FrancophonIA/ELRC3.0 huggingface dataset:
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: Improved physical function continued during the open-label extension up to week 136.
Maltese: It-titjib fil-funzjoni fiżika tkompla matul l-estensjoni open-label sa Ġimgħa 136.
English: • nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Maltese: • disturbi fin-nervituri (bħal infjammazzjoni tan-nerv tal-għajn u s-sindromu ta' Guillain-Barré li jista' jikkawża debolizza fil-muskoli, sensazzjonijiet mhux normali, tnemnim fl-idejn u l-parti ta'
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Maltese: < 40 kg • 40 mg f'ġimgħa 0 u 20 mg f'ġimgħa 2
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: 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: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Maltese: Adalimumab jimmodula ukoll 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: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa Week 56
Maltese: Titjib kliniku Rispons kliniku (CR-100) Pazjenti li kellhom titjib mingħajr sterojdi għal > = 90 ġurnataa Ġimgħa 56
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa clinical response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Maltese: Tnaqqis ta' leżjonijiet infjammatorji u prevenzjoni ta' aggravar ta' axxessi u tal-fistuli li jnixxu ġew evalwati bl-użu ta' Hidradenitis Suppurativa Rispons Kliniku (HiSCR; mill-inqas tnaqqis ta' 50% flaxxess total u l-għadd tal-noduli infjammatorji bl-ebda żieda fl-għadd tal-axxess u l-ebda żieda fil-għadd relattiv tal-fistula li tkun qed tnixxi mal-Linja Bażi).
English: Blue start button
Maltese: Buttuna blu biex tibda
English: Each pack contains 1, 2, 4 or 6 single use SureClick pre-filled pens.
Maltese: Kull pakkett fih 1, 2, 4 jew 6 pinen mimlija għal-lest SureClick għall-użu ta' darba.
English: 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: 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: 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).
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Maltese: * P < 0.05, ***P < 0.001, adalimumab kontra plaċebo.
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Maltese: Studju nr-axSpA I evalwa pazjenti b'nr-axSpA attiva.
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/m2 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: 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 f'Ġimgħa 156 għal 26 minn 31 (84%) pazjent fil-grupp ta' adalimumab li baqgħu fl-istudju.
English: Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease.
Maltese: Aggravar Parzjalid a Stima ta' SpondyloArthritis international Society b Linja bażi hija definita bħala linja bażi open label meta l-pazjenti jkollhom marda attiva.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies
Maltese: * hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8 ** li jinkludu l-istudji ta' estensjoni open-label
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Maltese: Aggravar jew bidu ta' psorjasi (li jinkludu psorjasi tat-tip palmoplantar pustular)1), Urtikarja,
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Maltese: Tuberkulosi attiva jew infezzjonijiet oħra severi bħal sepsis, u infezzjonijiet opportunistiċi (ara sezzjoni
English: Low dose 20/10 mg eow
Maltese: Doża Baxxa 20/10 mg eow
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Maltese: Il-konċentrazzjoni ta' adalimumab fil-fluwidu sinovjali ta' ħafna pazjenti li jbatu minn artrite rewmatika varjaw minn 31-96% minn dawk fis-serum.
English: Response, remission and mucosal healing in study UC-II (percent of patients)
Maltese: Rispons, titjib kliniku u fejqan tal-mukoża fi studju UC-II (persentaġġ ta' pazjenti)
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomised to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Maltese: Pazjenti li kisbu remissjoni sostnuta għal mill-inqas 12-il ġimgħa (N=305) (ASDAS < 1.3 f'Ġimgħat 16, 20, 24 u 28) waqt ilperjodu open-label imbagħad kienu randomised biex jirċievu trattament kontinwu b'adalimumab 40 mg eow (N=152) jew plaċebo (N=153) għal 40 ġimgħa addizzjonali f'perjodu double-blind, ikkontrollat bil-plaċebo (tul totali tal-istudju ta' 68 ġimgħa).
English: Radiographic mean changes at week 52 in RA study V
Maltese: Tibdil medju radjografiku f'Ġimgħa 52 fi studju RA V
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: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.
Maltese: Fi studju ta' 64 pazjent li jbatu minn artrite rewmatika li kienu ttrattati b'adalimumab, ma kien hemm lebda evidenza ta' tnaqqis ta' sensitività eċċessiva imdewma, tnaqqis tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelluli effettivi T-, B-, NK-, monoċistiċi/makrofaġi, u newtrofili.
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 għal-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: 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 anti-rewmatika li taffetwa 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: ASAS partial remission BASDAIb 50
Maltese: BASDAIb 50
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: Hepatitis,
Maltese: Ipokalimja,
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 studjati fi studju kollettiv multicenter, randomizzat,u double-blind f'171 tifel u tifla (li għandhom bejn 4-17-il sena) b'JIA poliartikulari.
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 anti-rewmatika li taffetwa l-proċess tal-mard.
English: • numbness;
Maltese: • tingiż;
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' kanċer tal-ġilda li m'humiex melonoma kienet ta' 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: 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: a. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'methotrexate waħdu u adalimumab u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. b. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u adalimumab u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. c. ilvalur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney.
English: ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Maltese: Rispons ACR fi studji tal-artrite psorjatika kontrollati bil-plaċebo (persentaġġ ta' pazjenti)
English: AMGEVITA is used to treat rheumatoid arthritis in adults.
Maltese: AMGEVITA jintuża biex jittratta artrite rewmatika fl-adulti.
English: P Value b
Maltese: Valur Pb
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p < 0.001, adalimumab versus placebo Table 18.
Maltese: 506 (62.2)b a Persentaġġ 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: Vertigo and visual impairment may occur following administration of AMGEVITA (see section 4.8).
Maltese: Jista jkun hemm vertigo u ndeboliment fil-vista wara li jingħata AMGEVITA (ara sezzjoni 4.8).
English: ACR response
Maltese: Rispons ACR
English: ● Alcohol wipes
Maltese: ● Imsielaħ tal-alkoħol
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: Fl-estensjoni open-label ta' studju RA V, il-bidla medja mil-linja bażi f'Sena 10 fil-Punteġġ Totali Sharp modifikati kienet ta' 10.8, 9.2 u 3.9 fil-pazjenti li oriġinarjament kienu randomised għal monoterapija b'methotrexate, monoterapija b'adalimumab u terapija kkombinata b'adalimumab/methotrexate, rispettivament.
English: For more information on vaccines see the “Warnings and precautions” section.
Maltese: Għal aktar informazzjoni dwar it-tilqim ara s-sezzjoni “Twissijiet u prekawzjonijiet”.
English: Inspect the AMGEVITA pre-filled syringe.
Maltese: Fil-każijiet kollha uża siringa ġdida.
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Maltese: Infezzjonijiet serji, li jinkludu sepsis kkawżati minn batterji, myco-batterji, fungus invażiv, parassiti, virus u infezzjonijiet opportunistiċi oħra bħal listeriżi, leġinellożi u pneumocystis, ġew rapportati f'pazjenti li kienu qed jirċievu adalimumab.
English: AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: AMGEVITA jintuża biex jittratta hidradenitis suppurativa fl-adulti u fl-adolexxenti minn 12-il sena.
English: Adalimumab 40 mg eow N = 80
Maltese: Adalimumab 40 mg kull eow N = 80
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, li sar għal pazjenti li żiedu d-doża minn 40 mg ġimgħa iva u ġimgħa le għal 40 mg fil-ġimgħa minħabba rispons tal-PASI taħt il-50%, 26.4% (92/349) u 37.8% (132/349) tal-pazjenti kisbu rispons ta' PASI 75 f'Ġimgħa 12 u 24, rispettivament.
English: AMGEVITA is used to treat moderate to severe plaque psoriasis in adults.
Maltese: AMGEVITA jintuża biex jittrata psorijasi tal-plakka moderata sa severa fl-adulti.
English: In CD study I, 299 TNF-antagonist naïve patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Maltese: Fi studju CD I, 299 pazjent li qatt ma ħadu antagonist ta' TNF ġew imqassma bl-addoċċ f'wieħed minn erbgħa gruppi ta' nies li kienu qegħdin jieħdu l-kura; plaċebo f'Ġimgħat 0 u 2, 160 mg adalimumab f'Ġimgħa 0 u 80 mg f'Ġimgħa 2, 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 2, u 40 mg f'Ġimgħa 0 u 20 mg f'Ġimgħa 2.
English: AMGEVITA is used to treat ulcerative colitis in adults.
Maltese: AMGEVITA huwa intenzjonat għat-trattament ta' kolite ulċerattiva fl-adulti.
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7% and 59.0%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Maltese: F'dawn il-pazjenti ir-rati tal-PASI 75 u l-PGA ta' fejn ma kienx hemm rispons jew fejn kien hemm rispons minimu kienu ta' 69.6% u 55.7%, rispettivament, wara 108 ġimgħat addizzjonali ta' terapija open-label (total ta' 160 ġimgħat).
English: Thigh
Maltese: ASDASc
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Maltese: Titjib kliniku Rispons kliniku (CR-100) Pazjenti li kellhom titjib mingħajr sterojdi għal > = 90 ġurnataa * 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 a
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 l-kura b'adalimumab, ġie osservat tnaqqis rapidu fil-livelli ta' sustanzi li jirreaġixxu fil-fażi akuta tal-infjammazzjoni (proteina C-reactive (CRP) u r-rata ta' tagħqid tal-eritroċit (ESR)) u cytokines fis-serum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: Paediatric ACR 30 response (n/N)
Maltese: OL-LI 16 il-ġimgħa ACR 30 rispons pedjatriku (n/N)
English: If you are over 65 years you may be more susceptible to infections while taking AMGEVITA.
Maltese: - Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet b'mod aktar faċli waqt li qed tieħu AMGEVITA.
English: AMGEVITA 20 mg solution for injection in pre-filled syringe EU/1/16/1164/001 - 1 pack
Maltese: AMGEVITA 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/16/1164/001 - pakkett wieħed
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 farmakokinetiċi u farmkokinetiċi/farmakodinamiċi tal-popolazzjoni bassru esponiment u effikaċja ta' adalimumab komparabbli f'pazjenti ttrattati bi 80 mg ġimgħa iva u ġimgħa le meta mqabbel ma' 40 mg kull ġimgħa (inklużi pazjenti adulti b'RA, HS, UC, CD jew Ps, pazjenti b'HS adolexxenti, u pazjenti pedjatriċi ≥ 40 kg b'CD).
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n = 102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Maltese: Fil-każ ta' suġġetti kkurati b'adalimumab li ma urew l-ebda progress radjografiku mil-linja bażi sa Ġimgħa 48 (n=102), 84% baqgħu ma urew l-ebda progress radjografiku matul 144 ġimgħa ta' kura.
English: - The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Maltese: - Is-sustanzi l-oħra huma glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide u ilma għall-injezzjonijiet.
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 b'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: 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 bi HS kienet prevista li tuża mudellar u simulazzjoni farmakokinetiku tal-popolazzjoni bbażata fuq cross-indication farmakokinetika f'pazjenti pedjatriċi oħra (psorjasi pedjatrika, artrite idjopatika ġovanili, marda Crohn pedjatrika u l-artrite relatata mal-entesite).
English: Figure 1: Kaplan-Meier Curves Summarising Time to Flare in Study nr-axSpA II
Maltese: Kaplan-Meier Curves li jagħtu Sommarju taż-Żmien sakemm seħħ Aggravar fi Studju nr-axSpA II
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Maltese: Wara dożi ta' 0.5 mg/kg (~40 mg), it tneħħija mill-ġisem varjat minn 11 sa 15 mL/siegħa, il-volum ta' distribuzzjoni (Vss) varja minn 5 sa 6litri u l-half-life medja tal-fażi terminali kienet ta' bejn wieħed u ieħor gimagħtejn.
English: a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Maltese: NA 4.5% 23.2% a Studju RA I fir-24 ġimgħa, Studju RA II fis-26 ġimgħa, u Studju RA III fl-24 u t-52 ġimgħa b 40 mg adalimumab mgħotija ġimgħa iva u ġimgħa le c MTX = methotrexate ** p < 0.01, adalimumab kontra l-plaċebo
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 jbatu min artrite idjopatika poliartikulari taż-żagħżagħ, mill-marda ta' Crohn, kolite ulċerattiva u hidradenitis suppurativa wara trattament b'adalimumab.
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, doublemasked, 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: 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 talĠisem u l-veloċità tat-tul kienu osservati fiż-żewġ gruppi tat-trattament.