FrancophonIA/ELRC3.0 huggingface dataset:
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Maltese: Studju RA III evalwa 619 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥18-il sena, u li kellhom rispons mhux effettiv meta ngħataw dożi ta' minn 12.5 sa 25 mg ta' methotrexate jew kienu intolleranti għal 10 mg ta' methotrexate fil-ġimgħa.
English: 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 evalwati fi studju multiċentriku u double-blind, fejn l-individwi ntgħażlu b'mod każwali, ta' 46 pazjent pedjatriku (6 sa 17-il sena) b'artrite moderata relatata mal-entesite.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Artrite Psorjatika u spondiloartrite assjali inkluż ankylosing spondylitis
English: Note: Treatment failure at or after week 6 (Study UV I), or at or after week 2 (Study UV II), was counted as event.
Maltese: Nota: Il-falliment tat-trattament fi jew wara ġimgħa 6 (Studju UV I), jew fi jew wara ġimgħa 2 (Studju UV II), ingħadd bħala avveniment.
English: EU/1/18/1319/006 6 pack
Maltese: EU/1/18/1319/003 6 pakketti
English: p-valuea p-valueb p-valuec
Maltese: Kif tipprepara l-pinna mimlija għal-lest
English: Injection syringe
Maltese: Infezzjonijiet serji
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 tar-riżultat 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: Hulio is used to treat moderate to severe plaque psoriasis in adults.
Maltese: Hulio huwa intenzjonat għall-kura ta' psorjasi tal-plakka moderata sa severa fl-adulti.
English: Serious adverse reactions have been reported for adalimumab.
Maltese: - Is-sustanza attiva hi adalimumab.
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'zewġ studji (pJIA I u II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż-żgħażagħ, u li kellhom varjetà ta' bidu ta' JIA (l-aktar frekwenti fattur rewmatoloġiku negattiv jew poliartrite pożittiva u oligoartrite fit-tul).
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew evalwati fi studji double-blind u kkontrollati bi plaċebo li fihom l-indivdiwi ntgħażlu b'mod każwali, u fi studju ta' estensjoni open-label f'pazjenti adulti b'hidradenitis suppurativa (HS) moderata sa severa li kienu intolleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill-inqas prova ta' 3 xhur ta' terapija antibijotika sistemika.
English: • DO NOT inject into scars or stretch marks.
Maltese: • TINJETTAX ġo ċikatriċi (scars) jew stretch marks.
English: Hulio is supplied as packs containing 1 or 2 boxes.
Maltese: Hulio hu fornut f'pakketti li fihom 1 jew 2 kaxex.
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Maltese: Koleċistite u kolelitijasi, steatożi tal fwied, żieda fil-bilirubina
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' dożi multipli ta' adalimumab ġew ivvalutati f'pazjenti adulti b'kolite ulċerattiva attiva minn moderata sa severa (Punteġġ Mayo 6 sa 12; b'sottopunteġġ 2 sa 3 blendoskopija) fi studji double-blind u kkontrollati bi plaċebo, li fihom l-individwi ntgħażlu b'mod każwali.
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 pazjent pedjatriku b'espożizzjoni ta' 655.6 sena ta' pazjent waqt provi b'adalimumab f'pazjenti b'artrite idjopatika taż-żgħażagħ (artrite idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite).
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Maltese: L-effikaċja ta' adalimumab kienet evalwata fi studju każwali, double-blind, u kkontrollat ta' 114-il pazjent pedjatriku minn 4 snin 'il fuq bi psorjasi tal-plakka severa kronika (kif iddefinita minn Valutazzjoni Globali tat-Tabib (PGA, Physician's Global Assessment) ≥4 jew >20% involviment talBSA jew >10% involviment tal-BSA b'leżjonijiet ħoxnin ħafna jew Indiċi tal-Parti Milquta millPsorijasi u s-Severità tagħha (PASI, Psoriasis Area and Severity Index) ≥20 jew ≥10 b'involviment klinikament rilevanti tal-wiċċ, ġenitali, jew idejn/saqajn) li ma kinux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati fi studju parallel multiċentriku u double-blind, fejn l-individwi ntgħażlu b'mod każwali, ta' 171 tifel u tifla (li għandhom bejn 4 - 17-il sena) b'JIA poliartikulari.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 0.8 ml vial contains 40 mg adalimumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett ta' 0.8 mL fih 40 mg ta' adalimumab.
English: Hulio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Maltese: Hulio huwa intenzjonat għall-kura ta' hidradenitis suppurativa f'adolexxenti minn 12-il sena 'l fuq.
English: Prior to launch of Hulio in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Hulio f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorisation Holder) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Psoriasis Study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Maltese: L-Istudju tal-Psorijasi III (REACH) ikkumpara l-effikaċja u s-sigurtà ta' adalimumab kontra l-plaċebo f'72 pazjent bi psorjasi tal-plakka kronika minn moderata sa severa u psorjasi fl-idejn u/jew fis-saqajn.
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 inattiva li teħtieġ trattament kroniku ta' kortikosterojdi (prednisone orali 10 sa 35 mg/jum) fil-linja bażi għall-kontroll tal-marda tagħhom.
English: Fill Marker
Maltese: Piż tal
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Maltese: • disturbi fin-nervituri (bħal infjammazzjoni tan-nerv ottiku u s-sindrome ta' Guillain-Barré,
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Maltese: Rati simili ta' titjib ġew osservati għad-dożaġġ tal-bidu ta' 160/80 mg u 80/40 mg milħuqa sa ġimgħa 8 u fil-grupp tal-160/80 mg, l-avvenimenti avversi ġew innutati b'mod aktar frekwenti.
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Maltese: F'ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi Studju HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatat ma' HS (ara Tabella 17).
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-il individwu inklużi fl-estensjoni mhux ikkontrollata fit-tul tal-Istudji UV I u UV II, 46 individwu kienu meqjusa ineliġibbli (eż. żviluppaw kumplikazzjonijiet sekondarji għal retinopatija dijabetika, minħabba kirurġija tal-katarretti jew vitrektomija) u kienu esklużi mill-analiżi primarja taleffikaċja.
English: Adalimumab was assessed in a multicentre, 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 individwu pedjatriku li għandhom bejn 6 u 17-il sena (inklużi), bil-marda ta' Crohn (CD) moderata sa severa definita bħala punteġġ tal-Indiċi talAttività tal-Marda Crohn (Crohn's disease) fit-Tfal (PCDAI, Paediatric Crohn's Disease Activity Index) >30.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Maltese: Antibijotiċi jistgħu jitkomplew waqt it-trattament b'Hulio jekk ikun meħtieġ.
English: Fever, bruising, bleeding or looking pale
Maltese: Tnaqqis fil-vista, konġuntivite, blefarite, nefħa fl-għajnejn
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Maltese: Fi studju UC-II, 248 pazjent irċivew 160 mg ta' adalimumab f'ġimgħa 0, 80 mg f'ġimgħa 2 u 40 mg ġimgħa iva u ġimgħa le minn hemm 'il quddiem, filwaqt li 246 pazjent irċivew plaċebo.
English: ALT elevations ≥ 3 x ULN occurred in 0.9% of adalimumab-treated patients and 0.9% of controlled-treated patients.
Maltese: Żidiet fil-livelli tal-ALT ta' ≥3 × ULN seħħew f'0.9% tal-pazjenti kkurati b'adalimumab u f'0.9% tal-pazjenti kkurati bil-kontroll.
English: Percent Change in Total Fingernail NAPSI (%)
Maltese: Bidla Perċentwali tat-Total tan-NAPSI tad-Dwiefer (%)
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Maltese: Pazjenti li kisbu PASI 75 u PGA xejn jew minimali kienu rtirati mit-trattament għal massimu ta' 36 ġimgħa u mmonitorjati għat-telf tal-kontroll tal-marda (jiġifieri aggravar tal-PGA ta' mill-inqas 2 gradi).
English: • asthma;
Maltese: • lewkimija;
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Maltese: *** p<0.001 għall-paraguni kollha bejn adalimumab u l-plaċebo * p<0.05 għall-paraguni kollha bejn adalimumab u l-plaċebo
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: Table 9: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Maltese: Tabella 9: Risponsi għall-ACR fi Provi Kkontrollati bil-Plaċebo (Perċentwali ta' Pazjenti) Rispons
English: The recommended Hulio 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: Il-kors tad-doża tal-bidu ta' Hulio rrakkomandat għal pazjenti adulti b'kolite ulċerattiva minn moderata sa severa huwa ta' 160 mg f'ġimgħa 0 (mogħtija bħala erba' 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: 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 ikkontrollat bil-Plaċebo - Studju ITnaqqis fisSinjali u s-Sintomi Rispons
English: Step 6 - Place pen
Maltese: Pass 6 - Poġġi l-pinna f'postha
English: Hulio is used to treat Crohn's disease in children aged 6 to 17 years.
Maltese: Hulio huwa intenzjonat għall-kura tal-marda ta' Crohn fi tfal li għandhom bejn 6 u 17-il sena.
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 rispons tal-PGA “xejn” jew “minimali” wara 16-il ġimgħa minn meta reġgħet inbdiet il-kura, irrispettivament minn jekk dawn il-pazjenti reġgħux esperjenzaw tfaċċar mill-ġdid ta' sintomi 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 u dawk li m'esperjenzawx tfaċċar mill-ġdid ta' sintomi rispettivament, matul il-perjodu li fih twaqqfet il-kura).
English: Each Hulio pre-filled pen contains 38.2 mg of sorbitol.
Maltese: Kull kunjett ta' Hulio fih 38.2 mg ta' sorbitol.
English: Table 23: Maintenance of Clinical Remission and Response (Percent of Patients) Placebo
Maltese: Tabella 23: Il-Manteniment tat-Titjib Kliniku u tar-Rispons (Perċentwali ta' Pazjenti) Plaċebo
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 anti-rewmatiċi li jaffettwaw il-proċess tal-mard, inkluż methotrexate, ma kienx adegwat.
English: Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus.
Maltese: Sintomi jistgħu jinkludu noduli ratba (nefħa) u axxessi (imsiemer fil-follikuli taxxagħar) li jistaw inixxu materja.
English: Table 17: Ps Study I (REVEAL) - Efficacy Results at 16 weeks Placebo N=398 n (%)
Maltese: - Riżultati tal-Effikaċja f'Ġimgħa 16 Plaċebo N=398 n (%)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 ml
Maltese: INDIVIDWALI 40 mg/0.8 mL
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'ġimgħa 24 (n=27 minn 30 pazjent), ir-risponsi Pedjatriċi ACR 30 inżammu sa 60 ġimgħa fil-fażi
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil-livelli ta' CPR f'pazjenti li jbatu minn artrite idjopatika poliartikulari taż-żgħażagħ, mill-marda ta' Crohn (Crohn's disease), minn kolite ulċerattiva u minn hidradenitis suppurativa wara trattament b'adalimumab.
English: • inflammatory skin rash;
Maltese: • raxx tal-ġilda infjammatorju;
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Maltese: Antagonisti ta' TNF, inkluż adalimumab, ġew assoċjati f'okkażjonijiet rari ma' sintomi kliniċi tal-bidu ġodda jew taħrix ta' sintomi kliniċi u/jew evidenza radjografika ta' mard li jaffettwa il-mijelina tannervituri fis-sistema nervuża ċentrali u jinkludu sklerożi multipla u nevrite ottika u mard li jaffettwa l-mijelina tan-nervituri fis-sistema periferali, li jinkludu s-sindrome ta' Guillain-Barré.
English: 2 alcohol pads
Maltese: 2 tajjariet bl-alkoħol
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Maltese: Il-punt tat-tmiem primarju kien il-bidla perċentwali mil-Linja Bażi sa ġimgħa 12 fin-numru ta' ġogi attivi bl-artrite (nefħa mhux minħabba sfigurazzjoni jew ġogi li m'għadhomx jiċċaqalqu flimkien ma' wġigħ u/jew sensittività), li kien milħuq bi tnaqqis filperċentwali medja ta' −62.6% (bidla perċentwali medja −88.9%) f'pazjenti fil-grupp ta' adalimumab meta kkumparat ma' −11.6% (bidla perċentwali medja −50.0%) f'pazjenti fil-grupp tal-plaċebo.
English: Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: Hulio huwa indikat għat-trattament ta' psorjasi tal-plakka severa u kronika fit-tfal u adolexxenti minn 4 snin 'il fuq u li kellhom rispons inadegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
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: 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: Għall-pazjenti li baqgħu jieħdu l-kura każwali tagħhom, il-medja (±SD) tal-konċentrazzjonijiet fillivell minimu ta' adalimumab fis-serum f'ġimgħa 52 kienet 9.5 ± 5.6 µg/mL għall-grupp tad-Doża Standard u 3.5 ±2.2 µg/mL għall-grupp tad-Doża Baxxa.
English: Hulio 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: Hulio jista' jittieħed flimkien ma' methotrexate jew ċerti aġenti antirewmatiċi li jaffettwaw il-proċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħataw b'injezzjoni), kortikosterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini antiinfjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs).
English: • blockage in an artery of the lung;
Maltese: • infjammazzjoni tal-vini u l-arterji;
English: Solution for injection 1 pre-filled syringe, 2 alcohol pads 2 pre-filled syringes, 2 alcohol pads 6 pre-filled syringes, 6 alcohol pads
Maltese: Soluzzjoni għall-injezzjoni 1 siringa mimlija għal-lest, 2 tajjariet bl-alkoħol 2 siringi mimlija għal-lest, 2 tajjariet bl-alkoħol 6 siringi mimlija għal-lest, 6 tajjariet bl-alkoħol
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Maltese: L-Istudju tal-Psorijasi II (CHAMPION) qabbel l-effikaċja u s-sigurtà ta' adalimumab kontra dik ta' methotrexate u tal-plaċebo f'271 pazjent.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Fi Studju nr-axSpA I, adalimumab 40 mg ġimgħa iva u ġimgħa le ġie evalwat f'185 pazjent fi studju li dam 12-il ġimgħa double-blind u kkontrollat bil-plaċebo li fih l-individwi ntgħażlu b'mod każwali, f'pazjenti b'nr axSpA attiva (punteġġ medju tal-linja bażi ta' attività tal-marda [Indiċi tal-Attività talMarda Ankylosing Spondylitis ta' Bath (BASDAI)] kien 6.4 għal pazjenti ttrattati b'adalimumab u 6.5 għal dawk fuq il-plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Maltese: Fi studju UC-I, 390 pazjent li ma kinux ħadu antagonisti tat-TNF ġew imqassma b'mod każwali biex jew jirċievu l-plaċebo f'ġimgħat 0 u 2, jew 160 mg adalimumab f'ġimgħa 0 segwit minn 80 mg f'ġimgħa 2, jew 80 mg adalimumab f ġimgħa 0 segwit minn 40 mg f'ġimgħa 2.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis Study III).
Maltese: Issigurtà u l-effikaċja ta' adalimumab ġew studjati wkoll f'pazjenti adulti li jbatu minn psorjasi talplakka kronika minn moderata sa severa bi psorjasi fl-idejn u/jew fis-saqajn fl-istess ħin li kienu kandidati għat-terapija sistemika fl-istudju każwali u double-blind (Studju tal-Psorijasi III).
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Maltese: Ipokalemija, żieda fl aċidu uriku, is sodium fid demm ikun anormali, ipokalċimija, ipergliċemija, ipofosfatimija, deidratazzjoni