FrancophonIA/ELRC3.0 huggingface dataset:
English: Adalimumabb N=113
Maltese: N=113
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 × 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 × ULN f'6.1 % tal-pazjenti trattati bi adalimumab u 1.3 % tal-pazjenti trattati bil-kontroll.
English: HRa
Maltese: TIKKETTAR
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Maltese: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ± 4.3 μg/mL meta adalimumab kien użat flimkien ma' methotrexate.
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 leħqu PGA ta' ‘ċar' jew ‘kważi ċar' għal psorijasi fl-idejn u/jew fis-saqajn meta mqabbel mal-pazjenti li rċevew il-plaċebo (30.6 % kontra 4.3 %, rispettivament [p = 0.
English: Results from the overall UC-II study population are shown in Table 28.
Maltese: Riżultati ġenerali li ħarġu mill-popolazzjoni tal-istudju UC-II huma preżentati f'Tabella 28.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Maltese: F'Ġimgħa 4, il-pazjenti kienu magħżula b'mod każwali 1:1 għal doża ta' manteniment Standard (40/20 mg eow) jew Baxxa (20/10 mg eow) fil-grupp ta' nies li qed jieħdu l-kura fuq bażi tal-piż tal-ġisem tagħhom.
English: Crohn's disease
Maltese: Il-marda Crohn (Crohn's Disease)
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu ġew studjati fi studju tat-tip multiċentru, b'mod każwali, double-blind f'46 pazjenti pedjatriċi (6 sa 17-il sena) b'artrite moderata relatata mal-entesite.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3441 li kienu kkurati b'adalimumab fl-istudji kollha tal artrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindromu li jixbaħlis-sindromu tal-lupus.
English: Blood and the lymphatic system disorders*
Maltese: Disturbi tad-demm u tassistema limfatika*
English: Imraldi is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Maltese: Imraldi huwa intenzjonat għall-kura tal-artrite attiva idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite.
English: Clinical remission Clinical response
Maltese: Rispons Kliniku
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 individwi adulti li jbatu minn artrite rewmatika u li kienu kkurati b'adalimumab jew bil-plaċebo, ġew osservati risponsi simili ta'anti-korpi għat-tilqima pnewmokokkali b'vaċċin standard 23-valent u t-tilqima tal-virus trivalenti tal-influwenza.
English: I − V. In these trials, 11.9 % of patients treated with adalimumab and 8.1% of placebo and active control treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Maltese: F'dawn ilprovi, 11.9 % tal-pazjenti kkurati b'adalimumab u 8.1 % tal-pazjenti kkurati bil-plaċebo u bis-sustanza attiva użata bħala kontroll, li bdew bl-livelli tal-anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi f'ġimgħa 24.
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Maltese: Ilkażijiet l-oħra kienu tumuri malinni oħra u inkludew malinni rari li normalment jiġu assocjati ma' immunosoppressjoni.
English: Imraldi 40 mg solution for injection in pre-filled pen Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Maltese: Imraldi 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Kull pinna mimlija għal-lest b'doża waħda ta' 0.8 mL fiha 40 mg adalimumab.
English: Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Maltese: Imraldi 40 mg soluzzjoni għall-injezzjoni f'kunjett li jintuża darba biss (ħġieġ tat-tip 1), mgħammar b'tappijiet tal-lastku, bil-piegi tal-aluminju u siġilli tat-tip flip-off.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX- treated.
Maltese: Fil-fażi tal-bidu open-label (OL LI) il-pazjenti kienu imqassma f'żewgt gruppi, dawk ikkurati b'MTX (methotrexate) u dawk li mhux trattati b'MTX (non-MTX).
English: Cardiac disorders* Common
Maltese: Investigazzjonijiet * Komuni
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Maltese: L-aktar reazzjonijiet avversi li gew irrapurtati b'mod komuni huma infezzjonijiet (bħal nasofarinġite, infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja u sinożite), reazzjonijiet fil-post tal-injezzjoni (eritema, ħakk, emorraġija, uġigħ jew nefħa), uġigħ ta' ras u uġigħ muskolu-skeletrali.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis
English: Mood alterations (including depression), anxiety,
Maltese: Tibdil fil-burdata (li tinkludi depressjoni), ansjetà, nuqqas ta' rqad
English: Most ALT
Maltese: Punt ta' Tmiem
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Maltese: Disgħa u sebgħin (20.1 %) pazjent ġew ikkurati flimkien ma' mediċini anti-rewmatiċi li li jaffetwaw il-proċess tal-marda, u 37 (9.4 %) pazjent flimkien ma' glukokortikojdi.
English: The safety and efficacy of adalimumab were assessed in two randomized, 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'spondyloarthrite axjali mhux radjografika (nr-axSpA). studju nraxSpA I evalwa pazjenti b'nr-axSpA attiv.
English: Skin Pain b
Maltese: d a methotrexate b
English: Imraldi in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Maltese: - trattament ta' artrite rewmatika attiva, minn moderata sa severa f'pazjenti adulti, meta r-rispons tagħhom għal mediċini anti-rewmatiċi li jaffetwaw il-proċess tal-mard, inkluż methotrexate, ma kienx adegwat.
English: • cough;
Maltese: • ħakk;
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 Psorajisi tiġi kkawżata minn problema fis-sistema immun,i tal-ġisem li twassal għal produzzjoni akbar ta' ċelluli tal-ġilda.
English: Imraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Maltese: Imraldi huwa indikat għat-trattament ta' uveite pedjatrika anterjuri kronika mhux infettiva f'pazjenti minn sentejn li kellhom rispons inadegwat għal jew li mhumiex tolleranti għat-terapija konvenzjonali, jew li fihom it-terapija konvenzjonali mhix adattata.
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 filperjodu li fih reġgħet inbdiet il-kura, kellhom PGA mingħajr rispons jew b' rispons minimu wara 16-il ġimgħa minn meta reġgħet inbdiet il-kura, irrispettivament minn jekk dawn il-pazjenti reġgħux esperjenzaw tfaċċar mill-ġdid ta' sintomi ta' Psorijasi matul il-perjodu li fih twaqqfet il-kura (69.1% [123/178] u 88.8% [95/107] għal dawk il-pazjenti li esperjenzaw tfaċċar mill-ġdid ta' sintomi talPsorijasi u dawk li m'esperjenzawx tfaċċar mill-ġdid ta' sintomi tal-Psorijasi rispettivament, matul ilperjodu li fih twaqqfet il-kura).
English: Side effects may occur up to 4 months or more after the last Imraldi injection.
Maltese: L-effetti sekondarji jistgħu ifeġġu sa 4 xhur jew aktar wara laħħar injezzjoni b' Imraldi.
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: Amongst those who responded at week 16 (n=144), the Paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Maltese: Fost dawk li rrispondu f'ġimgħa 16 (n = 144), ir-rispons Pedjatriku ACR 30/50/70/90 kien miżmum sa sitt snin fil-fażi
English: Chest pain, oedema, pyrexia1)
Maltese: • Aħżen is-siringa tiegħek fil-friġġ, iżda tiffriżahiex.
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 is-suġġett 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: Week 26 Placebo-Controlled
Maltese: 26 Ġimgħa Ikkontrollat bi Plaċebo
English: 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: Doża kbira 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 µg/mL matul il-perijodu tal-bidu.
English: Hepatitis reactivation of hepatitis B1)
Maltese: Epatite riattivazzjoni tal-epatite B epatite awtoimmuni
English: c Based on rank analysis d Joint Space Narrowing
Maltese: Ibbażat fuq analizi tar-rank d
English: In RA study III, where adalimumab treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
Maltese: Fi studju RA III, fejn pazjenti kkurati b'Imraldi kienu ilhom ibatu mill-artrite rewmatika għal medja ta' 11 -il sena, il-ħsara strutturali fil-ġogi kienet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (TSS) u l-komponenti tiegħu, il-punteġġ relatat ma' erożjoni u tnaqqis flispazju fil- ġogi.
English: Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Maltese: Hidradenitis suppurativa (xi kultant imsejħa akne inversa) hija marda tal-ġilda kronika u spiss bl-uġigħ infjammatorja.
English: Imraldi can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Imraldi jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' aġenti anti-rewmatiċi li jaffetwaw ilproċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħata b' injezzjoni), kortikosterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini antiinfjammatorji mhux sterojdi (NSAIDs).
English: * p <0.001 for adalimumab versus placebo pairwise comparisons of proportions
Maltese: 001, adalimumab kontra l-plaċebo
English: Genesis Pharma S.A.
Maltese: Kif tarmi s-siringa
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa,
Maltese: Dawn il-provi inkludew pazjenti li jbatu minn artrite rewmatika, kemm f'dawk li ma jkunux ilhom u dawk li jkunu ilhom bil-marda, f'artrite idjopatika taż-żgħażagħ (artrite idjopatika poliartikulari taż-żgħażagħ jew artrite relatata mal-entesite) kif ukoll pazjenti li jbatu minn axial spondyloarthritis (infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) u minn axial spondyloarthritis mingħajr evidenza radjografika ta' AS), minn artrite psorjatika, mill-marda Crohn (Crohn's disease), mill-kolite ulċerattiva, mill-psorijasi, minn hidradenitis suppurativa u minn uveite.
English: • oedema (a build up of fluid in the body which causes the affected tissue to swell);
Maltese: • edema (akkumulazzjoni ta' fluwidu fil-ġisem li tikkawża li t-tessut affettwat jintefaħ);
English: Imraldi should be used with caution in patients with mild heart failure (NYHA class I/II).
Maltese: Imraldi għandu jintuża b'attenzjoni f'pazjenti li jbatu minn insuffiċjenza tal-qalb ħafifa (NYHA klassi I/II).
English: Imraldi 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: Imraldi huwa indikat 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: vasculitis
Maltese: Twissijiet
English: Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Maltese: Figura 3: Kurvi ta' Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment fl-Istudju
English: Pull off needle cap
Maltese: UŻATI JEW SKART MINN DAWN
English: Table 23 Induction of Clinical Remission and Response (Percent of Patients)
Maltese: Tabella 23 Qlib għall-Aħjar fl-Istat Kliniku u Rispons (Persentaġġ ta' Pazjenti)
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Maltese: Fost is-68 pazjent li kellhom flare fil-grupp allokat għal irtirar ta' trattament, 65 kkompletaw 12-il ġimgħa ta' terapija ta' salvataġġ b'adalimumab, li minnhom 37 (56.9%) reġgħu kisbu remissjoni (ASDAS <1.3) wara 12-il ġimgħa li reġgħu jibdew it-trattament open-label.
English: P Valueb
Maltese: Valur b
English: Table 13 Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Maltese: Tabella 13 Risponsi tal-Effikaċja fi Studju AS kontrollat bil-Plaċebo Effikaċja- Studju I Tnaqqis fisSinjali u s-Sintomi
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Maltese: • Żomm il-pakkett tas-siringa u BIL-MOD iġbed l-istikka bajda tal-planġer 'il barra sa 0.1 mL aktar mid-doża preskritta (Pereżempju, jekk id-doża preskritta hija 0.5 mL, iġbed l-istikka bajda tal-planġer sa 0.6 mL).
English: Wait 15-30 minutes for your pre-filled syringe to reach to room temperature, which helps reduce your pain during injection.
Maltese: Stenna 15-30 minuta biex il-pinna mimlija għal-lest tiegħek tilħaq it-temperatura tal-kamra; dan jgħin biex inaqqas l-uġigħ tiegħek waqt l-injezzjoni.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Maltese: L-iskop primarju fi studji RA I, II u III u l-iskop sekondarju fi studju RA IV kien il-persentaġġ ta' pazjenti li laħqu rispons għall-ACR 20 f'Ġimgħa 24 jew 26.
English: 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate.
Maltese: 9 ± 5.2 µg/mL (47.7% CV) flimkien ma methotrexate.
English: For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3±11.4 μg/ml (40/20 mg, weekly) and 6.7±3.5 μg/ml (20/10 mg, weekly).
Maltese: 3±11.4 μg/mL (40/20 mg, kull ġimgħa) u 6.7±3.5 μg/mL (20/10 mg, kull ġimgħa).
English: RA study IIIa**
Maltese: Disturbi fil-qalb*
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more The recommended dose of Imraldi is an initial dose of 80 mg (as two 40-mg injections in one day), followed by 40 mg every other week starting one week later.
Maltese: Hidradenitis suppurativa fl-adolexxenti minn 12 sa 17-il sena, li jiżnu 30 kg jew aktar Id-doża rakkomandata ta' Imraldi hija doża inizjali ta' 80 mg (bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda), segwita b'40 mg ġimgħa iva u ġimgħa le li jibdew ġimgħa wara.
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 Imraldi 0.8 mg/kg kellhom rispons pożittivi tal-effikaċja (eż, PASI 75) milli dawk każwali għal 0.4 mg/kg eow jew MTX.
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate
Maltese: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'Ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ± 4.3 μg/mL meta adalimumab kien użat flimkien ma' methotrexate
English: Uncommon Deafness, tinnitus
Maltese: Uġigħ addominali, nawseja u rimettar
English: Adverse Reaction joint infections
Maltese: Ivvjaġġar/infezzjoni rikorrenti
English: Low Dose 20/10 mg eow P value
Maltese: Doża Baxxa 20/10 mg eow
English: Stratum
Maltese: BASDAI
English: Children and adolescents from 6 to 17 years of age weighing less than 40 kg
Maltese: Tfal u żagħżagħ minn 6 sa 17-il sena li jiżnu inqas minn 40 kg
English: 2) Preparing the Imraldi dose for injection
Maltese: 2) Biex tipprepara id-doża ta' Imraldi għall-injezzjoni
English: The combination of Imraldi and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Maltese: L-oftalmologi huma avżati biex jikkonsultaw ma' speċjalista xierqa qabel ma jinbeda t-trattament b'Imraldi (ara sezzjoni 4.4).
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Maltese: Ma ġewx osservati l-ebda tumuri malinni f'249 pazjenti pedjatriċi ta' età bejn is sentejn u 17-il sena b'espożizzjoni ta' 655.6 sena ta' pazjent waqt provi b'adalimumab f'pazjenti b'artrite idjopatika tażżgħażagħ (artrite idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite).
English: There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events.
Maltese: Ma jidher li hemm l-ebda korrelazzjoni bejn il-preżenza ta'anti-korpi kontra adalimumab u lokkorrenza ta' effetti avversi.
English: Continue to hold
Maltese: Inibizzjoni ta' infjammazzjoni
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Maltese: Adalimumab ma kienx studjat f'pazjenti b'indeboliment epatiku jew renali.
English: Hypersensitivity, allergies (including seasonal allergy) Uncommon Sarcoidosis1),
Maltese: Sensittività eċċessiva, allerġiji (li jinkludu l-allerġija assoċjata ma' listaġuni)
English: Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease.
Maltese: Il-linja bażi hija definita bħala linja bażi ‘open label' meta l-pazjenti għandhom mard attiv.
English: Imraldi is intended for treatment of:  rheumatoid arthritis,  polyarticular juvenile idiopathic arthritis,  enthesitis-related arthritis,  ankylosing spondylitis,  axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,  psoriatic arthritis,  psoriasis,  hidradenitis suppurativa,  Crohn's disease,  ulcerative colitis and  non-infectious uveitis.
Maltese: Infezzjonijiet serji, li jinkludu sepsis ikkawżati minn batterji, myco-batterji, fungus invażiv, parassiti, virus u infezzjonijiet opportunistiċi oħra bħal listeriżi, leġinellożi u pneumocystis, ġew rapportati f'pazjenti li kienu qed jirċievu Imraldi.
English: Table 20 Paediatric CD Study PCDAI Clinical Remission and Response
Maltese: Tabella 22 Qlib għall-Aħjar fl-Istat Kliniku u Rispons (Persentaġġ ta' Pazjenti)
English: ASASa 20
Maltese: ASAS 20