FrancophonIA/ELRC3.0 huggingface dataset:
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and GAIN.
Maltese: Il-qlib għall-aħjar fl-istat kliniku (definit bhala CDAI < 150) ġie evalwat f'żewġ studji, CLASSIC I u GAIN.
English: • Coughing;
Maltese: • Sogħla;
English: 1055 Λευκωσία Τηλ.
Maltese: Λεωφόρος Βουλιαγµένης 512
English: In patients with ankylosing spondylitis antibodies were identified in 17/204 subjects (8.3%) treated with adalimumab.
Maltese: F'pazjenti li jbatu minn infjammazzjoni tal-vertebri li tirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), ġew identifikati anti-korpi fi 17/204 suġġett (8.3%) ikkurati b'adalimumab.
English: ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Ġimgħa 24 ***,** Statistikament sinifikanti f'p < 0.001, <0.01 għall-paraguni kollha bejn Trudexa u lplaċebo f'Ġimgħa 2, 12 u 24 a Stima f' Ankylosing Spondylitis b Indiċi ta' l-Attività tal-Mard Bath Ankylosing Spondylitis
English: Rare hearing loss
Maltese: Rari rabdomijoliżi
English: Trudexa/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Maltese: It-terapija kombinata b'Trudexa/methotrexate kienet klinikament u statistikament superjuri għal methotrexate (p < 0.001) u Trudexa mogħtija waħedhom bħala kura (p < 0.001) fit-tilħiq ta'stat baxx ta' mard f'pazjenti li kienu ġew riċentament iddijanjostikati b'artrite rewmatika minn moderata sa severa.
English: P-2610-008 Amadora Tel: + 351 (0) 21 472 7100
Maltese: Alfrapark, Edificio D, P-2610-008 Amadora Tel: + 351 (0) 21 472 7100
English: • Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. Trudexa can cause reactivation of
Maltese: • Jekk int iġġorr il-virus ta' l-epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li għandek riskju li jaqbdek l-HBV, għarraf lit-tabib tiegħek.
English: Şos.
Maltese: Tilqim
English: HOW TO USE TRUDEXA
Maltese: Tużax Trudexa
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase halflife was approximately two weeks.
Maltese: Wara dożi ta' 0.5 mg/kg (~40 mg), ittneħħija mill-ġisem varjat minn 11 sa 15 ml/siegħa, il-volum ta' distribuzzjoni (Vss) varja minn 5 sa 6 litri u l-half-life medja tal-fażi terminali kienet ta' bejn wieħed u ieħor gimagħtejn.
English: LV-1004 Rīga Latvia
Maltese: Rīga Latvia
English: Common lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection
Maltese: Komuni infezzjonijiet fin-naħa ta' isfel tas-sistema respiratorja (inklużi pnewmonja, bronkite), infezzjonijiet virali (li jinkludu l-influwenza, infezzjonijiet ta' l-erpete), candidiasis, infezzjonijiet tal-batterji (li jinkludu infezzjonijiet fis-sistema urinarja), infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja
English: The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' Trudexa ġew stimati f''il fuq minn 1400 pazjent li jbatu mill-marda Crohn (Crohn's disease) attiva b'mod minn moderat sa sever (Indiċi ta' l-Attività tal-Marda Crohn (Crohn's disease) (CDAI) ≥ 220 u ≤ 450) fi studji double-blind, kontrollati bil-plaċebo, li saru b'ordni addoċċ.
English: During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among 2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for controltreated patients).
Maltese: Matul il-fażijiet kontrollati ta' għaxar provi ta' Trudexa li damu sejrin mill-inqas 12 -il ġimgħa (I-IX u CHARM) fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, artrite psorjatika, infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) u l-marda Crohn (Crohn's disease), tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' konfidenza) ta' 5.7 (3.3, 10.1) kull 1000 sena ta' pazjent fost 2887 pazjent ikkurat b'Trudexa, kontra rata ta' 4.1 (1.5, 10.9) kull 1000 sena ta' pazjent fost 1570 pazjenti kontrollati (il-medja tat-tul tal-kura kienet ta' 5.7 xhur għal Trudexa u 5.5 xhur għal pazjenti mogħtija kura kontrollata).
English: • nausea, diarrhoea, abdominal pain, mouth ulcers;
Maltese: • nawseja, dijarea, uġigħ addominali, ulċeri fil-ħalq;
English: 160/80 mg N=76
Maltese: Trudexa 160/80 mg N=76
English: Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexateintolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
Maltese: Studju III evalwa 619 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 -il sena, li kellhom effikaċja insuffiċjenti meta ngħataw dożi ta' minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil-ġimgħa u li d-doża ta' metothrexate tagħhom baqgħet kostanti meta ngħataw 12.5 sa 25 mg fil-ġimgħa.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
Maltese: Tendenzi simili (mhux kollha statistikament sinifikanti) ġew osservati fl-istudju iżgħar double-blind kontrollat bil-plaċebo li sar b'ordni addoċċ (IX) ta' 82 pazjent adult li jbatu b'infjammazzjoni talvertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis).
English: Uncommon neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, , lymphadenopathy, leucocytosis
Maltese: Rari limfopenja newtropenja (li tinkludi agranulocytosis), lewkopenja, thrombocytopaenia, anemija, mard fil-limfa, lewkoċitosi panċitopenja, purpura idjopatika thrombocytopaenia
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications.
Maltese: Dożi stabbli ta' aminosalicylates, corticosteroids, u/jew aġenti immunomodulatorji mittieħda fl-istess waqt, kienu permessi u 79% talpazjenti komplew jirċievu mill-inqas waħda minn dawn il-mediċini.
English: • Severe rash, hives or other signs of allergic reaction;
Maltese: • Raxx sever, urtikarja jew sinjali oħra ta' reazzjoni allerġika;
English: • upper respiratory tract infections (including cold, runny nose, sinus infection);
Maltese: • infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis sinus);
English: 40 mg Trudexa every week
Maltese: 40 mg Trudexa kull ġimgħa
English: If you take Trudexa your risk may increase.
Maltese: Jekk tieħu Trudexa, ir-riskju jista' jiżdied.
English: Uncommon mood disorders, anxiety (including nervousness and agitation)
Maltese: Mhux Komuni disturbi fil-burdata, ansjetà (inklużi nervożità u aġitazzjoni)
English: Week 52 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 ACR 50 Week 52 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 ACR 70 Week 52 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Ġimgħa 52 45.9% 41.2% 61.6% < 0.001 < 0.001 Ġimgħa 104 42.8% 36.9% 59.0% < 0.001 < 0.001 ACR 70 Ġimgħa 52 27.2% 25.9% 45.5% < 0.001 < 0.001 Ġimgħa 104 28.4% 28.1% 46.6% < 0.001 < 0.001 a. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'methotrexate waħdu u Trudexa u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. b. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'Trudexa waħdu u Trudexa u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. c. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'Trudexa waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney.
English: Erosion score JSNd score amethotrexate b95% confidence intervals for the differences in change scores between methotrexate and Trudexa.
Maltese: Punteġġ ta' lerożjoni Punteġġ JSNd amethotrexate b95% intervall ta' konfidenza ghad-differenza bejn il-punteġġi ta' methotrexate u Trudexa.
English: Panophthalmitis, iritis, glaucoma
Maltese: IL-KONTENUT SKOND IL-PIŻ, VOLUM, JEW PARTI
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (Studies I, III, IV).
Maltese: Tnaqqis statistikament sinifikanti fl-għejja, kif inhi mkejla mill-istima funzjonali tat-terapija talmard kroniku (FACIT) kien osservat fit-tliet studji li fihom saret l-istima (Studji I, III u IV).
English: In patients with Crohn's disease, the loading dose of 80 mg Trudexa on week 0 followed by 40 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ml during the induction period.
Maltese: F'pazjenti li jbatu mill-marda Crohn (Crohn's disease), id-doża kbira ta' 80 mg Trudexa f'ġimgħa 0 segwita b'40 mg Trudexa f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 5.5 µg/ml matul il-perijodu tal-bidu.
English: A rapid decrease in CRP levels was also observed in patients with Crohn's disease.
Maltese: Ġie osservat ukoll tnaqqis rapidu fil-livelli ta' CPR f'pazjenti li jbatu mill-marda Crohn (Crohn's disease).
English: There were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months.
Maltese: Kien hemm 114 -il pazjent minn 207 pazjenti li komplew jirċievu 40 mg Trudexa ġimgħa iva u ġimgħa le għal 60 xahar.
English: Common cough, nasopharyngeal pain
Maltese: Komuni sogħla, uġigħ rinofarinġali
English: Immune system disorders anaphylaxis
Maltese: Disturbi fis-sistema immuni anafilassi
English: Table 8 - Efficacy Responses in Placebo-Controlled AS Study - Study VIII Reduction of Signs and Symptoms
Maltese: Tabella 8- Risponsi ta' l-Effikaċja fi Studju AS kontrollat bil-Plaċebo Effikaċja- Studju VIII Tnaqqis fisSinjali u s-Sintomi
English: N/A N/A *** p < 0.001 for all comparisons between Trudexa and placebo * p < 0.05 for all comparisons between Trudexa and placebo N/A not applicable
Maltese: N/A N/A *** p < 0.001 għall-paraguni kollha bejn Humira u l plaċebo * p < 0.05 f għall-paraguni kollha bejn Humira u l plaċebo N/A ma japplikax
English: Rare lymphoma, solid organ tumours (including breast, ovarian, testicular), squamous cell carcinoma of the skin
Maltese: Rari tumur tal-ġilda beninn limfoma, tumuri fl-organi solidi (li jinkludu tumur fis-sider, tumur fl-ovarji, tumur testikulari), karċinoma tal-ġilda biċ-ċelluli tat-tip squamous
English: BP 90233
Maltese: FIN-02240
English: ACR 20 Week 52 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 ACR 50 Week 52 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 ACR 70 Week 52 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Ġimgħa 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Ġimgħa 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Ġimgħa 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Ġimgħa 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'methotrexate waħdu u Trudexa u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. b. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'Trudexa waħdu u Trudexa u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. c. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'Trudexa waħdu u methotrexate waħdu bl-użu tattest U Mann-Whitney.
English: Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Maltese: Studju I evalwa 271 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 -il sena, ma kinux irrispondew għal kura b'mill-inqas mediċina waħda anti-rewmatika li taffetwa l-proċess tal-mard u li kellhom effikaċja insuffiċjenti b'methotrexate f'dożi minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil-ġimgħa, u li d-doża ta' methotrexate tagħhom baqgħet kostanti minn 10 sa 25 mg fil-ġimgħa.
English: Rare rhabdomyolysis
Maltese: Effetti Newroloġiċi
English: 478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Maltese: 478 mill-pazjenti reġistrati (32%) ġew dikjarati bħala li jbatu minn marda severa (riżultat ta' CDAI > 300 u t-teħid fl-istess waqt ta' corticosteroid u/jew immunosoppressanti) li tikkorrespondi malpopolazzjoni definite fl-indikazzjoni (ara sezzjoni 4.1).
English: At week 52, 42.9% of patients who received Trudexa/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Trudexa monotherapy.
Maltese: F'ġimgħa 52, 42.9% tal-pazjenti li rċevew it-terapija kombinata ta' Trudexa/methotrexate laħqu titjib kliniku (DAS28 < 2.6) meta pparagunati ma' 20.
English: • Tingling;
Maltese: • Tnemnim;
English: In this leaflet:
Maltese: Pakketti ta:
English: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF blocking agents.
Maltese: Rapporti rari ta' panċitopenja, inkluża anemija aplastika, ġew irrappurtati b'aġenti li jimblukkaw tTNF.
English: Nervous system disorders demyelinating disorders (e.g. optic neuritis)
Maltese: Disturbi fis-sistema nervuża mard li jaffetwaw il-myelin tan-nervituri (eż nevrite fl-għajnejn)
English: There is no apparent correlation between the presence of anti-adalimumab antibodies and adverse events.
Maltese: Ma jidher li hemm l-ebda korrelazzjoni bejn il-preżenza ta'anti-korpi kontra adalimumab u effetti avversi.
English: Trudexa 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni f'kunjett li jintuża għal darba waħda biss (ħġieġ tip I), komplut bis-siġilli tal-lastku, magħluq bil-pressa bl-aluminju u bis-siġilli flip-off.
English: Rare vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm
Maltese: Rari sadd fil-vini, stenosi ta' l-aorta, thrombophlebitis, anewriżma ta' l-aorta
English: A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ml during the induction period.
Maltese: Doża kbira ta' 160 mg Trudexa f'ġimgħa 0 segwita b'80 mg Trudexa f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 µg/ml matul il-perijodu tal-bidu.
English: The needle cover of the syringe contains natural rubber (latex).
Maltese: L-għatu tal-labra tas-siringa fih lastiku naturali (latex).
English: Table 6: Radiographic Mean Changes at Week 52 in Study V
Maltese: Tabella 6: Tibdil Medju Radjografiku f'Ġimgħa 52 fi Studju V
English: Rare thyroid disorder (including goitre)
Maltese: Rari disturbi fit-tirojde (li jinkludi għanqra)
English: The rate (95% confidence interval) of lymphomas was 1.0 (0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patientyears among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' limfomi kienet ta' 1.0 (0.2, 3.8) kull 1000 sena ta' pazjent fost pazjenti kkurati b'Trudexa u 1.0 (0.1, 7.3) kull 1000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001
Maltese: Il-valuri-p kollha huma paraguni magħmula għal kull par ta' proporzjonijiet għal Trudexa kontra lplaċebo * p < 0.001 ** p < 0.01
English: Pharmacotherapeutic group: Selective immunosuppressive agents.
Maltese: Aġenti immumo-soppressanti selettivi, Kodiċi ATC:
English: In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Maltese: Fi Studi minn I-IV, pazjenti kkurati b'Trudexa laħqu risponsi statistikament sinifikanti għall-ACR 20 u 50 sa minn ġimgħa jew tnejn wara li nbdiet il-kura, meta pparagunati mal-plaċebo.
English: Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
Maltese: Rari hypokalaemia, żieda fil-lipidi, disturbi fl-aptit (li jinkludu anoressija), livelli ta' ureja għoljin fiddemm hypercalcaemia
English: • Cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Maltese: • Tipi ta' kanċer oħra, minbarra limfoma, ġew irrappurtati f'pazjenti li jbatu minn marda speċifika tal-pulmun, li tissejjaħ mard kroniku assoċjat ma' imblukkar fis-sistema respiratorja (COPD), u li jirċievu l-kura b'mediċina oħra li timblokka t-TNF.
English: Abbott Biotechnology Ltd. Road No. 2, Km.
Maltese: Abbott Biotechnology Ltd.
English: In a study of 64 patients with rheumatoid arthritis that were treated with Trudexa, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B cells and NK-cells, monocyte/macrophages, and neutrophils.
Maltese: Fi studju ta' 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b'Trudexa, ma kien hemm lebda evidenza ta' tnaqqis ta' sensitivita eċċessiva imdewma, tnaqqis tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelloli effettivi T u B u ċelloli NK, monoċistiċi /makrofaġi, u newtrofili.
English: Abbott Laboratories S.A.
Maltese: Abbott Laboratories Ltd.
English: Following subcutaneous administration of 40 mg of Trudexa every other week in rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ml (without concomitant methotrexate) and 8 to 9 µg/ml (with concomitant methotrexate), respectively.
Maltese: Wara t-teħid ta' Trudexa 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti li jbatu minn artrite rewmatika (AR), il-konċentrazzjoni minimali medja fissa kienet ta' bejn wieħed u ieħor 5µg/ml (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 µg/ml (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/methotrexate combination therapy versus methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
Maltese: Fi Studju V, it-titjib fl-indiċi ta' diżabilità HAQ u fil-komponent fiżiku ta' l-SF 36 wera titjib akbar (p < 0.001) għat-terapija kombinata ta' Trudexa/methotrexate versu l-kura b'methotrexate u l-kura b'Trudexa waħdu f'ġimgħa 52, liema titjib baqa' mantenut matul ġimgħa 104.
English: NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection Adalimumab
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni Adalimumab
English: • muscle weakness;
Maltese: • dgħufija tal-muskoli;
English: Rare intestinal stenosis, colitis, enteritis, oesophagitis
Maltese: Rari emorraġija fir-rektum, gastrite, rimettar, dispepsja, nefħa addominali, stitikezza stenosi ta' l-intestini, kolite, enterite, esofaġite
English: NAME OF THE MARKETING AUTHORISATION HOLDER Abbott Laboratories Ltd
Maltese: Abbott Laboratories Ltd
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I − V. In these trials, 11.9% of patients treated with Trudexa and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Maltese: F'dawn ilprovi, 11.9% tal-pazjenti kkurati b'Trudexa u 8.1% tal-pazjenti kkurati bil-plaċebo u bis-sustanza attiva użata bħala kontroll, li bdew bl-livelli tal-anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi fl- 24 ġimgħa.
English: Two patients out of 3441 treated with Trudexa in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3441 li kienu kkurati b'Trudexa fl-istudji kollha ta' lartrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindromu li jixbaħ lis-sindromu tal-lupus.
English: ASAS 50 Week 2
Maltese: ASAS 50
English: TRUDEXA/MTX 40 mg every other week
Maltese: TRUDEXA/MT X 40 mg ġimgħa
English: Common diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea
Maltese: Komuni dijarea, uġigħ addominali, stomatite u ulċeri filħalq, nawseja
English: Crohn's disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
Maltese: Il-provi kliniċi tal-marda Crohn (Crohn's disease): fi provi kliniċi kontrollati, iż-żiediet fil-livelli ta' lALT kienu simili f'pazjenti li kienu qegħdin jirċievu adalimumab jew il-plaċebo.
English: • Numbness;
Maltese: • Tirżiħ;
English: The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' kanċer tal-ġilda li m'humiex melonoma kienet ta' 7.6 (4.7, 12.4) kull 1000 sena ta' pazjent fost pazjenti kkurati b'Trudexa u 2.0 (0.5, 8.2) kull 1000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and aspergillosis.
Maltese: Kien hemm rapporti ta' infezzjonijiet opportunistiċi serji u severi assoċjati mat-terapija b'Trudexa, per eżempju pnewmonja pneumocystis carinii, histoplasmosis mifruxa, listeriosis u aspergillosis.