FrancophonIA/ELRC3.0 huggingface dataset:
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (n = 57) or placebo (n = 55) twice a week for 24 weeks.
Maltese: Mija u tnax-il pazjent (112) intgħażlu b'mod każwali biex jingħataw doża ta' 25 mg ta' etanercept (n = 57) jew plaċebo (n = 55) darbtejn fil-ġimgħa għal 24 ġimgħa.
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Maltese: Testijiet adattati tal-iscreening, i.e. test tal-ġilda tuberculin u X-ray tas-sider, għandhom jitwettqu fil-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu japplikaw).
English: Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age.
Maltese: L-istimi u l-volum tat-tneħħija f'pazjenti ta' bejn 65 u 87 sena kienu simili f'pazjenti li kellhom inqas minn 65 sena.
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year activecontrolled study.
Maltese: Mija u disgħa u għoxrin (129) tumuri malinni ġodda ta' diversi tipi kienu osservati f'4,114-il pazjent b'artrite rewmatojde kkurati b'etanercept fi provi kliniċi għal madwar bejn wieħed u ieħor 6 snin, li kienu jinkludu 231 pazjent ikkurati b'etanercept flimkien ma' methotrexate fl-istudju b'kontroll attiv li dam sentejn.
English: Biogen Belgium NV/S.A Tél/Tel: + 32 (0)2 808 5947
Maltese: Tél/Tel: + 32 (0)2 808 5947
English: These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Maltese: Dawn jinkludu wġigħ ta' ras (19% tal-pazjenti, 1.7 avvenimenti kull pazjent kull sena), dardir (9%, 1.0 avveniment kull pazjent kull sena), uġigħ addominali (19%, 0.74 ta' avveniment kull pazjent kull sena), u rimettar (13%, 0.74 ta' avveniment kull pazjent kull sena).
English: At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Maltese: Fil-linja bażi, il-pazjenti kellhom diżabilità moderata, b'punteġġi medji ta' HAQ ta' 1.4 sa 1.5.
English: Not included in pack: • 1 alcohol swab, gauze pad and plaster
Maltese: • 1 swab bl-alkoħol, gauze pad u stikk
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.
Maltese: Etanercept hu proteina umana b'fattur nekrotiku għat-tumuri b'funzjoni tar-riċettur p75 Fc, prodott b'teknoloġija rikombinanti tad-DNA bis-sistema ta' espressjoni mammifera fl-ovarji ta' ħamster Ċiniż (CHO). 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: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study.
Maltese: L-effikaċja ta' etanercept kienet evalwata fi studju randomised, double-blind u kkontrollat bil-plaċebo.
English: The efficacy of etanercept in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg etanercept with placebo.
Maltese: L-effikaċja ta' etanercept f'ankylosing spondylitis kienet evalwata fi 3 studji randomised, double-blind li qabblu l-għoti ta' 25 mg etanercept darbtejn fil-ġimgħa mal-plaċebo.
English: Adjusted mean change from baseline was 3.8 for etanercept treated (n = 95) versus 0.8 for placebo treated (n = 105) patients (p < 0.001).
Maltese: Il-bidla medja aġġustata mil-linja bażi kienet ta' 3.8 għallpazjenti li kienu qed jirċievu kura b'etanercept (n = 95) kontra 0.8 għal dawk li kienu qed jirċievu kura bi plaċebo (n = 105)
English: CNS demyelinating cases suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Maltese: Konvulżjonijiet Każijiet bit-telf talmajelin tas-CNS li jissuġġerixxu sklerożi multipla jew kundizzjonijiet bit-telf tal-majelin lokalizzati bħal newrite ottika u majelite transversa (ara sezzjoni 4.4), każijiet ta' telf talmajelin periferali, li jinkludu ssindrome ta' Guillain-Barré, polinewropatija infjammatorja kronika bit-telf talmajelin, polinewropatija bittelf tal-majelin, u newropatija multifokali talmoviment (ara sezzjoni 4.4),
English:  Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more.
Maltese: • Artrite psorjatika f'pazjenti mill-età ta' 12-il sena u li jiżnu 62.5 kg jew aktar.
English: Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Maltese: Fost ilpazjenti li temmew l-24 xahar kollha ta' terapija fl-istudju, ir-rati fejn ma sar l-ebda progress kienu ta' 78%, 70%, u 61%, rispettivament.
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept.
Maltese: Każijiet ta' tuberkulożi attiva li jinkludu tuberkulożi miljari u tuberkulożi b'sit extra-pulmonari kienu rrappurtati f'pazjenti kkurati b'etanercept.
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon).
Maltese: Fil-provi kliniċi kkontrollati li ppermettaw kura konkomitanti b'etanercept u methotrexate, il-frekwenza (il-proporzjon ta' inċidenza) ta' mard interstizjali tal-pulmun kienet ta' 0.47 % (frekwenza mhux komuni).
English: The efficacy of etanercept versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing etanercept with other systemic therapies.
Maltese: L-effikaċja ta' etanercept meta mqabbla ma' terapiji sistemiċi oħra f'pazjenti bi psorjasi minn moderata sa severa (li rrispondiet għal terapiji sistemiċi oħra) ma ġietx evalwata fi studji li qabblu etanercept direttament ma' terapiji sistemiċi oħrajn.
English: Benepali is available in packs containing 4 pre-filled syringes, multipacks containing 8 (2 packs of 4) pre-filled syringes and multipacks containing 24 (6 packs of 4) pre-filled syringes.
Maltese: Benepali hu disponibbli f'pakketti li fihom 4 siringi mimlija għal-lest, pakketti multipli li fihom 8 (2 pakketti ta' 4) siringi mimlija għal-lest u pakketti multipli li fihom 24 (6 pakketti ta' 4) siringa mimlija għal-lest.
English: Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Maltese: Ċar jew kważi ċar definiti bħala 0 jew 1 fuq skala 0 sa 5.
English: Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Maltese: Infezzjonijiet serji u fatali kienu rrappurtati wara li etanercept beda jintuża; patoġeni rrappurtati jinkludu batterji, mikobatterji (inkuż it-tuberkolożi), viruses u fungi.
English: Ewopharma AG Atstovybė Tel: +370 52 14 02 60
Maltese: Ewopharma AG pārstāvniecība Tel: + 371 66 16 40 32
English: In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Maltese: Fir-raba' studju, is-sigurtà u l-effikaċja ta' 50 mg ta' etanercept (żewġ injezzjonijiet taħt il-ġilda ta' 25 mg) mogħtija darba fil-ġimgħa vs. 25 mg ta' etanercept mogħtija darbtejn fil-ġimgħa kienu evalwati fi studju double-blind, ikkontrollat bil-plaċebo ta' 356 pazjent b'ankylosing spondylitis attiva.
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.
Maltese: 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: TSS Erosions JSN
Maltese: TA' KIF JINGĦATA
English: Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Maltese: Diversi tumuri malinni kienu wkoll irrappurtati bl-użu ta' etanercept, inkluż kanċer tas-sider, talpulmun, tal-ġilda u glandoli limfatiċi (limfoma).
English: Benepali 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Benepali 25 mg
English: Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Maltese: Radjografiji tal-idejn u lpolzijiet inkisbu fil-linja bażi u wara 6, 12, u 24 xahar.
English: The double-blind period was followed by an open-label period during which all patients receive etanercept 50 mg weekly for up to an additional 92 weeks.
Maltese: Il-perjodu double-blind kien segwit minn perjodu b'tikketta mikxufa li matulu l-pazjenti kollha rċevew etanercept 50 mg fil-ġimgħa sa 92 ġimgħa addizzjonali.
English: Biogen Hungary Kft. Tel.: + 36 (0)6 1 848 04 64
Maltese: Tel.: + 36 (0)6 1 848 04 64
English: Back
Maltese: Rispons
English: JSN
Maltese: SN
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.
Maltese: 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: Patients treated with Benepali should be given the Patient Alert Card. Benepali is available in strengths of 25 and 50 mg.
Maltese: Benepali hu disponibbli f'qawwiet ta' 25 u 50 mg.
English: • Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Maltese: • Psorjasi severa f'pazjenti mill-età ta' 6 snin u li jiżnu 62.5 kg jew aktar li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
English: Benepali is only available as 25 mg pre-filled syringe, 50 mg pre-filled syringe and 50 mg pre-filled pen.
Maltese: Benepali hu disponibbli biss bħala siringa mimlija għal-lest ta' 25 mg, siringa mimlija għal-lest ta' 50 mg u pinna mimlija għal-lest ta' 50 mg.
English: Autoimmune hepatitis
Maltese: Epatite awtoimmunitarja
English: b Values for Disease Activity Score (DAS) are means.
Maltese: Il-valuri għal Disease Activity Score (DAS) huma medji.
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more, the usual dose is 25 mg given twice a week or 50 mg given once a week.
Maltese: Għal poliartrite jew għal oligoartrite estiża f'pazjenti minn età ta' sentejn u li jiżnu 62.5 kg jew aktar, jew artrite relatata ma' entesite jew artrite psorjatika f'pazjenti minn età ta' 12-il sena u li jiżnu 62.5 kg jew aktar, id-doża li ssoltu tingħata hija 25 mg mogħtija darbtejn f'ġimgħa jew 50 mg mogħtija darba f'ġimgħa.
English: Month 12
Maltese: Xahar 12
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).
Maltese: L-istudju evalwa 234 pazjent adult li kellhom artrite rewmatojde attiva, u li fihom minn tal-inqas ma ħadmitx mediċina waħda, iżda mhux aktar minn erba' mediċini anti-rewmatiċi li jimmodifikaw ilmarda (DMARDs).
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 etanercept (11%) than in placebotreated patients (5%).
Maltese: 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'etanercept (11%) milli minn pazjenti li kienu kkurati bil-plaċebo (5%).
English: Placebo
Maltese: Plaċe bo
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all etanercept-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Maltese: Fil-ġimgħa 104, it-tibdil medju mil-linja bażi fil-punteġġ SPARCC imkejjel fuq MRI għall-individwi kollha kkurati b'etanercept kien 4.64 għall-SIJ (n = 153) u 1.40 issinsla (n = 154).
English: Undesirable effects in paediatric patients with plaque psoriasis In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Maltese: Fi studju li dam 48 ġimgħa li sar fuq 211-il tifel u tifla ta' bejn l-4 u s-17-il sena li kellhom psorjasi pedjatrika tal-plakka, l-avvenimenti avversi rrappurtati kienu simili għal dawk li kienu osservati fi studji li saru fil-passat fuq adulti bi psorjasi tal-plakka.
English: Solution for injection Multipack: 12 (3 packs of 4) pre-filled pens
Maltese: Pakkett multiplu: 12-il (3 pakketti ta' 4) pinna mimlija għal-lest
English: The safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Maltese: Is-sigurtà u l-effikaċja ta' 50 mg etanercept (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: In this study, 53 patients received placebo, 214 patients received 50 mg etanercept once weekly and 153 patients received 25 mg etanercept twice weekly.
Maltese: F'dan l-istudju, 53 pazjent ingħataw il-plaċebo, 214-il pazjent ingħataw 50 mg ta' etanercept darba fil-ġimgħa u 153 pazjent ingħataw 25 mg etanercept darbtejn fil-ġimgħa.
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with etanercept and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept (see sections 4.4 and 4.8).
Maltese: 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'etanercept u b'anakinra kellhom rata ogħla ta' infezzjonijiet serji (7%) u ta' newtropenija milli minn pazjenti kkurati b'etanercept biss (ara sezzjonijiet 4.4 u 4.8).
English: Teл.
Maltese: L.
English: The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
Maltese: Id-doża għandha tkun ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) darba fil-ġimgħa.
English: 46a
Maltese: 6 xhur a
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including etanercept, in the postmarketing setting.
Maltese: Tumuri malinni, xi wħud minnhom fatali, kienu rrappurtati fost tfal, adolexxenti u żgħażagħ adulti (li kellhom sa 22 sena) ikkurati b'antagonisti ta' TNF (il-bidu tat-terapija sar f'età ta' ≤ 18-il sena), li jinkludu etanercept fl-isfond ta' wara t-tqegħid fis-suq.
English: Baseline Week 52
Maltese: f'Ġimgħa 52
English: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Maltese: Il-kura ta' psorjasi kronika severa tal-plakka fit-tfal u fl-adolexxenti mill-età ta' 6 snin li huma kkontrollati b'mod inadegwat minn, jew li huma intolleranti għal, terapiji jew fototerapiji sistemiċi oħrajn.
English: Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash); Listeria (a bacterial infection).
Maltese: Karċinoma taċ-ċelluli Merkel (tip ta' kanċer tal-ġilda); attivazzjoni eċċessiva ta' ċelluli bojod tad-demm assoċjati ma' infjammazzjoni (sindrome tal-attivazzjoni tal-makrofagu); rikorrenza tal-epatite B (infezzjoni tal-fwied); aggravar ta' kundizzjoni msejħa dermatomijosite (infjammazzjoni u dgħufija tal-muskoli b'raxx tal-ġilda li jiġi magħha); Listeria (infezzjoni batterjali).
English: Each syringe contains 25 mg etanercept.
Maltese: Kull siringa fiha 25 mg ta' etanercept.
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).
Maltese: 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: Genesis Pharma (Cyprus) Ltd
Maltese: Biogen Idec (Ireland) Ltd.
English: (Scoreb) Baseline (Scoreb) Week 52
Maltese: (Punteġġ b) fil-Linja bażi (Punteġġ b)
English: The known side effects of Benepali include the following in groups of decreasing frequency:
Maltese: L-effetti sekondarji magħrufa ta' Benepali jinkludu dawn li ġejjin fi gruppi ta' frekwenza li tonqos:
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.
Maltese: 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: • moderate or severe rheumatoid arthritis;
Maltese: • artrite rewmatojde moderata jew severa;
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Maltese: Għal pazjenti li jkunu pożittivi għal infezzjoni tal-HBV, konsultazzjoni ma' tabib b'kompetenza filkura tal-epatite B hi rakkomandata.
English: Inflammatory bowel disease
Maltese: intestinali musrana infjammatorja
English: Paediatric patients with juvenile idiopathic arthritis The safety and efficacy of etanercept were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Maltese: Is-sigurtà u l-effikaċja ta' etanercept ġew evalwati fi studju maqsum f'żewġ partijiet fejn 69 tifel u tifla b'artrite idjopatika taż-żgħażagħ b'kors poliartikulari, li kellhom varjetà ta' tipi tal-bidu ta' artrite idjopatika taż-żgħażagħ (poliartrite, pawċiartrite, feġġa sistemika).
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon).
Maltese: Fil-provi kliniċi kkontrollati li ppermettaw kura konkomitanti b'etanercept u methotrexate, il-frekwenza (il-proporzjon ta' inċidenza) ta' epatite awtoimmunitarja kienet ta' 0.24 % (frekwenza mhux komuni).
English: Benepali 50 mg injection etanercept
Maltese: U MNEJN GĦANDU JINGĦATA Benepali 50 mg injezzjoni etanercept
English: ● You should be evaluated for tuberculosis (TB).
Maltese: ● Għandek tkun evalwat/a għat-tuberkulożi (TB).
English: The recommended dose is 50 mg etanercept administered once weekly (see section 5.1).
Maltese: Artrite rewmatojde Id-doża rakkomandata hi ta' 50 mg etanercept mogħtija darba fil-ġimgħa (ara sezzjoni 5.1).
English: disodium hydrogen phosphate heptahydrate, and water for injections.
Maltese: sodium hydrogen phosphate heptahydrate u ilma għall-injezzjonijiet.
English: Non-radiographic axial spondyloarthritis
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: In part 2, 6 of 25 (24%) patients remaining on etanercept experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p = 0.007).
Maltese: Fit-tieni parti, 6 minn 25 (24%) tal-pazjenti li baqgħu fuq etanercept kellhom żieda qawwija fl-intensità tal-marda meta mqabbla ma' 20 minn 26 (77%) pazjent li rċivew il-plaċebo (p = 0.007).
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).
Maltese: 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: 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.
Maltese: 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: Benepali 25 mg injection etanercept
Maltese: Benepali 25 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest etanercept
English: Each syringe contains 50 mg etanercept.
Maltese: Kull siringa fiha 50 mg ta' etanercept.
English: Contents of the pack and other information Instructions for use (see overleaf)
Maltese: Kontenut tal-pakkett u informazzjoni oħra Istruzzjonijiet għall-użu (Ara l-folja ta' wara)
English: Etanercept is recommended for use in patients as defined in section 4.1.
Maltese: Etanercept hu rakkomandat għall-użu f'pazjenti kif definit f'sezzjoni 4.1.
English: In study 1, the etanercept-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).
Maltese: Fi studju 1, il-grupp tal-kura b'etanercept 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: Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy).
Maltese: 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).