FrancophonIA/ELRC3.0 huggingface dataset:
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 kull ġimgħa supplenti ta' adolimumab f'pazjenti adulti mhux radjografiċi spondyloarthritis axjali, il-medja (± SD) ħawt (trough) ta' konċentrazzjoni ta' stat stabbli f'Ġimgħa 68 kienet ta' 8.0 ± 4.6 μg/mL.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Maltese: Aggravar jew bidu ta' psoriażi (li jinkludu psoriażi tat tip palmoplantar pustular) urtikarja, tbejnġil (li tinkludi l-purpura), dermatite (li tinkludi l-ekżema), onikoklasi, iperidrożisi, alopeċja ħakk
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi)*
English: Initial dose of 40 mg, followed by 40 mg one week later.
Maltese: Doża inizjali ta' 40 mg, segwita minn 40 mg ġimgħa wara.
English: RA Study II a**
Maltese: Studju RA II a**
English: 4.1 Choose an injection site (Figure L) on:
Maltese: 4.1 Agħżel sit għall-injezzjoni (Stampa L):
English: P=0.027, adalimumab 0.8 mg/kg versus MTX
Maltese: 027, adalimumab 0.8 mg/kg kontra MTX
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: Studju 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 anti-rewmatika li taffetwa 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: Total sharp score
Maltese: Punteġġ Totali Sharp
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Maltese: Il-Kartuniet ta' Tfakkir għall-Pazjent (adulti u pedjatriċi) fihom l-elementi ewlenin li ġejjin - infezzjonijiet, inkluż tuberkulosi - kanċer - problemi fis-sistema nervuża - tilqim
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Maltese: • kanċer, li jaffetwa s-sistema limfatika (limfoma) u melanoma (tip ta' kanċer tal-ġilda);
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: il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'monoterapija b'adalimumab u b'monoterapija b'methotrexate bl-użu tat-test U Mann-Whitney..
English: Figure E
Maltese: Stampa E
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: Ir-rata (95% intervall ta' 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: Figure C
Maltese: Stampa C
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Maltese: Sklerosi multipla, disturbi li jeffetwaw il-myelin (bħal newrite flgħajnejn, sindromu ta' Guillain-Barré)
English: Ulcerative colitis
Maltese: Kolite Ulċerattiva
English: ANNEX III
Maltese: 3. LISTA
English: Kromeya is used to treat ulcerative colitis in adults.
Maltese: Kromeya jintuża bħala trattament ta' kolite ulċerattiva fl-adulti.
English: >32 weeks 14 weeks a
Maltese: >32 ġimgħa
English: Low dose 20/10 mg eow p value
Maltese: Doża baxxa 20/10 mg eow valur p
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' kanċer tal-ġilda li m'humiex melonoma kienet 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Adalimumab 40 mg eow N=80
Maltese: Adalimumab 40 mg kull eow N=80
English: P=0.083, adalimumab 0.8 mg/kg versus MTX
Maltese: 083, adalimumab 0.8 mg/kg kontra MTX
English: Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day).
Maltese: Studju UV I evalwa 217 pazjent b'uveite attiva minkejja t-trattament b'kortikosterojdi (prednisone orali f'doża ta'10 sa 60 mg/kuljum).
English: 1.7 Leave the syringe at room temperature for 30 minutes to allow the medicine to warm up.
Maltese: 1.7 Ħalli s-siringa fit-temperatura ambjentali tal-kamra għal 30 minuta biex tippermetti l-mediċina tisħon.
English: After 5 years of adalimumab therapy, 74.0% (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0% (46/50) of patients continued to be in clinical response per PCDAI.
Maltese: Wara 5 snin ta' terapija b'adalimumab, 74.0% (37/50) tal-50 pazjent li fadal fl-istudju kompla jkun fil remissjoni klinika, u 92.0% (46/50) tal-pazjenti komplew ikollhom rispons kliniku għal kull PCDAI.
English: Other medicines and Kromeya
Maltese: Mediċini oħra u Kromeya
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of ≥ 30% in no more than 1 of the 6 criteria.
Maltese: Ilkriterji li jiddefinixxu li l-marda tmur għal-agħar huma li tmur lura b'  30% mill linja bażi f'  3 minn 6 kriterji prinċipali ta' ACR pedjatriċi  2 ġogi attivi, u titjib ta'  30% f'mhux aktar minn 1 minn 6 kriterji.
English: Population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Maltese: L-immudellar u s-simulazzjoni farmakokinetiku tal-popolazzjoni u farmkokinetiku/farmakodinamiku bassar espożizzjoni u effikaċja ta' adalimumab komparabbli f'pazjenti kkurati b'80 mg ġimgħa iva ġimgħa le meta mqabbel ma' 40 mg kull ġimgħa (inkluż pazjenti adulti b' RA, HS, UC, CD jew Ps, pazjenti b'HS adolexxenti, u pazjenti pedjatriċi ≥ 40 kg b'CD).
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: Psoriasis study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Maltese: Studju Psorajisi II (CHAMPION) qabbel l-effikaċja u s-sigurtà ta' adalimumab kontra methotrexate u plaċebo f'271 pazjent.
English: Pancreatitis, dysphagia, face oedema
Maltese: Ażma, dispneja, sogħla
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (Figure P).
Maltese: • B'moviment qasir, u ta' malajr, imbotta l-labra kollha 'l isfel ġol-ġilda f'angolu ta' bejn 45° u 90° (Stampa P).
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffetwaw sa persuna 1 f'1,000)
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Maltese: Fi studji kontrollati u open-label b'adalimumab fl-adulti u fit-tfal, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulosi (inklużi tuberkulosi b'ħafna għoqod tuberkulari mal-ġisem kollu u tuberkulosi f'postijiet barra mill-pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa jew barra l-pulmun, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis aspergillosis u listeriosis).
English: RA Study III a**
Maltese: Studju RA III a**
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double- masked, placebo-controlled studies (UV I and II).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati f'pazjenti adulti bi intermedja, posterjuri u panuveite mhux infettiva, esklużi pazjenti b'uveite anterjuri iżolati, f'żewġ studji każwali, doublemasked, ikkontrollati bi plaċebo (UV I u II).
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il-persentaġġ ta' pazjenti li ma avvanzatilhomx il-marda (bidla mil-linja bażi fit-tibdil tal-Puteġġ Totali Sharp  0.5) kien sinifikament ogħla bit-terapija kombinata ta' adalimumab/methotrexate (63.8% u 61.2% rispettivament) meta pparagunat ma' kura b' methotrexate waħdu (37.4% u 33.5% rispettivament, p<0.001) u kura b'adalimumab waħdu (50.7%, p < 0.002 u 44.5%, p < 0.001 rispettivament).
English: 1 sterile injection syringe 1 sterile needle 1 vial adaptor 2 alcohol pads
Maltese: Kull kaxxa fiha kunjett 1, siringa tal-injezzjoni sterili 1, labra sterili 1, adapter tal-kunjett 1 u 2 kuxxinetti bl-alkoħol.
English: Kromeya 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: Kromeya huwa ndikat għall-trattament ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw kura konvenzjonali li tinkludi kortikosteroidi u 6mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
Maltese: Studju RA I fir-24 ġimgħa, Studju RA II fis-26 ġimgħa , u Studju RA III fl-24 u t-52 ġimgħa b
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/m 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: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Maltese: Il-pazjenti nżammu fuq dożi stabbli ta' NSAIDs u jew prednisolone ( 0.2 mg /kg/ġurnata jew massimu ta' 10 mg/ġurnata).
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
Maltese: Tfal u adolexxenti minn eta ta' 4 snin sa 17-il sena li jiżnu bejn 15 kg sa inqas minn 30 kg
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 bl-addoċċ f'wieħed minn erbgħa 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: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Maltese: It-terapija kombinata b'adalimumab/methotrexate kienet klinikament u statistikament superjuri għal methotrexate (p < 0.001) u adalimumab mogħti waħdu bħala kura (p < 0.001) fit-tilħiq ta'stat baxx ta' mard f'pazjenti li kienu ġew riċentament iddijanjostikati b'artrite rewmatika minn moderata sa severa.
English: Response RA Study I a**
Maltese: Studju RA I a**
English: Kromeya is available in other presentations.
Maltese: Kromeya huwa disponibbli fi preżentazzjonijiet oħra.
English: • Store the Kromeya Vial Kit in a refrigerator between 2°C to 8°C.
Maltese: • Żomm il-Kitt tal-Kunjett ta' Kromeya fi friġġ f'temperatura ta' bejn 2°C sa 8°C.
English: Week 26 placebo-controlled
Maltese: 26 Ġimgħa bi plaċebobħala kontroll
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Maltese: Wara li l-Prodott tqiegħed fis-suq, kienu irrapurtati każijiet rari ta' hepatosplenic T-cell lymphoma f'pazjenti trattati b' adalimumab (ara sezzjoni 4.4).
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: Madankollu, ma ġewx 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: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test.
Maltese: il-valur-p jiġi mit-tqabbil bejn pari ta' trattament monoterapewtiku b'methotrexate u lkombinazzjoni ta' adalimumab u methotrexate bl-użu tat-test U Mann-Whitney.
English: (Figure O).
Maltese: I/II).
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 rapportati f'pazjenti li kienu qed jirċievu adalimumab.
English: Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Maltese: Nota: Il-falliment tat-trattament fi jew wara ġimgħa 6 (Studju UV I), jew fi jew wara ġimgħa 2 (Studju UV II), kien magħdud bħala avveniment.
English: Kromeya is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Kromeya huwa kontro-indikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: Disease flares at the end of 32 weeks a
Maltese: Il-marda tmur għal agħar fl-aħħar ta' 32 ġimgħa a
English: The following side effects have been observed with adalimumab:
Maltese: L-effetti sekondarji li ġejjin ġew osservati b'adalimumab:
English: Method and route of administration Kromeya is administered by injection under the skin (by subcutaneous injection).
Maltese: Metodu u rotta ta' amministrazzjoni Kromeya jiġi injettat taħt il-ġilda (injezzjoni għal taħt il-ġilda).
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Maltese: Tuberkulosi, inkluż riattivazzjoni u bidu ġdid ta' tuberkulosi, kienet irrapurtata f'pazenti li jierċievu adalimumab.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Maltese: * hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8 ** li jinkludu l-istudji ta' estensjoni open-label li jinkludu informazzjoni minn rapporti spontanji
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: Fl-estensjoni open-label ta' studju RA V, il-bidla medja mil-linja bażi f'Sena 10 fil-Puteġġ Totali Sharp modifikati kien 10.8, 9.2 u 3.9 fil-pazjenti li oriġinarjament randomizzati għal monoterapija b'methotrexate, monoterapija b'adalimumab u terapija kkombinata b'adalimumab /methotrexate, rispettivament.
English: Idiopathic thrombocytopenic purpura
Maltese: Purpura tromboċitopenika idjopatika
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: 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 wrew l-ebda progress radjografiku mil-linja bażi sa ġimgħa 48 (n=102), 84% baqgħu ma urew l-ebda progress radjografiku matul 144 ġimgħa ta' kura.
English: 1.2 You will also need (Figure A):
Maltese: 001) (Figura
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 mil- hs-CRP u MRI taż-żewġ Ġogi Sacroiljaċi u l-Spina nżamm f'pazjenti ttrattati b'adalimumab sa ġimgħa 156 u ġimgħa 104, rispettivament.
English: Table 17 Ps Study I (REVEAL) efficacy results at 16 weeks
Maltese: Tabella 17 Studju Ps I (REVEAL) -Riżultati ta' effikaċja f'16-il Ġimgħa
English: CD study II: infliximab experienced patients
Maltese: Studju CD II: Pazjenti li kienu diġà ħadu infliximab qabel
English: Step 2 Prepare Vial
Maltese: Stadju 2 Aħsel idejk
English: Kromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: Kromeya huwa indikat għat-trattament ta' psorjasi tal-plakka severa u kronika fit-tfal u adoloxxenti minn 4 snin il-fuq u li kellhom rispons mhux adegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
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: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Maltese: Adalimumab jimmodula ukoll ir-risponsi bijoloġiċi li jiġu kkawżati jew regolati mit-TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma risponsabbli għall-migrazzjoni tal-lewkoċite (ELAM-1, VCAM1, u ICAM-1 ma' xi IC50 ta' 0.
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Maltese: Wara dożi ta' 0.5 mg/kg (~40 mg), ittneħħija mill-ġisem varjat minn 11 sa 15 mL/siegħa, il-volum ta' distribuzzjoni (Vss) varja minn 5 sa 6 litri u l-half-life medja tal-fażi terminali kienet ta' bejn wieħed u ieħor gimagħtejn.
English: eye infections, diverticulitis 1)
Maltese: Reazzjoni avversa divertikulite1)
English: Adults with rheumatoid arthritis
Maltese: Adulti b'artrite rewmatika
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Maltese: Għalkemm mhux statistikament sinifikanti, il-maġġoranza tal-pazjenti wrew titjib kliniku filpuntu tat-tmiem sekondarji bħal numru ta' siti ta' entestie, għadd ta' ġogi sensttivi (TJC), għadd ta' ġogi minfuħa (SJC), rispons Pedjatriku ACR 50, u rispons Pedjatriku ACR 70.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Kromeya cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti ttratati b' Kromeya (ara sezzjoni 4.8).
English: • ulcerative colitis and
Maltese: • kolite ulċerattiva
English: Minimum, median and maximum dose
Maltese: Dożi minimi, medji u massimi
English: Table 12 Radiographic mean changes at week 52 in RA study V
Maltese: Tabella 12 Tibdil radjografiku medju f'ġimgħa 52 fi studju RA V
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt trattament ta'manutenzjoni kortikosteroidi jistgħu jigu mnaqqsa bil-mod skont il-linji gwida talprattika klinika.
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Maltese: 673 pazjent b'attività nr-axSpA (attività medja tal-marda bażika [BASDAI] kienet ta' 7.0) li kellhom rispons inadegwat għal ≥ 2 NSAIDs, jew intolleranza għal jew kontraindikazzjoni għal NSAIDs irreġistrati fil-perjodu open-label ta' Studju nr-axSpA II li matulu rċevew adalimumab 40 mg eow għal 28 ġimgħa.
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Maltese: 4%) kienu f'sekwenza (lebda leżjoni infjammatorja attiva, grad ta' ċellula AC ≤ 0.5+, VH grad ≤ 0.5+) b'doża ta' sterojdi konkomitanti ≤ 7.5 mg kuljum, u 184 (66.7% ) kienu bla kwiesċenza ta' sterojdi.
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.