FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
Latvian: MINIMĀLĀ INFORMĀCIJA, KAS JĀNORĀDA UZ STARPIEPAKOJUMA
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
Latvian: - Citas sastāvdaļas ir: Kapsulas saturs: preželatinizēta kukurūzas ciete un magnija stearāts Kapsulas apvalks: želatīns, titāna dioksīds un indigotīns Uzdrukas tinte: šellaka, melnais dzelzs oksīds, un kālija hidroksīds
English: Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse.
Latvian: Nelietojiet šīs zāles, ja barojat bērnu ar krūti, kamēr neesat konsultējusies ar savu ārstu, farmaceitu vai medmāsu.
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.
Latvian: Lietot Galafold kapsulu katru otro dienu, savukārt dienās, kad nelietojat Galafold, izspiest perforēto aplīti blistera plāksnītē.
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
Latvian: Otrais OLE pētījums (AT1001-042) ietvēra gan pacientus, kuri pārcelti no OLE pētījuma AT1001041, gan iekļauti tieši no III fāzes pētījuma ATTRACT, un tas vēl turpinās.
English: Galafold is not indicated for use in patients with non-amenable mutations (see section 5.1).
Latvian: Galafold nav indicēts lietošanai pacientiem ar nemainīgu mutāciju (skatīt 5.1. apakšpunktu).
English: • are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions
Latvian: • Jums ir alerģija (paaugstināta jutība) pret migalastātu vai kādu citu (6. punktā minēto) šo zāļu sastāvdaļu.
English: Do not take Galafold on two consecutive days.
Latvian: Nelietojiet Galafold divas dienas pēc kārtas.
English: Paraesthesia Dizziness Hypoaesthesia
Latvian: Parestēzija Reibonis Hipoestēzija
English: The infertility associated with migalastat treatment was reported at clinically relevant exposures.
Latvian: Tika ziņots par neauglību, kas saistīta ar migalastata terapiju atbilstošās klīnikās lietojamajās devās.
English: Galafold should not be taken on 2 consecutive days.
Latvian: Galafold nedrīkst lietot 2 dienas pēc kārtas.
English: The effects of Galafold on fertility in humans have not been studied.
Latvian: Nav pētīta Galafold ietekme uz cilvēku fertilitāti.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine until you have checked with your doctor, pharmacist, or nurse.
Latvian: Ja Jums ir iestājusies grūtniecība vai domājat, ka Jums varētu būt iestājusies grūtniecība vai plānojat grūtniecību, pirms šo zāļu lietošanas konsultējieties ar savu ārstu vai farmaceitu.
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.
Latvian: Pētījumā ar EAT-terapiju iepriekš ārstētiem pacientiem plazmas lyso-Gb3līmeņi nedaudz palielinājās, bet saglabājās zemi pacientiem, kuru mutācijas bija izmaināmas un tika ārstētas ar Galafold 30 pētījuma mēnešus.
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).
Latvian: Pirmais III fāzes pētījums (ATTRACT) bija randomizēts atklāts pētījums ar aktīvu salīdzināšanas līdzekli, kurā novērtēja Galafold efektivitāti un drošumu, salīdzinot ar enzīmu aizstājterapiju (EAT) (bētaagalzidāze, agalzidāzes alfa) 52 vīriešu un sieviešu dzimuma pacientiem ar Fabri slimību, kuri saņēma EAT pirms pētījuma uzsākšanas un kuru mutācijas bija izmaināmas (EAT-terapija iepriekš ārstētiem pacientiem).
English: UNKNOWN (E66_Y123del; del Exon2)
Latvian: NEZINĀMS (E66_Y123del; del Exon2)
English: It is not yet known whether this medicine passes into breast milk.
Latvian: Vēl nav zināms, vai zāles nokļūst mātes pienā.
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.
Latvian: Izspiediet lietojamās kapsulas nepāra dienās un pāra dienās izspiediet perforētos baltos aplīšus līdz pat 28. dienai ieskaitot.
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.
Latvian: Pētījumā ar EAT-terapiju agrāk neārstētiem pacientiem Galafold uzrādīja statistiski nozīmīgu plazmas lyso-Gb3 koncentrācijas samazinājumu un nieru intersticiāla kapilāru GL-3 iekļaušanu pacientiem, kuru mutācijas bija izmaināmas.
English: Marketing Authorisation Holder Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Latvian: Reģistrācijas apliecības īpašnieks Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
English: Migalastat is not a substrate for P-glycoprotein (P-gP) in vitro and it is considered unlikely that migalastat would be subject to drug-drug interactions with cytochrome P450s.
Latvian: Pamatojoties uz invitro pētījumiem, migalastats nav P-glikoproteīna (P-gp) substrāts un ir maz ticams, ka migalastatam varētu rasties mijiedarbība ar citām zālēm - citohromu P450s.
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
Latvian: Katra kapsula satur migalastatahidrohlorīdu, kas atbilst 123 mg migalastata.
English: UNKNOWN (E66_Y123del; del Exon2?)
Latvian: NEZINĀMS (E66_Y123del; del Exon2?)
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.
Latvian: Pacientu ziņotais iznākums - kuņģa-zarnu trakta simptomu vērtēšanas skala Pētījumā ar EAT-terapiju agrāk neārstētiem pacientiem kuņģa-zarnu trakta simptomu vērtēšanas skalas analīzes uzrādīja, ka ārstēšana ar Galafold izraisīja statistiski nozīmīgus uzlabojumus (p<0,05), salīdzinot ar placebo no sākumstāvokļa līdz 6. mēnesim diarejas gadījumā, un atviļņa slimības gadījumā pacientiem ar sākumstāvokļa simptomiem.
English: No reduction in proteinuria was observed in patients treated with Galafold.
Latvian: Pacientiem, kuri tika ārstēti ar Galafold, netika novērota proteīnūrijas samazināšanās.
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).
Latvian: Otrais III fāzes pētījums (FASETS) bija 6 mēnešu ilgs, randomizēts, dubultmaskēts, placebo kontrolēts pētījums (6. mēnesī) ar 18 mēnešu ilgu atklāto periodu, kurā novērtēja Galafold efektivitāti un drošumu 50 vīriešiem un sievietēm ar Fabri slimību, kuri iepriekš nebija saņēmuši EAT vai arī saņēma, taču bija pārtraukuši tās lietošanu vismaz 6 mēnešus, un kuru mutācijas bija izmaināmas (EAT-terapija agrāk neārstētiem pacientiem).
English: Elderly population No dosage adjustment is required based on age (see section 5.2).
Latvian: Vecāka gadagājuma pacienti Devas pielāgošana, pamatojoties uz vecumu, nav nepieciešama (skatīt 5.2. apakšpunktu).
English: This is a common spontaneous tumour in ad libitum-fed male rats.
Latvian: Tas ir izplatīts spontāns audzējs ar adlibitum barotiem žurku tēviņiem.
English: UNKNOWN IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T UNKNOWN
Latvian: IVS6-22C>T c.1000-10G>A/1000-22C>T NEZINĀMS
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).
Latvian: Pacienti, kuri tika randomizēti Galafold saņemšanai, 1. posmā uzrādīja statistiski nozīmīgu lielāku intersticiālo kapilāru GL-3 uzkrāšanās samazinājumu (±SEM) (-0,25 ± 0,10; -39%) 6. mēnesī, salīdzinot ar placebo (0,07 ± 0,13; + 14%) (p = 0,008).
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).
Latvian: Arī pacienti, kuri tika randomizēti placebo ārstēšanai 1. posmā un pārgāja uz Galafold terapiju 6. mēnesī (2. posms), uzrādīja statistiski nozīmīgu intersticiālo kapilāru GL-3 uzkrāšanās samazinājumu 12. mēnesī (-0,33 ± 0,15;-58%) (p=0,014).
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.
Latvian: Ja ir aizmirsta vienas dienas deva, pacientiem jālieto aizmirstā Galafold deva tikai, ja nav pagājušas vairāk kā 12 stundas no parastā devas lietošanas laika.
English: After Day 2, continue moving right on the blister sleeve.
Latvian: Pēc 2. dienas spiediet blistera plāksnītes labajā pusē.
English: Protein sequence change
Latvian: Olbaltumvielu sekvences izmaiņas
English: Disease Substrate
Latvian: Slimības substrāts
English: Protein Sequence change c.1A>C or c.1A>T
Latvian: Olbaltumvielu sekvences izmaiņas c.1A>C vai c.1A>T
English: You should not take Galafold if you are also receiving enzyme replacement therapy.
Latvian: Galafold nedrīkst lietot, ja Jūs saņemat enzīmu aizstājterapiju.
English: c.1018T>C or c.1018T>A c.T1018C or c.T1018A
Latvian: c.1018T>C vai c.1018T>A c.T1018C vai c.T1018A
English: Your doctor will monitor your condition and whether your medicine is working every 6 months while you are taking Galafold.
Latvian: Kamēr Jūs lietosiet Galafold, Jūsu ārsts ik pēc 6 mēnešiem pārbaudīs Jūsu veselības stāvokli.
English: The GLA mutations amenable and not amenable to treatment with Galafold are listed in Table 2 and Table 3 respectively below.
Latvian: GLA mutācijas, ko ārstēšanā ar Galafold var vai nevar izmainīt, uzskaitītas 2. un 3. tabulā.
English: BLISTER SLEEVE
Latvian: BLISTERA PLĒVE
English: It is not known whether Galafold is secreted in human milk.
Latvian: Nav zināms, vai Galafold izdalās mātes pienā.
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Latvian: c.1196G>A vai c.1197G>A c.G1196A vai c.G1197A
English: c.A1C or c.A1T
Latvian: c.A1C vai c.A1T
English: In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p< 0.05).
Latvian: Pētījumā ar EAT-terapiju iepriekš ārstētiem pacientiem pēc 18 mēnešus ilgas ārstēšanas ar Galafold novēroja statistiski nozīmīgu KKMI samazināšanos (p <0.05).
English: However, migalastat has been shown to be expressed in the milk of lactating rats.
Latvian: Tomēr pētījumi ar žurkām pierādījuši, ka migalastats izdalās ar mātes pienu.
English: p.P6fs*114
Latvian: P6fs*114
English: Left Ventricular Mass Index (LVMi)
Latvian: Kreisā kambara masas indekss (KKMI)
English: In rabbits, developmental toxicity was observed only at maternally toxic doses (see section 5.3).
Latvian: Pētījumos ar trušiem ietekme uz pēcnācējiem ir novērota tikai pie devām, kas izraisīja toksicitāti dzīvnieku mātītēm (skatīt 5.3. apakšpunktu).
English: Table 3: Mutations not amenable to Galafold (migalastat)
Latvian: Mutācijas, kuras ārstēšanā ar Galafold (migalastatu) nevar izmainīt
English: Blood Creatine Phosphokinase increased
Latvian: Kreatīnfosfokināzes līmeņa paaugstināšanās asinīs Ķermeņa masaspalielināšanās
English: How to store Galafold
Latvian: Kā uzglabāt Galafold
English: Pack size of 14 capsules.
Latvian: Iepakojumā 14 kapsulas.
English: • Muscle pain (myalgia)
Latvian: • Muskuļu sāpes (mialģija)
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.
Latvian: Ārstēšanas ar Galafold rezultātā II fāzes farmakodinamikas pētījumos baltajos asinsķermenīšos un vairumam pacientu arī ādā un nierēs palielinājās endogēnās α-Gal A darbības līmenis.
English: • Painful stiff neck
Latvian: • Sāpīgs un stīvs kakls (greizais kakls)
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Latvian: c.1019G>A vai c.1020G>A c.G1019A vai c.G1020A
English: From the metabolism and excretion pathways, it is not expected that a decreased hepatic function may affect the pharmacokinetics of migalastat.
Latvian: Nav veikti pētījumi pacientiem ar aknu darbības traucējumiem Nav sagaidāms, ka metabolisma un izdalīšanās ceļā pavājināta aknu darbība var ietekmēt migalastata farmakokinētiku.
English: In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Latvian: Pētījumā ar EAT-terapiju agrāk neārstētiem pacientiem un atklāto pagarināto posmu nieru darbība saglabājās stabila līdz 5 gadiem pacientiem, kuri saņēma Galafold.
English: See package leaflet for further instructions.
Latvian: Sīkāku informāciju skatīt lietošanas instrukcijā.
English: What Galafold contains - The active substance is migalastat.
Latvian: Ko Galafold satur? - Aktīvā viela ir migalastats.
English: c.G611A or G612A
Latvian: c.G611A vai G612A
English: Certain GLA mutations can result in the production of abnormally folded and unstable mutant forms of α-Gal A. Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of -Gal A, the genotypes of which are referred to as amenable mutations.
Latvian: Migalastats ir farmakoloģiskais čaperons, kas paredzēts, lai ar augstu afinitāti selektīvā un atgriezeniskā veidā sasaistītos ar noteiktu -Gal A mutantu formu aktīvajām vietām - genotipiem, kuri tiek attiecināti uz mainīgajām mutācijām.
English: c.A504C or c.A504T
Latvian: c.A504C vai c.A504T
English: c.712A>C or c.714T>A or c.714T>G
Latvian: c.712A>C vai c.714T>A vai c.714T>G
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Latvian: c.1202C>G vai c.1202C>A c.C1202G vai c.C1202A
English: c.140G>A or 141G>A
Latvian: c.140G>A vai 141G>A
English: c.T1147C or c.C1149G or c.C1149A
Latvian: c.T1147C vai c.C1149G vai c.C1149A
English: c.611G>A or 612G>A
Latvian: c.611G>A vai 612G>A
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
Latvian: Galafold nav ieteicams lietot pacientiem ar Fabri slimību, kuriem aprēķinātais GFĀ ir mazāks par 30 ml/min./1,73 m
English: g.2594_10904dup c.195-2500_999+197dup
Latvian: g.2594_10904dup c.195-2500_999+197dup g.2934_6378del
English: c.A924T or c.A924C
Latvian: c.A924T vai c.A924C
English: If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule.. Do not take two capsules to make up for your missed dose.
Latvian: Ja pagājušas vairāk kā 12 stundas, Jums ir jāatsāk Galafold lietošana nākamās plānotās devas dienā un laikā saskaņā ar katras otrās dienas dozēšanas grafiku.
English: c.442A>C or c.444T>A or c.444T>G
Latvian: c.442A>C vai c.444T>A vai c.444T>G
English: How to take Galafold
Latvian: Kā lietot Galafold
English: • Reduced sense of touch or sensation
Latvian: • Samazināta taustes sajūta vai jutība(hipoestēzija)
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).
Latvian: Pēc papildu OLE vidējais KKMI izmaiņu rādītājs no sākumstāvokļa 36. mēnesī bija -8,3 (95% TI: -17,1, 0,4; n=25) un 48. mēnesī bija -9,1 (95% TI: -20,3, 2.0; n=18).
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Latvian: Pētījumā ar EAT-terapiju iepriekš ārstētiem pacientiem nieru darbība ārstēšanā ar Galafold saglabājās stabila līdz pat 18 mēnešiem.
English: The effect of age was evaluated in a population pharmacokinetic analysis on plasma migalastat clearance in the ERT-naïve study population.
Latvian: Populācijas farmakokinētikas plazmas migalastata klīrensa analīzē pētījumā ar EAT-terapiju agrāk neārstētiem pacientiem tika izvērtēta vecuma ietekme.
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Latvian: c.1095T>A vai c.1095T>G c.T1095A vai c.T1095G
English: g.10237_11932del/11933_12083i nv/12084_12097del
Latvian: g.10237_11932del/11933_12083i nv/12084_12097del g.>5.5kbdel to 3UTR
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Latvian: c.1034C>G vai c.1034C>A c.C1034G vai c.C1034A
English: This minimum 4 hours fast around taking your medicine is needed to allow your medicine to be fully absorbed.
Latvian: Lai ļautu zālēm pilnībā uzsūkties, nepieciešamas, lai vismaz 4 stundas paietu bez ēšanas.
English: c.1045T>C or c.1045T>A c.T1045C or c.T1045A
Latvian: c.1045T>C vai c.1045T>A c.T1045C vai c.T1045A
English: c.G140A or G141A
Latvian: c.G140A vai G141A
English: c.504A>C or c.504A>T
Latvian: c.504A>C vai c.504A>T
English: c.1046G>A or c.1047G>A c.G1046A or c.G1047A
Latvian: c.1046G>A vai c.1047G>A c.G1046A vai c.G1047A
English: c.C816A or c.C816G
Latvian: c.C816A vai c.C816G
English: Abdominal pain Constipation Dry mouth
Latvian: Sāpes vēderā Aizcietējums Sausa mute
English: c.T139C or c.T139A
Latvian: c.T139C vai c.T139A
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Latvian: Tas attiecas arī uz iespējamām blakusparādībām, kas nav minētas šajā instrukcijā.Jūs varat ziņot par blakusparādībām arī tieši, izmantojot V pielikumā minēto nacionālās ziņošanas sistēmas kontaktinformāciju.
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Latvian: c.1065C>A vai c.1065C>G c.C1065A vai c.C1065G
English: (95% CI: -3.636, 1.575; n=18) in the ERT group.
Latvian: -3,636, 1,575; n=18) EAT ārstētu pacientu grupā.
English: c.A124C or c.A124T
Latvian: c.A124C vai c.A124T
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.
Latvian: 2. izmēra cietā kapsula (6,4 x 18,0 mm) ar zilu necaurspīdīgu vāciņu un baltu necaurspīdīgu korpusu.
English: How to store Galafold 6.
Latvian: Kā uzglabāt Galafold?
English: c.G412A or c.G412C
Latvian: c.G412A vai c.G412C
English: c.C159G or c.C159A
Latvian: c.C159G vai c.C159A
English: c.1147T>C or c.1149C>G or c.1149C>A
Latvian: c.1147T>C vai c.1149C>G vai c.1149C>A
English: c.C519A or c.C519G
Latvian: c.C519A vai c.C519G
English: c.280T>A or c.281G>C
Latvian: c.280T>A vai c.281G>C
English: c.216G>A or c.216G>T or c.216G>C
Latvian: c.216G>A vai c.216G>T vai c.216G>C
English: c.139T>C or c.139T>A
Latvian: c.139T>C vai c.139T>A
English: UNKNOWN (del Exon3 and 4?)
Latvian: NEZINĀMS (del Exon3 un 4?)
English: c.C279G or c.C279A
Latvian: c.C279G vai c.C279A
English: c.G103C or c.G103A
Latvian: c.G103C vai c.G103A
English: c.C207A or c.C207G
Latvian: c.C207A vai c.C207G
English: c.412G>A or c.412G>C
Latvian: c.412G>A vai c.412G>C
English: (dyspnoea)
Latvian: (dispepsija)
English: c.924A>T or c.924A>C
Latvian: c.924A>T vai c.924A>C
English: c.G285T or c.G285C
Latvian: c.G285T vai c.G285C
English: c.228G>C or c.228G>A or c.228G>T
Latvian: c.228G>C vai c.228G>A vai c.228G>T
English: c.G284A or c.G285A
Latvian: c.G284A vai c.G285A
English: Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Latvian: Klīniskajos pētījumos novērotās Galafold nevēlamās reakcijas Orgānu sistēmas klasifikācija
English: c.T241C or c.T241A
Latvian: c.T241C vai c.T241A
English: g.941_5845del p.?
Latvian: g.941_5845del p.?(Exon1_2del)
English: c.T881G or c.T881A
Latvian: c.T881G vai c.T881A
English: c.817T>C or c.819T>A or c.819T>G
Latvian: c.817T>C vai c.819T>A vai c.819T>G
English: c.337T>C or c.339T>A or c.339T>G
Latvian: c.337T>C vai c.339T>A vai c.339T>G
English: c.159C>G or c.159C>A
Latvian: c.159C>G vai c.159C>A
English: • Indigestion (dyspepsia)
Latvian: • Slikta dūša (nelabums)
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%).
Latvian: Farmakokinētiskajā pētījumā, iesaistot veselus brīvprātīgos vīriešus ar 150 mg C] -migalastataHCl, atklāja, ka 99% no plazmā konstatētās, ar radioaktīvo izotopu iezīmētās devas sastāvēja no migalastata (77%) neizmainītā veidā un 3 dehidrogenētiem O-glikuronīdu konjugētiem metabolītiem M1 uz M3 (13%).
English: c.T187A or c.G188C
Latvian: c.T187A vai c.G188C
English: c.561G>T or c.561G>A or c.561G>C
Latvian: c.561G>T vai c.561G>A vai c.561G>C
English: c.G261C or c.G261T
Latvian: c.G261C vai c.G261T
English: c.G540C or c.G540T
Latvian: c.G540C vai c.G540T
English: c.148T>C or c.150C>G or c.150C>A
Latvian: c.148T>C vai c.150C>G vai c.150C>A
English: c.T148C or c.C150G or c.C150A F50L
Latvian: c.T148C vai c.C150G vai c.C150A
English: c.284G>A or c.285G>A
Latvian: c.284G>A vai c.285G>A
English: c.C233G or c.C233A
Latvian: c.C233G vai c.C233A
English: c.242G>A or c.243G>A
Latvian: c.242G>A vai c.243G>A
English: c.261G>C or c.261G>T
Latvian: c.261G>C vai c.261G>T
English: c.G131A or c.G132A
Latvian: c.G131A vai c.G132A
English: c.187T>A or c.188G>C
Latvian: c.187T>A vai c.188G>C
English: c.124A>C or c.124A>T
Latvian: c.124A>C vai c.124A>T
English: c.G612T or c.G612C
Latvian: c.G612T vai c.G612C
English: c.207C>A or c.207C>G
Latvian: c.207C>A vai c.207C>G
English: c.G471C or c.G471T
Latvian: c.G471C vai c.G471T
English: Mean annualised rate of change in eGFRCKD-EPI was -0.40 mL/min/1.73 m
Latvian: Vidējais eGFĀCKD-EPI rādītājs gadā bija -0,40 ml/min./1,73 m
English: c.T166A or c.G167C
Latvian: c.T166A vai c.G167C
English: c.G982A or c.G982C
Latvian: c.G982A vai c.G982C
English: c.552T>A or c.552T>G
Latvian: c.552T>A vai c.552T>G
English: c.241T>C or c.241T>A
Latvian: c.241T>C vai c.241T>A
English: c.612G>T or c.612G>C
Latvian: c.612G>T vai c.612G>C
English: c.153G>A or c.153G>T or c.153G>C
Latvian: c.153G>A vai c.153G>T vai c.153G>C
English: c.519C>A or c.519C>G
Latvian: c.519C>A vai c.519C>G
English: c.C305G or c.C305A
Latvian: c.C305G vai c.C305A
English: c.G1074T or c.G1074C
Latvian: c.G1074T vai c.G1074C
English: c.G734A or c.G735A
Latvian: c.G734A vai c.G735A
English: c.471G>C or c.471G>T
Latvian: c.471G>C vai c.471G>T
English: • Sensation of spinning
Latvian: • Griešanās sajūta
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).
Latvian: Pētījumā ar EAT-terapiju agrāk neārstētiem pacientiem Galafold lietošana uzrādīja statistiski nozīmīgu KKMI samazināšanos (p<0.05); vidējais izmaiņu rādītājs no sākumstāvokļa 18.-24. mēnesī bija -7,7 (95% TI: -15,4, -0,01; n=27).
English: c.G609C or c.G609T
Latvian: c.G609C vai c.G609T
English: c.G132T or c.G132C
Latvian: c.G132T vai c.G132C
English: c.G243T or c.G243C
Latvian: c.G243T vai c.G243C
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Latvian: (95% TI: -2,272, 1,478; n=34) arGalafold ārstētu pacientu grupā, salīdzinot ar -1,03 ml/min/1,73 m2 (95% TI:
English: c.T258G or c.T258A
Latvian: c.T258G vai c.T258A
English: c.T552A or c.T552G
Latvian: c.T552A vai c.T552G