FrancophonIA/ELRC3.0 huggingface dataset:
English: Flixabi is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Madankollu, Flixabi jiġi ddilwit f'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays.
Maltese: Infliximab jinibixxi l-attività funzjonali ta' TNFα f'varjetà kbira ta' bioassays in vitro.
English: a a p < 0.001, for each infliximab treatment group vs. placebo
Maltese: a a p < 0.001, għal kull grupp ta' infliximab vs. plaċebo.
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: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c
Maltese: PGA ta' pazjenti bid-dwiefer imfejqa (0) jew minimu (1) PGA ta' pazjenti bid-dwiefer imfejqa (0), minimu (1), jew ħafif (2)
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Maltese: Titqib fil-musrana, stenożi fil-musrana, divertikulite, pankreatite, kejlite.
English: Flixabi contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Flixabi fih inqas minn 1 mmol sodium (23 mg) f'kull doża, i.e. huwa essenzjalment ‘ħieles mis-sodium.
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p < 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Maltese: Il-proporzjonijiet ta' pazjenti b'fejqan tal-membrana mukuża f'ġimgħa 26 kienu ogħla b'mod sinifikanti fil-gruppi tal-kombinazzjoni ta' infliximab flimkien ma' AZA (43.9%, p < 0.001) u ta' terapija b'infliximab waħdu (30.1%, p=0.023) meta mqbbla mal-grupp ta' terapija b'AZA waħdu (16.5%).
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Maltese: F'C0168T72, laktar reazzjonijiet avversi komuni kienu infezzjoni fil-parti ta' fuq tal-apparat respiratorju, farinġite, uġigħ addominali, deni u wġigħ ta' ras.
English: Other medicines and Flixabi
Maltese: Mediċini oħra u Flixabi
English: Date of Flixabi therapy initiation:
Maltese: Data ta' meta bdiet it-terapija b'Flixabi:
English: Among patients classified as non-responders at week 2, 32% (26/81) in the placebo maintenance group and 42% (68/163) in the infliximab group achieved clinical response by week 6.
Maltese: Fost il-pazjenti kklassifikati bħala persuni li ma rrispondewx f'ġimgħa 2, 32% (26/81) fil-grupp ta' manteniment fuq plaċebo u 42% (68/163) fil-grupp fuq infliximab kisbu rispons kliniku sas-6 ġimgħa.
English: Flixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Flixabi hu indikat għall-kura ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat għat-terapija konvenzjonali, inkluż kortikosterojdi u 6-mercaptopurine (6-MP) jew azathioprine (AZA), jew li huma intolleranti għal jew għandhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn.
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Maltese: Fit-tieni studju kliniku (ASSERT), 279 pazjent intgħażlu b'mod każwali sabiex jirċievu jew plaċebo (Grupp 1, n=78) jew 5 mg/kg infliximab (Grupp 2, n=201) f'ġimgħa 0,2 u 6 u kull 6 ġimgħat sa ġimgħa 24.
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Maltese: • Is-sustanzi mhux attivi l-oħra huma sucrose, polysorbate 80, monobasic sodium phosphate monohydrate u dibasic sodium phosphate heptahydrate.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Maltese: Immunosoppressanti, immunosoppressanti, inibituri tal-fattur tannekrożi alfa (TNFα) Kodiċi ATC:
English: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Maltese: Infezzjonijiet batterjali (eż. sepsis, ċellulite, axxess)
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Maltese: Tuberkulożi, infezzjonijiet ikkawżati minn moffa (eż. Kandidijażi, onikomikożi).
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Maltese: Madwar 93% tal-pazjenti qabel kienu ngħataw antibjotiċi jew terapija immunosoppressiva.
English: Vertigo, dizziness, hypoaesthesia, paraesthesia.
Maltese: Vertigo, sturdament, ipoestesija, parestesija.
English: Before reconstitution 4 years at 2°C - 8°C.
Maltese: Aħżen f'temperatura ta' 2°C - 8°C.
English: Concurrent use of stable doses of oral corticosteroids (≤ 10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Maltese: Użu fl-istess ħin ta' kortikosterojdi orali (≤ 10 mg/kuljum) u/jew NSAIDs ġie permess, u ngħataw supplementi ta' folate.
English: In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46.
Maltese: Fiż-żewġ studji, li fihom il-pazjenti ntgħażlu b'mod każwali biex jirċievu plaċebo, jew 5 mg/kg infliximab, jew 10 mg/kg infliximab f'ġimgħa 0, 2, 6, 14 u 22, u fl-ACT 1 f'ġimgħat 30, 38 u 46.
English: Infliximab Monotherapy
Maltese: * Infliximab huwa antikorp monoklonali
English: The following side effects have been observed with infliximab:
Maltese: Dawn l-effetti sekondarji li ġejjin ġew osservati b'infliximab:
English: In rheumatoid arthritis patients who received the recommended repeated treatment dose regimens with methotrexate, 8% of patients developed antibodies to infliximab.
Maltese: F'pazjenti b'artrite rewmatojde li rċivew korsijiet ta' kura b'dożi ripetuti rakkomandati ma' methotrexate, 8% tal-pazjenti żviluppaw antikorpi għal infliximab.
English: At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p < 0.01).
Maltese: F'ġimgħa 12, in-numru ta' dawk li kellhom rispons BASDAI 50 kienu 3.35 (9%) fil-grupp tal-plaċebo, u 20/35 (57%) fil-grupp tal5 mg/kg (p < 0.01).
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patientsyears (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Maltese: Fi studji kliniċi follow-up dwar is-sigurtà fit-tul b'infliximab li ħadu sa 5 snin, li jirrappreżentaw 6,234 snin ta' pazjenti (3,210 pazjenti), 5 każijiet ta' limfomi u 38 każijiet ta' tumuri malinni mhux limfomi kienu rrappurtati.
English: Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/kg infliximab compared to patients who received placebo (29.2% vs. 66.7% respectively, p=0.017).
Maltese: Kien hemm numru anqas b'mod sinifikanti ta' kolektomiji fit-3 xhur talistudju f'pazjenti li rċevew doża waħda ta' 5 mg/kg infliximab meta mqabbla ma' pazjenti li rċevew plaċebo (29.2% kontra 66.7% rispettivament, p=0.017).
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Maltese: Analiżi farmakokinetika tal-popolazzjoni bbażata fuq dejta miksuba minn pazjenti b'kolite ulċerattiva (N=60), marda ta' Crohn (N=112), artrite rewmatojde ġuvenili (N=117) u l-marda ta' Kawasaki (N=16) b'medda totali ta' età minn xahrejn sa 17-il sena, indikat espożizzjoni għal infliximab li kienet tiddependi fuq il-piż tal-ġisem b'mod mhux lineari.
English: It is recommended that therapeutic infectious agents not be given concurrently with Flixabi (see section 4.4).
Maltese: Huwa rrakkomandat li sustanzi terapewtiċi infettivi ma jingħatawx flimkien ma' Flixabi (ara sezzjoni 4.4).
English: In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Maltese: Fi studju kliniku ta' pazjenti bil-marda ta' Crohn (SONIC), reazzjonijiet marbuta mal-infużjoni seħħew f'16.6% (27/163) tal-pazjenti li kienu qed jirċievu terapija b'infliximab waħdu, f'5% (9/179) talpazjenti li kienu qed jirċievu infliximab flimkien ma' AZA, u f'5.6% (9/161) tal-pazjenti li kienu qed jirċievu terapija b'AZA waħdu.
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Maltese: Tromboċitopenija, limfopenija, limfoċitożi
English: For volumes greater than 250 ml, either use a larger infusion bag (e.g. 500 ml, 1000 ml) or use multiple 250 ml infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/ml.
Maltese: Għal volumi akbar minn 250 ml, uża borża tal-infużjoni akbar (eż. 500 ml, 1000 ml) jew uża boroż tal-infużjoni ta' 250 ml multipli biex tkun ċert li l-konċentrazzjoni tas-soluzzjoni għall-infużjoni ma tkunx aktar minn 4 mg/ml.
English: Flixabi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Maltese: Flixabi hu indikat għall-kura ta' ankylosing spondylitis attiva, severa, f'pazjenti adulti li ma kellhomx rispons adegwat għal terapija konvenzjonali.
English: For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8).
Maltese: Għal aktar informazzjoni dwar is-sigurtà ta' infliximab f'pazjenti anzjani (ara sezzjonijiet 4.4 u 4.8).
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001, respectively).
Maltese: Tnaqqis kliniku u fejqan tal-mukuża seħħew fi proporzjon akbar ta' pazjenti fil-grupp ta' kura li kienu fuq infliximab kombinat meta mqabbla mal-grupp ta' kura fuq ilplaċebo f'ġimgħa 54 (34.6% vs 16.5%, p < 0.001 u 46.1% vs 18.2%, p < 0.001, rispettivament).
English: There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including infliximab.
Maltese: Kien hemm rapporti ta' panċitopenija, lewkopenija, newtropenija, u tromboċitopenija f'pazjenti li kienu qed jirċievu imblokkaturi ta' TNF, inkluż infliximab.
English: * ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Maltese: Bażata fuq pazjenti li kellhom PASI > 2.5 fil-linja bażi għal IMPACT, u pazjenti b'> 3% BSA kellhom ukoll ġilda bi psorjasi fil-linja bażi f'IMPACT 2. ** Rispons PASI 75 għal IMPACT mhux inkluż minħabba N baxx; p < 0.001 għal infliximab vs plaċebo f'ġimgħa 24 għal IMPACT 2.
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebotreated patients (p=0.001).
Maltese: Barra dan, kien hemm għeluq tal-fistuli kollha f'55% tal-pazjenti lingħataw infliximab meta mqabbel ma' 13% tal-pazjenti li ngħataw plaċebo (p=0.001).
English: 8 and week 30)a
Maltese: 38 ġimgħa
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Maltese: Wara ġimgħa 54, 44.9% talpazjenti fil-grupp ta' kura b'infliximab kombinat kellhom rispons kliniku meta mqabbla ma' 19.8% filgrupp ta' plaċebo (p < 0.001).
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Maltese: Minħabba l-limitazzjonijiet fil-metodoloġija, assay negattiv ma teskludix il-presenza ta' antikorpi għal infliximab.
English: The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Maltese: Is-sigurtà u l-effikaċja ta' infliximab kienu evalwati fi studju kliniku, b'aktar minn ċentru wieħed, li fih il-parteċipanti ntgħażlu b'mod każwali, open label u bi grupp parallel (C0168T72) f'60 pazjent pedjatriku b'età minn 6 sa 17-il sena (età medjana ta' 14.5 snin) b'kolite bl-ulċeri attiva b'mod moderat sa sever (punteġġ Mayo ta' 6 sa 12; sottopunteġġ endoskopiku ta' ≥ 2) b'rispons mhux adegwat għal terapiji konvenzjonali.
English: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Maltese: Mijelite transversa, disturbi li jneħħu l-majelin tas-sistema nervuża ċentrali (mard li jixbah l-isklerożi multipla u nevrite ottika), disturbi li jneħħu l-majelin tas-sistema periferali (bħal sindrome ta' Guillain-Barré, polinewropatija bit-telf tal-majelin b'infjammazzjoni kronika u newropatija motorjali multifokali).
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Maltese: III-IV CHF talNYHA (frazzjoni tal-volum tal-ventrikulu tax-xellug ppumpjat ≤ 35%) kienu kkurati bi tliet infużjonijiet ta' infliximab ta' 5 mg/kg, 10 mg/kg, jew plaċebo fuq sitt ġimgħat.
English: The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p < 0.001; and 20.2% vs. 6.6%, p < 0.001, respectively).
Maltese: Ilproporzjonijiet tal-pazjenti b'rispons sostnut u tnaqqis sostnut f'ġimgħa 54 kien akbar fil-grupp ta' kura b'infliximab milli fil-grupp ta' kura bil-plaċebo (37.9% vs. 14.0%, p < 0.001, u 20.2% vs 6.6%, p < 0.001, rispettivament).
English: Use of TNF-blocking agents, including infliximab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Maltese: L-użu ta' sustanzi imblokkaturi ta' TNF, inkluż infliximab kien assoċjat ma' każijiet ta' bidu mill-ġdid jew taħrix ta' sintomi kliniċi u/jew evidenza radjografika ta' disturbi li jneħħu l-majelin tas-sistema nervuża ċentrali, li jinkludu sklerożi multipla u disturbi li jneħħu l-majelin tas-sistema periferali, inkluża s-sindrome Guillain-Barré.
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Maltese: Fi studji kliniċi fejn intużat doża waħda jew ħafna dożi ta' infliximab li varjaw minn 1 sa 20 mg/kg, instabu antikorpi għal infliximab f'14% tal-pazjenti fuq xi terapija immunosoppressiva, u f'24% talpazjent mingħajr terapija immunosoppressiva.
English: Appropriate screening tests, e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Maltese: Screening tests adattati, (eż.test tal ġilda bit-tuberkulin , X-rays tas-sider, u/jew Assaġġ tar-Rilaxx tal-Interferon Gamma), għandhom isiru fuq il-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu jkunu applikati).
English: Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Maltese: Il-pazjenti rċevew 3 jew 6 mg/kg ta' infliximab bħal kors ta' induzzjoni bi 3 dożi (ġimgħat 0, 2, 6 jew ġimgħat 14, 16, 20 rispettivament) segwiti minn terapija ta' manteniment kull 8 ġimgħat, flimkien ma' methotrexate.
English: Circulatory failure, petechia, vasospasm.
Maltese: Insuffiċjenza ċirkolatorja, petekje, vażospażmu.
English: Dizziness may occur following administration of Flixabi (see section 4.8).
Maltese: Jista' jkun hemm sturdamenti wara l-għoti ta' Flixabi (ara sezzjoni 4.8).
English: One vial contains 100 mg of infliximab*.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 100 mg ta' infliximab*.
English: 3 Number of patients evaluated for ALT.
Maltese: Numru ta' pazjenti evalwati għal ALT.
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p=0.145 and p=0.022, respectively).
Maltese: In-numru ta' operazzjonijiet kiruġiċi relatati mal-kolite ulċerattiva kien ukoll aktar baxx fil-gruppi ikkurati b'5 u 10 mg/kg infliximab milli fil-grupp tal-plaċebo (il-medja tan-numru ta' dawk li kellhom operazzjonijiet kirurġiċi għal kull 100 sena ta' individwu: 22 u 19 kontra 34; p=0.145 u p=0.022, rispettivament).
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab.
Maltese: Tuberkulożi, infezzjonijiet batteriċi, inkluża sepsis u pulmonite, infezzjonijiet invażivi fungali, virali, u infezzjonijiet opportunistiċi oħra, ġew osservati f'pazjenti li kienu qed jirċievu infliximab.
English: Vaccine breakthrough infection (after in utero exposure to infliximab) Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Maltese: Infezzjoni kkawżata mit-tilqima nnifisha (wara espożizzjoni in utero għal infliximab) Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Rari:
English: Dilute the total volume of the reconstituted Flixabi solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Iddilwixxi l-volum totali tad-doża tas-soluzzjoni rikostitwita Flixabi għal 250 ml b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
Maltese: • Disturbi serji fis-sistema nervuża bħal mijelite transversa, mard jixbah lill-isklerożi multipla,
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils
Maltese: • Problemi oħra fil-ġilda bħal eritema multiforme, reazzjonijiet likenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq il-membrani mukużi), infafet u ġilda titqaxxar, jew imsiemer (furunkulożi)
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji bilprodott mediċinali ta' referenza li fih infliximab f'kull sett tal-popolazzjoni pedjatrika fl-artrite rewmatojde, artrite idjopatika taż-żgħar, artrite psorjatika, ankylosing spondylitis, psorjasi u l-marda ta' Crohn (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Maltese: Xokk anafilattiku, vaskulite, reazzjoni tat-tip sarkojd.
English: Crohn's disease2
Maltese: ANNESS II
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Maltese: Tuberkulożi, infezzjonijiet ta' batterji, li jinkludu sepsis u pulmonite, infezzjonijiet invażivi fungali, virali, u infezzjonijiet opportunistiċi oħra, ġew osservati f'pazjenti li ngħataw infliximab.
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Maltese: (1) l-evalwazzjoni globali tal-evalwatur, (2) l-evalwazzjoni globali talpazjent, (3) kejl tal-funzjonalità/diżabiltà, (4) skala viżwali analoga tal-uġigħ u (5) rata ta' sedimentazzjoni tal-eritroċiti jew proteina reattiva-Ċ.
English: • That treatment with Flixabi may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Maltese: • Li t-trattament b'Flixabi jista' jżid ir-riskji ta' infezzjonijiet serji/sepsi, infezzjonijiet opprotunistiċi, tuberkulożi, riattivazzjoni tal-epatite B, u ifiġġ BCG fi trabi b'esponiment għal infliximab in utero, u meta għandek tfittex għajnuna mingħand HCP
English: The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Maltese: L-effikaċja ta' infliximab f'ġimgħa 54 kienet evalwata mill-istudju ACT 1.
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 infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab 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 infliximab [n = 46]) kellhom żieda effettiva doppja fit-titri għal vaċċin pnewmokokkali polivalenti, li jindika li infliximab ma nterferixxiex mar-risponsi immuni tal-umuri indipendenti miċ-ċelluli T. 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 infliximab, jistgħu jisiltu rispons immuni aktar baxx milli f'pazjenti li ma jkunux qed jirċievu terapija kontra TNF.
English: There have been reports of active tuberculosis in patients receiving infliximab.
Maltese: Kien hemm rapporti ta' tuberkulożi attiva f'pazjenti li kienu qed jirċievu infliximab.