FrancophonIA/ELRC3.0 huggingface dataset:
English: Adding solvent e.
Maltese: Kif iżżid is-solvent e.
English: Date of last renewal: 03 February 2010
Maltese: Data ta' l-aħħar tiġdid: 03 ta' Frar, 2010
English: Enbrel is a medicine that is made from two human proteins.
Maltese: Enbrel hu mediċina magħmula minn żewġ proteini umani.
English: Frequency Not Known (C an n ot be Estimated from Available Data)
Maltese: Frekwenza Mhux Magħruf (Ma tistax tittieħed Stima mid-Data Disponibbli)
English: Powder: Mannitol, sucrose and trometamol.
Maltese: Trab: Mannitol, sucrose u trometamol.
English: b: Values for Disease Activity Score (DAS) are means.
Maltese: b: Il-valuri għal Disease Activity Score (DAS) huma medji.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Maltese: Immunosoppressanti, Inibituri alpha tal-Fattur tan-Nekrosi tat-Tumur (TNF-α), Kodiċi ATC:
English: The differences in TSS and JSN were not statistically significant between methotrexate and Enbrel 25 mg.
Maltese: Id-differenzi fit-TSS u JSN ma kinux statistikament sinifikanti bejn methotrexate u Enbrel 25 mg.
English: Diagram 8
Maltese: Dijagramma 8
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Maltese: Pfizer Europe MA EEIG
English: Mannitol (E421) Sucrose Trometamol
Maltese: Mannitol (E421) Sucrose
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
Maltese: Artrite rewmatojde, artrite psorjatika, u spondiloartrite assjali li tinkludi ankylosing spondylitis
English: PASI 50 14 58* 70 74* 77 9 64* 77* 9 69* 83 PASI 75 4 34* 44 49* 59 3 34* 49* 2 38* 71 DSGA b, 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 Enbrel 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Maltese: PASI 50 14 58* 70 74* 77 9 64* 77* 9 69* 83 PASI 75 4 34* 44 49* 59 3 34* 49* 2 38* 71 DSGA
English: • Psoriatic arthritis in patients from the age of 12 years
Maltese: • Artrite psorjatika f'pazjenti mill-età ta' 12-il sena
English: T uberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Maltese: Tuberkulożi, infezzjoni opportunistika (li tinkludi infezzjonijiet fungali invażivi, protożoali, batterjali, mikobatterjali atipiċi, virali u Leġjonella)*
English: In an open-label, singledose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Maltese: Fi studju open-label, single-dose, two-treatment, crossover, f'voluntiera f'saħħithom, etanercept mogħti bħala injezzjoni waħda ta' 50 mg/ml, instab li kien bijoekwivalenti għal żewġ injezzjonijiet simultanji ta' 25 mg/ml.
English: On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6).
Maltese: Malli tisma t-tieni ‘klikk' (jew, jekk ma tismax it-tieni ‘klikk', wara li jkunu għaddew 10 sekondi), l-injezzjoni tiegħek tkun lesta (ara Dijagramma 6).
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of Enbrel (see section 4.8).
Maltese: Infezzjonijiet serji, sepsis, tuberkulosi, u infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, listeriosis u legionellosis, kienu rrappurtati bl-użu ta' Enbrel (ara sezzjoni 4.8).
English: Opportunistic infections have been reported in association with Enbrel, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Maltese: Infezzjonijiet opportunistiċi kienu rrappurtati b'rabta ma' Enbrel, li jinkludu infezzjonijiet fungali invażivi, parasitiċi (inkluż protożoali), virali (inkluż ħerpes zoster), batterjali (li jinkludu Listeria u Legionella), u infezzjonijiet mikobatterjali atipiċi.
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients).
Maltese: Il-perċentwali ta' pazjenti li żviluppaw antikorpi ġodda u pożittivi tat-tip DNA anti-double stranded kien ukoll ogħla b'assaġġ radjo-immunoloġiku (15% tal-pazjenti kkurati b'Enbrel imqabbel ma' 4% tal-pazjenti kkurati bil-plaċebo) u minn assaġġ bi Crithidia luciliae (3% tal-pazjenti kkurati b'Enbrel imqabbel ma' l-ebda pazjent ikkurat bil-plaċebo).
English: Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Maltese: Studju 4 evalwa 142 pazjent u kellu kriterji simili ta' l-inkluzjoni bħal studji 2 u 3.
English: L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
Maltese: L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Ilma għall-injezzjonijiet
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Maltese: B'mod alternattiv, intwera li 50 mg ta' Enbrel mogħtija darba fil-ġimgħa huma siguri u effettivi (ara sezzjoni 5.1).
English: In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 4.8 % of subjects with juvenile idiopathic arthritis.
Maltese: F'pazjenti kkurati b'dożi approvati ta' etanercept fi provi kliniċi sa 12-il xahar, ir-rati kumulattivi ta' antikorpi għal etanercept kienu ta' madwar 6% tal-pazjenti b'artrite rewmatojde, 7.5% tal-pazjenti b'artrite psorjatika 2% tal-pazjenti bi ankylosing spondylitis, 7% tal-pazjenti bi psorjasi, 9.7% talpazjenti bi psorjasi pedjatrika, u 4.8% tal-pazjenti b'artrite idjopatika taż-żgħażagħ.
English: In a group of 7,416 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Maltese: Fi grupp ta' 7,416-il pazjent ikkurati b'Enbrel fi provi kliniċi li kellhom artrite rewmatojde, artrite psorjatika, ankylosing spondylitis u psorjasi, 18-il limfoma kienu rrappurtati.
English: Abbreviation: sPGA-static Physician Global Assessment a. p < 0.0001 compared with placebo
Maltese: sPGA “ċara” jew “minima”, n (%) Taqsira: sPGA-static Physician Global Assessment a. p < 0.0001 meta mqabbel mal-plaċebo
English: Musculoskeleta l and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: ---------------Study 4-----------
Maltese: --------------Enbrel------------
English: 24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors
Maltese: 24 siringa mimlija għal-lest b'1 ml ta' solvent 24 labra ta' l-istainless steel għall-injezzjoni 24 adapter tal-kunjetti
English: EU/1/99/126/003 EU/1/99/126/004 EU/1/99/126/005
Maltese: EU/1/99/126/003 EU/1/99/126/004
English: These include rare reports of pancytopenia and very rare reports of aplastic anaemia.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenja u rapporti rari ħafna ta' anemija aplastika.
English: Within the organ system classes, 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 ta' l-organi, ir-reazzjonijiet avversi huma elenkati skond il-frekwenza (numru ta' pazjenti mistennija li jkollhom ir-reazzjoni) skond 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: Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
Maltese: (1) involviment distali interfalanġejali (DIP); (2) artrite poliartikulari (nuqqas ta' noduli rewmatojdi u l-preżenza ta' psorjasi); (3) artrite mutilans; (4) artrite psorjatika asimmetrika; jew (5) ankilosi li tixbah lill-ispondilite.
English: Česká Republika
Maltese: Republika
English: Diagram 10
Maltese: Dijagramma 10
English: Other presentations of Enbrel are available in strengths of 10 mg, 25 mg, and 50 mg.
Maltese: Preżentazzjonijiet oħra ta' Enbrel huma disponibbli f'qawwiet ta' 10 mg, 25 mg, u 50 mg.
English: Enbrel is available in strengths of 10, 25 and 50 mg.
Maltese: Enbrel hu disponibbli f'qawwiet ta' 10, 25 u 50 mg.
English: Enbrel 25 mg injection etanercept
Maltese: Enbrel 25 mg injezzjoni etanercept
English: Diagram 9
Maltese: Dijagramma 9
English: Diagram 1
Maltese: Dijagramma 1
English: In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with Enbrel at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Maltese: Fi studju ieħor ta' fergħa waħda bit-tikketta mikxufa, 60 pazjent b'oligoartrite estiża (15-il pazjent ta' bejn sentejn u 4 snin, 23 pazjent ta' bejn 5 u 11-il sena u 22 pazjent ta' bejn 12 u 17-il sena), 38 pazjent b'artrite relatata ma' entesite (12 sa 17-il sena) u 29 pazjent b'artrite psorjatika (12 sa 17-il sena) ġew ikkurati b'Enbrel f'doża ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) mogħtija kull ġimgħa għal 12-il ġimgħa.
English: The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Maltese: Il-medja talkonċentrazzjonijiet minimi fis-serum fl-istat fiss varjat minn 1.6 sa 2.1 mcg/ml f'ġimgħat 12, 24, u 48.
English: Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC).
Maltese: Ir-risponsi kliniċi kienu espressi f'perċentwali tal-pazjenti li kisbu rispons ta' ACR 20, 50 u 70, u f'perċentwali ta' titjib fil-Kriterji tar-Rispons ta' l-Artrite Psorjatika (PsARC).
English: A total of 401 patients were enrolled from which 203 were treated with Enbrel.
Maltese: Total ta' 401 pazjent kienu rreġistrati li fosthom 203 kienu kkurati b'Enbrel.
English: Responses of Patients with Psoriasis in Studies 2, 3 and 4
Maltese: Risponsi ta' Pazjenti bi Psorjasi fi Studji 2, 3 u 4
English: Diagram 18
Maltese: Dijagramma 18
English: Enbrel powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Maltese: Trab ta' Enbrel għal soluzzjoni għandu jiġi rikostitwit f'1 ml ta' solvent qabel l-użu (ara sezzjoni 6.6).
English: Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Maltese: Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate u ilma għall-injezzjonijiet.
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Maltese: TNF u lymphotoxin huma cytokines pro-infjammatorji li jeħlu ma' żewġ tipi differenti ta' riċetturi fuq is-superfiċje taċ-ċelluli: ir-riċetturi tal-fattur nekrotiku tat-tumuri (TNFRs) ta' 55-kilodalton (p55) u 75-kilodalton (p75).
English: Diagram 15
Maltese: Dijagramma 15
English: Diagram 17
Maltese: Dijagramma 17
English: Compared to placebo, treatment with Enbrel resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Maltese: Meta mqabbla ma' plaċebo, il-kura b'Enbrel wasslet għal titjib statistikament sinifikanti fl-ASAS 40, l-ASAS 20 u l-ASAS 5/6.
English: Ankylosing Spondylitis Response
Maltese: Rispons ta' Ankylosing Spondylitis
English: At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebotreated patients.
Maltese: F'ġimgħa 24, 56% talpazjenti fil-grupp ikkurat b'Enbrel kienu kisbu l-PASI 75 meta mqabbla ma' 5% tal-pazjenti kkurati bil-plaċebo.
English: Diagram 5
Maltese: Dijagramma 5
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 diseasemodifying antirheumatic drug (DMARD) other than methotrexate.
Maltese: Fi studju ieħor ikkontrollat attivament, double-blind u randomised, l-effikaċja klinika, is-sigurtà, u lprogressjoni radjografika f'pazjenti b'RA kkurati b'Enbrel waħdu (25 mg darbtejn f'ġimgħa) b'methotrexate waħdu (7.5 sa 20 mg fil-ġimgħa, b'doża medjana ta' 20 mg), u Enbrel 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 ta' l-anqas waħda millmediċina anti-rewmatojde li timmodifika l-marda (DMARD), minbarra methotrexate.
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 Enbrel 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 Enbrel, meta mqabbel ma pazjenti iżgħar.
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: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including Enbrel, 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 Enbrel.
English: Diagram 7
Maltese: Dijagramma 7
English: Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with Enbrel.
Maltese: Każijiet ta' tuberkulosi attiva li jinkludu tuberkulosi miljari u tuberkulosi b'sit extra-pulmonari kienu rrappurtati f'pazjenti kkurati b'Enbrel.
English: Diagram 16
Maltese: Dijagramma 16
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: batteremija, bronkite, bursite, ċellulite, koleċistite, dijarea, divertikulite, endokardite (issuspettata), gastroenterite, epatite B, herpes zoster, ulċera fir-riġlejn, infezzjoni fil-ħalq, osteomajelite, otitis, peritonite, pnewmonja, pajelonefrite, sepsis, artrite settika, sinusite, infezzjoni tal-ġilda, ulċera talġilda, infezzjoni fl-apparat ta' l-awrina, vaskulite, u infezzjoni fil-feriti.
English: Diagram 19
Maltese: Dijagramma 19
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue
Maltese: • Sinjali ta' lupus jew sindromu simili għal-lupus, bħal tibdil fil-piż, raxx persistenti, deni, uġigħ fil-ġogi jew fil-muskoli, jew għejja)
English: In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Maltese: Fi studju kliniku randomised, double blind, ikkontrollat bil-plaċebo f'pazjenti adulti b'artrite psorjatika, 184 pazjent ingħataw ukoll multivalent pneumococcal polysaccharide vaccine fir-4 ġimgħa.
English: A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener's granulomatosis.
Maltese: Prova kkontrollata bil-plaċebo, fejn 89 pazjent adult kienu kkurati b'Enbrel ukoll flimkien mat-terapija standard (inklużi cyclophosphamide u/jew methotrexate, u glukokortikojdi) fuq żmien medjan ta' 25 xahar, ma wrietx li Enbrel hu kura effettiva għal granulomatożi ta' Wegener.
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 ASAS ta' spondiloartrite assjali iżda li ma ssodisfawx il-kriterji modifikati ta' New York għal AS.
English: T oxic epidermal necrolysis
Maltese: Nekrolisi epidermali tossika
English: Histiocytosis haematophagic (macrophage activation syndrome)†
Maltese: Istijoċitożi ematofaġika (sindrome ta' attivazzjoni talmakrofagu)
English: 8 pre-filled syringes of 1 ml solvent 8 stainless steel injection needles 8 vial adaptors
Maltese: 8 siringi mimlija għal-lest b'1 ml ta' solvent 8 labar ta' l-istainless steel għall-injezzjoni 8 adapters tal-kunjetti
English: Step 4: Disposing of the used MYCLIC pen
Maltese: Pass 4: Kif tarmi l-pinna użata MYCLIC
English: Adjusted mean change from baseline was 3.8 for Enbrel treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Maltese: Il-bidla medja aġġustata mil-linja bażi kienet ta' 3.8 għallpazjenti li kienu qed jirċievu kura b'Enbrel (n=95) kontra 0.8 għal dawk li kienu qed jirċievu kura bi plaċebo (n=105) (p<0.001).
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Maltese: Infezzjoni (inkluż infezzjoni fl-apparat respiratorj u ta' fuq, bronkite, ċistite, infezzjoni tal-ġilda)*
English: CARTON TEXT - EU/1/99/126/003-005
Maltese: TAT-TREJ - EU/1/99/126/003-005
English: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 µg•hr/ml and 474 µg•hr/ml for 50 mg Enbrel once weekly (N = 154) and 25 mg twice weekly (N = 148), respectively.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'ankylosing spondylitis, l-AUCs fl-istat fiss ta' etanercept kienu ta' 466 μg*h/ml u 474 μg*h/ml għal 50 mg Enbrel darba fil-ġimgħa (N = 154) u 25 mg darbtejn fil-ġimgħa (N = 148), rispettivament.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including Enbrel.
Maltese: Kanċer tal-ġilda melanoma u mhux melanoma (NMSC) kienu rrappurtati f'pazjenti kkurati b'antagonisti ta' TNF, li jinkludu Enbrel.
English: In a group of 2,711 plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Maltese: Fi grupp ta' 2,711-il pazjent bi psorjasi tal-plakka kkurati b'Enbrel fi studji double-blind u open-label li damu sejrin sa sentejn u nofs, 30 tumur malinn u 43 kanċer tal-ġilda mhux melanoma kienu rrappurtati.
English: 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg Enbrel once weekly (n=21) vs. 25 mg Enbrel twice weekly (n=16), respectively.
Maltese: 316 mgh/l għal 50 mg Enbrel darba fil-ġimgħa (n=21) vs. 25 mg Enbrel darbtejn fil-ġimgħa (n=16), rispettivament.
English: Diagram 6
Maltese: Dijagramma 6
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Enbrel 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: Enbrel 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: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-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'Enbrel.
English: Diagram 14
Maltese: Dijagramma 14
English: Int erst it ial lung disease (including pneumonitis and pulmonary fibrosis)*
Maltese: Mard interstizjali talpulmun (li jinkludi pnewmonite u fibrożi pulmonari)*
English: Diagram 11
Maltese: Dijagramma 11
English: Diagram 13
Maltese: Dijagramma 13
English: Diagram 4
Maltese: Dijagramma 4
English: Powder: Mannitol (E421), sucrose, and trometamol.
Maltese: Mannitol (E421), sucrose u trometamol
English: 4 MYCLIC pre-filled pens 4 alcohol swabs
Maltese: 4 pinen MYCLIC mimlija għal-lest 4 swabs tal-alkoħol