FrancophonIA/ELRC3.0 huggingface dataset:
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Maltese: L­ interpretazzjoni tad­data jista' jkollha impatt minħabba limitazzjonijiet metodoloġiċi tal­istudju, inkluż daqs tal­kampjun żgħir u disinn mhux randomizzat.
English: Table 17: efficacy results at 12 weeks, HS studies I and II
Maltese: Tabella 17: Riżultati ta' effikaċja fi 12-il ġimgħa, Studji
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Maltese: B'kollox 19­il suġġett, li 11 minnhom mill­grupp tal­linja bażi ta' l­età ta' bejn l­4 u 12­il sena u 8 mill­grupp tal­linja bażi ta' l­età ta' bejn it­13 u 17­il sena kienu kkurati għal sitt snin jew aktar.
English: Idacio is used to treat rheumatoid arthritis in adults.
Maltese: Idacio jintuża biex jittratta artrite rewmatika fl­adulti.
English: Idacio 40 mg solution for injection in pre-filled pen EU/1/19/1356/003
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1356/001
English: • Hold the -pre-filled pen so that you can see the transparent syringe housing.
Maltese: • Żomm il­pinna mimlija għal­lest b'mod li tista' tara l­kompartament trasparenti tas­siringa.
English: JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: c. il­valur­p jiġi mit­tqabbil bejn pari ta' trattament b'monoterapija b'adalimumab u b'monoterapija b'methotrexate bl-użu tat-test U Mann-Whitney.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double−blind, placebo−controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Maltese: It­teħid ta' 40 mg adalimumab ġimgħa iva u ġimgħa le kien stimat fi 393 pazjent f'żewġ studji doubleblind, kontrollati bil­plaċebo li ħadu 24 ġimgħa u li saru b'ordni addoċċ fuq pazjenti li jbatu minn infjammazzjoni tal­vertebri li jirriżulta fil­vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il­punt medju tal­linja bażi ta' l­attività tal­mard [l­Indiċi ta' l­Attività tal­Mard Ankylosing Spondylitis (BASDAI)] kien 6.3 fil­gruppi kollha) li ma kellhomx rispons adegwata għat­terapija konvenzjonali.
English: opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections,
Maltese: Infezzjonijiet newroloġiċi (li jinkludu l­meninġite virali), infezzjonijiet opportunistiċi u tuberkulosi (li jinkludu coccidioidomycosis, histoplasmosis u infezzjoni tal-mycobacterium avium complex), infezzjonijiet tal-batterji, infezzjonijiet fl­għajnejn, divertikulite1)
English: Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Idacio huwa ndikat għall­trattament ta' psorijasi tat­tip li tikkawża qoxra mhux normali fuq il­ġilda, li hi minn moderata sa severa, f'pazjenti adulti li li huma kandidati għal terapija sistemika.
English: ≥30% Reduction in skin painb
Maltese: ≥30% Tnaqqis fl­uġigħ fil­ ġildab
English: Solution for injection 2 pre-filled pens 2 alcohol pads 6 pre-filled pens 6 alcohol pads
Maltese: Soluzzjoni għall­injezzjoni 2 siringi mimlija għal­lest 2 kuxxinetti bl­alkoħol 6 siringi mimlijin għal­lest 6 kuxxinetti bl­alkoħol
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and PASI ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab ġew studjati f'pazjenti adulti bi psorjasi tal­plakka kronika ( 10% involviment BSA u PASI  12 jew  10) li kienu kandidati għal terapija sistemika jew fototerapija fi studji każwali, double­blind. 73% tal­pazjenti rreġistrati fl­Studji Psorajisi I u II kienu rċevew minn qabel terapija sistemika jew fototerapija.
English: Figure A 1.3 Remove the box from the refrigerator (Figure B).
Maltese: Stampa A 1.3 Neħħi l­kaxxa minn ġol­friġġ (Stampa B).
English: Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child.
Maltese: Nota: Bl-esperjenza, ser issib li l­angolu (bejn 45° u 90°) li hu l­aktar komdu għalik u għal wild tiegħek.
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Maltese: Fost dawk li rrispondew (ACR Pedjatriku 30) f'ġ imgħa 24 (n=27 minn 30 pazjent), ir­rispons tal­ACR Pedjatriku 30 kien mantenut sa 60 ġimgħa fil­fażi OLE f'pazjenti li rċevew adalimumab matul dan il­perjodu.
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Maltese: F'ġimgħa 12, proporzjon ogħla ta' pazjenti ttrattati b'adalimumab kontra l­plaċebo kisbu HiSCR.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 mL vial contains 40 mg adalimumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Pinna waħda ta' 0.8 ml mimlija għal­lest fiha 40 mg adalimumab.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2).
Maltese: Iż­żewġ studji wrew effett kmieni u sostnut ta' adalimumab fuq ir­rata tal­falliment tat­trattament kontra l­plaċebo (ara Figura 2).
English: - Keep this leaflet.
Maltese: Għatu tal­ labra
English: Serious adverse reactions have been reported for adalimumab.
Maltese: Reazzjonijiet avversi serja, ġew irrapurtati b' adalimumab.
English: Idacio 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: Idacio jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' aġenti antirewmatiċi li jaffetwaw il­ proċess tal­mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad­deheb li jingħata b'injezzjoni), kortikosterojdi jew mediċini għall­uġigħ, li jinkludu mediċini anti­ infjammatorji mhux sterojdi (NSAIDs).
English: After 12 weeks of therapy, patients who had received adalimumab in Period A were re-randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Maltese: reġgħu ġew magħżula b'mod każwali fil­Perjodu B sa 1 minn 3 gruppi ta' trattament (adalimumab 40 mg kull ġimgħa, adalimumab 40 mg ġimgħa iva u ġimgħa le, jew plaċebo mill­ġimgħa12 sa ġimgħa 35).
English: Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Maltese: Fost il­250 is­ suġġett li temmew l­istudju ta'estensjoni open­label, titjib fil­funzjoni fiżika nżammet matul l­10 snin ta' trattament.
English: Adalimumab was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
Maltese: Adalimumab ġie evalwat fuq aktar minn 3000 pazjent fil­provi kliniċi kollha ta' l­artrite rewmatika.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Maltese: Ma hemm l­ebda użu ta' adalimumab li huwa rilevanti fi tfal għall­indikazzjonijiet ta' ankylosing spondylitis u artrite psorjatika.
English: ASASa partial remission ASDASc inactive disease Partial flared aAssessment of SpondyloArthritis international Society bBaseline is defined as open label baseline when patients have active disease.
Maltese: Flare parzjalid a Stima tas­Soċjeta Internazzjonali tal­ISpondiloArtrite b Il­linja bażi hija definita bħala linja bażi open label meta l­pazjenti għandhom mard attiv.
English: 6.3 Gently push the white plunger rod all the way down until the syringe is empty.
Maltese: 6.1 Bl­id l­oħra, oqros liwja ta' ġilda mnaddfa u żommha.
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti−rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Maltese: 1%) pazjent ġew ikkurati flimkien ma' mediċini anti­rewmatiċi li li jaffetwaw il­ proċess tal­marda, u 37 (9.4%) pazjent flimkien ma' glukokortikojdi.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Maltese: Immunosuppressanti , Inibitturi ta' Tumur Nekrosi Fattur alfa (TNFα).
English: Alcohol pads
Maltese: alkoħol.
English: • paediatric Crohn's disease
Maltese: • il-marda Crohn (Crohn's Disease) fit-tfal
English: • polyarticular juvenile idiopathic arthritis
Maltese: • artrite attiva idjopatika poliartikulari taż­żagħżagħ
English: The recommended Idacio dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Maltese: Ir­reġimen tad­doża ta' Idacio rrakamondata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'jum 1 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Maltese: Fost pazjenti li kellhom mill­inqas rispons parzjali f'ġimgħa 12, u li rċevew terapija kontinwa b'adalimumab kull ġimgħa, ir­rata ta' HiSCR f'ġimgħa 48 kienet 68.3% u f'ġimgħa 96 kien ta' 65.1%.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il­mediċina tinsab fuq is­sit elettroniku tal­Aġenzija Ewropea għall­ Mediċini http://www.ema.europa.eu
English: • adolescent hidradenitis suppurativa
Maltese: • hidradenitis suppurativa fl-adolexxenti
English: The safety profile for patients with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab.
Maltese: Il­profil tas­sigurtà għal pazjenti b'HHS ittrattati b'adalimumab kull ġimgħa kien konsistenti mal­ profil tas­sigurtà magħruf ta'adalimumab.
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: Antagonisti­TNF, inluż adalimumab, ġew assoċjati f'okkażjonijiet rari, ma' sintomi kliniċi ġodda jew taħrix ta' sintomi kliniċi u/jew evidenza radjografika ta' mard li jaffetwaw il­myelin tan-nervituri fissistema nervuża ċentrali u jinkludu sklerożi multipla u nevrite ottika u mard li jaffetwaw il­myelin tannervituri fis­sistema periferali, li jinkludu s­sindromu Guillain­Barré.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Maltese: Antagonisti tat­TNF, bħal adalimumab jeffetwaw is­sistema immunitarja u l­użu tagħhom jista' jeffetwa id­difiża tal­ġisem kontra infezzjoni u kanċer.
English: Idacio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Maltese: Idacio huwa ndikat għat­trattament ta' uveite pedjatrika anterjuri kronika mhux infettiva f'pazjenti minn sentejn li kellhom rispons inadegwat għal jew li mhumiex tolleranti għat­terapija konvenzjonali, jew li fihom it-terapija konvenzjonali mhix adattata.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal­manifattur tas­sustanza bijoloġika attiva
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 tas­serum f'adalimumab ta' bejn wieħed u ieħor 12 g/ml matul il-perijodu tal-bidu.
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Maltese: Fil-provi pivitali kontrollati li saru fl-adulti u fit-tfal, 12.9% tal-pazjenti kkurati b' adalimumab żviluppaw reazzjonijiet fil­post ta' l­injezzjoni (eritema u/jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunati ma' 7.2% tal­pazjenti li kienu qegħdin jirċievu l­plaċebo jew sustanza attiva użata bħala kontroll.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 29).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar­riskju tal­falliment tat­trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (Ara t­Tabella 28).
English: Cerebrovascular accident1), tremor, neuropathy
Maltese: Aċċident ċerebrovaskulari1), tregħid, newropatija
English: Discontinuation of immunomodulators2
Maltese: Twaqqif tal-immunomodulaturi2
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: pazjenti b'artrite relatata mal­entesite li kellhom minn 6 sa 17­il sena, il­konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'ġimgħa 24) ta' adalimumab fis­serum 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: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Idacio (see section 4.4).
Maltese: L­oftalmologi huma avżati biex jikkonsultaw ma' speċjalista adattat qabel ma tinbeda l­kura b'Idacio (ara sezzjoni 4.4).
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Maltese: Fi provi kkontrollati ta' adalimumab (dożi inizjali ta' 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2, segwiti minn 40 mg kull ġimgħa li jibdew f'ġimgħa 4), f'pazjenti bi suppurativa hidradenitis bil­perjodu ta' kontroll b'durazzjoni li tvarja minn 12 sa 16­il ġimgħa, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'0.3% tal-pazjenti ttrattati b'adalimumab u 0.6% tal-pazjenti ttrattati kkontrollati.
English: In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Maltese: Fi studju UV II, kienu osservati differenzi statistikament sinifikanti għal akutezza viżiva biss, iżda l­komponenti l­oħra kienu numerikament favur adalimumab.
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: PGA varjat minn “ħafif” (<1%) għal “moderat” (48%) għal “sever” (46%) għal “sever ħafna” (6%).
English: skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster),
Maltese: • lupus erythematosus sistemiku (disturb immuni li jinkludi infjammazzjoni tal ġilda, tal qalb, tal pulmun, tal ġogi u ta' sistemi ta' organi oħra);
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 21).
Maltese: F'ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi Studju HS­II esperjenzaw tnaqqis klinikament rilevanti fl­uġigħ fil­ġilda relatati ma' HS (ara t­Tabella 21).
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Maltese: Il­benefiċċju u r­riskju ta' trattament kontinwu fit­tul għandhom jiġu evalwati perjodikament (ara sezzjoni 5.1).
English: Clinical response
Maltese: Kliniku
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Maltese: Is­suġġetti kollha ngħataw kura tal­bidu open-label b'doża fuq bażi tal­linja bażi tal­piż tal­ġisem tagħhom: 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2 għal suġġetti ≥ 40 kg, u 80 mg u 40 mg, rispettivament, għal suġġetti < 40 kg.
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Maltese: Fi provi kkontrollati ta' Idacio (dożi inizjali ta' 80 mg f'Ġimgħa 0 segwita b'40 mg ġimgħa iva u ġimgħa le li tibda f'Ġimgħa 1) f'pazjenti adulti b'uveite sa 80 ġimgħa b'esponiment medjan ta' 166.5 ġurnata u 105.0 ġranet ttrattati b'Idacio u pazjenti ttrattati b'kontroll, rispettivament, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'2.4% ta' pazjenti ttrattati b'Idacio u 2.4% ta' pazjenti ttrattati b'kontroll.
English: • WATCH the syringe plunger to make sure it moves all the way down to the bottom (Figure P).
Maltese: • ARA l­planġer tas­siringa , biex taċċerta li tiċċaqlaq 'l isfel sal­qiegħ (Stampa P).
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Idacio.
Maltese: • Peress illi ġew irrappurtati każi ta' tuberkulosi f'pazjenti kkurati b'adalimumab, qabel tibda Idacio, it­tabib tiegħek se jeżaminak għal sinjali u sintomi tat­tuberkulosi.
English: Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Maltese: Eżitu tar­rappurtar tal­pazjent rigward il­funzjoni relatati mal­viżjoni kienu mkejla fiż­żewġ studji kliniċi, bl­użu ta' NEI VFQ­25.
English: Pancytopenia
Maltese: Panċitopenja
English: Idacio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Maltese: Idacio jintuża biex jittratta hidradenitis suppurativa fl­adolexxenti minn 12­il sena.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising,
Maltese: • sinjali u sintomi li għandhom x'jaqsmu ma' disturbi tad­demm bħal deni persistenti, tbenġil,
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Maltese: Is­suġġetti li ħarġu matul il­perjodu double­blind ingħataw terapija ta' salvataġġ ta' adalimumab 40 mg eow għal mill­inqas 12­il ġimgħa.
English: Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus.
Maltese: Sintomi jistgħu jinkludu noduli ratba (nefħa) u axxessi (imsiemer) li jistgħu jnixxu materja.
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Maltese: Studju RA V evalwa 799 pazjent adult li jbatu minn artrite rewmatika attiva minn moderata sa severa li għada fil­bidu (il­medja ta' kemm ilha li bdiet il­marda kien ta' 9 xhur) li ma kinux qatt għadhom ħadu methotrexate.
English: The safety and efficacy of adalimumab was assessed in an open-label, multicenter study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Maltese: Is­sigurtà u l­effikaċja ta' adalimumab kienu evalwati fi studju tat­tip multiċentriku u “open­label” fi 32 tfal (2 ­ < 4 snin jew li għandhom min 4 snin il­fuq u li jiżnu < 15 kg) li għandhom artrite poliartikulari
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: ġilda u psorijasi fl­idejn u/jew fis­saqajn fl­istess ħin li kienu kandidati għat­terapija sistemika fl­ istudju double-blind magħżula b'ordni addoċċ (Studju tal­Psorijasi III).
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Maltese: Tabella 7 Risponsi għall-ACR fi provi bil-plaċebo bħala kontroll (Persentaġġ ta' pazjenti)
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Maltese: Huwa importanti li inti tgħid lit­tabib tiegħek jekk għandek sintomi ta' infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas­snien (ara Twissijiet u prekawzjonijiet).
English: Idacio is intended for the treatment of the following inflammatory diseases:
Maltese: Idacio huwa intenzjonat għall­kura ta' mard infjammatorju li ġej:
English: Idacio is recommended for use in combination with methotrexate.
Maltese: Idacio hu rakkomandat għall­ użu f'kombinazzjoni ma' methotrexate.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il­mediċina tinsab fuq is­sit elettroniku tal­Aġenzija Ewropea għall­Mediċini http://www.ema.europa.eu.
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Maltese: Ma jistax jiġi eskluż ir­riskju ta' żvilupp ta' tumuri malinni fit­tfal u adoloxxenti kkurati b'antagonisti tat-TNF.
English: 7.2 Throw away the used syringe with the protected needle and the vial with attached vial adapter into a sharps container.
Maltese: 7.2 Armi s­siringa użata bil­labra protetta u l­kunjett bl­adapter mwaħħal tal­kunjett ġo reċipjent tal­ ixfafar.
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more
Maltese: Tfal u adolexxenti minn 4 snin sa 17­il sena ta' età u li jiżnu 30 kg jew aktar