FrancophonIA/ELRC3.0 huggingface dataset:
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 fil-kura tattuberkulosi.
English: 10 mg eow 20 mg eow
Maltese: < 40 kg 10 mg eow 20 mg eow ≥ 40 kg 20 mg eow 40 mg eow
English: Open your sharps container so it is ready.
Maltese: M'hemmx informazzjoni disponibbli.
English: 6.4 Inject
Maltese: 6.3 Agħti l-injezzjoni
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leucopenia) have been reported with adalimumab.
Maltese: Effetti avversi tas-sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopaenia, lewkopenja) ma ġewx irrappurtati b'Kromeya.
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 fin-numru ta' ġogi attivi bl-artrite kien mantenut waqt il-perijodu OL fil-ġimgħa 156 għall-26 minn 31 (84%) pazjent fil-grupp ta' adalimumab li baqa' flistudju.
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
Maltese: Fi studji tal-marda Crohn (Crohn's disease) fl-adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mall-infezjoni meta adalimumab kienet kkombinata ma' azathioprine/6-mercaptopurine meta mqabbla ma' adalimumab waħeda.
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' minn 12.5 sa 25 mg ta' methotrexate jew kienu intolleranti għal 10 mg ta' methotrexate fil-ġimgħa.
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Maltese: Rati simili ta' titjib ġew osservati għad-dożaġġ tal-bidu ta'160/80 mg u 80/40 mg milħuqa sa ġimgħa 8 u fil-grupp tal-160/80 mg, l-effetti avversi ġew innutati b'mod aktar frekwenti.
English: • the date
Maltese: • id-data
English: Kromeya 40 mg solution for injection in pre-filled syringe EU/1/19/1357/002
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Kromeya 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/19/1357/002
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Maltese: Disturbi fil-koagulazzjoni tad-demm u fil-ħruġ tad-demm (li jinkludu żieda parzjali fil-ħin ta' thromboplastin attivat), test pożittiv ta' autoantibody (li jinkludi DNA antibody bi strand doppja), żieda fil-blood lactate dehydrogenase
English: Injector body
Maltese: Uveite mhux infettiva
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7% and 59.0%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Maltese: Ir-rati ta' rispons ta' xejn jew minimali ta' PASI 75 u PGA f'dawn il-pazjenti kienu 74.7% u 59.0% rispettivament, wara 108 ġimgħat oħra ta' terapija open-label (total ta' 160 ġimgħa).
English: Study UV I
Maltese: Studju UV I
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati fi studju kollettiv multicenter, randomizzat,u double-blind f'171 tifel u tifla (li għandhom bejn 4-17 il-sena) b'JIA poliartikulari.
English: • Abdomen (inject at least 5 centimeters away from the belly button).
Maltese: • Iż-żaqq (injetta tal-inqas 5 ċentimetri miż-żokkra).
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Maltese: M'hemmx informazzjoni disponibbli li tipparaguna adalimumab u MTX wara 16-il ġimgħa ta' terapija.
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Maltese: Kromeya jintuża għal trattament tal-artrite idjopatika poliartikulari taż-żagħżagħ fit-tfal ta' bejn 2 u 17-il sena u artrite relatata mal-entestie fir-tfal u adolexxenti ta' bejn 6 u 17-il sena.
English: 6 months 6.7% 12 months NA
Maltese: 3%/36.7%, rispettivament.
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Maltese: Tabella 7 Risponsi għall-ACR fi Provi kontrollati bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B,- NK-cells, monocyte/macrophages, and neutrophils.
Maltese: Fi studju ta' 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b'adalimumab, ma kien hemm l-ebda evidenza ta' tnaqqis ta' sensitività eċċessiva imdewma, tnaqqis tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelloli effettivi T-, B-, NK-, monoċistiċi /makrofaġi, u newtrofili.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Kromeya.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti-infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il-kura bi Kromeya.
English: Adalimumab was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
Maltese: Adalimumab ġie evalwat fuq aktar minn 3000 pazjent fil-provi kliniċi kollha tal-artrite rewmatika.
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 adalimumab-treated 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 0.38-4.52) u 16/152 (10.
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Maltese: • disturbi fin-nervituri (bħal infjammazzjoni tan-nerv tal-għajn u s-sindromu ta' Guillain-Barré,
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Maltese: Minn 342 suġġetti li oriġinarjament kienu magħżula b'mod każwali għal monoterapija bi adalimumab jew terapija kkombinata b' adalimumab /methotrexate li daħlu fl-istudju ta' estensjoni open-label, 171 suġġetti temmew 10 snin ta' trattament b'adalimumab.
English: a p Value b
Maltese: Valur p b
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Maltese: Total ta' 76.5% (218/285) tal-pazjenti li daħlu fil-perjodu tat-trattament mill-ġdid kellhom rispons ta' PGA “xejn” jew “minimali” wara 16-il ġimgħa ta' trattament mill-ġdid, irrispettivament jekk dawn irkadew matul l-irtirar (69.1% [123/178] u 88.8% [95/107] tal pazjenti li rkadew u li ma rkadewx waqt il-perjodu ta' irtirar, rispettivament).
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew stimati fil fuq minn 1,500 pazjent li jbatu mill-marda Crohn (Crohn's disease) attiva b'mod minn moderat sa sever (Indiċi tal-Attività tal-Marda Crohn (CDAI)  220 u  450) fi studji double-blind, kontrollati bil-plaċebo, li saru b'mod każwali.
English: The recommended Kromeya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Maltese: Id-doża inizjali ta' Kromeya rrakkomandata għal pazjenti adulti b'kolite ulċerattiva minn moderata sa severa, hija ta' 160 mg mogħtija f'ġimgħa 0 (mogħtija bħalaerba' injezzjonijiet ta' 40 mg f'ġurnata jew bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata għal jumejn wara xulxin) u 80 mg f'ġimgħa 2 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Vertigo and visual impairment may occur following administration of Kromeya (see section 4.8).
Maltese: Jista jkun hemm vertigo u ndeboliment fil-vista wara li tingħata Kromeya (ara sezzjoni 4.8).
English: (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 steady-state (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 concomitant methotrexate.
Maltese: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti b' artrite idjopatika poliartikulari taż-żagħżagħ (JIA) li kellhom 4 sa 17-il sena, trough steady-state medju ta' koncetrazzjoni ta' adalimumab fis-serum (valuri mkejla minn ġimgħa 20 sa 48) kien 5.6 ± 5.6 µg/mL (102 %CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 10.
English: Table 15 Efficacy response in placebo-controlled period for study nr-axSpA II
Maltese: Tabella 15 Ir-rispons tal-effikaċja fil-perjodu tal-plaċebo bħala kontroll għall-istudju nr-axSpA II
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in one 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 oħra ġie evalwat f'185 pazjent fi studju double-blind ikkontrollat wieħed bil-plaċebo ta' 12-il ġimgħa f'pazjenti b'nr axSpA attiv (punteġġ medju ta' linja bażi ta' attività ta' mard [Bath Ankylosing Spondylitis Disease Indiċi ta' Attività (BASDAI)] kien 6.4 għal pazjenti ttrattati b'adalimumab u 6.5 għal dawk fuq il-plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥ 1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: • The name on the syringe says Kromeya (Figure K).
Maltese: • L-isem fuq is-siringa jgħid Kromeya (Stampa K).
English: • a cotton ball or gauze, and
Maltese: • ballun tal-qoton jew garża, u
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Maltese: Valutazzjoni tal-psorjasi tad-dwiefer tinkludi l-Indiċi Modifikata tas-Severità tal-Psorjasi tad-Dwiefer (mNAPSI), l-Evalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 19).
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis study I, and continued adalimumab in the open-label extension trial.
Maltese: Total ta' 233 suġġetti li kienu rrispondew għal PASI 75 f'ġimgħa 16 u ġimgħa 33, irċevew terapija kontinwa ta' adalimumab għal 52 ġimgħa fi Studju Psorajiżi I, u adalimumab kontinwa fil-prova ta' estensjoni open-label.
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Maltese: F'ġimgħa 52, 42.9% tal-pazjenti li rċevew it-terapija kombinata ta' adalimumab/methotrexate laħqu titjib kliniku (DAS28 (CRP) < 2.6) meta pparagunati ma' 20.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Maltese: Valutazzjoni tal-psorjasi tad-dwiefer tinkludi l-Indiċi Modifikata tas-Severità tal-Psorjasi tad-Dwiefer (mNAPSI), l-Evalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 16).
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 fisika kienu evalwati bl-użu tal-kwestjonarji HAQS u SF-36.
English: • enthesitis-related arthritis
Maltese: • artrite relatata mal-entesite
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Maltese: Wara l-kura b' adalimumab, ġie osservat tnaqqis rapidu fil-livelli ta' sustanzi li jirreaġixxu fil-fażi akuta ta' l-infjammazzjoni (proteina C-reactive (CRP) u r-rata ta' tagħqid ta' l-eritroċit (ESR)) u cytokines fis-serum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: Table 10 Radiographic mean changes at week 52 in RA study V
Maltese: Tabella 10 Tibdil Medju Radjografiku f'Ġimgħa 52 fi Studju RA V
English: • fatty liver (build-up of fat in liver cells);
Maltese: • perforazzjoni tal-intestini (toqba fis-superfiċje tal-musrana);
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Maltese: Pazjenti li kisbu remissjoni sostnuta għal mill-inqas 12-il ġimgħa (N = 305) (ASDAS <1.3 fil-ġimgħa 16, 20, 24 u 28) matul il-perjodu open-label kienu mbagħad ‘randomised' biex jirċievu jew kura kontinwa b'adalimumab 40 mg eow N=152) jew plaċebo (N=153)
English: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight
Maltese: Artrite rewmatika, artrite psorjatika, ankylosing spondylitis jew axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis
English: Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għal aġġustament tal-pH)
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebocontrolled 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'spondyloarthrite axjali mhux radjografika (nr-axSpA).
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 mil-linja bażi f'ġimgħa 16 meta mqabbel mal-plaċebo (Studji I u II) u ma' MTX (Studju II) u dan deher fl-DLQI (Indiċi tad-Dermatoloġija dwar il-Kwalità ta' Ħajja).
English: - if your child has a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Maltese: - jekk għandek infezzjoni severa, li tinkludi t-tuberkulosi, sepsis (avvelenament tad-demm) jew infezzjonijiet opportunistiċi oħrajn (infezzjonijiet mhux tas-soltu assoċjati ma' sistema immuni dgħajfa).
English: Kromeya in combination with methotrexate, is indicated for:
Maltese: Kromeya, flimkien ma' methotrexate, huwa indikat għall-:
English: Visual impairment, conjunctivitis, blepharitis, eye swelling
Maltese: Indeboliment tal-vista, konġuntivite, blefarite, nefħa fl-għajnejn
English: 4.1 Choose an injection site (Figure J) on:
Maltese: 4.1 Agħżel sit għall-injezzjoni (Stampa J) minn:
English: How to store Kromeya
Maltese: Tużax Kromeya
English: • neuropathy (nerve damage);
Maltese: • newropatija (ħsara fin-nervi;
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab/methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Maltese: Fi studju RA V, it-titjib fl-indiċi ta' diżabilità HAQ u fil-komponent fiżiku ta' l-SF 36 wera titjib akbar (p < 0.001) għat-terapija kombinata ta' adalimumab/methotrexate versu l-kura b'methotrexate u l-kura b'adalimumab waħdu f'ġimgħa 52, liema titjib baqa' mantenut matul Ġimgħa 104.
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Maltese: Ilbiodisponibiltà medja assoluta ta' adalimumab stimata minn tliet studji wara t-teħid ta' doża waħda ta' 40 mg taħt il-ġilda kienet ta' 64%.
English: Among those, 109 subjects (63.7%) were reported to be in remission at 10 years.
Maltese: Fost dawn, 109 suġġetti (63.7%) kienu rrappurtati li kienu f'remissjoni għal 10 snin.
English: Syringe
Maltese: Tilqim
English: Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
Maltese: Tfal u adolexxenti minn 6 snin li jiżnu 15 kg jew inqas minn 30 kg
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Maltese: Fi studju UC-II, 248 pazjent irċevew 160 mg ta' adalimumab f'ġimgħa 0, 80 mg f'ġimgħa 2 u 40 mg eow min hemm 'il quddiem, filwaqt li 246 pazjent irċevew plaċebo.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Maltese: Fi studju UC-I, 390 pazjent li ma kienux ħadu antagonisti tat-TNF kienu randomizzati biex jew jirċievu l-plaċebo f'ġimgħat 0 u 2, 160 mg adalimumab f'ġimgħa 0 u wara 80 mg f'ġimgħa 2, jew 80 mg adalimumab f'ġimgħa 0 u wara 40 mg f'ġimgħa 2.
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 mit-trattament għal 36 ġimgħa u mmonitorjati għat-telf tal-kontroll tal-marda (jiġifieri aggravar tal-PGA mill-inqas 2 gradi).
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/mL (79% CV).
Maltese: Wara l-amministrazzjoni ta' 0.8 mg/kg (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lil pazjenti pedjatriċi bi psorjasi tal-plakka kronika, il-medja ± SD ta' koncetrazzjoni minimali medja fissa ta' adalimumab kienet ta' madwar 7,4 ± 5.8 g/mL (79% CV).
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: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bl-artrite rewmatika u artrite psorjatika fejn il-pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żieda fil-livelli ta' lALT ≥ 3 x ULN f'3.7% tal-pazjenti trattati b'adalimumab u f'1.6% tal-pazjenti trattati bil-kontroll.
English: Paediatric Crohn's disease
Maltese: Il-marda Crohn (Crohn's Disease)
English: • pulmonary fibrosis (scarring of the lung);
Maltese: • fibrożi fil-pulmun (marki fil-pulmun)
English: A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an openlabel extension study.
Maltese: Total ta' 347 suġġetti li rrispondew b'mod stabbli, ħadu sehem f'evalwazzjoni tal-irtirar u trattament mill-ġdid fi studju ta' estensjoni open-label.
English: Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Maltese: Ġimgħa 2 Ġimgħa 12 Ġimgħa 24 ***,** Statistikament sinifikanti f'p < 0.001, <0.01 għall-paraguni kollha bejn adalimumab u l-plaċebo f'ġimgħat 2, 12 u 24 a Stima f'Ankylosing Spondylitis b
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Maltese: Il-punt tat-tmiem primarju kien il-bidla perċentwali mill-linja bażi sa ġimgħa 12 fin-numru ta' ġogi attivi bl-artrite (nefħa mhux minħabba sfigurazzjoni jew ġogi li madhomx jiċċaqalqu flimkien ma' wġigħ u/jew sensittività), li kien milħuq b'perċentwali medja ta' tnaqqis ta' -62.6% (bidla perċentwali medja -88.9%) f'pazjenti fil-grupp ta' adalimumab meta kkumparat ma' -11.6% (bidla perċentwali medja -50.0%) f'pazjenti fil-grupp tal-plaċebo.
English: Week 52
Maltese: Ġimgħa 52
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Maltese: L-effikaċja ta' adalimumab kienet evalwata fi studju każwali, double-blind, ikkontrollat ta' 114-il pazjent pedjatriku minn 4 snin il-fuq bi psorjasi tal-plakka severa kronika (kif definit minn involviment tal- Evalwazzjoni Globali tat-Tobba (PGA) ≥ 4 jew > 20% BSA jew > 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew Qasam tal-Psorjasi u Indiċi tas-Severità (PASI) ≥ 20 jew ≥ 10 bi klinikament rilevanti involviment tal-wiċċ, ġenitali, jew idejn/saqajn) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: Kromeya is used to treat psoriatic arthritis in adults.
Maltese: Kromeya jintuża għal trattament ta' artrite psorjatika fl-adulti.