FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of ustekinumab was assessed in 1,996 patients in two randomised, double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who were candidates for phototherapy or systemic therapy.
Croatian: Sigurnost i djelotvornost ustekinumaba je ispitana kod 1996 bolesnika u dva randomizirana, dvostruko slijepa, placebo kontrolirana ispitivanja kod bolesnika s umjerenom do teškom plak psorijazom i koji su bili kandidati za fototerapiju ili sustavnu terapiju.
English: Patients were treated with the recommended dose of ustekinumab (see section 4.2; n = 44) by subcutaneous injection at weeks 0 and 4 followed by every 12 week (q12w) dosing.
Croatian: Bolesnici su bili liječeni preporučenom dozom ustekinumaba (vidjeti dio 4.2; n = 44), koja se primjenjivala supkutanom injekcijom u 0. i 4. tjednu, a zatim svakih 12 tjedana.
English: Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Croatian: Stelara je namijenjena za primjenu uz vodstvo i nadzor liječnika sa iskustvom u dijagnozi i liječenju Crohnove bolesti ili ulceroznog kolitisa.
English: • Remove the needle from the vial
Croatian: • Izvucite iglu iz bočice.
English: • Blocked or stuffy nose
Croatian: • začepljen ili pun nos
English: All patients were followed for up to 52 weeks following first administration of study treatment.
Croatian: Svi bolesnici praćeni su do 52. tjedna nakon prve primjene lijeka u ispitivanju.
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 9).
Croatian: I u UNITI-1 i UNITI-2, značajno veći udio bolesnika bili su s kliničkim odgovorom i remisijom u skupini liječenoj ustekinumabom u usporedbi s placebom (Tablica 9).
English: Patients receiving ustekinumab experienced significantly more improvements in work productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI-GH questionnaire than patients receiving placebo.
Croatian: U usporedbi s bolesnicima koji su primali placebo, u onih liječenih ustekinumabom opažena su značajno veća poboljšanja radne produktivnosti, utvrđena na temelju većeg smanjenja ukupnog rezultata za narušenu radnu sposobnost i sposobnost obavljanja svakodnevnih aktivnosti prema upitniku WPAI-GH.
English: Patients with a CDLQI > 1 at baseline
Croatian: Bolesnici koji su na početku ispitivanja imali CDLQI > 1
English: Number of patients randomised PASI 50 response N (%) PASI 75 response N (%) PASI 90 response N (%) PGA of cleared or minimal N (%) Number of patients ≤ 100 kg
Croatian: Broj randomiziranih bolesnika PASI 50 odgovor N (%) PASI 75 odgovor N (%) PASI 90 odgovor N (%) PGAb pročišćenog ili minimalnog N (%)
English: Recommended dose of ustekinumab N = 249
Croatian: Preporučena doza ustekinumab a N = 249
English: Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 and followed by the same dose every 12 weeks.
Croatian: Bolesnici randomizirani na ustekinumab dobili su doze od 45 mg ili 90 mg u tjednima 0 i 4, nakon čega je slijedila ista doza lijeka svakih 12 tjedana.
English: A higher proportion of patients treated with ustekinumab who had spondylitis with peripheral arthritis as their primary presentation, demonstrated 50 and 70 percent improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores compared with placebo at week 24.
Croatian: Veći udio bolesnika liječenih ustekinumabom koji su na početku imali spondilitis sa perifernim artritisom, pokazali su 50% i 70%tno poboljšanje u BASDAI bodovima (engl.
English: • Infections of the chest are uncommon (may affect up to 1 in 100 people)
Croatian: • Infekcije u prsnom košu su manje česte (mogu se pojaviti u do 1 na 100 osoba)
English: Tell your doctor straight away if you notice any of the following signs.
Croatian: Recite svom liječniku ako primijetite bilo koji od sljedećih znakova.
English: Stelara contains sodium
Croatian: Stelara sadrži natrij
English: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).
Croatian: STELARA je indicirana za liječenje djece i adolescenata u dobi od 6 godina i starijih s umjerenom do teškom plak psorijazom koji nisu primjereno kontrolirani ili ne podnose drugu sustavnu terapiju ili fototerapiju (vidjeti dio 5.1).
English: Mucosal healing is defined as a Mayo endoscopic sub-score of 0 or 1.
Croatian: Cijeljenje sluznice definiranoje kao Mayo endoskopski podrezultat 0 ili 1.
English: Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy and compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab and etanercept.
Croatian: Ispitivanjem psorijaze 3 (ACCEPT) procijenjeno je 903 bolesnika s umjerenom do teškom psorijazom koji nisu imali primjeren odgovor na liječenje, koji su imali nepodnošenje liječenja ili im je kontraindicirana druga sustavna terapija.
English: Immunogenicity
Croatian: Imunoterapija
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 3).
Croatian: I u UNITI-1 i UNITI-2, značajno veći udio bolesnika bili su s kliničkim odgovorom i remisijom u skupini liječenoj ustekinumabom u usporedbi s placebom (Tablica 3).
English: The proportion of patients achieving a clinically meaningful ≥ 0.3 improvement in HAQ-DI score from baseline was also significantly greater in the ustekinumab groups when compared with placebo.
Croatian: Udio bolesnika koji su dostigli klinički značajno poboljšanje u HAQ-DI bodovima ≥ 0,3 od početne vrijednosti bio je značajno veći u skupinama koje su primale ustekinumab u odnosu na placebo.
English: VIAL LABEL TEXT (130 mg)
Croatian: TEKST NA NALJEPNICI BOČICE (130 mg)
English: Table 10: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Croatian: Tablica 10: Održavanje kliničkog odgovora i remisije u IM-UNITI (44. tjedan ; 52 tjedna od započinjanja uvodne doze)
English: Clinical response is defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1.
Croatian: Klinički odgovor definiran je kao smanjenje početnog Mayo rezultata za ≥ 30% i ≥ 3 boda, uz smanjenje početnog podrezultata za rektalno krvarenje za ≥1 bod ili podrezultat za rektalno krvarenje0 ili 1. Antagonist TNFα i/ili vedolizumab.
English: • Do not shake the Stelara vials.
Croatian: • Nemojte tresti bočice Stelare.
English: At Week 44 maintenance of this effect was observed with significantly more patients in histologic healing in the every 12 week (54%) and every 8 week (59%) ustekinumab groups as compared to placebo (33%).
Croatian: Taj se učinak održao do 44. tjedna, kada je opaženo značajno više bolesnika koji su postigli histološko cijeljenje u skupinama koje su primale ustekinumab svakih 12 tjedana (54%) i svakih 8 tjedana (59%) nego u skupini koja je primala placebo (33%).
English: Table 2 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Croatian: Tablica 2 daje popis nuspojava iz kliničkih ispitivanja psorijaze, psorijatičnog artritisa, Crohnove bolesti i ulceroznog kolitisa kod odraslih bolesnika kao i nuspojave prijavljene nakon stavljanja lijeka u promet.
English: Efficacy was higher in the tiered dose group (6 mg/kg) compared to the 130 mg dose group in select endpoints, and tiered dosing is therefore the recommended intravenous induction dose.
Croatian: Djelotvornost s obzirom na odabrane mjere ishoda bila je veća u skupini koja je primila dozu određenu prema tjelesnoj težini (6 mg/kg) nego u onoj koja je primila dozu od 130 mg, te se stoga za intravensku uvodnu dozu preporučuje doziranje prema tjelesnoj težini.
English: Table 4: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Croatian: Tablica 4: Održavanje kliničkog odgovora i remisije u IM-UNITI (44. tjedan ; 52 tjedna od započinjanja uvodne doze)
English: Stelara is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which STELARA is intended.
Croatian: Stelara je namijenjena za primjenu uz vodstvo i nadzor liječnika sa iskustvom u liječenju stanja za koja je STELARA namijenjena.
English: At week 44, maintenance of this effect was observed with significantly more patients in histo-endoscopic mucosal healing in the every 12 week (39%) and every 8 week (46%) ustekinumab groups compared to placebo (24%).
Croatian: U 44. tjednu opaženo je održanje tog učinka, uz značajno više bolesnika koji su postigli histo-endoskopsko cijeljenje sluznice u skupinama koje su primale ustekinumab svakih 12 tjedana (39%) i svakih 8 tjedana (46%) nego u skupini koja je primala placebo (24%).
English: In this case you will get training on how to inject Stelara yourself.
Croatian: U tom slučaju proći ćete primjerenu obuku u tehnici primjene potkožne injekcije Stelare (samoprimjena).
English: Number of patients with ≥ 3% BSA PASI 75 response, N (%) Number of patients > 100 kg ACR 20 response, N (%) Number of patients with ≥ 3% BSA PASI 75 response, N (%)
Croatian: Broj bolesnika s ≤ 100 kg ACR 20 odgovor, N (%) Broj bolesnika s ≥ 3% BSA PASI 75 odgovor, N (%) Broj bolesnika s > 100 kg ACR 20 odgovor, N (%) Broje bolesnika s ≥ 3% BSA PASI 75 odgovor, N (%)
English: Table 3 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Croatian: Tablica 3 daje popis nuspojava iz kliničkih ispitivanja psorijaze, psorijatičnog artritisa, Crohnove bolesti i ulceroznog kolitisa kod odraslih bolesnika kao i nuspojave prijavljene nakon stavljanja lijeka u promet.
English: Visually inspect the diluted solution before administration.
Croatian: Vizualno pregledajte razrijeđenu otopinu prije primjene.
English: How to use Stelara
Croatian: Kako primjenjivati Stelaru
English: • However, you and your doctor may decide that you may inject Stelara yourself.
Croatian: • Unatoč tome i u dogovoru sa svojim liječnikom, možete odlučiti da si sami dajete injekciju Stelare.
English: For patients with enthesitis and/or dactylitis at baseline, in PsA Study 1 significant improvement in enthesitis and dactylitis score was observed in the ustekinumab groups compared with placebo at week 24.
Croatian: Kod bolesnika s entezitisom i /ili daktilitisom na početku liječenja u PsA ispitivanju 1, zabilježeno je značajno poboljšanje bodova za entezitis i daktilitis u skupinama liječenim ustekinumabom u usporedbi s placebom u 24. tjednu.
English: • Inflammation of tissue under the skin (‘cellulitis') is uncommon (may affect up to 1 in 100 people)
Croatian: • upala potkožnog tkiva ('celulitis') je manje česta (može se pojaviti u do 1 na 100 osoba)
English: Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments did not work.
Croatian: Stelara se primjenjuje kod djece i adolescenata s umjerenom do teškom plak psorijazom, u dobi od 6 godina i starijih, koja ne podnose fototerapiju ili drugo sustavno liječenje, ili kada navedeno liječenje nije pokazalo rezultate.
English: • the solution is not discoloured or cloudy and does not contain any foreign particles
Croatian: • da otopina nije promijenila boju, nije zamućena i ne sadrži strane čestice
English: • Do not shake Stelara pre-filled syringes.
Croatian: • Nemojte tresti napunjene štrcaljke Stelare.
English: Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab.
Croatian: Tijekom razdoblja primjene ustekinumaba nakon stavljanja u promet bili su prijavljeni slučajevi alergijskog alveolitisa, eozinofilne upale pluća i neinfektivne organizirajuće upale pluća.
English: PGA b of cleared or minimal N
Croatian: b pročišćenog ili minimalnog N (%)
English: All patients were followed for efficacy for up to 52 weeks following first administration of study agent.
Croatian: U svih je bolesnika praćena djelotvornost liječenja tijekom razdoblja do 52 tjedna nakon prve primjene ispitivanog lijeka.
English: When using the single-dose vial, a 1 mL syringe with a 27 gauge, ½ inch (13 mm) needle is recommended.
Croatian: Kod primjene jednodozne bočice preporučuje se korištenje štrcaljke volumena 1 ml i igle veličine 27 G / 13 mm.
English: In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 11,561 patient-years of exposure in 6,709 patients, the median follow-up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 1.0 years for ulcerative colitis studies.
Croatian: Tijekom kontroliranog i nekontroliranog razdoblja kliničkog ispitivanja psorijaze, psorijatičnog artritisa, Crohnove bolesti i ulceroznog kolitisa, koje predstavlja 11 561 bolesnik-godinu izloženosti, u 6709 bolesnika, medijan praćenja bio je 1,0 godina; 1,1 godinu za ispitivanja psorijatične bolesti, 0,6 godina za ispitivanja Crohnove bolesti i 1,0 godina za ispitivanja ulceroznog kolitisa.
English: The solution is clear, colourless to light yellow.
Croatian: Otopina je bistra, bezbojna do svijetložuta.
English: 26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper.
Croatian: 26 ml otopine u bočici od 30 ml, izrađenoj od stakla tipa
English: Combined Symptomatic Remission and Mucosal Healing
Croatian: Kombinacija simptomatske remisije i cijeljenja sluznice
English: Combined symptomatic remission and mucosal healing is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. p<0.001 p<0.05
Croatian: Kombinacija simptomatske remisijei cijeljenjasluznicedefiniranaje kao podrezultat za učestalost pražnjenja crijeva0 ili 1, podrezultat za rektalno krvarenje 0 i endoskopski podrezultat 0 ili 1. p < 0,001 p < 0,05
English: PASI 90 response N (%)
Croatian: PASI 90 odgovor N (%)
English: A 45 mg vial is available for paediatric patients who need to receive less than the full 45 mg dose.
Croatian: Za pedijatrijske bolesnike koji trebaju primiti manje od pune doze od 45 mg dostupna je bočica od 45 mg.
English: Psoriatic arthritis (PsA) (Adults)
Croatian: Psorijatični artritis (PsA) (Odrasli bolesnici)
English: Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2).
Croatian: Bolesnici su bili randomizirani u skupine koje su primale supkutani režim održavanja od bilo 90 mg ustekinumaba svakih 8 tjedana, 90 mg ustekinumaba svakih 12 tjedana ili placebo tijekom 44 tjedna (za preporučeno doziranje održavanja, vidjeti dio 4.2).
English: Disposal:
Croatian: Odlaganje:
English: In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 11,581 patient-years of exposure in 6,709 patients, the median follow up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 1.0 years for ulcerative colitis studies.
Croatian: U kontroliranim i nekontroliranim razdobljima kliničkih ispitivanja psorijaze, psorijatičnog artritisa, Crohnove bolesti i ulceroznog kolitisa, koje je predstavilo izloženost od 11 581 bolesnik-godine u 6709 bolesnika, medijan praćenja bio je 1,0 godina; 1,1 godinu za ispitivanja psorijatične bolesti, 0,6 godina za ispitivanja Crohnove bolesti i 1,0 godina za ispitivanja ulceroznog kolitisa.
English: STELARA 45 mg solution for injection 2 years
Croatian: STELARA 45 mg otopina za injekciju 2 godine
English: • Do not remove the needle cover from the pre-filled syringe until instructed to do so
Croatian: • Ne uklanjajte zaštitnu kapicu s igle napunjene štrcaljke dok ne dođete do koraka u uputi kada je vrijeme za njeno uklanjanje
English: STELARA 90 mg solution for injection 2 years
Croatian: STELARA 90 mg otopina za injekciju 2 godine
English: • Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in
Croatian: • herpes zoster (vrsta bolnog osipa s mjehurićima) je manje čest (može se pojaviti u do 1 na
English: Any unused product remaining in the syringe should be thrown away.
Croatian: Sav neiskorišteni lijek koji je preostao u štrcaljki potrebno je primjereno zbrinuti.
English: It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial.
Croatian: Dostavlja se u kartonskom pakiranju koje sadrži 1 jednokratnu dozu lijeka u staklenoj bočici od 30 ml.
English: What Stelara looks like and contents of the pack Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection.
Croatian: Stelara je bistra do blago opalescentna (ima biserni sjaj), bezbojna do svijetložuta otopina za injekciju.
English: • burning when passing water
Croatian: • žarenje pri mokrenju
English: Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in the placebo group (5.7%, 10/175).
Croatian: Tijekom 44 tjedna ispitivanja UNIFI-M udio ispitanika hospitaliziranih zbog razloga povezanih s ulceroznim kolitisom bio je značajno niži među ispitanicima iz obje skupine liječene ustekinumabom (2,0%; 7/348) nego među onima koji su primali placebo (5,7%; 10/175).
English: STELARA 130 mg concentrate for solution for infusion
Croatian: STELARA 130 mg koncentrat za otopinu za infuziju
English: Excipients: EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, water for injection.
Croatian: Pomoćne tvari: EDTA dinatrijeva sol dihidrat, L-histidin, L-histidinklorid hidrat, L-metionin, polisorbat 80, saharoza, voda za injekcije.
English: Clinical Response (100 point), week 6 53 (21.5%) 84 (33.7%)
Croatian: Klinički odgovor (100 bodova), 8. tjedan a 67 (32,1%) 121 (57,9%)
English: STELARA is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which STELARA is indicated.
Croatian: STELARA je namijenjena za primjenu pod vodstvom i nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju stanja za koja je STELARA indicirana.
English: • the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow
Croatian: • da je otopina u napunjenoj štrcaljki bistra do blago opalescentna (biserno sjajna) i bezbojna do svijetložuta
English: b 60 (28.7%) 116 (55.5%) Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)
Croatian: Klinički odgovor (100 bodova), 6. tjedan b 60 (28,7%) 116 (55,5%)
English: At the start of your treatment,
Croatian: Dok to radite,
English: • the number of pre-filled syringes and strength is correct o If your dose is 90 mg you will get one 90 mg pre-filled syringe of Stelara.
Croatian: • da je količina napunjenih štrcaljki i jačina lijeka ispravna o Ako je Vaša doza 90 mg, dobit ćete jednu napunjenu štrcaljku Stelare od 90 mg.
English: It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe.
Croatian: Dostavlja se u kartonskom pakiranju koje sadrži 1 jednokratnu dozu lijeka u staklenoj napunjenoj štrcaljki od 1 ml.
English: STELARA 90 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
Croatian: STELARA 90 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 90 mg ustekinumaba u 1 ml otopine.
English: How to store Stelara
Croatian: Kako čuvati Stelaru
English: Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline
Croatian: Broj bolesnika sa zahvaćenošću kože psorijazom ≥ 3% površine tijela (BSA, engl. body surface area) na početku liječenja
English: Water for injection
Croatian: Upute za primjenu injekcije
English: Significantly higher proportions of patients maintained clinical remission and response in the ustekinumab treated groups compared to the placebo group at week 44 (see Table 10).
Croatian: Značajno veći udio bolesnika održao je kliničku remisiju i odgovor u skupinama liječenim ustekinumabom u usporedbi s placebo skupinom u 44. tjednu (vidjeti tablicu 10).
English: Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16 followed by dosing every 12 weeks.
Croatian: Bolesnici randomizirani u placebo grupu, primali su placebo u tjednima 0 i 4, potom su u tjednima 12 i 16, prešli na dobivanje ustekinumaba (od 45 mg ili 90 mg), nakon čega je slijedilo doziranje svakih 12 tjedana.
English: Solution for injection 45 mg/0.5 mL 1 vial
Croatian: Otopina za injekciju 45 mg/0,5 ml 1 bočica
English: Ustekinumab-treated patients showed significant improvement in physical function as assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24.
Croatian: Disability Index of the Health Assessment Questionnaire) u 24. tjednu.
English: STELARA 45 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
Croatian: STELARA 45 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 45 mg ustekinumaba u 0,5 ml otopine.
English: STELARA 130 mg concentrate for solution for infusion ustekinumab
Croatian: STELARA 130 mg koncentrat za otopinu za infuziju ustekinumab
English: • Turn the vial and the syringe upside down
Croatian: • Okrenite bočicu i štrcaljku naopako.
English: • Clean the stopper with an antiseptic swab
Croatian: • Očistite čep antiseptičkom maramicom.
English: It is supplied as a carton pack containing 1 single-dose, glass 2 mL vial.
Croatian: Dostavlja se u kartonskom pakiranju koje sadrži 1 jednokratnu dozu lijeka u staklenoj bočici od 2 ml.
English: A beneficial effect was also observed in induction in patients who failed at least one prior TNFα antagonist therapy and vedolizumab, however the number of patients in this subgroup was too small to draw definitive conclusions about the beneficial effect in this group during maintenance.
Croatian: Međutim, broj bolesnika u toj podskupini bio je premalen da bi se mogli donijeti konačni zaključci o korisnom učinku u toj skupini tijekom terapije održavanja.
English: Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Kod bolesnika s anamnezom latentne tuberkuloze ili aktivne tuberkuloze kod kojih se ne može utvrditi odgovarajući tijek liječenja, također se mora razmotriti antituberkulozno liječenje prije početka primjene STELARE.