FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate (95 % confidence interval) of non-melanoma 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: Ir-rata (intervall ta' konfidenza ta' 95 %) ta' kanċer tal-ġilda li mhux melanoma kienet ta' 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti ttrattati b'adalimumab u 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti ttrattati bil-kontroll.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati f'pazjenti adulti li jbatu minn Psorjasi kronika li tikkawża qoxra mhux normali fuq il-ġilda (≥ 10% involviment tal-BSA u l-Indiċi tal-Parti milquta mill-Psorjasi u s-Severità tagħha (PASI - Psoriasis Area and Severity Index) ≥ 12 jew ≥ 10) li kienu kandidati għat-terapija sistemika jew għall-fototerapija fi studji double-blind u randomised.
English: • high blood measurements for lactate dehydrogenase;
Maltese: • deterjorazzjoni anormali tal-muskoli;
English: p value for Standard Dose versus Low Dose comparison.
Maltese: valur p li huwa paragun tad-Doża Standard kontra Doża Baxxa.
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: Valutazzjonijiet tal-psorjasi tad-dwiefer kienu jinkludu l-Indiċi Modifikat tas-Severità tal-Psorjasi tad-Dwiefer (mNAPSI - Modified Nail Psoriasis Severity Index), l-Evalwazzjoni Globali tat-Tobba tal-Psorjasi tad-Dwiefer (PGA-F - Physician's Global Assessment of Fingernail Psoriasis) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI - Nail Psoriasis Severity Index) (ara Tabella 19).
English: The Cyltezo pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
Maltese: Il-pinna mimlija għal-lest Cyltezo hija disponibbli f'pakketti li fihom 1, 2, 4 u 6 pinen mimlija għallest.
English: • If you are over 65 years you may be more susceptible to infections while taking Cyltezo.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet b'mod aktar faċli waqt li tkun qed tieħu Cyltezo.
English: CI 95 % for HR
Maltese: 4 % kontra 47.
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: Il-punt finali primarju kien il-bidla perċentwali mill-linja bażi sa ġimgħa 12 finnumru ta' ġogi attivi bl-artrite (nefħa mhux minħabba sfigurazzjoni jew ġogi li m'għadhomx 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 fil-grupp ta' adalimumab meta kkumparat ma'11.6 % (bidla perċentwali medja -50.0 %) f'pazjenti fil-grupp tal-plaċebo.
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: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Maltese: %) kellhom rispons tal-ACR 20; 72 pazjent (63.2 %) kellhom rispons tal-ACR 50; u 41 pazjent (36 %) kellhom rispons tal-ACR 70.
English: 8) Insert needle
Maltese: 9) Injetta l-mediċina
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Maltese: Wara trattament b'adalimumab, ġie osservat tnaqqis rapidu fil-livelli ta' sustanzi li jirreaġixxu fil-fażi akuta tal-infjammazzjoni (proteina reattiva C (CRP - C-reactive protein) u r-rata ta' tagħqid taleritroċiti (ESR - erythrocyte sedimentation rate)) u ċitokini fis-serum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Maltese: Id-dejta disponibbli tissuġġerixxi li r-rispons kliniku huwa normalment milħuq fi żmien 2-8 ġimgħat ta' trattament.
English: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists.
Maltese: Rapporti rari ta' panċitopenija inkluża anemija aplastika, ġew irrappurtati b'antagonisti ta' TNF.
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: 8, 9.2 u 3.9 f'pazjenti li oriġinarjament kienu randomised għal monoterapija b'methotrexate, monoterapija b'adalimumab u terapija kkombinata ta' adalimumab/methotrexate, rispettivament.
English: • pleural effusion (abnormal collection of fluid in the pleural space);
Maltese: • effuzjoni plewrali (żamma mhux normali ta' ilma fl-ispazju plewrali);
English: Improved physical function continued during the open label extension up to week 136.
Maltese: It-titjib fil-funzjoni fiżika tkompla matul l-estensjoni openlabel sa ġimgħa 136.
English: • sleep interruptions;
Maltese: • disturbi fil-vista;
English: Undesirable Effects System Organ Class Frequency
Maltese: Tabella 6: Effetti Mhux Mixtieqa Klassi tas-Sistemi u tal-Organi
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil-livelli ta' CPR f'pazjenti li jbatu minn artrite idjopatika poliartikulari taż-żagħżagħ, mill-marda ta' Crohn, kolite ulċerattiva u hidradenitis suppurativa wara trattament b'adalimumab.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Cyltezo cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti ttratati b'Cyltezo (ara sezzjoni 4.8).
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 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: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions
Maltese: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo ** p < 0.02 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo
English: Methotrexate should be continued
Maltese: MTX = methotrexate
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
Maltese: Adalimumab jimmodula ukoll ir-risponsi bijoloġiċi li jiġu kkawżati jew regolati minn TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma responsabbli għall-migrazzjoni tal-lewkoċiti (ELAM-1, VCAM-1, u ICAM-1 ma' xi IC50 ta' 1 - 0.2 nM).
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease.
Maltese: Studju UV II evalwa 226 pazjent b'uveite inattiv li jeħtieġu trattament kroniku ta' kortikosterojdi (prednisone orali 10 sa 35 mg/jum) fil-linja bażi għall-kontroll tal-marda tagħhom.
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: Fil-gruppi kollha ta' trattament, il-punteġġ tal-PASI medju fil-linja bażi kien ta' 18.9 u l-punteġġ tal-Istima Ġenerali tat-Tabib (PGA - Physician's Global Assessment) fil-linja bażi varja minn “moderat” (53% tal-individwi li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Maltese: Il-punt finali primarju fi studji RA I, II u III u l-punt finali sekondarju fi studju RA IV kien ilpersentaġġ ta' pazjenti li laħqu rispons tal-ACR 20 f'ġimgħa 24 jew 26.
English: Erythema multiforme Stevens-Johnson syndrome angioedema cutaneous vasculitis lichenoid skin reaction
Maltese: , anġjoedima reazzjoni tal-lichenoid fil-ġilda Aggravar tas-sintomi tad-dermatomijosite
English: The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab fit-tfal b'età ta' 4-17-il sena għadhom ma ġewx determinati s'issa.
English: Cyltezo can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Cyltezo jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' sustanzi anti-rewmatiċi li jaffettwaw il-proċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħata b'injezzjoni), kortikosterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini anti-infjammatorji mhux sterojdi (NSAIDs - non-steroidal anti-inflammatory drugs).
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt trattament ta'manutenzjoni, kortikosteroidi jistgħu jiġu mnaqqsa bil-mod skont il-linji gwida talprattika klinika.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: double-blind f'46 pazjent pedjatriku (6 sa 17-il sena) b'artrite moderata relatata mal-entesite.
English: Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Maltese: Adalimumab jeħel speċifikament ma' TNF u jinnewtralizza il-funzjoni bijoloġika ta' TNF billi jimblokka l-interazzjoni tiegħu mar-riċetturi ta' TNF p55 u p75 fuq il-wiċċ taċ-ċellula.
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Il-pożoloġija ta' adalimumab f'dawn il-pazjenti ġiet determinata minn mudellar u simulazzjoni farmakokinetika (ara sezzjoni 5.2).
English: The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati f'żewgt studji (pJIA I u II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż-żagħżagħ, u li kellhom varjeta ta' tipi ta' bidu ta' JIA (l-aktar frekwenti fattur rewmatoloġiku negattiv jew poli-artrite pożittiva u oligoartrite fit-tul.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX-treated.
Maltese: Fil-fażi tal-bidu open-label (OL LI - open-label lead in) il-pazjenti kienu imqassma f'żewġ gruppi, dawk ittrattati b'MTX (methotrexate) u dawk li ma kinux ittrattati b'MTX (non-MTX).
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Maltese: Il-punt finali primarju fi Studju RA V kien il-persentaġġ ta' pazjenti li laħqu rispons tal-ACR 50 f'ġimgħa 52.
English: Hidradenitis Suppurativa Clinical Response
Maltese: Hidradenitis Suppurativa Rispons Kliniku (HiSCR)
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, it-titjib fl-indiċi ta' diżabilità ta' HAQ u fil-komponent fiżiku tal-SF 36 wera titjib akbar (p < 0.001) għat-terapija kombinata ta' adalimumab/methotrexate versus trattament b'methotrexate u trattament b'adalimumab waħdu f'ġimgħa 52, liema titjib baqa' miżmum matul ġimgħa 104.
English: Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Maltese: Adalimumab ġie evalwat f'aktar minn 3,000 pazjent fil-provi kliniċi kollha tal-artrite rewmatika.
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: Ir-rata ta' tqaliet li jintemmu b'għallinqas tarbija tat-twelid ħajja waħda b'difett maġġuri mat-twelid kienet 6/69 (8.7%) fin-nisa kkurati b'adalimumab b'RA u 5/74 (6.8%) fin-nisa mhux ikkurati b'RA (OR mhux aġġustata 1.31, 95% CI 0.38-4.52) u 16/152 (10.
English: Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Maltese: Minn 207 pazjenti, 81 pazjent komplew b'adalimumab 40 mg ġimgħa iva u ġimgħa le għal 10 snin.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/mL (79 % CV).
Maltese: Wara l-amministrazzjoni ta' 0.8 mg/kg (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lil pazjenti pedjatriċi bi psorjasi tal-plakka kronika, il-koncetrazzjoni minima medja± SD fi stat fiss ta' adalimumab kienet madwar 7.4 ± 5.8 μg/mL (79 % CV).
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: Fil-gruppi kollha ta' trattament, il-punteġġ tal-PASI medju fil-linja bażi kien ta' 19.7 u l-punteġġ tal-PGA fil-linja bażi varja minn “ħafif” (< 1%) għal “moderat” (48%) għal “sever” (46%) għal “sever ħafna” (6%).
English: 2) Inspect pen
Maltese: 9) Armi l-pinna
English: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Maltese: Studju PsA II li dam 12-il ġimgħa, ittratta 100 pazjent li kellhom rispons mhux adegwat għat-terapija DMARD.
English: Vertigo and visual impairment may occur following administration of Cyltezo (see section 4.8).
Maltese: Jista' jkun hemm vertigo u ndeboliment fil-vista wara l-għoti ta' Cyltezo (ara sezzjoni 4.8).
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: Mill-pazjenti li kellhom rispons f'ġimgħa 8, 47 % kienu fi stat ta' rispons, 29 % kienu fi stat ta' remissjoni, 41 % kellhom fejqan tal-mukuża, u 20 % kienu fi stat ta' remissjoni mingħajr sterojdi għal ≥ 90 jum f'ġimgħa 52.
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: Ir-rati ta' remissjoni klinika u ta' rispons kliniku (definit bħala tnaqqis fil-punteġġ tal-PCDAI ta' millinqas 15-il punt mill-linja bażi) huma preżentati f'Tabella 26.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Maltese: Fi studju UC-I, 390 pazjent li ma kienux ħadu antagonisti ta' TNF kienu randomised biex jirċievu plaċebo f'ġimgħat 0 u 2, 160 mg adalimumab f'ġimgħa 0 u wara 80 mg f'ġimgħa 2, jew 80 mg adalimumab f'ġimgħa 0 u wara 40 mg f'ġimgħa 2.
English: • scar;
Maltese: • ażżma;
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 µg/mL at week 2 and week 4.
Maltese: F'pazjenti adulti b'hidradenitis suppurativa, doża ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg f'ġimgħa 2 kisbu konċentrazzjonijiet minimi ta' adalimumab fis-serum ta' madwar 7 sa 8 μg/mL f'ġimgħa 2 u ġimgħa 4.
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 minn hs-CRP u MRI taż-żewġ Ġogi Sacroiliac u s-Sinsla tad-Dahar inżamm f'pazjenti ttrattati b'adalimumab sa ġimgħa 156 u ġimgħa 104, rispettivament.
English: In the open-label extension of RA Study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Maltese: Fl-estenzjoni open-label tal-istudju RA III, it-tnaqqis fir-rata ta' progress ta' ħsara strutturali inżamm għal 8 u 10 snin f'sottogrupp ta' pazjenti.
English: For storage information, see package leaflet.
Maltese: jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult
Maltese: B'mod ġenerali, l-effetti avversi f'pazjenti pedjatriċi kellhom frekwenza u tip simili għal dawk li ġew osservati f'pazjenti adulti.
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
Maltese: Infezzjonijiet serji, li jinkludu sepsis kkawżati minn batterji, mmikobatterji, fungu invażiv, parassiti, virus u infezzjonijiet opportunistiċi oħra bħal listeriosis, legionellosis u pnewmoċistite, ġew irrappurtati f'pazjenti li kienu qed jirċievu adalimumab.
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7 %) was higher than for those under 65 years of age (1.5 %).
Maltese: Il-frekwenza ta' infezzjonijiet serji f'individwi li għandhom aktar minn 65 sena ttrattati b'adalimumab (3.7 %), kienet aktar għolja mill-frekwenza ta' infezzjonijiet f'pazjenti taħt il-65 sena (1.5 %).
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20 % BSA involvement or > 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy
Maltese: L-effikaċja ta' adalimumab kienet evalwata fi studju randomised, double-blind, ikkontrollat ta' 114-il pazjent pedjatriku minn 4 snin il-fuq bi psorjasi tal-plakka severa kronika (kif definit minn involviment ta' PGA ≥ 4 jew> 20% BSA jew> 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew PASI ≥ 20 jew ≥ 10 b'involviment tal-wiċċ, ġenitali, jew idejn/saqajn klinikament rilevanti) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: Adalimumab exposure in adolescent HS patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Maltese: Espożizzjoni ta' adalimumab f'pazjenti adolexxenti b'HS kienet prevista bl-użu ta' mudellar u simulazzjoni farmakokinetiku tal-popolazzjoni bbażat fuq cross-indication farmakokinetika f'pazjenti pedjatriċi oħra (psorjasi pedjatrika, artrite idjopatika taż-żagħżagħ, marda ta' Crohn fit-tfal u l-artrite relatata mal-entesite).
English: A total of 76.5 % (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 % [123/178] and 88.8 % [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Maltese: Total ta' 76.5 % (218/285) tal-pazjenti li daħlu fil-perjodu li fih inbeda ttrattament mill-ġdid, kellhom rispons ta' PGA “ċar” jew “minimu” wara 16-il ġimgħa minn meta reġa' inbeda t-trattament, irrispettivament minn jekk dawn il-pazjenti reġgħux esperjenzaw tfaċċar mill-ġdid ta' sintomi ta' Psorjasi matul il-perjodu li fih twaqqaf it-trattament (69.1% [123/178] u 88.8% [95/107] għal dawk il-pazjenti li esperjenzaw tfaċċar mill-ġdid ta' sintomi tal-psorjasi u dawk li m'esperjenzawx tfaċċar mill-ġdid ta' sintomi tal-psorjasi rispettivament, matul il-perjodu li fih twaqqaf it-trattament).
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' panċitopenija, anemija aplastika, avvenimenti li jaffettwaw il-myelin tan-nervituri fissistema ċentrali jew periferali u rapporti ta' lupus, kondizzjonijiet relatati ma lupus u s-sindrome ta' Stevens-Johnson.
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Maltese: Tuberkulosi, inkluż riattivazzjoni u bidu ġdid ta' tuberkulosi, kienet irrappurtata f'pazenti li jirċievu adalimumab.
English: MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Maltese: Totali taddwiefer (%) p < 0.001, adalimumab kontra plaċebo
English: CD study I and CD study II induction of remission and response rates are presented in Table 23.
Maltese: Ir-rati tal-induzzjoni ta' remissjoni u ta' rispons fi studju CD I u studju CD II huma ppreżentati f'Tabella 23.
English: Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 2, 2, 4 or 6 alcohol pads, respectively.
Maltese: Kull pakkett fih 1, 2, 4 jew 6 siringi mimlijin għal-lest għall-użu mill-pazjent bi 2, 2, 4 jew 6 imsielaħ bl-alkoħol, rispettivament.
English: Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Maltese: Żidiet statistikament sinifikanti (titjib) mill-Linja Bażi sa ġimgħa 26 u 52 fl-Indiċi tal-Massa tal-Ġisem u l-veloċità tat-tul kienu osservati fiż-żewġ gruppi ta' trattament.
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 21).
Maltese: F'ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi Studju HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatat ma' HS (ara t-Tabella 21).