FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Maltese: - jekk int allerġiku għal eculizumab, proteini derivati minn prodotti tal-ġrieden, kellek reazzjoni allerġika għal antikorpi monoklonali oħra, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Human antibodies undergo endocytotic digestion in the cells of the reticuloendothelial system.
Maltese: L-antikorpi umani jgħaddu minn diġestjoni endoċitotika fiċ-ċelluli tas-sistema retikuloendoteljali.
English: Clearance values of Soliris in paediatric aHUS patients were 10.4, 5.3, and 2.2 mL/hr with body weight of 70, 30, and 10 kg, respectively; and the corresponding volume of distribution values were 5.23, 2.76, and 1.21 L, respectively.
Maltese: Il-valuri ta' tneħħija ta' Soliris f'pazjenti pedjatriċi b'aHUS kienu 10.4, 5.3 u 2.2 mL/siegħa b'piż tal-ġisem ta' 70, 30 u 10 kg, rispettivament.
English: 2 Study C08-002: 3 patients received ESA which was discontinued after eculizumab initiation Study C08-003: 8 patients received ESA which was discontinued in 3 of them during eculizumab therapy aHUS Study C10-004 enrolled 41 patients who displayed signs of thrombotic microangiopathy (TMA).
Maltese: 2 Studju C08-002: 3 pazjenti rċivew ESA li twaqqaf wara l-bidu ta' eculizumab studju C08-003: 8 pazjenti rċivew ESA li twaqqaf fi 3 minnhom matul it-terapija b'eculizumab
English: Abbreviations: ARR = adjudicated relapse rate; EDSS = Expanded Disability Status Scale; IST = immunosupressant therapy; Max = maximum; Min = minimum; NMOSD = neuromyelitis optica spectrum disorder; SD = standard deviation.
Maltese: NMOSD = disturb ta' newromajelite optica spectrum (neuromyelitis optica spectrum disorder); SD = devjazzjoni standard (standard deviation).
English: In aHUS Study C08-003A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Maltese: Fi Studju C08-003A/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.
English: • The requirement to vaccinate children against pneumococcus and Haemophilus influenzae before eculizumab treatment.
Maltese: • Il-ħtieġa li tlaqqam it-tfal kontra pneumococcus u Haemophilus influenzae qabel t-trattament b'eculizumab.
English: Septic shock, Peritonitis, Lower respiratory tract infection, Fungal infection, Viral a, infection, Abscess Cellulitis, Influenza, Gastrointestinal infection, Cystitis, Infection, Sinusitis,
Maltese: Xokk settiku, Peritonite, Infezzjoni fl-apparat respiratorju ta' isfel, Infezzjoni fungali, Infezzjoni virali, Axxess a,
English: Genitourinary tract gonococcal infection, Haemophilus influenzae infection,
Maltese: Haemophilus influenzae, Impetigo, Infezzjoni ġenġivali
English: Abbreviations: CI = confidence interval; EDSS = Expanded Disability Status Scale; IST = immunosuppressive therapy
Maltese: ARR = rata ta' rikaduta aġġudikata (adjudicated relapse rate); EDSS = Skala Mwessa' tal-Istat ta' Diżabilità (Expanded Disability Status Scale);
English: This medicinal product contains 5 mmol sodium per vial.
Maltese: Dan il-prodott mediċinali fih 5 mmol ta' sodium f'kull kunjett.
English: The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001).
Maltese: Is-sigurtà u l-effikaċja ta' Soliris f'pazjenti b'PNH b'emodijalisi kienu evalwati fi studju double-blind, ikkontrollat bil-plaċebo, magħmul b'għażla każwali, fuq 26 ġimgħa (C04-001).
English: The corresponding elimination half-life remained almost unchanged within a range of 349 to 378 h (approximately 14.5 to 15.8 days).
Maltese: Il-half-life ta' eliminazzjoni korrispondenti baqa' ma nbidilx fi ħdan il-medda ta' 349 sa 378 siegħa (madwar 14.5 sa 15.
English: A second population PK analysis with a standard 1 compartmental model was conducted on the multiple dose PK data from 37 aHUS patients receiving the recommended Soliris regimen in studies C08-002A/B
Maltese: Twettqet it-tieni analiżi għal PK tal-popolazzjoni b'mudell kompartimentali 1 standard fuq dejta PK ta' dożi multipli minn 37 pazjenti b'aHUS li kienu qed jirċievu l-kors rakkomandat ta' Soliris fi studji C08-002A/B u C08-003A/B.
English: The median patient age was 35 (range: 18 to 80 years).
Maltese: L-età medjana tal-pazjent kienet ta' 35 sena (medda 18 sa 80 sena).
English: In refractory gMG patients, uncontrolled terminal complement activation causes membrane attack complex (MAC) dependent lysis and C5a-dependent inflammation at the Neuromuscular Junction (NMJ) leading to failure of neuromuscular transmission.
Maltese: F'pazjenti b'gMG refrattorja, attivazzjoni tal-kumpliment terminali mhux ikkontrollata tikkawża lisi dipendenti fuq kumpless ta' attakk fuq il-membrani (MAC, membrane attack complex) u infjammazzjoni dipendenti fuq C5a fin-Neuromuscular Junction (NMJ), li jwasslu għal insuffiċjenza ta' trasmissjoni newromuskolari.
English: Renal impairment, Dysuria, Haematuria
Maltese: Indeboliment tal-kliewi, Disurja, Ematurja
English: Fresh frozen plasma infusion
Maltese: Infużjoni ta' plażma ffriżata friska
English: Table 1: Adverse Reactions reported in eculizumab clinical trials, including patients with PNH, aHUS, refractory gMG and NMOSD as well as from postmarketing experience MedDRA System Organ Class
Maltese: Tabella 1: Reazzjonijiet Avversi rrappurtati fi provi kliniċi ta' eculizumab, li jinkludu pazjenti b'PNH, aHUS , gMG refrattorja u NMOSD kif ukoll mill-esperjenza ta' wara t-tqegħid fis-suq Sistema tal-Klassifika tal-Organi
English: Meningococcal infection symptoms
Maltese: Sintomi tal-infezzjoni meningokokkali
English: In paediatric patients with shorter duration of current severe clinical thrombotic microangiopathy (TMA) manifestation prior to eculizumab, there was TMA control and improvement of renal function with eculizumab treatment (Table 15).
Maltese: F'pazjenti pedjatriċi b'tul ta' żmien iqsar ta' manifestazzjoni mikroanġjopatija trombotika (TMA) klinika severa kurrenti qabel eculizumab, kien hemm kontroll ta' TMA u titjib fil-funzjoni tal-kliewi bil-kura b'eculizumab (Tabella 15).
English: For 300 mg doses, use 30 ml of Soliris (10 mg/ml)
Maltese: Għal dożi ta' 300 mg, uża 30 ml ta' Soliris (10 mg/mL) u żid 30 mL ta' dilwent.
English: Anaphylactic reaction, Hypersensitivity
Maltese: Reazzjoni anafilattika Sensittività eċċessiva
English: Hematologic Normalization, n (%) Median duration of hematologic normalization, weeks (range) 1
Maltese: Normalizzazzjoni Ematoloġika, n (%) Tul medjan ta' normalizzazzjoni ematoloġika, ġimgħat (medda)
English: For adult aHUS, refractory gMG and NMOSD patients and paediatric aHUS patients supplemental dosing of Soliris is required in the setting of concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion):
Maltese: Għal adulti b'aHUS, pazjenti b'gMG refrattorja u b'NMOSD u pazjenti pedjatriċi b'aHUS, dożaġġ supplimentari ta' Soliris hu meħtieġ fl-isfond ta' PE/PI fl-istess ħin (plażmaferesi, skambju ta' plażma jew infużjoni ta' plażma ffriżata friska):
English: The most serious side effect was meningococcal sepsis.
Maltese: L-iktar effett sekondarju serju kienet sepsis meningokokkali.
English: Animal reproduction studies have not been conducted with eculizumab due to lack of pharmacologic activity in non-human species.
Maltese: Ma twettqux studji dwar ir-riproduzzjoni fl-annimali b'eculizumab minħabba n-nuqqas ta' attività farmakoloġika fi speċi mhux umani.
English: ≥15 mL/min/1.73 m2, n (%)
Maltese: Pazjenti b'titjib f'eGFR ta' ≥15 mL/min/1.73 m2, n (%)
English: For 1,200 mg doses, use 120 ml of Soliris and add
Maltese: Għal dożi ta' 1,200 mg uża 120 mL ta' Soliris u żid 120 mL ta' dilwent.
English: PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels.
Maltese: Pazjenti PNH għandhom jiġu mmonitorjati għal sinjali u sintomi ta' emolisi intravaskulari, fosthom illivelli ta' lactate dehydrogenase (LHD) fis-serum.
English: No clear treatment-related effects or adverse effects were observed in reproductive toxicology studies in mice with a surrogate terminal complement inhibitory antibody, which was utilized to assess the reproductive safety of C5 blockade.
Maltese: Ma kienu osservati ebda effetti marbuta mal-kura jew effetti avversi fi studji tat-tossikoloġija riproduttiva fi ġrieden b'antikorp sostitut li jimpedixxi l-komplement terminali, li kien utilizzat sabiex tiġi evalwata s-sigurtà riproduttiva ta' imblokk ta' C5.
English: Study C08-003A/B was a prospective, controlled, open-label study which accrued patients with longer term aHUS without apparent evidence of clinical thrombotic microangiopathy manifestations and receiving chronic PE/PI (≥1 PE/PI treatment every two weeks and no more than 3 PE/PI treatments/week for at least 8 weeks before the first dose).
Maltese: Studju C08-003A/B kien studju prospettiv, ikkontrollat, open-label, li ġabar pazjenti li kellhom aHUS aktar fit-tul mingħajr evidenza apparenti ta' manifestazzjonijiet kliniċi ta' mikroanġjopatija trombotika u li kienu qed jirċievu PE/PI kronika (≥1 kura PT kull ġimagħtejn u mhux iktar minn 3 kuri
English: The median patient age was 6.5 years (range: 5 months to 17 years).
Maltese: L-età medjana talpazjent kienet ta' 6.5 snin (medda: 5 snin sa 17-il sena).
English: • In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 1,200 mg (4 vials of 30 ml) over a 25 - 45 minute period.
Maltese: • Fil-ħames ġimgħa t-tabib tiegħek ser jagħti infużjoni ġol-vini ta' Soliris dilwit f'doża ta' sa 1,200 mg (4 kunjetti ta' 30 mL) fuq perjodu ta' 25 - 45 minuta.
English: In PNH patients, pharmacodynamic activity correlates directly with eculizumab serum concentrations and maintenance of trough levels above ≥ 35 microgram/mL results in essentially complete blockade of haemolytic activity in the majority of PNH patients.
Maltese: F'pazjenti b'PNH, l-attività farmakodinamika tikkorrelata direttament mal-konċentrazzjonijiet ta' eculizumab fis-serum u ż-żamma ta' livelli minimi ‘l fuq minn ≥ 35 mikrogramma/mL twassal tista' tgħid għal imblokk totali ta' l-attività emolitika fil-maġġoranza tal-pazjenti b'PNH.
English: These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Maltese: Dawn l-effetti dehru fost pazjenti f'kull wieħed mit-tliet strati ta' trasfużjoni ta' ċelluli ħomor tad-demm ta' qabel l-istudju (4 - 14-l unità; 15 - 25 unità; > 25 unità).
English: • Dilute Soliris to a final concentration of 5 mg/ml (initial concentration divided by 2) by adding the appropriate amount of diluent to the infusion bag.
Maltese: • Iddilwa Soliris għal konċentrazzjoni finali ta' 5 mg/mL (il-konċentrazzjoni inizjali diviża bin-nofs) billi żżid l-ammont korrett ta' dilwent mal-borża ta' l-infużjoni.
English: Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Maltese: Ikkonsulta mat-tabib tiegħek qabel tieħu Soliris biex tkun żgur li tirċievi tilqima kontra Neisseria meningitidis, organiżmu li jikkawża l-infezzjoni meningokokkali, qabel ma jew fi żmien li tkun ser tibda t-terapija, u ħu antibijotiċi biex tnaqqas ir-riskju ta' infezzjoni sa ġimagħtejn wara li tkun ġejt imlaqqam,.
English: EU/1/07/393/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/393/001
English: The median time from aHUS diagnosis to first dose of Soliris was 14 months (range <1, 110 months).
Maltese: Iż-żmien medjan minn dijanjosi ta' aHUS sal-ewwel doża ta' Soliris kien ta' 14-il xahar (medda <1, 110 xhur).
English: Human IgG are known to cross the human placental barrier, and thus eculizumab may potentially cause terminal complement inhibition in the foetal circulation.
Maltese: L-IgG umani huma magħrufa li jaqsmu l-barriera tal-plaċenta umana, u b'hekk eculizumab jista' potenzjalment jikkawża inibizzjoni tal-komplement terminali fiċ-ċirkolazzjoni tal-fetu.
English: All patients sustained a reduction in intravascular haemolysis over a total Soliris exposure time ranging from 10 to 54 months.
Maltese: Il-pazjenti kollha esperjenzaw tnaqqis fl-emolisi intravaskulari fuq perjodu totali ta' esponiment għal Soliris li varja minn 10 sa 54 xahar.
English: 002A/B C08-003A/B, C10-004) one in paediatric and adolescent patients (C10-003 ) and 30 patients in one retrospective study (C09-001r) were used to evaluate the efficacy of Soliris in the treatment of aHUS.
Maltese: Dejta minn 100 pazjent f'erba' studji prospettivi kkontrollati, tlieta f'pazjenti adulti u adolexxenti (C08-002A/B C08-003A/B C10-004) wieħed f'pazjenti pedjatriċi u adolexxenti (C10-003) u 30 pazjent fi studju retrospettiv wieħed (C09-001r) intużaw biex jevalwaw l-effikaċja ta' Soliris fil-kura ta' aHUS.
English: Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections
Maltese: Pazjenti li għandhom inqas minn 18-il sena jridu jiġu mlaqqma kontra Haemophilus influenzae u infezzjonijiet pnewmokokkali.
English: This medicinal product contains 115 mg sodium per vial.
Maltese: Dan il-prodott mediċinali fih 115 mmol ta' sodium f'kull kunjett.
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Maltese: • Riskju ta' kumplikazzjonijiet mikroanġjopatiċi trombotiċi severi (f'aHUS) wara ttwaqqif/posponiment tal-għoti ta' eculizumab, is-sinjali u s-sintomi tagħhom u rrakkomandazzjoni biex jikkonsultaw lil min jagħti r-riċetta qabel it-twaqqif/posponiment talgħoti ta' eculizumab.
English: Hypersensitivity to eculizumab, murine proteins or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal eculizumab, proteini tal-ġrieden jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Data from 143 patients in one controlled study (Study ECU-NMO-301) and from 119 patients who continued in one open-label extension trial (Study ECU-NMO-302) were used to evaluate the efficacy and safety of Soliris in the treatment of patients with NMOSD.
Maltese: Dejta minn 143 pazjent fi studju wieħed ikkontrollat (Studju ECU-NMO-301) u minn 119 pazjent li komplew fi prova waħda open-label ta' estensjoni (Studju ECU-NMO-302) intużaw biex jevalwaw leffikaċja ta' Soliris fil-kura ta' pazjenti b'NMOSD.
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
Maltese: Infezzjonijiet serji bi speċi ta' Neisseria (apparti Neisseria meningitidis),inklużi infezzjonijiet gonokokkali mifruxa, ġew irrappurtati.
English: Supportive safety data were obtained from 30 completed and one ongoing clinical studies that included 1,503 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG and NMOSD.
Maltese: Tagħrif ta' sostenn dwar is-sikurezza ġie miksub minn 30 studju kliniku komplut u wieħed li għadu għaddej li kienu jinkludu 1,503 pazjenti esposti għal eculizumab f'popolazzjonijiet ta' mard medjat mill-komplement li jinkludu PNH, aHUS, gMG refrattorja u NMOSD.
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only).
Maltese: • Riskju ta' kumplikazzjonijiet mikroanġjopatiċi trombotiċi severi wara t-twaqqif ta' eculizumab u l-posponiment tal-għoti, is-sinjali u s-sintomi tiegħu, monitoraġġ u mmaniġġjar (aHUS biss).
English: Soliris is indicated in adults for the treatment of: - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor
Maltese: Soliris huwa indikat fl-adulti għall-kura ta': - Mijastenija gravis refrattorja ġeneralizzata (gMG, generalized myasthenia gravis) f'pazjenti li huma pożittivi għall-antikorp tar-riċettur anti-acetylcholine (AChR) (anti-acetylcholine receptor (AChR) antibody-positive) (ara sezzjoni 5.1).
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger refractory gMG
Maltese: Ma ġew irrappurtati l-ebda differenzi globali fis-sigurtà bejn pazjenti anzjani (≥ 65 sena) u pazjenti iżgħar (< 65 sena) refrattarji għal gMG (ara sezzjoni 5.1).
English: In patients with gMG, their muscles can be attacked and damaged by the immune system which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk for aspiration, and markedly impaired activities of daily living.
Maltese: F'pazjenti b'gMG, ilmuskoli tagħhom jistgħu jiġu attakkati u ssirilhom ħsara mis-sistema immuni, u dan jista' jwassal għal dgħufija qawwija fil-muskoli, moviment imfixkel, qtugħ ta' nifs, għeja estrema, riskju ta' aspirazzjoni, u attivitajiet tal-ħajja ta' kuljum imxekkla ħafna.
English: Daily TMA Intervention Rate, median (range) Before eculizumab On eculizumab treatment 1 Through data cut-off (September 4, 2012), with median duration of Soliris therapy of 50 weeks (range: 13
Maltese: Sad-data tal-għeluq tad-dejta (4 ta' Settembru, 2012), b'tul medjan tat-terapija b'Soliris ta' 50 ġimgħa (medda: 13 sa 86 ġimgħa).
English: Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.
Maltese: Abbażi tal-effett ta' inibizzjoni potenzjali ta' eculizumab fuq iċ-ċitotossiċità ta' rituximab dipendenti fuq il-komplement, eculizumab jista' jnaqqas l-effetti farmakodinamiċi mistennija ta' rituximab.
English: For 600 mg doses, use 60 ml of Soliris and add 60 ml of diluent.
Maltese: Għal dożi ta' 600 mg, uża 60 mL ta' Soliris (10 mg/mL) u żid 60 mL ta' dilwent.
English: Jaundice
Maltese: Storja
English: • In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over a 25 - 45 minute period.
Maltese: • Fil-ħames ġimgħa, it-tabib tiegħek għandu jagħtik infużjoni fil-vini ta' Soliris dilwit f'doża ta' 900 mg (3 kunjetti ta' 30 mL) fuq perjodu ta' 25 - 45 minuta.
English: Each infusion will consist of a dose of 900 mg (3 vials of 30 ml) and will take 25 - 45 minutes.
Maltese: Kull infużjoni se tkun tikkonsisti minn doża sa 900 mg (1 sa 3 kunjetti ta' 30 mL, skont l-età u l-piż tal-ġisem tiegħek) u ser tieħu 25 - 45 minuta).
English: • skin tumor (melanoma), bone marrow disorder
Maltese: • tumur tal-ġilda (melanoma), disturb tal-mudullun
English: Mean (SD) Median Min, Max
Maltese: Medja (SD) Medjan Minimu, Massimu
English: Fifteen severe thrombotic microangiopathy (TMA) complications in 12 patients were observed following treatment discontinuation, and 2 severe TMA complications occurred in an additional 2 patients that received a reduced dosing regimen of Soliris outside of the approved dosing regimen (See Section 4.2).
Maltese: Ħmistax-il kumplikazzjoni ta' mikroanġjopatija trombotika (TMA) severa fi 12-il pazjent ġew osservati wara t-twaqqif tal-kura, u 2 kumplikazzjonijiet ta' TMA severa seħħew f'2 pazjenti addizzjonali li rċivew kors imnaqqas ta' dożaġġ ta' Soliris barra mill-kors ta' dożaġġ approvat (Ara Sezzjoni 4.2).
English: PRBC transfused during treatment (median)
Maltese: PRBC trasfużi matul il-kura (medjan)
English: Treatment discontinuation for refractory gMG:
Maltese: Twaqqif tal-kura għal gMG refrattorja:
English: In the non-controlled study C04-002 (SHEPHERD), PNH patients with at least one transfusion in the prior 24 months and at least 30,000 platelets/microliter received Soliris over a 52-week period.
Maltese: Fl-istudju mhux ikkontrollat C04-002 (SHEPHERD), pazjenti PNH b'mill-anqas trasfużjoni waħda fl-aħħar 24 xahar u mill-anqas 30,000 plejtlet/mikrolitru rċevew Soliris fuq perjodu ta' 52 ġimgħa.
English: (AChR) antibody-positive (see section 5.1).
Maltese: (AQP4) bi progressjoni tal-marda li terġa' titfaċċa (ara sezzjoni 5.1).
English: FACIT-Fatigue score at baseline (median)
Maltese: Punteġġ FACIT-Għeja fil-linja bażi (medjan)
English: The dosing regimen in paediatric patients and adolescents weighing less than 40 kg was defined based on a pharmacokinetic (PK) simulation that identified the recommended dose and schedule based on body weight (see section 4.2).
Maltese: Il-kors ta' dożaġġ f'pazjenti pedjatriċi u adolexxenti li kienu jiżnu inqas minn 40 kg ġie definit ibbażat fuq simulazzjoni farmakokinetika (PK) li identifikat id-doża u l-iskeda rakkomandati bbażat fuq il-piż tal-ġisem (ara sezzjoni 4.2).
English: Severe thrombotic microangiopathy complications post discontinuation can be identified by (i) any two, or repeated measurement of any one, of the following: a decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during Soliris treatment; an increase in serum creatinine of 25% or more as compared to baseline or to nadir during Soliris treatment; or, an increase in serum LDH of 25% or more as compared to baseline or to nadir during Soliris treatment; or (ii) any one of the following: a change in mental status or seizures; angina or dyspnoea; or thrombosis.
Maltese: Kumplikazzjonijiet severi ta' mikroanġjopatija trombotika wara t-twaqqif tal-kura jistgħu jiġu identifikati minn (i) kwalunkwe żewġ kejlijiet, jew kejl ripetut ta' kwalunkwe wieħed minn dawn li ġejjin: tnaqqis fl-għadd tal-plejtlits ta' 25% jew iktar meta mqabbel jew mal-linja bażi jew mal-għadd massimu tal-għadd tal-plejtlits matul il-kura b'eculizumab; żieda tal-krejatinina fis-serum ta' 25% jew iktar meta mqabbel mal-linja bażi jew mal-livell minimu matul il-kura b'eculizumab; jew, żieda f'LDH fis-serum ta' 25% jew iktar meta mqabbel mal-linja bażi jew mal-livell minimu matul il-kura b'eculizumab; jew (ii) kwalunkwe wieħed minn dawb li ġejjin: bidla fl-istat mentali jew puplesiji; anġina jew qtugħ ta' nifs; jew trombożi.
English: Rash, Pruritus, Alopecia
Maltese: Dijarea, Rimettar, Dardir
English: In all aHUS patients, eculizumab serum concentrations of approximately 50 - 100 microgram/mL are sufficient for essentially complete inhibition of terminal complement activity.
Maltese: Fil-pazjenti kollha b'aHUS, il-konċentrazzjonijiet ta' eculizumab fisserum ta' madwar 50 - 100 mikrogramma/mL huma biżżejjed għal inibizzjoni essenzjalment sħiħa ta' attività komplementari terminali.
English: • Risk of substantial disease exacerbation or relapse following eculizumab discontinuation (refractory gMG and NMOSD)
Maltese: • Riskju ta' aggravament sostanzjali tal-marda jew rikaduta wara t-twaqqif ta' eculizumab (gMG refrattorja jew NMOSD)
English: Change From Baseline MG-ADL Total Score
Maltese: Punteġġ MG-ADL fil-Linja Bażi
English: ECU-MG-301
Maltese: NMO-301
English: At 6 months, patients treated with Soliris with no history of RBC transfusion had significantly (p<0.001) reduced LDH levels (median LDH of 305 U/L; Table 4).
Maltese: 001) fil-livelli ta' LDH (medjan LDH ta' 305 U/L; Tabella 4).
English: Each vial of Soliris contains 300 mg of active ingredient in 30 ml of product solution.
Maltese: Kull kunjett ta' Soliris fih 300 mg ta' sustanza attiva fi 30 mL ta' soluzzjoni tal-prodott.
English: Antibodies to Soliris were detected in 2% of patients with PNH using an ELISA assay, 3% of patients with aHUS and 2% of patients with NMOSD using the ECL bridging format assay.
Maltese: Antikorpi għal Soliris kienu rilevanti fi 2% ta' pazjenti b'PNH permezz ta' assaġġ b'ELISA, fi 3% ta' pazjenti b'aHUS u 2% tal-pazjenti b'NMOSD permezz ta' ECL bridging format assay.
English: Soliris No transfusion
Maltese: Soliris L-Ebda trasfużjoni