FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Croatian: • ako bolujete od teške infekcije, uključujući tuberkulozu, sepsu (trovanje krvi) i druge oportunističke infekcije (neuobičajene infekcije povezane s oslabljenim imunološkim sustavom).
English: The conduct and results of these tests should be recorded on your patient reminder card.
Croatian: Provođenje i rezultati ovih pretraga moraju se zabilježiti na Vašoj Kartici s podsjetnikom za bolesnika.
English: Do not remove the needle from the skin when the plunger reaches the end.
Croatian: Slika R Nemojte izvlačiti iglu iz kože kada klip dođe do kraja.
English: Polyarticular juvenile idiopathic arthritis Age or body weight
Croatian: Poliartikularni juvenilni idiopatski artritis Dob ili tjelesna težina
English: In Psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Croatian: U ispitivanju Psoriasis Study I, u 28% bolesnika s odgovorom PASI 75 kojima je nakon 33. tjedna pri ponovnoj randomizaciji dodijeljen placebo, u usporedbi s 5% bolesnika koji su nastavili uzimati adalimumab (p<0,001), uočen je „gubitak primjerenog odgovora“ (PASI rezultat nakon 33. i u ili prije 52. tjedna koji je rezultirao odgovorom < PASI 50 u odnosu na početak terapije, uz porast PASI rezultata za najmanje 6 bodova u odnosu na 33. tjedan).
English: - Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before you are given Kromeya and during treatment with Kromeya.
Croatian: Liječnik će Vam također dati Karticu s podsjetnikom za bolesnika koja sadrži važne podatke o sigurnosti s kojima morate biti upoznati prije i za vrijeme liječenja lijekom Kromeya.
English: 4.1 Choose an injection site (Figure J) on:
Croatian: 4.1 Odaberite mjesto injiciranja (slika J) na:
English: 4.2 Insert the syringe tip into the yellow syringe connector and screw to connect.
Croatian: 4.2 Umetnite vrh štrcaljke u žuti priključak za štrcaljku i uvrtite ih kako bi se spojili.
English: • Do not insert your fingers into the opening of the clear needle guard.
Croatian: • Nemojte stavljati prste u otvor prozirnog štitnika za iglu.
English: Warning: Do not touch the yellow connector.
Croatian: Upozorenje: Nemojte dirati žuti priključak.
English: Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Kromeya se može davati i kao monoterapija ako bolesnik ne podnosi metotreksat ili kada kontinuirana primjena metotreksata nije prikladna.
English: - Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before your child is given Kromeya and during treatment with Kromeya.
Croatian: Liječnik će Vam također dati Karticu s podsjetnikom za bolesnika koja sadrži važne podatke o sigurnosti s kojima morate biti upoznati prije i za vrijeme liječenja Vašeg djeteta lijekom Kromeya.
English: PGA: Clear/minimal a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Croatian: PGA: bez bolesti/minimalno a, b a p<0,001 adalimumab naspram placeba b p<0,001 adalimumab naspram metotreksata c p<0,01 adalimumab naspram placeba d p<0,05 adalimumab naspram metotreksata
English: Textured finger pad
Croatian: Teksturirani jastučić za prst
English: 4.1 Peel open the needle packaging to uncover the yellow syringe connector.
Croatian: 4.1 Odlijepite kako biste otvorili pakiranje igle i otkrili žuti priključak za štrcaljku.
English: • The liquid is clear, colorless, and free of particles (Figure J).
Croatian: • tekućina je bistra, bezbojna i ne sadrži čestice (slika J).
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Croatian: Adalimumab nije ispitivan u bolesnika s oštećenom funkcijom jetre ili bubrega.
English: • Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Croatian: • Recite liječniku ako je Vaše dijete boravilo ili putovalo u predjele u kojima su uobičajene endemske gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: Adults with rheumatoid arthritis
Croatian: Odrasli s reumatoidnim artritisom
English: • the injection site
Croatian: • mjesto injiciranja
English: Do not use this medicine after the expiry date which is stated on the label/ carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici/kutiji iza oznake „Rok valjanosti“ ili „EXP“.
English: Your child may first be given other disease-modifying medicines, such as methotrexate.
Croatian: Moguće je da će Vašem djetetu prvo biti propisani drugi lijekovi koji mijenjaju tijek bolesti, kao što je metotreksat.
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Kromeya.
Croatian: Bolesnici koji trebaju dozu nižu od 40 mg moraju koristiti lijek Kromeya od 40 mg u bočici.
English: 5.3 Remove the clear needle cap by pulling it straight off and throw it away.
Croatian: 5.3 Skinite prozirni poklopac igle tako da ga povučete ravnim pokretom, a zatim ga bacite.
English: The pen is a single use, disposable, handheld, mechanical injection device.
Croatian: Brizgalica je mehanička naprava za ručno ubrizgavanje, za jednokratnu uporabu.
English: In the open-label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
Croatian: U otvorenom razdoblju ispitivanja, odgovor PASI 75 i PGA rezultat 'bez bolesti' ili 'minimalno' održali su se tijekom dodatna 52 tjedna, bez novih nalaza povezanih sa sigurnošću.
English: Kromeya may have a minor influence on the ability to drive and use machines.
Croatian: Kromeya može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Kromeya.
Croatian: • Ako se spremate podvrgnuti kakvom kirurškom ili stomatološkom zahvatu, recite svom liječniku da primjenjujete lijek Kromeya.
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double- masked, placebo-controlled studies (UV I and II).
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u odraslih bolesnika s neinfektivnim intermedijarnim, posteriornim i panuveitisom, isključujući bolesnike s izoliranim anteriornim uveitisom, u dvama randomiziranim, dvostruko maskiranim, placebom kontroliranim ispitivanjima (UV I i II).
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u randomiziranom, dvostruko maskiranom, kontroliranom ispitivanju provedenom u 90 pedijatrijskih bolesnika u dobi od 2 do < 18 godina koji su imali aktivan neinfektivni anteriorni uveitis povezan s JIA i koji su bili refraktorni na najmanje 12 tjedana liječenja metotreksatom.
English: Instructions For Use
Croatian: Upute za uporabu
English: Table 15 Efficacy response in placebo-controlled period for study nr-axSpA II
Croatian: Tablica 15 Djelotvornost u placebom kontroliranom razdoblju ispitivanja nr-axSpA II
English: The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Croatian: Kombinacija adalimumaba, kao i drugih TNF-antagonista i anakinre ili abatacepta se ne preporučuje zbog mogućeg povećanja rizika od infekcija, uključujući ozbiljne infekcije i druge moguće farmakološke interakcije.
English: Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Croatian: Ispitanici (n=215, 54,7%) koji nisu uspjeli postići ASAS 20 u 12., 16. ili 20. tjednu ranije su prebačeni u otvoreni dio ispitivanja i dobivali su 40 mg adalimumaba supkutano svaki drugi tjedan.
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Croatian: Prema pristupu utemeljenom na opaženim podacima, u 222 (80,4%) bolesnika bolest je bila u mirovanju (bez aktivnih upalnih lezija, stupanj prema broju stanica u prednjoj očnoj komori ≤ 0,5+, stupanj prema zamućenju staklovine ≤ 0,5+) uz istodobnu primjenu steroida u dozi od ≤ 7,5 mg na dan, dok je u njih 184 (66,7%) bolest bila u mirovanju bez primjene steroida.
English: • Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Croatian: • Recite svom liječniku ako ste boravili ili putovali u predjele u kojima su uobičajene endemske gljivične infekcije kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: ACR 50 Week 12 Week 24
Croatian: ACR 50 12. tjedan 24. tjedan
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Croatian: Među njima su 154 bolesnika (90,6%) imala odgovor ACR 20, 127 bolesnika (74,7%) odgovor ACR 50, a 102 bolesnika (60,0%) odgovor ACR 70.
English: Of 342 subjects originally randomised to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Croatian: Od 342 ispitanika izvorno randomizirana za monoterapiju adalimumabom ili liječenje kombinacijom adalimumaba i metotreksata koji su ušli u otvoreni produžetak ispitivanja, 171 ispitanik završio je 10 godina liječenja adalimumabom.
English: The primary efficacy endpoint was the proportion of patients with no flare by week 68 of the study.
Croatian: Primarna mjera ishoda za djelotvornost bio je udio bolesnika kod kojih nije došlo do egzacerbacije do 68. tjedna ispitivanja.
English: bacterial infections,
Croatian: • bakterijske infekcije,
English: Talk to your doctor or pharmacist before using Kromeya
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek Kromeya.
English: Amongst those who responded at week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Croatian: Među bolesnicima koji su imali klinički odgovor u 16. tjednu (n=144), pedijatrijski odgovori ACR 30/50/70/90 održali su se i do šest godina u otvorenom produžetku ispitivanja u bolesnika koji su uzimali adalimumab tijekom cijeloga ispitivanja.
English: pen containing a pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with latex-free needle cap and a plunger stopper (synthetic rubber).
Croatian: ) koja sadrži napunjenu štrcaljku (staklo tipa I) s iglom (29G Thin-Wall, ½ inča) s poklopcem za iglu bez lateksa i sa čepom klipa (sintetička guma).
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Croatian: Bolesnici koji su tijekom razdoblja otvorene primjene postigli remisiju koja se održala tijekom najmanje 12 tjedana (N=305) (ASDAS rezultat < 1,3 u 16., 20., 24. i 28. tjednu) zatim su bili randomizirani za nastavak liječenja adalimumabom u dozi od 40 mg svaka dva tjedna (N=152) ili za primanje placeba (N=153) tijekom dodatnih 40 tjedana u dvostruko slijepom, placebom kontroliranom razdoblju (ukupno trajanje ispitivanja: 68 tjedana).
English: Population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Croatian: Populacijskim farmakokinetičkim i farmakokinetičkim/farmakodinamičkim modeliranjem i simulacijom predviđena je usporediva izloženost adalimumabu i djelotvornost adalimumaba u bolesnika liječenih s 80 mg svaki drugi tjedan i u onih liječenih s 40 mg svaki tjedan (uključujući odrasle bolesnike s reumatoidnim artritisom, gnojnim hidradenitisom, ulceroznim kolitisom, Crohnovom bolešću ili psorijazom, bolesnike s adolescentnim gnojnim hidradenitisom, i pedijatrijske bolesnike ≥ 40 kg s Crohnovom bolešću).
English: 2.1 Wash your hands with soap and water (Figure G) and dry them well.
Croatian: 2.1 Dobro operite ruke sapunom i vodom (slika G) i osušite ih.
English: ACR responses were maintained in the open-label extension study for up to 136 weeks.
Croatian: U otvorenom produžetku ispitivanja ACR odgovor se održao tijekom do 136 tjedana.
English: Kromeya may have a minor influence on the ability to drive, cycle or use machines.
Croatian: Kromeya može imati manji utjecaj na sposobnost upravljanja vozilima, biciklom i strojevima.
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Croatian: U pivotalnim kontroliranim ispitivanjima u odraslih i djece, reakcije na mjestu primjene (eritem i/ili svrbež, krvarenje, bol ili oticanje) pojavile su se u 12,9% bolesnika liječenih adalimumabom u usporedbi sa 7,2% bolesnika koji su dobivali placebo ili aktivni kontrolni lijek.
English: 7.1 Throw away your used pre-filled pen in a sharps disposal container right away after use (Figure S).
Croatian: 7.1 Bacite iskorištenu štrcaljku u spremnik za odlaganje oštrih predmeta odmah nakon upotrebe (slika U).
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Kromeya therapy and regularly during treatment to assess for preexisting or developing central demyelinating disorders.
Croatian: U bolesnika s neinfektivnim intermedijarnim uveitisom treba provesti neurološku procjenu prije početka liječenja lijekom Kromeya i redovito tijekom liječenja kako bi se utvrdili otprije postojeći ili novorazvijeni demijelinizirajući poremećaji središnjeg živčanog sustava.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Croatian: Nakon 52 i 104 tjedna liječenja, postotak bolesnika bez progresije bolesti (promjena ukupnog zbroja bodova prema Sharpu ≤0,5) bio je značajno veći u skupini liječenoj kombinacijom adalimumaba i metotreksata (63,8% odnosno 61,2%) u usporedbi sa skupinom koja je dobivala monoterapiju metotreksatom (37% odnosno 33,5%, p < 0,001) i monoterapiju adalimumabom (50,7%, p < 0,002 odnosno 44,5%, p < 0,001).
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Croatian: U pivotalnim kontroliranim ispitivanjima u odraslih i djece, stopa infekcija bila je 1,51 po bolesnikgodini u bolesnika liječenih adalimumabom, odnosno 1,46 po bolesnik-godini u bolesnika koji su primali placebo ili aktivni kontrolni lijek.
English: Physicians should exercise caution when considering the use of Kromeya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Croatian: Liječnici trebaju oprezno razmotriti liječenje lijekom Kromeya u bolesnika s ponavljajućim infekcijama u anamnezi ili podležećim stanjima koja pogoduju razvoju infekcija u bolesnika, uključujući istodobnu primjenu imunosupresivnih lijekova.
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Croatian: Poboljšanje rezultata u broju aktivnih zglobova s artritisom održalo se tijekom otvorenog razdoblja kroz 156 tjedana ispitivanja za 26 od 31 (84%) bolesnika u skupini liječenoj adalimumabom koji su ostali u ispitivanju.
English: SPARCC MRI spine d,j a Assessment of Spondyloarthritis International Society b
Croatian: Djelomična egzacerbacija d a Međunarodno društvo za ocjenu spondiloartritisa b
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Croatian: • simptome ili probleme sa živcima kao što su trnci, utrnulost, dvoslike ili slabost u rukama ili nogama,
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Croatian: • znakove ili simptome infekcije kao što su vrućica, mučnina, rane, problemi sa zubima, pečenje pri mokrenju, osjećaj slabosti ili umora ili kašalj,
English: Efficacy outcomes
Croatian: Rezultati djelotvornosti
English: 1.4 Check the expiration date on the side of the box (Figure B).
Croatian: 1.4 Provjerite rok valjanosti na bočnoj strani kutije (slika B).
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Croatian: Nakon primjene doza od 0,5 mg/kg (~40 mg) klirens je bio u rasponu od 11 do 15 ml/sat, a volumen raspodjele (Vss) je iznosio od 5 do 6 litara.
English: During treatment with Kromeya, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Croatian: Tijekom liječenja lijekom Kromeya potrebno je prilagoditi ostalu istodobno primijenjenu terapiju (npr. kortikosteroide i/ili imunomodulatore).
English: Kromeya is contraindicated in moderate to severe heart failure (see section 4.3).
Croatian: Primjena lijeka Kromeya je kontraindicirana u bolesnika s umjerenim do teškim zatajenjem srca (vidjeti dio 4.3).
English: Of those receiving corticosteroids at baseline
Croatian: Onih koji su na početku uzimali kortikosteroide
English: Radiographs of hands, wrists, and feet were obtained at baseline and week 24 during the double-blind period when patients were on adalimumab or placebo and at week 48 when all patients were on open-label adalimumab.
Croatian: Zglobovi šaka, zapešća i stopala radiološki su snimljeni na početku ispitivanja, u 24. tjednu dvostruko slijepog dijela ispitivanja, kada su bolesnici primali adalimumab ili placebo, te u 48. tjednu otvorenog dijela ispitivanja, kada su svi bolesnici primali adalimumab.
English: Taking these results into consideration, Kromeya is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Croatian: Uzevši to u obzir, preporučuje se da se Kromeya daje u kombinaciji s metotreksatom, a monoterapija samo u onih bolesnika u kojih primjena metotreksata nije prikladna (vidjeti dio 4.2).
English: This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
Croatian: To obuhvaća detaljnu medicinsku procjenu, uključujući uzimanje povijesti bolesti i provođenje testova za otkrivanje bolesti (na primjer rendgenska snimka pluća i tuberkulinski test).
English: 5.2 Clean the injection site with an alcohol pad and throw the pad away.
Croatian: 5.2 Mjesto injiciranja očistite jastučićem natopljenim alkoholom, a zatim jastučić bacite.
English: • a sharps disposal container.
Croatian: • spremnik za oštre predmete.
English: Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab treated patients.
Croatian: Endoskopska ispitivanja intestinalne mukoze pokazala su znakove zacjeljivanja sluznice u bolesnika liječenih adalimumabom.
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Croatian: Bolesnicima koji su primili adalimumab kvaliteta života se u 12. tjednu znatno popravila i održala do 24. tjedna prema upitniku SF36 i upitniku za ocjenu kvalitete života kod ankilozantnog spondilitisa (engl.
English: The conduct and results of these tests should be recorded on your child's patient reminder card.
Croatian: Provođenje i rezultati ovih pretraga moraju se zabilježiti na djetetovoj Kartici s podsjetnikom za bolesnika.
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3% on placebo and 10% on adalimumab.
Croatian: Među bolesnicima koji nisu imali uspjeha s prethodnim liječenjem antagonistima TNF-a remisiju je u 52. tjednu postiglo 3% u skupini koja je primala placebo i 10% u skupini koja je primala adalimumab.
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Croatian: • infekcije dišnog sustava (uključujući prehladu, curenje nosa, infekciju sinusa, upalu pluća),
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Kromeya should be promptly discontinued.
Croatian: Ako se u bolesnika pojave znakovi i simptomi kao što su vrućica, malaksalost, gubitak težine, znojenje, kašalj, dispneja i/ili plućni infiltrati ili druge ozbiljne sistemske bolesti s istodobnim šokom ili bez njega, treba posumnjati na invazivnu gljivičnu infekciju te odmah prekinuti primjenu lijeka Kromeya.
English: • The needle cap is securely attached (Figure H).
Croatian: • poklopac igle je čvrsto spojen (slika H).
English: You should not take Kromeya with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Croatian: Kromeya se ne smije primjenjivati s drugim lijekovima koji sadrže djelatne tvari anakinru ili abatacept zbog povećanog rizika od ozbiljne infekcije.
English: 10 kg to < 30 kg
Croatian: 10 kg do < 30 kg