FrancophonIA/ELRC3.0 huggingface dataset:
English: Idursulfase treatment resulted in up to 60% reduction in urine output of glycosaminoglycans and in reductions of liver and spleen size: results were comparable to those found in study TKT024.
Croatian: Liječenje idursulfazom rezultiralo je smanjenjem izlučivanja glikozaminoglikana u urinu za 60% i smanjenjem veličine jetre i slezene: rezultati su bili usporedivi s onima utvrđenim u ispitivanju TKT024.
English: The primary efficacy endpoint was a two-component composite score based on the sum of the ranks of the change from baseline to the end of the study in the distance walked during six minutes (6minute walk test or 6MWT) as a measure of endurance, and % predicted forced vital capacity (FVC) as a measure of pulmonary function.
Croatian: Mjera primarnog ishoda djelotvornosti bio je dvokomponentan kompozitni rezultat koji se temeljio na zbroju rangova promjene od početne vrijednosti na kraju ispitivanja u udaljenosti prehodanoj tokom šest minuta (6-minutni test hodanja ili 6MWT) kao mjera izdržljivosti i % predviđenog forsiranog vitalnog kapaciteta (FVC) kao mjere plućne funkcije.
English: The safety and efficacy of Elaprase has been shown in three clinical studies: two randomised, placebo-controlled clinical studies (TKT008 and TKT024) in adults and children above the age of 5 years and one open-label, safety study (HGT-ELA-038) in children between the age of 16 months and 7.5 years.
Croatian: Sigurnost i djelotvornost lijeka Elaprase dokazana je u tri klinička ispitivanja: dva randomizirana, placebom kontrolirana klinička ispitivanja (TKT008 i TKT024) u odraslih i djece starije od 5 godina i jednom otvorenom ispitivanju sigurnosti (HGT-ELA-038) u djece u dobi između 16 mjeseci i 7,5 godina.
English: 52 weeks of treatment 0.5 mg/kg weekly Marginally weighted (OM) mean (SE)
Croatian: 52 tjedna liječenja 0,5 mg/kg tjedno Marginalno ponderirana (OM) srednja vrijednost (SE)
English: The chemical and physical stability of the diluted solution has been demonstrated for 8 hours at 25°C.
Croatian: Dokazana kemijska i fizička stabilnost razrijeđene otopine iznosi 8 sati pri 25 °C.
English: Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue.
Croatian: Tipični organi gdje se glikozaminoglikan nakuplja su slezena, jetra, pluća, srce i vezivno tkivo.
English: 12 to 18 (n=8)
Croatian: 12 do 18 (n=8)
English: This treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders.
Croatian: Liječenje treba nadzirati liječnik ili drugi zdravstveni djelatnik s iskustvom u liječenju bolesnika oboljelih od MPS II ili drugih nasljednih metaboličkih bolesti.
English: Delaying the infusion in patients who present with an acute febrile respiratory illness should be considered.
Croatian: Razmislite o odgodi infuzije kod bolesnika koji imaju akutnu febrilnu respiratornu bolest.
English: Across clinical studies, serious adverse reactions were reported in a total of 5 patients who received 0.5 mg/kg weekly or every other week.
Croatian: Ozbiljne nuspojave su u kliničkim ispitivanjima prijavljene kod ukupno 5 bolesnika koji su primali 0,5 mg/kg lijeka jednom tjedno ili svaki drugi tjedan.
English: Overall, there was no apparent trend in either systemic exposure or clearance rate of idursulfase with respect to either age or body weight.
Croatian: Sveukupno, nije primijećen očigledan trend u sistemskoj izloženosti niti u brzini klirensa idursulfaze s obzirom na dob ili tjelesnu težinu.
English: Degradation of idursulfase is achieved by generally well understood protein hydrolysis mechanisms to produce small peptides and amino acids, consequently renal and liver function impairment is not expected to affect the pharmacokinetics of idursulfase.
Croatian: Razgradnja idursulfaze uglavnom se postiže dobro poznatim mehanizmima proteinske hidrolize pri kojoj nastaju mali peptidi i aminokiseline, zbog čega se ne očekuje da će oštećenja bubrežne i jetrene funkcije utjecati na farmakokinetiku idursulfaze.
English: The higher the urinary GAG levels at baseline, the greater the magnitude of decreases in urinary GAG with idursulfase treatment.
Croatian: Što su bile više razine na početku terapije, to je veća bila magnituda pada GAG-a u urinu uz liječenje idursulfazom.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 if hypersensitivity is not controllable.
Croatian: Teška ili po život opasna preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1, ako se preosjetljivost ne može kontrolirati.
English: Fertility No effects on male fertility were seen in reproductive studies in male rats.
Croatian: Nisu primijećeni učinci na mušku plodnost tijekom ispitivanja učinaka na reprodukciju na mužjacima štakora.
English: It is supplied in a glass vial as a clear to slightly opalescent, colourless solution.
Croatian: Dostupan je u staklenim bočicama kao bistra do blago opalescentna, bezbojna otopina.
English: No patient discontinued treatment due to an infusion reaction during clinical studies.
Croatian: Ni jedan bolesnik nije prekinuo liječenje tijekom kliničkih ispitivanja zbog reakcije povezane s infuzijom.
English: Idursulfase is secreted as a 525 amino acid glycoprotein and contains 8 N-linked glycosylation sites that are occupied by complex, hybrid, and high-mannose type oligosaccharide chains.
Croatian: Idursulfaza se izlučuje kao glikoprotein s 525 aminokiselina i sadrži 8 N-vezanih glikozilacijskih mjesta koja su zauzeta kompleksnim, hibridnim i visokomanoznim oligasaharidnim lancima.
English: Across 4 clinical studies (TKT008, TKT018, TKT024 and TKT024EXT), 53/107 patients (50%) developed anti-idursulfase IgG antibodies at some point.
Croatian: U četiri klinička ispitivanja (TKT008, TKT018, TKT024 i TKT024EXT) 53/107 bolesnika (50%) u određenom su trenutku razvila anti-idursulfaza IgG protutijela.
English: Tachypnoea
Croatian: Tahipneja
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza „Rok valjanosti“/„EXP“.
English: Iduronate-2-sulfatase functions to catabolize the glycosaminoglycans (GAG) dermatan sulfate and heparan sulfate by cleavage of oligosaccharide-linked sulfate moieties.
Croatian: Funkcija iduronat-2-sulfataze je kataboliziranje glikozaminoglikana (GAG) dermatan sulfata i heparan sulfata cijepanjem sulfatnih skupina vezanih na oligosaharide.
English: In the placebo treatment group 128 infusion-related reactions were reported in 21 out of 32 patients following administration of a total of 1612 infusions.
Croatian: U placebo skupini bilo je prijavljeno 128 reakcija povezanih s infuzijom u 21 od 32 bolesnika nakon davanja ukupno 1612 infuzija.
English: • Pain in the joints
Croatian: • Bol u zglobovima
English: Infusion-site swelling, face oedema, oedema peripheral Injury, poisoning and procedural complications Infusion-related reaction
Croatian: Oticanje na mjestu infuzije, edem lica, periferni edem Ozljede, trovanja i proceduralne komplikacije Reakcije povezane s infuzijom
English: - The calculated volume of Elaprase should be withdrawn from the appropriate number of vials.
Croatian: - Potrebno je izvući izračunati volumen lijeka Elaprase iz odgovarajućeg broja bočica.
English: Very common side effects (may affect more than 1 in 10 people) are:
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) su:
English: Severe or potentially life-threatening hypersensitivity is a contraindication to rechallenge, if hypersensitivity is not controllable (see section 4.3).
Croatian: Teška ili potencijalno po život opasna preosjetljivost je kontraindikacija za ponovnu primjenu lijeka, ako se preosjetljivost ne može kontrolirati (vidjeti dio 4.3).
English: Table 1: Adverse reactions from clinical trials and post-marketing experience in patients treated with Elaprase.
Croatian: Tablica 1: Nuspojave iz kliničkih ispitivanja i nakon stavljanja lijeka u promet u bolesnika liječenih lijekom Elaprase.
English: This medicine will be given to you under the supervision of a doctor or nurse who is knowledgeable in the treatment of Hunter syndrome or other inherited metabolic disorders.
Croatian: Ovaj lijek se primjenjuje uz nadzor liječnika ili medicinske sestre koji imaju iskustvo u liječenju Hunterovog sindroma ili drugih nasljednih metaboličkih bolesti.
English: Patients treated with idursulfase may develop infusion-related reactions (see section 4.8).
Croatian: U bolesnika liječenih idursulfazom može doći do reakcija povezanih s infuzijom (vidjeti dio 4.8).
English: Liver volume normalised by Month 24 for 73% (52 out of 71) of patients with hepatomegaly at baseline.
Croatian: Volumen jetre normalizirao se do 24. mjeseca u 73% (52 od 71) bolesnika s hepatomegalijom na početku ispitivanja.
English: If you are treated with Elaprase you may experience side effects during or following an infusion (see section 4 Possible side effects).
Croatian: Ako se liječite lijekom Elaprase, mogu se pojaviti nuspojave tijekom ili nakon infuzije (pogledajte dio 4, Moguće nuspojave).
English: If you experience an allergic side effect following administration of this medicine, you should contact your doctor immediately.
Croatian: Ako osjetite nuspojavu alergijskog tipa nakon primanja ovog lijeka, trebate se odmah obratiti liječniku.
English: There is no experience with overdoses of Elaprase.
Croatian: Nema iskustva s predoziranjem lijekom Elaprase.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: Hypoxia, bronchospasm, cough
Croatian: Hipoksija, bronhospazam, kašalj
English: Statistically significant increases from treatment baseline in absolute FVC volume were seen at most visits for all treatment groups combined and for each of the prior TKT024 treatment groups.
Croatian: Statistički značajan porast u odnosu na početne vrijednosti apsolutnog volumena FVC-a bile su uočene pri većini pregleda u svim liječenim skupinama i u svakoj skupini prethodno ispitivanoj u TKT024.
English: The decreases in liver and spleen volumes observed at the end of study TKT024 (week 53) were maintained during the extension study (TKT024EXT) in all patients regardless of the prior treatment they had been assigned.
Croatian: Smanjenje volumena jetre i slezene uočeno na kraju ispitivanja TKT024 (53. tjedan) održalo se i tijekom nastavka ispitivanja (TKT024EXT) kod svih bolesnika bez obzira na prijašnje liječenje koje im je propisano.
English: Idursulfase has no or negligible influence on the ability to drive and use machines.
Croatian: Idursulfaza ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The patients in the weekly treatment group experienced a clinically significant 15% mean improvement in FEV1 at the end of the study.
Croatian: Bolesnici u skupini koja je primala lijek jednom tjedno osjetili su klinički značajnu srednju vrijednost poboljšanja od 15% u FEV1 na kraju ispitivanja.
English: Of the 25 patients with abnormally large livers at baseline in the weekly treatment group, 80% (20 patients) had reductions in liver volume to within the normal range by the end of the study.
Croatian: Od 25 bolesnika s abnormalno velikom jetrom na početku u skupini koja je lijek primala jednom tjedno, 80% (20 bolesnika) imalo je smanjeni volumen jetre do unutar normalnog raspona na kraju ispitivanja.
English: Uncommon side effects (may affect up to 1 in 100 people) are: • Quickened breathing
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba) su: • Ubrzano disanje
English: Over time the number of these infusion-associated reactions decreases.
Croatian: Broj tih reakcija povezanih s infuzijom smanjuje se tijekom vremena.
English: In a post-hoc analysis of immunogenicity in studies TKT024 and TKT024EXT (see section 4.8), patients were shown to have either the mis-sense mutation or the frameshift / nonsense mutation.
Croatian: U post hoc analizi imunogenosti u ispitivanjima TKT024 i TKT024EXT (vidjeti dio 4.8) bolesnici su pokazali ili „mis-sense“ mutaciju ili „frameshift“/„nonsense“ mutaciju.
English: Patients with the most severe pulmonary impairment at baseline (as measured by % predicted FVC) tended to show the least improvement.
Croatian: Kod bolesnika s najtežim oštećenjima funkcije pluća na početku ispitivanja (mjereno % predviđenog FVC-a) obično se pokazalo najmanje poboljšanje.
English: In a 52-week, randomized, double-blind, placebo-controlled clinical study, 96 patients between the ages of 5 and 31 years received Elaprase 0.5 mg/kg every week (n=32) or 0.5 mg/kg every other week (n=32), or placebo (n=32).
Croatian: Tijekom randomiziranog, dvostruko slijepog, placebom kontroliranog kliničkog ispitivanja u trajanju 52 tjedna, 96 bolesnika između 5 i 31 godine starosti dobivala su Elaprase 0,5 mg/kg jednom tjedno (n=32) ili 0,5 mg/kg svaki drugi tjedan (n=32), ili placebo (n=32).
English: Twenty-one percent (13/63) tested positive for neutralizing antibodies at least once and 13 % (8/63) tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Croatian: Dvadeset i jedan posto (13/63) bilo je pozitivno na neutralizirajuća protutijela najmanje jednom i 13 % (8/63) je bilo pozitivno na neutralizirajuća protutijela u najmanje 3 uzastopna studijska posjeta.
English: Approximately half of the patients in the weekly treatment group (15 of 32; 47%) had left ventricular hypertrophy at baseline, defined as LVM index 103 g/m2.
Croatian: Otprilike polovica bolesnika u skupini koja je primala lijek jednom tjedno (15 od 32; 47%) imala su hipertrofiju lijevog ventrikula na početku, definiranu kao indeks LVM 103 g/m2.
English: The longer-term effects of antibody development on clinical outcomes have not been established.
Croatian: Dugoročni učinci razvoja protutijela na kliničke ishode nisu utvrđeni.
English: Concentrate for solution for infusion 3 ml
Croatian: Koncentrat za otopinu za infuziju 3 ml
English: Mean cardiac LVMI remained stable over 36 months of idursulfase treatment within each TKT024 treatment group.
Croatian: Srednja vrijednost kardijalnog indeksa LVM ostala je stabilna tijekom 36 mjeseci liječenja idursulfazom kod svih liječenih skupina u ispitivanju TKT024.
English: Adverse reactions are listed in table 1 with information presented by system organ class and frequency.
Croatian: Nuspojave na lijek navedene su u tablici 1 zajedno s podacima prema klasifikaciji organskih sustava i učestalosti.
English: In addition, mean liver volume decreased to a near maximum extent by Month 8 in all patients previously treated, with a slight increase observed at Month 36.
Croatian: Pored toga, do 8. mjeseca je srednja vrijednost volumena jetre smanjena gotovo do maksimalne razine kod svih bolesnika koji su prethodno primali terapiju, da bi se blago povećanje uočilo u 36. mjesecu.
English: If an anaphylactoid/anaphylactic reaction occurs the infusion should be immediately suspended and appropriate treatment and observation initiated.
Croatian: U slučaju anafilaktoidne/anafilaktičke reakcije primjenu infuzije treba odmah prekinuti te je potrebno započeti odgovarajuće liječenje i promatranje.
English: Elaprase contains an active substance called idursulfase which works by acting as a replacement for the enzyme that is at a low level, thereby breaking down this carbohydrate in affected cells.
Croatian: Elaprase sadrži djelatnu tvar nazvanu idursulfaza koja djeluje kao zamjena za enzim kojeg nema dovoljno i koji razgrađuje taj ugljikohidrat u zahvaćenim stanicama.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution.
Croatian: Svaka bočica lijeka Elaprase namijenjena je samo za jednokratnu uporabu i sadrži 6 mg idursulfaze u 3 ml otopine.
English: Patients who have experienced anaphylactoid/anaphylactic reactions should be treated with caution when readministering idursulfase, appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) should be available during infusions.
Croatian: Posebnu pozornost treba obratiti tijekom ponovne primjene idursulfaze u bolesnika koji su doživjeli anafilaktoidne/anafilaktičke reakcije, tijekom infuzije mora biti dostupno odgovarajuće izvježbano osoblje i oprema za reanimaciju u hitnom slučaju (uključujući epinefrin).
English: Hunter syndrome is an X-linked disease caused by insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Croatian: Hunterov sindrom je X-vezana bolest koju uzrokuju nedovoljne razine lizosomskog enzima iduronat-2sulfataze.
English: Due to the missing or defective iduronate-2-sulfatase enzyme in patients with Hunter syndrome, glycosaminoglycans progressively accumulate in the cells, leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction.
Croatian: Zbog iduronat-2-sulfataza enzima koji nedostaje ili je defektan u bolesnika s Hunterovim sindromom, glikozaminoglikani se progresivno nakupljaju u stanicama što dovodi do povećanja stanica, organomegalije, uništenja tkiva i disfunkcije sustava organa.
English: A total of 11 of 31 (36%) patients in the weekly treatment group versus 5 of 31 (16%) patients in the placebo group had an increase in FEV1 of at least 0.2 l at or before the end of the study, indicating a dose-related improvement in airway obstruction.
Croatian: Ukupno 11 od 31 (36%) bolesnika u skupini koja je primala lijek jednom tjedno naspram 5 od 31 (16%) bolesnika u placebo skupini imalo je povećanje FEV1 od barem 0,2 l na kraju ili prije kraja ispitivanja, što upućuje na poboljšanje kod opstrukcije dišnih putova povezano s doziranjem.
English: Swollen tongue, dyspepsia
Croatian: Natečen jezik, dispepsija
English: Do not use this medicine if you notice that there is discolouration or presence of foreign particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite promjenu boje ili prisutnost vidljivih čestica.
English: Idursulfase is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme.
Croatian: Idursulfaza je pročišćeni oblik lizosomskog enzima iduronat-2-sulfataze koji se proizvodi u liniji ljudskih stanica osiguravajući ljudski glikozilacijski profil, analogan enzimu koji se prirodno pojavljuje.
English: This was an open-label, multicenter, single-arm study of idursulfase infusions in male Hunter syndrome patients between the age of 16 months and 7.5 years.
Croatian: To je bilo otvoreno, multicentrično ispitivanje infuzija idursulfaze s jednom skupinom ispitanika na muškim bolesnicima s Hunterovim sindromom u dobi između 16 mjeseci i 7,5 godina.
English: Idursulfase is taken up by selective receptor-mediated mechanisms involving binding to mannose 6phosphate receptors.
Croatian: Idursulfaza se preuzima mehanizmom putem selektivnih receptora koji uključuje vezanje na manoza-6fosfat receptore.
English: Specific Obligation 1 - Hunter Outcome Survey (HOS): available data and updates will be provided within Annual Reassessments.
Croatian: Hunter Outcome Survey): dostupni podaci i ažuriranja bit će dostavljeni u godišnjim procjenama.
English: Infusion-related reactions were treated or ameliorated by slowing the infusion rate, interrupting the infusion, or by administration of medicinal products, such as antihistamines, antipyretics, low-dose corticosteroids (prednisone and methylprednisolone), or beta-agonist nebulisation.
Croatian: Reakcije povezane s infuzijom liječene su ili ublažene sporijom primjenom infuzije, prekidom infuzije ili davanjem lijekova kao što su antihistaminici, antipiretici, kortikosteroidi u niskim dozama (prednizon i metilprednizolon) ili nebulizacijom beta-agonista.
English: These events did not recur with subsequent infusions using a slower infusion rate and administration of pre-infusion medicinal products, usually low-dose steroids, antihistamine, and beta-agonist nebulisation.
Croatian: Ti se događaji nisu ponovili u sljedećim infuzijama uz sporiju brzinu infuzije i uz davanje lijekova prije infuzije, obično niskih doza steroida, antihistaminika te nebulizacijom beta-agonista.
English: Among all patients, mean % predicted FVC was significantly increased at Month 16, although by Month 36, it was similar to the baseline.
Croatian: Kod svih bolesnika značajno je povećan i srednji postotak predviđenog FVC-a u 16. mjesecu, iako je u 36. mjesecu bio sličan početnim vrijednostima.
English: It is recommended to deliver the total volume of the infusion using a 0.2 µm in line filter.
Croatian: Preporučuje se primjena ukupnog volumena infuzije uporabom linijskog filtra za infuziju od 0,2 µm.
English: Elaprase contains sodium
Croatian: Elaprase sadrži natrij
English: • Rapid heartbeat, irregular heartbeat, bluish skin
Croatian: • Ubrzani otkucaji srca, nepravilni otkucaji srca, plavkasta koža
English: Special care should be taken when administering an infusion in patients with severe underlying airway disease.
Croatian: Potreban je poseban oprez prilikom primjene infuzije bolesnicima s teškom predležećom bolešću dišnih putova.
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) CL (mL/min/kg) Mean ± SD Vss (mL/kg)
Croatian: Cmax (μg/ml) Srednja vrijednost ± SD AUC0-∞ (min*μg/ml) Srednja vrijednost ± SD CL (ml/min/kg)
English: Pharmacokinetic parameters measured during the first infusion at week 1 of studies TKT024 (0.5 mg/kg weekly arm) and HGT-ELA-038 are displayed in table 3 and table 4 below as a function of age and body weight, respectively.
Croatian: Farmakokinetički parametri izmjereni tijekom prve infuzije 1. tjedna u ispitivanjima TKT024 (skupina koja je primala 0,5 mg/kg jednom tjedno) i HGT-ELA-038 prikazani su u tablici 3 i tablici 4 u nastavku kao funkcija dobi, odnosno tjelesne težine.
English: Of the 9 patients in the weekly treatment group with abnormally large spleens at baseline, 3 had spleen volumes that normalized by the end of the study.
Croatian: Od 9 bolesnika u skupini koja je primala lijek jednom tjedno s abnormalno velikom slezenom na početku, 3 su imala veličinu slezene koja se normalizirala do kraja ispitivanja.
English: The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing (redness).
Croatian: Najčešći simptomi su svrbež, osip, koprivnjača, vrućica, glavobolja, povećan krvni tlak i navale crvenila.
English: Fifty-four percent of patients tested positive for neutralizing antibodies at least once and half of the patients tested positive for neutralizing antibodies on at least three consecutive study visits.
Croatian: Pedeset i četiri posto bolesnika bilo je pozitivno na neutralizirajuća protutijela najmanje jednom i polovica bolesnika bila je pozitivna na neutralizirajuća protutijela u najmanje tri uzastopna studijska posjeta.
English: During the 53-week study, 67.9% (19 of 28) of patients had at least one blood sample that tested positive for anti-idursulfase antibodies, and 57.1% (16 of 28) tested positive for antibodies on at least three consecutive study visits.
Croatian: Tijekom 53-tjednog ispitivanja 67,9% (19 od 28) svih bolesnika imali su najmanje jedan uzorak krvi pozitivan na protutijela na idursulfazu, a 57,1% (16 od 28) bilo je pozitivno na protutijela u najmanje tri uzastopna studijska posjeta.