FrancophonIA/ELRC3.0 huggingface dataset:
English: The vast majority of Remicade 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 lijekom Remicade pojavila se u bolesnika s Crohnovom bolešću ili ulceroznim kolitisom, a većinom su prijavljeni u adolescenata ili mlađih odraslih muškaraca.
English: • Lung or chest infections such as bronchitis or pneumonia
Croatian: • infekcije dišnog sustava kao što su bronhitis ili upala pluća
English: Signs include shortness of breath or swelling of your feet.
Croatian: Simptomi obuhvaćaju nedostatak zraka ili oticanje stopala.
English: Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Croatian: Remicade 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: Remicade contains the active substance infliximab.
Croatian: Remicade sadrži djelatnu tvar infliksimab.
English: Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients.
Croatian: Protutijela na dvolančanu DNK po prvi puta su otkrivena u oko 17% bolesnika liječenih infliksimabom, u odnosu na 0% bolesnika koji su primali placebo.
English: A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnika kojemu je za vrijeme liječenja lijekom Remicade potrebna operacija nužno je pomno nadzirati kako bi se utvrdile eventualne infekcije i poduzele odgovarajuće mjere.
English: Fistulising Crohn's disease
Croatian: Fistulirajuća Crohnova bolest
English: No major age-related differences in clearance or volume of distribution were observed in clinical studies.
Croatian: U kliničkim ispitivanjima nisu opažene veće dobno uvjetovane razlike u klirensu i volumenu distribucije lijeka.
English: Steroid-Free Remission
Croatian: Remisija bez steroida
English: • Blood problems such as anaemia or low white blood cell count
Croatian: • poremećaji krvi kao što su anemija ili smanjen broj bijelih krvnih stanica (leukocita)
English: Remicade 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: Remicade 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: Uncommon: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Croatian: Često: alergijske reakcije dišnog sustava Manje često: anafilaktička reakcija, sindrom sličan lupusu, serumska bolest ili reakcije nalik serumskoj bolesti
English: At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p < 0.001).
Croatian: U 24. tjednu, klinički odgovor ASAS 20 imalo je 15 od 78 (19%) bolesnika u skupini koja je primala placebo i 123 od 201 (61%) bolesnika u skupini koja je primala infliksimab u dozi od 5 mg/kg (p < 0,001).
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
Croatian: • upala plućne ovojnice, koja uzrokuje oštru bol u prsnom košu koja se pogoršava disanjem
English: Remicade contains sodium
Croatian: Remicade sadrži natrij
English: At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p < 0.001).
Croatian: U 54. su tjednu navedeni udjeli iznosili 55,8% (29/52) u skupini koja je terapiju održavanja primala svakih 8 tjedana, odnosno 23,5% (12/51) u skupini koja ju je primala svakih 12 tjedana (p < 0,001).
English: Further doses
Croatian: 2. doza
English: In Phase III clinical studies, 18% of infliximab-treated 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% bolesnika koji su dobivali placebo.
English: Clinical response at week 30
Croatian: Klinički odgovor u 30. tjednu
English: • Psoriasis.
Croatian: • psorijazu
English: * P-values represent each infliximab treatment group vs. AZA monotherapy.
Croatian: * p-vrijednosti odnose se na usporedbu svake skupine koja je primala infliksimab sa skupinom koja je primala monoterapiju AZA.
English: The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Croatian: Sigurnost i djelotvornost lijeka Remicade u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze nisu još ustanovljene.
English: Rare: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Croatian: Često: bakterijske infekcije (npr. sepsa, celulitis, apsces) Manje često: tuberkuloza, gljivične infekcije (npr. kandidijaza, onihomikoza) Rijetko: meningitis, oportunističke infekcije (kao što su invazivne gljivične infekcije [pneumocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske infekcije [atipična mikobakterijska infekcija, listerioza, salmoneloza] i virusne infekcije [citomegalovirus]), parazitske infekcije, reaktivacija hepatitisa B Nepoznato: probojna infekcija uzrokovana cjepivom (nakon izlaganja infliksimabu in utero)*
English: Number of patients evaluated for ALT.
Croatian: Broj bolesnika uključenih u analizu ALT-a.
English: Rare: Complement factor abnormal.
Croatian: Rijetko: odstupanje od normalne vrijednosti faktora komplementa
English: p < 0.001, for each infliximab treatment group vs. control.
Croatian: 50. tjedan p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Croatian: • Druge pomoćne tvari su saharoza, polisorbat 80, natrijev dihidrogenfosfat i natrijev hidrogenfosfat.
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: Heijde-modified Sharp score) Change from baseline (Mean ± SD
Croatian: Heijdeova modifikacija Sharpove bodovne skale)
English: Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Croatian: Znakovi uključuju ustrajnu vrućicu, povećanu sklonost krvarenju ili nastanku modrica, male crvene ili ljubičaste točkice uzrokovane krvarenjem ispod kože ili bljedilo.
English: • adult patients with active disease when the response to disease-modifying antirheumatic drugs
Croatian: • odraslih bolesnika s aktivnom bolešću čiji odgovor na antireumatske lijekove koji modificiraju tijek bolesti (engl. disease-modifying antirheumatic drugs, DMARD), uključujući metotreksat,
English: Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Croatian: Djelotvornost i sigurnost primjene infliksimaba ispitivane su u dva multicentrična, dvostruko slijepa, placebom kontrolirana klinička ispitivanja u bolesnika s aktivnim psorijatičnim artritisom.
English: Before treatment with Remicade
Croatian: Prije liječenja lijekom Remicade
English: At week 54, the proportion of patients in clinical remission as measured by the PUCAI score was 38% (8/21) in the q8 week maintenance group and 18% (4/22) in the q12 week maintenance treatment group.
Croatian: U 54. je tjednu udio bolesnika u kliničkoj remisiji prema PUCAI rezultatu iznosio 38% (8/21) u skupini koja je terapiju održavanja primala svakih 8 tjedana i 18% (4/22) u skupini koja ju je primala svakih 12 tjedana.
English: Adult Crohn's disease
Croatian: Crohnova bolest u odraslih bolesnika
English: The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p < 0.001; and 20.2% vs. 6.6%, p < 0.001, respectively).
Croatian: Udio bolesnika s održanim terapijskim odgovorom i održanom remisijom u 54. tjednu bio je veći u skupinama liječenima infliksimabom (zbirni podaci) nego u skupini koja je primala placebo (37,9% naspram 14,0%, p < 0,001; odnosno 20,2% naspram 6,6%, p < 0,001).
English: Please make sure you also have a list of all other medicines that you are using with you at any visit to a healthcare professional.
Croatian: Prilikom svakog posjeta liječniku obavezno ponesite popis svih drugih lijekova koje uzimate.
English: Patients were randomised to receive AZA monotherapy, infliximab monotherapy, or infliximab plus AZA combination therapy.
Croatian: Bolesnici su bili randomizirani u skupinu koja je primala monoterapiju AZA, skupinu koja je primala monoterapiju infliksimabom ili u skupinu koja je primala kombiniranu terapiju infliksimab + AZA.
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see
Croatian: • ponovna primjena: infuzija u dozi od 5 mg/kg ako se ponovno pojave znakovi i simptomi bolesti (vidjeti "Ponovna primjena" u daljnjem tekstu i dio 4.4).
English: Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents including infliximab.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica (engl. hepatosplenic T-cell lymphoma, HSTCL) u bolesnika liječenih TNF-blokatorima uključujući infliksimab.
English: Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26.
Croatian: Physician Global Assessment, PGA) imali ≥ 3 boda, zadovoljili su kriterije da još jednom prime istu infuziju u 26. tjednu.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with Remicade administration (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet bilo je slučajeva reakcija nalik anafilaksiji, uključujući edem grkljana/ždrijela i teški bronhospazam te napadaje, koje su se povezivale s primjenom lijeka Remicade (vidjeti dio 4.4).
English: Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Croatian: Čini se da istodobna primjena imunosupresiva smanjuje učestalost reakcija vezanih uz infuziju.
English: • Maintenance: Additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or
Croatian: • terapija održavanja: dodatna infuzija u dozi od 5 mg/kg u 6. tjednu nakon početne doze te nakon toga infuzije svakih 8 tjedana ili
English: Psoriatic arthritis Plaque psoriasis
Croatian: Ankilozantn i spondilitis Psorijatični artritis Plak psorijaza
English: Signs include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems.
Croatian: Simptomi mogu biti vrućica, kašalj, simptomi nalik gripi, opća slabost, crvena ili užarena koža, rane ili problemi sa zubima.
English: The long half-life of infliximab should be taken into consideration if a surgical procedure is planned.
Croatian: Planira li se kirurški zahvat, treba voditi računa o dugom poluvijeku infliksimaba.
English: If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given.
Croatian: Ako bolesnik ne odgovori na terapiju nakon 14 tjedana (tj. nakon 4 doze), ne bi trebalo nastaviti liječenje infliksimabom.
English: all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs p < 0.001, for each infliximab treatment group vs. control 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. sve doze infliksimaba davale su se u kombinaciji s metotreksatom i folatima, a u nekim slučajevima i s kortikosteroidima i/ili nesteroidnim protuupalnim lijekovima p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s kontrolnom skupinom veće vrijednosti znače jače oštećenje zgloba
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p < 0.001).
Croatian: Četvrtog tjedna nakon primjene jednokratne doze ispitivanog lijeka klinički su odgovor postigla 22 od 27 (81%) bolesnika liječenih infliksimabom u dozi od 5 mg/kg naspram 4 od 25 (16%) bolesnika koji su primili placebo (p < 0,001).
English: • Stomach pain, feeling sick
Croatian: • bol u trbuhu, mučnina
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.
Croatian: Ozbiljne infekcije i neutropenija zabilježene su u kliničkim ispitivanjima istodobne primjene anakinre i drugog inhibitora TNFα, etanercepta, koja nije dovela do dodatnog kliničkog poboljšanja u odnosu na primjenu samo etanercepta.
English: The potential contribution of exposure to infliximab and/or the severity of the underlying disease in these outcomes remains unclear.
Croatian: Nije razjašnjeno pridonose li tim ishodima izloženost infliksimabu i/ili težina osnovne bolesti.
English: At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p < 0.01).
Croatian: U 12. tjednu, klinički odgovor BASDAI 50 imalo je 3 od 35 (9%) bolesnika u skupini koja je primala placebo i 20 od 35 (57%) bolesnika u skupini koja je primala infliksimab u dozi od 5 mg/kg (p < 0,01).
English: Remicade should be administered
Croatian: Remicade treba primjenjivati:
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Croatian: Nastavak liječenja treba pomno razmotriti u bolesnika u kojih nema dokaza o koristi terapije nakon prilagođavanja doze.
English: The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study (C0168T72) 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: Ulcerozni kolitis u pedijatrijskih bolesnika (6 do 17 godina) Sigurnost primjene i djelotvornost infliksimaba ispitivane su u multicentričnom, randomiziranom otvorenom kliničkom ispitivanju s paralelnim skupinama (C0168T72), 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: The concurrent administration of live vaccines with Remicade is not recommended.
Croatian: Ne preporučuje se istodobna primjena živih cjepiva s lijekom Remicade.
English: • Psoriatic arthritis
Croatian: • psorijatični artritis
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Croatian: Psoriasis Area and Severity Index [PASI] ≥ 12).
English: • You may get infections more easily when you are being treated with Remicade.
Croatian: • Tijekom liječenja lijekom Remicade možete postati osjetljiviji na infekcije.
English: • A hole in the bowel or blockage of the intestine, stomach pain or cramps
Croatian: • otvor u crijevu ili onemogućen rad crijeva, bol u trbuhu ili grčevi
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Remicade.
Croatian: Odmah obavijestite Vašeg liječnika ako razvijete simptome lupusa za vrijeme liječenja lijekom Remicade.
English: Patients treated with Remicade should be given the package leaflet and the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Remicade moraju dobiti uputu o lijeku i karticu s podsjetnikom za bolesnika.
English: Discontinuation of Remicade should be considered if these disorders develop.
Croatian: Ako se razviju ovakvi poremećaji, treba razmotriti prekid primjene lijeka Remicade.
English: Thirty two (32) evaluable paediatric patients crossed over (9 subjects in the q8 weeks and 23 subjects in the q12 weeks maintenance groups).
Croatian: Terapiju su promijenila 32 pedijatrijska bolesnika (9 ispitanika u skupini koja je primala terapiju održavanja svakih 8 tjedana i 23 ispitanika u skupini koja ju je primala svakih 12 tjedana).
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including Remicade (see section 4.8).
Croatian: U bolesnika liječenih TNF-blokatorima, uključujući Remicade, prijavljeni su melanom i karcinom Merkelovih stanica (vidjeti dio 4.8).
English: Corticosteroid tapering was permitted after week 6.
Croatian: Nakon 6. tjedna bilo je dopušteno postupno smanjenje doze kortikosteroida.
English: Change from baseline in total van der Heijde-modified Sharp score Mean ± SD
Croatian: Prosječna vrijednost ± SD Promjena od početnog ukupnog broja bodova prema van der Heijdeovoj modifikaciji Sharpove bodovne skale
English: Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Razrijedite ukupan volumen rekonstituirane otopine lijeka Remicade s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju do ukupnog volumena od 250 ml.
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p = 0.145 and p = 0.022, respectively).
Croatian: Broj kirurških zahvata zbog ulceroznog kolitisa također je bio 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 kirurških zahvata na 100 bolesnik-godina: 22 odnosno 19 naspram 34; p = 0,145 odnosno p = 0,022).
English: Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
Croatian: Nakon 0. tjedna bilo je dopušteno prekinuti primjenu imunomodulatora i postupno smanjivati dozu kortikosteroida.
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.
Croatian: Među bolesnicima koji su primali infliksimab i imali reakciju na infuziju u uvodnom razdoblju liječenja do 6. tjedna, njih je 27%
English: Week 30 Clinical Response
Croatian: 30. tjedan Klinički odgovor
English: 10 mg/kg Combined
Croatian: 10 mg/kg Zbirni podaci
English: Corticosteroid taper was permitted after week 8.
Croatian: Nakon 8. tjedna bilo je dopušteno postupno smanjenje doze kortikosteroida.
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving Remicade (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet, u bolesnika koji su primali Remicade prijavljeni su slučajevi žutice i hepatitisa, koji je u nekim slučajevima imao obilježja autoimunog hepatitisa (vidjeti dio 4.4).
English: Remicade 100 mg powder for concentrate infliximab
Croatian: Remicade 100 mg prašak za koncentrat infliksimab i.v.
English: Re-administration for ulcerative colitis
Croatian: Ponovna primjena u ulceroznom kolitisu
English: During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
Croatian: Tijekom 24 tjedana dvostruko slijepe faze ispitivanja, bolesnici su primali ili infliksimab u dozi od 5 mg/kg ili placebo u 0., 2., 6., 14. i 22. tjednu (100 bolesnika u svakoj skupini).
English: Sustained remission (in remission at both week 8 and week 30)
Croatian: 8. i u 30. tjednu)
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Remicade.
Croatian: Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Remicade.
English: • Fungal infections such as yeast infection or fungal infection of the nails
Croatian: • gljivične infekcije kao što su infekcije uzrokovane kvascima ili gljivične infekcije noktiju
English: Subjects randomised
Croatian: Broj randomiziranih ispitanika
English: • Rheumatoid arthritis
Croatian: • reumatoidni artritis
English: Re-administration for ankylosing spondylitis
Croatian: Ponovna primjena u ankilozantnom spondilitisu
English: Infliximab
Croatian: Infliksimab
English: Unchanged infliximab was not detected in urine.
Croatian: U mokraći nije pronađen nepromijenjeni infliksimab.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
Croatian: > 5% uključuju pneumocistozu, kandidijazu, listeriozu i aspergilozu (vidjeti dio 4.4).
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Croatian: Pomoćne tvari: saharoza, polisorbat 80, natrijev dihidrogenfosfat i natrijev hidrogenfosfat.
English: There were 53 subjects who continued on 5 mg/kg every 6 weeks.
Croatian: Pedeset i tri ispitanika nastavila su primati infliksimab u dozi od 5 mg/kg svakih 6 tjedana.
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including infliximab.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih TNF-blokatorima uključujući infliksimab.
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30 and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Croatian: Među 22 ispitanika u obje skupine (održavanje svakih 8 tjedana i svakih 12 tjedana) koji su imali fistule na početku ispitivanja, fistule su bile potpuno zatvorene u njih 63,6% (14/22) u 10. tjednu, u 59,1% (13/22) u 30. tjednu te u 68,2% (15/22) bolesnika u 54. tjednu.