FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Maltese: Is-sustanza attiva f'Esmya, l-aċetat tal-ulipristal, taħdem billi teħel mal-miri fuq iċ-ċelloli (riċetturi) li lormon tal-proġesteron normalment jeħel magħhom, u b'hekk tipprevjeni lill-proġesteron milli jkollu leffett tiegħu.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Maltese: Ir-rieżami sar mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), il-Kumitat responsabbli mill-valutazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini għall-użu mill-bniedem.
English: Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Maltese: Peress li l-proġesteron jista' jippromwovi t-tkabbir tal-fibrojdi, billi jipprevjeni l-effetti talproġesteron, l-aċetat tal-ulipristal inaqqas id-daqs tal-fibrojdi.
English: Liver testing also to be performed again 2-4 weeks after stopping treatment.
Maltese: Ittestjar tal-fwied li għandu jerġa' jsir ukoll 2-4 ġimgħat wara li titwaqqaf il-kura.
English: • Esmya will not be prescribed to you if you have liver problems.
Maltese: • Esmya mhuwiex ser jiġi preksritt lilek jekk għandek problemi tal-fwied.
English: The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury.
Maltese: Il-miżuri jinkludu: kontraindikazzjoni fin-nisa bi problemi tal-fwied magħrufin; testijiet tal-fwied qabel, matul u wara li titwaqqaf il-kura; kard għall-pazjenti biex tinfurmahom dwar il-ħtieġa għal monitoraġġ tal-fwied u biex jikkuntattjaw lit-tabib tagħhom jekk dawn jiżviluppaw sintomi ta' ħsara fil-fwied.
English: • Healthcare professionals prescribing Esmya in the EU will receive a letter with further details once a European Commission decision has been issued.
Maltese: • Il-professjonisti tal-kura tas-saħħa li jippreskrivu Esmya fl-UE ntbagħtitilhom ittra b'aktar dettalji.
English: • If no liver problems are detected, a single course of Esmya can be used in women who are about to have surgery for their fibroids; Esmya can be used for more than one course only in women who cannot have surgery.
Maltese: • Jekk ma tiġi identifikata l-ebda problema tal-fwied, jista' jintuża kors wieħed ta' Esmya f'nisa li jkunu waslu biex issirilhom kirurġija għall-fibrojdi tagħhom; Esmya jista' jintuża għal aktar minn kors wieħed biss f'nisa li ma tistax issirilhom kirurġija.
English: • A card will be included in the package of the medicine with information on the risk of liver injury and the need for liver monitoring.
Maltese: • Ser tiġi inkluża kard fil-pakkett tal-mediċina b'informazzjoni dwar ir-riskju ta' ħsara fil-fwied u lħtieġa għal monitoraġġ tal-fwied.
English: Esmya: new measures to minimise risk of rare but serious liver injury
Maltese: Esmya: miżuri ġodda għall-imminimizzar tar-riskju ta'
English: − Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN.
Maltese: − Il-kura għandha titwaqqaf f'pazjenti b'livelli ta' ALT jew AST aktar minn 3 darbiet tal-ULN.
English: ATCvet code: QI05AD02.
Maltese: Q105AD02.
English: Carbomer ........................................................................................................................................... 4 mg.
Maltese: Carboner ............................................................................................................................................. 4 mg
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Maltese: Laboratorju ta' Lyon Gerland 254, rue Marcel Mérieux, 69007 Lyon,
English: Date of first authorisation: 06/03/2003 Date of last renewal: 06/03/2013
Maltese: Data tal-ewwel awtorizzazzjoni: 06/03/2003 Data tal-aħħar tiġdid: 06/03/2013
English: * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Maltese: * Il-kontenut tal-vCP iċċekjat bil-FAID50 globali (doża infettiva florexxenti ta' prova 50 %) u r-ratio qPCR bejn vCP.
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta fil-friġġ 2 °C - 8 °C.
English: As a consequence, these components induce immunity against equine influenza virus (H3N8).
Maltese: Konsegwentement, dawn il-komponenti jinduċu immunità kontra l-virus tal-influwenza fiż-żwiemel (H3N8).
English: Carbomer ........................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Maltese: Carboner ............................................................................................................................................. 4 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Maltese: L-istrejns vCP2242 u vCP3011 tal-vaċċin huma virusijiet rikombinati tal-canarypox li jesprimu ilġene hæmagglutinin HA mill-istrejns tal-virus tal-influwenza fiż-żwiemel A/eq/ Ohio/03 (strejn Amerikan Florida sublineage clade 1) u A/eq/Richmond/1/07 (strejn Amerikan, Florida sublineage clade 2), rispettivament.
English: Protect from light.
Maltese: ProteqFlu-Te.
English: In rare occasions swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
Maltese: F'okkażjonijet rari n-nefħa tista' tilħaq dijametru ta' 15 - 20 cm, li ddum minn 2 - 3 ġimgħat, li tista' tirrekjedi kura sintomatika.
English: - Revaccination:
Maltese: Inkompatibilitajiet :
English: Influenza A/eq/Ohio/03 [H3N8] (vCP2242) ............................................................... ≥ 5.3 log10 FAID50 Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) .................................................... ≥ 5.3 log10 FAID50
Maltese: Influenza A/eq/ Ohio/03 {H3N8}virus rikombinat tal-canarypox (vCP2242) .................................................................................................................................. >5.3 log 10 FAID50* Influenza A/eq/Richmond/1/07 {H3N8} virus rikombinat tal-canarypox (vCP3011) .................................................................................................................................. >5.3 log 10 FAID50*
English: 2nd scheme - vaccination against equine influenza and tetanus:
Maltese: It-tieni skema - tilqim kontra l-influwenza ekwina u t-tetnu:
English: Name and address of the manufacturers of the biological active substances
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanzi bioloġiċi attivi
English: Onset of immunity: 14 days after primary vaccination course.
Maltese: Bidu ta' l-immunità: 14-il ġurnata wara l-ewwel kors ta' tilqim.
English: .. ≥ 5.3 log10 FAID50*
Maltese: 4.11 Perjodu ta' Tiżmim
English: The vaccine stimulates active immunity against equine influenza.
Maltese: Il-vaċċin jistimula immunità kontra l-influwenza fiż-żwiemel.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Maltese: F'każ li jiżdied ir-riskju ta' infezzjoni jew jekk ma jkunx qed jittieħed kolostrum biżżejjed, injezzjoni oħra fil-bidu ta' ProteqFlu tista' tingħata ta' 4 xhur segwita mill-programm komplet ta' tilqim (l ewwel kors ta' tilqim ta' 5-6 xhur u 4-6 ġimgħat wara segwit mit-tieni kors).
English: Butyl elastomer closure and aluminium cap.
Maltese: Aqra l-fuljett tal-pakkett qabel l-użu.
English: 1st scheme - vaccination against equine influenza:
Maltese: L-ewwel skema - tilqim kontra l-influwenza ekwina:
English: Box of 10 vials of 1 dose.
Maltese: Kaxxa ta' 10 fjali ta' doża waħda.
English: Do not use after the expiry date stated on the label.
Maltese: F'każi rari ħafna tista tiġi osservata l-materja .
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma' prodott mediċinali veterinarju ieħor.
English: - Revaccination: 5 months after primary vaccination course followed by annual booster injections.
Maltese: - It-tieni kors: 5 xhur wara l-ewwel kors ta' tilqim segwit minn injezzjonijiet booster ta' kull sena.
English: ProteqFlu suspension for injection for horses
Maltese: VETERINARJU ProteqFlu suspensjoni għall-injezzjoni għaż-żwiemel.
English: Administer one dose (1 ml of ProteqFlu), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later.
Maltese: Amministra doża waħda (1 ml) b'injezzjoni fil-muskolu, preferibbilment fl-għonq, skond din l-iskeda li ġejja:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Maltese: Ebda interazzjoni ma ġiet osservata meta l-vaċċin kien amministrat flimkien, iżda f'post differenti,
English: Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Maltese: Immunizzazzjoni attiva ta' żwiemel ta' 4 xhur jew akbar kontra l-influwenza fiż-żwiemel sabiex tnaqqas sinjali kliniċi u tneħħija tal-virus wara infezzjoni.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI
English: • 5 months after primary vaccination course with ProteqFlu-Te.
Maltese: • 5 xhur wara l-ewwel kors ta' tilqim bil-ProteqFlu-Te
English: Manufacturer responsible for the batch release: MERIAL
Maltese: Manifattur li jħalli l-konsenja tmur fis-suq: MERIAL,
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1st scheme - vaccination against equine influenza:
Maltese: U METODU TA' AMMINISTRAZZJONI L-ewwel skema - tilqim kontra l-influwenza ekwina:
English: For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material.
Maltese: Għall-amministrazzjoni tal-vaċċin, uża materjal sterilizzat li m'għandux diżinfettant jew antisettiku.
English: The maximum exposure was 5.6 years.
Maltese: L-esponiment massimu kien ta' 5.6 snin.
English: 26 May 2016
Maltese: 26 ta' Mejju, 2016
English: PVC / PCTFE / PVC/Al blister.
Maltese: Folja (Blister) tal-PVC / PCTFE / PVC/Al Daqs tal-pakkett ta' 14-il kapsula.
English: Capsule contents Pregelatinised starch (maize) Magnesium stearate
Maltese: Kontenut tal-kapsula Pregelatinised starch (qamħirrum) Magnesium stearate
English: QR code to be included + www.galafoldsmpc.co.uk
Maltese: Kodiċi QR għandha tiġi inkluża + www.galafoldsmpc.co.uk
English: c.42_48delTGCGCTT
Maltese: 42_48delTGCGCTT
English: c.963_964GG>CA
Maltese: 963_964GG>CA
English: UNKNOWN (delExon3_3'UTR?)
Maltese: MHUX MAGĦRUF (delExon3_3'UTR?)
English: At the 150 mg dose, CL/F was approximately 11 to 14 L/hr.
Maltese: Fid-doża ta' 150 mg, CL/F kien bejn wieħed u ieħor 11 sa 14 L/hr.
English: Dyspnoea Epistaxis
Maltese: Dispneja Epistassi
English: Amicus Therapeutics S.L.U.
Maltese: Amicus Therapeutics S.
English: c.A157C/A158T
Maltese: A157C/A158T
English: No data are available.
Maltese: L-ebda data ma hi disponibbli.
English: c.A164T/A170T
Maltese: A164T/A170T
English: UNKNOWN (Exon2_4dup?)
Maltese: MHUX MAGĦRUF (Exon2_4dup?)
English: Left Ventricular Mass Index (LVMi)
Maltese: Indiċi tal-Massa Ventrikulari tax-Xellug (Left Ventricular Mass Index - LVMi)
English: Fax: +353 (0) 1 588 6851 e-mail: info@amicusrx.co.uk
Maltese: +353 (0) 1 588 6851 e-mail: info@amicusrx.co.uk
English: (95% CI: -3.636, 1.575; n=18) in the ERT group.
Maltese: (95% CI: -3.636, 1.575; n=18) fil-grupp ERT.
English: Furthermore, migalastat is not an inhibitor or a substrate of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5.
Maltese: Barra minn hekk, migalastat mhuwiex inibitur jew sottostrat ta' CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, jew 3A4/5.
English: In addition, migalastat is not a substrate for MATE1, MATE2-K, OAT1, OAT3, or OCT2, nor is it an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2-K human uptake transporters.
Maltese: trasportaturi tal-assorbiment umani (human uptake transporters) OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, jew MATE2-K.
English: Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Maltese: Tabella 1: Reazzjonijiet avversi b'Galafold rraportati fi provi kliniċi Klassi tas-Sistema tal
English: c.760-762delGTT or c.761-763del c.760_762delGTT or c.761_763del p.V254del
Maltese: c.760-762delGTT jew c.761763del c.760_762delGTT jew c.761_763del p.V254del
English: p.D315_Q321del c.946_954dup c.946_954dup p.V316_A318dup p.V316_D322del c.946delG
Maltese: Bidla fis-Sekwenza tal-Proteina p.D315_Q321del c.946_954dup c.946_954dup p.V316_A318dup p.V316_D322del c.946delG
English: Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Maltese: Uġigħ ta' ras u sturdament kienu l-aktar reazzjonijiet avversi komuni rrapportati b'dożi ta' Galafold sa 1250 mg u 2000 mg, rispettivament.
English: UNKNOWN IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T UNKNOWN
Maltese: MHUX MAGĦRUF IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T MHUX MAGĦRUF
English: • Indigestion (dyspepsia)
Maltese: • Indiġestjoni (dispepsja)
English: c.323_324insCAGA
Maltese: 323_324insCAGA
English: c.G11T/A620C
Maltese: G11T/A620C
English: g.>5.5kbdel to 3UTR
Maltese: 5kbdel sa 3UTR
English: c.369+3_639+954del3129insT UNKNOWN (del Exon3 and 4?)
Maltese: c.369+3_639+954del3129insT MHUX MAGĦRUF (del Exon3 u 4?)
English: c.A836T/902G>A
Maltese: A836T/902G>A
English: c.207_369+651del814ins231 UNKNOWN (del Exon2?)
Maltese: c.207_369+651del814ins231 MHUX MAGĦRUF (del Exon2?)
English: Printing ink Shellac
Maltese: Linka ta' stampar Shellac
English: c.C1247A/T1248A
Maltese: C1247A/T1248A
English: c.C358T/T359C
Maltese: C358T/T359C
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%).
Maltese: C]-migalastat HC żvelat li 99% tad-doża radjutikkettata rkuprata fil-plażma kienet komposta minn migalastat mhux mibdul (77%) u minn 3 metaboliti konġugati ta dehydrogenated O-glucuronide, M1 sa M3 (13%).
English: Plasma migalastat exposure (AUC0-∞) and Cmax demonstrated dose-proportional increases at migalastat hydrochloride oral doses from 50 mg to 1,250 mg.
Maltese: L-esponiment fil-plażma ta' migalastat hydrochloride (AUC0-∞) u Cmax wrew żidiet proporzjonali mad-doża f'dożi orali ta' migalastat minn 50 mg sa 1,250 mg.
English: c.G790T/G805A
Maltese: G790T/G805A
English: c.1018T>C or c.1018T>A c.T1018C or c.T1018A
Maltese: c.1018T>C jew c.1018T>A c.T1018C jew c.T1018A
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Maltese: c.1196G>A jew c.1197G>A c.G1196A jew c.G1197A
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Maltese: c.1202C>G jew c.1202C>A c.C1202G jew c.C1202A
English: UNKNOWN (E66_Y123del; del Exon2?)
Maltese: MHUX MAGĦRUF (E66_Y123del; del Exon2?)
English: How to store Galafold 6.
Maltese: Kif taħżen Galafold 6.
English: Marketing Authorisation Holder Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
English: c.A644G/G811A
Maltese: A644G/G811A
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Maltese: c.1019G>A jew c.1020G>A c.G1019A jew c.G1020A
English: c.A504C or c.A504T
Maltese: A504C jew c.A504T
English: c.T280A/G281C
Maltese: T280A/G281C
English: Other medicines and Galafold
Maltese: Mediċini oħra u Galafold
English: A pharmacokinetic trial in healthy male volunteers with 150 mg [
Maltese: Prova farmakokinetika f'voluntiera rġiel f'saħħithom b'150 mg [
English: UNKNOWN (E66_Y123del; del Exon2)
Maltese: MHUX MAGĦRUF (E66_Y123del; del Exon2)
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).
Maltese: Pazjenti randomizzati għall-plaċebo fi Stadju 1 u li bdew jingħataw Galafold f'xahar 6 (Stadju 2) ukoll urew tnaqqis statistikament sinifikanti f'inklużjonijiet GL-3 fil-kapillari interstizjali f'xahar 12 (-0.33±0.15; -58%) (p=0.014).
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.
Maltese: Migalastat mhuwiex sottostrat ta' P-glycoprotein (P-gP) in vitro u huwa meqjus improbabbli li migalastat għamdu ikun soġġett għal interazzjonijiet bejn mediċina u ohra maċ- cytochrome P450s.
English: Galafold is not intended for concomitant use with enzyme replacement therapy (see section 4.4).
Maltese: Galafold mhuwiex intiż għall-użu fl-istess ħinma'terapija ta' sostituzzjoni tal-enzima (ara sezzjoni 4.4).
English: (proteinuria)
Maltese: (proteinurja)
English: • Muscle pain (myalgia)
Maltese: • Uġigħ fil-muskoli (mijalġja)
English: Based upon in vitro data, migalastat is not an inducer of CYP1A2, 2B6, or 3A4.
Maltese: Abbażi ta' data in vitro, migalastat mhuwiex induttur ta' CYP1A2, 2B6, jew 3A4.
English: OUTER CARTON
Maltese: KARTUNA ESTERNA
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Maltese: c.1095T>A jew c.1095T>G c.T1095A jew c.T1095G
English: c.A374T/G383A
Maltese: A374T/G383A
English: Migalastat is not a substrate for MDR1 or BCRP, nor is it an inhibitor of BCRP, MDR1, or BSEP human efflux transporters.
Maltese: Migalastat mhuwiex sottostrat ta' MDR1 jew BCRP, lanqas ma huwa inibitur ta' BCRP, MDR1 jew trasportaturi tal-effluss umani (human efflux transporters) BSEP.
English: c.504A>C or c.504A>T
Maltese: c.504A>C jew c.504A>T
English: c.A924T or c.A924C
Maltese: A924T jew c.A924C
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Maltese: c.1065C>A jew c.1065C>G c.C1065A jew c.C1065G
English: c.1147T>C or c.1149C>G or c.1149C>A
Maltese: c.1147T>C jew c.1149C>G jew c.1149C>A
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
Maltese: It-tieni prova OLE (AT1001-042) kient tinkludi pazjenti li kienu ġew ittrasferiti minn studju OLE AT1001-041 u direttament minn studju ta' Fażi 3 ATTRACT, u din għadha għaddejja.
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Maltese: c.1034C>G jew c.1034C>A c.C1034G jew c.C1034A
English: The GLA mutations are also accessible by health care providers at www.galafoldamenabilitytable.com.
Maltese: Il-mutazzjonijiet GLA huma wkoll aċċessibbli mill-fornituri tal-kura tas-saħħa f'www.galafoldamenabilitytable.com.
English: c.611G>A or 612G>A
Maltese: c.611G>A jew 612G>A
English: c.G412A or c.G412C
Maltese: c.G412A jew c.G412C
English: c.C816A or c.C816G
Maltese: c.C816A jew c.C816G
English: c.C519A or c.C519G
Maltese: c.C519A jew c.C519G
English: PUSH capsule through the foil 4.
Maltese: IMBOTTA l-kapsula minn ġol-fojl 4.
English: c.T139C or c.T139A
Maltese: T139C jew c.T139A
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
Maltese: Kull kapsula fiha migalastat hydrochloride ekwivalenti għal 123 mg migalastat.
English: Protein Sequence change c.1A>C or c.1A>T
Maltese: Bidla fis-Sekwenza tal-Proteina c.1A>C jew c.1A>T
English: c.G285T or c.G285C
Maltese: c.G285T jew c.G285C
English: Composite Clinical Outcomes
Maltese: Riżultati Kliniċi Komposti
English: c.712A>C or c.714T>A or c.714T>G
Maltese: c.712A>C jew c.714T>A jew c.714T>G
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.
Maltese: GL-3 kien osservat f'diversi tipi ta' ċelloli tal-kliewi: podoċiti (podocytes), ċelloli meżanġjali (mesangial cells), u ċelloli glomerulari endoteljali, rispettivament, fuq 12-il xahar ta' kura b'Galafold.
English: c.1045T>C or c.1045T>A c.T1045C or c.T1045A
Maltese: c.1045T>C jew c.1045T>A c.T1045C jew c.T1045A
English: g.941_5845del p.?
Maltese: g.941_5845del p.?(Exon1_2del)
English: c.A124C or c.A124T
Maltese: A124C jew c.A124T
English: c.1046G>A or c.1047G>A c.G1046A or c.G1047A
Maltese: c.1046G>A jew c.1047G>A c.G1046A jew c.G1047A
English: Following ascending single oral doses (25-675 mg migalastat hydrochloride), no trends were found for clearance, CL/F).
Maltese: Wara d-dożi orali waħdanin li jiżdiedu, (25-675 mg migalastat hydrochloride), ma nstabux xejriet għat-tneħħija (clearance), CL/F).
English: c.C159G or c.C159A
Maltese: c.C159G jew c.C159A
English: Galafold contains the active substance migalastat.
Maltese: X'fih Galafold - Is-sustanza attiva hija migalastat.
English: • Sensation of spinning
Maltese: • Sensazzjoni ta' tidwir
English: Galafold is available in a blister pack containing 14 capsules.
Maltese: Galafold jiġi f'pakketti li fihom 14-il kapsula.
English: c.442A>C or c.444T>A or c.444T>G
Maltese: 442A>C jew c.444T>A jew c.444T>G
English: c.T1147C or c.C1149G or c.C1149A
Maltese: T1147C jew c.C1149G jew c.C1149A
English: c.159C>G or c.159C>A
Maltese: c.159C>G jew c.159C>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).
Maltese: Ilkobor medju tal-esponiment tad-doża mqiegħda fis-suq ta' Galafold 123 mg QOD f'pazjenti li kienu qed ilestu studju AT1001-041 kien ta' 3.57 (±1.23) snin (n=85).
English: Based upon in vivo data, migalastat is a substrate for UGT, being a minor elimination pathway.
Maltese: Abbażi tad-data in vivo, migalastat huwa sottostrat ta' UGT, li huwa passaġġ minuri ta' eliminazzjoni.
English: c.C279G or c.C279A
Maltese: c.C279G jew c.C279A
English: c.140G>A or 141G>A
Maltese: c.140G>A jew 141G>A
English: c.T806G/G937T
Maltese: T806G/G937T
English: c.412G>A or c.412G>C
Maltese: c.412G>A jew c.412G>C
English: In healthy volunteers, the volume of distribution (Vz/F) of migalastat following ascending single oral doses (25-675 mg migalastat HCl) ranged from 77 to 133 L, indicating it is well distributed into tissues and greater than total body water (42 litres).
Maltese: F'voluntiera f'saħħithom, il-volum tad-distribuzzjoni (Vz/F) ta' migalastat wara dożi orali waħdanin li jiżdiedu (25-675 mg migalastat HCl) varja minn 77 sa 133 L, u dan jindika li huwa mqassam tajjeb fit-tessuti u akbar mit-total tal-ilma fil-ġisem (42 litru).
English: c.G103C or c.G103A
Maltese: c.G103C jew c.G103A
English: c.216G>A or c.216G>T or c.216G>C
Maltese: c.216G>A jew c.216G>T jew c.216G>C
English: c.924A>T or c.924A>C
Maltese: c.924A>T jew c.924A>C
English: c.280T>A or c.281G>C
Maltese: 280T>A jew c.281G>C