FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% vs. 9% respectively, p=0.031) and study UC-II (17% vs. 9% respectively, p=0.019).
Maltese: Pazjenti li ngħataw 160/80 mg adalimumab kellhom titjib kliniku f'perċentwali akbar li kienu statistikament sinjifikanti meta mqabbla ma plaċebo f'ġimgħa 8 fi studju UC-I (18% vs. 9% rispettivament, p=0.031) u fi studju UC-II (17% vs. 9% rispettivament, p=0.019).
English: Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Maltese: Flare parzjali huwa definit bhala ASDAS ≥ 1.3 izda < 2.1 at 2 żjarat konsekuttivi.
English: Juvenile idiopathic arthritis (JIA)
Maltese: Artrite idjopatika taż-żagħżagħ (JIA)
English: a a a p < 0.001, adalimumab vs. placebo
Maltese: a a a p < 0.001, adalimumab kontra plaċebo
English: Figure H
Maltese: Stampa H
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Maltese: Artrite idjopatika poliartikulari taż-żagħżagħ (pJIA)
English: 2 April 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 2 t'April 2019
English: Age group
Maltese: Grupp ta' età
English: • stroke;
Maltese: • ċikatriċi;
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Maltese: Ilkonċentrazzjoni apparenti ta' adalimumab fil-plażma li tipproduċi nofs il-probabbiltà massima ta' rispons PedAc 50 (EC50) kienet ta' 3 μg/ml (95% CI: 1-6 μg/ml).
English: Figure Q
Maltese: Stampa Q
English: In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Maltese: III, f'ġimgħa 4, 58% (499/854) tal-pazjenti kellhom rispons kliniku u ġew assessjati flanaliżi primarja.
English: Table 16 Ps study IV efficacy results at 16, 26 and 52 weeks
Maltese: Tabella 16 Ps Studju IV Riżultati tal-effikaċja wara 16, 26 u 52 ġimgħa
English: Figure N
Maltese: Stampa N
English: Placebo (N = 28)
Maltese: Plaċebo (N = 28)
English: Maintenance of clinical remission was evaluated in CD study III (CHARM).
Maltese: Il-fatt jekk ġiex mantenut it-titjib kliniku ġie evalwat fi studju CD III (CHARM).
English: ACR 20 Week 52 62.6% 54.4% 72.8% Week 104 56.0% 49.3% 69.4% ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Ġimgħa 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Ġimgħa 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Ġimgħa 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Ġimgħa 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864
English: • angioedema (localized swelling of the skin);
Maltese: • anġjoedima (nefħa lokalizzata tal-ġilda);
English: Figure A
Maltese: Stampa A
English: Placebo N=153
Maltese: Plaċebo N=153
English: PGA: Clear/minimal c a
Maltese: PGA: Xejn/minimali c a
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Maltese: Limfoma tat-tip hepatosplenic T-cell Karċinoma taċ-ċelluli Merkel (karċinoma talġilda newroendokrinika)
English: Sarcoidosis vasculitis
Maltese: Sarcoidosis infjammazzjoni vaskulari
English: Placebo N=53 n (%)
Maltese: Plaċebo N=53 n (%)
English: 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Maltese: d methotrexate 95% intervalli ta' konfidenza ghad-differenza bejn il-punteġġi ta' methotrexate u adalimumab.
English: Kromeya 40 mg injection adalimumab
Maltese: Kromeya 40 mg injezzjoni adalimumab
English: Figure F
Maltese: Stampa F
English: The active ingredient in Kromeya, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva fi Kromeya, adalimumab, hija antikorp monoklonali.
English: p value*
Maltese: Valur p *
English: Placebo N=74
Maltese: Plaċebo N=74
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Maltese: L-OR aġġustata (li tammonta għal differenzi fil-linja bażi) kienet 1.10 (95% CI 0.45-2.73) b'RA u CD ikkombinati.
English: Worsening of symptoms of dermatomyositis
Maltese: Aggravar tas-sintomi tad-dermotomijosite
English: Step 7
Maltese: Stadju 7
English: Double-blind response at week 12
Maltese: Rispons double-blind f'ġimgħa 12
English: Figure O
Maltese: Stampa O
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Maltese: Melanoma u karċinoma taċ-ċelluli Merkel kienu wkoll irrapurtati f'pazjenti kkurati bl-antagonisti ta' TNF inkluż adalimumab (ara sezzjoni 4.8).
English: Figure S
Maltese: Stampa S
English: Transparent syringe housing
Maltese: Kompartament trasparenti tassiringa
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Maltese: Il-persentaġġ ta' pazjenti kkurati b'adalimumab li jilħqu risponsi għall-ACR 20, 50 u 70 kien konsistenti fi studji RA I, II u III.
English: Table 19 Ps Study IV efficacy results at 16, 26 and 52 weeks
Maltese: Tabella 19 Ps Studju IV Riżultati tal-effikaċja wara 16, 26 u 52 ġimgħa
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Maltese: PASI 75 u PGA ċari jew minimi żdiedu b'konċentrazzjonijiet għoljin ta' adalimumab, it-tnejn b'EC50 apparenti simili ta' madwar 4.5 μg/mL (95% CI 0.4-47.6 u 1.9-10.5, rispettivament).
English: Placebo N=107
Maltese: Plaċebo N=107
English: Adult plaque psoriasis
Maltese: Plaque psoriasis
English: Figure L
Maltese: Stampa L
English: The response for the two monotherapy arms was similar (p = 0.447).
Maltese: Ir-rispons għaż-żewġ sezzjonijiet ta' kura mhux ikkombinata kien simili (p=0.447).
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' dożi multipli ta' adalimumab ġew stimati f'pazjenti adulti b'kolite ulċerattiva moderata sa severa (Punteġġ Mayo 6 sa 12; Sottopunteġġ 2 sa 3 bl-endoskopija) fi studji ikkontrollati bi plaċebo, randomizzati u double-blind.
English: 2.2 Check the label on the vial for Kromeya and expiration date.
Maltese: 2.2 Iċċekkja t-tikketta ta' fuq il-kunjett għal Kromeya u d-data ta' skadenza.
English: Kromeya is a biosimilar medicinal product.
Maltese: Kromeya huwa prodott mediċinali bijoloġiku simili.
English: p-value a p-value b p-value c
Maltese: valur-p a valur-p b valur-p c
English: • double vision;
Maltese: • vista doppja;
English: Double blind 32 weeks Adalimumab
Maltese: Double blind ta' 32 ġimgħa
English: Surgery or dental procedures
Maltese: Interventi kirurġiċi jew dentali
English: Figure R
Maltese: Stampa R
English: Table 18 Ps Study II (CHAMPION) efficacy results at 16 weeks
Maltese: Tabella 18 Studju Ps II (CHAMPION)
English: Figure D
Maltese: Stampa D
English: Table 15 Ps study II (CHAMPION) efficacy results at 16 weeks
Maltese: Tabella 15 Ps Studju II (CHAMPION)
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Maltese: • infezzjonijiet fis-sistema respiratorja (li jinkludu riħ, flissjoni, infezzjoni fis-sinus, pnewmonja);
English: Placebo n=110
Maltese: Plaċebo n=110
English: Figure T
Maltese: Stampa T
English: Placebo N=108
Maltese: Plaċebo N=108
English: Infections and infestations* Very common
Maltese: Infezzjonijiet u infestazzjonijiet*
English: PGA: Clear/minimal b a
Maltese: PGA: Xejn/minimali b a
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Maltese: Studju RA IV evalwa primarjament is-sigurtà tal-prodott f'636 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena.
English: Respiratory, thoracic and mediastinal disorders*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali *
English: Leucocytosis, thrombocytopenia
Maltese: Lewkoċitosi, tromboċitopenija
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Maltese: Il-lista li jmiss ta' reazzjonijiet avversi hija bbażata fuq esperjenza li ġejja minn studji kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq, u hija mniżżla skont il-klassi tas-sistema ta' l-organu u lfrekwenza f'Tabella 6 hawn taħt: komuni ħafna ( 1/10); komuni ( 1/100 sa < 1/10); mhux komuni ( 1/1,000 sa< 1/100); rari ( 1/10,000 sa < 1/1,000); u mhux magħrufa (li ma jistgħux jiġu kkalkulati mill-informazzjoni eżistenti).
English: Placebo N=166
Maltese: Plaċebo N=166
English: Hepatitis, reactivation of hepatitis B autoimmune hepatitis
Maltese: Epatite riattivazzjoni tal-epatite B epatite awtoimmuni
English: Placebo N=162
Maltese: Plaċebo N=162
English: PROBABILITY OF FAILING TREATMENT
Maltese: TA'FALLIMENT FI TRATTAMENT
English: • If you are over 65 years you may be more susceptible to infections while taking Kromeya.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Kromeya.
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: Il-livelli fis-serum ta' metalloproteinases fil-matriċi (MMP-1 u MMP-3) li jipproduċu tibdil fit-tessuti li hu responsabbli għall-qerda tal-qarquċa, naqsu ukoll wara li ngħata adalimumab.
English: Table 26 Response, remission and mucosal healing in study UC-II (percent of patients)
Maltese: Tabella 26 Rispons, titjib kliniku u fejqan tal-mukoża fi studju UC-II (persentaġġ ta' pazjenti)
English: Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: L-istudju tal-psorijasi I (REVEAL) evalwa 1,212 pazjent fi tliet perijodi ta' kura.
English: Figure M
Maltese: Stampa M
English: ACR 70 Week 12 Week 24
Maltese: ACR 70 Ġimgħa 12 Ġimgħa 24
English: Kromeya 40 mg solution for injection in pre-filled pen EU/1/19/1357/003
Maltese: Kromeya 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/19/1357/003
English: How to store Kromeya 6.
Maltese: Kif taħżen Kromeya 6.
English: Impaired lung function may increase the risk for developing infections.
Maltese: Indeboliment fil-funzjoni tal-pulmun jista' iżid ir-riskju li tiżviluppa infezzjoni.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa antikorp uman monoklonali rikombinanti prodott fiċ-ċelluli tal-ovarji tal-ħamster ċiniż.
English: Vial adapter
Maltese: Adapter tal-kunjett
English: Following 3 years of adalimumab therapy, 75% (301/402) continued to be in clinical remission per partial Mayo score.
Maltese: Wara 3 snin ta' terapija b'adalimumab, 75% (301/402) baqgħu fi stat ta' titjib kliniku skont il-punteġġ Mayo parzjali.
English: Table 10 ACR responses in RA study V (percent of patients)
Maltese: Tabella 10 Risponsi għall-ACR fi studju RA V (persentaġġ ta' pazjenti)
English: Low dose 20/10 mg eow N = 95
Maltese: Doża baxxa 20/10 mg eow N = 95
English: The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Maltese: 3%/61.3%/38.7% u 83.3%/73.
English: Nervous system disorders* Very common
Maltese: Disturbi fis-sistema nervuża*
English: Kromeya 40 mg/0.8 mL injection adalimumab
Maltese: Kromeya 40 mg/0.8 ml injezzjoni adalimumab
English: Table 8 ACR responses in RA study V (percent of patients)
Maltese: Tabella 8 Risponsi għall-ACR fi Studju RA V (persentaġġ ta' pazjenti)
English: Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion
Maltese: Emboliżmu fil-pulmun mard ta' l-interstizju tal-pulmun, mard kroniku ta' imblukkar fil-pulmun, pulmonite, effużjoni plerali
English: Each pack contains 1 vial (0.8 mL sterile solution), 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Maltese: Kull pakkett fih kunjett wieħed (0.8 mL ta' soluzzjoni sterili), siringa sterili għall-njezzjoni 1, labra sterili 1, adapter tal-kunjett 1 u 2 kuxxinetti bl-alkoħol.
English: Figure I
Maltese: Stampa I
English: Figure G
Maltese: Stampa G
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Maltese: Falliment tattrattament kien definit minn eżitu multi-komponent ibbażat fuq infjammazzjoni tal-chorioretinal u/jew infjammazzjoni tal-leżjonijiet vaskulari tar-retina, grad taċ-ċelloli tal-kompartiment anterjuri (AC), grad taċ-ċpar vitriju (VH) u l-aqwa akutezza kkoreġuta tal-vista (BCVA).
English: Clinical response * p value for Standard Dose versus Low Dose comparison.
Maltese: Rispons kliniku * valur p li huwa paragun tad-Doża Standard kontra Doża Baxxa.
English: • pleural effusion (abnormal collection of fluid in the pleural space);
Maltese: • effuzjoni plewrali (żamma mhux normali tal-ilma fl-ispazju plewrali);
English: Leukaemia
Maltese: Lewkemija
English: One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Maltese: Mitt pazjent (n=100) mill-Istudju Pedjatriku CD komplew fi studju ta' estensjoni fit-tul u open-label.
English: Figure J
Maltese: Stampa J
English: > 32 weeks 14 weeks a
Maltese: >32 ġimgħa 14-il ġimgħa a
English: Steroid-free remission for ≥ 90 days a
Maltese: Titjib tal-kundizzjoni migħajr sterojdi għal ≥ 90 days a
English: Figure P
Maltese: Stampa P
English: • non-infectious uveitis
Maltese: • uveite mhux infettiva
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Maltese: Il-qlib għall-aħjar fl-istat kliniku (definit bhala CDAI < 150) ġie evalwat f'żewġ studji, studju CD I (CLASSIC I) u studju CD II (GAIN).
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Maltese: Matul il-fażijiet kontrollati ta' provi pivitali ta' adalimumab fl-adulti li damu sejrin mill-inqas 12 -il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorijasi, hidradenitis suppurativa, millmarda Crohn (Crohn's disease), mill-kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' konfidenza) ta' 6.8 (4.4, 10.5) kull 1,000 sena ta' pazjent fost 5,291 pazjent ikkurat b'Kromeya, kontra rata ta' 6.3 (3.4, 11.8) kull 1,000 sena ta' pazjent fost 3,444 pazjent kontrollat (il-medja tat-tul tal-kura kienet ta' 4.0 xhur għal adalimumab u 3.8 xhur għal pazjenti mogħtija kura kontrollata).
English: In study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Maltese: Fi studju UV I kienu osservati differenzi statistikament sinifikanti favur adalimumab kontra plaċebo għal kull komponent tal-falliment tat-trattament.
English: Demyelinating disease
Maltese: Mard demyelinating
English: Injection button
Maltese: Buttuna t'injezzjoni
English: Figure B
Maltese: Stampa B
English: a partial remission ASDAS
Maltese: a remissjoni parzjali ASDAS
English: Figure K
Maltese: Stampa K
English: Adalimumab n=274 (95% confidence interval)
Maltese: MTX n=257 (95% Intervall ta' Konfidenza)
English: Number of patients at baseline n (%)
Maltese: Numru ta' pazjenti f'linja bażi n (%)
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Maltese: Titjib statistikament u klinikament sinifikanti mil-linja bażi kien wkoll osservat fiż-żewġ gruppi tattrattament għal parametri tal-kwalità tal-ħajja (inkluż IMPACT III).
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Maltese: Anewriżma ta' l-aorta, sadd fl-arterji, tromboflebite
English: confidence interval)
Maltese: Intervall ta' Konfidenza)
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
Maltese: Ġimgħa 26 Ġimgħa 52, valur p li huwa paragun tad-Doża Standard kontra Doża Baxxa.
English: In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Maltese: Fi studju CD III, 854 pazjent irċevew 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2, open label.
English: Adalimumab 40 mg eow N=109
Maltese: Adalimumab 40 mg kull eow N=109
English: Thirty-three (18%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Maltese: Tlieta u tletin (18%) pazjent kienu kkurati fl-istess ħin b'mediċini anti-rewmatiċi li jimmodifikaw ilmarda, u 146 (79%) pazjent b'NSAIDs fil-linja bażi.
English: Among those, 64 patients (79.0%) had ACR 20 responses; 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Maltese: Fost dawn, 64 pazjent (79.0%) kellhom rispons għal ACR 20; 56 pazjent (69.1%) kellhom rispons għal ACR 50; u 43 pazjent (53.1%) kellhom rispons għal ACR 70.
English: Note: P = Placebo (number at risk (flared)); A = Adalimumab (number at risk (flared)).
Maltese: Nota: P = Plaċebo (numru f'Riskju (flared)); A = Adalimumab (numru f'riskju (flared)).
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Maltese: 117/276 pazjent minn studju CD I u 272/777 pazjent minn CD II u III kienu segwiti għal mill-anqas 3 snin ta' terapija open-label ta' adalimumab. 88 u 189 pazjent, rispettivament, komplew bil-fejqan kliniku tagħhom.
English: Musculoskeletal pain
Maltese: Uġigħ muskolu-skeletrali
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Maltese: 6%) kellhom rispons għall-ACR 20; 127 pazjent (74.7%) kellhom rispons għall-ACR 50; u 102 pazjent (60.0%) kellhom rispons għall-ACR 70.
English: • vertigo (sensation of room spinning);
Maltese: • vertigo (sensazzjoni li l-kamra qed iddur);
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: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Maltese: Fi studju ta' estensjoni open-label, għal pazjenti li d-doża eskalat minn 40 mg ġimgħa iva u ġimgħa le għal 40 mg kull ġimgħa minħabba rispons PASI taħt 50%, 26.4% (92/349) u 37.8% (132/349) talpazjenti kisbu rispons ta' PASI 75 f'ġimgħa 12 u 24, rispettivament.
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Maltese: • sindromu Stevens-Johnson (reazzjoni li tista' tkun ta' theddida għall-ħajja b'sintomi bħal tal influwenza u raxx b'infafet);
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Maltese: Studju RA II evalwa 544 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena u li ma kinux irrispondew għal kura b'mill-inqas mediċina waħda antirewmatika li taffetwa l-proċess tal-mard.
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 days a
Maltese: Rispons kliniku (CR-100) Pazjenti li kellhom titjib mingħajr sterojdi għal >=90 ġurnata a
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Maltese: Kromeya 40 mg/0.8 mL soluzzjoni għall-injezzjoni għal użu pedjatriku jista' jinżamm f'temperaturi sa massimu ta' 25°C għal perijdu ta' 14-il jum.
English: Table 14 Ps study I (REVEAL) efficacy results at 16 weeks
Maltese: Tabella 14 Ps Studju I (REVEAL)
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Maltese: Adalimumab wera benefiċċju fittrattament f'pazjenti b'psorjasi tad-dwiefer bi gradi differenti ta' involvement tal-ġilda (BSA≥10% (60% tal-pazjenti) u BSA‹10% u ≥5% (40% tal-pazjenti)).
English: Excipients: 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: Table 14 Efficacy response in placebo-controlled study nr-axSpA I
Maltese: Tabella 14 Risponsi tal-effikaċja fi studju nr-axSpA I bil-plaċebo bħala kontroll
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA<10% and ≥5% (40% of patients)).
Maltese: Adalimumab wriet benefiċċju tattrattament f'pazjenti b-psorjasi tad-dwiefer bi gradi differenti ta' involvement tal-ġilda (BSA≥10% (60% tal-pazjenti) u BSA‹10% u ≥5% (40% tal-pazjenti)).
English: Based on rank analysis
Maltese: Ibbażat fuq analizi tar-rank.
English: • paediatric uveitis
Maltese: • uveite pedjatrika
English: Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Maltese: Rispons Ped ACR 30/50/70 f'ġimgħa 48 kien wisq akbar minn dak ta' pazjenti kkurati bil-plaċebo b p = 0.015
English: Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients) PsA study I
Maltese: Tabella 16 Rispons għall-ACR fi studji tal-artrite psorjatika kontrollati bil-Plaċebo (persentaġġ ta' pazjenti)