FrancophonIA/ELRC3.0 huggingface dataset:
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 tal-artrite rewmatojde.
English: Step 3:
Maltese: Pass 3:
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: Τηλ: + 30 211 176 8555
Maltese: Genesis Pharma S.A. Τηλ: + 30 211 176 8555
English: Alcoholic hepatitis
Maltese: Epatite alkoħolika
English: Within the System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Fost il-Klassijiet tas-Sistema tal-Organi, ir-reazzjonijiet avversi huma elenkati skont il-frekwenza (numru ta' pazjenti mistennija li jkollhom ir-reazzjoni) skont dawn il-kategoriji: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Benepali contains sodium
Maltese: Benepali fih is-sodium
English: Rheumatoid arthritis
Maltese: Artrite rewmatojde
English: 37b
Maltese: 3 xhur b
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: The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg.
Maltese: Id-differenzi fit-TSS u JSN ma kinux statistikament sinifikanti bejn methotrexate u etanercept 25 mg.
English: Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Maltese: Kura ta' adulti bi spondiloartrite assjali mhux radjografika severa b'sinjali oġġettivi ta' infjammazzjoni kif indikat minn proteina C-reattiva (CRP) għolja u/jew minn evidenza tal-immaġni tar-reżonanza manjetika (MRI), li kellhom rispons inadegwat għal mediċini anti-infjammatorji mhux sterojdali (NSAIDs).
English: See section 4.4 for vaccination advice.
Maltese: Ara sezzjoni 4.4 dwar pariri fuq it-tilqim.
English: Step 7:
Maltese: Pass 7:
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with etanercept for up to 48 months.
Maltese: Infezzjonijiet serji seħħew f'6.3% tal-pazjenti b'artrite rewmatojde kkurati b'etanercept sa 48 xahar.
English: How to use Benepali
Maltese: Tużax Benepali
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: Reports have included fatal and life-threatening infections and sepsis.
Maltese: Rapporti inkludew infezzjonijiet fatali u ta' theddida għall-ħajja u sepsis.
English: Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Maltese: Meta mqabbla ma' plaċebo, il-kura b'etanercept wasslet għal titjib statistikament sinifikanti fl-ASAS 40, l-ASAS 20 u l-ASAS 5/6.
English: Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Maltese: Etanercept wera titjib akbar li kien statistikament sinifikanti mil-linja bażi sal-ġimgħa 12 meta mqabbel ma' plaċebo f'ħafna mill-valutazzjonijiet tal-kwalità tal-ħajja relatata mas-saħħa u f'valutazzjonijiet tal-funzjoni fiżika, inklużi BASFI (Indiċi Funzjonali Spondilite Ankilosing ta' Bath), il-Punteġġ Globali tal-Istat tas-Saħħa EuroQol 5D u l-Punteġġ tal-Komponent Fiżiku SF-36.
English: 24a
Maltese: ġimgħ a 24
English: These include rare reports of pancytopenia and very rare reports of aplastic anaemia.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenija u rapporti rari ħafna ta' anemija aplastika.
English: A total of 401 patients were enrolled, from which 203 were treated with etanercept.
Maltese: Total ta' 401 pazjent kienu rreġistrati li fosthom 203 kienu kkurati b'etanercept.
English: Step 6:
Maltese: Pass 6:
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, li 39 minnhom kellhom bejn sentejn u 3 snin.
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Maltese: Ir-rata aġġustata għall-esponiment kienet ta' 0.06 avvenimenti kull 100 sena ta' ħajja tal-pazjenti.
English: Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Maltese: Il-proporzjonalità tad-doża ma ġietx evalwata formalment, iżda ma hemm ebda saturazzjoni apparenti ta' eliminazzjoni tul il-medda tad-dożaġġ.
English: At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebotreated patients.
Maltese: F'ġimgħa 24, 56% tal-pazjenti fil-grupp ikkurat b'etanercept kienu kisbu l-PASI 75 meta mqabbla ma' 5% talpazjenti kkurati bil-plaċebo.
English: Pancytopenia and aplastic anaemia
Maltese: Panċitopenija u anemija aplastika
English: Other medicines and Benepali
Maltese: Mediċini oħra u Benepali
English: There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Maltese: Kien hemm ukoll rapporti rari (< 0.1%) ta' bidu mill-ġdid ta' CHF, inkluż CHF f'pazjenti mingħajr mard kardjovaskulari pre-eżistenti.
English: The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Maltese: It-tnaqqis tal-ħsara periferali tal-ġogi kien osservat f'pazjenti b'involviment simmetriku poliartikulari tal-ġogi.
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: Patients with a significant exposure to varicella virus should temporarily discontinue Benepali therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Maltese: Pazjenti b'esponiment sinifikanti għall-virus tal-ġidri r-riħ għandhom iwaqqfu temporanjament it-terapija b'Benepali u jiġu kkunsidrati għall-kura profilattika b'Varicella Zoster Immune Globulin.
English: Paediatric plaque psoriasis
Maltese: Psorjasi pedjatrika tal-plakka
English: The efficacy of etanercept 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' etanercept 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: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Maltese: Infezzjoni (inklużi infezzjoni fissistema respiratorj a ta' fuq, bronkite, ċistite, infezzjoni talġilda)*
English: There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Maltese: Kien hemm 4 rapporti tas-sindrome tal-attivazzjoni tal-makrofagu fi provi kliniċi dwar l-artrite idjopatika taż-żgħażagħ.
English: There is no apparent pharmacokinetic difference between males and females.
Maltese: M'hemm l-ebda evidenza ta' differenza farmakokinetika bejn l-irġiel u n-nisa.
English: HAQ Baseline Week 52
Maltese: Linja bażi ġimgħa 52
English: New onset cardiac failure congestive (see section 4.4)
Maltese: Bidu mill-ġdid ta' insuffiċjenza kardijaka konġestiva (ara sezzjoni 4.4)
English: • Do not inject into scars or stretch marks.
Maltese: • Tinjettax ġo ċikatriċi jew stretch marks.
English: Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Maltese: Terapija kontinwa ta' aktar minn 24 ġimgħa tista' tkun adattata għal xi pazjenti adulti (ara sezzjoni 5.1).
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Maltese: L-impatt tal-età avvanzata kien studjat f'analiżi farmakokinetika ta' konċentrazzjonijiet ta' etanercept fis-serum f'populazzjoni ta' età avvanzata.
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-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'etanercept.
English: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
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 talepatite B (HBV) u li rċivew antagonisti ta' TNF, li jinkludu etanercept.
English: • Benepali is not for use in children and adolescents who weigh less than 62.5 kg.
Maltese: • Benepali mhuwiex għall-użu fit-tfal u adolexxenti li jiżnu inqas minn 62.5 kg.
English: Name and address of the manufacturer responsible for batch release Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Biogen (Denmark) Manufacturing ApS Biogen Allé 1
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 antiinflammatory 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: Serious infections experienced by etanercept-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'etanercept, kienu jinkludu ċellulite, gastroenterite, pnewmonja, koleċistite, osteomajelite, gastrite, appendiċite, faxxite Streptokokkali, mijosite, xokk settiku, divertikulite u axxess.
English: The largest of these trials (n = 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Maltese: L-ikbar numru f'dawn l-istudji (n = 277) kienu pazjenti ta' bejn it-18 u s-70 sena u li kellhom ankylosing spondylitis definita bħala punteġġ fuq liskala analoga viżwali (VAS) ta' ≥ 30 għal medja ta' żmien u intensità ta' ebusija ta' filgħodu flimkien ma' punteġġi VAS ta' ≥ 30 għal mill-inqas 2 minn dawn it-3 parametri li ġejjin: evalwazzjoni globali tal-pazjent; valuri medji tal-VAS għal uġigħ fid-dahar matul il-lejl u wġigħ totali fid-dahar; medja ta' 10 domandi fuq il-Bath Ankylosing Spondylitis Functional Index (BASFI).
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
Maltese: Fi studji kliniċi magħmula għal aktar minn sentejn bi 351 pazjent b'ankylosing spondylitis, 6 tumuri malinni kienu rrappurtati f'pazjenti kkurati b'etanercept.
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon); opportunistic infections (infections that occur because of a weakened immune system); lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Maltese: Reazzjonijiet allerġiċi serji (li jinkludu nefħa lokalizzata qawwija tal-ġilda u tħarħir); limfoma (tip ta' kanċer tad-demm); lewkimja (kanċer li jaffettwa d-demm u l-mudullun); melanoma (tip ta' kanċer tal-ġilda); għadd baxx ta' plejtlits, taċ-ċelluli ħomor u taċ-ċelluli bojod; disturbi tassistema nervuża (b'debbulizza severa fil-muskoli u sinjali u sintomi simili għal dawk ta' sklerożi multipla jew infjammazzjoni tan-nervituri tal-għajnejn jew tal-korda spinali); tuberkolożi; bidu mill-ġdid ta' insuffiċjenza konġestiva tal-qalb; aċċessjonijiet; sindrome ta' lupus jew bħal ta' lupus (is-sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil-ġogi u għeja); raxx tal-ġilda li jista' jwassal għal infafet u tqaxxir sever tal-ġilda; infjammazzjoni talfwied ikkawżata mis-sistema immunitarja stess tal-ġisem (epatite awtoimmunitarja; f'pazjenti li jkunu qed jirċievu wkoll kura b'methotrexate, il-frekwenza hi mhux komuni); disturb fissistema immuni li jista' jaffetwa l-pulmun, il-ġilda u l-glandoli limfatiċi żgħar (sarkojdożi), infjammazzjoni jew ċikatriċi tal-pulmun (f'pazjenti li jkunu qed jirċievu wkoll kura b'methotrexate, il-frekwenza tal-infjammazzjoni jew taċ-ċikatriċi tal-pulmun hi mhux komuni); infezzjonijiet opportunistiċi (infezzjonijiet li jseħħu minħabba sistema immuni mdgħajfa); Reazzjonijiet likenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq ilmembrani mukużi).
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Maltese: L-effikaċja ta' etanercept kienet evalwata fi studju randomised, double-blind, u kkontrollat bil-plaċebo li sar fuq 211-il pazjent pedjatriku bejn l-4 u 17-il sena, li kellhom psorjasi tal-plakka minn moderata sa severa (kif definita minn punteġġ sPGA ta' ≥ 3, li tinvolvi ≥ 10% tal-BSA, u PASI ta' ≥ 12).
English: ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Maltese: ASAS 50 u 70 użaw l-istess kriterji b'titjib ta' 50% jew ta' 70% rispettivament.
English: Percent of Patients Placebo n = 104
Maltese: % ta' Pazjenti Plaċebo n = 104
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Maltese: Fil-provi double-blind u open-label fuq pazjenti b'artrite psorjatika, pazjent wieħed irrapporta infezzjoni serja (pnewmonja).
English: No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.
Maltese: Ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi sinifikanti bejn mediċina u oħra fi studji b'methotrexate, digoxin jew warfarin.
English: Adult patients with ankylosing spondylitis
Maltese: Pazjenti adulti li għandhom ankylosing spondylitis
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: Benepali 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: Benepali 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: Tel.: + 48 22 116 86 94
Maltese: Biogen Poland Sp. z o.o. Tel.: + 48 22 116 86 94
English: Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months.
Maltese: Dożi ta' 10 mg u 25 mg ingħataw taħt il-ġilda (SC) darbtejn f'ġimgħa sa 24 xahar.
English: The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Maltese: Il-maġġoranza tar-rapporti b'riżultat fatali kienu f'pazjenti bi pnewmonja Pneumocystis, infezzjonijiet fungali sistemiċi mhux speċifiċi, u aspergillosi (ara sezzjoni 4.4).
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 matterapija standard (inklużi cyclophosphamide jew methotrexate, u glukokortikojdi) fuq żmien medjan ta' 25 xahar, ma wrietx li etanercept hu kura effettiva għal granulomatożi ta' Wegener.
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Maltese: B'mod alternattiv, 50 mg mogħtija darba fil-ġimgħa, intweriet li hi sigura u effettiva (ara sezzjoni 5.1).
English: Adult patients with psoriatic arthritis
Maltese: Pazjenti adulti b'artrite psorjatika
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
Maltese: Fi studju ieħor ikkontrollat attivament, double-blind u randomised, l-effikaċja klinika, is-sigurtà, u lprogressjoni radjografika f'pazjenti b'RA kkurati b'etanercept waħdu (25 mg darbtejn f'ġimgħa) 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: Plaque psoriasis
Maltese: Psorjasi tal-plakka
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with etanercept.
Maltese: • Mard infjammatorju tal-imsaren (IBD): Kien hemm każijiet ta' IBD f'pazjenti b'artrite idjopatika taż-żgħażagħ (JIA) ikkurati b'etanercept.
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, depressjoni/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: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Maltese: Mard interstizjali tal-pulmun (li jinkludi pnewmonite u fibrożi pulmonari)*
English: A higher rate of major birth defects was observed in an 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 (n = 370) matul l-ewwel trimestru, ma' tqaliet mhux esposti għal etanercept jew antagonisti oħrajn ta' TNF (n = 164) (proporzjon ta' probabbiltà aġġustat 2.4, 95% CI: 1.0 5.5).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI