FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical data are available on the use of a Hulio loading dose in children < 6 years of age (see section 5.2).
Maltese: M'hemmx dejta klinika dwar l-użu ta' doża kbira tal-bidu ta' Hulio fit-tfal ta' <6 snin (ara sezzjoni 5.2).
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 b'mod każwali biex jirċievu jew 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2, jew plaċebo f'ġimgħat 0 u 2.
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 punteġġ totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju għall-mard speċifiku dwar il-marda tal-infjammazzjoni tal-musrana (IBDQ, inflammatory bowel disease questionnaire), u dan f'pazjenti li ġew magħżula b'mod każwali u ngħataw adalimumab 80/40 mg u 160/80 mg meta mqabbel mal-plaċebo, u dan deher f'ġimgħat 26 u 56 fi Studju CD
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.
Maltese: F'pazjenti pedjatriċi li għandhom CD moderata sa severa, id-doża tal-bidu ta' adalimumab open-label kienet 160/80 mg jew 80/40 mg f'ġimgħat 0 u 2, rispettivament, li kienet tiddeppendi fuq punt ta' limitu tal-piż tal-ġisem ta' 40 kg.
English: • anxiety;
Maltese: • ansjetà;
English: Step 5 - Squeeze & hold injection site
Maltese: Pass 5 - Oqros u żomm is-sit tal-injezzjoni
English: Standard Dose 40/20 mg eow
Maltese: Doża Standard 40/20 mg ġimgħa iva u ġimgħa le
English: 26 PlaceboControlled
Maltese: Ikkontrollat bi Plaċebo
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6± 5.6 μg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/ml (47.7% CV) with concomitant methotrexate.
Maltese: Wara t-teħid ta' 24 mg/m² (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti b'artrite idjopatika poliartikulari taż-żgħażagħ (JIA) li kellhom 4 sa 17-il sena, il-livell minimu medju fl-istat fiss ta' konċentrazzjoni ta' adalimumab fis-serum (valuri mkejla minn ġimgħa 20 sa 48) kien 5.6 ±5.6 µg/mL (102% CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 10.
English: Adalimumab 40 mg eow N=80
Maltese: Adalimumab 40 mg ġimgħa iva u ġimgħa le N=80
English: The patients improved following discontinuation of therapy.
Maltese: Ilpazjenti marru għall-aħjar meta twaqqfet it-terapija.
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 b'0, 30 u 100 mg/kg (9 - 17-il xadina/grupp) u dan ma wera l-ebda evidenza ta' ħsara kkaġunata b'adalimumab fuq il-feti.
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati f'żewġ studji każwali, double-blind u kkontrollati bil-plaċebo f'pazjenti bi spondyloarthritis axjali mhux radjografika (nr-axSpA).
English: P Value b
Maltese: Valur pb
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Maltese: Huwa maħsub li psorajisi tiġi kkawżata minn problema fis-sistema immuni tal-ġisem li twassal għal produzzjoni akbar ta' ċelluli tal-ġilda.
English: Hulio is used to treat hidradenitis suppurativa in adults, and adolescents from 12 years of age.
Maltese: Hulio huwa intenzjonat għall-kura ta' hidradenitis suppurativa fl-adulti, u f'adolexxenti minn 12-il sena 'l fuq.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Maltese: Infezzjonijiet fatali u infezzjonijiet li jistgħu jpoġġu l-ħajja fil-periklu (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), attivazzjoni mill-ġdid tal-HBV u tumuri malinni oħra (li jinkludu lewkimja, limfoma u HSTCL) ġew irrappurtati wkoll bl-użu ta' adalimumab.
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Maltese: Pass 9 - Aqla' s-siringa mill-adattur tal-kunjett u waħħal il-labra
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
Maltese: Fi studji tal-marda ta' Crohn (Crohn's disease) fl-adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mal-infezjoni meta adalimumab kien ikkombinat ma' azathioprine/6-mercaptopurine meta mqabbla ma' adalimumab waħdu.
English: • severe rash, hives;
Maltese: • raxx sever, ħorriqija;
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Maltese: L-espożizzjoni ta' Adalimumab f'pazjenti pedjatriċi b'uveite kienet imbassra bl-użu ta' mudellar farmakokinetiku tal-popolazzjoni u simulazzjoni bbażata fuq farmakokinetika ta' indikazzjoni minn pazjenti pedjatriċi oħra (psorjasi pedjatrika, artrite idjopatika minorenni, marda ta' Crohn pedjatrika u artrite relatata mal-entesite).
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: 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 rċivew doża standardizzata ta' ġimagħtejn ta' prednisone 60 mg/jum meta ddaħlu fl-istudju segwita minn skeda obbligatorja li d-doża tiġi mnaqqsa ftit ftit, bi twaqqif komplut tal-kortikosterojdi sa ġimgħa 15.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Maltese: Fil-gruppi kollha ta' kura, il-punteġġ medju tal-linja bażi tal-PASI kien ta' 18.9 u l-punteġġ tal-linja bażi tal-PGA varja minn “moderat” (53% tal-individwi li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew evalwati f'aktar minn 1,500 pazjent li jbatu mill-marda ta' Crohn attiva b'mod minn moderat sa sever (Indiċi tal-Attività tal-Marda Crohn (CDAI, Crohn's Disease Activity Index) ≥220 u ≤450) fi studji double-blind u kkontrollati bil-plaċebo li fihom l-indiviwdi ntgħażlu b'mod każwali.
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 tal-BSA u PASI ≥12 jew ≥10) li kienu kandidati għal terapija sistemika jew fototerapija fi studji każwali u double-blind. 73% tal-pazjenti rreġistrati fl-Istudji tal-Psorijasi I u II kienu diġà rċivew terapija sistemika jew fototerapija qabel.
English: Children and adolescents from 2 to 17 years of age weighing 10 kg to less than 30 kg: The recommended dose of Hulio is 20 mg every other week.
Maltese: Tfal u adolexxenti minn 2 sa 17-il sena li jiżnu minn 10 kg sa anqas minn 30 kg: Id-doża rakkomandata ta' Hulio hija 20 mg ġimgħa iva u ġimgħa le.
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 b'hidradenitis suppurativa, doża ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg f'ġimgħa 2 kisbet konċentrazzjonijiet fil-livell minimu ta' adalimumab fis-serum ta' madwar 7 sa 8 µg/mL f'ġimgħa 2 u ġimgħa 4.
English: • any infection (including tuberculosis, blood poisoning, influenza, cellulitis, shingles, ear infections, tooth infections, cold sores, reproductive tract infections, urinary tract infection,
Maltese: • kwalunkwe infezzjoni (li jinkludu tuberkulożi, avvelenar tad-demm, influwenza, ċellulite, ħruq ta' Sant'Antnin,
English: OTHER
Maltese: i
English: Preparing the pre-filled pen
Maltese: Disturbi fil-fwied u filmarrara*
English: Hypertension, flushing, haematoma
Maltese: Pressjoni għolja, fwawar, ematoma
English: Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Maltese: Data disponibbli tindika li jekk jerġa' jingħata adalimumab wara li jkun twaqqaf għal 70 gurnata jew aktar, dan iwassal għall-istess rispons kliniku u profil ta' sigurtà li jixbah lil dak ta' qabel ma twaqqfet id-doża.
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenija, anemija aplastika, avvenimenti li jeffetwaw il-myelin b'mod ċentrali jew periferali u rapporti ta' lupus, kundizzjonijiet relatati ma lupus u s-sindromu ta' StevensJohnson.
English: Sustained Mucosal Healing
Maltese: Fejqan Mukosali Sostnut
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in single-use pre-filled syringe with an automatic needle guard.
Maltese: Pinna ta' 40 mg u siringa mimlija għal-lest ta' 40 mg huma wkoll disponibbli għal pazjenti biex tingħata d-doża sħiħa ta' 40 mg.
English: Table 18: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Maltese: Tabella 18: Proporzjon ta' Pazjentia li Kisbu HiSCRb f'Ġimgħat 24 u 36 Wara Assenjazzjoni tat-Trattament mill-Ġdid minn Adalimumab Kull Ġimgħa f'Ġimgħa 12
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti b'artrite idjopatika poliartikulari tażżgħażagħ li kellhom minn 4 sa 17-il sena u pazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, kien hemm żidiet fil-livelli tal-ALT ta' ≥3 × ULN f'6.1% tal-pazjenti kkurati b'adalimumab u f'1.3% tal-pazjenti kkurati bil-kontroll.
English: Medication
Maltese: Mediċina
English: Abdomen or Thighs
Maltese: ŻMIEN (XHUR)
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg: The recommended dose of Hulio is an initial dose of 20 mg, followed by 20 mg one week later, Thereafter the usual dose is 20 mg every other week.
Maltese: Tfal u adolexxenti minn 4 sa 17-il sena li jiżnu minn 15 kg sa anqas minn 30 kg: Id-doża rakkomandata ta' Hulio hija doża inizjali ta' 20 mg, segwita b'20 mg ġimgħa wara.
English: Step 6 - Pull plunger to dose + 0.1 ml Hold the syringe package and SLOWLY pull the white plunger to 0.1 ml beyond the prescribed dose (for example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Maltese: Żomm il-pakkett tas-siringa u BIL-MOD iġbed l-istikka bajda tal-planġer 'il barra sa 0.1 mL aktar mid-doża preskritta (pereżempju, jekk id-doża preskritta hija 0.5 mL, iġbed l-istikka bajda tal-planġer sa 0.6 mL).
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated 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-żgħażagħ (artrite idjopatika poliartikulari taż-żgħażagħ jew artrite relatata mal-entesite) kif ukoll pazjenti li jbatu minn spondiloartrite assjali (infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) u minn spondiloartrite assjali mingħajr evidenza radjografika ta' AS), minn artrite psorijatika, mill-marda ta' Crohn (Crohn's disease), mill-kolite ulċerattiva, mill-psorjasi, minn hidradenitis suppurativa u minn uveite.
English: Solution for injection 1 pre-filled pen, 2 alcohol pads 2 pre-filled pens, 2 alcohol pads 6 pre-filled pens, 6 alcohol pads
Maltese: 1 pinna mimlija għal-lest, 2 tajjariet bl-alkoħol 2 pinen mimlija għal-lest, 2 tajjariet bl-alkoħol 6 pinen mimlija għal-lest, 6 tajjariet bl-alkoħol
English: Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Maltese: Il-kors tad-doża tas-soltu huwa 40 mg adalimumab fil-bidu, segwita b'20 mg ġimagħtejn wara.
English: Adalimumab 40 mg eow
Maltese: 40 mg Adalimumab kull ġimgħa
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 l-istudju qabel ilġimgħa 78, 11% waqfu minħabba avvenimenti avversi, u 5% minħabba rispons insuffiċjenti għal trattament b'adalimumab.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Table 22: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Maltese: Tabella 22: Proporzjon ta' Pazjentia li Kisbu HiSCRb f'Ġimgħat 24 u 36 Wara Assenjazzjoni tat-Trattament mill-Ġdid minn Adalimumab Kull Ġimgħa f'Ġimgħa 12
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 relatat ma' HS (ara Tabella 21).
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 kronika severa (kif definit minn involviment ta' PGA ≥4 jew >20% BSA jew >10% involviment tal-BSA b'leżjonijiet ħoxnin ħafna jew PASI ≥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: Low Dose 20/10 mg eow
Maltese: Doża Baxxa 20/10 mg ġimgħa iva u ġimgħa le
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 fl-istess ħin b'mediċini antirewmatiċi li jaffettwaw il-proċess tal-marda, u 37 (9.4%) pazjent b'glukokortikojdi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Hulio 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Maltese: U KWANTITATTIVA Hulio 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest b'doża waħda ta' 0.8 mL fiha 40 mg adalimumab.
English: Time to Treatment Failure At or After week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab Time to Treatment Failure At or After week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab
Maltese: Żmien għall-Falliment tat-Trattament Fi jew Wara Ġimgħa 6 fi Studju UV I Analiżi Primarja (ITT) Plaċebo Adalimumab Żmien għall-Falliment tat-Trattament Fi jew Wara Ġimgħa 2 fi Studju UV II Analiżi Primarja (ITT) Plaċebo Adalimumab
English: Adalimumab 40 mg eow N=814 n (%)
Maltese: Adalimumab 40 mg ġimgħa iva u ġimgħa le N=814
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 ta' l-PASI kienet ta' 18.9 u l-linja bażi ta' l-Istima Ġenerali tat-Tabib (PGA) varjat minn “moderat” (53% tas-suġġetti li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
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: It-teħid ta' adalimumab 40 mg ġimgħa iva u ġimgħa le kien ivvalutat fi 393 pazjent f'żewġ studji double-blind u kkontrollati bil-plaċebo li ħadu 24 ġimgħa u li fihom l-individwi ntgħażlu b'mod każwali, f'pazjenti li jbatu minn infjammazzjoni tal-vertebri li tirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il-punteġġ medju tal-linja bażi tal-attività tal-mard [l-Indiċi tal-Attività talMarda Ankylosing Spondylitis (BASDAI, Bath Ankylosing Spondylitis Disease Activity Index)] kien 6.3 fil-gruppi kollha) li ma kellhomx rispons adegwata għat-terapija konvenzjonali.
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Maltese: a a HR ta' adalimumab vs plaċebo minn rigressjoni ta' perikli li huma proporzjonali mat-trattament bħala fattur.
English: Step 4 - Uncap needle
Maltese: Pass 4 - Neħħi l-għatu tal-pinna
English: Vial adapter
Maltese: Tfal u adolexxenti
English: EU/1/18/1319/005 2 pack
Maltese: EU/1/18/1319/002 2 pakketti
English: Table 10: ACR Responses in RA Study V (percent of patients)
Maltese: Risponsi għall-ACR fi Studju RA V (perċentwali ta' pazjenti) Rispons
English: Clinical Remission Mucosal Healing
Maltese: Titjib Kliniku Sostnut
English: The recommended Hulio 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' Hulio rrakkamondat għal pazjenti adulti b'hidradenitis suppurativa (HS) huwa 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), segwita minn 80 mg ġimagħtejn wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: 19.3% of patients had continued baseline oral antibiotic therapy during the study.
Maltese: 19.3% tal-pazjenti kellhom terapija kontinwa b'antibijotiċi mill-ħalq fil-linja bażi matul l-istudju.
English: Hulio 40 mg solution for injection in pre-filled syringe adalimumab
Maltese: Hulio 40 mg injezzjoni adalimumab
English: Children and adolescents from 6 to 17 years of age weighing 15 kg to less than 30 kg: The recommended dose of Hulio is 20 mg every other week.
Maltese: Tfal u adolexxenti minn 6 sa 17-il sena li jiżnu minn 15 kg sa anqas minn 30 kg: Id-doża rakkomandata ta' Hulio hija 20 mg ġimgħa iva u ġimgħa le.
English: Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: Hulio huwa indikat għall-kura tal-marda ta' Crohn attiva minn moderata sa severa fit-tfal (minn 6 snin 'il fuq) li kellhom rispons inadegwat għall-kura konvenzjonali inkluż terapija ta' nutrizzjoni primarja u kortikosterojde u/jew immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: JSN score 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 il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u methotrexate waħdu bl użu tat-test U Mann-Whitney.
English: Visual impairment, conjunctivitis, blepharitis, eye swelling
Maltese: Pankreatite, disfaġija, edima fil-wiċċ
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 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients.
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti bi psorjasi tal-plakka b'perjodu ta' kontroll b'tul li jvarja minn 12 sa 24 ġimgħa, żidiet fil-livelli tal-ALT ≥3 × ULN seħħew f'1.8% tal-pazjenti kkurati b'adalimumab u 1.8% tal-pazjenti kkurati bil-kontroll.
English: Adalimumabb / MTXc n=207
Maltese: Adalimumab/ MTXc n=207
English: Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Maltese: Figura 3: Kurvi ta' Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment tat-Trattament fl-Istudju Pedjatriku tal-Uveite