FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
Maltese: Total ta' 2 tumuri malinni kienu rrappurtati fi studji kliniċi li damu bejn wieħed u ieħor sentejn li involvew 240 pazjenti b'artrite psorjatika kkurati b'Enbrel.
English: Enbrel 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: Enbrel 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: • The risk of Congestive Heart Failure (CHF).
Maltese: • Ir-riskju ta' Kollass Konġestiv tal-Qalb (CHF).
English: CARTON TEXT - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
Maltese: KITBA FUQ IL-KARTUNA - EU/1/99/126//013-015, EU/1/99/126/026 (Siringa mimlija għal-lest 25 mg)
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Enbrel.
Maltese: • Mard infjammatorju tal-imsaren (IBD): Kien hemm każijiet ta' IBD f'pazjenti b'artrite idjopatika taż-żgħażagħ (JIA) ikkurati b'Enbrel.
English: Paediatric plaque psoriasis (age 6 years and above)
Maltese: Psorjasi pedjatrika tal-plakka (mill-età ta' 6 snin 'il fuq)
English: Long-term safety of Enbrel monotherapy (n=103), Enbrel 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' Enbrel (n=103), Enbrel 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: Inject slowly, at an angle of 45° to 90° to the skin.
Maltese: Injetta bil-mod, f'angolu ta' 45° sa 90° minn mal-ġilda.
English: In study 4, the Enbrel-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'Enbrel kellu proporzjon ogħla ta' pazjenti b'PASI 75 f'ġimgħa 12 (38%) meta mqabbel mal-grupp ikkurat bil-plaċebo (2%) (p<0.0001).
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: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Maltese: Kura ta' adulti bi psorjasi tal-plakka minn moderata sa severa li ma rreaġixxewx għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapija sistemika oħra inkluż ciclosporin, methotrexate jew psoralen u dawl ultravjola A (PUVA) (ara sezzjoni 5.1).
English: n = 166 wk 12
Maltese: n = 162 ġimgħ a 24
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (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' Enbrel (n=57) jew plaċebo (n=55) darbtejn fil-ġimgħa għal 24 ġimgħa.
English: Diagram 12
Maltese: Dijagramma 12
English: When reconstituted, the solution contains 10 mg/ml of etanercept.
Maltese: Meta rekostitwita is-soluzzjoni jkun fiha 10 mg/ml ta' etanercept.
English: Each pack contains 4, 8 or 24 pens and 4, 8 or 24 alcohol swabs.
Maltese: Kull pakkett fih 4, 8 jew 24 pinna u 4, 8 jew 24 swab bl-alkoħol.
English: Infect ions and infestations
Maltese: Infezzjonijiet u infestazzjonijiet
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 nonsteroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Maltese: Kienu studjati pazjenti ta' 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: 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% talpazjenti, 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: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinat ing event s, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropat hy, and multifocal motor neuropathy (see section 4.4), seizure
Maltese: Avvenimenti bit-telf tal-majelin tas-CNS li jissuġġerixxu sklerosi multipla jew kundizzjonijiet bittelf tal-majelin lokalizzati bħal newrite ottika u majelite transversa (ara sezzjoni 4.4), każijiet ta' telf talmajelin periferali, li jinkludu s-sindrome ta' Guillain-Barré, polinewropatija infjammatorja kronika bit-telf talmajelin, polinewropatija bittelf tal-majelin, u newropatija multifokali talmoviment (ara sezzjoni 4.4), konvulżjoni
English: Each pack contains 4 vials, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Maltese: Kull pakkett fih 4 kunjetti, 4 siringi mimlija għal-lest bl-ilma għall-injezzjonijiet, 4 labar, 4 adapters tal-kunjetti u 8 swabs bl-alkoħol.
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 Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 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'Enbrel fi provi kliniċi għal madwar bejn wieħed u ieħor 6 snin, li kienu jinkludu 231 pazjent ikkurati b'Enbrel flimkien ma' methotrexate fl-istudju b'kontroll attiv li dam sentejn.
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Maltese: L-impatt ta' l-età avvanzata kien studjat f'analiżi farmakokinetika ta' konċentrazzjonijiet ta' etanercept fis-serum f'populazzjoni ta' età avvanzata.
English: ASAS 70 2 weeks
Maltese: ASAS 70
English: The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate.
Maltese: L-effikaċja ta' Enbrel tqabblet ma' methotrexate fi studju randomised, ikkontrollat attivament b'evalwazzjonijiet radjografiċi blinded bħala endpoint primarju fi 632 pazjent adult bl-artrite rewmatojde attiva (għal < 3 snin) u li qatt ma kienu ħadu kura b'methotrexate.
English: 8 alcohol swabs
Maltese: 8 swabs ta' l-alkoħol
English: Enbrel is not recommended for the treatment of Wegener's granulomatosis.
Maltese: Enbrel mhuwiex rakkomandat għall-kura ta' granulomatożi ta' Wegener.
English: Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis.
Maltese: Il-fattur nekrotiku tat-tumur (TNF) hu cytokine dominanti fil-proċess infjammatorju ta' l-artrite rewmatojde.
English: A 50 mg strength of Enbrel is available for doses of 50 mg.
Maltese: Qawwa ta' 50 mg hija disponibbli għal dożi ta' 50 mg.
English: Patients treated with Enbrel should be given the Patient Alert Card.
Maltese: Pazjenti kkurati b'Enbrel għandhom jingħataw Patient Alert Card.
English: Diagram 3.
Maltese: Dijagramma 3
English: CARTON TEXT - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
Maltese: KITBA FUQ IL-KARTUNA - EU/1/99/126//016-018 (Siringa mimlija għal-lest 50 mg)
English: Dosing for adult patients (aged 18 years or over)
Maltese: Doża għal pazjenti adulti (ta' 18-il sena jew aktar)
English: Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Maltese: Diversi tumuri malinni kienu wkoll irrappurtati bl-użu ta' Enbrel, inkluż kanċer tas-sider, tal-pulmun, tal-ġilda u glandoli limfatiċi (limfoma).
English: Do NOT push down the adaptor at an angle (see Diagram 4).
Maltese: TIMBUTTAX l-adapter 'l isfel b'mod angolat (ara Dijagramma 4).
English: Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator).
Maltese: Injetta s-soluzzjoni meta tkun laħqet it-temperatura ambjentali tal-kamra (15 sa 30 minuta wara li tkun ħriġt il-prodott minn ġol-friġġ).
English: The safety and efficacy of 50 mg Enbrel (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 Enbrel (żewġ injezzjonijiet 25 mg taħt il-ġilda) mogħtija darba filġimgħa kienu evalwati fi stħarriġ double-blind, ikkontrollat bil-plaċebo fuq 420 pazjent b'RA attiva.
English: The efficacy of Enbrel versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing Enbrel with other systemic therapies.
Maltese: L-effikaċja ta' Enbrel 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 Enbrel direttament ma' terapiji sistemiċi oħrajn.
English: Serious and fatal infections have been reported during use of Enbrel; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Maltese: Infezzjonijiet serji u fatali kienu rrappurtati wara li Enbrel beda jintuża; patoġeni rrappurtati jinkludu batterji, mikobatterji (inkuż it-tuberkolosi), viruses u fungi.
English: Cartons contain 4, 8 or 24 vials of Enbrel with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Maltese: Il-kaxxi tal-kartun fihom 4, 8 jew 24 kunjetti ta' Enbrel b'4, 8 jew 24 siringa mimlija għal-lest bissolvent, 4, 8 jew 24 labra, 4, 8 jew 24 adapter tal-kunjett bi 8, 16 jew 48 swab bl-alkoħol.
English: 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors
Maltese: 4 siringi mimlija għal-lest b'1 ml ta' solvent 4 labar ta' l-istainless steel għall-injezzjoni 4 adapters tal-kunjetti
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: Listudju evalwa 234 pazjent adult li kellhom artrite rewmatojde attiva, u li fihom minn ta' l-inqas ma ħadmitx mediċina waħda, iżda mhux aktar minn erba' mediċini anti-rewmatiċi li jimmodifikaw ilmarda (DMARDs).
English: A 25 mg strength of Enbrel is available for doses of 25 mg.
Maltese: Qawwa ta' 25 mg hija disponibbli għal dożi ta' 25 mg.
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Maltese: Infezzjonijiet serji seħħew f'6.3% tal-pazjenti b'artrite rewmatojde kkurati b'Enbrel sa 48 xahar.
English: 8 MYCLIC pre-filled pens 8 alcohol swabs
Maltese: 8 pinen MYCLIC mimlija għal-lest 8 swabs ta' l-alkoħol
English: (n = 231) a: Patients who did not complete 12 months in the study were considered to be non-responders.
Maltese: 52 Ġimgħa a: Pazjenti fl-istudju li ma komplewx 12-il xahar kienu kkunsidrati li ma rrispondewx.
English: 70b a: 25 mg Enbrel SC twice weekly b: p < 0.001, Enbrel vs. placebo c: p < 0.01, Enbrel vs. placebo
Maltese: Is-sitt xahar a: 25 mg ta' Enbrel taħt il-ġilda darbtejn f'ġimgħa b: p < 0.001, Enbrel vs. plaċebo c: p < 0.01, Enbrel vs. plaċebo
English: Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
Maltese: Kienu rrappurtati diversi avvenimenti avversi inklużi l-ġidri r-riħ b'sinjali u sintomi ta' meninġite asettika li kienu mfejqa mingħajr sintomi wara l-marda (ara wkoll sezzjoni 4.4.), appendiċite, gastroenterite, dipressjoni/disturb tal-personalità, ulċera fil-ġilda, esofaġite/gastrite, xokk settiku minn streptokokku tat-tip A, dijabete mellitus ta' tip I, u infezzjoni fit-tessut l-artab u fil-ferita wara l-operazzjoni.
English: With continued therapy, responses were maintained up to 48 weeks.
Maltese: Mat-tkomplija tat-terapija, ir-risponsi nżammu sa 48 ġimgħa.
English: The efficacy of Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg Enbrel with placebo.
Maltese: L-effikaċja ta' Enbrel f'ankylosing spondylitis kienet evalwata fi 3 studji randomised, double-blind li qabblu l-għoti ta' 25 mg Enbrel darbtejn fil-ġimgħa mal-plaċebo.
English: Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Maltese: Kunjett ta' ħġieġ ċar (4 ml, ħġieġ ta' tip I) b'tappijiet tal-lastku, siġilli tal-aluminju, u għatjien talplastik flip-off.
English: There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Maltese: Kien hemm 4 rapporti tas-sindrome ta' l-attivazzjoni tal-makrofagu fi provi kliniċi dwar l-artrite idjopatika taż-żgħażagħ.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all Enbrel-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'Enbrel kien 4.64 għall-SIJ (n=153) u 1.40 is-sinsla (n=154).
English: 28b a: p <0.001, Enbrel vs.
Maltese: Ġimagħtejn 3 xhur 6 xhur a: p<0.001, Enbrel vs.
English: ASAS 50 2 weeks
Maltese: ASAS 50
English: A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
Maltese: Rata ogħla ta' difetti kbar mattwelid kienet osservata fi studju ta' osservazzjoni wieħed li jqabbel it-tqaliet esposti għal etanercept matul l-ewwel trimestru, ma' tqaliet mhux esposti għal etanercept (n=370) jew antagonisti oħrajn ta' TNF (n=164) (proporzjon ta' probabbiltà aġġustat 2.4, 95% CI: 1.0-5.5).
English: Elevat ed liver enzymes*
Maltese: Żieda fl-enżimi talfwied*
English: The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Maltese: L-effikaċja ta' Enbrel kienet evalwata fi studju randomised, double-blind u kkontrollat bil-plaċebo.
English: Enbrel was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Maltese: Enbrel kien ikkunsidrat li mhuwiex ġenotossiku minn serje ta' studji in vitro u in vivo.
English: Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Maltese: Radjografiji ta' l-idejn u lpolzijiet inkisbu fil-linja bażi u wara 6, 12, u 24 xahar.
English: Each vial contains 10 mg of etanercept.
Maltese: Kull kunjett fih 10 mg ta' etanercept.
English: Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Maltese: Infezzjonijiet serji li seħħew f'pazjenti kkurati b'Enbrel, kienu jinkludu ċellulite, gastroenterite, pnewmonja, koleċistite, osteomajelite, gastrite, appendiċite, faxxite Streptokokkali, mijosite, xokk settiku, divertikulite u axxess.
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs. methotrexate, † = p < 0.05 for comparisons of Enbrel + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs. Enbrel.
Maltese: Paragun f'pari tal-valuri p: * = p < 0.05 għall-paragun ta' Enbrel vs. methotrexate, † = p < 0.05 għall-paraguni ta' Enbrel + methotrexate vs. methotrexate u  = p < 0.05 għall-paraguni ta' Enbrel + methotrexate vs.
English: Responses were measured using 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: Diagram 2
Maltese: Dijagramma 2
English: After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 µg/ml, and the area under the curve was 235 ± 96.6 µg•hr/ml.
Maltese: Wara doża waħda taħt il-ġilda ta' 25 mg ta' Enbrel, il-medja talkonċentrazzjoni massima fis-serum osservata f'voluntiera b'saħħithom kienet ta' 1.65  0.66 g/ml, u l-erja ta' taħt il-kurva kienet ta' 235  96.6 μg•h/ml.
English: 8 pre-filled syringes 8 alcohol swabs
Maltese: 8 siringi mimlija għal-lest 8 swabs ta' l-alkoħol
English: Each pack contains 2, 4 or 12 pens and 2, 4 or 12 alcohol swabs.
Maltese: Kull pakkett fih 2, 4 jew 12-il pinna u 2, 4 jew 12-il swab bl-alkoħol.
English: The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Maltese: Ilvolum ċentrali tad-distribuzzjoni ta' etanercept hu ta' 7.6 l, waqt li l-volum tad-distribuzzjoni fl-istat fiss hu ta' 10.4
English: Pfizer Kft. Tel: +36 1 488 3700
Maltese: Tel: +36 1 488 3700
English: The efficacy of Enbrel in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Maltese: L-effikaċja ta' Enbrel f'pazjenti bi spondiloartrite assjali mhux radjografika (nr-AxSpa) ġiet evalwata fi studju każwali, double-blind u kkontrollat bil-plaċebo ta' 12-il ġimgħa.
English: EU/1/99/126/013 4 pre-filled syringes EU/1/99/126/014 8 pre-filled syringes EU/1/99/126/015 24 pre-filled syringes EU/1/99/126/026 12 pre-filled syringes
Maltese: EU/1/99/126/013 4 siringi mimlijin għal-lest EU/1/99/126/014 8 siringi mimlijin għal-lest EU/1/99/126/015 24 siringa mimlija għal-lest EU/1/99/126/026 12-il siringa mimlija għal-lest
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 Enbrel (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'Enbrel (11%) milli minn pazjenti li kienu kkurati bil-plaċebo (5%).
English: EU/1/99/126/003 4 vials EU/1/99/126/004 8 vials EU/1/99/126/005 24 vials
Maltese: EU/1/99/126/003 4 kunjetti EU/1/99/126/004 8 kunjetti EU/1/99/126/005 24 kunjett
English: The double-blind period was followed by an open-label period during which all patients receive Enbrel 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 Enbrel 50 mg fil-ġimgħa sa 92 ġimgħa addizzjonali.
English: Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Maltese: Kull kunjett ta' Enbrel 25 mg fih 25 mg ta' etanercept.
English: Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.
Maltese: 2 f'pazjenti bi psorjasi tal-plakka klinikament stabbli imma attiva li tinvolvi  10% tal-erja tal-wiċċ tal-ġisem li kellhom  18-il sena.
English: In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs. 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebocontrolled study of 356 patients with active ankylosing spondylitis.
Maltese: Fir-raba' studju, is-sigurtà u l-effikaċja ta' 50 mg ta' Enbrel (żewġ injezzjonijiet taħt il-ġilda ta' 25 mg) mogħtija darba fil-ġimgħa vs. 25 mg ta' Enbrel mogħtija darbtejn fil-ġimgħa kienu evalwati fi studju double-blind, ikkontrollat bil-plaċebo ta' 356 pazjent b'ankylosing spondylitis attiva.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website ta' l-Aġenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu.
English: In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Maltese: Fl-istudji kliniċi, ma ġewx osservati interazzjonijiet meta Enbrel ingħata flimkien ma' glukokortikojdi, salicylates (ħlief sulfasalazine), mediċini kontra l-infjammazzjoni li mhumiex sterojdi (NSAIDs), analġesiċi, jew methotrexate.