FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended Idacio induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Maltese: Id­dożaġġ irrakkomandat biex tinbeda l­kura b'Idacio fuq pazjenti adulti li jbatu mill­marda Crohn (Crohn's disease) b'attività moderata sa severa, huwa ta' 80 mg f'ġimgħa 0 segwiti b'40 mg f'ġimgħa 2.
English: Idacio 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: Idacio huwa ndikat għall­kura ta' artrite attiva relatata mal­entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jitollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: Amongst those who responded at week 16 (n=144), the Pediatric 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), ir­rispons pedjatriku ACR 30/50/70/90 kien miżmum sa sitt snin fil­fażi OLE f'pazjenti li rċevew adalimumab matul l­istudju kollu.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at week 24 or 26.
Maltese: L­iskop primarju fi studji RA I, II u III u l­iskop sekondarju fi Studju RA IV kien il­persentaġġ ta' pazjenti li laħqu rispons għall­ACR 20 f'Ġimgħa 24 jew 26.
English: Adverse reaction urinary tract infections (including pyelonephritis), fungal infections, joint infections
Maltese: Reazzjoni avversa speċifikati (inklużi ċesti u polipi)*
English: Table 9 ACR responses in placebo-controlled trials (percent of patients)
Maltese: Tabella 9 Risponsi għall-ACR fi provi bil-plaċebo bħala kontroll (persentaġġ ta' pazjenti)
English: Paraesthesias (including hypoaesthesia), migraine, nerve root compression
Maltese: Parasteżija (inkluża ipoestesija), emigranja, tagħfis fuq l­għerq tan­nerv
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Maltese: Fost pazjenti li t­trattament b'adalimumab ġie irtirat fil­ġimgħa 12 fi Studji HS­I u HS­II, ir­rata ta' HiSCR f'12­il ġimgħa wara l­introduzzjoni mill­ġdid ta' adalimumab 40 mg kull ġimgħa marret lura għal livelli simili għal dik osservata qabel l­irtirar (56.0%).
English: Idacio is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Maltese: Idacio jintuża għal trattament biex jittratta artrite idjopatika poliartikulari taż­żagħżagħ u l­artrite relatata mal­entesite.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 mL pre-filled syringe contains 40 mg adalimumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Siringa waħda ta' 0.8 ml mimlija għal­lest fiha 40 mg adalimumab.
English: Table 10 Radiographic mean changes at week 52 in RA study V MTX n=257 confidence interval)
Maltese: Tabella 10 Tibdil radjografiku medju f'ġimgħa 52 fi studju RA V
English: Standard dose
Maltese: Viżjoni doppja
English: Table 18 Ps Study II (CHAMPION) efficacy results at 16 weeks Placebo N=53 n (%)
Maltese: Tabella 18 Studju Ps II (CHAMPION)
English: • fatty liver (build-up of fat in liver cells);
Maltese: • infjammazzjoni vaskulite (infjammazzjoni tal-vini u l-arterji);
English: Injector body
Maltese: Disturbi gastro-intestinali
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Maltese: Fil­prova ta' Fażi 3 ta' adalimumab fit­tfal bil­marda Crohn (Crohn's disease) li evalwat l­effikaċja u s­sigurtà f'żewġ reġimi ta' dożaġġ ta' manteniment irranġati skont il­piż tal­ġisem wara terapija tal­ bidu li wkoll kienet irranġata skont il­piż tal­ġisem sa 52 ġimgħa ta' trattament, kien hemm żidiet fl­ ALT ta' ≥ 3 x ULN f'2.6% (5/192) tal­pazjenti li minnhom 4 kienu qed jirċievu immunosuppressanti konkomitanti fil­linja bażi.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Maltese: Pazjenti minn studji UC­I u UC­II kellhom l­għażla li jaqilbu għal estensjoni ta' studju open-label fuq tul ta' żmien (UC III).
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab should be carefully considered.
Maltese: Ir­riskju potenzjali b'kombinazzjoni ta' azathioprine jew 6­mercaptopurine u adalimumab għandu jiġi kkunsidrat bir­reqqa.
English: • oedema (a build-up of fluid in the body which causes the affected tissue to swell);
Maltese: • edima (akkumulazzjoni ta' fluwidu fil­ġisem li jikkaġuna t­tessut affettwat biex jintefaħ);
English: Visual impairment, conjunctivitis, blepharitis, eye swelling
Maltese: Pankreatite, disfaġja edima fil­wiċċ
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Maltese: Fi studju UC-II, min dawk il­pazjenti ttrattati b' adalimumab u li kellhom titjib kliniku f'ġimgħa 8, 21/41 (51%) kellhom ukoll titjib kliniku f'ġimgħa 52.
English: Paediatric uveitis Age or body weight
Maltese: Kwalità tal­ħajja u funzjoni fiżika
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Maltese: L­iskop primarju fi Studju RA V kien il­ persentaġġ ta' pazjenti li laħqu rispons għall­ACR 50 f'Ġimgħa 52.
English: Plunger Rod
Maltese: Jekk tuża
English: • paediatric plaque psoriasis
Maltese: • psorijasi tal-plakka pedjatrika
English: 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: kura ta' artrite rewmatika attiva minn moderata sa severa f'pazjenti adulti, meta r-rispons tagħhom għal mediċini anti­rewmatiċi li jaffetwaw il­proċess tal­mard, inkluż methotrexate, ma kienx adegwat.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Idacio and is positive for antibodies against double-stranded DNA, further treatment with Idacio should not be given (see section 4.8).
Maltese: Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis­sindromu tal­lupus wara li tkun ingħatat kura b'Idacio, u jkun pożittiv għall­anti­korpi kontra DNA li hi double stranded, m'għandhiex tingħata aktar kura b'Idacio (ara sezzjoni 4.8).
English: There is limited safety experience of surgical procedures in patients treated with adalimumab.
Maltese: L­esperjenza ta' sigurtà ta' proċeduri kirurġiċi f'pazjenti kkurati b'adalimumab hija limitata.
English: 4.1 Peel open the needle packaging to uncover the yellow syringe connector.
Maltese: 4.1 Qaxxar u iftaħ l­ippakkjar tal­labra biex tikxef il­konnettur isfar tas­siringa.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Idacio.
Maltese: It­tnaqqis tal­corticosteroid ftit ftit sakemm jitwaqqaf totalment, kien permess wara ġimgħa 8.
English: Idacio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: Idacio huwa ndikat għall­kura tal­marda Crohn (Crohn's diease) attiva minn moderata sa severa fittfal (minn 6 snin il­fuq) li ma kellhomx rispons kif mistenni għall­kura konvenzjonali inkluż terapija ta' nutrizzjoni primarja u kortikosterojde u/jew immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it­terapiji.
English: Idacio 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Maltese: Idacio 40 mg soluzzjoni għall­injezzjoni (injezzjoni) f'pinna mimlija għal­lest hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Maltese: Minn dawk li jirċievu l­kortikosterjdi fil­linja bażi
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l­awtorizzazzjoni tal­prodott mediċinali.
English: Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Maltese: Xi wħud minn­dawn il­pazjenti kienu wkoll qed jiġu ttrattati bil­mediċini azathioprine jew 6­ mercaptopurine.
English: Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Maltese: Adalimumab jeħel speċifikament mat­TNF u jinnewtralizza il­funzjoni bijoloġika tat­TNF billi jimblokka l­interazzjoni tiegħu ma'riċetturi TNF p55 u p75 fuq il­wiċċ taċ­ċellola.
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Maltese: Ir­rati rrappurtati ta' kanċer tal­ġilda li m'humiex melanoma u limfomi, huma ta' bejn wieħed u ieħor 0.2 u 0.3 kull 1,000 sena ta' trattament ta' pazjenti, rispettivament (ara sezzjoni 4.4).
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Maltese: Il­pazjenti rċivew il­plaċebo, doża inizjali ta' MTX 7.5 mg li tiżdied sa ġimgħa 12, b'doża massima ta' 25 mg jew doża inizjali ta'80 mg adalimumab segwita b'40 mg ġimgħa iva u ġimgħa le (li tibda ġimgħa wara d­doża inizjali) għal 16­il ġimgħa.
English: It is recommended that the conduct and results of these tests are recorded in the patient reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Maltese: Min jagħti l­mediċina huwa mfakkar fir­riskju ta' testijiet negattivi tal­ġilda għat­ tuberkolina foloz, speċjalment f'pazjenti li huma morda serjament jew li għandhom immunità kompromessa.
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Maltese: F'reġistru ta' koorti prospettiv, ġew irreklutati 257 mara b'artrite rewmatojde (RA, rheumatoid arthritis) jew bil­marda ta' Crohn (CD, Crohn's disease) ikkurati b'adalimumab għallinqas matul l­ ewwel trimestru u 120 mara b'RA jew CD mhux ikkurati b'adalimumab.
English: Solution for injection 2 pre-filled syringes 2 alcohol pads 6 pre-filled syringes 6 alcohol pads
Maltese: Soluzzjoni għall­injezzjoni 2 pinen mimlijin għal­lest 2 kuxxinetti bl­alkoħol 6 siringi mimlijin għal­lest 6 kuxxinetti tal­alkoħol.
English: Idacio is used in adults to treat these conditions.
Maltese: Idacio tista' tkun disponibbli fi preżentazzjonijiet oħra skont il­ħtiġijiet ta' trattament individwali.
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Maltese: Jekkint għandek ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis inti lewwel tingħata mediċini oħra.
English: Patients in steroid-free remission for >=90 daysa * 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 < 0.02 għall­paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra lplaċebo a
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Maltese: Fil­każi fejn hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8, tidher asterisk (*) fil-kolonna tas-Sistema tal-Klassifika tal-Organi.
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab- treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Minn dawn il­kanċer tal­ġilda, kien hemm l­okkorrenza ta' karċinoma biċ­ċelluli tat­tip squamous b'rati (95% intervall ta' konfidenza) ta' 2.7 (1.4, 5.4) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p< 0.001) in the adalimumab group (at week 48).
Maltese: Il­kura b'adalimumab naqqset ir­rata li biha tipprogressa l­ħsara fil­ġogi periferali meta mqabbla mal­ kura bil­plaċebo, kif imkejla mit­tibdil li kien hemm mil­linja bażi fil­punteġġ mTSS (medja ± SD) 0.8 ± 2.5 fil­grupp tal­plaċebo (f'ġimgħa 24) meta mqabbel ma' 0.0 ± 1.9 (p<0.001) fil­grupp ta' adalimumab (f'ġimgħa 48).
English: Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Maltese: Mill­424­ilsuġġett inklużi fl­estensjoni mhux ikkontrollata fit­tul tal­istudji UV I u UV II, 60 individwu kienu meqjusa ineliġibbli (eż. minħabba devjazzjonijiet jew minħabba kumplikazzjonijiet sekondarji għal retinopatija dijabetika, minħabba kirurġija tal­katarretti jew vitrectomy) u kienu esklużi mill­analiżi primarja tal­effikaċja.
English: Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Maltese: IV ġew mqabbla l­effikaċja u s­sigurtà ta' adalimumab ma' plaċebo f'217 pazjent adult b' psorjasi tad­dwiefer moderata għal severa.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 µg/mL for the Standard Dose group and 3.5±2.2 µg/mL for the Low Dose group.
Maltese: Għall­pazjenti li baqgħu jieħdu l­kura każwali tagħhom, il­medja (±SD) tal­aktar konċentrazzjonijiet baxxi ta' adalimumab fis­serum f'ġimgħa 52 kienet 9.5±5.6 g/mL għal grupp li qed jingħata Doża Standard u 3.5±2.2 g/mL għal grupp li qed jingħata Doża Baxxa.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Maltese: L­Aġenzija Ewropea għall­Mediċini iddifferiet l­obbligu li jiġu ppreżentati riżultati tal­istudji bil­ prodott mediċinali ta' referenza li fih adalimumab f'wieħed jew iktar kategoriji tal­popolazzjoni pedjatrika b'kolite ulċerattiva, ara sezzjoni 4.2 għal informazzjoni dwar l­użu pedjatriku.
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Maltese: Tfal, adolexxenti u adulti minn 6 snin sa 17­il sena li jiżnu 40 kg jew aktar
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Idacio.
Maltese: Pazjenti li jeħtieġu doża ta' inqas minn 40 mg għandhom jużaw il­preżentazzjoni tal­kunjett ta' 40 mg ta' Idacio.
English: Axial spondyloarthritis without radiographic evidence of AS Idacio 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: Idacio huwa indikat għall­kura ta' adulti li jbatu minn infjammazzjoni tal­vertebri li jirriżulta fil­ vertebri jitwaħħlu flimkien (ankylosing spondylitis), li ma kellhomx rispons adegwat meta ngħataw kura konvenzjonali.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control treated patients.
Maltese: Il-proporzjon ta' pazjenti li waqt il-porzjoni kontrollata double-blind fl­istudji pivitali ma baqgħux jieħdu l­kura minħabba effetti avversi kien ta' 5.9% għall­pazjenti li kienu qegħdin jieħdu adalimumab u 5.4% għal pazjenti kkurati b'mod kontrollat.
English: The Idacio pre-filled pen contains a pre-filled syringe with Idacio.
Maltese: Il­kura b'Idacio tista' tirriżulta fil­formazzjoni ta'anti­korpi awtoimmuni.
English: All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Maltese: Il­pazjenti kollha rċevew doża standardizzat ta' ġimgħatejn ta' prednisone 60mg/jum meta ddaħlu fl­istudju segwit minn skeda obbligatorja li d­doża tiġi mnaqqsa ftit ftit, bi twaqqif komplut tal­kortikosterojdi sa ġimgħa 15.
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: L­espożizzjoni ta' Adalimumab f'pazjenti pedjatriċi b'uveite kienet imbassra bl­użu ta' mudellar farmakokinetiku tal­popolazzjoni u simulazzjoni bbażata fuq farmakokinetika ta' indikazzjoni minn pazjenti pedjatriċi oħra (psorijasi pedjatrika, artrite idjopatika minorenni, marda ta' Crohn pedjatrika u artrite relatata mal­entesite).
English: 5.1 Choose an injection site on:
Maltese: 5.1 Agħżel sit għall­injezzjoni minn:
English: There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Maltese: M'hemm l­ebda użu rilevanti ta' Idacio fit­tfal b'età inqas minn 12­il sena f'din l­indikazzjoni.
English: Idacio therapy should not be continued in patients failing to respond within this time period.
Maltese: Tarmix mediċini mal­ilma tad­dranaġġ jew mal­iskart domestiku.
English: After proper training in injection technique, patients may self-inject with Idacio if their physician determines that it is appropriate and with medical follow-up as necessary.
Maltese: B'mod ġenerali, ir­reazzjonijiet fil­post ta' l­injezzjoni ma kkaġunawx it­twaqqif tat­teħid tal­prodott mediċinali.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L­MAH għandu jwettaq l­attivitajiet u l­interventi meħtieġa ta' farmakoviġilanza ddettaljati fl­ RMP maqbul ippreżentat fil­Modulu 1.8.2 tal­Awtorizzazzjoni għat­Tqegħid fis­Suq u kwalunkwe aġġornament sussegwenti maqbul tal­RMP.
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient years.
Maltese: Ir­rata osservata ta' kanċer tal­ġilda li m'humiex melanoma hija ta' bejn wieħed u ieħor 9.6 kull 1,000 sena ta' pazjent, u r­rata osservata ta' limfomi hija ta' bejn wieħed u ieħor 1.3 kull 1,000 sena ta' pazjent.
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 fl­istess waqt, kienu permessi u 80% tal­pazjenti komplew jirċievu mill­inqas waħda minn dawn il­ mediċini.
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 Of those receiving corticosteroids at baseline
Maltese: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra lplaċebo ** p < 0.02 għall­paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra lplaċebo a Minn dawk li jirċievu l-kortikosterojdi fil-linja bażi
English: In Psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Maltese: Fi Studju Psorajisi I, 28% tal­pazjenti li kienu rrispondew għal PASI 75 u reġgħu ġew magħżula b'ordni addoċċ għall­plaċebo f'ġimgħa 33 meta mqabbla ma' 5% li komplew jirċievu adalimumab, p <0.
English: Antibiotics may be continued during treatment with Idacio if necessary.
Maltese: Antibijotiċi jistgħu jitkomplew waqt it­trattament b'Idacio jekk ikun meħtieġ.
English: • Idacio Vial Kit is for single use only.
Maltese: • Idacio hija siringa mimlija għal­lest li tintuża darba biss.
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Maltese: Rigward it­teħid flimkien ta' Idacio ma' mediċini anti­rewmatiċi li jaffetwaw il­proċess tal­mard, minbarra methotrexate, ara sezzjoni 4.4 u 5
English: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Maltese: F'ġimgħa 52, studji RA III u V kellhom skop primarju addizzjonali tat­tfiegħ lura tal­progress tal­marda (kif jidher mir­riżultati ta' l­ X-rays).
English: • Give plunger a final push to ensure the full dose has been injected (Figure R).
Maltese: • Agħti l­aħħar imbottatura lill­planġer biex tiżgura li d­doża sħiħa ġiet injettata (Figure R).
English: This risk may increase if his/her lung function is reduced.
Maltese: Dan ir­riskju jista jiżdied jekk il­funzjoni tal­pulmun tiegħek tkun imnaqqsa.
English: NAME OF THE MEDICINAL PRODUCT Idacio 40 mg solution for injection in pre-filled syringe Idacio 40 mg solution for injection in pre-filled pen
Maltese: U KWANTITATTIVA Idacio 40 mg soluzzjoni għall­injezzjoni f'siringa mimlija għal­lest
English: Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Maltese: Pazjenti b'mill­inqas rispons parzjali għal adalimumab 40 mg kull ġimgħa wara 12­il ġimgħa ta' trattament.