FrancophonIA/ELRC3.0 huggingface dataset:
English: Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Norwegian Bokmål: Radjografiji ta' l-idejn u lpolzijiet inkisbu fil-linja bażi u wara 6, 12, u 24 xahar.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Norwegian Bokmål: li jissuġġerixxu sklerosi multipla jew kundizzjonijiet bittelf tal-majelin lokalizzati bħal newrite ottika u majelite transversa (ara sezzjoni 4.4), każijiet ta' telf talmajelin periferali, li jinkludu s-sindrome ta' Guillain-Barré, polinewropatija infjammatorja kronika bit-telf talmajelin, polinewropatija bittelf tal-majelin, u newropatija multifokali talmoviment (ara sezzjoni 4.4), konvulżjoni
English: 4 vials of powder
Norwegian Bokmål: 4 kunjetti ta' trab
English: The safety profile was consistent with that observed in other JIA studies.
Norwegian Bokmål: Il-profil tas-sigurtà kien konsistenti ma' dak osservat fi studji JIA oħrajn.
English: 4 pre-filled syringes 4 alcohol swabs
Norwegian Bokmål: 4 siringi mimlija għal-lest 4 swabs ta' l-alkoħol
English: Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Norwegian Bokmål: Simulazzjoni tad-dożaġġ turi li waqt tfal ta' età akbar (ta' bejn 10 u 17-il sena) ser ikollhom livelli ta' serum qrib dawk osservati fl-adulti, tfal iżgħar ikollhom livelli ferm iktar baxxi.
English: Powder
Norwegian Bokmål: Tilqim
English: Autoimmune hepatitis
Norwegian Bokmål: Epatite awtoimmunitarja
English: See section 4.8 for how to report adverse reactions.
Norwegian Bokmål: Ara sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: Antibodies to LIFMIOR
Norwegian Bokmål: Mediċini oħra u LIFMIOR
English: Diagram 2
Norwegian Bokmål: Dijagramma 2
English: After a single subcutaneous dose of 25 mg LIFMIOR, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 μg/ml, and the area under the curve was 235 ± 96.6 μg•hr/ml.
Norwegian Bokmål: Wara doża waħda taħt il-ġilda ta' 25 mg ta' LIFMIOR, il-medja talkonċentrazzjoni massima fis-serum osservata f'voluntiera b'saħħithom kienet ta' 1.65  0.66 g/ml, u l-erja ta' taħt il-kurva kienet ta' 235  96.6 μg•h/ml.
English: 2 MYCLIC pre-filled pens 2 alcohol swabs
Norwegian Bokmål: 2 pinen MYCLIC mimlija għal-lest 2 swabs ta' l-alkoħol
English: PsARC Month 3
Norwegian Bokmål: ANNESS III
English: OTHER MYCLIC Pre-filled pen
Norwegian Bokmål: Disturbi filfwied u filmarrara
English: 8 vials of powder
Norwegian Bokmål: 8 kunjetti ta' trab
English: When reconstituted, the solution contains 10 mg/ml of etanercept.
Norwegian Bokmål: Meta rekostitwita is-soluzzjoni jkun fiha 10 mg/ml ta' etanercept.
English: Each vial of LIFMIOR 25 mg contains 25 mg of etanercept.
Norwegian Bokmål: Kull kunjett ta' LIFMIOR 25 mg fih 25 mg ta' etanercept.
English: Each vial contains 25 mg of etanercept.
Norwegian Bokmål: Kull kunjett fih 25 mg ta' etanercept.
English: Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Norwegian Bokmål: Pazjenti bi psorjasi pedjatrika tal-plakka (bejn l-4 u s-17-il sena) ingħataw 0.8 mg/kg (sa doża massima ta' 50 mg kull ġimgħa) ta' etanercept darba f'ġimgħa sa 48 ġimgħa.
English: Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with LIFMIOR (11%) than in placebotreated patients (5%).
Norwegian Bokmål: Mill-pazjenti bl-artrite rewmatojde, evalwati għal antikorpi kontra n-nukleju (ANA), il-perċentwali ta' pazjenti li żviluppaw ANA (1:40) ġdid u pożittiv, kien ogħla f'pazjenti kkurati b'LIFMIOR (11%) milli minn pazjenti li kienu kkurati bil-plaċebo (5%).
English: Use in children and adolescents
Norwegian Bokmål: Tfal u adolexxenti
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Norwegian Bokmål: L-effikaċja ta' LIFMIOR kienet evalwata fi studju randomised, double-blind, u kkontrollat bil-plaċebo li sar fuq 211-il pazjent pedjatriku bejn l-4 u 17-il sena, li kellhom psorjasi tal-plakka minn moderata sa severa (kif definita minn punteġġ sPGA ta' ≥ 3, li tinvolvi ≥ 10% tal-BSA, u PASI ta' ≥ 12).
English: Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Norwegian Bokmål: Ħafna mill-patoloġija tal-ġogi fl-artrite rewmatojde u fl-immobilità tal-ankylosing spondylitis u patologija tal-ġilda fi psorjasi tal-plakka hi medjata minn molekuli pro-infjammatorji li huma magħqudin flimkien ġo network ikkontrollat mit-TNF.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Norwegian Bokmål: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website ta' l-Aġenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of LIFMIOR, and in accordance with local recommendations.
Norwegian Bokmål: Jekk tkun iddijanjostikata tuberkulosi inattiva (‘moħbija'), għandha tinbeda kura għal tuberkulosi moħbija b'terapija kontra t-tuberkulosi qabel il-bidu tal-kura b'LIFMIOR, u b'konformità marrakkomandazzjonijiet lokali.
English: Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound.
Norwegian Bokmål: Il-valuri ta' etanercept fis-serum kienu stabbliti bil-metodu Enzyme-Linked Immunosorbent Assay (ELISA), li bih jistgħu jiġu osservati l-prodotti ta' degradazzjoni li jagħmlu reazzjoni għal ELISA, kif ukoll is-sustanza originali.
English: 0.8†,φ a: Patients who did not complete 12 months in the study were considered to be nonresponders.
Norwegian Bokmål: 52 Ġimgħa a: Pazjenti fl-istudju li ma komplewx 12-il xahar kienu kkunsidrati li ma rrispondewx.
English: Malignancies and lymphoproliferative disorders
Norwegian Bokmål: Tumuri malinni u disturbi limfoproliferattivi
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Norwegian Bokmål: Ir-rata aġġustata għall-espożizzjoni kienet ta' 0.06 avvenimenti kull 100 sena ta' ħajja tal-pazjenti.
English: Responses were measured using the ACR Pedi 30, defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Norwegian Bokmål: Ir-rispons tkejjel bl-ACR Pedi 30, definita bħala  30% titjib f'mill-inqas tlieta minn sitta, u  30% aggravament f'mhux aktar minn wieħed minn sitta tal-kriterji bażiċi magħżula tal-JRA, li jinkludu l-għadd ta' ġogi attivi, limitazzjoni tal-moviment, evalwazzjonijiet globali tat-tabib u tal-pazjent/ġenitur, evalwazzjoni funzjonali u rata ta' sedimentazzjoni taċ-ċelluli l-ħomor tad-demm (ESR).
English: 25 mg BIW
Norwegian Bokmål: 25 mg/0.5 ml
English: INFORMATION IN BRAILLE LIFMIOR 25 mg
Norwegian Bokmål: LIFMIOR 25 mg
English: 24.8c
Norwegian Bokmål: 24-il xahar
English: In clinical trials, no interactions have been observed when LIFMIOR was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Norwegian Bokmål: Fl-istudji kliniċi, ma ġewx osservati interazzjonijiet meta LIFMIOR ingħata flimkien ma' glukokortikojdi, salicylates (ħlief sulfasalazine), mediċini kontra l-infjammazzjoni li mhumiex sterojdi (NSAIDs), analġesiċi, jew methotrexate.
English: Responses observed during the open-label period were similar to those observed in the double-blind period.
Norwegian Bokmål: Ir-risponsi osservati matul il-perjodu open-label kienu simili għal dawk osservati fil-perjodu double-blind.
English: In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
Norwegian Bokmål: Fl-ewwel parti tal-istudju, 51 minn 69 (74%) tal-pazjenti wrew rispons kliniku u daħlu għat-tieni parti ta' l-istudju.
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study.
Norwegian Bokmål: L-effikaċja ta' LIFMIOR kienet evalwata fi studju randomised, double-blind u kkontrollat bil-plaċebo.
English: Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Norwegian Bokmål: Studju 3 evalwa 583 pazjent u kellu l-istess kriterji ta' inkluzjoni bħal studju 2.
English: In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).
Norwegian Bokmål: Fil-perjodi double-blind ta' provi kliniċi kkontrollati li ppermettew kura fl-istess ħin b'etanercept u b'methotrexate, il-frekwenza (il-proporzjon ta' inċidenza) ta' avvenimenti avversi ta' żieda fl-enżimi tal-fwied kienet ta' 4.18 % (frekwenza komuni).
English: The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
Norwegian Bokmål: L-istudju evalwa 234 pazjent adult li kellhom artrite rewmatojde attiva, u li fihom minn ta' l-inqas ma ħadmitx mediċina waħda, iżda mhux aktar minn erba' mediċini anti-rewmatiċi li jimmodifikaw ilmarda (DMARDs).
English: Clinical responses among nr-AxSpa patients who received LIFMIOR were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Norwegian Bokmål: Ir-risponsi kliniċi fost pazjenti b'nr-AxSpa li rċevew LIFMIOR kienu evidenti waqt l-ewwel vista (ġimagħtejn) u nżammu sa sentejn ta' terapija.
English: n = 90 wk 24a
Norwegian Bokmål: 50 mg darba fi lġimgħa n = 90 ġimgħ a 24
English: The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
Norwegian Bokmål: Id-doża għandha tkun ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) darba f'ġimgħa.
English: The safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Norwegian Bokmål: Is-sigurtà u l-effikaċja ta' 50 mg LIFMIOR (żewġ injezzjonijiet 25 mg taħt il-ġilda) mogħtija darba fil-ġimgħa kienu evalwati fi stħarriġ double-blind, ikkontrollat bil-plaċebo fuq 420 pazjent b'RA attiva.
English: The differences in TSS and JSN were not statistically significant between methotrexate and LIFMIOR 25 mg.
Norwegian Bokmål: Id-differenzi fit-TSS u JSN ma kinux statistikament sinifikanti bejn methotrexate u LIFMIOR 25 mg. Ir-riżultati jidhru fil-figuri t'hawn taħt.
English: • Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Norwegian Bokmål: • Psorjasi severa f'pazjenti mill-età ta' 6 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
English: • Risk Management Plan (RMP)
Norwegian Bokmål: • Pjan tal-immaniġġar tar-riskju (RMP)
English: 5.1 Pharmacodynamic properties
Norwegian Bokmål: 5.1 Tagħrif farmakodinamiku
English: The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
Norwegian Bokmål: L-istudju evalwa 215-il pazjent adult (popolazzjoni modifikata b'intenzjoni li tiġi kkurata) b'nr-AxSpa attiva (18 sa 49 sena), definiti bħala dawk il-pazjenti li ssodisfaw il-kriterji tal-klassifikazzjoni ASAS ta' spondiloartrite assjali iżda li ma ssodisfawx il-kriterji modifikati ta' New York għal AS. Il-pazjenti kienu wkoll meħtieġa jkollhom rispons inadegwat jew intolleranza għal żewġ NSAIDs jew aktar.
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Norwegian Bokmål: Testijiet adattati ta' l-iscreening, i.e. test tal-ġilda tuberculin u X-ray tas-sider, għandhom jitwettqu fil-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu japplikaw).
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the LIFMIOR in combination with methotrexate group compared with the LIFMIOR alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
Norwegian Bokmål: F'analiżi li fiha l-pazjenti kollha li ħarġu mill-istudju għal kwalunkwe raġuni kienu kkunsidrati li għamlu progress, il-perċentwali ta' pazjenti mingħajr progressjoni (bidla fit-TSS ta' ≤ 0.5) wara 24 xahar kienet ogħla fil-grupp li ngħata LIFMIOR flimkien ma' methotrexate meta mqabbel malgruppi li ħadu LIFMIOR waħdu u methotrexate waħdu (62%, 50%, and 36%, rispettivament; p<0.05).
English: In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with LIFMIOR (see sections 4.4 and 4.8).
Norwegian Bokmål: Flimkien ma' dan, fi studju double-blind u kkontrollat bil-plaċebo f'pazjenti adulti li kienu qed jieħdu methotrexate ukoll, kien osservat li pazjenti kkurati b'LIFMIOR u b'anakinra kellhom rata ogħla ta' infezzjonijiet serji (7%) u ta' newtropenja milli minn pazjenti kkurati b'LIFMIOR biss (ara sezzjonijiet 4.4 u 4.8).
English: Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Norwegian Bokmål: Ċar jew kważi ċar definiti bħala 0 jew 1 fuq skala 0 to 5.
English: In study 1, the LIFMIOR-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001).
Norwegian Bokmål: Fi studju 1, il-grupp tal-kura b'LIFMIOR kellu proporzjon ogħla ta' pazjenti b'rispons PASI 75 f'ġimgħa 12 (30%) meta mqabbel mal-grupp ikkurat bil-plaċebo (2%) (p<0.0001).
English: In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs. 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Norwegian Bokmål: Fir-raba' studju, is-sigurtà u l-effikaċja ta' 50 mg ta' LIFMIOR (żewġ injezzjonijiet taħt il-ġilda ta' 25 mg) mogħtija darba fil-ġimgħa vs. 25 mg ta' LIFMIOR mogħtija darbtejn fil-ġimgħa kienu evalwati fi studju double-blind, ikkontrollat bil-plaċebo ta' 356 pazjent b'ankylosing spondylitis attiva.
English: Thus the combined use of LIFMIOR and anakinra is not recommended (see sections 4.5 and 4.8).
Norwegian Bokmål: Għalhekk l-użu ta' LIFMIOR flimkien ma' anakinra mhux rakkomandat (ara sezzjonijiet 4.5 u 4.8).
English: In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon).
Norwegian Bokmål: Fil-perjodi double-blind ta' provi kliniċi kkontrollati ta' etanercept fl-indikazzjonijiet kolha, ilfrekwenza (il-proporzjon ta' inċidenza) ta' avvenimenti avversi ta' żieda fl-enżimi tal-fwied f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate fl-istess ħin kienet ta' 0.54 % (frekwenza mhux komuni).
English: LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Norwegian Bokmål: Il-kura b'LIFMIOR għandha tinbeda taħt is-superviżjoni ta' tobba speċjalisti b'esperjenza fid-dijanjosi u fil-kura ta' artrite rewmatojda, artrite idjopatika taż-żgħażagħ, artrite psorjatika, ankylosing spondylitis, spondiloartrite assjali mhux radjografika, psorjasi tal-plakka jew psorjasi pedjatrika talplakka.
English: Patients with a significant exposure to varicella virus should temporarily discontinue LIFMIOR therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Norwegian Bokmål: Pazjenti b'espożizzjoni sinifikanti għall-virus tal-ġidri r-riħ għandhom iwaqqfu temporanjament it-terapija b'LIFMIOR u jiġu kkunsidrati għall-kura profilattika b'Varicella Zoster Immune Globulin.
English: The long-term safety and effectiveness of LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Norwegian Bokmål: Is-sikurezza u l-effikaċja fit-tul ta' LIFMIOR 0.8 mg/kg (sa 50 mg) darba fil-ġimgħa ġew ivvalutati fi studju ta' estensjoni b'tikketta mikxufa ta' 181 suġġett pedjatriku bi psorjasi tal-plakka għal massimu ta' sentejn apparti l-istudju ta' 48 ġimgħa diskuss hawn fuq.
English: Paediatric population
Norwegian Bokmål: Popolazzjoni pedjatrika
English: Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs.
Norwegian Bokmål: Kull pakkett fih 2, 4 jew 12-il siringa mimlija għal-lest u 2, 4 jew 12-il swab bl-alkoħol.
English: MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.
Norwegian Bokmål: Saru MRIs tal-ġog sakroiljaku u tas-sinsla biex tiġi evalwata l-infjammazzjoni fil-linja bażi u fil-ġimgħat 12 u 104.
English: Clinical Efficacy Results at 12 Months: Comparison of LIFMIOR vs. Methotrexate vs. LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration
Norwegian Bokmål: Riżultati tal-Effikaċja Klinika wara 12-il Xahar: Paragun ta' LIFMIOR vs. Methotrexate vs. LIFMIOR Flimkien ma' Methotrexate f'Pazjenti b'RA ta' bejn 6 Xhur u 20 Sena
English: The double-blind period was followed by an open-label period during which all patients receive LIFMIOR 50 mg weekly for up to an additional 92 weeks.
Norwegian Bokmål: Il-perjodu double-blind kien segwit minn perjodu b'tikketta mikxufa li matulu l-pazjenti kollha rċevew LIFMIOR 50 mg fil-ġimgħa sa 92 ġimgħa addizzjonali.
English: Doses of 10 mg or 25 mg LIFMIOR were administered subcutaneously (SC) twice a week for up to 24 months.
Norwegian Bokmål: Dożi ta' 10 mg u 25 mg ingħataw taħt il-ġilda (SC) darbtejn f'ġimgħa sa 24 xahar.
English: *Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p<0.001, b:<0.01 and c:<0.05, respectively between LIFMIOR and placebo
Norwegian Bokmål: ASAS** 40 ASAS 20 ASAS 5/6 Remissjoni parzjali fuq ASAS BASDAI***50 * Xi pazjenti ma pprovdewx dejta sħiħa għal kull endpoint ** ASAS=Soċjetà Internazzjonali ta' Evalwazzjonijiet ta' Spondiloartrite *** Indiċi ta' Attività tal-Marda Spondilite Ankilosing ta' Bath a: p<0.001, b:<0.01 u c:<0.05, rispettivament bejn LIFMIOR u plaċebo
English: Paediatric population See Summary of the safety profile, above.
Norwegian Bokmål: Popolazzjoni pedjatrika Ara s-sommarju tal-profil ta' sigurtà, hawn fuq.
English: Worsening of symptoms of dermatomyositis
Norwegian Bokmål: Aggravar tassintomi ta' dermatomijosite
English: 24 pre-filled syringes 24 alcohol swabs
Norwegian Bokmål: 24 siringa mimlija għal-lest 24 swab ta' l-alkoħol
English: LIFMIOR has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Norwegian Bokmål: Intwera li LIFMIOR itejjeb ilfunzjoni fiżika f'pazjenti b'artrite psorjatika, u li jnaqqas ir-rata ta' progressjoni ta' ħsara periferali talġogi kif imkejla bl-X-ray f'pazjenti b'sotto-tipi simmetriċi poliartikulari tal-marda.
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with LIFMIOR (see section
Norwegian Bokmål: Mard infjammatorju tal-imsaren (IBD) u uveitis f'pazjenti b'artrite idjopatika taż-żgħażagħ (JIA) Kien hemm rapporti ta' IBD u uveitis f'pazjenti b'JIA li kienu qed jiġu kkurati b'LIFMIOR (ara sezzjoni 4.8).
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use etanercept
Norwegian Bokmål: LIFMIOR 10 mg trab u solvent għal soluzzjoni għall-injezzjoni għal użu pedjatriku etanercept
English: CARTON TEXT - EU/1/16/1165/002-004
Norwegian Bokmål: KITBA FUQ IL-KARTUNA- EU/1/16/1165/002-004
English: Patients in the LIFMIOR in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Norwegian Bokmål: Il-pazjenti fil-grupp ta' LIFMIOR flimkien mal-grupp tat-terapija b'methotrexate kellhom risponsi b'mod sinifikanti aktar għolja ta' ACR 20, ACR 50, ACR 70 u titjib fil-punteġġ tad-DAS u HAQ kemm wara 24 kif ukoll 52 ġimgħa milli minn pazjenti li kienu fil-gruppi tat-terapija b'mediċina waħda (ir-riżultati jidhru fit-tabella t'hawn taħt).
English: Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy).
Norwegian Bokmål: Flimkien ma' dan, kien hemm rapporti rari ta' polinewropatiji bit-telf tal-majelin periferali (li jinkludu s-sindrome ta' Guillain-Barré, polinewropatija bit-telf tal-majelin infjammatorja kronika, polinewropatija bit-telf tal-majelin, u newropatija multifokali tal-moviment).
English: n = 46 wk 12
Norwegian Bokmål: Plaċebo n = 46 ġimgħa
English: In a study of 49 adult patients with rheumatoid arthritis treated with LIFMIOR, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Norwegian Bokmål: Fi studju fuq 49 pazjent adult bl-artrite rewmatojde li ngħataw LIFMIOR, ma nstabet l-ebda evidenza ta' tnaqqis ta' sensittività eċċessiva tat-tip li jittardja, ta' tnaqqis tal-livelli ta' l-immunoglobina, jew tibdil fl-enumerazzjoni tal-popolazzjonijiet taċ-ċelluli effector.
English: Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.
Norwegian Bokmål: Studju 1 kien studju ta' Fażi 2 f'pazjenti bi psorjasi tal-plakka klinikament stabbli imma attiva li tinvolvi  10% tal-erja tal-wiċċ tal-ġisem li kellhom  18-il sena.