FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult Crohn's disease
Maltese: Il-marda Crohn fl-adulti (Crohn's Disease)
English: Imraldi 40 mg injection adalimumab SC
Maltese: Imraldi 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest adalimumab
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/ml (79% CV).
Maltese: Wara l-amministrazzjoni ta' 0.8 mg/kg (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lil pazjenti pedjatriċi bi psorjasi tal-plakka kronika, il-medja ± SD ta' koncetrazzjoni minimali medja fissa ta' adalimumab kienet ta' madwar 7,4 ± 5.8 g / mL (79 % CV).
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 tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 29).
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 kienux ħadu antagonisti tat-TNF kienu randomizzati biex jew jirċievu l-plaċebo f'ġimgħat 0 u 2, 160 mg adalimumab f'ġimgħa 0 u wara 80 mg f'ġimgħa 2, jew 80 mg adalimumab f ġimgħa 0 u wara 40 mg f'ġimgħa 2.
English: Table 9 Radiographic Mean Changes Over 12 Months in RA Study III
Maltese: Tabella 9 Tibdil Medju Radjografiku fuq perjodu ta' 12 -il xahar fi Studju RA III
English: CD Study I: Infliximab Naive Patients
Maltese: Studju CD I: Pazjenti li qatt ma ħadu infliximab
English: Uncommon Nocturia
Maltese: Komuni takikardija
English: Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Maltese: HS hija bbażata fuq cross-indication tal-profil tas-sigurtà tal-adalimumab kemm f'adulti u f'pazjenti pedjatriċi b'dożi simili jew iżjed frekwenti (ara sezzjoni 5.2).
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: In controlled Phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥3 × ULN occurred in 1.8% of adalimumab-treated patients and 1.8 % of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bi Psorjasi tal-plakka bi durazzjoni ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 × ULN seħħew f'1.8 % tal-pazjenti ttrattati b'adalimumab u 1.8 % tal-pazjenti kkurati kkontrollati.
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 I tal-Psorijasi, 28% tal-pazjenti li kellhom rispons tal-PASI ta' 75 u li reġgħu ġew magħżula b'ordni addoċċ f'Ġimgħa 33 meta mqabbla ma' 5% li komplew jirċievu adalimumab, p<0.001, esperjenzaw “telf ta' rispons adegwat” (riżultat tal-PASI wara Ġimgħa 33 u f'Ġimgħa 52 jew qabilha li rriżulta f'rispons tal-PASI ta' <50 relatat mal-linja bażi b'żieda minima ta' 6 punti fir-riżultat talPASI relattiv ma' Ġimgħa 33).
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: DO NOT over-tighten.
Maltese: Proċessi awtoimmuni
English: Also this medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Maltese: Ukoll, dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża ta' 0.8 mL, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose.
Maltese: • Iġbed il-planġer BIL-MOD 'il barra sa 0.1 mL aktar mid-doża preskritta.
English: Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Maltese: Ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis,huma mard infjammatorju tal-ispina.
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 ċinomologi li b' 0, 30 u 100 mg/kg (9-17 -il xadina/grupp) u dan ma wera l-ebda evidenza ta' dannu kkaġunat b'adalimumab fuq il-feti.
English: Adalimumab 110 60 (54.5) Time to Treatment Failure At or After Week 2 in study UV II Primary analysis (ITT)
Maltese: Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 2 fi Studju UV II Analiżi Primarja (ITT)
English: interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Maltese: Emboliżmu fil-pulmun mard tal-interstizju tal-pulmun, mard kroniku ta' imblukkar fil-pulmun, pulmonite, effużjoni plerali
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 HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatati ma' HS (ara t-Tabella 21).
English: Not known (frequency cannot be estimated from available data):
Maltese: Mhux magħruf (frekwenza ma tistax tiġi stabbilita min informazzjoni li hemm):
English: In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Maltese: Fi studju CD I u studju CD II, f'ġimgħa 4, ġie milħuq riżultat totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju għall-mard speċifiku dwar il-marda tal-infjammazzjoni tal-musrana (IBDQ) , u dan f'pazjenti li ġew magħżula b'ordni addoċċ u ngħataw 80/40 mg u 160/80 mg adalimumab meta mqabbel mal-plaċebo, u dan deher f'Ġimgħat 26 u 56 fi studju CD III, kif ukoll filgruppi tal-kura b'adalimumab meta mqabbla mal-grupp tal-plaċebo.
English: 2 pre-filled syringes 2 alcohol pads
Maltese: 2 siringi mimlija għal-lest 2 pads tal-alkoħol
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 tal-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: Uncommon Pancreatitis, dysphagia, face oedema
Maltese: Pankreatite, disfaġja
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration
Maltese: Hypokalaemia, żieda fl-aċtu uriku, is-sodju fid-demm ikun arormali, ipokalċimija, ipergliċemija, ipofosfatimija, deidratazzjoni
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: Anti-adalimumab antibodies may develop during adalimumab treatment.
Maltese: Antibijotiċi jistgħu jitkomplew waqt it-trattament b'Imraldi jekk ikun meħtieġ.
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: and uveitis patients.
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Maltese: Fost il-pazjenti li waqqfu listudju qabel il-ġimgħa 78, 11% waqfu minħabba avvenimenti avversi, u 5% minħabba rispons insuffiċjenti għal trattament b'adalimumab.
English: The recommended Imraldi 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: Ir-reġimen tad-doża ta' Imraldi rakkamondata għal pazjenti adulti b'idradenite suppurativa (HS) hija inizjalment ta' 160 mg 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: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at week 2 and week 4.
Maltese: F'pazjenti adulti bi hidradenitis suppurativa, doża ta' 160 mg adalimumab f'Ġimgħa 0 segwita b'80 mg f'Ġimgħa 2 kisbu konċentrazzjonijiet baxxi t'adalimumab fis-serum ta' madwar 7-8 μg/mL f'Ġimgħa 2 u Ġimgħa 4.
English: Table 11 Radiographic Mean Changes Over 12 Months in RA Study III
Maltese: Tabella 11 Tibdil Medju Radjografiku fuq Perjodu ta' 12-il Xahar fi studju RA III
English: -44.2a
Maltese: Ġimgħa 4
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jista 'jaffettwa sa 1 minn kull 100 persuna)
English: How to use Imraldi
Maltese: X'fih Imraldi
English: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Maltese: 72 pazjent (63.2%) kellhom rispons għal ACR 50; u 41 pazjent (36%) kellhom rispons għal ACR 70.
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor b 2-sided P value from log rank test c NE = not estimable.
Maltese: Iż-żewġ studji wrew effett kmieni u sostnut ta' adalimumab fuq ir-rata tal-falliment tat-trattament kontra l-plaċebo (ara Figura 2).
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 tarriżultat tal-PASI kienet ta' 18.9 u l-linja bażi tal-Istima Ġenerali tat-Tabib (PGA) varjat minn “moderat” (53 % tas-suġġetti li ġew inklużi) għal “sever” (41 %) għal “sever ħafna” (6 %).
English: Imraldi is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Maltese: Imraldi huwa indikat għall-kura tal-marda Crohn (Crohn's disease) fi tfal li għandhom bejn 6 sa 17il sena.
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 24).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 24).
English: Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment.
Maltese: Id-dejta disponibbli jissuġġerixxi li r-rispons kliniku normalment jintlaħaq fi żmien 2-8 ġimgħat ta' trattament.
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 × 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 × ULN f'2.6 % (5/192) tal-pazjenti li minnhom 4 kienu qed jirċievu immunosuppressanti konkomitanti fil-linja bażi.
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: Improvement in health-related quality of life and physical function was maintained during the openlabel extension through week 156.
Maltese: Titjib fil-kwalità tal-ħajja rrelatata mas-saħħa u funzjoni fiżika nżamm matul l-estensjoni open-label sa ġimgħa 156.
English: Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Maltese: Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 6 (Studji UV I) jew Ġimgħa 2 (Studju UV II)
English: The usual dose of Imraldi is 20 mg every other week with methotrexate.
Maltese: Id-doża ta' Imraldi normalment hija 20 mg ġimgħa iva u ġimgħa le b'methotrexate.
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/ml during the induction period.
Maltese: F'pazjenti li jbatu mill-marda Crohn (Crohn's disease), id-doża kbira ta' 80 mg adalimumab f'Ġimgħa 0 segwita b'40 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 5.5 µg/mL matul il-perijodu tal-bidu.
English: 2 pre-filled pens 2 alcohol pads
Maltese: 1 adapter tal-kunjett sterili 2 pads tal-alkoħol
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis study I, and continued adalimumab in the open-label extension trial.
Maltese: Fi studju tal-Psorijasi I, total ta' 233 pazjent li wrew rispons għal PASI 75 f'Ġimgħa 16 u Ġimgħa 33 ingħataw terapija kontinwa b'adalimumab għal 52 ġimgħa, u komplew jingħataw adalimumab filprova ta' estensjoni open-label.
English: SPARCC MRI Spined,j a Assessments in SpondyloArthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Maltese: Id-dożaġġ rakkomandat biex tinbeda l-kura b'Imraldi fuq pazjenti adulti li jbatu mill-marda ta' Crohn (Crohn's disease) b'attività moderata sa severa, huwa ta' 80 mg f'ġimgħa 0 segwiti b'40 mg f'ġimgħa 2.
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Maltese: Fi studju RA III, ħafna mis-suġġetti kellhom titjib fil-funzjoni fiżika u t-titjib ġie mantenut waqt li tkompliet il-kura matul Ġimgħa 520 (120 xahar) tal-kura open-label.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab.
Maltese: Minkejja trattament profilattiku għat-tuberkulosi, kien hemm każijiet ta' riattivazzjoni tat-tuberkulosi f'pazjenti kkurati bi adalimumab.
English: Quality of Life
Maltese: Grupp ta' età
English: • itching;
Maltese: • tirżiħ;
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 fl-istess waqt, kienu permessi u 80 % tal-pazjenti komplew jirċievu mill-inqas waħda minn dawn ilmediċini.
English: Discontinued corticosteroids
Maltese: Twaqqif tal-Kortikosterojdi
English: Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Maltese: Bejn wieħed u ieħor 40 % tal-pazjenti fi studju UC-II kellhom trattament qabel b' anti-TNF u li ma ħadimx.
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 il-kanċer tal-ġilda, kien hemm l-okkorrenza ta' karċinoma biċ-ċelluli 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 1000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Very common Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Maltese: Infezzjonijiet fis-sistema respiratorja (li jinkludu infezzjoni fin-naħa ta' isfel u fin-naħa ta' fuq tas-sistema respiratorja, pnewmonja, sinożite, fariniġite, rinofarinġite u pnewmonja virali talherpes)
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Maltese: Seħħet riattivazzjoni ta' epatite B f'pazjenti li kienu qed jirċievu xi antagonist ta' TNF, inkluż adalimumab, u li kienu jġorru dan il-virus b'mod kroniku (jigifieri pożittivi għal surface antigen).
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively.
Maltese: Wara t-teħid ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn artrite rewmatika (AR), il-konċentrazzjoni minimali medja fissa kienet ta' bejn wieħed u ieħor 5 µg/mL (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 µg/mL (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Maltese: Huwa importanti li inti tgħid lit-tabib tiegħek jekk għandek sintomi ta' infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas-snien.
English: Each 0.8 ml vial contains 40 mg adalimumab.
Maltese: Kull kunjett ta' 0.8 mL fih 40 mg ta' adalimumab.
English: This medicinal product contains 20 mg sorbitol in each vial.
Maltese: Din il-mediċina fiha 20 mg sorbitol f'kull pinna mimlija għal-lest.
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p <0.001 ** p <0.01
Maltese: Il-valuri-p kollha huma paraguni magħmula għal kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo * p < 0.001 ** p < 0.01
English: Do not use this medicine after the expiry date which is stated on the label of the carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-kartuna wara EXP.
English: 6 months 12 months ACR 50
Maltese: 12 -il xaharACR 50
English: • Hold the vial with the vial stopper facing up.
Maltese: • Imraldi huwa likwidu ċar u mingħajr kulur.
English: DO NOT shake the syringe.
Maltese: NE = mhux stmat.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Maltese: Tnaqqis statistikament sinifikanti fl-għejja, kif inhi mkejla mill-istima funzjonali tat-terapija tal-mard kroniku (FACIT) kien osservat fit-tliet studji li fihom saret l-istima (studji I, III u IV).
English: 13 to 17 years
Maltese: Minn 13 sa 17 il-sena
English: Among those, 109 subjects (63.7 %) were reported to be in remission at 10 years.
Maltese: Fost dawn, 109 suġġetti (63.7 %) kienu rrappurtati li kienu f'remissjoni għal 10 snin.
English: ASASa 40 ASAS 20 ASAS 5/6 ASAS partial remission BASDAIb 50
Maltese: ASAS 5/6
English: Hepato-biliary events
Maltese: żieda fil-bilirubina
English: - If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Maltese: - Jekk it-tifel/tifla tiegħek għandhom infezzjoni severa, inkluż tuberkulosi (ara “Twissijiet u prekawzjonijiet”).
English: Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Maltese: Imraldi huwa intenzjonat għall-kura tal-artrite attiva idjopatika poliartikulari taż-żgħażagħ fit-tfal ta' bejn 2 u 17 il-sena u artrite relatata mal-entesite fit-tfal u adoloxxenti ta' bejn 6 u 17-il sena.
English: Adults with Crohn's disease
Maltese: Adulti bil-marda ta' Crohn (Crohn's disease)
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: 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: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Maltese: M'hawnx informazzjoni adegwata minn trattament ta' pazjenti li jġorru l-HBV permezz ta' terapija anti-virali flimkien ma' terapija b'antagonist ta' TNF biex tiġi evitata r-riattivazzjoni tal-HBV.