FrancophonIA/ELRC3.0 huggingface dataset:
English: What EndolucinBeta looks like and contents of the pack
Maltese: Kif jidher EndolucinBeta u l-kontenut tal-pakkett
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Maltese: L-esponiment għar-radjazzjoni jonizzanti huwa marbut mal-induzzjoni tal-kanċer u mal-possibbiltà li jiżviluppaw difetti ereditarji.
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Lutetium (177Lu) to the radiation dose following the administration of a Lutetium (177Lu)-labelled medicinal product or resulting from an accidental intravenous injection of EndolucinBeta.
Maltese: It-tabella tad-dożimetrija ta' hawn taħt hija ppreżentata sabiex jiġi vvalutat il-kontribut ta' Lutetium (177Lu) mhux konjugat għad-doża ta' radjazzjoni wara l-għoti ta' prodott mediċinali ttikkettat b'Lutetium (177Lu) jew li tirriżulta wara l-injezzjoni aċċidentali ta' EndolucinBeta ġol-vina.
English: Each pack contains 1 vial placed into a lead container for protective shielding and packed in a metallic can and an outer carton.
Maltese: Kull pakkett fih kunjett wieħed impoġġi f'kontenitur taċ-ċomb għall-ilqugħ protettiv u ppakkjat f'landa metallika u kartuna ta' barra.
English: Due to the capacity of the chelating ligands (DTPA, EDTA) of forming water soluble complexes, the complexes and bound Lutetium (177Lu) are rapidly eliminated by the kidneys.
Maltese: Minħabba l-kapaċità tal-ligands kelanti (DTPA, EDTA) ta' kumplessi li jdubu fl-ilma li jiffurmaw, il-kumplessi u Lutetium (177Lu)
English: Treatment with Lutetium (177Lu) radioligand therapy may lead to the following side effects - a reduced number of red blood cells (anaemia) - a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding - a reduced number of white blood cells (leukopenia, lymphopenia or neutropenia) which are important for protecting the body against infection
Maltese: It-trattament b'terapija ta' radjuligand ta' Lutetium (177Lu) jista' jwassal għall-effetti sekondarji li ġejjin - għadd imnaqqas ta' ċelluli ħomor tad-demm (anemija) - għadd imnaqqas ta' plejtlits fid-demm (tromboċitopenija) li huma importanti biex twaqqaf l emorraġija
English: The absolute bioavailability is 76%.
Maltese: Il-bijodisponibiltà assoluta hi ta' 76%.
English: Sepsis or risk of sepsis.
Maltese: Sepsis jew riskju ta' sepsis.
English: Placeb o
Maltese: Plaċeb o
English: Common to < 1/10
Maltese: Komuni sa < 1/10
English: • The risk of opportunistic infections and tuberculosis (TB)
Maltese: • Ir-riskju ta' infezzjonijiet opportunistiċi u tuberkulożi (TB)
English: 2616 LR Delft The Netherlands
Maltese: 2616 LR Delft L-Olanda
English: The osmolality of the solution is 325 ± 35 mOsm/kg.
Maltese: L-osmolalità tas-soluzzjoni hi ta' 325 ± 35 mOsm/kg.
English: Rare ≥ 1/10,000 to
Maltese: Rari ≥ 1/10,000 sa
English: Hepatitis B reactivation, listeria
Maltese: Riattivazzjoni talepatite B, listeria
English: Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Maltese: Il-pazjenti kienu kkurati qabel b'NSAIDs (86%), DMARDs (80%), u kortikosterojdi (24%).
English: Samsung BioLogics Co., Ltd. 300, Songdo bio-daero Yeonsu-gu, Incheon City, 21987, Korea, Republic of
Maltese: 300, Songdo bio-daero Yeonsu-gu, Incheon City, 21987, ir-Repubblika tal-Korea
English: Etanercept n = 103 to 105*
Maltese: Etanercept n = 103 sa 105*
English: Uveitis, scleritis
Maltese: Uveite, sklerite
English: Date:
Maltese: Data:
English: ACR Responsesa
Maltese: Risponsi ACR
English: Biogen (Czech Republic) s.r.o.
Maltese: Česká republika Biogen (Czech Republic) s.r.o.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU -BARCODE 2D
English: Response
Maltese: Risponsi
English: 36 months.
Maltese: 36 xahar.
English: 79 (75%)a sPGA “clear” or “minimal”, n (%)
Maltese: a sPGA “ċara” jew “minima”, n (%)
English: Abbreviation: sPGA-static Physician Global Assessment a p < 0.0001 compared with placebo
Maltese: Taqsira: sPGA-static Physician Global Assessment a p < 0.0001 meta mqabbel mal-plaċebo
English: Placebo n = 106 to 109*
Maltese: Plaċebo n = 106 sa 109*
English: Benepali contains the active substance, etanercept.
Maltese: Benepali fih is-sustanza attiva, etanercept.
English: Very Rare
Maltese: Rari Ħafna
English: Wegener's granulomatosis
Maltese: Granulomatożi ta' Wegener
English: Etanercept 0.8 mg/kg Once Weekly (N = 106)
Maltese: Etanercept 0.8 mg/kg Darba filĠimgħa (N = 106)
English: 196 n = 46 n =
Maltese: n = 196 n = 46 n = 96 n = 90
English: Benepali is a biosimilar medicinal product.
Maltese: Benepali hu prodott mediċinali bijoloġiku simili.
English: 50 mg/1 ml
Maltese: INDIVIDWALI 50 mg/1 mL
English: Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Maltese: Etanercept fih 934 amino aċidi u għandu toqol molekulari apparenti ta' bejn wieħed u ieħor 150 kilodaltons.
English: Component of a multipack, cannot be sold separately
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament
English: Serious allergic/anaphyla ctic reactions (including angioedema, bronchospasm), sarcoidosis
Maltese: Reazzjonijiet allerġiċi/anafilattiċi serji (inklużi anġjoedema, bronkospażmu), sarkojdożi
English: Placebo n = 139
Maltese: Plaċebo n = 139
English: 25 mg/0.5 ml
Maltese: INDIVIDWALI 25 mg/0.5 ml
English: Histiocytosis haematophagic (macrophage activation syndrome)*
Maltese: Istijoċitożi ematofaġika (sindrome ta' attivazzjoni talmakrofagu)*
English: Biogen Slovakia s.r.o.
Maltese: Slovenská republika Biogen Slovakia s.r.o.
English: Toxic epidermal necrolysis
Maltese: Nekrolisi epidermali tossika
English: Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.
Maltese: Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, ilma għall-injezzjonijiet.
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received etanercept.
Maltese: F'sett ta' dejta miġbura ta' provi kliniċi, l-inċidenza totali ta' infezzjonijiet opportunistiċi kienet ta' 0.09% għal 15,402 persuna li rċivew etanercept.
English: Immunosuppression
Maltese: Immunosoppressjoni
English: 28b a p < 0.001, etanercept vs. placebo b p = 0.002, etanercept vs. placebo
Maltese: 6 xhur b a p < 0.001, etanercept vs. plaċebo b p = 0.002, etanercept vs. plaċebo
English: There may be new information.
Maltese: Jista' jkun hemm informazzjoni ġdida.
English: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Water for injections
Maltese: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Ilma għall-injezzjonijiet
English: - The other ingredients are sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate,
Maltese: - Is-sustanzi l-oħra huma sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate,
English: • The risk of Congestive Heart Failure (CHF)
Maltese: • Ir-riskju ta' Insuffiċjenza Konġestiva tal-Qalb (Congestive Heart Failure, CHF)
English: Date of first authorisation: 14 January 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 Jannar 2016
English: Placebo (N = 105)
Maltese: Plaċebo (N = 105)
English: This appearance is normal for Benepali.
Maltese: Din id-dehra hi normali għal Benepali.
English: Responses of patients with psoriasis in studies 2, 3 and 4
Maltese: Risponsi ta' pazjenti bi psorjasi fi studji 2, 3 u 4
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Biogen Belgium NV/S.A
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Maltese: Sindrome ta' Stevens-Johnson, vaskulite tal-ġilda (li tinkludi vaskulite b'sensittività eċċessiva), eritema multiforme, Reazzjonijiet likenojdi
English: Etanercepta n = 101
Maltese: Etanercept a n = 101
English: c Remission is defined as DAS <1.6.
Maltese: Tnaqqis fil-mard hu definita bħala DAS < 1.6
English: Placebo (n = 104)
Maltese: Plaċebo (n = 104)
English: Worsening of symptoms of dermatomyositi s
Maltese: Aggravar tas-sintomi ta' dermatomijosite
English: Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød Denmark
Maltese: Biogen (Denmark) Manufacturing ApS Biogen Allé 1
English: EU/1/15/1074/006 multipack of 8 pre-filled syringes (2 packs of 4) EU/1/15/1074/007 multipack of 24 pre-filled syringes (6 packs of 4)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1074/006 pakkett multiplu ta' 8 siringi mimlija għal-lest (2 pakketti ta' 4) EU/1/15/1074/007 pakkett multiplu ta' 24 siringa mimlija għal-lest (6 pakketti ta' 4)
English: Methotrexate Etanercept Etanercept + Methotrexate
Maltese: METODU TA' KIF GĦANDU JINGĦATA
English: • moderate or severe psoriasis.
Maltese: • psorjasi moderata jew severa.
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Maltese: Tromboċitopenija, anemija, lewkopenja, newtropenja
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Maltese: Immunosoppressanti, Inibituri alpha tal-Fattur tan-Nekrożi tat-Tumur (TNF-α), Kodiċi ATC:
English: Uncommon ≥ 1/1,000 to
Maltese: Mhux Komuni ≥ 1/1,000 sa
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.
Maltese: 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: Tabulated list of adverse reactions
Maltese: Tabella b'lista ta' avvenimenti avversi
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
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 tas-sinsla skont il-Grad Radjoloġiku ta' New York modifikat, indikattiv ta' spondiloartropatija assjali.
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Maltese: Reazzjonijiet allerġiċi; deni; raxx; ħakk; antikorpi diretti kontra tessut normali (il-formazzjoni ta' awto-antikorpi).
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: Ewopharma AG Representative Office
Maltese: România Ewopharma AG Representative Office
English: Multipack: 8 (2 packs of 4) pre-filled syringes Multipack: 24 (6 packs of 4) pre-filled syringes
Maltese: Pakkett multiplu: 8 (2 pakketti ta' 4) siringi mimlija għal-lest Pakkett multiplu: 24 (6 pakketti ta' 4) siringa mimlija għal-lest
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Maltese: Vaskulite (inkluż vaskulite pożittiva tal-antikorpi ċitoplażmika antinewtrofilika)
English: Biogen Pharma d.o.o.
Maltese: Hrvatska Ewopharma d.o.o
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, irreġjuni CH2 u CH3 iżda mhux ir-reġjun CH1 ta' IgG1.
English: Step 5:
Maltese: Pass 5:
English: Antibodies to etanercept
Maltese: Antikorpi għal etanercept
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Maltese: Infezzjonijiet serji (inklużi pnewmonja, ċellulite, artrite batterjali, sepsis u infezzjoni parasitika)*
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Maltese: Lupus erythematosus talġilda, lupus erythematosus sotto-akut tal-ġilda, sindrome simili għal-lupus
English: Serious allergic reactions are rare.
Maltese: Reazzjonijiet allerġiċi serji huma rari.
English: Name and address of the manufacturer of the biological active substance Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Biogen (Denmark) Manufacturing ApS Biogen Allé 1
English: Study 2
Maltese: Studju 2
English: This may include a thorough medical history, a chest X-ray and a tuberculin test.
Maltese: Dan jista' jinkludi storja medika dettaljata, X-ray tas-sider u test tat-tuberculin.
English: Pancytopenia* Aplastic anaemia*
Maltese: APanċitopenija* Anemija aplastika*
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.
Maltese: 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: Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Maltese: Studju 4 evalwa 142 pazjent u kellu kriterji simili tal-inkluzjoni bħal studji 2 u 3.
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 nonmelanoma 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 ta' sa 2.5 snin, 30 malinni u 43 kanċer tal-ġilda li mhux melanoma kienu rrappurtati.
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.
Maltese: 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 tal-awrina, vaskulite, u infezzjoni fil-feriti.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept (see section 4.8).
Maltese: Infezzjonijiet serji, sepsis, tuberkulożi, u infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, listeriosis u legionellosis, kienu rrappurtati bl-użu ta' etanercept (ara sezzjoni 4.8).
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).
Maltese: 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 tal-Artrite Psorjatika (PsARC).
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).
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: 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.
Maltese: (1) involviment distali interfalanġejali (DIP); (2) artrite poliartikulari (nuqqas ta' nodulirewmatojdi u l-preżenza ta' psorjasi); (3) artrite mutilans; (4) artrite psorjatika asimmetrika; jew (5) ankilożi li tixbah lill-ispondilite.
English: Study 4
Maltese: Studju 4
English: Opportunistic infections have been reported in association with etanercept, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Maltese: Infezzjonijiet opportunistiċi kienu rrappurtati b'rabta ma' etanercept, li jinkludu infezzjonijiet fungali invażivi, parasitiċi (inkluż protożoali), virali (inkluż ħerpes zoster), batterjali (li jinkludu Listeria u Legionella), u infezzjonijiet mikobatterjali atipiċi.
English: Autoimmune hepatitis*
Maltese: Epatite awtoimmunitarja*
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 talkonċentrazzjonijiet minimi fis-serum fl-istat fiss varjat minn 1.6 sa 2.1 mcg/mL f'ġimgħat 12, 24, u 48.
English: 70b a 25 mg etanercept SC twice weekly b p < 0.001, etanercept vs. placebo c p < 0.01, etanercept vs. placebo
Maltese: 25 mg ta' etanercept taħt il-ġilda darbtejn f'ġimgħa b p < 0.001, etanercept vs. placebo c p < 0.01, etanercept vs. placebo
English: • psoriatic arthritis; • severe axial spondyloarthritis including ankylosing spondylitis;
Maltese: • spondiloartrite assjali severa li tinkludi ankylosing spondylitis;
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
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: 33.0a
Maltese: 3 xhur a
English: Malignant melanoma (see section 4.4),
Maltese: Melanoma malinna (ara sezzjoni 4.4), limfoma, lewkimja
English: These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Maltese: Dawn linfezzjonijiet kienu kkawżati minn batterji, mikobatterji, fungi, viruses u parassiti (inkluż protożoa).
English: Benepali is a medicine that is made from two human proteins.
Maltese: Benepali hu mediċina magħmula minn żewġ proteini umani.
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: 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'etanercept imqabbel ma' 4% tal-pazjenti kkurati bil-plaċebo) u minn assaġġ bi Crithidia luciliae (3% tal-pazjenti kkurati b'etanercept imqabbel mal-ebda pazjent ikkurat bil-plaċebo).
English: ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses).
Maltese: Ir-risponsi tal-ACR 20 u 50 kienu ogħla f'pazjenti li ġew ikkurati b'etanercept għal 3 xhur u 6 xhur milli minn f'pazjenti kkurati bil-plaċebo (ACR 20: etanercept 62% u 59%, plaċebo 23% u 11% wara 3 u 6 xhur rispettivament:
English: Step 2:
Maltese: Pass 2:
English: With continued therapy, responses were maintained up to 48 weeks.
Maltese: Mat-tkomplija tat-terapija, irrisponsi nżammu sa 48 ġimgħa.
English: Axial spondyloarthritis
Maltese: Spondiloartrite assjali
English: In adults (aged 18 and over), Benepali can be used for:
Maltese: Fl-adulti (ta' 18-il sena jew aktar), Benepali jista' jintuża għal:
English: In a group of 7,416 patients treated with etanercept in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Maltese: Fi grupp ta' 7,416-il pazjent ikkurati b'etanercept fi provi kliniċi li kellhom artrite rewmatojde, artrite psorjatika, ankylosing spondylitis u psorjasi, 18-il limfoma kienu rrappurtati.
English: Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
Maltese: Artrite psorjatika, ankylosing spondylitis u spondiloartrite assjali mhux radjografika
English: In another open-label single-arm study, 60 patients with extended oligoarthrits (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 psorjatika (12 sa 17-il sena) ġew ikkurati b'etanercept f'doża ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) mogħtija kull ġimgħa għal 12-il ġimgħa.
English: Study 3
Maltese: Studju 3
English: Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections and Legionella)*
Maltese: Tuberkulożi, infezzjonijiet opportunistiċi (li jinkludu infezzjonijiet fungali invażivi, protożoali, batterjali, mikobatterjali atipiċi, virali u Leġjonella)*
English: Step 4:
Maltese: Pass 4:
English: Worsening of cardiac failure congestive (see section 4.4)
Maltese: Iggravar ta' insuffiċjenza kardijaka konġestiva (ara sezzjoni 4.4).
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: 25 m g
Maltese: 25 mg.
English: n = 166 n =
Maltese: n = 46 n = 96 n = 90