FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 Based on a stratified Cox proportional hazards model.
Maltese: Abbażi tal-mudell ta' perikli proporzjonali ta' Cox stratifikat.
English: influenza, sinusitis, tooth infection (abscess)
Maltese: (ċellulite), influwenza, sinusite, infezzjoni fis-snien (axxess)
English: If serious haemolysis occurs after Soliris discontinuation, consider the following procedures/treatments: blood transfusion (packed RBCs), or exchange transfusion if the PNH RBCs are >50% of the total RBCs by flow cytometry; anticoagulation; corticosteroids; or reinstitution of Soliris.
Maltese: Jekk ikun hemm emolisi serja wara li Soliris jitwaqqaf, wieħed għandu jikkunsidra l-proċeduri/trattamenti li ġejjin: trasfużjoni tad-demm (ċelluli ħomor tad-demm ippakkjati), jew trasfużjoni ta' skambju jekk l-PNH RBC ikun > 50% tat-total taċ-ċelluli ħomor tad-demm biċċitometrija tal-fluss; antikoagulazzjoni; kortikosterojdi; jew l-użu mill-ġdid ta' Soliris.
English: Patients in aHUS Study C08-002 A/B received Soliris for a minimum of 26 weeks.
Maltese: Pazjenti fi Studju C08-002 A/B dwar aHUS irċivew Soliris għal minimu ta' 26 ġimgħa.
English: Table 6 summarizes the efficacy results for aHUS Study C08-003A/B.
Maltese: Tabella 6 turi filqosor ir-riżultati tal-effikaċja għal Studju C08-003A/B dwar aHUS.
English: PK parameters are consistent across PNH, aHUS, refractory gMG and NMOSD patient populations.
Maltese: Il-parametri PK huma konsistenti fost il-popolazzjonijiet tal-pazjenti b'PNH, aHUS, gMG refrattorja u NMOSD.
English: Soliris.
Maltese: Tużax Soliris
English: (≥1/1,000 to <1/100)
Maltese: Mhux komuni (≥1/1,000 sa <1/100)
English: Treatment discontinuation for NMOSD:
Maltese: Twaqqif tal-kura għal NMOSD:
English: Study ECU-NMO-301 was a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study of Soliris in patients with NMOSD.
Maltese: Studju ECU-NMO-301 kien studju ta' Fażi 3, double-blind, li fih il-pazjenti ntgħażlu b'mod każwali, ikkontrollat bil-plaċebo, multi-ċentriku dwar Soliris f'pazjenti b'NMOSD.
English: Thrombotic microangiopathy (TMA) complications have been observed as early as 4 weeks and up to 127 weeks following discontinuation of Soliris treatment in some patients.
Maltese: Kumplikazzjonijiet ta' mikroanġjopatija trombotika (TMA) ġew osservati kmieni sa minn 4 ġimgħat u sa 127 ġimgħa wara t-twaqqif tal-kura b'Soliris f'xi pazjenti.
English: In aHUS, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated thrombotic microangiopathy.
Maltese: F'aHUS, l-għoti kroniku ta' Soliris irriżulta fi tnaqqis mgħaġel u tnaqqis sostnut fil-komplement medjat minn mikroanġjopatija trombotika.
English: One hundred and eighteen (118) of the 125 (94%) patients completed the 26-week treatment period and 117 (94%) patients subsequently enrolled in Study ECU-MG-302, an open-label, multi-center long-term safety and efficacy extension study in which all patients received Soliris treatment.
Maltese: Mija u tmintax-il (118) pazjent mill-125 (94%) pazjent li temmew il-perjodu ta' kura ta' 26 ġimgħa, u 117-il (94%) pazjent sussegwentement irreġistraw fi Studju ECU-MG-302, u studju ta' estensjoni, open-label, multiċentriku, dwar is-sigurtà fit-tul tal-effikaċja, li fih il-pazjenti kollha rċivew kura b'Soliris.
English: • Maintenance phase: 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).
Maltese: • Fażi inizjali: 900 mg ta' Soliris mogħti permezz ta' infużjoni ġol-vini ta' 25 - 45 minuta kull ġimgħa għall-ewwel 4 ġimgħat.
English: Time from current clinical TMA manifestation until first study dose (months), median ( min, max) Baseline platelet count (× 109/L), median (, min, max ) Baseline LDH (U/L), median (, min, max) Baseline eGFR (mL/min/1.73m2), median (min, max)
Maltese: Żmien mill-manifestazzjoni TMA klinika kurrenti sal- iscreening f'xhur, medjan (min, max) Numru ta' sessjonijiet PE/PI għal manifestazzjoni TMA klinika kurrenti, medjan (min, max)
English: Abbreviations: ARR = annualized relapse rate; CI = confidence interval.
Maltese: SEM = Standard Error of the Mean (Żball Standard tal-Medja) CI = Confidence Interval (Intervall ta'
English: 2) Failed at least one immunosuppressant therapy and required chronic plasma exchange or IVIg to control symptoms, ie, patients require PE or IVIg on a regular basis for the management of muscle weakness at least every 3 months over previous 12 months.
Maltese: 2) Ma rnexxewx f'mill-inqas therapija immunosoppressanti waħda u kienu jeħtieġu skambju kroniku tal-plażma jew IVIg biex jikkontrollaw is-sintomi, i.e., pazjenti li kienu jeħtieġu PE jew IVIg fuq bażi regolari għall-immaniġġjar ta' dgħufija fil-muskoli mill-inqas kull 3 xhur matul it-12-il xahar preċedenti.
English: *One patient achieved eGFR improvement after renal transplant A total of 22 paediatric and adolescents patients (aged 5 months to 17 years) received Soliris in aHUS Study C10-003.
Maltese: Total ta' 22 pazjent pedjatriku u adolexxenti (bejn 5 xhur sa 17-il sena) irċevew Soliris fl-Istudju aHUS C10-003.
English: For 900 mg doses, use 90 ml of Soliris and add 90 ml of diluent.
Maltese: Għal dożi ta' 900 mg uża 90 mL ta' Soliris u żid 90 mL ta' dilwent.
English: Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing.
Maltese: Tfal u adolexxenti b'PNH jew aHUS u li jiżnu 40 kg u iżjed jiġu kkurati bid-dożaġġ għall-adulti.
English: Table 14: Efficacy Outcomes in Paediatric PNH Study M07-005
Maltese: Riżultati tal-Effikaċja f'Pazjenti Pedjatriċi b'PNH fi Studju M07-005
English: Of the 125 patients enrolled in ECU-MG-301, 117 patients subsequently were enrolled in a long-term extension study (Study ECU-MG-302), in which all receive Soliris.
Maltese: Mill-125 pazjent li rreġistraw f'ECU-MG-301, 117-il pazjent sussegwentement ġew irreġistrati fi studju ta' estensjoni fit-tul (Studju ECU-MG-302), li fih il-pazjenti kollha rċivew Soliris.
English: What Soliris looks like and contents of the pack Soliris is presented as a concentrate for solution for infusion (30 ml in a vial - pack size of 1).
Maltese: Soliris huwa ppreżentat bħala konċentrat għal soluzzjoni għall-infużjoni (kunjett ta' 30 mL - pakkett ta' 1).
English: When treatment was continued for more than 26 weeks, two additional patients achieved and maintained Complete TMA response due to normalization of LDH (1 patient) and a decrease in serum creatinine (2 patients).
Maltese: Meta t-trattament kompla għal aktar minn 26 ġimgħa, żewġ pazjenti addizzjonali kisbu u żammew rispons sħiħ ta' TMA minħabba normalizzazzjoni ta' LDH (pazjent 1) u tnaqqis tal-kreatinina fis-serum (2 pazjenti).
English: The risks of stopping Soliris include an increase in the inflammation of your platelets, which may cause: - A significant fall in your platelets (thrombocytopenia), - A significant rise in destruction of your red blood cells, - Decreased urination (problems with your kidneys), - An increase in your serum creatinine level (problems with your kidneys), - Confusion or change in how alert you are, - Chest pain, or angina, - Shortness of breath, or - Thrombosis (blood clotting).
Maltese: - Tnaqqis sinifikanti fil-plejtlits (tromboċitopenija), - Żieda sinifikantifi fil-qerda taċ-ċelluli ħomor tad-demm, - Tnaqqis fl-awrina (problemi fil-kliewi), - Żieda fil-livell tas-kreatinina fis-serum (problemi fil-kliewi), - Konfużjoni jew tibdil f'kemm tkun żvelt, - Uġigħ fis-sider, jew anġina, - Qtugħ ta' nifs, jew - Trombożi (embolu tad-demm).
English: Patients in aHUS C10-003 received Soliris for a minimum of 26 weeks.
Maltese: Pazjenti f'aHUS C10-003 irċevew Soliris għal minimu ta' 26 ġimgħa.
English: Transfusion Avoidance during treatment (%)
Maltese: Evitar tat-Trasfużjonijiet matul il-kura (%)
English: Immunosuppressant and anticholinesterase therapies Patients in refractory gMG clinical trials continued treatment with immunosuppressant and anticholinesterase therapies while on Soliris treatment.
Maltese: Terapiji b'immunosoppressanti u anticholinesterase Il-pazjenti fil-provi kliniċi dwar gMG refrattorja komplew il-kura b'terapiji immunosoppressanti u anticholinesterase waqt li kienu fuq il-kura b'Soliris.
English: Complete TMA response, n (%)
Maltese: Rispons TMA Sħiħ, n (%)
English: Cough, Oropharyngeal pain
Maltese: Popolazzjoni pedjatrika
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in eculizumab completed clinical trials, including PNH, aHUS, refractory gMG and NMOSD studies.
Maltese: Tabella 1 turi r-reazzjonijiet avversi osservati minn rappurtaġġ spontanju u fi provi kliniċi kompluti ta' eculizumab, li jinkludu studji ta' PNH, aHUS, gMG refrattorja u NMOSD.
English: Haematologic normalization was defined as normalization of platelet counts and LDH levels sustained for ≥2 consecutive measurements for ≥4 weeks.
Maltese: Normalizzazzjoni ematoloġika ġiet definita bħala normalizzazzjoni tal-għadd tal-plejtlits u livelli ta' LDH sostnuta għal ≥2 miżuri konsekuttivi għal ≥4 ġimgħat.
English: Table 16: Efficacy Outcomes in Paediatric Patients in Study C09-001r according to duration of current severe clinical thrombotic microangiopathy (TMA) manifestation Duration of current severe clinical TMA manifestation
Maltese: Riżultati tal-Effikaċja f'Pazjenti Pedjatriċi fi Studju C09-001r skont it-tul ta' żmien ta' manifestazzjoni mikroanġjopatija trombotika (TMA) klinika severa kurrenti Tul ta' żmien ta' manifestazzjoni ta' TMA klinika severa kurrenti
English: 20g/L, n (%) (95% CI)
Maltese: TMA, n (%) (95% CI)
English: Haemoglobin decreased
Maltese: Fażi Inizjali
English: Hepatic impairment The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Maltese: Indeboliment epatiku Is-sigurtà u l-effikaċja ta' Soliris ma ġietx studjata f'pazjenti b'indeboliment epatiku.
English: No unexpected tissue cross-reactivity was observed.
Maltese: Ma ġiet osservata l-ebda reattività inkroċjata mhux mistennija mat-tessut.
English: NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Soliris 300 mg konċentrat għal soluzzjoni għall-infużjoni
English: • The need for children to be vaccinated against pneumococcus and Haemophilus influenzae before eculizumab treatment.
Maltese: • Il-ħtieġa li t-tfal jiġu mlaqqma kontra pneumococcus u Haemophilus influenzae qabel jew fi żmien li jibda jingħata t-trattament b'eculizumab.
English: Patients in aHUS study C08-003A/B received Soliris for a minimum of 26 weeks.
Maltese: Pazjenti fi Studju C08-003A/B dwar aHUS irċivew Soliris għal minimu ta' 26 ġimgħa.
English: eGFR improvement ≥15 mL/min/ 1.73•m2, n (%) Change in eGFR ( ≥15 mL/min/1.73•m2) at 26
Maltese: Titjib f'eGFR ta' ≥15 mL/min/1.73 m2, n (%) (95% CI)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 ml (10 mg/ml)
Maltese: 30 mL (10 mg/mL)
English: Soliris is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Maltese: Soliris huwa kompost minn żewġ katini tqal ta' l-aċidu amminiku 448 u żewġ katini ħfief ta' l-aċidu amminiku 214 u għandu piż molekulari ta' madwar 148kDa.
English: • The diluted solution of Soliris should be administered by intravenous infusion over 25 to 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 b'infużjoni fil-vini fuq medda ta' 25 sa 45 minuta f'adulti u f'1-4 sigħat f'pazjenti pedjatriċi permezz ta' gravity feed, pompa t-tip ta' siringa, jew pompa ta' l-infużjoni.
English: Hypertension
Maltese: Infezzjonijiet
English: 1) Failed treatment for at least one year with 2 or more immunosuppressant therapies (either in combination or as monotherapy), ie, patients continued to have impairment in activities of daily living despite immunosuppressant therapies
Maltese: 1) Kura li ma rnexxietx għal mill-inqas sena, b'2 terapiji immunosoppressanti jew aktar' (jew flimkien jew waħidhom), i.e., il-pazjenti baqa' jkollhom indeboliment fl-attivitajiet tal-għajxien ta' kuljum minkejja t-terapiji immunosoppressanti
English: Plasma exchange resulted in an approximately 50% decline in eculizumab concentrations following a 1 hour intervention and the elimination half-life of eculizumab was reduced to 1.3 hours.
Maltese: L-iskambju ta' plażma rriżulta fi tnaqqis ta' madwar 50% fil-konċentrazzjonijiet ta' eculizumab wara intervent ta' siegħa b'intervent u l-half-life tal-eliminazzjoni ta' eculizumab tnaqqas għal 1.3 sigħat.
English: Gingivitis
Maltese: Anzjani
English: The aHUS, refractory gMG and NMOSD dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase:
Maltese: Il-kors ta' dożaġġ ta' aHUS, gMG refrattorja u NMOSD għal pazjenti adulti (≥ 18-il sena) jikkonsisti minn fażi inizjali ta' 4 ġimgħat segwita minn fażi ta' manteniment:
English: For children and adolescents with PNH and aHUS aged less than 18 years:
Maltese: Għat-tfal u adolexxenti b'PNH u aHUS li jkollhom inqas minn 18-il sena:
English: BL1234 8 12 16 20 26BL Double Blind Induction
Maltese: fil-linja bażi għal 281 ± 123 x10
English: The efficacy of eculizumab treatment in paediatric PNH patients appears to be consistent with that observed in adult PNH patients enrolled in PNH pivotal Studies (C04-001 and C04-002) (Table 3 and
Maltese: L-effikaċja tal-kura b'eculizumab f'pazjenti pedjatriċi b'PNH tidher li hi konsistenti ma' dik osservata f'pazjenti adulti b'PNH irreġistrati fl-Istudji importanti ħafna dwar PNH (C04-001 u C04002) (Tabella 3 u 14).
English: In 40 patients with PNH, a 1-compartmental model was used to estimate pharmacokinetic parameters after multiple doses.
Maltese: F'40 pazjent b'PNH, intuża mudell ta' kompartiment wieħed biex jiġu kkalkulati l-parametri farmakokinetiċi wara diversi dożi.
English: Administration of Soliris may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis), though immune system disorders within 48 hours of Soliris administration did not differ from placebo treatment in PNH, aHUS, refractory gMG, NMOSD and other studies conducted with Soliris.
Maltese: L-għoti ta' Soliris jista' jirriżulta f'reazzjonijiet ta' l-infużjoni jew f'immunoġeniċità li jistgħu jikkawżaw reazzjonijiet allerġiċi jew ta' sensittività eċċessiva (li jinkludu anafilassi), għalkemm iddisturbi tas-sistema immunitarja sa 48 siegħa mill-għoti ta' Soliris ma varjawx mill-kura bi plaċebo fi studji PNH, aHUS, gMG refrattorja, NMOSD u studji oħrajn imwettqa b'Soliris.
English: Baseline platelet count (x 109/L), median ( min, max)
Maltese: Għadd ta' plejtlits fil-linja bażi ta' riferiment (× 9/L) medjan (min, max)
English: Maintenance Phase
Maltese: Fażi ta' Manteniment
English: All patients enrolled in both prospective studies had an ADAMTS-13 level above 5%.
Maltese: Il-pazjenti kollha rreġistrati fiż-żewġ studji prospettivi kellhom livell ADAMTS-13 ogħla minn 5%.
English: A total of 15 paediatric patients (aged 2 months to 12 years) received Soliris in aHUS Study C09-001r.
Maltese: Total ta' 15-il pazjent pedjatriku (li kellhom minn xahrejn sa 12-il sena) irċivew Soliris fi Studju C09001r dwar aHUS.
English: In the eculizumab NMOSD clinical development program, the dose of Soliris in adult patients with NMOSD was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg at Week 5 ± 2 days, then 1200 mg every 14 ± 2 days for the study duration.
Maltese: Fil-programm ta' żvilupp kliniku ta' eculizumab għal NMOSD, id-doża ta' Soliris f'pazjenti adulti b'NMOSD kienet ta' 900 mg kull 7 ± jumejn għal 4 ġimgħat, segwita minn 1,200 mg f'Ġimgħa 5± jumejn, imbagħad 1,200 mg kull 14 ± jumejn għat-tul tal-istudju.
English: Overall, the efficacy results for these paediatric patients appeared consistent with what was observed in patients enrolled in aHUS pivotal Studies C08-002 and C08-003 (Table 6).
Maltese: Globalment, ir-riżultati tal-effikaċja għal dawn il-pazjenti pedjatriċi dehru konsistenti ma' dak li kien osservat f'pazjenti rreġistrati fl-Istudji importanti ħafna dwar aHUS C08-002 u C08-003 (Tabella 6).
English: Patients in aHUS Study C10-004 received Soliris for a minimum of 26 weeks.
Maltese: Pazjenti fi Studju aHUS C10-004 irċevew Soliris għal minimu ta' 26 ġimgħa.
English: PE/PI Event-Free Status, n (%) New Dialysis Event-Free Status, n (%)
Maltese: Kwalunkwe appoġġ bil-ventilatur fil-passat minn meta saret id-dijanjosi, n (%)
English: Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
Maltese: Eculizumab jippreserva l-komponenti bikrija ta' l-attivazzjoni komplementari li huma essenzjali għall-opsonizzazzjoni talmikro-organiżmi u t-tneħħija tal-kumplessi immunitarji.
English: Soliris is produced in a murine myeloma (NS0 cell line) expression system and purified by affinity and ion exchange chromatography.
Maltese: Soliris huwa magħmul f'sistema ta' espressjoni ta' myeloma tal-ġrieden (razza ta' ċelluli NSO) u ppurifikat bi kromatografija ta' l-affinità u ta' skambju ta' l-ijoni.
English: Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Maltese: Ma twettqux studji dwar ir-riproduzzjoni fl-annimali b'eculizumab (ara sezzjoni 5.3).
English: Pre-treatment LDH levels (median, U/L) Free Haemoglobin at baseline (median, mg/dL)
Maltese: Emoglobina libera fil-linja bażi (medjan,mg/dL)
English: No substantial differences were seen in safety and efficacy related to age.
Maltese: Ma ġew osservati l-ebda differenzi sostanzjali fis-sigurtà u effikaċja relatati mal-età.
English: Adverse reactions reported in patients with disease other than PNH, aHUS, refractory gMG or NMOSD were similar to those reported in patients with PNH, aHUS, refractory gMG or NMOSD (see Table 1 above).
Maltese: Reazzjonijiet avversi għall-mediċina rapportati f'pazjenti b'mard li mhux PNH, aHUS, gMG refrattorja jew NMOSD kienu simili għal dawk rapportati b'PNH, aHUS, gMG refrattorja jew NMOSD (ara Tabella 1 fuq).
English: ≥15 mL/min/1.73 m2,
Maltese: Titjib f'eGFR ta' ≥15 mL/min/1.732
English: Baseline MG-ADL Score Mean (SD) Median Baseline QMG Score Mean (SD) Median ≥3 Prior Immunosuppressive Therapies*
Maltese: Minħabba l-mekkaniżmu ta' kif jaġixxi, Soliris ikabbar is-suxxettibilità tal-pazjent għal infezzjoni meningokokkali (Neisseria meningitidis).
English: In this model, the clearance of Soliris for a typical aHUS patient weighing 70 kg was 0.0139 L/hr and the volume of distribution was 5.6 L. The elimination half-life was 297 h (approximately 12.4 days).
Maltese: F'dan mudell, it-tneħħija ta' Soliris għal pazjent tipiku b'aHUS li jiżen 70 kg kienet ta' 0.0139 L/siegħa u l-volum tad-distribuzzjoni kien ta' 5.6 L.
English: Number of PE/PI sessions for current clinical TMA manifestation, median (min, max)
Maltese: Żmien mill-manifestazzjoni klinika ta' TMA attwali sal-ewwel doża tal-istudju (xhur) medjan (min, max)
English: Table 15: Efficacy Results in Paediatric Patients Enrolled in aHUS C09-001r
Maltese: Riżultati tal-Effikaċja f'Pazjenti Pedjatriċi fi Studju C09-001r dwar aHUS
English: In all studies, the dose of eculizumab was 600 mg every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
Maltese: Fl-istudji kollha, id-doża ta' eculizumab kienet 600 mg kull 7 ± 2 ġranet għal 4 ġimgħat, segwiti minn 900 mg 7 ± 2 ġranet wara, imbagħad 900 mg kull 14± 2 ġranet għat-tul ta' l-istudju.
English: Soliris therapy must not be initiated in patients (see section 4.4): - with unresolved Neisseria meningitidis infection - who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Maltese: It-terapija b'Soliris m'għandhiex tinbeda f'pazjenti (ara sezzjoni 4.4): - b'infezzjoni ta' Neisseria meningitidis mhux riżolta - li ma jkunux imlaqqma kontra Neisseria meningitidis ħlief jekk jirċievu kura profilattika b'antibijotiċi adattati sa ġimagħtejn wara t-tilqima.
English: aHUS Laboratory Monitoring aHUS patients receiving Soliris therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Maltese: Pazjenti b'aHUS li jkunu qed jirċievu terapija b'Soliris għandhom jiġu mmonitorjati għal mikroanġjopatija permezz tal-għadd tal-plejtlits, LDH fis-serum u krejatinina fis-serum, u jista' jkollhom bżonn ta' aġġustament fid-doża fi żmien l-iskeda tad-dożaġġ rakkomandata ta' 14±jumejn matul il-fażi ta' manteniment (għal sa kull 12-il jum).
English: Gender - Female (%) History of Aplastic Anaemia or MDS (%) Concomitant Anticoagulants (%) Concomitant Steroids/Immunosuppressant Treatments (%)
Maltese: Storja ta' Anemija Aplastika jew MDS (%) Antikoagulanti mogħtija mal-Prodott (%) Sterojdi/Trattamenti immunosuppressanti mogħtija mal-Prodott (%) Trattament imwaqqaf PRBC fit-12-il xahar preċedenti (medjan (Q1,Q3))
English: Table 9 presents the baseline characteristics of the refractory gMG patients enrolled in Study ECU-MG
Maltese: Tabella 9 tippreżenta l-karatteristiċi fil-linja bażi tal-pazjenti b'gMG refrattorja li kienu rreġistrati fi Studju ECU-MG-301.
English: One vial of 30 ml contains 300 mg of eculizumab (10mg/ml) Eculizumab is a humanised monoclonal IgG2/4 k antibody produced in NS0 cell line by recombinant DNA technology.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' 30 mL fih 300 mg ta' eculizumab (10 mg/mL) Eculizumab huwa antikorp monoklonali
English: Soliris treatment is recommended to continue for the patient's lifetime, unless the discontinuation of Soliris is clinically indicated (see section 4.4).
Maltese: Il-kura b'Soliris hi rakkomandata li tkompli matul il-ħajja tal-pazjent, ħlief jekk it-twaqqif ta' Soliris ikun klinikament indikat (ara sezzjoni 4.4).
English: Meningococcal and other Neisseria infections alert Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhea.
Maltese: Twissija ta' infezzjonijiet meningokokkali u infezzjonijiet oħra ta' Neisseria Il-kura b'Soliris tista' tnaqqas ir-reżistenza naturali tiegħek kontra l-infezzjonijiet, speċjalment kontra ċerti organiżmi li jikkawżaw infezzjoni meningokokkali (infezzjoni severa tal-kisja tal-moħħ u sepsis) u infezzjonijiet oħra ta' Neisseria inkluż gonorrea mifruxa.
English: Drug distribution will only be possible after written confirmation that the patient received or will receive meningococcal vaccination and/or antibiotic prophylaxis.
Maltese: Id-distribuzzjoni tal-mediċina se tkun possibbli biss wara konferma bil-miktub li l-pazjent irċieva jew ser jirċievi tilqima meningokokkali u/jew profilassi antibijotika.
English: • Transfer the recommended dose to an infusion bag.
Maltese: • Ittrasferixxi d-doża rakkomandata għal borża ta' l-infużjoni.
English: Dedicated studies have not been conducted to evaluate the pharmacokinetics of Soliris in special patient populations identified by gender, race, age (geriatric), or the presence of renal or hepatic impairment.
Maltese: Ma twettqux studji dedikati biex tiġi evalwata l-farmakokinetika ta' Soliris f'popolazzjonijiet speċjali ta' pazjenti identifikati skont il-ġeneru sesswali, razza, età (xjuħ), jew il-preżenza ta' indeboliment renali jew tal-fwied.
English: Data on a limited number of pregnancies exposed to eculizumab (less than 300 pregnancy outcomes) indicate there is no increased risk of foetal malformation or foetal-neonatal toxicity.
Maltese: Dejta dwar numru limitat ta' tqaliet esposti għal eculizumab (inqas minn 300 riżultat ta' tqala) tindika li ma hemm l-ebda żieda firriskju ta' malformazzjoni fetali jew tossiċità fetali jew fit-trabi tat-twelid.