FrancophonIA/ELRC3.0 huggingface dataset:
English: Revlimid was also expected to be used for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with Revlimid, melphalan, and prednisone (other medicines to treat multiple myeloma), or following autologous stem cell transplant (a transplant of the patient's own blood-producing cells).
Maltese: Revlimid kien mistenni li jintuża wkoll għat-trattament ta' manutenzjoni ta' pazjenti b'majeloma multipla li tkun għadha kif ġiet djanjostikata u li ma għamlux progress wara trattament inizjali b'Revlimid, melphalan, u prednisone (mediċini oħrajn użati biex jittrattaw majeloma multipla), jew wara trapjant awtologu taċ-ċelluli staminali (trapjant taċ-ċelluli li jipproduċu d-demm tal-pazjent stess).
English: On 20 June 2012, Celgene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Revlimid, to extend its use to the treatment of patients with newly diagnosed multiple myeloma.
Maltese: Fl-20 ta' Ġunju 2012, Celgene Europe Ltd. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għal bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għal Revlimid, biex jestendi l-użu tiegħu għat-trattament ta' pazjenti b'majeloma multipla li tkun għadha kif ġiet djanjostikata.
English: Lenalidomide works in a number of different ways in multiple myeloma: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells.
Maltese: Lenalidomide taħdem b'numru ta' modi differenti fil-majeloma multipla: timblokka l-iżvilupp ta' ċelluli ta' tumur, tipprevjeni t-tkabbir ta' vini tad-demm fi ħdan tumuri u tistimola wkoll uħud miċ-ċelluli speċjalizzati tas-sistema immuni sabiex jattakkaw iċ-ċelluli tal-kanċer.
English: Revlimid has been authorised in the European Union (EU) since 14 June 2007 and is marketed in 21 EU Member States1.
Maltese: Revlimid ġie awtorizzat fl-Unjoni Ewropea (UE) sa mill-14 ta' Ġunju 2007 u huwa mqiegħed fis-suq f'21 Stat Membru tal-UE1.
English: Revlimid is an anticancer medicine.
Maltese: Revlimid huwa mediċina għal kontra l-kanċer.
English: Furthermore, since Revlimid was associated with an increased risk of developing new cancers, the CHMP could not rule out that the lack of a longer survival could be due to death caused by new cancers.
Maltese: Barra minn hekk, peress li Revlimid kien assoċjat ma' riskju miżjud ta' żvilupp ta' kanċers ġodda, is-CHMP ma setax jelimina kompletament il-possibilità li nuqqas ta' sopravvivenza itwal seta' jkun dovut għal mewt ikkaġunat minn kanċers ġodda.
English: What was Revlimid expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Revlimid?
English: In the first study, patients were given melphalan and prednisone together with either Revlimid or placebo (a dummy treatment) during an initial phase, followed by a maintenance phase where patients received Revlimid or placebo.
Maltese: Fl-ewwel studju, il-pazjenti ngħataw melphalan u prednisone flimkien ma' Revlimid jew plaċebo (trattament finta) matul fażi inizjali, segwiti minn fażi ta' manutenzjoni li fiha l-pazjenti rċivew Revlimid jew plaċebo.
English: The Committee was concerned that, while there was a clear benefit in terms of delaying the progression of the disease in newly diagnosed multiple myeloma patients, this did not lead to a meaningful improvement of symptoms and longer survival.
Maltese: Il-Kumitat tħasseb li, filwaqt li kien hemm benefiċċju ċar f'termini ta' ttardjar tal-progressjoni talmarda f'pazjenti b'majeloma multipla li tkun għadha kif ġiet djanjostikata, dan ma wassalx għal titjib notevoli fis-sintomi u sopravvivenza itwal.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Maltese: Wara li s-CHMP evalwa t-tweġibiet tal-kumpanija għall-mistoqsijiet, kien għad hemm xi problemi mhux solvuti.
English: It is used in combination with dexamethasone (an antiinflammatory medicine) to treat adults with multiple myeloma whose disease has been treated at least once in the past (second-line treatment).
Maltese: Jintuża flimkien ma' dexamethasone (mediċina antiinfjammatorja) biex jittratta adulti b'majeloma multipla li l-marda tagħhom tkun ġiet ittrattata talinqas darba fl-imgħoddi (trattament tat-tieni linja). Majeloma multipla huwa kanċer taċ-ċelluli talplażma fil-mudullun tal-għadam.
English: The company informed the CHMP that clinical trials or compassionate use programmes will not be interrupted and patients will continue to be carefully monitored with respect to overall survival and development of new cancers.
Maltese: X'inhuma l-konsegwenzi ta' dan l-irtirar għall-pazjenti fi provi kliniċi jew fi programmi ta' użu b'kompassjoni?
English: • impotence.
Maltese: • impotenza.
English: CI 95% for HRa
Maltese: CI 95% għall-HRa
English: AndersonBrecon (UK) Limited Units 2-7
Maltese: AndersonBrecon (UK) Limited Unitajiet 2-7
English: • Stevens-Johnson syndrome;
Maltese: • sindrome ta' Stevens-Johnson;
English: ASDAS Inactive Disease hs-CRPd,f,g
Maltese: ASDAS Marda Inattiva hs-CRPd, f, g
English: 61352 Bad Homburg v. d. Höhe Germany
Maltese: 61352 Bad Homburg v. d. Höhe Il-Ġermanja
English: Analysis Treatment
Maltese: Analizi Trattament
English: Tuberculosis (TB)
Maltese: Tuberkulosi (TB)
English: 0.8 ml
Maltese: INDIVIDWALI 0.8 mL
English: Rhabdomyolysis, systemic lupus erythematosus
Maltese: Rabdomijolożi, lupus erythematosus sistemiku
English: Step 8
Maltese: Pass 8
English: Hulio is a biosimilar medicinal product.
Maltese: Hulio huwa prodott mediċinali biosimili.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Hulio jiġi injettat taħt il-ġilda (b'injezzjoni għal taħt il-ġilda).
English: Step 7 - Inject Hulio
Maltese: Pass 7 - Injetta Hulio
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Maltese: 79 (73.1)a, b a p<0.001 adalimumab vs. plaċebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. plaċebo d p<0.05 adalimumab vs. methotrexate
English: 13 to 17 years
Maltese: 13 sa 17-il sena
English: PGA-F clear/minimal and ≥2-grade improvement (%)
Maltese: PGA-F xejn/minimali u titjib ta' ≥2 gradi (%)
English: 4 to 7 years
Maltese: 4 sa 7 snin
English: Hidradenitis Suppurativa Clinical Response (HiSCR)a
Maltese: Rispons Kliniku ta' Hidradenitis Suppurativa (HiSCR)a
English: Sarcoidosis1), vasculitis
Maltese: Sarkojdożi1), vaskulite
English: • A 2nd “CLICK” is heard,
Maltese: • Tinstema' t-tieni “KLIKK”,
English: Hulio contains sodium and sorbitol
Maltese: Hulio fih sodium u sorbitol
English: • 1 vial adapter (2)
Maltese: • adapter 1 tal-kunjett (2)
English: fungal infections, joint infections);
Maltese: infezzjonijiet fungali, infezzjonijiet fil-ġogi);
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Maltese: Studju HS-II (PIONEER II) evalwa 326 pazjent b'2 perjodi ta' trattament.
English: Multipack containing 2 (2 packs of 1) vials.
Maltese: Pakkett multiplu b'2 kunjetti (2 pakketti ta' 1).
English: Efficacy Outcomes Double Blind 32 weeks Adalimumab /MTX (N = 38)
Maltese: Riżultati tal-Effikaċja Double-Blind 32 ġimgħa Adalimumab/MTX (N=38)
English: Placebo (treatment withdrawal) N = 73
Maltese: Plaċebo (trattament irtirat) N=73
English: INFORMATION IN BRAILLE Hulio 40 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Hulio 40 mg
English: Also contains: monosodium glutumate, sorbitol (E420), methionine, polysorbate 80, hydrochloric acid and water for injections.
Maltese: Fih ukoll: monosodium glutumate, sorbitol (E420), methionine, polysorbate 80, hydrochloric acid u ilma għall-injezzjonijiet.
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Maltese: Emorraġija gastrointestinali, dispepsja, mard ta' rifluss gastro-intestinali, sindrome sikka
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1), lichenoid skin reaction1)
Maltese: Eritema multiforme1), Sindrome ta' Stevens-Johnson1), anġjoedema1), vaskulite tal-ġilda1), reazzjoni tal-lichenoid fil-ġilda1)
English: Adalimumab /MTX n=268 (95% confidence interval)
Maltese: Adalimumab/MTX n=268 (95% intervall ta' kunfidenza)
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: • 2 alcohol pads (4)
Maltese: • 2 tajjariet bl-alkoħol (4)
English: Double-Blind Response at week 12
Maltese: Double-Blind Rispons f'Ġimgħa 12
English: NA 9.5% 41.5%
Maltese: MA MA MA 9.5% 41.5%
English: Adalimumab n=274 confidence interval)
Maltese: Adalimumab n=274 intervall ta' kunfidenza)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 Settembru 2018
English: SPARCCh MRI Sacroiliac Jointsd,i
Maltese: SPARCCh MRI Ġogi Sacroiliacd,
English: NA 24.0% 58.9%
Maltese: MA MA MA 24.0% 58.9%
English: a a a p<0.001, adalimumab vs. placebo
Maltese: 001, adalimumab vs. plaċebo
English: Placebo / MTX (N = 37)
Maltese: Plaċebo/MTX (N=37)
English: INFORMATION IN BRAILLE Hulio 40 mg/0.8 ml
Maltese: INFORMAZZJONI BIL-BRAILLE Hulio 40 mg/0.8 mL
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Maltese: Anewriżma tal-aorta, okklużjoni arterjali vaskulari, tromboflebite
English: Pack sizes of:
Maltese: Daqsijiet tal-pakketti ta':
English: Week 104 42.8% 36.9%
Maltese: Ġimgħa 104 42.8% 36.9%
English: 15 kg to < 30 kg
Maltese: 15 kg sa <30 kg
English: The active ingredient in Hulio, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Hulio, adalimumab, hija antikorp monoklonali.
English: Placebo/MTXAdalimumab /MTX (95% Confidence Intervalb)
Maltese: Plaċebo/MTXAdalimumab/MTX (95% Intervall ta' Kunfidenzab)
English: Leukopenia (including neutropenia and agranulocytosis), anaemia
Maltese: Lewkopenija (li tinkludi newtropenja u agranuloċitożi), anemija
English: 10 kg to < 30 kg
Maltese: 10 kg sa <30 kg
English: Week 52 62.6% 54.4%
Maltese: Ġimgħa 52 62.6% 54.4%
English: • 1 syringe (1)
Maltese: • siringa 1 (1)
English: Total Sharp
Maltese: Punteġġ Totali Sharp
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Maltese: Studju HS-I (PIONEER I) evalwa 307 pazjenti b'2 perjodi ta' trattament.
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: Ilkonċentrazzjoni apparenti ta' adalimumab fil-plażma li tipproduċi nofs il-probabbiltà massima ta' rispons Ped ACR 50 (EC50) kienet ta' 3 µg/mL (95% CI: 1 - 6 µg/mL).
English: Placebo (N = 28)
Maltese: Plaċebo (N=28)
English: Note: P = Placebo (Number at Risk); H = adalimumab (Number at Risk).
Maltese: Nota: P = Plaċebo (Numru f'Riskju); H = adalimumab (Numru f'Riskju)
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 tat-trattament f'pazjenti bi psorjasi tad-dwiefer bi gradi differenti ta' involvement tal-ġilda (BSA≥10% (60% tal-pazjenti) u BSA<10% u ≥5% (40% talpazjenti)).
English: EU/1/18/1319/001 1 pack EU/1/18/1319/002 2 pack EU/1/18/1319/003 6 pack
Maltese: EU/1/18/1319/004 1 pakkett EU/1/18/1319/005 2 pakketti EU/1/18/1319/006 6 pakketti
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 b'mod statistikament sinifikanti 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: urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhydrosis, alopecia 1),
Maltese: urtikarja, tbenġil (li jinkludi purpura), dermatite (li tinkludi l ekżema), onikoklasi, iperidrożi, alopeċja1),
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Maltese: Limfoma**, neoplażmi fl-organi solidi (li jinkludu kanċer tassider, neoplażma fil-pulmun u neoplażma fittirojde), melanoma**
English: Medication Orange Indicator
Maltese: Indikatur Oranġjo
English: • cancer of the lymph system (lymphoma);
Maltese: • kanċer fis-sistema limfatika (limfoma);
English: Hepatitis, reactivation of hepatitis B1), autoimmune hepatitis1)
Maltese: Epatite, attivazzjoni mill-ġdid ta' epatite B1), epatite awtoimmuni1)
English: Hydrochloric acid (for pH-adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)
English: It may harm them, even if their signs of illness are the same as your child's.
Maltese: Hulio jiġi injettat taħt il-ġilda (injezzjoni għal taħt il-ġilda).
English: [Text displayed on the tray inside the box:] Hulio
Maltese: [Test muri fuq it-trej ġewwa l-kaxxa:] Hulio
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: • 1 vial of Hulio solution (3)
Maltese: • kunjett 1 b'soluzzjoni ta' Hulio (3)
English: Week 52 45.9% 41.2%
Maltese: Ġimgħa 52 45.9% 41.2%
English: 1 sterile vial adapter 2 alcohol pads
Maltese: 1 adapter sterili tal-kunjett 2 tajjariet bl-alkoħol
English: Usually, Hulio is used with methotrexate.
Maltese: Ġeneralment, Hulio jintuża ma' methotrexate.
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: PASI 75 u PGA xejn jew minimali żdiedu b'konċentrazzjonijiet jiżdiedu ta' 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: Placebo / MTXc n=200
Maltese: Plaċebo/ MTXc n=200
English: Week 104 56.0% 49.3%
Maltese: Ġimgħa 104 56.0% 49.3%
English: 8 to 12 years
Maltese: 8 sa 12-il sena
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Maltese: Emboliżmu pulmonari1), mard interstizjali tal-pulmun, mard kroniku ta' imblukkar fil-pulmun, pulmonite, effużjoni plerali1)
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: * aktar informazzjoni tinsab f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8 ** inklużi studji ta' estensjoni open-label 1) inkluża dejta minn rappurtar spontanju
English: • Orange Indicator has stopped and completely blocked the Viewing Window.
Maltese: • l-Indikatur Oranġjo waqaf u mblokka t-Tieqa tal-Ispezzjoni kompletament.
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Maltese: Fażi OL-LI 16-il ġimgħa Rispons Ped ACR 30 (n/N)
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Maltese: Aggravar jew bidu ta' psorjasi (li jinkludu psorjasi tat-tip palmoplantar pustulari)1),
English: Nervous system disorders*
Maltese: Disturbi fis- sistema nervuża*
English: 1 sterile injection syringe 1 sterile needle
Maltese: 1 siringa sterili għall-injezzjoni 1 labra sterili
English: Each vial contains 38.2 mg sorbitol (E420).
Maltese: Kull kunjett fih 38.2 mg sorbitol (E420).
English: Week 52 27.2% 25.9%
Maltese: Ġimgħa 52 27.2% 25.
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: PASI 75b 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: 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, kandidjażi u influwenza), infezzjonijiet intestinali (li jinkludu virus talgastroenterite), infezzjonijiet tal-ġilda u fit-tessuti rotob tal-ġilda (li jinkludu paronkija, ċellulite, impetiġini, faxxite nekrotika u herpes zoster), infezzjonijiet fil-widnejn, infezzjonijiet fil-ħalq (li jinkludu herpes simplex, herpes orali u infezzjonijiet tas-snien), infezzjonijiet fis-sistema riproduttiva (li jinkludu infezzjoni mikotika vulvavaġinali), infezzjonijiet fis-sistema urinarja (li jinkludi pjelonefrite), infezzjonijiet tal-fungu, infezzjonijiet fil-ġogi
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome) 1)
Maltese: Sklerożi multipla, disturbi li jaffettwaw il-myelin (eż. newrite flgħajnejn, sindrome ta' Guillain-Barré)1)
English: Chest pain, oedema, pyrexia1)
Maltese: Uġigħ fis-sider, edima, deni1)
English: Table 19: Ps Study IV Efficacy Results at 16, 26 and 52 weeks
Maltese: Studju tal-Ps IV Riżultati tal-Effikaċja f'Ġimgħa 16, 26 u 52
English: Table 15: Ps Study II (CHAMPION) Efficacy Results at 16 weeks Placebo N=53 n (%)
Maltese: Studju tal-Ps II (CHAMPION) Riżultati tal-Effikaċja f'Ġimgħa 16 Plaċebo N=53 n (%)
English: Step 7 - Begin injection Step 8 - Hold down for 2nd “CLICK” & 10 seconds
Maltese: Pass 7 - Ibda l-injezzjoni Pass 8 - Żomm 'l isfel sat-tieni “KLIKK” u għal 10 sekondi
English: Table 28: Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients) Placebo
Maltese: Tabella 28: Rispons, Titjib Kliniku u Fejqan Mukosali fi Studju UC-II (Perċentwali ta' Pazjenti) Plaċebo
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 ta' l-organu u lfrekwenza 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 mill-informazzjoni eżistenti).
English: • 1 alcohol swab
Maltese: • tajjara 1 bl-alkoħol
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: * P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients.
Maltese: * P<0.05, ***P<0.001, adalimumab kontra plaċebo a Fost il-pazjenti kollha magħżula b'mod każwali.
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-serum 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: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Maltese: Studju PsA II li dam 12-il ġimgħa, tratta 100 pazjent li kellhom rispons inadegwat għat-terapija DMARD.
English: c Based on rank analysis d Joint Space Narrowing
Maltese: c Ibbażat fuq analiżi tar-rank d Tnaqqis fl-Ispazju fil-Ġogi (JSN, Joint Space Narrowing)
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: T1) Karċinoma taċ-ċelluli Merkel (karċinoma tal-ġilda newroendokrinika)1)
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 b'adalimumab fl-adulti li damu sejrin mill-inqas 12-il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), spondiloartrite assjali mingħajr evidenza radjografika ta' AS, artrite psorijatika, psorjasi, hidradenitis suppurativa, marda ta' Crohn (Crohn's disease), kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' kunfidenza) 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 ta' kontroll (il-medja tat-tul tal-kura kienet ta' 4.0 xhur għal adalimumab u 3.8 xhur għal pazjenti mogħtija kura bis-sustanza ta' kontroll).
English: Week 24 BASDAIb 50
Maltese: BASDAIb 50
English: • acidity/acid reflux;
Maltese: • aċidità/rifluss tal-aċidu;
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 wkoll ir-risponsi bijoloġiċi li jiġu kkawżati jew regolati mit-TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma responsabbli għall-migrazzjoni tal-lewkoċiti (ELAM-1, VCAM-1, u ICAM-1 b'IC50 ta' 0.1 - 0.2 nM).
English: Week 16 Placebo-Controlled
Maltese: Ġimgħa 16 Ikkontrollat bi Plaċebo
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) 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: 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 prednisone (≤0.2 mg/kg/ġurnata jew massimu ta' 10 mg/ġurnata).
English: ASAS Partial Remission BASDAIb 50
Maltese: ASAS Titjib Parzjali Kliniku BASDAIb 50