or c.831G>A
Slovak: c.830G>A alepo c.831G>A
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
Slovak: Priemerná anualizovaná miera zmeny eGFRCKD-EPI u pacientov liečených počas tridsiatich mesiacov liekom Galafold od začiatku liečby bola -1,72 ml/min/1,73 m2 (95 % IS: -2,653; -0,782; n=31).
English: c.G860A or c.G861A
Slovak: c.G860A alepo c.G861A
English: c.734G>A or c.735G>A
Slovak: c.734G>A alepo c.735G>A
English: Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Slovak: Najčastejšie nežiaduce reakcie hlásené pri užívaní lieku Galafold v dávkach do 1 250 mg a 2 000 mg boli bolesť hlavy, závraty, v uvedenom poradí.
English: c.831G>T or c.831G>C
Slovak: c.831G>T alepo c.831G>C
English: Migalastat binding stabilizes these mutant forms of -Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes.
Slovak: v endoplazmatickom retikule a uľahčuje ich náležitú migráciu do lyzozómov.
English: c.G861C or c.G861T
Slovak: c.G861C alepo c.G861T
English: c.T859C or c.T859A
Slovak: c.T859C alepo c.T859A
English: c.486G>C or c.486G>T
Slovak: c.486G>C alepo c.486G>T
English: c.288G>A or c.288G>T or c.288G>C
Slovak: c.288G>A alepo c.288G>T alepo c.288G>C
English: c.784T>A or c.784T>C
Slovak: c.784T>A alepo c.784T>C
English: c.108G>C or c.108G>T
Slovak: c.108G>C alepo c.108G>T
English: c.C159G or c.C159A
Slovak: c.159C>G alepo c.159C>A c.C159G alepo c.C159A
English: c.514T>A or c.515G>C
Slovak: c.514T>A alepo c.515G>C
English: c.154T>A or c.155G>C
Slovak: c.154T>A alepo c.155G>C
English: c.T817C or c.T819A or c.T819G F273L
Slovak: c.T817C alepo c.T819A alepo c.T819G
English: c.G394A or c.G394C
Slovak: c.G394A alepo c.G394C
English: c.T667A or c.G668C
Slovak: c.T667A alepo c.G668C
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.
Slovak: 0,05) zlepšenia oproti začiatku, pokiaľ ide o hnačku a trávenie a pozoroval sa trend zlepšenia, pokiaľ ide o zápchu.
English: c.859T>C or c.859T>A
Slovak: c.859T>C alepo c.859T>A
English: c.T834G or c.T834A
Slovak: c.T834G alepo c.T834A
English: After an average of 3.4 years of treatment, the mean annualised rate of change in eGFRCKD-EPI was -0.74 mL/min/1.73 m
Slovak: Po priemerne 3,4 roka liečby bola priemerná anualizovaná miera zmeny eGFRCKD-EPI -0,74 ml/min/1,73 m2 (95 % IS: -1,89; 0,40; n=41).
English: UNKNOWN (del Exon3_7?)
Slovak: NEZNÁME (del Exon3_7?)
English: c.588A>T or c.588A>C
Slovak: c.588A>T alepo c.588A>C
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Slovak: M353R c.1065C>A alepo c.1065C>G c.C1065A alepo c.C1065G
English: c.A868C or c.A868T
Slovak: c.A868C alepo c.A868T
English: c.T894G or c.T894A
Slovak: c.T894G alepo c.T894A
English: c.G785A or c.G786A
Slovak: c.G785A alepo c.G786A
English: c.G108C or c.G108T
Slovak: c.G108C alepo c.G108T
English: Amicus Therapeutics, UK Limited Tel: +44 175 3888 567 / 08 0823 46864 e-mail: MedInfo@amicusrx.com
Slovak: +44 175 3888 567 / 08 0823 46864 e-mail: MedInfo@amicusrx.com
English: c.G486C or c.G486T
Slovak: c.G486C alepo c.G486T
English: c.834T>G or c.834T>A
Slovak: c.834T>G alepo c.834T>A
English: c.71G>A or c.72G>A
Slovak: c.71G>A alepo c.72G>A
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.
Slovak: Ak uplynie viac ako 12 hodín, pokračujte v užívaní lieku Galafold v najbližší plánovaný deň a čas užitia dávky v súlade s dávkovacím režimom každý druhý deň.
English: c.T280A or c.G281C
Slovak: c.T280A alepo c.G281C
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
Slovak: Po sledovaní v OLE bola priemerná zmena LVMi od začiatku do 36. mesiaca u pacientov s hypertrofiou ľavej komory na začiatku -30,0 (95 % IS: -57,9; -2,2; n=4) a do 48. mesiaca 33,1 (IS: -60,9; -5,4; n=4).
English: See package leaflet for further instructions.
Slovak: Ďalšie pokyny sa nachádzajú v písomnej informácii pre používateľa.
English: c.785G>A or c.786G>A
Slovak: c.785G>A alepo c.786G>A
English: UNKNOWN (del Exon2_3?)
Slovak: NEZNÁME (del Exon2_3?)
English: c.978G>C or c.978G>T
Slovak: c.978G>C alepo c.978G>T
English: c.708G>C or c.708G>T
Slovak: c.708G>C alepo c.708G>T
English: c.702T>G or c.702T>A
Slovak: c.702T>G alepo c.702T>A
English: c.T337C or c.T339A or c.T339G F113L
Slovak: c.T337C alepo c.T339A alepo c.T339G
English: c.G707A or c.G708A
Slovak: c.G707A alepo c.G708A
English: c.837G>C or c.837G>T
Slovak: c.837G>C alepo c.837G>T
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Slovak: Ak plánujete otehotnieť, poraďte sa so svojím lekárom, lekárnikom alebo zdravotnou sestrou.
English: c.894T>G or c.894T>A
Slovak: c.894T>G alepo c.894T>A
English: c.720G>C or c.720G>T
Slovak: c.720G>C alepo c.720G>T
English: c.747C>G or c.747C>A
Slovak: c.747C>G alepo c.747C>A
English: c.870G>A or c.870G>C or c.870G>T
Slovak: c.870G>A alepo c.870G>C alepo c.870G>T
English: c.888G>A or c.888G>T or c.888G>C
Slovak: c.888G>A alepo c.888G>T alepo c.888G>C
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).
Slovak: 18. mesiaca u pacientov s hypertrofiou ľavej komory (ženy s LVMi na začiatku > 95 g/m2 a muži s LVMi na začiatku > 115 g/m2) bola -8,4 (95 % IS: -15,7; 2,6; n=13) pre migalastát a 4,5 (95 % IS: -10,7; 18,4; n=5) pre ERT.
English: c.[790G>T; 805G>A]
Slovak: Zmena sekvencie proteínov c.[790G>T; 805G>A]
English: c.936G>T or c.936G>C
Slovak: c.936G>T alepo c.936G>C
English: c.T402G or c.T402A
Slovak: c.T402G alepo c.T402A
English: c.G772C or c.G772A
Slovak: c.G772C alepo c.G772A
English: c.G729C or c.G729T
Slovak: c.G729C alepo c.G729T
English: c.G837C or c.G837T
Slovak: c.G837C alepo c.G837T
English: c.T702G or c.T702A
Slovak: c.T702G alepo c.T702A
English: c.G561T or c.G561A or c.G561C M187I
Slovak: c.G561T alepo c.G561A alepo c.G561C
English: c.G978C or c.G978T
Slovak: c.G978C alepo c.G978T
English: c.A886T or c.A886C
Slovak: c.A886T alepo c.A886C
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Slovak: R363P c.1095T>A alepo c.1095T>G c.T1095A alepo c.T1095G Y365X c.1115T>A
English: c.706T>C or c.706T>A
Slovak: c.706T>C alepo c.706T>A
English: c.102T>G or c.102T>A
Slovak: c.102T>G alepo c.102T>A
English: c.963G>C or c.963G>T
Slovak: c.963G>C alepo c.963G>T
English: c.840A>T or c.840A>C
Slovak: c.840A>T alepo c.840A>C
English: c.T706C or c.T706A
Slovak: c.T706C alepo c.T706A
English: c.G720C or c.G720T
Slovak: c.G720C alepo c.G720T
English: c.G708C or c.G708T
Slovak: c.G708C alepo c.G708T
English: c.667T>A or c.668G>C
Slovak: c.667T>A alepo c.668G>C
English: c.A712C or c.T714A or c.T714G S238R
Slovak: c.A712C alepo c.T714A alepo c.T714G
English: c.T70C or c.T70A
Slovak: c.T70C alepo c.T70A
English: c.729G>C or c.729G>T
Slovak: c.729G>C alepo c.729G>T
English: c.402T>G or c.402T>A
Slovak: c.402T>G alepo c.402T>A
English: c.T102G or c.T102A
Slovak: c.T102G alepo c.T102A
English: Amicus Therapeutics Europe Limited Tfn: 020 795 493 e-post: MedInfo@amicusrx.com
Slovak: Limited Tfn: 020 795 493 e-post: MedInfo@amicusrx.com
English: c.G228C or c.G228A or c.G228T M76I
Slovak: c.G228C alepo c.G228A alepo c.G228T
English: c.G126A or c.G126C or c.G126T M42I
Slovak: c.G126A alepo c.G126C alepo c.G126T
English: c.C279G or c.C279A
Slovak: c.279C>G alepo c.279C>A c.C279G alepo c.C279A
English: c.886A>T or c.886A>C
Slovak: c.886A>T alepo c.886A>C
English: Diarrhoea Nausea
Slovak: Psychické poruchy depresia
English: c.868A>C or c.868A>T
Slovak: c.868A>C alepo c.868A>T
English: c.72G>C or c.72G>T
Slovak: c.72G>C alepo c.72G>T
English: c.G778C or c.G778A
Slovak: c.G778C alepo c.G778A
English: c.678G>T or c.678G>C
Slovak: c.678G>T alepo c.678G>C
English: Do not take Galafold if you:
Slovak: Neužívajte Galafold
English: Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Slovak: Galafold hlásené v klinických skúšaniach
English: c.70T>C or c.70T>A
Slovak: c.70T>C alepo c.70T>A
English: c.G288A or c.G288T or c.G288C M96I
Slovak: c.G288A alepo c.G288T alepo c.G288C
English: c.G153A or c.G153T or c.G153C M51I
Slovak: c.G153A alepo c.G153T alepo c.G153C
English: c.772G>C or c.772G>A
Slovak: c.772G>C alepo c.772G>A
English: Patient-Reported Outcome - Gastrointestinal Symptoms Rating Scale In the ERT-naïve trial, analyses of the Gastrointestinal Symptoms Rating Scale demonstrated that treatment with Galafold was associated with statistically significant (p<0.05) improvements versus placebo from baseline to month 6 in the diarrhoea domain, and in the reflux domain for patients with symptoms at baseline.
Slovak: V skúšaní u pacientov, ktorí nedostávali ERT, analýzy stupnice hodnotenia gastrointestinálnych symptómov preukázali, že liečba liekom Galafold sa spájala so štatisticky významnými (p <
English: c.786G>C or c.786G>T
Slovak: c.786G>C alepo c.786G>T
English: Protein Sequence change p.T412Sfs*37
Slovak: p.T412Sfs*37
English: Amicus Therapeutics Europe Limited Teл.
Slovak: Therapeutics Europe Limited Tél/Tel:
English: c.1023A >C or c.1023A>T
Slovak: >C alepo c.1023A>T
English: c.G678T or c.G678C
Slovak: c.G678T alepo c.G678C
English: c.G786C or c.G786T
Slovak: c.G786C alepo c.G786T
English: : 00800 111 3214 имейл: MedInfo@amicusrx.com
Slovak: Limited Teл.: 00800 111 3214 имейл: MedInfo@amicusrx.com
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Slovak: Priemerná anualizovaná miera zmeny eGFRCKD-EPI bola -0,40 ml/min/1,73 m2 (95 % IS: -2,272; 1,478; n=34) v skupine užívajúcej liek Galafold v porovnaní s -1,03 ml/min/1,73 m2
English: c.778G>C or c.778G>A
Slovak: c.778G>C alepo c.778G>A
English: c.G888A or c.G888T or c.G888C M296I
Slovak: c.G888A alepo c.G888T alepo c.G888C
English: Amicus Therapeutics Europe Limited Tlf: 800 13837 e-post: MedInfo@amicusrx.com
Slovak: Limited Tlf: 800 13837 e-post: MedInfo@amicusrx.com
English: c.G72C or c.G72T
Slovak: c.G72C alepo c.G72T
English: Protein Sequence change c.290delC
Slovak: Zmena sekvencie proteínov c.722delG
English: c.T139C or c.T139A
Slovak: c.139T>C alepo c.139T>A c.T139C alepo c.T139A
English: • Protein in the urine
Slovak: • bielkovina v moči
English: You should not take Galafold if you are also receiving enzyme replacement therapy.
Slovak: Ak dostávate aj enzýmovú substitučnú liečbu, neužívajte liek Galafold.
English: c.G963C or c.G963T
Slovak: c.G963C alepo c.G963T
English: c.1018T>C or c.1018T>A c.T1018C or c.T1018A
Slovak: V339G c.1018T>C alepo c.1018T>A
English: c.[1067G>A; 1078G>C]
Slovak: N355K c.[1067G>A; 1078G>C]
English: c.G870A or c.G870C or c.G870T M290I
Slovak: c.G870A alepo c.G870C alepo c.G870T
English: c.G936T or c.G936C
Slovak: c.G936T alepo c.G936C
English: c.A442C or c.T444A or c.T444G S148R
Slovak: c.A442C alepo c.T444A alepo c.T444G
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Slovak: W340R c.1019G>A alepo c.1020G>A