FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of clinical responders at Week 26 with no rescue therapy was 59.7% on Soliris compared with 39.7% on placebo (p=0.0229).
Maltese: Il-proporzjon ta' persuni li rrispondew b'mod kliniku kien ta' 59.7% għal Soliris meta mqabbel ma 39.7% fuq il-plaċebo (p=0.0229).
English: 60 minutes prior to each infusion of fresh frozen plasma
Maltese: 60 minuta qabel kull infużjoni ta' plażma ffriżata friska
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gammaglutamyltransferase increased, Haematocrit decreased,
Maltese: Żieda fl-alanine aminotransferase, Żieda flaspartate aminotransferase, Żieda fil-gammaglutamyltransferase, Tnaqqis fl-ematokrit, Żieda fl-emoglobina
English: Soliris was administered as an intravenous infusion over 35 minutes.
Maltese: Soliris ingħata bħala infużjoni ġol-vini fuq perjodu ta' 35 minuta.
English: Table 3: Efficacy Outcomes in C04-001 and C04-002 C04-001
Maltese: Tabella 3: Riżultati ta' l-Effikaċja f'C04-001 u C04-002
English: • pain in thejoints (arms and legs)
Maltese: • uġigħ fil-ġogi (dirgħajn u riġlejn)
English: A significant effect on the time to first adjudicated On-trial Relapse was observed for eculizumab compared with placebo (relative risk reduction 94%; hazard ratio 0.058; p<0.0001) (Figure 2).
Maltese: Ġie osservat effett sinifikanti fuq iż-żmien għall-ewwel Rikaduta Matul il-Prova aġġudikata għal eculizumab meta mqabbel mal-plaċebo (tnaqqis relattiv tar-riskju 94%; proporzjon ta' periklu 0.058; p<0.0001) (Figura 2).
English: Open Label Eculizumab
Maltese: Bi trattament b'eculizumab
English: After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Maltese: Wara d-dilwizzjoni, il-konċentrazzjoni finali tas-soluzzjoni li trid tiġi hija 5 mg/mL.
English: Table 8: Efficacy Outcomes in Prospective aHUS Study C10-004
Maltese: Tabella 8: Riżultati ta' Effikaċja fi Studju Prospettiv aHUS C10-004
English: • bruise
Maltese: • Fażi
English: • vision blurred
Maltese: • vista mċajpra
English: Fertility No specific study of eculizumab on fertility has been conducted.
Maltese: Fertilità Ma sar ebda studju speċifiku dwar eculizumab dwar il-fertilità.
English: • severe infection (meningococcal infection), sepsis, septic shock, viral infection, , lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis
Maltese: • infezzjoni severa (infezzjoni meningokokkali), sepsis, xokk settiku, infezzjoni virali, infezzjoni fil parti t'isfel tal-passaġġ respiratorju, influwenza fl-istonku (infezzjoni gastrointestinali), ċistite
English: In Study ECU-NMO-301, patients with NMOSD with a positive serologic test for anti-AQP4 antibodies, a history of at least 2 relapses in last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to screening and an Expanded Disability Status Scale (EDSS) score ≤ 7, were randomized 2:1 to either Soliris (n = 96) or placebo (n = 47).
Maltese: Fl-Istudju ECU-NMO-301, il-pazjenti b'NMOSD li kellhom riżultati pożittivi għat-test seroloġiku għal antikorpi kontra AQP4, storja medika ta' mill-inqas 2 rikaduti fl-aħħar 12-il xahar jew 3 rikaduti fl-aħħar 24 xahar b'mill-inqas rikaduta waħda fit-12-il xahar qabel l-iscreening u punteġġ tal-Iskala Mwessa' tal-Istat ta' Diżabilità (EDSS, Expanded Disability Status Scale) ta' ≤ 7, intgħażlu b'mod każwali fi proporzjon ta' 2:1 għal Soliris (n=96) jew għall-plaċebo (n=47).
English: The final volume of a 5 mg/ml diluted solution is 60 ml for 300 mg doses, 120 ml for 600 mg doses, 180 ml for 900 mg doses and 240 ml for 1,200 mg doses.
Maltese: Il-volum finali ta' soluzzjoni dilwita ta' 5 mg/mL huwa 60 mL għal dożi ta' 300 mg, 120 mL għal dożi ta' 600 mg, 180 mL għal dożi ta' 900 mg u 240 mL għal dożi ta' 1,200 mg.
English: Supplemental Soliris Dose With Each PE/PI Intervention
Maltese: Intervent PE/PI
English: Baseline LDH (U/L) median (min, max )
Maltese: LDH fil-linja bażi (U/L), medjan (min, max)
English: The diluted solution of Soliris should be administered by intravenous infusion over 25 - 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump.
Maltese: Is-soluzzjoni dilwita ta' Soliris għandha tingħata permezz ta' infużjoni ġol-vini fuq perjodu ta' 25 - 45 minuta f'adulti u 1-4 sigħat f'pazjenti pedjatriċi permezz ta' gravity feed, pompa tat-tip siringa, jew pompa tal-infużjoni.
English: Chronic administration of Soliris results in immediate, complete, and sustained inhibition of terminal complement activity.
Maltese: L-għoti kroniku ta' Soliris jirriżulta f'inibizzjoni immedjata, kompleta, u sostnuta tal-attività komplementari terminali.
English: Pneumonia, Upper respiratory tract infection, Bronchitis, Nasopharyngitis, Urinary tract infection, Oral Herpes
Maltese: Pnewmonja, Infezzjoni fil-parti ta' fuq tal-apparat respiratorju, Bronkite, Nażofarinġite, Infezzjoni fl-apparat urinarju, Herpes Orali
English: Dyspnoea, Epistaxis, Throat irritation, Nasal congestion, Rhinorrhoea
Maltese: Dispnea, Epistassi, Irritazzjoni tal-griżmejn, Konġestjoni nażali, Uġigħ
English: Impetigo,
Maltese: Dermatite,
English: Atypical Haemolytic Uremic Syndrome
Maltese: - Sindrome uremiku emolitku atipiku (atypical haemolytic uremic syndrome - aHUS).
English: However, chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C.
Maltese: Madankollu, l-istabbiltà kimika u fiżika ġiet murija għal 24 siegħa f'temperatura ta' 2°C - 8°C.
English: 150 x 109/L despite PE/PI, and LDH and serum creatinine above upper limits of normal.
Maltese: 9/L minkejja terapija b'PE/PI, u LDH u krejatinina fis-serum ogħla mil-limiti ta' fuq tan-normal.
English: PNH patients were also treated with Soliris in a single arm 52 week study (C04-002), and in a long term extension study (E05-001).
Maltese: Pazjenti PNH kienu kkurati wkoll b'Soliris fi studju single arm ta' 52 ġimgħa (C04-002), u fi studju ta' estensjoni fuq perjodu fit-tul (E05-001).
English: Neuromyelitis Optica Spectrum Disorders
Maltese: Disturbi ta' Newromajelite Optica Spectrum
English: Your doctor will discuss the possible side effects and risks with you.
Maltese: It-tabib tiegħek se jiddiskutu l-effetti sekondarji u r-riskji possibbli miegħek.
English: • diarrhea, vomiting, nausea, abdominal pain, rash, hair loss (alopecia), itchy skin (pruritus)
Maltese: • dijarea, rimettar, nawseja, uġigħ ta' żaqq, raxx, telf ta' xagħar (alopeċja); ġilda bil-ħakk (prurite)
English: 2 to <12 years (n=10)
Maltese: Sentejn sa <12il sena (n=10)
English: N=10 (%)
Maltese: < xahrejn N=10 (%)
English: Soliris 300 mg concentrate for solution for infusion Eculizumab
Maltese: Soliris 300 mg, konċentrat għal soluzzjoni għall-infużjoni Eculizumab
English: Tinnitus, Vertigo
Maltese: Tinnite, Vertiġini
English: In Study ECU-MG-301, gMG patients with a positive serologic test for anti-AChR antibodies, MGFA (Myasthenia Gravis Foundation of America) clinical classification class II to IV and MG-ADL total score
Maltese: Fi Studju ECU-MG-301, pazjenti b'gMG b'test seroloġiku b'riżultat pożittiv għal antikorpi kontra AChR, il-klassifikazzjoni klinika ta' MGFA (Myasthenia Gravis Foundation of America) klassi II sa IV, u l-punteġġ totali ta' MG-ADL ta' ≥6 intgħażlu b'mod każwali jew għal Soliris (n = 62) jew plaċebo (n = 63).
English: Compared to placebo-treated patients, Soliris-treated patients had reduced annualized rates of hospitalizations (0.04 for Soliris versus 0.31 for placebo), of intravenous corticosteroid administrations to treat acute relapses (0.07 for Soliris versus 0.42 for placebo), and of plasma exchange treatments (0.02 for Soliris versus 0.19 for placebo).
Maltese: Meta mqabbla ma' pazjenti kkurati bil-plaċebo, il-pazjenti kkurati b'Soliris kellhom rati annwalizzati mnaqqsa kemm ta' dħul fl-isptar (0.04 għal Soliris kontra 0.31 għall-plaċebo), ta' għoti ta' kortikosterojdi ġol-vina biex jiġu ttrattati rikaduti akuti (0.07 għal Soliris kontra 0.42 għal plaċebo), u ta' kura bi skambju tal-plażma (0.02 għal Soliris kontra 0.19 għall-plaċebo).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 30 ml (10 mg/ml)
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 1 kunjett ta' 30 mL (10 mg/mL)
English: Table 6: Efficacy Outcomes in Prospective aHUS Studies C08-002A/B and C08-003A/B C08-002A/B
Maltese: Tabella 6: Riżultati tal-Effikaċja fi Studji Prospettivi C08-002A/B u C08-003A/B dwar aHUS
English: Constipation, Dyspepsia, Abdominal distension
Maltese: Stitikezza, Dispepsja, Distensjoni addominali,
English: Soliris is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and inhibits the activation of terminal complement.
Maltese: IgG2/4κ umanizzat li jeħel mal-proteina tal-komplement C5 umana u jimpedixxi l-attivazzjoni tal-komplement terminali.
English: FACIT-Fatigue score at last available assessment (median)
Maltese: Punteġġ FACIT-Għeja fl-aħħar evalwazzjoni disponibbli (medjan)
English: The adjudicated on-trial annualized relapse rate (ARR) ratio (95% CI) for eculizumab compared with placebo was 0.045 (0.013, 0.151), representing a 95.5% relative reduction in adjudicated On-trial ARR for patients treated with eculizumab compared with placebo (p<0.0001) (Table 13).
Maltese: Il-proporzjon (95% CI) tar-rata annwalizzata tar-rikaduta (ARR, annualized relapse rate) matul ilprova aġġudikata għal eculizumab meta mqabbel mal-plaċebo kien ta' 0.045 (0.013, 0.151), li jirrappreżenta tnaqqis relattiv ta' 95.5% fl-ARR matul il-prova aġġudikata għal pazjenti kkurati b'eculizumab meta mqabbel mal-plaċebo (p<0.0001) (Tabella 13).
English: Children and adolescents
Maltese: L/siegħa f'pazjenti adolexxenti.
English: (urinary tract infection),
Maltese: (infezzjoni fl-apparat urinarju)
English: Complete TMA response was defined as haematologic normalization and a ≥25% reduction in serum creatinine sustained in ≥ 2 consecutive measurements for ≥ 4 weeks.
Maltese: TMA sħiħ kien definit bħala normalizzazzjoni ematoloġika u tnaqqis ta' ≥25% tal-krejatinina fis-serum sostnut f' ≥ 2 miżuri konsekuttivi għal ≥4 ġimgħat.
English: In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).
Maltese: Fl-istudju C04-001 (TRIUMPH), pazjenti PNH b'mill-anqas 4 trasfużjonijiet fl-aħħar 12-il xahar, konferma ċitometrika tal-fluss ta' mill-anqas 10% ċelluli PNH u b'għadd ta' plejtlits ta' mill-anqas 100,000/mikrolitru ġew magħżula b'mod każwali għal Soliris (n = 43) jew għal plaċebo (n = 44).
English: • The importance of meningococcal vaccination prior to treatment with eculizumab and/or to receive antibiotic prophylaxis.
Maltese: • L-importanza ta' tilqima meningokokkali qabel il-kura b'eculizumab u/jew biex jirċievu profilassi antibijotika.
English: - Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4)
Maltese: - Disturb ta' newromajelite optica spectrum (NMOSD, Neuromyelitis optica spectrum disorder) f'pazjenti li huma pożittivi għall-antikorp anti-aquaporin-4
English: N = 43 P - Value Soliris N = 97 P - Value
Maltese: Soliris N = 97 Valur - P
English: Pharmacodynamic activity measured by free C5 concentrations of <0.5 ug/mL, is correlated with essentially complete blockade of terminal complement activity in PNH, aHUS, refractory gMG and NMOSD patients.
Maltese: L-attività farmakodinamika mkejla minn konċentrazzjonijiet ta' C5 ħieles ta' < 0.5 µg/mL, hi korrelatata ma' imblokk essenzjalment komplet tal-attività komplementari terminali f'pazjenti b'PNH, aHUS, gMG refrattorja u NMOSD.
English: Baseline eGFR (mL/min/1.73 m2 ), median (min,
Maltese: eGFR fil-linja bażi (mL/min/1.73 m2 ), medjan (min, max)
English: <2 years (n=5)
Maltese: <sentejn (n=5)
English: Mean (SD) Median
Maltese: Medja (SD)
English: Conjunctival irritation
Maltese: Irritazzjoni filkonġuntiva
English: 5.3 Preclinical safety data The specificity of eculizumab for C5 in human serum was evaluated in two in vitro studies.
Maltese: L-ispeċifiċità ta' eculizumab għal C5 fis-serum uman kienet evalwata f'żewġ studji in vitro.
English: The primary analysis of the QMG was a Worst-Rank ANCOVA with a mean rank of 54.7 for Soliris and 70.7 for placebo, based on 125 study patients (p=0.0129).
Maltese: L-analiżi primarja ta' QMG kienet Worst-Rank ANCOVA bi klassifikazzjoni (rank) medja ta' 54.7 għal Soliris u 70.7 għall-plaċebo ibbażat fuq 125 pazjenti flistudju (p=0.0129).
English: Sepsis is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.8).
Maltese: Sepsis hija preżentazzjoni komuni ta' infezzjonijiet meningokokkali f'pazjenti kkurati b'Soliris (ara sezzjoni 4.8).
English: In Studies ECU-MG301 and ECU-MG-302, the dose of Soliris in adult refractory gMG patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg at Week 5± 2 days, then 1,200 mg every 14 ± 2 days for the study duration.
Maltese: Fi Studji ECU-MG-301 u ECU-MG302, id-doża ta' Soliris f'pazjenti adulti b'gMG refrattorja, kienet ta' 900 mg kull 7 ± 2 jiem għal 4 ġimgħat, segwita minn 1200 mg f'Ġimgħa 5± 2 jiem, imbagħad 1,200 mg kull 14 ± 2 jiem għat-tul tal-istudju.
English: At the last evaluation, 25 of 41 patients (61%) achieved eGFR improvement of ≥ 15 mL/min/1.73 m2 from baseline.
Maltese: Fl-aħħar evalwazzjoni, 25 minn 41 pazjent (61%) kisbu titjib f'eGFR ta' ≥ 15 mL/min/1.73 m2 mil-linja bażi.
English: • abnormal leakage of the infused drug out of the vein, infusion site abnormal sensation, feeling hot
Maltese: • tnixxija abnormali tal-mediċina infuża minn ġol-vina, sensazzjoni abnormali fis-sit tal-infużjoni,
English: Instructions:
Maltese: Inizjali:
English: Soliris may be administered to patients aged 65 years and over.
Maltese: Soliris jista' jingħata lil pazjenti ta' 65 sena u aktar.
English: One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).
Maltese: Kunjett wieħed ta' 30 mL fih 300 mg ta' eculizumab (10 mg/mL).
English: Eculizumab Placebo
Maltese: Proporzjon tar-rata (eculizumab/placebo)
English: In Study ECU-MG-301, a clinical responder in the QMG total score was defined as having at least a 5point improvement.
Maltese: Fi Studju ECU-MG-301, persuna li rrispondiet b'mod kliniku fil-punteġġ totali ta' QMG ġiet definita bħala li jkollha mill-inqas 5 punti ta' titjib.
English: Free Haemoglobin at end of study (median, mg/dL)
Maltese: Emoglobina libera fit-tmiem ta' l-istudju (medjan, mg/dL)
English: C5 expression in the human tissue panel examined in this study is consistent with published reports of C5 expression, as C5 has been reported in smooth muscle, striated muscle, and renal proximal tubular epithelium.
Maltese: L-espressjoni C5 fil-panil tat-tessut uman eżaminat f'dan l-istudju hija konsistenti ma' rapporti ppubblikati ta' l-espressjoni C5, billi C5 ġiet irrapportata f'muskolu mieles, muskolu mtarraz, u fl-epitelju tubulari prosimmali tal-kliewi.
English: A total of 7 PNH paediatric patients, with a median weight of 57.2 kg (range of 48.6 to 69.8 kg) and aged from 11 to 17 years (median age : 15.6 years), received Soliris in study M07-005.
Maltese: Total ta' 7 pazjenti pedjatriċi b'PNH, b'piż medjan ta' 57.2 kg (medda ta' 48.6 sa 69.8 kg) u li kellhom minn 11 sa 17-il sena (età medjana: 15.6 snin), irċivew Soliris fi studju M07-005.
English: In a NMOSD placebo controlled study, 2/96 (2%) of the Soliris treated patients showed antidrug antibody response post-baseline.
Maltese: Fi studju dwar NMOSD ikkontrollat bil-plaċebo, 2/96 (2%) tal-pazjenti kkurati b'Soliris urew rispons tal-antikorpi kontra l-mediċina wara l-linja bażi.
English: Rare: may affect up to 1 in 1,000 people:
Maltese: Rari: jistgħu jaffettwaw sa persuna 1 f'1,000
English: • infusion related reaction
Maltese: • reazzjoni relatata mal-infużjoni
English: Table 9: Patient Demographic and Characteristics in Study ECU-MG-301
Maltese: Tabella 9: Demografika u Karatteristiċi tal-Pazjenti fi Studju ECU-MG-301 Soliris (n=62)
English: The pharmacokinetics of eculizumab was evaluated in Study M07-005 in PNH paediatric patients (aged from 11 to less than 18 years) and in Studies C08-002, C08-003, C09-001r and C10-003 in aHUS pediatric patients (aged 2 months to less than 18 years) with body-weight based dose regimen.
Maltese: Il-farmakokinetika ta' eculizumab ġiet evalwata fi Studju M07-005 f'pazjenti pedjatriċi b'PNH (li kellhom minn 11 sa inqas minn 18-il sena) u fi Studji C08-002, C08-003, C09-001r u C10-003 filpazjenti pedjatriċi b'aHUS (li kellhom minn xahrejn sa inqas minn 18-il sena) b'kors tad-doża bbażat fuq il-piż tal-ġisem.
English: Patients that were previously treated with Soliris in Study ECU-MG-301 continued to demonstrate a sustained effect of Soliris on all measures (MG-ADL, QMG, MGC and MG-QoL15) over an additional 52 weeks of treatment with Soliris.
Maltese: Pazjenti li qabel ġew ikkurati b'Soliris fi Studju ECU-MG-301, komplew juru effett sostnut ta' Soliris fuq il-kejl kollu (MG-ADL, QMG, MGC u MG-QoL15) fuq perjodu addizzjonali ta' 52 ġimgħa ta' kura b'Soliris.
English: Responses were similar across all ages from 5 months to 17 years of age.
Maltese: Ir-rispons kien simili fl-etajiet kollha minn 5 xhur sa 17-il sena.
English: Arthralgia, Myalgia, Muscle spasms, Bone pain, Back pain, Neck pain, Joint swelling,
Maltese: Artralġja, Mijalġja Spażmi muskolari, Uġigħ fl-għadam, Uġigħ fiddahar, Uġigħ fl-għonq,
English: Figure 1 presents the change from baseline in both MG-ADL (A) and QMG (B) after 26 weeks of treatment in Study ECU-MG-301 and after 52 weeks of treatment in Study ECU-MG-302.
Maltese: Figura 1 tippreżenta l-bidla mil-linja bażi kemm f'MG-ADL (A) kif ukoll fi QMG (B) wara 26 ġimgħa ta' kura fi Studju ECU-MG-301, u wara 52 Ġimgħa ta' kura fi Studju ECU-MG-302.
English: The median time from current thrombotic microangiopathy manifestation to first dose of Soliris was 1 month (range <1 to 16 months).
Maltese: Iż-żmien medjan minn manifestazzjoni kurrenti mikroanġjopatija trombotika sal-ewwel doża ta' Soliris kien ta' xahar (medda <1 sa 16il xahar).
English: Vaccines against serogroups A, C, Y, W 135 and B where available are recommended in preventing the commonly pathogenic meningococcal serogroups.
Maltese: Vaċċini kontra s-serogruppi A, C, Y u W 135 u B fejn ikunu disponibbli, huma rakkomandati għall-prevenzjoni ta' serogruppi meningokokkali patoġeniċi komuni.
English: Study C08-002A/B was a prospective, controlled, open-label study which accrued patients in the early phase of aHUS with evidence of clinical thrombotic microangiopathy manifestations with platelet count ≤
Maltese: Studju C08-002A/B kien studju prospettiv, ikkontrollat, open-label, li ġabar pazjenti fil-fażi bikrija ta' aHUS b'evidenza ta' manifestazzjonijiet kliniċi ta' mikroanġjopatija trombotika b'għadd tal-plejtlits ta' ≤ 150 x 10
English: Total number of relapses
Maltese: Numru totali ta' rikaduti
English: Body Weight
Maltese: Generic Core
English: n (%)
Maltese: Nisa, n (%)
English: Data from 139 patients in two prospective controlled studies (Studies C08-001 and ECU-MG-301), and one open-label extension trial (Study ECU-MG-302) were used to evaluate the efficacy of Soliris in the treatment of patients with refractory gMG.
Maltese: Dejta minn 139 pazjent f'żewġ studji prospettivi kkontrollati (Studji C08-001 u ECU-MG-301), u prova waħda open-label ta' estensjoni (Studju ECU-MG-302) intużaw biex jevalwaw l-effikaċja ta' Soliris fil-kura ta' pazjenti b'gMG refrattorja.
English: In Study ECU-MG-301, a clinical responder in the MG-ADL total score was defined as having at least a 3-point improvement.
Maltese: Fi Studju ECU-MG-301, persuna li rrispondiet b'mod kliniku fil-punteġġ totali ta' MG-ADL ġiet definita bħala li jkollha mill-inqas 3 punti ta' titjib.
English: Total number of patients reporting clinical deterioration n (%) Total number of patients requiring rescue therapy n (%)
Maltese: Numru totali ta' pazjenti li rrappurtaw deterjorament kliniku n (%)
English: Timing of
Maltese: TIKKETTAR
English: Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take 25 - 45 minutes.
Maltese: Kull infużjoni tkun tikkonsisti minn doża ta' 600 mg (2 kunjetti ta' 30 mL) li tieħu 25 - 45 minuta.
English: Soliris contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies.
Maltese: Soliris fih is-sustanza attiva eculizumab u tappartjeni għal klassi ta' mediċini msejħa antikorpi monoklonali.
English: Treatment effect a
Maltese: Statistik a
English: Furthermore, 74% of the patients without a history of transfusion and treated with Soliris experienced clinically meaningful improvements in FACIT-Fatigue score (i.e., increase by 4 points or more) and 84% in EORTC fatigue score (i.e., decrease by 10 points or more).
Maltese: Barra minn hekk, 74% tal-pazjenti mingħajr storja medika ta' trasfużjoni u kkurati b'Soliris kellhom titjib kliniku sinifikanti fil-punteġġ FACIT-Għeja (i.e., żieda b'4 punti jew aktar) u 84% fil-punteġġ talgħeja EORTC (i.e., tnaqqis b'10 punti jew aktar).
English: SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Mean clearance was 0.31 ± 0.12 mL/hr/kg, mean volume of distribution was 110.3 ± 17.9 mL/kg, and mean elimination half-life was 11.3 ± 3.4 days.
Maltese: 3 ± 17.9 mL/kg, u l-half-life medja ta' l-eliminazzjoni kienet ta' 11.3 ± 3.4-il ġurnata.
English: N=5 (%)
Maltese: > xahrejn N=5 (%)
English: Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as eculizumab and thereby decrease serum eculizumab concentrations.
Maltese: Trattament kroniku ġol-vini b'immunoglobulina umana (IVIg) jista' jinterferixxi mal-mekkaniżmu tar-riċiklar tar-riċettur Fc endosomali tat-trabi tat-twelid (FcRn) ta' antikorpi monoklonali bħal eculizumab u b'hekk inaqqas il-konċentrazzjoni ta' eculizumab fis-serum.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology.
Maltese: U KWANTITATTIVA Eculizumab hu antikorp monoklonali umanizzat (IgG2/4κ) prodott f'razza ta' ċelluli NS0 permezz ta' teknoloġija ta' DNA rikombinanti.
English: Study ECU-MG-301 (REGAIN) was a 26-week double-blind, randomized, placebo-controlled, multicenter Phase 3 study of Soliris in patients who had failed previous therapies and remain symptomatic.
Maltese: Studju ECU-MG-301 (REGAIN) kien studju ta' Fażi 3, double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, multiċentriku, li dam 26 ġimgħa, dwar Soliris, f'pazjenti li ma rnexxewx b'terapiji preċedenti u li baqgħu sintomatiċi.
English: Eculizumab, the active ingredient in Soliris, is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.
Maltese: Eculizumab, l-ingredjent attiv f'Soliris, huwa inibitur tal-komplement terminali li jaqbad b'mod speċifiku mal-proteina komplementari C5 b'affinità kbira, u b'hekk jimpedixxi l-qasma tagħha f'C5a u C5b u jevita l-ġenerazzjoni tal-kumpless tal-komplement terminali C5b-9.
English: − The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
Maltese: − Is-sustanza attiva hija eculizumab (300 mg/30 mL f'kunjett li jikkorrispondu għal 10 mg/mL).
English: Table 5: Patient Demographics and Characteristics in C08-002A/B and C08-003A/B
Maltese: Demografija u Karatteristiċi tal-Pazjenti f'C08-002A/B, C08-003A/B Parametru
English: In aHUS Study C08-002A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Maltese: Fi Studju C08-002A/B dwar aHUS, ir-risponsi għal Soliris kienu simili f'pazjenti bi u mingħajr mutazzjonijiet identifikati fl-encoding tal-ġeni tal-proteini tal-fattur regolatorju komplementari.