FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/ml (79% CV).
Maltese: Wara l-amministrazzjoni ta' 0.8 mg/kg (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le għal pazjenti pedjatriċi bi psorjasi kronika tal-plakka, il-medju ± SD ta' trough steady-state talkoncetrazzjoni ta' adalimumab kienet madwar 7.4 ± 5.8 μg / ml (79% CV).
English: Humira is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Maltese: Humira huwa intenzjonat għall-kura tal-marda Crohn (Crohn's disease) fl-adulti u fi tfal li għandhom bejn 6 sa 17-il sena.
English: the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Maltese: il-kura ta' artrite rewmatika attiva u progressive severa f'adulti li ma ġewx ikkurati qabel b'methotrexate.
English: Of 342 subjects originally randomized to Humira monotherapy or Humira/methotrexate combination therapy who entered the openlabel extension study, 171 subjects completed 10 years of Humira treatment.
Maltese: Minn 342 suġġetti li oriġinarjament kienu magħżula b'mod każwali għal monoterapija bi Humira jew terapija kkombinata b' Humira /methotrexate li daħlu fl-istudju ta' estensjoni open-label, 171 suġġetti temmew 10 snin ta' trattament b'Humira.
English: In patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years old or aged 4 and above weighing <15 kg, anti-adalimumab antibodies were identified in 7% (1/15) of patients, and the one patient was receiving concomitant methotrexate.
Maltese: F'pazjenti b'artrite idjopatika poliartikulari taż-żagħżagħ li kellhom minn 2 sa <4 snin jew ta' età ta' 4 snin jew aktar li jiżnu <15 kg, antikorpi anti-adalimumab ġew identifikati f'7% (1/15) tal-pazjenti, u l-pazjent kien qed jirċievi methotrexate konkomitanti.
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 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' 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 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: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Maltese: Kunjett wieħed (0.8 ml soluzzjoni sterili), siringa waħda vojta sterili għall-injezzjoni, labra waħda, adattatur tal-kunjett wieħed u 2 kuxxinetti bl-alkoħol.
English: 4 pre-filled syringes 4 alcohol pads
Maltese: 4 siringi mimlijin għal-lest 4 kuxxinetti bl-alkoħol
English: Humira is used to treat moderate to severe chronic plaque psoriasis in adults.
Maltese: Humira huwa intenzjonat għall-kura ta' psorijasi tal-plakka kronika moderata sa severa fl-adulti.
English: • Merkel cell carcinoma (a type of skin cancer)
Maltese: • karċinoma taċ-ċelloli Merkel (tip ta' kanċer tal-ġilda)
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks Placebo N=53 n (%)
Maltese: Riżultati ta' l-Effikaċja f' 16 -il Ġimgħa Plaċebo N=53 n (%)
English: Continue with injection site and dose preparation immediately.
Maltese: M'hemmx informazzjoni disponibbli.
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 Humira, 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: Fi Studju Psorajisi I, 28% tal-pazjenti li kienu rrispondew għal PASI 75 u reġgħu ġew randomizzati għall-plaċebo f'Ġimgħa 33 meta mqabbla ma' 5% li komplew fuq Humira, p <0.001, esperjenzaw “telf ta' rispons adegwat” (punteġġ PASI wara Ġimgħa 33 u f' Ġimgħa 52 jew qabel, li rriżultaw f'rispons <PASI 50 relattiv għal-linja bażi b'minimu ta' żieda ta' 6 punt fil-punteġġ PASI relattiv għall-Ġimgħa 33).
English: NA NA 4.5% 23.2% RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks 40 mg Humira administered every other week MTX = methotrexate **p < 0.01, Humira versus placebo
Maltese: Studju RA I fir-24 ġimgħa, Studju RA II fis-26 ġimgħa , u Studju RA III fl-24 u t-52 ġimgħa b 40 mg Humira mgħotija ġimgħa iva u ġimgħa le c
English: Week 52 Fistula remission
Maltese: Ġimgħa 52 Fejqan tal-fistla
English: For storage information, see package leaflet.
Maltese: Kontenut tal-pakkett u informazzjoni oħra Struzzjonijiet għall-użu.
English: Room spinning sensation and vision disturbances may occur after taking Humira.
Maltese: Jista jkun hemm sensazzjoni li l-kamra qed iddur bik u disturbi fil-vista wara li tingħata Humira.
English: • Enthesitis-related arthritis
Maltese: • Artrite relatata mal-entesite
English: Humira 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: Humira huwa intenzjonat għall-kura ta' l-artrite attiva idjopatika poliartikulari taż-żagħżagħ fit-tfal ta' bejn 2 u 17 il-sena u artrite relatata mal-entestie fir-tfal u adoloxxenti ta' bejn 6 u 17-il sena.
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: • Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: • Axial spondyloarthrits mingħajr evidenza radjografika ta' ankylosing spondylitis
English: Children, adolescents and adults from 6 years of age weighing 40 kg or more
Maltese: Tfal, adoloxxenti u adulti minn 6 snin li jiżnu 40 kg jew iktar
English: • nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Maltese: • disturbi fin-nervituri (bħal infjammazzjoni tan-nerv tal-għajn u s-sindromu ta' Guillain-Barré li jista' jikkawża debolizza fil-muskoli, sensazzjonijiet mhux normali, tnemnim fl-idejn u l-parti ta' fuq tal-ġisem;
English: Where should I give my injection?
Maltese: Kemm u kemm ta' spiss tieħu?
English: Percent Change in Total Fingernail NAPSI (%) p<0.001, Humira vs. placebo
Maltese: MTX = methotrexate **p < 0.01, Humira kontra l-plaċebo
English: AbbVie Biotechnology Ltd. Road No. 2, Km.
Maltese: AbbVie Biotechnology Ltd.
English: Packs of: • 2 pre-filled syringes (0.2 ml sterile solution), each with 1 alcohol pad, in a blister.
Maltese: 2 siringi mimlijin għal-lest (0.2 ml soluzzjoni sterili), kull wieħed b'kuxxinett ta' alkoħol, f'folja.
English: Humira 40 mg solution for injection in pre-filled syringe EU/1/03/256/012
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/03/256/012
English: Plunger
Maltese: Kanċer
English: 6 pre-filled syringes 6 alcohol pads
Maltese: 6 siringi mimlijin għal-lest 6 kuxxinetti bl-alkoħol
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis);
Maltese: • disturbi fl-immunità li jistgħu jeffetwaw il-pulmun, ġilda u in-nodi tal-limfa (ippreżentata l-aktar komuni bħala sarcoidosis);
English: The white needle sleeve will cover the needle tip.
Maltese: Jekk trid uża stikka.
English: The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days) and 80 mg at Week 2.
Maltese: Id-doża inizjali ta' Humira rrakkomandata għal pazjenti adulti b'kolite ulċerattiva minn moderata sa severa, hija ta' 160 mg mogħtija f'Ġimgħa 0 (mogħtija bħala żewġ injezzjonijiet ta' 80 mg f'ġurnata waħda jew bħala injezzjoniji waħda ta' 80 mg kuljum għal jumejn konsekuttivi) u 80 mg f' Ġimgħa 2.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Maltese: Artrite attiva idjopatika poliartikulari taż-żagħżagħ u l-artrite relatata mal-entesite
English: Two patients out of 3,441 treated with Humira in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3441 li kienu kkurati b'Humira fl-istudji kollha ta' l-artrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindromu li jixbaħ lissindromu tal-lupus.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg Humira 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 Humira 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 patients with ulcerative colitis, a loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 12 g/ml during the induction period.
Maltese: F'pazjenti li għandhom kolite ulċerattiva, d-doża kbira ta' 160 mg Humira f'Ġimgħa 0 segwita b'80 mg Humira f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 g/ml matul il-perijodu tal-bidu .
English: Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Maltese: Humira huwa ndikat għall-trattament ta' intermedja, posterjuri u panuveite mhux infettiva f'pazjenti adulti li ma kellhomx rispons adegwat għal kortikosterojdi, f'pazjenti fl-użu meqjus talkortikosterojdi, jew li fihom it-trattament b'kortikosterojdi mhux xieraq.
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 16).
Maltese: Valutazzjoni tal-psorjasi tad-dwiefer tinkludi l-Indiċi Modifikata tas-Severità tal-Psorjasi tad-Dwiefer (mNAPSI), lEvalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 16).
English: Week a. p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Week a. valur p għall-paraguni magħmula bejn kull par ta' monoterapija b'methotrexate u terapija kombinata ta' Humira/methotrexate permezz tat-test Mann-Whitney U.
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: Humira Pre-filled Syringe
Maltese: Humira jintuża fit-trattament ta'
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira.
Maltese: Minkejja trattament profilattiku għat-tuberkulosi, kien hemm każijiet ta' riattivazzjoni tat-tuberkulosi f'pazjenti kkurati bi Humira.
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
Maltese: Tfal u adolexxenti minn 4 sa 17-il sena li jiżnu minn 15 kg sa inqas minn 30 kg
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques
Maltese: • Tinjettax fil-ġilda li hija mweġġa', imbenġla, ħamra, iebsa, imġirfa, għandha stretch marks, jew żoni bi plakki tal-psorjasi
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.
Maltese: Fi studju CD II, 325 pazjent li ma kinux baqgħu juru rispons għall-kura jew li ma kinux jittolleraw infliximab kienu mqassma bl-addoċċ biex jirċievu jew 160 mg Humira f'Ġimgħa 0 u 80 mg f'Ġimgħa 2 jew plaċebo f'Ġimgħat 0 u 2.
English: Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Maltese: Humira ġie evalwat fuq aktar minn 3000 pazjent fil-provi kliniċi kollha ta' l-artrite rewmatika.
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomized to methotrexate monotherapy,
Maltese: Fl-estensjoni open-label ta' studju RA V, il-bidla medja mil-linja bażi f'Sena 10 fil-Puteġġ Totali Sharp modifikati kien 10.8, 9.2 u 3.9 fil-pazjenti li oriġinarjament randomizzati għal monoterapija b'methotrexate, monoterapija b'Humira u terapija kkombinata b'Humira /methotrexate,
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 g/ml (without concomitant methotrexate) and 8 to 9 g/ml (with concomitant methotrexate), respectively.
Maltese: Wara t-teħid ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn artrite rewmatika (AR), il-konċentrazzjoni minimali medja fissa kienet ta' bejn wieħed u ieħor 5g/ml (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 g/ml (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: In patients with moderate to severe hidradenitis suppurativa, anti-adalimumab antibodies were identified in 10/99 subjects (10.1%) treated with adalimumab.
Maltese: F'pazjenti bi hidradenitis suppurativa moderata sa severa, antikorpi ta' anti-adalimumab ġew identifikati fil-10/99 suġġetti (10.
English: Humira 80 mg solution for injection in pre-filled pen EU/1/03/256/021
Maltese: Humira 80 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/03/256/021
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), lEvalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 19).
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: • If your child takes Humira the risk of getting lymphoma, leukaemia, or other cancers may increase.
Maltese: • Jekk tieħu Humira jista jikber r-riskju li jaqbdek lymphoma, lewkimja jew tip ta' kanċer ieħor.
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: Of 207 patients who were randomised to Humira 40 mg every other week, 114 patients continued on Humira 40 mg every other week for 5 years.
Maltese: Minn 207 pazjenti li kienu randomizzati għal Humira 40mg ġimgħa iva u ġimgħa le, 114-il pazjent komplew bi Humira 40 mg ġimgħa iva u ġimgħa le għal 5 snin.
English: • Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
Maltese: • Jekk int iġġorr il-virus ta' l-epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li għandek riskju li jaqbdek l-HBV, għarraf lit-tabib tiegħek.
English: One 0.8 ml pre-filled syringe contains 80 mg adalimumab.
Maltese: Siringa waħda ta' 0.8 ml mimlija għal-lest bil-labra mgħottija awtomatika fiha 80 mg adalimumab.
English: The safety and efficacy of Humira were assessed in two randomized, double-blind placebo-controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Maltese: Is-sigurtà u l-effikaċja ta 'Humira ġew ivvalutati f'żewġ studji randomised, double-blind ikkontrollati bil-plaċebo f'pazjenti b'spondyloarthrite axjali mhux radjografika (nr-axSpA).
English: Placebo / MTX (N = 37)
Maltese: Plaċebo (N = 37)
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 10).
Maltese: Valutazzjoni tal-psorjasi tad-dwiefer tinkludi l-Indiċi Modifikata tas-Severità tal-Psorjasi tad-Dwiefer (mNAPSI), lEvalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 10).
English: There is no relevant use of Humira in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Maltese: Ma hemm l-ebda użu ta' Humira li huwa rilevanti fi tfal għal indikazzjonijiet ta' ankylosing spondylitis u artrite psorjatika.
English: Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Maltese: Humira huwa intenzjonat għall-kura ta' ankylosing spondylitis severa u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis fl-adulti.
English: Humira 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Maltese: It-teħid ta' 40 mg Humira ġimgħa iva u ġimgħa le kien stimat fi 393 pazjent f'żewġ studji doubleblind, kontrollati bil-plaċebo li ħadu 24 ġimgħa u li saru b'ordni addoċċ fuq pazjenti li jbatu minn infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il-punt medju tal-linja bażi ta' l-attività tal-mard [l-Indiċi ta' l-Attività tal-Mard Ankylosing Spondylitis (BASDAI)] kien 6.3 fil-gruppi kollha) li ma kellhomx rispons adegwata għat-terapija konvenzjonali.
English: After Week 2, patients in both adalimumab arms received 40 mg eow.
Maltese: Wara Ġimgħa 2, pazjenti fiż-żewġt gruppi ta' adalimumab irċevew 40 mg eow.
English: Adverse Reaction tremor, neuropathy
Maltese: Uġigħ addominali, nawseja u rimettar
English: The safety and efficacy of Humira were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: Is-sigurtà u l-effikaċja ta' Humira kienu ġew studjati fi studju tat-tip multiċentru, b'mod każwali, double-blind f'46 pazjenti pedjatriċi (6 sa 17-il sena) b'artrite moderata relatata mal-entesite.
English: Humira 40 mg solution for injection in pre-filled pen EU/1/03/256/016
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/03/256/016
English: • certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
Maltese: • ċerti tipi ta' aġenti anti-rewmatiċi li jaffetwaw il-proċess tal-mard (per eżempju sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħata b' injezzjoni)
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 22).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'Humira kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 22).
English: Humira 40 mg solution for injection in pre-filled syringe with needle guard EU/1/03/256/006
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/03/256/007
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: (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: b 50
Maltese: ASAS 50
English: Table 7 Radiographic Mean Changes at Week 52 in RA Study V
Maltese: Tabella 7 Tibdil Medju Radjografiku f'Ġimgħa 52 fi Studju RA IV
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 ta' l-PASI kienet ta' 18.9 u l-linja bażi ta' l-Istima Ġenerali tat-Tabib (PGA) varjat minn “moderat” (53% tassuġġetti li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through Week 520 (120 months) of open-label treatment.
Maltese: Fi Studju RA III, ħafna mis-suġġetti kellhom titjib fil-funzjoni fiżika u t-titjib ġie mantenut waqt li tkompliet il-kura matul Ġimgħa 520 (120 xahar) tal-kura open-label.
English: Chest pain, oedema, pyrexia
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM, JEW PARTI
English: • certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine,
Maltese: Dawn it-terapiji jinkludu methotrexate, leflunomide, hydroxychloroquine,
English: The recommended Humira 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' Humira 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: pruritus
Maltese: UŻU