FrancophonIA/ELRC3.0 huggingface dataset:
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Maltese: Erythema multiforme1), sindrome ta' Stevens-Johnson1), angioedema1), vaskulite tal-ġilda1) reazzjoni tal-lichenoid fil-ġilda1)
English: PASI 75b PGA: clear/minimalc a
Maltese: PASI 75b PGA: xejn/minimali c a
English: Concurrent treatment with azathioprine/6-mercaptopurine
Maltese: Kura flimkien ma' azathioprine/6-mercaptopurine
English: adalimumab n = 274 (95 % confidence interval)
Maltese: adalimumab n = 274 (95 % Intervall ta' Konfidenza)
English: Tabulated list of adverse reactions
Maltese: Tabella tal-lista ta' reazzjonijiet avversi
English: Table 29 time to treatment failure in studies UV I and UV II
Maltese: Tabella 29 Żmien għall-Falliment tat-Trattament fi Studji UV I and UV II
English: MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Maltese: MTX = methotrexate ** p < 0.01, adalimumab kontra l-plaċebo
English: Immune system disorders*
Maltese: Disturbi fis-sistema immuni*
English: Table 12 ped ACR 30 responses in the JIA study stratum
Maltese: Tabella 12 Risponsi ped ACR 30 fi studju JIA
English: Rare
Maltese: Rari
English: HS study II
Maltese: HS studju II
English: 48.9a percent change in total fingernail NAPSI (%)
Maltese: 48.9a bidla perċentwali tat-total tad-dwiefer NAPSI (%)
English: Leucopaenia (including neutropaenia and agranulocytosis), anaemia
Maltese: Lewkopenja (li tinkludi newtropenja u agranulocytosis), anemija
English: adalimumab / M TX n = 268
Maltese: adalimumab/MTX n=268
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: • psoriasis,
Maltese: • psorjasi,
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Maltese: Din it-tip ta' T-cell lymphoma rari hi aggressiva ħafna u ġeneralment tkun fatali.
English: Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Maltese: Nota: P = Plaċebo (Numru f'Riskju (flared)); A = Adalimumab (Numru f'Riskju (flared)).
English: Moderate to severe heart failure (NYHA class III / IV) (see section 4.4).
Maltese: Insuffiċjenza tal-qalb minn moderata sa severa (NYHA klassi III / IV) (ara sezzjoni 4.4).
English: Table 5.
Maltese: Tabella 5.
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 31.3 %, 23.7 % u 36.7 % rispettivament.
English: • vision disturbances;
Maltese: • disturbi fil-vista;
English: 10, 20 and 25 mg
Maltese: 10, 20 u 25 mg
English: RA Study IIIa**
Maltese: Studju RA IIIa**
English: Figure B: items not included in the carton See “4.
Maltese: Figura B: oġġetti mhux inklużi fil-kartuna Ara “4.
English: Renal impairment, haematuria
Maltese: Indeboliment renali, ematurja
English: 25, 40 and 40 mg
Maltese: 25, 40 u 40 mg
English: The proportions of subjects with PedACR50 / 70 / 90 at week 12 and week 24 were 90.3 % / 61.3 % / 38.7 % and 83.3 % / 73.3 % / 36.7 %, respectively.
Maltese: Il-proporzjonijiet ta' pazjenti b' PedACR50 / 70 / 90 f'ġimgħa 12 u f'ġimgħa 24 kienu ta' 90.3 % / 61.3 % / 38.7 % u 83. 3 % / 73.3 % / 36.7 %, rispettivament.
English: c p = 0.083, adalimumab 0.8 mg / kg versus MTX
Maltese: c p = 0.083, adalimumab 0.8 mg / kg kontra MTX
English: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Maltese: Studju HS-II (PIONEER II) evalwa 326 pazjenti b'żewġ perjodi ta' kura.
English: placebo n = 110
Maltese: plaċebo n = 110
English: • inflammations.
Maltese: • infjammazzjonijiet.
English: Hepatitis reactivation of hepatitis B1) autoimmune hepatitis1)
Maltese: Epatite riattivazzjoni tal-epatite B1) epatite awtoimmuni1)
English: N (%)
Maltese: N Falliment N (%)
English: RA Study IIa**
Maltese: Studju RA IIa**
English: Ankylosing Spondylitis Disease Activity Score d partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Maltese: c Punteġġ ta l-Attività ta' Ankylosing Spondylitis Disease d Flare Parzjali huwa definit bhala ASDAS ≥1.3 izda <2.1 at 2 żjarat konsekuttivi.
English: MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg versus MTX
Maltese: MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg kontra MTX
English: Hepatitis B virus
Maltese: Virus tal-epatite B
English: Adalimumab Δ Censored
Maltese: Adalimumab Δ Ċensurat
English: Leucocytosis, thrombocytopaenia
Maltese: Lewkoċitożi, tromboċitopenija
English: Worsening of symptoms of dermatomyositis1)
Maltese: Aggravar tas-sintomi tad-dermotomijosite1)
English: Psoriasis
Maltese: Psorjasi
English: Study nr-axSpA I
Maltese: Studju nr-axSpA I
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u sigurtà
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Maltese: dispepsja, mard ta' reflux gastro-esofagali sindrome sikka
English: Figure 1: Kaplan-Meier Curves summarizing time to flare in study nr-axSpA II
Maltese: Figura 1: Sommarju tal-Kurvi Kaplan-Meier tal-Ħin tal-Flare fi Studju nr-axSpA II
English: Other opportunistic infections
Maltese: Infezzjonijiet opportunistiċi oħra
English: Table 4.
Maltese: Tabella 4.
English: Intestinal perforation1)
Maltese: Perforazzjoni tal-intestini1)
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Maltese: Studju nraxSpA I evalwa pazjenti b'nr-axSpA attiv.
English: • erythema multiforme (inflammatory skin rash);
Maltese: • erythema multiforme (raxx u infjammazzjoni fil-ġilda);
English: ACR 50 6 months
Maltese: ACR 50
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 % vs. 9 % respectively, p = 0.031) and study UC-II (17 % vs. 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 mal-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: Patients received adalimumab 0.8 mg / kg eow (up to 40 mg), 0.4 mg / kg eow (up to 20 mg), or methotrexate 0.1-0.4 mg / kg weekly (up to 25 mg).
Maltese: Pazjenti rċevew adalimumab 0.8 mg / kg eow (sa 40 mg), 0.4 mg/kg eow (sa 20 mg), jew methotrexate 0.1 -0.4 mg / kg kull ġimgħa (sa 25 mg).
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: efficacy outcomes double blind 32 weeks adalimumab / MTX (N =38)
Maltese: riżultati tal-effikaċja double blind ta' 32 ġimgħa adalimumab / MT X (N = 38)
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-sistema ta' informazzjoni osservata.
English: analysis
Maltese: Analiżi
English: placebo adalimumab 40 mg weekly placebo adalimumab 40 mg weekly hidradenitis suppurativa clinical response (HiSCR)a
Maltese: plaċebo adalimumab 40 mg kull ġimgħa plaċebo adalimumab 40 mg kull ġimgħa hidradenitis suppurativa rispons kliniku (HiSCR)a
English: ACR 20 6 months
Maltese: ACR 20
English: Nervous system disorders*
Maltese: Disturbi fis-sistema nervuża*
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-perċentwal ta' pazjenti kkurati b'adalimumab li jilħqu risponsi għall-ACR 20, 50 u 70 kien konsistenti fi studji RA I, II u III.
English: Infections and infestations*
Maltese: Infezzjonijiet u infestazzjonijiet*
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 fl-analiżi primarja.
English: 20, 25 and 40 mg
Maltese: 20, 25 u 40 mg
English: PGA: clear/minimal
Maltese: PGA: xejn / minimali
English: PGA: clear / minimal
Maltese: PGA: xejn/minimali
English: The active ingredient in Hefiya, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Hefiya, adalimumab, hija antikorp monoklonali.
English: Immunosuppression
Maltese: Immunoġeniċità
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Maltese: Adalimumab naqqas b'mod sinifikanti r-riskju ta' falliment tat-trattament b'75% meta mqabbel mal-plaċebo, kif inhu muri mill-proporzjon ta' periklu (HR = 0.25 [95% CI: 0.12, 0.49]).
English: Date of first authorisation: 26 July 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 26 ta' Lulju 2018
English: • rash;
Maltese: • raxx;
English: • angioedema (localised swelling of the skin);
Maltese: • anġjoedima (nefħa lokalizzata tal-ġilda);
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 irrappurtati f'pazjenti kkurati bl-antagonisti ta' TNF inkluż adalimumab (ara sezzjoni 4.8).
English: double-blind response at week 12
Maltese: rispons double-blind f'ġimgħa 12
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Maltese: neoplażmi fl-organi solidi (li jinkludu kanċer tas-sider, neoplażma fil-pulmun u neoplażma fit-tirojde), melanoma**
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 tal-kura 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: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class (SOC) 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 is-sistema tal-klassifika tal-organi (SOC) 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 magħruf (ma tistax tittieħed stima middata disponibbli).
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Maltese: • infezzjonijiet fis-sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis-sinus, pnewmonja);
English: ACR 70 6 months
Maltese: ACR 70
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Maltese: Artrite idjopatika poliartikulari taż-żgħażagħ (pJIA)
English: • Crohn's disease,
Maltese: • il-marda Crohn (Crohn's Disease),
English: Ulcerative colitis
Maltese: Kolite ulċerattiva
English: Rhabdomyolysis, systemic lupus erythematosus
Maltese: lupus erythematosus sistemiku
English: • benign tumours;
Maltese: • tumuri beninni;
English: • reactivation of hepatitis B infection;
Maltese: • riattivazzjoni ta' infezzjoni tal-epatite B;
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Maltese: • lifoma hepatosplenic T-cell (kanċer tad-demm rari li ħafna drabi huwa fatali);
English: 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: 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: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Maltese: • kanċer, inkluż kanċer li jaffetwa s-sistema limfatika (limfoma) u melanoma (tip ta' kanċer talġilda);
English: Pulmonary fibrosis1)
Maltese: Fibrożi tal-pulmun1)
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Maltese: Il-livelli fis-seru ta' metalloproteinases fil-matriċi (MMP-1 u MMP-3) li jipproduċu tibdil fit-tessuti li hu responsabbli għall-qerda tal-qarquċa, naqsu ukoll wara li ngħata adalimumab.
English: Hefiya 40 mg solution for injection in pre-filled syringe with needle guard EU/1/18/1287/001
Maltese: Hefiya 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bi protezzjoni tal-labra EU/1/18/1287/001
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Maltese: Studju HS-I (PIONEER I) evalwa 307 pazjenti b'żewġ perjodi ta' kura.
English: ANNEX II
Maltese: Tabella 24
English: placebo adalimumab 40 mg eow week 52
Maltese: plaċebo adalimumab 40 mg eow ġimgħa 52
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat tessuti konnettivi
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Maltese: 19.3 % tal-pazjenti kellhom bil-linja bażi terapija kontinwa ta' antibijotiċi orali matul l-istudju.
English: phase OL-LI 16 weeks ped ACR 30 response (n/N)
Maltese: OL-LI 16 il-ġimgħa ped ACR 30 rispons (n/N)
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.452.73) with RA and CD combined.
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: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' dożi multipli ta' adalimumab ġew stmati f'pazjenti adulti b'kolite ulċerattiva moderata sa severa (Punteġġ Mayo 6 sa 12; Sottopunteġġ 2 sa 3 bl-endoskopija) fi studji kkontrollati bi plaċebo, randomizzati u double-blind.
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: rispons PedAc 50 (EC50) kienet ta' 3 μg / ml (95% CI: 1 6 μg / ml).
English: How to store Hefiya
Maltese: Tużax Hefiya
English: Mean exposure in all adalimumab population was 762 days.
Maltese: L-esponiment medju fil-popolazzjoni kollha ta' adalimumab kien ta' 762 ġurnata.
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Adalimumab f'dawn il-pazjenti ġiet iddeterminata minn mudellar u simulazzjoni farmakokinetika (ara sezzjoni 5.2).
English: Adults with ulcerative colitis
Maltese: Adulti bil-kolite ulċerattiva
English: Hefiya 40 mg injection adalimumab SC
Maltese: Hefiya 40 mg injezzjoni adalimumab SC
English: 10 kg to < 30 kg ≥ 30 kg
Maltese: 10 kg sa < 30 kg ≥ 30 kg
English: • psoriatic arthritis,
Maltese: • artrite psorjatika,
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
Maltese: Tuberkulożi attiva jew infezzjonijiet oħra severi bħal sepsis, u infezzjonijiet opportunistiċi
English: Adults with non-infectious uveitis
Maltese: Adulti b'uveite mhux infettiva
English: Gastrointestinal disorders
Maltese: Emorraġija gastrointestinali,
English: Musculoskeletal pain
Maltese: Uġigħ muskolu-skeletriku
English: Hefiya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Maltese: Hefiya huwa intenzjonat għall-kura tal-marda Crohn (Crohn's disease) fl-adulti u fi tfal li għandhom bejn 6 sa 17-il sena.
English: • Hold your pen at 90 degrees to the cleaned injection site (see Figure G).
Maltese: • Żomm il-pinna tiegħek fi grad ta' 90 għas-sit ta' injezzjoni mnaddaf (ara Figura G).
English: At week 52, 42.9 % of patients who received adalimumab / methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Maltese: F'ġimgħa 52, 42.9 % tal-pazjenti li rċevew it-terapija kombinata ta' adalimumab / methotrexate laħqu titjib kliniku (DAS28 (CRP) < 2.6) meta pparagunati ma' 20.6 % tal-pazjenti li rċevew kura b'methotrexate waħdu bħala kura u 23.4% li rċevew adalimumab waħdu bħala kura.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: 15 kg to < 30 kg ≥ 30 kg
Maltese: 15 kg sa < 30 kg ≥ 30 kg
English: Rheumatoid arthritis
Maltese: Artrite rewmatika
English: • non-infectious uveitis.
Maltese: • uveite mhux infettiva.
English: Hefiya 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: Hefiya huwa indikat fil-kura ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'pazjenti adulti u adolexxenti minn 12-il sena b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjoni 5.1 u 5.2).
English: ASDAS inactive disease hs-CRPd,f,g
Maltese: ASDAS marda inattiva hs-CRPd,f,g SPARCCh MRI ġogi sacroiliacd,i
English: • fever;
Maltese: • fwawar;
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 għall-ACR 20; 127 pazjent (74.7%) kellhom rispons għall-ACR 50; u 102 pazjent (60.0%) kellhom rispons għall-ACR 70.
English: • Hefiya pre-filled SensoReady pen/s (see Figure A).
Maltese: • Hefiya pinna/pinen mimlija għal-lest SensoReady (ara Figura A).
English: 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: 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: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffetwaw sa persuna waħda minn kull 1,000):
English: • rheumatoid arthritis,
Maltese: • artrite rewmatika,
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Maltese: Studju RA IV evalwa primarjament is-sigurtà tal-prodott f'636 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 -il sena.
English: Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Maltese: Karċinoma taċ-ċelluli Merkel (karċinoma tal- ġilda newroendokrinika)1)
English: Usually, Hefiya is used with methotrexate.
Maltese: Ġeneralment, Hefiya jintuża ma' methotrexate.
English: o DO NOT USE the syringe (see Figure D).
Maltese: o TUŻAX is-siringa (ara Figura D).
English: Component of a multipack, cannot be sold separately.
Maltese: Il-komponent ta' pakkett multiplu ma jistax jinbiegħ separatament.
English: Check the green indicator fills the window (see Figure J):
Maltese: Iċċekkja li l-indikatur aħdar jimla t-tieqa (ara Figura J):
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 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Maltese: HS-I u HS-II, meta mqabbla ma' dawk fil-grupp adalimumab li kellhom aggravament ta' axxessi (23.0% vs 11.4%, rispettivament) u fistuli li jnixxu (30.0 % vs 13.9%, rispettivament).
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: Placebo
Maltese: plaċebo
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12 sa 17-il sena, li jiżnu 30kg jew aktar)
English: Hepatitis B reactivation
Maltese: Riattivazzjoni ta' Epatite B
English: Table 28 response, remission and mucosal healing in study UC-II (percent of patients)
Maltese: Tabella 28 rispons, titjib kliniku u fejqan tal-mukoża fi studju UC-II
English: Leukaemia1)
Maltese: Lewkemija1)
English: One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Maltese: Mitt pazjent (n = 100) mill-Istudju Pedjatriku CD komplew fi studju ta' estensjoni fit-tul u open-label.
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Maltese: • kura ta' artrite rewmatika attiva u progressiva severa f'adulti li ma jkunux ingħataw kura b'methotrexate qabel.
English: • stroke;
Maltese: • lewkemija;
English: Hefiya in combination with methotrexate, is indicated for:
Maltese: Hefiya, flimkien ma' methotrexate, huwa indikat għall-:
English: Renal and / or hepatic impairment
Maltese: Indeboliment renali u/jew epatiku
English: • urinary tract infection;
Maltese: • infezzjoni fis-sistema urinarja;
English: Figure J: check the green indicator
Maltese: Figura J: iċċekkja l-indikatur aħdar
English: Juvenile idiopathic arthritis (JIA)
Maltese: Artrite idjopatika taż-żgħażagħ (JIA)
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Maltese: adalimumab, it-tnejn b'EC50 apparenti simili ta' madwar 4.5 μg/mL (95% CI 0.4-47.6 u 1.9-10.5, rispettivament).
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Maltese: F'dawn is-suġġetti, ried ikun hemm falliment tat-terapija konvenzjonali (inkluż kortikosterojde u/jew immunomodulatur) għal CD.
English: Table 14 efficacy response in placebo-controlled study nr-axSpA I
Maltese: Risponsi ta' l-Effikaċja fi Studju kontrollat bil-Plaċebo nr-axSpA I
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 tal-kura kien definit minn eżitu multikomponent ibbażat fuq leżjonijiet infjammazzjoni korjoretinali u/jew infammazzjoni vaskulari tar-retina, grad taċ-ċelloli tal-kompartiment anterjuri (AC), grad taċ-ċpar vitriju (VH) u l-aqwa akutezza kkoreġuta tal-vista (BCVA).
English: ASAS partial remission BASDAIb 50
Maltese: ASAS titjib parzjali kliniku BASDAIb 50
English: Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Maltese: Minn 207 pazjenti, 81 pazjent komplew bi adalimumab 40 mg ġimgħa iva u ġimgħa le għal 10 snin.
English: • reproductive tract infections;
Maltese: • infezzjonijiet fis-sistema riproduttiva;