FrancophonIA/ELRC3.0 huggingface dataset:
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Maltese: Seħħet riattivazzjoni ta' epatite B f'pazjenti li kienu qed jirċievu xi antagonist ta' TNF, inkluż adalimumab, u li kienu jġorru dan il-virus b'mod kroniku (jigifieri pozittivi għal-surface antigen).
English: Adults with psoriasis
Maltese: Adulti bil-psorjasi
English: Breast-feeding
Maltese: TAL-PRODOTT
English: • bruising;
Maltese: • puplesija;
English: Small bowel obstruction
Maltese: Disturbi vaskulari
English: UNITED STATES
Maltese: UNITI
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: 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 kinux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: double-blind response at week 68
Maltese: Rispons fil-Ġimgħa 68
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-perċentwal 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
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n = 27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Maltese: (n = 27 minn 30 pazjent), ir-rispons tal-ACR Pedjatriku 30 kien mantenut sa 60 ġimgħa fil-fażi
English: Hospitalisation rates
Maltese: IL-PRODOTT MEDIĊINALI
English: Paediatric Crohn's disease
Maltese: Il-marda Crohn (Crohn's disease)
English: Lupus-like syndrome1)
Maltese: Sindromu bħal ta' lupus1)
English: 36.8 % (14 / 38) 64.9 % (24 / 37)b 43.3 % (13 / 30) 71.4 % (20 / 28)c median time to disease flare
Maltese: 42.8 % 36.9 % 59.0 % < 0.001 < 0.001 0.162 ACR 70
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: placebo / MTXc n = 60
Maltese: MTXc n = 60
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: • kura ta' artrite rewmatika attiva minn moderata sa severa f'pazjenti adulti, meta r-rispons tagħhom għal mediċini antirewmatiċi li jaffetwaw il-proċess tal-mard, inkluż methotrexate, ma kinitx adegwata.
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) mil-linja bażi sa ġimgħa 26 u 52 fl-Indiċi tal-Massa tal-Ġisem u l-veloċità tat-tul kienu osservati fiż-żewġ gruppi tal-kura.
English: Hepatic or renal impairment
Maltese: Indeboliment epatiku jew renali
English: Inflammation
Maltese: Infezzjoni
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Maltese: sadd fl-arterji, tromboflebite
English: Surgery
Maltese: Kirurġija
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 relatati ma' HS (ara t-tabella 21).
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Maltese: Id-doża li s-soltu tingħata għall-adulti b'artrite rewmatika, ankylosing spondylitis, axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis u għal artrite psorjatika hija 40 mg adalimumab bħala doża waħda kull ġimagħtejn.
English: Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Maltese: Jista' jkun hemm vertigo u indeboliment fil-vista wara li tingħata Hefiya (ara sezzjoni 4.8).
English: • fungal infections;
Maltese: • infezzjonijiet tal-fungu;
English: 8 to 12 years
Maltese: Minn 8 sa 12 il-sena
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Maltese: Fi studju UC-II, 248 pazjent irċevew 160 mg ta' adalimumab f'ġimgħa 0, 80 mg f'ġimgħa 2 u 40 mg eow min hemm il-quddiem, filwaqt li 246 pazjent irċevew plaċebo.
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: 79 (73.1) a, b a p<0.001 adalimumab kontra l-plaċebo b p<0.001 adalimumab kontra methotrexate c p<0.01 adalimumab kontra l-plaċebo d p<0.05 adalimumab kontra methotrexate 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
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab.
Maltese: Minkejja kura profilattika għat-tuberkulożi, kien hemm każijiet ta' riattivazzjoni tat-tuberkulożi f'pazjenti kkurati b'adalimumab.
English: without MTX
Maltese: mingħajr MTX
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hefiya.
Maltese: Il-kartuni tal-pakkett multiplu fihom 6 (3 pakketti ta' 2) pinen mimlijin għal-lest ta' Hefiya.
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg / m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Maltese: Il-perjodu double-blind huwa segwit mill-perijodu open-label (OL) fejn il-pazjenti rċevew 24 mg/m2 (BSA) ta' 24 mg / m2 sa massimu ta' 40 mg ġimgħa iva u ġimgħa le mogħtija taħt il-ġilda sa 192 ġimgħa oħra.
English: Hefiya dose for paediatric patients with Crohn's disease
Maltese: Doża ta' Hefiya għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease)
English: week 4 clinical remission clinical response (CR
Maltese: titjib kliniku rispons kliniku (CR-100)
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: (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 fil-gruppi tal- kura b'adalimumab meta mqabbla mal-grupp tal-plaċebo.
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 kinux ħadu antagonisti tat-TNF kienu randomizzati biex jew jirċievu l-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: • that Hefiya treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Maltese: o infezzjonijiet, inkluż tuberkulosi o kanċer o problemi fis-sistema nervuża o tilqim
English: In CD Study I, 299 TNF-antagonist naive 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: ġew imqassma bl-addoċċ f'wieħed minn erba' 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: • abdominal (belly) pain;
Maltese: • uġigħ addominali (ta' żaqq);
English: week 26 week 52 p value for standard dose versus low dose comparison.
Maltese: 1 valur p li huwa paragun tad-doża standard kontra doża baxxa.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Maltese: Huwa maħsub li psorjasi tiġi kkawżata minn problema fis-sistema immuni tal-ġisem li twassal għal produzzjoni akbar ta' ċelluli tal-ġilda.
English: An embryo-foetal developmental toxicity / perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg / kg (9-17 monkeys / group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Maltese: Sar studju fuq l-effett tat-tossiċità waqt l-iżvilupp embrijofetali / l-iżvilupp fiż-żmien immedjatament qabel jew wara t-twelid, fuq xadini ċinomologi li b' 0, 30 u 100 mk / kg (9-17 -il xadina / grupp) u dan ma wera l-ebda evidenza ta' dannu kkaġunat b'adalimumab fuq il-feti.
English: Polyarticular juvenile idiopathic arthritis
Maltese: Artrite idjopatika poliartikulari taż-żgħażagħ
English: week 52
Maltese: ġimgħa 52
English: • headache;
Maltese: • deidratazzjoni;
English: Table 27 paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission standard dose 40 / 20 mg eow low dose 20 / 10 mg eow p value1
Maltese: Tabella 27 studju ta' CD fit-tfal twaqqif tal-kortikosterojdi jew immunomodulaturi u fejqan tal-fistla doża standard
English: • pain in the muscles.
Maltese: • uġigħ fil-muskoli.
English: Hefiya 40 mg solution for injection in single-use pre-filled SensoReady pen Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Maltese: Hefiya 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest SensoReady Hefiya jiġi fornut f'siringa mimlija għal-lest li tintuża darba biss f'pinna forma ta' trijanglu b'tieqa u tikketta trasparenti (SensoReady).
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-għeja, 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: Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: L-Istudju tal-Psorjasi I (REVEAL) evalwa 1212 pazjent fi tliet perjodi ta' kura.
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 tar-rispons, 29 % kienu fi stat ta' titjib, 41 % kellhom fejqan tal-mukuża, u 20 % kienu fl-istat ta' titjib mingħajr sterojdi għal ≥ 90 jum f'ġimgħa 52.
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 irregolati mit-TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma responsabbli għall-migrazzjoni tal-lewkoċite (ELAM-1,
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 x ULN occurred in 0.3 % of adalimumabtreated 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'dewmien li jvarja minn 12 sa 16-il ġimgħa, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'0.3 % tal-pazjenti kkurati b'adalimumab u 0.6 % tal-pazjenti kkurati kkontrollati.
English: • if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Maltese: • jekk għandek infezzjoni severa, inkluż tuberkulożi, sepsis (avvelenament tad-demm) jew infezzjonijiet opportunistiċi oħra (infezzjonijiet mhux normali assoċjati ma' sistema immuni mdgħajfa).
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Maltese: mard tal-interstizju tal-pulmun, mard kroniku ta' imblukkar fil-pulmun, pulmonite,
English: Improvement in health-related quality of life and physical function was maintained during the open- label extension through week 156.
Maltese: Titjib fil-kwalità tal-ħajja rrelatata mas-saħħa u funzjoni fiżika nżamm matul l-estensjoni open-label sa Ġimgħa 156.
English: Hefiya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Maltese: Hefiya fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq is-sistema immuni (tad-difiża) talġisem.
English: Table 9 radiographic mean changes over 12 months in RA study III
Maltese: Tabella 9 Tibdil medju radjografiku fuq perjodu ta' 12 -il xahar fi studju RA III
English: pJIA II
Maltese: ANNESS II
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 (3.7%) f'pazjenti li għandhom aktar minn 65 sena u kkurati b'adalimumab kienet akar għolja mill-frekwenza ta' infezzjonijiet f'pazjenti taħt il-65 sena (1.5 %).
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: Sacroiliac u l-Ispina nżamm f'pazjenti kkurati b'adalimumab sa ġimgħa 156 u ġimgħa 104,
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Maltese: It-titjib kliniku (definit bħala Punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ > 1) ġie evalwat f'ġimgħa 8.
English: In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and / or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control.
Maltese: Reazzjonijiet fil-post tal-injezzjoni Fil-provi pivitali kkontrollati li saru fl-adulti u fit-tfal, 12.9 % tal-pazjenti kkurati b'adalimumab żviluppaw reazzjonijiet fil-post tal-injezzjoni (eritema u / jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunati ma' 7.2 % tal-pazjenti li kienu qegħdin jirċievu l-plaċebo jew sustanza attiva użata bħala kontroll.
English: Uncommon
Maltese: Mhux komuni
English: disease flares at the end of 32 weeksa (n/N)
Maltese: il-marda tmur għallagħar fl-aħħar ta' 32 ġimgħaa (n/N)
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: pJIA II Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju tat-tip multiċentriku 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: Sodium content
Maltese: Kontenut tas-sodju
English: Very common
Maltese: Dan huwa normali
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: 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: STATEMENT OF ACTIVE SUBSTANCE
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg / ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg / ml with concomitant methotrexate.
Maltese: Wara l-ammistrazzjoni ta' 24 mg / m2 (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lill-pazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'ġimgħa 24) ta' adalimumab fis-seru kienu 8.8 ± 6.6 μg / ml meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ± 4.3 μg / ml meta adalimumab kien użat flimkien ma' methotrexate.
English: • gallbladder inflammation, gallbladder stones;
Maltese: • infjammazzjoni fl-għajnejn;
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Maltese: < 40 kg • 40 mg f'ġimgħa 0 and 20 mg f'ġimgħa
English: The recommended Hefiya 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' Hefiya rrakkomandata 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: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Maltese: Pazjenti li kisbu PASI 75 u PGA xejn jew minimali kienu irtirati mill-kura għal 36 ġimgħa u mmonitorjati għat-telf tal-kontroll tal-marda (jiġifieri aggravar tal-PGA mill-inqas 2 gradi).
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Maltese: Studju nr-axSpA II 673 pazjent b'attività nr-axSpA (attività medja tal-marda bażika [BASDAI] kienet ta' 7.0) li kellhom rispons inadegwat għal ≥ 2 NSAIDs, jew intolleranza għal jew kontraindikazzjoni għal NSAIDs irreġistrati fil-perjodu open-label ta' Studju nr-axSpA II li matulu rċevew adalimumab 40 mg eow għal
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Maltese: B'mod ġenerali, l-effetti avversi f'pazjenti pedjatriċi kellhom frekwenza u t-tip simili għal dawk li ġew osservati f'pazjenti adulti.
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Maltese: Tfal, adolexxenti u adulti minn sitt snin 'il fuq li jiżnu 30 kg jew aktar Id-doża ta' Hefiya rrakkomandata hija 40mg ġimgħa iva u ġimgħa le.
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Maltese: Minn dawn il-kanċer tal-ġilda, kien hemm l-okkorrenza ta' karċinoma biċ-ċelluli tat-tip squamous b'rati (95% intervall ta' konfidenza) ta' 2.7 (1.4, 5.4) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5)
English: − The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections.
Maltese: − Is-sustanzi mhux attivi l-oħra huma adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide u ilma għall-injezzjonijiet.
English: • ulcerative colitis and
Maltese: • kolite ulċerattiva u
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 psoriatic arthritis.
Maltese: Ma hemm l-ebda użu ta' adalimumab li huwa rilevanti fi tfal għal indikazzjonijiet ta' ankylosing spondylitis u artrite psorjatika.
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Maltese: Hefiya ġie numerikament iffavorit għall-maġġoranza tal- sottopunteġġ b'differenzi medji statistikament sinifikanti għall-viżjoni ġenerali, uġigħ fl-għajn, viżjoni fil-qrib, issaħħa mentali, u punteġġ totali fi studju UV I, u għall-viżjoni ġenerali u s-saħħa mentali fl-istudju UV
English: Hefiya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Maltese: bejn 2 u 17 il-sena u artrite relatata mal-entestie fir-tfal u adolexxenti ta' bejn 6 u 17-il sena.
English: Table 10 radiographic mean changes at week 52 in RA study V
Maltese: Tibdil medju radjografiku f'ġimgħa 52 fi studju RA V