FrancophonIA/ELRC3.0 huggingface dataset:
English: In the subcutaneous clinical study, which excluded patients with a history of psychiatric disorders, serious psychiatric events were reported in 0.2% (1/556) of patients receiving Benlysta and in no patients receiving placebo.
Maltese: Fl-istudju kliniku taħt il-ġilda, li eskluda pazjenti bi storja ta' disturbi psikjatriċi, ġew irrappurtati avvenimenti psikjatriċi serji f'0.2% (1/556) tal-pazjenti li rċivew Benlysta u fl-ebda pazjent li rċieva plaċebo.
English: Serious depression was reported in 0.6% (4/674) of patients receiving Benlysta 10 mg/kg and 0.3% (2/675) of patients receiving placebo.
Maltese: Depressjoni serja ġiet irrappurtata f'0.6 % (4/674) tal-pazjenti li rċivew Benlysta 10 mg/kg u 0.3 % (2/675) tal-pazjenti li rċivew plaċebo.
English: In intravenous clinical studies, serious infusion and hypersensitivity reactions included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Maltese: Fi studji kliniċi ġol-vini, reazzjonijiet serji għall-infużjoni u ta' sensittività eċċessiva inkludew reazzjoni anafilattika, bradikardija, pressjoni baxxa, anġjoedima, u dispnea.
English: SRI response rate at week-76 (%) Observed treatment difference vs placebo (%)
Maltese: Rata ta' rispons SRI fil-Ġimgħa 76 (%) Differenza osservata bil-kura vs plaċebo (%)
English: Injecting Benlysta
Maltese: Injetta Benlysta
English: The efficacy of Benlysta administered subcutaneously was evaluated in a randomised, double-blind, placebo-controlled 52-week Phase III study (HGS1006-C1115; BEL112341) in 836 adult patients with a clinical diagnosis of SLE according to the American College of Rheumatology classification criteria.
Maltese: II (HGS1006-C1115; BEL112341) fi 836 pazjent adult b'dijanjożi klinika ta' SLE skont il-kriterji ta' klassifikazzjoni tal-Kulleġġ Amerikan tar-Rewmatoloġija.
English: (Figure 3)
Maltese: (Figura 3)
English: Contents of the pack and other information What Benlysta contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Benlysta
English: The reduction in systemic clearance estimated by population PK modelling for patients at the midpoints of the renal impairment categories relative to patients with median creatinine clearance in the PK population (79.9 ml/min) were 1.4% for mild (75 ml/min), 11.7% for moderate (45 ml/min) and 24.0% for severe (22.5 ml/min) renal impairment.
Maltese: It tnaqqis fit-tneħħija sistemika stmata b'immudellar PK tal-popolazzjoni għal pazjenti f'punti medji talkategoriji ta' indeboliment tal-kliewi mqabblin ma' pazjenti bi tneħħija medjana tal-krejatinina fil popolazzjoni PK (79.9 ml/min) kienu 1.4% għal indeboliment ħafif (75 ml/min), 11.7% għal indeboliment moderat (45 ml/min) u 24.0% għal indeboliment qawwi (22.5 ml/min) tal-kliewi.
English: The adverse reaction profile in paediatric patients is based on 52-week safety data from a placebo-controlled study in which 53 patients (6 to 17 years of age) with SLE received Benlysta (10 mg/kg intravenously on Days 0, 14, 28, and then every 28 days, on a background of concomitant treatments).
Maltese: Il-profil tar-reazzjonijiet avversi f'pazjenti pedjatriċi huwa bbażat fuq data tas-sigurtà ta' 52 ġimgħa minn studju kkontrollat bi plaċebo li fih 53 pazjent (età ta' 6 sa 17-il sena) b'SLE rċivew Benlysta (10 mg/kg intravenuż f'Jiem 0, 14, 28 imbagħad kull 28 jum, fuq sfond ta' trattamenti konkomitanti).
English: The subcutaneous pharmacokinetic parameters below are based on population parameter estimates from 661 subjects, comprised of 554 SLE patients and 107 healthy subjects, who received Benlysta subcutaneously.
Maltese: Il-parametri farmakokinetiċi taħt il-ġilda ta' hawn taħt huma bbażati fuq l-istimi tal-parametri tal popolazzjoni għal 661 pazjent, kompromessi minn 554 pazjent b'SLE u 107 individwu b'saħħithom, li rċivew Benlysta taħt il-ġilda.
English: In patients with low complement levels, normalization of C3 and C4 was observed by Week 52 in 38% and 44% of patients receiving Benlysta and in 17% and 18% of patients receiving placebo, respectively.
Maltese: F'pazjenti b'livelli baxxi ta' komplement, normalizzazzjoni ta' C3 u C4 kienet osservata mal-Ġimgħa 52 fi 38% u 44% tal-pazjenti li kienu qed jingħataw Benlysta u fi 17% u 18% tal-pazjenti li kienu qed jingħataw plaċebo, rispettivament.
English: The mean change of score at Week 52 from baseline is significantly greater with Benlysta compared to placebo (4.70 vs 2.46, p=0.0006).
Maltese: Il-bidla medja tal-punteġġ fil-Ġimgħa 52 mill-linja bażi hija ogħla b'mod sinifikanti b'Benlysta meta mqabbla mal-plaċebo (4.70 vs 2.46, p=0.0006).
English: Body weight/Body Mass Index (BMI)
Maltese: Piż tal-ġisem/Indiċi tal-massa tal-ġisem (BMI)
English: In a pooled analysis of the two studies, the percentage of patients receiving >7.5 mg/day prednisone (or equivalent) at baseline, whose average corticosteroid dose was reduced by at least 25% to a dose equivalent to prednisone ≤7.5 mg/day during Weeks 40 through 52, was 17.9% in the group receiving Benlysta and 12.3% in the group receiving placebo (p=0.0451).
Maltese: 25% għal-doża ekwivalenti għal prednisone ≤7.5 mg/jum waqt il-Ġimgħat 40 sa 52, kien 17.9% fil-grupp li kien qed jirċievi Benlysta u 12.3% fil-grupp li kien qed jirċievi plaċebo (p=0.0451).
English: SC
Maltese: PC:
English: Following intravenous administration of 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter, belimumab exposures were similar between paediatric and adult SLE subjects.
Maltese: Wara għoti intravenuż ta' 10 mg/kg f'Jiem 0, 14 u 28, u f'intervalli ta' 4 ġimgħat wara dan, l-esponiment ta' belimumab kien simili bejn l-individwi
English: • The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sucrose and polysorbate 80.
Maltese: - Is-sustanzi l-oħra huma citric acid monohydrate (E330), sodium citrate (E331), sucrose u polysorbate 80.
English: During clinical development Benlysta was studied in patients with SLE and renal impairment (261 subjects with moderate renal impairment, creatinine clearance ≥30 and <60 ml/min; 14 subjects with severe renal impairment, creatinine clearance ≥15 and <30 ml/min).
Maltese: Waqt l-iżvilupp kliniku Benlysta ġie studjat f'pazjenti b'SLE u indeboliment tal-kliewi (261 individwu b'indeboliment moderat tal-kliewi, tneħħija tal-krejatinina ≥30 u <60 ml/min; 14-il individwu b'indeboliment qawwi tal-kliewi, tneħħija tal-kreatinina ≥15 u <30 ml/min).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Also contains: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections.
Maltese: Fih ukoll: Arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, ilma għall-injezzjonijiet.
English: The safety and efficacy of Benlysta was evaluated in a randomised, double-blind, placebo-controlled, 52-week study (PLUTO) in 93 paediatric patients with a clinical diagnosis of SLE according to the ACR classification criteria.
Maltese: Is-sigurtà u l-effikaċja ta' Benlysta ġiet evalwata fi studju ta' 52 ġimgħa randomizzat, double-blind, ikkontrollat bi plaċebo (PLUTO) fi 93 pazjent pedjatriku b'dijanjożi klinika ta' SLE skont il-kriterji ta' klassifikazzjoni tal-ACR.
English: Background medicinal products included corticosteroids (96%; >7.5 mg/day 69%), immunosuppressives (42%), and anti-malarials
Maltese: Prodotti mediċinali fl-isfond kienu jinkludu kortikosterojdi (96%; >7.5 mg/jum 69%), immunosoppressivi (42%), u mediċini kontra l-malarja (67%).
English: Concomitant use with B cell targeted therapy or cyclophosphamide
Maltese: B jew ma' cyclophosphamide.
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and
Maltese: • l-ebda punteġġ A ġdid tal-Grupp ta' Stima tal-Lupus tal-Gżejjer Brittaniċi (BILAG) tad-dominju tal organu jew 2 punteġġi B ġodda BILAG tad-dominju tal-organu, u
English: Each vial contains 400 mg belimumab (80 mg/ml after reconstitution)
Maltese: Kull kunjett fih 400 mg belimumab (80 mg/ml wara r-rikostituzzjoni)
English: Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper respiratory tract infection
Maltese: Gastroenterite ikkawżata minn virus, farinġite, nasofarinġite, infezzjoni virali fl-apparat respiratorju tan-naħa ta' fuq
English: The mechanism of action of belimumab could increase the risk for the development of infections, including opportunistic infections.
Maltese: Il-mod ta' kif jaħdem belimumab jista' jżid ir-riskju għall-iżvilupp ta' infezzjonijiet, inkluż infezzjonijiet opportunistiċi.
English: This was consistent with the findings from the adult intravenous clinical trials.
Maltese: Dan kien konsistenti mas-sejbiet mill-provi kliniċi intravenużi fl-adulti.
English: SRI response rate at week 52 (%) Observed treatment difference vs placebo (%)
Maltese: Rata ta' rispons SRI fil-ġimgħa 52 (%) Differenza osservata bil-kura vs plaċebo (%)
English: Flares in SLE were defined by the modified SELENA SLEDAI SLE Flare Index.
Maltese: Żbroff ta' SLE kien iddefinit mill-Indiċi SELENA SLEDAI modifikati għal żbroff ta' SLE.
English: Psychiatric disorders: In the pre-registration intravenous clinical studies, serious psychiatric events were reported in 1.2% (8/674) of patients receiving Benlysta 10 mg/kg and 0.4% (3/675) of patients receiving placebo.
Maltese: Fl-istudji kliniċi ta' qabel ir-reġistrazzjoni ġol-vini, ġew irrappurtati avvvenimenti psikjatriċi serji f'1.2 % (8/674) tal-pazjenti li rċivew Benlysta 10 mg/kg u 0.4 % (3/675) tal-pazjenti li rċivew plaċebo.
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt skont il-klassi tas-sistemi u tal-organi MedDRA u l frekwenza.
English: At baseline 62.2% of patients had high disease activity (SELENA SLEDAI score ≥10), 88% of patients had mucocutaneous, 78% had musculoskeletal, 8% had haematological, 12% had renal, and 8% had vascular organ involvement.
Maltese: tal-pazjenti kellhom involviment tal-organu mukokutanju, 78% kellhom involviment tal-organu muskoluskelettriku, 8% kellhom involviment tal-organu ematoloġiku, 12% kellhom involviment tal-organu renali u, 8% kellhom involviment tal-organu vaskulari.
English: Using the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) Juvenile SLE Response Evaluation Criteria, a higher proportion of paediatric patients receiving Benlysta demonstrated improvement compared with placebo (Table 4).
Maltese: Permezz tal-Kriterji ta' Evalwazzjoni tar-Rispons SLE Ġovanili tal-Organizzazzjoni tal-Provi Internazzjonali tar-Rewmatoloġija Pedjatrika/Kulleġġ Amerikan tar-Rewmatoloġija (PRINTO/ACR), proporzjon ogħla ta' pazjenti pedjatriċi li rċivew Benlysta wera titjib fil-pazjenti meta mqabbel mal-plaċebo (Tabella 4).
English: Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.2 and 4.8).
Maltese: Ġiet osservata wkoll rikorrenza ta' reazzjonijiet klinikament sinifikanti wara kura inizjali xierqa tas-sintomi (ara sezzjonijiet 4.2 u 4.8).
English: After about 7 years, a 28% median reduction in IgG levels was observed, with 1.6% of subjects experiencing a decrease in IgG levels to below 400 mg/dl. Over the course of the study, the reported incidence of AEs generally remained stable or declined.
Maltese: Wara madwar 7 snin, kien osservat tnaqqis medjan ta' 28% fil-livelli tal-IgG, b'1.6% tal-individwi li kellhom tnaqqis fil-livelli ta' IgG għal inqas minn 400 mg/dL.
English: Adverse reactions were reported in 87% of Benlysta-treated patients and 90% of placebo-treated patients.
Maltese: Reazzjonijiet avversi kienu rrappurtati fi 87% tal-pazjenti kkurati b'Benlysta u fi 90% tal-pazjenti kkurati bi plaċebo.
English: 12- to 17-year-old group: infections were reported in 22/43 patients receiving Benlysta and 25/37 patients receiving placebo, and serious infections were reported in 3/43 patients receiving Benlysta and 3/37 patients receiving placebo.
Maltese: Grupp ta' 12 sa 17-il sena: ġew irrappurtati infezzjonijiet fi 22/43 pazjent li rċivew Benlysta u 25/37 pazjent li rċivew il-plaċebo, u infezzjonijiet serji ġew irrappurtati fi 3/43 pazjent li rċivew Benlysta u 3/37 pazjent li rċivew il-plaċebo.
English: Effects on male and female fertility in monkeys were assessed in the 6-month repeat dose toxicology studies of belimumab at doses up to and including 50 mg/kg.
Maltese: Effetti fuq il-fertilità fix-xadini rġiel u nisa kienu stmati fi studji tossikoloġiċi minn dożi ripetuti ta' 6 xhur b'dożi ta' belimumab sa u inkluż 50 mg/kg.
English: Each vial contains 120 mg belimumab (80 mg/ml after reconstitution)
Maltese: Kull kunjett fih 120 mg belimumab (80 mg/ml wara r-rikostituzzjoni)
English: Preparation of 400 mg solution for infusion
Maltese: Preparazzjoni tas-soluzzjoni ta' 400 mg għall-infużjoni
English: * Among patients with baseline prednisone dose >7.5 mg/day
Maltese: * Fost pazjenti b'doża ta' >7.5 mg/jum ta' prednisone fil-linja bażi
English: In patients with anti-dsDNA antibodies at baseline, by Week 52, 18% of patients treated with Benlysta had converted to anti-dsDNA negative compared with 15% of the patients receiving placebo.
Maltese: F'pazjenti b'antikorpi anti-dsDNA fil-linja bażi, sa Ġimgħa 52, 18 % tal-pazjenti kkurati b'Benlysta kienu qalbu gal anti-dsDNA negattiv meta mqabbel ma' 15 % tal-pazjenti li kienu qed jingħataw il-plaċebo.
English: Changes in B cells (including naïve, memory and activated B cells, and plasma cells) and IgG levels occurring in patients during ongoing treatment with intravenous belimumab were followed in a long-term uncontrolled extension study.
Maltese: Tibdil fiċ-ċelluli B (inkluż ċelluli B inġenwi, tal-memorja, attivati u ċelluli tal-plażma) u l-livelli tal-IgG jseħħu f'pazjenti waqt trattament kontinwu ta' belimumab minn ġol-vina kienu segwiti fi studju ta 'estensjoni mhux ikkontrollat fit-tul.
English: • bacterial infections (see ‘Infections' above)
Maltese: • infezzjonijiet ikkawżati minn batterja (ara “Infezzjonijiet” hawn fuq)
English: Preparation of 120 mg solution for infusion
Maltese: Preparazzjoni tas-soluzzjoni ta' 120 mg għall-infużjoni Rikostituzzjoni
English: At baseline 52% of patients had high disease activity (SELENA SLEDAI score ≥10), 59% of patients had mucocutaneous, 60% had musculoskeletal, 16% had haematological, 11% had renal and 9% had vascular organ domain involvement (BILAG A or B at baseline).
Maltese: Fil-linja bażi 52% tal-pazjenti kellhom attività għolja tal-marda (punteġġ SELENA SLEDAI ≥10), mill pazjenti li kellhom involviment ta' dominju ta' organu (BILAG A jew B fil-linja bażi) 59% kellhom involviment mukokutanju, 60% kellhom involviment muskoluskelettriku, 16% kellhom involviment ematoloġiku, 11% kellhom involviment renali u 9% kellhom involviment vaskulari.
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Benlysta.
Maltese: Depressjoni u suwiċidju Kien hemm rapporti ta' depressjoni, ħsibijiet suwiċidali, u tentattivi ta' suwiċidju waqt il-kura b'Benlysta.
English: Efficacy was evaluated in 448 patients.
Maltese: L-effikaċja ġiet evalwata f'448 pazjent.
English: Each 20 ml vial contains 400 mg belimumab.
Maltese: Kull kunjett ta' 20 ml fih 400 mg ta' belimumab.
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline
Maltese: Tabella 2: Pazjenti b'komplement baxx u pożittivi għal anti-dsDNA fil-linja bażi
English: After 7 and a half years of treatment (including the 72-week parent study), a substantial and sustained decrease in various B cell subsets was observed leading to 87% median reduction in naïve B cells, 67% in memory B cells, 99% in activated B cells, and 92% median reduction in plasma cells after more than 7 years of treatment.
Maltese: Wara 7 snin u nofs b'kura (inkluż studju ewlieni ta' 72 ġimgħa) kien osservat tnaqqis sostanzjali u miżmum f'diversi sottosettijiet taċ-ċelluli B li wassal għal tnaqqis medjan ta' bejn 87% fiċ-ċelluli B inġenwi, 67% f'ċelluli B tal-memorja, 99% fiċ-ċelluli B attivati u tnaqqis medjan sa 92% fiċ ċelluli tal-plażma wara aktar minn 7 snin ta' kura.
English: The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation.
Maltese: Il-formazzjoni ta' xi enzimi CYP450 hija mrażżna b'livelli miżjuda ta' ċerti ċitokini matul infjammazzjoni kronika.
English: 5- to 11-year-old group: infections were reported in 8/10 patients receiving Benlysta and 3/3 patients receiving placebo, and serious infections were reported in 1/10 patients receiving Benlysta and 2/3 patients receiving placebo (see section 4.4).
Maltese: Grupp ta' 5 sa 11-il sena: ġew irrappurtati infezzjonijiet fi 8/10 pazjenti li rċivew Benlysta u 3/3 pazjenti li rċivew il-plaċebo, u infezzjonijiet serji ġew irrappurtati f'1/10 pazjenti li rċivew Benlysta u 2/3 pazjenti li rċivew il-paċebo (ara sezzjoni 4.4).
English: What Benlysta is and what it is used for Benlysta as a subcutaneous injection is a medicine used to treat lupus (systemic lupus erythematosus, SLE)
Maltese: Benlysta bħala infużjoni hija mediċina li tintuża biex tikkura l-lupus (lupus erythematosus sistemiku,
English: In a randomised, double-blind, placebo-controlled, post-marketing study with Benlysta 10 mg/kg administered intravenously, serious psychiatric events were reported in 1.0% (20/2002) of patients receiving Benlysta and 0.3% (6/2001) of patients receiving placebo.
Maltese: Fi studju randomizzat, double-blind, ikkontrollat bi plaċebo, ta' wara t-tqegħid fis-suq b'Benlysta 10 mg/kg mogħti ġol-vini, ġew irrappurtati avvenimenti psikjatriċi serji f'1.0% (20/2002) tal-pazjenti li rċivew
English: Intravenous infusion in adults
Maltese: Infużjoni ġol-vini fl-adulti
English: The currently available data are described in the Summary of Product Characteristics of Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion.
Maltese: Id-data disponibbli bħalissa hija deskritta fis-Sommarju tal-Karatteristiċi tal-Prodott ta' Benlysta 120 mg u 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: benlysta syringe
Maltese: pinna benlysta
English: The majority (94.6%) of patients were female.
Maltese: Il-maġġoranza (94.6%) tal-pazjenti kienu nisa.
English: EXP
Maltese: Korp
English: Subcutaneous injection
Maltese: Disturbi gastro-intestinali
English: Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
Maltese: Benlysta huwa indikat bħala terapija miżjuda ma' oħrajn f'pazjenti adulti li għandhom lupus erythematosus sisitemiku (SLE, systemic lupus erythematosus) attiv u pożittiv għal awtoantikorpi bi grad għoli ta' attività tal-marda (eż. pożittiv għal anti-dsDNA u b'kompliment baxx) minkejja terapija standard (ara sezzjoni 5.1).
English: Of the anti-phospholipid antibodies, only anti-cardiolipin antibody was measured.
Maltese: Mill-antikorpi anti-fosfolipidi kollha, tkejjel biss l-antikorp anti-kardjolipin.
English: Each 5 ml vial contains 120 mg belimumab.
Maltese: Kull kunjett ta' 5 ml fih 120 mg ta' belimumab.
English: Patient median age was 15 years (range 6 to 17 years).
Maltese: L-età medjana tal-pazjenti kienet 15-il sena (medda 6 sa 17il sena).
English: Infections leading to discontinuation of treatment occurred in 0.7% of patients receiving Benlysta and 1.5% of patients receiving placebo.
Maltese: Infezzjonijiet li wasslu għat-twaqqif tal-kura seħħew f'0.7% tal-pazjenti li kienu qed jingħataw Benlysta u f'1.5 % tal-pazjenti li kienu qed jingħataw lplaċebo.
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 18 February 2016
Maltese: Data tal-aħħar tiġdid: 18 ta' Frar 2016
English: Following subcutaneous administration, belimumab had a terminal half-life of 18.3 days.
Maltese: Wara għoti taħt il-ġilda, belimumab kellu half-life ta' 18.3 jiem.
English: Solution of Benlysta diluted in sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection may be stored at 2°C to 8°C or room temperature (15°C to 25°C).
Maltese: Is-soluzzjoni ta' Benlysta ddilwita f'soluzzjoni ta' sodium chloride 9 mg/ml (0.9%), ta' sodium chloride 4.5 mg/ml (0.45 %), jew ta' Lactated Ringer għall-injezzjoni tista' tinħażen f'temperatura ta' 2°C sa 8°C jew f'temperatura tal-kamra (15°C sa 25°C).
English: • diarrhoea, vomiting
Maltese: • dijarea, rimettar
English: Infusion or injection-related systemic reactions*, pyrexia
Maltese: Reazzjonijiet sistemiċi marbuta malinfużjoni jew mal-injezzjoni*, deni
English: The overall incidence of serious suicidal ideation or behaviour or self-injury without suicidal intent was 0.7% (15/2002) in patients receiving Benlysta and 0.2% (5/2001) in the placebo group.
Maltese: L-inċidenza globali ta' ideat jew imġiba serja ta' suwiċidju jew korriment personali mingħajr intenzjoni ta' suwiċidju kienet 0.7% (15/2002) fil-pazjenti li rċivew Benlysta u 0.2% (5/2001) fil-grupp tal-plaċebo.
English: The MAH shall provide the 1 year data report on a randomized, double-blind placebo-controlled large safety study, based on a protocol agreed with CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jipprovdi r-rapport minn dejta ta' sena dwar studju kbir ta' sigurtà, randomised double-blind u kkontrollat bi plaċebo, ibbażat fuq protokoll miftiehem mas-CHMP.
English: No new safety signals were observed in the paediatric population 12 years of age and above (n=43).
Maltese: Ma ġie osservat l ebda sinjal ġdid tas-sigurtà fil-popolazzjoni pedjatrika ta' età ta' 12-il sena u akbar (n=43).
English: BLISS-76 and BLISS-52 pooled data
Maltese: Ġabra ta' dejta minn BLISS-76 u BLISS-52
English: Each vial contains 120 mg of belimumab.
Maltese: Kull kunjett fih 120 mg ta' belimumab.
English: In adult patients with hypergammaglobulinemia, normalization of IgG levels was observed by Week 52 in 49% and 20% of patients receiving Benlysta and placebo, respectively.
Maltese: F'pazjenti adulti b'ipergammaglobulinimja, normalizzazzjoni tal-livelli tal-IgG kienet osservata mal-Ġimgħa 52 f'49% u 20%
English: The reconstituted medicinal product is diluted to 250 ml with sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection.
Maltese: Il-prodott mediċinali rrikostitwit huwa ddilwit sa 250 ml b'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%), ta' sodium chloride 4.5 mg/ml (0.45 %), jew ta' Lactated Ringer.
English: The maximum serum concentration (Cmax) of belimumab at steady state was 108 µg/ml.
Maltese: belimumab fi stat fiss kienet ta' 108 µg/ml.
English: Benlysta 400 mg powder for concentrate for solution for infusion Type 1 glass vials (20 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 400 mg of powder.
Maltese: Kunjetti tal-ħġieġ tat-tip 1 (20 ml), issiġillati b'tapp tal-gomma chlorobutyl silikonizzat u siġill tal aluminjum li jinqala' b'daqqa ta' saba' li fihom 400 mg ta' trab.
English: Gather and check supplies Gather supplies
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Complete the injection
Maltese: Infezzjonijiet u infestazzjonijiet
English: Serious infections occurred in 5% of patients in both groups receiving Benlysta or placebo; serious opportunistic infections accounted for 0.4% and 0% of these, respectively.
Maltese: Infezzjonijiet serji seħħew f'5% tal-pazjenti fiż-żewġ gruppi li kienu qed jingħataw Benlysta jew plaċebo; infezzjonijiet opportunistiċi serji ammontaw għal 0.4 % u 0 % minn dawn, rispettivament.