FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Croatian: Djelotvornost i sigurnost infliksimaba ocjenjivale su se u dva multicentrična, dvostruko slijepa, placebom kontrolirana ispitivanja u bolesnika s aktivnim ankilozantnim spondilitisom (rezultat ≥ 4 prema Bathovu indeksu aktivnosti ankilozantnog spondilitisa [engl.
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Croatian: • Drugi sastojci su saharoza, polisorbat 80, natrijev dihidrogenfosfat hidrat i natrijev hidrogenfosfat heptahidrat.
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24 and 50.
Croatian: Tablica 10 Sažeti prikaz PASI odgovora, PGA odgovora i postotka bolesnika bez psorijatičnih promjena na noktima u 10., 24. i 50 tjednu, EXPRESS
English: If these medicines do not work well enough, you will be given Flixabi to treat your disease.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, za liječenje bolesti dobit ćete Flixabi.
English: Therefore, the combination of Flixabi and anakinra is not recommended.
Croatian: Stoga se ne preporučuje kombinirana primjena lijeka Flixabi i anakinre.
English: • Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest
Croatian: • Znakove problema s plućima kao što su kašalj, otežano disanje ili stezanje u prsnom košu.
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 ustanovljene.
English: Before treatment with Flixabi
Croatian: Prije liječenja lijekom Flixabi
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 Flixabi treatment.
Croatian: Sve bolesnike treba uputiti da se jave liječniku ako se tijekom ili nakon liječenja lijekom Flixabi pojave znakovi/simptomi koji bi mogli ukazivati na tuberkulozu (npr. perzistirajući kašalj, gubitak tjelesne težine, subfebrilnost).
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Croatian: tuberkuloza, gljivične infekcije (npr. kandidijaza, onihomikoza)
English: If you are not sure if any of the above applies to you, talk to your doctor before you are given Flixabi.
Croatian: Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte sa svojim liječnikom prije nego primite Flixabi.
English: Change from baseline in total van der Heijde-modified Sharp score b
Croatian: Promjena od početnog ukupnog broja bodova prema van der Heijdeovoj modifikaciji Sharpove bodovne skaleb Prosječna vrijednost ± SDa
English: Clinical response at week 30
Croatian: 30. tjedan Klinički odgovora
English: Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Croatian: Flixabi 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: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating
Croatian: • Znakove infekcije (uključujući TBC) kao što su vrućica, umor, kašalj koji može biti ustrajan, nedostatak zraka, simptomi nalik gripi, gubitak tjelesne težine, noćno znojenje, proljev, rane, nakupljanje gnoja u crijevima ili oko anusa (apsces), problemi sa zubima ili osjećaj žarenja pri mokrenju.
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 povezanih s infuzijom.
English: OUTER CARTON
Croatian: VANJSKA KARTONSKA KUTIJA
English: Concurrent administration of TNF-alpha inhibitor and abatacept In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Croatian: U kliničkim ispitivanjima istodobna primjena inhibitora TNFα i abatacepta bila je povezana s povećanim rizikom od razvoja infekcija, uključujući i ozbiljne infekcije, u odnosu na primjenu samo antagonista TNF-a, a pritom nije došlo do povećanja kliničkog učinka.
English: • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Croatian: • teške alergijske reakcije (npr. anafilaksija), poremećaj imunološkog sustava poznat kao lupus,
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 koji se zove lupus 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: Flixabi is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Croatian: Flixabi je indiciran za liječenje teške, aktivne Crohnove bolesti u djece i adolescenata u dobi između 6 i 17 godina, koji nisu odgovorili na konvencionalnu terapiju uključujući kortikosteroid, imunomodulator i primarnu nutritivnu terapiju, te onih koji ne podnose takve vrste terapija ili su im one kontraindicirane.
English: Abnormal skin openings • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Flixabi.
Croatian: • Obavijestite svog liječnika ako imate neprirodne otvore na koži (fistule) prije nego što počnete primati Flixabi.
English: • Treat active Crohn's disease,
Croatian: • liječila aktivna Crohnova bolest
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 povezanu s infuzijom razvilo je 18% bolesnika liječenih infliksimabom u odnosu na 5% bolesnika koji su dobivali placebo.
English: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Croatian: bulozne erupcije, seboreja, rozacea, papilomi, hiperkeratoza, poremećaj pigmentacije
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Croatian: perforacija crijeva, stenoza crijeva, divertikulitis, pankreatitis, heilitis
English: During treatment with Flixabi
Croatian: Tijekom liječenja lijekom Flixabi
English: Flixabi should be administered intravenously.
Croatian: Flixabi se primjenjuje intravenski.
English: Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Croatian: Flixabi je indiciran za liječenje umjerene do teške plak psorijaze u odraslih bolesnika u kojih je druga sustavna terapija, koja uključuje ciklosporin, metotreksat ili terapiju psoralenom u kombinaciji s ultraljubičastim zračenjem A (PUVA), nedjelotvorna, kontraindicirana ili je bolesnici ne podnose (vidjeti dio 5.1).
English: Do not infuse Flixabi concomitantly in the same intravenous line with other agents.
Croatian: Flixabi se ne smije davati istodobno u istoj infuziji s drugim lijekovima.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi,
Croatian: • Te infekcije mogu biti ozbiljne, a uključuju tuberkulozu, virusne infekcije, gljivične infekcije, bakterijske infekcije ili infekcije uzrokovane drugim mikroorganizmima iz okoliša te sepsu, koja može ugroziti život.
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: • You are allergic (hypersensitive) to proteins that come from mice.
Croatian: • ako ste alergični (preosjetljivi) na bjelančevine mišjeg podrijetla
English: Efficacy and safety were assessed in two multicentre, 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: 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 ACT 1 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 ACT 1 još i u 30., 38. i 46. tjednu.
English: Flixabi 100 mg powder for concentrate for solution for infusion.
Croatian: Flixabi 100 mg prašak za koncentrat za otopinu za infuziju.
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Flixabi over 1 hour.
Croatian: • Lijek će se primijeniti infuzijom (ukapavanjem) tijekom 2 sata u jednu od vena, obično na ruci.
English: Dilute the total volume of the reconstituted Flixabi solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Razrijedite ukupan volumen rekonstituirane otopine lijeka Flixabi s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju do ukupnog volumena od 250 ml.
English: A patient who requires surgery while on Flixabi should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnika kojemu je za vrijeme liječenja lijekom Flixabi potrebna operacija nužno je pomno nadzirati kako bi se utvrdile eventualne infekcije i poduzele odgovarajuće mjere.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab 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 infliksimaba (vidjeti dio 4.4).
English: Concurrent use of stable doses of oral corticosteroids (≤ 10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Croatian: Dopuštala se istodobna primjena ustaljenih doza peroralnih kortikosteroida (≤ 10 mg/dan) i/ili nesteroidnih protuupalnih lijekova, a davala se i nadomjesna terapija folatima.
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 blokatorima TNF-a uključujući infliksimab.
English: Flixabi 100 mg
Croatian: Flixabi 100 mg infliksimab
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 TNFα-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: * 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: Flixabi 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 6-mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Flixabi je indiciran za liječenje umjerenog do teškog aktivnog ulceroznog kolitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju koja uključuje kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), odnosno koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
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 Flixabi therapy.
Croatian: Preporučuje se da, ako je to moguće, prije početka liječenja lijekom Flixabi bolesnici prime sva cjepiva u skladu s važećim smjernicama za cijepljenje.
English: Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:  adult patients with active disease when the response to disease-modifying antirheumatic drugs
Croatian: Flixabi je u kombinaciji s metotreksatom indiciran za smanjivanje znakova i simptoma te poboljšavanje fizičkih funkcija u:
English: Total peripheral white blood cell counts were minimally affected in infliximab-treated patients, although changes in lymphocytes, monocytes and neutrophils reflected shifts towards normal ranges.
Croatian: Ukupan broj perifernih bijelih krvnih stanica bio je minimalno promijenjen u bolesnika liječenih infliksimabom, iako su promjene u limfocitima,
English: How to store Flixabi
Croatian: Kako primjenjivati Flixabi
English: Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Croatian: Postotak ispitanika u kliničkoj remisiji i održanoj remisiji Klinička remisija u 8. tjednu a
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis,
Croatian: novonastala psorijaza ili pogoršanje postojeće uključujući pustularnu psorijazu (primarno palmarnu i plantarnu), urtikarija, osip, svrbež, hiperhidroza, suha koža, gljivični dermatitis, ekcem, alopecija
English: Granulomatous lesion.
Croatian: edem otežano zacjeljivanje granulomatozna lezija
English: The safety and efficacy of infliximab were assessed in a multicentre, 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: * ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Croatian: Na temelju broja bolesnika s početnim PASI ≥ 2,5 u ispitivanju IMPACT i bolesnika s početnom zahvaćenošću kože psorijazom ≥ 3% BSA u ispitivanju IMPACT 2. ** Odgovor PASI 75 u ispitivanju IMPACT nije uključen zbog malog N; p < 0,001 za infliksimab u usporedbi s placebom u 24. tjednu ispitivanja IMPACT 2.
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: Starting at week 16, placebo patients were switched to infliximab and all patients subsequently received 5 mg/kg infliximab every 8 weeks up to week 46.
Croatian: Od 16. tjedna nadalje bolesnici koji su primali placebo počeli su dobivati infliksimab, tako da su do kraja 46. tjedna svi bolesnici dobivali dozu od 5 mg/kg infliksimaba svakih 8 tjedana.
English: HAQ change from baseline over timee (patients evaluated) Mean ± SD
Croatian: Promjena HAQ-a od početne vrijednostie (evaluirani bolesnici)
English: Allergic respiratory symptom.
Croatian: alergijske reakcije dišnog sustava
English: Liver failure.
Croatian: zatajenje jetre
English: Cyanosis, pericardial effusion.
Croatian: cijanoza, perikardijalni izljev
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 tjedna 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: If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with Flixabi should be given.
Croatian: Ako bolesnik ne odgovori na terapiju nakon 14 tjedana (tj. nakon 4 doze), ne bi trebalo nastaviti liječenje lijekom Flixabi.
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Flixabi.
Croatian: Odmah obavijestite svog liječnika ako razvijete simptome lupusa za vrijeme liječenja lijekom Flixabi.
English: Fistula Response (%)
Croatian: 54. tjedan Odgovor fistula (%)
English: Flixabi 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: Flixabi 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 koja uključuje kortikosteroide i 6-MP ili AZA, odnosno u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
English: It is recommended that live vaccines not be given concurrently with Flixabi.
Croatian: Ne preporučuje se istodobna primjena živih cjepiva s lijekom Flixabi.
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet, u bolesnika koji su primali infliksimab prijavljeni su slučajevi žutice i hepatitisa, koji je u nekim slučajevima imao obilježja autoimunog hepatitisa (vidjeti dio 4.4).
English: Patients treated with Flixabi should be given the package leaflet and the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Flixabi moraju dobiti uputu o lijeku i karticu s podsjetnikom za bolesnika.
English: After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Croatian: Nakon izlaganja infliksimabu in utero, dojenčad može biti pod povećanim rizikom od razvoja infekcije,
English: The potential contribution of exposure to inflixumab 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: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Croatian: Klinički odgovor postiglo je 68% bolesnika (21/31) liječenih infliksimabom u dozi od 5 mg/kg naspram 26% bolesnika (8/31) koji su primali placebo (p = 0,002).
English: Clinical remission at week 30
Croatian: Klinička remisija u 30. tjednu a
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Croatian: Ako lijek ne bude upotrijebljen do isteka novog roka valjanosti ili do isteka roka valjanosti otisnutog na kutiji, štogod je prije, lijek treba zbrinuti u otpad.
English: You should not be given Flixabi if
Croatian: Nemojte primiti Flixabi
English: After reconstitution one mL contains 10 mg infliximab.
Croatian: Nakon rekonstitucije jedan ml sadrži 10 mg infliksimaba.
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Croatian: Pomoćne tvari: saharoza, polisorbat 80, natrijev dihidrogenfosfat hidrat i natrijev hidrogenfosfat heptahidrat.
English: b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks b Absence of any draining fistulas
Croatian: Smanjenje početnog broja fistula iz kojih se cijedi sadržaj za ≥ 50% tijekom razdoblja od ≥ 4 tjedna.
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Croatian: trombocitopenija, limfopenija, limfocitoza
English: Uncommon: may affect up to1 in 100 people
Croatian: Manje česte: mogu se javiti u do 1 na 100 osoba
English: Flixabi 100 mg powder for concentrate for solution for infusion infliximab
Croatian: Flixabi 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
English: There have been reports of active tuberculosis in patients receiving infliximab.
Croatian: U bolesnika liječenih infliksimabom prijavljeni su slučajevi aktivne tuberkuloze.
English: General disorders and administration site conditions Very common:
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često: Često:
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab.
Croatian: U bolesnika liječenih infliksimabom opažene su tuberkuloza, bakterijske infekcije uključujući sepsu i pneumoniju, invazivne gljivične, virusne i druge oportunističke infekcije.
English: • Contact details of the prescriber
Croatian: • kontakt podatke liječnika koji je propisao lijek.