FrancophonIA/ELRC3.0 huggingface dataset:
English: Endoscopic studies of intestinal mucosa have shown evidence of mucosal healing in infliximab-treated patients.
Maltese: Studji endoskopiċi talmukuża tal-imsaren wrew evidenza ta' fejqan tal-mukuża f'pazjenti kkurati b'infliximab.
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of Remicade 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' Remicade fit-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: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including Remicade in the post-marketing setting.
Maltese: Tumuri malinni, xi wħud fatali, kienu rrappurtati fost tfal, adolexxenti u adulti żgħażagħ (sa 22 sena) ikkurati b'sustanzi li jimblokkaw it-TNF (bidu tat-terapija ≤ 18-il sena), inkluż Remicade fi sfond ta' wara t-tqegħid fis-suq.
English: • Headache
Maltese: • Puplesija
English: Uncommon: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Maltese: Mhux komuni: Joħorġu l-imsiemer, seborreja, rosaċeja, papilloma tal-ġilda, iperkeratożi, kulur tal-ġilda anormali Rari:
English: At week 14, 282 patients were assessed for clinical response and randomised to receive either placebo or 5 mg/kg infliximab every 8 weeks through week 46.
Maltese: F'ġimgħa 14, 282 pazjent kienu evalwati għar-rispons kliniku u tqassmu b'mod li ntgħażlu b'mod każwali biex jingħataw plaċebo jew 5 mg/kg infliximab kull 8 ġimgħat sas-46 ġimgħa.
English: • Serious lung problems (such as interstitial lung disease)
Maltese: • Problemi serji fil-pulmun (bħal mard tal-interstizju tal-pulmun).
English: Common: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Maltese: Infezzjoni tan-naħa ta' isfel tal-passaġġ respiratorju (eż. bronkite, pulmonite), qtugħ ta' nifs, epistassi.
English: • You have heart failure that is moderate or severe.
Maltese: • Int għandek insuffiċjenza tal-qalb li tkun moderata jew severa.
English: Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Maltese: III fil-marda ta' Crohn's, ACCENT I u ACCENT II, irċivew doża tal-bidu ta' 5 mg/kg infliximab fil-bidu tal-istudju u kienu fuq plaċebo fil-fażi ta' manteniment.
English: • Blood test result showing ‘antibodies' against your own body.
Maltese: • Riżultat ta' test tad-demm li juri ‘antikorpi' kontra ġismek stess.
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 kien ukoll studjat 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: Remicade should be used with caution in patients with mild heart failure (NYHA class I/II).
Maltese: Remicade għandu jintuża b'attenzjoni f'pazjenti b'insuffiċjenza ħafifa tal-qalb (NYHA klassi I/II).
English: In the first study (P01522), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
Maltese: Fl-ewwel studju (P01522), li kellu fażi ta 3 xhur double-blind, 70 pazjent irċevew jew 5 mg/kg infliximab jew plaċebo f'ġimgħat 0, 2, 6 (35 pazjent f'kull grupp).
English: The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies: SPIRIT and EXPRESS.
Maltese: L-effikaċja ta' infliximab kienet evalwata f'żewġ studji multiċentriċi, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind: SPIRIT u EXPRESS.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Maltese: Infliximab b'AZA jew mingħajru kien evalwat fi studju komparatur b'mod attiv, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind (SONIC) ta' 508 pazjenti adulti b'marda ta' Crohn minn moderata sa severa (CDAI ≥ 220 ≤ 450) li qatt ma kienu ħadu sustanzi bijoloġiċi u immunosoppressanti u li kellhom il-marda għal tul ta' żmien medjan ta' 2.3 snin.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNF and interferon.
Maltese: Analiżi ta' ċelluli mononukleari tal-lamina propria miksuba permezz ta' bijopsija tal-mukuża tal-musrana wriet li kura b'infliximab ikkawżat tnaqqis fin-numru ta' ċelluli li kienu kapaċi jesprimu TNF u interferon .
English: Experimental data show that TNF is essential for the clearing of intracellular infections.
Maltese: Tagħrif sperimentali juri li TNF huwa essenzjali biex jitneħħew infezzjonijiet intraċellulari.
English: However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Maltese: Madankollu, ir-riżultati huma inċerti minħabba limitazzjonijiet fil-metodi li ntużaw għall-analiżi ta' infliximab fis-serum u l-antikorpi kontra infliximab.
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Maltese: Fi studju kliniku esploratorju li kien jinvolvi pazjenti b'COPD moderat sa sever li kienu jew ipejpu fil-preżent jew kienu jpejpu fil-passat, 157 pazjent adult kienu kkurati b'REMICADE b'dożi simili għal dawk użati f'artrite rewmatojde u l-marda ta' Crohn.
English: Concurrent administration of TNF-alpha inhibitor and abatacept In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Maltese: L-għoti fl-istess ħin mal-inibitur TNF-alpha u abatacept Fi studji kliniċi l-għoti fl-istess ħin mal-antagonist-TNF u abatacept kienet assoċjata ma' riskju akbar ta' infezzjonijiet inklużi infezzjonijiet serji meta mqabbla ma' antagonisti-TNF waħidhom, mingħajr żieda fil-benefiċċju kliniku.
English: • treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Maltese: • kura tal-marda ta' Crohn attiva b'mod moderat sa qawwi, f'pazjenti adulti li ma kellhomx rispons minkejja kors sħiħ u adegwat ta' terapija b'kortikosterojdi u/jew immunosoppressant; jew li ma jittollerawx jew ma jistgħux jingħataw dawn it-terapiji għal raġunijiet mediċi.
English: • Rheumatoid arthritis
Maltese: • Artrite rewmatojde,
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 kienet eżaminata wkoll 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 fil-vini u li għalhekk kellhom riskju akbar li jkollhom kolektomija.
English: How to store Remicade
Maltese: X'fih Remicade
English: • Psoriasis, skin problems such as eczema and hair loss
Maltese: • Psorjasi, problemi fil-ġilda bħal ekżema u jaqa' x-xagħar
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 komuni serja.
English: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Maltese: Il-proporzjon ta' pazjenti b'infezzjonijiet f'C0168T72 kien simili għal dak fl-istudju dwar il-marda ta' Crohn fit-tfal (REACH) iżda ogħla mill-proporzjon fl-istudji dwar kolite bl-ulċeri fl-adulti (ACT 1 u ACT 2).
English: There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Maltese: M'hemmx biżżejjed tagħrif ta' qabel l-użu kliniku sabiex isiru konklużjonijiet dwar l-effetti ta' infliximab fuq il-fertilità u funzjoni riproduttiva ġenerali (sezzjoni 5.3).
English: Infusion reactions following re-administration of Remicade A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Maltese: Reazzjonijiet għall-infużjoni wara l-għoti mill-ġdid ta' Remicade Studju kliniku f'pazjenti bi psorjasi moderata sa severa kien maħsub biex tiġi evalwata l-effikaċja u ssigurtà ta' terapija fit-tul kontra kura mill-ġdid b'kors ta' induzzjoni ta' Remicade (massimu ta' erba' infuzjonijiet f'ġimgħat 0, 2 6 u 14) wara li tkun ħraxet il-marda.
English: Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Maltese: Pazjenti li żviluppaw antikorpi għal infliximab kellhom probabbiltà akbar (xi 2-3 darbiet aktar) li jiżviluppaw reazzjonijiet marbuta mal-infużjoni.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Maltese: Użu ieħor ta' sustanzi terapewtiċi infettivi bħal batterji ħajjin attenwati (eż. l-instillazzjoni ta' BCG fil-bużżieqa tal-awrina għall-kura tal-kanċer) jista' jwassal għal infezzjonijiet kliniċi, inkluż infezzjonijiet mifruxa.
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Maltese: Pazjenti b'insuffiċjenza tal-qalb moderata jew serja ħafna (NYHA klassi III/IV) (ara sezzjonijiet 4.4 u
English: Infliximab treatment of Crohn's disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
Maltese: Kura b'infliximab f'pazjenti bilmarda ta' Crohn kien ukoll assoċjat ma' tnaqqis sostanzjali fil-marker infjammatorju tas-serum, CRP,
English: • Some patients receiving Remicade have developed symptoms of an immune system disorder called lupus.
Maltese: • Xi pazjenti li kienu qed jirċievu Remicade żviluppaw sintomi ta' disturb fis-sistema immuni msejjaħ lupus.
English: Patient Reminder Card
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Following administration of 5 mg/kg Remicade 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 drug exposure in adults.
Maltese: Wara għoti ta' 5 mg/kg ta' Remicade 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-mediċina fi stat fiss f'persuni adulti.
English: In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity.
Maltese: In vivo, infliximab malajr jifforma kumplessi stabbli ma' TNF uman, proċess li jimxi b'mod parallel mat-telf ta' bijoattività ta' TNF.
English: Your doctor may recommend temporarily stopping Remicade.
Maltese: It-tabib tiegħek jista' jirrikkmandalek li twaqqaf Remicade temporanjament.
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 [75.0%]) vs.15/60 [25.0%]).
Maltese: F'dan l-istudju, kien hemm iktar pazjenti fil-grupp ta' età ta' 12-17-il sena milli fil-grupp ta' età ta' 6-11-il sena (45/60 [75.
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 għall-ħajja.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remicade cannot be excluded (see section 4.8).
Maltese: Riskju li tiżviluppa limfoma epatosplenika taċ-ċelluli T f'pazjenti kkurati b'Remicade ma jistax jiġi eskluż (ara sezzjoni 4.8).
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Maltese: L-attivazzjoni mill-ġdid ta' epatite B seħħet f'pazjenti li kienu qed jirċievu antagonist ta' TNF inkluż infliximab li jġorru b'mod kroniku dan il-virus.
English: The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of < 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day.
Maltese: Il-punt aħħari primarju tal-istudju kien in-nuqqas totali ta' sinjali u sintomi kliniċi mingħajr kortikosterojdi f'ġimgħa 26, definit bħala dawk il-pazjenti b'nuqqas totali ta' sinjali u sintomi kliniċi (CDAI ta' < 150) li, għal mill-anqas 3 ġimgħat, ma kinux ħadu kortikosterojdi sistemiċi mill-ħalq (prednisone jew ekwivalenti) jew budesonide f'doża ta' > 6 mg/kuljum.
English: These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
Maltese: Dawn ilpazjenti kienu kklassifikati bħala persuni li rrispondew sa ġimgħa 2 u kienu inklużi fl-analiżi primarja (ara Tabella 5).
English: * P-values represent each infliximab treatment group vs. AZA monotherapy.
Maltese: * Il-valuri P jirrappreżentaw kull grupp ta' kura b'infliximab vs. terapija b'AZA waħdu.
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Maltese: Kien meħtieġ li l-pazjenti kollha jkunu fuq doża stabbli ta' 6-MP, AZA jew MTX (35% kienu qed jingħataw ukoll kortikosterojdi fil-linja bażi).
English: • Depression, problems sleeping
Maltese: • Depressjoni, problemi biex torqod
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Maltese: Ma jistax ikun eskluż riskju għal żvilupp ta' tumuri malinni fi tfal u adoloxxenti li jkunu kkurati b'imblokkaturi ta' TNF.
English: Starting at week 16, placebo patients were switched to infliximab and all patients subsequently received 5 mg/kg infliximab every 8 weeks up to week 46.
Maltese: F'ġimgħa 16, il-pazjenti fuq plaċebo nqalbu għal infliximab u minn hemm 'il quddiem ingħataw 5 mg/kg infliximab kull 8 ġimgħat sa ġimgħa 46.
English: Clinical response at week 8 was similar between those with or without concomitant immunomodulator use at baseline.
Maltese: Rispons kliniku f'ġimgħa 8 kien simili bejn dawk bi jew mingħajr l-użu ta' immunomodulatur fl-istess ħin fil-linja bażi.
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Maltese: Infliximab kien assoċjat ma' reazzjonijiet akuti relatati mal-infużjoni li jinkludu xokk anafilattiku u reazzjoni ta' sensittività eċċessiva li ddum ma sseħħ (ara sezzjoni 4.8).
English: Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Maltese: Mill-pazjenti kkurati b'infliximab li kellhom reazzjoni għall-infużjoni waqt il-perjodu ta' induzzjoni sa ġimgħa 6, 27% kellhom reazzjoni marbuta mal-infużjoni waqt il-perjodu ta' manteniment, minn ġimgħa 7 sa ġimgħa 54.
English: Names and addresses of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Maltese: Il-punt aħħari primarju kien ilproporzjon ta' pazjenti li kellhom rispons kliniku, definit bħala tnaqqis ta' ≥ 50% mil-linja bażi finnumru ta' fistuli li jnixxu meta jkunu magħfusa bil-mod mill-inqas f'żewġ eżamijiet konsekuttivi (b'4 ġimgħat bejniethom), mingħajr żieda fl-użu tal-prodotti mediċinali jew kirurġija għal marda ta' Crohn.
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: Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents.
Maltese: Minħabba n-natura tar-reazzjonijiet avversi li ġew osservati bil-kombinazzjoni ta' etanercept u terapija b'anakinra, effetti tossiċi simili jistgħu jitfaċċaw meta anakinra jingħata flimkien ma' aġenti oħra li jimblokkaw TNF.
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: • Viral infections such as herpes or flu
Maltese: • Infezzjonijiet ikkawżati minn bħal herpes jew influwenza
English: • Abnormal tissue swelling or growth
Maltese: • Kanċer fi tfal u adulti
English: In an exploratory clinical study evaluating the use of Remicade in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in Remicade-treated patients compared with control patients.
Maltese: Fi studju kliniku ta' stħarriġ li evalwa l-użu ta' Remicade f'pazjenti b'mard ostruttiv kroniku talpulmun (COPD) minn moderat sa sever, kien hemm aktar tumuri rrappurtati bil-pazjenti kkurati b'Remicade meta mqabbla ma' pazjenti tal-kontroll.
English: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Maltese: Uża biss sett tal-infużjoni li jkollu filtru fil-pajp, sterili, li ma jikkawżax iddeni, u li jeħel miegħu livell baxx ta' proteini (daqs tal-pori 1.2 mikrometru jew inqas).
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with Remicade during pregnancy.
Maltese: • Numru ta' ċelluli bojod tad-demm imnaqqas b'mod sever kien irrappurtat fi trabi mwielda lil nisa ttrattati b'Remicade waqt it-tqala.
English: Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Maltese: F'pazjenti li qed jirċievu terapija kontra TNF, hemm disponibbli tagħrif limitat dwar ir-rispons għattilqima b'vaċċini ħajjin jew fuq it-trasmissjoni sekondarja ta' infezzjoni mill-vaċċini ħajjin.
English: Among patients in the infliximab 5 mg/kg group who crossed over because of loss of fistula response after week 22, 57% (12/21) responded to re-treatment with infliximab 10 mg/kg every 8 weeks.
Maltese: Fost il-pazjenti fil-grupp fuq infliximab 5 mg/kg li qalbu minħabba li tilfu r-rispons għal fistuli wara gimgħa 22, 57% (12/21) kellhom rispons għall-kura mill-ġdid b'infliximab 10 mg/kg kull 8 ġimgħat.
English: In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Maltese: F'IMPACT u IMPACT 2, rispons kliniċi kienu diġà bdew jidhru mat-2 ġimgħa u baqgħu sa ġimgħa 98 u ġimgħa 54 rispettivament.
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: At week 24, all placebo-treated patients crossed over to infliximab induction.
Maltese: F'ġimgħa 24, il-pazjenti kollha kkurati bi plaċebo qalbu għall-induzzjoni fuq infliximab.
English: Uncommon: Autoantibody positive.
Maltese: Investigazzjonijiet Mhux komuni: Awto-antikorpi pożittivi.
English: Absence of any draining fistulas.
Maltese: Inċidenti ċerebrovaskulari qrib ħafna taż-żmien tal-infużjoni.
English: The median terminal half-life at these doses ranged from 8 to 9.5 days.
Maltese: Il-half-life terminali medjan ta' infliximab b'dawn id-dożi jvarja bejn 8 u 9.5 ijiem.
English: All patients received an induction regimen of 5 mg/kg infliximab at weeks 0, 2, and 6.
Maltese: Il-pazjenti kollha rċevew skeda ta' induzzjoni ta' 5 mg/kg infliximab f'ġimgħa 0, 2, u 6.
English: Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).
Maltese: Pazjenti b'tuberkulożi jew infezzjonijiet oħra qawwija bħal sepsis, qradijiet u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: 10 mg/kg Combined
Maltese: 10 mg/kg Flimkien
English: Common: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Maltese: Infezzjoni virali (eż. influwenza, infezzjonijiet bil-virus talerpes) Komuni: Infezzjonijiet batterjali (eż. sepsis, ċellulite, axxess)
English: • Some patients who have received TNF-blockers, including Remicade have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Maltese: • Xi pazjenti li rċevew imblokkaturi ta' TNF, inkluż Remicade żviluppaw tip ta' kanċer rari li jissejjaħ limfoma taċ-ċellula-T epatosplenika.
English: The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss (Vd medjan ta' 3.0 sa 4.1 litri) ma kienx jiddependi fuq id-doża mogħtija u wera li infliximab huwa distribwit fil-biċċa l-kbira teigħu fil-kompartiment vaskulari.
English: Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Maltese: Il-psorjasi fid-dwiefer kienet evalwata permezz tal-Indiċi tas-Severità tal-Psorjasi tadDwiefer (NAPSI).
English: Write the new expiry date on the carton including day/month/year.
Maltese: Ikteb id-data l-ġdida ta' skadenza fuq ilkartuna inkluż jum/xahar/sena.