FrancophonIA/ELRC3.0 huggingface dataset:
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 (SOC) 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: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Croatian: Prijave su obuhvaćale slučajeve pulmonalne i ekstrapulmonalne (tj. diseminirane)
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: Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Croatian: Bolesnici s kliničkim odgovorom (smanjenje CDAI rezultata od ≥ 70) u 4. tjednu stratificirani su i analizirani odvojeno od bolesnika bez kliničkog odgovora u 4. tjednu.
English: Efficacy results
Croatian: Rezultati djelotvornosti
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Croatian: Rezultati kliničke remisije održali su se relativno stalnim bez obzira na prethodno liječenje antagonistima TNF-a.
English: • Push the needle all the way in to ensure that the medication can be fully administered
Croatian: • Gurnite iglu do kraja kako biste osigurali da se lijek može u cijelosti primijeniti.
English: • pain in the muscles.
Croatian: • bol u mišićima.
English: 2 pre-filled pens (SensoReady) Component of a multipack, cannot be sold separately.
Croatian: 2 napunjene brizgalice(SensoReady) Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: The decision to stop using Hefiya should be discussed with your doctor.
Croatian: Odluku o prekidu primjene lijeka Hefiya potrebno je raspraviti sa svojim liječnikom.
English: There were three groups in this study.
Croatian: Bolesnici su bili podijeljeni u tri skupine.
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Croatian: U ispitivanju RA III, kod većine koji su postigli poboljšanje fizičke funkcije i nastavili liječenje održano je poboljšanje tijekom 520 tjedana (120 mjeseci) otvorenog liječenja.
English: If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Croatian: Ako dobijete vrućicu koja ne prolazi, ako jako lako dobivate modrice ili krvarite, ili izgledate jako blijedo, odmah nazovite liječnika.
English: If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Croatian: Ako bolujete od KOPB-a ili puno pušite, provjerite kod liječnika je li terapija blokatorom TNFα primjerena za Vas.
English: If you accidentally inject Hefiya more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Croatian: Ako slučajno primijenite lijek Hefiya češće nego što ste trebali, nazovite liječnika ili ljekarnika i obavijestite ih da ste uzeli veću količinu od potrebne.
English: Hepatitis B virus
Croatian: Virus hepatitisa B
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Croatian: Liječenje adalimumabom u dozi od 40 mg svaki tjedan značajno je smanjilo rizik od pogoršanja apscesa i drenirajućih fistula.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Hefiya.
Croatian: I Vi i Vaš liječnik morate obratiti posebnu pažnju na znakove infekcije dok se liječite lijekom Hefiya.
English: 36.8 % (14 / 38) 64.9 % (24 / 37)b 43.3 % (13 / 30) 71.4 % (20 / 28)c median time to disease flare
Croatian: 36,8% (14/38) 64,9% (24/37)b 43,3% (13/30) 71,4% (20/28)c medijan vremena do reaktivacije bolesti
English: • Use your pen within 5 minutes of removing the cap.
Croatian: • Upotrijebite brizgalicu u roku od 5 minuta nakon što skinete zatvarač.
English: • Look through the viewing window.
Croatian: • Pogledajte kroz prozorčić za pregled otopine.
English: Patients who experience insufficient response may benefit from an increase in dosage.
Croatian: Bolesnici u kojih se ne postigne zadovoljavajući odgovor mogli bi imati koristi od povećanja doziranja.
English: Impaired lung function may increase the risk for developing infections.
Croatian: Oštećena funkcija pluća može povisiti rizik od nastanka infekcija.
English: Cerebrovascular accident1), tremor, neuropathy
Croatian: Manje često Cerebrovaskularni događaj1), tremor, neuropatija
English: Not included in your carton are (see Figure B):
Croatian: U kutiji se ne nalazi (vidjeti Sliku B):
English: The impact of longterm treatment with adalimumab on the development of autoimmune diseases is unknown.
Croatian: Utjecaj dugotrajnog liječenja adalimumabom na razvoj autoimunih bolesti nije poznat.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Talk to your doctor or pharmacist before using Hefiya.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek Hefiya.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in table 26.
Croatian: Stope kliničke remisije i kliničkog odgovora (definirano kao smanjenje PCDAI rezultata za barem 15 bodova od početne vrijednosti) prikazane su u tablici 26.
English: Travel / recurrent infection
Croatian: Putovanja/ponavljajuće infekcije
English: After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Croatian: Nakon prilagodbe prema tjelesnoj težini, čini se da spol i dob bolesnika imaju minimalan učinak na klirens adalimumaba.
English: • allergic reactions (including seasonal allergy);
Croatian: • alergijske reakcije (uključujući sezonsku alergiju),
English: Autoantibodies
Croatian: Autoprotutijela
English: Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Croatian: Ostale ozbiljne infekcije primijećene u kliničkim ispitivanjima uključuju pneumoniju, pijelonefritis, septički artritis i septikemiju.
English: • asthma;
Croatian: • astma,
English: • On rare occasions, treatment with Hefiya could result in lupus-like syndrome.
Croatian: • U rijetkim slučajevima liječenje lijekom Hefiya može dovesti do pojave sindroma sličnog lupusu.
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Croatian: Općenito su štetni događaji u pedijatrijskih bolesnika prema učestalosti i tipu bili slični onima u odraslih bolesnika.
English: PASI 75b PGA: clear/minimalc a
Croatian: PASI 75b PGA: bez bolesti/minimalnoc a
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Croatian: • Vrlo se rijetko javljaju određene vrste raka u djece i odraslih bolesnika liječenih adalimumabom ili nekim drugim TNFα blokatorom.
English: When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: Kada je potrebno (primjerice, ako putujete), Hefiya se može čuvati na sobnoj temperaturi (do 25°C) najviše do 14 dana - pazite da ga zaštitite od svjetlosti.
English: • For a more comfortable injection, take the blister containing the syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.
Croatian: • Radi ugodnije injekcije, izvadite blister koji sadrži štrcaljku iz hladnjaka i ostavite ga neotvorenog na radnoj površini15-30 minuta tako da dostigne sobnu temperaturu.
English: • neuropathy (nerve damage);
Croatian: • neuropatija (oštećenje živaca),
English: 30 months
Croatian: 30 mjeseci
English: • If you receive Hefiya during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: • Ako ste primili Hefiya tijekom trudnoće, Vaše dijete može imati povećan rizik od dobivanja infekcije.
English: You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds.
Croatian: Možete pritisnuti pamučnu vatu ili gazu na mjesto primjene injekcije i držati je 10 sekundi.
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Croatian: Radi zdravlja i sigurnosti kako Vas tako i drugih osoba, igle i korištene štrcaljke ne smiju se nikada ponovno koristiti.
English: ASASa,b 20
Croatian: ASASa,b 20 ASASa,b 40
English: The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Croatian: Bolesnici u ispitivanjima HS-I i HS-II imali su bolest stadija II ili III prema Hurleyevoj klasifikaciji te najmanje 3 apscesa ili upalna nodula.
English: efficacy outcomes double blind 32 weeks adalimumab / MTX (N =38)
Croatian: ishodi za djelotvornost dvostruko slijepa32 tjedna adalimumab/MTX (N=38)
English: Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.
Croatian: Većina slučajeva tuberkuloze dijagnosticirana je u prvih osam mjeseci liječenja, što može biti posljedica aktivacije postojećeg latentnog oblika bolesti.
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%
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TEKST NA BLISTERU
English: Alternative Storage:
Croatian: Alternativne mjere čuvanja:
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Croatian: Doziranje adalimumaba u tih bolesnika utvrđeno je na temelju farmakokinetičkog modeliranja i simulacije (vidjeti dio 5.2).
English: If you have questions, please ask your doctor.
Croatian: Ako imate kakvih pitanja, upitajte svog liječnika.
English: adalimumab n = 274 (95 % confidence interval)
Croatian: adalimumab n=274 (95% interval pouzdanosti)
English: See “4.
Croatian: Vidjeti “4.
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: U bolesnika koji su pozitivni na infekciju virusom hepatitisa B, preporučuje se potražiti savjet liječnika s iskustvom u liječenju hepatitisa B.
English: Since exposure to adalimumab can be affected by body size, adolescents with higher body weight and inadequate response may benefit from receiving the recommended adult dose of 40 mg every week.
Croatian: Budući da veličina tijela može utjecati na izloženost adalimumabu, adolescenti s većom tjelesnom težinom u kojih nije postignut zadovoljavajući odgovor mogli bi imati koristi od primjene preporučene doze za odrasle od 40 mg svaki tjedan.
English: Hefiya is a biosimilar medicinal product.
Croatian: Hefiya je biosličan lijek.
English: It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy so they can decide when your baby should receive any vaccine.
Croatian: Važno je da liječnika svoga djeteta i druge zdravstvene radnike obavijestite o tome da ste u trudnoći uzimali lijek Hefiya kako bi oni mogli odlučiti kada Vaše dijete treba primiti cjepivo.
English: The potential risk with the combination of azathioprine or 6mercaptopurine and Hefiya should be carefully considered.
Croatian: Potrebno je pažljivo razmotriti mogući rizik kod primjene kombinacije azatioprina ili 6-merkaptopurina i lijeka Hefiya.
English: Tuberculosis
Croatian: Tuberkuloza
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Croatian: • autoimuni hepatitis (upala jetre uzrokovana vlastitim tjelesnim imunološkim sustavom),
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: What Hefiya looks like and contents of the pack
Croatian: Kako Hefiya izgleda i sadržaj pakiranja
English: Most side effects are mild to moderate.
Croatian: Većina nuspojava su blage do umjerene.
English: Figure J: lift the needle straight out
Croatian: Slika J: podignite iglu ravno van
English: ASAS 5/6
Croatian: ASASa 40 ASAS 20 ASAS 5/6
English: Hefiya can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Croatian: Hefiya može smanjiti broj nodula i apscesa koje imate te ublažiti bol koja često prati ovu bolest.
English: After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase (table 12).
Croatian: Nakon 32 tjedna, odnosno nakon reaktivacije bolesti, bolesnici su mogli biti uključeni u otvoreni produžetak ispitivanja (tablica 12).
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Croatian: Kvaliteta života vezana uz zdravlje i fizička funkcija ocjenjivale su se uz pomoć upitnika HAQ-S i SF-36.
English: • Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).
Croatian: • Polako otpustite klip i pustite da štitnik igle automatski prekrije izloženu iglu (vidjeti Sliku K).
English: The pre-filled syringe / pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Croatian: Napunjenu štrcaljku / napunjenu brizgalicu mora se zaštiti od svjetlosti i zbrinuti ako se ne iskoristi unutar 14 dana.
English: Included in your carton is:
Croatian: U kutiji se nalazi:
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hefiya (see section 4.4).
Croatian: Oftalmolozima se preporučuje da se posavjetuju s odgovarajućim specijalistom prije nego što započnu liječenje lijekom Hefiya (vidjeti dio 4.4).
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: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Croatian: Pri dugoročnijem liječenju adalimumabom u dozi od 40 mg svaki tjedan tijekom 96 tjedana nisu otkriveni novi nalazi povezani sa sigurnošću.
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: Hefiya works by reducing this inflammation.
Croatian: Hefiya djeluje tako što smanjuje tu upalu.
English: The response for the two monotherapy arms was similar (p = 0.447).
Croatian: Odgovor bolesnika u dvjema skupinama liječenima monoterapijom bio je sličan (p=0,447).
English: 48.9a percent change in total fingernail NAPSI (%)
Croatian: 48,9a postotna promjena ukupnog NAPSI rezultata za psorijazu noktiju na rukama (%)
English: • sensation of heart beating rapidly;
Croatian: • osjećaj brzog kucanja srca,
English: • Do not throw away any medicines via wastewater or household waste.
Croatian: • Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and / or 12 did not receive further dose increases.
Croatian: Bolesnicima koji su primali MTX i koji su u 8. i/ili 12. tjednu postigli odgovor ≥ PASI 50 doza se nije dalje povećavala.
English: If active tuberculosis is diagnosed, Hefiya therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Hefiya (vidjeti dio 4.3).
English: The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Croatian: Sigurnost adalimumaba u pedijatrijskih bolesnika s plak psorijazom ocjenjivala se tijekom srednjeg razdoblja od 13 mjeseci.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
Croatian: Koncentracije adalimumaba u sinovijalnoj tekućini nekolicine bolesnika s reumatoidnim artritisom iznosile su 31-96% koncentracija u serumu.
English: Ankylosing Spondylitis Disease Activity Score d partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Croatian: c Rezultat za aktivnost ankilozantnog spondilitisa d Djelomična egzacerbacija definirala se kao ASDAS rezultat ≥ 1,3, ali < 2,1 pri dva uzastopna posjeta.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Croatian: U ispitivanju UC-II liječenje adalimumabom rezultiralo je poboljšanjem rezultata upitnika o upalnoj bolesti crijeva (IBDQ).
English: • If you have an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hefiya.
Croatian: • Bolujete li od infekcije, uključujući dugotrajnu ili lokaliziranu infekciju (primjerice, ulceraciju na nozi), obratite se liječniku prije nego počnete primjenjivati lijek Hefiya.
English: If you receive Hefiya while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Croatian: Ako ste lijek Hefiya uzimali tijekom trudnoće, Vaše dijete može biti pod povećanim rizikom od dobivanja takve infekcije i do pet mjeseci nakon što ste primili posljednju dozu u trudnoći.
English: NE = not estimable.
Croatian: NP = ne može se procijeniti.
English: Treatment with Hefiya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Croatian: Liječenje lijekom Hefiya ne smije se započeti u bolesnika s aktivnim infekcijama, uključujući kronične ili lokalizirane infekcije, sve dok se te infekcije ne stave pod kontrolu.
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: Exposure-response relationship in paediatric population
Croatian: Veza između izloženosti i odgovora na liječenje u pedijatrijskoj populaciji
English: Following 3 years of adalimumab therapy, 75 % (301 / 402) continued to be in clinical remission per partial Mayo score.
Croatian: Nakon 3 godine terapije adalimumabom, 75% (301/402) je i dalje bilo u kliničkoj remisiji prema djelomičnom Mayo rezultatu.
English: Hefiya can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Croatian: Hefiya može usporiti oštećenja hrskavičnih i koštanih zglobnih struktura uzrokovana bolešću i poboljšati fizičku funkciju.
English: Worsening of symptoms of dermatomyositis1)
Croatian: Nepoznato Pogoršanje simptoma dermatomiozitisa1)
English: Pulmonary fibrosis1)
Croatian: Plućna fibroza1)
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Croatian: Zbog inhibicije faktora tumorske nekroze α (TNFα), adalimumab primijenjen u trudnoći mogao bi utjecati na normalne imune odgovore novorođenčeta.
English: If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Croatian: Ako Vas brine izgled otopine, obratite se ljekarniku za pomoć.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hefiya, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, prije početka liječenja lijekom Hefiya mora se započeti odgovarajuća profilaksa tuberkuloze, u skladu s lokalnim preporukama.
English: Treatment with Hefiya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Croatian: Liječenje lijekom Hefiya može se započeti u kombinaciji s kortikosteroidima i/ili drugim nebiološkim imunomodulatorima.
English: Clinical Response
Croatian: Klinički odgovor
English: -56.2a a p < 0.001, adalimumab vs. placebo
Croatian: -56,2a a p < 0,001, adalimumab naspram placeba
English: After 5 years of adalimumab therapy, 74.0 % (37 / 50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46 / 50) of patients continued to be in clinical response per PCDAI.
Croatian: Nakon 5 godina terapije adalimumabom, 74,0% (37/50) od 50 bolesnika koji su ostali u ispitivanju i dalje su bili u kliničkoj remisiji dok je 92,0% (46/50) bolesnika nastavilo imati klinički odgovor prema PCDAI.
English: • Take the syringe out of the blister.
Croatian: • Izvadite štrcaljku iz blistera.
English: Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Croatian: Primjena adalimumaba bez metotreksata rezultirala je povećanim stvaranjem protutijela, povećanim klirensom i smanjenom djelotvornošću adalimumaba (vidjeti dio 5.1).
English: Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests.
Croatian: Neke nuspojave zabilježene uz adalimumab mogu biti bez simptoma te se mogu otkriti samo krvnim pretragama, a uključuju sljedeće:
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Croatian: Slični trendovi (ne svi statistički značajni) viđeni su i u manjem, randomiziranom, dvostruko slijepom ispitivanju kontroliranom placebom AS II, u kojem su sudjelovala 82 odrasla bolesnika s aktivnim ankilozantnim spondilitisom.
English: Hefiya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Croatian: Hefiya je namijenjen liječenju Crohnove bolesti u odraslih i djece u dobi od 6 do 17 godina.
English: • The 1st click indicates the injection has started.
Croatian: • Prvi klik označava da je injekcija započela.
English: Study nr-axSpA II
Croatian: Ispitivanje nr-axSpA II