FrancophonIA/ELRC3.0 huggingface dataset:
English: Sixty-eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Maltese: Tmienja u sittin fil-mija (21/31) tal-pazjenti li ngħataw infliximab b'kors b'doża ta' 5 mg/kg kellhom reazzjoni klinika kontra 26% (8/31) tal-pazjenti li ngħataw plaċebo (p=0.002).
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 il5 mg/kg kull 6 ġimgħat.
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p <0.001).
Maltese: Fir-4 ġimgħa, wara l-għoti ta' doża waħda tal-mediċina studjata, 22/27 (81%) tal-pazjenti kkurati b'infliximab li ngħataw doża ta' 5 mg/kg kellhom rispons kliniku kontra 4/25 (16%) tal-pazjenti li ngħataw plaċebo (p < 0.001).
English: Inflectra 100 mg powder for concentrate for solution for infusion
Maltese: Inflectra 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: For patients receiving corticosteroids at baseline, the proportion of patients in remission and not receiving corticosteroids at week 54 was 38.5% (5/13) for the q8 week and 0% (0/13) for the q12 week maintenance treatment group.
Maltese: Għall-pazjenti li kienu qed jirċievu kortikosterojdi fil-linja bażi, il-proporzjon ta' pazjenti fi tnaqqis u li ma kinux qed jirċievu kortikosterojdi f'ġimgħa 54 kien ta' 38.5% (5/13) filgrupp ta' kura ta' manteniment ta' q8 ġimgħat u 0% (0/13) fil-grupp ta' kura ta' manteniment ta' q12-il ġimgħa.
English: Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Maltese: Fattur alfa tan-nekrożi tat-tumur (TNFα) jikkontrolla l-infjammazzjoni u jimmodula r-rispons immuni taċ-ċelluli.
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 infliximab, 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 infliximab, jistgħu jisiltu rispons immuni aktar baxx milli f'pazjenti li ma jkunux qed jirċievu terapija kontra TNF.
English: During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
Maltese: Waqt l-24 ġimgħa tal-fażi double-blind, pazjenti rċevew 5 mg/kg infliximab jew placebo f'ġimgħa 0, 2, 6, 14 u 22 (100 pazjent f'kull grupp).
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fissezzjonijiet 4.8 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna sa 25°C qabel ir-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: • Blood test result showing ‘antibodies' against your own body.
Maltese: • Riżultat ta' test tad-demm li juri “antikorpi” kontra ġismek stess.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Maltese: Infliximab huwa antikorp monoklonali - tip ta' proteina li teħel ma' mira speċifika fil-ġisem imsejħa TNF (fattur tannekrosi tat-tumur - tumour necrosis factor) alfa.
English: Inflectra 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: Inflectra 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: Maintenance treatment in fistulising active Crohn's disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (ACCENT II).
Maltese: L-effikaċja ta' infużjonijiet ripetuti ta' infliximab f'pazjenti bil-marda ta' Crohn fistulizzanti kienet studjata fi studju kliniku ta' sena (ACCENT II).
English: Concurrent use of stable doses of oral corticosteroids (≤10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Maltese: (≤ 10 mg/kuljum) u/jew NSAIDs ġie permess, u ngħataw supplementi ta' folate.
English: Neutropenia, leukopenia, anaemia, lymphadenopathy.
Maltese: Newtropenija, lewkopenija, anemija, limfadenopatija.
English: The required volume of the reconstituted Inflectra solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: Il-volum meħtieġ tad-doża tas-soluzzjoni rikostitwita Inflectra għandu jiġi dilwit għal 250 mL b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/mL (0.9%).
English: 3 vials
Maltese: III funzjonali.
English: Inflectra contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Inflectra fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles missodium'.
English: Inflectra contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Maltese: Infliximab għandu jintuża b'attenzjoni f'pazjenti b'insuffiċjenza ħafifa tal-qalb (NYHA klassi I/II).
English: Each Inflectra vial contains 100 mg infliximab.
Maltese: Kull kunjett fih 100 mg ta' infliximab.
English: Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Maltese: Inflectra huwa indikat għall-kura ta' ankylosing spondylitis attiva, severa, f'pazjenti adulti li ma kellhomx rispons adegwat għal terapija konvenzjonali.
English: N ≥ 90% improvement a
Maltese: 38 ġimgħa
English: Eighty-nine percent (50/56) of patients who lost clinical response on infliximab 5 mg/kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/kg.
Maltese: Disgħa u tmenin fil-mija (50/56) tal-pazjenti li tilfu r-rispons kliniku fuq infliximab 5 mg/kg bħala terapija ta' manteniment wara ġimgħa 14 kellhom rispons għal kura b'infliximab 10 mg/kg.
English: PASI 75 response**
Maltese: ACR 50 rispons*
English: • Infections due to a weakened immune system
Maltese: • Infezzjoni minn tilqima ħajja minħabba sistema immuni mdgħajfa
English: Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Maltese: Inflectra jintuża għal kura tal-marda ta' Crohn attiva, severa, fi tfal u adoloxxenti ta' etajiet bejn 6 sa 17-il sena, li ma kellhomx rispons għat-terapija konvenzjonali inklużi kortikosterojd, immunomodulatur u terapija ta' nutrizzjoni primarja, jew li huma intolleranti jew għandhom kontraindikazzjonijiet għal dawn it-tipi ta' terapiji.
English: Therefore, the combination of infliximab and anakinra is not recommended.
Maltese: Għalhekk, il-kombinazzjoni ta' infliximab u anakinra mhijiex rakkomandata.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Maltese: F'pazjenti b'artrite psorijatika li rċevew 5 mg/kg b'methotrexate jew mingħajru, fi 15% tal-pazjenti seħħew antikorpi (l-antikorpi seħħew f'4% tal-pazjenti li rċevew methotrexate u f'26% tal-pazjenti li ma kinux qed jirċievu methotrexate fil-linja bażi).
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: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: • Store in a refrigerator (2 °C - 8 °C).
Maltese: • Aħżen fi friġġ (2C - 8C).
English: e HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Maltese: e HAQ=Kwestjonarju Dwar l-Evalwazzjoni tas-Saħħa; valuri ikbar jindikaw inqas diżabilità.
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 Inflectra.
Maltese: Id-dilwizzjoni tista' ssir billi jinġibed volum tas-soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/mL (0.9%) mill-flixkun tal-ħġieġ jew borża tal-infużjoni ta' 250 mL li jkun daqs il-volum ta' Inflectra rikostitwit.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C - 8 °C and for an additional 24 hours at 25 C after removal from refrigeration.
Maltese: L-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni ddilwita intweriet sa 28 jum f'temperatura bejn 2 °C u 8 °C u għal 24 siegħa addizzjonali f'temperatura ta' 25C wara li titneħħa mill-friġġ.
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: Sustained response (clinical response at both week 8 and week 30)a
Maltese: Rispons sostnut (rispons kliniku f'ġimgħa 8 kif ukoll f'ġimgħa 30)
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Maltese: Limfoma fil-fwied u fil-marrara taċ-ċelluli T (l-aktar f'adolexxenti u adulti żgħażagħ irġiel bil-marda ta' Crohn u kolite ulċerattiva), karċinoma taċ-ċellula ta' Merkel.
English: • If you received Inflectra during your pregnancy, your baby may have a higher risk for getting an infection.
Maltese: • Jekk irċevejt Inflectra waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju akbar li tieħu infezzjoni.
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: >40 weeks
Maltese: > 40 ġimgħa
English: Inflectra works by selectively attaching to TNF alpha (tumour necrosis factor alpha) and blocking its action.
Maltese: Inflectra jaħdem billi selettivament jeħel ma' TNF alfa (fattur tan-necrożi tat-tumur alfa) u jimblokka l-azzjoni tagħha.
English: One vial contains 100 mg of infliximab*.
Maltese: Kunjett wieħed fih 100 mg ta' infliximab*.
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 rrappurtati l-aktar frekwenti b'rata ta' mortalità > 5% jinkludu pnewmoċistożi, kandidijasi, listerjożi u asperġillożi.
English: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Maltese: Joħorġu l-imsiemer, seborreja, rosaċeja, papilloma tal-ġilda, iperkeratożi, kulur tal-ġilda anormali.
English: 3 mg/kg q 8 wks
Maltese: Kontroll a 3 mg/kg q 8 ġimgħ at
English: Patients with no deterioration/patients evaluated (%)
Maltese: Pazjenti li ma marrux għallagħar/pazjenti evalwati (%)
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state medicinal product exposure in adults.
Maltese: Wara għoti ta' 5 mg/kg ta' infliximab kull 8 ġimgħat, il-medjan imbassar tal-esponiment fi stat fiss ta' infliximab (żona taħt il-kurva konċentrazzjoni-ħin fi stat fiss, AUCss) f'pazjenti pedjatriċi li kellhom minn 6 snin sa 17-il sena kien madwar 20% iktar baxx mill-medjan imbassar tal-espożizzjoni tal-prodott mediċinali fi stat fiss f'persuni adulti.
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC AZA Monotherapy
Maltese: Tabella 6 Perċentwali ta' pazjenti li kisbu nuqqas totali tas-sinjali u s-sintomi kliniċi mingħajr kortikosterojdi f'ġimgħa 26, SONIC
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: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n=45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Maltese: It-tnaqqis fl-inċidenza tal-kolektomija kien eżaminat ukoll fi studju ieħor li fih il-parteċipanti ntgħażlu b'mod każwali, double blind (C0168Y06) f'pazjenti fl-isptar (n=45) b'kolite ulċerattiva moderata sa severa li ma kellhomx rispons għal kortekosterojdi ġol-vini u li għalhekk kellhom riskju akbar li jkollhom kolektomija.
English: • Viral infections such as herpes or flu
Maltese: • Infezzjonijiet ikkawżati minn virus bħal herpes jew influwenza
English: • you have heart failure that is moderate or severe.
Maltese: • int għandek insuffiċjenza tal-qalb li tkun moderata jew severa.
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 millinja bażi fil-punteġġ totali modifikat ta' vdH-S (medja ± punteġġ SD kien 0.
English: Inflectra 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: Inflectra 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: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' infliximab fi tfal u adoloxxenti iżgħar minn 18-il sena għall-indikazzjoni tal-artrite idjopatka ġuvenili, artrite psorijatika u ankylosing spondylitis ma ġewx determinati s'issa.
English: In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Maltese: F'rapporti li saru b'mod spontanju wara t-tqegħid fis-suq, infezzjonijiet kienu l-aktar reazzjoni avversa serja.
English: EXP
Maltese: EXPRESS
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils
Maltese: • Problemi oħra fil-ġilda bħal eritema multiforme, infafet u ġilda titqaxxar, jew imsiemer
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively).
Maltese: In-numru ta' dawk li kellhom imorru l-isptar minħabba kolite ulċerattiva kien aktar baxx b'mod sinifikanti filgruppi ta' kura b'5 u 10 mg/kg infliximab milli fil-grupp tal-plaċebo (il-medja tan-numru ta' dawk li marru l-isptar għal kull 100 sena ta' individwu: 21 u 19 kontra 40 fil-grupp tal-plaċebo; p=0.019 u p=0.007, rispettivament).
English: Week 54 Clinical Response a
Maltese: Rispons kliniku f'ġimgħa 8
English: Concurrent administration of TNF-alpha inhibitor and anakinra
Maltese: • Jinġabar id-demm barra l-kanali tad-demm (ematoma) jew tbenġil
English: • Serious lung problems (such as interstitial lung disease)
Maltese: • Problemi serji fil-pulmun (bħal mard tal-interstizju tal-pulmun)
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may, be life-threatening.
Maltese: • Dawn l-infezzjonijiet jistgħu jkunu serji u jinkludu tuberkulożi, infezzjonijiet ikkawżati minn viruses, fungi, batterji jew organiżmi oħra fl-ambjent u sepsi li tista', tkun ta' periklu għallħajja.
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Maltese: • Sinjali ta' infezzjoni (inkluża TB) bħal deni, tħossok għajjien, sogħla li tista' tkun persistenti, qtugħ ta' nifs, sintomi bħal tal-influwenza, telf tal-piż, issir għarqan/a bil-lejl, dijarea, ġrieħi, tinġabar il-materja fil-musrana jew madwar l-anus (axxess), problemi fis-snien jew sensazzjoni ta' ħruq meta tgħaddi l-awrina.
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab, cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.
Maltese: Każijiet (xi wħud fatali) ta' iskemija/infart mijokardijaku ġew rapportati, xi wħud b'assoċjazzjoni temporali viċina ma' infużjoni ta' infliximab, inċidenti ċerebrovaskulari ġew irrappurtati wkoll qrib ħafna l-ħin tal-infużjoni ta' infliximab.
English: • It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB.
Maltese: • Huwa importanti ħafna li tgħid lit-tabib tiegħek jekk qattx kellek it-tuberkulożi (TB), jew jekk kellek kuntatt mill-qrib ma' xi ħadd li kellu t-TB.
English: Placebo Maintenance (n=99)
Maltese: ACCENT II (Persuni li rrispondew sa ġimgħa 14) Manteniment bi Plaċebo (n=99)
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Maltese: • It-tabib tiegħek ser jittestjak biex jara jekk għandekx TB.
English: Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Maltese: Inflectra, flimkien ma' methotrexate, huwa indikat għat-tnaqqis fis-sinjali u s-sintomi kif ukoll għattitjib fil-funzjoni fiżika:
English: Brand name: Batch number:
Maltese: Numru tal-lott:
English: In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Maltese: Fi studju li dam 6 xhur dwar tossiċità b'dożi ripetuti li sar fil-ġrieden, fejn intuża l-istess antikorp analogu kontra TNFα tal-ġrieden, depożiti kristallini kienu osservati fuq il-kapsula tal-lenti ta' wħud mill-ġrieden irġiel ikkurati.
English: • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Maltese: • jew waħdu f'pazjenti li juru intolleranza għal methotrexate jew li għalihom methotrexate huwa kontra-indikat.
English: Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety follow-up.
Maltese: Pazjenti li ma rrispondewx għal infliximab f'ġimgħa 8 (n=15) ma rċevewx aktar prodott mediċinali u rritornaw għall-vista ta' sigurtà.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with infliximab cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż riskju għall-iżvilupp ta' limfoma fil-fwied u l-marrara kkawżata minn ċelluli T f'pazjenti kkurati b'infliximab (ara sezzjoni 4.8).
English: Induction treatment in fistulising active Crohn's disease The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration.
Maltese: L-effikaċja ġiet valutata wkoll fi studju li ntgħażlu b'mod każwali, double-blinded, ikkontrollat bi plaċebo f'94 pazjent bil-marda ta' Crohn fistulizzanti li kellhom fistuli li kienu ilhom mill-inqas 3 xhur.
English: >54 weeks
Maltese: Ġimgħa 54
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximab-treated patients compared with control patients.
Maltese: Fi studju kliniku ta' stħarriġ li evalwa l-użu ta' infliximab f'pazjenti b'mard ostruttiv kroniku talpulmun (COPD) minn moderat sa sever, kien hemm aktar tumuri rrappurtati fil-pazjenti kkurati b'infliximab meta mqabbla ma' pazjenti tal-kontroll.
English: 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Maltese: F'ġimgħa 102 kien hemm 49 individwu li kienu għadhom fuq il-kura b'infliximab u fost dawk, 30 (61%) kellhom rispons BASDAI 50.
English: Inflectra and Kineret should not be used together.
Maltese: Il-kombinazzjoni ta' infliximab ma' abatacept mhux rakkomandata.
English: The co-primary endpoints were the proportion of patients in clinical remission (CDAI < 150) at week 30 and time to loss of response through week 54.
Maltese: Il-ko-punti aħħarin ewlenin kienu l-proporzjon ta' pazjenti fit-tnaqqis kliniku (CDAI< 150) f'ġimgħa 30 u ż-żmien sakemm intilef ir-rispons sa ġimgħa 54.
English: Juvenile rheumatoid arthritis
Maltese: Artrite rewmatojde