FrancophonIA/ELRC3.0 huggingface dataset:
English: In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
Maltese: F'pazjenti b'sintomi ta' artrite rewmatojde, artrite psorijatika u l-marda ta' Crohn, hemm indikazzjonijiet li meta jingħataw methotrexate u immunomodulaturi oħra fl-istess ħin, dan inaqqas ilformazzjoni ta' antikorpi kontra infliximab u jżid il-konċentrazzjonijiet ta' infliximab fil-plażma.
English: No dose adjustment is required (see section 5.2).
Maltese: M'hemmx bżonn ta' tibdil tad-doża (ara sezzjoni 5.2).
English: At 38 weeks, 9 of 101 patients treated with Remicade (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Maltese: Wara 38 ġimgħa, 9 minn 101 pazjent li ngħataw Remicade (2 b'5 mg/kg u 7 b'10 mg/kg) mietu meta mqabbel ma' mewt waħda fost id-49 pazjent fuq plaċebo.
English: In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Maltese: F'individwi kkurati b'infliximab, risponsi sinifikanti PASI 50 kienu evidenti mal-ewwel żjara (ġimgħa 2) u rispons PASI 75 mat-tieni żjara (ġimgħa 6).
English: Each Remicade vial contains 100 mg infliximab.
Maltese: Kull kunjett ta' Remicade fih 100 mg ta' infliximab.
English: • If you received Remicade during your pregnancy, your baby may have a higher risk for getting an infection.
Maltese: • Jekk irċevejt Remicade waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju akbar li tieħu infezzjoni.
English: In a fertility and general reproductive function study, the number of pregnant mice was reduced following administration of the same analogous antibody.
Maltese: Fi studju dwar il-fertilità u l-funzjoni riproduttiva ġenerali, in-numru ta' ġrieden tqal naqas wara l-għoti tal-istess antikorp analogu.
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
Maltese: • Disturbi serji fis-sistema nervuża bħal mijelite transversa, mard jixbah lill-isklerożi multipla,
English: Use of live vaccines can result in clinical infections, including disseminated infections.
Maltese: L-użu ta' tilqim ħaj jista' jwassal għal infezzjonijiet kliniċi, inkluż infezzjonijiet mifruxa.
English: Remicade 100 mg powder for concentrate for solution for infusion infliximab
Maltese: Remicade 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni infliximab
English: However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including Remicade, may elicit a lower immune response than in patients not receiving anti-TNF therapy.
Maltese: Madankollu, studji mil-letteratura ppubblikata f'diversi indikazzjonijiet (eż. artrite rewmatika, psorjasi, marda ta' Crohn) jissuġġerixxu li tilqim mhux ħaj li wieħed jirċievi waqt trattament b'terapiji kontra TNF, inkluż Remicade, jistgħu jisiltu rispons immuni aktar baxx milli f'pazjenti li ma jkunux qed jirċievu terapija kontra TNF.
English: • Hepatitis B infection when you have had hepatitis B in the past
Maltese: • Infezzjoni tal-epatite B jekk kellek epatite B fil-passat
English: Remicade may be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but not exceeding the original expiry date.
Maltese: Remicade jista' jinħażen f'temperaturi sa massimu ta' 25 °C għal perjodu wieħed sa 6 xhur, iżda li ma jaqbiżx id-data ta' skadenza oriġinali.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Maltese: Fil-partijiet ikkontrollati tal-istudji kliniċi ta' aġenti li jimblokkaw TNF, aktar każijiet ta' tumuri malinni inkluża limfoma, ġew osservati fost pazjenti li kienu qed jingħataw imblokkatur ta' TNF meta mqabbla ma' pazjenti tal-kontroll.
English: Rare: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Maltese: Xokk anafilattiku, vaskulite, reazzjoni tat-tip sarkojd.
English: Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
Maltese: Infliximab ingħata f'doża ta' 5 mg/kg fil-ġimgħat 0, 2, 6, u mbagħad kull 8 ġimgħat.
English: Fistulising, active Crohn's disease
Maltese: Kura ta' manteniment fil-marda ta' Crohn fistulizzanti attiva
English: 3 vials 100 mg
Maltese: 3 kunjetti ta' 100 mg
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI < 150) and clinical response over time.
Maltese: Il-punti aħħarin sekondarji kienu jinkludu l-proporzjon ta' pazjenti b'fejqan kliniku fir-4 ġimgħa (CDAI < 150) u rispons kliniku maż-żmien.
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Maltese: Fil-parti tal-istudju dwar dawk li ngħataw kura mill-ġdid, 4% (8/219) tal-pazjenti kellhom reazzjoni serja għall-infużjoni kontra < 1% (1/222) ta' dawk fuq terapija ta' manteniment.
English: There were 95 subjects from group 2 who continued on 5 mg/kg every 6 weeks.
Maltese: Kien hemm 95 individwu minn grupp 2 li komplew fuq il-5 mg/kg kull 6 ġimgħat.
English: In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age
Maltese: Fi studji kliniċi dwar artrite rewmatojde, l-inċidenza ta' infezzjonijiet serji kienet akbar f'pazjenti ta' 65 sena u akbar ikkurati b'infliximab flimkien ma' methotrexate (11.3%) minn f'dawk taħt il-65 sena (4.6%).
English: 10 mg/kg q 8 wks
Maltese: 10 mg/k q 8 ġimgħat
English: > 40 weeks
Maltese: > 40 ġimgħa
English: Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
Maltese: Infezzjoni fin-naħa ta' fuq tal-apparat tan-nifs kienet l-aktar reazzjoni avversa komuni għall-mediċina (ADR) rrappurtata fi provi kliniċi, li seħħet f'25.3% ta' pazjenti kkurati b'infliximab meta mqabbla ma' 16.5% ta' pazjenti fil-grupp tal-kontroll.
English: Remicade contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Remicade fih anqas minn 1 mmol sodium (23 mg) f'kull doża, li tista' tgħid huwa essenzjalment ‘ħieles mis-sodium'.
English: • Infections of the vagina
Maltese: • Infezzjonijiet tal-vaġina
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Maltese: Antikorpi antinukleari (ANA)/ antikorpi kontra double stranded DNA (dsDNA) Madwar nofs il-pazjenti li ngħataw infliximab fi studji kliniċi u li fil-bidu kienu negattivi għal ANA fil-linja bażi żviluppaw ANA waqt l-istudju meta mqabbel ma' madwar wieħed minn kull ħames pazjenti li ġew ikkurati bi plaċebo.
English: Infliximab + AZA Combination Therapy
Maltese: Kura mħallta b'infliximab + AZA
English: Cases of agranulocytosis have also been reported (see section 4.8).
Maltese: Kienu rrappurtati wkoll każijiet ta' agranuloċitosi (ara sezzjoni 4.8).
English: Adequate data of treating patients who are carriers of HBV with antiviral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Maltese: M'hemmx dejta adegwata dwar il-kura ta' pazjenti li jġorru HBV b'terapija antivirali flimkien ma' antagonist-TNF sabiex tiġi evitata lattivazzjoni mill-ġdid tal-HBV.
English: Rare: Apathy.
Maltese: Apatija.
English: Antibodies to infliximab developed in 38% of patients receiving 3 mg/kg compared with 12% of patients receiving 6 mg/kg.
Maltese: Antikorpi għal infliximab żviluppaw f'38% tal-pazjenti li kienu qed jirċievu 3 mg/kg imqabbla ma' 12% tal-pazjenti li kienu qed jirċievu 6 mg/kg.
English: Therefore, the combination of Remicade and anakinra is not recommended.
Maltese: Għalhekk, il-kombinazzjoni ta' Remicade u anakinra mhijiex rakkomandata.
English: Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab.
Maltese: Esperjenza klinika turi li d-difiża tal-host kontra l-infezzjonijiet tiġi kompromessa f'xi pazjenti li jingħataw infliximab.
English: Rare: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Maltese: Limfoma, limfoma mhux ta' Hodgkin, marda ta' Hodgkin, lewkimja, melanoma, kanċer tal-għonq tal-utru.
English: One serious infusion reaction (< 1%) occurred in a patient on infliximab monotherapy.
Maltese: Seħħet reazzjoni għall-infużjoni waħda ta' grad serju (< 1%) f'pazjent li kien fuq terapija b'infliximab waħdu.
English: Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6, and then every 4 or 8 weeks thereafter.
Maltese: Pazjenti rċevew plaċebo, 3 mg/kg jew 10 mg/kg infliximab f'ġimgħat 0, 2 u 6, u mbagħad kull 4 jew 8 ġimgħat minn hemm 'il quddiem.
English: In Phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Maltese: III, 18% tal-pazjenti kkurati b'infliximab kellhom reazzjoni marbuta mal-infużjoni meta mqabbel ma' 5% tal-pazjenti kkurati bi plaċebo.
English: Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Maltese: Irrikonoxximent minn kmieni ta' preżentazzjonijiet kliniċi mhux tipiċi ta' infezzjonijiet serji u ta' preżentazjoni klinika tipika ta' infezzjonijiet rari u mhux tas-soltu huwa kritiku sabiex jitnaqqsu ddewmien tad-dijanjosi u l-kura.
English: Rare: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Maltese: Mard tal-interstizju tal-pulmun (inkluż mard li javvanza malajr, fibrożi fil-pulmun u pnewmonite).
English: Uncommon: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Maltese: Mhux komuni: Reazzjoni anafilattika, sindrome bħal tal-lupus, marda tas-serum jew reazzjoni bħal marda tas-serum.
English: At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Maltese: Fl-aħħar stima li saret, 57% tal-pazjenti li kienu ngħataw infliximab baqgħu pożittivi għal kontra dsDNA.
English: After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Maltese: Wara espożizzjoni in utero għal infliximab, it-trabi jistgħu jkunu f'riskju akbar ta' infezzjoni, inkluż infezzjoni mifruxa serja li tista' ssir fatali.
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Maltese: B'kollox 573 pazjenti bil-marda ta'Crohn attiva b'mod moderat sa sever (CDAI ≥ 220 ≤ 400) irċevew infużjoni waħda ta' 5 mg/kg f'ġimgħa 0. 178 mill-580 pazjent irreġistrat (30.
English: • Swollen lymph nodes
Maltese: • Għoqod tal-limfa minfuħin
English: Remicade is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Maltese: Remicade huwa indikat għall-kura ta' kolite ulċerattiva attiva ħafna, fi tfal u adolexxenti li għandhom minn 6 sa 17-il sena, li kellhom rispons mhux adegwat għal terapija konvenzjonali inkluż kortikosterojdi u 6-MP jew AZA, jew li huma intolleranti għal jew għandhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn.
English: Infusion reactions occurred in 35% of patients with juvenile rheumatoid arthritis receiving 3 mg/kg compared with 17.5% of patients receiving 6 mg/kg.
Maltese: Reazzjonijiet tal-infużjoni seħħew f'35% tal-pazjenti b'artrite rewmatojde ġuvenili li kienu qed jirċievu 3 mg/kg imqabbla ma' 17.5% tal-pazjenti li kienu qed jirċievu 6 mg/kg.
English: Paediatric Crohn's disease
Maltese: Marda ta' Crohn fistulanti
English: • Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
Maltese: • Sinjali ta' problema fis-sistema nervuża (inklużi problemi fl-għajnejn) bħal sinjali ta' puplesija (tnemnim jew dgħufija f'daqqa waħda fil-wiċċ, fi driegħ jew riġel, speċjalment fuq naħa waħda ta' ġismek; konfużjoni f'daqqa waħda, diffikultà biex titkellem jew tifhem; diffikultà biex tara minn għajn waħda jew miż-żewġ għajnejn, diffikultà biex timxi, sturdament, telf tal-bilanċ jew tal-koordinazzjoni jew uġigħ ta' ras qawwi), aċċessjonijiet, tingiż/tnemnim fi kwalunkwe parti ta' ġismek, jew dgħjufija fid-dirgħajn jew fir-riġlejn, tibdil fil-vista bħal meta tara doppju jew problemi oħra tal-għajnejn.
English: Remicade 100 mg powder for concentrate for solution for infusion.
Maltese: Remicade 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Rare: Complement factor abnormal.
Maltese: Fattur tal-komplement mhux normali.
English: Week 10
Maltese: Ġimgħa 10
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Maltese: Każijiet ta' tumuri malinni, inkluż limfoma kienu wkoll irrappurtati fl-isfond ta' wara t-tqegħid fissuq (ara sezzjoni 4.4).
English: Not known: Myocardial ischaemia/myocardial infarction.
Maltese: Iskemija mijokardijaka/infart mijokardijaku.
English: In one of the study arms (group 2, n = 329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Maltese: F'wieħed mill-partijiet talistudji (grupp 2, n = 329), pazjenti li ma kellhomx rispons adegwat kellhom id-dożi ttitrati b'inkrementi ta' 1.5 mg/kg minn 3 sa 9 mg/kg.
English: In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Maltese: F'REACH, 17.5% tal-pazjenti li ntgħażlu b'mod każwali ħassew 1 jew aktar reazzjonijiet talinfużjoni.
English: At week 8, 45 patients were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Maltese: F'ġimgħa 8, 45 pazjent intgħażlu b'mod każwali u rċevew 5 mg/kg infliximab f'ġimgħa q8 jew f'ġimgħa q12 bħala skeda ta' kura ta' manteniment.
English: Each vial contains 100 mg of infliximab.
Maltese: Kull kunjett fih 100 mg ta' infliximab.
English: Not known: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Maltese: Mhux magħruf: Limfoma fil-fwied u fil-marrara taċ-ċelluli T (l-aktar f'adolexxenti u rġiel adulti żgħar bil-marda ta' Crohn jew kolite ulċerattiva), karċinoma taċ-ċellula ta' Merkel.
English: 178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Maltese: 7%) kienu definiti bħala li kellhom marda severa (punteġġ CDAI > 300 u kortikosterojdi fl-istess ħin u/jew immunosoppressanti) jikkorrispondu għall-popolazzjoni definita fl-indikazzjoni (ara sezzjoni 4.1).
English: Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Maltese: Ma jidhirx li kortikosterojdi jaffetwaw il-farmakokinetika ta' infliximab sa livell li huwa rilevanti b'mod kliniku.
English: Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Maltese: Infezzjonijiet seħħew f'68% (41/60) tat-tfal li kienu qed jirċievu 3 mg/kg fuq perjodu ta' 52 ġimgħa, 65% (37/57) tat-tfal li kienu qed jirċievu infliximab 6 mg/kg fuq perjodu ta' 38 ġimgħa u 47% (28/60) tat-tfal li kienu qed jirċievu plaċebo fuq perjodu ta' 14-il ġimgħa (ara sezzjoni 4.4).
English: Dizziness may occur following administration of Remicade (see section 4.8).
Maltese: Jista' jkun hemm sturdamenti wara l-għoti ta' Remicade (ara sezzjoni 4.8).
English: Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001).
Maltese: Il-kura b'infliximab naqqset r-rata tal-avvanz tal-ħsara periferali fil-ġogi meta mqabbla mal-kura bi plaċebo fil-punt aħħari primarju ta' ġimgħa 24 hekk kif imkejla mill-bidla milllinja bażi fil-punteġġ totali modifikat ta' vdH-S (medja ± punteġġ SD kien 0.
English: In clinical studies, infections have been reported in a higher proportion of paediatric patients compared to adult patients (see section 4.8).
Maltese: Fi studji kliniċi, kienu rrappurtati infezzjonijiet fi proporzjon akbar ta' pazjenti pedjatriċi meta mqabbla ma' pazjenti adulti (ara sezzjoni 4.8).
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Maltese: Fi trabi esposti in utero għal infliximab, kien irrappurtat riżultat fatali minħabba infezzjoni mifruxa kkawżata minn Bacillus Calmette Guérin (BCG) wara l-għoti tat-tilqima ta' BCG wara t-twelid.
English: Nearly 50% of reported deaths have been associated with infection.
Maltese: Kważi 50% tal-imwiet irrappurtati kienu assoċjati ma' infezzjoni.
English: Week 30 Clinical Response
Maltese: Ġimgħa 30 Rispons Kliniku
English: Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Maltese: Remicade intwera li jtejjeb il-funzjoni fiżika f'pazjenti b'artrite psorijatika, u li jnaqqas ir-rata li bih tavvanza l-ħsara periferali fil-ġogi hekk kif imkejla bl-X-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda (ara sezzjoni 5.1).
English: List of other medicines:
Maltese: Kategorija farmakoterapewtika:
English: Nine of these patients developed malignancies, including 1 lymphoma.
Maltese: Disgħa minn dawn il-pazjenti żviluppaw tumuri malinni, inkluża limfoma.
English: The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Maltese: L-effikaċja ta' Remicade f'ġimgħa 54 kienet evalwata mill-istudju ACT 1.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Maltese: Uħud minn dawn l-infezzjonijiet kienu fatali; l-infezzjonijiet opportunistiċi li kienu irrappurtati l-aktar frekwenti b'rata ta' mortalità > 5% jinkludu pnewmoċistożi, kandidijasi, listerjożi u asperġillożi.
English: No further clinically relevant accumulation was observed.
Maltese: L-ebda akkumulazzjoni oħra li kienet klinikament rilevanti ma ġiet osservata.
English: All infliximab
Maltese: Kontroll infliximab
English: At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab (see section 4.6).
Maltese: Huwa rakkomandat perjodu ta' mill-inqas sitt xhur wara t-twelid qabel l-għoti ta' tilqim ħaj lil trabi esposti in utero għal infliximab (ara sezzjoni 4.6).
English: Before reconstitution: 3 years at 2 °C - 8 °C.
Maltese: Qabel ir-rikostituzzjoni: 3 snin f'temperatura ta' 2 °C - 8 °C.
English: Chronic Obstructive Pulmonary Disease (COPD) or if you are a heavy smoker.
Maltese: Marda Kronika Ostruttiva tal-Pulmun (COPD) jew jekk tpejjep ħafna.
English: Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
Maltese: B'mod globali, 8 (13.3%) mis-60 pazjent ikkurati kellhom esperjenza ta' reazzjoni għall-infużjoni waħda jew aktar, b'4 minn 22 (18.2%) fil-grupp ta' kura ta' manteniment ta' q8 ġimgħat u 3 minn 23 (13.0%) fil-grupp ta' kura ta' manteniment ta' q12-il ġimgħa.
English: Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
Maltese: Perċentwali ta' individwi li kellhom tnaqqis kliniku u tnaqqis sostnut Rispons kliniku f'ġimgħa 8
English: During the 16-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, and 14 (52 patients in each group).
Maltese: Waqt is-16-il ġimgħa tal-fażi double-blind, il-pazjenti rċevew 5 mg/kg infliximab jew plaċebo f'ġimgħat 0, 2, 6, 14 (52 pazjent f'kull grupp).
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Remicade.
Maltese: Id-dilwizzjoni tista' ssir billi jinġibed volum tas-soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) mil-flixkun tal-ħġieġ jew borża tal-infużjoni ta' 250 ml li jkun daqs il-volum ta' Remicade rikostitwit.
English: Similar trends in the achievement of corticosteroid-free clinical remission were observed at week 50.
Maltese: Tendenzi jixxiebhu fil-kisba ta' nuqqas totali ta' sinjali u sintomi kliniċi mingħajr kortikosterojdi kienu osservati f'ġimgħa 50.
English: In group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Maltese: Fi grupp 2, mis-36 ġimgħa, pazjenti li kellhom BASDAI ≥ 3 wara żewġ viżti konsekuttivi, irċevew 7.5 mg/kg infliximab kull 6 ġimgħat minn hemm 'il quddiem sa ġimgħa 96.
English: Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Maltese: Dejta farmakokinetika disponibbli hi deskritta fis-sezzjoni 5.2 imma l-ebda rakkomandazzjoni dwar ilpożoloġija ma tista' tingħata fi tfal li għandhom inqas minn 6 snin.
English: Patients assessed by the investigator to be in clinical response at week 10 were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Maltese: Pazjenti li kienu evalwati mill-investigatur bħala li kellhom rispons kliniku f'ġimgħa 10 intgħażlu b'mod każwali u rċevew 5 mg/kg infliximab f'ġimgħat q8 jew ġimgħat q12 bħala kors ta' kura ta' manteniment.
English: Ulcerative colitis Paediatric Ulcerative colitis
Maltese: Kolite ulċerattiva fit-tfal
English: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Maltese: HAQ =Kwestjonarju Dwar l-Evalwazzjoni tas-Saħħa; valuri ikbar jindikaw inqas diżabilità.