FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the observed data approach, 216 (80.3%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 178 (66.2 %) were in steroid-free quiescence.
Maltese: Ibbażat fuq l­approwċ tad­dejta osservat, 216 (80.3%) kienu f'sekwenza (l­ebda leżjoni infjammatorja attiva, grad ta' ċellula AC ≤ 0.5+, VH grad ≤ 0.5+) b'doża ta' sterojdi konkomitanti ≤ 7.5 mg kuljum, u 178 (66.2%) kienu bla kwiesċenza ta' sterojdi.
English: • Abdomen (inject at least 5 centimeters away from the belly button).
Maltese: • Iż­żaqq (injetta tal­inqas 5 ċentimetri miż­żokkra).
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Maltese: Fi studju ta' estensjoni open­label, għal pazjenti li d­doża eskalat minn 40 mg ġimgħa iva u ġimgħa le għal 40 mg kull ġimgħa minħabba rispons PASI taħt 50%, 26.4% (92/349) u 37.8% (132/349) tal­ pazjenti kisbu rispons ta' PASI 75 f'ġimgħa 12 u 24, rispettivament.
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Maltese: Studju RA IV evalwa primarjament is-sigurtà tal-prodott f'636 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 ­il sena.
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Maltese: Titjib statistikament u klinikament sinifikanti mil­linja bażi kien wkoll osservat fiż­żewġ gruppi tat­ trattament għal parametri tal­kwalità tal­ħajja (inkluż IMPACT III).
English: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists.
Maltese: Rapporti rari ta' panċitopenja, inkluża anemija aplastika, ġew irrappurtati b'antagonisti tat­TNF.
English: Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Maltese: Tabella 16 Rispons għall-ACR fi studji tal-artrite psorjatika kontrollati bil-Plaċebo (persentaġġ ta' pazjenti)
English: Table 27 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission Standard dose 40/20 mg eow
Maltese: Tabella 27 Studju ta' CD fit-tfal Twaqqif tal-kortikosterojdi jew immunomodulaturi u fejqan tal-fistla Doża standard 40/20 mg eow
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Maltese: • kanċer, li jaffetwa s­sistema limfatika (limfoma) u melanoma (tip ta' kanċer tal­ġilda);
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa anti­korp uman monoklonali rikombinanti prodott fiċ­ċelluli tal­ovarji tal­ħamster ċiniż.
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA<10% and ≥5% (40% of patients)).
Maltese: Adalimumab wriet benefiċċju tat­ trattament f'pazjenti b­psorjasi tad­dwiefer bi gradi differenti ta' involvement tal­ġilda (BSA≥10% (60% tal­pazjenti) u BSA‹10% u ≥5% (40% tal­pazjenti)).
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Maltese: Matul il­fażijiet kontrollati ta' provi pivitali ta' adalimumab fl­adulti li damu sejrin mill­inqas 12 ­il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, infjammazzjoni tal­vertebri li jirriżulta fil­vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorijasi, hidradenitis suppurativa, mill­ marda Crohn (Crohn's disease), mill­kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal­ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' konfidenza) ta' 6.8 (4.4, 10.5) kull 1,000 sena ta' pazjent fost 5,291 pazjent ikkurat b'Idacio, kontra rata ta' 6.3 (3.4, 11.8) kull 1,000 sena ta' pazjent fost 3,444 pazjent kontrollat (il­medja tat­tul tal­kura kienet ta' 4.0 xhur għal adalimumab u 3.8 xhur għal pazjenti mogħtija kura kontrollata).
English: • Merkel cell carcinoma (a type of skin cancer);
Maltese: • karċinoma taċ­ċelloli Merkel (tip ta' kanċer tal­ġilda);
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Maltese: Il­ konċentrazzjoni ta' adalimumab fil­fluwidu sinovjali ta' ħafna pazjenti li jbatu minn artrite rewmatika varjaw minn 31-96% minn dawk fis-serum.
English: The primary endpoint was ‘time to treatment failure'.
Maltese: Il­punt tat­tmiem primarju kien ‘iż­żmien għall­falliment tat­trattament'.
English: Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment.
Maltese: Mit­364 pazjent li fadal, 269 pazjent evalwabbli (74%) laħqu 78 ġimgħa ta' trattament b'adalimumab open-label.
English: Table 21 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission Standard dose 40/20 mg eow
Maltese: Tabella 21 Studju ta' CD fit-Tfal Twaqqif tal-kortikosterojdi jew immunomodulaturi u fejqan tal-fistla Doża standard 40/20 mg eow
English: • a cotton ball or gauze, and
Maltese: • ballun tal­qoton jew garża, u
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome) 1)
Maltese: Sklerosi multipla, disturbi li jeffetwaw il-myelin (bħal newrite fl­ għajnejn, sindromu ta' Guillain-Barré) 1)
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Maltese: 6%) kellhom rispons għall­ACR 20; 127 pazjent (74.7%) kellhom rispons għall­ACR 50; u 102 pazjent (60.0%) kellhom rispons għall­ACR 70.
English: Adalimumab 40 mg weekly
Maltese: Adalimumab 40 mg Kull
English: Note: P = Placebo (number at risk (flared)); A = Adalimumab (number at risk (flared)).
Maltese: Nota: P = Plaċebo (numru f'Riskju (flared)); A = ADALIMUMAB (numru f'riskju (flared)).
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Maltese: Jekk ikun hemm suspett ta' tuberkulosi rieqda, għandu jiġi kkonsultat tabib li jkun espert fil­kura tat­ tuberkulosi.
English: HS study II
Maltese: Studju HS II
English: Idacio is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Idacio huwa kontro­indikat f'pazjenti li jbatu minn insuffiċjenza tal­qalb minn moderata sa severa (ara sezzjoni 4.3).
English: HS Study I
Maltese: Studju HS I
English: Metabolism and nutrition disorders
Maltese: Disturbi fil­metaboliżmu u n-nutrizzjoni
English: Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
Maltese: Eċċipjenti: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodoium citrate, polysorbate 80, sodium hydroxide u ilma għall­ injezzjonijiet.
English: Fever, bruising, bleeding or looking pale
Maltese: Indeboliment tal-vista, konġuntivite, blefarite, nefħa fl­għajnejn
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il­persentaġġ ta' pazjenti li ma avvanzatilhomx il­marda (bidla mil­linja bażi fit­tibdil tal­Puteġġ Totali Sharp  0.5) kien sinifikament ogħla bit­terapija kombinata ta' adalimumab/methotrexate (63.8% u 61.2% rispettivament) meta pparagunat ma' kura b' methotrexate waħdu (37.4% u 33.5% rispettivament, p<0.001) u kura b'adalimumab waħdu (50.7%, p < 0.002 u 44.5%, p < 0.001 rispettivament).
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Idacio cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir­riskju li tiżviluppa hepatosplenic T­cell lymphoma f'pazjenti ttratati b' Idacio (ara sezzjoni 4.8).
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 xejn jew minimali kienu irtirati mit­trattament għal 36 ġimgħa u mmonitorjati għat­telf tal­kontroll tal­marda (jiġifieri aggravar tal­PGA mill­inqas 2 gradi).
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Maltese: Titjib fin­numru ta' ġogi attivi bl­artrite kien mantenut waqt il­ perijodu OL fil­ġimgħa 156 għall­26 minn 31 (84%) pazjent fil­grupp ta' adalimumab li baqa' fl­ istudju.
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Maltese: Studju RA II evalwa 544 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena u li ma kinux irrispondew għal kura b'mill­inqas mediċina waħda anti­ rewmatika li taffetwa l­proċess tal­mard.
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Maltese: Falliment tat­ trattament kien definit minn eżitu multi­komponent ibbażat fuq infjammazzjoni tal­chorioretinal u/jew infjammazzjoni tal­leżjonijiet vaskulari tar­retina, grad taċ­ċelloli tal­kompartiment anterjuri (AC), grad taċ­ċpar vitriju (VH) u l­aqwa akutezza kkoreġuta tal­vista (BCVA).
English: Psoriasis study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Maltese: Studju Psorajisi II (CHAMPION) qabbel l­effikaċja u s­sigurtà ta' adalimumab kontra methotrexate u plaċebo f'271 pazjent.
English: Other medicines and Idacio
Maltese: Mediċini oħra u Idacio
English: Idacio is available in other presentations.
Maltese: Idacio huwa disponibbli fi preżentazzjonijiet oħra.
English: PsA study II with 12 -week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Maltese: Studju PsA II li dam 12 ­il ġimgħa, tratta 100 pazjent li kellhom rispons mhux adegwat għat­terapija DMARD.
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Maltese: Rispons kliniku (CR-100) Pazjenti li kellhom titjib mingħajr sterojdi għal >=90 ġurnataa
English: Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Idacio huwa ndikat għall­trattament ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw kura konvenzjonali li tinkludi kortikosteroidi u 6­ mercaptopurine (6­MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it­terapiji.
English: Idacio 40 mg/0.8 mL solution for injection for paediatric use may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Maltese: Idacio 40 mg/0.8 mL soluzzjoni għall­injezzjoni għal użu pedjatriku jista' jinżamm f'temperaturi sa massimu ta' 25°C għal perijdu ta' 14­il jum.
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Il­pożoloġija ta' adalimumab f'dawn il­pazjenti ġiet iddeterminata minn mudellar u simulazzjoni farmakokinetika (ara sezzjoni 5.2).
English: Adolescents from 12 to 17 years of age weighing 30 kg or more
Maltese: Adolexxenti minn 12 sa 17-il sena li jiżnu 30 kg jew aktar
English: Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Maltese: Żidiet statistikament sinifikanti (titjib) mil­linja bażi sa ġimgħa 26 u 52 fl­Indiċi tal­Massa tal­Ġisem u l­veloċità tat­tul kienu osservati fiż­żewġ gruppi tat­trattament.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt trattament ta'manutenzjoni kortikosteroidi jistgħu jigu mnaqqsa bil­mod skont il­linji gwida tal­ prattika klinika.
English: Lot
Maltese: Ras
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil­livelli ta' CPR f'pazjenti jbatu min artrite idjopatika poliartikulari taż­żagħżagħ, mill­marda Crohn (Crohn's disease), kolite ulċerattiva u hidradenitis suppurativa wara trattament b' adalimumab.
English: • pleural effusion (abnormal collection of fluid in the pleural space);
Maltese: • effuzjoni plewrali (żamma mhux normali tal­ilma fl­ispazju plewrali);
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Maltese: Il­frekwenza ta' infezzjonijiet serji (3.7%) f'pazjenti li għandhom aktar minn 65 sena u kkurati b' adalimumab, kienet akar għolja mill­frekwenza ta' infezzjonijiet f'pazjenti taħt il­65 sena (1.5%).
English: Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Maltese: Nota: Il­falliment tat­trattament fi jew wara ġimgħa 6 (studju UV I), jew fi jew wara ġimgħa 2 (studju UV II), kien magħdud bħala avveniment.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Artrite Psorjatika u axial spondyloarthritis inkluż ankylosing spondylitis
English: • The name on the syringe says Idacio (Figure K).
Maltese: • L­isem fuq is­siringa jgħid Idacio (Stampa K).
English: Musculoskeletal pain
Maltese: Uġigħ muskolu­skeletrali
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12-il sena, li jiżnu mill-anqas 30kg) M'hemm l­ebda provi kliniċi b'adalimumab f'pazjenti adolexxenti bi HS.
English: Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Maltese: Kien hemm titjib sinifikanti mil­linja bażi f'ġimgħa 16 meta mqabbel mal­plaċebo (Studji I u II) u ma' MTX (Studju II) u dan deher fl­DLQI (Indiċi tad­Dermatoloġija dwar il­Kwalità ta' Ħajja).
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of ≥ 30% in no more than 1 of the 6 criteria.
Maltese: Il­ kriterji li jiddefinixxu li l­marda tmur għal­agħar huma li tmur lura b'  30% mill linja bażi f'  3 minn 6 kriterji prinċipali ta' ACR pedjatriċi  2 ġogi attivi, u titjib ta'  30% f'mhux aktar minn 1 minn 6 kriterji.
English: Psoriasis study I (REVEAL) evaluated 1212 patients within three treatment periods.
Maltese: L-istudju tal-psorijasi I (REVEAL) evalwa 1212 pazjent fi tliet perijodi ta' kura.
English: After 5 years of adalimumab therapy, 74.0% (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0% (46/50) of patients continued to be in clinical response per PCDAI.
Maltese: Wara 5 snin ta' terapija b'adalimumab, 74.0% (37/50) tal-50 pazjent li fadal fl-istudju kompla jkun fil remissjoni klinika, u 92.0% (46/50) tal­pazjenti komplew ikollhom rispons kliniku għal kull PCDAI.
English: Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall­aġġustament tal­pH)
English: 4.3 Pull the needle packaging off.
Maltese: 4.3 Neħħi l­ippakkjar tal­labra minnha.
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Maltese: 117/276 pazjent minn studju CD I u 272/777 pazjent minn CD II u III kienu segwiti għal mill­anqas 3 snin ta' terapija open-label ta' adalimumab. 88 u 189 pazjent, rispettivament, komplew bil-fejqan kliniku tagħhom.
English: Injection button
Maltese: Uveite mhux infettiva
English: Impaired healing * 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 f'sezzjonijiet 4.3, 4.4 u 4.8 ** li jinkludu l-istudji ta' estensjoni open-label
English: Thirty-three (18%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Maltese: Tlieta u tletin (18%) pazjent kienu kkurati fl­istess ħin b'mediċini anti­rewmatiċi li jimmodifikaw il­ marda, u 146 (79%) pazjent b'NSAIDs fil­linja bażi.
English: 1.7 Leave the syringe at room temperature for 30 minutes to allow the medicine to warm up.
Maltese: 1.7 Ħalli s­siringa fit­temperatura ambjentali tal­kamra għal 30 minuta biex tippermetti l­mediċina tisħon.
English: 1 sterile injection syringe 1 sterile needle 1 vial adaptor 2 alcohol pads
Maltese: Kull kaxxa fiha kunjett 1, siringa tal-injezzjoni sterili 1, labra sterili 1, adapter tal-kunjett 1 u 2 kuxxinetti bl­alkoħol.
English: No dose-limiting toxicity was observed during clinical trials.
Maltese: L­ebda tossiċità li tillimita d­doża ma ġiet osservata matul il­provi kliniċi.
English: • pain in the muscles.
Maltese: • uġigħ fil­muskoli.
English: Table 18: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Maltese: Tabella 18: Proporzjon ta' pazjentia li kisbu HiSCRb f'ġimgħat 24 u 36 wara
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Maltese: Dawn it­terapiji jinkludu methotrexate, leflunomide, hydroxychloroquine, sulfasalazine u/jew sustanzi tad­deheb.
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) 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: Ir­rata (95% intervall ta' konfidenza) ta' limfomi kienet ta' 0.7 (0.2, 2.7) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
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 fin­naħa ta' isfel u fin­naħa ta' fuq tas-sistema respiratorja, pnewmonja, sinożite, fariniġite, rinofarinġite u pnewmonja virali tal-herpes)
English: INFORMATION IN BRAILLE Idacio 40 mg
Maltese: Idacio 40 mg
English: The following side effects have been observed with adalimumab:
Maltese: L­effetti sekondarji li ġejjin ġew osservati b'adalimumab:
English: joints and other organ systems);
Maltese: tal­pulmun, tal­ġogi u ta' sistemi ta' organi oħra);
English: • neuropathy (nerve damage);
Maltese: • newropatija (ħsara fin­nervi;
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 µg/ml.
Maltese: Wara amministrazzjoni ta' 40 mg ta' adalimumab kull ġimgħa supplenti ta' adolimumab f'pazjenti adulti mhux radjografiċi spondyloarthritis axjali, il­medja (± SD) ħawt (trough) ta' konċentrazzjoni ta' stat stabbli f'Ġimgħa 68 kienet ta' 8.0 ± 4.6 μg/mL.
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double- masked, placebo-controlled studies (UV I and II).
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab ġew ivvalutati f'pazjenti adulti bi intermedja, posterjuri u panuveite mhux infettiva, esklużi pazjenti b'uveite anterjuri iżolati, f'żewġ studji każwali, doublemasked, ikkontrollati bi plaċebo (UV I u II).
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Maltese: puntu tat­tmiem sekondarji bħal numru ta' siti ta' entestie, għadd ta' ġogi sensttivi (TJC), għadd ta' ġogi minfuħa (SJC), rispons Pedjatriku ACR 50, u rispons Pedjatriku ACR 70.
English: • A sharps container (see section 7.2).
Maltese: • Reċipjent għar­rimi tal­ixfafar (ara sezzjoni 7.2).
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Maltese: It­terapija kombinata b'adalimumab/methotrexate kienet klinikament u statistikament superjuri għal methotrexate (p < 0.001) u adalimumab mogħtija waħedhom bħala kura (p < 0.001) fit­tilħiq ta'stat baxx ta' mard f'pazjenti li kienu ġew riċentament iddijanjostikati b'artrite rewmatika minn moderata sa severa.
English: Yellow syringe connector
Maltese: Konnettur isfar għas­ siringa
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 l­Prodott tqiegħed fis­suq, kienu irrapurtati każijiet rari ta' hepatosplenic T­cell lymphoma f'pazjenti trattati b' adalimumab (ara sezzjoni 4.4).
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centeradjusted rate b p<0.001, adalimumab vs. placebo
Maltese: 506 (62.2)b a Perċentaġġ ta' pazjenti li kisbu rispons ta' PASI75 ġie kkalkulat bħala r­ rata aġġustata fiċ­ċentru b p<0.001, adalimumab vs. placebo
English: Vertigo and visual impairment may occur following administration of Idacio (see section 4.8).
Maltese: Jista jkun hemm vertigo u ndeboliment fil­vista wara li tingħata Idacio (ara sezzjoni 4.8).