FrancophonIA/ELRC3.0 huggingface dataset:
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Maltese: Valutazzjonijiet tal-psorjasi tad-dwiefer inkludew l-Indiċi Modifikata tasSeverità tal-Psorijasi tad-Dwiefer (mNAPSI, Modified Nail Psoriasis Severity Index), il-Valutazzjoni Globali tat-Tabib tal-Psorijasi tad-Dwiefer (PGA-F, Physician's Global Assessment of Fingernail Psoriasis) u l-Indiċi tas-Severità tal-Psorijasi tad-Dwiefer (NAPSI, Nail Psoriasis Severity Index) (ara Tabella 19).
English: What Hulio contains - The active substance is adalimumab - The other ingredients are monosodium glutumate, sorbitol, methionine, polysorbate 80,
Maltese: - Is-sustanzi mhux attivi l-oħra huma monosodium glutumate, sorbitol, methionine,
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7 ± 6.6 μg/ml for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/ml for patients < 40 kg (80/40 mg).
Maltese: 7 ± 6.6 µg/mL fil-pazjenti ≥40 kg (160/80 mg) u 10.6 ± 6.1 µg/mL fil-pazjenti <40 kg (80/40 mg).
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Maltese: Fi studju ta' estensjoni open-label, li sar għal pazjenti li żiedu d-doża minn 40 mg ġimgħa iva u ġimgħa le għal 40 mg fil-ġimgħa minħabba rispons tal-PASI taħt il-50%, 26.4% (92/349) u 37.8% (132/349) tal-pazjenti laħqu rispons tal-PASI ta' 75 f'ġimgħa 12 u 24, rispettivament.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Maltese: Ilkonċentrazzjoni ta' adalimumab fil-fluwidu sinovjali ta' ħafna pazjenti li jbatu minn artrite rewmatika varjaw minn 31 - 96% minn dawk fis-serum.
English: Minimum, median and maximum dose
Maltese: Doża minima, medja u massima
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Maltese: Fi Studju CD I, 299 pazjent li qatt ma ħadu antagonist ta' TNF ġew imqassma b'mod każwali f'wieħed minn erba' gruppi ta' nies li kienu qegħdin jieħdu l-kura; plaċebo f'ġimgħat 0 u 2, 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2, 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2, u 40 mg f'ġimgħa 0 u 20 mg f'ġimgħa 2.
English: For more information on vaccines see the “Warnings and precautions”.
Maltese: Għal aktar informazzjoni dwar it-tilqim ara s-sezzjoni “Twissijiet u prekawzjonijiet”.
English: • Tell your child's doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
Maltese: • Għid lit-tabib tiegħek jekk inti ġġor il-virus tal-epatite B (HBV), jekk għandek infezzjoni talHBV attiva jew jekk taħseb li għandek riskju li jaqbdek l-HBV.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P < 0.0001 from log rank test).
Maltese: Adalimumab ittardja b'mod sinifikanti l-ħin għall-falliment tat-trattament, meta mqabbel mal-plaċebo (Ara Figura 1, P<0.0001 mit-test ta' log rank).
English: Hulio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Hulio huwa indikat għat-trattament ta' kolite ulċerattiva attiva li hi minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw terapija konvenzjonali li tinkludi kortikosterojdi u 6-mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li huma intolleranti għal, jew li jkollhom kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Maltese: Wara l-kura b'adalimumab, ġie osservat tnaqqis rapidu fil-livelli ta' sustanzi li jirreaġixxu fil-fażi akuta tal-infjammazzjoni (proteina C-reattiva (CRP) u r-rata ta' tagħqid tal-eritroċiti (ESR)) u cytokines fis-serum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: • Check the expiry date printed on the syringe.
Maltese: • Iċċekkja d-data ta' meta tiskadi stampata fuq is-siringa.
English: Hulio in combination with methotrexate, is indicated for:
Maltese: Hulio flimkien ma' methotrexate huwa indikat għal:
English: Adalimumab exposure in adolescent HS 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: Espożizzjoni ta' adalimumab f'pazjenti adolexxenti bi HS kienet prevista li jużaw mudellar u simulazzjoni farmakokinetiku tal-popolazzjoni bbażata fuq cross-indication farmakokinetika f'pazjenti pedjatriċi oħra (psorjasi pedjatrika, artrite idjopatika ġovanili, marda ta' Crohn pedjatrika u l-artrite relatata mal-entesite).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007 2 vials (2 packs of 1)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1319/007 2 kunjetti (2 pakketti ta' 1)
English: hydrochloric acid and water for injections.
Maltese: polysorbate 80, hydrochloric acid u ilma għall-injezzjonijiet.
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 μg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 μg/ml (71.2% CV) with concomitant methotrexate.
Maltese: F'pazjenti b'JIA poliartikulari li kellhom bejn 2 sa <4 snin jew li għandhom min 4 snin il-fuq u li jiżnu <15 kg, dożati b'adalimumab 24 mg/m² trough steady-state medju ta' koncetrazzjoni ta' adalimumab fis-serum kien 6.0 ±6.1 µg/mL(101% CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 7.9 ±5.6 µg/mL (71.2% CV) flimkien ma methotrexate.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing at least 30 kg
Maltese: Adolexxenti b'hidradenitis suppurativa li għandhom bejn 12 u 17-il sena, li jiżnu mill-inqas 30 kg
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Maltese: L-istudju tal-RA I evalwa 271 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥18-il sena, ma kinux irrispondew għal kura b'mill-inqas mediċina waħda antirewmatika li timmodifika l-proċess tal-mard u li kellhom effikaċja insuffiċjenti b'methotrexate f'dożi minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil-ġimgħa, u li d-doża ta' methotrexate tagħhom baqgħet kostanti minn 10 sa 25 mg fil-ġimgħa.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Maltese: Fil-każ ta' individwi kkurati b'adalimumab li ma wrew l-ebda progress radjografiku mil-linja bażi sa ġimgħa 48 (n=102), 84% baqgħu ma wrew l-ebda progress radjografiku sa 144 ġimgħa ta' kura.
English: Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for Standard Dose versus Low Dose comparison.
Maltese: Ġimgħa 26 Titjib kliniku Rispons kliniku Ġimgħa 52 Titjib kliniku Rispons kliniku * valur p li huwa paragun tad-Doża Standard kontra d-Doża Baxxa
English: In CD Study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Maltese: III, 854 pazjent irċevew 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2, open label.
English: • gallbladder inflammation, gallbladder stones;
Maltese: • fluwidu eċċessiv madwar il-pulmun;
English: • If you are over 65 years you may be more susceptible to infections while taking Hulio.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Hulio.
English: Adalimumab 40 mg weekly N = 70
Maltese: Adalimumab 40 mg kull ġimgħa N=70
English: The syringe inside the pen is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Maltese: Is-siringa fil-pinna hi magħmula minn plastik tal-polimer cyclo olefin b'tapp (lastku tal-chlorobutyl) u labra (tal-azzar inossidabbli) b'għatu tal-labra (tal-butyl/ diene blend polymer u polypropylene).
English: The syringe is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Maltese: Is-siringa hi magħmula minn plastik tal-polimer cyclo olefin b'tapp (lastku tal chlorobutyl) u labra (tal-azzar inossidabbli) b'għatu tal-labra (tal-butyl/ diene blend polymer upolypropylene).
English: 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 fil-passaġġ tan-nifs ta' fuq u t'isfel, pulmonite, sinusite, farinġite, nasofarinġite u virus tal-herpes tal-pulmonite)
English: Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Maltese: Żidiet statistikament sinifikanti (titjib) mil-Linja Bażi sa ġimgħa 26 u 52 fl-Indiċi tal-Massa tal-Ġisem u l-veloċità tat-tul kienu osservati fiż-żewġ gruppi tat-trattament.
English: Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Maltese: Id-dejta disponibbli jissuġġerixxi li r-rispons kliniku huwa normalment milħuq fi żmien 2 - 8 ġimgħat ta' trattament.
English: Hulio 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: Hulio huwa intenzjonat għall-kura tal-artrite idjopatika poliartikulari taż-żgħażagħ fit-tfal u l-adolexxenti ta' bejn 2 u 17-il sena u artrite relatata mal-entesite fit-tfal u l-adolexxenti ta' bejn 6 u 17-il sena.
English: Hulio 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers (fluoropolymer-laminated butyl rubber), aluminium crimps and flip-off seals.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Hulio 40 mg soluzzjoni għall-injezzjoni f'kunjett li jintuża darba biss (ħġieġ ta' tip I), b'tappijiet tallastku (lastku tal-butyl laminat bil-fluoropolymer), magħluq bil-pressa bl-aluminju u bis-siġilli flip-off.
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2 - <4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju multiċentriku u open-label fi 32 tfal (2 - <4 snin jew li għandhom minn 4 snin 'il fuq u li jiżnu <15 kg) li għandhom artrite poliartikulari JIA moderata jew severa.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).
Maltese: Adalimumab ittardja b'mod sinifikanti l-ħin għall-falliment tat-trattament, meta mqabbel mal-plaċebo (Ara Figura 2, P<0.0001 mit-test ta' log rank).
English: Table 12: Ped ACR 30 Responses in the JIA study
Maltese: Tabella 12: Risponsi Ped ACR 30 fl-istudju tal-JIA Taqsima
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, - NK-cells, monocyte/macrophages, and neutrophils.
Maltese: Fi studju ta' 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b'adalimumab, ma kien hemm l-ebda evidenza ta' tnaqqis ta' sensittività eċċessiva imdewma, tnaqqis fil-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelluli effettivi T-, B-, NK-, monoċistiċi/makrofaġi, u newtrofili.
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Maltese: Infezzjonijiet serji, li jinkludu sepsis kkawżati minn batterji, myco-batterji, fungus invażiv, parassiti, virus u infezzjonijiet opportunistiċi oħra bħal listerjożi, leġinellożi u pnewmoċistite, ġew irrappurtati f'pazjenti li kienu qed jirċievu adalimumab.
English: Hulio is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Maltese: Hulio huwa intenzjonat għall-kura ta' ankylosing spondylitis u spondiloartrite assjali mingħajr evidenza radjografika ta' ankylosing spondylitis fl-adulti.
English: Österreich Mylan Österreich GmbH
Maltese: Deutschland Mylan Healthcare GmbH
English: NA NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Maltese: MA MA MA 4.5% 23.2% a Studju RA I fir-24 ġimgħa, Studju RA II fis-26 ġimgħa, u Studju RA III fl-24 u t-52 ġimgħa b 40 mg adalimumab mogħtija ġimgħa iva u ġimgħa le c MTX = methotrexate ** p<0.01, adalimumab kontra l-plaċebo
English: • 1 gauze pad or cotton ball (not included in Hulio pack)
Maltese: • garża 1 jew tajjara 1 (mhux inklużi fil-pakkett ta' Hulio)
English: Pancreatitis, dysphagia, face oedema
Maltese: • indiġestjoni, nefħa, ħruq ta' stonku;
English: • migraine;
Maltese: • emigranja;
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Maltese: Fil-każi fejn hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8, tidher asterisk (*) filkolonna tas-Sistema tal-Klassifika tal-Organi (SOC, System Organ Class).
English: • Check the expiry date printed on the pen.
Maltese: • Iċċekkja d-data ta' meta tiskadi stampata fuq il-pinna.
English: • 80 mg at week 0 and 40 mg at week 2
Maltese: • 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 2
English: Table 12: Radiographic Mean Changes at week 52 in RA Study V
Maltese: Tabella 12: Tibdil Medju Radjografiku f'Ġimgħa 52 fi Studju RA V
English: Placebo/ MTXa
Maltese: Plaċebo/MTXa Adalimumab/MTX
English: Dose Preparation
Maltese: Preparazzjoni tad-Doża
English: Adalimumab 40 mg eow N=109
Maltese: Adalimumab 40 mg ġimgħa iva u ġimgħa le N=109
English: Hulio is intended for the treatment of the following inflammatory diseases: - rheumatoid arthritis; - polyarticular juvenile idiopathic arthritis; - enthesitis-related arthritis; - ankylosing spondylitis; - axial spondyloarthritis without radiographic evidence of ankylosing spondylitis; - psoriatic arthritis; - psoriasis; - hidradenitis suppurativa; - Crohn's disease; - ulcerative colitis; - non-infectious uveitis in adults and children.
Maltese: Hulio huwa intenzjonat għall-kura ta' mard infjammatorju kif spjegati hawn taħt: - artrite rewmatika; - artrite idjopatika poliartikulari taż-żgħażagħ; - artrite relatata mal-entesite; - ankylosing spondylitis; - spondiloartrite assjali mingħajr evidenza radjografika ta' ankylosing spondylitis; - artrite psorijatika; - psorjasi; - hidradenitis suppurativa; - il-marda ta' Crohn; - kolite ulċerattiva; - uveite mhux infettiva f'adulti u tfal.
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Maltese: Adalimumab wera aktar titjib statistikament sinifikanti fil-punteġġ totali ta' HAQ-S u filPunteġġ tal-Komponent Fiżiku (PCS) tal-SF-36 mil-linja bażi sa ġimgħa 12 meta mqabbel malplaċebo.
English: Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; * p<0.05 for adalimumab vs. placebo pairwise comparison of proportions **p<0.001 for adalimumab vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Maltese: It-titjib kliniku huwa definit bħala punteġġ Mayo ≤2 bl-ebda sottopunteġġ >1; Ir-rispons kliniku huwa tnaqqis mil-linja bażi fil-punteġġ Mayo ≥3 punti u ≥30% flimkien ma' tnaqqis fis-sottopunteġġ tal-ħruġ tad-demm mir-rektum [RBS, rectal bleeding subscore] ≥1 jew RBS assolut ta' 0 jew 1; * p<0.05 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab vs. plaċebo ** p<0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab vs. plaċebo a Minn dawk li jirċievu l-kortikosterjdi fil-linja bażi
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Maltese: Minn 342 individwu li oriġinarjament kienu magħżula b'mod każwali għal monoterapija b'adalimumab jew terapija kkombinata b'adalimumab/methotrexate li daħlu fl-istudju ta' estensjoni open-label, 171 individwu temmew 10 snin ta' trattament b'adalimumab.
English: Table 14: Ps Study I (REVEAL) - Efficacy Results at 16 weeks
Maltese: Tabella 17: Studju tal-Ps I (REVEAL)
English: Hulio 40 mg/0.8 ml solution for injection
Maltese: Hulio 40 mg/0.8 mL soluzzjoni għall-injezzjoni
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
Maltese: 506 (62.2)b a Il-perċentwali ta' pazjenti li kisbu rispons ta' PASI 75 ġie kkalkulat bħala r-rata aġġustata fiċċentru b p<0.001, adalimumab vs. plaċebo
English: Week 26
Maltese: Tabella 26:
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Maltese: F'ġimgħa 52, 42.9% tal-pazjenti li rċevew it-terapija kkombinata ta' adalimumab/methotrexate laħqu titjib kliniku (DAS28 (CRP) <2.6) meta pparagunati ma' 20.
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti b'artrite rewmatika u artrite psorijatika fejn il-pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żieda fil-livelli tal-ALT ta' ≥3 × ULN f'3.7% tal-pazjenti kkurati b'adalimumab u f'1.6% tal-pazjenti kkurati bil-kontroll.
English: Non-infectious uveitis in adults and children
Maltese: Uveite mhux infettiva f'adulti u tfal
English: Adult plaque psoriasis
Maltese: Psorijasi tal-plakka fl-adulti
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 millinqas waħda minn dawn il-mediċini.
English: 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: b il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u adalimumab u methotrexate mogħtija flimkien bl-użu tat-test U Mann-Whitney.
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: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Maltese: ≥40 kg • 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 2
English: 1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
Maltese: Kull kaxxa fiha kunjett 1, siringa sterili għall-injezzjoni 1, labra sterili 1, adattur sterili talkunjett 1 u 2 tajjariet bl-alkoħol.
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 b'hidradenitis suppurativa b'perjodu ta' kontroll b'tul li jvarja minn 12 sa 16-il ġimgħa, żidiet fil-livelli tal-ALT ≥3 × ULN seħħew f'0.3% talpazjenti kkurati b'adalimumab u 0.6% tal-pazjenti kkurati bil-kontroll.
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Maltese: Titjib sinifikanti ta' sinjali ta' infjammazzjoni kif imkejjel minn hs-CRP u MRI taż-żewġ Ġogi Sacroiliac u l-Ispina nżamm f'pazjenti ttrattati b'adalimumab sa ġimgħa 156 u ġimgħa 104, rispettivament.
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 għall-ACR 50; u 41 pazjent (36%) kellhom rispons għall-ACR 70.
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Maltese: 8, 9.2 u 3.9 f'pazjenti li oriġinarjament ntgħażlu b'mod każwali għallmonoterapija b'methotrexate, monoterapija b'adalimumab u terapija kkombinata b'adalimumab/methotrexate, rispettivament.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Maltese: Il-kwalità tal-ħajja relatata mas-saħħa u l-funzjoni fiżika kienu evalwati bl-użu tal-kwestjonarji HAQ-S u SF-36.
English: • severe rash, hives
Maltese: • raxx sever, ħorriqija