FrancophonIA/ELRC3.0 huggingface dataset:
English: C]-migalastat hydrochloride in the concentration range between 1 and
Maltese: C]-migalastat hydrochloride fil-firxa ta' konċentrazzjoni bejn 1 u 100 M.
English: c.C305G or c.C305A
Maltese: c.C305G jew c.C305A
English: c.284G>A or c.285G>A
Maltese: c.284G>A jew c.285G>A
English: c.T241C or c.T241A
Maltese: T241C jew c.T241A
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Maltese: n=34) fil-grupp ta' Galafold meta mqabbla ma' -1.03 mL/min/1.73 m
English: c.G982A or c.G982C
Maltese: c.G982A jew c.G982C
English: c.G261C or c.G261T
Maltese: G261C jew c.G261T
English: c.C207A or c.C207G
Maltese: c.C207A jew c.C207G
English: c.187T>A or c.188G>C
Maltese: c.187T>A jew c.188G>C
English: Elderly (> 65 years) Clinical studies of Galafold included small number of patients aged 65 and over.
Maltese: Studji kliniċi ta' Galafold inkludew numru żgħir ta' pazjenti mill-età ta' 65 sena u aktar.
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.
Maltese: C]-migalastat hydrochloride żvelat li bejn wieħed u ieħor 77% tad-doża radjutikkettata kienet irkuprata fl-awrina li minnha, 55% kienet imneħħija (excreted) bħala migalastat mhux mibdul u 4% bħala metaboliti kombinati M1, M2 u M3.
English: c.G540C or c.G540T
Maltese: c.G540C jew c.G540T
English: Netfang: MedInfo@amicusrx.com
Maltese: MedInfo@amicusrx.com
English: c.471G>C or c.471G>T
Maltese: c.471G>C jew c.471G>T
English: c.T552A or c.T552G
Maltese: c.T552A jew c.T552G
English: c.C525G or c.C525A
Maltese: c.C525G jew c.C525A
English: c.T881G or c.T881A
Maltese: T881G jew c.T881A
English: c.A644G/G937T
Maltese: A644G/G937T
English: c.261G>C or c.261G>T
Maltese: c.261G>C jew c.261G>T
English: c.242G>A or c.243G>A
Maltese: c.242G>A jew c.243G>A
English: c.124A>C or c.124A>T
Maltese: c.124A>C jew c.124A>T
English: c.A840T or c.A840C
Maltese: A840T jew c.A840C
English: c.G471C or c.G471T
Maltese: G471C jew c.G471T
English: c.139T>C or c.139T>A
Maltese: 139T>C jew c.139T>A
English: Fabry disease is caused by the lack of or a faulty enzyme called alpha-galactosidase A (α-Gal A).
Maltese: Il-marda ta' Fabry hija kkawżata min-nuqqas ta' jew enzima difettuża li tissejjaħ alpha-galactosidase A (α-Gal A).
English: c.G132T or c.G132C
Maltese: c.G132T jew c.G132C
English: c.T960G or c.T960A
Maltese: c.T960G jew c.T960A
English: c.279C>G or c.279C>A
Maltese: c.279C>G jew c.279C>A
English: c.552T>A or c.552T>G
Maltese: c.552T>A jew c.552T>G
English: This is a common spontaneous tumour in ad libitum-fed male rats.
Maltese: Dan huwa tumur spontanju komuni f'firien irġiel mitmugħin ad libitum.
English: c.285G>T or c.285G>C
Maltese: c.285G>T jew c.285G>C
English: c.G567C or c.G567T
Maltese: c.G567C jew c.G567T
English: c.T166A or c.G167C
Maltese: c.T166A jew c.G167C
English: c.241T>C or c.241T>A
Maltese: 241T>C jew c.241T>A
English: c.C897G or c.C897A
Maltese: c.C897G jew c.C897A
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
Maltese: Pregelatinised maize starch u magnesium stearate Qoxra tal-kapsula: Gelatin, titanium dioxide, u indigotine Linka ta' stampar:
English: c.207C>A or c.207C>G
Maltese: c.207C>A jew c.207C>G
English: Pharmacotherapeutic group: Various alimentary tract and metabolism products ATC code: A16AX14
Maltese: Prodotti varji tal-passaġġ tal-ikel u tal-metaboliżmu; kodiċi ATC:
English: c.C233G or c.C233A
Maltese: C233G jew c.C233A
English: c.G609C or c.G609T
Maltese: c.G609C jew c.G609T
English: UNKNOWN (del Exon1_2?)
Maltese: MHUX MAGĦRUF (del Exon1_2?)
English: c.228G>C or c.228G>A or c.228G>T
Maltese: c.228G>C jew c.228G>A jew c.228G>T
English: c.G140A or G141A
Maltese: c.G140A jew G141A
English: c.153G>A or c.153G>T or c.153G>C
Maltese: c.153G>A jew c.153G>T jew c.153G>C
English: c.982G>A or c.982G>C
Maltese: c.982G>A jew c.982G>C
English: c.612G>T or c.612G>C
Maltese: c.612G>T jew c.612G>C
English: c.561G>T or c.561G>A or c.561G>C
Maltese: c.561G>T jew c.561G>A jew c.561G>C
English: Then, punch out the left-most capsule labelled Day 1.
Maltese: Imbagħad, taqqab 'il barra l-kapsula tax-xellug nett ittikkettata Jum 1.
English: c.A588T or c.A588C
Maltese: A588T jew c.A588C
English: Paraesthesia Dizziness Hypoaesthesia
Maltese: Ipostesija (Hypoaesthesia)
English: c.525C>G or c.525C>A
Maltese: c.525C>G jew c.525C>A
English: c.817T>C or c.819T>A or c.819T>G
Maltese: c.817T>C jew c.819T>A jew c.819T>G
English: c.T187A or c.G188C
Maltese: T187A jew c.G188C
English: c.T465A or c.T465G
Maltese: c.T465A jew c.T465G
English: c.337T>C or c.339T>A or c.339T>G
Maltese: c.337T>C jew c.339T>A jew c.339T>G
English: c.T258G or c.T258A
Maltese: T258G jew c.T258A
English: c.863delC
Maltese: 863delC
English: c.166T>A or c.167G>C
Maltese: c.166T>A jew c.167G>C
English: c.148T>C or c.150C>G or c.150C>A
Maltese: c.148T>C jew c.150C>G jew c.150C>A
English: c.T859C or c.T859A
Maltese: c.T859C jew c.T859A
English: c.243G>T or c.243G>C
Maltese: c.243G>T jew c.243G>C
English: c.363delT
Maltese: 363delT
English: c.G284A or c.G285A
Maltese: G284A jew c.G285A
English: Muscle spasms Myalgia
Maltese: Spażmi fil-muskoli Mijalġja
English: c.G144T or c.G144C
Maltese: c.G144T jew c.G144C
English: c.103G>C or c.103G>A
Maltese: c.103G>C jew c.103G>A
English: Blood Creatine Phosphokinase increased
Maltese: Żieda fil-Kreatina Phosphokinase fid-Demm Żieda fil-piż
English: c.881T>G or c.881T>A
Maltese: c.881T>G jew c.881T>A
English: c.G611A or G612A
Maltese: G611A jew G612A
English: c.G612T or c.G612C
Maltese: G612T jew c.G612C
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).
Maltese: Fil-prova mingħajr esperjenza tal-ERT, Galafold irriżulta fi tnaqqis statistikament sinifikanti fil-LVMi (p< 0.05); il-bidla medja mil-linja bażi fil-LVMi għal Xahar 18 sa 24 kienet ta' -7.7 (95% CI: -15.4, -0.01; n=27).
English: c.519C>A or c.519C>G
Maltese: c.519C>A jew c.519C>G
English: c.258T>G or c.258T>A
Maltese: c.258T>G jew c.258T>A
English: c.T514A or c.G515C
Maltese: c.T514A jew c.G515C
English: c.816C>A or c.816C>G
Maltese: c.816C>A jew c.816C>G
English: c.131G>A or c.132G>A
Maltese: c.131G>A jew c.132G>A
English: c.T148C or c.C150G or c.C150A F50L
Maltese: T148C jew c.C150G jew c.C150A
English: België/Belgique/Belgien Amicus Therapeutics Europe Limited Tél/Tel: 0800 79245 e-mail: MedInfo@amicusrx.com
Maltese: België/Belgique/Belgien Amicus Therapeutics Europe Limited Tél/Tel: 0800 79245 e-mail:
English: c.609G>C or c.609G>T
Maltese: c.609G>C jew c.609G>T
English: c.C747G or c.C747A
Maltese: C747G jew c.C747A
English: c.G243T or c.G243C
Maltese: G243T jew c.G243C
English: c.233C>G or c.233C>A
Maltese: 233C>G jew c.233C>A
English: c.G216A or c.G216T or c.G216C M72I
Maltese: c.G216A jew c.G216T jew c.G216C
English: c.C453G or c.C453A
Maltese: C453G jew c.C453A
English: • Muscle spasms
Maltese: • Tħossok imdardar
English: Approximately 5% of the total sample radioactivity was unassigned components.
Maltese: Madwar 5% tar-radjuattività totali tal-kampjun kienet komponenti mhux assenjati.
English: c.707G>A or c.708G>A
Maltese: c.707G>A jew c.708G>A
English: c.830G>A or c.831G>A
Maltese: c.830G>A jew c.831G>A
English: c.305C>G or c.305C>A
Maltese: c.305C>G jew c.305C>A
English: c.897C>G or c.897C>A
Maltese: c.897C>G jew c.897C>A
English: c.132G>T or c.132G>C
Maltese: c.132G>T jew c.132G>C
English: c.G131A or c.G132A
Maltese: G131A jew c.G132A
English: c.144G>T or c.144G>C
Maltese: c.144G>T jew c.144G>C
English: c.946delG
Maltese: 946delG
English: c.141G>C or c.141G>T
Maltese: c.141G>C jew c.141G>T
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.
Maltese: Alterna kuljum bejn li tieħu l-kapsula f'jiem b'numru fard u ttaqqab 'il barra iċ-ċrieki bojod mtaqqba f'jiem b'numru żewġ, sa u inkluż jum 28.
English: c.540G>C or c.540G>T
Maltese: c.540G>C jew c.540G>T
English: c.610T>C or c.610T>A
Maltese: c.610T>C jew c.610T>A
English: c.T610C or c.T610A
Maltese: c.T610C jew c.T610A
English: The clinical efficacy and safety of Galafold have been evaluated in two Phase 3 pivotal trials and two open-label extension (OLE) trials.
Maltese: L-effikaċja klinika u s-sigurtà ta' Galafold ġew evalwati f'żewġ provi pivotali tal-Fażi 3 u f'żewġ provi ta' estensjoni open-label (OLE).
English: c.960T>G or c.960T>A
Maltese: c.960T>G jew c.960T>A
English: c.567G>C or c.567G>T
Maltese: c.567G>C jew c.567G>T
English: Approximately 9% of the total radioactivity was unassigned.
Maltese: Bejn wieħed u ieħor 9% tar-radjuattività totali ma kinitx assenjata.
English: c.453C>G or c.453C>A
Maltese: c.453C>G jew c.453C>A
English: c.G734A or c.G735A
Maltese: G734A jew c.G735A
English: c.734G>A or c.735G>A
Maltese: c.734G>A jew c.735G>A
English: c.T280A or c.G281C
Maltese: c.T280A jew c.G281C
English: c.C456A or c.C456G
Maltese: c.C456A jew c.C456G
English: • raised levels of creatine phosphokinase in blood tests
Maltese: • żieda fil-livelli ta' kreatina phosphokinase fit-testijiet tad-demm
English: • Palpitations (the feeling of a pounding heart)
Maltese: • Palpitazzjonijiet (is sensazzjoni ta' qalb tħabbat)
English: c.859T>C or c.859T>A
Maltese: c.859T>C jew c.859T>A
English: c.T369G or c.T369A
Maltese: T369G jew c.T369A
English: c.T408A or c.T408G
Maltese: T408A jew c.T408G
English: c.514T>A or c.515G>C
Maltese: c.514T>A jew c.515G>C
English: UNKNOWN (del Exon2_3?)
Maltese: MHUX MAGĦRUF (del Exon2_3?)
English: c.860G>A or c.861G>A
Maltese: c.860G>A jew c.861G>A
English: c.G830A or c.G831A
Maltese: c.G830A jew c.G831A
English: c.154T>A or c.155G>C
Maltese: c.154T>A jew c.155G>C
English: Approximately 20% of the total radiolabeled dose was excreted in faeces, with unchanged migalastat being the only measured component.
Maltese: Bejn wieħed u ieħor 20% tad-doża totali radjutikkettata kienet imneħħija (excreted) fl-ippurgar, b'migalastat mhux mibdul ikun l-unika komponent imkejjel.
English: c.465T>A or c.465T>G
Maltese: 465T>A jew c.465T>G
English: c.108G>C or c.108G>T
Maltese: c.108G>C jew c.108G>T
English: Defaecation urgency Dyspepsia
Maltese: Urġenza biex tipporga Dispepsja
English: c.T154A or c.G155C
Maltese: T154A jew c.G155C
English: c.G485A or c.G486A
Maltese: c.G485A jew c.G486A
English: c.413dupG
Maltese: 413dupG
English: c.C966A or c.C966G
Maltese: c.C966A jew c.C966G
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Maltese: Fil-prova b' esperjenza tal-ERT, wara 18-il xahar ta' kura b'Galafold, kien hemm tnaqqis statistikament sinifikanti fil-LVMi (p< 0.05).
English: c.G141C or c.G141T
Maltese: G141C jew c.G141T
English: c.966C>A or c.966C>G
Maltese: c.966C>A jew c.966C>G
English: c.T402G or c.T402A
Maltese: c.T402G jew c.T402A
English: c.T676C or c.T676A
Maltese: T676C jew c.T676A
English: c.A868C or c.A868T
Maltese: A868C jew c.A868T
English: c.485G>A or c.486G>A
Maltese: c.485G>A jew c.486G>A
English: c.831G>T or c.831G>C
Maltese: c.831G>T jew c.831G>C
English: c.428dupC
Maltese: 428dupC
English: c.439G>A or c.439G>C
Maltese: c.439G>A jew c.439G>C
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).
Maltese: Wara segwitu fl-OLE, il-bidla medja mil-linja bażi fil-LVMi f'Xahar 36 kienet ta' -8.3 (95% CI: -17.1, 0.4; n=25) u f'Xahar 48 kienet ta' -9.1 (95% CI: -20.3, 2.0; n=18).
English: c.T667A or c.G668C
Maltese: c.T667A jew c.G668C
English: BLISTER FOIL
Maltese: FOLJA (BLISTER)
English: In case of meaningful clinical deterioration, further clinical evaluation or discontinuation of treatment with Galafold should be considered.
Maltese: F'każ ta' deterjorament klinikament sinifikanti, għandha titqies aktar evalwazzjoni klinika jew twaqqif tal-kura b'Galafold.
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat
Maltese: Kull kapsula fiha migalastat hydrochloride ekwivalenti għal 123 mg migalastat
English: • Nose bleed (epistaxis)
Maltese: • Tinfaraġ (epistassi)
English: c.T648A or c.T648G
Maltese: T648A jew c.T648G
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
Maltese: Fi studju ta' doża waħda b'Galafold f'individwi mingħajr Fabry bi gradi varji ta' insuffiċjenza tal-kliewi, l-esponimenti żdiedu b'4.3 darbiet f'individwi b'indeboliment tal-kliewi sever (GFR < 30 mL/min/1.73 m
English: c.G831T or c.G831C
Maltese: G831T jew c.G831C
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittivita' eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: c.588A>T or c.588A>C
Maltese: c.588A>T jew c.588A>C
English: c.456C>A or c.456C>G
Maltese: c.456C>A jew c.456C>G
English: c.[604T>C; 644A>G]
Maltese: T>C; 644A>G]
English: c.G108C or c.G108T
Maltese: c.G108C jew c.G108T
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.
Maltese: Kapsula iebsa tad-daqs 2 (6.4x18.0 mm) b'għatu blu opak u l-parti l-oħra bajda opaka b' 'A1001' stampat bl-iswed, li fiha trab abjad sa kannella ċar.
English: c.102T>G or c.102T>A
Maltese: c.102T>G jew c.102T>A
English: In the ERT-experienced trial, an analysis of a composite clinical outcome composed of renal, cardiac, and cerebrovascular events, or death, showed that the frequency of events observed in the Galafold treatment group was 29% compared to 44% in the ERT group over 18 months.
Maltese: Fil-prova b'' esperjenza tal-ERT analiżi ta' riżultat kliniku kompost magħmul minn avvenimenti tal-kliewi, tal-qalb, ċerebrovaskulari, jew mewt, il-frekwenza tal-avvenimenti osservati fil-grupp tal-kura ta' Galafold kienet ta' 29% imqabbla ma' 44% fil-grupp ERT fuq 18-il xahar.
English: c.861G>C or c.861G>T
Maltese: c.861G>C jew c.861G>T
English: c.837G>C or c.837G>T
Maltese: c.837G>C jew c.837G>T
English: c.646dupT
Maltese: 646dupT
English: c.T894G or c.T894A
Maltese: T894G jew c.T894A
English: c.G861C or c.G861T
Maltese: c.G861C jew c.G861T
English: c.394G>A or c.394G>C
Maltese: 394G>A jew c.394G>C
English: c.288G>A or c.288G>T or c.288G>C
Maltese: c.288G>A jew c.288G>T jew c.288G>C
English: c.784T>A or c.784T>C
Maltese: c.784T>A jew c.784T>C
English: c.71G>A or c.72G>A
Maltese: c.71G>A jew c.72G>A
English: c.T70C or c.T70A
Maltese: c.T70C jew c.T70A
English: c.369T>G or c.369T>A
Maltese: c.369T>G jew c.369T>A
English: c.G486C or c.G486T
Maltese: c.G486C jew c.G486T
English: c.676T>C or c.676T>A
Maltese: c.676T>C jew c.676T>A
English: • Protein in the urine
Maltese: • Proteina fl-awrina
English: c.G860A or c.G861A
Maltese: c.G860A jew c.G861A
English: c.G772C or c.G772A
Maltese: c.G772C jew c.G772A
English: c.A1023C or c.A1023T
Maltese: c.1023A >C jew c.1023A>T c.A1023C jew c.A1023T
English: From the metabolism and excretion pathways, it is not expected that a decreased hepatic function may affect the pharmacokinetics of migalastat.
Maltese: Mill-passaġġi tal-metaboliżmu u t-tnehhija (excretion), mhuwiex mistenni li tnaqqis fil-funzjoni epatika jista' jaffettwa l-farmakokinetika ta' migalastat.
English: c.894T>G or c.894T>A
Maltese: c.894T>G jew c.894T>A
English: c.834T>G or c.834T>A
Maltese: c.834T>G jew c.834T>A
English: c.888G>A or c.888G>T or c.888G>C
Maltese: c.888G>A jew c.888G>T jew c.888G>C
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.
Maltese: Dan id-difett tal-enzima jwassal għal depożiti anormali ta' sustanza xaħmija magħrufa bħala globotriaosylceramide (GL-3) fil-kliewi, fil-qalb, u organi oħrajn, li jwassal għas-sintomi tal-marda ta' Fabry.
English: c.T834G or c.T834A
Maltese: T834G jew c.T834A
English: The frequency of events in patients treated with Galafold over 30 months (32%) was similar to the 18 month period.
Maltese: Il-frekwenza ta' avvenimenti f'pazjenti kkurati b'Galafold fuq perjodu ta' 30 xahar (32%) kienet simili għall-perjodu ta' 18-il xahar.
English: c.G729C or c.G729T
Maltese: c.G729C jew c.G729T
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
Maltese: Wara medja ta' 3.4 snin ta' kura, ir-rata medja annwali ta' bidla f'eGFRCKD-EPI kienet ta' -0.74 mL/min/1.73 m
English: One Galafold blister sleeve = 14 hard capsules = 28 days of therapy
Maltese: Folja (Blister) waħda ta' Galafold = 14-il kapusla iebsa = 28 jum ta' kura
English: c.708G>C or c.708G>T
Maltese: c.708G>C jew c.708G>T
English: c.T687A or c.T687G
Maltese: T687A jew c.T687G
English: c.C666A or c.C666G
Maltese: c.C666A jew c.C666G
English: c.G439A or c.G439C
Maltese: c.G439A jew c.G439C
English: c.702T>G or c.702T>A
Maltese: c.702T>G jew c.702T>A
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Maltese: M1R c.3G>A jew c.3G>T jew c.3G>C c.G3A jew 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).
Maltese: 7, 18.4; n=5) għall-ERT. Wara 30 xahar ta' kura b'Galafold, il-bidla medja mil-linja bażi f'LVMi kienet ta' -3.8 (95% CI: -8.9, 1.3; n=28) u l-bidla medja mil-linja bażi f'LVMi f'pazjenti b'ipertrofija ventrikulari tax-xellug fil-linja bażi kienet ta' -10.
English: Migalastat binding stabilizes these mutant forms of -Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes.
Maltese: It-twaħħil ta' migalastat jistabbilizza dawn il-forom mutanti ta' -Gal A fir-retikulu endoplażmiku u jiffaċilita t-traffikar proprju tagħhom għal liżożomi.
English: c.408T>A or c.408T>G
Maltese: 408T>A jew c.408T>G
English: c.G394A or c.G394C
Maltese: c.G394A jew c.G394C
English: c.747C>G or c.747C>A
Maltese: c.747C>G jew c.747C>A
English: c.T784A or c.T784C
Maltese: T784A jew c.T784C
English: c.870G>A or c.870G>C or c.870G>T
Maltese: c.870G>A jew c.870G>C jew c.870G>T
English: c.A886T or c.A886C
Maltese: A886T jew c.A886C
English: c.T337C or c.T339A or c.T339G F113L
Maltese: T337C jew c.T339A jew c.T339G
English: c.G978C or c.G978T
Maltese: c.G978C jew c.G978T
English: c.486G>C or c.486G>T
Maltese: c.486G>C jew c.486G>T
English: Migalastat administered with a high-fat meal, or 1 hour before a high-fat or light meal, or 1 hour after a light meal, resulted in significant reductions of 37% to 42% in mean total migalastat exposure (AUC0-∞) and reductions of 15% to 40% in mean peak migalastat exposure (Cmax) compared with the fasting state.
Maltese: Migalastat mogħti ma' ikla b'kontenut għoli ta' xaħam, jew siegħa qabel ikla b'kontenut għoli ta' xaħam jew inkella ikla ħafifa, jew siegħa wara ikla ħafifa, irriżulta fi tnaqqis sinifikanti ta' 37% sa 43% fil-medja tal-esponiment totali ta' migalastat (AUC0-∞) u tnaqqis ta' 15% sa 40% fil-medja tal-esponiment massimuta' migalastat (Cmax) meta mqabbel ma' stat ta' sawm.
English: Table 2: Galafold (migalastat) amenability table
Maltese: Tabella 2: Tabella ta' mutazzjonijiet li jirrispondu għal Galafold (migalastat) Bidla fin-nukleotidi
English: c.G720C or c.G720T
Maltese: c.G720C jew c.G720T
English: c.720G>C or c.720G>T
Maltese: c.720G>C jew c.720G>T
English: c.G242A or c.G243A
Maltese: G242A jew c.G243A
English: c.729G>C or c.729G>T
Maltese: c.729G>C jew c.729G>T
English: c.T484C or c.T484A
Maltese: T484C jew c.T484A
English: c.G71A or c.G72A
Maltese: G71A jew c.G72A
English: c.G963C or c.G963T
Maltese: c.G963C jew c.G963T
English: c.70T>C or c.70T>A
Maltese: c.70T>C jew c.70T>A
English: c.G837C or c.G837T
Maltese: G837C jew c.G837T
English: c.T817C or c.T819A or c.T819G F273L
Maltese: T817C jew c.T819A jew c.T819G
English: c.T702G or c.T702A
Maltese: c.T702G jew c.T702A
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.
Maltese: Fil-prova mingħajr esperjenza tal-ERT, Galafold wera tnaqqis statistikament sinifikanti f'konċentrazzjonijiet tal-plażma ta' lyso-Gb3 u ta' inklużjonijiet GL-3 tal-kapillari interstizjali tal-kliewi f'pazjenti b'mutazzjonijiet li jirrispondu ghal Galafold.
English: c.840A>T or c.840A>C
Maltese: c.840A>T jew c.840A>C
English: c.32delG
Maltese: 32delG
English: c.772G>C or c.772G>A
Maltese: c.772G>C jew c.772G>A
English: c.G785A or c.G786A
Maltese: c.G785A jew c.G786A
English: c.677G>A or c.678G>A
Maltese: c.677G>A jew c.678G>A
English: c.T706C or c.T706A
Maltese: c.T706C jew c.T706A
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.
Maltese: Fil-prova mingħajr esperjenza tal-ERT, analiżi tal-Iskala tal-Klassifika tas-Sintomi Gastrointestinali wriet li l-kura b'Galafold kienet assoċjata ma' titjib statistikament sinfikanti (p<0.05) meta mqabbel mal-plaċebo mil-linja bażi għal xahar 6 fil-qasam tad-dijarea, u fil-qasam tar-rifluss għal pazjenti bis-sintomi fil-linja bażi.
English: c.G561T or c.G561A or c.G561C M187I
Maltese: c.G561T jew c.G561A jew c.G561C
English: c.G708C or c.G708T
Maltese: c.G708C jew c.G708T
English: (torticollis)
Maltese: (prurite)
English: c.A712C or c.T714A or c.T714G S238R
Maltese: A712C jew c.T714A jew c.T714G
English: UNKNOWN (del Exon5_7?)
Maltese: MHUX MAGĦRUF (del Exon5_7?)
English: c.G936T or c.G936C
Maltese: c.G936T jew c.G936C
English: c.706T>C or c.706T>A
Maltese: c.706T>C jew c.706T>A
English: c.G707A or c.G708A
Maltese: c.G707A jew c.G708A
English: c.868A>C or c.868A>T
Maltese: c.868A>C jew c.868A>T
English: c.666C>A or c.666C>G
Maltese: c.666C>A jew c.666C>G
English: c.785G>A or c.786G>A
Maltese: c.785G>A jew c.786G>A
English: c.G778C or c.G778A
Maltese: G778C jew c.G778A
English: c.A442C or c.T444A or c.T444G S148R
Maltese: A442C jew c.T444A jew c.T444G
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).
Maltese: Galafold huwa indikat għal kura fit-tul ta' adulti u adolexxenti fl-età ta' 16-il sena u aktar b'dijanjożi kkonfermata tal-marda ta' Fabry (defiċjenza ta' α-galactosidase A) u li għandhom mutazzjoni li tirrispondi għal Galafold (ara t-tabelli fis-sezzjoni 5.1).
English: c.778G>C or c.778G>A
Maltese: c.778G>C jew c.778G>A
English: c.72G>C or c.72G>T
Maltese: c.72G>C jew c.72G>T
English: No clinically significant differences were observed during the initial 6-month placebo-controlled period.
Maltese: Ma ġewx osservati differenzi klinikament sinifikanti fil-LVMi waqt il-perjodu inizjali ta' 6 xhur ikkontrollat mill-plaċebo.
English: c.G153A or c.G153T or c.G153C M51I
Maltese: G153A jew c.G153T jew c.G153C
English: g.6736_11545del c.370-533_c.1290+277del
Maltese: Bidla fis-Sekwenza tal-Proteina g.6736_11545del c.370-533_c.