FrancophonIA/ELRC3.0 huggingface dataset:
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: Table 22 Time to Treatment Failure in Studies UV I and UV II
Maltese: Tabella 22 Żmien għall-Falliment tat-Trattament fi Studji UV I and UV II
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Maltese: • lifoma hepatosplenic T-cell (kanċer tad-demm rari li ħafna drabi huwa fatali)
English: Vertigo and visual impairment may occur following administration of Humira (see section 4.8).
Maltese: Jista jkun hemm vertigo u ndeboliment fil-vista wara li tingħata Humira (ara sezzjoni 4.8).
English: Humira is used to treat moderate to severe ulcerative colitis in adults.
Maltese: Humira huwa intenzjonat għall-kura ta' kolite ulċerattiva moderata sa severa fl-adulti.
English: The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among Humira-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' kanċer tal-ġilda li m'humiex melonoma kienet 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'Humira u 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Week 8 and 52 Sustained Response Sustained Remission Sustained Mucosal Healing Clinical remission is Mayo score ≤ 2 with no subscore > 1; Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; p<0.05 for Humira vs. placebo pairwise comparison of proportions **p<0.001 for Humira vs. placebo pairwise comparison of proportions a
Maltese: Titjib kliniku hu l-punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ > 1; Rispons kliniku huwa tnaqqis mill-linja bażi fil-punteġġ Mayo ta' ≥3 punti u ≥30% flimkien ma' tnaqqis fil-fsada rektali b'sottopunteġġ [RBS] ta' ≥1 jew RBS assolut ta' 0 jew 1; p<0.05 għal Humira vs. placebo bil-proporzjonijiet imqabblin flimkien **p<0.
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, Humira monotherapy and Humira/methotrexate combination therapy, respectively.
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, rispettivament.
English: p-valuea p-valueb p-valuec
Maltese: Valur-pa Valur-pb Valur-pc
English: Humira 40 mg/0.8 ml solution for injection
Maltese: Humira 40 mg/0.8mL soluzzjoni għall-injezzjoni
English: Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Maltese: Tabella 16 Rispons għall-ACR fi Studji ta' l-Artrite Psorjatika kontrollati bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: The frequency of serious infections among Humira 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' Humira, kienet akar għolja mill-frekwenza ta' infezzjonijiet f'pazjenti taħt il-65 sena (1.5%).
English: Table 8 Ped ACR 30 Responses in the JIA study
Maltese: Tabella 8 Rispons PedACR fi studju JIA
English: A total of 233 PASI 75 responders at Week 16 and Week 33 received continuous Humira therapy for 52 weeks in Psoriasis Study I, and continued Humira in the open-label extension trial.
Maltese: Fl-Istudju tal-Psorijasi I, total ta' 233 pazjent li wrew rispons għal PASI 75 f'Ġimgħa 16 u Ġimgħa 33 ingħataw terapija kontinwa b'Humira għal 52 ġimgħa, u komplew jingħataw Humira fil-prova ta' estensjoni open-label.
English: • Paediatric Crohn's disease
Maltese: • Il-marda Crohn (Crohn's Disease)
English: A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an open-label extension study.
Maltese: Total ta' 347 suġġetti li rrispondew b'mod stabbli, ħadu sehem f'evalwazzjoni tal-irtirar u trattament mill-ġdid fi studju ta' estensjoni open-label.
English: Humira is used to treat enthesitis-related arthritis in patients from 6 years of age.
Maltese: Humira jintuża biex jittrata artrite relatata mal-entesite f'pazjenti minn 6 snin.
English: Serious adverse reactions have been reported for Humira.
Maltese: Reazzjonijiet avversi serja, ġew irrapurtati b' Humira.
English: One 0.2 ml pre-filled syringe contains 20 mg adalimumab.
Maltese: Siringa mimlija għal-lest ta' 0.2 ml li fiha 20 mg adalimumab.
English: Table 28 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients) Placebo Humira 40 mg eow
Maltese: Tabella 28 Rispons, Titjib kliniku u Fejqan tal-Mukoża fi Studju UC-II (Persentaġġ ta' Pazjenti)
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non- MTX-treated.
Maltese: Fil-fażi tal-bidu open-label (OL LI) il-pazjenti kienu imqassma f'żewgt gruppi, dawk ikkurati b'MTX (methotrexate) u dawk li mhux trattati b'MTX (non-MTX).
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at Week 52, which was maintained through Week 104.
Maltese: Fi Studju RA V, it-titjib fl-indiċi ta' diżabilità HAQ u fil-komponent fiżiku ta' l-SF 36 wera titjib akbar (p < 0.001) għat-terapija kombinata ta' Humira/methotrexate versu l-kura b'methotrexate u lkura b'Humira waħdu f'Ġimgħa 52, liema titjib baqa' mantenut matul Ġimgħa 104.
English: At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy.
Maltese: F'Ġimgħa 52, 42.9% tal-pazjenti li rċevew it-terapija kombinata ta' Humira/methotrexate laħqu titjib kliniku (DAS28 (CRP) < 2.6) meta pparagunati ma' 20.
English: 1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
Maltese: Adattatur tal-kunjett sterili 2 kuxxinetti bl-alkoħol
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
English: Adolescents from 12 to 17 years of age weighing 30 kg or more
Maltese: Adoloxxenti minn 12 sa 17-il sena, li jiżnu 30kg jew aktar
English: The safety and efficacy of Humira were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, doublemasked, placebo-controlled studies (UV I and II).
Maltese: Is-sigurtà u l-effikaċja ta' Humira ġew ivvalutati f'pazjenti adulti bi intermedja, posterjuri u panuveite mhux infettiva, esklużi pazjenti b'uveite anterjuri iżolati, f'żewġ studji każwali, double-masked, ikkontrollati bi plaċebo (UV I u II).
English: Table 13 Induction of Clinical Remission and Response (Percent of Patients) CDStudy I: Infliximab Naive Patients
Maltese: Tabella 13 Qlib għall-Aħjar fl-Istat Kliniku u Rispons (Persentaġġ ta' Pazjenti) Studju CD I: Pazjenti li qatt ma ħadu infliximab
English: Detailed information on this medicinal product 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 għallMediċini http://www.ema.europa.eu
English: In controlled Phase 3 trials of Humira in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of Humira-treated patients and 1.6% of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' Humira f'pazjenti bl-artrite rewmatika u artrite psorjatika fejn ilpazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żieda fil-livelli ta' l-ALT ≥ 3 x ULN f'3.7% tal-pazjenti trattati bi Humira u f'1.6% tal-pazjenti trattati bil-kontroll.
English: In Study nr-axSpA I, Humira 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 Humira 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, Humira 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'Humira u 6.5 għal dawk fuq il-plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥ 1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1)
Maltese: Il-benefiċċju u r-riskju tat-trattament kontinwu li jitkompla fit-tul għandhom jiġu evalwati perjodikament (ara dejta ta' adulti fit-taqsima 5.1).
English: In adult plaque psoriasis patients on long term adalimumab monotherapy who participated in a withdrawal and retreatment study, the rate of antibodies to adalimumab after retreatment (11 of 482 subjects, 2.3%) was similar to the rate observed prior to withdrawal (11 of 590 subjects, 1.9%).
Maltese: F'pazjenti adulti bil-psorjasi tal-plakka fuq monoterapija b'adalimumab fit-tul li pparteċipaw fi studju ta' rtirar u trattament mill-ġdid, ir-rata ta' antikorpi għal adalimumab wara trattament mill-ġdid (11 minn 482 suġġett, 2.3%) kienet simili għar-rata osservata qabel irtirar (11 minn 590 suġġett, 1.9%).
English: Humira Pre-filled Pen
Maltese: Żieda fil-lipidi
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at Weeks 0 and 2, 160 mg Humira at Week 0 followed by 80 mg at Week 2, or 80 mg Humira at Week 0 followed by 40 mg at Week 2.
Maltese: Fi studju UC-I, 390 pazjent li ma kienux ħadu antagonisti tat-TNF kienu randomizzati biex jew jirċievu l-plaċebo f'Ġimgħat 0 u 2, 160 mg Humira f'Ġimgħa 0 u wara 80 mg f' Ġimgħa 2, jew 80 mg Humira f Ġimgħa 0 u wara 40 mg f'Ġimgħa 2.
English: In patients with ankylosing spondylitis anti-adalimumab antibodies were identified in 17/204 subjects (8.3%) treated with adalimumab.
Maltese: F'pazjenti li jbatu minn infjammazzjoni tal-vertebri li tirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), ġew identifikati anti-korpi ta' kontra adalimumab fi 17/204 suġġett (8.3%) ikkurati b'adalimumab.
English: • elevated bilirubin measurement (liver blood test)
Maltese: • kejl tal-bilirubin elevat (test tad-demm tal-fwied)
English: Plum Activator Button
Maltese: Buttuna tal-Attivatur kulur l-għanbaqra
English: • 80 mg at Week 0 and 40 mg at Week 2
Maltese: • 80 mg f' ġimgħa 0 and 40 mg f' ġimgħa 2
English: Excipients: mannitol, polysorbate 80 and water for injections.
Maltese: Is-sustanzi l-oħra huma mannitol, polysorbate 80 u ilma għall-injezzjonijiet.
English: • If you have a severe infection, including active tuberculosis (see “Warnings and precautions”).
Maltese: • Jekk it-tifel jew it-tifla tiegħek għandhom infezzjoni severa, inkluż tuberkulosi attiva (ara “Twissijiet u prekawzjonijiet”).
English: Humira b/ MTX n=63
Maltese: Humira b/ MTX
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 Humira 80/40 mg and 160/80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Maltese: Fi studju CD I u studju CD II, f'ġimgħa 4, ġie milħuq riżultat totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju għall-mard speċifiku dwar il-marda ta' l-infjammazzjoni tal-musrana (IBDQ), u dan f'pazjenti li ġew magħżula b'ordni addoċċ u ngħataw 80/40 mg u 160/80 mg Humira meta mqabbel mal-plaċebo, u dan deher f'Ġimgħat 26 u 56 fi studju CD III, kif ukoll fil-gruppi talkura b'adalimumab meta mqabbla mal-grupp tal-plaċebo.
English: NEVER pull past the 0.9 ml position regardless of prescribed dose.
Maltese: Tiġbed QATT aktar mil-marka ta' 0.9 ml irrispettivament mid-doża preskritta.
English: The injection is complete when the yellow indicator stops moving.
Maltese: L-injezzjoni tkun kompleta meta l-indikatur isfar ikun waqaf jiċċaqlaq.
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: The safety and efficacy of Humira were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' Humira ġew studjati fi studju kollettiv multicenter, randomizzat,u doubleblind f'171 tifel u tifla (li għandhom bejn 4-17 il-sena) b'JIA poliartikulari.
English: • expiry (EXP) date has passed
Maltese: • id-data tal-iskadenza (EXP) tkun għaddiet
English: • urinary tract infection
Maltese: • infezzjoni fis-sistema urinarja
English: Of those receiving corticosteroids at baseline
Maltese: ASAS titjin parzjali kliniku BASDAI
English: Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: L-Istudju tal-Psorijasi I (REVEAL) evalwa 1212 pazjent fi tliet perijodi ta' kura.
English: • moderate to severe Crohn's disease in adults and
Maltese: • tal-marda Crohn (Crohn's disease) moderata sa severa fl-adulti
English: 40 mg at Week 2.
Maltese: 40mg/0.
English: Humira is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Maltese: Humira jintuża biex jittratta hidradenitis suppurativa fl-adolexxenti minn 12-il sena.
English: • oedema;
Maltese: • edima;
English: Humira 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: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with Humira 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Maltese: Pazjenti li kisbu remissjoni sostnuta għal mill-inqas 12il ġimgħa (N = 305) (ASDAS <1.3 fil-Ġimgħa 16, 20, 24 u 28) matul il-perjodu open-label kienu mbagħad ‘randomised' biex jirċievu jew kura kontinwa b'Humira 40 mg eow N=152) jew plaċebo (N=153) għal perjodu ta'40 ġimgħa addizzjonali f'perjodu double-blind ikkontrollat bi plaċebo (tul totali ta' studju ta' 68 ġimgħa).
English: • vertigo (feeling of dizziness or spinning)
Maltese: • vertigo (sensazzjoni ta' sturdament jew għażil)
English: Humira 40 mg solution for injection in pre-filled syringe Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Humira 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest li tintuża darba biss (ħġieġ tip I) bi planġer tapp (bromobutyl rubber) u labra bil-kappa (thermoplastic elastomer).
English: Hepatitis reactivation of hepatitis B
Maltese: Riattivazzjoni ta' Epatite B
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Artrite rewmatika, artrite psorjatika, ankylosing spondylitis jew axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis
English: • Polyarticular juvenile idiopathic arthritis
Maltese: • Artrite idjopatika poliartikulari taż-żagħżagħ
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by Week 8 and adverse events were more frequently noted in the 160/80 mg group.
Maltese: Rati simili ta' titjib ġew osservati għad-dożaġġ tal-bidu ta'160/80 mg u 80/40 mg milħuqa sa Ġimgħa 8 u fil-grupp tal-160/80 mg, l-effetti avversi ġew innutati b'mod aktar frekwenti.
English: 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' trattament, il-punteġġ medju PASI tal-linja bażi kien 19.7 u l-punteġġ PGA tal-linja bażi varja minn “ħafif” (<1%) għal “moderat” (48%) għal “sever” (46%) għal “sever ħafna” (6 %).
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' trattament, il-punteġġ medju PASI tal-linja bażi kien ta' 18.9 u punteġġ tal-PGA tal-linja bażi varja minn “moderati” (53% tas-suġġetti inklużi) għal “sever” (41%) għal “sever ħafna” (6% ).
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Maltese: Fil-provi pivitali kontrollati li saru fl-adulti u fit-tfal, 12.9% tal-pazjenti kkurati b'Humira żviluppaw reazzjonijiet fil-post ta' l-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: Table 5 ACR Responses in RA Study V (percent of patients)
Maltese: Risponsi għall-ACR fi Studju RA V (persentaġġ ta' pazjenti)
English: In controlled trials of Humira (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 Humira-treated patients and 0.6% of control-treated patients.
Maltese: Fi provi kkontrollati ta' Humira (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 x ULN seħħew f'0.3% tal-pazjenti ttrattati b'Humira u 0.6% tal-pazjenti ttrattati kkontrollati.
English: Humira 40 mg weekly N = 70
Maltese: Humira 40 mg kull ġimgħa N = 70
English: Humira is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Maltese: Humira jintuża biex jittratta artrite idjopatika poliartikulari taż-żagħżagħ u l-artrite relatata malentesite.
English: • pulmonary embolism (blockage in an artery of the lung)
Maltese: • emboliżmu fil-pulmun (imblukkar f'arterja tal-pulmun)
English: The safety and efficacy of Humira 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' Humira 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
English: Table 19 Time to Treatment Failure in Studies UV I and UV II
Maltese: Tabella 19 Żmien għall-Falliment tat-Trattament fi Studji UV I and UV II
English: Humira 80 mg solution for injection in pre-filled syringe Humira 80 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Humira 80 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Humira 80 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest li tintuża darba biss (ħġieġ tip I) bi planġer tapp (bromobutyl rubber) u labra bil-kappa (thermoplastic elastomer).
English: Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Maltese: Humira ġie studjat f'9,506 pazjent fi provi pivitali kontrollati u open-label li damu sejrin sa 60 xahar jew aktar.
English: In patients not given concomitant methotrexate, the incidence was 13.5% (24/178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Maltese: F'pazjenti li ma ngħatawx ukoll methotrexate flimkien ma' adalimumab, l-inċidenza kienet ta' 13.5% (24/178 suġġett), meta pparagunat ma' 7% (14 minn 198 suġġett) meta adalimumab kien użat addizzjonalment ma' methotrexate.
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 Humira.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil-livelli ta' CPR f'pazjenti jbatu min artrite idjopatika poliartikulari taż-żagħżagħ, mill-marda Crohn (Crohn's disease), kolite ulċerattiva u hidradenitis suppurativa wara trattament b'Humira.
English: PGA: Clear/minimal a, b p < 0.001 Humira vs. placebo p < 0.001 Humira vs. methotrexate p < 0.01 Humira vs. placebo p < 0.05 Humira vs. methotrexate
Maltese: N/A N/A *** p < 0.001 għall-paraguni kollha bejn Humira u l-plaċebo * p < 0.05 f għall-paraguni kollha bejn Humira u l-plaċebo N/A ma japplikax
English: • musculoskeletal pain
Maltese: • spażmi fil-muskoli
English: • Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the age of 2
Maltese: • Tagħtix Humira lil tfal b'artrite idjopatika poliartikulari tal-minorenni taħt l-età ta' sentejn.
English: Table 22 Induction of Clinical Remission and Response (Percent of Patients) CD Study I: Infliximab Naive Patients
Maltese: Tabella 22 Qlib għall-aħjar fl-Istat Kliniku u Rispons (Persentaġġ ta' Pazjenti) Studju I ta' CD: Pazjenti li qatt ma ħadu infliximab
English: Table 12 Radiographic Mean Changes at Week 52 in RA Study V
Maltese: Tabella 12 Tibdil Medju Radjografiku f'Ġimgħa 52 fi Studju RA V