FrancophonIA/ELRC3.0 huggingface dataset:
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Maltese: < 40 kg ≥ 40 kg • 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa
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 adalimumab in the post marketing setting.
Maltese: Ġew irrappurtati tumuri malinni, xi wħud fatali, fit-tfal, adolexxenti, u adulti żgħażagħ (sa 22 sena) ittrattati b'antagonisti ta' TNF (fejn it-trattament ikun inbeda ≤ 18 il-sena), li jinkludu adalimumab wara li tqiegħed fuq is-suq.
English: Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Maltese: Studju nr-axSpA II
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Maltese: Antagonisti ta' TNF, inkluż adalimumab, ġew assoċjati f'okkażjonijiet rari, ma' sintomi kliniċi ġodda jew taħrix ta' sintomi kliniċi u/jew evidenza radjografika ta' mard li jaffettwa il-myelin tan-nervituri fis-sistema nervuża ċentrali, li jinkludi sklerosi multipla u nevrite ottika u mard li jaffettwa il-myelin tan-nervituri fis-sistema periferali, li jinkludi s-sindrome Guillain-Barré.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those
Maltese: Il konċentrazzjoniiet ta' adalimumab fil-fluwidu sinovjali ta' ħafna pazjenti li jbatu minn artrite rewmatika varjaw minn 31-96% minn dawk fis-serum.
English: Efficacy Response in Placebo-Controlled Study nr-axSpA I
Maltese: Studju nr-axSpA I
English: Hepato-biliary events
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Minn dawn il-kanċers tal-ġilda, karċinomi taċ-ċelluli skwamużi seħħew b'rati (intervall ta' konfidenza ta' 95 %) ta' 2.7 (1.4, 5.4) kull 1,000 sena ta' pazjent fost pazjenti ttrattati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti ttrattati bil-kontroll.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Maltese: Il-kwalità tal-ħajja relatata mas-saħħa u l-funzjoni fiżika kienu evalwati bl-użu tal-kwestjonarji HAQS u SF-36.
English: Cyltezo is used to treat psoriatic arthritis in adults.
Maltese: Cyltezo jintuża għat-trattament ta' artrite psorjatika fl-adulti.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Maltese: Fi studju li sar fuq 226 individwu adulti li jbatu minn artrite rewmatika u li kienu ttrattati b'adalimumab jew bil-plaċebo, ġew osservati risponsi simili ta' anti-korpi għat-tilqima standard 23-valent pneumococcal u t-tilqima trivalent tal-virus tal-influwenza.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see Table 29).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (ara t-Tabella 29).
English: Table 6:
Maltese: Tabella 7:
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju open-label, b'aktar minn ċentru wieħed fi 32 tifel u tifla (2 - < 4 snin jew li għandhom minn 4 snin 'il fuq u li jiżnu < 15 kg) li għandhom JIA poliartikulari attiva moderata sa qawwija.
English: Boehringer Ingelheim Sp.zo.o.
Maltese: Boehringer Ingelheim France S.A.S.
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, il-punt finali 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: • flushing;
Maltese: • fwawar;
English: • Hold pen straight up from injection site (at a 90 degree angle).
Maltese: • Żomm il-pinna dritta fuq is-sit tal-injezzjoni (f'angolu ta' 90 grad).
English: • vasculitis (inflammation of blood vessels);
Maltese: • newropatija (ħsara fin-nervaturi);
English: How to use Cyltezo
Maltese: X'fih Cyltezo
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6 % versus 4.3 %, respectively [p = 0.014]).
Maltese: F'ġimgħa 16, kien hemm proporzjon akbar statistikament sinifikanti ta' pazjenti li rċevew adalimumab li laħqu PGA ta' ‘ċar' jew ‘kważi ċar' għal psorjasi fl-idejn u/jew fis-saqajn meta mqabbel mal-pazjenti li rċevew il-plaċebo (30.6 % kontra 4.3%, rispettivament [p = 0.
English: The safety and efficacy of adalimumab were assessed in two randomised, double-blind placebo-controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati f'żewġ studji randomised, double-blind ikkontrollati bil-plaċebo f'pazjenti b'spondyloarthritis axjali mhux radjografika (nr-axSpA).
English: • high blood pressure;
Maltese: • pressjoni għolja;
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Fi Studju nr-axSpA I, adalimumab 40 mg ġimgħa iva u ġimgħa le kien stmat f'185 pazjent fi studju randomised, double-blind, ikkontrollat bil-plaċebo li ħa 12-il ġimgħa f'pazjenti b'nr-axSpA attiva (punteġġ medju fil-linja bażi tal-attività tal-marda [Indiċi ta' Bath tal-Attività tal-Marda Ankylosing Spondylitis (BASDAI - Bath Ankylosing Spondylitis Disease Activity Index)] kien 6.4 għall-pazjenti ttrattati b'adalimumab u 6.5 għal dawk li kienu qed jieħdu l-plaċebo) li ma kellhomx rispons adegwat jew ma kienux tolleranti għal ≥ 1 NSAIDs, jew NSAIDs kienu kontraindikati.
English: Following the administration of 24 mg/m² (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steadystate (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 μg/mL (102 % CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/mL (47.7 % CV) with
Maltese: Wara ogħti ta' 24 mg/m2 (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti b' artrite idjopatika poliartikulari taż-żagħżagħ (JIA - juvenile idiopathic arthritis) li kellhom 4 sa 17-il sena, il-konċentrazzjoni minima medja fi stat fiss ta' adalimumab fis-serum (valuri mkejla minn ġimgħa 20 sa 48) kienet 5.6 ± 5.6 µg/mL (102 % CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 10.
English: The inner part of the cap of the syringe (the needle cover) contains natural rubber (latex).
Maltese: Il-parti ta' ġewwa tal-għatu tas-siringa (l-għatu tal-labra) fiha gomma naturali (latex).
English: In Study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Maltese: Fi Studju UV II, kienu osservati differenzi statistikament sinifikanti għall-akutezza viżiva biss, iżda l-komponenti l-oħra kienu numerikament favur adalimumab.
English: In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Maltese: Fi Studju CD I u Studju CD II, f'ġimgħa 4, ġie milħuq punteġġ totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju dwar mard speċifiku tal-infjammazzjoni tal-musrana (IBDQ - diseasespecific inflammatory bowel disease questionnaire), u dan f'pazjenti randomised għal 80/40 mg u 160/80 mg adalimumab meta mqabbel mal-plaċebo, u dan deher f'ġimgħat 26 u 56 fi Studju CD
English: the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with
Maltese: ▪ trattament ta' artrite rewmatika attiva u progressiva severa f'adulti li ma jkunux ingħataw trattament b'methotrexate qabel.
English: 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
Maltese: Rispons kliniku huwa tnaqqis mil-linja bażi fil-punteġġ Mayo ta' ≥ 3 punti u ≥ 30% flimkien ma' tnaqqis fis-sottopunteġġ ta' fsada mir-rektum [RBS - rectal bleeding subscore] ta' ≥ 1 jew RBS assolut ta' 0 jew 1;
English: Cyltezo is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS
Maltese: Cyltezo huwa indikat għat-trattament ta' hidradenitis suppurativa (acne inversa) attiva moderata sa severa f'pazjenti adulti u adolexxenti minn 12-il sena b'rispons inadegwat għat-terapija sistemika konvenzjonali ta' HS (ara sezzjonijiet 5.1 u 5.2).
English: Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion
Maltese: mard tal-interstizju tal-pulmun, mard kroniku ta' imblukkar fil-pulmun,
English: Sverige
Maltese: Danmark
English: week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u ssintomi ta' nr-axSpA attiva f'pazjenti ttrattati b'adalimumab meta mqabbla mal-plaċebo (Tabella 14).
English: Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Maltese: Wara li l-prodott tqiegħed fis-suq, kienu identifikati każijiet rari ta' hepatosplenic T-cell lymphoma f'pazjenti trattati b'adalimumab.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Maltese: It-teħid ta' 40 mg Adalimumab ġimgħa iva u ġimgħa le kien stmat fi 393 pazjent f'żewġ studji randomised, double-blind, ikkontrollati bil-plaċebo li ħadu 24 ġimgħa fuq pazjenti li jbatu minn ankylosing spondylitis (il-punteġġ medju tal-linja bażi tal-attività tal-mard [l-Indiċi ta' Bath talAttività tal-Marda Ankylosing Spondylitis (BASDAI - Bath Ankylosing Spondylitis Disease Activity Index)] kien 6.3 fil-gruppi kollha) li ma kellhomx rispons adegwata għat-terapija konvenzjonali.
English: • signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;
Maltese: • sinjali ta' infezzjoni bħal deni, tħossok marid, feriti, problemi tas-snien, ħruq waqt li tgħaddi l awrina;
English: Cyltezo is used to treat rheumatoid arthritis in adults.
Maltese: Cyltezo jintuża biex jittratta artrite rewmatika fl-adulti.
English: Side effects may occur up to 4 months or more after the last Cyltezo injection.
Maltese: L-effetti sekondarji jistgħu jseħħu sa 4 xhur jew aktar wara l-aħħar injezzjoni b'Cyltezo.
English: Diplopia
Maltese: Frekwenza
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Maltese: Studju RA III evalwa 619 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18-il sena, u li kellhom rispons mhux effettiv meta ngħataw dożi ta' 12.5 sa 25 mg ta' methotrexate jew kienu intolleranti għal 10 mg ta' methotrexate fil-ġimgħa.
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Maltese: Pazjenti li kisbu PASI 75 u PGA ta' xejn jew minimali kienu irtirati mit-trattament sa 36 ġimgħa u mmonitorjati għat-telf tal-kontroll tal-marda (jiġifieri aggravar tal-PGA b'mill-inqas 2 gradi).
English: Pancreatitis, dysphagia, face oedema
Maltese: kliniċi, bl-użu ta' NEI
English: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Maltese: Fi Studju tal-Psorjasi IV ġew imqabbla l-effikaċja u s-sigurta ta' adalimumab ma' plaċebo f'217-il pazjent adult bi psorjasi tad-dwiefer moderata għal severa.
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Maltese: Sar studju fuq l-effett tossiku waqt l-iżvilupp tal-embriju-fetu/l-iżvilupp fiż-żmien immedjatament qabel jew wara t-twelid, fuq xadini ċinomologi b 0, 30 u 100 mg/kg (9-17 -il xadina/grupp) u dan ma wera l-ebda evidenza ta' dannu kkaġunat minn adalimumab fuq il-feti.
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 ta' Crohn, id-doża ogħla tal-bidu ta' 80 mg adalimumab f'ġimgħa 0 segwita b'40 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimi ta' adalimumab fis-serum ta' bejn wieħed u ieħor 5.5 µg/mL matul il-perjodu ta' induzzjoni.
English: Among the patients who discontinued the study prior to week 78, 11 % discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Maltese: Fost il-pazjenti li waqqfu listudju qabel il-ġimgħa 78, 11 % waqfu minħabba avvenimenti avversi, u 5 % minħabba rispons insuffiċjenti għal trattament b'adalimumab.
English: • asthma;
Maltese: • puplesija;
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Maltese: Tnaqqis statistikament sinifikanti fl-għeja, kif imkejjel mill-istima funzjonali ta' terapija ta' mard kroniku (FACITfunctional assessment of chronic illness therapy) kien osservat fit-tliet studji kollha li fihom saret listima (Studji RA I, III u IV).
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Maltese: Kanċer tal-ġilda li mhux melanoma (li jinkludi karċinoma tat-tip basal cell u karċinoma biċ-ċelluli tat-tip squamous), neoplażma beninna
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis
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 għattrattament jew li ma kinux jittolleraw infliximab kienu randomised biex jirċievu 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2 jew plaċebo f'ġimgħat 0 u 2.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3 % of adalimumab-treated patients
Maltese: Fi provi kkontrollati ta' adalimumab (dożi inizjali ta' 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2, segwiti minn 40 mg kull ġimgħa li jibdew f'ġimgħa 4), f'pazjenti b'hidradenitis suppurativa b'perjodu ta' kontroll b'tul li jvarja minn 12 sa 16-il ġimgħa, elevazzjonijiet ta' ALT ta' ≥ 3 x ULN seħħew f'0.3 % tal-pazjenti ttrattati b'adalimumab u f'0.6 % tal-pazjenti ttrattati bil-kontroll.
English: Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Maltese: Tabella 17: Studju Ps I (REVEAL)
English: Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Maltese: Pazjenti kienu mgħotija mill-ġdid it-trattament ta' adalimumab 0.8 mg/kg eow għal 16-il ġimgħa oħra u r-rati ta' rispons li kienu osservati matul it-trattament kienu simili għall-perjodu double-blind preċedenti: rispons ta' PASI 75 ta' 78.9% (15 minn 19-il individwu) u PGA xejn jew minimali ta' 52.6% (10 minn 19-il individwu).
English: • facial oedema;
Maltese: • ċikatriċi;
English: Ankylosing Spondylitis Disease Activity Score
Maltese: Stimi f'Ankylosing Spondylitis
English: Prior to launch of Cyltezo in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Cyltezo f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u d-disinn tal-programm edukattiv, li jinkludi mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Antibiotics may be continued during treatment with Cyltezo if necessary.
Maltese: Antibijotiċi jistgħu jitkomplew waqt it-trattament b'Cyltezo jekk ikun meħtieġ.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of
Maltese: Infezzjonijiet fatali u infezzjonijiet li jistgħu jpoġġu l-ħajja fil-periklu (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), riattivazzjoni tal-HBV u diversi tumuri malinni (li jinkludu lewkimja, limfoma u HSTCL) ġew irrappurtati ukoll bl-użu ta' adalimumab.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies
Maltese: * hemm iżjed informazzjoni pprovduta f'partijiet oħra fis-sezzjonijiet 4.3, 4.4 u 4.8 ** li jinkludu l-istudji ta' estensjoni open-label li jinkludu data minn rapporti spontanji
English: EXP
Maltese: Tarf
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing
Maltese: Artrite Psorjatika u axial spondyloarthritis inkluż ankylosing spondylitis
English: Cyltezo should be used with caution in patients with mild heart failure (NYHA class I/II).
Maltese: Cyltezo għandu jintuża b'attenzjoni f'pazjenti li jbatu minn insuffiċjenza tal-qalb ħafifa (NYHA klassi I/II).
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-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti b'artrite idjopatika poliartikulari tażżagħżagħ 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 fl-ALT ta' ≥ 3 x ULN f'6.1 % tal-pazjenti ttrattati b'adalimumab u f'1.3 % tal-pazjenti trattati bil-kontroll.
English: The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients
Maltese: 7 ± 6.6 µg/mL għall-pazjenti ta' ≥ 40 kg (160/80 mg) u 10.6 ± 6.1 µg/mL għall-pazjenti ta' < 40 kg (80/40 mg).
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you might be at risk of contracting HBV.
Maltese: • Jekk int iġġorr il-virus tal-epatite B (HBV - hepatitis B virus), jekk għandek infezzjoni ta' HBV
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Cyltezo.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti-infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt it-trattament b'Cyltezo.
English: ***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at
Maltese: ***,** Statistikament sinifikanti f'p < 0.001, < 0.01 għall-paraguni kollha bejn adalimumab u l-plaċebo f'Ġimgħa 2, 12 u 24
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Maltese: • epatite awtoimmuni (infjammazzjoni tal-fwied ikkawżata mis-sistema immuni tal-istess ġisem)
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Maltese: Aggravar jew bidu ġdid ta' psorjasi (li jinkludi psorjasi tat-tip palmoplantar bl-infafet) tbenġil (li jinkludi l-purpura), dermatite (li tinkludi l-ekżema),
English: 5) Clean injection site
Maltese: 3) Aħsel idejk
English: Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Indiċi ta' Bath tal-Attività tal-Marda Ankylosing Spondylitis
English: For patients who stayed on their randomised therapy, the mean (± SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 μg/mL for the Standard Dose group and 3.5 ± 2.2 μg/mL for the Low Dose group.
Maltese: Għall-pazjenti i li baqgħu jieħdu t-terapija randomised tagħhom, il-konċentrazzjonijiet minimi medji (± SD) ta' adalimumab fis-serum f'ġimgħa 52 kienu 9.5 ± 5.6 µg/mL għall-grupp li kien qed jingħata Doża Standard u 3.5 ± 2.2 µg/mL għal grupp li kien qed jingħata Doża Baxxa.
English: 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)