FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may prescribe another strength of Kromeya if your child needs a different dose.
Croatian: Vaš liječnik može propisati drugu jačinu lijeka Kromeya ako Vaše dijete treba drugačiju dozu.
English: ASDAS inactive disease hs-CRP
Croatian: ASDAS neaktivna bolest hs-CRP
English: Week 8 and 52
Croatian: 8. i 52. tjedan
English: 6.5 Center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it locks.
Croatian: 6.5 Stavite palac ili kažiprst u sredinu teksturiranog jastučića za prst te gurnite sigurnosni pokrov prema naprijed preko igle dok ne čujete ili ne osjetite da se zaključao.
English: Figure Q Warning: Call your healthcare professional or pharmacist if you have any problem.
Croatian: Slika Q Upozorenje: Nazovite svog liječnika ili ljekarnika ako imate bilo kakvih problema.
English: Check with your child's doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.
Croatian: Provjerite s liječnikom Vašeg djeteta ili ljekarnikom ako niste sigurni oko bilo kojih uputa ili ako imate bilo kakva pitanja.
English: • high blood pressure;
Croatian: • visok krvni tlak,
English: 1.3 Remove the box from the refrigerator (Figure B).
Croatian: 1.3 Izvadite kutiju iz hladnjaka (slika B).
English: The recommended doses for Kromeya in each of the approved uses are shown in the following table.
Croatian: Preporučene doze lijeka Kromeya za svaku od odobrenih uporaba su prikazane u sljedećoj tablici:
English: A similar safety profile was observed during retreatment as before withdrawal.
Croatian: Tijekom ponovnog liječenja uočen je sličan profil sigurnosti kao i prije ukidanja liječenja.
English: MTX = methotrexate b
Croatian: MTX = metotreksat b
English: • new onset or worsening of psoriasis;
Croatian: • nova pojava ili pogoršanje psorijaze,
English: This is to remove any air gaps or bubbles.
Croatian: Na taj način uklonit ćete sve zračne prostore ili mjehuriće.
English: What Kromeya looks like and contents of the pack
Croatian: Kako Kromeya izgleda i sadržaj pakiranja
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Croatian: Na interpretaciju podataka mogu utjecati metodološka ograničenja ispitivanja, uključujući malu veličinu uzorka i dizajn koji nije uključivao randomizaciju.
English: Failure N (%)
Croatian: N Neuspjeh N (%)
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Croatian: Adalimumab je ispitivan u 9506 bolesnika u pivotalnim kontroliranim i otvorenim ispitivanjima tijekom razdoblja do 60 mjeseci ili dulje.
English: - The active substance is adalimumab.
Croatian: - Djelatna tvar je adalimumab.
English: Results from the overall UC-II study population are shown in Table 26.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u Tablici 26.
English: Not all presentations may be marketed.
Croatian: Na tržištu se ne moraju nalaziti svi oblici.
English: • Do not use the 40 mg pre-filled syringe or 40 mg pre-filled pen if doses other than 40 mg are recommended.
Croatian: • Nemojte koristiti napunjenu štrcaljku od 40 mg ili napunjenu brizgalicu od 40 mg ako se preporučuju doze drukčije od 40 mg.
English: The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Croatian: Odgovarajući udio bolesnika bez radiološke progresije iznosio je 31,3%, 23,7% odnosno 36,7%.
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Croatian: 117/276 bolesnika iz ispitivanja CD I i 272/777 bolesnika iz ispitivanja CD II i III praćeno je tijekom najmanje 3 godine otvorene terapije adalimumabom.
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Croatian: Klinička remisija (definirana kao Mayo rezultat ≤ 2 bez podrezultata > 1) ocjenjivala se u osmom tjednu.
English: Note : images for illustration purposes only
Croatian: Napomena: slike su samo za ilustraciju
English: Doing so could damage the syringe or activate the clear needle guard.
Croatian: Time možete oštetiti štrcaljku ili aktivirati prozirni štitnik igle.
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Croatian: Indukcija kliničke remisije (definirana kao CDAI < 150) ispitivala se u dva ispitivanja, CD I (CLASSIC I) i CD II (GAIN).
English: 1.4 You will also need following supplies that are not included in the kit:
Croatian: Bit će vam potreban i sljedeći pribor koji nije uključen u set:
English: In rare cases, these infections may be lifethreatening.
Croatian: U rijetkim slučajevima te infekcije mogu biti opasne po život.
English: Kromeya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Croatian: Kromeya sadrži djelatnu tvar adalimumab, lijek koji djeluje na imunološki (obrambeni) sustav Vašeg tijela.
English: What Kromeya contains
Croatian: Što Kromeya sadrži
English: Kromeya is intended for the treatment of the following inflammatory diseases:
Croatian: Kromeya je namijenjena liječenju sljedećih upalnih bolesti:
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Croatian: U svim niže opisanim situacijama potrebno je vrlo pažljivo procijeniti omjer koristi i rizika liječenja.
English: By attaching to TNFα, Kromeya blocks its action and reduces the inflammation in these diseases.
Croatian: Vezivanjem za TNFα, Kromeya inhibira njegovo djelovanje i smanjuje upalu kod tih bolesti.
English: • Children under 12 years of age are not allowed to inject themselves and injection must be done by a trained adult.
Croatian: • Djeca mlađa od 12 godina ne smiju si sama davati injekcije, već im injekciju treba primijeniti za to osposobljena odrasla osoba.
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Croatian: Zvjezdica (*) u stupcu 'Organski sustav' znači da se detaljnije informacije mogu pronaći u dijelovima 4.3, 4.4 i 4.8.
English: 3.4 Keep the vial and syringe vertical and slowly pull the prescribed dose.
Croatian: 3.4 Držite bočicu i štrcaljku vertikalno te polako izvucite propisanu dozu.
English: Warning: Do not use the pre-filled pen if the name on the label is not Kromeya and/or the expiration date on the label has passed.
Croatian: Upozorenje: Nemojte upotrebljavati brizgalicu ako ime na oznaci nije Kromeya i/ili ako je rok valjanosti na oznaci istekao.
English: After proper training in injection technique, patients may self-inject with Kromeya if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Nakon odgovarajuće poduke o tehnici ubrizgavanja injekcija, bolesnici mogu sami sebi davati injekcije lijeka Kromeya ako njihov liječnik procijeni da je to moguće provesti, uz medicinsko praćenje po potrebi.
English: According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Croatian: U ispitivanju provedenom u trudnica nije utvrđen povećan rizik od urođenih mana kada su majke primale adalimumab tijekom trudnoće u odnosu na majke s istom bolešću koje nisu primale adalimumab.
English: Discontinued corticosteroids
Croatian: Prekinuti kortikosteroidi
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
Croatian: Najveća ispitivana doza bila je višestruka intravenska doza od 10 mg/kg, koja je oko 15 puta veća od preporučene doze.
English: 2-sided p value from log rank test.
Croatian: Dvostrana P-vrijednost iz log rang testa.
English: • If you are over 65 years you may be more susceptible to infections while taking Kromeya.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka Kromeya.
English: Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.
Croatian: Tuberkuloza se može razviti tijekom liječenja čak i ako ste imali preventivnu terapiju za tuberkulozu.
English: Moderate to severe heart failure (NYHA class III/IV) (see section 4.4).
Croatian: Umjereno do teško zatajenje srca (NYHA razred III/IV) (vidjeti dio 4.4).
English: In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Croatian: U 4. tjednu ispitivanja CD III 58% bolesnika (499/854) imalo je klinički odgovor i bilo je uvršteno u primarnu analizu.
English: 6.2 With a quick, short motion, push the needle into the skin at an angle of 45°.
Croatian: 6.2 Brzim i kratkim pokretom, zabodite iglu u kožu pod kutom od 45°.
English: Again slowly pull the plunger out to the prescribed dose and stop.
Croatian: Ponovno polako izvucite klip do propisane doze i zatim ga zaustavite.
English: In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Croatian: U ispitivanju UV II, statistički značajne razlike primijećene su samo za oštrinu vida, ali su druge komponentne brojčano bile u korist adalimumaba.
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 days a
Croatian: Klinička remisija Klinički odgovor (CR-100) Bolesnici u remisiji bez primjene steroida >= 90 dana a
English: 6.4 Remove the needle from the skin, being careful to pull it out at the same angle that it was inserted.
Croatian: 6.4 Izvucite iglu iz kože pazeći pritom da je izvlačite pod istim kutom pod kojim je uvedena.
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of ≥ 30% in no more than 1 of the 6 criteria.
Croatian: Egzacerbacija bolesti definirana je pogoršanjem od ≥ 30% od početnog stanja u ≥ 3 od 6 ključnih kriterija za pedijatrijski ACR, ≥ 2 aktivna zgloba i poboljšanje veće od 30% u najviše 1 od 6 kriterija.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja i nakon stavljanja lijeka u promet, a prikazane su dolje u Tablici 6 prema organskom sustavu i učestalosti: vrlo često (≥ 1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Kromeya may be available in other presentations depending on the individual treatment needs.
Croatian: Kromeya može biti dostupna i u drugim oblicima, ovisno o terapijskim potrebama pojedinog bolesnika.
English: NA 24.0% 58.9%
Croatian: ND ND 24,0% 58,9%
English: These include:
Croatian: Svako pakiranje sadrži:
English: The safety guard will slide down and lock into place to protect you from the needle (Figure Q).
Croatian: Sigurnosni štitnik će skliznuti dolje i zaključati se na svom mjestu kako bi Vas zaštitio od igle. (slika Q).
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Croatian: Prividna plazmatska koncentracija adalimumaba uz koju se postiže polovica maksimalne vjerojatnosti za odgovor PedACR 50 (EC50) bila je 3 μg/ml (95% CI: 1-6 μg/ml).
English: - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab should be carefully considered.
Croatian: Potrebno je pažljivo razmotriti mogući rizik kod primjene kombinacije azatioprina ili 6-merkaptopurina i adalimumaba.
English: Warning: If the plunger rod is pulled completely out, throw away the syringe.
Croatian: Upozorenje: Ako se štapić klipa izvuče do kraja van, bacite štrcaljku.
English: Tuberculosis can develop during therapy even if your child has had preventative treatment for tuberculosis.
Croatian: Tuberkuloza se može razviti tijekom liječenja čak i ako je Vaše dijete imalo preventivnu terapiju za tuberkulozu.
English: Alternatively, if a patient has stopped Kromeya and signs and symptoms of disease recur, Kromeya may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek Kromeya, a znakovi i simptomi bolesti su se opet pojavili, Kromeya se može ponovno primijeniti.
English: Do not try to recap needle as it could lead to needle stick injury.
Croatian: Nemojte pokušavati vratiti poklopac na iglu jer može doći do ubodne ozljede iglom.
English: 1.5 Take a pre-filled pen out of the original box:
Croatian: 1.5 Izvadite brizgalicu iz originalne kutije:
English: • Always inject using the technique your healthcare professional taught you.
Croatian: • Uvijek primijenite ovaj lijek pomoću tehnike koju Vas je naučio zdravstveni radnik.
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table
Croatian: To se poboljšanje prvi put uočilo u drugom tjednu i održalo se 24 tjedna (Tablica 13).
English: Phase
Croatian: Faza
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Croatian: Kartica s podsjetnikom za bolesnika (odrasle i djecu) sadrži sljedeće ključne elemente: - infekcije, uključujući tuberkulozu - rak - problemi živčanog sustava - cijepljenje
English: After single intravenous doses ranging from 0.25 to 10 mg/kg,
Croatian: Nakon pojedinačnih intravenskih doza koje su se kretale od 0,25 do 10 mg/kg,
English: • The clear needle guard does not activate after injecting.
Croatian: • prozirni štitnik igle se ne aktivira nakon injiciranja.
English: These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Croatian: Ove infekcije mogu biti ozbiljnije i uključuju tuberkulozu, infekcije uzrokovane virusima, gljivicama, parazitima ili bakterijama, ili drugim neuobičajenim infektivnim organizmima i sepsu (trovanje krvi).
English: Needle covered
Croatian: Pokrivena igla
English: • an alcohol pad (included in the box)
Croatian: • jastučić natopljen alkoholom (priložen u kutiji)
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Croatian: Ograničeni podaci iz objavljene literature ukazuju na to da se adalimumab izlučuje u majčino mlijeko u vrlo maloj koncentraciji te da koncentracije adalimumaba u majčinom mlijeku iznose 0,1% do 1% razine u serumu majke.
English: p-value a p-value b p-value c
Croatian: p-vrijednost a p-vrijednost b p-vrijednost c
English: This will unlock the injection button (Figure O).
Croatian: To će otključati gumb za injektiranje (slika O).
English: • On rare occasions, treatment with Kromeya could result in lupus-like syndrome.
Croatian: • U rijetkim slučajevima liječenje lijekom Kromeya može dovesti do pojave sindroma sličnog lupusu.
English: Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Croatian: Neuspješan odgovor na terapiju za Crohnovu bolest može biti znak fiksne fibrozne strikture koju je možda potrebno kirurški liječiti.
English: Kromeya can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Croatian: Kromeya može usporiti oštećenja hrskavičnih i koštanih zglobnih struktura uzrokovana bolešću i poboljšati fizičku funkciju.
English: Week 16 placebo-controlled
Croatian: 16. tjedan Placebom kontrolirano
English: Analysis treatment
Croatian: Analiza Liječenje
English: Step 1
Croatian: 1. korak
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (Figure P).
Croatian: • Brzim i kratkim pokretom pogurnite iglu do kraja u kožu pod kutom od 45° i 90° (slika P).
English: • Children are not allowed to inject themselves and injection must be done by a trained adult.
Croatian: • Djeca si ne smiju sama davati injekcije, već im injekciju treba primijeniti za to osposobljena odrasla osoba.
English: p value*
Croatian: P vrijednost*
English: Hypersensitivity, allergies (including seasonal allergy)
Croatian: često preosjetljivost, alergije (uključujući sezonske alergije)
English: Excipients with known effects
Croatian: Pomoćne tvari s poznatim učinkom
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Kromeya.
Croatian: Budite sigurni da ste pročitali i razumjeli te da slijedite ove Upute za uporabu prije nego primijenite lijek Kromeya.
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Croatian: U ispitivanju UC-II, među onima koji su uz adalimumab bili u remisiji u osmom tjednu, njih 21/41 (51%) bilo je u remisiji u 52. tjednu.
English: Study UV II
Croatian: Ispitivanje UV II
English: Kromeya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Kromeya is indicated.
Croatian: Liječenje lijekom Kromeya moraju započeti i nadzirati liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju stanja za koja je Kromeya indicirana.
English: Most ALT elevations occurred with concomitant methotrexate use.
Croatian: Većinom je povišenje ALTa zabilježeno pri istodobnoj primjeni s metotreksatom.
English: Warning: Do not lift the pre-filled pen from the skin until the plunger has moved all the way down and all the liquid has been injected.
Croatian: Upozorenje: Nemojte podizati brizgalicu s Vaše kože sve dok se klip nije spustio skroz do kraja i dok sva tekućina nije injektirana.
English: Week 26 placebo-controlled
Croatian: 26. tjedan Placebom kontrolirano
English: • Place your thumb above (not touching) the yellow injection button (Figure M).
Croatian: • Postavite Vaš palac (bez dodirivanja) iznad žutog gumba za injektiranje (slika M).
English: Kromeya is a biosimilar medicinal product.
Croatian: Kromeya je biosličan lijek.
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite liječnika Vašeg djeteta ili ljekarnika ako Vaše dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove.
English: Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Croatian: Dostupni podaci upućuju na to da se klinički odgovor obično postiže unutar 2-8 tjedana liječenja.
English: Adalimumab n=274 (95% confidence interval)
Croatian: Adalimumab n=274 (95% interval pouzdanosti)
English: Psoriasis study I (REVEAL) evaluated 1212 patients within three treatment periods.
Croatian: U ispitivanju Psoriasis Study I (REVEAL) evaluirano je 1212 bolesnika u tri razdoblja terapije.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Croatian: Iako nije statistički značajno, većina bolesnika pokazala je kliničko poboljšanje sekundarnih mjera ishoda kao što su broj mjesta s entezitisom, broj osjetljivih zglobova, broj otečenih zglobova, pedijatrijski odgovor ACR 50 i pedijatrijski odgovor ACR 70.
English: - if your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako je Vaše dijete alergično na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Kromeya.
Croatian: Doza istodobno primijenjenih kortikosteroida može se postupno smanjivati u skladu s kliničkom praksom, počevši dva tjedna nakon započinjanja liječenja lijekom Kromeya.
English: • With your other hand gently pinch skin (without squeezing) to avoid injecting into a muscle
Croatian: • Drugom rukom nježno uhvatite kožu u nabor (bez stiskanja) da biste izbjegli injiciranje u mišić (slika O).
English: Kromeya is available in other presentations.
Croatian: Kromeya je dostupna i u drugim oblicima.
English: Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Croatian: Djelomična egzacerbacija definirala se kao ASDAS rezultat ≥ 1,3, ali < 2,1 pri dva uzastopna posjeta.
English: NA 9.5% 41.5%
Croatian: ND ND 9,5% 41,5%
English: You may see drops of liquid at the needle tip.
Croatian: Možda ćete vidjeti kapljice tekućine na vrhu igle.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Croatian: Ove terapije uključuju metotreksat, leflunomid, hidroksiklorokin, sulfasalazin i/ili soli zlata.
English: Your doctor will decide if your child should receive Kromeya.
Croatian: Vaš liječnik će odlučiti da li Vaše dijete smije primiti lijek Kromeya.
English: Warning: Do not keep any unused medicine.
Croatian: Upozorenje: Nemojte čuvati neiskorišteni dio lijeka.
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
Croatian: 26. tjedan 52. tjedan p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: Travel/recurrent infection
Croatian: Putovanja/ponavljajuće infekcije
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Croatian: Učestalost ozbiljnih infekcija među bolesnicima liječenima adalimumabom veća je u osoba starijih od 65 godina (3,7%) nego u osoba mlađih od 65 godina (1,5%).
English: In the open-label extension of RA study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Croatian: Iz otvorenog produžetka ispitivanja RA III vidi se da je smanjenje stope progresije strukturnog oštećenja u određenog dijela bolesnika održano kroz 8 i 10 godina.
English: If you become pregnant, you should see your doctor.
Croatian: Ako zatrudnite, morate posjetiti svog liječnika.
English: • < 40 kg: 20 mg every week
Croatian: • < 40 kg: 20 mg svaki tjedan
English: RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
Croatian: Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III nakon 24 tjedna i nakon 52 tjedna b
English: Warning: Do not use the syringe if there is a large amount of air in the syringe.
Croatian: Upozorenje: Nemojte upotrebljavati štrcaljku ako je u njoj prisutna velika količina zraka.
English: • Push the injection button (Figure P).
Croatian: • Pritisnite gumb za injektiranje (slika P).
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Croatian: U 12. i 24. tjednu, pedijatrijski odgovor ACR30 bio je 93,5%, odnosno 90,0%, što je utvrđeno na temelju zabilježenih podataka.
English: • Do not give Kromeya to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
Croatian: • Ne primjenjujte lijek Kromeya djeci s poliartikularnim juvenilnim idiopatskim artritisom mlađoj od 2 godine.