FrancophonIA/ELRC3.0 huggingface dataset:
English: A pharmacokinetic trial in healthy male volunteers with 150 mg [
Polish: Badanie farmakokinetyczne u zdrowych ochotników płci męskiej ze 150 mg [14C]-migalastatu HCl wykazało,
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Polish: W badaniu u osób stosujących wcześniej ERT czynność nerek pozostawała stabilna przez okres do 18 miesięcy leczenia produktem Galafold.
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).
Polish: Pacjenci losowo przydzieleni do grupy otrzymującej Galafold w etapie 1 wykazywali znamiennie statystycznie większe obniżenie (±SEM) średniego odkładania GL-3 w śródmiąższowych naczyniach włosowatych (-0,25±0,10; -39%) w 6. miesiącu w porównaniu do placebo (+0,07 ± 0,13; +14%) (p=0,008).
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.
Polish: Ocena efektów leczenia przez pacjentów - skala oceny objawów ze strony układu pokarmowego W badaniu u osób nieleczonych wcześniej ERT analiza skali oceny objawów ze strony układu pokarmowego wykazała, że leczenie produktem Galafold było związane ze znamienną statystycznie (p<0,05) poprawą w stosunku do placebo od punktu wyjściowego do 6. miesiąca w zakresie biegunki i w zakresie refluksu dla pacjentów z objawami w punkcie wyjściowym.
English: This is a common spontaneous tumour in ad libitum-fed male rats.
Polish: Jest to częsty samoistnie powstający guz u samców szczurów karmionych ad libitum.
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%).
Polish: że 99% radioznakowanej dawki odzyskanej w osoczu składało się z migalastatu w niezmienionej postaci (77%) i 3 odwodornionych metabolitów sprzężonych z O-glukuronidem, M1 do M3 (13%).
English: Do not take Galafold if you:
Polish: Kiedy nie przyjmować leku Galafold:
English: • Indigestion (dyspepsia)
Polish: • Nudności (mdłości)
English: Marketing Authorisation Holder Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Polish: Podmiot odpowiedzialny Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Polish: W badaniu u osób otrzymujących wcześniej ERT po 18 miesiącach leczenia produktem Galafold odnotowano istotny statystycznie spadek LVMi (p< 0,05).
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Polish: c.1196G>A lub c.1197G>A c.G1196A lub c.G1197A
English: Galafold should not be taken on 2 consecutive days.
Polish: Produktu Galafold nie należy przyjmować w ciągu 2 kolejnych dni.
English: Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Polish: Najczęstszymi reakcjami niepożądanymi zgłaszanymi przy dawkach produktu Galafold wynoszących do 1250 mg i 2000 mg były odpowiednio ból głowy i zawroty głowy.
English: No reduction in proteinuria was observed in patients treated with Galafold.
Polish: U pacjentów leczonych produktem Galafold nie obserwowano zmniejszenia białkomoczu.
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
Polish: W badaniu pojedynczej dawki dla produktu Galafold u osób nie cierpiących na chorobę Fabry`ego z różnym stopniem niewydolności nerek ekspozycja wzrosła 4,3-krotnie u osób z ciężkim upośledzeniem czynności nerek (GFR < 30 ml/min/1,73 m2).
English: c.G611A or G612A
Polish: c.G611A lub G612A
English: Do not eat food at least 2 hours before and 2 hours after taking your medicine.
Polish: Nie spożywać posiłku w ciągu co najmniej 2 godzin przed i 2 godzin po przyjęciu produktu Galafold.
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Polish: c.1019G>A lub c.1020G>A c.G1019A lub c.G1020A
English: p.A20_W24del p.A20_G28delfs*2
Polish: Zmiana sekwencji białkowej p.A20_G28delfs*2
English: If more than 12 hours has passed the patient should resume taking Galafold at the next planned dosing day and time according to the every other day dosing schedule.
Polish: Jeśli upłynęło ponad 12 godzin należy wznowić przyjmowanie produktu Galafold w dniu i porze przyjęcia kolejnej dawki, przestrzegając harmonogramu przewidującego dawkowanie co drugi dzień.
English: In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Polish: W badaniu osób niestosujących ERT i w przedłużeniu badania prowadzonym metodą otwartej próby czynność nerek pozostawała stabilna przez maksymalnie 5 lat leczenia produktem Galafold.
English: In patients with amenable mutations, GL-3 levels tended to decrease in urine and in kidney interstitial capillaries.
Polish: U pacjentów z wrażliwymi mutacjami poziom GL-3 w moczu i śródmiąższowych naczyniach włosowatych w nerkach miał tendencje do spadku.
English: c.A504C or c.A504T
Polish: c.A504C lub c.A504T
English: c.T1147C or c.C1149G or c.C1149A
Polish: c.T1147C lub c.C1149G lub c.C1149A
English: c.140G>A or 141G>A
Polish: c.140G>A lub 141G>A
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Polish: c.1202C>G lub c.1202C>A c.C1202G lub c.C1202A
English: Always take this medicine exactly as your doctor, pharmacist, or nurse has told you.
Polish: Ten lek należy zawsze stosować zgodnie z zaleceniami lekarza, farmaceuty lub pielęgniarki.
English: Fabry disease is a progressive X-linked lysosomal storage disorder which affects males and females.
Polish: Choroba Fabry`ego jest postępującą chorobą spichrzeniową związaną z chromosomem X, występującą u mężczyzn i kobiet.
English: Protein Sequence change c.290delC
Polish: Zmiana sekwencji białkowej c.590delG
English: g.2594_10904dup c.195-2500_999+197dup
Polish: g.2594_10904dup c.195-2500_999+197dup g.2934_6378del
English: C]-migalastat hydrochloride revealed that approximately 77% of the radiolabeled dose was recovered in urine of which 55% of was excreted as unchanged migalastat and 4% as combined metabolites M1, M2 and M3.
Polish: Badanie farmakokinetyczne u zdrowych ochotników płci męskiej ze 150 mg [14C]-migalastatu chlorowodorku wykazało, że około 77% radioznakowanej dawki odzyskano w moczu, w tym 55% zostało wydalone jako migalastat w postaci niezmienionej, a 4% jako łączne metabolity M1, M2 i M3. Około 5% całkowitej radioaktywności próbki pochodziło z nieokreślonych składników.
English: c.A924T or c.A924C
Polish: c.A924T lub c.A924C
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).
Polish: Po obserwacji w ramach OLE, średnia zmiana LVMi po w 36. miesiącu w stosunku do wartości wyjściowej wyniosła -8,3 (95% CI: -17,1, 0,4; n=25) a w 48. miesiącu -9,1 (95% CI: -20,3, 2,0, n=18).
English: Protein Sequence change c.1A>C or c.1A>T
Polish: Zmiana sekwencji białkowej c.1A>C lub c.1A>T
English: You should not take Galafold if you are also receiving enzyme replacement therapy.
Polish: Leku Galafold nie należy przyjmować, jeżeli pacjent otrzymuje jednocześnie enzymatyczną terapię zastępczą.
English: g.10237_11932del/11933_12083i nv/12084_12097del
Polish: g.10237_11932del/11933_12083i nv/12084_12097del g.>5.5kbdel w 3UTR
English: c.611G>A or 612G>A
Polish: c.611G>A lub 612G>A
English: • Sensation of spinning
Polish: • Uczucie wirowania
English: c.442A>C or c.444T>A or c.444T>G
Polish: c.442A>C lub c.444T>A lub c.444T>G
English: Blood Creatine Phosphokinase increased
Polish: Badania diagnostyczne wzrost stężenia fosfokinazy kreatynowej we krwi zwiększenie masy ciała
English: c.504A>C or c.504A>T
Polish: c.504A>C lub c.504A>T
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Polish: c.1034C>G lub c.1034C>A c.C1034G lub c.C1034A
English: c.1045T>C or c.1045T>A c.T1045C or c.T1045A
Polish: c.1045T>C lub c.1045T>A c.T1045C lub c.T1045A
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Polish: c.1095T>A lub c.1095T>G c.T1095A lub c.T1095G
English: c.G412A or c.G412C
Polish: c.G412A lub c.G412C
English: c.C519A or c.C519G
Polish: c.C519A lub c.C519G
English: c.C816A or c.C816G
Polish: c.C816A lub c.C816G
English: c.T139C or c.T139A
Polish: c.T139C lub c.T139A
English: c.C159G or c.C159A
Polish: c.C159G lub c.C159A
English: c.C207A or c.C207G
Polish: c.C207A lub c.C207G
English: c.280T>A or c.281G>C
Polish: c.280T>A lub c.281G>C
English: c.G140A or G141A
Polish: c.G140A lub G141A
English: c.A124C or c.A124T
Polish: c.A124C lub c.A124T
English: How to take Galafold
Polish: Jak przyjmować lek Galafold
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Polish: c.1065C>A lub c.1065C>G c.C1065A lub c.C1065G
English: c.561G>T or c.561G>A or c.561G>C
Polish: c.561G>T lub c.561G>A lub c.561G>C
English: c.G103C or c.G103A
Polish: c.G103C lub c.G103A
English: Hepatic impairment No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Polish: Nie jest wymagana modyfikacja dawki produktu Galafold u pacjentów z zaburzeniem czynności wątroby (patrz punkt 5.2).
English: c.G284A or c.G285A
Polish: c.G284A lub c.G285A
English: c.1147T>C or c.1149C>G or c.1149C>A
Polish: c.1147T>C lub c.1149C>G lub c.1149C>A
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).
Polish: W badaniu u osób nieotrzymujących wcześniej ERT Galafold spowodował istotny statystycznie spadek LVMi (p< 0,05); średnia zmiana od wartości wyjściowej po upływie 18. do 24. miesięcy wynosiła 7,7 (95% CI: -15,4, -0,01; n=27).
English: c.924A>T or c.924A>C
Polish: c.924A>T lub c.924A>C
English: c.139T>C or c.139T>A
Polish: c.139T>C lub c.139T>A
English: c.216G>A or c.216G>T or c.216G>C
Polish: c.216G>A lub c.216G>T lub c.216G>C
English: c.412G>A or c.412G>C
Polish: c.412G>A lub c.412G>C
English: c.1046G>A or c.1047G>A c.G1046A or c.G1047A
Polish: c.1046G>A lub c.1047G>A c.G1046A lub c.G1047A
English: c.T241C or c.T241A
Polish: c.T241C lub c.T241A
English: c.148T>C or c.150C>G or c.150C>A
Polish: c.148T>C lub c.150C>G lub c.150C>A
English: c.T881G or c.T881A
Polish: c.T881G lub c.T881A
English: c.G982A or c.G982C
Polish: c.G982A lub c.G982C
English: c.G471C or c.G471T
Polish: c.G471C lub c.G471T
English: c.C233G or c.C233A
Polish: c.C233G lub c.C233A
English: How to store Galafold
Polish: Jak przechowywać lek Galafold
English: c.T187A or c.G188C
Polish: c.T187A lub c.G188C
English: c.817T>C or c.819T>A or c.819T>G
Polish: c.817T>C lub c.819T>A lub c.819T>G
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.
Polish: Wartości wyjściowe wynosiły 95,3 g/m2 dla grupy Galafold i 92,9 g/m2 dla grupy ERT, a średnia zmiana LVMi w miesiącu 18 w porównaniu z poziomem wyjściowym wynosiła -6,6 (przedział ufności 95% CI: -11,0, -2,1; n=31) dla Galafold i -2,0 (przedział ufności 95% CI: -11,0, 7,0; n=13) dla ERT.
English: c.C279G or c.C279A
Polish: c.C279G lub c.C279A
English: c.G131A or c.G132A
Polish: c.G131A lub c.G132A
English: c.G285T or c.G285C
Polish: c.G285T lub c.G285C
English: c.159C>G or c.159C>A
Polish: c.159C>G lub c.159C>A
English: c.337T>C or c.339T>A or c.339T>G
Polish: c.337T>C lub c.339T>A lub c.339T>G
English: c.G261C or c.G261T
Polish: c.G261C lub c.G261T
English: c.187T>A or c.188G>C
Polish: c.187T>A lub c.188G>C
English: c.G540C or c.G540T
Polish: c.G540C lub c.G540T
English: c.C525G or c.C525A
Polish: c.C525G lub c.C525A
English: c.612G>T or c.612G>C
Polish: c.612G>T lub c.612G>C
English: c.G242A or c.G243A
Polish: c.G242A lub c.G243A
English: c.153G>A or c.153G>T or c.153G>C
Polish: c.153G>A lub c.153G>T lub c.153G>C
English: c.261G>C or c.261G>T
Polish: c.261G>C lub c.261G>T
English: c.284G>A or c.285G>A
Polish: c.284G>A lub c.285G>A
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Polish: Jeśli pacjentka planuje mieć dziecko, powinna poradzić się lekarza lub farmaceuty.
English: c.T148C or c.C150G or c.C150A F50L
Polish: c.T148C lub c.C150G lub c.C150A
English: c.G734A or c.G735A
Polish: c.G734A lub c.G735A
English: c.T166A or c.G167C
Polish: c.T166A lub c.G167C
English: c.285G>T or c.285G>C
Polish: c.285G>T lub c.285G>C
English: c.241T>C or c.241T>A
Polish: c.241T>C lub c.241T>A
English: c.T552A or c.T552G
Polish: c.T552A lub c.T552G
English: c.519C>A or c.519C>G
Polish: c.519C>A lub c.519C>G
English: c.552T>A or c.552T>G
Polish: c.552T>A lub c.552T>G
English: (torticollis)
Polish: (białkomocz)
English: c.G612T or c.G612C
Polish: c.G612T lub c.G612C
English: c.207C>A or c.207C>G
Polish: c.207C>A lub c.207C>G
English: c.242G>A or c.243G>A
Polish: c.242G>A lub c.243G>A
English: c.124A>C or c.124A>T
Polish: c.124A>C lub c.124A>T
English: c.C747G or c.C747A
Polish: c.C747G lub c.C747A
English: c.C305G or c.C305A
Polish: c.C305G lub c.C305A
English: c.982G>A or c.982G>C
Polish: c.982G>A lub c.982G>C
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
Polish: Średnio po 3,4 latach leczenia średni wskaźnik zmiany eGFRCKD-EPI w ujęciu rocznym wynosił -0,74 ml/min/1,73 m2 (95% CI: -1,89, 0,40, n=41).
English: c.C453G or c.C453A
Polish: c.C453G lub c.C453A
English: Galafold has not been studied in patients with Fabry disease who have a GFR less than 30 mL/min/1.73 m2.
Polish: Nie badano produktu Galafold u pacjentów z chorobą Fabry`ego, u których GFR wynosi poniżej 30 ml/min/1,73 m2.
English: c.T258G or c.T258A
Polish: c.T258G lub c.T258A
English: c.G132T or c.G132C
Polish: c.G132T lub c.G132C
English: c.G243T or c.G243C
Polish: c.G243T lub c.G243C
English: c.C897G or c.C897A
Polish: c.C897G lub c.C897A
English: c.132G>T or c.132G>C
Polish: c.132G>T lub c.132G>C
English: c.G609C or c.G609T
Polish: c.G609C lub c.G609T
English: c.T960G or c.T960A
Polish: c.T960G lub c.T960A
English: c.G144T or c.G144C
Polish: c.G144T lub c.G144C
English: c.279C>G or c.279C>A
Polish: c.279C>G lub c.279C>A
English: c.816C>A or c.816C>G
Polish: c.816C>A lub c.816C>G
English: c.243G>T or c.243G>C
Polish: c.243G>T lub c.243G>C
English: c.T514A or c.G515C
Polish: c.T514A lub c.G515C
English: c.G567C or c.G567T
Polish: c.G567C lub c.G567T
English: c.233C>G or c.233C>A
Polish: c.233C>G lub c.233C>A
English: c.A840T or c.A840C
Polish: c.A840T lub c.A840C
English: c.T280A or c.G281C
Polish: c.T280A lub c.G281C
English: c.144G>T or c.144G>C
Polish: c.144G>T lub c.144G>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
Polish: Galafold nie jest wskazany do stosowania u pacjentów z ciężką niewydolnością nerek, które zdefiniowano jako szacowaną wartość GFR poniżej 30 ml/min/1,73m2 (patrz punkt 5.2).
English: c.103G>C or c.103G>A
Polish: c.103G>C lub c.103G>A
English: UNKNOWN (del Exon1_2?)
Polish: NIEZNANA (del Exon1_2?)
English: c.525C>G or c.525C>A
Polish: c.525C>G lub c.525C>A
English: c.T610C or c.T610A
Polish: c.T610C lub c.T610A
English: UNKNOWN (del Exon5_7?)
Polish: NIEZNANA (del Exon5_7?)
English: c.258T>G or c.258T>A
Polish: c.258T>G lub c.258T>A
English: c.707G>A or c.708G>A
Polish: c.707G>A lub c.708G>A
English: c.T859C or c.T859A
Polish: c.T859C lub c.T859A
English: c.A588T or c.A588C
Polish: c.A588T lub c.A588C
English: c.T154A or c.G155C
Polish: c.T154A lub c.G155C
English: c.540G>C or c.540G>T
Polish: c.540G>C lub c.540G>T
English: c.T369G or c.T369A
Polish: c.T369G lub c.T369A
English: c.G831T or c.G831C
Polish: c.G831T lub c.G831C
English: c.609G>C or c.609G>T
Polish: c.609G>C lub c.609G>T
English: c.G141C or c.G141T
Polish: c.G141C lub c.G141T
English: c.141G>C or c.141G>T
Polish: c.141G>C lub c.141G>T
English: c.G830A or c.G831A
Polish: c.G830A lub c.G831A
English: c.830G>A or c.831G>A
Polish: c.830G>A lub c.831G>A
English: UNKNOWN (del Exon3?)
Polish: NIEZNANA (del Exon3?)
English: c.734G>A or c.735G>A
Polish: c.734G>A lub c.735G>A
English: c.881T>G or c.881T>A
Polish: c.881T>G lub c.881T>A
English: c.166T>A or c.167G>C
Polish: c.166T>A lub c.167G>C
English: c.108G>C or c.108G>T
Polish: c.108G>C lub c.108G>T
English: c.G216A or c.G216T or c.G216C M72I
Polish: c.G216A lub c.G216T lub c.G216C
English: c.567G>C or c.567G>T
Polish: c.567G>C lub c.567G>T
English: c.T408A or c.T408G
Polish: c.T408A lub c.T408G
English: c.305C>G or c.305C>A
Polish: c.305C>G lub c.305C>A
English: c.T465A or c.T465G
Polish: c.T465A lub c.T465G
English: c.G860A or c.G861A
Polish: c.G860A lub c.G861A
English: c.453C>G or c.453C>A
Polish: c.453C>G lub c.453C>A
English: c.870G>A or c.870G>C or c.870G>T
Polish: c.870G>A lub c.870G>C lub c.870G>T
English: c.C966A or c.C966G
Polish: c.C966A lub c.C966G
English: c.G485A or c.G486A
Polish: c.G485A lub c.G486A
English: c.960T>G or c.960T>A
Polish: c.960T>G lub c.960T>A
English: Psychiatric disorders
Polish: Zaburzenia psychiczne depresja
English: Do not take Galafold on two consecutive days.
Polish: Nie przyjmować leku Galafold w ciągu dwóch kolejnych dni.
English: c.G108C or c.G108T
Polish: c.G108C lub c.G108T
English: c.439G>A or c.439G>C
Polish: c.439G>A lub c.439G>C
English: c.71G>A or c.72G>A
Polish: c.71G>A lub c.72G>A
English: c.831G>T or c.831G>C
Polish: c.831G>T lub c.831G>C
English: c.C456A or c.C456G
Polish: c.C456A lub c.C456G
English: c.G71A or c.G72A
Polish: c.G71A lub c.G72A
English: c.G439A or c.G439C
Polish: c.G439A lub c.G439C
English: c.G394A or c.G394C
Polish: c.G394A lub c.G394C
English: c.G861C or c.G861T
Polish: c.G861C lub c.G861T
English: Musculoskeletal and connective tissue disorders
Polish: Zaburzenia mięśniowoszkieletowe i tkanki łącznej skurcze mięśni bóle mięśniowe kręcz szyi ból kończyny
English: c.860G>A or c.861G>A
Polish: c.860G>A lub c.861G>A
English: c.888G>A or c.888G>T or c.888G>C
Polish: c.888G>A lub c.888G>T lub c.888G>C
English: c.859T>C or c.859T>A
Polish: c.859T>C lub c.859T>A
English: c.T676C or c.T676A
Polish: c.T676C lub c.T676A
English: c.T337C or c.T339A or c.T339G F113L
Polish: c.T337C lub c.T339A lub c.T339G
English: c.394G>A or c.394G>C
Polish: c.394G>A lub c.394G>C
English: c.897C>G or c.897C>A
Polish: c.897C>G lub c.897C>A
English: c.154T>A or c.155G>C
Polish: c.154T>A lub c.155G>C
English: c.288G>A or c.288G>T or c.288G>C
Polish: c.288G>A lub c.288G>T lub c.288G>C
English: c.514T>A or c.515G>C
Polish: c.514T>A lub c.515G>C
English: c.G486C or c.G486T
Polish: c.G486C lub c.G486T
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
Polish: Po obserwacji w ramach OLE, średnia zmiana LVMi w stosunku do wartości wyjściowej u pacjentów z hipertrofią lewej komory w punkcie wyjściowym w 36. miesiącu wyniosła -30,0 (95% CI: -57,9, -2,2; n=4) a w 48. miesiącu 33,1 (CI: -60,9, -5,4, n=4).
English: c.966C>A or c.966C>G
Polish: c.966C>A lub c.966C>G
English: c.708G>C or c.708G>T
Polish: c.708G>C lub c.708G>T
English: p.I303Mfx*10
Polish: Zmiana sekwencji białkowej p.I303Mfx*10
English: c.T648A or c.T648G
Polish: c.T648A lub c.T648G
English: c.G837C or c.G837T
Polish: c.G837C lub c.G837T
English: c.588A>T or c.588A>C
Polish: c.588A>T lub c.588A>C
English: (95% CI: -2.653, -0.782; n=31).
Polish: g/m2) wyniosła -18,6 (95% CI: -38,2, 1,0; n=8).
English: Respiratory, thoracic, and mediastinal disorders
Polish: Zaburzenia układu oddechowego, klatki piersiowej i śródpiersia duszność krwawienia z nosa
English: c.T817C or c.T819A or c.T819G F273L
Polish: c.T817C lub c.T819A lub c.T819G
English: Table 2: Galafold (migalastat) amenability table
Polish: Tabela 2: Tabela wrażliwości na Galafold (migalastat)
English: c.T834G or c.T834A
Polish: c.T834G lub c.T834A
English: c.485G>A or c.486G>A
Polish: c.485G>A lub c.486G>A
English: UNKNOWN (del Exon3_7?)
Polish: NIEZNANA (del Exon3_7?)
English: c.861G>C or c.861G>T
Polish: c.861G>C lub c.861G>T
English: c.T667A or c.G668C
Polish: c.T667A lub c.G668C
English: MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
Polish: MINIMUM INFORMACJI ZAMIESZCZANYCH NA OPAKOWANIU BEZPOŚREDNIM RĘKAW BLISTRA
English: c.465T>A or c.465T>G
Polish: c.465T>A lub c.465T>G
English: c.G126A or c.G126C or c.G126T M42I
Polish: c.G126A lub c.G126C lub c.G126T
English: c.T102G or c.T102A
Polish: c.T102G lub c.T102A
English: c.A868C or c.A868T
Polish: c.A868C lub c.A868T
English: c.408T>A or c.408T>G
Polish: c.408T>A lub c.408T>G
English: c.A712C or c.T714A or c.T714G S238R
Polish: c.A712C lub c.T714A lub c.T714G
English: c.102T>G or c.102T>A
Polish: c.102T>G lub c.102T>A
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Polish: M1R c.3G>A lub c.3G>T lub c.3G>C c.G3A lub c.G3T lub c.G3C M1I c.19G>T
English: c.456C>A or c.456C>G
Polish: c.456C>A lub c.456C>G
English: c.676T>C or c.676T>A
Polish: c.676T>C lub c.676T>A
English: While taking Galafold you should use effective birth control.
Polish: Podczas stosowania leku Galafold należy stosować skuteczne środki antykoncepcyjne.
English: c.837G>C or c.837G>T
Polish: c.837G>C lub c.837G>T
English: c.C666A or c.C666G
Polish: c.C666A lub c.C666G
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Polish: SPOSÓB I <DROGA> <DROGI> PODANIA
English: c.T70C or c.T70A
Polish: c.T70C lub c.T70A
English: c.T687A or c.T687G
Polish: c.T687A lub c.T687G
English: c.G707A or c.G708A
Polish: c.G707A lub c.G708A
English: c.G936T or c.G936C
Polish: c.G936T lub c.G936C
English: c.486G>C or c.486G>T
Polish: c.486G>C lub c.486G>T
English: c.T402G or c.T402A
Polish: c.T402G lub c.T402A
English: c.T894G or c.T894A
Polish: c.T894G lub c.T894A
English: c.70T>C or c.70T>A
Polish: c.70T>C lub c.70T>A
English: c.T484C or c.T484A
Polish: c.T484C lub c.T484A
English: c.G153A or c.G153T or c.G153C M51I
Polish: c.G153A lub c.G153T lub c.G153C
English: c.784T>A or c.784T>C
Polish: c.784T>A lub c.784T>C
English: c.G963C or c.G963T
Polish: c.G963C lub c.G963T
English: g.6547_9783del
Polish: Zmiana sekwencji białkowej g.6547_9783del
English: c.840A>T or c.840A>C
Polish: c.840A>T lub c.840A>C
English: c.747C>G or c.747C>A
Polish: c.747C>G lub c.747C>A
English: c.712A>C or c.714T>A or c.714T>G
Polish: Zmiana sekwencji białkowej c.712A>C lub c.714T>A lub c.714T>G
English: There was no detectable plasma protein binding following administration of [
Polish: Nie stwierdzono wykrywalnego wiązania z białkami osocza po podaniu [14C]-migalastatu chlorowodorku w zakresie stężeń od 1 do 100 M.
English: c.720G>C or c.720G>T
Polish: c.720G>C lub c.720G>T
English: c.978G>C or c.978G>T
Polish: c.978G>C lub c.978G>T
English: c.G978C or c.G978T
Polish: c.G978C lub c.G978T
English: c.G772C or c.G772A
Polish: c.G772C lub c.G772A
English: c.369T>G or c.369T>A
Polish: c.369T>G lub c.369T>A
English: c.G228C or c.G228A or c.G228T M76I
Polish: c.G228C lub c.G228A lub c.G228T
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).
Polish: Zmiana LVMi (g/m2) od wartości początkowej do 18. miesiąca u pacjentów z hipertrofią lewej komory (kobiety z wyjściową wartością LVMi > 95 g/m2 i mężczyźni z wyjściową wartością LVMi > 115 g/m2) wynosiła -8,4 (95% CI: -15,7,
English: c.G778C or c.G778A
Polish: c.G778C lub c.G778A
English: c.T784A or c.T784C
Polish: c.T784A lub c.T784C
English: c.729G>C or c.729G>T
Polish: c.729G>C lub c.729G>T