FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
Maltese: Fi provi kliniċi kkontrollati ta' etanercept fl-indikazzjonijiet kollha, il-frekwenza (il-proporzjon ta' inċidenza) ta' mard interstizjali tal-pulmun f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate konkomitanti kienet ta' 0.06 % (frekwenza rari).
English: The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Maltese: Jekk irċevejt Benepali waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju ogħla li tieħu infezzjoni.
English: In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
Maltese: Fl-ewwel parti tal-istudju, 51 minn 69 (74%) tal-pazjenti wrew rispons kliniku u daħlu għat-tieni parti ta' l-istudju.
English: Benepali treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Maltese: Il-kura b'Benepali għandha tinbeda taħt is-superviżjoni ta' tobba speċjalisti b'esperjenza fid-dijanjosi u fil-kura ta' artrite rewmatojde, artrite idjopatika taż-żgħażagħ, artrite psorjatika, ankylosing spondylitis, spondiloartrite assjali mhux radjografika, psorjasi tal-plakka, jew psorjasi pedjatrika talplakka.
English: Responses observed during the open-label period were similar to those observed in the double-blind period.
Maltese: Ir-risponsi osservati matul il-perjodu open-label kienu simili għal dawk osservati fil-perjodu double-blind.
English: Benepali is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Maltese: Tfal u adolexxenti Benepali mhuwiex indikat għall-użu fi tfal u adolexxenti li jiżnu inqas minn 62.5 kg.
English: Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 513 33 33
Maltese: Biogen Spain, S.L. Tel: + 34 931 790 519
English: Patients should be evaluated for infections before, during, and after treatment with Benepali, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Maltese: Il-pazjenti għandhom ikunu evalwati għal infezzjonijiet qabel, matul, u wara l-kura b'Benepali, u trid tkun ikkunsidrata li l-medja tal-half-life tal-eliminazzjoni ta' etanercept hi ta' madwar 70 siegħa (medda ta' 7 sa 300 siegħa).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Benepali is available in packs containing 4 pre-filled pens and multipacks containing 12 (3 packs of 4) pre-filled pens.
Maltese: Benepali hu disponibbli f'pakketti li fihom 4 pinen mimlija għal-lest u pakketti multipli li fihom 12-il (3 pakketti ta' 4) pinna mimlija għal-lest.
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: It-tneħħija hi ta' 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: Solid and haematopoietic malignancies (excluding skin cancers) Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Maltese: Tumuri malinni solidi u ematopojetiċi (li jeskludu kankrijiet tal-ġilda) Rapporti ta' diversi tumuri malinni (li jinkludu karċinoma tas-sider u tal-pulmun u limfoma) kienu rrappurtati fil-perjodu ta' wara l-bejgħ tal-prodott mediċinali (ara sezzjoni 4.8).
English: TSS
Maltese: DSGA
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mg × hr/l vs. 316 mg × hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept twice weekly (n = 16), respectively.
Maltese: 316 mg × h/L għal 50 mg etanercept darba fil-ġimgħa (n = 21) vs. 25 mg etanercept darbtejn fil-ġimgħa (n = 16), rispettivament.
English: The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
Maltese: L-istudju evalwa 215-il pazjent adult (popolazzjoni modifikata b'intenzjoni li tiġi kkurata) b'nr-AxSpa attiva (18 sa 49 sena), definiti bħala dawk il-pazjenti li ssodisfaw il-kriterji tal-klassifikazzjoni
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use.
Maltese: Avvenimenti ta' mard li jneħħi l-majelin tas-sistema ċentrali u periferali ġew irrappurtati b'mod rari u rari ħafna, rispettivament, bl-użu ta' etanercept.
English: Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Maltese: Intwera li etanercept itejjeb ilfunzjoni fiżika f'pazjenti b'artrite psorjatika, u li jnaqqas ir-rata ta' progressjoni ta' ħsara periferali talġogi kif imkejla bl-X-ray f'pazjenti b'sotto-tipi simmetriċi poliartikulari tal-marda.
English: Benepali 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Benepali 50 mg
English: OTHER
Maltese: a
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: Failure of the bone marrow to produce crucial blood cells; damage to nerves, including Guillain-Barré syndrome (a serious condition which can affect breathing and damage body organs); toxic epidermal necrolysis (a life-threatening skin condition).
Maltese: Il-mudullun jonqos milli jipproduċi ċelluli tad-demm kruċjali; ħsara lin-nervaturi, li tinkludi ssindrome ta' Guillain-Barré (kundizzjoni serja li tista' taffettwa t-teħid tan-nifs u tagħmel ħsara lill-organi tal-ġisem); nekrolisi epidermali tossika (kundizzjoni ta' theddida għall-ħajja).
English: Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Maltese: Il-pazjenti fil-grupp ta' etanercept flimkien mal-grupp tat-terapija b'methotrexate kellhom risponsi b'mod sinifikanti aktar għolja ta' ACR 20, ACR 50, ACR 70 u titjib fil-punteġġ tad-DAS u HAQ kemm wara 24 kif ukoll 52 ġimgħa milli minn pazjenti li kienu fil-gruppi tat-terapija b'mediċina waħda (ir-riżultati jidhru fit-tabella t'hawn taħt).
English: In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon).
Maltese: Fil-perjodi double-blind ta' provi kliniċi kkontrollati ta' etanercept fl-indikazzjonijiet kolha, ilfrekwenza (il-proporzjon ta' inċidenza) ta' avvenimenti avversi ta' żieda fl-enżimi tal-fwied f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate fl-istess ħin kienet ta' 0.54 % (frekwenza mhux komuni).
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Maltese: L-aktar avvenimenti avversi rrappurtati b'mod komuni huma reazzjonijiet fis-sit fejn tingħata linjezzjoni (bħal uġigħ, nefħa, ħakk, ħmura u ħruġ ta' demm minn parti li kienet mtaqqba), infezzjonijiet (bħal infezzjonijiet fis-sistema respiratorja ta' fuq, bronkite, infezzjonijiet fil-bużżieqa tal-awrina, ċistite, infezzjonijiet tal-ġilda), reazzjonijiet allerġiċi, formazzjoni ta' awtoantikorpi, ħakk, u deni.
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare).
Maltese: Fi provi kliniċi kkontrollati ta' etanercept fl-indikazzjonijiet kollha, il-frekwenza (il-proporzjon ta' inċidenza) ta' epatite awtoimmunitarja f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate konkomitanti kienet ta' 0.02 % (frekwenza rari).
English: Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Maltese: Studju 3 evalwa 583 pazjent u kellu l-istess kriterji ta' inkluzjoni bħal studju 2.
English: In studies when adult patients received concurrent treatment with etanercept plus anakinra, a higher rate of serious infections compared to etanercept alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1,000/mm3).
Maltese: Fi studji fejn pazjenti adulti kkurati b'etanercept fl-istess waqt li kienet għaddejja l-kura b'anakinra, ġie osservat li kien hemm rata ogħla ta' infezzjonijiet serji meta mqabbla mal-użu ta' etanercept waħdu, u 2% tal-pazjenti (3/139) żviluppaw newtropenija (għadd assolut tan-newtrofili < 1,000/mm
English: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Maltese: Infezzjonijiet (li jinkludu rjiħat, sinusite, bronkite, infezzjonijiet tal-apparat urinarju u infezzjonijiet tal-ġilda); reazzjonijiet fis-sit tal-injezzjoni (li jinkludu ħruġ ta' demm, tbenġil, ħmura, ħakk, uġigħ u nefħa).
English: Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Maltese: Kura ta' poliartrite (fattur rewmatojde pożittiv jew negattiv) u oligoartrite estiża fit-tfal u adolexxenti mill-età ta' sentejn li kellhom rispons mhux adegwat għal, jew li ntwera li ma jittollerawx, methotrexate.
English: Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Maltese: Il-profili talkonċentrazzjoni fis-serum kienu simili għal dawk il-pazjenti adulti li kellhom l-artrite rewmatojde.
English: Benepali should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg.
Maltese: Normalment Benepali ma għandux jintuża fi tfal b'poliartrite jew b'oligoartrite estiża ta' inqas minn sentejn, jew li jiżnu inqas minn 62.5 kg, jew fi tfal ta' taħt it-12-il sena b'artrite relatata ma' entesite jew artrite psorjatika jew li jiżnu inqas minn 62.5 kg, jew fi tfal b'psorjażi ta' inqas minn 6 snin jew li jiżnu inqas minn 62.5 kg.
English: In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months.
Maltese: II, randomised, ikkontrollat bil-plaċebo, ta' 48 pazjent li kienu l-isptar, ikkurati b'etanercept jew bil-plaċebo, għal epatite alkoħolika minn moderata sa severa, etanercept ma kienx effikaċi, u r-rata ta' mortalità f'pazjenti kkurati b'etanercept kienet ogħla b'mod sinifikanti wara 6 xhur.
English: Biogen Idec Limited Tel: +44 (0)20 360 886 22
Maltese: United Kingdom Biogen Idec Limited Tel: +44 (0)20
English: • Material to remind healthcare professionals that Benepali is not for use in children and adolescents who weigh less than 62.5 kg
Maltese: • Materjal biex ifakkar lill-professjonisti fil-qasam mediku li Benepali mhuwiex għall-użu fi tfal u adolexxenti li jiżnu inqas minn 62.5 kg
English: The 10 mg etanercept dose had consistently less effect on structural damage than the 25 mg dose.
Maltese: Id-doża ta' etanercept ta' 10 mg kellha inqas effett b'mod konsistenti fuq il-ħsara strutturali milli mid-doża ta' 25 mg.
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Maltese: Dan jinkludi rapporti ta' attivazzjoni mill-ġdid tal-epatite B f'pazjenti li kienu pożittivi għal anti-HBc iżda negattivi għal HBsAg.
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); Abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems.
Maltese: Infezzjonijiet serji (li jinkludu pnewmonja, infezzjonijiet profondi tal-ġilda, infezzjonijiet talġogi, infezzjoni tad-demm, u infezzjonijiet f'siti differenti); iggravar ta' insuffiċjenza konġestiva tal-qalb, għadd baxx taċ-ċelluli bojod tad-demm, għadd baxx ta' newtrofili (tip ta' ċelluli bojod tad-demm); għadd baxx ta' plejtlits fid-demm; kanċer tal-ġilda (ħlief ilmelanoma); nefħa lokalizzata tal-ġilda (anġjoedema); ħorriqija (irqajja' elevati ta' ġilda ħamra jew pallida li ħafna drabi jqabbduk il-ħakk); infjammazzjoni tal-għajnejn; psorjasi (ġdida jew li tmur għall-agħar); infjammazzjoni tal-vini/arterji tad-demm li taffettwa bosta organi; żieda flenżimi tal-fwied fid-demm (f'pazjenti li jkunu qed jirċievu wkoll kura b'methotrexate, ilfrekwenza taż-żieda fl-enżimi tal-fwied fid-demm hija komuni); bugħawwiġ u uġigħ fl-addome, dijarea, telf fil-piż jew demm fl-ippurgar (sinjali ta' problemi tal-musrana).
English:  Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more.
Maltese: • Poliartrite (fattur rewmatojde pożittiv jew negattiv) u oligoartrite estiża f'pazjenti li għandhom minn sentejn 'il fuq u li jiżnu 62.5 kg jew aktar.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Maltese: Fl-istudji kliniċi, ma ġewx osservati interazzjonijiet meta etanercept ingħata flimkien ma' glukokortikojdi, salicylates (ħlief sulfasalazine), mediċini kontra l-infjammazzjoni li mhumiex sterojdi (NSAIDs), analġesiċi, jew methotrexate.
English: Adult patients with plaque psoriasis
Maltese: Pazjenti adulti bi psorjasi tal-plakka
English: Benepali is available in packs containing 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes.
Maltese: Benepali hu disponibbli f'pakketti li fihom 4 siringi mimlija għal-lest u pakketti multipli li fihom 12-il (3 pakketti ta' 4) siringa mimlija għal-lest.
English: Adult patients with non-radiographic axial spondyloarthritis The efficacy of etanercept in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Maltese: Fost il-pazjenti b'ankylosing spondylitis li rċivew etanercept, ir-risponsi kliniċi kienu apparenti flewwel viżta (ġimagħtejn) u komplew matul is-sitt xhur tat-terapija.
English: The long-term safety and effectiveness of etanercept 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Maltese: Is-sikurezza u l-effikaċja fit-tul ta' etanercept 0.8 mg/kg (sa 50 mg) darba fil-ġimgħa ġew ivvalutati fi studju ta' estensjoni b'tikketta mikxufa ta' 181 suġġett pedjatriku bi psorjasi tal-plakka għal massimu ta' sentejn apparti l-istudju ta' 48 ġimgħa diskuss hawn fuq.
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
Maltese: F'analiżi li fiha l-pazjenti kollha li ħarġu mill-istudju għal kwalunkwe raġuni kienu kkunsidrati li għamlu progress, il-perċentwali ta' pazjenti mingħajr progressjoni (bidla fit-TSS ta' ≤ 0.5) wara 24 xahar kienet ogħla fil-grupp li ngħata etanercept flimkien ma' methotrexate meta mqabbel malgruppi li ħadu etanercept waħdu u methotrexate waħdu (62%, 50%, u 36%, rispettivament;
English: The possibility exists for TNF-antagonists, including etanercept, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Maltese: Teżisti l-possibbiltà għal antagonisti ta' TNF, inkluż etanercept, li jaffettwaw id-difiża tal-bniedem kontra infjammazzjonijiet u tumuri malinni, peress li t-TNF jimmedja l-infjammazzjoni u jimmodula rispons immunitarju taċ-ċelluli.
English: Radiographs of hands/wrists and feet were read at baseline and 6, 12, and 24 months.
Maltese: Qari mir-radjografiji tal-idejn/tal-polzijiet u tassaqajn ittieħdu fil-linja bażi u wara 6, 12 u 24 xahar.
English: Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUCbased serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Maltese: Etanercept ma kkawżax tossiċità li tillimita d-doża jew tossiċità fl-organu fil-mira fixxadini tat-tip cynomolgus wara li ngħataw injezzjonijiet taħt il-ġilda darbtejn fil-ġimgħa għal 4 jew 26 ġimgħa konsekuttiva b'doża (15 mg/kg) li rriżultat f'konċentrazzjoni tal-mediċina fis-serum ibbażata fuq l-AUC li kienet aktar minn 27 darba iktar minn dak miksub fil-bniedem bid-doża rakkomandata ta' 25 mg.
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Maltese: F'analiżi li fiha l-pazjenti kollha li ħarġu mill-istudju għal xi raġuni kienu kkunsidrati li kellhom progress, il-perċentwali ta' pazjenti mingħajr progressjoni (bidla fit-TSS ta' ≤ 0.5) wara 12-il xahar kien ogħla fil-grupp ta' etanercept meta mqabbel mal-grupp talplaċebo (73% vs. 47%, rispettivament, p ≤ 0.001).
English: Benepali is available in packs containing 4 pre-filled syringes, multipacks comprising 2 cartons, each containing 4 pre-filled syringes and multipacks comprising 6 cartons, each containing 4 pre-filled syringes.
Maltese: Benepali hu disponibbli f'pakketti li fihom 4 siringi mimlija għal-lest, pakketti multipli li fihom 2 kaxxi tal-kartun, kull waħda fiha 4 siringi mimlija għal-lest u pakketti multipli li fihom 6 kaxxi tal kartun, kull waħda fiha 4 siringi mimlija għal-lest.
English: After a single subcutaneous dose of 25 mg etanercept, 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' etanercept, il-medja talkonċentrazzjoni massima fis-serum osservata f'voluntiera b'saħħithom kienet ta' 1.65 ± 0.66 μg/mL, u l-erja ta' taħt il-kurva kienet ta' 235 ± 96.6 μg × h/mL
English: Clinical responses among nr-AxSpa patients who received etanercept were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Maltese: Ir-risponsi kliniċi fost pazjenti b'nr-AxSpa li rċevew etanercept kienu evidenti waqt l-ewwel vista (ġimagħtejn) u nżammu sa sentejn ta' terapija.
English: In a study of 49 adult patients with rheumatoid arthritis treated with etanercept, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Maltese: Fi studju fuq 49 pazjent adult bl-artrite rewmatojde li ngħataw etanercept, ma nstabet l-ebda evidenza ta' tnaqqis ta' sensittività eċċessiva tat-tip li jittardja, ta' tnaqqis tal-livelli tal-immunoglobina, jew tibdil fl-enumerazzjoni tal-popolazzjonijiet taċ-ċelluli effector.
English: Open
Maltese: Tqala
English: Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of etanercept compared to the 349 adult rheumatoid arthritis patients.
Maltese: Diversi avvenimenti avversi kienu rrappurtati aktar ta' spiss fil-każ ta' 69 pazjent bl-artrite idjopatika taż-żgħażagħ li ħadu etanercept għal 3 xhur, imqabbla mat-349 pazjent adult b'artrite rewmatojde.
English: Caution should be exercised when administering Benepali in patients previously infected with HBV.
Maltese: Għandha tingħata attenzjoni meta Benepali jingħata lil pazjenti li qabel kienu infettati bl-HBV.
English: Inspect the pre-filled pen:
Maltese: Mhux inklużi fil-pakkett:
English: The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Maltese: It-tipi ta' infezzjonijiet murija fi provi kliniċi f'pazjenti b'artrite idjopatika taż-żgħażagħ li għandhom bejn sentejn u 18-il sena kienu ġeneralment minn ħfief sa moderati u konsistenti ma' dawk li komunament jidhru fil-popolazzjonijiet pedjatriċi outpatient.
English: Thus, the combined use of Benepali and anakinra is not recommended (see sections 4.5 and 4.8).
Maltese: Għalhekk l-użu ta' Benepali flimkien ma' anakinra mhux rakkomandat (ara sezzjonijiet 4.5 u 4.8).
English: PC SN NN
Maltese: Ġimagħtejn b
English: MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.
Maltese: Saru MRIs tal-ġog sakroiljaku u tas-sinsla biex tiġi evalwata l-infjammazzjoni fil-linja bażi u fil-ġimgħat 12 u 104.
English: DSGAb, clear or almost clear * p ≤ 0.0001 compared with placebo a No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving etanercept 25 mg BIW or 50 mg once weekly from week 13 to week 24. b Dermatologist Static Global Assessment.
Maltese: L-ebda paraguni statistiċi mal-plaċebo ma saru f'ġimgħa 24 fi Studju 2 u 4 għax il-grupp oriġinali tal-plaċebo beda jingħata 25 mg ta' etanercept darbtejn fil-ġimgħa (BIW) jew 50 mg darba fil-ġimgħa (QW) minn ġimgħa 13 sa ġimgħa 24.
English: Tel: + 386 (0)1 888 81 07
Maltese: Biogen Pharma d.o.o. Tel: + 386 (0)1 888 81 07