FrancophonIA/ELRC3.0 huggingface dataset:
English: Two doses up to 20 mg/kg administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.
Maltese: Żewġ dożi sa 20 mg/kg mogħija 21 jum bogħod minn xulxin permezz ta' infużjoni fil-vina ngħataw lil bnedmin mingħajr l-ebda żieda fl-inċidenza jew fil-qawwa ta' reazzjonijiet avversi meta mqabbla ma' dożi ta' 1, 4, jew 10 mg/kg.
English: In clinical studies, serious infusion and hypersensitivity reactions affected approximately 0.9% of adult patients, and included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Maltese: Fi studji kliniċi, reazzjonijiet serji għall-infużjoni u ta' sensittività eċċessiva affettwaw madwar 0.9% tal pazjenti adulti, u kienu jinkludu, reazzjoni anafilattika, bradikardija, pressjoni baxxa, anġjoedima, u qtugħ ta'
English: Observed treatment difference vs. placebo (median difference)
Maltese: Differenza osservata bil-kura vs plaċebo (differenza medja)
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON -- PRE-FILLED PEN- Multipack containing 12 pre-filled pens (3 packs of 4 pre-filled pens)with out blue box
Maltese: KARTUNA TA' BARRA - Pakkett multiplu li fih 12-il pinna mimlija għal-lest (3 pakketti ta' 4 pinen mimlija għal-lest)- bil-kaxxa blu
English: There is an association between plasma BLyS levels and SLE disease activity.
Maltese: Hemm assoċjazzjoni bejn il-livelli ta' BLyS fil-plasma u l-attività tal-marda ta' SLE.
English: Each vial contains 400 mg of belimumab.
Maltese: Kull kunjett fih 400 mg ta' belimumab.
English: These adverse events of special interest include serious infections (including opportunistic infections and PML), selected serious psychiatric events, and malignancies (including non-melanoma skin cancer).
Maltese: Dawn il-każijiet avversi ta' interess speċjali jinkludu infezzjonijiet serji (li jinkludu infezzjonijiet opportunistiċi u PML), każijiet psikjatriċi serji magħżula, u mard malinn (li jinkludi kanċer tal-ġilda li mhux melanoma).
English: Solutions 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: Soluzzjonijiet ddilwiti 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 jistgħu jinħażnu f'temperatura ta' 2°C sa 8°C jew f'temperatura tal-kamra (15°C sa 25°C).
English: The data presented in the table below reflect exposure to Benlysta administered (10 mg/kg intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days for up to 52 weeks) in 674 patients with SLE, including 472 exposed for at least 52 weeks, and 556 patients exposed to 200 mg Benlysta subcutaneously once weekly for up to 52 weeks.
Maltese: Id-dejta ppreżentata fit-tabella ta' hawn taħt tirrifletti l-esponiment għal Benlysta mogħti ġol-vini (10 mg/kg ġol-vini fuq perjodu ta' siegħa f'Jiem 0, 14, 28, imbagħad kull 28 jum sa 52 ġimgħa) f'674 pazjent b'SLE, inkluż 472 esposti għal mill-anqas 52 ġimgħa, u 556 pazjent esposti għal 200 mg Benlysta taħt il-ġilda darba fil-ġimgħa sa 52 ġimgħa.
English: Injection site reactions: In the subcutaneous trial, the frequency of injection site reactions was 6.1% (34/556) and 2.5% (7/280) for patients receiving Benlysta and placebo, respectively.
Maltese: Fil-prova taħt il-ġilda, il-frekwenza ta' reazzjonijiet fis-sit tal-injezzjoni kienet ta' 6.1 % (34/556) u ta' 2.5 % (7/280) għall-pazjenti li kienu qed jirċievu Benlysta u l-plaċebo,
English: • container with a tight-fitting lid for pen disposal (not included in the pack).
Maltese: • kontenitur b'għatu li jingħalaq sew għar-rimi tal-pinna (mhux inkluż fil-pakkett).
English: See ‘Important information about the contents of Benlysta' in section 2 for further information.
Maltese: Ara tagħrif importanti dwar il-kontenut ta' Benlysta f'taqsima 2 għal aktar informazzjoni.
English: The primary efficacy endpoint was the SLE Responder Index (SRI) at Week 52 as described in the adult intravenous trials.
Maltese: Il-punt tat-tmiem tal-effikaċja primarja kien l-Indiċi tar-Rispondent SLE (SRI) f'Ġimgħa 52 kif deskritt filprovi intravenużi fl-adulti.
English: Reproductive studies have been performed in pregnant cynomolgus monkeys receiving belimumab 150 mg/kg by intravenous infusion (approximately 9 times the anticipated maximum human clinical exposure) every 2 weeks for up to 21 weeks, and belimumab treatment was not associated with direct or indirect harmful effects with respect to maternal toxicity, developmental toxicity, or teratogenicity.
Maltese: Studji ta' riproduzzjoni saru f'xadini cynomolgus tqal li ngħataw 150 mg/kg ta' belimumab permezz ta' infużjoni fil-vina (madwar 9 darbiet aktar mill-ogħla esponiment kliniku antiċipat fil-bnedmin) kull ġimagħtejn sa 21 ġimgħa, u kura b'belimumab ma kinitx assoċjata ma' effetti ta' ħsara diretti jew indiretti f'dak li għandu x'jaqsam ma' tossiċità fl-omm, tossiċità fl-iżvilupp, jew teratoġeniċità.
English: The mechanism of action of belimumab could increase the risk for the development of infections in adults and children with lupus, including opportunistic infections, and younger children may be at increased risk.
Maltese: Il-mod ta' kif jaħdem belimumab jista' jżid ir-riskju għall-iżvilupp ta' infezzjonijiet f'adulti u tfal b'lupus, inkluż infezzjonijiet opportunistiċi, u tfal iżgħar jistgħu jkunu f'riskju miżjud.
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B
Maltese: • l-ebda punteġġ A ġdid tal-Grupp ta' Stima tal-Lupus tal-Gżejjer Brittaniċi (BILAG) tad-dominju talorganu jew 2 punteġġi B ġodda BILAG tad-dominju tal-organu, u
English: In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered (see section 4.2).
Maltese: F'każ ta' reazzjoni qawwija, l-għoti ta' Benlysta għandu jitwaqqaf u għandha tingħata terapija medika xierqa (ara sezzjoni 4.2).
English: B cell numbers recovered after the cessation of belimumab treatment by about 1 year post-partum in adult monkeys and by 3 months of life in infant monkeys; IgM levels in infants exposed to belimumab in utero recovered by 6 months of age.
Maltese: In-numru ta' ċelluli B irkupraw wara t-twaqqif ta' kura b'belimumab wara madwar sena minn wara li x-xadini adulti welldu u mal-ewwel 3 xhur f'xadini frieħ; livelli ta' IgM f'xadini frieħ esposti għal belimumab in utero rkupraw mal-età ta' 6 xhur.
English: Very common Bacterial infections, e.g. bronchitis, urinary tract infection
Maltese: Infezzjonijiet ikkawżati minn batterja, eż. bronkite, infezzjoni fl apparat tal-awrina
English: Description of selected adverse reactions
Maltese: Differenza osservata kontra
English: Storage
Maltese: Rikostituzzjoni
English: Read the information ‘Increased risk of brain infection' in section 4 of this leaflet.
Maltese: Aqra l-informazzjoni “Riskju miżjud ta' infezzjoni fil-moħħ” f'sezzjoni 4 ta' dan il-fuljett.
English: Benlysta 120 mg powder for concentrate for solution for infusion Type 1 glass vials (5 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 120 mg of powder.
Maltese: Kunjetti tal-ħġieġ tat-tip 1 (5 ml), issiġillati b'tapp tal-gomma chlorobutyl silikonizzat u siġill tal-aluminjum li jinqla' b'daqqa ta' saba' li fihom 120 mg ta' trab.
English: EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens
Maltese: EU/1/11/700/003 1 pinna mimlija għal-lest EU/1/11/700/004 4 pinen mimlijin għal-lest
English: The recommended dose regimen for children aged 5 years and older is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Maltese: Il-kors tad-doża rakkomandat għal tfal li għandhom 5 snin u akbar huwa 10 mg/kg Benlysta f'Jiem 0, 14 u 28 u f'intervalli ta' 4 ġimgħat wara dan.
English: In one study in 6 to 17-year-old paediatric patients (n=53), none of the patients developed anti-belimumab antibodies.
Maltese: Fi studju wieħed f'pazjenti pedjatriċi ta' 6 sa 17-il sena (n=53), l-ebda wieħed mill-pazjent ma żviluppa antikorpi kontra belimumab.
English: The most frequently reported adverse reactions (≥5% of patients with SLE treated with Benlysta plus standard of care and at a rate ≥1% greater than placebo) were viral upper respiratory tract infections,
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti (≥5% tal-pazjenti b'SLE kkurati b'Benlysta flimkien ma' kura standard u b'rata ta' ≥1% ogħla mill-plaċebo) kienu infezzjonijiet fl-apparat respiratorju tan-naħa ta' fuq, bronkite u dijarea.
English: Warnings
Maltese: Rispons
English: There were too few patients ≥65 years of age or black patients enrolled in the controlled clinical trials with subcutaneous Benlysta to draw meaningful conclusions about the effects of age or race on clinical outcomes.
Maltese: Kien hemm ftit wisq pazjenti li kellhom ≥65 sena li ddaħħlu fil-provi kliniċi kkontrollati biex wieħed jiġbed konklużjoni li tagħmel sens dwar l-effetti tal-età fuq ir-riżultati kliniċi.
English: SLE patients transitioning from 10 mg/kg intravenously every 4 weeks to 200 mg subcutaneously weekly using a 1 to 4 week switching interval had pre-dose belimumab serum concentrations at their first subcutaneous dose close to their eventual subcutaneous steady-state trough concentration (see section 4.2).
Maltese: Tranżizzjoni minn għoti ġol-vini għal għoti taħt il-ġilda Il-pazjenti b'SLE li jaqilbu minn 10 mg/kg ġol-vini kull 4 ġimgħat għal 200 mg taħt il-ġilda kull ġimgħa li jużaw intervall ta' qlib ta' 1 għal 4 ġimgħat kelhom konċentrazzjonijiet ta' belimumab fis-serum ta' qabel iddoża fl-ewwel doża taħt il-ġilda tagħhom li kienu viċin tal-konċentrazzjoni minima fi stat fiss taħt il-ġilda eventwali tagħhom (ara sezzjoni 4.2).
English: The incidence of post-injection systemic reactions and hypersensitivity reactions occurring within 3 days of subcutaneous administration was 7% in the group receiving Benlysta and 9% in the group receiving placebo.
Maltese: L-inċidenza ta' reazzjonijiet sistemiċi ta' wara l-injezzjoni u ta'reazzjonijiet ta' sensittività eċċessiva li jseħħu fi żmien 3 ijiem minn għoti taħt il-ġilda kienet ta' 7 % fil-grupp li kien qed jingħata Benlysta u ta' 9 % fil-grupp li kien qed jingħata l-plaċebo.
English: All patients received standard therapy.
Maltese: Il-pazjenti kollha ngħataw terapija standard.
English: (Figure 2) Injecting cold Benlysta may take longer and may be uncomfortable.
Maltese: (Figura 2) L-injezzjoni ta' Benlysta kiesħa tista' tieħu aktar fit-tul u tista' tkun skomda.
English: The 400 mg single-use vial of belimumab is reconstituted with 4.8 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Maltese: Il-kunjett ta' 400 mg ta' belimumab li jintuża darba biss huwa rrikostitwit b'4.8 ml ta' ilma għall injezzjonijiet biex jagħti konċentrazzjoni finali ta' 80 mg/ml belimumab.
English: Clinically significant hypersensitivity reactions associated with Benlysta administered subcutaneously and requiring permanent treatment discontinuation were reported in 0.2% of patients receiving Benlysta and in no patients receiving placebo.
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva klinikament sinifikanti assoċjati ma' Benlysta mogħti taħt il-ġilda u li kienu jeħtieġu twaqqif permanenti talkura f'0.2 % tal-pazjenti li kienu qed jingħataw Benlysta u fl-ebda pazjent minn dawk li kienu qed jingħataw l-plaċebo.
English: Elderly: Benlysta has been studied in a limited number of elderly patients.
Maltese: Benlysta ġie studjat f'numru limitat ta' pazjenti anzjani.
English: • burning sensation while passing urine.
Maltese: • sensazzjoni ta' ħruq waqt li tgħaddi l-awrina.
English: In the two Phase III studies in adults, 4 of the 563 (0.7%) patients in the 10 mg/kg group and 27 out of 559 (4.8%) patients in the 1 mg/kg group tested positive for persistent presence of anti-belimumab antibodies.
Maltese: F'żewġ studji tal-Fażi III fl-adulti, 4 mill-563 (0.7%) pazjent fil-grupp ta' 10 mg/kg u 27 minn 559 (4.8%)
English: Injection site reactions**
Maltese: Reazzjonijiet fis-sit tal-injezzjoni**
English: The 400 mg single-use vial of Benlysta is reconstituted with 4.8 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Maltese: Il-kunjett li jintuża darba biss ta' 400 mg ta' Benlysta huwa rrikostitwit b'4.8 ml ta' ilma għall-injezzjonijiet biex jagħti konċentrazzjoni finali ta' 80 mg/ml belimumab.
English: IgG1 molecules such as belimumab are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue and changes in hepatic function are unlikely to have any effect on the elimination of belimumab.
Maltese: IgG1 bħal belimumab huma kkatabolizzati minn enzimi proteolitiċi li huma mifruxa ħafna, li mhumiex ristretti għat-tessut tal-fwied u tibdiliet fil-funzjoni tal-fwied x'aktarx ma jkolliex effett fuq it-tneħħija ta' belimumab.
English: Patients were on a stable SLE treatment regimen (standard of care) and had similar inclusion criteria as the adult studies.
Maltese: Il-pazjenti kienu fuq kors ta' trattament SLE stabbli (standard tal-kura) u kellhom kriterji tal-inklużjoni simili bħall-istudji fl-adulti.
English: Benlysta 400 mg powder for concentrate for solution for infusion belimumab
Maltese: Benlysta 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni belimumab
English: However, consistent with results from other studies, in black patients with high disease activity (low complement and positive anti-dsDNA at baseline, n=141) the SRI-S2K response was 45.1% for Benlysta 10 mg/kg compared with 24.0% for placebo (odds ratio 3.00; 95% CI: 1.35, 6.68).
Maltese: Madankollu, b'mod konsistenti mar-riżultati minn studji oħra, f'pazjenti suwed b'attvità tal-marda għolja (komplement baxx u anti-dsDNA pożittiv fil-linja bażi, n=141), ir-rispons ta' SRI-S2K kien ta' 45.1 % għal Benlysta 10 mg/kg meta mqabbel ma' 24.0
English: No detrimental effects on such activities are predicted from the pharmacology of belimumab.
Maltese: Ma huma mbassra l-ebda effetti ta' ħsara fuq attivitajiet bħal dawn mill-farmakoloġija ta' belimumab.
English: Benlysta 400 mg powder for concentrate for solution for infusion.
Maltese: Benlysta 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Benlysta 200 mg weekly
Maltese: Benlysta 200 mg kull ġimgħa
English: The 120 mg single-use vial of Benlysta is reconstituted with 1.5 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Maltese: Il-kunjett li jintuża darba biss ta' 120 mg ta' Benlysta huwa rrikostitwit b'1.5 ml ta' ilma għall-injezzjonijiet biex jagħti konċentrazzjoni finali ta' 80 mg/ml ta' belimumab.
English: WARNING: The 5 ml and 20 ml vials are reconstituted with different volumes of diluent, see below: 120 mg vial
Maltese: Il-kunjetti ta' 5 ml u ta' 20 ml huma rrikostitwiti b'volumi ta' dilwent differenti, ara hawn taħt:
English: Within the overall SLE intravenous study population, age did not affect belimumab exposure in the population pharmacokinetic analysis.
Maltese: Fil-popolazzjoni globali tal istudju li ngħatat mediċina minn ġol-vina għal SLE, l-età m'affetwatx l-esponiment għal belimumab flanaliżi ta' farmakokinetika tal-popolazzjoni.
English: Symptoms of PML include:
Maltese: Effetti sekondarji oħra:
English: The 120 mg single-use vial of belimumab is reconstituted with 1.5 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Maltese: Il-kunjett ta' 120 mg ta' belimumab li jintuża darba biss huwa rrikostitwit b'1.5 ml ta' ilma għall injezzjonijiet biex jagħti konċentrazzjoni finali ta' 80 mg/ml belimumab.
English: However, given the small number of subjects ≥65, an effect of age cannot be ruled out conclusively.
Maltese: Madankollu, meta wieħed iqis innumru żgħir ta' individwi ≥65, l-effett tal-età ma jistax jiġi eskluż b'mod konklużiv.
English: After reconstitution, the solution contains 80 mg belimumab per ml.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni fiha 80 mg belimumab għal kull ml.
English: Patients who had severe active lupus nephritis, severe active CNS lupus, primary immunodeficiency, IgA deficiency or acute or chronic infections requiring management were excluded from the study.
Maltese: Il-pazjenti li kellhom lupus nefrite attiva severa, lupus CNS attiva severa, immunodefiċjenza primarja, defiċjenza tal-IgA jew infezzjoni akuta jew kronika li kienet teħtieġ immaniġġjar ġew esklużi mill-istudju.
English: ‘Infusion or injection-related systemic reactions' covers a group of terms and can manifest as a range of symptoms including bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, dizziness, and arthralgia.
Maltese: Ġew osservati wkoll reazzjonijiet ta' sensittività eċċessiva tat-tip li jieħdu ż-żmien biex joħorġu, mhux akuti u inkludew sintomi bħal raxx, nawsja, għeja, majalġja, uġigħ ta' ras, u edema tal-wiċċ.
English: Volume of diluent
Maltese: NUMRU TAL-LOTT
English: Other medicines and Benlysta
Maltese: Mediċini oħra u Benlysta
English: ≤7.5 mg/day during weeks 24 through 52* (%) Observed treatment difference vs. placebo (%)
Maltese: Tnaqqis fil-prednisone b'≥25% mil-linja bażi għal ≤7.5 mg/jum mill-ġimgħat 24 sa 52* (%) Differenza osservata bil-kura vs plaċebo (%)
English: Median IgG levels at Week 52 were reduced by 11% in patients receiving Benlysta compared with an increase of 0.7% in patients receiving placebo.
Maltese: IgG medji f'Ġimgħa 52 tnaqqsu bi 11 % f'pazjenti li kienu qed jingħataw Benlysta meta mqabbla ma' żieda ta' 0.7 % f'pazjenti li kienu qed jingħataw il-plaċebo.
English: Reductions in naïve and transitional B cells, as well as the SLE B cell subset were observed as early as Week 8.
Maltese: Ġie osservat tnaqqis fiċ-ċelluli inġenwi u tranżizzjonali B, kif ukoll issottosett taċ-ċellua B SLE sa minn Ġimgħa 8.
English: Do not give Benlysta as a subcutaneous injection to children or adolescents younger than 18 years of age.
Maltese: Tagħtix Benlysta bħala injezzjoni taħt il-ġilda lil tfal jew adolexxenti iżgħar minn 18-il sena.
English: There are a limited amount of data from the use of Benlysta in pregnant women.
Maltese: Hemm esperjenza limitata b'doża eċċessiva ta' Benlysta.
English: Patients who had severe active lupus nephritis and patients who had severe active central nervous system (CNS) lupus were excluded.
Maltese: Pazjenti li kellhom nefrite qawwija attiva tal-lupus u pazjenti li kellhom lupus attiv u qawwi tas-sistema nervuża ċentrali (CNS) ġew esklużi.
English: The risk of severe flares was reduced by 49% during the 52 weeks of observation in the group receiving Benlysta compared with the group receiving placebo (hazard ratio=0.51; p=0.0004).
Maltese: Ir-riskju ta' żbroff divers tnaqqas b'49 % matul it-52 ġimgħa ta' osservazzjoni fil-grupp li kien qed jingħata Benlysta meta mqabbel mal-grupp li kien qed jirċievi l-plaċebo (proporzjon ta' periklu=0.51; p=0.0004).
English: Blood and lymphatic system disorders
Maltese: Mard malinn u disturbi limfoproliferattivi
English: Benlysta 120 mg powder for concentrate for solution for infusion belimumab
Maltese: Benlysta 120 mg trab għal konċentrat għal soluzzjoni għall-infużjoni belimumab
English: Table 3 - Paediatric response rate at Week 52 Response
Maltese: Tabella 3 - Rata tar-rispons pedjatriku f'Ġimgħa 52
English: Age did not affect belimumab exposure in the subcutaneous population pharmacokinetic analysis.
Maltese: L-età ma affetwatx l-esponiment għal belimumab fl-analiżi ta' farmakokinetika tal-popolazzjoni taħt il-ġilda.
English: Infusion or injection-related systemic reactions and hypersensitivity: Infusion or injection-related systemic reactions and hypersensitivity were generally observed on the day of administration, but acute hypersensitivity reactions may also occur several days after dosing.
Maltese: Reazzjonijiet sistemiċi marbuta mal-infużjoni jew mal-injezzjoni u sensittività eċċessiva: Reazzjonijiet sistemiċi marbuta mal-infużjoni jew mal-injezzjoni ġeneralment u sensittività eċċessiva kienu osservati filjum tal-għoti, iżda reazzjonijiet ta' sensittività eċċessiva akuti jistgħu jseħħu wkoll diversi jiem wara ddożaġġ.
English: Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta (see section 4.4).
Maltese: Premedikazzjoni inkluż dik b'antiistamin, flimkien ma' mediċina kontra d-deni jew mingħajrha, tista' tingħata qabel l-infużjoni ta' Benlysta (ara sezzjoni 4.4).
English: Pre-filled syringe Each 1-ml pre-filled syringe contains 200 mg of belimumab.
Maltese: pazjent fil-grupp ta' 1 mg/kg instabu pożittivi għall-preżenza persistenti ta' antikorpi kontra belimumab.
English: Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered.
Maltese: Kien hemm rapporti ta' pazjenti li żviluppaw sintomi ta' sensittività eċċessiva akuta diversi sigħat wara l-għoti tal-infużjoni.
English: In patients with anti-dsDNA antibodies at baseline, median anti-dsDNA antibodies levels at Week 52 were reduced by 56% in patients receiving Benlysta compared with 41% in patients receiving placebo.
Maltese: tnaqqsu b'56 % f'pazjenti li kienu qed jingħataw Benlysta meta mqabbla ma' 41 % f'pazjenti li kienu qed jingħataw il-plaċebo.
English: Components of SLE Responder Index Percent of patients with reduction in SELENA-SLEDAI ≥4 (%) Odds ratio (95% CI) vs placebo
Maltese: Proporzjon ta' probabbiltà (95% CI) kontra plaċebo Perċentwal ta' pazjenti bl-ebda aggravar skont PGA (%) Proporzjon ta' probabbiltà (95% CI) kontra plaċebo
English: White to off-white powder.
Maltese: Trab minn abjad sa offwajt.
English: Anti-dsDNA positive AND low complement Placebo
Maltese: Placebo + Standard Therapy
English: Percent of patients with reduction in SELENASLEDAI ≥4
Maltese: Perċentwal ta' pazjenti bi tnaqqis fi SELENA-SLEDAI ≥4
English: From a 250 ml (or 100 ml) infusion bag or bottle of sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection, withdraw and discard a volume equal to the volume of the reconstituted Benlysta solution required for the patient's dose.
Maltese: Minn borża jew flixkun tal-infużjoni ta' 250 ml (jew 100 ml) ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%), ta' sodium chloride 4.5 mg/ml (0.45 %), jew ta' Lactated Ringer iġbed u armi volum daqs il-volum tas-soluzzjoni rikostitwita ta' Benlysta meħtieġa għad-doża tal-pazjent.
English: Intravenous use.
Maltese: ijiem wara injezzjoni.
English: The response for the individual components of the endpoint were consistent with that of the SRI (Table 3).
Maltese: Ir-rispons għall-komponenti individwali tal-punt tat-tmiem kien konsistenti ma' dak tas-SRI (Tabella 3).
English: After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each 5 ml vial.
Maltese: Wara r-rikostituzzzjoni, volum ta' 1.5 ml (li jikkorrispondi għal 120 mg ta' belimumab) jista' jinġibed minn kull kunjett ta' 5 ml.
English: The package leaflet should be provided to the patient each time Benlysta is administered (see section 4.4).
Maltese: Il-fuljett ta' tagħrif għandu jiġi pprovdut lill-pazjent kull darba li jingħata Benlysta (ara sezzjoni 4.4).
English: Using such medicines in combination with Benlysta may make your immune system less effective.
Maltese: L-użu ta' mediċini bħal dawn flimkien ma' Benlysta jista' jagħmel lis sistema immuni tiegħek inqas effettiva.
English: The intravenous pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies.
Maltese: Il-parametri farmakokinetiċi ikkwotati hawn taħt huma bbażati fuq l-istimi tal-parametri tal-popolazzjoni għal 563 pazjent li rċivew 10 mg/kg Benlysta fiż-żewġ studji tal-Fażi III.