FrancophonIA/ELRC3.0 huggingface dataset:
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Maltese: Wara dożi ta' 0.5 mg/kg (~40 mg), it­ tneħħija mill­ġisem varjat minn 11 sa 15 mL/siegħa, il­volum ta' distribuzzjoni (Vss) varja minn 5 sa 6 litri u l­half­life medja tal­fażi terminali kienet ta' bejn wieħed u ieħor gimagħtejn.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Maltese: Fi studji kontrollati u open-label b' adalimumab fl­adulti u fit­tfal, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulosi (inklużi tuberkulosi b'ħafna għoqod tuberkulari mal­ġisem kollu u tuberkulosi f'postijiet barra mill­pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa jew barra l-pulmun, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis aspergillosis u listeriosis).
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Maltese: Adalimumab wera aktar titjib statistikament sinifikanti fil­punteġġ totali ta' HAQ­S u fil­ Punteġġ Kompetenti Fisiku (PCS) tal­SF­36 mill­linja bażi sa ġimgħa 12 meta mqabbel mal­plaċebo.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, ,blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Maltese: Fi studji kontrollati u open-label b'adalimumab fl­adulti u fit­tfal, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulosi (inklużi tuberkulosi b'ħafna għoqod tuberkulari mal­ġisem kollu u tuberkulosi f'postijiet barra mill­pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa jew barra l-pulmun, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis aspergillosis u listeriosis).
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab ġew studjati fi studju kollettiv multicenter, randomizzat,u double-blind f'171 tifel u tifla (li għandhom bejn 4­17 il­sena) b'JIA poliartikulari.
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Maltese: Il­punt tat­tmiem primarju kien il­bidla perċentwali mill­linja bażi sa ġimgħa 12 fin­numru ta' ġogi attivi bl­artrite (nefħa mhux minħabba sfigurazzjoni jew ġogi li madhomx jiċċaqalqu flimkien ma' wġigħ u/jew sensittività), li kien milħuq b'perċentwali medja ta' tnaqqis ta' ­62.6% (bidla perċentwali medja ­88.9%) f'pazjenti fil­grupp ta' Idacio meta kkumparat ma' ­11.6% (bidla perċentwali medja ­ 50.0%) f'pazjenti fil­grupp tal­plaċebo.
English: 4.1 Choose an injection site (Figure J) on:
Maltese: 4.1 Agħżel sit għall­injezzjoni (Stampa J) minn:
English: Idacio is used to treat psoriatic arthritis in adults.
Maltese: Idacio jintuża għal trattament ta' artrite psorjatika fl­adulti.
English: >32 weeks 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Maltese: >32 ġimgħa 14­il ġimgħa a Rispons Ped ACR 30/50/70 f'ġimgħa 48 kien wisq akbar minn dak ta' pazjenti kkurati bil­plaċebo b p = 0.015
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/mL (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/mL (47.7% CV) with concomitant methotrexate.
Maltese: artrite idjopatika poliartikulari taż­żagħżagħ (JIA) li kellhom 4 sa 17­il sena, trough steady-state medju ta' koncetrazzjoni ta' adalimumab fis­serum (valuri mkejla minn ġimgħa 20 sa 48) kien 5.6 ± 5.6 µg/mL (102 %CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 10.
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Maltese: Adalimumab jimmodula ukoll ir­risponsi bijoloġiċi li jiġu kkawżati jew regolati mit­TNF, inkluż tibdil fil­livelli tal­molekuli li jeħlu li huma risponsabbli għall­migrazzjoni tal­lewkoċite (ELAM­1, VCAM­ 1, u ICAM-1 ma' xi IC50 ta' 0.
English: Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: Idacio huwa ndikat għat­trattament ta' psorjasi tal­plakka severa u kronika fit­tfal u adoloxxenti minn 4 snin il­fuq u li kellhom rispons mhux adegwat jew huma kandidati mhux xierqa għat­terapija topika u fototerapiji.
English: Note: P# = Placebo (Number of events/Number at risk); A# = Adalimumab (number of events/Number at risk).
Maltese: Nota: P# = Plaċebo (Numru ta' Avvenimenti/Numru fir­Riskju); A# = Adalimumab (Numru ta' Avvenimenti/Numru fir-Riskju).
English: In CD study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Maltese: Fi studju CD I, 299 pazjent li qatt ma ħadu antagonist ta' TNF ġew imqassma bl­addoċċ f'wieħed minn erbgħa gruppi ta' nies li kienu qegħdin jieħdu l­kura; plaċebo f'ġimgħat 0 u 2, 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2, 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2, u 40 mg f'ġimgħa 0 u 20 mg f'ġimgħa 2.
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Maltese: Studju RA I evalwa 271 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena, ma kinux irrispondew għal kura b'mill­inqas mediċina waħda anti­rewmatika li taffetwa l­proċess tal­mard u li kellhom effikaċja insuffiċjenti b'methotrexate f'dożi minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil­ġimgħa, u li d­doża ta' methotrexate tagħhom baqgħet kostanti minn 10 sa 25 mg fil­ġimgħa.
English: Adalimumab 40 mg weekly Placebo
Maltese: Adalimumab 40 mg kull ġimgħa Plaċebo
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab ġew stimati fil fuq minn 1,500 pazjent li jbatu mill­marda Crohn (Crohn's disease) attiva b'mod minn moderat sa sever (Indiċi tal­Attività tal­Marda Crohn (Crohn's disease) (CDAI)  220 u  450) fi studji double-blind, kontrollati bil­plaċebo, li saru b'mod każwali.
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Maltese: Il­valuri­p kollha huma paraguni magħmula għal kull par ta' proporzjonijiet għal adalimumab kontra l­plaċebo * p < 0.001 ** p < 0.01
English: 1.2 Leave the kit at room temperature for at least 30 minutes to allow the medicine to warm up.
Maltese: 1.2 Ħalli l­kitt fit­temperatura tal­kamra għal mill­inqas 30 minuta biex tippermetti l­mediċina tisħon.
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Maltese: Studju RA III evalwa 619 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena, u li kellhom rispons mhux effettiv meta ngħataw dożi ta' minn 12.5 sa 25 mg ta' methotrexate jew kienu intolleranti għal 10 mg ta' methotrexate fil­ġimgħa.
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Maltese: Mill­pazjenti li kellhom rispons f'ġimgħa 8, 47% kienu fi stat tar­rispons, 29% kienu fi stat ta' titjib, 41% kellhom fejqan tal­mukuża, u 20% kienu fl­istat ta' titjib mingħajr sterojdi għal ≥ 90 jum f' ġimgħa 52.
English: Idacio 40 mg/0.8 mL solution for injection for paediatric use adalimumab
Maltese: Idacio 40 mg/0.8 mL injezzjoni adalimumab
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Maltese: Madankollu, ma ġewx osservati l­ebda tumuri malinni f'192 pazjenti b'espożizzjoni ta' 498.1 sena ta' pazjent waqt provi b'adalimumab f'pazjenti pedjatriċi bil­marda Crohn (Crohn's disease).
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
Maltese: Fi studji tal-marda Crohn (Crohn's disease) fl­adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mall-infezjoni meta adalimumab kienet kkombinata ma' azathioprine/6­mercaptopurine meta mqabbla ma' adalimumab waħeda.
English: • pulmonary fibrosis (scarring of the lung);
Maltese: • fibrożi fil­pulmun (marki fil­pulmun)
English: Myocardial infarction1), arrhythmia, congestive heart failure
Maltese: Infart mijokardiku1), tħabbit irregolari tal­qalb, insuffiċjenza tal­qalb konġestiva
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg.
Maltese: F'pazjenti pedjatriċi li għandhom CD moderata sa severa, d­doża tal­bidu ta' adalimumab open-label kienet 160/80 mg jew 80/40 mg f'ġimgħa 0 u 2, rispettivament, li kienet tiddeppendi fuq il­punt ta' qtugħ tal­piż tal­ġisem ta' 40 kg.
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Maltese: Rati simili ta' titjib ġew osservati għad­dożaġġ tal­bidu ta'160/80 mg u 80/40 mg milħuqa sa ġimgħa 8 u fil­grupp tal­160/80 mg, l­effetti avversi ġew innutati b'mod aktar frekwenti.
English: Table 23 Induction of clinical remission and response (percent of patients) CD study I: Infliximab naive patients
Maltese: Tabella 23 Qlib għall-aħjar fl-istat kliniku u rispons (persentaġġ ta' pazjenti) Studju CD I: Pazjenti li qatt ma ħadu infliximab
English: Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Maltese: Infezzjonijiet serji, li jinkludu sepsis kkawżati minn batterji, myco­batterji, fungus invażiv, parassiti, virus u infezzjonijiet opportunistiċi oħra bħal listeriżi, leġinellożi u pneumocystis, ġew rapportati f'pazjenti li kienu qed jirċievu adalimumab.
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leucopenia) have been reported with adalimumab.
Maltese: Effetti avversi tas­sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopaenia, lewkopenja) ma ġewx irrappurtati b'Idacio.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Maltese: Seħħet riattivazzjoni ta' epatite B f'pazjenti li kienu qed jirċievu xi antagonist ta' TNF, inkluż adalimumab, u li kienu jġorru dan il­virus b'mod kroniku (jigifieri pozittivi għal­surface antigen).
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Maltese: Ir­rata ta' tqaliet li jintemmu b'għallinqas tarbija tat­twelid ħajja waħda b'difett maġġuri mat­twelid kienet 6/69 (8.7%) fin­nisa kkurati b'adalimumab b' RA u 5/74 (6.8%) fin­nisa mhux ikkurati b'RA (OR mhux aġġustata 1.31, 95% CI 0.38-4.52) u 16/152 (10.
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab ġew evalwati fi studji li kienu imqassma b'mod każwali, double­blind, ikkontrollati bi plaċebo u studju ta' estensjoni open­label f'pazjenti adulti bi hidradenitis suppurativa (HS) moderata sa severa li kienu intoleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill­inqas ta' 3 xhur provi ta' terapija antibijotika sistemika.
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
Maltese: Tfal u adolexxenti minn eta ta' 4 snin sa 17­il sena li jiżnu bejn 15 kg sa inqas minn 30 kg
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
Maltese: Eċċipjenti: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide u ilma għall­ injezzjonijiet..
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Maltese: Titjib kliniku hu l­punteġġ Mayo ≤ 2 bl­ebda sottopunteġġ > 1;
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Maltese: Il­livelli fis­serum ta' metalloproteinases fil­matriċi (MMP­1 u MMP­3) li jipproduċu tibdil fit­tessuti li hu responsabbli għall­qerda tal­qarquċa, naqsu ukoll wara li ngħata adalimumab.
English: Table 17 Ps Study I (REVEAL) efficacy results at 16 weeks Placebo N=398 n (%)
Maltese: Tabella 17 Studju Ps I (REVEAL) -Riżultati ta' effikaċja f'16-il Ġimgħa
English: • severe rash, hives;
Maltese: • Raxx sever, urtikarja;
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Maltese: Fil­gruppi kollha ta' trattament, il­punteġġ medju PASI tal­linja bażi kien ta' 18.9 u punteġġ tal­PGA tal­linja bażi varja minn “moderati” (53% tas­ suġġetti inklużi) għal “sever” (41%) għal “sever ħafna” (6% ).
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenja, anemija aplastika, avvenimenti li jeffetwaw il­myelin b'mod ċentrali jew periferali u rapporti ta' lupus, kundizzjonijiet relatati ma lupus u s­sindromu ta' Stevens­ Johnson.
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Maltese: Ir­rata (95% intervall ta' konfidenza) ta' kanċer tal­ġilda li m'humiex melonoma kienet 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Maltese: Titjib fil­kwalità tal­ħajja rrelatata mas­saħħa u funzjoni fiżika nżamm matul l­estensjoni open-label sa ġimgħa 156.
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Maltese: F'ġimgħa 12, proporzjon sinifikattivament ogħla ta' pazjenti fi Studju HS­II esperjenzat tnaqqis klinikament rilevanti fl­uġigħ tal­ġilda relatati mal­HS (ara t­Tabella 17).
English: 3.1 Peel open the syringe packaging and grab the syringe by the barrel.
Maltese: 3.1 Qaxxar biex tiftaħ l­ippakkjar tas­siringa u aqbad is­siringa mill­bittija.
English: Single use components and medicine vial (adalimumab) for subcutaneous injection 40 mg/0.8 mL
Maltese: Komponenti ta' użu ta' darba u kunjett tal-mediċina (adalimumab) għall-injezzjoni taħt il-ġilda 40 mg/0.8 mL
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Maltese: M'hemmx informazzjoni disponibbli li tipparaguna adalimumab u MTX wara 16­il ġimgħa ta' terapija.
English: the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Maltese: kura ta' artrite rewmatika attiva u progressiva severa f'adulti li ma jkunux ingħataw kura b'methotrexate qabel.
English: Italy.
Maltese: L-Italja
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Maltese: B'mod ġenerali, l­effetti avversi f'pazjenti pedjatriċi kellhom frekwenza u t­tip simili għal dawk li ġew osservati f'pazjenti adulti.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA/I
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Maltese: Titjib sinifikanti ta' sinjali ta' infjammazzjoni kif imkejjel mil­ hs­CRP u MRI taż­żewġ Ġogi Sacroiljaċi u l­Spina nżamm f'pazjenti ttrattati b'adalimumab sa ġimgħa 156 u ġimgħa 104, rispettivament.
English: • facial oedema (swelling);
Maltese: • infjammazzjoni tal­ġilda (bħall­ekżema);
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
Maltese: Ir­rati tal­qlib għall­aħjar fl­istat kliniku u r­rispons kliniku (definit bħala tnaqqis fir­riżultat tal­ PCDAI ta' mill­inqas 15­il punt mill­linja bażi) huma preżentati f'Tabella 26.
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Maltese: F'ġimgħa 52, 42.9% tal­pazjenti li rċevew it­terapija kombinata ta' adalimumab/methotrexate laħqu titjib kliniku (DAS28 (CRP) < 2.6) meta pparagunati ma' 20.
English: • Store the Idacio Vial Kit in a refrigerator between 2°C to 8°C.
Maltese: • Żomm il­Kitt tal­Kunjett ta' Idacio fi friġġ f'temperatura ta' bejn 2°C sa 8°C.
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab/methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Maltese: Fi studju RA V, it­titjib fl­indiċi ta' diżabilità HAQ u fil­komponent fiżiku ta' l­SF 36 wera titjib akbar (p < 0.001) għat­terapija kombinata ta' adalimumab/methotrexate versu l­kura b'methotrexate u l­kura b'adalimumab waħdu f'ġimgħa 52, liema titjib baqa' mantenut matul Ġimgħa 104.
English: Chest pain, oedema, pyrexia1)
Maltese: Uġigħ fis­sider, edima, deni 1)
English: Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Maltese: Wara li l­prodott tqiegħed fis­suq, kienu identifikati każijiet rari ta' hepatosplenic T­cell lymphoma f'pazjenti trattati b' adalimumab.
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Maltese: • disturbi fin­nervituri (bħal infjammazzjoni tan­nerv tal­għajn u s­sindromu ta' Guillain­Barré,
English: Week 16 placebo-controlled
Maltese: 16­ilĠimgħa bi plaċebo bħala kontroll
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7% and 59.0%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Maltese: Ir-rati ta' rispons ta' xejn jew minimali ta' PASI 75 u PGA f'dawn il-pazjenti kienu 74.7% u 59.0% rispettivament, wara 108 ġimgħat oħra ta' terapija open­label (total ta' 160 ġimgħa).
English: 10 mg eow 20 mg eow
Maltese: Doża baxxa 20/10 mg eow
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 12).
Maltese: Fi studju RA V, il­ħsara strutturali fil­ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil­Punteġġ Totali Sharp (ara Tabella 12).
English: Table 22: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Maltese: Tabella 22: Proporzjon ta' pazjentia li kisbu HiSCRb fil-ġimgħat 24 u 36 wara trattament assenjat mill-ġdid minn adalimumab kull ġimgħa f'ġimgħa 12
English: The safety and efficacy of adalimumab were assessed in a multicenter, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab kienu ġew studjati fi studju tat­tip multiċentru, b'mod każwali, double-blind f'46 pazjenti pedjatriċi (6 sa 17­il sena) b'artrite moderata relatata mal­entesite.