FrancophonIA/ELRC3.0 huggingface dataset:
English: Acute infusion-related events that were reported in > 0.1% and ≤ 1% of patients treated with abatacept included cardiopulmonary symptoms such as hypotension, decreased blood pressure, tachycardia, bronchospasm, and dyspnea; other symptoms included myalgia, nausea, erythema, flushing, urticaria, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, infusion site extravasation, infusion site pain, infusion site swelling, infusion related reaction, and rash.
Maltese: Avvenimenti akuti relatati ma' l-infuzjoni li ġew irrapportati f'> 0.1% u ≤ 1% ta' pazjenti ttrattati b'abatacept inkludew sintomi kardjo-pulmonari bħal pressjoni baxxa, tnaqqis fil-pressjoni, takikardija, bronkospażmu, u dispneja; sintomi oħra nkludew uġigħ fil-muskoli, dardir, eritema, fwawar, urtikarja, sensittività eċċessiva, ħakk, għafis fil-griżmejn, skumdità fis-sider, tertir ta' bard, estravażjoni fis-sit tal-infużjoni, uġigħ fis-sit tal-infużjoni, nefħa fis-sit tal-infużjoni, reazzjoni relatata mal-infużjoni, u raxx.
English: In patients assessed for anti-abatacept antibodies after discontinuation of abatacept (> 42 days after last dose), 103 of 1,888 (5.5%) were seropositive.
Maltese: F'pazjenti vvalutati għall-antikorpi kontra abatacept wara t-twaqqif ta' abatacept (> 42 jum waral-aħħar doża), 103 mill-1,888 (5.5%) kienu seropożittivi.
English: Three patients had SAEs (postoperative wound infection, H1N1 influenza, and myocardial ischemia in 1 patient each) that were not considered related to the study drug.
Maltese: Tliet pazjenti kellhom SAEs (infezzjoni tal-ġerħa kirurġika, influwenza H1N1, u iskemija mijokardijaka f'kull pazjent, rispettivament) li ma kinux ikkunsidrati relatati mal-mediċina tal-istudju.
English: 1 silicone-free syringe
Maltese: Siringa 1 bla silikon
English: Important instructions for use.
Maltese: Struzzjonijiet għall-użu importanti.
English: Baseline (Mean)
Maltese: Linja Bażi (Medja)
English: Immunogenicity in adults treated with intravenous abatacept
Maltese: Immunoġeniċità f'pazjenti adulti ttrattati b'abatacept ġol-vini
English: This medicine contains 34.5 mg sodium (main component of cooking/table salt) per maximum dose of 4 vials (8.625 mg sodium per vial).
Maltese: Din il-mediċina fiha 34.5 mg sodium (komponent ewlieni tal-melħ tat-tisjir) f'doża massima ta' 4 kunjetti (8.625 mg sodium f'kull kunjett).
English: Of the 219 patients entering the study, 56 (25.6%) had previously been treated with biologic DMARD therapy (including TNF inhibitors and tocilizumab).
Maltese: Mill-219-il pazjent li daħlu fl-istudju, 56 (25.6%) kienu ġew ikkurati preċedentement b'terapija DMARD bijoloġika (li tinkludi inibituri ta' TNF u tocilizumab).
English: Of the 133 (70%) patients with no prior TNF-inhibitor therapy, 101 (76%) achieved at least an ACR Pedi 30 response; of the 57 patients who had received prior TNF-inhibitor therapy, 22 (39%) achieved at least an ACR Pedi 30 response.
Maltese: Mill-133 (70%) tal-pazjenti mingħajr lebda terapija b'inibitur ta' TNF fil-passat, 101 (76%) kisbu mill-inqas rispons għal ACR Pedi 30; mis57 pazjent li fil-passat irċivew terapija b'inibitur ta' TNF, 22 (39%) kisbu mill-inqas rispons għal ACR Pedi 30.
English: In the substudy 108 subjects were randomised 1:1 in double blinded fashion to receive abatacept at doses approximating 10 mg/kg (ABA 10) or 5 mg/kg (ABA 5).
Maltese: Fis-sottostudju, 108 persunaa ntagħżlu b'mod każwali 1:1 b'mod double-blind biex jirċievu abatacept f'dożi li joqorbu 10 mg/kg (ABA 10) jew 5 mg/kg (ABA 5).
English: At 24 months, 50.6% (127/251) [95% CI: 44.4, 56.8] of patients in abatacept and 53.3% (130/244) [95% CI: 47.0, 59.5] of patients in adalimumab groups achieved DAS 28 < 2.6.
Maltese: Wara 24 xahar, 50.6% (127/251) [95% CI: 44.4, 56.8] ta' pazjenti fil-grupp ta' abatacept u 53.3% (130/244)
English: Rare (may affect up to 1 in 1,000 people): tuberculosis inflammation of uterus, fallopian tubes and/or ovaries gastrointestinal infection cancer of white blood cells, lung cancer
Maltese: Rari (jista' jaffettwa sa persuna 1 minn kull 1,000): tuberkolożi infjammazzjoni tal-utru, tat-tubi fallopjani u/jew tal-ovarji infezzjoni gastrointestinali kanċer taċ-ċelloli tad-demm bojod, kanċer tal-pulmun
English: b 61% of patients were previously treated with TNF inhibitor.
Maltese: b 61% tal-pazjenti ġew ikkurati qabel b'inibitur ta' TNF.
English: Headache, dizziness Uncommon Migraine, paraesthesia
Maltese: Uġigħ ta' ras, sturdament Mhux komuni Emigranja, parasteżija
English: During the 24-week placebo-controlled period in the larger study PsA-II, the proportion of patients with adverse reactions was similar in the abatacept and placebo treatment groups (15.5% and 11.4%, respectively).
Maltese: Waqt il-perjodu ta' 24 ġimgħa kkontrollat bi plaċebo fl-istudju ikbar PsA-II, il-proporzjon ta' pazjenti b'reazzjonijiet avversi kien simili fil-gruppi ta' kura ta' abatacept u plaċebo (15.5 % u 11.4 %, rispettivament).
English: At 12 months 61% (148/242) of the patients treated with abatacept plus methotrexate and 53% (128/242) of the patients treated with methotrexate plus placebo had no progression (TSS ≤ 0).
Maltese: Wara 12-il xahar 61% (148/242) tal-pazjenti kkurati b'abatacept flimkien ma' methotrexate u 53% (128/242) tal-pazjenti kkurati b'methotrexate flimkien ma' plaċebo ma kellhomx progressjoni (TSS ≤ 0).
English: The pJIA SC study included 46 patients in the 2 to 5 year age cohort and 173 patients in the 6 to 17 year age cohort.
Maltese: L-istudju ta' pJIA SC inkluda 46 pazjent fil-koorti tal-età ta' sentejn sa 5 snin u 173 pazjent fil-koorti tal-età ta' 6 sa 17-il sena.
English: SDAI Clinical Remissionb Estimate of Difference (95% CI) vs. MTX
Maltese: Remissjoni Klinika ta' SDAIb Stima ta' Differenza (95% CI) vs.
English: c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating,
Maltese: c Kwestjonarju dwar il-Valutazzjoni tas-Saħħa; 0 = l-aħjar, 3 = l-agħar; 20 mistoqsija; 8 kategoriji: tbiddil u kura personali,
English: In study SC-III, the proportion of subjects with a HAQ response as a measure of clinically meaningful improvement in physical function (reduction from baseline in HAQ-D1 score of ≥ 0.3) was greater for the abatacept+ MTX group vs. the MTX group at month 12 (65.5% vs 44.0%, respectively; treatment difference vs. MTX group of 21.6% [95% CI: 8.3, 34.9]).
Maltese: Fi studju SC-III, il-proporzjon ta' individwi b'rispons tal-HAQ bħala kejl ta' titjib klinikament sinifikanti fil-funzjoni fiżika (it-tnaqqis mil-linja bażi fil-punteġġ ta' HAQ-DI ta' > 0.3) kien akbar għall-grupp ta' abatacept + MTX vs il-grupp tal-MTX f'xahar 12 (65.5% vs 44.0%, rispettivament; iddifferenza fil-kura vs il-grupp tal-MTX ta' 21.6% [95% CI: 8.3, 34.9]).
English: You may need to read it again.
Maltese: II, VI u SCII.
English: Participants in Period C at day 1765 included 33 of the 58 Period B abatacept recipients, 30 of the 59 Period B placebo recipients, and 13 of the 36 Period A non-responders.
Maltese: Il-parteċipanti fil-Perjodu Ċ f'jum 1765 inkludew 33 mit-58 reċipjent ta' abatacept tal-Perjodu B, 30 mid-59 reċipjent ta' plaċebo ta' Perjodu B, u 13 mis-36 li ma rrispondewx ta' Perjodu A.
English: To be administered as a 30-minute intravenous infusion at the dose specified in Table 1.
Maltese: Għandu jingħata bħala infużjoni fil-vini fuq 30 minuta b'doża speċifikata f'Tabella 1.
English: Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses.
Maltese: Studji indikaw li risponsi naïve għal limfoċiti-T huma iktar affetwati b'abatacept milli risponsi għal limfoċiti-T tal-memorja.
English: Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injections.
Maltese: Eċċipjenti: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, ilma għall-injezzjonijiet.
English: In study PsA-II, the ACR 20 responses with abatacept 125 mg subcutaneous vs placebo in patients who were TNF inhibitor-naive were 44.0% vs 22.2%, respectively (21.9 [8.3, 35.6], estimate of difference [95% CI]), and in patients who were TNF inhibitor-experienced were 36.4% vs 22.3%, respectively (14.0 [3.3, 24.8], estimate of difference [95% CI]).
Maltese: Fl-istudju PsA-II, ir-risponsi ta' ACR 20 b'abatacept 125 mg taħt il-ġilda vs plaċebo f'pazjenti li ma kellhomx esperjenza ta' inibitur ta' TNF kienu ta' 44.0% vs 22.2%, rispettivament (21.9 [8.3, 35.6], stima ta' differenza [95% CI]), u f'pazjenti li kellhom esperjenza ta' inibitur ta' TNF kienu ta' 36.4% vs 22.3%, rispettivament (14.0 [3.3, 24.8], stima ta' differenza [95% CI]).
English: Doses up to 50 mg/kg have been administered intravenously without apparent toxic effect.
Maltese: Dożi sa 50 mg/kg ingħataw mingħajr sinjali ta' effett tossiku.
English: The frequency of local injection site reactions was 3.8% (12/318) and 9.1% (30/328) at 12 months (p=0.006) and 4.1% (13/318) and 10.4% (34/328) at 24 months for abatacept SC and adalimumab SC, respectively.
Maltese: Il-frekwenza ta' reazzjonijiet lokali fis-sit tal-injezzjoni kienet ta' 3.8% (12/318) u 9.1% (30/328) wara 12-il xahar (p = 0.006) u 4.1% (13/318) u 10.
English: In placebo-controlled clinical trials, malignancies were reported in 1.2% (31/2,653) of abatacepttreated patients and in 0.9% (14/1,485) of placebo-treated patients.
Maltese: Fi provi kliniċi kkontrollati bi plaċebo, tumuri malinni ġew rappurtati f'1.2% (31/2,653) tal-pazjenti trattati b'abatacept u f'0.9% (14/1,485) tal-pazjenti trattati bi plaċebo.
English: Mean estimates for systemic clearance (0.28 mL/h/kg), volume of distribution (0.11 L/kg), and terminal half-life (14.3 days) were comparable between subcutaneous and intravenous administration.
Maltese: L-istimi medji għat-tneħħija sistemika (0.28 mL/h/kg), il-volum ta' distribuzzjoni (0.11 L/kg), u l-half-life terminali (14.3-il jum) kienu komparabbli bejn l-għoti taħt il-ġilda u l-għoti fil-vini.
English: Patients were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial.
Maltese: Il-pazjenti tħallew jirċievu dożi stabbli ta' methotrexate, sulfasalazine, leflunomide, hydroxychloroquine konkomitanti, kortikosterojdi ta' dożi baxxi (ekwivalenti għal ≤ 10 mg ta' prednisone) u/jew NSAIDs matul il-prova.
English: There is limited experience with use of abatacept in combination with TNF-inhibitors (see section 5.1).
Maltese: Hemm esperjenza limitata dwar l-użu ta' abatacept f'kombinazzjoni ma' inibituri ta' TNF (ara sezzjoni 5.1).
English: Preparation of infusion: immediately after reconstitution, dilute the concentrate to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Preparazzjoni tal-infużjoni: minnufih wara rikostituzzjoni, iddilwa l-konċentrat għal 100 mL b'sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: At 24 months, 20.8 % (66/318) of patients on abatacept and 25.3 % (83/328) on adalimumab had discontinued.
Maltese: Wara 24 xahar, 20.8% (66/318) tal-pazjenti fuq abatacept u 25.3% (83/328) fil-grupp ta' adalimumab kienu waqqfu l-kura.
English: e DAS28-CRP Remission is defined as a DAS28-CRP score < 2.6 f Per protocol data is presented in table.
Maltese: e DAS28-CRP Remissjoni hi mfissra bħala punteġġ ta' < 2.6 ta' DAS28-CRP f Skont il-protokoll, id-dejta hija ppreżentata fit-tabella.
English: Antibodies directed against the abatacept molecule were assessed by ELISA assays in 3,985 rheumatoid arthritis patients treated for up to 8 years with abatacept.
Maltese: Antikorpi li ġew diretti kontra l-molekula ta' abatacept ġew ivvalutati b'analiżi ta' ELISA fi 3,985 pazjent b'artrite rewmatojde ttrattati għal mhux aktar minn 8 snin b'abatacept.
English: Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Maltese: Analiżi farmakokinetika tal-popolazzjoni ma wriet l-ebda effett ta' methotrexate, NSAIDs u kortikosterojdi fuq l-eliminazzjoni ta' abatacept (ara sezzjoni 5.2).
English: 87.5 mg/0.7 mL Pre-filled Syringe
Maltese: 87.5 mg/0.7 mL Siringa mimlija għal-Lest
English: After 24 months, adverse reactions were reported in 41.5% (132/318) and 50% (164/328) of abatacept and adalimumab-treated patients.
Maltese: Wara 24 xahar, reazzjonijiet avversi ġew irrappurtati f'41.5% (132/318) u 50% (164/328) tal-pazjenti kkurati b'abatacept u adalimumab.
English: No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies.
Maltese: L-ebda mutaġeniċità jew klastoġeniċità ma ġew osservati b'abatacept f'batterija ta' studji in vitro.
English: Abatacept has been studied in patients with active psoriatic arthritis in two placebo-controlled clinical trials (341 patients with abatacept, 253 patients with placebo) (see Section 5.1).
Maltese: Abatacept ġie studjat f'pazjenti b'artrite psorjatika attiva f'żewġ provi kliniċi kkontrollati bi plaċebo (341 pazjent b'abatacept, 253 pazjent bi plaċebo) (ara Sezzjoni 5.1).
English: The other ingredients are maltose, sodium dihydrogen phosphate monohydrate and sodium chloride (see section 2 "ORENCIA contains sodium").
Maltese: L-ingredjenti l-oħra huma maltose, sodium dihydrogen phosphate monohydrate u sodium chloride (ara sezzjoni 2 “ORENCIA fih sodium”).
English: During the 12-month treatment period, adverse reactions were reported in 44.5% (53/119), 41.4% (48/116), and 44.0% (51/116) and serious adverse reactions were reported in 2.5% (3/119), 2.6% (3/116) and 0.9% (1/116) of patients treated in the three treatment groups, respectively.
Maltese: Waqt il-perjodu tal-kura ta' 12-il xahar, ir-reazzjonijiet avversi kienu rrapportati f'44.5% (53/119), 41.4% (48/116), u 44.0% (51/116) u reazzjonijiet avversi serji kienu rrapportati f'2.5% (3/119), 2.6% (3/116) u 0.9% (1/116) ta' pazjenti kkurati fit-tliet gruppi ta' kura, rispettivament.
English: † p < 0.05, abatacept plus MTX vs MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
Maltese: p < 0.05, abatacept flimkien ma' MTX vs MTX flimkien ma' placebo a Doża fissa li tqarreb 10 mg/kg (ara sezzjoni 4.2).
English: In placebo-controlled clinical trials with abatacept, adverse reactions (ARs) were reported in 49.4% of abatacept-treated patients and 45.8% of placebo-treated patients.
Maltese: Fi provi kliniċi b'abatacept ikkontrollati bi plaċebo, reazzjonijiet avversi (ARs) ġew irrapportati f'49.4% tal-pazjenti ttrattati b'abatacept u f'45.8% tal-pazjenti ttrattati bi plaċebo.
English: In study SC-II, structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde-modified Total Sharp Score (mTSS) and its components.
Maltese: Fi studju SC-II, il-ħsara strutturali tal-ġogi ġiet evalwata permezz ta' mod radjografiku u espressa bħala bidla mil-linja bażi fil-van der Heijde-modified Total Sharp Score (mTSS) u l-komponenti tiegħu.
English: In study PsA-I, the proportion of patients with ≥ 0.30 decrease from baseline in HAQ-DI score was 45.0% with intravenous abatacept vs 19.0% with placebo (26.1 [6.8, 45.5], estimate of difference [95% CI]) at Week 24.
Maltese: Fi studju PsA-I, il-proporzjon ta' pazjenti bi tnaqqis ta' ≥ 0.30 mil-linja bażi fil-punteġġ ta' HAQ-DI kien ta' 45.0% b'abatacept ġol-vini vs 19.0% bi plaċebo (26.1 [6.8, 45.5], stima ta' differenza [95% CI]) f'Ġimgħa 24.
English: In the 6 to 17 year age cohort 132 (76.3%) patients completed 2 years.
Maltese: Fil-koorti ta' dawk bejn is-6 u s 17-il sena ta' età, 132 (76.3%) pazjent temmew is-sentejn.
English: A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2).
Maltese: Linja ko-stimulatorja maġġura tinvolvi li CD80 jaqbad ma'molekoli ta' CD86 fuq il-wiċċ ta' ċelluli li fihom antiġen għar-iċettur CD28 fuq il-limfoċiti T (sinjal 2).
English: The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 1).
Maltese: Il-profil ta' sigurtà globali kien komparabbli bejn l-istudji PsA-I u PsA-II u konsistenti mal-profil ta' sigurtà f'artrite tar-rewmatiżmu (Tabella 1).
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe The active substance is abatacept.
Maltese: ORENCIA 87.5 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Is-sustanza attiva hi abatacept.
English: They had active disease, with a mean active joint count of 11.8, mean number of joints with loss of motion of 10.3, and a mean elevated C-reactive protein (CRP) level of 1.24 mg/dL at baseline.
Maltese: Dawn kellhom marda attiva, b'għadd tal-ġogi attiv medju ta' 11.8, numru medju ta' ġogi b'telf ta' mozzjoni ta' 10.3, u livell miżjud medju ta' proteina C-reattiva (CRP) ta' 1.24 mg/dL fil-linja bażi.
English: Anti-rheumatic therapies have been associated with hepatitis B reactivation.
Maltese: It-terapiji antirewmatiċi ġew assoċjati ma' riattivazzjoni tal-epatite B.
English: The dose of abatacept was 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1,000 mg for patients weighing greater than 100 kg. Study V patients were randomised to receive this same fixed dose of abatacept or 3 mg/kg infliximab or placebo for 6 months.
Maltese: Id-doża ta' abatacept kienet 500 mg għall-pazjenti li kienu jiżnu inqas minn 60 kg, 750 mg għall-pazjenti li kienu jiżnu 60 sa 100 kg, u 1,000 mg għall-pazjenti li kienu jiżnu iktar minn 100 kg. Pazjenti ta' studju V ġew mifrudin fuq bażi każwali biex jirċievu din l-istess doża fissa ta' abatacept jew 3 mg/kg infloximab jew plaċebo għal 6 xhur.
English: e DAS28-CRP Remission is defined as a DAS28-CRP score < 2.6
Maltese: e DAS28-CRP Remissjoni hi mfissra bħala punteġġ ta' < 2.6 ta' DAS28-CRP
English: Common adverse reactions: pyrexia Uncommon adverse reactions: haematuria, otitis (media and externa).
Maltese: Reazzjonijiet avversi komuni: deni Reazzjonijiet avversi mhux komuni: ematurja, otite (medja u esterna).
English: In study PsA-II, the proportion of patients with at least ≥ 0.35 decrease from baseline in HAQ-DI was 31.0% with abatacept vs. 23.7% with placebo (7.2 [-1.1, 15.6], estimate of difference [95% CI]).
Maltese: Fi studju PsA-II, il-proporzjon ta' pazjenti bi tnaqqis ta' tal-inqas ≥ 0.35 mil-linja bażi f'HAQ-DI kien ta' 31.0% b'abatacept vs 23.7% bi plaċebo (7.2 [-1.1, 15.6], stima ta' differenza [95% CI]).
English: Rheumatoid arthritis (RA) affects everyone differently.
Maltese: L-artrite rewmatojde (RA) taffettwa lil kulħadd b'mod differenti.
English: After influenza vaccination, 73 of 119 abatacept-treated patients without protective antibody levels at baseline were able to mount an adequate immune response of at least a 4-fold increase in antibody titers to trivalent influenza vaccine.
Maltese: Wara t-tilqima kontra l-influwenza, 73 mill-119-il pazjent ikkurati b'abatacept mingħajr livelli ta' antikorpi protettivi fil-linja bażi kienu kapaċi jipproduċu rispons immuni adegwat ta' mill-inqas żieda ta' 4 darbiet ta' titres ta' antikorpi għattilqima trivalenti kontra l-influwenza.
English: Rheumatoid arthritis Adults
Maltese: Artrite tar-rewmatiżmu Adulti
English: Reversible pharmacological effects consisted of minimal transient decreases in serum IgG and minimal to severe lymphoid depletion of germinal centres in the spleen and/or lymph nodes.
Maltese: Effetti farmakoloġiċi riversibbli kienu jikkonsistu fi tnaqqis temporanju minimu fl-IgG tas-serum, u tbattil minimu għal sever taċ-ċentri tal-ġerminazzjoni tal-limfomi fil-milsa u/jew fil-glandoli limfatiċi.
English: The primary endpoint showed noninferiority (predefined margin of 12%) of ACR 20 response after 12 months of treatment, 64.8% (206/318) for the abatacept SC group and 63.4% (208/328) for the adalimumab SC group; treatment difference was 1.8% [95% confidence interval (CI): -5.6, 9.2], with comparable responses throughout the 24-month period.
Maltese: Il-punt aħħari primarju wera noninferjorità (marġni definit minn qabel ta' 12%) ta' rispons ACR 20 wara 12-il xahar ta' kura, 64.8% (206/318) għall-grupp ta' abatacept SC u 63.4% (208/328) għall-grupp ta' adalimumab SC; id-differenza fil-kura kienet ta' 1.8% [95% intervall ta' fiduċja (CI): -5.6, 9,2 [sic: 9.2]], b'risponsi komparabbli matul il-perjodu kollu ta' 24 xahar.
English: The geometric mean estimate (90% confidence interval) for the bioavailability of abatacept following subcutaneous administration relative to intravenous administration is 78.6% (64.7%, 95.6%).
Maltese: L-istima ġeometrika medja (intervall ta' kunfidenza ta' 90%) għall-bijodisponibilità ta' abatacept wara għoti taħt il-ġilda meta mqabbla ma' għoti ġol-vini hija 78.6% (64.7%, 95.6%).
English: The mean change was, 0.41 and 0.74 from year 1 to year 2 (n=290, 130), 0.37 and 0.68 from year 2 to year 3 (n=293, 130), 0.34 and 0.43 from year 3 to year 4 (n=290, 128) and the change was 0.26 and 0.29 (n=233, 114) from year 4 to year 5 for patients originally randomised to abatacept plus MTX and placebo plus MTX respectively.
Maltese: Il-bidla medja kienet, 0.41 u 0.74 minn sena 1 sa sena 2 (n = 290, 130), 0.37 u 0.68 minn sena 2 sa sena 3 (n = 293, 130). 0.34 u 0.43 minn sena 3 sa sena 4 (n = 290, 128) u l-bidla kienet 0.26 u 0.29 (n-233, 114) minn sena 4 sa sena 5 għal pazjenti oriġinarjament magħżula b'mod każwali biex jirċievu abatacept flimkien ma' MTX u plaċebo flimkien ma' MTX rispettivament.
English: Placebo +MTX n = 214
Maltese: Plaċebo +MTX n = 214
English: In the 2 to 5 year age cohort, 39 (84.8%) patients completed 2 years.
Maltese: Fil-koorti ta' dawk bejn is-sentejn u l- ħames snin ta' età, 39 (84.8%) pazjent temmew is-sentejn.
English: Abatacept was evaluated in an open-label study in rheumatoid arthritis patients administered the 23valent pneumococcal vaccine.
Maltese: Abatacept ġie evalwat fi studju open-label f'pazjenti b'artrite rewmatojde li ngħataw it-tilqima pnewmokokkali ta' 23 valent.
English: In those patients who initially received infliximab and then switched to abatacept, the reduction in the mean DAS28 score from baseline was 3.29 at day 729 and 2.48 at day 365.
Maltese: F'dawk il-pazjenti li fil-bidu kienu jirċievu infliximab u mbagħad qalbu għal abatacept, it-tnaqqis filpunteġġ medju ta' DAS28 mil-linja bażi kien ta' 3.29 f'Jum 729 u 2.48 f'Jum 365.
English: ORENCIA contains sodium
Maltese: ORENCIA fih is-sodium
English: After multiple intravenous infusions (days 1, 15, 30, and every 4 weeks thereafter), the pharmacokinetics of abatacept in rheumatoid arthritis patients showed dose-proportional increases of Cmax and AUC over the dose range of 2 mg/kg to 10 mg/kg.
Maltese: Wara infużjonijiet ġol-vini ripetuti (jiem 1, 15, 30 u kull 4 ġimgħat minn hemm ‘il quddiem), ilfarmakokinetiċi ta' abatacept f'pazjenti b'artrite tar-rewmatiżmu wrew żidiet proporzjonati għad-doża ta' Cmas u AUC fuq il-medda ta' dożi ta' bejn 2 mg/kg u 10 mg/kg.
English: Study SC-I was a randomised, double-blind, double-dummy noninferiority study administered to patients stratified by body weight (< 60 kg, 60 to 100 kg, > 100 kg) that compared the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis (RA), receiving background methotrexate (MTX), and experiencing an inadequate response to MTX (MTX-IR).
Maltese: L-Istudju SC-I kien studju double-blind, double-dummy, mhux ta' inferjorità, randomizzat, imwettaq fuq pazjenti stratifikati skont il-piż talġisem (< 60 kg, 60 sa 100 kg, > 100 kg) li qabbel l-effikaċja u s-sigurtà ta' abatacept mogħti taħt ilġilda u ġol-vini f'individwi b'artrite rewmatika (RA), li kienu qegħdin jirċievu methotrexate (MTX) fl-isfond, u esperjenzaw rispons inadegwat għal MTX (MTX-IR).
English: After reconstitution, each mL contains 25 mg of abatacept.
Maltese: Wara rikostituzzjoni, kull mL fih 25 mg ta' abatacept.
English: EU/1/07/389/012 12 pre-filled pens (3 packs of 4)
Maltese: EU/1/07/389/012 12-il pinna mimlijin għal-lest (3 pakketti ta' 4)
English: Major Clinical Responsec
Maltese: Rispons Kliniku Maġġuric
English: Orange plunger
Maltese: Planġer oranġjo