FrancophonIA/ELRC3.0 huggingface dataset:
English: 79 (73.1) a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
Maltese: 79 (73.1) a, b a p < 0.001 adalimumab kontra l-plaċebo b p < 0.001 adalimumab kontra methotrexate c p < 0.01 adalimumab kontra l-plaċebo d p < 0.05 adalimumab kontra methotrexate
English: 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: PGA: Xejn/minimalic a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg kontra MTX c P=0.083, adalimumab 0.8 mg/kg kontra MTX
English: Renal impairment, Haematuria
Maltese: Indeboliment renali, Ematurja
English: Ps study II (CHAMPION) efficacy results at 16 weeks Placebo N = 53 n (%)
Maltese: Studju Ps II (CHAMPION) riżultati tal-effikaċja wara 16-il Ġimgħa Plaċebo N=53 n (%)
English: Placebo/MTXadalimumab /MTX (95% confidence intervalb)
Maltese: Plaċebo/MTXAdalimumab/MT X (95% Intervall ta' Konfidenzab)
English: Erythema multiforme1), Stevens-Johnson syndrome1), Angioedema1), Cutaneous vasculitis1) Lichenoid skin reaction1)
Maltese: Erythema multiforme1), Sindrome ta' Stevens-Johnson1), Anġjoedima1),
English: Ps study IV efficacy results at 16, 26 and 52 weeks
Maltese: Riżultati tal-Effikaċja ta' studju Ps IV wara 16, 26 u 52 ġimgħa
English: RA study IIIa**
Maltese: Studju RA IIIa**
English: 0.8 mL of solution.
Maltese: INDIVIDWALI 0.8 mL
English: Note: P# = Placebo (number of events/number at risk); A# = Adalimumab (number of events/number at risk).
Maltese: Nota: P# = Plaċebo (Numru ta' Avvenimenti/Numru fir-Riskju); A# = Adalimumab (numru ta' Avvenimenti/Numru fir-Riskju).
English: ACR responses in RA study V (percent of patients)
Maltese: Risponsi ACR fi Studju RA V (persentaġġ ta' pazjenti)
English: The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Maltese: Il-proporzjonijiet li jikkorrispondu ta' pazjenti bl-ebda progressjoni radjografika kienu ta' 31.3%, 23.7% u 36.7% rispettivament.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Maltese: Il-konċentrazzjoni apparenti ta' adalimumab fil-plażma li tipproduċi nofs il-probabbiltà massima ta' rispons PedAc 50 (EC50) kienet ta' 3 μg/mL (95% CI: 1-6 μg/mL).
English: AMGEVITA contains sodium
Maltese: AMGEVITA fih sodium
English: Double-Blind Response at Week 68
Maltese: Rispons Double-Blind f'Ġimgħa 68
English: RA study IIa**
Maltese: Studju RA IIa**
English: The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody.
Maltese: Is-sustanza attiva f'AMGEVITA, adalimumab, hija antikorp monoklonali uman.
English: 8 to 12 years
Maltese: Minn 8 sa 12-il sena
English: Name and address of the manufacturers of the biological active substance Amgen Inc
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Amgen Inc
English: Adalimumabb / MTXc n = 63
Maltese: imumabb/ MTXc n=63
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNFα) inhibitors.
Maltese: Immunosuppressanti, Inibitturi tal-Fattur tan-Nekrosi tat-Tumur alfa (TNF-α - Tumour Necrosis Factor alpha).
English: EU/1/16/1164/005 - 6 (3x2) multipack AMGEVITA 40 mg solution for injection in pre-filled pen EU/1/16/1164/006 - 1 pack
Maltese: EU/1/16/1164/005 - 6 (3x2) pakkett multiplu AMGEVITA 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/16/1164/006 - pakkett wieħed
English: Very common Leukopenia (including neutropenia and agranulocytosis), Anaemia
Maltese: Komuni ħafna lewkopenja (li tinkludi newtropenja u agranulocytosis), anemija
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Maltese: • trattament ta' artrite rewmatika attiva u progressiva severa f'adulti li ma jkunux ingħataw trattament b'methotrexate qabel.
English: Placebo/ MTXc n = 200
Maltese: Plaċebo/ MTXc n=200
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Maltese: F' Ġimgħa 12 u Ġimgħa 24, ir-rispons PedACR30 kien ta' 93.5% u 90.0% rispettivament meta intużat is-sitema ta' informazzjoni osservata.
English: Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: L-Istudju tal-Psorjasi I (REVEAL) evalwa 1,212 pazjent fi tliet perijodi ta' kura.
English: Reactivation of hepatitis B1), Autoimmune hepatitis1)
Maltese: Riattivazzjoni tal-epatite B1) Epatite awtoimmuni1)
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Maltese: Adalimumab wera benefiċċju tattrattament f'pazjenti b'psorjasi tad-dwiefer bi gradi differenti ta' involvement tal-ġilda (BSA≥10% (60% tal-pazjenti) u BSA < 10% u ≥ 5% (40% tal-pazjenti)).
English: PGA-F clear/minimal and ≥ 2-grade improvement
Maltese: PGA-F xejn/minimali u titjib ta' ≥ 2 gradi (%)
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Maltese: Il-persentaġġ ta' pazjenti kkurati b'adalimumab li jilħqu risponsi ACR 20, 50 u 70 kien konsistenti fi studji RA I, II u III.
English: Placebo / MTX (N = 37)
Maltese: Plaċebo / MTX (N = 37)
English: ● Plaster
Maltese: ● Stikk
English: SPARCC MRI Spined,j a Assessment of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
Maltese: ASDAS Marda Inattiva hs-CRP d,f,g SPARCCh MRI Ġogi Sacroiliac d,i SPARCC SpinaMRI d,j a Valutazzjonijiet tas-Soċjetà internazzjonali ta' SpondyloArthritis b Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis c Punteġġ tal-Attivita tal-Mard Ankylosing Spondylitis d Bidla medja mil-linja bażi e n=91 plaċebo u n=87 adalimumab f Proteina Ċ-reattiva b'sensittività għolja (mg/L) g n=73 plaċebo u n=70 adalimumab h Konsorzju tal-Kanada għar-riċerka ta' Spondyloarthritis i n= 84 plaċebo u adalimumab j n= 82 plaċebo u n=85 adalimumab ***, **, * Statistikament sinifikanti meta p < 0.001, < 0.01, u < 0.05, rispettivament, għal paraguni kollha bejn adalimumab u l-plaċebo.
English: System Organ Class Frequency
Maltese: Klassi tas-Sistemi u tal-Organi
English: Paraesthesias (including hypoaesthesia), Migraine,
Maltese: Parasteżija (inkluża ipoestesija), emigranja,
English: Usually, AMGEVITA is used with methotrexate.
Maltese: Ġeneralment, AMGEVITA jintuża ma' methotrexate.
English: In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Maltese: III, f'Ġimgħa 4, 58% (499/854) tal-pazjenti kellhom rispons kliniku u ġew assessjati flanaliżi primarja.
English: ASASa Partial Remission
Maltese: Remissjoni Parzjali ASASa
English: Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
Maltese: Emboliżmu fil-pulmun1), Mard tal-interstizju tal-pulmun, Mard kroniku ta' imblukkar fil-pulmun, Pulmonite,
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% versus 9% respectively, p = 0.031) and study UC-II (17% versus 9% respectively, p = 0.019).
Maltese: Pazjenti li ngħataw 160/80 mg adalimumab kellhom titjib kliniku f'perċentwali akbar li kienu statistikament sinjifikanti meta mqabbla ma plaċebo f' Ġimgħa 8 fi studju UC-I (18% vs. 9% rispettivament, p = 0.031) u fi studju UC-II (17% vs. 9% rispettivament, p = 0.019).
English: Clinical response is usually achieved within 2-8 weeks of treatment.
Maltese: Rispons kliniku normalment jintlaħaq fi żmien 2-8 ġimgħat ta' trattament.
English: Step 4: Finish
Maltese: It-Tieni Pass: Lesti
English: Table 28.
Maltese: Tabella 28.
English: CD study II: infliximab experienced patients
Maltese: Studju CD II: Pazjenti li kienu diġà ħadu infliximab
English: Paediatric ACR 30 responses in the JIA study
Maltese: Rispons PedACR 30 fi studju JIA
English: b 2-sided P value from log rank test. c NE = not estimable.
Maltese: b 2-naħat valur P minn test log rank.
English: Table 24.
Maltese: Tabella 24.
English: Table 23.
Maltese: Tabella 23.
English: Table 27.
Maltese: Tabella 27.
English: Paediatric CD study PCDAI clinical remission and response Standard dose 40/20 mg eow N = 93
Maltese: Studju ta' CD fit-tfal qlib għall-aħjar fl-istat kliniku u rispons kliniku tal-PCDAI Doża Standard 40/20 mg eow N=93
English: Standard dose 40/20 mg eow
Maltese: Doża Standard 40/20 mg eow
English: Mean exposure in all adalimumab population was 762 days.
Maltese: L-esponiment medju filpopolazzjoni kollha ta' adalimumab kien ta' 762 ġurnata.
English: Placebo/ MTXc n = 60
Maltese: Plaċebo/ MTXc n=60
English: Placebo N = 107
Maltese: Plaċebo N=107
English: Table 25.
Maltese: Tabella 25.
English: 1 p value for standard dose versus low dose comparison
Maltese: 1 valur p li huwa paragun tad-Doża Standard kontra Doża Baxxa.
English: INFORMATION IN BRAILLE AMGEVITA 20 mg syringe
Maltese: INFORMAZZJONI BIL-BRAILLE AMGEVITA 20 mg siringa
English: Multipack: 6 (3 packs of 2) SureClick pre-filled pens.
Maltese: 6 (3 pakketti ta' 2) pinen mimlija għal-lest SureClick.
English: Table 29.
Maltese: Tabella 29.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD
Maltese: L-OR aġġustata (li tammonta għal differenzi fil-linja bażi) kienet 1.10 (95% CI 0.45-2.73) b'RA u CD ikkombinati.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Maltese: Melanoma u karċinoma taċ-ċelluli Merkel kienu wkoll irrapurtati f'pazjenti kkurati blantagonisti ta' TNF inkluż adalimumab (ara sezzjoni 4.8).
English: Other medicines and AMGEVITA
Maltese: Mediċini oħra u AMGEVITA
English: Placebo n = 110
Maltese: Plaċebo n=110
English: Leukocytosis, Thrombocytopenia
Maltese: Komuni lewkoċitosi, tromboċitopenija
English: Side effects may occur at least up to 4 months after the last AMGEVITA injection.
Maltese: L-effetti sekondarji jistgħu jseħħu mill-inqas sa 4 xhur wara l-aħħar injezzjoni ta' AMGEVITA.
English: Time to treatment failure at or after week 6 in study UV I Primary analysis (ITT)
Maltese: Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 6 fi Studju UV I Analiżi Primarja (ITT)
English: AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Maltese: AMGEVITA huwa indikat fi trattament ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'adulti u f'adolexxenti minn 12-il sena b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjonijiet 5.1 u 5.2).
English: Table 21.
Maltese: Tabella 21.
English: Placebo N = 398 n (%)
Maltese: Plaċebo N=398 n
English: Week 52 Fistula remission3
Maltese: Ġimgħa 52 Fejqan tal-fistla3
English: Placebo N = 166
Maltese: Plaċebo N=166
English: Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Maltese: Nota: P = Plaċebo (Numru f'Riskju (b'aggravar)); A = Adalimumab (Numru f'Riskju (b'aggravar)).
English: AMGEVITA contains the active substance adalimumab.
Maltese: X'fih AMGEVITA - Is-sustanza attiva hi adalimumab.
English: EU/1/16/1164/009 - 6 (3x2) multipack
Maltese: EU/1/16/1164/009 - 6 (3x2) pakkett multiplu
English: Placebo N = 162
Maltese: Plaċebo N=162
English: Low dose 20/10 mg eow N = 95
Maltese: Doża Baxxa 20/10 mg eow N=95
English: Table 22.
Maltese: Tabella 22.
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: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg/kg/day or 10 mg/day maximum).
Maltese: Ilpazjenti nżammu fuq dożi stabbli ta' NSAIDs u jew prednisolone (≤ 0.2 mg/kg/ġurnata jew massimu ta' 10 mg/ġurnata).
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Maltese: 6%) kellhom rispons ACR 20; 127 pazjent (74.7%) kellhom rispons ACR 50; u 102 pazjent (60.0%) kellhom rispons ACR 70.
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 l-plaċebo f'Ġimgħa 2, 12 u 24 a Stimi f'Ankylosing Spondylitis b Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Maltese: Il-lista li jmiss ta' reazzjonijiet avversi hija bbażata fuq esperjenza li ġejja minn studji kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq, u hija mniżżla skont il-klassi tas-sistema tal-organu u l-frekwenza f'Tabella 6 hawn taħt: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa< 1/100); rari (≥ 1/10,000 sa < 1/1,000); u mhux magħrufa (li ma jistgħux jiġu kkalkulati millinformazzjoni eżistenti).
English: Placebo N = 74
Maltese: Plaċebo N=74
English: Demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)1)
Maltese: Disturbi li jeffetwaw il-myelin (bħal newrite flgħajnejn, sindrome ta' Guillain-Barré) 1)
English: Table 26.
Maltese: Tabella 26.
English: For a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting.
Maltese: Għal injezzjoni aktar komda, ħalli s-siringa f'temperatura tal-kamra għal 15 sa 30 minuta qabel tinjetta.
English: Statistically and clinically significant improvements from baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Maltese: Titjib statistikament u klinikament sinifikanti mill-linja bażi kien wkoll osservat fiż-żewġ gruppi tat-trattament għal parametri tal-kwalità tal-ħajja (inkluż IMPACT III).
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Maltese: Matul il-fażijiet kontrollati ta' provi pivitali ta' adalimumab fl-adulti li damu sejrin mill-inqas 12-il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, infjammazzjoni talvertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorjasi, hidradenitis suppurativa, mill-marda ta' Crohn, mill-kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' konfidenza) ta' 6.8 (4.4, 10.5) kull 1,000 sena ta' pazjent fost 5,291 pazjent ikkurat b'adalimumab, kontra rata ta' 6.3 (3.4, 11.8) kull 1,000 sena ta' pazjent fost 3,444 pazjent kontrollat (il-medja tat-tul tal-kura kienet ta' 4.0 xhur għal adalimumab u 3.8 xhur għal pazjenti mogħtija kura kontrollata).
English: Do not use AMGEVITA:
Maltese: Tużax AMGEVITA:
English: Placebo N = 94
Maltese: Plaċebo N=94
English: Placebo N = 49
Maltese: Plaċebo N=49
English: P value1
Maltese: Valur P1
English: Gastroesophageal reflux disease, Sicca syndrome
Maltese: Mard ta' rifluss gastro-esofagali Sindrome sikka
English: Pleural effusion1)
Maltese: Effużjoni plerali1)
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: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% versus 11.4%, respectively) and draining fistulas (30.0% versus 13.9%, respectively).
Maltese: HS-I u HS-II, meta mqabbla ma' dawk fil-grupp ta' adalimumab li kellhom aggravament ta' axxessi (23.0% kontra 11.4%, rispettivament) u fistuli li jnixxu (30.0 % kontra 13.9%, rispettivament).
English: AMGEVITA is a biosimilar medicinal product.
Maltese: AMGEVITA huwa prodott mediċinali bijoloġiku simili.
English: Efficacy results at 12 weeks, HS studies I and II
Maltese: Riżultati ta' effikaċja f'ġimgħa 12, HS Studji I u II
English: ACR 20 Week 12 Week 24
Maltese: ACR 20 Ġimgħa 12 Ġimgħa 24
English: PROBABILITY OF FAILING TREATMENT
Maltese: TA' FALLIMENT FI TRATTAMENT
English: Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Maltese: Mhux magħrufa Limfoma tat-tip hepatosplenic T-cell 1) Karċinoma taċ-ċelluli Merkel (karċinoma tal-ġilda newroendokrinika)1)
English: Time to treatment failure in studies UV I and UV II
Maltese: UV I and UV II
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Maltese: Titjib kliniku hu l-punteġġ Mayo ≤ 2 bl-ebda sottopunteġġ > 1;
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Maltese: Falliment tattrattament kien definit minn eżitu multi-komponent ibbażat fuq infjammazzjoni tal-chorioretinal u/jew infjammazzjoni tal-leżjonijiet vaskulari tar-retina, grad taċ-ċelluli tal-kompartiment anterjuri (AC), grad taċ-ċpar vitriju (VH) u l-aqwa akutezza kkoreġuta tal-vista (BCVA).
English: LIST OF EXCIPIENTS Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Maltese: TA' EĊĊIPJENTI Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide u ilma għall-injezzjoni.
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the openlabel extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of retreatment, respectively.
Maltese: Minn dawk il-pazjenti li tilfu r-rispons adegwat wara li intgħażlu b'ordni addoċċ biex jirċievu l-plaċebo, li mbagħad ġew miktuba fil-prova ta' estensjoni open-label, 38% (25/66) u 55% (36/66) reġgħu laħqu rispons tal-PASI ta' 75 wara 12 u 24 ġimgħa ta' kura għal darba oħra, rispettivament.
English: In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Maltese: Fi studju CD III, 854 pazjent irċevew 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 2, open label.
English: The posology of AMGEVITA in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Il-pożoloġija ta' AMGEVITA f'dawn il-pazjenti ġiet iddeterminata minn mudellar u simulazzjoni farmakokinetika (ara sezzjoni 5.2).
English: Week 16 Placebo-controlled
Maltese: Ġimgħa 16 Ikkontrollat bi Plaċebo
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 fil-puntu tat-tmiem sekondarji bħal numru ta' siti ta' entestie, għadd ta' ġogi sensttivi (TJC - tender joint count), għadd ta' ġogi minfuħa (SJCswollen joint count), rispons Pedjatriku ACR 50, u rispons Pedjatriku ACR 70.
English: Hyperhidrosis,
Maltese: Ipofosfatimija,
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 versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Maltese: Rispons kliniku huwa tnaqqis mill-linja bażi fil-punteġġ Mayo ta' ≥ 3 punti u ≥ 30% flimkien ma' tnaqqis filfsada rektali b'sottopunteġġ [RBS] ta' ≥ 1 jew RBS assolut ta' 0 jew 1; * p < 0.05 għal adalimumab vs. placebo bil-proporzjonijiet imqabblin flimkien ** p < 0.001 għal adalimumab vs. placebo bil-proporzjonijiet imqabblin flimkien a min dawk li rċevew kortikosterojdi f'linja bażi
English: Plunger rod
Maltese: Fi Studju RA
English: Efficacy response in placebo-controlled Study nr-axSpA I Double-Blind Response at week
Maltese: Risponsi tal-effikaċja fi Studju nr-axSpA I ikkontrollat bil-plaċebo Rispons Double-Blind f'Ġimgħa 12
English: Thirty-three (18%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Maltese: Tlieta u tletin (18%) pazjent kienu kkurati fl-istess ħin b'mediċini anti-rewmatiċi li jimmodifikaw ilmarda, u 146 (79%) pazjent b'NSAIDs fil-linja bażi.
English: INFORMATION IN BRAILLE AMGEVITA 40 mg pen
Maltese: INFORMAZZJONI BIL-BRAILLE AMGEVITA 40 mg pinna
English: Steroid-free remission for ≥ 90 daysa
Maltese: Titjib tal-kundizzjoni migħajr sterojdi għal ≥ 90 daysa
English: Sodium hydroxide (for pH adjustment)
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: Room spinning sensation and vision disturbances may occur after taking AMGEVITA.
Maltese: Jista jkun hemm sensazzjoni li l-kamra qed iddur bik u disturbi fil-vista wara li tingħata AMGEVITA.
English: INFORMATION IN BRAILLE AMGEVITA 40 mg syringe
Maltese: INFORMAZZJONI BIL-BRAILLE AMGEVITA 40 mg siringa
English: Ps study I (REVEAL) - efficacy results at 16 weeks
Maltese: Studju Ps I (REVEAL) - riżultati tal-effikaċja wara 16-il Ġimgħa