FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study C10-003, patients who enrolled in the study were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH above the upper limits of normal and serum creatinine level ≥97 percentile for age without the need for chronic dialysis.
Maltese: Fl-Istudju C10-003, pazjenti li ġew arwolati fl-istudju kienu meħtieġa li jkollhom l-għadd ta' plejtlits < medda normali tal-limitu ta' taħt (LLN), evidenza ta' emolisi bħal żieda ta' LDH fis-serum, u kreatinina fis-serum >97 perċentili għal età, mingħajr il-bżonn ta' dijalisi kronika.
English: • dizziness, taste disorders (dysgeusia), high blood pressure
Maltese: • sturdament, disturbi fit-togħma (indeboliment fis-sens tat-togħma), pressjoni għolja tad-demm
English: In a refractory gMG placebo controlled study, none (0/62) of the Soliris treated patients showed antidrug antibody response during the 26 week active treatment.
Maltese: Fi studju kkontrollat bi plaċebo dwar gMG refrattorja, ħadd (0/62) mill-pazjenti kkurati b'Soliris ma wera rispons tal-antikorpi kontra l-mediċina matul is-26 Ġimgħa ta' kura attiva.
English: • Risk of serious haemolysis (in PNH) 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' emolisi serja (f'PNH) wara t-twaqqif/posponiment tal-għoti ta' eculizumab, is-sinjali u s-sintomi tagħhom u r-rakkomandazzjoni biex jikkonsultaw lil min jagħti r-riċetta qabel ittwaqqif/posponiment tal-għoti ta' eculizumab.
English: Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Maltese: Reazzjonijiet allerġiċi Soliris fih proteina, u l-proteini jistgħu jikkawżaw reazzjonijiet allerġiċi f'ċerti nies.
English: The PNH registry (M07-001) was used to evaluate the efficacy of Soliris in PNH patients with no history of RBC transfusion.
Maltese: Ir-reġistru PNH (M07-001) intuża biex jevalwa l-effikaċja ta' Soliris f'pazjenti b'PNH bl-ebda storja medika ta' trasfużjoni ta' RBC.
English: LDH level at baseline (median , U/L)
Maltese: Livelli ta' LDH ta' qabel it-trattament (medjan, U/L)
English: When immunosuppressant therapy is decreased or discontinued, patients should be monitored closely for signs and symptoms of potential NMOSD relapse.
Maltese: Meta t-terapija b'immunosoppressanti titnaqqas jew titwaqqaf, il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' rikaduta potenzjali ta' NMOSD.
English: Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of <5 g/dL or a decrease of >4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Maltese: Emolisi serja hija identifikata minn livelli ta' LDH fis-serum ogħla mil-livell ta' qabel il-kura, flimkien ma' xi waħda minn dawn li ġejjin: tnaqqis assolut ta' aktar minn 25% fid-daqs tal-klonu PNH (fin-nuqqas ta' dilwizzjoni minħabba trasfużjoni) f'ġimgħa waħda jew anqas; livell ta' l-emoglobina ta' < 5 g/dL jew tnaqqis ta' > 4 g/dL f'ġimgħa waħda jew anqas; anġina; tibdil fl-istat mentali; żieda ta' 50% fil-livell ta' krejatinina fis-serum; jew trombożi.
English: Soliris is not expected to affect the aplastic component of anaemia in patients with PNH.
Maltese: Soliris mhux mistenni li jaffettwa l-komponent aplastiku ta' l-anemija f'pazjenti b'PNH.
English: Daily TMA intervention rate, median (range) Before eculizumab On eculizumab treatment
Maltese: Rata ta' intervent kuljum b'TMA, medjan (medda) Qabel eculizumab Meta ngħatat kura b'eculizumab
English: Longer term treatment with Soliris (median 55 weeks ranging from 1day to 107 weeks) was associated with an increased rate of clinically meaningful improvements in paediatric and adolescent patients with aHUS.
Maltese: Kura aktar fit-tul b'Soliris (medjan ta' 55 ġimgħa li varja minn jum 1 sa 107 ġimgħa) ġiet assoċjata ma' żieda fir-rata ta' titjib klinikament sinifikanti f'pazjenti pedjatriċi u adolexxenti b'aHUS.
English: Stratified analyses are based on four randomization strata: (i) low EDSS at randomization (<=2.0), (ii) high EDSS (>=2.5 to <=7) and treatment naive at randomization, (iii) high EDSS (>=2.5 to <=7) and continuing on the same IST(s) since last relapse at randomization, (iv) high EDSS (>=2.5 to <=7) and changes in IST(s) since last relapse at randomization.
Maltese: (i) punteġġ baxx ta' EDSS meta l-pazjenti ntgħażlu b'mod każwali (<=2.0), (ii) punteġġ għoli ta' EDSS (>=2.5 sa <=7) u ma kinux irċivew kura fil-passat meta l-pazjenti ntgħażlu b'mod każwali, (iii) punteġġ għoli ta' EDSS (>=2.5 sa <=7) u komplew bl-istess IST(s) mill-aħħar rikaduta fl-għażla każwali, (iv) punteġġ għoli ta' EDSS (>=2.5 sa <=7) u bidliet fl-IST(s) millaħħar rikaduta fl-għażla każwali.
English: • infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), Haemophilus influenzae infection, gum infection, impetigo, bacterial sexual transmitted disease (gonorrhea)
Maltese: • dispnea (diffikultà biex tieħu n-nifs), l-imnieħer jinfaġar, imnieħer miżdud (konġestjoni nażali), irritazzjoni tal-griżmejn, uġigħ fil-griżmejn (uġigħ faringolarinġeali), imnieħer joqtor (rinorrea)
English: Soliris has not been studied in patients with PNH who weigh less than 40kg.
Maltese: Soliris ma ġiex studjat f'pazjenti b'PNH li jiżnu inqas minn 40 kg.
English: Gastroesophageal reflux disease, Gingival pain
Maltese: Infezzjoni gastrointestinali, Ċistite, Infezzjoni, Sinusite
English: When immunosuppressant and anticholinesterase therapies are decreased or discontinued, patients should be monitored closely for signs of disease exacerbation.
Maltese: Meta t-terapiji b'immunosoppressanti u anticholinesterase jitnaqqsu jew jitwaqqfu, ilpazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali ta' aggravament tal-mard.
English: In aHUS C10-004, mean (±SD) platelet count increased from 119 ± 66 x109/L at baseline to 200 ± 84 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 252 ± 70 x109/L).
Maltese: Dan l-effett kien mantenut matul 26 ġimgħa (għadd ta' plejtlits medju (±SD) f'ġimgħa 26: 252 ± 70 x10
English: There was an un-vaccinated patient diagnosed with idiopathic membranous glomerulonephropathy who experienced meningococcal meningitis.
Maltese: Wara dilwizzjoni, il-prodott mediċinali għandu jintuża immedjatament.
English: Normalization of platelet count All patients, n (%) (95% CI) Patients with abnormal baseline, n/n (%) TMA event-free status, n (%) (95% CI) TMA intervention rate Daily preeculizumab rate, median (min, max) Daily duringeculizumab rate, median (min, max) P-value
Maltese: Normalizzazzjoni fl-għadd tal-plejtlits Il-pazjenti kollha, n (%) (95% CI) Pazjenti bl-linja bażi anormali, n/n (%)
English: The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues.
Maltese: Ir-reattività ta' eculizumab mat-tessut kienet evalwata billi ġiet imkejla r-rabta ma' penil ta' 38 tessut uman.
English: Meningococcal Infection
Maltese: Infezzjoni meningokokkali:
English: In refractory gMG placebo-controlled studies, no antidrug antibodies were observed.
Maltese: Fi studji kkontrollati bi plaċebo dwar gMG refrattorja, ma ġew osservati l-ebda antikorpi kontra l-mediċina.
English: Daily TMA Intervention rate, median (range) Before eculizumab treatment, median On eculizumab treatment, median
Maltese: Qabel it-trattament b'eculizumab, medjan Waqt it-trattament b'ecukizumab, medjan
English: LDH AUC at end of study (median, U/L x Day)
Maltese: LDH AUC fit-tmiem ta' listudju (medjan, U/L x Ġurnata)
English: When Soliris treatment was continued for more than 26 weeks, three additional patients (63% of patients in total) achieved Complete TMA response and four additional patients (98% of patients in total) achieved hematologic normalization.
Maltese: Meta l-kura b'Soliris tkompliet għal aktar minn 26 ġimgħa, tliet pazjenti addizzjonali (63% tal-pazjenti b'kollox) kisbu rispons Komplet għal TMA u erba' pazjenti addizzjonali (98% tal-pazjenti b'kollox) kisbu normalizzazzjoni ematoloġika.
English: In patients with NMOSD, uncontrolled terminal complement activation caused by autoantibodies against AQP4 leads to the formation of the MAC and C5a-dependent inflammation which results in astrocyte necrosis and increased permeability of the blood brain barrier, as well as death of the surrounding oligodendrocytes and neurons.
Maltese: F'pazjenti b'NMOSD, attivazzjoni komplementari terminali mhux ikkontrollata kkawżata minn awtoantikorpi kontra AQP4 twassal għall-formazzjoni ta' MAC (membrane attack complex - kumpless ta' attakk fuq il-membrani) u infjammazzjoni dipendenti fuq C5a li jirriżultaw f'nekrożi tal-astroċiti u żieda fil-permeabilità tal-barriera ematoenċefalika, kif ukoll fil-mewt tal-oligodendroċiti u n-newroni.
English: Soliris has not been evaluated in paediatric patients with NMOSD.
Maltese: Soliris hija soluzzjoni ċara u bla kulur.
English: Pregnancy/ Breast-feeding
Maltese: Disturbi fil-qalb
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali wara d-dilwizzjoni, ara sezzjoni 6.3. 6.5
English: In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event).
Maltese: Fl-istudju SHEPHERD, 96 mis97 pazjent irreġistrat ikkompletaw l-istudju (pazjent wieħed miet wara episodju trombotiku).
English: Soliris has not been evaluated in paediatric patients with refractory gMG.
Maltese: Soliris ma ġiex evalwat f'pazjenti pedjatriċi b'gMG refrattorja.
English: Meningococcal infection includes the following group of PTs: Meningococcal infection, Meningococcal sepsis, Meningitis meningococcal, Neisseria infection.
Maltese: Infezzjoni meningokokkali, Sepsi meningokokkali, Meninġite meningokokkali, Infezzjoni neisseria.
English: From the 195 patients that originated in C04-001, C04-002 and other initial studies, Soliris-treated PNH patients were enrolled in a long term extension study (E05-001).
Maltese: Mill-195 pazjent li bdew f'C04-001, C04-002 u studji oħra inizjali, il-pazjenti PNH ikkurati b'Soliris ġew irreġistrati fi studju ta' estensjoni fuq perjodu twil (E05-001).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku talAġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Table 17: Baseline Characteristics of Paediatric and Adolescents Patients Enrolled in aHUS Study
Maltese: Tabella 17: Karatteristiċi fil-Linja Bażi għal Pazjenti Pedjatriċi u Adolexxenti Arwolati flIstudju aHUS C10-003
English: No specific studies have been performed to evaluate the hepatic, renal, lung, or gastrointestinal routes of excretion/elimination for Soliris.
Maltese: Ma sarux studji speċifiċi biex jiġu evalwati r-rotot ta' tneħħija/eliminazzjoni mill-fwied, kliewi, pulmun, jew gastrointestinali għal Soliris.
English: In aHUS C10-003, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins or auto-antibodies to factor H.
Maltese: F'aHUS C10-003 ir-risponsi għal Soliris kienu simili f'pazjenti bi jew mingħajr mutazzjonijiet identifikati f'ġeni li jikkodifikaw protein ta' fattur regolatorju komplimentari jew awto-antikorpi għal fattur H.
English: TMA Event-Free Status, n (%)
Maltese: Stat Mingħajr Avvenimenti ta' TMA, n (%)
English: Fifty percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Maltese: Ħamsin fil-mija tal-pazjenti kellhom fattur regolatorju kumplimentari identifikat ta' mutazzjoni jew awto-antikorp.
English: 600 mg per each plasmapheresis or plasma exchange session
Maltese: 600 mg għal kull plażmaferesi jew sessjoni ta' skambju ta' plażma
English: • disease with thyroid overactivity (Basedow's disease)
Maltese: • mard minħabba attività eċċessiva tat-tirojde (mard ta' Basedow)
English: TMA Event-free Status, n (%) 95% CI
Maltese: TMA sħiħ, n (%) (95% CI)
English: In aHUS Study C08-002A/B, the median duration of Soliris therapy was approximately100 weeks (range: 2 weeks to 145 weeks).
Maltese: Fi Studju C08-002A/B dwar aHUS, il-medjan tat-tul taż-żmien tatterapija b'Soliris kien ta' madwar 100 ġimgħa (medda: ġimagħtejn sa 145 ġimgħa).
English: As a result, patients with complement-mediated diseases, including PNH, aHUS, refractory gMG and NMOSD, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH), TMA (aHUS), MG exacerbation (refractory gMG) or relapse (NMOSD).
Maltese: Bħala riżultat, pazjenti b'mard medjat millkomplement, li jinkludi PNH, aHUS, gMG refrattorja u NMOSD, jista' jkollhom żieda fis-sinjali u ssintomi tal-marda sottostanti tagħhom, bħal emolisi (PNH), TMA (aHUS), aggravament ta' MG (gMG refrattorja) jew rikaduta (NMOSD).
English: Number of PE/PI sessions in 7 days prior to first dose of eculizumab, median (min, max) Baseline platelet count (× 109/L), mean (SD) Baseline LDH (U/L), mean (SD) Patients without identified mutation, n (%)
Maltese: Numru ta' sessjonijiet PE/PI fis-7 ijiem qabel l-ewwel doża ta' eculizumab, medjan (min, max) Għadd tal-plejtlits fil-linja bażi (× 10
English: Patients enrolled in aHUS C10-003 had an ADAMTS-13 level above 5%.
Maltese: Il-pazjenti kollha arwolati f'aHUS C10-003 kellhom livell ta' ADAMTS-13 ogħla minn 5%.
English: In PNH patients, uncontrolled terminal complement activation and the resulting complement-mediated intravascular haemolysis are blocked with Soliris treatment.
Maltese: Ġie osservat tnaqqis fl-attività komplementari terminali filpazjenti kollha wara l-bidu ta' Soliris.
English: Longer term treatment with Soliris (median 52 weeks ranging from 15 to 126 weeks) was associated with an increased rate of clinically meaningful improvements in adult patients with aHUS.
Maltese: Kura aktar fit-tul b'Soliris (medjan ta' 52 ġimgħa li varja minn 15 sa 126 ġimgħa) ġiet assoċjata ma' żieda fir-rata ta' titjib klinikament sinifikanti f'pazjenti adulti b'aHUS.
English: At 26 weeks At 2 years1 At 26 weeks At 2 years1
Maltese: Xahar 1 sa <12il sena (N = 18) Wara 26 ġimgħa
English: In the open-label extension trial (Study ECU-MG-302), physicians had the option to adjust background immunosuppressant therapies.
Maltese: Fil-prova ta' estensjoni open-label (Studju ECU-MG-302), it-tobba kellhom l-għażla li jaġġustaw itterapiji immunosoppressanti fl-isfond.
English: • spasm of mouth muscle
Maltese: • spażmu tal-muskolu tal-ħalq
English: The second population PK model was applied to the multiple dose PK data from 22 paediatric aHUS patients receiving the recommended Soliris regimen in aHUS C10-003.
Maltese: It-tieni mudell għal popolazzjoni PK kien applikat għat-tagħrif PK għal doża multipla minn 22 pazjent pedjatriku b'aHUS li rċevew il-programm ta' kura rakkomandat ta' SOLIRIS f'aHUS C10-003.
English: TMA-event free status was defined as the absence for at least 12 weeks of the following: decrease in platelet count of > 25% from baseline, PE/PI, and new dialysis.
Maltese: Stat mingħajr każijiet ta' TMA ġie definit innuqqas għal mill-inqas 12-il ġimgħa ta dawn li ġejjin: tnaqqis fl-għadd tal-plejtlits ta' > 25% mil-linja bażi, PT, u dijalisi ġdida.
English: Within 60 minutes after each plasmapheresis or plasma exchange
Maltese: Fi żmien 60 minuta wara kull plażmaferesi jew skambju ta' plażma
English: Through data cut-off (October 12, 2012), with median duration of Soliris therapy of 44 weeks (range: 1 dose to 88
Maltese: sad-data miftehma għal tagħrif miġbur (12 ta' Ottubru, 2012), b'tul medjan tat-terapija b'Soliris ta' 44 ġimgħa (medda: doża 1 sa 88 ġimgħa).
English: patients (< 65 years) (see section 5.1).
Maltese: (ara sezzjoni 5.1).
English: • upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex)
Maltese: bronkite, postumetti (herpes simplex)
English: Dosing for paediatric patients <40 kg is based on paediatric patients with aHUS.
Maltese: Dożaġġ għal pazjenti pedjatriċi li jiżnu <40 kg hu bbażat fuq pazjenti pedjatriċi b'aHUS.
English: • ringing in the ears, vertigo
Maltese: • tisfir fil-widnejn, vertiġini
English: Population PK analysis on data collected across studies in PNH, aHUS, gMG and NMOSD patients showed gender, race, age (geriatric), or the presence of renal or hepatic impairment.function do not influence the PK of eculizumab.
Maltese: L-analiżi tal-PK fil-popolazzjoni fuq dejta miġbura minn studji dwar pazjenti b'PNH, aHUS, gMG u NMOSD uriet li l-ġeneru sesswali, ir-razza, l-età (xjuħ), jew il-preżenza ta' indeboliment tal-funzjoni renali jew epatika ma nfluwenzawx il-PK ta' eculizumab.
English: • Treatment with eculizumab increases the risk of severe infection and sepsis, especially of Neisseria meningitidis and other Neisseria species, including disseminated gonorrhoeae.
Maltese: • Il-kura b'eculizumab iżżid ir-riskju ta' infezzjoni severa u sepsis, b'mod speċjali ta' Neisseria meningitidis u speċi oħra ta' Neisseria inkluż gonorrea mifruxa.
English: As with all proteins there is a potential for immunogenicity.
Maltese: Bħalma jiġri b'kull proteina oħra hemm potenzjal ta' immunoġeniċità.
English: • Maintenance phase: 1,200 mg of Soliris administered via a 25 - 45 minute intravenous infusion for the fifth week, followed by 1,200 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).
Maltese: • Fażi inizjali: 600 mg ta' Soliris mogħtija permezz ta' infużjoni ġol-vini ta' 25 - 45 minuta kull ġimgħa għall-ewwel 4 ġimgħat
English: Headache Dizziness, Dysgeusia
Maltese: UŻATI JEW SKART MINN DAWN
English: • sleep disorder, abnormal dreams
Maltese: • disturb fl-irqad, ħolm abnormali
English: If you use this medicine to treat aHUS, refractory gMG or NMOSD For adults:
Maltese: Jekk tuża din il-mediċina għal kura ta' aHUS, gMG refrattorja jew NMOSD Għall-adulti:
English: Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Maltese: Soliris jintuża għall-kura ta' pazjenti adulti u tfal b'ċertu tip ta' marda li taffettwa s-sistema tad-demm imsejħa Emoglobinurja Notturna Parossimali (PNH - Paroxysmal Nocturnal Haemoglobinuria).
English: Complete Hematologic Normalization, n (%)
Maltese: Pazjenti mingħajr mutazzjoni identifikata, n (%)
English: In PNH, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated haemolytic activity.
Maltese: F'PNH, l-għoti kroniku ta' Soliris irriżulta fi tnaqqis veloċi u sostnut fl-attività emolitika medjata missistema komplementari.
English: In all studies, the dose of Soliris in adult and adolescent aHUS patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1,200 mg 7 ± 2 days later, then 1,200 mg every 14 ± 2 days for the study duration.
Maltese: Fl-istudji kollha, id-doża ta' Soliris f'pazjenti adulti u adolexxenti b'aHUS kienet ta' 900 mg kull 7 ± jumejn għal 4 ġimgħat, segwita minn 1,200 mg 7 ± jumejn wara dan il-perjodu, imbagħad 1,200 mg kull 14 ± jumejn għal kemm dam listudju.
English: How to store Soliris
Maltese: X'inhu Soliris
English: Table 18 summarizes the efficacy results for aHUS C10-003.
Maltese: Tabella 18 tiġbor fil-qosor ir-riżultati ta' effikaċja għal aHUS C10-003.
English: 300 mg per each plasmapheresis or plasma exchange session
Maltese: 300 mg għal kull plażmaferesi jew sessjoni ta' skambju ta' plażma
English: Change From Baseline QMG Total Score
Maltese: Bidla f'Soliris relattiva għallplaċebo
English: • infection, fungal infection, collection of pus (abscess), type of infection of the skin (cellulitis),
Maltese: • infezzjoni minn moffa (infezzjoni ta' Aspergillus), infezzjoni fuq il-ġog (artrite batterika),
English: Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: • Risk of substantial disease exacerbation or relapse (in refractory gMG and NMOSD) following discontinuation/postponement of eculizumab administrations and recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Maltese: • Riskju ta' aggravament sostanzjali tal-marda jew rikaduta (f'pazjenti b'gMG refrattorja u NMOSD) wara t-twaqqif/posponiment tal-għoti ta' eculizumab, u rakkomandazzjoni biex ilpazjent jikkonsulta lil min ikun għamillu r-riċetta għall-prodott, qabel ma jwaqqaf/jipposoponi l-għoti ta' eculizumab.
English: What is Soliris
Maltese: X'fih Soliris
English: No IST usage at baseline n (%)
Maltese: L-ebda użu ta' IST fil-linja bażi n (%)
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care.
Maltese: • Sinjali u sintomi ta' infezzjoni severa u l-ħtieġa li tikseb kura medika urġenti.
English: Approximately half were White (49.0%).
Maltese: Madwar nofshom kienu Bojod (49.0%).
English: CKD improvement by
Maltese: Parametru ta' Effikaċja
English: In aHUS clinical studies, 61 patients (21 paediatric patients) discontinued Soliris treatment with a median follow-up period of 24 weeks.
Maltese: Fi studji kliniċi dwar aHUS, 61 pazjent (21 pazjent pedjatriku) waqqfu l-kura b'Soliris b'perjodu ta' follow-up medjan ta' 24 ġimgħa.
English: - If you have a meningococcal infection.
Maltese: - jekk għandek infezzjoni meningokokkali.
English: • All patients must be monitored for signs of meningococcal infection.
Maltese: • Il-pazjenti kollha għandhom jiġu mmonitorjati għal sinjali ta' infezzjoni meningokokkali.
English: The mean (±SD) platelet count increased from 88 ± 42 x109/L at baseline to 281 ± 123 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 293 ± 106 x109/L).
Maltese: (għadd ta' plejtlits medju (±SD) f'ġimgħa 26: 293 ± 106 x10
English: Patients with platelet count normalization, n (%) Complete TMA response, n (%)
Maltese: Pazjenti b'normalizzazzjoni flgħadd tal-plejtlits, n (%)
English: Paraesthesia, Tremor Syncope
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Table 7 summarizes the key baseline clinical and diseaserelated characteristics of patients enrolled in aHUS C10-004.
Maltese: Tabella 8 tiġbor fil-qosor ir-riżultati ta' effikaċja għal studju aHUS C10-004.
English: The primary endpoint for Study ECU-MG-301 was the change from baseline in the MG Activities of Daily Living Profile (MG-ADL - a patient reported outcome measure validated in gMG) total score at Week 26.
Maltese: Il-punt aħħari primarju għall-Studju ECU-MG-301 kienet il-bidla mil-linja bażi fil-punteġġ totali ta' MG Attivitajiet tal-Profil tal-Għajxien ta' Kuljum (MG-ADL - Activities of Daily Living Profile - kejl tar-riżultati rrappurtati mill-pazjent ivvalidati f'gMG f'Ġimgħa 26.
English: Supportive safety data were obtained in 12 completed clinical studies that included 934 patients exposed to eculizumab in other disease populations other than PNH, aHUS, refractory gMG or NMOSD.
Maltese: Tagħrif ta' sostenn dwar is-sigurtà tal-mediċina ġie miksub fi 12-il studju kliniku li tlesta li kienu jinkludu 934 pazjent esposti għal eculizumab f'popolazzjonijiet ta' mard ieħor għajr PNH, aHUS, gMG refrattorja jew NMOSD.
English: Other Systemic Infections
Maltese: Infezzjonijiet Sistemiċi Oħra
English: Very Common
Maltese: tinħass sħun