FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Maltese: Abbażi ta' studju ta' osservazzjoni mill-Ewropa tat-Tramuntana, ġew osservati żieda fir-riskju (OR, CI ta' 95%; valur p) ta' ċesarja (1.50, 1.14-1.96; p = 0.0032), twelid qabel iż-żmien (1.48, 1.05-2.09; p = 0.024), tarbija żgħira għall-età tat-tqala (2.79, 1.54-5.04; p = 0.0007), u piż tat-twelid baxx (2.03, 1.41-2.94; p = 0.0002) f'nisa esposti għal infliximab matul it-tqala (flimkien ma' immunomodulaturi/kortikosterojdi jew mingħajrhom, 270 tqala) meta mqabbla ma' nisa esposti għal immunomodulaturi u/jew kortikosterojdi biss (6,460 tqala).
English: Serious infections were reported in 12% (7/60) of all treated patients.
Maltese: Infezzjonijiet serji kienu rrappurtati fi 12% (7/60) mill-pazjenti kollha kkurati.
English: Infusion reactions and hypersensitivity
Maltese: Reazzjonijiet tal-infużjoni u sensittività eċċessiva
English: At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Maltese: Fil-linja bażi, 87% tal-pazjenti kellhom fistuli perianali, 14% kellhom fistuli fl-addome, 9% kellhom fistuli rektovaġinali.
English: Table 8 Effects on clinical response, clinical remission and mucosal healing at weeks 8 and 30.
Maltese: Tabella 8 Effetti fuq ir-rispons kliniku, tnaqqis kliniku u fejqan tal-mukuża f'ġimgħat 8 u 30.
English: Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Maltese: Immunoġeniċità Antikorpi għal infliximab kienu osservati f'4 (7.7%) pazjenti sa ġimgħa 54.
English: In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Maltese: F'din ilprova, sitta u sittin fil-mija tal-pazjenti (686 minn 1,040) irċevew mill-anqas infużjoni waħda mqassra ta' 90 minuta jew anqas u 44% tal-pazjenti (454 minn 1,040) irċevew mill-anqas infużjoni waħda imqassra ta' 60 minuta jew anqas.
English: EXPRESS evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Maltese: EXPRESS evalwa l-effikaċja tat-terapija ta' induzzjoni b'infliximab u terapija ta' manteniment f'378 pazjent bi psorjasi tal-plakka.
English: Date of first authorisation: 13 August 1999.
Maltese: Data tal-ewwel awtorizzazzjoni: 13 Awwissu 1999.
English: 5.7% [95% CI 2.65%-10.6%].
Maltese: 0%]) vs. 15/60 [25.0%]).
English: Infliximab Maintenance 5 mg/kg (n = 113) (p value)
Maltese: Manteniment b'Infliximab 5 mg/kg (n = 113) (Valur p)
English: Paediatric ulcerative colitis (6 to 17 years)
Maltese: Kolite ulċerattiva fit-tfal (6 snin sa 17-il sena)
English: Placebo Maintenance
Maltese: Manteniment bi Plaċebo
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30 and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Maltese: Minn 22 individwu li kellhom fistuli fil-linja bażi, 63.6% (14/22), 59.1% (13/22) u 68.2% (15/22) kellhom rispons sħiħ tal-fistula f'ġimgħa 10, 30 u 54, rispettivament, fil-gruppi ta' manteniment kombinati tal-ġimgħat q8 u ġimgħat q12.
English: Rare: Autoimmune hepatitis, jaundice.
Maltese: Epatite awtoimmuni, suffejra.
English: Powder for concentrate for solution for infusion 1 vial 100 mg
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni 1 kunjett 1 ta'100 mg
English: ≥ 90% improvement
Maltese: Titjib ta' ≥ 90%
English: For preparation and administration instructions, see section 6.6.
Maltese: Għall-preparazzjoni u istruzzjonijiet dwar l-għoti, ara sezzjoni 6.6.
English: Rare: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Maltese: Agranuloċitożi (inkluż trabi esposti in utero għal infliximab), purpura trombotika tromboċitopenika, panċitopenija, anemija emolitika, purpura tromboċitopenika idjopatika.
English: DO NOT SHAKE.
Maltese: AZA flimkien ma' infliximab.
English: Remicade 100 mg powder for concentrate infliximab
Maltese: Remicade 100 mg trab għal konċentrat infliximab
English: Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Maltese: Immunoġeniċità Antikorpi għal infliximab instabu fi 3 (2.9%) pazjenti tfal.
English: Remicade is produced in packs of 1, 2, 3, 4 or 5 vials.
Maltese: Remicade jiġi f'pakketti ta' 1, 2, 3, 4 jew 5 kunjetti.
English: • Ankylosing spondylitis (Bechterew's disease)
Maltese: • Ankylosing spondylitis (marda ta' Bechterew)
English: Remicade contains the active substance infliximab.
Maltese: Remicade fih is-sustanza attiva infliximab.
English: The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Maltese: Il-proporzjon ta' pazjenti b'rispons kliniku f'ġimgħa 8 kien ta' 73.3% (44/60).
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Maltese: • Is-sustanzi l-oħra huma sucrose, polysorbate 80, monobasic sodium phosphate u dibasic sodium phosphate.
English: Infliximab Maintenance 10 mg/kg (n = 112) (p value)
Maltese: Manteniment b'Infliximab 10 mg/kg (n = 112) (Valur p)
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: 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); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Fil-klassijiet tassistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima middata disponibbli).
English: Rare: Granulomatous lesion.
Maltese: Leżjoni granulomatoża.
English: Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Maltese: Tnaqqis kliniku f'ġimgħa 8 kienet ta' 33.3% (17/51) kif imkejjel bil-punteġġ tal-Indiċi talAttività ta' Kolite ulerattiva fit-Tfal (PUCAI).
English: Psoriatic arthritis Plaque psoriasis
Maltese: Spondilite Ankylosing Artrite psorijatika Plakka psorijatika
English: In clinical studies 36% of infliximab-treated patients were treated for infections compared with 25% of placebo-treated patients.
Maltese: Fi studji kliniċi, 36% tal-pazjenti li ngħataw infliximab kienu kkurati għal infezzjonijiet mqabbla ma' 25% ta' pazjenti li ġew ikkurati bi plaċebo.
English: START was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Maltese: START kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, multiċentriku, double-blind, bi 3 partijiet tal-istudji, ta' grupp parallel.
English: (anaphylactic shock)
Maltese: (xokk anafilattiku)
English: In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
Maltese: Fi SPIRIT, il-proporzjon ta' pazjenti li kisbu PASI 75 f'ġimgħa 10 kien 71.7% fil-grupp fuq 3 mg/kg infliximab, 87.9% fil-grupp fuq 5 mg/kg infliximab, u 5.9% fil-grupp fuq plaċebo (p < 0.001).
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Maltese: Artrite bi psorjasi, Ankylosing spondylitis (marda ta' Bechterew), psorjasi, kolite ulċerattiva u lmarda ta' Crohn
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including Remicade (see section 4.8).
Maltese: Melanoma u karċinoma taċ-ċellula ta' Merkel kienu rrappurtati f'pazjenti kkurati b'terapija li timblokka TNF, inkluż Remicade (ara sezzjoni 4.8).
English: Total score d (van der
Maltese: Punteġġ totali d (punteġġ van der Heijde Sharp)
English: In patients treated with methotrexate alone, the incidence of serious infections was 5.2% in patients 65 years and older compared to 2.7% in patients under 65 (see section 4.4).
Maltese: F'pazjenti kkurati b'methotrexate waħdu, l-inċidenza ta' infezzjonijiet serji kienet ta' 5.2% f'pazjenti li kellhom 65 sena jew aktar meta mqabbla ma' 2.7% f'pazjenti taħt il-65 sena (ara sezzjoni 4.4).
English: The most serious ADRs associated with the use of TNF blockers that have been reported for Remicade include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Maltese: L-aktar ADRs serji assoċjati ma' użu ta' imblokkaturi ta' TNF li kienu rrappurtati għal Remicade jinkludu attivazzjoni mill-ġdid ta' HBV, CHF (congestive heart failure, insuffiċjenza konġestiva tal-qalb), infezzjonijiet serji (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), mard tas-serum (reazzjonijiet ta' sensittività eċċessiva li jdumu biex iseħħu), reazzjonijiet ematoloġiċi, lupus erythematosus sistemiku/sindrome jixbah il-lupus, disturbi ta' demijelinazzjoni, avvenimenti tal-fwied u tal-marrara, limfoma, HSTCL, lewkimja, karċinoma taċċellula ta' Merkel, melanoma, tumuri malinni fit-tfal, sarkojdosi/ reazzjoni li tixbah lil sarkojdosi, axxess fl-imsaren jew perianali
English: Rare: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Maltese: Meninġite, infezzjonijiet opportunistiċi (bħal infezzjonijiet invażivi fungali [pnewmoċistożi, istoplasmożi, asperġillożi, kokkidijoidomikożi, kriptokokkożi, blastomikożi], infezzjonijiet batterjali [b'mikobatterji mhux tipiċi, listerijożi, salmonellożi] u infezzjonijiet virali [ċitomegalovirus]), infezzjonijiet parassitiċi, attivazzjoni mill-ġdid tal-epatite B.
English: Significant improvements from baseline were demonstrated in DLQI (p < 0.001) and the physical and mental component scores of the SF 36 (p < 0.001 for each component comparison).
Maltese: Titjib sinifikanti mill-linja bażi ġew osservati fil-DLQI (p < 0.001) u l-punteġġi fiżiċi u mentali talkomponenti tal-SF 36 (p < 0.001 għall-paragun ta' kull komponent).
English: At week 54, the proportion of patients in clinical remission as measured by the PUCAI score was 38% (8/21) in the q8 week maintenance group and 18% (4/22) in the q12 week maintenance treatment group.
Maltese: F'ġimgħa 54, il-proporzjon ta' pazjenti fi tnaqqis kliniku kif imkejjel bil-punteġġ PUCAI kien ta' 38% (8/21) fil-grupp ta' manteniment ta' q8 ġimgħat u ta' 18% (4/22) fil-grupp ta' kura ta' manteniment ta' q12-il ġimgħa.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT infliximab
Maltese: Tabella 3 Effetti fuq ACR 20, Ħsara Strutturali fil-Ġogi u Funzjoni Fiżika fl-ġimgħa 54, ATTRACT
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Maltese: Tabella 2 Proporzjon ta' pazjenti b'żieda fl-attività ALT fi studji kliniċi
English: Group 1 received 5 mg/kg infliximab.
Maltese: Il-parteċipanti fi Grupp 1 irċevew 5 mg/kg infliximab.
English: No rebound was observed.
Maltese: Ma deherx effett rebound.
English: Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Maltese: X-rays tal-idejn u s-saqajn inġabru fil-linja bażi, f'ġimgħa 24 u 54.
English: Infliximab inhibits the functional activity of TNF in a wide variety of in vitro bioassays.
Maltese: Infliximab jinibixxi l-attività funzjonali ta' TNF f'varjetà kbira ta' bioassays in vitro.
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Maltese: • Valuri mhux normali ta' proteina tad-demm imsejħa ‘complement factor' li hija parti mis sistema immuni.
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg Remicade [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that Remicade did not interfere with T-cell independent humoral immune responses.
Maltese: F'sottosett ta' 90 pazjent adult b'artrite rewmatojde mill-istudju ASPIRE proporzjon simili ta' pazjenti f'kull grupp ta' trattament (methotrexate flimkien ma': plaċebo [n = 17], 3 mg/kg [n = 27] jew 6 mg/kg Remicade [n = 46]) kellhom żieda effettiva doppja fit-titri għal vaċċin pnewmokokkali polivalenti, li jindika li Remicade ma nterferixxiex mar-risponsi immuni tal-umuri indipendenti miċċelluli T.
English: Hepatitis B (HBV) reactivation
Maltese: L-attivazzjoni mill-ġdid ta' epatite B (HBV)
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF) inhibitors, ATC code: L04AB02.
Maltese: Immunosoppressanti, inibituri tal-fattur tan-nekrożi alfa (TNF), Kodiċi ATC:
English: At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds.
Maltese: Fil-linja bażi 27.4% tal-pazjenti kienu qed jirċievu kortikosterojdi sistemiċi, 14.2% tal-pazjenti kienu qed jirċievu budesonide, u 54.3% tal-pazjenti kienu qed jirċievu komposti ta' 5-ASA.
English: Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Maltese: Infezzjonijiet kienu rrappurtati f'31 (51.7%) minn 60 pazjent ikkurat f'C0168T72 u 22 (36.7%) kellhom bżonn kura b'sustanza orali jew parenterali kontra l-mikrobi.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Maltese: • Problemi serji fil-ġilda bħal nekroliżi tossika tal-epiderme, Sindrome ta' Stevens-Johnson u pustullożi ekżantematuża mifruxa akuta
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Maltese: Infużjonijiet ġol-vina ta' darba ta' 1, 3, 5, 10 jew 20 mg/kg ta' infliximab irriżultaw f'żidiet proporzjonali għad-dożi tal-konċentrazzjoni massima fis-serum (Cmax) u fl-erja taħt il-kurva talkonċentrazzjoni mal-ħin (AUC).
English: Corticosteroid taper was permitted after week 8.
Maltese: It-tnaqqis gradwali ta' kortikosterojdi kien permess wara ġimgħa 8.
English: • Store in a refrigerator (2 °C - 8 °C).
Maltese: • Aħżen fi-friġġ (2 °C - 8 °C).
English: ≥ 75% improvement
Maltese: Titjib ta' ≥ 75%
English: In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
Maltese: Fl-istudju REACH, 112-il pazjent (6 sa 17-il sena, età medjana 13.0-il sena) b'marda ta' Crohn attiva minn moderata sa severa (CDAI pedjatriku medjan ta' 40) u rispons inadegwat għal terapiji konvenzjonali kellhom jirċievu 5 mg/kg infliximab fil-ġimgħat 0, 2, u 6.
English: Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Maltese: L-effikaja u s-sigurtà ta' infliximab kienu evalwati f'żewġ studji multiċentriċi, double-blind, ikkontrollati bi plaċebo f'pazjenti b'ankylosing spondylitis attiva (Indiċi tal-Marda Ankylosing Spondylitis ta' Bath [BASDAI] punteġġ ≥ 4 u wġigħ fis-sinsla ≥ 4 fuq skala minn 1-10).
English: The safety and efficacy of Remicade were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Maltese: Is-sigurtà u l-effikaċja ta' Remicade kienu evalwati f'żewġ studji kliniċi (ACT 1 u ACT 2) li fihom ilparteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo f'pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever (Punteġġ Mayo 6 sa 12; Sottopunteġġ tal-endoskopija ≥ 2) b'rispons inadegwat għat-terapiji konvenzjonali [kortikosterojdi orali, aminosalicylates u/jew immunomodulaturi (6-MP, AZA)].
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p = 0.022, ACT1 data).
Maltese: Proporzjon akbar ta' pazjenti fil-grupp ta' kura b'infliximab kombinat setgħu jwaqqfu lkortikosterojdi fil-waqt li baqgħu bi tnaqqis kliniku meta mqabbla ma' grupp ta' kura bi plaċebo kemm f'ġimgħa 30 (22.3% vs 7.2%, p < 0.001, dejta ACT 1 u ACT 2 mgħaqqdin flimkien) u ġimgħa 54 (21.0% vs. 8.9%, p = 0.022, dejta ACT 1).
English: Clinical Remission
Maltese: Tnaqqis Kliniku
English: p < 0.001, for each infliximab treatment group vs. placebo.
Maltese: p < 0.001, għal kull grupp ta' infliximab vs. plaċebo.
English: Further doses
Maltese: Dożi addizzjonali
English: Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8).
Maltese: Infużjonijiet mqassra b'dożi ta' > 6 mg/kg ma ġewx studjati (ara sezzjoni 4.8).
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p = 0.011]) than in the placebo group
Maltese: Kien hemm anqas individwi li għamlu kolektomija fil grupp ta' 5 mg/kg infliximab (28/242 jew 11.6% [N.S.]) u l-grupp ta' 10 mg/kg infliximab (18/242 jew 7.4% [p = 0.011]) milli fil-grupp talplaċebo (36/244; 14.
English: Remicade has been studied only in combination with conventional immunosuppressive therapy.
Maltese: Remicade ġie studjat biss f'kombinazzjoni ma' terapija konvenzjonali immunosoppressiva.
English: In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
Maltese: Fit-tieni studju kliniku (IMPACT 2), l-effikaċja u s-sigurtà ta' infliximab kienu studjati f'200 pazjent b'artrite psorjatika attiva (≥ 5 ġogi minfuħin u ≥ 5 ġogi teneri).
English: Placebo (week 16)
Maltese: Plaċebo (ġimgħa 16)
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: “Infusion reactions and hypersensitivity”).
Maltese: F'pazjenti psorijatiċi kkurati b'infliximab bħala kors ta' manteniment fl-assenza ta' immunomodulaturi li jingħataw fl-istess ħin, madwar 28% żviluppaw antikorpi għal infliximab (ara sezzjoni 4.4: “Reazzjonijiet tal-infużjoni u sensittività eċċessiva”).
English: Cancer and lymphoma
Maltese: Kanċer u limfoma
English: At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p < 0.001).
Maltese: Mal-24 ġimgħa, innumru ta' persuni li rrispondew għal ASAS 20 kienu 15/78 (19%) fil-grupp tal-plaċebo, u 123/201 (61) fil-grupp fuq 5 mg/kg infliximab (p < 0.001).
English: Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap.
Maltese: Ħġieġ tat-tip 1 b'tappijiet tal-lasktu u piegi ta' aluminium protetti b'għotjien tal-plastik.
English: Overall, the adverse reactions reported in the paediatric ulcerative colitis trial (C0168T72) and adult ulcerative colitis (ACT 1 and ACT 2) studies were generally consistent.
Maltese: B'mod globali, ir-reazzjonijiet avversi rrappurtati fil-prova dwar kolite bl-ulċeri fit-tfal (C0168T72) u fl-istudji dwar kolite bl-ulċeri fl-adulti (ACT 1 u ACT 2) kienu ġeneralment konsistenti.
English: Corticosteroid tapering was permitted after week 6.
Maltese: It-tnaqqis gradwali tal-kortikosterojdi kien permess wara ġimgħa 6.
English: At baseline 53% of patients were receiving immunomodulator therapy (6-MP, AZA and/or MTX) and 62% of patients were receiving corticosteroids.
Maltese: Fil-linja bażi 53% tal-pazjenti kienu qed jirċievu terapija b'immunomodulatur (6-MP, AZA u/jew MTX) u 62% tal-pazjenti kienu qed jirċievu kortikosterojdi.
English: PGA of cleared (0) or minimal (1)
Maltese: PGA ta' pazjenti bid-dwiefer imfejqa (0) jew minimu (1)
English: At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/kg) followed by infliximab maintenance therapy (5 mg/kg).
Maltese: F'ġimgħa 24, il-grupp fuq plaċebo nqaleb fuq itterapija ta' induzzjoni b'infliximab (5 mg/kg) segwit minn terapija ta' manteniment b'infliximab (5 mg/kg).
English: Ankylosing spondylitis (Bechterew's disease)
Maltese: Ankylosing spondylitis (Marda ta' Bechterew)
English: Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Maltese: Analiżi kienet ibbażata fuq individwi psorijatika tad-dwiefer fil-linja bażi (81.8% tal-individwi).
English: In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing 941 patient years.
Maltese: Fi studji kliniċi b'infliximab fejn kienu kkurati 5,780 pazjent, li jirrappreżentaw 5,494 sena ta' pazjenti, 5 każijiet ta' limfomi u 26 tumuri malinni mhux limfomi instabu meta mqabbla mal-ebda każ ta' limfoma u każ wieħed ta' tumur malinn mhux limfoma f'1,600 pazjent ikkurati bi plaċebo li jirrapreżentaw 941 sena ta' pazjenti.
English: Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Maltese: Tnaqqis fil-parametri ta' attività periferali karatteristika ta' artrite psorijatika ( bħannumru ta' ġogi minfuħin, numru ta' ġogi bl-uġigħ/teneri, daktilite u preżenza ta' entesopatija) ġew osservati f'pazjenti kkurati b'infliximab.
English: • Swelling of your pancreas (pancreatitis)
Maltese: • Nefħa fil-frixa (pankreatite)
English: Uncommon: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Maltese: Mhux komuni: Titqib fil-musrana, stenożi fil-musrana, divertikulite, pankreatite, kejlite.
English: The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112).
Maltese: Il-proporzjon ta' individwi li fiequ b'mod kliniku f'ġimgħa 10 kien 58.9% (66/112).