FrancophonIA/ELRC3.0 huggingface dataset:
English: The needle cover on the syringe in the STELARA pre-filled syringe is manufactured from dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Croatian: Pokrov igle koja se nalazi na napunjenoj štrcaljki STELARE proizveden je od suhe prirodne gume (derivat lateksa) koja može izazvati alergijske reakcije u osoba osjetljivih na lateks.
English: As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu STELARE tijekom trudnoće.
English: Responses observed in the ustekinumab treated groups were similar in patients receiving and not receiving concomitant MTX, and were maintained through weeks 52 and 100.
Croatian: Odgovori zabilježeni u skupinama liječenim ustekinumabom bili su slični i u bolesnika koji su istodobno primali i u bolesnika koji nisu istodobno primali MTX, te su se održali kroz 52 i 100 tjedana.
English: Ustekinumab has been shown to improve signs and symptoms, physical function and health-related quality of life, and reduce the rate of progression of peripheral joint damage in adult patients with active PsA.
Croatian: Za ustekinumab se pokazalo da poboljšava znakove i simptome, fizičku funkciju i kvalitetu života vezanu uz zdravlje, te da smanjuje stopu progresije oštećenja perifernih zglobova u odraslih bolesnika s aktivnim PsA.
English: Common: Back pain, myalgia, arthralgia
Croatian: Često: bol u leđima, mialgija, artralgija
English: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat.
Croatian: o poteškoće s disanjem ili gutanjem o nizak krvni tlak, koji može izazvati omaglicu ili ošamućenost o oticanje lica, usana, ustiju ili grla.
English: Of these 51 patients, 70.6% achieved clinical response and 39.2% percent achieved clinical remission 16 weeks after receiving the first subcutaneous dose of ustekinumab.
Croatian: Od tog 51 bolesnika, 70,6% postiglo je klinički odgovor i 39,2% postiglo je kliničku remisiju 16 tjedana nakon primanja prve supkutane doze ustekinumaba.
English: Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
Croatian: Zbog mogućnosti nuspojava na ustekinumab kod dojenčadi, odluku o tome treba li prekinuti dojenje tijekom liječenja i do 15 tjedana nakon liječenja ili prekinuti liječenje sa STELAROM mora se donijeti uzimajući u obzir korist dojenja za dijete i korist liječenja STELAROM za majku.
English: Endoscopic Normalization
Croatian: Normalizacija endoskopskih nalaza
English: No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in mice.
Croatian: Nisu zapaženi štetni učinci na pokazatelje ženske plodnosti korištenjem analognih protutijela na IL-12/23 kod miševa.
English: • The active substance is ustekinumab.
Croatian: • Djelatna tvar je ustekinumab.
English: • In some patients, after the first injection under the skin, 90 mg Stelara may be given every 8 weeks.
Croatian: • Kod nekih bolesnika, nakon prve injekcije pod kožu, može se davati 90 mg Stelare svakih 8 tjedana.
English: Stelara may make you less able to fight infections, and some infections could become serious.
Croatian: Stelara može oslabiti mogućnost borbe organizma protiv infekcija, pa neke infekcije mogu postati ozbiljne.
English: Dispose of your sharps container according to your local regulations
Croatian: Odložite spremnik za oštre predmete prema lokalnim propisima
English: The primary endpoint for both induction studies was the proportion of subjects in clinical response (defined as a reduction in CDAI score of ≥ 100 points) at week 6.
Croatian: Mjera primarnog ishoda za oba ispitivanja uvodnog liječenja bila je udio bolesnika s kliničkim odgovorom (definirano kao smanjenje CDAI skora od ≥ 100 bodova) u 6. tjednu.
English: The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57.2% in patients with psoriasis.
Croatian: Procijenjena apsolutna bioraspoloživost ustekinumaba nakon jedne supkutane primjene bila je 57,2% kod bolesnika s psorijazom.
English: * Following response to IV ustekinumab.
Croatian: * Nakon odgovora na intravensku dozu ustekinumaba.
English: Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI score by at least 100 points or being in clinical remission
Croatian: Klinička remisija je definirana kao CDAI skor < 150; Klinički odgovor je definiran kao smanjenje u CDAI skoru za barem 100 bodova ili bivanje u kliničkoj remisiji
English: You must look out for signs of infection while you are using Stelara.
Croatian: Morate obratiti pažnju na znakove infekcije dok primjenjujete Stelaru.
English: • the solution in the pre-filled syringe is not frozen.
Croatian: • da otopina u napunjenoj štrcaljki nije smrznuta.
English: Stelara contains the active substance ‘ustekinumab', a monoclonal antibody.
Croatian: Stelara sadrži djelatnu tvar 'ustekinumab', monoklonsko protutijelo.
English: The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section 4.5).
Croatian: Učinci IL-12 ili IL-23 na regulaciju enzima CYP450, procijenjeni su u in vitro ispitivanju humanih hepatocita, u kojem se pokazalo da IL-12 i/ili IL-23 u koncentraciji od 10 ng/mL nisu utjecali na promjenu aktivnosti humanih enzima CYP450 (CYP1A2, 2B6, 2C9, 2C19, 2D6 ili 3A4; vidjeti dio 4.5).
English: In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
Croatian: U populacijskim farmakokinetičkim analizama ispitivanja faze 3, procijenjen je učinak istodobno primijenjenih lijekova koji su najčešće korišteni kod bolesnika s psorijazom (uključujući paracetamol, ibuprofen, acetilsalicilatnu kiselinu, metformin, atorvastatin, levotiroksin) na farmakokinetiku ustekinumaba.
English: Before live viral or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
Croatian: Prije cijepljenja živim virusnim ili živim bakterijskim cjepivom, mora se prekinuti liječenje STELAROM barem 15 tjedana nakon posljednje doze, a liječenje se može nastaviti po isteku barem 2 tjedna od cijepljenja.
English: • Redness and pain where the injection is given
Croatian: • crvenilo i bol na mjestu davanja injekcije
English: STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Croatian: STELARA se mora primjenjivati u 0. i 4. tjednu, a nakon toga svakih 12 tjedana.
English: Efficacy (defined as PGA 0 or 1) was observed as early as the first post-baseline visit at week 4 and the proportion of subjects who achieved a PGA score of 0 or 1 increased through week 16 and then remained relatively stable through week 52.
Croatian: Djelotvornost (koja se definirala kao PGA 0 ili 1) je opažena već u 4. tjednu, pri prvom posjetu nakon početka ispitivanja, a udio ispitanika koji su postigli PGA skor 0 ili 1 povećavao se do 16. tjedna, da bi se zatim održao na relativno stabilnoj razini do 52. tjedna.
English: Using these therapies together with Stelara has not been studied.
Croatian: Zajednička primjena tih terapija sa Stelarom nije ispitana.
English: There was significant improvement in DLQI scores in the ustekinumab groups as compared with placebo at week 24, which was maintained through weeks 52 and 100.
Croatian: Došlo je do značajnog poboljšanja DLQI bodova u skupinama s ustekinumabom u usporedbi s placebom u 24. tjednu, koje se održalo kroz 52 i 100 tjedana.
English: Treatment of latent tuberculosis infection should be initiated prior to administering STELARA.
Croatian: Liječenje infekcije latentne tuberkuloze mora se započeti prije primjene STELARE.
English: Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI of at least 100 points or being in clinical remission * The placebo group consisted of patients who were in response to ustekinumab and were randomized to receive placebo at the start of maintenance therapy.
Croatian: Klinička remisija je definirana kao CDAI skor < 150; Klinički odgovor je definiran kao smanjenje u CDAI skoru za barem 100 bodova ili bivanje u kliničkoj remisiji * Placebo skupina se sastojala od bolesnika koji su odgovorili na ustekinumab i bili randomizirani u skupinu koja je primila placebo na početku terapije održavanja.
English: Some types of vaccines (live vaccines) should not be given while using Stelara.
Croatian: Neki tipovi cjepiva (živa cjepiva) ne smiju se davati dok se primjenjuje Stelara.
English: Visually inspect the diluted solution before infusion.
Croatian: Vizualno pregledajte razrijeđenu otopinu prije infuzije.
English: Caution should be exercised when considering concomitant use of other immunosuppressants and STELARA or when transitioning from other immunosuppressive biologics (see section 4.5).
Croatian: Potreban je oprez ako se razmatra istovremena primjena drugih imunosupresiva i STELARE ili kod prijelaza s drugih imunosupresivnih bioloških lijekova (vidjeti dio 4.5).
English: Do not remove the syringe's needle cover while allowing it to reach room temperature
Croatian: Nemojte uklanjati zaštitnu kapicu s igle na štrcaljki dok čekate da temperatura štrcaljke dosegne sobnu temperaturu.
English: Prepare the dose: • Take the cap off the top of the vial (see Figure 3)
Croatian: Pripremite dozu: • Skinite poklopac s vrha bočice (pogledajte Sliku 3).
English: The infusion should be completed within 8 hours of the dilution in the infusion bag.
Croatian: Infuziju je potrebno završiti unutar 8 sati od razrjeđivanja u infuzijskoj vrećici.
English: The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2.
Croatian: Ispitivanje terapije održavanja (IM-UNITI), ocijenilo je 388 bolesnika koji su postigli klinički odgovor od 100 bodova u 8. tjednu uvodnog liječenja s ustekinumabom u ispitivanjima UNITI-1 i UNITI-2.
English: Patients or their caregivers should be instructed to inject the prescribed amount of STELARA according to the directions provided in the package leaflet.
Croatian: Potrebno je uputiti bolesnike ili njihove njegovatelje da primijene propisanu količinu otopine STELARE prema uputstvima navedenim u Uputi o lijeku.
English: What Stelara contains
Croatian: Što Stelara sadrži
English: Table 2 Injection volumes of STELARA for paediatric psoriasis patients < 60 kg Body weight at time of dosing (kg)
Croatian: Tablica 2: Injekcijski volumeni STELARE za pedijatrijske bolesnike s psorijazom < 60 kg Tjelesna težina u vrijeme doziranja (kg)
English: STELARA has not been evaluated in patients who have undergone allergy immunotherapy.
Croatian: Primjena Stelare nije procijenjena kod bolesnika koji su prošli imunoterapiju alergija.
English: Elderly (≥ 65 years) No dose adjustment is needed for elderly patients (see section 4.4).
Croatian: Stariji (≥ 65 godina) Za starije bolesnike prilagodba doze nije potrebna (vidjeti dio 4.4).
English: Patients in UNITI-2 had failed at least one conventional therapy, including corticosteroids or immunomodulators, and were either anti-TNF-α naïve (68.6%) or had previously received but not failed anti-TNFα therapy (31.4%).
Croatian: Bolesnici u UNITI-2 imali su barem jednu neuspješnu konvencionalno terapiju, uključujući kortikosteroide ili imunomodulatore, te prethodno ili nisu primili anti-TNF-α terapiju (68,6%) ili su prethodno primili anti-TNFα terapiju koja je bila uspješna (31,4%).
English: Serious side effects Some patients may have serious side effects that may need urgent treatment.
Croatian: Neki bolesnici mogu imati ozbiljne nuspojave koje možda treba hitno liječiti.
English: The first subcutaneous dose should be given at week 8 following the intravenous dose.
Croatian: Prva supkutana doza treba se dati u 8. tjednu nakon intravenske doze.
English: Population pharmacokinetic analysis showed that there was a trend towards a higher clearance of ustekinumab in patients who tested positive for antibodies to ustekinumab.
Croatian: Farmakokinetičke analize populacije pokazale su da postoji trend prema višem klirensu ustekinumaba kod bolesnika koji su bili pozitivni na protutijela ustekinumaba.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Croatian: Psorijatični artritis je upalna bolest zglobova, uobičajeno praćena psorijazom.
English: Eight weeks later, 50.5% of the patients achieved clinical response and continued to receive maintenance dosing every 8 weeks; among these patients with continued maintenance dosing, a majority maintained response (68.1%) and achieved remission (50.2%) at week 44, at proportions that were similar to the patients who initially responded to ustekinumab induction.
Croatian: Osam tjedana kasnije, 50,5% bolesnika postiglo je klinički odgovor i nastavilo je primati doziranje održavanja svakih 8 tjedana; među tim bolesnicima s kontinuiranim doziranjem održavanja, većina je zadržala odgovor (68,1%) i postiglo je remisiju (50,2%) u 44. tjednu, u udjelima koji su slični bolesnicima koji su inicijalno odgovorili na uvođenje ustekinumaba.
English: Of those patients, 9% of patients who were initially randomized to the recommended induction dose achieved clinical remission and 58% achieved clinical response at Week 16.
Croatian: Od tih je bolesnika njih 9% koji su prvobitno bili randomizirani na preporučenu uvodnu dozu postiglo kliničku remisiju, a njih 58% klinički odgovor do 16. tjedna.
English: • Inject the dose promptly after removing the needle cover.
Croatian: • Primijenite dozu odmah nakon uklanjanja zaštitne kapice s igle.
English: Table 5 Summary of clinical response at week 12 in Psoriasis Study 3 (ACCEPT) Psoriasis Study 3
Croatian: Tablica 5. Sažetak kliničkog odgovora u Tjednu 12 u Ispitivanju psorijaze 3 (ACCEPT) Ispitivanje psorijaze 3
English: Psoriasis Study 2 (PHOENIX 2) evaluated 1,230 patients.
Croatian: Ispitivanje psorijaze 2 (PHOENIX 2) procijenilo je 1230 bolesnika.
English: Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see section 5.1, section 5.2).
Croatian: Bolesnici koji izgube odgovor na doziranje svakih 12 tjedana mogu imati korist od povećanja učestalosti doziranja na svakih 8 tjedana (vidjeti dijelove 5.1 i 5.2).
English: • Do not hold by the plunger head, plunger, needle guard wings, or needle cover
Croatian: • Nemojte držati štrcaljku za glavu klipa, klip, krilca štitnika igle ili zaštitnu kapicu igle
English: Among patients who entered the study extension, clinical remission and response were generally maintained through week 92 for both patients who failed TNF-therapies and those who failed conventional therapies.
Croatian: Među bolesnicima koji su ušli u produžetak ispitivanja, klinička remisija i odgovor bili su općenito održani do 92 tjedna za obje skupine bolesnika, bolesnike koji su neuspješno liječeni TNF-terapijama i bolesnike koji su neuspješno liječeni konvencionalnim terapijama.
English: PASI 75 response N (%) Number of patients > 100 kg
Croatian: PASI 75 odgovor N (%) Broj bolesnika > 100 kg
English: Long term treatment with STELARA does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines (see section 5.1).
Croatian: Dugotrajno liječenje STELAROM ne suprimira humoralni imunosni odgovor na pneumokokne polisaharide ili cjepiva protiv tetanusa (vidjeti dio 5.1).
English: No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients.
Croatian: Općenito, u kliničkim ispitivanjima primjene u odobrenim indikacijama nisu primijećene razlike u djelotvornosti ili sigurnosti primjene kod bolesnika od 65 godina i starijih koji su primali STELARU u usporedbi s mlađim bolesnicima, međutim broj bolesnika od 65 godina i starijih nije dostatan kako bi se utvrdilo jesu li na liječenje odgovorili različito od mlađih bolesnika.
English: Of 131 patients who responded to ustekinumab induction, and were randomized to the placebo group at the start of the maintenance study, 51 subsequently lost response and received 90 mg ustekinumab subcutaneously every 8 weeks.
Croatian: Od 131 bolesnika koji su odgovorili na uvođenje ustekinumaba i koji su bili randomizirani u placebo skupinu na početku ispitivanja terapije održavanja, njih 51 je naknadno izgubilo odgovor i primalo 90 mg ustekinumaba supkutano svakih 8 tjedana.
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 with juvenile idiopathic arthritis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka ustekinumab u jednoj ili više podskupina pedijatrijske populacije s juvenilnim idiopatskim artritisom (vidjeti dio 4.2 za informacije pedijatrijskoj primjen)
English: Clinical Remission** In patients who failed conventional therapy, but not a biologic d49% (50/102)
Croatian: Klinička remisija** U bolesnika neuspješno liječenih konvencionalnom, ali ne i biološkom terapijom d 49% (50/102)
English: Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis)
Croatian: Ponekad se razviju slični simptomi (eritrodermna psorijaza) kao prirodna promjena vrste simptoma psorijaze.
English: Recommended dose of Ustekinumab
Croatian: Preporučena doza ustekinumaba
English: During the long term extension of Psoriasis Study 2 (PHOENIX 2), adult patients treated with STELARA for at least 3.5 years mounted similar antibody responses to both pneumococcal polysaccharide and tetanus vaccines as a non-systemically treated psoriasis control group.
Croatian: Tijekom dugoročnog produžetka Ispitivanja psorijaze 2 (PHOENIX 2), odrasli bolesnici liječeni STELAROM najmanje 3,5 godine imali su sličan odgovor protutijela na pneumokokne polisaharide i na cjepiva protiv tetanusa, kao i kontrolna skupina kojoj psorijaza nije liječena sistemski.
English: The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis (see section 4.4).
Croatian: Najozbiljnije prijavljene nuspojave uz STELARU bile su ozbiljne reakcije preosjetljivosti uključujući anafilaksu (vidjeti dio 4.4).
English: Systemic and respiratory hypersensitivity reactions
Croatian: Sistemske i respiratorne reakcije preosjetljivosti
English: However, you and your doctor may decide that you may inject Stelara yourself.
Croatian: Međutim, Vi i Vaš liječnik možete odlučiti da ćete si injekciju Stelare davati sami.
English: As early as Week 2, the earliest scheduled study visit, and at each visit thereafter, a higher proportion of ustekinumab patients had no rectal bleeding or achieved normal stool frequency as compared with placebo patients.
Croatian: Već u 2. tjednu, odnosno pri prvom planiranom posjetu u sklopu ispitivanja, kao i pri svakom sljedećem posjetu, veći udio bolesnika liječenih ustekinumabom nego onih koji su primili placebo nije imao rektalno krvarenje ili je postigao normalnu učestalost pražnjenja crijeva.
English: • Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis).
Croatian: • crvenilo i ljuštenje kože veće površine tijela, koji mogu biti praćeni svrbežom ili biti bolni (eksfolijativni dermatitis).
English: Crohn's Disease
Croatian: Crohnova bolest
English: Driving and using machines Stelara has no or negligible influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Stelara ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i strojevima.
English: Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection.
Croatian: Prije početka liječenja STELAROM u bolesnika se mora procijeniti moguća infekcija tuberkulozom.
English: STELARA has no or negligible influence on the ability to drive and use machines.
Croatian: STELARA ne utječe ili zanemarivo utječe na na sposobnost upravljanja vozilima i rada sa strojevima.
English: Talk to your doctor if you are on a low salt diet.
Croatian: Razgovarajte s liječnikom ako ste na dijeti koja zahtijeva nizak unos natrija.
English: Choose an injection site (see Figure 2)
Croatian: Odaberite mjesto za primjenu injekcije (pogledajte Sliku 2)
English: Let the vial stand for about half an hour.
Croatian: Ostavite bočicu da odstoji oko pola sata.
English: Approximately 48% of the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies.
Croatian: Otprilike 48% bolesnika imalo je 1 neuspješnu prethodnu anti-TNFα terapiju, a 52% imalo je neuspješne 2 ili 3 prethodne anti-TNFα terapije.
English: The rate of infection was 0.91 per patient-year of follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02 per patient-year of follow-up in ustekinumab-treated patients (199 serious infections in 11,581 patient-years of follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, gastroenteritis and viral infections.
Croatian: Stopa infekcije je bila 0,91 po bolesnik-godini praćenja bolesnika liječenih ustekinumabom, a stopa ozbiljnih infekcija bila je 0,02 po bolesnik-godini praćenja bolesnika liječenih ustekinumabom (199 ozbiljnih infekcija u 11 581 bolesnik-godini praćenja), a zabilježene ozbiljne infekcije uključivale su upalu pluća, analni apsces, celulitis, divertikulitis, gastroenteritis i virusne infekcije.
English: • Put the vial on a flat surface.
Croatian: • Stavite bočicu na ravnu površinu.
English: Nominally significant (p < 0.05)
Croatian: Nominalno značajno (p < 0,05)
English: Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 cell surface receptors.
Croatian: Ustekinumab se ne može vezati na IL-12 ili IL-23 koji je već vezan na IL-12R1 površinske stanične receptore.
English: At week 12, placebo treated patients crossed over to receive ustekinumab.
Croatian: U 12. tjednu, bolesnici liječeni placebom prešli su na primanje ustekinumaba.
English: IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL-23 induces the T helper 17 (Th17) pathway.
Croatian: IL-12 i IL-23 su heterodimerni citokini koje izlučuju aktivirane antigen prezentirajuće stanice, kao što su makrofagi i dendritičke stanice, te oba citokina sudjeluju u imunološkoj funkciji; IL-12 stimulira stanice prirodne ubojice (NK) i potiče diferencijaciju CD4+ Tstanica prema fenotipu T 1 pomagačkih stanica (Th1), IL-23 inducira razvoj prema T 17 pomagačkim stanicama (Th17).
English: • Serious allergic reactions (‘anaphylaxis') are rare in people taking Stelara (may affect up to 1 in 1,000 people).
Croatian: • Ozbiljne alergijske reakcije (‘anafilaksija') su rijetke kod ljudi kojima se primjenjuje Stelara (mogu se pojaviti u do 1 na 1000 osoba).