FrancophonIA/ELRC3.0 huggingface dataset:
English: p-valuea p-valueb p-valuec
Maltese: valur-pa valur-pb valur-pc
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 il marda, u 146 (79%) pazjent b'NSAIDs fil-linja bażi.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa anti-korp uman monoklonali rikombinanti, prodott fiċ-ċelluli tal-ovarji tal-ħamster ċiniż.
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab / methotrexate combination therapy, respectively.
Maltese: Sharp modifikati kien 10.8, 9.2 u 3.9 fil-pazjenti li oriġinarjament randomizzati għal monoterapija b'methotrexate, monoterapija b'adalimumab u terapija kkombinata b'adalimumab / methotrexate, rispettivament.
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 tal kura għal parametri tal-kwalità tal-ħajja (inkluż IMPACT III).
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
Maltese: infezzjonijiet opportunistiċi u tuberkulożi (li jinkludu coccidioidomycosis, histoplasmosis u infezzjoni tal-mycobacterium avium complex), infezzjonijiet tal-batterji,
English: Anaphylaxis1)
Maltese: Anafilassi1)
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
English: Figure B: items not included in the carton
Maltese: Figura B: oġġetti mhux inklużi fil-kartuna
English: Impaired lung function may increase the risk for developing infections.
Maltese: Indeboliment fil-funzjoni tal-pulmun jista' jżid ir-riskju li tiżviluppa infezzjoni.
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 thrombocytopaenia, lewkopenja) ma ġewx irrappurtati b'adalimumab.
English: Psoriatic arthritis
Maltese: Artrite Psorjatika
English: Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg / day).
Maltese: Studju UV I evalwa 217 pazjent b'uveite attiva minkejja l-kura b'kortikosterojdi (prednisone orali f'doża ta'10 sa 60 mg / kuljum).
English: Note: treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Maltese: Nota: Il-falliment tat-trattament fi jew wara Ġimgħa 6 (studju UV I), jew fi jew wara Ġimgħa 2 (studju UV II), kien magħdud bħala avveniment.
English: Liver failure1)
Maltese: effużjoni plerali1)
English: fistula remission3
Maltese: fejqan tal-fistla3
English: Adults with hidradenitis suppurativa
Maltese: Adulti bi hidradenitis suppurativa
English: Infection
Maltese: Infezzjonijiet
English: Hefiya 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 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Hefiya huwa indikat għall-kura ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li kellhom rispons inadegwat meta ngħataw kura konvenzjonali li tinkludi kortikosterojdi u 6- mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
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 (l ebda 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: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists.
Maltese: Rapporti rari ta' panċitopenja, inkluża anemija aplastika, ġew irrappurtati b'antagonisti tat-TNF.
English: • 80 mg at week 0 and 40 mg at week 2 ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Maltese: • 80 mg f'ġimgħa 0 and 40 mg f'ġimgħa 2 ≥ 40 kg • 80 mg f'ġimgħa and 40 mg f'ġimgħa 2
English: Vertigo
Maltese: Komuni vertigo
English: • Hefiya pre-filled syringe/s (see Figure A).
Maltese: • Hefiya siringa/i mimlija għal-lest (ara Figura A).
English: Erectile dysfunction
Maltese: Disfunzjoni erettili
English: Hidradenitis suppurativa in adults and adolescents
Maltese: Hidradenitis suppurativa fl-adulti u fl-adolexxenti
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: PASI relattiv ma' ġimgħa 33). 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: Uveitis
Maltese: Uveite
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections.
Maltese: Eċċipjenti: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, ilma għall-injezzjoni.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)1)
Maltese: disturbi li jaffettwaw il-myelin (bħal newrite fl-għajnejn, sindrome ta' Guillain-Barré) 1)
English: • asthma;
Maltese: • ażma;
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Maltese: Kura b'adalimumab 40 mg kull ġimgħa naqqset b'mod sinifikanti r-riskju ta' aggravar ta' axxessi u fistuli li jnixxu.
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Maltese: • sindrome Stevens-Johnson (reazzjoni ta' periklu għall-ħajja b'sintomi bħal ta' riħ u raxx bi nfafet);
English: HS study I
Maltese: HS studju I
English: Hefiya is a biosimilar medicinal product.
Maltese: Hefiya huwa prodott mediċinali bijoloġiku simili.
English: Pregnancy
Maltese: emigranja,
English: placebo / MTXc n = 200
Maltese: MTXc n = 200
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: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double-masked, placebo-controlled studies (UV I and II).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati f'pazjenti adulti bi intermedja, posterjuri u panuveite mhux infettiva, esklużi pazjenti b'uveite anterjuri iżolati, f'żewġ studji każwali, double-masked, ikkontrollati bi plaċebo (UV I u II).
English: Disposing of used syringes:
Maltese: Rimi ta' siringi użati:
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
English: Pancytopaenia
Maltese: Panċitopenja
English: Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria.
Maltese: Il-kriterji li jiddefinixxu li l-marda tmur għall-agħar huma li tmur lura b' ≥ 30 % mill linja bażi f'≥3 minn 6 kriterji prinċipali ta' ACR pedjatriċi ≥ 2 ġogi attivi, u titjib ta' > 30 % f'mhux aktar minn 1 minn 6 kriterji.
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: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %).
Maltese: kienet ta' 18.9 u l-linja bażi tal-Istima Ġenerali tat-Tabib (PGA) varjat minn “moderat” (53 % tas suġġetti li ġew inklużi) għal “sever” (41 %) għal “sever ħafna” (6 %).
English: 14 weeks a 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: 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 taffettwa l-proċess tal-mard.
English: Population pharmacokinetic and pharmacokinetic / pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Maltese: L-immudellar u s-simulazzjoni farmakokinetiku tal-popolazzjoni u farmkokinetiku/farmakodinamiku bassar espożizzjoni u effikaċja ta' adalimumab komparabbli f'pazjenti kkurati b'80 mg ġimgħa iva ġimgħa le meta mqabbel ma' 40 mg kull ġimgħa (inkluż pazjenti adulti b' RA, HS, UC, CD jew Ps, pazjenti b'HS adolexxenti, u pazjenti pedjatriċi ≥ 40 kg b'CD).
English: Idiopathic thrombocytopaenic purpura
Maltese: Purpura tromboċitopenika idjopatika
English: Paediatric plaque psoriasis
Maltese: Psorjasi tal-plakka pedjatrika
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: low dose 20 / 10 mg eow N = 95
Maltese: 20 / 10 mg eow N = 95
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: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati fi studju kollettiv multicenter, randomizzat,u double-blind f'171 tifel u tifla (li għandhom bejn 4-17 il-sena) b'JIA poliartikulari.
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 3-month trial of systemic antibiotic therapy.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew evalwati fi studji li kienu imqassma b'mod każwali, double- blind, ikkontrollati bi plaċebo u studju ta' estensjoni open-label f'pazjenti adulti bi hidradenitis suppurativa (HS) moderata sa severa li kienu intolleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill-inqas ta' 3 xhur provi ta' terapija antibijotika sistemika.
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: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Maltese: Għalkemm mhux statistikament sinifikanti, il-maġġoranza tal-pazjenti wrew titjib kliniku fil-punti tat-tmiem sekondarji bħal numru ta' siti ta' entestie, għadd ta' ġogi sensttivi (TJC), għadd ta' ġogi minfuħa (SJC), rispons Pedjatriku ACR 50, u rispons Pedjatriku ACR 70.
English: Table 8 ACR responses in RA study V (percent of patients)
Maltese: Tabella 8 Risponsi għall-ACR fi studju RA V
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg / day or 10 mg / day maximum).
Maltese: Il-pazjenti nżammu fuq dożi stabbli ta' NSAIDs u jew prednisolone (≤ 0.2 mg / kg / ġurnata jew massimu ta' 10 mg / ġurnata).
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
Maltese: infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorjasi, hidradenitis suppurativa, mill- marda 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)
English: • 160 mg at week 0 and 80 mg at week 2
Maltese: • 160 mg f'ġimgħa 0 and 80 mg f'ġimgħa 2
English: • inject Hefiya 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Maltese: • tinjetta Hefiya 15-30 minuta wara li tneħħih mill-friġġ għal injezzjoni aktar komda.
English: a adalimumab / MTX 40 mg every other week placebo / MTXadalimumab / MTX (95 % confidence interval b)
Maltese: adalimumab / MTX (95 % Intervall ta' Konfidenzab)
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'mill-inqas mediċina waħda antirewmatika li taffettwa l-proċess tal-mard u li kellhom effikaċja insuffiċjenti b'methotrexate f'dożi minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil-ġimgħa, u li d-doża ta' methotrexate tagħhom baqgħet kostanti minn 10 sa 25 mg fil-ġimgħa.
English: EU/1/18/1287/003 6 pre-filled syringes (3 packs of 2)
Maltese: EU/1/18/1287/003 6 siringi mimlijin għal-lest (3 pakketti ta' 2)
English: Table 19 Ps study IV efficacy results at 16, 26 and 52 weeks endpoint week 16 placebo-controlled week 26 placebo-controlled week 52 open-label placebo N = 108
Maltese: Ps studju IV riżultati tal-effikaċja f'16, 26 u 52 ġimgħa punt ta' tmiem
English: Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Maltese: Adalimumab ġie evalwat fuq aktar minn 3,000 pazjent fil-provi kliniċi kollha tal-artrite rewmatika.
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 fin-nervituri (bħal infjammazzjoni tan-nerv ottiku tal-għajn u s-sindrome ta' Guillain-Barré, kondizzjoni li tista' tikkawża debolizza fil-muskoli, sensazzjonijiet mhux normali, tnemnim fl-idejn u l-parti ta' fuq tal-ġisem;
English: Table 21 efficacy results at 12 weeks, HS studies I and II
Maltese: Riżultati ta' effikaċja fi 12-il ġimgħa, HS studji I u II
English: ACR 20 week 52 62.6 % 54.4 % 72.8 % 0.013 < 0.001 0.043 week 104 56.0 % 49.3 % 69.4 % 0.002 < 0.001 0.140 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
Maltese: ġimgħa 104 56.0 % 49.3 % 69.4 % 0.002 < 0.001 0.140 ACR 50
English: EU/1/18/1287/001 1 pre-filled syringe EU/1/18/1287/002 2 pre-filled syringes
Maltese: EU/1/18/1287/001 siringa 1 mimlija għal-lest EU/1/18/1287/002 2 siringi mimlijin għal-lest
English: Study nr-axSpA II
Maltese: L-istudju n-axSpA
English: d score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab c based on rank analysis d
Maltese: JSNd a methotrexate b 95 % intervall ta' konfidenza ghad-differenza bejn il-punteġġi ta' methotrexate u adalimumab.
English: • Store your outer carton of syringes in a refrigerator, between 2°C to 8°C.
Maltese: • Aħżen il-pinna tiegħek fil-kartuna fi friġġ, bejn 2°C sa 8°C.
English: - Keep this leaflet.
Maltese: (perċentwal ta' pazjenti)
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: (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulożi (inklużi tuberkulożi b'ħafna għoqod tuberkulari mal-ġisem kollu u tuberkulożi f'postijiet barra mill-pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa jew barra l-pulmun, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis aspergillosis u listeriosis).
English: EU/1/18/1287/004 1 pre-filled pen EU/1/18/1287/005 2 pre-filled pens
Maltese: EU/1/18/1287/004 pinna 1 mimlija għal-lest EU/1/18/1287/005 2 pinen mimlijin għal-lest
English: • pulmonary fibrosis (scarring of the lung);
Maltese: • fibrożi fil-pulmun (marki fil-pulmun);
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Maltese: • Għid lit-tabib tiegħek jekk inti iġġorr il-virus tal-epatite B (HBV), jekk għandek infezzjoni HBV attiva jew jekk taħseb li għandek riskju li jaqbdek l-HBV.
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84 %) patients in the adalimumab group who remained in the study.
Maltese: Titjib fin-numru ta' ġogi attivi bl-artrite kien mantenut waqt il-perjodu OL fil-ġimgħa 156 għall-26 minn 31 (84 %) pazjent fil-grupp ta' adalimumab li baqa' fl-istudju.
English: response
Maltese: LISTA
English: Bath ankylosing spondylitis disease activity index c ankylosing spondylitis disease activity score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L)
Maltese: SPARCC spina MRI d,j a valutazzjonijiet tas-Soċjetà Internazzjonali tas-SpondyloArthritis b indiċi tal-attività tal-mard Bath ankylosing spondylitis c punteġġ tal-attivita tal-mard ankylosing spondylitis d bidla medja mil-linja bażi e n=91 plaċebo u n=87 adalimumab f
English: • polyarticular juvenile idiopathic arthritis,
Maltese: • artrite attiva idjopatika poliartikulari taż-żgħażagħ,
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 16 -il ġimgħa ta' terapija.
English: An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Maltese: * hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (< 1 %) to “moderate” (48 %) to “severe” (46 %) to “very severe” (6 %).
Maltese: PGA varjat minn “ħafif” (< 1 %) għal “moderat” (48 %) għal “sever” (46 %) għal “sever ħafna” (6 %).
English: < 40 kg 10 mg eow 20 mg eow ≥ 40 kg 20 mg eow 40 mg eow
Maltese: 10 mg eow 20 mg eow
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 19).
Maltese: Valutazzjoni tal-psorjasi tad-dwiefer tinkludi l-Indiċi Modifikata tas-Severità tal-Psorjasi tad-Dwiefer (mNAPSI), l- Evalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara tabella 19).
English: • severe rash, hives;
Maltese: • raxx sever, urtikarja;
English: adalimumab 40 mg eow N = 80
Maltese: adalimumab 40 mg kull eow N=80
English: Adalimumab / methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Maltese: It-terapija kombinata adalimumab / methotrexate kienet klinikament u statistikament superjuri għal methotrexate (p < 0.001) u adalimumab mogħtija waħedhom bħala kura (p < 0.001) fit-tilħiq ta'stat baxx ta' mard f'pazjenti li kienu ġew riċentament iddijanjostikati b'artrite rewmatika minn moderata sa severa.
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 nżamm ma' terapija b'adalimumab sa ġimgħa 156.
English: Adults with Crohn's disease
Maltese: Adulti bil-marda Crohn (Crohn's disease)
English: 506 (62.2)b a percent of patients achieving PASI75 response was calculated as centreadjusted rate b p<0.001, adalimumab vs. placebo
Maltese: 506 (62.2)b a perċentwal ta' pazjenti li laħqu rispons tal-PASI ta' 75 ġie kkalkulat bħala rata rranġata skont iċ-ċentru b p<0.001, adalimumab kontra l-plaċebo
English: Hefiya is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: Hefiya jintuża biex jikkura hidradenitis suppurativa fl-adulti u fl-adolexxenti minn 12-il sena.