FrancophonIA/ELRC3.0 huggingface dataset:
English: • Some patients who have received TNF-blockers, including Flixabi have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Croatian: • U nekih bolesnika koji su liječeni blokatorima TNF-a uključujući Flixabi razvio se rijedak oblik raka zvan hepatosplenički limfom T-stanica.
English: • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding
Croatian: • Moguće znakove raka koji uključuju, ali nisu ograničeni na oticanje limfnih čvorova, gubitak tjelesne težine, vrućicu, neuobičajene kvržice na koži, promjene izgleda madeža ili boje kože ili neuobičajeno krvarenje iz rodnice.
English: Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section
Croatian: Preosjetljivost na djelatnu tvar, druge mišje proteine ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Croatian: Ograničeno iskustvo ponovne primjene lijeka u bolesnika s psorijazom davanjem jedne doze infliksimaba nakon 20 tjedana ukazuje na smanjenu djelotvornost i povećanu incidenciju blagih do umjereno jakih reakcija na infuziju u odnosu na one tijekom prvobitne primjene uvodnog režima liječenja (vidjeti dio 5.1).
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Croatian: Infliksimab se povezuje s akutnim reakcijama povezanim s infuzijom, uključujući anafilaktički šok te reakcije kasne preosjetljivosti (vidjeti dio 4.8).
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
Croatian: • ozbiljni poremećaji živčanog sustava kao što su poprečni mijelitis, bolesti nalik multiploj sklerozi, optički neuritis i Guillain-Barréov sindrom
English: Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Croatian: Kliničko ispitivanje infliksimaba provedeno je u 120 bolesnika (dobni raspon: 4-17 godina) s aktivnim juvenilnim reumatoidnim artritisom usprkos liječenju metotreksatom.
English: Flixabi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Croatian: Flixabi je indiciran za liječenje teškog, aktivnog ankilozantnog spondilitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju.
English: d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Croatian: d p = 0,030 za skupinu koja je primala dozu od 3 mg/kg i p < 0,001 za skupinu koja je primala dozu od 6 mg/kg u usporedbi s placebo + MTX.
English: If you are not sure, talk to your doctor before you are given Flixabi.
Croatian: Ako niste sigurni, obratite se svom liječniku prije nego što primite Flixabi.
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Croatian: U istraživanju razvojne toksičnosti provedenom na miševima pomoću analognog protutijela koje selektivno inhibira funkcionalnu aktivnost mišjeg TNFα, nije bilo znakova toksičnosti za majku, embriotoksičnosti ni teratogenosti (vidjeti dio 5.3).
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
Croatian: • napomenu da liječenje lijekom Flixabi može povećati rizik od ozbiljnih infekcija/sepse, oportunističkih infekcija, tuberkuloze, reaktivacije hepatitisa B i probojne infekcije BCG-om u dojenčadi koja je bila izložena infliksimabu in utero, te kada je potrebno zatražiti medicinsku pomoć zdravstvenog radnika
English: Upper respiratory tract infection, sinusitis.
Croatian: infekcija gornjih dišnih puteva, sinusitis
English: Flixabi treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Croatian: Liječenje lijekom Flixabi uvodi se i provodi pod nadzorom liječnika specijalista s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, upalnih bolesti crijeva, ankilozantnog spondilitisa, psorijatičnog artritisa ili psorijaze.
English: In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8).
Croatian: U kliničkim su ispitivanjima reakcije kasne preosjetljivosti bile manje česte i javljale su se nakon što se infliksimab nije primjenjivao u razdoblju kraćem od godinu dana (vidjeti dijelove 4.4 i 4.8).
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, međutim, nije moguće dati preporuku o doziranju.
English: Flixabi is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Međutim, Flixabi se razrjeđuje u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za infuziju.
English: Hepatic function abnormal, transaminases increased.
Croatian: poremećaj funkcije jetre, povišene transaminaze
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Croatian: zatajenje srca (novonastalo ili pogoršanje postojećeg), aritmija, sinkopa, bradikardija
English: Available data do not support further Flixabi treatment, in patients not responding within 6 weeks of the initial infusion.
Croatian: Na temelju dostupnih podataka ne preporučuje se daljnje liječenje lijekom Flixabi u bolesnika koji u roku od 6 tjedana od početne infuzije nisu odgovorili na terapiju.
English: Subjects randomised Percentage ACR improvement Mean ± SD
Croatian: Broj randomiziranih ispitanika Postotak poboljšanja ACR odgovora Prosječna vrijednost ± SDa
English: Caution should be exercised when considering the use of Flixabi in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Croatian: Potreban je oprez kad se razmatra mogućnost primjene lijeka Flixabi u bolesnika s kroničnim ili ponavljajućim infekcijama, uključujući one koji istodobno primaju imunosupresive.
English: In a Phase II study aimed at evaluating infliximab in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Croatian: U kliničkom ispitivanju faze II s ciljem procjene učinka infliksimaba na kongestivno zatajenje srca uočena je veća incidencija mortaliteta uslijed pogoršanja srčane funkcije u bolesnika liječenih infliksimabom, osobito u onih koji su primali dozu veću od 10 mg/kg (tj. dvostruko veću od maksimalne odobrene doze).
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).
Croatian: Zabilježeno je značajno manje kolektomija tijekom 3 mjeseca od infuzije ispitivanog lijeka u bolesnika koji su primili jednu dozu infliksimaba od 5 mg/kg u odnosu na bolesnike koji su primili placebo (29,2% naspram 66,7%, p = 0,017).
English: When reconstitution and dilution are performed under aseptic conditions, Flixabi infusion solution can be used within 24 hours if stored at 2°C to 8°C.
Croatian: Kada se rekonstitucija otopine i razrjeđivanje izvode u aseptičnim uvjetima, otopina za infuziju lijeka Flixabi može se uporabiti u roku od 24 sata ako se čuva na temperaturi od 2°C do 8°C.
English: Infliximab 5 mg/kg
Croatian: Infliksimab 5 mg/kg
English: b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p < 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Croatian: b Sve doze infliksimaba davale su se u kombinaciji s metotreksatom i folatima, a u nekim slučajevima i s kortikosteroidima i/ili nesteroidnim protuupalnim lijekovima c p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s kontrolnom skupinom d Veće vrijednosti znače jače oštećenje zgloba e HAQ = upitnik za procjenu zdravlja (engl.
English: 3 Number of patients evaluated for ALT.
Croatian: 3 Broj bolesnika uključenih u analizu ALT-a.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Flixabi and is positive for antibodies against double-stranded DNA, further treatment with Flixabi must not be given (see section 4.8).
Croatian: Ako bolesnik nakon liječenja lijekom Flixabi razvije simptome koji ukazuju na sindrom sličan lupusu i ako ima pozitivan nalaz protutijela na dvolančanu DNK, ne smije nastaviti liječenje lijekom Flixabi (vidjeti dio 4.8).
English: Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.
Croatian: Povišene aminotransferaze (češće ALT nego AST) primijećene su u većem postotku u bolesnika koji su primali infliksimab nego u kontrolnim skupinama, kako pri primjeni infliksimaba u monoterapiji, tako i pri primjeni u kombinaciji s drugim imunosupresivima.
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.
Croatian: Ukupno je 573 bolesnika sa umjerenom do teškom aktivnom Crohnovom bolešću (CDAI ≥ 220 i ≤ 400) primilo jednokratnu infuziju infliksimaba u dozi od 5 mg/kg u nultom tjednu.
English: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Croatian: agranulocitoza (uključujući dojenčad izloženu infliksimabu in utero), trombotička trombocitopenična purpura, pancitopenija, hemolitička anemija, idiopatska trombocitopenična purpura
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 (4.6%).
Croatian: U kliničkim ispitivanjima reumatoidnog artritisa, incidencija ozbiljnih infekcija u skupini koja je liječena infliksimabom i metotreksatom bila je veća u bolesnika u dobi od 65 ili više godina (11,3%) nego u onih mlađih od 65 godina (4,6%).
English: Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Croatian: Potreban je oprez kada se razmatra liječenje blokatorom TNF-a u bolesnika koji su bolovali od zloćudne bolesti odnosno kada se razmatra nastavak liječenja bolesnika u kojih se razvila zloćudna bolest.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Croatian: Pri jednokratnim dozama od 3, 5 odnosno 10 mg/kg, medijan Cmax iznosio je 77, 118 odnosno
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 steadystate drug exposure in adults.
Croatian: Nakon primjene infliksimaba u dozi od 5 mg/kg svakih 8 tjedana, predviđena izloženost infliksimabu u stanju dinamičke ravnoteže (područje pod krivuljom koncentracija-vrijeme u stanju dinamičke ravnoteže, AUCss) u pedijatrijskih bolesnika u dobi od 6 do 17 godina bila je približno 20% niža nego predviđena izloženost lijeku u stanju dinamičke ravnoteže u odraslih.
English: Flixabi is not likely to affect your ability to drive or use tools or machines.
Croatian: Nije vjerojatno da bi Flixabi mogao utjecati na Vašu sposobnost upravljanja vozilima i strojevima i rada sa alatima.
English: Tachycardia, palpitation.
Croatian: tahikardija, palpitacije
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Flixabi can be re-administered within 16 weeks following the last infusion.
Croatian: Ako se ponovno pojave znakovi i simptomi bolesti, Flixabi se može ponovno primijeniti u roku od 16 tjedana od zadnje infuzije.
English: If serious reactions occur, symptomatic treatment must be given and further Flixabi infusions must not be administered (see section 4.8).
Croatian: Ako se pojave ozbiljne reakcije, mora se primijeniti simptomatska terapija i više se ne smiju davati infuzije lijeka Flixabi (vidjeti dio 4.8).
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Croatian: gastrointestinalno krvarenje, proljev, dispepsija, gastroezofagealni refluks, konstipacija
English: • Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer.
Croatian: • U nekih žena koje su se liječile infliksimabom zbog reumatskog artritisa, razvio se rak grlića maternice.
English: Apathy.
Croatian: apatija
English: The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Croatian: Sigurnost i djelotvornost lijeka pri ponovnoj primjeni nisu ustanovljene, osim kada se davao svakih 6 do 8 tjedana (vidjeti dijelove 4.4 i 4.8).
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.
Croatian: U kontroliranim dijelovima kliničkih ispitivanja blokatora TNF-a zabilježeno je više slučajeva zloćudnih bolesti, uključujući limfome, u bolesnika koji su primali blokator TNF-a u odnosu na kontrolnu skupinu bolesnika.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Croatian: Najozbiljnije nuspojave povezane s primjenom blokatora TNF-a, koje su prijavljene za infliksimab, uključuju reaktivaciju hepatitisa B (HBV), kongestivno zatajenje srca, teške infekcije (uključujući sepsu, oportunističke infekcije i tuberkulozu), serumsku bolest (reakcija kasne preosjetljivosti), hematološke reakcije, sistemski eritematozni lupus/sindrom sličan lupusu, demijelinizacijske poremećaje, poremećaje jetre i žuči, limfom, hepatosplenički limfom T-stanica, leukemiju, karcinom Merkelovih stanica, melanom, zloćudne bolesti u pedijatrijskih bolesnika, sarkoidozu/ reakciju nalik na sarkoidozu, intestinalne ili perianalne apscese (kod Crohnove bolesti) i ozbiljne reakcije na infuziju (vidjeti dio 4.4).
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).
Croatian: transverzalni mijelitis, demijelinizacijski poremećaji središnjeg živčanog sustava (bolest nalik multiploj sklerozi i optički neuritis), demijelinizacijski poremećaji perifernog živčanog sustava (kao što su Guillain-Barréov sindrom, kronična upalna demijelinizacijska polineuropatija i multifokalna motorička neuropatija)
English:  treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Croatian: • liječenje fistulirajuće, aktivne Crohnove bolesti u odraslih bolesnika koji nisu odgovorili na punu i odgovarajuću konvencionalnu terapiju (uključujući antibiotike, drenažu i imunosupresijsku terapiju).
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.
Croatian: U eksplorativnom kliničkom ispitivanju u kojem se ocjenjivala primjena infliksimaba u bolesnika s umjereno teškom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB), prijavljeno je više slučajeva zloćudnih bolesti u bolesnika liječenih infliksimabom nego u bolesnika u kontrolnoj skupini.
English: Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Croatian: U bolesnika koji su razvili protutijela na infliksimab vjerojatnost pojave reakcija povezanih s infuzijom bila je veća (približno 2 do 3 puta).
English: Use of anti-tuberculosis therapy should also be considered before the initiation of Flixabi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu antituberkulozne terapije treba razmotriti prije početka liječenja lijekom Flixabi i u bolesnika koji u anamnezi imaju latentnu ili aktivnu tuberkulozu, a u kojih se ne može potvrditi da su bili liječeni na odgovarajući način.
English: Flixabi contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Flixabi sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Croatian: U istraživanju razvojne toksičnosti provedenom na miševima pomoću analognog protutijela koje selektivno inhibira funkcionalnu aktivnost mišjeg TNFα, nije bilo znakova toksičnosti za majku, embriotoksičnosti ni teratogenosti.
English: Administration of Flixabi should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Ako bolesnik razvije novu ozbiljnu infekciju ili sepsu, treba prekinuti liječenje lijekom Flixabi i uvesti odgovarajuću antimikrobnu ili antimikotičku terapiju sve dok infekcija ne bude pod kontrolom.
English: For results see Table 6.
Croatian: Rezultati su prikazani u tablici 6.
English: Headache.
Croatian: glavobolja
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever
Croatian: • Znakove problema s jetrom (uključujući infekciju hepatitisom B ako ste u prošlosti već imali hepatitis B) kao što su žutilo kože ili bjeloočnica, tamnosmeđa boja mokraće, bol ili oticanje u gornjem desnom dijelu trbuha, bol u zglobovima, kožni osipi ili vrućica.
English: At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013).
Croatian: U 30. tjednu je udio ispitanika u kliničkoj remisiji bio veći u skupini koja je terapiju održavanja primala svakih 8 tjedana (59,6%, 31/52) nego u skupini koja je terapiju održavanja primala svakih 12 tjedana (35,3%, 18/51; p = 0,013).
English: Cases of transient visual loss occurring during or within 2 hours of infliximab infusion have been reported.
Croatian: Prijavljeni su slučajevi prolaznog gubitka vida koji su se javljali tijekom ili do 2 sata nakon primanja infuzije infliksimaba.
English: Flixabi contains sodium
Croatian: Flixabi sadrži natrij
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Flixabi therapy.
Croatian: U bolesnika s već postojećim ili novonastalim demijelinizacijskim bolestima treba pažljivo procijeniti rizike i koristi anti-TNF terapije prije početka liječenja lijekom Flixabi.
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group (36/244; 14.8%).
Croatian: Kolektomiji je podvrgnut manji broj bolesnika koji su primali infliksimab u dozama od 5 mg/kg (28/242 ili 11, 6% [N.S.]) i 10 mg/kg (18/242 ili 7,4% [p = 0, 011]) nego onih koji su primali placebo (36/244; 14,8%).
English: 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Croatian: 1 Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
English: Crohn's disease Crohn's disease is an inflammatory disease of the bowel.
Croatian: Crohnova bolest je upalna bolest crijeva.
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.
Croatian: Nema odgovarajućih podataka o bolesnicima nositeljima HBV-a koji su uz antagonist TNF-a primali i antivirusne lijekove radi sprječavanja reaktivacije hepatitisa B.
English: Infliximab 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).
Croatian: Ispitivanja su pokazala da infliksimab poboljšava funkcionalnu sposobnost u bolesnika s psorijatičnim artritisom te smanjuje brzinu napredovanja oštećenja perifernih zglobova, što je ocijenjeno temeljem rendgenskih snimaka u bolesnika s poliartikularnim simetričnim podtipovima bolesti (vidjeti dio 5.1).
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Croatian: Bolesnici s povišenim ALT-om i AST-om u pravilu nisu imali simptoma, a odstupanja bi se smanjila ili vratila na normalne vrijednosti bilo s nastavkom ili prekidom davanja infliksimaba ili modifikacijom istodobno primijenjenih lijekova.
English: Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays.
Croatian: Farmakodinamički učinci Infliksimab inhibira funkcionalno djelovanje TNFα u raznim vrstama bioloških pokusa in vitro.
English: The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Croatian: Velika većina ovih slučajeva među bolesnicima liječenim infliksimabom pojavila se u bolesnika s Crohnovom bolešću ili ulceroznim kolitisom, a većinom su prijavljeni u adolescenata ili mlađih odraslih muškaraca.