FrancophonIA/ELRC3.0 huggingface dataset:
English: These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Norwegian Bokmål: Dawn kienu jinkludu axxess (f'partijiet differenti), batteremija, bronkite, bursite, ċellulite, koleċistite, dijarea, divertikulite, endokardite (issuspettata), gastroenterite, epatite B, herpes zoster, ulċera fir-riġlejn, infezzjoni fil-ħalq, osteomajelite, otitis, peritonite, pnewmonja, pajelonefrite, sepsis, artrite settika, sinusite, infezzjoni tal-ġilda, ulċera talġilda, infezzjoni fl-apparat ta' l-awrina, vaskulite, u infezzjoni fil-feriti.
English: ACR 20 and 50 responses were higher in patients treated with LIFMIOR at 3 and 6 months than in patients treated with placebo (ACR 20: LIFMIOR 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: LIFMIOR 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 LIFMIOR vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Norwegian Bokmål: Ir-risponsi ta' l-ACR 20 u 50 kienu ogħla f'pazjenti li ġew ikkurati b'LIFMIOR għal 3 xhur u 6 xhur milli minn f'pazjenti kkurati bil-plaċebo (ACR 20: LIFMIOR 62% u 59%, plaċebo 23% u 11% wara 3 u 6 xhur rispettivament; ACR 50: LIFMIOR 41% u 40%, plaċebo 8% u 5% wara 3 u 6 xhur rispettivament; p<0.01 LIFMIOR vs. plaċebo f'kull punt taż-żmien għar-risponsi ta' ACR 20 kif ukoll ACR 50).
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Norwegian Bokmål: Reazzjonijiet allerġiċi; raxx; deni; ħakk; antikorpi diretti kontra tessut normali (il-formazzjoni ta' awto-antikorpi).
English: Store in a refrigerator (2°C - 8°C).
Norwegian Bokmål: Aħżen fi friġġ (2C - 8C).
English: • Psoriatic arthritis in patients from the age of 12 years
Norwegian Bokmål: • Artrite psorjatika f'pazjenti mill-età ta' 12-il sena
English: Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Norwegian Bokmål: Studju 2 evalwa 652 pazjent bi psorjasi tal-plakka kronika billi ntużaw l-istess kriterji ta' inklużjoni bħal fi studju 1 biż-żieda ta' minimu ta' psoriasis area and severity index (PASI) ta' 10 waqt liscreening.
English: This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1.
Norwegian Bokmål: Dan il-komponiment Fc fih il-hinge, irreġjuni CH2 u CH3 iżda mhux ir-reġjun CH1 ta' IgG1.
English: In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
Norwegian Bokmål: Fi studju ta' osservazzjoni ieħor b'reġistru ta' bosta pajjiżi li qabbel ir-riskju ta' eżiti avversi tat-tqala f'nisa esposti għal etanercept flewwel 90 ġurnata tat-tqala (n=425) ma' dawk esposti għal mediċini mhux bijoloġiċi (n=3497), ma ġie osservat l-ebda riskju akbar ta' difetti tat-twelid maġġuri (proporzjon ta' probabbiltà crude [OR]= 1.22, 95% CI: 0.79-1.90; OR aġġustat =0.96, 95% CI: 0.58-1.60 wara aġġustament skont il-pajjiż, mard tal-omm, parità, età tal-omm u tipjip fil-bidu tat-tqala).
English: LIFMIOR is a medicine that is made from two human proteins.
Norwegian Bokmål: LIFMIOR hu mediċina magħmula minn żewġ proteini umani.
English: Autoimmune hepatitis*
Norwegian Bokmål: Epatite awtoimmunitarja*
English: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis.
Norwegian Bokmål: LIFMIOR mhuwiex rakkomandat għall-kura ta' granulomatożi ta' Wegener.
English: Uncommon ≥ 1/1,000 to < 1/100
Norwegian Bokmål: Mhux Komuni ≥ 1/1,000 sa
English: The needle cover contains dry natural rubber (latex) (see section 4.4).
Norwegian Bokmål: L-għatu tal-labra fih gomma naturali xotta (latex) (ara sezzjoni 4.4).
English: Opportunistic infections have been reported in association with LIFMIOR, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Norwegian Bokmål: Infezzjonijiet opportunistiċi kienu rrappurtati b'rabta ma' LIFMIOR, li jinkludu infezzjonijiet fungali invażivi, parasitiċi (inkluż protożoali), virali (inkluż ħerpes zoster), batterjali (li jinkludu Listeria u Legionella), u infezzjonijiet mikobatterjali atipiċi.
English: With continued therapy, responses were maintained up to 48 weeks.
Norwegian Bokmål: Mat-tkomplija tat-terapija, irrisponsi nżammu sa 48 ġimgħa.
English: This may include a thorough medical history, a chest X-ray and a tuberculin test.
Norwegian Bokmål: Dan jista' jinkludi storja medika dettaljata, X-ray tas-sider u test tattuberculin.
English: PHARMACEUTICAL FORM AND CONTENTS
Norwegian Bokmål: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitislike ankylosis.
Norwegian Bokmål: Il-pazjenti kellhom bejn 18 u 70 sena u kellhom artrite psorjatika attiva ( 3 ġogi minfuħin u  3 ġogi sensittivi) f'mill-anqas waħda minn dawn ilforom: (1) involviment distali interfalanġejali (DIP); (2) artrite poliartikulari (nuqqas ta' noduli rewmatojdi u l-preżenza ta' psorjasi); (3) artrite mutilans; (4) artrite psorjatika asimmetrika; jew (5) ankilosi li tixbah lill-ispondilite.
English: Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1.
Norwegian Bokmål: Etanercept hu dimer ta' proteina kimerika magħmula permezz ta' inġinerija ġenetika bilfużjoni tad-dominju extra-ċellulari li jgħaqqad il-ligandi tal-fattur uman nekrotiku għat-tumuri tarriċettur-2 (TNFR2/p75) mad-dominju Fc ta' IgG1 uman.
English: In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Norwegian Bokmål: Fi studju open-label, single-dose, two-treatment, crossover, f'voluntiera f'saħħithom, etanercept mogħti bħala injezzjoni waħda ta' 50 mg/ml, instab li kien bijoekwivalenti għal żewġ injezzjonijiet simultanji ta' 25 mg/ml.
English: 6.5 Nature and contents of container
Norwegian Bokmål: 6.5 In-natura tal-kontenitur u ta' dak li hemm ġo fih
English: Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Norwegian Bokmål: Fost il-klassijiet tas-sistema ta' l-organi, ir-reazzjonijiet avversi huma elenkati skond il-frekwenza (numru ta' pazjenti mistennija li jkollhom ir-reazzjoni) skond dawn il-kategoriji: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Psoriatic arthritis
Norwegian Bokmål: Artrite psorjatika
English: L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
Norwegian Bokmål: L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Ilma għall-injezzjonijiet
English: ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Norwegian Bokmål: Risponsi ASAS 50 u 70 użaw l-istess kriterji b'titjib ta' 50% jew ta' 70% rispettivament.
English: A. LABELLING
Norwegian Bokmål: A. TIKKETTAR
English: In a group of 7,416 patients treated with LIFMIOR in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Norwegian Bokmål: Fi grupp ta' 7,416-il pazjent ikkurati b'LIFMIOR fi provi kliniċi li kellhom artrite rewmatojde, artrite psorjatika, ankylosing spondylitis u psorjasi, 18-il limfoma kienu rrappurtati.
English: d. Adding solvent
Norwegian Bokmål: Kif iżżid is-solvent
English: These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Norwegian Bokmål: Dawn linfezzjonijiet kienu kkawżati minn batterji, mikobatterji, fungi, viruses u parassiti (inkluż protożoa).
English: 24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors
Norwegian Bokmål: 24 siringa mimlija għal-lest b'1 ml ta' solvent 24 labra ta' l-istainless steel għall-injezzjoni 24 adapter tal-kunjetti
English: These include rare reports of pancytopenia and very rare reports of aplastic anaemia.
Norwegian Bokmål: Dawn jinkludu rapporti rari ta' panċitopenja u rapporti rari ħafna ta' anemija aplastika.
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Norwegian Bokmål: TNF u lymphotoxin huma cytokines pro-infjammatorji li jeħlu ma' żewġ tipi differenti ta' riċetturi fuq is-superfiċje taċ-ċelluli: ir-riċetturi tal-fattur nekrotiku tat-tumuri (TNFRs) ta' 55-kilodalton (p55) u 75-kilodalton (p75).
English: Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Norwegian Bokmål: Studju 4 evalwa 142 pazjent u kellu kriterji simili ta' l-inkluzjoni bħal studji 2 u 3.
English: 1 LIFMIOR vial
Norwegian Bokmål: Tużax LIFMIOR
English: Rheumatoid arthritis
Norwegian Bokmål: Artrite rewmatojde
English: Compared to placebo, treatment with LIFMIOR resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Norwegian Bokmål: Meta mqabbla ma' plaċebo, il-kura b'LIFMIOR wasslet għal titjib statistikament sinifikanti fl-ASAS 40, l-ASAS 20 u l-ASAS 5/6.
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with LIFMIOR compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with LIFMIOR compared to none of placebo-treated patients).
Norwegian Bokmål: Il-perċentwali ta' pazjenti li żviluppaw antikorpi ġodda u pożittivi tat-tip DNA anti-double stranded kien ukoll ogħla b'assaġġ radjo-immunoloġiku (15% tal-pazjenti kkurati b'LIFMIOR imqabbel ma' 4% tal-pazjenti kkurati bil-plaċebo) u minn assaġġ bi Crithidia luciliae (3% tal-pazjenti kkurati b'LIFMIOR imqabbel ma' l-ebda pazjent ikkurat bil-plaċebo).
English: Diagram 10
Norwegian Bokmål: Dijagramma 10
English: DSGA b, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving LIFMIOR 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Norwegian Bokmål: *p 0.0001 meta mqabbel mal-plaċebo a. L-ebda paraguni statistiċi mal-plaċebo ma saru f'ġimgħa 24 fi Studju 2 u 4 għax il-grupp oriġinali talplaċebo beda jingħata 25 mg ta' LIFMIOR darbtejn fil-ġimgħa jew 50 mg darba fil-ġimgħa minn ġimgħa 13 sa ġimgħa 24. b. Dermatologist Static Global Assessment.
English: • Wegener's granulomatosis: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Norwegian Bokmål: • Granulomatosi ta' Wegener: LIFMIOR mhuwiex rakkomandat għall-kura ta' granulomatosi ta' Wegener, marda rari infjammatorja.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of LIFMIOR (see section 4.8).
Norwegian Bokmål: Infezzjonijiet serji, sepsis, tuberkulosi, u infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, listeriosis u legionellosis, kienu rrappurtati bl-użu ta' LIFMIOR (ara sezzjoni 4.8).
English: Diagram 9
Norwegian Bokmål: Dijagramma 9
English: PHARMACOLOGICAL PROPERTIES
Norwegian Bokmål: GĦAMLA FARMAĊEWTIKA
English: Diagram 1
Norwegian Bokmål: Dijagramma 1
English: Responses of Patients with Psoriasis in Studies 2, 3 And 4
Norwegian Bokmål: Risponsi ta' Pazjenti bi Psorjasi fi Studji 2, 3 u 4
English: Lot
Norwegian Bokmål: Lott
English: Ankylosing Spondylitis Response
Norwegian Bokmål: Rispons ta' Ankylosing Spondylitis
English: Reports have included fatal and life-threatening infections and sepsis.
Norwegian Bokmål: Rapporti inkludew infezzjonijiet fatali u ta' theddida għall-ħajja u sepsis.
English: Diagram 18
Norwegian Bokmål: Dijagramma 18
English: Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Norwegian Bokmål: Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate u ilma għall-injezzjonijiet.
English: In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with LIFMIOR at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Norwegian Bokmål: Fi studju ieħor ta' fergħa waħda bit-tikketta mikxufa, 60 pazjent b'oligoartrite estiża (15-il pazjent ta' bejn sentejn u 4 snin, 23 pazjent ta' bejn 5 u 11-il sena u 22 pazjent ta' bejn 12 u 17-il sena), 38 pazjent b'artrite relatata ma' entesite (12 sa 17-il sena) u 29 pazjent b'artrite psorjatika (12 sa 17-il sena) ġew ikkurati b'LIFMIOR f'doża ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) mogħtija kull ġimgħa għal 12-il ġimgħa.
English: The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma.
Norwegian Bokmål: L-iktar infezzjonijiet fungali invażivi li kienu rrappurtati b'mod komuni kienu jinkludu Candida, Pneumocystis, Aspergillus, u Histoplasma.
English: The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Norwegian Bokmål: Il-medja talkonċentrazzjonijiet minimi fis-serum fl-istat fiss varjat minn 1.6 sa 2.1 mcg/ml f'ġimgħat 12, 24, u 48.
English: LIFMIOR is available in strengths of 10, 25 and 50 mg.
Norwegian Bokmål: LIFMIOR hu disponibbli f'qawwiet ta' 10, 25 u 50 mg.
English: • Latex: The needle cap of the MYCLIC pen is made from latex (dry natural rubber).
Norwegian Bokmål: • Latex: L-għatu tal-labra hu magħmul mil-latex (lastku naturali niexef).
English: Diagram 15
Norwegian Bokmål: Dijagramma 15
English: Adjusted mean change from baseline was 3.8 for LIFMIOR treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Norwegian Bokmål: Il-bidla medja aġġustata mil-linja bażi kienet ta' 3.8 għallpazjenti li kienu qed jirċievu kura b'LIFMIOR (n=95) kontra 0.8 għal dawk li kienu qed jirċievu kura bi plaċebo (n=105) (p<0.001).
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg LIFMIOR once weekly (n=21) vs. 25 mg LIFMIOR twice weekly (n=16), respectively.
Norwegian Bokmål: Profili medji tal-konċentrazzjoni fis-serum fl-istat fiss f'pazjenti b'RA kkurati kienu Cmax ta' 2.4 mg/l vs. 2.6 mg/l, Cmin ta' 1.2 mg/l vs. 1.4 mg/l, u AUC parzjali ta' 297 mgh/l vs. 316 mgh/l għal 50 mg LIFMIOR darba fil-ġimgħa (n=21) vs. 25 mg LIFMIOR darbtejn fil-ġimgħa (n=16), rispettivament.
English: Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC).
Norwegian Bokmål: Ir-risponsi kliniċi kienu espressi f'perċentwali tal-pazjenti li kisbu rispons ta' ACR 20, 50 u 70, u f'perċentwali ta' titjib fil-Kriterji tar-Rispons ta' l-Artrite Psorjatika (PsARC).
English: Diagram 17
Norwegian Bokmål: Dijagramma 17
English: In a group of 2,711 plaque psoriasis patients treated with LIFMIOR in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Norwegian Bokmål: Fi grupp ta' 2,711-il pazjent bi psorjasi tal-plakka kkurati b'LIFMIOR fi studji double-blind u open-label li damu sejrin sa sentejn u nofs, 30 tumur malinn u 43 kanċer tal-ġilda mhux melanoma kienu rrappurtati.
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with LIFMIOR.
Norwegian Bokmål: Każijiet ta' tuberkulosi attiva li jinkludu tuberkulosi miljari u tuberkulosi b'sit extra-pulmonari kienu rrappurtati f'pazjenti kkurati b'LIFMIOR.
English: 70b a: 25 mg LIFMIOR SC twice weekly b: p < 0.001, LIFMIOR vs. placebo c: p < 0.01, LIFMIOR vs. placebo
Norwegian Bokmål: Is-sitt xahar a: 25 mg ta' LIFMIOR taħt il-ġilda darbtejn f'ġimgħa b: p < 0.001, LIFMIOR vs. plaċebo c: p < 0.01, LIFMIOR vs. plaċebo
English: There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Norwegian Bokmål: Kien hemm ukoll rapporti rari (< 0.1%) ta' bidu mill-ġdid ta' CHF, inkluż CHF f'pazjenti mingħajr mard kardjovaskulari pre-eżistenti.
English: Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Norwegian Bokmål: Il-proporzjonalità tad-doża ma ġietx evalwata formalment, iżda ma hemm ebda saturazzjoni apparenti ta' eliminazzjoni tul il-medda tad-dożaġġ.
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue
Norwegian Bokmål: • Sinjali ta' lupus jew sindromu simili għal-lupus, bħal tibdil fil-piż, raxx persistenti, deni, uġigħ fil-ġogi jew fil-muskoli, jew għejja)
English: Diagram 5
Norwegian Bokmål: Dijagramma 5
English: The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Norwegian Bokmål: L-ikbar numru f'dawn l-istudji (n = 277) kienu pazjenti ta' bejn it-18 u s-70 sena u li kellhom ankylosing spondylitis definita bħala punteġġ fuq liskala analoga viżwali (VAS) ta'  30 għal medja ta' żmien u intensità ta' ebusija ta' filgħodu flimkien ma' punteġġi VAS ta'  30 għal mill-inqas 2 minn dawn it-3 parametri li ġejjin: evalwazzjoni globali tal-pazjent; valuri medji tal-VAS għal uġigħ fid-dahar matul il-lejl u wġigħ totali fid-dahar; medja ta' 10 domandi fuq il-Bath Ankylosing Spondylitis Functional Index (BASFI).
English: A total of 401 patients were enrolled from which 203 were treated with LIFMIOR.
Norwegian Bokmål: Total ta' 401 pazjent kienu rreġistrati li fosthom 203 kienu kkurati b'LIFMIOR.
English: At 24 weeks, 56% of patients in the LIFMIOR-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
Norwegian Bokmål: F'ġimgħa 24, 56% tal-pazjenti fil-grupp ikkurat b'LIFMIOR kienu kisbu l-PASI 75 meta mqabbla ma' 5% tal-pazjenti kkurati bil-plaċebo.
English: 6.1 List of excipients
Norwegian Bokmål: 6.1 Lista ta' sustanzi mhux attivi
English: INFORMATION IN BRAILLE LIFMIOR 10 mg
Norwegian Bokmål: LIFMIOR 10 mg
English: Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Norwegian Bokmål: Kura ta' adulti bi spondiloartrite assjali mhux radjografika severa b'sinjali oġġettivi ta' infjammazzjoni kif indikat minn proteina C-reattiva (CRP) għolja u/jew minn evidenza tal-immaġni tar-reżonanza manjetika (MRI), li kellhom rispons inadegwat għal mediċini anti-infjammatorji mhux sterojdali (NSAIDs).
English: Diagram 7
Norwegian Bokmål: Dijagramma 7
English: Diagram 16
Norwegian Bokmål: Dijagramma 16
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with LIFMIOR alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of LIFMIOR and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Norwegian Bokmål: Fi studju ieħor ikkontrollat attivament, double-blind u randomised, l-effikaċja klinika, is-sigurtà, u lprogressjoni radjografika f'pazjenti b'RA kkurati b'LIFMIOR waħdu (25 mg darbtejn f'ġimgħa) b'methotrexate waħdu (7.5 sa 20 mg fil-ġimgħa, b'doża medjana ta' 20 mg), u LIFMIOR mibdi flimkien ma' methotrexate ġew imqabbla f'682 pazjent adult b'artrite rewmatojde attiva li kien ilha bejn 6 xhur u 20 sena (medjan ta' 5 snin) li kellhom rispons inqas minn sodisfaċenti għal ta' l-anqas waħda mill-mediċina anti-rewmatojde li timmodifika l-marda (DMARD), minbarra methotrexate.
English: Diagram 19
Norwegian Bokmål: Dijagramma 19
English: LIFMIOR powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Norwegian Bokmål: Trab ta' LIFMIOR għal soluzzjoni għandu jiġi rikostitwit f'1 ml ta' solvent qabel l-użu (ara sezzjoni 6.6).
English: 50b
Norwegian Bokmål: 1050 Bruxelles
English: There is no apparent pharmacokinetic difference between males and females.
Norwegian Bokmål: M'hemm l-ebda evidenza ta' differenza farmakokinetika bejn l-irġiel u n-nisa.
English: Long-term safety of LIFMIOR monotherapy (n=103), LIFMIOR plus methotrexate (n=294), or methotrexate monotherapy (n=197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Norwegian Bokmål: Is-sigurtà għal perjodu ta' żmien twil ta' monoterapija ta' LIFMIOR (n=103), LIFMIOR flimkien ma' methotrexate (n=294), jew monoterapija ta' methotrexate (n=197) ġew evalwati għal massimu ta' 3 snin f'reġistru ta' 594 tifel/tifla ta' bejn 2 u 18-il sena b'artrite taż-żgħażagħ idjopatika, li 39 minnhom kellhom bejn sentejn u 3 snin.
English: Worsening of cardiac failure congestive (see section 4.4)
Norwegian Bokmål: Iggravar ta' insuffiċjenza kardijaka konġestiva (ara sezzjoni 4.4).
English: 4 MYCLIC pre-filled pens 4 alcohol swabs
Norwegian Bokmål: 4 pinen MYCLIC mimlija għal-lest 4 swabs ta' l-alkoħol
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Norwegian Bokmål: A. MANIFATTURI TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI RESPONSABBLI GĦALL-ĦRUĠ TALLOTT