FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.3 Gently push the white plunger rod all the way down until the syringe is empty.
Maltese: 6.1 Bl-id l-oħra, oqros liwja ta' ġilda mnaddfa u żommha.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Maltese: Artrite idjopatika poliartikulari taż-żagħżagħ u l-artrite relatata mal-entesite
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 pedjatriċi b'uveite kienet imbassra bl-użu ta' mudellar farmakokinetiku tal-popolazzjoni u simulazzjoni bbażata fuq farmakokinetika ta' indikazzjoni minn pazjenti pedjatriċi oħra (psorijasi pedjatrika, artrite idjopatika minorenni, marda ta' Crohn pedjatrika u artrite relatata mal-entesite).
English: • < 40 kg: 20 mg every week
Maltese: • < 40 kg: 20 mg kull ġimgħa
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 bi durazzjoni ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 x ULN seħħew f'1.8% tal-pazjenti ttrattati b'adalimumab u 1.8% tal-pazjenti ttrattati kkontrollati.
English: CD study II: Infliximab experienced patients
Maltese: Studju II ta' CD: Pazjenti li kienu diġà ħadu infliximab qabel
English: Lupus-like syndrome
Maltese: Sindromu bħal ta' lupus
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide u ilma għall-injezzjonijiet.
English: The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati f'zewgt studji (pJIA I and II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż-żagħżagħ, u li kellhom varjeta ta' bidu ta' JIA (l-aktar frekwenti fattur rewmatoloġiku negattiv jew poli-artrite pożittiva u oligo-artrite fit-tul.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA/I
English: Ankylosing Spondylitis Disease Activity Score
Maltese: Punteġġ tal-Attività ta' Ankylosing Spondylitis Disease d
English: Without MTX
Maltese: Mingħajr MTX
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: d score methotrexate
Maltese: SPARCC spinaMRI
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 riżultat totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju għall-mard speċifiku dwar il-marda ta' l-infjammazzjoni tal-musrana (IBDQ), u dan f'pazjenti li ġew magħżula b'ordni addoċċ u ngħataw 80/40 mg u 160/80 mg adalimumab meta mqabbel mal-plaċebo, u dan deher f'ġimgħat 26 u 56 fi studju CD III, kif ukoll filgruppi tal-kura b'adalimumab meta mqabbla mal-grupp tal-plaċebo.
English: Placebo /MTX (N = 37)
Maltese: Plaċebo (N = 37)
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenja, anemija aplastika, avvenimenti li jeffetwaw il-myelin b'mod ċentrali jew periferali u rapporti ta' lupus, kundizzjonijiet relatati ma lupus u s-sindromu ta' StevensJohnson.
English: Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis c
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 < 40 kg (80/40 mg).
Maltese: 7±6.6 g/ml għall-pazjenti 40 kg (160/80 mg) u 10.
English: Immune system disorders* Common
Maltese: Disturbi fis-sistema immuni*
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 27).
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 27).
English: Hepatic or renal impairment
Maltese: Ivvjaġġar/infezzjoni rikorrenti
English: Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Maltese: Kromeya huwa ndikat għall-trattament ta' intermedja, posterjuri u panuveite mhux infettiva f'pazjenti adulti li ma kellhomx rispons adegwat għal kortikosterojdi, f'pazjenti fl-użu meqjus talkortikosterojdi, jew li fihom it-trattament b'kortikosterojdi mhux xieraq.
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 kontrollati 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 f'ALT ta' ≥ 3 x ULN f'6.1% tal-pazjenti trattati b'adalimumab u 1.3% tal-pazjenti trattati bil-kontroll.
English: Clinical remission 12% 24% 36%*
Maltese: Ġimgħa 12 14% 58% Ġimgħa 24 15% 57%
English: Table 9 Radiographic mean changes over 12 months in RA study III
Maltese: Tabella 9 Tibdil Medju Radjografiku fuq perjodu ta' 12 -il xahar fi Studju RA III
English: • rheumatoid arthritis,
Maltese: • artrite rewmatika
English: • psoriatic arthritis,
Maltese: • artrite psorjatika
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Maltese: Fost dawk li rrispondew (ACR Pedjatriku 30) f'ġ imgħa 24 (n=27 minn 30 pazjent), ir-rispons tal-ACR Pedjatriku 30 kien mantenut sa 60 ġimgħa fil-fażi
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 a
Maltese: Titjib kliniku hu l-punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ > 1; Rispons kliniku huwa tnaqqis mill-linja bażi fil-punteġġ Mayo ta' ≥3 punti u ≥30% flimkien ma' tnaqqis fil-fsada rektali b'sottopunteġġ [RBS] ta' ≥1 jew RBS assolut ta' 0 jew 1;
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease and ulcerative colitis after treatment with adalimumab.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil-livelli ta' CPR f'pazjenti jbatu min artrite idjopatika poliartikulari taż-żagħżagħ, mill-marda ta' Crohn u kolite ulċerattiva wara trattament b' adalimumab.
English: In adult patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/mL during the induction period.
Maltese: F'pazjenti adulti li għandhom kolite ulċerattiva, id-inizjali ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 g/ml matul il-perijodu tal-bidu .
English: p-value
Maltese: Valur P
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
Maltese: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra lplaċebo ** p < 0.02 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra lplaċebo a
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Maltese: Dożi stabbli ta' aminosalicylates, kortikosterojdi, u/jew aġenti immunomodulatorji mittieħda fl-istess waqt, kienu permessi u 80% tal-pazjenti komplew jirċievu mill-inqas waħda minn dawn il-mediċini.
English: Sustained mucosal healing
Maltese: Uveite mhux nfettiva
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Maltese: It-titjib kliniku (definit bħala Punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ > 1) ġie evalwat f' ġimgħa 8.
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease.
Maltese: Studju UV II evalwa 226 pazjent b'uveite inattiv li jeħtieġu trattament kroniku ta' kortikosterojdi (prednisone orali 10 sa 35 mg/kuljum) fil-linja bażi għall-kontroll tal-marda tagħhom.
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Maltese: Hypokalaemia, żieda fl-aċtu uriku, is-sodju fid-demm ikun arormali, ipokalċimija, ipergliċemija, ipofosfatemija, deidratazzjoni
English: • polyarticular juvenile idiopathic arthritis
Maltese: • artrite attiva idjopatika poliartikulari taż-żagħżagħ
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: PASI 75 rispons ta' 78.9% (15 minn 19-il suġġett) u PGA xejn jew minimali ta' 52.6% (10 minn 19-il suġġett).
English: Table 11 Radiographic mean changes over 12 months in RA study III
Maltese: Tabella 11 Tibdil radjografiku medju fuq perjodu ta' 12-il xahar fi studju RA III
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising,
Maltese: • sinjali u sintomi li għandhom x'jaqsmu ma' disturbi tad-demm bħal deni persistenti, tbenġil,
English: • an alcohol pad (included in the box)
Maltese: • kuxxinett tal-alkoħol (inkluż fil-kaxxa)
English: Week 56
Maltese: Ġimgħa 56
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: Il-frekwenza ta' infezzjonijiet serji (3.7%) f'pazjenti li għandhom aktar minn 65 sena u kkurati b' adalimumab, kienet akar għolja mill-frekwenza ta' infezzjonijiet f'pazjenti taħt il-65 sena (1.5%).
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, ,blastomycosis, coccidioidomycosis,
Maltese: Fi studji kontrollati u open-label b' adalimumab fl-adulti u fit-tfal, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulosi (inklużi tuberkulosi b'ħafna għoqod tuberkulari mal-ġisem kollu u tuberkulosi f'postijiet barra mill-pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa jew barra l-pulmun, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis aspergillosis u listeriosis).
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Maltese: Titjib fil-kwalità tal-ħajja rrelatata mas-saħħa u funzjoni fiżika nżamm matul l-estensjoni open-label sa ġimgħa 156.
English: Adalimumab was assessed in a multicenter, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Maltese: Din il-prova saret f'192 suġġetti pedjatriċi li għandhom bejn 6 u 17 (inkluż) -il sena, bil-marda Crohn (CD) moderata sa severa definita bħala riżultat tal-Indiċi talAttività tal-marda Crohn (Crohn's disease) fit-tfal (PCDAI) > 30.
English: JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1)
Maltese: Minn 8 sa 12 il-sena 71 (41.5)
English: Week 16 placebo-controlled
Maltese: 16-ilĠimgħa bi plaċebo bħala kontroll
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Maltese: Fil-gruppi kollha ta' trattament, il-punteġġ medju PASI tal-linja bażi kien ta' 18.9 u punteġġ tal-PGA tal-linja bażi varja minn “moderati” (53% tassuġġetti inklużi) għal “sever” (41%) għal “sever ħafna” (6% ).
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, dyspnoea, cough
Maltese: Ażżma, dispneja, sogħla
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 qed tgħaddi l-awrina, tħossok dgħajjef jew għajjien jew tisgħol;
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 adalimumab.
Maltese: Infezzjonijiet fatali u infezzjonijiet li jistgħu jpoġġu l-ħajja fil-periklu, (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), riattivazzjoni tal-HBV u tumuri malinni oħra (li jinkludu lewkimja, limfoma u HSTCL) gew irrapurtati ukoll bl-użu ta' adalimumab.
English: Kromeya dose for patients with polyarticular juvenile idiopathic arthrtis
Maltese: Kromeya jintuża biex jittratta artrite rewmatika fl-adulti.
English: Among those, 86 patients (75.4%) had ACR 20 responses; 72 patients (63.2%) had ACR 50 responses; and 41 patients (36%) had ACR 70 responses.
Maltese: 72 pazjent (63.2%) kellhom rispons għal ACR 50; u 41 pazjent (36%) kellhom rispons għal ACR 70.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use in single-use vial 0.8 mL solution in vial (type I glass) with a rubber stopper (synthetic rubber) and aluminium crimp seal.
Maltese: Kromeya 40 mg/8 mL soluzzjoni għall-injezzjoni (injezzjoni) għall-użu pedjatriku jiġi bħala soluzzjoni sterili ta' 0.8 mL ċara u mingħajr kulur ta' 40 mg adalimumab.
English: Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Maltese: Bejn wieħed u ieħor 40% tal-pazjenti fi studju UC-II kellhom trattament qabel b'anti-TNF u li ma ħadimx.
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.
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) milli dawk każwali għal 0.4 mg/kg eow jew MTX.
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 14 and 15).
Maltese: Fl-istudji Psorajisi I u II, punt ta' tmiem primarju kien il-proporzjon ta' pazjenti li kisbu rispons ta' PASI 75 mill-linja bażi f'Ġimgħa 16 (ara t-Tabelli 14 u15).
English: There is limited experience in the initiation of treatment with adalimumab alone.
Maltese: Hemm esperjenza limitata filbidu tat-trattament b'adalimumab waħdu.
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (< 1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Maltese: Fil-gruppi kollha ta' kura, il-linja bażi medja tarriżultat ta' l-PASI kienet ta' 19.7 u l-linja bażi tar-riżultat PGA varjat minn “ħafif” (<1%) għal “moderat” (48%) għal “sever” (46%) għal “sever ħafna” (6%).
English: Side effects may occur up to 4 months or more after the last Kromeya injection.
Maltese: L-effetti sekondarji jistgħu ifeġġu sa mill-inqas 4 xhur wara laħħar injezzjoni bi Kromeya.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Kromeya and is positive for antibodies against double-stranded DNA, further treatment with Kromeya should not be given (see section 4.8).
Maltese: Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis-sindromu tal-lupus wara li tkun ingħatat kura bi Kromeya, u jkun pożittiv għall-anti-korpi kontra DNA li hi double stranded, m'għandhiex tingħata aktar kura bi Kromeya (ara sezzjoni 4.8).
English: Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Maltese: Kromeya huwa indikat għall-kura ta' artrite attiva relatata mal-entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jitollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: Solution for injection 2 pre-filled pens 2 alcohol pads 6 pre-filled pens 6 alcohol pads
Maltese: Soluzzjoni għall-injezzjoni 2 pinen mimlijin għal-lest 2 kuxxinetti bl-alkoħol 6 siringi mimlijin ħal-lest 6 kuxxinetti tal-alkoħol
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 12).
Maltese: Fi studju RA V, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (ara Tabella 12).
English: • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Maltese: • axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis
English: Following the administration of 24 mg/m
Maltese: Wara t-teħid ta' 24 mg/m
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 bil-marda ta' Crohn, id-doża ta' tagħbija ta' 80 mg adalmumab f'ġimgħa 0 segwita minn 40 mg adalimumab fi ġimgħa 2 tilħaq konċentrazzjonijiet ta' adalimumab fis-serum ta' madwar 5.5 μg/mL matul il-perjodu ta' induzzjoni.
English: By Week 68, patients receiving continuous Kromeya treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Maltese: Sal-ġimgħa 68, pazjenti li kienu qed jirċievu trattament kontinwa b'Kromeya wrew titjib statistikament sinifikanti akbar tas-sinjali u s-sintomi ta' nr-axSpA meta mqabbla ma' pazjenti allokati għal irtirar ta' trattament matul il-perjodu double-blind tal-istudju (Tabella 15).
English: • 80 mg at week 0 and 40 mg at week 2
Maltese: • 80 mg f'ġimgħa 0 and 40 mg f'ġimgħa 2
English: Kromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Kromeya huwa indikat għall-trattament ta' psorijasi tat-tip li tikkawża qoxra mhux normali fuq ilġilda, li hi minn moderata sa severa, f'pazjenti adulti li li huma kandidati għal terapija sistemika.
English: Results from the overall UC-II study population are shown in Table 26.
Maltese: Riżultati ġenerali li ħarġu mill-popolazzjoni tal-istudju UC-II huma preżentati f'Tabella 26.
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: Table 12 Ped ACR 30 responses in the JIA study
Maltese: Tabella 12 Rispons PedACR 30 fl-istudju JIA
English: kg
Maltese: UŻU
English: Children, adolescents and adults from 6 years of age weighing 40 kg or more
Maltese: Tfal, adolexxenti u adulti minn 6 snin li jiżnu 40 kg jew aktar
English: Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Maltese: Mill-417-ilsuġġett inklużi fl-estensjoni mhux ikkontrollata fit-tul tal-istudji UV I u UV II, 46 individwu kienu meqjusa ineliġibbli (eż. kumplikazzjonijiet żviluppati sekondarji għal retinopatija dijabetika, minħabba kirurġija tal-katarretti jew vitrectomy) u kienu esklużi mill-analiżi primarja taleffikaċja.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Maltese: Huwa maħsub li l-psorajisi tiġi kkawżata minn problema fis-sistema immuni tal-ġisem li twassal għal produzzjoni akbar ta' ċelluli tal-ġilda.
English: Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Maltese: Pazjenti li żammew rispons  PASI 75 f'ġimgħa 33 u li kienu oriġinarjament f'terapija każwali għal terapija attiva filPerjodu A, kienu reġgħu ġew randomizzati fil-perjodu C biex jirċievu 40 mg adalimumab ġimgħa iva u ġimgħa le jew plaċebo għal 19-il ġimgħa oħra.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Maltese: • disturbi fl-immunità li jistgħu jeffetwaw il-pulmun, ġilda u in-nodi tal-limfa (komunement kondizzjoni msejħa sarcoidosis);