FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of 50 mg etanercept (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 etanercept (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: DO NOT USE
Maltese: OĦRA TAL
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; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike whitegrey lines on mucous membranes); 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).
Maltese: Infezzjonijiet serji (li jinkludu pnewmonja, infezzjonijiet profondi tal-ġilda, infezzjonijiet tal ġogi, 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 iqabbduk 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,
English: Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Maltese: Infezzjonijiet serji u fatali kienu rrappurtati wara li etanercept beda jintuża; patoġeni rrappurtati jinkludu batterji, mikobatterji (inkuż it-tuberkolosi), viruses u fungi.
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 fit-tielet studju randomised, ikkontrollat attivament b'evalwazzjonijiet radjografiċi blinded bħala endpoint primarju fi 632 pazjent adult blartrite rewmatojde attiva (għal < 3 snin) u li qatt ma kienu ħadu kura b'methotrexate.
English: INFORMATION IN BRAILLE Erelzi 25 mg
Maltese: Etanercept 25 mg
English: 4 pre-filled SensoReady pens.
Maltese: Erelzi SensoReady.
English: The safety and efficacy of etanercept were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Maltese: Is-sigurtà u l-effikaċja ta' etanercept ġew evalwati fi studju maqsum f'żewġ partijiet fejn 69 tifel u tifla b'artrite idjopatika taż-żgħażagħ b'kors poliartikulari, li kellhom varjetà ta' tipi tal-bidu ta' artrite idjopatika taż-żgħażagħ (poliartrite, pawċiartrite, feġġa sistemika).
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: Erelzi is available in strengths of 25 mg and 50 mg.
Maltese: Erelzi hu disponibbli f'qawwiet ta' 25 mg u 50 mg.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Maltese: Immunosoppressanti, inibituri alpha tal-fattur tan-nekrosi tat-tumur
English: Each pack contains 1, 2 or 4 pre-filled syringes with a needle guard, multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes with a needle guard or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes with a needle guard.
Maltese: Kull pakkett fih 1, 2 jew 4 siringi mimlija għal-lest bi protezzjoni tal-labra, il-pakketti multipli fihom 12-il siringa mimlija għal-lest ta' 25 mg jew 50 mg (3 pakketti ta' 4) bi protezzjoni tal-labra jew 8 (2 pakketti ta' 4) jew 24 (6 pakketti ta' 4) siringa mimlija għal-lest ta' 25 mg bi protezzjoni tal-labra.
English: EU/1/17/1195/013 8 pre-filled syringes EU/1/17/1195/004 12 pre-filled syringes EU/1/17/1195/014 24 pre-filled syringes
Maltese: EU/1/17/1195/013 8 siringi mimlija għal-lest EU/1/17/1195/004 12-il siringa mimlija għal-lest EU/1/17/1195/014 24 siringa mimlija għal-lest
English: The other ingredients are citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: Is-sustanzi attivi l-oħra huma citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide. hydrochloric acid u ilma għall-injezzjonijiet.
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 tal ġogi kif imkejla bl-X-ray f'pazjenti b'sotto-tipi simmetriċi poliartikulari tal-marda.
English: 4 pre-filled syringes with a needle guard.
Maltese: 4 siringi mimlija għal-lest bi protezzjoni tal-labra.
English: In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Maltese: Fi studju li dam 48 ġimgħa li sar fuq 211-il tifel u tifla ta' bejn l-4 u s-17-il sena li kellhom psorjasi pedjatrika tal-plakka, l-avvenimenti avversi rrappurtati kienu simili għal dawk li kienu osservati fi studji li saru fil-passat fuq adulti bi psorjasi tal-plakka.
English: The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l. Elimination
Maltese: Il volum ċentrali tad-distribuzzjoni ta' etanercept hu ta' 7.6 l, waqt li l-volum tad-distribuzzjoni fl-istat fiss hu ta' 10.4
English: Histiocytosis haematophagic (macrophage activation syndrome)*
Maltese: (sindrome ta' attivazzjoni talmakrofagu)*
English: wk 12 wk
Maltese: TAGĦRIF
English: In this study, 53 patients received placebo, 214 patients received 50 mg etanercept once weekly and 153 patients received 25 mg etanercept twice weekly.
Maltese: F'dan l-istudju, 53 pazjent ingħataw il-plaċebo, 214-il pazjent ingħataw 50 mg ta' etanercept darba filġimgħa u 153 pazjent ingħataw 25 mg etanercept darbtejn fil-ġimgħa.
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: ġie osservat li kien hemm rata ogħla ta' infezzjonijiet serji meta mqabbla ma' l-użu ta' etanercept waħdu, u 2% tal-pazjenti (3/139) żviluppaw newtropenja (għadd assolut tan-newtrofili < 1000/mm3).
English: Responses were measured using the 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: 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: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including etanercept, in the post-marketing setting.
Maltese: Tumuri malinni, xi wħud minnhom fatali, kienu rrappurtati fost tfal, adolexxenti u żgħażagħ adulti (li kellhom sa 22 sena) ikkurati b'antagonisti ta' TNF (il-bidu tat-terapija sar f'età ta' ≤ 18-il sena), li jinkludu etanercept fl-isfond ta' wara t-tqegħid fis-suq.
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 jiżnu 62.5 kg jew aktar.
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with etanercept and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept (see sections 4.4 and 4.8).
Maltese: Flimkien ma' dan, fi studju double-blind u kkontrollat bil-plaċebo f'pazjenti adulti li kienu qed jieħdu methotrexate ukoll, kien osservat li pazjenti kkurati b'etanercept u b'anakinra kellhom rata ogħla ta' infezzjonijiet serji (7%) u ta' newtropenja milli minn pazjenti kkurati b'etanercept biss (ara sezzjonijiet 4.4 u 4.8).
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: L-istudju 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: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Maltese: każijiet ta' telf tal majelin 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),
English: The double-blind period was followed by an open-label period during which all patients received etanercept 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 etanercept 50 mg fil-ġimgħa sa 92 ġimgħa addizzjonali.
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: peritonite, pnewmonja, pajelonefrite, sepsis, artrite settika, sinusite, infezzjoni tal-ġilda, ulċera talġilda, infezzjoni fl-apparat tal-awrina, vaskulite, u infezzjoni fil-feriti.
English: EU/1/17/1195/001 1 pre-filled syringe EU/1/17/1195/002 2 pre-filled syringes EU/1/17/1195/003 4 pre-filled syringes
Maltese: EU/1/17/1195/001 EU/1/17/1195/002 EU/1/17/1195/003 EU/1/17/1195/004
English: • Instruction to immediately seek for medical attention after detection of symptoms suggestive for infection
Maltese: • Struzzjoni biex il-pazjenti jfittxu attenzjoni medika immedjatament wara d-detezzjoni ta'
English: 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: L-effikaċja ta' etanercept 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: All healthcare professionals (HCPs) who are most likely to prescribe Erelzi for patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis, juvenile idiopathic arthritis, plaque psoriasis and paediatric plaque psoriasis are provided with a Patient Alert Card for distribution to patients receiving Erelzi.
Maltese: artrite psorjatika, spondiloartrite assjali li tinkludi ankylosing spondylitis, artrite idjopatika tażżgħażagħ, psorjasi tal-plakka u psorjasi pedjatrika tal-plakka huma provduti b'Kard ta' Twissija talPazjent għal distribuzzjoni lil pazjenti li jirċievu Erelzi.
English: Avoid areas with scars or stretch marks.
Maltese: Evita żoni b'ċikatrici jew bi stretch marks.
English: In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), non-steroidal 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: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Erelzi, and in accordance with local recommendations.
Maltese: Jekk tkun iddijanjostikata tuberkulosi inattiva (‘moħbija'), għandha tinbeda kura għal tuberkulosi moħbija b'terapija kontra t-tuberkulosi qabel il-bidu tal-kura b'Erelzi, u b'konformità marrakkomandazzjonijiet lokali.
English: • Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Maltese: • Psorjasi severa f'pazjenti mill-età ta' 6 snin u jiżnu 62.5 kg jew aktar li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled SensoReady pen after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta tal-pinna mimlija għal-lest SensoReady wara “EXP”.
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: 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: Simulation of dosing suggests that while older children (1017 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Maltese: Simulazzjoni tad-dożaġġ turi li waqt tfal ta' età akbar (ta' bejn 10 u 17-il sena) ser ikollhom livelli ta' serum qrib dawk osservati fl-adulti, tfal iżgħar ikollhom livelli ferm iktar baxxi.
English: Elderly
Maltese: Awtoantikorpi
English: Concurrent treatment with sulfasalazine
Maltese: Ġwienaħ tal protezzjoni tallabra
English: Patients with a significant exposure to varicella virus should temporarily discontinue Erelzi therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Maltese: Pazjenti b'espożizzjoni sinifikanti għall-virus tal-ġidri r-riħ għandhom iwaqqfu temporanjament it-terapija b'Erelzi u jiġu kkunsidrati għall-kura profilattika b'Varicella Zoster Immune Globulin.
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 AUC-based 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: This medicinal product contains less than 1 mmol sodium (23 mg) per 25mg or 50 mg, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull 50 mg, jiġifieri essenzjalment
English: Erelzi is a biosimilar medicinal product.
Maltese: L04AB01 Erelzi huwa prodott mediċinali bijoloġiku simili.
English: NAME OF THE MEDICINAL PRODUCT Erelzi 50 mg injection etanercept
Maltese: Erelzi 50 mg injection etanercept
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 25 MG PRE-FILLED SYRINGE
Maltese: KARTUNA INTERMEDJA TAL-PAKKETT MULTIPLU (MINGĦAJR IL-KAXXA BLU)
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (n = 57) or placebo (n = 55) twice a week for 24 weeks.
Maltese: intgħażlu b'mod każwali biex jingħataw doża ta' 25 mg ta' etanercept (n = 57) jew plaċebo (n = 55) darbtejn fil-ġimgħa għal 24 ġimgħa.
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 jew 50 mg darba fil-ġimgħa minn ġimgħa 13 sa ġimgħa 24.
English: • Sandoz staff will be trained on the correct use of Erelzi in order to support HCPs in case of questions
Maltese: • Il-persunal ta' Sandoz se jiġi mħarreġ dwar l-użu korrett ta' Erelzi sabiex HCPs jiġu appoġġjati f'każ ta' mistoqsijiet
English: Radiographic progression: comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration (12 month results)
Maltese: Progressjoni radjografika: paragun ta' etanercept vs. methotrexate vs. etanercept flimkien ma' methotrexate f'pazjenti b'RA ta' bejn 6 xhur u 20 sena (riżultati wara 12-il xahar)
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•hr/l għal 50 mg etanercept darba fil-ġimgħa (n = 21) vs. 25 mg etanercept darbtejn fil-ġimgħa (n = 16), rispettivament.
English: Remissionc
Maltese: Rispons
English: Not included in the carton:
Maltese: • Vaċċinazzjonijiet:
English: Erelzi 25 mg solution for injection in pre-filled syringe etanercept
Maltese: Erelzi 25 mg injection etanercept
English: Thus, the combined use of Erelzi and anakinra is not recommended (see sections 4.5 and 4.8).
Maltese: Għalhekk l-użu ta' Erelzi flimkien ma' anakinra mhux rakkomandat (ara sezzjonijiet 4.5 u 4.8).
English: Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Maltese: infezzjoni opportunistika (li tinkludi infezzjonijiet fungali invażivi, protożoali,
English: The same information is also available on www.erelzi.eu and through the code below.
Maltese: L-istess informazzjoni hija disponibbli wkoll fuq www.erelzi.eu u permezz tal-kodiċi ta' hawn taħt.
English: • Use the pen within 5 minutes of removing the cap.
Maltese: • Uża l-pinna fi żmien 5 minuti minn meta tneħħi l-għatu.
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more, the usual dose is 25 mg given twice a week or 50 mg given once a week.
Maltese: jew artrite relatata ma' entesite jew artrite psorijatika f'pazjenti minn età ta' 12-il sena u jiżnu 62.5 kg jew aktar, id-doża li ssoltu tingħata hija 25 mg, mogħtija darbtejn fil-ġimgħa jew 50 mg mogħtija darba fil-ġimgħa.
English: The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Maltese: Jekk irċevejt Erelzi waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju ogħla li tieħu infezzjoni.
English: Additionally, the pharmacokinetics of etanercept in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Maltese: Artrite rewmatojde, artrite psorjatika, u spondiloartrite assjali li tinkludi ankylosing spondylitis
English: Caution should be exercised when administering Erelzi in patients previously infected with HBV.
Maltese: Għandha tingħata attenzjoni meta Erelzi jingħata lil pazjenti li qabel kienu infettati bl-HBV.
English: Your Erelzi SensoReady pen:
Maltese: F'dan il-fuljett:
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 talimmunoglobina, jew tibdil fl-enumerazzjoni tal-popolazzjonijiet taċ-ċelluli effector.