FrancophonIA/ELRC3.0 huggingface dataset:
English: Based upon in vivo data, migalastat is a substrate for UGT, being a minor elimination pathway.
Croatian: Na temelju podataka in vivo zaključuje se da je migalastat supstrat za UGT enzim koji predstavlja manje značajan put eliminacije.
English: Elderly population No dosage adjustment is required based on age (see section 5.2).
Croatian: Starija populacija Nije potrebna prilagodba doze na temelju dobi (vidjeti dio 5.2).
English: This enzyme defect leads to abnormal deposits of a fatty substance known as globotriaosylceramide (GL-3) in kidneys, heart, and other organs, leading to the symptoms of Fabry disease.
Croatian: Oštećenje tog enzima dovodi do abnormalnog taloženja masne tvari poznate pod nazivom globotriaozilceramid (GL-3) u bubrezima, srcu i ostalim organima, što dovodi do pojave simptoma Fabryjeve bolesti.
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.
Croatian: Uzimajte kapsule na neparne dane i bušite perforirane krugove na parne dane do (uključujući) 28. dana.
English: Do not eat food at least 2 hours before and 2 hours after taking your medicine to give a minimum 4 hours fast.
Croatian: Nemojte jesti najmanje 2 sata prije i 2 sata poslije uzimanja lijeka kako biste omogućili najmanje 4 sata posta.
English: Migalastat binding stabilizes these mutant forms of -Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes.
Croatian: Vezivanje migalastata stabilizira te mutirane oblike enzima -Gal A u endoplazmatskom retikulumu i olakšava njihov pravilan transport do lizosoma.
English: There are limited data from the use of Galafold in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni lijeka Galafold u trudnica.
English: Qualitative reductions in GL-3 levels were observed in multiple renal cell types: podocytes, mesangial cells, and glomerular endothelial cells, respectively, over 12 months of treatment with Galafold.
Croatian: Kvalitativna smanjenja razina GL-3 primijećena su u više vrsta bubrežnih stanica: podocitima, mezangijalnim stanicama, glomerularnim endotelnim stanicama, tijekom 12 mjeseci liječenja lijekom Galafold.
English: Pack size of 14 capsules.
Croatian: Pakiranje od 14 kapsula.
English: Migalastat did not affect fertility in female rats.
Croatian: Migalastat nije imao učinka na plodnost u ženki štakora.
English: If a dose is missed entirely for the day, the patient should take the missed dose of Galafold only if it is within 12 hours of the normal time the dose is taken.
Croatian: Ako je propustio dozu za cijeli jedan dan, bolesnik treba uzeti propuštenu dozu lijeka Galafold samo ako je to unutar 12 sati od uobičajenog vremena uzimanja doze.
English: (95% CI: -3.636, 1.575; n=18) in the ERT group.
Croatian: (95 % CI: -3,636; 1,575; n = 18) u skupini koja je primala ERT.
English: Fax: +353 (0) 1 588 6851 e-mail: info@amicusrx.co.uk
Croatian: Fax: +353 (0) 1 588 6851 e-pošta: info@amicusrx.co.uk
English: Plasma lyso- Gb3 levels also remained low in patients on ERT for up to 18 months.
Croatian: Razine lyso-Gb3 u plazmi također su ostale niske u bolesnika koji su primali ERT u razdoblju do 18 mjeseci.
English: The infertility associated with migalastat treatment was reported at clinically relevant exposures.
Croatian: Neplodnost povezana s liječenjem migalastatom zabilježena je pri klinički značajnim izloženostima.
English: In rabbits, developmental toxicity was observed only at maternally toxic doses (see section 5.3).
Croatian: U kunića je razvojna toksičnost uočena samo pri dozama toksičnim za majku (vidjeti dio 5.3).
English: Fabry disease-causing mutations in the GLA gene result in a deficiency of the lysosomal enzyme -galactosidase A (-Gal A) that is required for glycosphingolipid substrate (e.g., GL-3, lyso-Gb3) metabolism.
Croatian: Mutacije u genu GLA koje uzrokuju Fabryjevu bolest dovode do nedostatka lizosomskog enzima -galaktozidaze A (-Gal A) koji je potreban za metabolizam supstrata glikosfingolipida (npr. supstrata GL-3, lyso-Gb3).
English: c.760-762delGTT or c.761-763del c.760_762delGTT or c.761_763del p.V254del
Croatian: c.760-762delGTT ili c.761-763del c.760_762delGTT ili c.761_763del p.V254del
English: Reduced -Gal A activity is, therefore, associated with the progressive accumulation of substrate in vulnerable organs and tissues, which leads to the morbidity and mortality associated with Fabry disease.
Croatian: Stoga se smanjena aktivnost enzima -Gal A povezuje s progresivnim nakupljanjem supstrata u podložnim organima i tkivima što dovodi do morbiditeta i mortaliteta povezanih s Fabryjevom bolešću.
English: Based upon in vitro data, migalastat is not an inducer of CYP1A2, 2B6, or 3A4.
Croatian: Na temelju in vitro podataka, utvrđeno je da migalastat nije induktor enzima CYP1A2, 2B6 ili 3A4.
English: This is a common spontaneous tumour in ad libitum-fed male rats.
Croatian: Riječ je o čestom spontanom tumoru u mužjaka štakora hranjenih ad libitum.
English: No clinically significant differences were observed during the initial 6-month placebo-controlled period.
Croatian: Nisu zabilježene klinički značajne razlike u pogledu LVMi tijekom početnog 6-mjesečnog, placebom kontroliranog razdoblja.
English: What Galafold contains - The active substance is migalastat.
Croatian: Što sadrži Galafold - Djelatna tvar je migalastat.
English: After Day 2, continue moving right on the blister sleeve.
Croatian: Nakon 2.dana nastavite uzimati kapsule na blister kartici u desnu stranu.
English: Similar findings have been noted pre-clinically following treatment with other iminosugars (see section 5.3).
Croatian: Slični nalazi primijećeni su u pretkliničkoj fazi nakon liječenja drugim iminošećerima (vidjeti dio 5.3).
English: To access the package leaflet, scan the code below.
Croatian: Za pristup uputi o lijeku očitajte sljedeći kod.
English: Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Croatian: Tablica 1.: Nuspojave lijeka Galafold zabilježene u kliničkim ispitivanjima Klasifikacija organskih sustava
English: UNKNOWN (E66_Y123del; del Exon2)
Croatian: NEPOZNATO (E66_Y123del; del Exon2)
English: You should only take Galafold once every other day.
Croatian: Galafold smijete uzimati samo jedanput svaki drugi dan.
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
Croatian: - Drugi sastojci su: Sadržaj kapsule: prethodno geliran kukuruzni škrob i magnezijev stearat Ovojnica kapsule: želatina, titanijev dioksid i indigotin Tinta za označavanje: šelak, crni željezov oksid i kalijev hidroksid
English: Table 3: Mutations not amenable to Galafold (migalastat)
Croatian: Tablica 3.: Mutacije koje isključuju odgovili na lijek Galafold (migalastat)
English: Galafold is not intended for concomitant use with enzyme replacement therapy (see section 4.4).
Croatian: Galafold nije namijenjen za istodobnu primjenu s enzimskom nadomjesnom terapijom (vidjeti dio 4.4).
English: Take Galafold capsule every other day and punch out the perforated circle on the blister sleeve on the days you are not taking Galafold.
Croatian: Kapsulu lijeka Galafold uzmite svaki drugi dan te probušite perforirani krug na blister kartici na one dane kada ne uzimate Galafold.
English: Elderly (> 65 years) Clinical studies of Galafold included small number of patients aged 65 and over.
Croatian: Klinička ispitivanja lijeka Galafold obuhvatila su mali broj bolesnika u dobi od 65 godina i starijih.
English: The clinical efficacy and safety of Galafold have been evaluated in two Phase 3 pivotal trials and two open-label extension (OLE) trials.
Croatian: Klinička djelotvornost i sigurnost lijeka Galafold ocijenjene su u dvama pivotalnim ispitivanjima faze 3 te u dva otvorena nastavka ispitivanja.
English: Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1).
Croatian: Galafold je indiciran za dugotrajno liječenje odraslih i adolescenata u dobi od 16 godina i starijih s potvrđenom dijagnozom Fabryjeve bolesti (nedostatak α-galaktozidaze A) i koji imaju mutacije koje omogućuju odgovor na liječenje (vidjeti tablice u dijelu 5.1).
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.
Croatian: Ako je prošlo više od 12 sati, bolesnik treba nastaviti uzimati Galafold onog dana i u ono doba za koje je predviđena sljedeća doza u skladu s rasporedom doziranja svakog drugog dana.
English: It is not yet known if this medicine affects fertility in men.
Croatian: Još nije poznato utječe li ovaj lijek na plodnost u muškaraca.
English: UNKNOWN (E66_Y123del; del Exon2?)
Croatian: NEPOZNATO (E66_Y123del; del Exon2?)
English: MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI UNUTARNJE PAKIRANJE
English: If you stop taking Galafold Do not stop taking this medicine without talking to your doctor.
Croatian: Nemojte prestati uzimati lijek bez prethodnog razgovora sa svojim liječnikom.
English: During the first period (18-months) ERT-experienced patients were randomised to switch from ERT to Galafold or continue with ERT.
Croatian: Tijekom prvog razdoblja (18-mjesečno) bolesnici koji su prethodno primali ERT bili su randomizirani na prelazak s ERT-a na lijek Galafold ili na nastavak uzimanja ERT-a.
English: The mean extent of exposure to the marketed dose of Galafold 123 mg QOD in patients completing study AT1001-041 was 3.57 (±1.23) years (n=85).
Croatian: Srednja vrijednost duljine izloženosti dozi lijeka Galafold od 123 mg (koja se nalazi na tržištu) svakog drugog dana u bolesnika koji su završili ispitivanje AT1001-041 bila je 3,57 (±1,23) godina (n = 85).
English: Marketing Authorisation Holder Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
English: • Muscle pain (myalgia)
Croatian: • bol u mišićima (mialgija)
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
Croatian: Svaka kapsula sadrži migalastatklorid koji odgovara 123 mg migalastata.
English: See package leaflet for further instructions.
Croatian: Vidjeti uputu o lijeku za dodatne upute.
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).
Croatian: Prvo ispitivanje faze 3 (ATTRACT) bilo je randomizirano otvoreno ispitivanje s aktivnim usporednim lijekom kojim su ocijenjene djelotvornost i sigurnost lijeka Galafold u usporedbi s enzimskom nadomjesnom terapijom (ERT, engl. enzyme replacement therapy) (agalzidaza beta, agalzidaza alfa) u 52 muških i ženskih bolesnika s Fabryjevom bolešću koji su primali ERT prije pridruživanja ispitivanju te koji imaju mutacije koje omogućuju odgovor na liječenje (ispitivanje s bolesnicima koji su prethodno primali ERT).
English: Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque white body with “A1001” printed in black, containing white to pale brown powder.
Croatian: Tvrda kapsula veličine 2 (6,4 x 18,0 mm) s neprozirnom plavom kapicom i neprozirnim bijelim tijelom s oznakom „A1001” ispisanom crnom bojom koja sadrži prašak bijele do svijetlosmeđe boje.
English: How to take Galafold
Croatian: Kako uzimati Galafold
English: While taking Galafold you should use effective birth control.
Croatian: Tijekom uzimanja lijeka Galafold trebate koristiti učinkovitu kontracepciju.
English: Fabry disease is a progressive X-linked lysosomal storage disorder which affects males and females.
Croatian: Fabryjeva bolest je progresivni X-vezani poremećaj nakupljanja u lizosomima koji se javlja u muškaraca i žena.
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Croatian: U ispitivanju s bolesnicima koji su prethodno primali ERT, a nakon 18-mjesečnog liječenja lijekom Galafold, došlo je do statistički značajnog smanjenja LVMi (p < 0,05).
English: Once in lysosomes dissociation of migalastat restores -Gal A activity, leading to the catabolism of GL-3 and related substrates.
Croatian: Jednom kada je u lizosomima, odvajanje migalastata obnavlja aktivnost enzima -Gal A, što dovodi do katabolizma supstrata GL-3 i srodnih supstrata.
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
Croatian: Drugi otvoreni nastavak ispitivanja (AT1001-042) uključuje i bolesnike koji su prešli iz nastavka ispitivanja AT1001-041 i one koji su prešli izravno iz ispitivanja faze 3, ATTRACT, i još uvijek je u tijeku.
English: BLISTER FOIL
Croatian: FOLIJA BLISTERA
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).
Croatian: Bolesnici koji su bili randomizirani u skupinu koja je primala placebo u 1. fazi te koji su prešli na Galafold u 6. mjesecu (2.faza) također su pokazali statistički značajno smanjenje inkluzija GL-3 u intersticijskim kapilarama u 12. mjesecu (-0,33 ± 0,15; -58 %) (p = 0,014).
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti”.
English: The second Phase 3 trial (FACETS) was a 6-month randomised double-blind placebo-controlled trial (through month 6) with an 18-month open-label period to evaluate the efficacy and safety of Galafold in 50 male and female patients with Fabry disease who were naïve to ERT, or had previously been on ERT and had stopped for at least 6 months and who have amenable mutations (ERT-naïve trial).
Croatian: Drugo ispitivanje faze 3 (FACETS) bilo je 6-mjesečno randomizirano, dvostruko slijepo i placebom kontrolirano ispitivanje (tijekom 6. mjeseca) s 18-mjesečnim otvorenim razdobljem radi ocjenjivanja djelotvornosti i sigurnosti lijeka Galafold u 50 muških i ženskih bolesnika s Fabryjevom bolešću koji nisu prethodno primali ERT ili koji su prethodno primali ERT i prekinuli su terapiju na najmanje šest mjeseci te koji imaju mutacije koje omogućuju odgovor na liječenje (ispitivanje s bolesnicima koji nisu prethodno primali ERT).
English: c.1018T>C or c.1018T>A c.T1018C or c.T1018A
Croatian: c.1018T>C ili c.1018T>A c.T1018C ili c.T1018A
English: It is not known whether Galafold is secreted in human milk.
Croatian: Nije poznato luči li se Galafold u majčino mlijeko u ljudi.
English: Galafold should not be taken on 2 consecutive days.
Croatian: Galafold se ne smije uzimati dva uzastopna dana.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class.
Croatian: U okviru svake skupine učestalosti nuspojave su prikazane redoslijedom od veće prema manjoj učestalosti u okviru svakog razreda klasifikacije organskih sustava.
English: Galafold is not intended for concomitant use with enzyme replacement therapy.
Croatian: Galafold nije namijenjen za istodobnu primjenu s enzimskom nadomjesnom terapijom.
English: • Sudden need to defecate
Croatian: • iznenadna potreba za pražnjenjem crijeva
English: In patients with amenable mutations, GL-3 levels tended to decrease in urine and in kidney interstitial capillaries.
Croatian: U bolesnika s mutacijama koje omogućavaju odgovor na liječenje, razine GL-3 imale su tendenciju smanjenja u urinu te u intersticijskim kapilarama bubrega.
English: • Reduced sense of touch or sensation
Croatian: • smanjenje osjeta dodira ili osjetljivosti kože (hipoestezija)
English: (proteinuria)
Croatian: (proteinurija)
English: What Galafold looks like and contents of the pack Opaque, blue, and white hard capsules, marked with “A1001” in black ink, containing white to pale brown powder.
Croatian: Neprozirne, plave i bijele tvrde kapsule, označene oznakom „A1001” crnom tintom, koje sadrže prašak bijele do svijetlosmeđe boje.
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).
Croatian: Bolesnici koji su bili randomizirani u skupinu koja je primala Galafold u 1. fazi pokazali su statistički značajno veće smanjenje (±SEM) srednjeg taloženja GL-3 u intersticijskim kapilarama (-0,25 ± 0,10; -39 %) u 6. mjesecu u usporedbi sa skupinom koja je primala placebo (+0,07 ± 0,13; +14 %) (p = 0,008).
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat
Croatian: Svaka kapsula sadrži migalastatklorid koji odgovara 123 mg migalastata
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Croatian: c.1202C>G ili c.1202C>A c.C1202G ili c.C1202A
English: Mean annualised rate of change in eGFRCKD-EPI was -0.40 mL/min/1.73 m
Croatian: Srednja godišnja stopa promjene u eGFRCKD-EPI iznosila je -0,40 mL/min/1,73 m
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%).
Croatian: 99 % radioaktivno označene doze nađene u plazmi sastojalo od neizmijenjenog migalastata (77 %) te od tri dehidrogenirana konjugirana metabolita O-glukuronida M1 do M3 (13 %).
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.
Croatian: Savjetuje se da se u bolesnika koji su počeli uzimati migalastat ili koji su prešli na lijek Galafold, periodično (svakih 6 mjeseci) prate bubrežna funkcija, ehokardiografski parametri i biokemijski markeri.
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Croatian: c.1196G>A ili c.1197G>A c.G1196A ili c.G1197A
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.
Croatian: U ispitivanju s bolesnicima koji nisu prethodno primali ERT, Galafold je pokazao statistički značajna smanjenja koncentracija lyso-Gb3 u plazmi te inkluzija GL-3 u intersticijskim bubrežnim kapilarama u bolesnika s mutacijama koje omogućuju odgovor na liječenje.
English: c.A1C or c.A1T
Croatian: c.A1C ili c.A1T
English: Fertility in women It is not yet known if this medicine affects fertility in women.
Croatian: Još nije poznato utječe li ovaj lijek na plodnost u žena.
English: c.A1023C or c.A1023T
Croatian: c.A1023C ili c.A1023T
English: Treatment with Galafold in Phase 2 pharmacodynamic trials generally resulted in increases in endogenous α-Gal A activity in WBCs, as well as in skin and kidney for the majority of patients.
Croatian: Liječenje lijekom Galafold u farmakodinamičkim ispitivanjima faze 2 u većine je bolesnika općenito dovelo do povećanja aktivnosti endogenog enzima α-Gal
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Croatian: c.1019G>A ili c.1020G>A c.G1019A ili c.G1020A
English: c.T148C or c.C150G or c.C150A F50L
Croatian: c.T148C ili c.C150G ili c.C150A F50L
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.
Croatian: U ispitivanju s bolesnicima koji su prethodno primali ERT, razine lyso-Gb3 u plazmi blago su se povećale, ali ostale su niske u bolesnika s mutacijama koje omogućuju odgovor na liječenje koji su liječeni lijekom Galafold u razdoblju od 30 mjeseci trajanja ispitivanja.
English: How to store Galafold
Croatian: Kako čuvati Galafold
English: c.G561T or c.G561A or c.G561C M187I
Croatian: c.G561T ili c.G561A ili c.G561C M187I
English: Blood Creatine Phosphokinase increased
Croatian: Pretrage povišena razina kreatin fosfokinaze u krvi povećana težina
English: c.T337C or c.T339A or c.T339G F113L
Croatian: c.T337C ili c.T339A ili c.T339G F113L
English: c.A712C or c.T714A or c.T714G S238R
Croatian: c.A712C ili c.T714A ili c.T714G S238R
English: c.G611A or G612A
Croatian: c.G611A ili G612A
English: c.G153A or c.G153T or c.G153C M51I
Croatian: c.G153A ili c.G153T ili c.G153C M51I
English: • Sensation of spinning
Croatian: • osjećaj vrtnje
English: c.A504C or c.A504T
Croatian: c.A504C ili c.A504T
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Croatian: Ako planirate imati dijete, obratite se za savjet svom liječniku, ljekarniku ili medicinskoj sestri.
English: c.T817C or c.T819A or c.T819G F273L
Croatian: c.T817C ili c.T819A ili c.T819G F273L
English: In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Croatian: U ispitivanju i otvorenom nastavku ispitivanja s bolesnicima koji nisu prethodno primali ERT, funkcija bubrega ostala je stabilna do 5 godina terapije lijekom Galafold.
English: Protein Sequence change c.1A>C or c.1A>T
Croatian: Promjena slijeda u proteinu c.1A>C ili c.1A>T
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.
Croatian: Farmakokinetičko ispitivanje u zdravih muških dobrovoljaca s dozom od 150 mg C]-migalastatklorida pokazalo je da je otprilike 77 % radioaktivno označene doze pronađeno u urinu od kojih je 55% bilo izlučeno kao neizmijenjeni migalastat, a 4 % kao kombinirani metaboliti M1, M2 i M3. Otprilike 5 % ukupne radioaktivnosti uzorka bilo je od nedodijeljenih komponenata.
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
Croatian: Srednja godišnja stopa promjene od početne vrijednosti eGFRCKD-EPI u bolesnika liječenih lijekom Galafold u trajanju od 30 mjeseci bila je -1,72 mL/min/1,73 m
English: c.T1147C or c.C1149G or c.C1149A
Croatian: c.T1147C ili c.C1149G ili c.C1149A
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Croatian: U ispitivanju s bolesnicima koji su prethodno primali ERT, funkcija bubrega ostala je stabilna do 18 mjeseci terapije lijekom Galafold.
English: Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse.
Croatian: Ne uzimajte lijek ako dojite prije nego što se savjetujete sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
English: g.2594_10904dup c.195-2500_999+197dup
Croatian: g.2594_10904dup c.195-2500_999+197dup g.2934_6378del
English: It is not yet known whether this medicine passes into breast milk.
Croatian: Nije poznato izlučuje li se ovaj lijek u majčino mlijeko.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip svrbež
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Croatian: (95 % CI: -2,272; 1,478; n = 34) u skupini koja je primala Galafold u usporedbi s -1,03 mL/min/1,73 m
English: The mutations not amenable to treatment with Galafold are listed in Table 3 below.
Croatian: Mutacije koje isključuju odgovor na liječenje lijekom Galafold navedene su u tablici 3. u nastavku.