FrancophonIA/ELRC3.0 huggingface dataset:
English: In most patients, infliximab could be detected in the serum for at least 8 weeks after the recommended single dose of 5 mg/kg for Crohn's disease and the rheumatoid arthritis maintenance dose of 3 mg/kg every 8 weeks.
Croatian: U većini se slučajeva infliksimab mogao pronaći u serumu još najmanje 8 tjedana nakon jednokratne primjene preporučene doze od 5 mg/kg u bolesnika s
English: At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Croatian: Nakon 38 tjedana umrlo je 9 od 101 bolesnika liječenih infliksimabom (dvoje koji su primali dozu od 5 mg/kg i sedmero koji su primali dozu od 10 mg/kg), dok je među 49 bolesnika koji su primali placebo zabilježen samo jedan smrtni slučaj.
English: Table 5 Effects on response and remission rate in patients with moderately to severely active Crohn's disease, data from study 4 (week-2 responders)
Croatian: Učinci na stope odgovora i remisije u bolesnika s umjerenom do teškom aktivnom Crohnovom bolešću, podaci iz ispitivanja 4 (bolesnici s odgovorom u 2. tjednu)
English: The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study 15 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.
Croatian: Sigurnost primjene i djelotvornost infliksimaba ispitivane su u multicentričnom, randomiziranom otvorenom kliničkom ispitivanju 15 s paralelnim skupinama, provedenom u 60 pedijatrijskih bolesnika u dobi od 6 do 17 godina (medijan dobi 14,5 godina) s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo rezultat 6-12, endoskopski ≥ 2) koji nisu odgovorili na konvencionalnu terapiju na odgovarajući način.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Croatian: Preporučuje se da, ako je to moguće, prije početka liječenja infliksimabom bolesnici prime sva cjepiva u skladu s važećim smjernicama za cijepljenje.
English: It is recommended that therapeutic infectious agents not be given concurrently with Zessly.
Croatian: Ne preporučuje se primjenjivati terapijske infektivne agense istodobno s lijekom Zessly.
English: infliximab Maintenance 10 mg/kg (n = 112) (p value)
Croatian: Terapija održavanja infliksimabom 10 mg/kg (n = 112) (p-vrijednost)
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have also been reported, some in close temporal association with infusion of infliximab.
Croatian: ishemije/infarkta miokarda i aritmije, od kojih su neki bili vremenski usko povezani s infuzijom infliksimaba.
English: PATIENT REMINDER CARD
Croatian: KARTICA S PODSJETNIKOM ZA BOLESNIKA
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE
English: Can be stored at temperatures up to 30°C for a single period up to 6 months, but not exceeding the original expiry date.
Croatian: Može se čuvati na temperaturi do 30°C neprekinuto tijekom razdoblja od najviše 6 mjeseci, ali ne nakon isteka originalnog roka valjanosti.
English: Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i bilo koje druge lijekove za liječenje Crohnove bolesti, ulceroznog kolitisa, reumatoidnog artritisa,
English: Week 10 Week 24
Croatian: 10. tjedan 24. tjedan
English: Clinical remission at week 8a Clinical remission at week 30a Sustained remission (in remission at both week 8 and week 30)a
Croatian: Održana remisija (u remisiji i u 8. i u 30. tjednu)a
English: In the first study, (study 8), 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).
Croatian: U prvom ispitivanju (ispitivanje 8), u kojemu je dvostruko slijepa faza trajala 3 mjeseca, 70 bolesnika primilo je ili dozu od 5 mg/kg infliksimaba ili placebo u 0., 2. i 6. tjednu (35 bolesnika u svakoj skupini).
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).
Croatian: U bolesnika s psorijatičnim artritisom koji su primali dozu od 5 mg/kg s ili bez metotreksata, protutijela su se pojavila u ukupno 15% bolesnika (protutijela su se pojavila u 4%
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after Zessly treatment.
Croatian: Sve bolesnike treba uputiti da se jave liječniku ako se tijekom ili nakon liječenja lijekom Zessly pojave znakovi/simptomi koji bi mogli ukazivati na tuberkulozu (npr. perzistirajući kašalj, gubitak tjelesne težine, subfebrilnost).
English: • Signs of an immune system disorder such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis)..
Croatian: • Znakove poremećaja imunološkog sustava kao što su bol u zglobovima ili osip na obrazima ili rukama osjetljiv na sunce (lupus) ili kašalj, nedostatak zraka, vrućica ili kožni osip (sarkoidoza).
English: Zessly is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Croatian: Zessly je indiciran za liječenje aktivnog i progresivnog psorijatičnog artritisa u odraslih bolesnika u kojih odgovor na prethodno liječenje antireumatskim lijekovima koji modificiraju tijek bolesti nije bio odgovarajući.
English: Do not infuse Zessly concomitantly in the same intravenous line with other agents.
Croatian: Zessly se ne smije davati istodobno u istoj infuziji s drugim lijekovima.
English: Data to support dose titration in rheumatoid arthritis come from study 1, study 2 and study 3.
Croatian: Titraciju doze u bolesnika s reumatoidnim artritisom podupiru podaci koji dolaze iz ispitivanja 1,
English: Patients received 5 mg/kg infliximab- or placebo-infusions at weeks 0, 2, and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
Croatian: Bolesnici su primili infuziju infliksimaba u dozi od 5 mg/kg ili placeba u 0., 2. i 6. tjednu, nakon čega je slijedila terapija održavanja svakih 8 tjedana koja je trajala do 22. tjedna u placebo skupini, odnosno do 46. tjedna u skupini koja je primala infliksimab.
English: Zessly and Kineret should not be used together.
Croatian: Zessly i Kineret ne smiju se istodobno uzimati.
English: HAQ change from baseline over timee (patients evaluated)
Croatian: Promjena HAQ-a od početne vrijednostie (evaluirani bolesnici)
English: Tachycardia, palpitation.
Croatian: Često: tahikardija, palpitacije
English: Zessly should be administered intravenously.
Croatian: Zessly se primjenjuje intravenski.
English: When reconstitution and dilution are performed under aseptic conditions, Zessly infusion solution can be used within 24 hours if stored at 2°C - 8°C.
Croatian: Kada se rekonstitucija otopine i razrjeđivanje izvode u aseptičnim uvjetima, otopina za infuziju lijeka Zessly može se uporabiti u roku od 24 sata ako se čuva na temperaturi od 2°C do 8°C.
English: Patients received 3 or 6 mg/kg infliximab as a 3dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20 respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Croatian: Bolesnici su kao uvodnu terapiju primili 3 doze infliksimaba u dozi od 3 mg/kg (u 0., 2. i 6. tjednu) ili 6 mg/kg (u 14., 16. i 20. tjednu), a nakon toga se provodila terapija održavanja svakih 8 tjedana, u kombinaciji s metotreksatom.
English: A patient who requires surgery while on Zessly should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnika kojemu je za vrijeme liječenja lijekom Zessly potrebna operacija nužno je pomno nadzirati kako bi se utvrdile eventualne infekcije i poduzele odgovarajuće mjere.
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Croatian: bolesnici su imali snižene koncentracije interleukina 6 (IL-6) i C-reaktivnog proteina (CRP) u serumu u odnosu na vrijednosti na početku liječenja, dok je u bolesnika s reumatoidnim artritisom i sniženom koncentracijom hemoglobina na početku liječenja došlo do povišenja koncentracije hemoglobina.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Croatian: što predstavlja ukupno 6234 bolesnik-godina (3210 bolesnika), prijavljeno je 5 slučajeva limfoma i 38 slučajeva zloćudne bolesti koja nije bila limfom.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
Croatian: Boehringer Ingelheim Pharma GmbH & Co.
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Zessly.
Croatian: Odmah obavijestite Vašeg liječnika ako razvijete simptome lupusa za vrijeme liječenja lijekom Zessly.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies.
Croatian: Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa, klinička ispitivanja.
English: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Croatian: Rijetko: anafilaktički šok, vaskulitis, reakcija nalik na sarkoidozu Psihijatrijski poremećaji
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, study 1
Croatian: Učinci na ACR20, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu,
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Zessly and is positive for antibodies against double-stranded DNA, further treatment with Zessly must not be given (see section 4.8).
Croatian: Ako bolesnik nakon liječenja lijekom Zessly razvije simptome koji ukazuju na sindrom sličan lupusu i ako ima pozitivan nalaz protutijela na dvolančanu DNK, ne smije nastaviti liječenje lijekom Zessly
English: The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (clinical Study 5).
Croatian: Terapija održavanja u fistulirajućoj, aktivnoj Crohnovoj bolesti Djelotvornost ponovljenih infuzija infliksimaba u bolesnika s fistulirajućim oblikom Crohnove bolesti ispitivala se u jednogodišnjem kliničkom ispitivanju (ispitivanje 5).
English: The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Croatian: Sigurnost i djelotvornost infliksimaba u djece mlađe od 6 godina koja boluju od Crohnove bolesti nisu ispitivani.
English: Patients treated with Zessly should be given the package leaflet and the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Zessly moraju dobiti uputu o lijeku i karticu s podsjetnikom za bolesnika.
English: Maintenance (n = 99)
Croatian: Terapija održavanja placebom (n = 99)
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to
Croatian: Zloćudne bolesti, neke sa smrtnim ishodom, prijavljene su u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (liječenje započeto u dobi
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Croatian: Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa nisu još ustanovljene.
English: • The other ingredients are disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Croatian: • Druge pomoćne tvari su dinatrijev sukcinat heksahidrat, sukcinatna kiselina, saharoza i polisorbat 80.
English: PREGNANCY AND VACCINATIONS
Croatian: TRUDNOĆA I CIJEPLJENJE
English: A population-based retrospective cohort study found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age (see section 4.4).
Croatian: Populacijsko retrospektivno kohortno ispitivanje pokazalo je povećanu incidenciju raka cerviksa u žena s reumatoidnim artritisom liječenih infliksimabom u usporedbi s bolesnicama koje nisu bile liječene biološkim lijekovima ili općom populacijom, uključujući i one starije od 60 godina
English: Zessly 100 mg powder for concentrate for solution for infusion.
Croatian: Zessly 100 mg prašak za koncentrat za otopinu za infuziju.
English: Zessly 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 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Zessly je indiciran za liječenje umjerenog do teškog, aktivnog ulceroznog kolitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), odnosno koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
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: (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: Table 2 Proportion of patients with increased ALT activity in clinical studies
Croatian: Udio bolesnika s povišenom aktivnošću ALT-a u kliničkim ispitivanjima
English: 3rd dose
Croatian: 3. doza
English: Mean ± SDd a p < 0.001, for each infliximab treatment group vs. control.
Croatian: Prosječna vrijednost ± SDd a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
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).
Croatian: Broj hospitalizacija vezanih uz ulcerozni kolitis bio je značajno manji u skupinama koje su primale dozu infliksimaba od 5 mg/kg odnosno 10 mg/kg u odnosu na skupinu koja je primala placebo (prosječan broj hospitalizacija na 100 bolesnik godina: 21 odnosno 19 naspram 40 u placebo skupini, p = 0,019, odnosno p = 0,007).
English: Mean ± SDc 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: Dopuštala se istodobna primjena ustaljenih doza peroralnih kortikosteroida (≤ 10 mg/dan) i/ili nesteroidnih protuupalnih lijekova, a davala se i nadomjesna terapija folatima. 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
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: Ponovna primjena u ankilozantnom spondilitisu Sigurnost i djelotvornost lijeka pri ponovnoj primjeni nisu ustanovljene, osim kada se daje svakih 6 do 8 tjedana (vidjeti dijelove 4.4 i 4.8).
English: Signs and symptoms included myalgia and/or arthralgia with fever and/or rash, with some patients experiencing pruritus, facial, hand or lip oedema, dysphagia, urticaria, sore throat and headache.
Croatian: Znakovi i simptomi obuhvaćali su mialgiju i/ili artralgiju s vrućicom i/ili osipom, dok su neki bolesnici razvili pruritus, edem lica, šaka ili usana,
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 study 6 at weeks 30, 38, and 46.
Croatian: U oba klinička ispitivanja bolesnici su bili randomizirani u skupine koje su primale placebo, infliksimab u dozi od 5 mg/kg ili infliksimab u dozi od 10 mg/kg i to u 0., 2., 6., 14. i 22. tjednu, a u ispitivanju 6 još i u 30., 38. i 46. tjednu.
English: infliximab (week 98)
Croatian: Infliksima b (98. tjedan
English: Study 2 evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Croatian: U ispitivanju 2 ocjenjivali su se odgovori na terapiju nakon 54 tjedna u 1004 bolesnika s aktivnim reumatoidnim artritisom (medijan broja otečenih zglobova 19, a osjetljivih zglobova 31) u ranoj fazi
English: In Phase III clinical studies, 18% of infliximabtreated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Croatian: U kliničkim ispitivanjima faze III reakciju vezanu uz infuziju razvilo je 18% bolesnika liječenih infliksimabom u odnosu na 5%
English: Zessly 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.
Croatian: Zessly je indiciran za liječenje teškog oblika aktivnog ulceroznog kolitisa u djece i adolescenata u dobi između 6 i 17 godina koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-MP ili AZA, odnosno u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
English: Amnesia, agitation, confusion, somnolence, nervousness.
Croatian: Često: depresija, nesanica Manje često: amnezija, agitacija, konfuzija, somnolencija, nervoza Rijetko: apatija
English: Zessly is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Zessly se razrijeđuje u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za infuziju.
English: INFECTIONS Before treatment with Zessly
Croatian: Prije liječenja lijekom Zessly
English: If active tuberculosis is diagnosed, Zessly therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Zessly
English: (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Croatian: brzini sedimentacije eritrocita ili C-reaktivnog proteina.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Croatian: U bolesnika liječenih infliksimabom opažene su tuberkuloza, bakterijske infekcije uključujući sepsu i pneumoniju, invazivne gljivične, virusne i druge oportunističke infekcije.
English: b Based on patients with PASI ≥ 2.5 at baseline for study 10, and patients with ≥ 3% BSA
Croatian: Na temelju broja bolesnika s početnim PASI ≥ 2,5 u ispitivanju 10 i bolesnika s početnom zahvaćenošću kože psorijazom ≥ 3% BSA u ispitivanju 11.
English: Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double blinded, placebo-controlled, dose-response study.
Croatian: CDAI, ≥ 220 i ≤ 400) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju odgovora na dozu.
English: Table 8 Effects on clinical response in adult patients with moderately to severely active ulcerative colitis, clinical remission and mucosal healing at weeks 8 and 30.
Croatian: Učinci na klinički odgovor, kliničku remisiju i cijeljenje sluznice u 8. i 30. tjednu u odraslih bolesnika s umjerenim do teškim aktivnim ulceroznim kolitisom.
English: Maintenance treatment in moderately to severely active Crohn's disease in adults
Croatian: Terapija održavanja u umjerenoj do teškoj, aktivnoj Crohnovoj bolesti u odraslih bolesnika
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Croatian: Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze nisu još ustanovljene.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for study 1 (described below), landmark ACR-N for study 2 (described below)), the prevention of structural joint damage, and the improvement in physical function.
Croatian: American College of Rheumatology, ACR) (ACR20 za ispitivanje 1 (opisano u nastavku), granična vrijednost ACR-N za ispitivanje 2 (opisano u nastavku)),
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte: mogu se javiti u do 1 na 100 osoba
English: Arthralgia, myalgia, back pain.
Croatian: Često: artralgija, mialgija, bol u leđima
English: Infusion-related reaction, pain.
Croatian: Vrlo često: reakcije vezane uz infuziju, bol
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: (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,
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Croatian: Nadalje, nakon stavljanja lijeka u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih infliksimabom, s time da se većina slučajeva javila u bolesnika s Crohnovom bolešću i ulceroznim kolitisom i to većinom u adolescenata i mlađih odraslih muškaraca