FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were then re-treated with adalimumab 0.8 mg / kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Maltese: rispons li kienu osservati matul il-kura kienu simili għall-perjodu precedent ta' double-blind: PASI 75 rispons ta' 78.9 % (15 minn 19-il suġġett) u PGA xejn jew minimali ta' 52.6 %
English: RA Study Ia**
Maltese: Studju RA Ia**
English: The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati f'żewġ studji (pJIA I and II) fi tfal b'artrite poliartikulari attiva jew artrite raffa idjopatika poliartikulari taż-żgħażagħ, u li kellhom varjetà ta' bidu ta' JIA (l-aktar frekwenti fattur rewmatoloġiku negattiv jew poliartrite pożittiva u oligoartrite fit-tul).
English: EU/1/18/1287/006 6 pre-filled pens (3 packs of 2)
Maltese: EU/1/18/1287/006 6 pinen mimlijin għal-lest (3 pakketti ta' 2)
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: Fl-Istudju tal-Psorjasi 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 fil-prova ta' estensjoni open-label.
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: prednisone 60 mg / 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: 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 taż-żgħażagħ, marda Crohn pedjatrika u l-artrite relatata mal-entesite).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Maltese: IL-KARTUNA TA' BARRA TAL-PAKKETT MULTIPLU (INKLUŻ
English: Hefiya is used to treat ulcerative colitis in adults.
Maltese: Hefiya huwa intenzjonat għall-kura ta' kolite ulċerattiva fl-adulti.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: paleness.
Maltese: żmien.
English: The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Maltese: Il-perijodu double-blind kien segwit minn perijodu open-label fejn il-pazjenti rċivew 40 mg Hefiya taħt il-ġilda ġimgħa iva u ġimgħa le sa 144 ġimgħa addizzjonali.
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' sensitività eċċessiva mdewma, tnaqqis tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelloli effettivi T-, B-, NK-, monoċistiċi / makrofaġi, u newtrofili.
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Maltese: 12-il ġimgħa (N = 305) (ASDAS <1.3 fil-Ġimgħa 16, 20, 24 u 28) matul il-perjodu open-label kienu mbagħad ‘randomised' biex jirċievu jew kura kontinwa b'adalimumab 40 mg eow (N=152) jew plaċebo (N=153) għal perjodu ta' 40 ġimgħa addizzjonali f'perjodu double-blind ikkontrollat bi plaċebo (tul totali ta' studju ta' 68 ġimgħa).
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: double-blind f'46 pazjenti pedjatriċi (6 sa 17-il sena) b'artrite moderata relatata mal-entesite.
English: Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Maltese: Kien hemm titjib sinifikanti mil-linja bażi f'ġimgħa 16 meta mqabbel mal-plaċebo (Studji I u II) u ma' MTX (Studju II) u dan deher fl-DLQI (Indiċi tad-Dermatoloġija dwar il-Kwalità ta' Ħajja).
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' suġġetti kkurati b'adalimumab li ma urew l-ebda progress radjografiku mil-linja bażi sa ġimgħa 48 (n=102), 84% baqgħu ma wrew l-ebda progress radjografiku matul 144 ġimgħa ta' kura.
English: Table 18 Ps study II (CHAMPION) efficacy results at 16 weeks placebo N = 53 n (%)
Maltese: studju Ps II (CHAMPION) riżultati tal-effikaċja f'16 -il ġimgħa plaċebo
English: • systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
Maltese: • lupus erythematosus sistemiku (disturb immuni li jinkludi infjammazzjoni tal-ġilda, tal-qalb,
English: Improved physical function continued during the open label extension up to week 136.
Maltese: It-titjib fil-funzjoni fiżika tkompla matul l-estensjoni open-label sa ġimgħa 136.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 8.0 ± 4.6 µg/ml.
Maltese: Wara amministrazzjoni ta' 40 mg ta' adalimumab ġimgħa iva u ġimgħa le f'pazjenti adulti bi spondyloarthritis axjali mhux radjografika, il-medja (± SD) permezz ta' konċentrazzjoni ta' stat stabbli f'ġimgħa 68 kienet ta' 8.0 ± 4.6 μg / ml.
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 il-pazjenti ≥40 kg (160 / 80 mg) u 10.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt kura ta'manutenzjoni, il-kortikosteroidi jistgħu jigu mnaqqsa bil-mod skont il-linji gwida tal-prassi klinika.
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 Crohn (Crohn's disease) fl-adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mal-infezjoni meta adalimumab kienet kkombinata ma' azathioprine/6-mercaptopurine meta mqabbla ma' adalimumab waħdu.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hefiya.
Maltese: Il-kartuniet tal-pakkett multiplu fihom 6 (3 pakketti ta' 2) siringi mimlijin għal-lest ta' Hefiya.
English: Dosing regimen
Maltese: doża standard
English: In study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Fi Studju nr-axSpA I, adalimumab 40 mg ġimgħa iva u oħra ġie evalwat f'185 pazjent fi studju doubleblind ikkontrollat bil-plaċebo ta' 12-il ġimgħa f'pazjenti b'nr axSpA attiv (punteġġ medju ta' linja bażi ta' attività ta' mard [Bath Ankylosing Spondylitis Disease Indiċi ta' Attività (BASDAI)] kien 6.4 għal pazjenti ttrattati b'adalimumab u 6.5 għal dawk fuq il-plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥ 1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Artrite psorjatika u axial spondyloarthritis inkluż ankylosing spondylitis
English: • abnormal muscle breakdown;
Maltese: • deterjorazzjoni anormali tal-muskoli;
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: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil-livelli ta' CPR f'pazjenti jbatu minn artrite idjopatika poliartikulari taż-żgħażagħ, mill-marda Crohn (Crohn's disease) kolite ulċerattiva u hidradenitis suppurativa wara kura b'adalimumab.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hefiya cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti kkurati b'Hefiya (ara sezzjoni 4.8).
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 Kompetenti Fisiku (PCS) tal-SF-36 mill-linja bażi sa ġimgħa 12 meta mqabbel mal-plaċebo.
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 listeriżi, leġinellożi u pneumocystis, ġew irrapportati f'pazjenti li kienu qed jirċievu adalimumab.
English: Chest pain, oedema, pyrexia1)
Maltese: onikoklażi, iperidrożisi, alopeċja1),
English: p-value total Sharp score c erosion score JSN
Maltese: Valur-pa Valur-pb Valur-pc punteġġ totali Sharp punteġġ tal erożjoni punteġġ
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab / methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Maltese: Fi Studju RA V, it-titjib fl-indiċi ta' diżabilità HAQ u fil-komponent fiżiku tal-SF 36 wera titjib akbar (p < 0.001) għat-terapija kombinata ta' adalimumab / methotrexate versus il-kura b'methotrexate u l-kura b'adalimumab waħdu f'ġimgħa 52, liema titjib baqa' mantenut matul ġimgħa 104.
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Hefiya.
Maltese: Jista' jkun hemm sensazzjoni li l-kamra qed iddur bik (vertigo) u disturbi fil-vista wara li tingħata Hefiya.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Maltese: malinni u dawk mhux speċifikati (inklużi ċesti u polipi)*
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: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Maltese: ma ġew osservati l-ebda tumuri malinni f'192 pazjenti b'espożizzjoni ta' 498.1 sena ta' pazjent waqt provi b'adalimumab f'pazjenti pedjatriċi bil-marda Crohn (Crohn's disease).
English: • facial oedema (swelling);
Maltese: • epatite (infjammazzjoni tal-fwied);
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Maltese: Immunosuppressanti, Inibituri ta' Tumur Nekrożi Fattur alfa (TNF-α),
English: • Listen for the 2nd click.
Maltese: • Oqgħod attent biex tisma' t-2 klikk.
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-reactive (CRP) u r-rata ta' tagħqid tal-eritroċit (ESR)) u ċitokini fis-seru (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
Maltese: Il-konċentrazzjoni ta' adalimumab fil-fluwidu sinovjali ta' ħafna pazjenti li jbatu minn artrite rewmatika varjaw minn 31-96 % minn dawk fis-seru.
English: • Merkel cell carcinoma (a type of skin cancer);
Maltese: • karċinoma taċ-ċelloli Merkel (tip ta' kanċer tal-ġilda);
English: Similar remission rates were observed for the 160 / 80 mg and 80 / 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160 / 80 mg group.
Maltese: Rati simili ta' titjib ġew osservati għad-dożaġġ tal-bidu ta'160 / 80 mg u 80 / 40 mg milħuqa sa ġimgħa 8 u fil-grupp tal-160 / 80 mg, l-effetti avversi ġew innutati b'mod aktar frekwenti.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Maltese: Huwa importanti li inti tgħid lit-tabib tiegħek jekk għandek sintomi ta' infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas-snien (ara “Twissijiet u prekawzjonijiet”).
English: Table 17 Ps study I (REVEAL) - efficacy results at 16 weeks placebo N = 398 n (%)
Maltese: studju Ps I (REVEAL) - riżultati tal-effikaċja f'16 -il ġimgħa plaċebo
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Maltese: • epatite awtoimmuni (infjammazzjoni tal-fwied ikkawżata mis-sistema immunitarja tal-istess ġisem);
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) 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: konfidenza) ta' limfomi kienet ta' 0.7 (0.2, 2.7) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Blood and the lymphatic system disorders*
Maltese: Disturbi tad-demm u tas-sistema limfatika*
English: • pulmonary embolism (blockage in an artery of the lung);
Maltese: • emboliżmu fil-pulmun (imblukkar f'arterja tal-pulmun);
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: 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' kura b'adalimumab waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney.
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-il 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: 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: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Maltese: Pazjenti minn studji UC-I u UC-II kellhom l-għażla li jaqilbu għal estensjoni ta' studju open-label fuq tul ta' żmien (UC III).
English: No dose-limiting toxicity was observed during clinical trials.
Maltese: L-ebda tossiċità li tillimita d-doża ma ġiet osservata matul il-provi kliniċi.
English: Table 25 maintenance regimen patient weight low dose standard dose
Maltese: Reġim ta' manteniment piż tal-pazjent doża baxxa doża standard
English: Rash (including exfoliative rash)
Maltese: Parasteżija (inkluża ipoestesija),
English: Table 15 efficacy response in placebo-controlled period for study nr-axSpA II
Maltese: Tabella 15 Ir-Rispons tal-Effikaċja fil-Perjodu Kontrollat bil-Plaċebo għall-Istudju nr-axSpA II
English: • kidney problems;
Maltese: • problemi tal-kliewi;
English: • oedema (a build-up of fluid in the body which causes the affected tissue to swell);
Maltese: • edima (akkumulazzjoni ta' fluwidu fil-ġisem li ġġiegħel it-tessut affettwat jintefaħ);
English: Each syringe contains 40 mg/0.8 ml of Hefiya.
Maltese: Kull siringa fiha 40 mg/0.8 ml ta' Hefiya.
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, inkluż 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 fis-sistema nervuża ċentrali u jinkludu sklerożi multipla u nevrite ottika u mard li jaffetwaw il-myelin tan- nervituri fis-sistema periferali, li jinkludu s-sindrome Guillain-Barré.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and / or gold salts.
Maltese: Dawn it-terapiji jinkludu methotrexate, leflunomide, hydroxychloroquine, sulfasalazine u / jew sustanzi tad-deheb.
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Maltese: Tnaqqis ta' leżjonijiet infjammatorji u prevenzjoni ta' aggravar ta' axxessi u tal-fistuli li jnixxu ġew evalwati bl-użu ta' Hidradenitis Suppurativa Rispons Kliniku (HiSCR; mill-inqas tnaqqis ta' 50%
English: Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses.
Maltese: Fost dawn, 64 pazjent (79.0 %) kellhom rispons għal ACR 20; 56 pazjent (69.1 %)
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: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64 %.
Maltese: Il-biodisponibiltà medja assoluta ta' adalimumab stmata minn tliet studji wara t-teħid ta' doża waħda ta' 40 mg taħt il-ġilda kienet ta' 64 %.
English: • enthesitis-related arthritis,
Maltese: • artrite relatata mal-entesite,
English: NE = not estimable.
Maltese: NE = mhux stmat.
English: Figure D: choose your injection site
Maltese: Figura D: agħżel is-sit ta' injezzjoni tiegħek
English: • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Maltese: • axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis,
English: Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment.
Maltese: Id-dejta disponibbli tissuġġerixxi li r-rispons kliniku huwa normalment milħuq fi żmien 2-8 ġimgħat ta' kura.
English: BASDAIb 50 week 2 week 12 week 24 ***,** statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Maltese: ***,** statistikament sinifikanti f'p < 0.001, <0.01 għall-paraguni kollha bejn adalimumab u l- plaċebo f'ġimgħat 2, 12 u 24
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Maltese: li jinkludu 6,427 pazjent u aktar minn 26,439 sena ta' pazjent ta' terapija, ir-rata ta' tumuri malinni osservati, minbarra limfoma u kanċer tal-ġilda li mhumiex melanoma, hija ta' bejn wieħed u ieħor 8.5 kull 1,000 sena ta' pazjent.
English: Holding the pen:
Maltese: Huwa important li inti:
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u s sintomi ta' nr-axSpA attiv f'pazjenti kkurati bi Hefiya meta mqabbla mal-plaċebo (Tabella 14).
English: • vertigo (sensation of room spinning);
Maltese: • vertigo (sensazzjoni li l-kamra qed iddur bik);
English: Maintenance of clinical remission was evaluated in CD study III (CHARM).
Maltese: (CLASSIC I) u studju CD II (GAIN).
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'Hefiya kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 29).