FrancophonIA/ELRC3.0 huggingface dataset:
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection),
Maltese: Infezzjonijiet sistemiċi (li jinkludu sepsis, candidiasis u influwenza), infezzjonijiet intestinali (li jinkludu gastroenterite virali), infezzjonijiet fil-ġilda u fit-tessuti rotob tal-ġilda (li jinkludu infjammazzjoni fit-tessuti tal-ġilda madwar id-difer, ċellulite, impetiġini, faxxite bin-nekrosi u ħruq ta' Sant'Antnin), infezzjonijiet fil-widnejn, infezzjonijiet fil-ħalq (li jinkludu herpes simplex, herpes fil-ħalq u infezzjonijiet fis-snien), infezzjonijiet fis-sistema riproduttiva
English: 1) Setting up
Maltese: 1) Il-preparazzjoni
English: • pleural effusion (abnormal collection of fluid on the pleural space);
Maltese: • effuzjoni plewrali (żamma mhux normali tal-ilma fl-ispazju plewrali);
English: • If you are over 65 years you may be more likely to get infections while taking Humira.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Humira.
English: • moderate to severe chronic plaque psoriasis in adults and
Maltese: • psorijasi tal-plakka kronika moderata sa severa fl-adulti u
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 inqas minn 1 mmol ta' sodium (23 mg) għal kull doża ta' 0.8 ml, jiġifieri essenzjalment 'ħieles mis-sodju'.
English: Other medicines and Humira
Maltese: Mediċini oħra u Humira
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: In patients not given concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Maltese: F'pazjenti li ma ngħatawx methotrexate flimkien ma' adalimumab, linċidenza kienet ta' 12.4%, imqabbla ma' 0.6% meta adalimumab kien użat addizzjonalment ma' methotrexate.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Humira, 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 Humira, u li kienu jġorru dan il-virus b'mod kroniku (jigifieri pozittivi għal-surface antigen).
English: a Partial Remission ASDAS
Maltese: ASASa Remissjoni Parzjali ASDAS
English: Table 16 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Maltese: Tabella 16 Ps Studju IV Riżultati tal-Effikaċja f' 16, 26 u 52 ġimgħa
English: In the open-label extension, improvement in the signs and symptoms was maintained with Humira therapy through Week 156.
Maltese: Fl-estensjoni open-label, titjib fis-sinjali u s-sintomi inżamm ma' terapija b'Humira sa Ġimgħa 156.
English: After treatment with Humira, 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'Humira, ġie osservat tnaqqis rapidu fil-livelli ta' sustanzi li jirreaġixxu fil-fażi akuta ta' l-infjammazzjoni (proteina C-reactive (CRP) u r-rata ta' tagħqid ta' l-eritroċit (ESR)) u cytokines fisserum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: Enthesitis-related arthritis
Maltese: Artrite relatata mal-Entesit
English: • tremor (shaking)
Maltese: ŻMIEN (XHUR)
English: 1 sterile vial adapter
Maltese: Adattatur tal-kunjett sterili
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 sinifikattivament ogħla ta' pazjenti fi Studju HS-II esperjenzat tnaqqis klinikament rilevanti fl-uġigħ tal-ġilda relatati mal-HS (ara t-Tabella 17).
English: Table 10 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Maltese: Tabella 10 Ps Studju IV Riżultati tal-Effikaċja f' 16, 26 u 52 ġimgħa
English: 80 mg/0.8 ml
Maltese: INDIVIDWALI 80 mg/0.8 ml
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Maltese: Għalkemm mhux statistikament sinifikanti, il-maġġoranza tal-pazjenti wrew titjib kliniku fil-puntu tat tmiem sekondarji bħal numru ta' siti ta' entestie, għadd ta' ġogi sensttivi (TJC), għadd ta' ġogiminfuħa (SJC), rispons Pedjatriku ACR 50, u rispons Pedjatriku ACR 70.
English: Humira/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Humira 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'Humira/methotrexate kienet klinikament u statistikament superjuri għal methotrexate (p < 0.001) u Humira 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: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in Humira-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'Humira sa Ġimgħa 156 u Ġimgħa 104, rispettivament.
English: This represented an 84% median reduction in injection site pain.
Maltese: Dan jirrappreżenta tnaqqis medjan ta' 84% fl-uġigħ fis-sit ta' injezzjoni.
English: Surgery or dental procedure
Maltese: Operazzjoni jew proċedura dentali
English: The safety and efficacy of Humira were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Maltese: Is-sigurtà u l-effikaċja ta' Humira ġew evalwati fi studji li kienu imqassma b'mod każwali, doubleblind, ikkontrollati bi plaċebo u studju ta' estensjoni open-label f'pazjenti adulti bi hidradenitis suppurativa (HS) moderata sa severa li kienu intoleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill-inqas ta' 3 xhur provi ta' terapija antibijotika sistemika.
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 Humira 40 mg eow for 28 weeks.
Maltese: 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 Humira 40 mg eow għal 28 ġimgħa.
English: Worsening or new onset of psoriasis(including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Maltese: Aggravar jew bidu ta' psoriażi (li jinkludu psoriażi tat tip palmoplantar pustular) urtikarja, tbejnġil (li tinkludi l-purpura), dermatite (li tinkludi l-ekżema), onikoklasi, iperidrożisi, alopeċja ħakk
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis
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: o One vial adapter (2) o One vial for paediatric use of Humira for injection (3) o Two alcohol pads (4) o One needle (5)
Maltese: o Żewġ kuxxinetti bl-alkoħol (4) o Labra waħda (5)
English: • severe infection in the blood (sepsis)
Maltese: • infezzjoni severa fid-demm (sepsis)
English: In study UC-II, 248 patients received 160 mg of Humira 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' Humira f'Ġimgħa 0, 80 mg f'Ġimgħa 2 u 40 mg eow min hemm il-quddiem, filwaqt li 246 pazjent irċevew plaċebo.
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 of62.6% (median percent change -88.9%) in patients in the Humira group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Maltese: Ilpunt 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' Humira meta kkumparat ma' -11.6% (bidla perċentwali medja50.
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during Humira trials in paediatric patients with Crohn's disease.
Maltese: Madankollu, ma ġewx osservati l-ebda tumuri malinni f'192 pazjenti b'espożizzjoni ta' 498.1 sena ta' pazjent waqt provi b'Humira f'pazjenti pedjatriċi bil-marda Crohn (Crohn's disease).
English: The double-blind period was followed by an open-label period during which patients receive Humira 40 mg every other week subcutaneously for up to an additional 144 weeks.
Maltese: Il-perijodu double-blind kien segwit minn perijodu open-label fejn il-pazjenti rċivew 40 mg Humira taħt il-ġilda ġimgħa iva u ġimgħa le sa 144 ġimgħa addizzjonali.
English: During the controlled portions of pivotal Humira trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 Humira treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for Humira and 3.8 months for control-treated patients).
Maltese: Matul il-fażijiet kontrollati ta' provi pivitali ta' Humira fl-adulti li damu sejrin mill-inqas 12 -il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, infjammazzjoni talvertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorijasi, hidradenitis suppurativa, millmarda Crohn (Crohn's disease), kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' konfidenza) ta' 6.8 (4.4, 10.5) kull 1,000 sena ta' pazjent fost 5,291 pazjent ikkurat b'Humira, kontra rata ta' 6.3 (3.4, 11.8) kull 1,000 sena ta' pazjent fost 3,444 pazjent kontrollat (il-medja tat-tul tal-kura kienet ta' 4.0 xhur għal Humira u 3.8 xhur għal pazjenti mogħtija kura kontrollata).
English: Humira is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: Humira jintuża biex jittratta hidradenitis suppurativa fl-adulti u fl-adolexxenti minn 12-il sena.
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 Humira 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: EU/1/03/256/002 EU/1/03/256/003 EU/1/03/256/004 EU/1/03/256/005
Maltese: EU/1/03/256/002 EU/1/03/256/003 EU/1/03/256/004
English: In patients with Crohn's disease, anti-adalimumab antibodies were identified in 7/269 subjects (2.6%).
Maltese: F'pazjenti bil-marda ta' Crohn, antikorpi kontra adalimumab ġew identifikati f'7/269 suġġett (2.6%).
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with Humira.
Maltese: Effetti avversi tas-sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopaenia, lewkopenja) ma ġewx irrappurtati b'Humira.
English: Humira is used to treat ulcerative colitis in adults.
Maltese: Humira huwa intenzjonat għall-kura ta' kolite ulċerattiva fl-adulti.
English: The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Il-pożoloġija ta' Humira f'dawn il-pazjenti ġiet iddeterminata minn mudellar u simulazzjoni farmakokinetika (ara sezzjoni 5.2).
English: Pad
Maltese: RATA
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 Humira.
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 Humira.
English: Table 17: Efficacy Results at 12 Weeks, HS Studies I and II
Maltese: Tabella 17: Riżultati tal-Effikaċja fi 12-il ġimgħa, HS Studji I u II
English: Table 19 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Maltese: Tabella 19 Ps Studju IV Riżultati tal-Effikaċja f' 16, 26 u 52 ġimgħa
English: Humira 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: Humira huwa ndikat għat-trattament ta' psorjasi tal-plakka severa u kronika fit-tfal u adoloxxenti minn 4 snin il-fuq u li kellhom rispons mhux adegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
English: Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Maltese: Hidradenitis suppurativa (xi kultant imsejħa akne inversa) hija marda kronika u spiss bl-uġigħ infjammatorja fil-ġilda.
English: You will set the volume to the prescribed dose in step 4, Dose Preparation.
Maltese: Inti ser tissettja il-volum tad-doża preskritta f'punt 4, Preparazzjoni tad-doża.
English: • pleural effusion (abnormal collection of fluid in the pleural space)
Maltese: • effuzjoni plewrali (żamma mhux normali tal-ilma fl-ispazju plewrali)
English: The safety and efficacy of Humira 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' Humira kienu evalwati f'zewgt studji (pJIA I and II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż-żagħżagħ, u li kellhom varjeta ta' bidu ta' JIA (l-aktar frekwenti fattur rewmatoloġiku negattiv jew poli-artrite pożittiva u oligo-artrite fit-tul.
English: Among patients whose Humira treatment was withdrawn at Week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of Humira 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' Humira 40 mg kull ġimgħa marret lura għal livelli simili għal dik osservata qabel l-irtirar (56.0%).
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: • 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: 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: All p-values are pairwise comparisons of proportions for Humira versus placebo p < 0.001 p < 0.01
Maltese: Humira kontra l-plaċebo b p<0.001
English: 40 mg/0.8 ml
Maltese: INDIVIDWALI 40 mg/0.8 ml
English: Table 19 Maintenance regimen Patient Weight
Maltese: Tabella 19 Reġim ta' Manteniment
English: Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Maltese: B'kollox fost il-pazjenti li waqqfu l-istudju, 18% waqfu minħabba avvenimenti avversi, u 8% minħabba rispons insuffiċjenti għal trattament b'adalimumab.
English: Fever, bruising, bleeding or looking pale
Maltese: Indeboliment tal-vista, konġuntivite, blefarite, nefħa fl-għajnejn
English: The safety and efficacy of Humira were assessed in over 1500 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' Humira 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 ta' l-Attività tal-Marda Crohn (Crohn's disease) (CDAI)  220 u  450) fi studji double-blind, kontrollati bil-plaċebo, li saru b'mod każwali.
English: b at Weeks 24 and 36 After Treatment Reassignment from Weekly Humira at Week 12
Maltese: b fil-Ġimgħat 24 u 36 Wara Trattament Assenjat mill-ġdid minn Humira Kull Ġimgħa f'Ġimgħa 12
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: In patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years, anti- adalimumab antibodies were identified in 15.8% (27/171) of patients treated with adalimumab.
Maltese: F'pazjenti li jbatu minn artrite idjopatika poliartikulari taż-żagħżagħ li kellhom minn 4 sa 17-il sena kienu identifikati anti-korpi anti-adalimumab f'15.8% (27/171) pazjenti kkurati b' adalimumab.
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
Maltese: • infezzjonijiet fis-sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis-sinus, pnewmonja)
English: 29.7a
Maltese: 24 ġimgħa.
English: The efficacy of Humira 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 Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (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' Humira 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 talEvalwazzjoni Globali tat-Tobba (PGA) ≥ 4 jew > 20% BSA jew > 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew Qasam tal-Psorjasi u Indiċi tas-Severità (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: In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate.
Maltese: F'pazjenti li ma ngħatawx ukoll methotrexate flimkien ma' adalimumab, linċidenza kienet ta' 16/185 (8.6%), meta pparagunat ma' 1/19 (5.3%) meta adalimumab kien użat addizzjonalment ma' methotrexate.
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 filgħadd relattiv tal-fistula li tkun qed tnixxi mal-Linja Bażi) .
English: EU/1/03/256/012 EU/1/03/256/013 EU/1/03/256/014 EU/1/03/256/015
Maltese: EU/1/03/256/012 EU/1/03/256/013 EU/1/03/256/014
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/m 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: Excipients: mannitol, polysorbate 80, and water for injections.
Maltese: Is-sustanzi l-oħra huma mannitol, polysorbate 80, u ilma għall-injezzjonijiet.
English: If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml.
Maltese: Jekk id-doża preskritta hija 0.5 ml, iġbed l-istikka bajda tal-planġer ‘il barra sa 0.6 ml.
English: Ped ACR 30/50/70 responses Week 48 significantly greater than those of placebo treated patients p = 0.015 c p = 0.031
Maltese: Rispons Ped ACR 30/50/70 f'Ġimgħa 48 kien wisq akbar minn dak ta' pazjenti kkurati bil-plaċebo b p = 0.015
English: • moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.
Maltese: • tal-marda Crohn (Crohn's disease) moderata sa severa fi tfal u adolexxenti li għandhom bejn 6 sa 17-il sena.