FrancophonIA/ELRC3.0 huggingface dataset:
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Maltese: 673 pazjent b'attività nr­axSpA (attività medja tal­marda bażika [BASDAI] kienet ta' 7.0) li kellhom rispons inadegwat għal ≥ 2 NSAIDs, jew intolleranza għal jew kontraindikazzjoni għal NSAIDs irreġistrati fil­perjodu open­label ta' Studju nr­axSpA II li matulu rċevew adalimumab 40 mg eow għal 28 ġimgħa.
English: The recommended Idacio 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: Id­doża inizjali ta' Idacio 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: Study nraxSpA I evaluated patients with active nr-axSpA.
Maltese: Studju nr­ axSpA I evalwa pazjenti b'nr-axSpA attiv.
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Maltese: Il­ biodisponibiltà medja assoluta ta' adalimumab stimata minn tliet studji wara t­teħid ta' doża waħda ta' 40 mg taħt il­ġilda kienet ta' 64%.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 10).
Maltese: Fi studju RA V, il­ħsara strutturali fil­ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil­Punteġġ Totali Sharp (ara Tabella 10).
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, id­inizjali ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas­serum f'adalimumab ta' bejn wieħed u ieħor 12 g/ml matul il­perijodu tal­bidu .
English: • gallbladder inflammation, gallbladder stones;
Maltese: • infjammazzjoni fl­għajnejn;
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 l­amministrazzjoni ta' 0.8 mg/kg (sa massimu ta' 40 mg) taħt il­ġilda ġimgħa iva u ġimgħa le lil pazjenti pedjatriċi bi psorjasi tal­plakka kronika, il­medja ± SD ta' koncetrazzjoni minimali medja fissa ta' adalimumab kienet ta' madwar 7,4 ± 5.8 g/mL (79% CV).
English: Ulcerative colitis is an inflammatory disease of the bowel.
Maltese: Kolite ulċerattiva hija marda infjammatorja tal­musrana.
English: Idacio 40 mg solution for injection in pre-filled syringe EU/1/19/1356/002
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Idacio 40 mg soluzzjoni għall­injezzjoni f'siringa mimlija għal­lest EU/1/19/1356/002
English: Clinical remission 12% 24% 36%*
Maltese: Ġimgħa 12 14% 58%*** Ġimgħa 24 15% 57%***
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: Fil­Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bl­artrite rewmatika u artrite psorjatika fejn il­pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żieda fil­livelli ta' l­ ALT ≥ 3 x ULN f'3.7% tal­pazjenti trattati b'adalimumab u f'1.6% tal­pazjenti trattati bil­kontroll.
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Maltese: L­għoti flimkien ta' DMARDS bijoloġiċi jew ta' antagonisti TNF
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: Fil­gruppi kollha ta' trattament, il­punteġġ medju PASI tal­linja bażi kien 19.7 u l­punteġġ PGA tal­linja bażi varja minn “ħafif” (<1%) għal “moderat” (48%) għal “sever” (46%) għal “sever ħafna” (6 %).
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 fil­prova ta' estensjoni open-label.
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: L­effikaċja 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 tat­Tobba (PGA) ≥ 4 jew > 20% BSA jew > 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew Qasam tal­Psorjasi u Indiċi tas­Severità (PASI) ≥ 20 jew ≥ 10 bi klinikament rilevanti involviment tal­wiċċ, ġenitali, jew idejn/saqajn) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: 4.1 Choose an injection site (Figure L) on:
Maltese: 4.1 Agħżel sit għall­injezzjoni (Stampa L) minn:
English: Idacio contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Maltese: Idacio fih is­sustanza attiva adalimumab, mediċina li taġixxi fuq is­sistema immuni (difiża) ta' ġismek.
English: • systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
Maltese: • lupus erythematosus sistemiku (disturb immuni li jinkludi infjammazzjoni tal­ġilda, tal­qalb,
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 għall­pazjenti  40 kg (160/80 mg) u 10.
English: Adalimumab exposure in adolescent HS 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: Espożizzjoni ta' adalimumab f'pazjenti adolexxenti bi HS kienet prevista li jużaw mudellar u simulazzjoni farmakokinetiku tal­popolazzjoni bbażata fuq cross­indication farmakokinetika f'pazjenti pedjatriċi oħra (psorjasi pedjatrika, artrite idjopatika ġovanili, marda Crohn pedjatrika u l-artrite relatata mal­entesite).
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1)
Maltese: Il­benefiċċju u r­riskju tat­trattament kontinwu li jitkompla fit­tul għandhom jiġu evalwati perjodikament (ara dejta ta' adulti fit-taqsima 5.1).
English: 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, il­pazjenti kienu magħżula b'mod każwali 1:1 għal doża ta' manteniment Standard (40/20 mg eow) jew Baxxa (20/10 mg eow) fil­grupp ta' nies li qed jieħdu l­ kura fuq bażi tal­piż tal­ġisem tagħhom.
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 tal­irtirar u trattament mill­ġdid fi studju ta' estensjoni open­label.
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 il­prova saret f'192 suġġetti pedjatriċi li għandhom bejn 6 u 17 (inkluż) -il sena, bil­marda Crohn (CD) moderata sa severa definita bħala riżultat tal­Indiċi tal­ Attività tal-marda Crohn (Crohn's disease) fit­tfal (PCDAI) > 30.
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) tal­pazjenti li daħlu fil­perjodu tat­trattament mill­ġdid kellhom rispons ta' PGA “xejn” jew “minimali” wara 16­il ġimgħa ta' trattament mill­ġdid, 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 il­perjodu ta' irtirar, rispettivament).
English: 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
Maltese: 2 Kura bl­immunosuppressanti setgħat tkun mwaqqfa biss f'ġimgħa 26 jew wara skont id­ diskrezzjoni tal­investigatur jekk is­suġġett leħaq il­kriterji tar­rispons kliniku 3 definita bħala l­għeluq tal­fistuli kollha li kienu qed inixxu fil­linja bażi għal mill­inqas 2 viżti konsekkutivi wara l­linja bażi
English: Idacio is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: Idacio jintuża biex jittratta hidradenitis suppurativa fl­adulti u fl­adolexxenti minn 12­il sena.
English: There is limited experience in the initiation of treatment with adalimumab alone.
Maltese: Hemm esperjenza limitata fil­ bidu tat­trattament b'adalimumab waħdu.
English: p-value
Maltese: Valur p1
English: 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Maltese: Madwar darbtejn ir­proporzjon ta' pazjenti fil­grupp tal­plaċebo fl­ewwel 12­il ġimgħa ta' Studji HS­I u HS­II, meta mqabbla ma' dawk fil­grupp adalimumab li kellhom aggravament ta' axxessi (23.0% vs 11.4%, rispettivament) u fistuli li jnixxu (30.0 % vs 13.9%, rispettivament).
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
Maltese: Fl­istudji RA minn I­IV, il­komponenti kollha tal­kriterji tar­rispons għall­ACR (numru ta' ġogi bl­ uġigħ u minfuħa, l­istima ta' l­attività tal­mard u ta' l­uġigħ magħmula mit­tabib u mill­pazjent, il­ punti ta' l­indiċi ta' diżabilità (HAQ) u valuri tas­CRP (mg/dl)) marru għall­aħjar fir­24 u fis­26 ġimgħa meta pparagunati mal­plaċebo.
English: Your symptoms may return upon stopping treatment.
Maltese: Is­sintomi tiegħek jistgħu jerġgħu jiġu wara li twaqqaf it­trattament.
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: Fil­Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti b'artrite idjopatika poliartikulari taż­ żagħżagħ li kellhom minn 4 sa 17­il sena u pazjenti b'artrite relatata mal­entesite li kellhom minn 6 sa 17­il sena, kien hemm żidiet f'ALT ta' ≥ 3 x ULN f'6.1% tal­pazjenti trattati b'adalimumab u 1.3% tal­pazjenti trattati bil­kontroll.
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 tal­livelli ta' immunoglobuli, jew tibdil fin­numri ta' ċelloli effettivi T­, B­, NK­, monoċistiċi /makrofaġi, u newtrofili.
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 fl­istudji kollha ta' l­ artrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindromu li jixbaħ lis­sindromu tal­lupus.
English: Idacio in combination with methotrexate, is indicated for:
Maltese: Idacio, flimkien ma' methotrexate, huwa indikat għall­:
English: • pulmonary embolism (blockage in an artery of the lung);
Maltese: • emboliżmu fil­pulmun (imblukkar f'arterja tal­pulmun);
English: In the open-label extension of RA study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Maltese: Fil­fażi ta' estensjoni open-label tal­istudju RA III , it­tnaqqis fir­rata ta' progress ta' ħsara strutturali huwa mantenut għal 8 u 10 snin.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Maltese: Minkejja trattament profilattiku għat­tuberkulosi, kien hemm każijiet ta' riattivazzjoni tat­tuberkulosi f'pazjenti kkurati b'adalimumab.
English: Idacio 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: Idacio jintuża għal trattament tal­artrite idjopatika poliartikulari taż­żagħżagħ fit­tfal ta' bejn 2 u 17­il sena u artrite relatata mal­entesite fit­tfal u adolexxenti ta' bejn 6 u 17­il sena.
English: Idacio 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: 0.8 mL ta' soluzzjoni f'kunjett (ħġieġ tip I) b'tapp tal­lastku (lastiku sintetiku) u siġill ikkompressat tal-aluminju.
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 mill­inqas 12­il ġimgħa (N = 305) (ASDAS <1.3 fil­ġimgħa 16, 20, 24 u 28) matul il­perjodu open­label kienu mbagħad ‘randomised' biex jirċievu jew kura kontinwa b'adalimumab 40 mg eow N=152) jew plaċebo (N=153)
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 19­il suġġett) u PGA xejn jew minimali ta' 52.6% (10 minn 19­il suġġett).
English: Idacio is used to treat:
Maltese: Idacio aktar milli suppost:
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Maltese: F'dawn il­pazjenti ir­rati tal­PASI 75 u l­PGA ta' fejn ma kienx hemm rispons jew fejn kien hemm rispons minimu kienu ta' 69.6% u 55.7%, rispettivament, wara 108 ġimgħat addizzjonali ta' terapija open­label (total ta' 160 ġimgħat).
English: • hepatitis (liver inflammation);
Maltese: • epatite (infjammazzjoni tal-fwied);
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies 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 il­ provi, 11.9% tal­pazjenti kkurati b'adalimumab u 8.1% tal­pazjenti kkurati bil­plaċebo u bis­sustanza attiva użata bħala kontroll, li bdew bl­livelli tal­anti­korpi anti­nukleari negattivi, irrappurtaw livelli pożittivi f'ġimgħa 24.
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 and uveitis patients.
Maltese: Dawn il-provi inkludew pazjenti li jbatu minn artrite rewmatika, kemm f'dawk li ma jkunux ilhom u dawk li jkunu ilhom bil­marda, f'artrite idjopatika taż­żagħżagħ (artrite idjopatika poliartikulari taż­żagħżagħ jew artrite relatata mal­entesite) kif ukoll pazjenti li jbatu minn axial spondyloarthritis (infjammazzjoni tal­vertebri li jirriżulta fil­vertebri jitwaħħlu flimkien (ankylosing spondylitis) u axial spondyloarthritis mingħajr evidenza radjografika ta' AS), minn artrite psorjatika, mill-marda Crohn (Crohn's disease), mill­kolite ulċerattiva, mill­psorijasi, minn hidradenitis suppurativa u minn uveite.
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Maltese: It­titjib kliniku (definit bħala Punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ > 1) ġie evalwat f' ġimgħa 8.
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: Is­sigurtà u l­effikaċja ta' adalimumab kienu evalwati f'zewgt studji (pJIA I and II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż­żagħżagħ, u li kellhom varjeta ta' bidu ta' JIA (l­aktar frekwenti fattur rewmatoloġiku negattiv jew poli­artrite pożittiva u oligo­artrite fit­tul.
English: • an alcohol pad (included in the box)
Maltese: • kuxxinett tal­alkoħol (inkluż fil­kaxxa)
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 UC­II, 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 the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Maltese: Fil­fażi tal­bidu open-label (OL LI) il­pazjenti kienu imqassma f'żewgt gruppi, dawk ikkurati b'MTX (methotrexate) u dawk li mhux trattati b'MTX (non-MTX).
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table
Maltese: Ir­riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas­sinjali u s­ sintomi ta' nr­axSpA attiva f'pazjenti kkurati b'adalimumab meta mqabbla mal­plaċebo (Tabella 14).
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 fil­kwestjonarju għall­mard speċifiku dwar il­marda ta' l­infjammazzjoni tal­musrana (IBDQ), u dan f'pazjenti li ġew magħżula b'ordni addoċċ u ngħataw 80/40 mg u 160/80 mg adalimumab meta mqabbel mal­plaċebo, u dan deher f'ġimgħat 26 u 56 fi studju CD III, kif ukoll fil­ gruppi tal­kura b'adalimumab meta mqabbla mal­grupp tal­plaċebo.
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 nr­axSPA I, adalimumab 40 mg ġimgħa iva u oħra ġie evalwat f'185 pazjent fi studju double­blind ikkontrollat wieħed bil­plaċebo ta' 12­il 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 il­plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥ 1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Maltese: Tnaqqis statistikament sinifikanti fl­għejja, kif inhi mkejla mill­istima funzjonali tat­ terapija tal-mard kroniku (FACIT) kien osservat fit-tliet studji li fihom saret l-istima (Studji RA I, III u IV).
English: • The needle cap is securely attached (Figure H).
Maltese: • It­tapp tal­labra huwa mwaħħal sew (Stampa H).
English: Idacio 40 mg solution for injection in pre-filled syringe adalimumab
Maltese: Idacio 40 mg injezzjoni adalimumab
English: Idacio dose for paediatric patients with Crohn's disease
Maltese: Doża ta' Idacio għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease)
English: • If you are over 65 years you may be more susceptible to infections while taking Idacio.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Idacio.