FrancophonIA/ELRC3.0 huggingface dataset:
Greek: C]-μιγαλαστάτης προέκυψε ότι το 99% της ραδιοσημασμένης δόσης που ανιχνεύθηκε στο πλάσμα αποτελούνταν από αναλλοίωτη μεγαλαστάτη (77%) και τους συζευγμένους με 3-O-γλυκουρονίδιο αφυδρογονωμένους μεταβολίτες M1 έως M3 (13%).
Romanian: C] administrat unor voluntari sănătoși, de sex masculin, a evidențiat că 99% din doza marcată radioactiv recuperată din plasmă a constat din migalastat nemodificat (77%) și din trei metaboliți O-glucuronoconjugați dehidrogenați, de la M1 la M3 (13%).
Greek: Η νόσος Fabry είναι προοδευτικό, φυλοσύνδετο στο χρωμόσωμα X λυσοσωμικό αθροιστικό νόσημα το οποίο εμφανίζεται σε άνδρες και γυναίκες.
Romanian: Boala Fabry este o afecțiune X-linkată, caracterizată prin acumularea lizozomală progresivă, care afectează bărbații și femeile.
Greek: Κάθε καψάκιο περιέχει υδροχλωρική μιγαλαστάτη ισοδύναμη με 123 mg μιγαλαστάτης.
Romanian: Fiecare capsulă conține clorhidrat de migalastat, echivalentul a 123 mg migalastat.
Greek: Κάθε καψάκιο περιέχει υδροχλωρική μιγαλαστάτη ισοδύναμη με 123 mg μιγαλαστάτης
Romanian: Fiecare capsulă conține clorhidrat de migalastat, echivalentul a 123 mg migalastat
Greek: ΑΓΝΩΣΤΟ (del Exon3 και 4?)
Romanian: NECUNOSCUTĂ (del Exon3 și 4?)
Greek: Στους ασθενείς που τυχαιοποιήθηκαν στην ομάδα του Galafold κατά το Στάδιο 1 παρατηρήθηκε τον μήνα 6 στατιστικά σημαντικά μεγαλύτερη μείωση (±SEM) στη μέση εναπόθεση GL-3 στα τριχοειδή αγγεία του μεσοκυττάριου χώρου (-0,25±0,10, -39%) σε σύγκριση με το εικονικό φάρμακο (+0,07 ± 0,13, +14%) (p=0,008).
Romanian: În luna 6, pacienții randomizați pentru tratamentul cu Galafold în faza 1 au demonstrat o reducere semnificativ mai mare din punct de vedere statistic (±ESM) a depunerii medii de GL-3 în capilarele interstițiale (-0,25±0,10; -39%) comparativ cu placebo (+0,07 ± 0,13; +14%) (p=0,008).
Greek: • Μυρμήγκιασμα στα άκρα (παραισθησία)
Romanian: • Furnicături în extremități (parestezie)
Greek: c.G611A ή G612A
Romanian: c.G611A sau G612A
Greek: Αλλαγή στην πρωτεϊνική αλληλουχία c.1A>C ή c.1A>T
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice c.1A>C sau c.1A>T
Greek: Κατόπιν χορήγησης υδροχλωρικής [
Romanian: Nu s-a detectat nicio legare a proteinelor plasmatice în urma administrării clorhidratului de migalastat [
Greek: Μετά από 30 μήνες θεραπείας με το Galafold, η μέση αλλαγή από την τιμή έναρξης της LVMi ήταν -3,8 (95% CI: -8,9, 1,3, n=28) και η μέση αλλαγή από την τιμή έναρξης της LVMi στους ασθενείς με υπερτροφία αριστερής κοιλίας από την τιμή έναρξης ήταν -10,0 (95% CI: -16,6, -3,3, n=10).
Romanian: După 30 luni de tratament cu Galafold, modificarea medie a IMVS față de momentul inițial a fost de -3,8 (IÎ 95%: -8,9, 1,3; n=28) și modificarea medie a IMVS față de momentul inițial la pacienții cu hipertrofie ventriculară stângă la momentul inițial a fost de -10,0 (IÎ 95%: -16,6, -3,3; n=10).
Greek: c.A504C ή c.A504T
Romanian: c.A504C sau c.A504T
Greek: Στους ασθενείς που τυχαιοποιήθηκαν στην ομάδα του εικονικού φαρμάκου κατά το Στάδιο 1 και εντάχθηκαν στην ομάδα του Galafold τον μήνα 6 (Στάδιο 2) παρατηρήθηκαν ομοίως στατιστικά σημαντικές μειώσεις των εναποθέσεων GL-3 στα τριχοειδή αγγεία του μεσοκυττάριου χώρου κατά τον μήνα 12 (-0,33±0,15, -58%) (p=0,014).
Romanian: În luna 12, pacienții randomizați pentru tratamentul cu placebo în faza 1 și trecuți la tratamentul cu Galafold în luna 6 (faza 2) au demonstrat de asemenea scăderi semnificative din punct de vedere statistic ale incluziunilor GL-3 în capilarele interstițiale (-0,33±0,15; -58%) (p=0,014).
Greek: Εάν έχουν περάσει πάνω από 12 ώρες θα πρέπει να συνεχίσετε να λαμβάνετε το Galafold κατά την επόμενη προγραμματισμένη ημέρα και ώρα λήψης της δόσης σύμφωνα με το δοσολογικό σας σχήμα που προβλέπει λήψη δόσης κάθε δεύτερη ημέρα.
Romanian: Dacă au trecut mai mult de 12 ore, trebuie să reluați administrarea Galafold în următoarea zi și la următoarea oră de administrare planificată, conform schemei de administrare o dată la două zile.
Greek: c.A924T ή c.A924C
Romanian: c.A924T sau c.A924C
Greek: c.140G>A ή 141G>A
Romanian: c.140G>A sau 141G>A
Greek: • Αίσθημα περιστροφής
Romanian: • Senzație de rotire
Greek: c.T1147C ή c.C1149G ή c.C1149A
Romanian: c.T1147C sau c.C1149G sau c.C1149A
Greek: IVS6-22C>T c.1000-10G>A/1000-22C>T ΑΓΝΩΣΤΟ
Romanian: NECUNOSCUTĂ IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T NECUNOSCUTĂ
Greek: c.712A>C ή c.714T>A ή c.714T>G
Romanian: c.712A>C sau c.714T>A sau c.714T>G
Greek: g.2594_10904dup c.195-2500_999+197dup
Romanian: g.2594_10904dup c.195-2500_999+197dup g.2934_6378del
Greek: 167G>T] c.C138G/G153T/G167T
Romanian: c.[138C>G; 153G>T; 167G>T] c.C138G/G153T/G167T
Greek: 255T>G] c.G253A/G254T/T255G
Romanian: c.[253G>A; 254G>T; 255T>G] c.G253A/G254T/T255G
Greek: Οι αρχικές τιμές ήταν 95,3 g/m για το σκέλος Galafold και 92,9 g/m για το σκέλος ERT και η μέση μεταβολή από την αρχική τιμή του δείκτη LVMi τον Μήνα 18 ήταν -6,6 (95% CI: -11,0, -2,1, n=31) για το σκέλος Galafold και -2,0 (95% CI: -11,0, 7,0, n=13) για το σκέλος ERT.
Romanian: Valorile de la momentul inițial au fost de 95,3 g/m pentru grupul de tratament cu Galafold și de 92,9 g/m pentru grupul de tratament cu TSE, iar modificarea medie în Luna 18 față de momentul inițial a IMVS a fost de -6,6 (IÎ 95%: -11,0, -2,1; n=31) pentru grupul de tratament cu Galafold și de -2,0 (IÎ 95%: 11,0, 7,0; n=13) pentru grupul de tratament cu TSE.
Greek: • Παρουσία πρωτεϊνών στα ούρα (πρωτεϊνουρία)
Romanian: • Proteine în urină
Greek: Αυξημένη κρεατινοφωσφοκινάση αίματος Αύξηση βάρους
Romanian: Creșterea valorilor plasmatice ale creatinfosfokinazei Creștere ponderală
Greek: Προζελατινοποιηµένο άµυλο (αραβοσίτου) Στεατικό μαγνήσιο
Romanian: Conținutul capsulei Amidon pregelatinizat (porumb) Stearat de magneziu
Greek: c.504A>C ή c.504A>T
Romanian: c.504A>C sau c.504A>T
Greek: c.611G>A ή 612G>A
Romanian: c.611G>A sau 612G>A
Greek: c.G140A ή G141A
Romanian: c.G140A sau G141A
Greek: Αλλαγή στην πρωτεϊνική αλληλουχία c.1049delC
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice c.946delG
Greek: (ίλιγγος)
Romanian: (prurit)
Greek: c.1147T>C ή c.1149C>G ή c.1149C>A
Romanian: c.1147T>C sau c.1149C>G sau c.1149C>A
Greek: c.A124C ή c.A124T
Romanian: c.A124C sau c.A124T
Greek: c.T139C ή c.T139A
Romanian: c.T139C sau c.T139A
Greek: c.C816A ή c.C816G
Romanian: c.C816A sau c.C816G
Greek: Εάν πάρετε μεγαλύτερη δόση Galafold από την κανονική Εάν πάρετε περισσότερα καψάκια από τα προβλεπόμενα, διακόψτε τη λήψη του φαρμάκου και επικοινωνήστε με τον γιατρό σας.
Romanian: Dacă luați mai multe capsule decât trebuie, va trebui să întrerupeți administrarea medicamentului și să vă adresați medicului dumneavoastră.
Greek: c.216G>A ή c.216G>T ή c.216G>C
Romanian: c.216G>A sau c.216G>T sau c.216G>C
Greek: c.C159G ή c.C159A
Romanian: c.C159G sau c.C159A
Greek: c.924A>T ή c.924A>C
Romanian: c.924A>T sau c.924A>C
Greek: ΣΠΡΩΞΤΕ το καψάκιο ώστε να βγει από το αλουμίνιο 4.
Romanian: ÎMPINGEȚI capsula prin folie 4.
Greek: c.139T>C ή c.139T>A
Romanian: c.139T>C sau c.139T>A
Greek: • Μειωμένη αφή και αισθητικότητα (υπαισθησία)
Romanian: • Simț sau senzație tactilă redusă (hipoestezie)
Greek: • Αιφνίδια ανάγκη αφόδευσης
Romanian: • Necesitate bruscă de a elimina materii fecale
Greek: c.C279G ή c.C279A
Romanian: c.C279G sau c.C279A
Greek: c.C207A ή c.C207G
Romanian: c.C207A sau c.C207G
Greek: c.159C>G ή c.159C>A
Romanian: c.159C>G sau c.159C>A
Greek: c.561G>T ή c.561G>A ή c.561G>C
Romanian: c.561G>T sau c.561G>A sau c.561G>C
Greek: Στο πλαίσιο μελέτης μίας δόσης Galafold σε ασθενείς με νεφρική ανεπάρκεια ποικίλου βαθμού οι οποίοι δεν έπασχαν από νόσο Fabry, η έκθεση των ασθενών με σοβαρή νεφρική ανεπάρκεια αυξήθηκε κατά 4,3 φορές (GFR < 30 mL/min/1,73 m
Romanian: Într-un studiu cu Galafold administrat în doză unică la subiecți care nu aveau boala Fabry, dar care prezentau diferite grade de insuficiență renală, expunerile au fost de 4,3 ori mai mari la subiecții cu insuficiență renală severă (RFG < 30 ml/min/1,73 m
Greek: c.G285T ή c.G285C
Romanian: c.G285T sau c.G285C
Greek: Το Galafold δεν ενδείκνυται για χρήση σε ασθενείς με μεταλλάξεις μη επιδεκτικές θεραπείας (βλ. παράγραφο 5.1).
Romanian: Galafold este contraindicat la pacienții cu mutații non-sensibile (vezi pct. 5.1).
Greek: c.412G>A ή c.412G>C
Romanian: c.412G>A sau c.412G>C
Greek: Να φυλάσσεται σε θέση, την οποία δεν βλέπουν και δεν προσεγγίζουν τα παιδιά.
Romanian: A nu se lăsa la vederea și la îndemâna copiilor.
Greek: Κατά την αρχική, ελεγχόμενη με εικονικό φάρμακο, φάση διάρκειας 6 μηνών δεν παρατηρήθηκαν κλινικά σημαντικές διαφορές.
Romanian: Nu au fost observate diferențe semnificative din punct de vedere clinic în cursul perioadei inițiale de 6 luni controlate cu placebo.
Greek: c.T187A ή c.G188C
Romanian: c.T187A sau c.G188C
Greek: c.C519A ή c.C519G
Romanian: c.C519A sau c.C519G
Greek: c.148T>C ή c.150C>G ή c.150C>A
Romanian: c.148T>C sau c.150C>G sau c.150C>A
Greek: Ορισμένες μεταλλάξεις του γονιδίου GLA μπορούν να έχουν ως αποτέλεσμα την παραγωγή ασταθών μεταλλαγμένων μορφών της α-Gal A. Η μιγαλαστάτη είναι φαρμακευτική πρωτεΐνη-συνοδός, σχεδιασμένη να συνδέεται εκλεκτικά, αναστρέψιμα και με υψηλή συγγένεια σε ενεργές θέσεις ορισμένων μεταλλαγμένων μορφών της -Gal A, οι γονότυποι των οποίων αναφέρονται ως μεταλλάξεις επιδεκτικές θεραπείας.
Romanian: Migalastatul este un șaperon farmacologic conceput pentru a se lega selectiv și reversibil, cu afinitate crescută, de situsurile active ale anumitor forme mutante ale genei -Gal A, ale căror genotipuri sunt denumite mutații sensibile.
Greek: c.G284A ή c.G285A
Romanian: c.G284A sau c.G285A
Greek: 4 χρόνια 6.4 Ιδιαίτερες προφυλάξεις κατά τη φύλαξη του προϊόντος
Romanian: 6.4 Precauții speciale pentru păstrare
Greek: c.442A>C ή c.444T>A ή c.444T>G
Romanian: c.442A>C sau c.444T>A sau c.444T>G
Greek: g.941_5845del p.?
Romanian: g.941_5845del p.?(Exon1_2del)
Greek: c.817T>C ή c.819T>A ή c.819T>G
Romanian: c.817T>C sau c.819T>A sau c.819T>G
Greek: c.C525G ή c.C525A
Romanian: c.C525G sau c.C525A
Greek: c.T881G ή c.T881A
Romanian: c.T881G sau c.T881A
Greek: c.G412A ή c.G412C
Romanian: c.G412A sau c.G412C
Greek: Για περισσότερες πληροφορίες, ανατρέξτε στο φύλλο οδηγιών χρήσης.
Romanian: Pentru instrucțiuni suplimentare, vezi prospectul.
Greek: c.284G>A ή c.285G>A
Romanian: c.284G>A sau c.285G>A
Greek: Το Galafold πρέπει να λαμβάνεται κάθε δεύτερη ημέρα.
Romanian: Galafold trebuie luat o dată la două zile.
Greek: c.187T>A ή c.188G>C
Romanian: c.187T>A sau c.188G>C
Greek: c.T166A ή c.G167C
Romanian: c.T166A sau c.G167C
Greek: 937G>T] c.A644G/G811A/G937T
Romanian: c.[644A>G; 811G>A; 937G>T] c.A644G/G811A/G937T
Greek: c.153G>A ή c.153G>T ή c.153G>C
Romanian: c.153G>A sau c.153G>T sau c.153G>C
Greek: c.285G>T ή c.285G>C
Romanian: c.285G>T sau c.285G>C
Greek: Λαμβάνετε ένα καψάκιο κάθε δεύτερη ημέρα, την ίδια ώρα κάθε ημέρα.
Romanian: Luați câte o capsulă o dată la două zile, la aceeași oră.
Greek: c.T241C ή c.T241A
Romanian: c.T241C sau c.T241A
Greek: c.337T>C ή c.339T>A ή c.339T>G
Romanian: c.337T>C sau c.339T>A sau c.339T>G
Greek: c.207C>A ή c.207C>G
Romanian: c.207C>A sau c.207C>G
Greek: c.552T>A ή c.552T>G
Romanian: c.552T>A sau c.552T>G
Greek: c.G261C ή c.G261T
Romanian: c.G261C sau c.G261T
Greek: c.C233G ή c.C233A
Romanian: c.C233G sau c.C233A
Greek: c.C747G ή c.C747A
Romanian: c.C747G sau c.C747A
Greek: c.471G>C ή c.471G>T
Romanian: c.471G>C sau c.471G>T
Greek: c.816C>A ή c.816C>G
Romanian: c.816C>A sau c.816C>G
Greek: Από την παρακολούθηση κατά την περίοδο ανοιχτής ετικέτας προέκυψε ότι η μέση μεταβολή του LVMi από την έναρξη έως το διάστημα των Μηνών 36 ήταν -8,3 (95% CI: 17,1, 0,4, n=25) και τον Μήνα 48 ήταν -9,1 (95% CI: -20,3, 2,0, n=18).
Romanian: După studiul de urmărire din faza de extensie deschisă, modificarea medie a IMVS de la momentul inițial până în luna 30 a fost de -8,3 (IÎ 95%: - 17,1, 0,4; n=25), iar până în luna 48 a fost de -9,1 (IÎ 95%: -20,3, 2,0; n=18).
Greek: c.G982A ή c.G982C
Romanian: c.G982A sau c.G982C
Greek: c.261G>C ή c.261G>T
Romanian: c.261G>C sau c.261G>T
Greek: c.G103C ή c.G103A
Romanian: c.G103C sau c.G103A
Greek: Περίπου 20% της συνολικής ραδιοσημασμένης δόσης απεκκρίθηκε στα κόπρανα.
Romanian: Aproximativ 20% din doza totală marcată radioactiv s-a eliminat în fecale, migalastatul nemodificat fiind singurul component măsurat.
Greek: c.519C>A ή c.519C>G
Romanian: c.519C>A sau c.519C>G
Greek: c.G612T ή c.G612C
Romanian: c.G612T sau c.G612C
Greek: c.C305G ή c.C305A
Romanian: c.C305G sau c.C305A
Greek: c.241T>C ή c.241T>A
Romanian: c.241T>C sau c.241T>A
Greek: c.G734A ή c.G735A
Romanian: c.G734A sau c.G735A
Greek: c.G540C ή c.G540T
Romanian: c.G540C sau c.G540T
Greek: c.982G>A ή c.982G>C
Romanian: c.982G>A sau c.982G>C
Greek: c.612G>T ή c.612G>C
Romanian: c.612G>T sau c.612G>C
Greek: c.124A>C ή c.124A>T
Romanian: c.124A>C sau c.124A>T
Greek: c.131G>A ή c.132G>A
Romanian: c.131G>A sau c.132G>A
Greek: c.G132T ή c.G132C
Romanian: c.G132T sau c.G132C
Greek: c.T514A ή c.G515C
Romanian: c.T514A sau c.G515C
Greek: c.G471C ή c.G471T
Romanian: c.G471C sau c.G471T
Greek: c.G144T ή c.G144C
Romanian: c.G144T sau c.G144C
Greek: Λεπτομερείς πληροφορίες για το φάρμακο αυτό είναι διαθέσιμες στον δικτυακό τόπο του Ευρωπαϊκού Οργανισμού Φαρμάκων: http://www.ema.europa.eu.
Romanian: Informații detaliate privind acest medicament sunt disponibile pe site-ul Agenției Europene pentru Medicamente: http://www.ema.europa.eu. Există, de asemenea, linkuri către alte site-uri despre boli rare și tratamente.
Greek: c.C897G ή c.C897A
Romanian: c.C897G sau c.C897A
Greek: Εάν έχετε περαιτέρω απορίες σχετικά με τη χρήση αυτού του φαρμάκου, ρωτήστε τον γιατρό, τον φαρμακοποιό ή τον νοσοκόμο σας.
Romanian: Dacă aveți orice întrebări suplimentare cu privire la acest medicament, adresați-vă medicului dumneavoastră, farmacistului sau asistentei medicale.
Greek: Εάν λαμβάνετε θεραπεία ενζυμικής υποκατάστασης, απευθυνθείτε στον γιατρό σας προτού πάρετε το Galafold.
Romanian: Înainte să luați Galafold adresați-vă medicului dumneavoastră dacă vă aflați sub terapie de substituție enzimatică.
Greek: c.228G>C ή c.228G>A ή c.228G>T
Romanian: c.228G>C sau c.228G>A sau c.228G>T
Greek: c.126G>A ή c.126G>C ή c.126G>T
Romanian: c.126G>A sau c.126G>C sau c.126G>T
Greek: ΑΓΝΩΣΤΟ (del Exon5_7?)
Romanian: NECUNOSCUTĂ (del Exon5_7?)
Greek: ΑΓΝΩΣΤΟ (del Exon1_2?)
Romanian: NECUNOSCUTĂ (del Exon1_2?)
Greek: c.T258G ή c.T258A
Romanian: c.T258G sau c.T258A
Greek: c.132G>T ή c.132G>C
Romanian: c.132G>T sau c.132G>C
Greek: c.T960G ή c.T960A
Romanian: c.T960G sau c.T960A
Greek: c.G242A ή c.G243A
Romanian: c.G242A sau c.G243A
Greek: c.525C>G ή c.525C>A
Romanian: c.525C>G sau c.525C>A
Greek: c.A588T ή c.A588C
Romanian: c.A588T sau c.A588C
Greek: c.243G>T ή c.243G>C
Romanian: c.243G>T sau c.243G>C
Greek: Αλλαγή στην πρωτεϊνική αλληλουχία p.Q119_Y123del
Romanian: p.113del6aa p.Q119_Y123del
Greek: c.A840T ή c.A840C
Romanian: c.A840T sau c.A840C
Greek: c.C453G ή c.C453A
Romanian: c.C453G sau c.C453A
Greek: c.G131A ή c.G132A
Romanian: c.G131A sau c.G132A
Greek: c.T552A ή c.T552G
Romanian: c.T552A sau c.T552G
Greek: c.609G>C ή c.609G>T
Romanian: c.609G>C sau c.609G>T
Greek: c.G243T ή c.G243C
Romanian: c.G243T sau c.G243C
Greek: c.T148C ή c.C150G ή c.C150A F50L
Romanian: c.T148C sau c.C150G sau c.C150A
Greek: c.279C>G ή c.279C>A
Romanian: c.279C>G sau c.279C>A
Greek: c.233C>G ή c.233C>A
Romanian: c.233C>G sau c.233C>A
Greek: Το Galafold δεν μελετήθηκε σε ασθενείς με νόσο Fabry οι οποίοι έχουν ρυθμό σπειραματικής διήθησης (GFR) κάτω των 30 mL/min/1,73 m2.
Romanian: Galafold nu a fost studiat la pacienți cu boală Fabry prezentând un RFG mai mic de 30 ml/min/1,73 m2.
Greek: ΑΓΝΩΣΤΟ (del Exon3?)
Romanian: NECUNOSCUTĂ (del Exon3?)
Greek: Από την παρακολούθηση κατά την περίοδο ανοιχτής ετικέτας προέκυψε ότι η μέση μεταβολή του LVMi στους ασθενείς με υπερτροφία αριστερής κοιλίας κατά την έναρξη τον Μήνα 36 ήταν -30,0 (95%) CI: -57,9, -2.2, n=4) και τον Μήνα 48 ήταν -33,1 (CI:-60,9, -5,4, n=4).
Romanian: După studiul de urmărire din faza de extensie deschisă, modificarea medie a IMVS de la momentul inițial până în luna 36 a fost de -30,0 (IÎ 95%: -57,9, -2,2; n=4), iar la luna 48 a fost de -33,1 (IÎ:-60,9, -5,4; n=4).
Greek: c.144G>T ή c.144G>C
Romanian: c.144G>T sau c.144G>C
Greek: c.T369G ή c.T369A
Romanian: c.T369G sau c.T369A
Greek: c.540G>C ή c.540G>T
Romanian: c.540G>C sau c.540G>T
Greek: c.G609C ή c.G609T
Romanian: c.G609C sau c.G609T
Greek: c.G567C ή c.G567T
Romanian: c.G567C sau c.G567T
Greek: c.707G>A ή c.708G>A
Romanian: c.707G>A sau c.708G>A
Greek: c.3G>A ή c.3G>T ή c.3G>C c.G3A ή c.G3T ή c.G3C
Romanian: M1R c.3G>A sau c.3G>T sau c.3G>C c.G3A sau c.G3T sau c.G3C M1I c.19G>T
Greek: c.T859C ή c.T859A
Romanian: c.T859C sau c.T859A
Greek: c.108G>C ή c.108G>T
Romanian: c.108G>C sau c.108G>T
Greek: c.831G>T ή c.831G>C
Romanian: c.831G>T sau c.831G>C
Greek: c.258T>G ή c.258T>A
Romanian: c.258T>G sau c.258T>A
Greek: c.G831T ή c.G831C
Romanian: c.G831T sau c.G831C
Greek: c.881T>G ή c.881T>A
Romanian: c.881T>G sau c.881T>A
Greek: c.T280A ή c.G281C
Romanian: c.T280A sau c.G281C
Greek: c.830G>A ή c.831G>A
Romanian: c.830G>A sau c.831G>A
Greek: c.T610C ή c.T610A
Romanian: c.T610C sau c.T610A
Greek: (95% CI: -2,653, -0,782, n=31).
Romanian: (IÎ 95%: -2,653,
Greek: c.G860A ή c.G861A
Romanian: c.G860A sau c.G861A
Greek: c.T154A ή c.G155C
Romanian: c.T154A sau c.G155C
Greek: c.305C>G ή c.305C>A
Romanian: c.305C>G sau c.305C>A
Greek: c.G71A ή c.G72A
Romanian: c.G71A sau c.G72A
Greek: c.610T>C ή c.610T>A
Romanian: c.610T>C sau c.610T>A
Greek: c.734G>A ή c.735G>A
Romanian: c.734G>A sau c.735G>A
Greek: c.141G>C ή c.141G>T
Romanian: c.141G>C sau c.141G>T
Greek: c.T408A ή c.T408G
Romanian: c.T408A sau c.T408G
Greek: c.G830A ή c.G831A
Romanian: c.G830A sau c.G831A
Greek: c.G141C ή c.G141T
Romanian: c.G141C sau c.G141T
Greek: c.T465A ή c.T465G
Romanian: c.T465A sau c.T465G
Greek: Το Galafold δεν ενδείκνυται για χορήγηση σε ασθενείς με σοβαρή νεφρική ανεπάρκεια, χαρακτηριζόμενη από εκτιμώμενο ρυθμό σπειραματικής διήθησης (GFR) μικρότερο από 30 mL/min/1,73m
Romanian: Galafold este contraindicat la pacienții cu insuficiență renală severă, definită ca rată de filtrare glomerulară estimată mai mică de 30 ml/min/1,73m
Greek: c.567G>C ή c.567G>T
Romanian: c.567G>C sau c.567G>T
Greek: c.453C>G ή c.453C>A
Romanian: c.453C>G sau c.453C>A
Greek: c.897C>G ή c.897C>A
Romanian: c.897C>G sau c.897C>A
Greek: c.C966A ή c.C966G
Romanian: c.C966A sau c.C966G
Greek: c.G485A ή c.G486A
Romanian: c.G485A sau c.G486A
Greek: c.960T>G ή c.960T>A
Romanian: c.960T>G sau c.960T>A
Greek: c.103G>C ή c.103G>A
Romanian: c.103G>C sau c.103G>A
Greek: c.860G>A ή c.861G>A
Romanian: c.860G>A sau c.861G>A
Greek: c.859T>C ή c.859T>A
Romanian: c.859T>C sau c.859T>A
Greek: c.439G>A ή c.439G>C
Romanian: c.439G>A sau c.439G>C
Greek: c.T70C ή c.T70A
Romanian: c.T70C sau c.T70A
Greek: Σύνθετα κλινικά αποτελέσματα
Romanian: Criterii clinice compuse
Greek: c.394G>A ή c.394G>C
Romanian: c.394G>A sau c.394G>C
Greek: c.288G>A ή c.288G>T ή c.288G>C
Romanian: c.288G>A sau c.288G>T sau c.288G>C
Greek: Αλλαγή στην πρωτεϊνική αλληλουχία c.1046G>A ή c.1047G>A c.G1046A ή c.G1047A
Romanian: c.1046G>A sau c.1047G>A c.G1046A sau c.G1047A
Greek: c.T676C ή c.T676A
Romanian: c.T676C sau c.T676A
Greek: c.870G>A ή c.870G>C ή c.870G>T
Romanian: c.870G>A sau c.870G>C sau c.870G>T
Greek: C]-μιγαλαστάτης στο εύρος συγκέντρωσης από 1 έως 100 M δεν ανιχνεύθηκε δέσμευσή της από τις πρωτεΐνες του πλάσματος.
Romanian: C] la concentrații cuprinse între 1 și 100 M.
Greek: Η μεταβολή του LVMi (g/m2) από την έναρξη έως τον μήνα 18 σε ασθενείς με υπερτροφία αριστερής κοιλίας (γυναίκες με LVMi > 95 g/m2 στην έναρξη και άνδρες με LVMi > 115 g/m2 στην έναρξη) ήταν -8,4 (95% CI: από -15,7 έως
Romanian: Modificarea IMVS (g/m2) de la momentul inițial până în luna 18 la pacienții cu hipertrofie ventriculară stângă (femei cu IMVS inițial > 95 g/m și bărbați cu IMVS inițial > 115 g/m a fost de -8,4 (IÎ 95%: -15,7, 2,6; n=13) pentru migalastat și de 4,5 (IÎ 95%: -10,7, 18,4; n=5) pentru TSE.
Greek: c.840A>T ή c.840A>C
Romanian: c.840A>T sau c.840A>C
Greek: c.888G>A ή c.888G>T ή c.888G>C
Romanian: c.888G>A sau c.888G>T sau c.888G>C
Greek: c.G108C ή c.G108T
Romanian: c.G108C sau c.G108T
Greek: ΑΓΝΩΣΤΟ (del Exon3_7?)
Romanian: NECUNOSCUTĂ (del Exon3_7?)
Greek: c.154T>A ή c.155G>C
Romanian: c.154T>A sau c.155G>C
Greek: c.966C>A ή c.966C>G
Romanian: c.966C>A sau c.966C>G
Greek: c.G439A ή c.G439C
Romanian: c.G439A sau c.G439C
Greek: c.G216A ή c.G216T ή c.G216C M72I
Romanian: c.G216A sau c.G216T sau c.G216C
Greek: c.588A>T ή c.588A>C
Romanian: c.588A>T sau c.588A>C
Greek: c.485G>A ή c.486G>A
Romanian: c.485G>A sau c.486G>A
Greek: c.G861C ή c.G861T
Romanian: c.G861C sau c.G861T
Greek: [253G>A;
Romanian: c.[253G>A; 254G>A]
Greek: c.708G>C ή c.708G>T
Romanian: c.708G>C sau c.708G>T
Greek: c.71G>A ή c.72G>A
Romanian: c.71G>A sau c.72G>A
Greek: ΑΛΟΥΜΙΝΙΟ ΣΥΣΚΕΥΑΣΙΑΣ ΚΥΨΕΛΗΣ
Romanian: Spasme musculare Mialgie
Greek: c.G936T ή c.G936C
Romanian: c.G936T sau c.G936C
Greek: c.C456A ή c.C456G
Romanian: c.C456A sau c.C456G
Greek: c.G486C ή c.G486T
Romanian: c.G486C sau c.G486T
Greek: Εξάνθημα Κνησμός
Romanian: • Gură uscată
Greek: (ναυτία)
Romanian: (dispnee)
Greek: c.514T>A ή c.515G>C
Romanian: c.514T>A sau c.515G>C
Greek: c.102T>G ή c.102T>A
Romanian: c.102T>G sau c.102T>A
Greek: c.T834G ή c.T834A
Romanian: c.T834G sau c.T834A
Greek: c.465T>A ή c.465T>G
Romanian: c.465T>A sau c.465T>G
Greek: ΚΑΡΤΕΛΑ ΣΥΣΚΕΥΑΣΙΑΣ ΚΥΨΕΛΗΣ
Romanian: Cerneală pentru inscripționare Șelac
Greek: c.861G>C ή c.861G>T
Romanian: c.861G>C sau c.861G>T
Greek: c.G837C ή c.G837T
Romanian: c.G837C sau c.G837T
Greek: c.T894G ή c.T894A
Romanian: c.T894G sau c.T894A
Greek: c.T102G ή c.T102A
Romanian: c.T102G sau c.T102A
Greek: c.676T>C ή c.676T>A
Romanian: c.676T>C sau c.676T>A
Greek: c.T648A ή c.T648G
Romanian: c.T648A sau c.T648G
Greek: c.A1023C ή c.A1023T
Romanian: c.1023A >C sau c.1023A>T c.A1023C sau c.A1023T
Greek: c.T484C ή c.T484A
Romanian: c.T484C sau c.T484A
Greek: c.C666A ή c.C666G
Romanian: c.C666A sau c.C666G
Greek: c.747C>G ή c.747C>A
Romanian: c.747C>G sau c.747C>A
Greek: ΠΑΡΤΙΔΑ/LOT:
Romanian: LOT:
Greek: c.978G>C ή c.978G>T
Romanian: c.978G>C sau c.978G>T
Greek: [164A>T;
Romanian: c.[164A>T; 170A>T]
Greek: c.T667A ή c.G668C
Romanian: c.T667A sau c.G668C
Greek: Κόμμεα λάκκας Μαύρο οξείδιο του σιδήρου Υδροξείδιο του καλίου 6.2 Ασυμβατότητες
Romanian: Oxid negru de fier Hidroxid de potasiu
Greek: c.T687A ή c.T687G
Romanian: c.T687A sau c.T687G
Greek: c.408T>A ή c.408T>G
Romanian: c.408T>A sau c.408T>G
Greek: c.G978C ή c.G978T
Romanian: c.G978C sau c.G978T
Greek: Στους ασθενείς που ξεκινούν θεραπεία με το Galafold ή αντικαθιστούν με αυτό προηγούμενη θεραπεία, συνιστάται να υποβάλλονται σε τακτική (ανά 6μηνο) παρακολούθηση της νεφρικής λειτουργίας, των ηχοκαρδιογραφικών παραμέτρων και των βιοχημικών δεικτών τους.
Romanian: Se recomandă monitorizarea periodică a funcției renale, a parametrilor ecocardiografici și a markerilor biochimici (o dată la 6 luni) la pacienții care au început tratamentul cu Galafold sau care au fost trecuți la acest tratament.
Greek: c.486G>C ή c.486G>T
Romanian: c.486G>C sau c.486G>T
Greek: Το παρόν έγγραφο αποτελεί σύνοψη της Ευρωπαϊκής Δημόσιας Έκθεσης Αξιολόγησης (EPAR) του Galafold.
Romanian: Prezentul document este un rezumat al Raportului public european de evaluare (EPAR) pentru Galafold.
Greek: Καταρτίστηκε σχέδιο διαχείρισης κινδύνου προκειμένου να διασφαλιστεί ότι το Galafold χρησιμοποιείται με τον ασφαλέστερο δυνατό τρόπο.
Romanian: A fost elaborat un plan de management al riscurilor pentru ca Galafold să fie utilizat în cel mai sigur mod posibil.
Greek: Όσον αφορά την ασφάλεια, το Galafold ήταν καλά ανεκτό.
Romanian: În ceea ce privește siguranța, Galafold a fost bine tolerat.
Greek: Λοιπές πληροφορίες για το Galafold
Romanian: Alte informații despre Galafold
Greek: Το Galafold διατίθεται υπό μορφή καψακίων (123 mg).
Romanian: Galafold este disponibil sub formă de capsule (123 mg).
Greek: Το Galafold μελετήθηκε σε δύο βασικές μελέτες, στις οποίες συμμετείχαν συνολικά 127 ασθενείς με τη νόσο Fabry.
Romanian: Galafold a fost evaluat în două studii principale la care au participat în total 127 de pacienți cu boala Fabry.
Greek: Στους ασθενείς που πάσχουν από τη νόσο Fabry αυτό το ένζυμο δεν λειτουργεί σωστά.
Romanian: La pacienții cu boală Fabry această enzimă nu funcționează corespunzător.