FrancophonIA/ELRC3.0 huggingface dataset:
English: Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Maltese: Fost pazjenti b'evalwazzjoni tal-uġigħ fil-ġilda relatat ma' HS fil-linja bażi ta' ≥ 3, ibbażat fuq Skala ta'Klassifikazzjoni Numerika 0 - 10; 0 = l-ebda uġigħ fil-ġilda, 10 = l-agħar uġigħ fil-ġilda li tista' timmaġina.
English: In controlled Phase 3 trials of adalimumab in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks, ALT elevations ≥ 3 x ULN occurred in 0.9 % of adalimumabtreated patients and 0.9 % of controlled-treated patients.
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti bil-marda ta' Crohn u kolite ulċerattiva fejn il-pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 52 ġimgħa, kien hemm żidiet fl-ALT ta' ≥ 3 x ULN f'0.9 % tal-pazjenti ttrattati b'adalimumab u f'0.9 % tal-pazjenti ttrattati bil-kontroll.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Maltese: Huwa maħsub li Psorajisi tiġi kkawżata minn problema fis-sistema immuni tal-ġisem li twassal għal produzzjoni akbar ta' ċelluli tal-ġilda.
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Maltese: Ankylosing spondylitis, axial spondyloarthritis mingħajr evidenza radjografika ta' AS u artrite psorjatika
English: In Psoriasis Study I, 28 % of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5 % continuing on adalimumab, p < 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Maltese: Fl-Istudju I tal-Psorjasi, 28% tal-pazjenti li kellhom rispons tal-PASI ta' 75 u li reġgħu kienu randomised għal plaċebo f'ġimgħa 33 meta mqabbla ma' 5% li komplew jirċievu adalimumab,
English: Liver failure
Maltese: Analiżi Trattament N Falliment
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Cyltezo.
Maltese: Jista' jkun hemm sensazzjoni li l-kamra qed iddur bik (sturdament) u disturbi fil-vista wara li tingħata Cyltezo.
English: • 6 pre-filled pens (0.8 mL sterile solution), each in a blister, with 6 alcohol pads.
Maltese: • 6 pinen mimlija għal-lest (0.8 mL ta' soluzzjoni sterili), kull waħda f'folja b'6 imsielaħ bl alkoħol.
English: Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Maltese: Hidradenitis suppurativa (xi kultant imsejħa akne inversa) hija marda kronika fil-ġilda u spiss bluġigħ.
English: Vertigo Deafness, tinnitus
Maltese: Jekk tinsa tuża Cyltezo
English: Seventy-nine (20.1 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4 %) patients with glucocorticoids.
Maltese: 1%) pazjent ġew ittrattati fl-istess waqt b'mediċini anti-rewmatiċi li jaffettwaw il-proċess tal-marda, u 37 (9.4%) pazjent bi glukokortikojdi.
English: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Maltese: Rispons ACR fi Studji tal-Artrite Psorjatika kkontrollata bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Maltese: Mill-417 is-suġġett inklużi fl-estensjoni mhux ikkontrollata fit-tul tal-Istudji UV I u UV II, 46 individwu kienu meqjusa ineliġibbli (eż. Kumplikazzjonijiet żviluppati sekondarji għal retinopatija dijabetika, minħabba kirurġija tal-katarretti jew vitrectomy) u kienu esklużi mill-analiżi primarja taleffikaċja.
English: • The following instructions explain how to give yourself a subcutaneous injection of CYLTEZO using the pre-filled syringe.
Maltese: • Tippruvax terġa' tuża pinna Cyltezo użata.
English: Call your
Maltese: Sími:
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Maltese: Fi studju RA IV, ir-rispons tal-ACR 20 ta' pazjenti ttrattati b'adalimumab flimkien ma' standard ta' kura, kien statistikament aħjar b'mod sinifikanti f'dawn il-pazjenti, milli kien f'pazjenti ttrattati bilplaċebo flimkien ma' standard ta' kura (p < 0.001).
English: Maintenance of remission and response rates are presented in Table 24.
Maltese: Lista ta' reazzjonijiet avversi f'tabella
English: Results from the Short Form Health Survey (SF 36) for all doses/schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Maltese: Riżultati tal-Istħarriġ tas-Saħħa fil-Forma l-Qasira (SF 36 - Short Form 36) għad-dożi/skedi kollha ta' adalimumab fl-erba' studji kollha, jsostnu dawn is-sejbiet, b'punteġġi tas-sommarju dwar il-komponent fiżiku (PCS - physical component summary) li huma statistikament sinifikanti, kif ukoll punteġġi tad-dominju tal-uġigħ u l-vitalita li huma statistikament sinifikanti għad-doża ta' 40 mg ġimgħa iva u ġimgħa le.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12-il sena, li jiżnu mill-anqas 30 kg)
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Maltese: Dawn il-provi inkludew pazjenti li jbatu minn artrite rewmatika, kemm dawk li ma jkunux ilhom kif ukoll dawk li jkunu ilhom bil-marda, artrite idjopatika taż-żagħżagħ (artrite idjopatika poliartikulari taż-żagħżagħ u artrite relatata mal-entesite) kif ukoll pazjenti li jbatu minn axial spondyloarthritis (ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' AS), minn artrite psorjatika, mill-marda ta' Crohn, minn kolite ulċerattiva, millpsorjasi, minn hidradenitis suppurativa u minn uveite.
English: • 4 pre-filled pens (0.8 mL sterile solution), each in a blister, with 4 alcohol pads.
Maltese: • 4 pinen mimlija għal-lest (0.8 mL ta' soluzzjoni sterili), kull waħda f'folja b'4 imsielaħ bl alkoħol.
English: Sarcoidosis vasculitis
Maltese: Effetti Newroloġiċi
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3 % and at week 96 was 65.1 %.
Maltese: Fost pazjenti li kellhom mill-inqas rispons parzjali f'ġimgħa 12, u li rċevew terapija kontinwa b'adalimumab kull ġimgħa, ir-rata ta' HiSCR f'ġimgħa 48 kienet ta' 68.3%, u f'ġimgħa 96 kienet ta' 65.1%.
English: One 0.8 mL pre-filled pen contains 40 mg adalimumab.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pinna waħda ta' 0.8 mL mimlija għal-lest fiha 40 mg adalimumab.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9 %) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Maltese: Fost is-68 pazjent li kellhom flare fil-grupp allokat għal irtirar ta' trattament, 65 kkompletaw 12-il ġimgħa ta' terapija ta' salvataġġ b'adalimumab, li minnhom 37 (56.9%) reġgħu kisbu remissjoni (ASDAS < 1.3) wara 12-il ġimgħa li reġgħu jibdew it-trattament open-label.
English: Cyltezo is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Maltese: Cyltezo huwa indikat għat-trattament ta' adulti li jbatu minn infjammazzjoni tal-vertebra li tirriżulta fil-vertebra jitwaħħlu flimkien (ankylosing spondylitis) severa u attiva, li ma kellhomx rispons adegwat meta ngħataw terapija konvenzjonali.
English: • new onset or worsening of psoriasis;
Maltese: • bidu jew aggravar ta' psorjasi;
English: Crohn's disease is an inflammatory disease of the digestive tract.
Maltese: Crohn's Disease Activity Index) ta' > 30.
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during adalimumab 40 mg every other week monotherapy treatment.
Maltese: F'pazjenti adulti li jbatu mill-psorjasi, il-konċentrazzjoni minima medja fi stat fiss kienet ta' 5 µg/mL meta kien qed jingħata trattament b'adalimumab waħdu b'doża ta' 40 mg ġimgħa iva u ġimgħa le.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis Study III).
Maltese: Issigurtà u l-effikaċja ta' adalimumab ġew studjati wkoll f'pazjenti adulti li jbatu minn Psorjasi kronika moderata sa severa li tikkawża qoxra mhux normali fuq il-ġilda u psorjasi fl-idejn u/jew fis-saqajn fl istess ħin li kienu kandidati għat-terapija sistemika fl-istudju double-blind u randomised (Studju talPsorjasi III).
English: Double-Blind Response at Week 12
Maltese: ‘Double-Blind' Rispons fil-Ġimgħa 68
English: • 6 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 6 alcohol pads.
Maltese: • 6 siringi mimlija għal-lest (0.8 mL ta' soluzzjoni sterili) kull waħda f'folja, b'6 imsielaħ blalkoħol.
English: Cyltezo 40 mg solution for injection in pre-filled pen Each 0.8 mL single dose pre-filled pen contains 40 mg of adalimumab.
Maltese: U KWANTITATTIVA Cyltezo 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest b'doża waħda ta' 0.8 mL fiha 40 mg adalimumab.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of
Maltese: Dożi stabbli ta' aminosalicylates, kortikosterojdi, u/jew sustanzi immunomodulatorji mittieħda fl-istess waqt, kienu permessi u 80% tal-pazjenti komplew jirċievu mill-inqas waħda minn dawn il-mediċini.
English: • abnormal muscle breakdown;
Maltese: • spażmi fil-muskoli;
English: Your doctor may recommend temporary discontinuation of Cyltezo.
Maltese: Mediċini oħra u Cyltezo
English: Cyltezo is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: Cyltezo huwa indikat għat-trattament tal-marda ta' Crohn attiva b'mod moderat sa sever fit-tfal (minn 6 snin 'il fuq) li ma kellhomx rispons adegwat għal terapija konvenzjonali inkluż terapija primarja ta' nutrizzjoni u kortikosterojd u/jew immunomodulatur, jew li ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: • Inspect Cyltezo pre-filled syringe, medication, and expiration date.
Maltese: • Eżamina s-siringa mimlija għal-lest ta' Cyltezo, il-mediċina, u d-data ta' meta tiskadi.
English: Portugal
Maltese: France
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see 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: Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
Maltese: Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Maltese: Minn dawn, 48 pazjent ma wrew l-ebda progress ta' ħsara strutturali definita mill-bidla mill-linja bażi fl-mTSS li kienet ta' 0.5 jew inqas.
English: Subjects (n = 215, 54.7 %) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Maltese: (n = 215, 54.7%) li ma laħqux l-ASAS 20 f'ġimgħat 12, jew 16 jew 20 irċevew 40 mg adalimumab ħruġ kmieni open-label taħt il-ġilda ġimgħa iva u ġimgħa le, u kienu sussegwentament trattati bħala pazjenti li ma jirrispondux fl-analiżi statistika double- blind.
English: Plaque psoriasis in adults and children
Maltese: Psorjasi tal-plakka fl-adulti u fit-tfal
English: Clinical remission Clinical response (CR-100)
Maltese: Iż-Żamma tar-Remissjoni Klinika u tar-Rispons (Persentaġġ ta' Pazjenti)
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Maltese: F'ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti ttrattati b'adalimumab kontra l-plaċebo kisbu HiSCR.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Maltese: Artrite idjopatika poliartikulari taż-żagħżagħ u artrite relatata mal-entesite
English: The needle cover of the syringe contains natural rubber (latex).
Maltese: Il-parti ta' ġewwa tal-għatu (l-għatu tal-labra) tas-siringa fih gomma naturali (latex).
English: Intestinal perforation
Maltese: Immunoġeniċità
English: Children and adolescents with plaque psoriasis
Maltese: Tfal u adolexxenti bi psorjasi
English: There is limited experience in the initiation of treatment with adalimumab alone.
Maltese: Hemm esperjenza limitata fil-bidu tattrattament b'adalimumab waħdu.
English: • 4 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 4 alcohol pads.
Maltese: • 4 siringi mimlija għal-lest (0.8 mL ta' soluzzjoni sterili) kull waħda f'folja, b'4 imsielaħ blalkoħol.
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients
Maltese: L-ebda tumuri malinni ma ġew osservati f'60 pazjent pedjatriku b'espożizzjoni ta' 58.4 snin ta' pazjenti waqt prova ta' adalimumab f'pazjenti pedjatriċi b'uveite.
English: Figure 1:
Maltese: Figura 2: Kurvi
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated
Maltese: Il-proporzjon ta' pazjenti li waqt il-porzjon ikkontrollat double-blind fl-istudji pivitali ma baqgħux jieħdu t-trttament minħabba effetti avversi kien ta' 5.9 % għall-pazjenti li kienu qegħdin jieħdu adalimumab u 5.4 % għall-pazjenti trattati bil-kontroll.
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Maltese: Studju PsA I li dam 24 ġimgħa, ittratta 313-il pazjent adult li kellhom rispons mhux adegwat għal terapija b'mediċina anti-infjammatorja mhux sterojda, u minn dawn, bejn wieħed u ieħor 50% kienu qegħdin jieħdu methotrexate.
English: The recommended dose of Cyltezo is an initial dose of 40 mg, followed by 40 mg one week later.
Maltese: Id-doża ta' Cyltezo normalment hija 40 mg ġimgħa iva u ġimgħa le b'methotrexate.
English: Rash (including exfoliative rash)
Maltese: Raxx (li jinkludi raxx li jqaxxar il-ġilda),
English: Psoriasis Study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Maltese: Fl-Istudju tal-Psorjasi III (REACH), l-effikaċja u s-sigurtà ta' adalimumab kienu kkumparati malplaċebo f'72 pazjent bi psorjasi kronika li tikkawża qoxra mhux normali fuq il-ġilda moderata sa severa u psorjasi fl-idejn u/jew fis-saqajn.
English: Hypertension, flushing, haematoma
Maltese: Disturbi respiratorji, toraċiċi u medjastinali*
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Maltese: Fi prova klinika esploratorja li evalwat l-użu ta' antagonist ieħor ta' TNF, infliximab, f'pazjenti li jbatu minn mard kroniku ostruttiv tal-pulmun (COPD - chronic obstructive pulmonary disease), minn moderata sa severa, ġew irrappurtati aktar tumuri malinni, l-aktar fil-pulmun, jew fir-ras u l-għonq, f'pazjenti ttrattati b'infliximab meta pparagunati ma' pazjenti ta' kontroll.
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is
Maltese: F'pazjenti li jkollhom test pożittiv għal infezzjoni ta' epatite B, huwa rakkomandat li jkun hemm konsultazzjoni ma tabib espert fit-trattament tal-epatite B.
English: After 12 weeks of therapy, patients who had received adalimumab in Period A were re-randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Maltese: Wara 12-il ġimgħa ta' terapija, il-pazjenti li kienu rċevew adalimumab f'Perjodu A reġgħu kienu randomised f'Perjodu B għal 1 minn 3 gruppi ta' trattament (adalimumab 40 mg kull ġimgħa, adalimumab 40 mg ġimgħa iva u ġimgħa le, jew plaċebo minn ġimgħa 12 sa ġimgħa 35).
English: Week 16 Placebo-Controlled
Maltese: 16 il-Ġimgħa Ikkontrollat bi Plaċebo
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n = 27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Maltese: (n = 27 minn 30 pazjent), ir-rispons Pedjatriku tal-ACR 30 kien miżmum sa 60 ġimgħa fil-fażi
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Maltese: Fl-estensjoni open-label għal studju RA V, rati ta' rispons tal-ACR ġew miżmuma meta kienu segwiti sa 10 snin.
English: Österreich
Maltese: España
English: Alcohol wipe
Maltese: Fejqan tal-Mukoża
English: By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Maltese: Sal-Ġimgħa 68, pazjenti li kienu qed jirċievu trattament kontinwa b'adalimumab urew titjib statistikament sinifikanti akbar tas-sinjali u s-sintomi ta' nr-axSpA meta mqabbla ma' pazjenti allokati għal irtirar ta' trattament matul il-perjodu double-blind tal-istudju (Tabella 15).
English: The recommended Cyltezo induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Maltese: Il-kors ta' dożaġġ ta' induzzjoni rakkomandat għal Cyltezo għall-pazjenti adulti li jbatu mill-marda ta' Crohn attiva b'mod moderat sa severa, huwa ta' 80 mg f'ġimgħa 0 segwit b'40 mg f'ġimgħa 2.
English: Amongst those who responded at week 16 (n = 144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Maltese: Fost dawk li rrispondew f'ġimgħa 16 (n = 144), ir-rispons Pedjatriku tal-ACR 30/50/70/90 kien miżmum sa sitt snin fil-fażi
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Maltese: Meta wieħed jgħaqqad il-porzjonijiet ikkontrollati ta' dawn il-provi u l-istudji ta' estensjoni open-label li ġew kompluti u dawk li għadhom sejrin bħalissa ma' tul medjan ta' bejn wieħed u ieħor 3.3 snin, li jinkludu 6,427 pazjent u aktar minn 26,439 sena ta' pazjent ta' terapija, ir-rata ta' tumuri malinni osservata, minbarra limfoma u kanċer tal-ġilda li mhux melanoma, hija ta' bejn wieħed u ieħor 8.5 kull 1000 sena ta' pazjent.
English: In Period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Maltese: F'Perjodu A, pazjenti rċevew plaċebo jew adalimumab b'doża inizjali ta' 160 mg f'ġimgħa 0, 80 mg f'ġimgħa 2, u 40 mg kull ġimgħa li tibda f'ġimgħa 4 sa ġimgħa 11.
English: • haematoma (a solid sweling with clotted blood);
Maltese: • melanoma (tip ta' kanċer tal-ġilda);
English: 40 mg Adalimumab every week
Maltese: 40 mg Adalimumab kull ġimgħa
English: Corticosteroid taper was permitted after week 8.
Maltese: It-tnaqqis tal-kortikosterojd ftit ftit sakemm jitwaqqaf totalment, kien permess wara ġimgħa 8.
English: Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Maltese: L-għoti ta' adalimumab flimkien ma' DMARDS bijoloġiċi oħra (eż., anakinra u abatacept) jew antagonisti ta' TNF oħra, mhux rakkomandat fuq bażi ta' żieda possibli fir-riskju ta' infezzjonijiet, inkluż infezzjonijiet serji u interazzjonijiet farmakoloġiċi potenzjali oħra.
English: There is limited safety experience of surgical procedures in patients treated with adalimumab.
Maltese: L-esperjenza ta' sigurtà ta' proċeduri kirurġiċi f'pazjenti ttrattati b'adalimumab hija limitata.
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Maltese: Ir-riżultati ta' remissjoni klinika baqgħu relattivament kostanti, irrispettivament minn esponimenti għal antagonist ta' TNF li kien hemm fil-passat.
English: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Maltese: III u V kellhom punt finali primarju addizzjonali ta' ittardjar tal-progress tal-marda (kif jidher mir-riżultati tal-X-rays).
English: Dose interruption
Maltese: Disturbi vaskulari
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Maltese: Minn dawn, 40 pazjent ma wrew l-ebda progress ta' ħsara strutturali definita mill-bidla mill-linja bażi fl-mTSS li kienet ta' 0.5 jew inqas.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Cyltezo.
Maltese: • Peress illi ġew irrappurtati każi ta' tuberkulosi f'pazjenti ttrattati b'adalimumab, qabel tibda Cyltezo, it-tabib tiegħek se jeżaminak għal sinjali u sintomi tat-tuberkulosi.
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m² BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Maltese: Il-perjodu double-blind huwa segwit mill-perjodu open-label (OL) fejn il-pazjenti rċevew 24 mg/m BSA ta' adalimumab sa massimu ta' 40 mg ġimgħa iva u ġimgħa le mogħtija taħt il-ġilda sa 192 ġimgħa oħra.
English: Quality of life and physical function
Maltese: Kwalità tal-ħajja u funzjoni fiżika