FrancophonIA/ELRC3.0 huggingface dataset:
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 nonmelanoma 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 12il 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), 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'adalimumab, 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: Table 8 Paed ACR 30 Responses in the JIA study
Maltese: Tabella 8 Risponsi PedACR 30 fi Studju JIA
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 tat-trattament 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: Standard Dose 40/20 mg eow N=93
Maltese: Doża Standard 40/20 mg eow N = 93
English: o 1) One 1 ml syringe o 2) One vial adapter o 3) One vial for paediatric use of Imraldi for injection o 4) Two alcohol swabs o 5) One needle
Maltese: o 1) Siringa waħda ta' 1 mL o 2) Adattur tal-kunjett o 3) Kunjett wieħed ta' Imraldi għall-injezzjoni għal użu pedjatriku o 4) Żewġ tajjariet bl-alkoħol o 5) Labra waħda
English: Placebo / MTX (N=37)
Maltese: Plaċebo / MTX (N = 37)
English: <0.001c
Maltese: p < 0.01
English: PGA: Clear/minimal a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Maltese: PGA: Xejn/minimali a, b a p<0.001 adalimumab kontra l-plaċebo b p<0.001 adalimumab kontra methotrexate c p<0.01 adalimumab kontra l-plaċebo d p<0.05 adalimumab kontra methotrexate
English: Time to Treatment Failure At or After Week 6 in study UV I Primary analysis (ITT)
Maltese: Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 6 fi Studju UV I Analiżi Primarja (ITT)
English: • intestinal perforation;
Maltese: • perforazzjoni tal-intestini;
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Maltese: Trattament b'adalimumab 40 mg kull ġimgħa naqqas b'mod sinifikanti r-riskju ta' aggravar ta' axxessi u fistuli li jnixxu.
English: ASDAS Inactive Disease hs-CRPd,f,g
Maltese: ASDAS Marda inattiva hs-CRP
English: At week 12 and week 24, PaedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Maltese: F'Ġimgħa 12 u Ġimgħa 24, ir-rispons PedACR30 kien ta' 93.5% u 90.0% rispettivament meta intużat is-sitema ta' informazzjoni osservata.
English: Ankylosing spondylitis (AS)
Maltese: Spondilite bl-ankilożi (AS - ankylosing spondylitis)
English: Pulmonary fibrosis1)
Maltese: Fibrożi tal-pulmun
English: Placebo N=107
Maltese: Plaċebo N = 107
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Maltese: Punteġġ ta l-Attività ta' Ankylosing Spondylitis Disease d Flare Parzjali huwa definit bhala ASDAS ≥ 1.3 izda < 2.1 at 2 żjarat konsekuttivi. ***, ** Statistikament sinifikanti f'p <0.
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: • psoriatic arthritis,
Maltese: • artrite psorijatika,
English: Note: P = Placebo (Number at Risk); H = Adalimumab (Number at Risk).
Maltese: Nota: P = Plaċebo (Numru f'riskju); H = Adalimumab (Numru f'riskju).
English: Hidradenitis suppurativa (HS)
Maltese: Idradenite suppurativa (HS - hidradenitis suppurativa)
English: • paediatric uveitis.
Maltese: • uveite pedjatrika.
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: Table 12 Paed ACR 30 Responses in the JIA study
Maltese: Tabella 12 Rispons PedACR 30 fi Studju JIA
English: • If you are over 65 years you may be more susceptible to infections while taking Imraldi.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Imraldi.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré
Maltese: Sklerosi multipla, disturbi li jeffetwaw il-myelin (bħal newrite flgħajnejn, sindromu ta' Guillain-Barré)
English: Clinical remission 12% Clinical response (CR-100)
Maltese: Titjib kliniku Rispons kliniku (CR-100)
English: Imraldi is intended for treatment of:
Maltese: Imraldi huwa intenzjonat għall-kura ta':
English: Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Maltese: Tabella 14 Risponsi tal-Effikaċja fi Studju kontrollat bil-Plaċebo nr-axSpA attiv
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: PGA: Clear/minimal
Maltese: PGA: Xejn/minimali b a
English: Adalimumab Δ Censored 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: At week 52, 42.9 % of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 <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 % tal-pazjenti li rċevew it-terapija kombinata ta' adalimumab/methotrexate laħqu titjib kliniku (DAS28 (CRP) < 2.6) meta pparagunati ma' 20.6 % tal-pazjenti li rċevew kura b'methotrexate waħdu bħala kura u 23.4 % li rċevew adalimumab waħdu bħala kura.
English: Table 17 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Maltese: Tabella 17 Studju Ps I (REVEAL)
English: Placebo N=94
Maltese: Plaċebo N = 94
English: Ewopharma AG Representative Office
Maltese: Ewopharma AG Representative Office Teл.:
English: Placebo N=49
Maltese: Plaċebo N = 49
English: Not Known Worsening of symptoms of dermatomyositis1)
Maltese: Aggravar tas-sintomi tad-dermatomijosite
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12 sa 17-il sena, li jiżnu 30kg jew aktar)
English: Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: L-Istudju tal-Psorijasi I (REVEAL) evalwa 1212 pazjent fi tliet perijodi ta' kura.
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 mill-linja bażi kien wkoll osservat fiż-żewġ gruppi tattrattament għal parametri tal-kwalità tal-ħajja (inkluż IMPACT III).
English: Age Group Number of patients at Baseline N (%) Minimum, median and maximum
Maltese: Numru ta' pazjenti f'linja bażi N (%) Dożi minimi, medji u massimi
English: Rheumatoid arthritis
Maltese: Artrite Rewmatika
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: Fost dawn, 154 pazjent (90.6 %) 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: Imraldi 40 mg solution for injection in pre-filled syringe EU/1/17/1216/001
Maltese: Imraldi 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/17/1216/001
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
Maltese: • lupus erythematosus sistemiku (li tinkludi infjammazzjoni tal-ġilda, tal-qalb, tal-pulmun, tal-ġogi u ta' sistemi ta' organi oħra);
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' limfomi kienet ta' 0.7 (0.2, 2.7) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Low Dose 20/10 mg eow N=95
Maltese: Doża Baxxa 20/10 mg eow N = 95
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
Maltese: Effetti avversi tas-sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopenia, lewkopenja) ma ġewx irrappurtati b'adalimumab.
English: Placebo N=162
Maltese: Plaċebo N = 162
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥40 kg (160/80 mg) and 10.6±6.1 µg/ml for patients <40 kg (80/40 mg).
Maltese: 7 ± 6.6 µg/mL il-pazjenti ≥ 40 kg (160/80 mg) u 10.6 ± 6.1 µg/mL għas-suġġetti <40 kg (80/40 mg).
English: Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Maltese: Tabella 16 Rispons għall-ACR fi Studji tal-Artrite Psorjatika kontrollati bil-Plaċebo (Persentaġġ ta' pazjenti)
English: Table 17 Efficacy Results at 12 Weeks, HS Studies I and II
Maltese: Tabella 17 Riżultati ta' Effikaċja fi 12-il Ġimgħa, HS Studji I u II
English: Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Imraldi huwa indikat għall-trattament ta' psorijasi tal-plakka kronika minn moderata sa severa, f'pazjenti adulti li huma kandidati għal terapija sistemika.
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Maltese: 19.3% tal-pazjenti kellhom bil-linja bażi terapija kontinwa ta' antibijotiċi orali matul l-istudju.
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: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Maltese: Studju HS-I (PIONEER I) evalwa 307 pazjenti b'żewġ perjodi ta' trattament.
English: • abdominal (belly) pain;
Maltese: • uġigħ addominali (fiż-żaqq);
English: Imraldi 40 mg solution for injection in pre-filled pen EU/1/17/1216/005
Maltese: Imraldi 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/17/1216/005
English: Biogen Idec Limited (UK) Tel: +44 (0)20 360 886 22
Maltese: United Kingdom Biogen Idec Limited (UK) Tel: +44 (0)20
English: Placebo N=166
Maltese: Plaċebo N = 166
English: Placebo N=74
Maltese: Plaċebo N = 74
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 tal-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 (ma tistax tittieħed stima mid data disponibbli).
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 l-adalimumab kontra plaċebo għal kull komponent tal-falliment tat-trattament.
English: Sustained Response Sustained Remission Sustained Mucosal Healing Clinical remission is Mayo score ≤2 with no subscore >1; Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; * p<0.05 for adalimumab vs. placebo pairwise comparison of proportions
Maltese: Rispons kliniku huwa tnaqqis mill-linja bażi fil-punteġġ Mayo ta' ≥ 3 punti u ≥ 30 % flimkien ma' tnaqqis fil-fsada rektali b'sottopunteġġ [RBS] ta' ≥ 1 jew RBS assolut ta' 0 jew 1; * p < 0.05 għal adalimumab vs. placebo bil-proporzjonijiet imqabblin flimkien ** p < 0.001 għal adalimumab vs. placebo bil-proporzjonijiet imqabblin flimkien a min dawk li rċevew kortikosterojdi f'linja bażi
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 ICAM1 with an IC50 of 0.1-0.2 nM).
Maltese: Adalimumab jimmodula ukoll ir-risponsi bijoloġiċi li jiġu kkawżati jew regolati mit-TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma risponsabbli għall-migrazzjoni tal-lewkoċite (ELAM-1, VCAM1, u ICAM-1 ma' xi IC50 ta'1-0.2 nM).
English: CD Study II: Infliximab Experienced Patients
Maltese: Studju CD II: Pazjenti li kienu diġà ħadu infliximab qabel
English: Table 24 Time to Treatment Failure in Studies UV I and UV II
Maltese: Żmien għall-Falliment tat-Trattament fi Studji UV I and UV II
English: Placebo N=110
Maltese: Plaċebo N=110
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: 104 Week 56.0% 49.3% 69.4% 0.002 <0.001 0.140
Maltese: ACR 20 Ġimgħa 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Ġimgħa 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50
English: Adults with ulcerative colitis
Maltese: Adulti b'kolite ulċerattiva
English: Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Maltese: Imraldi huwa indikat għat-trattament ta' idradenite suppurativa (acne inversa) attiva minn moderata sa severa fl-adulti u adolexxenti minn 12-il sena 'il fuq b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjonijiet 5.1 u 5.2).
English: • myocardial infarction;
Maltese: • infart mijokardjali;
English: Imraldi 40 mg/0.8 ml injection adalimumab
Maltese: Imraldi 40 mg/0.8 mL soluzzjoni għall-injezzjoni adalimumab
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Maltese: M'hemmx data disponibbli li tipparaguna adalimumab u MTX wara 16 -il ġimgħa ta' terapija.
English: Corticosteroid taper was permitted after week 8.
Maltese: It-tnaqqis tal-corticosteroid ftit ftit sakemm jitwaqqaf totalment, kien permess wara ġimgħa 8.
English: • elevated bilirubin measurement (liver blood test).
Maltese: • kejl tal-bilirubin elevat (test tad-demm tal-fwied).
English: Imraldi is used to treat ulcerative colitis in adults.
Maltese: Imraldi huwa intenzjonat għall-kura ta' kolite ulċerattiva fl-adulti.
English: • Crohn's disease,
Maltese: • tal-marda Crohn (Crohn's Disease),
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38 % (25/66) and 55 % (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Maltese: Minn dawk il-pazjenti li tilfu r-rispons adegwat wara li intgħażlu b'ordni addoċċ biex jirċievu l-plaċebo, li mbagħad ġew miktuba fil-prova ta' estensjoni open-label, 38% (25/66) u 55% (36/66) reġgħu laħqu rispons tal-PASI ta' 75 wara 12 u 24 ġimgħa ta' kura għal darba oħra, rispettivament.
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Maltese: HS-I u HS-II, meta mqabbla ma' dawk fil-grupp adalimumab li kellhom aggravament ta' axxessi (23.0 % vs 11.4 %, rispettivament) u fistuli li jnixxu (30.0 % vs 13.9 %, rispettivament).
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: Imraldi is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Maltese: Imraldi huwa intenzjonat għall-kura tal-marda Crohn (Crohn's disease) fl-adulti u fi tfal li għandhom bejn 6 sa 17-il sena.
English: After 5 years of adalimumab therapy, 74.0 % (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46/50) of patients continued to be in clinical response per PCDAI.
Maltese: Wara 5 snin ta' terapija b'adalimumab, 74.0 % (37/50) tal-50 pazjent li fadal fl-istudju kompla jkun fil remissjoni klinika, u 92.0 % (46/50) tal-pazjenti komplew ikollhom rispons kliniku għal kull PCDAI.
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Maltese: Fl-estensjoni open-label, titjib fis-sinjali u s-sintomi inżamm ma' terapija b'adalimumab sa ġimgħa 156.
English: • polyarticular juvenile idiopathic arthritis,
Maltese: • artrite idjopatika poliartikulari taż-żgħażagħ,
English: Table 14 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Maltese: Tabella 14 Studju Ps I (REVEAL)
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Maltese: HS-I u HS-II), is-sodisfazzjon globali tal-pazjent bi trattament medikui kif imkejjel millSodisfazzjon Trattament Kwestjonarju - medikazzjoni (TSQM; studji HS-I u HS-II), u s-saħħa fiżika kif imkejla minn l-għadd sommarju ta' komponent fiżiku tal-SF-36 (studju HS-I).
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: Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger, a plunger rod, a safe-shield body, a finger flange and 2, 2, 4 or 6 alcohol pads enclosed in packs respectively.
Maltese: Imraldi hu disponibbli f'pakketti li fihom 1, 2, 4 jew 6 siringa(i) mimlija għal-lest (ħġieġ ta' tip I) b'labra ta' azzar li ma jsaddadx, protezzjoni riġida tal-labra, planġer tal-lastku, lasta tal-planġer, safeshield body, finger flange għall-użu mill-pazjent u 2, 2, 4 jew 6 pads tal-alkoħol huma magħluqin f'pakketti rispettivament.
English: Table 21 Efficacy Results at 12 Weeks, HS Studies I and II
Maltese: Tabella 21 Riżultati ta' Effikaċja fi 12-il Ġimgħat, HS Studji I u II
English: Based on the observed data approach, 222 (80.4 %) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Maltese: Ibbażat fuq l-approċċ tad-dejta osservat, 222 (80.4 %) kienu f'sekwenza (lebda leżjoni infjammatorja attiva, grad ta' ċellula AC ≤ 0.5+, VH grad ≤ 0.5+) b'doża ta' sterojdi konkomitanti ≤ 7.5 mg kuljum, u 184 (66.7 % ) kienu bla kwiesċenza ta' sterojdi.
English: Imraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Imraldi huwa indikat għal trattament ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw kura konvenzjonali li tinkludi kortikosteroidi u 6-mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: Other medicines and Imraldi
Maltese: Mediċini oħra u Imraldi
English: Response
Maltese: LISTA
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: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Maltese: Titjib kliniku Rispons kliniku (CR-100) Pazjenti li kellhom titjib mingħajr sterojdi għal > = 90 ≥ ġurnata a
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate.
Maltese: F'pazjenti b'JIA poliartikulari li kellhom bejn 2 sa < 4 snin jew li għandhom min 4 snin il-fuq u li jiżnu < 15 kg, dożati b'adalimumab 24 mg/m trough steady-state medju ta' koncetrazzjoni ta' adalimumab fis-serum kien 6.0 ± 6.1 µg/mL (101% CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 7.9 ± 5.6 µg/mL (71.2% CV) flimkien ma methotrexate.
English: N Failure N
Maltese: Komuni Ħafna
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p <0.001) and adalimumab monotherapy (50.7 %, p <0.002 and 44.5 %, p <0.001 respectively).
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il-persentaġġ ta' pazjenti li ma avvanzatilhomx il-marda (bidla mil-linja bażi fit-tibdil tal-Puteġġ Totali Sharp ≤ 0.5) kien sinifikament ogħla bit-terapija kombinata ta' adalimumab/methotrexate (63.8 % u 61.2 % rispettivament) meta pparagunat ma' kura b' methotrexate waħdu (37.4 % u 33.5 % rispettivament, p < 0.001) u kura b'adalimumab waħdu (50.7 %, p < 0.002 u 44.5 %, p < 0.001 rispettivament).