FrancophonIA/ELRC3.0 huggingface dataset:
English: One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Maltese: Mitt pazjent (n=100) mill-Istudju Pedjatriku CD komplew fi studju ta' estensjoni fit-tul u openlabel.
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 tat-tmiem primarju kien il-bidla perċentwali milllinja bażi sa Ġimgħa 12 fin-numru ta' ġogi attivi bl-artrite (nefħa mhux minħabba sfigurazzjoni jew ġogi li madhomx 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: AMGEVITA 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: AMGEVITA huwa indikat għat-trattament ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw trattament konvenzjonali li jinkludi kortikosterojdi u 6-mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: Asthma, Dyspnoea, Cough
Maltese: Ażżma, Dispneja, Sogħla
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX
Maltese: Fil-fażi tal-bidu open-label (OL LI) il-pazjenti kienu imqassma f'żewgt gruppi, dawk ikkurati b'MTX (methotrexate) u dawk li mhux trattati b'MTX (non-MTX).
English: Visual impairment, Conjunctivitis, Blepharitis, Eye swelling
Maltese: Indeboliment tal-vista, Konġuntivite, Blefarite,
English: Percent change in total fingernail NAPSI (%)
Maltese: Bidla perċentwali ta' NAPSI tad-dwiefer talidejn totali (%)
English: Eye infections,
Maltese: Infezzjonijiet tal-fungu,
English: Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Maltese: Kien hemm titjib sinifikanti mil-linja bażi f'Ġimgħa 16 meta mqabbel mal-plaċebo (Studji I u II) u ma' MTX (Studju II) u dan deher fl-DLQI (Indiċi tad-Dermatoloġija dwar il-Kwalità ta' Ħajja).
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 10).
Maltese: Fi Studju RA V, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (ara tabella 10).
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 μg/mL (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/mL (47.7% CV) with concomitant methotrexate.
Maltese: Wara t-teħid ta' 24 mg/m2 (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti b' artrite idjopatika poliartikulari taż-żagħżagħ (JIA) li kellhom 4 sa 17-il sena, trough steady-state medju ta' koncetrazzjoni ta' adalimumab fis-serum (valuri mkejla minn ġimgħa 20 sa 48) kien 5.6 ± 5.6 µg/mL (102 % CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 10.
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' kura, il-linja bażi medja tar-riżultat tal-PASI kienet ta' 19.7 u l-linja bażi tar-riżultat PGA varjat minn “ħafif” (< 1%) għal “moderat” (48%) għal “sever” (46%) għal “sever ħafna” (6%).
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 jinkludu l-Indiċi Modifikata tas-Severità talPsorjasi 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: AMGEVITA 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection (injection).
Maltese: AMGEVITA 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest (SureClick) Soluzzjoni għall-injezzjoni (injezzjoni).
English: Before initiation of therapy with AMGEVITA, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Maltese: Qabel jinbeda t-trattament b'AMGEVITA, il-pazjenti kollha għandhom jiġu evalwati għall-infezzjoni tat-tuberkulosi kemm attiva kif ukoll mhux attiva (“rieqda”).
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 HAQ u fil-komponent fiżiku tal-SF 36 wera titjib akbar (p < 0.001) għat-terapija kombinata ta' adalimumab/methotrexate versu l-kura b'methotrexate u l-kura b'adalimumab waħdu f'Ġimgħa 52, liema titjib baqa' mantenut matul Ġimgħa 104.
English: RA study Ia**
Maltese: Studju RA Ia**
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in psoriasis study I, and continued adalimumab in the open-label extension trial.
Maltese: Fl-Istudju tal-Psorjasi I, total ta' 233 pazjent li wrew rispons għal PASI 75 f'Ġimgħa 16 u Ġimgħa 33 ingħataw terapija kontinwa b'adalimumab għal 52 ġimgħa, u komplew jingħataw adalimumab filprova ta' estensjoni open-label.
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Adulti b'artrite rewmatika, artrite psorjatika, ankylosing spondylitis jew axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 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.
English: Adults with plaque psoriasis
Maltese: Adulti bi psorjasi tal-plakka
English: Of 342 subjects originally randomised to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Maltese: 342 suġġetti li oriġinarjament kienu magħżula b'mod każwali għal monoterapija bi adalimumab jew terapija kkombinata b'adalimumab/methotrexate li daħlu fl-istudju ta' estensjoni open-label, 171 suġġetti temmew 10 snin ta' trattament b'adalimumab.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża ta' 0.8 mL, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphatemia, Dehydration
Maltese: Żieda fl-aċidu uriku, Sodium fid-demm ikun anormali, Ipokalċimija,
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: 4%) kellhom marda mhux attiva (l-ebda leżjoni infjammatorja attiva, grad ta' ċellula AC ≤ 0.5+, grad VH ≤ 0.5+) b'doża ta' sterojdi konkomitanti ≤ 7.5 mg kuljum, u 184 (66.7% ) kellhom marda mhux attiva u ma kienux qed jirċievu sterojdi.
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 and heliotherapy or phototherapy.
Maltese: L-effikaċja ta' adalimumab kienet evalwata fi studju każwali, 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 bi klinikament rilevanti involviment tal-wiċċ, ġenitali, jew idejn/saqajn) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: AMGEVITA 40 mg solution for injection in pre-filled syringe EU/1/16/1164/002 - 1 pack
Maltese: AMGEVITA 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/16/1164/002 - pakkett wieħed
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given AMGEVITA and during treatment with AMGEVITA.
Maltese: - It-tabib tiegħek se jagħtik ukoll Kartuna ta' Tfakkir għall-Pazjent, li fiha informazzjoni importanti dwar is-sigurtà, li inti għandek tkun taf biha qabel it-tifel jew it-tifla tiegħek jingħataw AMGEVITA u waqt it-trattament b'AMGEVITA.
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti-infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt it-trattament b'AMGEVITA.
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 mil- hs-CRP u MRI taż-żewġ Ġogi Sacroiliac u l-Spina nżamm f'pazjenti ttrattati b'adalimumab sa Ġimgħa 156 u Ġimgħa 104, rispettivament.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of AMGEVITA, and in accordance with local recommendations.
Maltese: Jekk ikun hemm dijanjosi ta' tuberkulosi rieqda, għandha tinbeda kura bi trattament profilattiku għal kontra t-tuberkulosi qabel ma jinbeda AMGEVITA, u skont rakkomandazzjonijiet lokali.
English: ACR 70 6 months 12 months
Maltese: ACR 70 Ġimgħa 12 Ġimgħa 24
English: • 160 mg at week 0 and 80 mg at week 2
Maltese: • 160 mg f'ġimgħa 0 u 80mg f'ġimgħa2
English: Psoriasis study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Maltese: L-Istudju tal-Psorjasi II (CHAMPION) qabbel l-effikaċja u s-sigurtà ta' adalimumab kontra dik ta' methotrexate u tal-plaċebo f'271 pazjent.
English: Amongst those who responded (paediatric ACR 30) at week 24 (n = 27 out of 30 patients), the paediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Maltese: Fost dawk li rrispondew (ACR Pedjatriku 30) f' Ġimgħa 24 (n=27 minn 30 pazjent), ir-rispons tal-ACR Pedjatriku 30 kien mantenut sa 60 ġimgħa fil-fażi
English: • Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: • Axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis
English: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Maltese: • trattament ta' artrite rewmatika attiva minn moderata sa severa f'pazjenti adulti, meta r-rispons tagħhom għal mediċini anti-rewmatiċi li jaffetwaw il-proċess tal-mard, inkluż methotrexate, ma kienx adegwat.
English: Time to treatment failure at or after week 2 in study UV II Primary analysis (ITT)
Maltese: Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 2 fi Studju UV II Analiżi Primarja (ITT)
English: The recommended AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Maltese: Id-doża inizjali ta' AMGEVITA rakkomandata għal pazjenti adulti b'kolite ulċerattiva minn moderata sa severa, hija ta' 160 mg mogħtija f'Ġimgħa 0 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata jew bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata għal jumejn wara xulxin) u 80 mg f'Ġimgħa 2 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Maltese: Studju RA III evalwa 619 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 -il sena, u li kellhom rispons mhux effettiv meta ngħataw dożi ta' minn 12.5 sa 25 mg ta' methotrexate jew kienu intolleranti għal 10 mg ta' methotrexate fil-ġimgħa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.4 mL
Maltese: INDIVIDWALI 0.4 mL
English: Dermatitis (including eczema), Onychoclasis,
Maltese: Tbenġil (li jinkludi l-purpura), Dermatite (li tinkludi l-ekżema), Onikoklasi,
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with AMGEVITA cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti ttratati b' AMGEVITA (ara sezzjoni 4.8).
English: In psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p < 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Maltese: Fl-Istudju I tal-Psorjasi, 28% tal-pazjenti li kellhom rispons tal-PASI ta' 75 u li reġgħu ġew magħżula b'ordni addoċċ f'Ġimgħa 33 meta mqabbla ma' 5% li komplew jirċievu adalimumab, p < 0.001, esperjenzaw “telf ta' rispons adegwat” (riżultat tal-PASI wara Ġimgħa 33 u f'Ġimgħa 52 jew qabilha li rriżulta f'rispons tal-PASI ta' < 50 relatat mal-linja bażi b'żieda minima ta' 6 punti fir-riżultat tal-PASI relattiv ma' Ġimgħa 33).
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1).
Maltese: Il-benefiċċju u r-riskju tat-trattament kontinwu li jitkompla fit-tul għandhom jiġu evalwati perjodikament (ara dejta ta' adulti fit-taqsima 5.1).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 20 mg injection adalimumab
Maltese: U MNEJN GĦANDU JINGĦATA AMGEVITA 20 mg injezzjoni adalimumab
English: AMGEVITA in combination with methotrexate, is indicated for:
Maltese: AMGEVITA, flimkien ma' methotrexate, huwa indikat għal:
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Maltese: Il-kwalità tal-ħajja relatata mas-saħħa u l-funzjoni fisika kienu evalwati bl-użu tal-kwestjonarji HAQ-S u SF-36.
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 bi hidradenitis suppurativa, doża ta' 160 mg adalimumab f'Ġimgħa 0 segwit b'80 mg f'Ġimgħa 2 kisbu konċentrazzjonijiet baxxi t'adalimumab fis-serum ta' madwar 7-8 μg/mL f'Ġimgħa 2 u Ġimgħa 4.
English: In controlled phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bl-artrite rewmatika u artrite psorjatika fejn il-pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żieda fil-livelli tal-ALT ≥ 3 x ULN f'3.7% tal-pazjenti trattati b'adalimumab u f'1.6% tal-pazjenti trattati bil-kontroll.
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg The recommended dose of AMGEVITA is an initial dose of 20 mg, followed by 20 mg one week later.
Maltese: Tfal u adolexxenti minn 4 snin sa 17-il sena li jiżnu minn 15-il kg sa inqas minn 30 kg Id-doża rakkomandata ta' AMGEVITA hija doża inizjali ta' 20 mg, segwita b'20 mg ġimgħa wara.
English: Double blind 32 weeks Adalimumab /
Maltese: Riżultati tal-effikaċja Double Blind ta' 32 ġimgħa
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Maltese: Rati simili ta' titjib ġew osservati għad-dożaġġ tal-bidu ta'160/80 mg u 80/40 mg milħuqa sa Ġimgħa 8 u fil-grupp tal-160/80 mg, l-effetti avversi ġew innutati b'mod aktar frekwenti.
English: The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 μg/mL during adalimumab 40 mg every week treatment.
Maltese: Livelli minimali medji fissi tal-konċentrazzjoni f'Ġimgħa 12 sa Ġimgħa 36 kienu bejn wieħed u ieħor 8 sa 10 μg/mL matul trattament b'adalimumab 40 mg kull ġimgħa.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (ara tabella 29).
English: Multipack: 6 (3 packs of 2) pre-filled syringes.
Maltese: 6 (3 pakketti ta' 2) siringi mimlija għal-lest.
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
Maltese: Fost il-pazjenti li waqqfu l-istudju qabel ġimgħa 78, 11% waqfu minħabba avvenimenti avversi, u 5% minħabba rispons insuffiċjenti għal trattament b'adalimumab.
English: Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Maltese: IV ġew mqabbla l-effikaċja u s-sigurta ta' adalimumab ma' plaċebo f'217-il pazjent adult b'psorjasi tad-dwiefer moderata sa severa.
English: 4 SureClick pre-filled pens.
Maltese: 4 pinen mimlija għal-lest SureClick.
English: AMGEVITA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: AMGEVITA huwa indikat għat-trattament ta' psorjasi tal-plakka severa u kronika fit-tfal u adolexxenti minn 4 snin il-fuq u li kellhom rispons mhux adegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
English: Disease flares at the end of 32 weeksa (n/N)
Maltese: Il-marda tmur għal agħar fl-aħħar ta' 32 ġimgħaa (n/N)
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0%).
Maltese: HS-I u HS-II, ir-rata ta' HiSCR f'12-il ġimgħa wara l-introduzzjoni mill-ġdid ta' adalimumab 40 mg kull ġimgħa marret lura għal livelli simili għal dik osservata qabel l-irtirar (56.0%).
English: A single AMGEVITA pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Maltese: Pinna waħda mimlija għal-lest ta' AMGEVITA tista' tkun maħżuna f'temperaturi sa massimu ta' 25°C għal-perjodu sa 14-il ġurnata.
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' kura, il-linja bażi medja tar-riżultat tal-PASI kienet ta' 18.9 u l-linja bażi tal-Istima Ġenerali tat-Tabib (PGA) varjat minn “moderat” (53% tassuġġetti li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Maltese: Tnaqqis statistikament sinifikanti fl-għejja, kif inhi mkejla mill-istima funzjonali tat-terapija tal-mard kroniku (FACIT) kien osservat fit-tliet studji li fihom saret l-istima (Studji I, III u IV).
English: In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Maltese: Fi studju CD I u studju CD II, f'ġimgħa 4, ġie milħuq riżultat totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju għall-mard speċifiku dwar il-marda tal-infjammazzjoni tal-musrana (IBDQ), u dan f'pazjenti li ġew magħżula b'ordni addoċċ u ngħataw 80/40 mg u 160/80 mg adalimumab meta mqabbel mal-plaċebo, u dan deher f'Ġimgħat 26 u 56 fi studju CD III, kif ukoll filgruppi tal-kura b'adalimumab meta mqabbla mal-grupp tal-plaċebo.
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Maltese: Din il-prova saret f'192 suġġetti pedjatriċi li għandhom bejn 6 u 17 (inkluż) -il sena, bil-marda ta' Crohn (CD - Crohn's disease) moderata sa severa definita bħala riżultat tal-Indiċi tal-Attività tal-marda ta' Crohn fit-tfal (PCDAI) > 30.
English: Patients received adalimumab 0.8 mg/kg every other week (up to 40 mg), 0.4 mg/kg every other week (up to 20 mg), or methotrexate 0.1-0.4 mg/kg weekly (up to 25 mg).
Maltese: Pazjenti rċevew adalimumab 0.8 mg/kg ġimgħa iva u ġimgħa le (sa 40 mg), 0.4 mg/kg ġimgħa iva u ġimgħa le (sa 20 mg), jew methotrexate 0.1-0.4 mg/kg kull ġimgħa (sa 25 mg).