FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Maltese: B'mod alternattiv, intwera li 50 mg ta' etanercept mogħtija darba fil-ġimgħa huma siguri u effettivi (ara sezzjoni 5.1).
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Maltese: Vaskulite (inkluż vaskulite pożittiva tal antikorpi ċitoplażmika anti-newtrofilika)
English: With continued therapy, responses were maintained up to 48 weeks.
Maltese: Mat-tkomplija tat-terapija, ir risponsi nżammu sa 48 ġimgħa.
English: SN
Maltese: JSN
English: At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
Maltese: Fil-ġimgħa 104, 8 individwi avvanzaw għal punteġġ ta' Grad 2 bilaterali fuq Raġġi-X tassinsla skont il-Grad Radjoloġiku ta' New York modifikat, indikattiv ta' spondiloartropatija assjali.
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 nonbiologic 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).
Maltese: 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' malformazzjonijiet 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: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 µg•hr/ml and 474 µg•hr/ml for 50 mg etanercept once weekly (N = 154) and 25 mg twice weekly (N = 148), respectively.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'ankylosing spondylitis, l-AUCs fl-istat fiss ta' etanercept kienu ta' 466 μg•h/mL u 474 μg•h/mL għal 50 mg etanercept darba fil-ġimgħa (N = 154) u 25 mg darbtejn fil-ġimgħa (N = 148), rispettivament.
English: These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Maltese: Dawn l infezzjonijiet kienu kkawżati minn batterji, mikobatterji, fungi, viruses u parassiti (inkluż protożoa).
English: This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1.
Maltese: Dan il-komponiment Fc fih il-hinge, ir reġjuni CH2 u CH3 iżda mhux ir-reġjun CH1 ta' IgG1.
English: Store in the refrigerator between 2 °C to 8 °C.
Maltese: Aħżen fil-friġġ f'temperatura bejn 2 °C sa 8 °C.
English: Each pack contains 1, 2 or 4 pens, multipacks contain 12 (3 packs of 4) pens.
Maltese: Kull pakkett fih 1, 2 jew 4 pinen, il-pakketti multipli fihom 12-il pinna(3 pakketti ta' 4).
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: imkejjel fuq MRI għall-individwi kollha kkurati b'etanercept kien 4.64 għall-SIJ (n = 153) u 1.40 issinsla (n = 154).
English: Paediatric plaque psoriasis outcomes at 12 weeks Etanercept 0.8 mg/kg Once Weekly (N = 106)
Maltese: Riżultati tal-psorijasi pedjatrika tal-plakka f'ġimgħa 12 Etanercept 0.8 mg/kg Darba fil-Ġimgħa (N = 106)
English: EU/1/17/1195/012 12 pre-filled SensoReady pens
Maltese: EU/1/17/1195/012 12-il pinna SensoReady mimlija għal-lest
English: Placebo N = 106 to 109*
Maltese: N = 106 sa 109*
English: Important safety checks before you inject:
Maltese: Aspetti ta' sigurtà importanti qabel ma tieħu l-injezzjoni:
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
Maltese: • Sinjali ta' lupus jew sindromu simili għal-lupus, bħal tibdil fil-piż, raxx persistenti, deni, uġigħ fil-ġogi jew fil-muskoli, jew għeja);
English: ▼This medicinal product is subject to additional monitoring.
Maltese: ▼Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Erelzi is administered by subcutaneous injection (see section 6.6).
Maltese: Erelzi jingħata permezz ta' injezzjoni taħt il-ġilda (ara sezzjoni 6.6).
English: Erelzi 50 mg solution for injection in pre-filled pen EU/1/17/1195/009
Maltese: Erelzi 50 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/17/1195/009
English: Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
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
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Maltese: anemija, lewkopenja, newtropenja
English: The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus and Histoplasma.
Maltese: L-iktar infezzjonijiet fungali invażivi li kienu rrappurtati b'mod komuni kienu jinkludu Candida, Pneumocystis, Aspergillus u Histoplasma.
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: 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: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
Maltese: Kienet irrappurtata l-attivazzjoni mill-ġdid tal-epatite B f'pazjenti li qabel kienu infettati bil-virus tal epatite B (HBV) u li rċivew antagonisti ta' TNF, li jinkludu etanercept.
English: In a group of 2,711 plaque psoriasis patients treated with etanercept in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 non-melanoma skin cancers were reported.
Maltese: Fi grupp ta' 2,711-il pazjent bi psorjasi tal-plakka kkurati b'etanercept 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: Pairwise comparison p-values: * = p < 0.05 for comparisons of etanercept vs. methotrexate, † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and ϕ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Maltese: Paragun f'pari tal-valuri p: * = p < 0.05 għall-paragun ta' etanercept vs. methotrexate, † = p < 0.05 għall-paraguni ta' etanercept + methotrexate vs. methotrexate u ϕ = p < 0.05 għall-paraguni ta' etanercept + methotrexate vs. etanercept.
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients.
Maltese: Fi studji ta' Fażi 3 dwar artrite rewmatojde, artrite psorjatika, u ankylosing spondylitis, ma kienu osservati l-ebda differenzi globali f'avvenimenti avversi, avvenimenti avversi serji, u infezzjonijiet serji f'pazjenti li kellhom 65 sena jew aktar, li rċivew etanercept, meta mqabbel ma pazjenti iżgħar.
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) (p< 0.001).
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients).
Maltese: (15% tal-pazjenti kkurati b'etanercept imqabbel ma' 4% tal-pazjenti kkurati bil-plaċebo) u minn assaġġ bi Crithidia luciliae (3% tal-pazjenti kkurati b'etanercept imqabbel ma' l-ebda pazjent ikkurat bil-plaċebo).
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: (CHO). Etanercept hu dimer ta' proteina kimerika magħmula permezz ta' inġinerija ġenetika bil fużjoni 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: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single non-steroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Maltese: bejn 4 u 17-il sena b'artrite idjopatika taż-żgħażagħ b'kors poliartikulari bejn moderata u severa li ma fiqitx b'methotrexate jew li kienet intolleranti għal methotrexate; il-pazjenti baqgħu fuq doża waħda stabbli ta' mediċina kontra l-infjammazzjoni li mhix sterojdi u/jew fuq prednisone (< 0.2 mg/kg/kuljum jew massimu ta' 10 mg).
English: Erelzi is a medicine that is made from two human proteins.
Maltese: Erelzi hu mediċina magħmula minn żewġ proteini umani.
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 etanercept at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Maltese: 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 psorijatika
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 50 mg, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull 25 mg jew 50 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Maltese: Fi studju kliniku randomised, double blind, ikkontrollat bil-plaċebo f'pazjenti adulti b'artrite psorjatika, 184 pazjent ingħataw ukoll multivalent pneumococcal polysaccharide vaccine fir-4 ġimgħa.
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' tuberkulosi attiva li jinkludu tuberkulosi miljari u tuberkulosi b'sit extra-pulmonari kienu rrappurtati f'pazjenti kkurati b'etanercept.
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) spondylitis-like ankylosis.
Maltese: (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
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 etanercept and placebo
Maltese: *** Indiċi ta' Attività tal-Marda Spondilite Ankilosing ta' Bath a: p < 0.001, b:< 0.01 u c:< 0.05, rispettivament bejn etanercept u plaċebo
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 non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: 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: At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
Maltese: F'ġimgħa 24, 56% tal-pazjenti fil-grupp ikkurat b'etanercept kienu kisbu l-PASI 75 meta mqabbla ma' 5% tal-pazjenti kkurati bil-plaċebo.
English: Cardiac disorders
Maltese: insuffiċjenza kardijaka konġestiva
English: Use in adult patients (aged 18 years or over)
Maltese: Użu f'pazjenti adulti (ta' 18-il sena jew aktar)
English: A 25 mg strength of Erelzi is available for doses of 25 mg.
Maltese: Qawwa ta' 25 mg ta' Erelzi hi disponibbli għal dożi ta' 25 mg.
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Maltese: (inkluż infezzjoni fl-apparat respiratorj u ta' fuq, bronkite, ċistite, infezzjoni tal-ġilda)*
English: A placebo-controlled trial, in which 89 adult patients were treated with etanercept in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown etanercept to be an effective treatment for Wegener's granulomatosis.
Maltese: Prova kkontrollata bil-plaċebo, fejn 89 pazjent adult kienu kkurati b'etanercept ukoll flimkien mat terapija standard (inklużi cyclophosphamide u/jew methotrexate, u glukokortikojdi) fuq żmien medjan ta' 25 xahar, ma wrietx li etanercept hu kura effettiva għal granulomatożi ta' Wegener.
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and ϕ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Maltese: Paragun f'pari tal-valuri p: † = p < 0.05 għal etanercept + methotrexate vs. methotrexate u ϕ = p < 0.05 għall-paraguni ta' etanercept + methotrexate vs. etanercept.
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi.
Maltese: • Mard infjammatorju tal-imsaren (IBD): Kien hemm każijiet ta' IBD f'pazjenti b'artrite idjopatika taż-żgħażagħ (JIA) ikkurati b'Erelzi.
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with etanercept alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of etanercept 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.
Maltese: b'methotrexate waħdu (7.5 sa 20 mg fil-ġimgħa, b'doża medjana ta' 20 mg), u etanercept 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 tal-anqas waħda mill-mediċina anti-rewmatojde li timmodifika l-marda (DMARD), minbarra methotrexate.
English: Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Maltese: Artrite rewmatojde Erelzi f'taħlita ma' methotrexate hu indikat għall-kura ta' artrite rewmatojde attiva minn moderata sa severa fl-adulti meta r-rispons għall-mediċini antirewmatiċi li jimmodifikaw il-marda, inkluż methotrexate (kemm-il darba mhux kontraindikat), kienet inadegwata.
English: n = 166 n =
Maltese: N = 139
English: The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Maltese: Il-medja tal konċentrazzjonijiet minimi fis-serum fl-istat fiss varjat minn 1.6 sa 2.1 mcg/mL f'ġimgħat 12, 24,
English: Long-term safety of etanercept monotherapy (n = 103), etanercept 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.
Maltese: Is-sigurtà għal perjodu ta' żmien twil ta' monoterapija ta' etanercept (n = 103), etanercept 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,
English: EU/1/17/1195/009 1 pre-filled SensoReady pen EU/1/17/1195/010 2 pre-filled SensoReady pens EU/1/17/1195/011 4 pre-filled SensoReady pens
Maltese: EU/1/17/1195/010 2 pinen SensoReady mimlija għal-lest EU/1/17/1195/011 4 pinen SensoReady mimlija għal-lest
English: Erelzi is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Maltese: Erelzi mhux indikat għall-użu fi tfal u adolexxenti li jiżnu inqas minn 62.5 kg.
English: 0.8 †, ϕ a: Patients who did not complete 12 months in the study were considered to be non-responders.
Maltese: 0.8 †, ϕ a: Pazjenti fl-istudju li ma komplewx 12-il xahar kienu kkunsidrati li ma rrispondewx.
English: In study 4, the etanercept-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001).
Maltese: Fi studju 4, il-grupp ikkurat b'etanercept kellu proporzjon ogħla ta' pazjenti b'PASI 75 f'ġimgħa 12 (38%) meta mqabbel mal-grupp ikkurat bil-plaċebo (2%) (p < 0.0001).
English: 4 pre-filled SensoReady pens
Maltese: Il-pinna Erelzi SensoReady tiegħek
English: Baseline Week 52
Maltese: Linja bażi Ġimgħa 52
English: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Maltese: toraċiċi u medjastinali pnewmonite u fibrożi pulmonari)*
English: Erelzi 25 mg injection etanercept SC
Maltese: Erelzi 25 mg injezzjoni etanercept SC
English: scaly or hard.
Maltese: Armi l għatu tal-labra.
English: L-Lysine hydrochloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
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 il-pazjenti 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: 39.8% †, ϕ
Maltese: 16.7% 22.0% 39.8% †, Φ
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, tal pulmun, tal-ġilda u glandoli limfatiċi (limfoma).
English: The other ingredients are: citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: Is-sustanzi l-oħra huma: citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: Placebo (N = 105)
Maltese: (N = 105)
English: Other medicines and Erelzi
Maltese: Mediċini oħra u Erelzi
English: How to store Erelzi
Maltese: Tużax Erelzi
English: Placebo (n = 104)
Maltese: (n = 104)
English: 25 mg BIW
Maltese: Erelzi 25 mg
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55)
Maltese: 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: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including etanercept.
Maltese: Kanċer tal-ġilda melanoma u mhux melanoma (NMSC) kienu rrappurtati f'pazjenti kkurati b'antagonisti ta' TNF, li jinkludu etanercept.
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 a 2-year active-controlled 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: Clearance is approximately 0.066 l/hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/hr observed in healthy volunteers.
Maltese: madwar 0.066 l/h f'pazjenti bl-artrite rewmatojde, xi ftit aktar baxxa minn dik ta' 0.11 l/h osservata f'voluntiera b'saħħithom.
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Maltese: Ir-rata aġġustata għall-espożizzjoni kienet ta' 0.06 avvenimenti kull 100 sena ta' ħajja tal-pazjenti.
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 jiżnu 62.5 kg jew aktar.
English: Multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes or pre-filled pens or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes of Erelzi.
Maltese: Pakketti multipli fihom 12 (3 pakketti ta' 4) siringi mimlija għal-lest jew pinen mimlija għal-lest ta' 25 mg jew 50 mg jew 8 (2 pakketti ta' 4) jew 24 (6 pakketti ta' 4) siringa mimlija għal-lest ta' 25 mg ta' Erelzi.
English: Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.
Maltese: Pakkett multiplu: 12-il siringi mimlija għal-lest (3 pakketti ta' 4) bi protezzjoni tal-labra
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 placebo-treated 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: 50 mg BIW
Maltese: Erelzi 50 mg
English: EU/1/17/1195/008 12 pre-filled syringes
Maltese: EU/1/17/1195/008 12-il siringa mimlija għal-lest
English: Multipack: 12 (3 packs of 4) pre-filled SensoReady pens.
Maltese: Pakkett multiplu: 12-il pinna SensoReady mimlija għal-lest (3 pakketti ta' 4)