FrancophonIA/ELRC3.0 huggingface dataset:
English: Maintenance of clinical remission through Week 44 is defined as patients in clinical remission through Week 44 among patients in clinical remission at maintenance baseline.
Croatian: Održana klinička remisija tijekom 44 tjedna definirana je kao klinička remisija od početka terapije održavanja do 44.tjedna u bolesnika koji su bili u kliničkoj remisiji na početku terapije održavanja.
English: Stelara is not recommended for use in children under 18 years of age with Crohn's disease or ulcerative colitis because it has not been studied in this age group.
Croatian: Stelara se ne preporučuje za primjenu kod djece mlađe od 18 godina s Crohnovom bolesti ili ulceroznim kolitisom, jer nije ispitivana u toj dobnoj skupini.
English: For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.
Croatian: Bolesnicima tjelesne težine > 100 kg supkutano se primjenjuje inicijalna doza od 90 mg, nakon čega slijedi nova doza od 90 mg 4 tjedna kasnije, a nakon toga svakih 12 tjedana.
English: These improvements were generally better maintained in ustekinumab-treated patients in the IM-UNITI study through week 44 when compared to placebo.
Croatian: Ova poboljšanja bila su općenito bolje održana u bolesnika liječenih ustekinumabom u IM-UNITI ispitivanju do 44. tjedna, u usporedbi s placebom.
English: What Stelara is
Croatian: Što je Stelara
English: Patients who were not in clinical response to ustekinumab induction at week 8 of the UNITI-1 and UNITI-2 induction studies (476 patients) entered into the non-randomized portion of the maintenance study (IM-UNITI) and received a 90 mg subcutaneous injection of ustekinumab at that time.
Croatian: Bolesnici koji nisu imali klinički odgovor na uvođenje ustekinumaba u 8. tjednu ispitivanja uvodnog liječenja UNITI-1 i UNITI-2 (476 bolesnika) ušli su u ne-randomizirani dio ispitivanja terapije održavanja (IM-UNITI) i tada su primili 90 mg ustekinumaba supkutanom injekcijom.
English: STELARA is available in a 1 vial pack or a pack of 1 pre-filled syringe.
Croatian: STELARA je dostupna u pakiranju sa 1 bočicom ili u pakiranju sa 1 napunjenom štrcaljkom.
English: Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells.
Croatian: Ustekinumab inhibira bioaktivnost ljudskog interleukina IL-12 i IL-23 sprječavanjem vezanja p40 s IL-12R1 receptorskim proteinom istaknutim na površini imunih stanica.
English: Treatment with ustekinumab resulted in significant improvements in the measures of disease activity compared to placebo at week 24.
Croatian: Liječenje ustekinumabom rezultiralo je značajnim poboljšanjem u mjerenju aktivnosti bolesti u usporedbi s placebom u 24. tjednu.
English: Table 1 Recommended dose of STELARA for paediatric psoriasis Body weight at the time of dosing
Croatian: Tablica 1: Preporučena doza STELARE za pedijatrijsku psorijazu Tjelesna težina u vrijeme doziranja
English: In patients with Crohn's disease and ulcerative colitis, following an intravenous dose of ~6 mg/kg, starting at week 8, subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 or 12 weeks.
Croatian: U bolesnika s Crohnovom bolesti i ulceroznim kolitisom, nakon intravenske doze od ~6 mg/kg, koja je započeta u 8. tjednu, supkutana doza održavanja od 90 mg ustekinumaba bila je primijenjena svakih 8 ili 12 tjedana.
English: • Then press the plunger until all of the air (but none of the liquid) has been removed • Do not lay the syringe down or allow the needle to touch anything.
Croatian: • Zatim pritišćite klip dok se ne ukloni sav zrak (ali ne i tekućina).
English: • Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete obratite se svom liječniku za svjet prije nego uzmete ovaj lijek.
English: In patients who failed biological therapy
Croatian: U bolesnika neuspješno liječenih biološkom terapijom
English: Take the vial(s) out of the refrigerator.
Croatian: Uzmite bočicu (bočice) iz hladnjaka.
English: STELARA concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.
Croatian: STELARA koncentrat za otopinu za infuziju mora razrijediti, pripremiti i primijeniti putem infuzije zdravstveni radnik koristeći aseptičku tehniku.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Croatian: Obratite se svom liječniku ako imate bilo kakvih pitanja o samoprimjeni injekcije.
English: 90 mg ustekinumab every 12 weeks
Croatian: 90 mg ustekinumaba svakih 12 tjedana
English: Serum ustekinumab concentrations in paediatric psoriasis patients 6 to 17 years of age, treated with the recommended weight-based dose were generally comparable to those in the adult psoriasis population treated with the adult dose.
Croatian: Serumske koncentracije ustekinumaba kod pedijatrijskih bolesnika u dobi od 6 do 17 godina s psorijazom, liječenih preporučenom dozom koja se temelji na tjelesnoj težini, općenito su bile usporedive s onima u odrasloj populaciji bolesnika s psorijazom liječenih dozom za odrasle.
English: Table 11: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Croatian: Tablica 11: Sažetak ključnih ishoda za djelotvornost u ispitivanju UNIFI-I (8. tjedan) Placebo
English: The solution in the STELARA vial should not be shaken.
Croatian: Otopina u bočici STELARE ne smije se tresti.
English: For storage conditions after dilution of the medicinal product, see section 6.3
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3
English: Administer the diluted solution over a period of at least one hour.
Croatian: Razrijeđenu otopinu primijenite tijekom razdoblja od najmanje jednog sata.
English: Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in children under 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis because it has not been studied in this age group.
Croatian: Stelara se ne preporučuje za primjenu kod djece s psorijazom mlađe od 6 godina ili za primjenu kod djece mlađe od 18 godina s psorijatičnim artritisom, Crohnovom bolesti ili ulceroznim kolitisom, jer nije ispitivana u toj dobnoj skupini.
English: Patients who were re-randomised to placebo at week 40 reinitiated ustekinumab at their original dosing regimen when they experienced at least a 50% loss of their PASI improvement obtained at week 40.
Croatian: Bolesnicima koji su tijekom ponovne randomizacije u 40. tjednu svrstani u placebo grupu, ponovno je započela primjena ustekinumaba, prema njihovom početnom planu doziranja, ako im je primijećen gubitak PASI poboljšanja od barem 50% u odnosu na prethodno ostvaren u 40. tjednu.
English: The primary endpoint was change from baseline in Simplified Endoscopic Disease Severity Score for Crohn's Disease (SES-CD), a composite score across 5 ileocolonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
Croatian: Simplified Endoscopic Disease Severity Score for Crohn's Disease [SESCD]), kompozitni skor 5 ileo-kolonalnih segmenata na prisutnost/veličinu ulkusa, udio površine sluznice prekriven ulkusima, udio površine sluznice zahvaćen bilo kakvim drugim lezijama i prisutnost/tip suženja/striktura.
English: OUTER CARTON (130 mg)
Croatian: VANJSKA KUTIJA (130 mg)
English: (see section 4.4).
Croatian: (pogledajte Sliku 4).
English: The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis.
Croatian: Sustavna izloženost ustekinumabu (Cmax i AUC) povećala se na način približno proporcionalan dozi nakon jedne intravenske primjene u dozama koje se kreću od 0,09 mg/kg do 4,5 mg/kg ili nakon jedne supkutane primjene pri dozama koje se kreću od približno 24 mg do 240 mg kod bolesnika s psorijazom.
English: At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
Croatian: U 18. mjesecu (76. tjedan), 84% bolesnika koji su ponovno randomizirani na održavanje liječenja imalo je odgovor PASI 75, u usporedbi s 19% bolesnika ponovno randomiziranih u placebo grupu (prekid liječenja).
English: Uncommon: Cellulitis, dental infections, herpes zoster, lower respiratory tract infection, viral upper respiratory tract infection, vulvovaginal mycotic infection
Croatian: Često: infekcija gornjeg dišnog sustava, nazofaringitis, sinusitis Manje često: celulitis, dentalne infekcije, herpes zoster, infekcija donjeg dišnog sustava, virusna infekcija gornjeg dišnog sustava, vulvovaginalne gljivične infekcije
English: Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Croatian: Jedna bočica sadrži 130 mg ustekinumaba u 26 ml (5 mg/ml).
English: This includes antiseptic wipes, a cotton ball or gauze, and a sharps container.
Croatian: To uključuje antiseptičke maramice, komadić vate ili gaze i spremnik za odlaganje oštrih predmeta.
English: • If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
Croatian: • Ukoliko je Vaša tjelesna težina 60 kg do 100 kg, preporučena doza je 45 mg Stelare.
English: However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Croatian: Međutim, abnormalna regulacija IL-12 i IL-23 bila je povezana s bolestima posredovanim imunitetom, kao što su psorijaza, psorijatični artritis, Crohnova bolest i ulcerozni kolitis.
English: Patients were randomised to receive either placebo (n = 37), or the recommended dose of ustekinumab (see section 4.2; n = 36) or half of the recommended dose of ustekinumab (n = 37) by subcutaneous injection at Weeks 0 and 4 followed by every 12 week (q12w) dosing.
Croatian: Bolesnici su bili randomizirani kako bi primili ili placebo (n = 37), ili preporučenu dozu ustekinumaba (vidjeti dio 4.2; n = 36) ili polovinu preporučene doze ustekinumaba (n = 37) u obliku supkutane injekcije u 0. i 4. tjednu, a zatim je slijedilo doziranje svakih 12 tjedana (q12w).
English: STELARA concentrate for solution for infusion must be diluted and prepared by a healthcare professional using aseptic technique.
Croatian: STELARA koncentrat za otopinu za infuziju mora razrijediti i pripremiti zdravstveni radnik koristeći aseptičku tehniku.
English: • After the starting intravenous dose, you will have the next dose of 90 mg Stelara by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks therafter.
Croatian: • Nakon početne doze u venu, dobit ćete sljedeću dozu od 90 mg Stelare injekcijom pod kožu (supkutana injekcija) 8 tjedana kasnije, a nakon toga svakih 12 tjedana.
English: Endoscopic appearance of the mucosa was evaluated in 252 patients with eligible baseline endoscopic disease activity in a substudy.
Croatian: Endoskopski izgled sluznice bio je ocijenjen u 252 bolesnika u podispitivanju s početnom vrijednosti endoskopski utvrđene aktivnosti bolesti koja je zadovoljavala uvjete.
English: The primary endpoint was the proportion of patients who achieved a PGA score of cleared (0) or minimal (1) at week 12.
Croatian: Primarni ishod bio je udio bolesnika koji su u 12. tjednu postigli PGA skor čist (0) ili minimalan (1).
English: The primary endpoint for the induction study was the proportion of subjects in clinical remission at week 8.
Croatian: Primarna mjera ishoda u ispitivanju uvodnog liječenja bio je udio ispitanika koji su postigli kliničku remisiju do 8. tjedna.
English: Over 70% and 40% of the patients in both studies had enthesitis and dactylitis at baseline, respectively.
Croatian: Više od 70% u oba ispitivanja na početku je imalo entezitis, a 40% bolesnika daktilitis.
English: Malignancies excluding non-melanoma skin cancers were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patientyears of follow-up for ustekinumab-treated patients).
Croatian: Maligne bolesti isključujući nemelanomski rak kože prijavljene su kod 62 bolesnika u 11 561 bolesnik-godini praćenja (incidencija 0,54 na 100 bolesnik-godina praćenja za bolesnike liječene ustekinumabom).
English: In a subgroup of patients with draining fistulas at baseline (8.8%; n = 26), 12/15 (80%) of ustekinumab-treated patients achieved a fistula response over 44 weeks (defined as ≥ 50% reduction from baseline of the induction study in the number of draining fistulas) compared to 5/11 (45.5%) exposed to placebo.
Croatian: U podskupini bolesnika s fistulama iz kojih izlazi sadržaj na početku (8,8%; n = 26), 12/15 (80%) bolesnika liječenih ustekinumabom postiglo je odgovor fistule tijekom 44 tjedna (definirano kao ≥ 50% smanjenje broja fistula iz kojih izlazi sadržaj u udnosu na početne vrijednosti ispitivanja uvodnog liječenja) u usporedbi s 5/11 (45,5%) izloženih placebu.
English: Table 5: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Croatian: Tablica 5: Sažetak ključnih ishoda za djelotvornost u ispitivanju UNIFI-I (8. tjedan) Placebo
English: PASI 75 response N (%)
Croatian: PASI 75 odgovor N (%)
English: A combined endpoint of histo-endoscopic mucosal healing defined as subjects having both mucosal healing and histologic healing was evaluated at week 8 of UNIFI-I and week 44 of UNIFI-M.
Croatian: Histo-endoskopsko cijeljenje sluznice kao kombinirana mjera ishoda koja se definirala kao ispitanici koji su postigli i cijeljenje sluznice i histološko cijeljenje ocjenjivala se u 8. tjednu ispitivanja UNIFI-I i 44. tjednu ispitivanja UNIFI-M.
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept.
Croatian: p < 0,001 za ustekinumab 45 mg ili 90 mg u usporedbi s etanerceptom.
English: Symptomatic Remission Combined Symptomatic Remission and Mucosal Healing
Croatian: Simptomatska remisija Kombinacija simptomatske remisije i cijeljenja sluznice
English: Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
Croatian: Doza infuzije ustekinumaba određena prema režimu doziranja na temelju tjelesne težine opisanom u Tablici 1.
English: • Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward
Croatian: • Držite napunjenu štrcaljku za tijelo štrcaljke sa zaštitnom kapicom igle okrenutom prema gore
English: • Do not touch the needle or allow it to touch any surface
Croatian: • Ne dirajte iglu i pazite da igla ne dotakne bilo koju površinu.
English: 49% of patients had failed conventional therapy, but not a biologic (of which 94% where biological-naïve).
Croatian: Četrdeset i devet posto (49%) bolesnika bilo je neuspješno liječeno konvencionalnom, ali ne i biološkom terapijom (među kojima 94% prethodno nije bilo liječeno biološkim lijekovima).
English: STELARA is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Međutim, STELARA se razrjeđuje otopinom natrijeva klorida za infuziju od 9 mg/ml (0,9%).
English: The safety and efficacy of STELARA in treatment of Crohn's disease or ulcerative colitis in children less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost STELARE u liječenju Crohnove bolesti ili ulceroznog kolitisa u djece mlađe od 18 godina nisu još ustanovljene.
English: To calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body weight (kg) x 0.0083 (mL/kg) or see Table 2.
Croatian: Za izračun volumena injekcije (ml) za bolesnike tjelesne težine < 60 kg treba primijeniti sljedeću formulu: tjelesna težina (kg) x 0,0083 (ml/kg) ili vidjeti Tablicu 2. Dobiveni volumen treba zaokružiti na najbližih 0,01 ml i primijeniti koristeći graduiranu štrcaljku volumena 1 ml.
English: In ulcerative colitis, population PK model based simulations demonstrated that adjusting dosing from 90 mg every 12 weeks to every 8 weeks would be expected to result in a 3-fold increase in steady-state trough ustekinumab concentrations.
Croatian: Kod ulceroznog kolitisa, simulacije utemeljene na populacijskom farmakokinetičkom modelu pokazale su da se nakon prelaska s primjene doze od 90 mg svakih 12 tjedana na primjenu svakih 8 tjedana očekuje trostruko povećanje najnižih koncentracija ustekinumaba u stanju dinamičke ravnoteže.
English: Any diluted infusion solution or unused product remaining in the vial and the syringe should be thrown away in accordance with local requirements.
Croatian: Sva razrijeđena otopina za infuziju ili sav neiskorišten lijek koji je preostao u bočici i štrcaljki potrebno je primjereno zbrinuti sukladno nacionalnim propisima.
English: The formation of anti-ustekinumab antibodies is associated with increased clearance of ustekinumab in patients with Crohn's disease or ulcerative colitis.
Croatian: Nastanak protutijela na ustekinumab povezan je s povećanim klirensom ustekinumaba u bolesnika s Crohnovom bolešću ili ulceroznim kolitisom.
English: 90mg ustekinumab every 8 Weeks N = 176
Croatian: 90 mg ustekinumaba svakih 8 tjedana N = 176
English: Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials discard 78 mL, for 4 vials- discard 104 mL).
Croatian: Izvucite i uklonite volumen 9 mg/ml (0,9%-tne) otopine natrijevog klorida iz infuzijske vrećice od 250 ml, jednak volumenu STELARE koji će se dodati (uklonite 26 ml otopine natrijevog klorida za svaku bočicu STELARE koju trebate, za 2 bočice- uklonite 52 ml, za 3 bočiceuklonite 78 ml, za 4 bočice- uklonite 104 ml).
English: • Back, muscle or joint pain
Croatian: • bol u leđima, mišićima ili zglobovima
English: • Stelara is given as an injection under the skin (‘subcutaneously').
Croatian: • Stelara se daje u obliku potkožne injekcije ('supkutano').
English: Paediatric plaque psoriasis
Croatian: Pedijatrijska plak psorijaza
English: • Antiseptic wipes and other supplies can be disposed of in your garbage.
Croatian: • Antiseptičke maramice te drugi pribor možete odložiti u kućni otpad.
English: At week 12, subjects treated with ustekinumab showed significantly greater improvement in their psoriasis and health related quality of life compared with placebo (Table 7).
Croatian: U 12. tjednu ispitanici liječeni ustekinumabom pokazali su značajno veće poboljšanje psorijaze i kvalitete života povezane sa zdravljem, u usporedbi s placebom (Tablica 7).
English: The proportion of patients achieving a clinically significant improvement in fatigue (4 points in FACIT-F) was also significantly greater in the ustekinumab groups compared with placebo.
Croatian: Omjer bolesnika koji su dostigli klinički značajno poboljšanje vezano uz umor (4 boda u FACIT-F) također je bilo značajno veće u skupinama liječenim ustekinumabom u usporedbi s placebom.
English: ** Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
Croatian: **Klinička remisija definiranaje kao Mayo rezultat ≤2bodai nijedan pojedinačni podrezultat>1.
English: • Wipe the injection site on the skin with an antiseptic wipe
Croatian: • Obrišite mjesto za davanje injekcije na koži antiseptičkom maramicom.
English: • Used syringes should be placed in a puncture-resistant container, like a sharps container (see
Croatian: • Upotrijebljene štrcaljke moraju se odložiti u spremnik koji se ne može probušiti, poput spremnika za oštre predmete (pogledajte sliku 8).
English: For the posology of the intravenous dosing regimen, see section 4.2 of the STELARA 130 mg Concentrate for solution for infusion SmPC.
Croatian: Za doziranje intravenskog režima doziranja, vidjeti dio 4.2 sažetka opisa svojstava lijeka za STELARA 130 mg koncentrat za otopinu za infuziju.
English: Secondary endpoints included PASI 75, PASI 90, and change from baseline in Children's Dermatology Life Quality Index (CDLQI) at week 12.
Croatian: Sekundarne mjere ishoda uključivale su PASI 75, PASI 90 i promjenu vrijednosti dječjeg dermatološkog indeksa kvalitete života (CDLQI) od početka ispitivanja do 12. tjedna.
English: STELARA 45 mg and 90 mg vials or pre-filled syringes are for subcutaneous injection only.
Croatian: STELARA 45 mg i 90 mg u bočicama ili u napunjenim štrcaljkama se primjenjuje samo supkutanom injekcijom.
English: PGA of cleared (0) PASI
Croatian: PGA čist (0) PASI
English: Patients originally randomised to ustekinumab who achieved Psoriasis Area and Severity Index 75 response (PASI improvement of at least 75% relative to baseline) at both Weeks 28 and 40 were re-randomised to receive ustekinumab every 12 weeks or to placebo (i.e., withdrawal of therapy).
Croatian: Psoriasis Area and Severity Index) odgovor 75 (PASI poboljšanje od barem 75% u odnosu na prvu vizitu), ponovno su randomizirani i u tjednu 28 i u tjednu 40 kako bi dobili ili ustekinumab svakih 12 tjedana ili placebo (tj. prekinuli terapiju).
English: Psoriasis Study 1
Croatian: Ispitivanje psorijaze 1
English: In patients re-randomised to placebo, and who reinitiated their original ustekinumab treatment regimen after loss of ≥ 50% of PASI improvement 85% regained PASI 75 response within 12 weeks after re-initiating therapy.
Croatian: Kod bolesnika koji su pri ponovnoj randomizaciji pripali placebo grupi i kojima je početni režim liječenja ustekinumabom ponovno iniciran nakon gubitka ≥ 50% PASI vrijednosti, nakon ponovnog početka terapije u roku od 12 tjedana, kod 85% bolesnika PASI odgovor iznosio je 75.
English: Recommended dose of ustekinumab N = 322
Croatian: Preporučena doza ustekinumaba N = 322
English: What Stelara is used for
Croatian: Za što se Stelara koristi
English: STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Croatian: STELARA je indicirana za liječenje odraslih bolesnika s umjerenim do teškim oblikom aktivne Crohnove bolesti, koji su imali neadekvatan odgovor ili su izgubili odgovor ili nisu podnosili bilo konvencionalnu terapiju ili terapiju antagonistom TNFα ili koji imaju medicinske kontraindikacije za takve terapije.
English: * Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
Croatian: *Klinička remisija definiranaje kao Mayo rezultat ≤2bodai nijedan pojedinačni podrezultat>1.
English: The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.
Croatian: Liječenje STELAROM preporučuje se započeti supkutanom primjenom inicijalne doze od 45 mg, nakon čega slijedi nova doza od 45 mg 4 tjedna kasnije, a nakon toga svakih 12 tjedana.
English: Baseline disease characteristics were generally consistent across all treatment groups in Psoriasis Studies 1 and 2 with a median baseline PASI score from 17 to 18, median baseline Body Surface Area (BSA) ≥ 20, and median Dermatology Life Quality Index (DLQI) range from 10 to 12.
Croatian: Karakteristike osnovne bolesti bile su uglavnom konzistentne kroz sve liječene grupe u Ispitivanju psorijaze 1 i 2 s medijanom polaznog PASI rezultata od 17 do 18 i medijanom polazne zahvaćene površine tijela (eng.
English: Marketing Authorisation Holder Janssen-Cilag International NV
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Janssen-Cilag International NV