FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
Maltese: Palpitazzjonijiet, takikardja, insuffiċjenza konġestiva tal-qalb3, edema filpulmun
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Maltese: Ma kien hemm l-ebda bidla filfarmakokinetiċi ta' imatinib meta ngħataw dożi ripetuti, u kien hemm akkumulazjoni ta' 1.5-2.5-il darba fl-istat fiss meta d-doża ingħatat darba kuljum.
English: Pancytopenia, febrile neutropenia
Maltese: Panċitopenja, newtropenija bid-deni
English: The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Maltese: Il-proporzjon fil-ħalib u l-plażma studjat f'pazjenta waħda kien iddeterminat li kien 0.5 għal imatinib u 0.9 għall-metabolit, li jissuġġerixxi distribuzzjoni ogħla tal-metabolit fil-ħalib.
English: Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL.
Maltese: Hemm esperjenza limitata fi tfal b' Ph+ ALL u hemm esperjenza limitata ħafna fi tfal b'MDS/MPD, DFSP u HES/CEL.
English: Name and address of the manufacturer responsible for batch release S.C. Sindan-Pharma S.R.L.
Maltese: Anoressija, nuqqas fil-piż jew tibdil fis-sens tat-togħma.
English: Colitis, ileus, inflammatory bowel disease
Maltese: Kolite, iljus, marda ta' l-infjammazzjoni ta' l-imsaren
English: Each capsule contains 400 mg imatinib (as mesilate).
Maltese: Kull kapsula iebsa fiha 400 mg ta' imatinib (bħala mesilate).
English: Anaphylactic shock*
Maltese: Xokk anafilattiku*
English: Dose increase from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Maltese: Żieda tad-doża minn 100 mg għal 400 mg tista' tiġi ikkonsidrata f'assenza ta' reazzjonijiet avversi talmediċina jekk l-istimi jindikaw li ma hemmx biżżejjed rispons għat-terapija.
English: At a dose of 60 mg/kg, female rats had significant post implantation foetal loss and a reduced number of live foetuses.
Maltese: B'doża ta' 60 mg/kg, il firien tas-sess feminili kellhom numru sinifikanti ta' feti li ntilfu wara l-impjant tal-bajda u numru iżgħar ta' feti ħajjin.
English: Depression, libido decreased, anxiety
Maltese: Dipressjoni, tnaqqis fil-libido, ansjetà
English: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Maltese: Id-doża tal-bidu hija 600 mg, li għandha tittieħed bħalam pillola ta' 400 mg inkluża ma' 2 pilloli ta' 100 mg darba kuljum.
English: Hard capsule with light orange cap and light orange body imprinted with 100 mg in black ink.
Maltese: Kapsula iebsa b' għatu oranġjo ċar u korp oranġjo ċar immarkat b' 100 mg bl-inka sewda.
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil,
Maltese: Wieħed għandu joqgħod attent meta imatinib jittieħed ma' inibituri tal protease, sustanzi kontra l-moffa azole, ċerti makrolidi (ara sezzjoni 4.5), sottostrati ta' CYP3A4
English: - If you are being treated for DFSP:
Maltese: - Jekk qed tiġi ikkurat għall-DFSP:
English: Headache2
Maltese: Sentejn
English: These effects were not seen at doses ≤ 30 mg/kg.
Maltese: Dawn leffetti ma dehrux b'dożi ta' ≤ 30 mg/kg.
English: The dose is 800 mg per day (2 tablets), to be taken as one tablet in the morning and a second tablet in the evening.
Maltese: Id-doża hija 800 mg kuljum (2 pilloli), li għandha tittieħed bħala pillola waħda filgħodu u it tieni pillola filgħaxija.
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Maltese: Tabella 1 Sommarju f'tabella ta' reazzjonijiet avversi
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Maltese: Nota: Din SPC, tabellar, u fuljett ta' tagħrif huwa il-verżjoni valida fil-ħin tad-deċiżjoni tallKummissjoni.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Maltese: B'hekk, din l-SPC, tabellar, u fuljett ta' tagħrif mhux bilfors jirrapreżenta t-test kurrenti.
English: Wait 30 minutes min
Maltese: Wait for 30 minutes
English: Do not sell separately.
Maltese: Tbigħux separatament.
English: Component of a multipack.
Maltese: Komponent ta' pakkett multiplu.
English: Age and race
Maltese: Età u razza
English: Benlysta is not compatible with 5% glucose.
Maltese: Benlysta mhuwiex kompatibbli ma' 5% glucose.
English: Response, n (%)
Maltese: Rispons, n (%)
English: • alcohol swab (not included in the pack)
Maltese: Alcohol swab (not included)
English: • gauze pad or cotton wool ball (not included in the pack)
Maltese: Gauze pad or cotton wool ball (not included)
English: Angioedema, urticaria, rash
Maltese: Anġjoedima, urtikarja, raxx
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Maltese: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, L- Irlanda
English: • hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl)
Maltese: • ipogammaglobulinimja (IgG <400 mg/dl) jew defiċjenza ta' IgA (IgA <10 mg/dl)
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA26
Maltese: Immunosoppressanti selettivi, Kodiċi ATC: L04AA26
English: • ≥4-point reduction in the SELENA-SLEDAI score, and
Maltese: • tnaqqis ta' ≥4 punti mill-punteġġ SELENA-SLEDAI, u
English: Look out for important symptoms
Maltese: Oqgħot attent għal sintomi importanti
English: Benlysta contains belimumab (a monoclonal antibody).
Maltese: Benlysta fih belimumab (antikorp monoklonali).
English: SLE Responder Index (%)
Maltese: Indiċi tar-Rispondent SLE (%)
English: Immunisation
Maltese: Immunoġeniċità
English: Placebo n=40
Maltese: Plaċebo n=40
English: Summary of the safety profile in adults
Maltese: Sommarju tal-profil ta' sigurtà fl-adulti
English: (Figure 6a)
Maltese: (Figura 6a)
English: Response
Maltese: Responders
English: Immunomodulatory medicinal products, including Benlysta, may increase the risk of malignancy.
Maltese: Prodotti mediċinali immunomodulatorji, inkluż Benlysta, jistgħu jżidu r-riskju ta' mard malinn.
English: Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom
Maltese: Glaxo Operations UK Ltd Harmire Road Barnard Castle Durham, DL12 8DT
English: Data on patients ≥65 years are limited to <1.8% of the studied population.
Maltese: ≥65 sena hija limitata għal <1.8% tal-popolazzjoni studjata.
English: Steady-state geometric mean Cmax, Cmin, and AUC values were 305 µg/mL, 42 µg/mL, and 2569 day•µg/mL in the 5- to 11-year-old-group, and 317 µg/mL, 52 µg/mL, and 3126 day•µg/mL in the 12- to 17-year-old-group (n=43).
Maltese: AUC kienu 305 µg/mL, 42 µg/mL, u 2569 jum•µg/mL fil-grupp tal-età ta' 5 sa 11-il sena, u 317 µg/mL, 52 µg/mL, u 3126 jum•µg/mL fil-grupp tal-età ta' 12 sa 17-il sena (n=43).
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali:
English: • severe active lupus nephritis (see section 5.1)
Maltese: • nefrite attiva u qawwija tal-lupus (ara sezzjoni 5.1)
English: The systemic clearance was 215 ml/day (range: 69-622 ml/day).
Maltese: It-tneħħija sistemika kienet ta' 215 ml/kuljum (medda: 69-622 ml/jum).
English: The rates of infusion reactions among persistent-positive subjects were comparable to the rates for ADA negative patients of 75/552 (14%), 78/523 (15%), and 83/559 (15%) in the placebo, 1 mg/kg and 10 mg/kg groups, respectively.
Maltese: Ir rati ta' reazzjonijiet għall-infużjoni fost individwi pożittivi b'mod persistenti kien jixbah lir-rati ta' pazjenti negattivi għal ADA ta' 75/552 (14%), 78/523 (15%), u 83/559 (15%) fil-gruppi ta' plaċebo, ta' 1 mg/kg u ta' 10 mg/kg, rispettivament.
English: • cough, breathing problems
Maltese: • sogħla, problemi bin-nifs
English: • Do not inject within 5 cm (2 inches) of the navel (belly button).
Maltese: • Tinjettax sa 5 cm (2 pulzieri) miż-żokra.
English: Serum belimumab concentrations declined in a bi-exponential manner, with a distribution half-life of 1.75 days and terminal half-life 19.4 days.
Maltese: Konċentrazzjonijiet ta' belimumab fis-serum naqsu b'manjiera bi-esponenzjali, b'half-life ta' distribuzzjoni ta' 1.75 jum u half-life terminali ta' 19.4 jum.
English: Reconstituted solution
Maltese: Belysta solution
English: The maximum serum concentration was 313 µg/ml (range: 173-573 µg/ml) based on simulating the concentration time profile using the typical parameter values of the population pharmacokinetic model.
Maltese: L-ogħla konċentrazzjoni fis-serum kienet ta' 313 µg/ml (medda: 173-573 µg/ml) ibbażata fuq simulazzjoni tal-profil tal-konċentrazzjoni u l-ħin bl-użu ta' valuri tipiċi ta' parametri tal-mudell farmakokinetiku tal-popolazzjoni.
English: Severe flares were observed in 22.6% of the Benlysta group compared to 42.5% of the placebo group over the 52 weeks of observation (observed treatment difference = 19.9%; hazard ratio= 0.38, 95% CI: 0.18, 0.82).
Maltese: Ġie osservat żbroff sever fi 22.6 % tal-grupp ta' Benlysta meta mqabbel ma' 42.5 % tal-grupp tal-plaċebo matul it-52 ġimgħa ta' osservazzjoni (differenza fit-trattament osservata = 19.9%; proporzjon ta' periklu= 0.38, 95% CI: 0.18, 0.82).
English: In the 5- to 11-year-old-group (n=13) the SELENA-SLEDAI score ranged from 4 to 13, and in 12- to 17-year-old-group (n=79) the SELENA-SLEDAI score ranged from 4 to 20.
Maltese: Fil-grupp ta' 5 sa 11-il sena (n=13), il-punteġġ SELENA-SLEDAI varja minn 4 sa 13, u fil-grupp ta' 12 sa 17-il sena (n=79) il-punteġġ SELENA-SLEDAI varja minn 4 sa 20.
English: • Leave the syringe at room temperature for 30 minutes.
Maltese: • Ħalli s-siringa toqgħod f'temperatura ambjentali għal 30 minuta.
English: ≥1/100 to <1/10
Maltese: ≥1/100 sa <1/10
English: Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B).
Maltese: Belimumab huwa antikorp IgG1λ monoklonali uman speċifiku għall-proteina umana li ddub li Tistimula lLimfoċit B (BLyS, magħrufa wkoll bħala BAFF u TNFSF13B).
English: EU/1/11/700/001 1 vial - 120 mg EU/1/11/700/002 1 vial - 400 mg
Maltese: EU/1/11/700/001 1 kunjett - 120 mg EU/1/11/700/002 1 kunjett - 400 mg
English: There were two suicides in Benlysta-treated patients (including one receiving 1 mg/kg Benlysta).
Maltese: Kien hemm żewġ suwiċidji f'pazjenti kkurati b'Benlysta (inkluż wieħed li rċieva 1 mg/kg Benlysta).
English: Of these patients, 64.5% had SELENA SLEDAI scores ≥ 10 at baseline.
Maltese: Minn dawn il-pazjenti, 64.5% kellhom punteġġi SELENA SLEDAI ta' ≥ 10 fil-linja bażi.
English: (Figure 8)
Maltese: (Figura 8)
English: Odds ratio (95% CI) vs placebo
Maltese: Proporzjon ta' probabbilità (95% CI) vs plaċebo
English: The active ingredient is belimumab.
Maltese: Is-sustanza attiva hija belimumab.
English: Observed difference vs placebo
Maltese: Differenza osservata vs plaċebo
English: EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens EU/1/11/700/005 12 (3x4) pre-filled pens (multipack) EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
Maltese: EU/1/11/700/003 1 pinna mimlija għal-lest EU/1/11/700/004 4 pinen mimlijin għal-lest EU/1/11/700/005 12 (3x4) pinen mimlijin għal-lest (pakkett multiplu) EU/1/11/700/006 1 siringa mimlija għal-lest
English: There is limited clinical experience with overdose of Benlysta.
Maltese: Hemm esperjenza klinika limitata b'doża eċċessiva ta' Benlysta.
English: (Figure 1)
Maltese: (Figura 1)
English: Suicidal behaviour, suicidal ideation
Maltese: Imġiba suwiċidali, ideat ta' suwiċidju
English: Depression and suicidality
Maltese: Depressjoni u suwiċidalità
English: Placebo* (n=562)
Maltese: Plaċebo* (n=562)
English: Severe infections, including fatal cases, have been reported in SLE patients receiving immunosuppressant therapy, including belimumab (see section 4.8).
Maltese: Infezzjonijiet severi, inkluż każijiet fatali, ġew irrapportati f'pazjenti b'SLE li kienu qegħdin jirċievu terapija immunosoppressiva, inkluż belimumab (ara sezzjoni 4.8).
English: Placebo (n=40)
Maltese: Plaċebo (n=40)
English: A risk for indirect reduction of CYP activity by belimumab cannot be excluded.
Maltese: Riskju għal tnaqqis indirett ta' attività ta' CYP minn belimumab ma jistax jiġi eskluż.
English: Progressive multifocal leukoencephalopathy (PML) has been reported with Benlysta treatment for SLE.
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy) ġiet irrappurtata b'kura b'Benlysta għal SLE.
English: ≥1/1,000 to <1/100
Maltese: ≥1/1,000 sa <1/100
English: Belimumab was distributed to tissues with steady-state volume (Vss) of distribution of approximately 5 litres.
Maltese: Belimumab tqassam fit-tessuti b'volum fi stat fiss (Vss, steady-state volume) ta' distribuzzjoni ta' madwar 5 litri.
English: ≥1/10,000 to <1/1000
Maltese: ≥1/10,000 sa <1/1000
English: Benlysta was administered intravenously to black patients in a randomised (2:1), double-blind, placebo-controlled, 52-week Phase III/IV study (EMBRACE).
Maltese: Benlysta ngħata ġol-vina lil pazjenti suwed fi studju randomizzat (2:1), double-blind, ikkontrollat bi plaċebo, ta' 52 ġimgħa tal-Fażi III/IV (EMBRACE).
English: Gently swirl the vial for 60 seconds.
Maltese: Dawwar il-kontenut talkunjett bil-mod għal 60 sekonda.
English: Observed treatment difference vs placebo (%)
Maltese: Differenza osservata bil-kura vs plaċebo (%)
English: The systemic clearance was 204 ml/day.
Maltese: It-tneħħija sistemika kienet ta' 204 ml/jum.
English: Safety data in children younger than 12 years of age (n=10) are limited.
Maltese: Id-data tassigurtà fi tfal iżgħar mill-età ta' 12-il sena (n=10) hija limitata.
English: • severe active central nervous system lupus
Maltese: • lupus attiv u qawwi fis-sistema nervuża ċentrali
English: Among persistent-positive subjects in the Phase III studies, 1/10 (10%), 2/27 (7%) and 1/4 (25%) subjects in the placebo, 1 mg/kg and 10 mg/kg groups, respectively, experienced infusion reactions on a dosing day; these infusion reactions were all non-serious and mild to moderate in severity.
Maltese: Fost individwi pożittivi b'mod persistenti fl-istudji tal-Fażi III, 1/10 (10%), 2/27 (7%) u 1/4 (25%) tal individwi fil-gruppi ta' plaċebo, ta' 1 mg/kg u ta' 10 mg/kg, rispettivament, kellhom reazzjonijiet għall infużjoni fil-jum li fih ingħatat id-doża; dawn ir-reazzjonijiet għall-infużjoni ma kinux serji u kienu minn ħfief sa moderati fil-qawwa tagħhom.
English: BLISS-76 and BLISS-52 Pooled
Maltese: BLISS-76 u BLISS-52
English: For anti-cardiolipin IgA antibody a 37% reduction at Week 52 was seen (p=0.0003), for anti-cardiolipin IgG antibody a 26% reduction at Week 52 was seen (p=0.0324) and for anti-cardiolipin IgM a 25% reduction was seen (p=NS,
Maltese: Għall-antikorp anti-kardjolipin IgA deher tnaqqis ta' 37% (p=0.0003) fil-Ġimgħa 52, għall-antikorp anti-kardjolipin IgG deher tnaqqis ta' 26% (p=0.0324) fil-Ġimgħa 52 u għall-antikorp anti-kardjolipin IgM deher tnaqqis ta' 25% (p=NS, 0.46).
English: Paediatric population: The pharmacokinetic parameters are based on individual parameter estimates from a population pharmacokinetic analysis of 53 patients from a study in paediatric patients.
Maltese: Il-parametri tal-farmakokinetika huma bbażati fuq stimi tal-parametri individwali minn analiżi tal-popolazzjoni farmakokinetika ta' 53 pazjent minn studju f'pazjenti pedjatriċi.
English: The efficacy of Benlysta administered intravenously was evaluated in 2 randomized, double-blind, placebo-controlled studies in 1,684 patients with a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
Maltese: L-effikaċja ta' Benlysta mogħti ġol-vini ġiet evalwata f'2 studji randomised, double blind, ikkontrollati bi plaċebo f'1,684 pazjent b'dijanjożi klinika ta' SLE skont il-kriterji ta' klassifikazzjoni tal-Kulleġġ Amerikan tar-Rewmatoloġija (ACR).
English: In patients with anti-dsDNA antibodies, 16% of patients treated with Benlysta converted to anti-dsDNA negative compared with 7% of the patients receiving placebo by Week 52.
Maltese: F'pazjenti b'antikorpi anti-dsDNA, 16% tal-pazjenti kkurati b'Benlysta saru negattivi għal anti-dsDNA meta mqabbla ma' 7% tal-pazjenti li kienu qed jingħataw plaċebo mal-Ġimgħa 52.
English: • Leave the pen at room temperature for 30 minutes.
Maltese: • Ħalli l-pinna toqgħod f'temperatura ambjentali għal 30 minuta.
English: Table 1: Response rate at week 52
Maltese: Tabella 1: Rata ta' rispons fil-ġimgħa 52
English: Adults and children (5 years of age and older)
Maltese: Adulti u tfal (età ta' 5 snin u akbar)
English: During clinical development, Benlysta was studied in a limited number of SLE patients with mild (creatinine clearance [CrCl] ≥60 and <90 ml/min), moderate (CrCl ≥30 and <60 ml/min), or severe (CrCl ≥15 and <30 ml/min) renal impairment: 121 patients with mild renal impairment and 30 patients with moderate renal impairment received Benlysta subcutaneously; 770 patients with mild renal impairment, 261 patients with moderate renal impairment and 14 patients with severe renal impairment received Benlysta intravenously.
Maltese: Waqt l-iżvilupp kliniku Benlysta ġie studjat f'numru limitat ta' pazjenti b'SLE b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina [CrCl] ≥60 u <90 ml/min), moderat (CrCl ≥30 u <60 ml/min), jew qawwi (CrCl ≥15 u <30 ml/min): 121 pazjent b'indeboliment tal-kliewi ħafif u 30 pazjent b'indeboliment tal-kliewi moderat ingħataw Benlysta taħt il-ġilda; 770 pazjent b'indeboliment talkliewi ħafif, 261 pazjent b'indeboliment tal-kliewi moderat u 14-il pazjent b'indeboliment tal-kliewi qawwi ngħataw Benlysta ġol-vini.
English: Multipack:12 pre-filled pens (3 cartons of 4 pre-filled pens).
Maltese: Pakkett multiplu: 12-il pinna mimlija għal-lest (3 kartuni ta' 4 pinen mimlija għal-lest).
English: The differences between the treatment groups were apparent by Week 16 and sustained through Week 52 (Figure 1).
Maltese: Id-differenzi bejn il-gruppi ta' kura dehru sa Ġimgħa 16 u nżammu sa Ġimgħa 52 (Figura 1).
English: Benlysta 200 mg injection belimumab
Maltese: Benlysta 200 mg injezzjoni belimumab SC
English: hours or discarded.
Maltese: Armi u spezzjona
English: There are no data on the effects of belimumab on human fertility.
Maltese: M'hemm l-ebda dejta dwar l-effetti ta' belumimab fuq il-fertilità umana.
English: In one study in paediatric patients (6 to 17 years of age) the pharmacodynamic response was consistent with the adult data.
Maltese: Fi studju wieħed f'pazjenti pedjatriċi (età ta' 6 sa 17-il sena), ir-rispons farmakodinamiku kien konsistenti mad-data tal-adulti.
English: Background medicinal products included corticosteroids (86%; >7.5 mg/day prednisone equivalent 60%), immunosuppressives (46%), and antimalarials (69%).
Maltese: Prodotti mediċinali fl-isfond kienu jinkludu kortikosterojdi (86%; >7.5 mg/jum prednisone ekwivalenti 60%), immunosoppressivi (46%), u mediċini kontra l-malarja (69%).
English: (Figure 9)
Maltese: (Figura 9)
English: Prednisone reduction by ≥25% from baseline to ≤7.5 mg/day during weeks 40 through 52*
Maltese: Tnaqqis fil-prednisone b'≥25% mil-linja bażi għal ≤7.5 mg/jum mill-ġimgħat 40 sa 52* (%)
English: 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 and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar- 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 l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal mediċini.
English: (Figure 7)
Maltese: (Figura 7)
English: Severe flares were observed in 15.6% of the Benlysta group compared to 23.7% of the placebo group over the 52 weeks of observation (observed treatment difference =8.1%; hazard ratio=0.64, p=0.0011).
Maltese: 6% tal-grupp Benlysta meta mqabbel ma' 23.7% tal-grupp ta' plaċebo matul il-perijodu ta' 52 ġimgħa ta' osservazzjoni (differenzi osservati fil-kura = -8.1%; proporzjon ta' riskju =0.64, p=0.0011).
English: Placebo* (n=275)
Maltese: Plaċebo* (n=275)
English: Gold needle guard Expiry date
Maltese: Gold needle guard
English: • high temperature or fever
Maltese: Ħalliha tiġi f'temperatura ambjentali
English: Infusion reactions and hypersensitivity
Maltese: Reazzjonijiet għall-infużjoni u sensittività eċċessiva
English: • feeling sick, diarrhoea.
Maltese: • dardir, dijarea.
English: Table 4 - PRINTO/ACR response rate at Week 52
Maltese: Tabella 4 - Rata tar-rispons PRINTO/ACR f'Ġimgħa 52
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline Subgroup
Maltese: Tabella 2: Pazjenti b'komplement baxx u pożittivi għal anti-dsDNA fil-linja bażi Sottogrupp
English: Eligible patients had active SLE disease, defined as a SELENA-SLEDAI score ≥8 and positive anti-nuclear antibody (ANA or anti-dsDNA) test results (ANA titre ≥1:80 and/or a positive anti-dsDNA [≥30 units/ml])
Maltese: Indiċi ta' Attività tal-Marda tal-Lupus Erythematosus Sistemiku) ta' ≥6 u riżultati pożittivi għal testiiet ta' antikorp anti-nuklejari (ANA) (titre ta' ANA ≥1:80 u/jew pożittivi għal anti-dsDNA [≥30 unitajiet/ml]) meta ġew eżaminati.
English: Odds ratio (95% CI) vs Placebo *The five PRINTO/ACR components were percent change at Week 52 in: Parent's Global Assessment (Parent GA), PGA, SELENA SLEDAI score, 24-hour proteinuria, and, Paediatric Quality of Life Inventory - Generic Core Scale (PedsQL GC) physical functioning domain score.
Maltese: *Il-ħames komponenti PRINTO/ACR kienu bidla perċentwali f'Ġimgħa 52 fi: Valutazzjoni Globali talĠenitur (GA tal-Ġenitur), PGA, punteġġ SELENA SLEDAI, proteinurja f'24 siegħa, u, punteġġ tad-dominju tal-funzjonament fiżiku tal-Inventarju tal-Kwalità tal-Ħajja Pedjatrika - Punteġġ Ewlieni Ġenerali (PedsQL
English: Placebo* (n=287)
Maltese: Plaċebo* (n=287)
English: Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile Parma
Maltese: I-43056 San Polo di Torrile Parma
English: Benlysta significantly reduced circulating overall, transitional, naïve, and SLE B cells, as well as plasma cells at Week 52.
Maltese: Benlysta naqqas b'mod sinifikanti ċelluli li jiċċirkolaw, globali, tranżizzjonali, inġenwi u SLE B, kif ukoll ċelluli tal-plażma f'Ġimgħa 52.
English: No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed.
Maltese: Ma kienu osservati l-ebda inkompatibilitajiet bejn Benlysta u boroż tal-polyvinylchloride jew polyolefin.
English: In controlled clinical intravenous and subcutaneous studies, psychiatric disorders (depression, suicidal ideation and behaviour including suicides) have been reported more frequently in patients receiving Benlysta (see section 4.8).
Maltese: Fi studji kliniċi kkontrollati ġol-vini u taħt il-ġilda, ġew irrappurtati disturbi psikjatriċi (depressjoni, ideat u mġiba ta' suwiċidju inkluż suwiċidji) b'mod aktar frekwenti f'pazjenti li rċivew Benlysta (ara sezzjoni 4.8).
English: Background medicinal products included corticosteroids (76%; >7.5 mg/day 46%), immunosuppressives (56%), and anti-malarials (63%).
Maltese: Prodotti mediċinali flisfond kienu jinkludu kortikosterojdi (76%; >7.5 mg/jum 46%), immunosoppressivi (56%), u mediċini kontra l-malarja (63%).
English: (Figure 6)
Maltese: (Figura 6)
English: Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2).
Maltese: Madankollu hija rrakkomadata l-kawtela f'pazjenti b'indeboliment qawwi tal-kliewi minħabba nuqqas ta' dejta (ara sezzjoni 5.2).