FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumabtreated patients and 1.8 % of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bi Psorjasi tal-plakka b'dewmien ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 x ULN seħħew f'1.8 % tal-pazjenti kkurati b'adalimumab u 1.8 % tal-pazjenti kkurati kkontrollati.
English: ASASa partial remission ASDASc inactive disease partial flared a assessment of SpondyloArthritis International Society b baseline is defined as open label baseline when patients have active disease.
Maltese: ASASa Remissjoni Parzjali ASDASc Marda Inattiva Flare Parzjalid a Stima tas-Soċjeta Internazzjonali tas-SpondyloArthritis b Il-linja bażi hija definita bħala linja bażi ‘open label' meta l-pazjenti għandhom mard attiv.
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kkontrollati ta' adalimumab f'pazjenti b'artrite idjopatika poliartikulari taż-żgħażagħ li kellhom minn 4 sa 17-il sena u pazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, kien hemm żidiet f'ALT ta' ≥ 3 x ULN f'6.1 % tal-pazjenti kkurati b'adalimumab u 1.3 % tal-pazjenti kkurati bil-kontroll.
English: Ulcerative colitis is an inflammatory disease of the bowel.
Maltese: Kolite ulċerattiva hija marda infjammatorja tal-musrana.
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg / ml during the induction period.
Maltese: F'pazjenti li jbatu mill-marda Crohn (Crohn's disease), id-doża kbira ta' 80 mg adalimumab f'ġimgħa 0 segwita b'40 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 5.5 µg / ml matul il-perjodu tal-bidu.
English: Non-infectious uveitis in adults and children
Maltese: Uveite mhux infettiva fl-adulti u tfal
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg / ml (without concomitant methotrexate) and 8 to 9 µg / ml (with concomitant methotrexate), respectively.
Maltese: Wara t-teħid ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn artrite rewmatika (AR), il-konċentrazzjoni minimali medja fissa kienet ta' bejn wieħed u ieħor 5µg / ml (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 µg / ml (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: Elderly
Maltese: fażi
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Maltese: infezzjonijiet fis-sistema riproduttiva (li jinkludu infezzjoni tal-fungi fil-vulva u fil-vaġina), infezzjoni fis-sistema urinarja (li tinkludi infezzjoni fil-kliewi u fis-sistema urinarja tan-naħa ta' fuq), infezzjonijiet tal-fungu, infezzjonijiet fil-ġogi
English: 10 A-6250 Kundl Austria
Maltese: 6 xhur 12-il xahar
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Maltese: Tabella 7 Risponsi għall-ACR fi provi kontrollati bil-plaċebo
English: Figure G: hold your pen
Maltese: Figura G: iġbed il-protezzjoni tal labra
English: • low blood potassium.
Maltese: • potassju tad-demm baxx.
English: The recommended Hefiya dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Maltese: Ir-reġimen tad-doża ta' Hefiya rrakkomandata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'Jum 1 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Maltese: Infezzjonijiet fis-sistema respiratorja (li jinkludu infezzjoni fin-naħa ta' isfel u fin-naħa ta' fuq tas-sistema respiratorja, pnewmonja, sinożite, fariniġite, rinofarinġite u pnewmonja virali tal-herpes)
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see tables 17 and 18).
Maltese: Fl-istudji tal-Psorjasi I u II, l-iskop primarju kien il-proporzjon ta' pazjenti li rnexxielhom jilħqu rispons tal-PASI ta' 75 mil-linja bażi f'ġimgħa 16 (ara tabelli 17 u 18).
English: Traceability
Maltese: Fertilità
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Maltese: Wara li l-prodott tqiegħed fis-suq, kienu rrappurtati każijiet rari ta' hepatosplenic T-cell lymphoma f'pazjenti kkurati b'adalimumab (ara sezzjoni 4.4).
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
Maltese: Ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis, huma mard infjammatorju tal-ispina.
English: Hefiya is used to treat rheumatoid arthritis in adults.
Maltese: Hefiya jintuża biex jittratta artrite rewmatika fl-adulti.
English: Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment.
Maltese: Mit-371 pazjent li fadal, 276 pazjent evalwabbli laħqu 78 ġimgħa ta' trattament b'adalimumab open-label.
English: Night sweats, scar
Maltese: DATA TA' SKADENZA
English: clinical remission clinical response * p-value for standard dose versus low dose comparison.
Maltese: * valur p li huwa paragun tad-doża standard kontra doża baxxa.
English: solution for injection 1 pre-filled pen (SensoReady) 2 pre-filled pens (SensoReady)
Maltese: 2 pinen mimlijin għal-lest (SensoReady)
English: Enthesitis-related arthritis
Maltese: Artrite relatata mal-entesite
English: • fatty liver (build-up of fat in liver cells);
Maltese: • perforazzjoni tal-intestini (toqba fil-ħajt tal-musrana);
English: Mannitol
Maltese: Il-Manifattur
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Maltese: L-espożizzjoni ta' adalimumab f'pazjenti b'uveite pedjatrika kienet imbassra bl-użu ta' mudellar farmakokinetiku tal-popolazzjoni u simulazzjoni bbażata fuq farmakokinetika ta' indikazzjoni minn pazjenti pedjatriċi oħra (psorjasi pedjatrika, artrite idjopatika minorenni, marda ta' Crohn pedjatrika u artrite relatata mal-entesite).
English: Table 22 proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Maltese: Tabella 22 Proporzjon ta' pazjentia li kisbu HiSCRb fil-ġimgħat 24 u 36 wara kura assenjata mill-ġdid minn adalimumab kull ġimgħa f'ġimgħa 12 plaċebo
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Maltese: Il-kombinazzjoni ta' adalimumab kif ukoll ta' antagonisti TNF oħra u anakinra jew abatacept mhijiex irrakkomandata abbażi tar-riskju miżjud possibbli għal infezzjonijiet, inkluż infezzjonijiet serji u interazzjonijiet farmakoloġiċi potenzjali oħra.
English: Vision related effects were not numerically in favour of adalimumab for colour vision in study UV I and for colour vision, peripheral vision and near vision in study UV II.
Maltese: II. Effetti relatati mal-viżjoni ma kinux numerikament favur ta' Hefiya għall viżjoni tal-kulur fi studju UVI u għal viżjoni tal-kulur, vista periferali u l-viżjoni fil-qrib fi studju UV II.
English: In these trials, 11.9 % of patients treated with adalimumab and 8.1 % of placebo and active control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Maltese: F'dawn il provi, 11.9% tal-pazjenti kkurati b'adalimumab u 8.1% tal-pazjenti kkurati bil-plaċebo u bis-sustanzaattiva użata bħala kontroll, li bdew bl-livelli tal-anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi f'ġimgħa 24.
English: Hefiya 40 mg solution for injection in a single-use pre-filled syringe Hefiya is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Hefiya 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Hefiya jiġi fornut f'siringa tal-ħġieġ tat-tip I ċar li tintuża darba biss b'tapp tal-gomma u labra tal istainless steel bil-kappa awtomatika bi flanġ għas-suba', protezzjoni tal-labra tal-gomma u planġer tal-plastik, li fiha 0.8 ml ta' soluzzjoni.
English: week 8 and 52 sustained response sustained remission sustained mucosal healing clinical remission is Mayo score ≤ 2 with no subscore > 1; clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a of those receiving corticosteroids at baseline
Maltese: flimkien ma' tnaqqis fil-fsada rektali b'sottopunteġġ [RBS] ta' ≥1 jew RBS assolut ta' 0 jew 1; * p<0.05 għal adalimumab vs. plaċebo bil-proporzjonijiet imqabblin flimkien ** p<0.001 għal adalimumab vs. plaċebo bil-proporzjonijiet imqabblin flimkien a min dawk li rċevew kortikosterojdi f'linja bażi
English: Serious adverse reactions have been reported for adalimumab.
Maltese: Reazzjonijiet avversi serja, ġew irrappurtati b'adalimumab.
English: clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa week 56
Maltese: pazjenti li kellhom titjib mingħajr sterojdi għal > = 90 ġurnataa ġimgħa 56
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test.
Maltese: c ilvalur-p jiġi mit-tqabbil bejn pari ta' kura b'adalimumab waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney.
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Maltese: L-ebda tumuri malinni ma ġew osservati f'60 pazjent pedjatriku b'espożizzjoni ta' 58.4 snin ta' pazjenti waqt prova ta' adalimumab f'pazjenti pedjatriċi b'uveite.
English: • The green indicator shows the progress of the injection.
Maltese: • L-indikatur aħdar juri l-progress tal-injezzjoni.
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Maltese: • sinjali u sintomi ta' infezzjoni bħal deni, tħossok marid, feriti, problemi tas-snien, ħruq waqt li tgħaddi l-awrina, tħossok dgħajjef jew għajjien jew sogħla;
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Maltese: Studju RA V evalwa 799 pazjent adult li jbatu minn artrite rewmatika attiva minn moderata sa severa li għada fil-bidu (il-medja ta' kemm ilha li bdiet il-marda kien ta' 9 xhur) li kienu għadhom qatt ma ħadu methotrexate.
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Maltese: *** p < 0.001 għall-paraguni kollha bejn adalimumab u l-plaċebo
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3441 li kienu kkurati b'adalimumab fl-istudji kollha tal artrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindrome li jixbah lis-sindrome tal-lupus.
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and wellcontrolled studies.
Maltese: L-effikaċja ta' adalimumab kienet evalwata fi studju każwali, double-blind, ikkontrollat ta'
English: Hypertension, flushing, haematoma
Maltese: ipofosfatimija, deidratazzjoni
English: Axial spondyloarthritis without radiographic evidence of AS
Maltese: Axial spondyloarthritis mingħajr evidenza radjografika ta' AS
English: primary analysis (ITT) placebo adalimumab
Maltese: 52 ġimgħa open-label plaċebo
English: discontinued corticosteroids
Maltese: twaqqif tal-kortikosterojdi
English: Bath ankylosing spondylitis disease activity index
Maltese: a stima f'ankylosing spondylitis b indiċi tal-attività tal-mard bath ankylosing spondylitis
English: • cough;
Maltese: • sogħla;
English: • joint infections;
Maltese: • emigranja;
English: Figure 2: Kaplan-Meier curves summarizing time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Maltese: Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 6 (Studji UV I) jew Ġimgħa 2 (Studju UV II)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: • If you are over 65 years you may be more susceptible to infections while taking Hefiya.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Hefiya.
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Maltese: Figura 3: Kurvi ta' Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment fl-Istudju Pedjatriku tal-Uveite
English: Tachycardia
Maltese: newropatija
English: • gastrointestinal bleeding;
Maltese: • diffikultà biex torqod;
English: Hefiya dose for patients with polyarticular juvenile idiopathic arthritis
Maltese: Tfal, adolexxenti u adulti bl-artrite idjopatika poliartikulari taż-żgħażagħ
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumabtreated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16).
Maltese: Ir-rata ta' tqaliet li jintemmu b'għallinqas tarbija tat-twelid ħajja waħda b'difett maġġuri mat-twelid kienet 6/69 (8.7%) fin-nisa kkurati b'adalimumab b' RA u 5/74 (6.8%) fin-nisa mhux ikkurati b'RA (OR mhux aġġustata 1.31, 95% CI
English: • sensation disorders such as tingling, prickling or numbness;
Maltese: • disturbi ta' sensazzjoni bħal tnemnim, tingiż jew tirżiħ;
English: For patients who dose-escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg / ml (40 / 20 mg, weekly) and 6.7 ± 3.5 μg / ml (20 / 10 mg, weekly).
Maltese: 3±11.4 μg / ml (40 / 20 mg, kull ġimgħa) u 6.7±3.5 μg / ml (20 / 10 mg, kull ġimgħa).
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at Weeks 0 and 2.
Maltese: Fi studju CD II, 325 pazjent li ma kinux baqgħu juru rispons għall-kura jew li ma kinux jittolleraw infliximab kienu mqassma bl-addoċċ biex jirċievu jew 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2 jew plaċebo f'ġimgħat 0 u 2.
English: • Sharps disposal container
Maltese: • Kontenitur għar-rimi ta' sharps
English: adalimumab / M TX n=268 (95% confidence interval) p-valuea p-valueb p-valuec total Sharp score erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Suġġetti (n = 215, 54.7 %) li ma laħqux l-ASAS 20 f'ġimgħat 12, jew 16 jew 20 irċevew 40 mg adalimumab ħruġ kmieni open-label taħt il-ġilda ġimgħa iva u ġimgħa le, u kienu sussegwentament kkurati bħala pazjenti li ma jirrispondux għal kura fl-analiżi tal-istatistika double- blind.
English: Impaired healing
Maltese: Rispons Kliniku
English: Each pen contains 40 mg/0.8 ml of Hefiya.
Maltese: Kull pinna fiha 40 mg/0.8 ml ta' Hefiya.
English: Amongst those who responded at week 16 (n = 144), the paediatric ACR 30 / 50 / 70 /90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Maltese: Fost dawk li rrispondu f'ġimgħa 16 (n = 144), ir-rispons pedjatriku ACR 30 / 50 / 70 /90 kien miżmum sa sitt snin fil-fażi
English: Your Hefiya single-use pre-filled SensoReady pen
Maltese: Il-kura b'Hefiya tista' tirriżulta fil-formazzjoni ta'anti-korpi awtoimmuni.
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Maltese: HiSCR f'12-il ġimgħa wara l-introduzzjoni mill-ġdid ta' adalimumab 40 mg kull ġimgħa marret lura għal livelli simili għal dik osservata qabel l-irtirar (56.0 %).
English: Hepato-biliary disorders*
Maltese: Disturbi fil-qalb*
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA/I
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Maltese: Dawn il-provi inkludew pazjenti li jbatu minn artrite rewmatika, kemm f'dawk li ma jkunux ilhom u dawk li jkunu ilhom bil-marda, f'artrite idjopatika taż-żgħażagħ (artrite idjopatika poliartikulari taż-żgħażagħ jew artrite relatata mal-entesite) kif ukoll pazjenti li jbatu minn axial spondyloarthritis (infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) u minn axial spondyloarthritis mingħajr evidenza radjografika ta' AS), minn artrite psorjatika, mill-marda Crohn (Crohn's disease), mill-kolite ulċerattiva, mill-psorjasi, minn hidradenitis suppurativa u minn uveite.
English: • For a more comfortable injection, take your pen out of the refrigerator 15 to 30 minutes before injecting Hefiya to allow it to reach room temperature.
Maltese: • Għal injezzjoni aktar komda, oħroġ il-pinna mill-friġġ 15 sa 30 minuta qabel tinjetta Hefiya sabiex tħalliha tilħaq temperatura normali.
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Maltese: ALT≥ 3 x ULN f'3.7% tal-pazjenti kkurati b'adalimumab u f'1.6% tal-pazjenti kkurati bil-kontroll.
English: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Maltese: M'hawnx informazzjoni adegwata minn kura ta' pazjenti li jġorru l-HBV permezz ta' terapija antivirali flimkien ma' terapija b'antagonist ta' TNF biex tiġi evitata r-riattivazzjoni tal-tal-HBV.
English: At Week 16, more patients randomised to adalimumab 0.8 mg / kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg / kg eow or MTX (table 20).
Maltese: F'ġimgħa 16, aktar pazjenti magħżula b'mod każwali u li ngħataw adalimumab 0.8 mg / kg kellhom rispons pożittivi tal-effikaċja (eż, PASI 75)
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Maltese: għandhom isiru wara konsultazzjoni ma' tabib espert fil-kura ta' pazjenti b'infezzjonijiet fungali invażivi.
English: During the injection you will hear 2 loud clicks: o The 1st click indicates that the injection has started.
Maltese: Waqt l-injezzjoni se tisma' 2 klikks jgħajtu: o L-1 klikk tindika li l-injezzjoni bdiet.
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal antiinflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Maltese: Studju PsA I li dam 24 ġimgħa, tratta 313 pazjent adult li kellhom rispons inadegwat għall-kura b'mediċina antiinfjammatorja mhux sterojdi, u minn dawn, bejn wieħed u ieħor 50% kienu qegħdin jieħdu methotrexate.
English: Disposing of used pens:
Maltese: Pakkkett multiplu:
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Maltese: Ma ġew osservati l-ebda tumuri malinni f'249 pazjenti pedjatriċi ta' età bejn is sentejn u 17-il sena b'espożizzjoni ta' 655.6 sena ta' pazjent waqt provi b'adalimumab f'pazjenti b'artrite idjopatika taż-żgħażagħ (artrite idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite).
English: clinical response clinical remission mucosal healing steroid-free remission for ≥ 90 daysa
Maltese: rispons kliniku titjib kliniku fejqan tal-Mukoża titjib tal-kondizzjoni mingħajr sterojdi għal ≥ 90 juma
English: placebo (treatment withdrawal) N = 73
Maltese: (kura rtirata) N = 73
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Maltese: • infjammazzjoni vaskulari (infjammazzjoni tal-vini u l-arterji);