FrancophonIA/ELRC3.0 huggingface dataset:
English: Under aseptic conditions, reconstitute each Remicade vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Croatian: U aseptičkim uvjetima, rekonstituirajte otopinu u svakoj bočici lijeka Remicade s 10 ml vode za injekcije, koristeći štrcaljku s iglom promjera 21 G (0,8 mm) ili užom.
English: • Fluid around the lungs (pleural effusion)
Croatian: • nakupljanje tekućine oko pluća (pleuralni izljev)
English: Remicade 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 Remicade 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: 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: 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.
Croatian: Infliksimab s ili bez AZA ispitivao se u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom (SONIC) u 508 odraslih bolesnika sa srednje teškom do teškom Crohnovom bolešću (CDAI ≥ 220 i ≤ 450) koji prethodno nisu primali biološke lijekove niti imunosupresive i u kojih je medijan trajanja bolesti iznosio 2,3 godine.
English: Common: Hepatic function abnormal, transaminases increased.
Croatian: Često: poremećaj funkcije jetre, povišene transaminaze
English: In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at doses of 6 mg/kg or greater (see section 4.4).
Croatian: U kliničkim ispitivanjima reumatoidnog artritisa, incidencija teških infekcija, uključujući pneumoniju, bila je veća u skupini bolesnika liječenih infliksimabom i metotreksatom nego u skupini koja je primala samo metotreksat, osobito pri dozama od 6 mg/kg ili višim (vidjeti dio 4.4).
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Remicade with other agents.
Croatian: Nisu provedena ispitivanja fizikalno-biokemijske kompatibilnosti istodobne primjene lijeka Remicade s drugim lijekovima.
English: In rheumatoid arthritis, treatment with infliximab reduced infiltration of inflammatory cells into inflamed areas of the joint as well as expression of molecules mediating cellular adhesion, chemoattraction and tissue degradation.
Croatian: Tijekom liječenja reumatoidnog artritisa infliksimabom smanjili su se infiltrati upalnih stanica u područjima upale u zglobu kao i ekspresija molekula koje posreduju pri staničnoj adheziji, kemoatrakciji i razgradnji tkiva.
English: Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval.
Croatian: Dostupni podaci ukazuju na povećanje rizika od razvoja reakcija kasne preosjetljivosti što je dulje razdoblje u kojemu se Remicade ne primjenjuje.
English: Particular attention regarding the risk for infection should be paid when treating the elderly (see section 4.8).
Croatian: U liječenju starijih bolesnika osobitu pozornost treba posvetiti riziku od razvoja infekcije (vidjeti dio 4.8).
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Croatian: Svi su bolesnici morali primati ustaljenu dozu 6-MP, AZA ili MTX (35% ih je na početku ispitivanja primalo i kortikosteroide).
English: Serious infections were reported in 12% (7/60) of all treated patients.
Croatian: Ozbiljne infekcije prijavljene su u 12% svih liječenih bolesnika
English: Reduction in the rate of progression of structural damage was observed at weeks 30 and 54 in the infliximab + methotrexate groups compared to methotrexate alone.
Croatian: Opaženo je smanjenje brzine napredovanja strukturnog oštećenja zglobova u 30. i 54. tjednu u skupinama bolesnika koji su primali infliksimab + metotreksat, u odnosu na bolesnike koji su liječeni samo metotreksatom.
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: • Tell your doctor before you are given Remicade if you are a carrier of hepatitis B or have ever had it.
Croatian: • Prije nego počnete primati Remicade, obavijestite svog liječnika ako ste nositelj virusa hepatitisa B ili ste ikad imali hepatitis B.
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 Remicade therapy.
Croatian: U bolesnika s već postojećim ili novonastalim demijelinizacijskim bolestima treba pažljivo procijeniti rizike i koristi anti-TNF terapije prije početka liječenja lijekom Remicade.
English: • Ankylosing spondylitis (Bechterew's disease)
Croatian: • ankilozantni spondilitis (Bechterewljeva bolest)
English: • Tell your doctor before you are given Remicade if you have an infection even if it is a very minor one.
Croatian: • Prije nego primite Remicade, obavijestite svog liječnika ako imate neku infekciju, čak i ako je vrlo blaga.
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: • Heart attack
Croatian: • srčani udar
English: Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
Croatian: Na temelju dostupnih podataka ne preporučuje se daljnje liječenje infliksimabom u bolesnika koji u roku od 6 tjedana od početne infuzije nisu odgovorili na terapiju.
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months, but not exceeding the original expiry date.
Croatian: Može se čuvati na sobnoj temperaturi (do 25°C) neprekinuto tijekom razdoblja od najviše 6 mjeseci, ali ne izvan originalnog roka valjanosti.
English: • Tell your doctor before you are given Remicade if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Croatian: • Prije nego počnete primati Remicade, obavijestite liječnika ako bolujete ili ste bolovali od limfoma (vrsta raka krvi) ili neke druge vrste raka.
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.
Croatian: U eksplorativnom kliničkom ispitivanju u kojem se ocjenjivala primjena lijeka Remicade u bolesnika s srednje teškom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB), prijavljeno je više slučajeva zloćudnih bolesti u bolesnika liječenih lijekom Remicade nego u bolesnika u kontrolnoj skupini.
English: Remicade is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Međutim, Remicade se razrjeđuje u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za infuziju.
English: Placebo Maintenance
Croatian: Terapija održavanja placebom
English: Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Croatian: Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
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 vs.15/60).
Croatian: U ovom je ispitivanju bilo više bolesnika u dobnoj skupini od 12 do 17 godina (45/60) nego u dobnoj skupini od 6 do 11 godina (15/60).
English: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Croatian: • Znakove alergijske reakcije kao što su oticanje lica, usana, usta ili grla, koje može izazvati poteškoće pri gutanju ili disanju, osip, koprivnjaču, oticanje šaka, stopala ili gležnjeva.
English: Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Croatian: Nail Psoriasis Severity Index, NAPSI).
English: • Chills, a build up of fluid under the skin causing swelling
Croatian: • zimica, nakupljanje tekućine ispod kože koje uzrokuje oticanje
English: Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
Croatian: Postotak ispitanika s kliničkim odgovorom i održanim kliničkim odgovorom Klinički odgovor u 8. tjednu
English: • Treat active Crohn's disease
Croatian: • liječila aktivna Crohnova bolest
English: • Narrowed airway in the lungs, causing difficulty breathing
Croatian: • suženje dišnih putova u plućima, koje uzrokuje otežano disanje
English: Remicade may have a minor influence on the ability to drive and use machines.
Croatian: Remicade malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In all situations described below, the benefit/risk balance of Remicade therapy should be very carefully considered.
Croatian: U svim situacijama opisanima u daljnjem tekstu potrebno je vrlo pažljivo odvagnuti omjer rizika i koristi liječenja lijekom Remicade.
English: In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year.
Croatian: U kliničkim su ispitivanjima reakcije kasne preosjetljivosti bile manje česte i javljale su se nakon što se Remicade nije primjenjivao u razdoblju kraćem od godinu dana.
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 daje svakih 6 do 8 tjedana (vidjeti dijelove 4.4 i 4.8).
English: Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment (see section 5.1).
Croatian: Na temelju dostupnih podataka ne preporučuje se daljnje liječenje infliksimabom u pedijatrijskih bolesnika koji nisu odgovorili na terapiju u prvih 8 tjedana (vidjeti dio 5.1).
English: It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Croatian: Potrebno je upozoriti na rizik lažno negativnih tuberkulinskih testova, osobito u teško bolesnih i imunokompromitiranih bolesnika.
English: Patients treated with Remicade should be given the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Remicade moraju dobiti karticu s podsjetnikom za bolesnika.
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Croatian: Prosječni početni NAPSI rezultati iznosili su 4,6 u skupini liječenoj infliksimabom i 4,3 u placebo skupini.
English: There are no known side effects of having too much of Remicade.
Croatian: Nisu poznate nuspojave kod primjene prevelike količine lijeka Remicade.
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
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: • The table below shows how often you will usually have this medicine after your first dose.
Croatian: • Koliko se često ovaj lijek obično primjenjuje nakon prve doze prikazano je u tablici ispod.
English: If you are not sure, talk to your doctor before you are given Remicade.
Croatian: Ako niste sigurni, obratite se svom liječniku prije nego što primite Remicade.
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: Nakon liječenja infliksimabom, 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: Infliximab Maintenance (5 mg/kg) (n = 96)
Croatian: Terapija održavanja infliksimabom (5 mg/kg) (n = 96)
English: Remicade 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.
Croatian: Remicade se može čuvati na temperaturi do najviše 25°C neprekinuto tijekom razdoblja od najviše 6 mjeseci, ali ne izvan originalnog roka valjanosti.
English: START was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Croatian: START je bilo randomizirano, multicentrično, dvostruko slijepo ispitivanje sigurnosti primjene u 3 paralelne skupine bolesnika.
English: • Talk to your doctor if you recently have had or are due to have a vaccine.
Croatian: • Obavijestite svog liječnika ako ste se nedavno cijepili ili se trebate uskoro cijepiti.
English: Pregnancy and Vaccinations
Croatian: Trudnoća i cijepljenje
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 TNF-antagonist primali i antivirusne lijekove radi sprječavanja reaktivacije hepatitisa B.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remicade cannot be excluded (see section 4.8).
Croatian: Ne može se isključiti rizik od razvoja hepatospleničkog limfoma T-stanica u bolesnika koji se liječe lijekom Remicade (vidjeti dio 4.8).
English: • Collection of blood outside the blood vessels (haematoma) or bruising
Croatian: • nakupljanje krvi izvan krvnih žila (hematom) ili nastanak modrica
English: • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Croatian: • odraslih bolesnika s teškom, aktivnom i progresivnom bolešću, koji se prethodno nisu liječili metotreksatom ili drugim antireumatskim lijekovima koji modificiraju tijek bolesti.
English: The safety and efficacy of Remicade were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Croatian: Sigurnost i djelotvornost lijeka Remicade ispitivane su u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja (ACT 1 i ACT 2) u odraslih bolesnika s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo bodovi 6 do 12; endoskopski ≥ 2), koji nisu odgovorili na konvencionalno liječenje na odgovarajući način [peroralne kortikosteroide, aminosalicilate i/ili imunomodulatore (6-MP, AZA)].
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of Remicade 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Croatian: U tom je ispitivanju 150 bolesnika s kroničnim zatajenjem srca NYHA stupnja III-IV (ejekcijska frakcija lijeve klijetke ≤ 35%) liječeno sa 3 infuzije lijeka Remicade u dozi od 5 mg/kg odnosno 10 mg/kg ili je primalo placebo tijekom 6 tjedana.
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leucopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Croatian: U djece su se više javljale sljedeće nuspojave: smanjen broj crvenih krvnih stanica (anemija), krv u stolici, smanjen ukupan broj bijelih krvnih stanica (leukopenija), crvenilo ili crvenjenje (navale crvenila), virusne infekcije, smanjen broj bijelih krvnih stanica koje se bore protiv infekcije (neutropenija), lom kostiju, bakterijske infekcije te alergijske reakcije dišnog sustava.
English: Beginning at week 14, patients who had responded to treatment, but subsequently lost their clinical benefit, were allowed to cross over to a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Croatian: Počevši od 14. tjedna, bolesnike koji su odgovorili na liječenje, no u kojih se kliničko poboljšanje kasnije izgubilo, bilo je dopušteno prebaciti na dozu infliksimaba koja je bila za 5 mg/kg veća od one koju su primali nakon randomizacije.
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with Remicade 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 lijekom Remicade, s time da se većina slučajeva javila u bolesnika s Crohnovom bolešću i ulceroznim kolitisom i to većinom u adolescenata i mlađih odraslih muškaraca (vidjeti dio 4.4).
English: Antibodies to infliximab developed in 38% of patients receiving 3 mg/kg compared with 12% of patients receiving 6 mg/kg.
Croatian: Protutijela na infliksimab razvila su se u 38% bolesnika koji su primali dozu od 3 mg/kg te u 12% bolesnika koji su primali dozu od 6 mg/kg.
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n = 78) or 5 mg/kg infliximab (Group 2, n = 201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Croatian: U drugom kliničkom ispitivanju (ASSERT), 279 bolesnika randomizirano je u skupinu koja je primala placebo (skupina 1, n = 78) ili u skupinu koja je primala infliksimab u dozi od 5 mg/kg (skupina 2, n = 201) u 0., 2. i 6. tjednu, a zatim svakih 6 tjedana do ukupno 24 tjedna.
English: Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Croatian: Najčešće prijavljene infekcije dišnog sustava bile su infekcije gornjih dišnih puteva (7/60 [12%]) i faringitis (5/60 [8%]).
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin,
Croatian: • drugi problemi s kožom kao što su multiformni eritem, lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici), mjehurići na koži i ljuštenje kože ili gnojni čirevi (furunkuloza)
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Croatian: U 54. je tjednu klinički odgovor imalo 44,9% bolesnika u objema skupinama liječenima infliksimabom, u odnosu na 19,8% ispitanika u skupini koja je primala placebo (p < 0,001).
English: • Infection of the skin due to a fungus
Croatian: • infekcija kože uzrokovana gljivicama
English: An association between development of antibodies to infliximab and reduced duration of response has also been observed.
Croatian: Uočena je i povezanost između razvoja protutijela na infliksimab i kraćeg trajanja odgovora na terapiju.
English: Remicade and Kineret should not be used together.
Croatian: Remicade i Kineret ne smiju se istodobno uzimati.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Croatian: Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa, pivotalna klinička ispitivanja: ATTRACT i ASPIRE.
English: Endoscopic studies of intestinal mucosa have shown evidence of mucosal healing in infliximab-treated patients.
Croatian: Endoskopska istraživanja sluznice crijeva pokazala su znakove zacjeljenja sluznice u bolesnika liječenih infliksimabom.
English: Beginning at week 22, patients who initially responded to treatment and subsequently lost their response were eligible to cross over to active re-treatment every 8 weeks at a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Croatian: Počevši od 22. tjedna, bolesnike koji su prvobitno odgovorili na liječenje, no u kojih se klinički odgovor kasnije izgubio, bilo je dopušteno prebaciti na aktivno ponovno liječenje svakih 8 tjedana, dozom infliksimaba koja je bila za 5 mg/kg veća od one koju su primali nakon randomizacije.
English: Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Croatian: Vaše dijete ne smije primiti živo cjepivo poput BCG-a u razdoblju od 6 mjeseci nakon rođenja.
English: • Slow down the damage in your joints
Croatian: • usporilo oštećenje zglobova
English: Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Croatian: Simptomi obuhvaćaju ustrajan kašalj, gubitak tjelesne težine, umor, vrućicu, noćno znojenje.
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.
Croatian: U ispitivanjima IMPACT i IMPACT 2 klinički su odgovori primijećeni već u 2. tjednu i održali su se do 98. tjedna u ispitivanju IMPACT odnosno do 54. tjedna u ispitivanju IMPACT 2. Djelotvornost je potvrđena s ili bez istodobne primjene metotreksata.
English: If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
Croatian: Postigne li se odgovarajući odgovor, treba nastaviti liječenje odabranom dozom odnosno učestalošću primjene.
English: At week 24, all placebo-treated patients crossed over to infliximab induction.
Croatian: U 24. tjednu u svih se bolesnika liječenih placebom počeo primjenjivati uvodni režim liječenja infliksimabom.
English: If serious reactions occur, symptomatic treatment must be given and further Remicade 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 Remicade (vidjeti dio 4.8).