FrancophonIA/ELRC3.0 huggingface dataset:
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 white-grey 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: • Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1000): 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' sklerosi multipla jew infjammazzjoni tan-nervituri tal-għajnejn jew tal-korda spinali); tuberkolosi; 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; reazzjonijiet liċenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq il-membrani mukużi); infjammazzjoni tal-fwied 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 fis-sistema 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 talpulmun hi mhux komuni).
English: Powder: Mannitol (E421), sucrose and trometamol Solvent: Water for injections
Maltese: Mannitol (E421), sucrose u trometamol Solvent:
English: Diagram 3 White needle cap
Maltese: Djiagramma 2 Dijagramma 3 Dijagramma 4
English: CARTON TEXT - EU/1/99/126/023-025 (25 mg Pre-filled Pen)
Maltese: KITBA FUQ IL-KARTUNA - EU/1/99/126/023-025 (Pinna Mimlija għal-Lest 25 mg)
English: in the postmarketing setting.
Maltese: Ħalli s-siringa f'postha.
English: The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
Maltese: Id-doża għandha tkun ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) darba f'ġimgħa.
English: EU/1/99/126/016 2 pre-filled syringes EU/1/99/126/017 4 pre-filled syringes EU/1/99/126/018 12 pre-filled syringes
Maltese: EU/1/99/126/016 2 siringi mimlijin għal-lest EU/1/99/126/017 4 siringi mimlijin għal-lest EU/1/99/126/018 12-il siringa mimlijin għal-lest
English: ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20: Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 Enbrel vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Maltese: Enbrel 41% u 40%, plaċebo 8% u 5% wara 3 u 6 xhur rispettivament; p<0.01 Enbrel vs. plaċebo f'kull punt taż-żmien għar-risponsi ta' ACR 20 kif ukoll ACR 50).
English: Pairwise comparison p-values: † = 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 għal Enbrel + methotrexate vs. methotrexate u  = p < 0.05 għall-paraguni ta' Enbrel + methotrexate vs.
English: Push the open end of the pen firmly against the skin, so that the needle safety shield is pushed completely inside of the pen.
Maltese: Il-pinna tista' tiġi attivata biss meta l-protezzjoni tas-sigurtà tal-labra tiġi mbuttata kompletament ġol-pinna.
English: CARTON TEXT - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
Maltese: KITBA FUQ IL-KARTUNA - EU/1/99/126/019-021 (Pinna Mimlija għal-Lest 50 mg)
English: 42a
Maltese: ġimgħ a 12
English: • Severe psoriasis in patients from the age of 6 years 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 li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
English: 4 vials of powder
Maltese: 4 kunjetti ta' trab
English: Enbrel +
Maltese: Tużax Enbrel
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 25 mg/0.5 ml
Maltese: 25 mg/0.5 ml
English: TEXT FOR PRE-FILLED SYRINGE LABEL - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
Maltese: KITBA FUQ IT-TIKKETTA TAS-SIRINGA MIMLIJA GĦAL-LEST- EU/1/99/126/013-015, EU/1/99/126/026 (Siringa mimlija għal-lest 25 mg)
English: 28b a: p<0.001, Enbrel vs. placebo b: p = 0.002, Enbrel vs. placebo
Maltese: Ġimagħtejn 3 xhur 6 xhur a: p<0.001, Enbrel vs. plaċebo b: p = 0.002, Enbrel vs. plaċebo
English: n = 90 wk 24a
Maltese: 50 mg darba fi lġimgħa n = 90 ġimgħ a 24
English: Injection advice:
Maltese: Progressjoni Radjografika:
English: Enbrel 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 Enbrel 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: In study 1, the Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001).
Maltese: Fi studju 1, il-grupp tal-kura b'Enbrel kellu proporzjon ogħla ta' pazjenti b'rispons PASI 75 f'ġimgħa 12 (30%) meta mqabbel mal-grupp ikkurat bil-plaċebo (2%) (p<0.0001).
English: 24 MYCLIC pre-filled pens 24 alcohol swabs
Maltese: 24 pinna MYCLIC mimlija għal-lest 24 swab ta' l-alkoħol
English: *Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p <0.001, b:<0.01 and c:<0.05, respectively between Enbrel and placebo
Maltese: ASAS 5/6 Remissjoni parzjali fuq ASAS BASDAI***50 * Xi pazjenti ma pprovdewx dejta sħiħa għal kull endpoint ** ASAS=Soċjetà Internazzjonali ta' Evalwazzjonijiet ta' Spondiloartrite *** Indiċi ta' Attività tal-Marda Spondilite Ankilosing ta' Bath a: p<0.001, b:<0.01 u c:<0.05, rispettivament bejn Enbrel u plaċebo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT - EU/1/99/126/002
Maltese: KITBA FUQ IL-KARTUNA - EU/1/99/126/002
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Maltese: Testijiet adattati ta' l-iscreening, i.e. test tal-ġilda tuberculin u X-ray tas-sider, għandhom jitwettqu fil-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu japplikaw).
English: Enbrel 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'Enbrel għandha tinbeda taħt is-superviżjoni ta' tobba speċjalisti b'esperjenza fid-dijanjosi u fil-kura ta' artrite rewmatojda, artrite idjopatika taż-żgħażagħ, artrite psorjatika, ankylosing spondylitis, spondiloartrite assjali mhux radjografika, psorjasi tal-plakka jew psorjasi pedjatrika talplakka.
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use Etanercept
Maltese: Enbrel 10 mg trab u solvent għal soluzzjoni għall-injezzjoni għal użu pedjatriku etanercept
English: Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Maltese: Kull pakkett fih 4, 8 jew 24 kunjett ta' doża waħda, 4, 8 jew 24 siringa mimlija għal-lest bl-ilma għallinjezzjonijiet, 4, 8 jew 24 labra, 4, 8 jew 24 adapters tal-kunjett u 8, 16 jew 48 swab bl-alkoħol.
English: PsARC Month 3
Maltese: ANNESS III
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 Enbrel in combination with methotrexate group compared with the Enbrel 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 Enbrel flimkien ma' methotrexate meta mqabbel mal-gruppi li ħadu Enbrel waħdu u methotrexate waħdu (62%, 50%, and 36%, rispettivament; p<0.05).
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (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'Enbrel u b'anakinra kellhom rata ogħla ta' infezzjonijiet serji (7%) u ta' newtropenja milli minn pazjenti kkurati b'Enbrel biss (ara sezzjonijiet 4.4 u 4.8).
English: 50 mg QW
Maltese: 50 mg/1 ml
English: Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4, 8, 12 or 24 alcohol swabs.
Maltese: Kull pakkett fih 4, 8, 12 jew 24 siringi mimlija għal-lest b'4, 8, 12 jew 24 swab bl-alkoħol.
English: 4 pre-filled syringes 4 alcohol swabs
Maltese: 4 siringi mimlija għal-lest 4 swabs ta' l-alkoħol
English: Enbrel 0.8 mg/kg Once Weekly (N = 106)
Maltese: Riżultati tal-Psorjasi Pedjatrika tal-Plakka f'Ġimgħa 12 Enbrel 0.8 mg/kg Darba filĠimgħa (N = 106)
English: Paediatric population See Summary of the safety profile, above.
Maltese: Popolazzjoni pedjatrika Ara s-sommarju tal-profil ta' sigurtà, hawn fuq.
English: Enbrel 25 mg solution for injection in pre-filled syringe EU/1/99/126/013
Maltese: Enbrel 25 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/99/126/013
English: 2 MYCLIC pre-filled pens 2 alcohol swabs
Maltese: 2 pinen MYCLIC mimlija għal-lest 2 swabs ta' l-alkoħol
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Enbrel, 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'Enbrel, u b'konformità marrakkomandazzjonijiet lokali.
English: 50b
Maltese: 1050 Bruxelles
English: OTHER MYCLIC Pre-filled pen
Maltese: Disturbi filfwied u filmarrara
English: Slovenija Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400
Maltese: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use.
Maltese: Avvenimenti ta' mard li jneħħi l-majelin tas-sistema ċentrali u periferali ġew irrapurtati b'mod rari u rari ħafna, rispettivament, bl-użu ta' Enbrel.
English: Enbrel 25 mg solution for injection in pre-filled pen EU/1/99/126/023
Maltese: Enbrel 25 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/99/126/023
English: Enbrel 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: Enbrel ma kkawżax tossiċità li tillimita d-doża jew tossiċità fl-organu fil-mira fix-xadini 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: For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of Enbrel per kg of bodyweight (up to a maximum of 50 mg) given once weekly.
Maltese: Għal poliartrite jew għal oligoartrite estiża f'pazjenti minn età ta' sentejn, jew artrite relatata ma' entesite jew artrite psorjatika f'pazjenti minn età ta' 12-il sena, id-doża li ssoltu tingħata hija 0.4 mg ta' Enbrel għal kull kg ta' piż tal-ġisem (sa massimu ta' 25 mg), mogħtija darbtejn fil-ġimgħa, jew 0.8 mg ta' Enbrel għal kull kg piż tal-ġisem (sa massimu ta' 50 mg) mogħtija darba fil-ġimgħa.
English: Enbrel 50 mg solution for injection in pre-filled syringe EU/1/99/126/016
Maltese: Enbrel 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/99/126/016
English: In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1000/mm3).
Maltese: Fi studji fejn pazjenti adulti kkurati b'Enbrel fl-istess waqt li kienet għaddejja l-kura b'anakinra, ġie osservat li kien hemm rata ogħla ta' infezzjonijiet serji meta mqabbla ma' l-użu ta' Enbrel waħdu, u 2% tal-pazjenti (3/139) żviluppaw newtropenja (għadd assolut tan-newtrofili < 1000/mm
English: Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available.
Maltese: Dejta adegwata miġbura mill-kura ta' pazjenti infettati bl-HBV b'terapija antivirali flimkien ma' terapija b'antagonisti ta' TNF mhijiex disponibbli.
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs.
Maltese: Profili medji tal-konċentrazzjoni fis-serum fl-istat fiss f'pazjenti b'RA kkurati kienu Cmax ta' 2.4 mg/l vs.
English: Methotrexate
Maltese: Erozjoni
English: Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel 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'Enbrel u jiġu kkunsidrati għall-kura profilattika b'Varicella Zoster Immune Globulin.
English: Clinical responses among nr-AxSpa patients who received Enbrel 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 Enbrel kienu evidenti waqt l-ewwel vista (ġimagħtejn) u nżammu sa sentejn ta' terapija.
English: Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Maltese: Ċar jew kważi ċar definiti bħala 0 jew 1 fuq skala 0 to 5.
English: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Maltese: Il-kura ta' psorjasi kronika severa tal-plakka fit-tfal u fl-adolexxenti mill-età ta' 6 snin, li huma kkontrollati b'mod inadegwat minn, jew li huma intolleranti għal, terapiji jew fototerapiji sistemiċi oħrajn.
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 Enbrel, in the postmarketing 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 Enbrel fl-isfond ta' wara t-tqegħid fis-suq.
English: 24.8c
Maltese: 24-il xahar
English: Posology
Maltese: Risponsi
English: Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel 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 Enbrel għal 3 xhur, imqabbla mat-349 pazjent adult b'artrite rewmatojde.
English: CARTON TEXT - EU/1/99/126/022 (For paediatric use)
Maltese: TAT-TREJ - EU/1/99/126/022 (Għal użu pedjatriku)
English: The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Maltese: L-għatu tal-labra fih lastku naturali niexef (latex)
English: 8 vials of powder
Maltese: 8 kunjetti ta' trab
English: 2 pre-filled syringes 2 alcohol swabs
Maltese: 2 siringi mimlija għal-lest 2 swabs ta' l-alkoħol
English: Antibodies to Enbrel
Maltese: Mediċini oħra u Enbrel
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: Baseline scoreb
Maltese: Linja bażi
English: • The needle has been placed in a plastic container to keep it sterile.
Maltese: Il-labra tqiegħdet f'kontenitur tal-plastik biex tinżamm sterilizzata.
English: n = 46 wk 12
Maltese: Plaċebo n = 46 ġimgħa
English: See section 5 for instructions on how to store Enbrel.
Maltese: Jekk jogħġbok ara sezzjoni 5 għal istruzzjonijiet dwar kif taħżen Enbrel.
English: In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, 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 Enbrel, ma nstabet l-ebda evidenza ta' tnaqqis ta' sensittività eċċessiva tat-tip li jittardja, ta' tnaqqis tal-livelli ta' l-immunoglobina, jew tibdil fl-enumerazzjoni tal-popolazzjonijiet taċ-ċelluli effector.
English: Thus the combined use of Enbrel and anakinra is not recommended (see sections 4.5 and 4.8).
Maltese: Għalhekk l-użu ta' Enbrel flimkien ma' anakinra mhux rakkomandat (ara sezzjonijiet 4.5 u 4.8).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TEXT FOR TRAY BACKING - EU/1/99/126/003-005
Maltese: KITBA FUQ IT-TIKKETTA TAS-SIRINGA - EU/1/99/126/003-005
English: You should allow 15 to 30 minutes for the Enbrel solution in the syringe to reach room temperature.
Maltese: Għandek tħalli 15 sa 30 minuta għas-soluzzjoni ta' Enbrel biex tilħaq it-temperatura talkamra.
English: Worsening of symptoms of dermatomyositis
Maltese: Aggravar tassintomi ta' dermatomijosite
English: The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticularcourse juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset) .
Maltese: Is-sigurtà u l-effikaċja ta' Enbrel 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: Caution should be exercised when administering Enbrel in patients previously infected with HBV.
Maltese: Għandha tingħata attenzjoni meta Enbrel jingħata lil pazjenti pazjenti li qabel kienu infettati bl-HBV.
English: 24a n = 193 wk 12
Maltese: 25 mg darbtejn filġimgħa n = 196 ġimgħa
English: Solution for injection.
Maltese: INJEZZJONI TA' ENBREL”.
English: Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Maltese: Il-profili tal-konċentrazzjoni fis-serum kienu simili għal dawk il-pazjenti adulti li kellhom l-artrite rewmatojde.
English: The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Maltese: Jekk irċevejt Enbrel waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju ogħla li tieħu infezzjoni.
English: Pyrexia
Maltese: Siringa
English: In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly.
Maltese: F'dan l-istudju, 53 pazjent ingħataw il-plaċebo, 214-il pazjent ingħataw 50 mg ta' Enbrel darba filġimgħa u 153 pazjent ingħataw 25 mg Enbrel darbtejn fil-ġimgħa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
Maltese: KITBA FUQ IT-TIKKETTA TAS-SIRINGA MIMLIJA GĦAL-LEST- EU/1/99/126/016-018 (Siringa mimlija għal-lest 50 mg)
English: Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
Maltese: Erġa' ibda b'kunjett ġdid ta' Enbrel, ilma għall-injezzjonijiet, siringa, labra u swabs.
English: The possibility exists for TNF-antagonists, including Enbrel, 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 Enbrel, 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: Patients in the Enbrel 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' Enbrel 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 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: Syste m O rgan Class
Maltese: Is-sustanzi l-oħra huma:
English: The safety and efficacy of Enbrel in patients with immunosuppression have not been evaluated.
Maltese: Is-sigurtà u l-effikaċja ta' Enbrel f'pazjenti b'immunosoppressjoni ma kinux evalwati.