FrancophonIA/ELRC3.0 huggingface dataset:
English: This includes a syringe, needle, antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).
Croatian: To uključuje štrcaljku, iglu, antiseptičke maramice, komadić vate ili gaze i spremnik za odlaganje oštrih predmeta (pogledajte Sliku 1).
English: Ask your doctor if you are not sure.
Croatian: Obratite se svom liječniku, ako niste sigurni.
English: 80, sucrose and water for injections.
Croatian: polisorbat 80, saharoza i voda za injekcije.
English: During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, rash and urticaria have each been observed in < 1% of patients (see section 4.4).
Croatian: Tijekom kontroliranog razdoblja kliničkih ispitivanja psorijaze i psorijatičnog artritisa s ustekinumabom, osip i urtikarija pojedinačno su primijećeni kod < 1% bolesnika (vidjeti dio 4.4).
English: Uncommon: Pustular psoriasis, skin exfoliation, acne Rare: Exfoliative dermatitis
Croatian: Manje često: pustularna psorijaza, eksfolijacija kože, akne Rijetko: eksfolijativni dermatitis
English: * See section 4.4, Systemic and respiratory hypersensitivity reactions.
Croatian: * Vidjeti odlomak „Sistemske i respiratorne reakcije preosjetljivosti“ u dijelu 4.4
English: In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment compared with treatment withdrawal (p < 0.001).
Croatian: Ispitivanju psorijaze 1, održavanje PASI vrijednosti 75 znatno je bolje uz stalno liječenje u usporedbi s prekinutim liječenjem (p < 0,001).
English: Prescribers should consult the Summary of Product Characteristics for the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Croatian: Liječnici koji propisuju lijek moraju pregledati Sažetak opisa svojstava lijeka za određeno cjepivo zbog dodatnih informacija i smjernica o istovremenoj primjeni imunosupresivnih pripravaka nakon cijepljenja.
English: If you forget a dose, contact your doctor or pharmacist.
Croatian: Ako zaboravite uzeti dozu lijeka, kontaktirajte svog liječnika ili ljekarnika.
English: Concomitant doses of oral corticosteroids, immunomodulators, and aminosalicylates were permitted and 90% of patients continued to receive at least one of these medications.
Croatian: Istodobna primjena oralnih kortikosteroida, imunomodulatora i aminosalicilata bila je dopuštena pa je 90% bolesnika nastavilo primati najmanje jedan od tih lijekova.
English: Approximately 43% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Croatian: Približno 43% bolesnika bilo je prethodno izloženo konvencionalnoj sustavnoj terapiji ili fototerapiji.
English: This includes exposure to STELARA in the controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,577 and 3,253 patients respectively with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis) and exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).
Croatian: To uključuje izloženost STELARI u kontroliranim i nekontroliranim razdobljima kliničkih ispitivanja od barem 6 mjeseci ili 1 godinu (4577 odnosno 3253 bolesnika s psorijazom, psorijatičnim artritisom, Crohnovom bolesti ili ulceroznim kolitisom) i izloženost barem od 4 ili 5 godina (1482 odnosno 838 bolesnika s psorijazom).
English: For further instructions on preparation and special precautions for handling, see section 6.6.
Croatian: Radi daljnjih uputa o pripremi i posebnim mjerama opreza vezanim uz rukovanje lijekom vidjeti dio 6.6.
English: • A 45 mg vial is available if you need to receive less than the full 45 mg dose.
Croatian: • Bočica od 45 mg je dostupna ako trebate primiti manje od pune doze od 45 mg.
English: • Moderate to severe ulcerative colitis - in adults
Croatian: • Umjereni do teški ulcerozni kolitis - u odraslih
English: You may cover the injection site with a small adhesive bandage, if necessary.
Croatian: Ako je potrebno, mjesto primjene injekcije možete pokriti malim flasterom.
English: In IM-UNITI, patients who completed the study through week 44 were eligible to continue treatment in a study extension.
Croatian: U IM-UNITI, bolesnici koji su završili ispitivanje unutar 44 tjedna, ispunili su uvjete za nastavak liječenja u produžetku ispitivanja.
English: Similar proportions of adult patients developed protective levels of anti-pneumococcal and anti-tetanus antibodies and antibody titers were similar among STELARA-treated and control patients.
Croatian: Sličan udio odraslih bolesnika razvio je zaštitne razine anti-pneumokoknih i anti-tetanus protutijela, a titri protutijela bili su slični kod bolesnika liječenih STELAROM i u kontrolnih bolesnika.
English: p = 0.012 for ustekinumab 45 mg in comparison with etanercept.
Croatian: p = 0,012 za ustekinumab 45 mg u usporedbi s etanerceptom.
English: Table 3: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Croatian: Tablica 3: Indukcija kliničkog odgovora i remisija u UNITI-1 i UNITI 2 UNITI-1*
English: Approximately 11% of the patients had prior exposure to biologics.
Croatian: Približno 11% bolesnika bilo je prethodno izloženo biološkim lijekovima.
English: Approximately 5% of the patients had prior exposure to biologics.
Croatian: Približno 5% bolesnika bilo je prethodno izloženo biološkim lijekovima.
English: • In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4)
Croatian: • Jednim brzim pokretom uvedite iglu pod kožu, koliko ide (pogledajte sliku 4).
English: Endoscopy
Croatian: Endoskopija
English: In developmental and reproductive toxicity studies in cynomolgus monkeys, neither adverse effects on male fertility indices nor birth defects or developmental toxicity were observed.
Croatian: U razvojnim i reproduktivnim ispitivanjima toksičnosti u makaki majmuna nisu zapaženi ni štetni učinci na pokazatelje muške plodnosti niti kongenitalne anomalije ili razvojna toksičnost.
English: Approximately 60% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Croatian: Približno 60% bolesnika bilo je prethodno izloženo konvencionalnoj sustavnoj terapiji ili fototerapiji.
English: • the pre-filled syringe is not damaged
Croatian: • da napunjena štrcaljka nije oštećena
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36 and EuroQoL-5D (EQ-5D) questionnaires.
Croatian: Kvaliteta života povezana sa zdravljem ocjenjivala se upitnikom za procjenu kvalitete života bolesnika s upalnim bolestima crijeva (IBDQ), upitnikom SF-36 i europskim upitnikom o kvaliteti života EuroQoL-5D (EQ-5D).
English: Following the recommended intravenous induction dose, median peak serum ustekinumab concentration, observed 1 hour after the infusion, was 126.1 μg/mL in patients with Crohn's disease and 127.0 µg/mL in patients with ulcerative colitis.
Croatian: Nakon preporučene intravenske uvodne doze, medijan vršne koncentracije ustekinumaba u serumu, uočen 1 sat nakon infuzije, bio je 126,1 μg/ml u bolesnika s Crohnovom bolesti te 127,0 μg/ml u bolesnika s ulceroznim kolitisom.
English: Table 9: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Croatian: Tablica 9: Indukcija kliničkog odgovora i remisija u UNITI-1 i UNITI 2 UNITI-1*
English: • Do not use the pre-filled syringe if it is dropped without the needle cover in place.
Croatian: • Nemojte upotrijebiti napunjenu štrcaljku ako je pala bez zaštitne kapice igle.
English: Talk to your doctor about when you will have your injections and follow-up appointments.
Croatian: Razgovarajte s liječnikom o tome kada ćete primati injekcije i kada morate doći na preglede u svrhu praćenja.
English: At week 8, after a single intravenous induction dose, the change in SES-CD score was greater in the ustekinumab group (n = 155, mean change = -2.8) than in the placebo group (n = 97, mean change = -0.7, p = 0.012).
Croatian: U 8. tjednu, nakon jedne intravenske uvodne doze, promjena u SESCD skoru bila je veća u skupini s ustekinumabom (n = 155, srednja vrijednost promjene = -2,8) nego u placebo skupini (n = 97, srednja vrijednost promjena = -0,7, p = 0,012).
English: No new safety concerns were identified in this study extension with up to 2 years of treatment in patients with Crohn's Disease.
Croatian: U ovom produžetku ispitivanja uz liječenje u trajanju do 2 godine nisu utvrđeni nikakvi novi problemi vezani uz sigurnost primjene lijeka u bolesnika s Crohnovom bolesti.
English: In patients with Crohn's disease and ulcerative colitis, variability in ustekinumab clearance was affected by body weight, serum albumin level, sex, and antibody to ustekinumab status while body weight was the main covariate affecting the volume of distribution.
Croatian: U bolesnika s Crohnovom bolesti i ulceroznim kolitisom na varijabilnost klirensa ustekinumaba utjecala je tjelesna težina, razina albumina u serumu, spol i status protutijela na ustekinumab dok je tjelesna težina bila glavna kovarijata koja je imala utjecaj na volumen distribucije.
English: No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving STELARA.
Croatian: Nisu provedena ispitivanja koja bi uključila bolesnike s anamnezom maligne bolesti ili koja nastavljaju liječenje bolesnika u kojih se pojavila maligna bolest tijekom liječenja STELAROM.
English: Paediatric plaque psoriasis (6 years and older)
Croatian: Pedijatrijska plak psorijaza (6 godina i stariji)
English: Fistula Response
Croatian: Odgovor fistule
English: In Crohn's disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose.
Croatian: U ispitivanjima uvodnog intravenskog liječenja Crohnove bolesti i ulceroznog kolitisa, nisu bili prijavljeni događaji anafilaksije ili druge ozbiljne reakcije na infuziju nakon jedne intravenske doze.
English: Durable Remission is defined as partial Mayo remission at ≥80% of all visits prior to Week 44 and in partial Mayo remission at last visit (Week 44).
Croatian: Dugotrajna remisija definirana je kao djelomična remisija prema Mayo rezultatu pri ≥ 80% svih posjeta prije 44.tjedna i djelomična remisija prema Mayo rezultatu pri posljednjem posjetu (44.tjedan).
English: • When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6)
Croatian: • Kada je klip pritisnut do kraja, nastavite pritiskati glavu klipa, izvucite iglu i pustite kožu (pogledajte sliku 6).
English: Table 4 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Croatian: Tablica 4. Sažetak kliničkog odgovora u Ispitivanju psorijaze 1 (PHOENIX 1) i Ispitivanju psorijaze 2 (PHOENIX 2)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ustekinumab in one or more subsets of the paediatric population in Crohn's Disease and ulcerative colitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka ustekinumaba u jednoj ili više podskupina pedijatrijske populacije za Crohnovu bolest i ulcerozni kolitis (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
Croatian: • Možete pritisnuti komadić vate ili gaze na mjesto primjene injekcije i držati 10 sekundi.
English: In a population pharmacokinetic analysis using data from patients with psoriasis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
Croatian: U farmakokinetičkoj analizi populacije koristeći podatke bolesnika s psorijazom, utvrđeno je da je tjelesna težina najznačajnija kovarijata koja utječe na klirens ustekinumaba.
English: No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Croatian: Nisu dostupni farmakokinetički podaci za bolesnike s oštećenjem bubrega ili jetre.
English: • Bleeding, bruising, hardness, swelling and itching where the injection is given
Croatian: • krvarenje, modrice, otvrdnuće, oticanje i svrbež na mjestu primjene injekcije
English: In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA.
Croatian: U ispitivanjima psorijatičnog artritisa, istodobno primijenjen MTX nije imao utjecaj na sigurnost ili djelotvornost STELARE.
English: Improvements in FACIT scores were maintained through week 52.
Croatian: Poboljšanja FACIT bodova održana su kroz 52 tjedna.
English: • the solution is not frozen.
Croatian: • da otopina nije smrznuta.
English: • Do not remove the stopper
Croatian: • Nemojte ukloniti čep.
English: Nominally significant (p < 0.001)
Croatian: Nominalno značajno (p < 0,001)
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
Croatian: p < 0,001 za ustekinumab 45 mg ili 90 mg u usporedbi s placebom (PBO).
English: The pharmacokinetics of ustekinumab were generally comparable between Asian and non-Asian patients with psoriasis and ulcerative colitis.
Croatian: Farmakokinetika ustekinumaba bila je općenito usporediva kod bolesnika s psorijazom i ulceroznim kolitisom azijskog i ne-azijskog porijekla.
English: The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Croatian: Medijan najniže serumske koncentracije ustekinumaba kod bolesnika veće tjelesne težine (> 100 kg) u grupi od 90 mg mogla se usporediti s bolesnicima niže tjelesne težine (≤ 100 kg) u grupi s 45 mg.
English: Choose two different sites for these injections (for example one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Croatian: Za te injekcije odaberite dva različita mjesta primjene (na primjer jednu injekciju u desno bedro, a drugu injekciju u lijevo bedro) i primijenite injekcije točno jednu za drugom.
English: Hypersensitivity and infusion reactions
Croatian: Reakcije preosjetljivosti i reakcije na infuziju
English: Make sure you tell your doctor about any illness you have before each treatment.
Croatian: Svakako obavijestite liječnika o svim bolestima koje imate prije svake primjene lijeka.
English: • Stelara is given by injection under the skin (subcutaneously)
Croatian: • Stelara se daje injekcijom pod kožu (supkutano).
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Croatian: Ako niste sigurni odnosi li se bilo što od gore navedenog na Vas, razgovarajte sa svojim liječnikom ili ljekarnikom prije nego što upotrijebite Stelaru.
English: Concentrate for Solution for infusion 130 mg/26 mL
Croatian: Koncentrat za otopinu za infuziju 130 mg/26 ml
English: In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Croatian: U ispitivanjima psorijaze, sigurnost i djelotvornost primjene STELARE u kombinaciji s imunosupresivima, uključujući biološke lijekove, ili fototerapiju nisu ispitivani.
English: During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g. PGA of cleared (0), PASI 90).
Croatian: Tijekom placebom kontroliranog razdoblja kroz 12. tjedan, djelotvornost u primarnom ishodu (69,4% odnosno 67,6%) je općenito bila usporediva u obje skupine, s preporučenom dozom i s polovinom preporučene doze, premda je postojao dokaz o odgovoru na dozu za višu razinu kriterija učinkovitosti (npr. PGA čisti (0), PASI 90).
English: 90 mg ustekinumab every 8 weeks
Croatian: 90 mg ustekinumaba svakih 8 tjedana
English: • There may be a small amount of blood or liquid at the injection site.
Croatian: • Na mjestu uboda injekcije može se pojaviti malo krvi ili tekućine.
English: You must look out for certain signs of illness while you are taking Stelara.
Croatian: Morate paziti na određene znakove bolesti za vrijeme korištenja Stelare.
English: By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Croatian: Vežući se na zajedničku p40 podjedinicu IL-12 i IL-23, ustekinumab može imati klinički učinak na psorijazu, na psorijatični artritis, na Crohnovu bolest i na ulcerozni kolitis kroz prekid Th1 i Th17 citokinskih putova koji su u središtu patologije ovih bolesti.
English: Serum ustekinumab concentrations in paediatric psoriasis patients 12-17 years of age (CADMUS) treated with half of the recommended weight-based dose were generally lower than those in adults.
Croatian: Serumske koncentracije ustekinumaba kod pedijatrijskih bolesnika s psorijazom u dobi od 12 do 17 godina (CADMUS) liječenih s pola preporučene doze temeljene na tjelesnoj težini bile su općenito niže od onih kod odraslih bolesnika.
English: • During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor through a drip in a vein in your arm (intravenous infusion).
Croatian: • Tijekom liječenja, prvu dozu od otprilike 6 mg/kg Stelare primijenite će Vam liječnik putem infuzije kap po kap (drip) u venu ruke (infuzija u venu).
English: In this study, 29.1% of the patients had an inadequate initial response (primary non-responders), 69.4% responded but lost response (secondary non-responders), and 36.4% were intolerant to antiTNFα therapies.
Croatian: U ovom ispitivanju, 29,1% bolesnika imalo je neadekvatan inicijalni odgovor (primarno nisu odgovorili), 69,4% ih je odgovorilo ali su izgublili odgovor (sekundarno nisu odgovorili), a 36,4% ih nije podnosilo anti-TNFα terapiju.
English: Common: Oropharyngeal pain Uncommon: Nasal congestion Rare: Allergic alveolitis, eosinophilic pneumonia Very rare: Organising pneumonia*
Croatian: Manje često: kongestija nosa Rijetko: alergijski alveolitis, eozinofilna upala pluća Vrlo rijetko: organizirajuća upala pluća*
English: In the placebo-controlled period of these clinical studies, the rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in placebo-treated patients.
Croatian: U placebom kontroliranom razdoblju tih kliničkih ispitivanja stopa infekcije bila je 1,36 po bolesnik-godini praćenja za bolesnike liječene ustekinumabom, te 1,34 kod bolesnika u placebo grupi.
English: If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of STELARA should be discontinued (see section 4.8).
Croatian: Ako se pojavi anafilaktička ili druge ozbiljne reakcije preosjetljivosti, potrebno je započeti s odgovarajućim liječenjem i primjena STELARE mora se prekinuti (vidjeti dio 4.8).
English: In patients who failed conventional therapy, but not a biologic
Croatian: U bolesnika neuspješno liječenih konvencionalnom, ali ne i biološkom terapijom
English: In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
Croatian: U ispitivanju 1, prethodno liječenje anti-(TNF)α lijekovima nije bilo dozvoljeno.
English: If infection has been excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see section 4.8).
Croatian: Ako je infekcija isključena te dijagnoza potvrđena, ukinite ustekinumab te uvedite prikladno liječenje (vidjeti dio 4.8).
English: The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Croatian: Ukupni sigurnosni profil bio je sličan za bolesnike s psorijazom, psorijatičnim artritisom, Crohnovom bolesti i ulceroznim kolitisom.
English: • If the seal is broken.
Croatian: • Ako je uništen zaštitni poklopac.
English: Dose linearity
Croatian: Linearnost doza
English: Additionally in Crohn's disease, clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus non-Asian).
Croatian: Nadalje, kod Crohnove su bolesti na klirens utjecali i C-reaktivni protein, neuspjeh liječenja antagonistima TNF-a i rasa (Azijci naspram ostalih).
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA.
Croatian: Podaci o sekundarnoj transmisiji infekcije primjenom živih cjepiva u bolesnika koji se liječe STELAROM nisu poznati.
English: Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Croatian: Za te injekcije odaberite dva različita mjesta primjene (npr. jednu injekciju u desno bedro, a drugu injekciju u lijevo bedro) i primijenite injekcije točno jednu za drugom.
English: Check the pre-filled syringe(s) to make sure
Croatian: Provjerite napunjenu štrcaljku (ili štrcaljke) kako biste bili sigurni
English: Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection (see section 4.3).
Croatian: Mora se biti oprezan kod razmatranja primjene STELARE u bolesnika s kroničnom infekcijom ili rekurentnom infekcijom u anamnezi (vidjeti dio 4.3).
English: • Used syringes and needles should be placed in a puncture-resistant container, like a sharps container.
Croatian: • Upotrijebljene štrcaljke i igle moraju se odložiti u spremnik koji se ne može probušiti, poput spremnika za oštre predmete.
English: Psoriasis or Psoriatic Arthritis
Croatian: Psorijaza ili psorijatični artritis
English: The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3 studies in 6,709 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn's disease and 825 patients with ulcerative colitis).
Croatian: Niže opisani podaci o sigurnosti primjene odražavaju izloženost odraslih bolesnika ustekinumabu u 14 ispitivanja faze II i III u 6709 bolesnika (4135 s psorijazom i/ili psorijatičnim artritisom, 1749 s Crohnovom bolesti i 825 bolesnika s ulceroznim kolitisom).
English: The median steady-state trough concentration ranged from 0.21 μg/mL to 0.26 μg/mL (45 mg) and from 0.47 μg/mL to 0.49 μg/mL (90 mg).
Croatian: Medijan stabilne najniže koncentracije kretao se od 0,21 μg/ml do 0,26 μg/ml (45 mg) te od 0,47 μg/ml do 0,49 μg/ml (90 mg).
English: • Pull the needle cover straight off and throw it away.
Croatian: • Povucite zaštitnu kapicu s igle tako da ju ravno povučete s igle i bacite ju.
English: • Take the pre-filled syringe(s) out of the refrigerator.
Croatian: • Uzmite napunjenu štrcaljku (ili štrcaljke) iz hladnjaka.
English: • the vial is not damaged and the seal is not broken
Croatian: • da bočica nije oštećena, a zaštitni poklopac nije slomljen
English: The proportion of patients with a PGA score of cleared (0) or minimal (1) at week 12 was 77.3%.
Croatian: Udio bolesnika kod kojih je u 12. tjednu zabilježen PGA skor čist (0) ili minimalan (1) iznosio je 77,3%.
English: The median CL/F in patients with weight > 100 kg was approximately 55% higher compared to patients with weight ≤ 100 kg.
Croatian: Medijan CL/F kod bolesnika težine > 100 kg bio je približno 55% viši u usporedbi s bolesnicima s težinom ≤ 100 kg.
English: Approximately 50% of the patients had failed at least 1 prior anti-TNF therapy (of which 48% were primary non-responders) and 17% had failed at least 1 anti-TNFα therapy and vedolizumab.
Croatian: Približno 50% bolesnika imalo je najmanje 1 neuspješnu prethodnu anti-TNFα terapiju (od kojih 48% nije ostvarilo primarni odgovor), a njih 17% bilo je neuspješno liječeno najmanje jednom anti-TNFα terapijom i vedolizumabom.