FrancophonIA/ELRC3.0 huggingface dataset:
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Maltese: • vaskulite (infjammazzjoni tal-vini u l-arterji);
English: In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Maltese: Fi studju CD II, 325 pazjent li ma kinux baqgħu juru rispons għall-kura jew li ma kinux jittolleraw infliximab kienu mqassma bl-addoċċ biex jirċievu jew 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2 jew plaċebo f'ġimgħat 0 u 2.
English: Standard dose 40/20 mg eow
Maltese: Doża baxxa 20/10 mg eow
English: • 40 mg at week 0 and 20 mg at week 2
Maltese: • 40 mg f'ġimgħa 0 and 20 mg f'ġimgħa 2
English: pneumocystis, candidiasis, aspergillosis and listeriosis).
Maltese: Sensittività eċċessiva, allerġiji (li jinkludu l-allerġija assoċjata ma' listaġuni)
English: 0.8 mL solution in pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with a latex-free needle cap, a plunger stopper (synthetic rubber), extended finger flanges and a passive needle shield.
Maltese: 0.8 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ ta' tip I) b'wiċċ 29G irqieq, labra tan-nofs pulzier u b'tapp tal-labra li huwa ħieles mill-latex, tapp tal-planġer (lastku sintetiku) falanġi estiżi għas-swaba u tarka passiva għal-labra.
English: diverticulitis
Maltese: Pożoloġija
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 PGA ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or 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, ikkontrollat ta' 114-il pazjent pedjatriku minn 4 snin il-fuq bi psorjasi tal-plakka severa kronika (kif definit minn involviment ta' PGA ≥ 4 jew> 20% BSA jew> 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew PASI ≥ 20 jew ≥ 10 bi klinikament rilevanti involviment tal-wiċċ, ġenitali, jew idejn/saqajn) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
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: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati f'pazjenti adulti bi psorjasi tal-plakka kronika ( 10% involviment BSA u PASI  12 jew  10) li kienu kandidati għal terapija sistemika jew fototerapija fi studji każwali, double-blind. 73% tal-pazjenti rreġistrati fl-Studji Psorajisi I u II kienu rċevew minn qabel terapija sistemika jew fototerapija.
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 fil-bidu (il-medja ta' kemm ilha li bdiet il-marda kien ta' 9 xhur) li ma kinux qatt għadhom ħadu methotrexate.
English: Yellow syringe connector
Maltese: Konnettur isfar għassiringa
English: • reactivation of hepatitis B infection;
Maltese: • riattivazzjoni tal-infezzjoni ta' epatite B;
English: Enthesitis-related arthritis
Maltese: Artrite relatata mal-Entesite
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Maltese: Mill-pazjenti li kellhom rispons f'ġimgħa 8, 47% kienu fi stat tar-rispons, 29% kienu fi stat ta' titjib, 41% kellhom fejqan tal-mukuża, u 20% kienu fl-istat ta' titjib mingħajr sterojdi għal ≥ 90 jum f' ġimgħa 52.
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Maltese: Kromeya jintuża għal trattament biex jittratta artrite idjopatika poliartikulari taż-żagħżagħ u l-artrite relatata mal-entesite.
English: Ped ACR 30 response (n/N)
Maltese: OL-LI 16 il-ġimgħa Ped ACR 30 rispons (n/N)
English: Needle cap
Maltese: Iftaħ hawn
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, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (ara Tabella 10).
English: • The name on the syringe is not Kromeya.
Maltese: • L-isem fuq is-siringa mhux Kromeya.
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull doża ta' 0.8 mL, jiġifieri tista' titqies li hi ‘hielsa mis-sodju'.
English: Table 25 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Maltese: Tabella 25 Studju ta' CD fit-tfal Twaqqif tal-kortikosterojdi jew immunomodulaturi u fejqan tal-fistla Doża standard 40/20 mg eow
English: The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Maltese: Il-kombinazzjoni ta' adalimumab kif ukoll ta' antagonisti TNF oħrajn u anakinra jew abatacept mhix rakkomandata abbażi ta' riskju ogħla ta' infezzjonijiet, li jinkludu infezzjonijiet serji u interazzjonijiet farmakoloġiċi potenzjali.
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 bil-perjodu ta' kontroll b'durazzjoni li tvarja minn 12 sa 16-il ġimgħa, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'0.3% tal-pazjenti ttrattati b'adalimumab u 0.6% tal-pazjenti ttrattati kkontrollati.
English: Adult Crohn's disease
Maltese: Il-marda Crohn (Crohn's disease) fl-adulti
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Maltese: Sar studju fuq l-effett tat-tossiċità waqt l-iżvilupp embrijo-fetali/l-iżvilupp fiż-żmien immedjatament qabel jew wara t-twelid, fuq xadini ċinomolgi li b' 0, 30 u 100mk/kg (9-17 -il xadina/grupp) u dan ma wera l-ebda evidenza ta' dannu kkaġunat b'adalimumab fuq il-feti.
English: After week 2, patients in both adalimumab arms received 40 mg eow.
Maltese: Wara ġimgħa 2, pazjenti fiż-żewġt gruppi ta' adalimumab irċevew 40 mg eow.
English: (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
Maltese: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ± 4.3 μg/mL meta adalimumab kien użat flimkien ma' methotrexate
English: Kromeya 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: Kromeya jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' aġenti antirewmatiċi li jaffetwaw il-proċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħata b'injezzjoni), kortikosterojdi jew mediċini għall-uġigħ, li jinkludu mediċini antiinfjammatorji mhux sterojdi (NSAIDs).
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: Fil-fażi ta' estensjoni tal-istudju RA III open-label, it-tnaqqis fir-rata ta' progress ta' ħsara strutturali huwa mantenut għal 8 u 10 snin.
English: Adverse reaction opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections,
Maltese: Infezzjonijiet newroloġiċi (li jinkludu l-meninġite virali), infezzjonijiet opportunistiċi u tuberkulosi (li jinkludu coccidioidomycosis, histoplasmosis u infezzjoni tal-mycobacterium avium complex), infezzjonijiet tal-batterji, infezzjonijiet fl-għajnejn,
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 għat-tuberkulosi, kien hemm każijiet ta' riattivazzjoni tat-tuberkulosi f'pazjenti kkurati b'adalimumab.
English: Needle
Maltese: Siringa
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'analiżi li fiha l-pazjenti kollha li ħarġu mill-istudju minħabba avvenimenti avversi jew nuqqas ta' effikaċja, jew fejn id-doża eskalat, kienu kkunsidrati li ma rrispondewx, Ir-rati ta' rispons ta' xejn jew minimali ta' PASI 75 u PGA f'dawn il-pazjenti kienu 69.6% u 55.7%, rispettivament, wara 108 ġimgħat oħra ta' terapija open-label (total ta' 160 ġimgħa).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.>
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: Fil-prova ta' Fażi 3 ta' adalimumab fit-tfal bil-marda Crohn (Crohn's disease) li evalwat l-effikaċja u s-sigurtà f'żewġ reġimi ta' dożaġġ ta' manteniment irranġati skont il-piż tal-ġisem wara terapija talbidu li wkoll kienet irranġata skont il-piż tal-ġisem sa 52 ġimgħa ta' trattament, kien hemm żidiet flALT ta' ≥ 3 x ULN f'2.6% (5/192) tal-pazjenti li minnhom 4 kienu qed jirċievu immunosuppressanti konkomitanti fil-linja bażi.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Maltese: • Jekk int iġġorr il-virus tal-epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li għandek riskju li jaqbdek l-HBV, għarraf lit-tabib tiegħek.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3441 li kienu kkurati b'adalimumab fl-istudji kollha ta' lartrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindromu li jixbaħ lis-sindromu tal-lupus.
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 bil-marda, f'artrite idjopatika taż-żagħżagħ (artrite idjopatika poliartikulari taż-żagħżagħ jew artrite relatata mal-entesite) kif ukoll pazjenti li jbatu minn axial spondyloarthritis (infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) u axial spondyloarthritis mingħajr evidenza radjografika ta' AS), minn artrite psorjatika, mill-marda Crohn (Crohn's disease), mill-kolite ulċerattiva, mill-psorijasi, minn hidradenitis suppurativa u minn uveite.
English: Adalimumab N=91
Maltese: Plaċebo N=94 Adalimumab N=91
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 19-il suġġett, li 11 minnhom mill-grupp tal-linja bażi ta' l-età ta' bejn l-4 u 12-il sena u 8 mill-grupp tal-linja bażi ta' l-età ta' bejn it-13 u 17-il sena kienu kkurati għal sitt snin jew aktar.
English: Kromeya 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: Kromeya huwa ndikat għat-trattament ta' uveite pedjatrika anterjuri kronika mhux infettiva f'pazjenti minn sentejn li kellhom rispons inadegwat għal jew li mhumiex tolleranti għat-terapija konvenzjonali, jew li fihom it-terapija konvenzjonali mhix adattata.
English: • difficulty in swallowing;
Maltese: • nawsja u rimettar;
English: Kromeya dose for paediatric patients with Crohn's disease
Maltese: Doża ta' Kromeya għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease)
English: Pancytopenia
Maltese: Anafilassi
English: Refer to package leaflet for alternative storage details.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi mgħażula.
English: Solution for injection 2 pre-filled syringes 2 alcohol pads 6 pre-filled syringes 6 alcohol pads
Maltese: Soluzzjoni għall-injezzjoni 2 siringi mimlija għal-lest 2 kuxxinetti bl-alkoħol 6 siringi mimlija għal-lest 6 kuxxinetti bl-alkoħol
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 ta' tagħbija ta' 160 mg adalimumab f'ġimgħa 0 segwita minn 80 mg adalimumab fuq ġimgħa 2 tikseb konċentrazzjonijiet ta' adalimumab fis-serum ta' madwar 12 μg/mL matul il-perjodu ta' induzzjoni.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use adalimumab
Maltese: Kromeya 40 mg/0.8 ml soluzzjoni għall-injezzjoni għall-użu pedjatriku adalimumab
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 ilprovi, 11.9% tal-pazjenti kkurati b'adalimumab u 8.1% tal-pazjenti kkurati bil-plaċebo u bis-sustanza attiva użata bħala kontroll, li bdew bl-livelli tal-anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi f'ġimgħa 24.
English: Standard dose
Maltese: Doża baxxa Doża standard
English: Polyarticular juvenile idiopathic arthritis
Maltese: Artrite idjopatika poliartikulari taż-żagħżagħ
English: Pediatric Uveitis
Maltese: Popolazzjoni pedjatrika
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-TNF, inluż adalimumab, ġew assoċjati f'okkażjonijiet rari, ma' sintomi kliniċi ġodda jew taħrix ta' sintomi kliniċi u/jew evidenza radjografika ta' mard li jaffetwaw il-myelin tan-nervituri fissistema nervuża ċentrali u jinkludu sklerożi multipla u nevrite ottika u mard li jaffetwaw il-myelin tannervituri fis-sistema periferali, li jinkludu s-sindromu Guillain-Barré.
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' adalimumab (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'Kromeya u pazjenti ttrattati b'kontroll, rispettivament, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'2.4% ta' pazjenti ttrattati b'Kromeya u 2.4% ta' pazjenti ttrattati b'kontroll.
English: Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution.
Maltese: Kull kunjett fih 40 mg ta' adalimumab fi 0.8 ml ta' soluzzjoni.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Maltese: Fil-gruppi kollha ta' kura, il-linja bażi medja tar-riżultat tal-PASI kienet ta' 18.9 u l-linja bażi ta' l-Istima Ġenerali tat-Tabib (PGA) varjat minn “moderat” (53% tassuġġetti li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: Plunger Rod
Maltese: Mhux magħrufa
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 fil-post ta' l-injezzjoni (eritema u/jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunati ma' 7.2% tal-pazjenti li kienu qegħdin jirċievu l-plaċebo jew sustanza attiva użata bħala kontroll.
English: Kromeya is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Maltese: Kromeya huwa indikat għall-kura tal-marda ta' Crohn fit-tfal ta' bejn 6 u 17 il-sena.
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 l-effikaċja u s-sigurtà ta' adalimumab ma' plaċebo f'217 pazjent adult b' psorjasi tad-dwiefer moderata għal severa.
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: Il-pazjenti kollha rċevew doża standardizzat ta' ġimgħatejn ta' prednisone 60mg/jum meta ddaħlu fl-istudju segwit minn skeda obbligatorja li d-doża tiġi mnaqqsa ftit ftit, bi twaqqif komplut tal-kortikosterojdi sa ġimgħa 15.
English: Note: P = Placebo (Number at Risk); A = Adalimumab (Number at Risk).
Maltese: Nota: P = Plaċebo (Numru f'riskju); H = Adalimumab (Numru f'riskju).
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Maltese: Tfal u adolexxenti minn 6 snin sa 17-il sena li jiżnu inqas minn 40 kg
English: Exposure-response relationship in paediatric population On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Maltese: Relazzjoni bejn espożizzjoni u rispons fil-popolazzjoni pedjatrika Fuq il-bażi tad-dejta tal-prova klinika f'pazjenti b'JIA (pJIA u ERA), ġiet stabbilita relazzjoni bejn lespożizzjoni u r-rispons bejn il-konċentrazzjonijiet fil-plażma u r-rispons PedACR 50.
English: The safety and efficacy of adalimumab were assessed in a multicenter, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu ġew studjati fi studju tat-tip multiċentru, b'mod każwali, double-blind f'46 pazjenti pedjatriċi (6 sa 17-il sena) b'artrite moderata relatata mal-entesite.
English: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Maltese: Ma hemm l-ebda użu ta' adalimumab li huwa rilevanti fi tfal għall-indikazzjonijiet ta' ankylosing spondylitis u artrite psorjatika.
English: • abdominal (belly) pain;
Maltese: • uġigħ (ta' żaqq) addominali;
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Maltese: Jekk hemm id-demm jew likwidu fis-sit tal-injezzjoni, agħfas bil-mod, b'ballun tal-qoton jew garża fuq il-ġilda (Stampa T).
English: Treatment with Kromeya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Maltese: It-trattament b'Kromeya jista' jinbeda flimkien ma' kortikosterojdi u/jew ma' aġenti oħra immunomodulatorji li mhumiex bijoloġiċi.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Maltese: F'ġimgħa 4, il-pazjenti kienu magħżula b'mod każwali 1:1 għal doża ta' manteniment Standard (40/20 mg eow) jew Baxxa (20/10 mg eow) fil-grupp ta' nies li qed jieħdu lkura fuq bażi tal-piż tal-ġisem tagħhom.
English: Serious adverse reactions have been reported for adalimumab.
Maltese: Reazzjonijiet avversi serja, ġew irrapurtati b'adalimumab.
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 l-komponenti l-oħra kienu numerikament favur adalimumab.
English: Kromeya is used to treat moderate to severe plaque psoriasis in adults.
Maltese: Kromeya jintuża għal trattament ta' psorijasi tal-plakka minn moderata sa severa fl-adulti.
English: 1.2 Leave the kit at room temperature for at least 30 minutes to allow the medicine to warm up.
Maltese: 1.2 Ħalli l-kitt fit-temperatura tal-kamra għal mill-inqas 30 minuta biex tippermetti l-mediċina tisħon.
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Maltese: • in-numru tal-lott (fuq it-tikketta tal-kunjett).