FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew evalwati fi studji li kienu imqassma b'mod każwali, double-blind, ikkontrollati bi plaċebo u studju ta' estensjoni open-label f'pazjenti adulti bi hidradenitis suppurativa (HS) moderata sa severa li kienu intoleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill-inqas ta' 3 xhur provi ta' terapija antibijotika sistemika.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt trattament ta' manteniment kortikosterojdi jistgħu jitnaqqsu bil-mod b'mod konformi mal-linji gwida tal-prattika klinika.
English: • reactivation of hepatitis B;
Maltese: • riattivazzjoni ta' epatite B;
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 mogħtija waħedhom 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: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Il-pożoloġija ta' adalimumab f'dawn il-pazjenti ġiet iddeterminata minn immudellar u simulazzjoni farmakokinetiċi (ara sezzjoni 5.2).
English: Imraldi is used to treat rheumatoid arthritis in adults.
Maltese: Imraldi jintuża biex jittratta artrite rewmatika fl-adulti.
English: The rate (95% confidence interval) of non-melanoma 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 ta' 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumabu 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: 26.0a
Maltese: Ġimgħa 26
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: d a il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'methotrexate waħdu u adalimumab u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney b il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u adalimumab u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney c ilvalur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney
English: -56.2a a p<0.001, adalimumab vs. placebo
Maltese: a a a p < 0.001, adalimumab kontra plaċebo
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%) kellhom rispons għal ACR 50; u 43 pazjent (53.1%) kellhom rispons għal ACR 70.
English: Date of first authorisation: 24 August 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' Awwissu 2017
English: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Maltese: Kunjett (0.8 mL soluzzjoni sterili), siringa għall-injezzjoni sterili vojta, labra, adapter tal-kunjett u żewġ pads tal-alkoħol.
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% flaxxess total u l-għadd tal-noduli infjammatorji bl-ebda żieda fl-għadd tal-axxess u l-ebda żieda filgħadd relattiv tal-fistula li tkun qed tnixxi mal-Linja Bażi) .
English: Imraldi Dose for Paediatric Patients with Crohn's disease
Maltese: Doża ta' Imraldi għal Pazjenti Pedjatriċi bil-Marda Crohn (Crohn's Disease)
English: p-valuea p-valueb p-valuec
Maltese: valur-p a valur-p b valur-p c
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: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumab-treated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16).
Maltese: Ir-rata ta' tqaliet li jintemmu b'għallinqas tarbija tat-twelid ħajja waħda b'difett maġġuri mat-twelid kienet 6/69 (8.7%) fin-nisa kkurati b'adalimumab b' RA u 5/74 (6.8%) fin-nisa mhux ikkurati b'RA (OR mhux aġġustata 1.31, 95% CI 0.38-4.52) u 16/152 (10.
English: • 160 mg at week 0 and 80 mg at week 2
Maltese: • 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2
English: 1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
Maltese: soluzzjoni għall-injezzjoni 1 siringa mimlija għal-lest 2 pads tal-alkoħol
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Maltese: Infezzjonijiet sistemiċi (li jinkludu sepsis, candidiasis u influwenza), infezzjonijiet intestinali (li jinkludu gastroenterite virali), infezzjonijiet fil-ġilda u fit-tessuti rotob tal-ġilda (li jinkludu infjammazzjoni fit-tessuti tal-ġilda madwar id-difer, ċellulite, impetiġini, faxxite bin-nekrosi u ħruq ta' Sant'Antnin), infezzjonijiet fil-widnejn, infezzjonijiet fil-ħalq (li jinkludu herpes simplex, herpes fil-ħalq u infezzjonijiet fis-snien), infezzjonijiet fis-sistema riproduttiva (li jinkludu infezzjoni tal-fungi fil-vulva u fil-vaġina), infezzjoni fis-sistema urinarja (li tinkludi infezzjoni fil-kliewi u fis-sistema urinarja tan-naħa ta' fuq), infezzjonijiet tal-fungu, infezzjonijiet fil-ġogi
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Imraldi cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż irriskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti ttratati b' Imraldi (ara sezzjoni 4.8).
English: The needle is now attached to the syringe.
Maltese: Jekk trid uża stikka.
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: 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: Pazjenti li kisbu remissjoni sostnuta għal mill-inqas 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: • neuropathy (nerve damage);
Maltese: • newropatija (ħsara fin-nervaturi);
English: Table 26 Paediatric CD Study PCDAI Clinical Remission and Response
Maltese: Tabella 26 Studju ta' CD fit-Tfal Qlib għall-aħjar fl-istat Kliniku u Rispons Kliniku tal-PCDAI
English: Adult hidradenitis suppurativa
Maltese: Hidradenitis suppurativa fl-adulti
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Maltese: Artrite attiva idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite
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 urew l-ebda progress radjografiku matul 144 ġimgħa ta' kura.
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 randomized 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: 6 months 12 months ACR 70
Maltese: 12 -il xahar ACR 70
English: Mean exposure in all adalimumab population was 762 days.
Maltese: Il-medja tal-esponiment filpopolazzjoni kollha ta' adalimumab kienet ta' 762 jum.
English: • numbness;
Maltese: • ażżma;
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: 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 3, P <0.0001 mit-test ta' log rank).
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 r-rispons tal-PASI ta' 75 f'Ġimgħa 12 u 24, rispettivament.
English: 5) Injecting Imraldi
Maltese: 5) Kif Tinjetta Imraldi
English: Low Dose 20/10 mg eow P value1
Maltese: Doża Baxxa 20/10 mg eow Valur P
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) 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: Imraldi is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: Imraldi jintuża biex jittratta hidradenitis suppurativa fl-adulti u fl-adolexxenti minn 12-il sena.
English: Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Maltese: Erythema multiforme sindromu ta' Stevens-Johnson angioedema vaskulite tal-ġilda reazzjoni tal-lichenoid fil-ġilda
English: If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml.
Maltese: Jekk id-doża preskritta hija 0.5 mL, iġbed l-istikka bajda tal-planġer ‘il barra sa 0.6 mL.
English: For instructions for use, refer to section 7.
Maltese: Għal istruzzjonijiet dwar lużu, irreferi għal sezzjoni 7.
English: Imraldi 40 mg/0.8 ml solution for injection
Maltese: Imraldi 40 mg/0.8 mL soluzzjoni għall-injezzjoni
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: 48.9a
Maltese: 20 ġimgħa
English: • severe rash, hives or other signs of allergic reaction;
Maltese: • raxx sever, urtikarja jew sinjali oħra ta' reazzjoni allerġika;
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 tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelloli effettivi T-, B-, NK-, monoċistiċi /makrofaġi, u newtrofili.
English: 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 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Ġimgħa 2 Ġimgħa 12 Ġimgħa 24 ***,** Statistikament sinifikanti f'p < 0.001, < 0.01 għall-paraguni kollha bejn adalimumab u lplaċebo f'ġimgħa 2, 12 u 24
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 versu l-kura b'methotrexate u l-kura b'Imraldi waħdu f'Ġimgħa 52, liema titjib baqa' mantenut matul Ġimgħa 104.
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 Physician's Global Assessment (PGA) ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or Psoriasis Area and Severity Index (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' Imraldi kienet evalwata fi studju każwali, double-blind, ikkontrollat ta' 114-il pazjent pedjatriku minn 4 snin il-fuq bi psorjasi tal-plakka severa kronika (kif definit minn involviment talEvalwazzjoni Globali tat-Tabib (PGA) ≥ 4 jew> 20% BSA jew> 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew il-Parti Milquta mill-Psorjasi u l-Indiċi tas-Severità tal-Psorjasi (PASI) ≥ 20 jew ≥ 10 bi klinikament rilevanti involviment tal-wiċċ, ġenitali, jew idejn/saqajn) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84 %) patients in the adalimumab group who remained in the study.
Maltese: Titjib fin-numru ta' ġogi attivi bl-artrite kien mantenut waqt il-perijodu OL fil-Ġimgħa 156 għall-26 minn 31 (84%) pazjent fil-grupp ta' adalimumab li baqa' fl-istudju.
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), Paediatric ACR 50 response, and Paediatric 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: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Maltese: Studju RA II evalwa 544 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18-il sena u li ma kinux irrispondew għal kura b'mill-inqas mediċina waħda anti-rewmatika li taffetwa l-proċess tal-mard.
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: Table 27 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Maltese: Tabella 27 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla
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 Sacroiliac u l-Spina nżamm f'pazjenti ttrattati b'adalimumab sa ġimgħa 156 u ġimgħa 104, rispettivament.
English: PASI 75b PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
Maltese: P = 0.027, adalimumab 0.8 mg/kg kontra MTX
English: This medicinal product contains 20.0 mg sorbitol.
Maltese: Din il-mediċina fiha 20 mg sorbitol f'kull kunjett.
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, doublemasked, 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: NEVER pull past the 0.9 ml position regardless of prescribed dose.
Maltese: Tiġbed QATT aktar mil-marka ta' 0.9 mL irrispettivament mid-doża preskritta.
English: • ankylosing spondylitis,
Maltese: Stima f' Ankylosing Spondylitis b
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: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallelgroup study in 171 children (4-17 years old) with polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati fi studju kollettiv multicenter, randomizzat,u double-blind f'171 tifel u tifla (li għandhom bejn 4-17-il sena) b'JIA poliartikulari.
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: 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Maltese: Rispons Ped ACR 30/50/70 f'Ġimgħa 48 kien wisq akbar minn dak ta' pazjenti kkurati bil-plaċebo b p = 0.015
English: • coughing;
Maltese: • sogħla;
English: 6 pre-filled pens 6 alcohol pads
Maltese: 6 pinen mimlija għal-lest 6 pads tal-alkoħol
English: Vertigo and visual impairment may occur following administration of Imraldi (see section 4.8).
Maltese: Jista jkun hemm vertigo u indeboliment fil-vista wara li jingħata Imraldi (ara sezzjoni 4.8).
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 ×ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bl-artrite rewmatika u artrite psorjatika fejn il-pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żieda fil-livelli tal-ALT ≥3 × ULN f'3.7 % tal-pazjenti trattati bi adalimumab u f'1.6 % tal-pazjenti trattati bil-kontroll.
English: • paediatric Crohn's disease,
Maltese: • tal-marda Crohn fit-tfal (Crohn's Disease),
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (Creactive 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 cytokines fis-serum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1).
Maltese: Il-benefiċċju u r-riskju tat-trattament kontinwu li jitkompla fit-tul għandhom jiġu evalwati perjodikament (ara dejta ta' adulti fis-sezzjoni 5.1).
English: Clinical Response
Maltese: KLINIKU
English: Erosion Score JSNd Score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Maltese: d methotrexate 95% intervall ta' konfidenza ghad-differenza bejn il-punteġġi ta' methotrexate u adalimumab.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Maltese: • Jekk int iġġorr il-virus tal-epatite B (HBV), jekk għandek infezzjoni HBV attiv jew jekk taħseb li għandek riskju li jaqbdek l-HBV, għid lit-tabib tiegħek.