FrancophonIA/ELRC3.0 huggingface dataset:
English: ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults and also polyarticular juvenile idiopathic arthritis in children 6 years of age and older.
Maltese: ORENCIA jintuża biex jikkura l-artrite rewmatojde u l-artrite psorjatika fl-adulti u wkoll artrite idjopatika ġovanili poliartikulari fit-tfal ta' età ta' 6 snin u ikbar.
English: Check the expiry date printed on the label.
Maltese: Iċċekkja d-data ta' skadenza pprintjata fuq it-tikketta.
English: The incidence rates for malignancies was 1.3 (0.9, 1.9) per 100 patient-years for abatacept-treated patients and 1.1 (0.6, 1.9) per 100 patient-years for placebo-treated patients.
Maltese: Ir-rati ta' inċidenza ta' tumuri malinni kienu ta' 1.3 (0.9, 1.9) għal kull 100 sena ta' pazjent għal pazjenti li ngħataw kura b'abatacept u ta' 1.1 (0.6, 1.9) għal kull 100 sena ta' pazjent għal pazjenti li ngħataw kura bi plaċebo.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe 2.
Maltese: ORENCIA 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest ORENCIA 87.5 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest ORENCIA 125 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 2.
English: † p < 0.01, abatacept plus MTX vs. MTX plus placebo ‡ p < 0.001, abatacept plus MTX vs. MTX plus placebo †† p < 0.05, abatacept plus MTX vs. MTX plus placebo § 95% CI: −4.2, 4.8 (based on prespecified margin for non-inferiority of −7.5%) §§ITT data is presented in table a Fixed dose approximating 10 mg/kg (see section 4.2).
Maltese: MTX flimkien ma' plaċebo § 95% CI: −4.2, 4.8 (ibbażat fuq marġinu speċifikat minn qabel għal non-inferjorità ta' −7.5%) §§dejta ITT hija ppreżentata fit-tabella a Doża fissa li tqarreb 10 mg/kg (ara sezzjoni 4.2).
English: Abdominal pain, diarrhoea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting Uncommon Gastritis
Maltese: Uġigħ ta' żaqq, dijareja, nawsja, dispepsja, ulċera fil-ħalq, stomatite aftuża, rimettar Mhux komuni Gastrite
English: SC bioavailability (F) increased by 28% and the absorption rate constant (KA) was higher in pJIA patients than RA patients.
Maltese: Il-bijodisponibbiltà SC (F) żdiedet bi 28 % u r-rata ta' assorbiment kostanti (KA) kienet ogħla f'pazjenti ta' pJIA milli f'pazjenti ta' RA.
English: No systemic accumulation of abatacept occurred upon continued repeated treatment with 10 mg/kg at monthly intervals in rheumatoid arthritis patients.
Maltese: L-ebda akkumulazzjoni sistemika ta' abatacept ma seħħet wara trattament ripetut li tkompla b'10 mg/kg f'intervalli ta' kull xahar f'pazjenti bl-artrite tar-rewmatiżmu.
English: In SC-II, serious infections were reported in 3.8 % (12/318) of patients treated with abatacept SC weekly, none of which led to discontinuation and in 5.8 % (19/328) of patients treated with adalimumab SC every-other-week, leading to 9 discontinuations in the 24-month period.
Maltese: F'SC-II, infezzjonijiet serji ġew irrappurtati fi 3.8% (12/318) tal-pazjenti kkurati b'abatacept SC kull ġimgħa, li l-ebda waħda minnhom ma wasslet għal twaqqif u f'5.8% (19/328) tal-pazjenti kkurati b'adalimumab SC kull ġimagħtejn, li wasslu għal 9 pazjenti li waqqfu l-kura f'perjodu ta' 24 xahar.
English: End of Period Ba (day 169)
Maltese: Tmiem il-Perjodu Ba (jum 169)
English: End of Period A (day 113)
Maltese: Tmiem ta' Perjodu A (jum 113)
English: b Each vial provides 250 mg of abatacept for administration.
Maltese: b Kull kunjett jipprovdi 250 mg ta' abatacept għall-għoti.
English: Immunogenicity to abatacept following long-term subcutaneous administration was assessed by a new electrochemiluminescence (ECL) assay.
Maltese: L-immunoġeniċità għal abatacept wara għoti taħt il-ġilda għal żmien twil ġiet valutata b'analiżi ta' electrochemiluminescence (ECL) ġdida.
English: The incidence rates (95% CI) for serious infections was 3.0 (2.3, 3.8) per 100 patient-years for abatacept-treated patients and 2.3 (1.5, 3.3) per 100 patient-years for placebo-treated patients in the double-blind studies.
Maltese: Ir-rata ta' inċidenza (95% CI) għal infezzjonijiet serji kienet ta' 3.0 (2.3, 3.8) għal kull 100 sena ta' pazjent għal pazjenti li ngħataw kura b'abatacept u ta' 2.3 (1.5, 3.3) għal kull 100 sena ta' pazjent għal pazjenti li ngħataw kura bi plaċebo fl-istudji fl-istudji double-blind.
English: Not assessed a day 169 Last Observation Carried Forward (LOCF) for patients treated in Period C b As observed
Maltese: Mhux evalwata a jum 169 L-aħħar Osservazzjoni Miġjuba (LOCF) għal pazjenti kkurati f'Perjodu Ċ b Kif osservat
English: The most frequently reported malignancy in the placebo-controlled clinical trials was non-melanoma skin cancer; 0.6 (0.3, 1.0) per 100 patient-years for abatacept-treated patients and 0.4 (0.1, 0.9) per 100 patient-years for placebo-treated patients and 0.5 (0.4, 0.6) per 100 patient-years in the cumulative period.
Maltese: Fil-provi kliniċi kkontrollati bi plaċebo l-aktar tumur malinn rapportat b'mod frekwenti kien kanċer tal-ġilda mhux melanoma; 0.6 (0.3, 1.0) għal kull 100 sena ta' pazjent għal pazjenti li ngħataw kura b'abatacept u ta' 0.4
English: The overall safety profile with respect to adverse reactions was similar between the two groups over the 24-month period.
Maltese: Il-profil tas-sigurtà globali fir-rigward ta' reazzjonijiet avversi kien simili bejn iż-żewġ gruppi fuq perjodu ta' 24 xahar.
English: Plunger head
Maltese: Planġer ċelesti
English: This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA.
Maltese: Din il-kartuna ta' twissija fiha informazzjoni importanti dwar is-sigurtà li inti trid tkun taf qabel tingħata ORENCIA u matul t-trattament b'ORENCIA.
English: The other ingredients are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections (see section 2 "ORENCIA contains sodium").
Maltese: L-ingredjenti l-oħra huma sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, u ilma għall-injezzjonijiet (ara sezzjoni 2 “ORENCIA fih issodium”).
English: Physical function response
Maltese: Rispons ta' funzjoni fiżika
English: Physical Function Response
Maltese: Rispons ta' Funzjoni Fiżika
English: The reduction from baseline in mean DAS28 score at day 365 (-3.06) was maintained through day 729 (-3.34) in those patients who continued with abatacept.
Maltese: It-tnaqqis mil-linja bażi fil-punteġġ medju ta' DAS28 f'Jum 365 (-3.06) ġie sostnut sa Jum 729 (-3.34) f'dawk il-pazjenti li komplew jirċievu abatacept.
English: Combination with other medicinal products that affect the immune system and with vaccinations
Maltese: Kombinazzjoni ma' prodotti mediċinali oħra li jaffetwaw is-sistema immuni u ma' tilqim
English: Health-related quality of life was assessed by the SF-36 questionnaire at 6 months in studies I, II, and III and at 12 months in studies I and II.
Maltese: Il-kwalità tal-ħajja relatata mas-saħħa ġiet ivvalutata bil-kwestjonarju SF-36 fis-6 xahar fi studji I, II u III u fit-12-il xahar fi studji I u II.
English: In study PsA-I, 170 patients received placebo or abatacept intravenously on Day 1, 15, 29, and then every 28 days thereafter in a double blind manner for 24 weeks, followed by open-label abatacept 10 mg/kg intravenous every 28 days.
Maltese: Fi studju PsA-I, 170 pazjent irċivew plaċebo jew abatacept ġol-vini f'Jum 1, 15, 29, imbagħad kull 28 jum wara dak il-perjodu b'mod double blind għal 24 ġimgħa, segwit minn abatacept open-label 10 mg/kg ġol-vini kull 28 jum.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Maltese: ORENCIA 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni abatacept
English: No dose adjustment is required (see section 4.4).
Maltese: Ma huwa meħtieġ ebda aġġustament tad-doża (ara sezzjoni 4.4).
English: When the intravenous loading dose was not administered, a mean trough concentration of 12.6 mcg/mL was achieved after 2 weeks of dosing.
Maltese: Meta ma ngħatatx id-doża qawwija talbidu fil-vini, konċentrazzjoni minima medja ta' 12.6 mcg/mL inkisbet wara ġimagħtejn ta' dożaġġ.
English: The median duration of abatacept treatment in Period C was 1815 days (range 57-2,415 days; nearly 61 months).
Maltese: Id-durata medja ta' kura b'abatacept fil-Perjodu Ċ kienet 1815-il jum (medda 57-2,415-il jum; kważi 61 xahar).
English: Acute infusion-related events (adverse reactions occurring within 1 hour of the start of the infusion) in seven pooled intravenous studies (for studies II, III, IV and V see section 5.1) were more common in the abatacept-treated patients than the placebo-treated patients (5.2% for abatacept, 3.7% for placebo).
Maltese: II, III, IV u V ara sezzjoni 5.1) kienu aktar komuni f'pazjenti ttrattati b'abatacept milli f'pazjenti ttrattati bi plaċebo (5.2% għal abatacept, 3.7% għall-plaċebo).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION ORENCIA 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.
Maltese: U KWANTITATTIVA ORENCIA 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 50 mg ta' abatacept f'0.4 mL.
English: During the 24-month cumulative period of the pJIA SC study (4-month short term period plus 20-month extension period), a higher frequency of infections was reported in the 2 to 5 year age cohort (87.0%) compared to that reported in the 6 to 17 year age cohort (68.2%).
Maltese: Matul il-perjodu kumulattiv ta' 24 xahar tal-istudju pJIA SC (perjodu qasir ta' 4 xhur flimkien ma' perjodu ta' estensjoni ta' 20-xahar), ġiet irrapportata frekwenza ogħla ta' infezzjonijiet fil-koorti ta' dawk bejn is-sentejn u l-ħames snin (87.0%) meta mqabbla ma' dik rapportata fil-koorti ta' dawk bejn is-6-17-il sena (68.2%).
English: Serious infections at least possibly related to treatment were reported in 1.5% of abatacept-treated patients and 1.1% of placebo-treated patients.
Maltese: Infezzjonijiet serji li ta' l-inqas jista' jkollhom il-possibbiltà li għandhom x'jaqsmu mat-trattament ġew irrapportati f'1.5% tal-pazjenti ttrattati b'abatacept u f'1.1% tal-pazjenti ttrattati bi plaċebo.
English: Abatacept has been studied in patients with pJIA in two clinical trials (pJIA SC study and pJIA IV study).
Maltese: Abatacept ġie studjat f'pazjenti b'pJIA f'2 provi kliniċi (studju ta' pJIA SC li għadu għaddej u studju ta' pJIA IV).
English: Common (may affect up to 1 in 10 people): infections of lungs, urinary infections, painful skin blisters (herpes), flu headache, dizziness high blood pressure cough abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting rash fatigue, weakness, injection site reactions abnormal liver function tests.
Maltese: Komuni (jista' jaffettwa sa persuna 1 minn kull 10): infezzjonijiet tal-pulmun, infezzjonijiet tas-sistema tal-awrina, nuffati fil-ġilda bl-uġigħ (herpes), influwenza uġigħ ta' ras, sturdament pressjoni tad-demm għolja sogħla uġigħ addominali, dijarea, nawsja, stonku mqalleb, ħalq misluħ, rimettar raxx għeja, dgħufija testijiet anormali tal-funzjoni tal-fwied
English: PREPARE YOUR CLICKJECT PEN
Maltese: Perjodu ta' estensjoni fit-tul
English: MARKETING AUTHORISATION NUMBERS EU/1/07/389/011-012
Maltese: EU/1/07/389/011-012
English: Each pre-filled syringe contains 125 mg of abatacept in one mL.
Maltese: Siringa mimlija għal-lest fiha 125 mg abatacept f'1 mL.
English: In study PsA-II following weekly subcutaneous administration of abatacept at 125 mg, steady-state of abatacept was reached at day 57 with the geometric mean (CV%) cmin ranging from 22.3 (54.2%) to 25.6 (47.7%) mcg/mL on days 57 to 169, respectively.
Maltese: Fl-istudju PsA-II wara għoti taħt il-ġilda kull ġimgħa ta' abatacept b'125 mg, l-istat fiss ta' abatacept intlaħaq f'jum 57 bil-medja ġeometrika (CV%) cmin li tvarja minn 22.3 (54.2%) sa 25.
English: Subcutaneous use.
Maltese: Żommha sod.
English: Studies in vitro and in animal models demonstrate that abatacept modulates T lymphocyte-dependent antibody responses and inflammation.
Maltese: Studji in vitro u f'mudelli ta' l-annimali juru li abatacept jimmodula risponsi ta' antikorpi li huma dipendenti fuq limfoċiti-T u infjammazzjoni.
English: ORENCIA can be used by adults over 65 with no change in dose.
Maltese: ORENCIA jista' jintuża minn adulti ta' aktar minn 65 sena bl-ebda bidla fid-doża.
English: Uncommon (may affect up to 1 in 100 people): blood in urine ear infection
Maltese: Mhux komuni (jista' jaffettwa sa persuna 1 minn kull 100): demm fl-awrina infezzjoni tal-widnejn
English: Description of selected adverse reactions Infections
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Infezzjonijiet
English: ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.
Maltese: ORENCIA, waħdu jew f'kombinazzjoni ma' methotrexate (MTX), huwa indikat għall-kura ta' artrite psorjatika (psoriatic arthritis, PsA) attiva f'pazjenti adulti meta r-rispons għal terapija b'DMARD li ngħatat qabel, inkluż MTX kien inadegwat, u għal min ma jeħtieġx terapija sistemika addizzjonali għal leżjonijiet tal-ġilda psorjatiċi.
English: Remove one pre-filled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature.
Maltese: Neħħi siringa mimlija għal-lest waħda mill-friġġ u stenna 30 minuta biex tħalliha toqgħod f'temperatura ambjentali.
English: In study II, ACR responses were assessed at 5 years in 270 patients with 84% ACR 20 responses, 61% ACR 50
Maltese: Fi studju II, ir-risponsi ta' ACR ġew evalwati wara 5 snin f'270 pazjent b'rispons ta' 84% għal ACR 20, rispons ta' 61% għal ACR 50,
English: At baseline 79% of 219 patients enrolled and treated in the study were taking methotrexate (mean dose at study entry, 12.3 mg/m2/week) and 21% of patients received abatacept monotherapy.
Maltese: Fil-linja bażi, 79 % tal-219-il pazjent irreġistrati u kkurati fl-istudju kienu qed jieħdu methotrexate (doża medja fid-dħul tal-istudju, 12.3 mg/m2/ġimgħa) u 21 % tal-pazjenti rċivew monoterapija ta' abatacept.
English: In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score < 2.6) versus the methotrexate plus placebo group (23%) at year 1.
Maltese: Fi studju VI, li kien jinkludi adulti biss, proporzjon sinifikanti ogħla ta' pazjenti fil-grupp ta' abatacept flimkien ma' methotrexate (41%) laħaq remissjoni skont kif imfissra b'DAS28 (CRP) (punteġġ ta' < 2.6) meta mqabbel mal-grupp ta' methotrexate flimkien mal-plaċebo (23%) fis-sena 1.
English: The most common hematologic malignancy was lymphoma 0.04 (0, 0.24) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients and 0.06 (0.03, 0.1) per 100 patient-years in the cumulative period.
Maltese: L-aktar tumur malinn ematoloġiku komuni kien limfoma 0.04 (0, 0.24) għal kull 100 sena ta' pazjent għal pazjenti li ngħataw kura b'abatacept, 0 għal pazjenti li ngħataw kura bi plaċebo u ta' 0.06 (0.03, 0.1) għal kull 100 sena ta' pazjent fil-perjodu kumulattiv.
English: Children and adolescents with moderate to severe active pJIA, ages 6 to 17 years with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents, were enrolled.
Maltese: Ġew irreġistrati tfal u adolexxenti b'pJIA attiva moderata sa severa, etajiet 6 sa 17-il sena b'rispons inadegwat jew intolleranza għal tal-inqas DMARD wieħed, li seta' inkluda aġenti bijoloġiċi.
English: The efficacy and safety of abatacept were assessed in two randomised, double-blind, placebocontrolled trials (studies PsA-I and PsA-II) in adult patients, age 18 years and older.
Maltese: L-effikaċja u s-sigurtà ta' abatacept ġew ivvalutati f'żewġ provi kliniċi randomizzati, double-blind, ikkontrollati bi plaċebo (studji PsA-I u PsA-II) f'pazjenti adulti, ta' età ta' 18-il sena jew aktar.
English: The COPD patients treated with abatacept developed adverse reactions more frequently than those treated with placebo (51.4% vs. 47.1%, respectively).
Maltese: Ilpazjenti b'COPD ttrattati b'abatacept żviluppaw reazzjonijiet avversi b'iktar frekwenza milli dawk ttrattati bi plaċebo (51.4% vs. 47.
English: During the 24-month cumulative period of the pJIA SC study (4-month shortterm period plus 20-month extension period), a higher frequency of infections was reported in the 2 to 5 year age cohort (87.0%) compared to that reported in the 6 to 17 year age cohort (68.2%).
Maltese: Matul il-perjodu kumulattiv ta' 24 xahar tal-istudju pJIA SC (perjodu qasir ta' 4 xhur flimkien ma' perjodu ta' estensjoni ta' 20 xahar), ġiet irrapportata frekwenza ogħla ta' infezzjonijiet fil-koorti ta' dawk bejn is-sentejn u l-ħames snin (87.0%) meta mqabbla ma' dik irrapportata fil-koorti ta' dawk bejn is-6 u s-17-il sena (68.2%).
English: Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.
Maltese: Siringa waħda mimlija għal-lest fiha 87.5 mg abatacept f'0.7 mL.
English: Hypersensitivity was reported uncommonly.
Maltese: Rapporti ta' sensittività eċċessiva ma kinux komuni.
English: Of the 219 patients with pJIA treated with subcutaneous abatacept during the first 4-month abatacept treatment, the frequency of local injection reactions was 4.6% (10/219); injection site pain and injection site erythema were the most frequently reported local injection reactions.
Maltese: Mill-219-il pazjent b'pJIA li kienu kkurati b'abatacept taħt il-ġilda waqt l-ewwel kura b'abatacept ta' 4 xhur, il-frekwenza ta' reazzjonijiet marbuta mal-injezzjoni lokali kienet 4.6 % (10/219); uġigħ fis-sit tal-injezzjoni u eritema fis-sit tal-injezzjoni kienu r-reazzjonijiet marbuta mal-injezzjoni lokali li ġew irrappurtati bl-aktar mod frekwenti.
English: The adjusted geometric mean of abatacept at steady state trough concentration (Cminss) was 25.3 mcg/mL for the subcutaneous pre-filled pen and 27.8 mcg/mL for the subcutaneous pre-filled syringe with a ratio of 0.91 [90% CI: 0.83, 1.00].
Maltese: 3 mcg/mL għall-pinna mimlija għal-lest taħt il-ġilda u 27.8 mcg/mL għas-siringa mimlija għal-lest taħt il-ġilda bi proporzjon ta' 0.91 [90% CI: 0.83, 1.00].
English: EU/1/07/389/014 4 pre-filled syringes with needle guard
Maltese: EU/1/07/389/014 4 siringi mimlijin għal-lest bi protezzjoni għal-labra
English: Children and adolescents with polyarticular juvenile idiopathic arthritis
Maltese: Tfal u adolexxenti b'artrite idjopatika ġovanili poliartikulari
English: You will be trained by your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.
Maltese: Il-professjonisti fil-qasam mediku jimmonitorjawk waqt li tirċievi ORENCIA b'infużjoni.
English: EU/1/07/389/013 4 pre-filled syringes with needle guard
Maltese: EU/1/07/389/013 4 siringi mimlijin għal-lest bi protezzjoni għal-labra
English: Cough
Maltese: WARA
English: Clinical responses were maintained or continued to improve up to one year in studies PsA-I and PsA-II.
Maltese: Ir-risponsi kliniċi nżammu jew komplew jitjiebu sa sena fi studji PsA-I u PsA-II.
English: In pre-clinical embryo-fetal development studies no undesirable effects were observed at doses up to 29-fold a human 10 mg/kg dose based on AUC.
Maltese: Fi studji ta' qabel l-użu kliniku ma ġie osservat l-ebda effett mhux mixtieq fuq l-iżvilupp embrijo-fetali f'dożi sa 29 darba d-doża fl-umani ta' 10 mg/kg fuq il-bażi ta' AUC.
English: Abatacept therapy did not lead to increased formation of autoantibodies, i.e., antinuclear and antidsDNA antibodies, compared with placebo.
Maltese: Terapija b'abatacept ma wasslitx għal żieda fil-formazzjoni ta' awto-antikorpi, jiġifieri antikorpi antinukleari u antidsDNA, meta mqabbla mal-plaċebo.
English: Paediatric population in polyarticular juvenile idiopathic arthritis
Maltese: Popolazzjoni pedjatrika b'artrite idjopatika ġovanili poliartikulari
English: There is a theoretical concern that treatment with abatacept might increase the risk for autoimmune processes in adults, for example deterioration of multiple sclerosis.
Maltese: Jeżisti tħassib teoretiku li trattament b'abatacept jista' jżid ir-riskju ta' proċessi awto-immuni fl-adulti, per eżempju deterjorazzjoni ta' sklerożi multipla.
English: In the cumulative period 7,044 patients treated with abatacept during 21,011 patient-years (of which over 1,000 were treated with abatacept for over 5 years), the incidence rate of malignancy was 1.2 (1.1, 1.4) per 100 patient-years, and the annualized incidence rates remained stable.
Maltese: Fil-perjodu kumulattiv 7,044 pazjent trattati b'abatacept matul 21,011 sena ta' pazjent (li minnhom aktar minn 1,000 kienu trattati b'abatacept għal aktar minn 5 snin), ir-rati tal-inċidenza tat-tumuri malinni kienet ta' 1.2 (1.1, 1.4) għal kull 100 sena ta' pazjent, u r-rati annwalizzati ta' inċidenza baqgħu stabbli.
English: Period A was a 4-month open-label lead-in designed to induce an ACR Pedi 30 response.
Maltese: Perjodu A kien perjodu inizjali tal-bidu ta' 4 xhur, open label li kien maħsub biex jinduċi rispons għal ACR Pedi 30.
English: Total Sharp score Erosion score JSN score a Based on non-parametric analysis.
Maltese: Għalhekk, testijiet għall-epatite virali jridu jsiru skond il-linji gwidi ippubblikati qabel ma tinbeda terapija b'ORENCIA.
English: ORENCIA selectively modulates the activation of T cells involved in the immune system's inflammatory response.
Maltese: Abatacept huwa l-ewwel modulatur selettiv ta' aktar minn stimulu wieħed.
English: ORENCIA is given to you into a vein, usually in your arm, over a period of 30 minutes.
Maltese: ORENCIA jingħatalek ġol-vina, normalment fi driegħ, fuq perijodu ta' 30 minuta.
English: Dose Vials
Maltese: Tieqa ta' Viżjoni
English: Package leaflet: Information for the patient ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Maltese: Informazzjoni għall-pazjent ORENCIA 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni abatacept
English: How to store ORENCIA
Maltese: Doża ta' ORENCIAa
English: In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary gland tumours (in females) occurred.
Maltese: Fi studju dwar il-karċinogeniċita fil-ġrieden, kien hemm żidiet fl-inċidenza fil-limfomi malinni u f'tumuri fil-glandoli mammarji (fin-nisa).
English: A study of open-label abatacept on a background of nonbiologic DMARDs was conducted in patients with active RA who had an inadequate response to previous (washout for at least 2 months; n=449) or current (no washout period; n=597) TNF-inhibitor therapy (study VII).
Maltese: n = 449) jew attwali (ebda perjodu ta' washout, n = 597) għal terapija b'inibitur ta' TNF (studju VII).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodju (23 mg) f'kull doża, jiġifieri hija essenzjalment ‘ħielsa mis-sodju'.
English: In a pre- and postnatal development study in rats, limited changes in immune function were observed at 11-fold higher than a human 10 mg/kg dose based on AUC (see section 5.3).
Maltese: Fi studju fuq l-iżvilupp qabel u wara t-twelid fil-firien, ġie osservat tibdil limitat fuq il-funzjoni ta' l-immunità f'dożi li hija 11-il darba ogħla mid-doża fl-umani ta' 10 mg/kg fuq il-bażi ta'AUC (ara sezzjoni 5.3).
English: Uncommon Thrombocytopenia, leukopenia
Maltese: Taħt il-ġilda