FrancophonIA/ELRC3.0 huggingface dataset:
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Maltese: Spondilite bl-ankilożi, spondiloartrite assjali mingħajr evidenza radjografika ta' AS (ankylosing spondylitis) u artrite psorjatika.
English: 6 pre-filled syringes 6 alcohol pads
Maltese: 6 siringi mimlija għal-lest 6 pads tal-alkoħol
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12-il sena 'l fuq, li jiżnu mill-anqas 30 kg) M'hemm l-ebda provi kliniċi b'adalimumab f'pazjenti adolexxenti b'HS.
English: The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 and ≤450) in randomised, double blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew stimati f''il fuq minn 1,500 pazjent li jbatu mill-marda Crohn (Crohn's disease) attiva b'mod minn moderat sa sever (Indiċi tal-Attività tal-Marda Crohn (Crohn's disease) (CDAI) ≥ 220 u ≤ 450) fi studji double-blind, kontrollati bil-plaċebo, li saru b'ordni addoċċ.
English: Serious adverse reactions have been reported for adalimumab.
Maltese: Reazzjonijiet avversi serji, ġew irrapurtati b'adalimumab.
English: 4 pre-filled pens 4 alcohol pads
Maltese: 4 pinen mimlija għal-lest 4 pads tal-alkoħol
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2<4 years old or aged 4 and above weighing <15 kg) with moderately to severely active polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju tat-tip multiċentru u “open-label” fi 32 tfal (2 - <4 snin jew li għandhom min 4 snin il-fuq u li jiżnu <15 kg) li għandhom artrite poliartikulari JIA moderata jew qawwija.
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-żgħażagħ, mill-marda Crohn (Crohn's disease) kolite ulċerattiva u hidradenitis suppurativa wara trattament b'adalimumab.
English: ≥ PASI 75a
Maltese: Ġimgħa 52
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 mill-linja 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: Imraldi is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Imraldi huwa kontro-indikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: • 40 mg at week 0 and 20 mg at week 2
Maltese: • 40 mg f'ġimgħa 0 u 20 mg f'ġimgħa 2
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, spondilite bl-ankilożi jew spondiloartrite assjali mingħajr evidenza radjografika ta' spondilite bl-ankilożi
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 ikkawżati 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: 4 pre-filled syringes 4 alcohol pads
Maltese: 4 siringi mimlija għal-lest 4 pads tal-alkoħol
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 17).
Maltese: F'Ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi studju HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatati ma' HS (ara t-Tabella 17).
English: Table 10 Radiographic Mean Changes at Week 52 in RA Study V
Maltese: Tabella 10 Tibdil Medju Radjografiku f'Ġimgħa 52 fi Studju RA V
English: HS Study I
Maltese: HS Studju I
English: (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: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti b' artrite idjopatika poliartikulari taż-żgħażagħ (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: Absorption and distribution Following the administration of 24 mg/m
Maltese: Wara t-teħid ta' 24 mg/m
English: • paediatric plaque psoriasis,
Maltese: • artrite psorijatika fit-tfal,
English: Median Time to Failure (months)
Maltese: TAL-FALLIMENT TATTRATTAMENT (%)
English: Imraldi 40 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Imraldi 40 mg
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 lejn l-għajn, u s-sindromu ta' Guillain-Barré, kundizzjoni li tista' tikkawża debolizza fil-muskoli, sensazzjonijiet mhux normali, tnemnim fl-idejn u l-parti ta' fuq tal-ġisem;
English: In study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Fi studju nr-axSPA I, adalimumab 40 mg ġimgħa iva u oħra ġie evalwat f'185 pazjent fi studju doubleblind ikkontrollat bil-plaċebo ta '12-il ġimgħa f'pazjenti b'nr axSpA attiv (punteġġ medju ta' linja bażi ta' attività ta' mard [Bath Ankylosing Spondylitis Disease Indiċi ta' Attività (BASDAI)] kien 6.4 għal pazjenti ttrattati b'adalimumab u 6.5 għal dawk fuq il-plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥ 1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: • 80 mg at week 0 and 40 mg at week 2
Maltese: • 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2
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 (PGAF) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 19).
English: Adult plaque psoriasis
Maltese: Psorijasi fil-plakka fl-adulti
English: Double-Blind Response at Week 68
Maltese: Rispons fil-Ġimgħa 68
English: There is limited experience in the initiation of treatment with Imraldi alone.
Maltese: Hemm esperjenza limitata filbidu tat-trattament b'Imraldi waħdu.
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 Crohn (CD) moderata sa severa definita bħala riżultat tal-Indiċi talAttività tal-marda Crohn (Crohn's disease) fit-tfal (PCDAI) > 30.
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: Insomnia
Maltese: infezzjoni.
English: Cautions
Maltese: Infjammazzjoni
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Maltese: • epatite awtoimmuni (infjammazzjoni tal-fwied ikkawżata mis-sistema immunitarja tal-istess ġisem)
English: Adalimumab 40 mg weekly N = 70
Maltese: Adalimumab 40 mg kull ġimgħa N = 70
English: pruritus
Maltese: Pożoloġija
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffetwaw sa persuna waħda minn kull 10):
English: The recommended Imraldi 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' Imraldi 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: Table 7 ACR Responses in Placebo Controlled Trials (Percent of Patients)
Maltese: Tabella 7 Risponsi għall-ACR fi Provi kontrollati bil-Plaċebo (Persentaġġ ta' pazjenti)
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'zewgt studji (pJIA I and II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż-żgħażagħ, u li kellhom varjeta ta' bidu ta' JIA (l-aktar frekwenti fattur rewmatoloġiku negattiv jew poli-artrite pożittiva u oligo-artrite fit-tul.
English: RA study IIa**
Maltese: Kwalità ta' Ħajja
English: Table 15 Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Maltese: Tabella 15 Ir-Rispons tal-Effikaċja fil-Perjodu Kontrollat bil-Plaċebo għall-Istudju nr-axSpA II
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 jużaw 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: 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: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64 %.
Maltese: Ilbiodisponibiltà medja assoluta ta' adalimumab stimata minn tliet studji wara t-teħid ta' doża waħda ta' 40 mg taħt il-ġilda kienet ta' 64%.
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 irrapurtata f'pazenti li jirċievu adalimumab.
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: Fil-fażi ta' estensjoni open-label tal-istudju RA III, it-tnaqqis fir-rata ta' progress ta' ħsara strutturali huwa mantenut għal 8 u 10 snin.
English: • tingling;
Maltese: • tnemnim;
English: • adolescent hidradenitis suppurativa,
Maltese: • hidradenitis suppurtiva fl-adolexxenti,
English: 36.8 % (14/38) 64.9 % (24/37)b 43.3 % (13/30) 71.4 % (20/28)c Median time to disease flare >32 weeks
Maltese: % (92/349) u 37.8 % (132/349) tal-pazjenti laħqu r-rispons tal-PASI ta' 75 f'ġimgħa 12 u 24, rispettivament.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥3 × ULN occurred in 0.3 % of adalimumab treated patients and 0.6 % of control-treated patients.
Maltese: Fi provi kkontrollati ta' adalimumab (dożi inizjali ta' 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2, segwiti minn 40 mg kull ġimgħa li jibdew f'ġimgħa 4), f'pazjenti bi suppurativa hidradenitis bil-perjodu ta' kontroll b'durazzjoni li tvarja minn 12 sa 16-il ġimgħa, elevazzjonijiet ta' ALT ≥3 × ULN seħħew f'0.3 % tal-pazjenti ttrattati b'adalimumab u 0.6 % tal-pazjenti ttrattati kkontrollati.
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: 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 tarriżultat 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: 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-sigurtà ta' adalimumab ma' plaċebo f'217 pazjent adult b'psorjasi tad-dwiefer moderata sa severa.
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 tat-trattament.
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), ittneħħija mill-ġisem varjat minn 11 sa 15 mL/siegħa, il-volum ta' distribuzzjoni (Vss) varja minn 5 sa 6 litri u l-half-life medja tal-fażi terminali kienet ta' bejn wieħed u ieħor gimagħtejn.
English: 104 Week 42.8% 36.9% 59.0% <0.001 <0.001 0.162
Maltese: Ġimgħa 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Ġimgħa 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Ġimgħa 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Ġimgħa 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Maltese: Minn 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: Table 9 ACR Responses in Placebo Controlled Trials (Percent of Patients)
Maltese: Tabella 9 Risponsi għall-ACR fi Provi Kontrollati bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 μg/ml.
Maltese: Wara amministrazzjoni ta' 40 mg ta' adalimumab kull ġimgħa ta' ġimgħa ta' adolimumab f'pazjenti adulti mhux skuri radjografiċi spondyloarthritis axjali, il-medja (± SD) permezz ta' konċentrazzjoni ta' stat stabbli f'Ġimgħa 68 kienet ta' 8.0 ± 4.6 μg / mL.
English: Enthesitis-related arthritis
Maltese: Artrite relata mal-entesite
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Maltese: Fil-każi fejn hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8, tidher asterisk (*) fil-kolonna tas-Sistema tal-Klassifika tal-Organi (SOC, System Organ Class).
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' panċitopenja, anemija aplastika, avvenimenti li jaffetwaw il-myelin b'mod ċentrali jew periferali u rapporti ta' lupus, kundizzjonijiet relatati ma' lupus u s-sindromu ta' StevensJohnson.
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: Inspect medicine & expiration date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Maltese: Infezzjonijiet fatali u infezzjonijiet li jistgħu jpoġġu l-ħajja fil-periklu, (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), riattivazzjoni tal-HBV u tumuri malinni oħra (li jinkludu lewkimja, limfoma u HSTCL) ġew irrapurtati ukoll bl-użu ta' adalimumab.
English: 1.9-10.5, respectively).
Maltese: 3%/36.7%, rispettivament.
English: • signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;
Maltese: • sinjali ta' infezzjoni bħal deni, tħossok marid, feriti, problemi tas-snien, ħruq waqt għamil tal awrina;
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatric arthritis.
Maltese: Artrite Psorjatika u spondiloartrite assjali li jinkludi spondilite bl-ankilożi M'hemm l-ebda użu rilevanti ta' adalimumab fi tfal għal indikazzjonijiet ta' spondilite bl-ankilożi u artrite psorjatika.
English: Uncommon Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
Maltese: Infezzjonijiet newroloġiċi (li jinkludu l-meninġite virali), infezzjonijiet opportunistiċi u tuberkulosi (li jinkludu coccidioidomycosis, histoplasmosis u infezzjoni tal-mycobacterium avium complex), infezzjonijiet tal-batterji, infezzjonijiet fl-għajnejn, divertikulite
English: week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u ssintomi ta' nr-axSpA attiv f'pazjenti kkurati bi adalimumab meta mqabbla mal-plaċebo (Tabella 14).
English: 79 (73.1)a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Maltese: 001 adalimumab kontra methotrexate c p <0.01 adalimumab kontra l-plaċebo d p <0.05 adalimumab kontra methotrexate
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline 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-PGA varjat minn “moderat” (53% tas-suġġetti li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Maltese: PASI 75 rispons ta' 78.9% (15 minn 19-il suġġett) u PGA xejn jew minimali ta' 52.6% (10 minn 19-il suġġett).
English: Additional risk minimisation measures
Maltese: Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Maltese: • disturbi fl-immunità li jistgħu jeffetwaw il-pulmun, ġilda u in-nodi tal-limfa (l-aktar komuni bħala kundizzjoni msejħa sarcoidosis);
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/kuljum) fil-linja bażi għall-kontroll tal-marda tagħhom.
English: * 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: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal Imraldi kontra l-plaċebo ** p < 0.02 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal Imraldi kontra l-plaċebo a
English: Table 21 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Maltese: Tabella 21 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla
English: Leukocytosis, thrombocytopenia Uncommon Idiopathic thrombocytopenic purpura Rare
Maltese: Limfoma tat-tip hepatosplenic T-cell Karċinoma taċ-ċelluli Merkel (karċinoma talġilda newroendokrinika)