FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 1: Serum Phosphate Concentration (mmol/L) over Time in the Phase 2 Paediatric Study in Children 5-12 years Receiving Burosumab Every 2 Weeks (Q2W)
Croatian: Slika 1: Koncentracija fosfata u serumu (mmol/L) tijekom vremena u pedijatrijskom ispitivanju faze 2 provedenom u djece u dobi od 5 do 12 godina koja su primala burosumab svaka 2 tjedna (Q2W)
English: Administration of burosumab may result in local injection site reactions.
Croatian: Primjena burosumaba može za posljedicu imati lokalne reakcije na mjestu primjene injekcije.
English: Burosumab was detected in serum from fetuses indicating that burosumab was transported across the placenta to the fetus.
Croatian: Burosumab je otkriven u serumu fetusa, što pokazuje da je burosumab prolazio kroz posteljicu u fetus.
English: Studies in rabbits and adult and juvenile cynomolgus monkeys demonstrated dose-dependent elevations of serum phosphate and 1,25 (OH)2D confirming the pharmacologic actions of burosumab in these species.
Croatian: Ispitivanja provedena na kunićima te odraslim i mladim makaki majmunima pokazala su povišenja serumskog fosfata i 1,25(OH)2D ovisna o dozi, što potvrđuje farmakološko djelovanje burosumaba u tih vrsta.
English: Monitoring for signs and symptoms of nephrocalcinosis, e.g. by renal ultrasonography, is recommended at the start of treatment and every 6 months for the first 12 months of treatment, and annually thereafter.
Croatian: Praćenje znakova i simptoma nefrokalcinoze, npr. ultrazvukom bubrega, preporučuje se na početku liječenja te svakih 6 mjeseci u prvih 12 mjeseci liječenja, a nakon toga jednom godišnje.
English: If used together they may lower blood calcium.
Croatian: oni mogu sniziti kalcij u krvi.
English: Rickets Severity Score (RSS)
Croatian: Rezultat procjene težine rahitisa (RSS)
English: Burosumab should be administered using aseptic technique and sterile disposable syringes and injection needles.
Croatian: Burosumab treba primijeniti aseptičkom tehnikom pomoću sterilnih jednokratnih štrcaljki i injekcijskih igli.
English: o redness or rash o pain or itching o swelling o bleeding or bruising
Croatian: o crvenilo ili osip o bol ili svrbež o oticanje o krvarenje ili nastanak modrice
English: Bone changes were consistent with the pharmacology of burosumab and the role of phosphate in bone mineralization, metabolism and turnover.
Croatian: Promjene kostiju bile su u skladu s farmakologijom burosumaba i ulogom fosfata u mineralizaciji kostiju, njihovu metabolizmu i pregradnji.
English: These effects were consistent with an exaggerated response to the inhibition of normal FGF23 levels resulting in a supraphysiologic increase in serum phosphate beyond the upper limit of normal.
Croatian: Ti su se učinci podudarali s pretjeranim odgovorom na inhibiciju normalnih razina FGF23 koje su za posljedicu imale suprafiziološki porast fosfata u serumu iznad gornje granice normale.
English: The most common adverse drug reaction (ADR) reported in paediatric patients up to 64 weeks was injection site reactions (57%), headache (54%), pain in extremity (42%), vitamin D decreased (28%), rash (23%), toothache (19%), tooth abscess (14%), myalgia (14%), and dizziness (11%) (See section 4.4 and ‘Description of selected adverse reactions' below).
Croatian: Najčešće nuspojave lijeka prijavljene u pedijatrijskih bolesnika do 64. tjedna bile su reakcije na mjestu primjene injekcije (57%), glavobolja (54%), bol u udovima (42%), snižen vitamin D (28%), osip (23%), zubobolja (19%), apsces zuba (14%), mialgija (14%) i omaglica (11%) (vidjeti dio 4.4 i „Opis odabranih nuspojava“ u nastavku).
English: • People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
Croatian: • Osobe s ovom bolešću imaju više razine hormona pod nazivom čimbenik rasta fibroblasta 23 (FGF23).
English: The recommended starting dose is 0.4 mg/kg of body weight and the normal maintenance dose is 0.8 mg/kg burosumab given every two weeks.
Croatian: Preporučena početna doza iznosi 0,4 mg/kg tjelesne težine, a uobičajena doza održavanja 0,8 mg/kg burosumaba davanog svaka dva tjedna.
English: Do not use CRYSVITA after the expiry date which is stated on the carton and label.
Croatian: Lijek CRYSVITA ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.
English: CRYSVITA is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek CRYSVITA tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Each vial contains 45.91 mg sorbitol.
Croatian: Jedna bočica sadrži 45,91 mg sorbitola.
English: In XLH patients, the observed volume of distribution of burosumab approximates the volume of plasma, suggesting limited extravascular distribution.
Croatian: U bolesnika s XLH-om, opaženi volumen distribucije burosumaba približava se volumenu plazme što ukazuje na ograničenu ekstravaskularnu distribuciju.
English: Burosumab must be discontinued if serious hypersensitivity reactions occur and appropriate medical treatment should be initiated.
Croatian: Ako nastupe ozbiljne reakcije preosjetljivosti, primjenu burosumaba treba prekinuti i započeti odgovarajuće medicinsko liječenje.
English: By inhibiting FGF23, burosumab increases tubular reabsorption of phosphate from the kidney and increases serum concentration of 1, 25 dihydroxy-Vitamin D.
Croatian: Inhibirajući FGF23, burosumab povećava reapsorpciju fosfata iz bubrežnih kanalića i povećava koncentraciju 1,25-dihidroksivitamina D u serumu.
English: CRYSVITA attaches to FGF23 in the blood which stops FGF23 from working and increases the phosphate levels in the blood so that normal levels of phosphate can be achieved.
Croatian: CRYSVITA se veže na FGF23 u krvi što zaustavlja djelovanje FGF23 i povećava razine fosfata u krvi tako da se mogu postići normalne razine fosfata.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Croatian: Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: In a murine model of XLH, a significant reduction in the incidence of ectopic mineralisation was observed at equivalent levels of serum phosphate, suggesting that the risk of mineralisation is less in the presence of excess FGF23.
Croatian: Na mišjem modelu XLH-a, značajno smanjenje incidencije ektopične mineralizacije opaženo je pri jednakim razinama serumskog fosfata, što upućuje na zaključak da je rizik od mineralizacije manji u prisutnosti viška FGF23.
English: Pack size of one vial.
Croatian: Pakiranje od jedne bočice.
English: a) The estimates of LS means and p-values are from the generalized estimation equation model accounting for baseline RSS, visits and regimen and its interaction.
Croatian: a) Procjene srednjih vrijednosti metodom najmanjih kvadrata i p-vrijednosti uzete su iz modela generalizirane jednadžbe za procjenu koja uključuje početni RSS, preglede i režim te interakciju.
English: Each vial is for single use only.
Croatian: Jedna bočica namijenjena je samo za jednokratnu upotrebu.
English: There are no or limited amount of data from the use of burosumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni burosumaba u trudnica ograničeni.
English: Anti-drug antibodies (ADA) have been detected in a small percentage of patients receiving burosumab who had also tested positive for ADA prior to dosing; no adverse events or loss of efficacy was associated with these findings.
Croatian: Protutijela na lijek otkrivena su u malom postotku bolesnika koji su primali burosumab i kojima je nalaz testa na protutijela na lijek bio pozitivan i prije doziranja; s tim nalazom nisu bili povezani nikakvi štetni događaji ili gubitak djelotvornosti.
English: Bone effects seen in adult and juvenile monkeys included changes in bone metabolism markers, increases in thickness and density of cortical bone, increased density of total bone and thickening of long bone.
Croatian: Učinci na kosti nađeni u odraslih i mladih majmuna uključivali su promjene biljega koštanog metabolizma, povećanja debljine i gustoće kortikalne kosti, veću ukupnu koštanu gustoću i zadebljanje duge kosti.
English: Patients with severe renal impairment or end stage renal disease.
Croatian: Bolesnici s teškim oštećenjem funkcije bubrega ili završnim stadijem bolesti bubrega.
English: Following subcutaneous administration, the time to reach maximum serum concentrations (Tmax) of burosumab is approximately 5-10 days.
Croatian: Nakon supkutane primjene vrijeme potrebno da burosumab dosegne maksimalne koncentracije u serumu (Tmax) iznosi približno 5-10 dana.
English: Table 2: Rickets Response in Children 5-12 years Receiving Burosumab in Study UX023-CL201
Croatian: Tablica 2: Odgovor rahitisa u djece u dobi od 5 do 12 godina koja su primala burosumab u ispitivanju UX023-CL201
English: Ectopic mineralisation, as manifested by nephrocalcinosis, has been observed in patients with XLH treated with oral phosphorous and vitamin D analogues; these medicinal products should be stopped at least 1 week prior to initiating burosumab treatment (see section 4.2).
Croatian: Ektopična mineralizacija koja se očitovala kao nefrokalcinoza, opažena je u bolesnika s X-vezanom hipofosfatemijom (engl. X-linked hypophosphataemia, XLH) koji su liječeni peroralnim fosforom i analozima vitamina D; primjenu tih lijekova treba prekinuti najmanje 1 tjedan prije započinjanja terapije burosumabom (vidjeti dio 4.2).
English: Hydrochloric acid, 10% (for pH adjustment) Water for injections
Croatian: L-metionin kloridna kiselina, 10%-tna (za podešavanje pH) voda za injekcije
English: If fasting serum phosphate is below the reference range for age, the dose may be increased stepwise by 0.4 mg/kg up to a maximum dose of 2.0 mg/kg (maximum dose of 90 mg).
Croatian: Ako je fosfat u serumu natašte ispod referentnog raspona za dob, dozu se može postupno povećavati za 0,4 mg/kg do najviše doze od 2,0 mg/kg (maksimalna doza je 90 mg).
English: CRYSVITA contains the active substance burosumab.
Croatian: CRYSVITA sadrži djelatnu tvar burosumab.
English: Shortening of the gestation period and associated increased incidence of premature births were observed in pregnant monkeys at doses of ≥ 0.3 mg/kg which corresponded to burosumab exposures that are ≥0.875- to 1.39-fold anticipated clinical levels.
Croatian: Skraćeno razdoblje gestacije i s tim povezana veća incidencija prijevremenih okota opaženi su u skotnih majmunica pri dozama ≥0,3 mg/kg, što odgovara izloženostima burosumabu koje su ≥0,875 do 1,39 puta veće od očekivanih kliničkih razina.
English: If fasting serum phosphate is above the reference range for age, the next dose should be withheld and the fasting serum phosphate reassessed within 4 weeks.
Croatian: Ako je fosfat u serumu natašte iznad referentnog raspona za dob, potrebno je izostaviti sljedeću dozu, a fosfat u serumu natašte ponovno izmjeriti unutar 4 tjedna.
English: Burosumab absorption from subcutaneous injection sites to blood circulation is nearly complete.
Croatian: Burosumab se s mjesta primjene supkutane injekcije gotovo potpuno apsorbira u krvotok.
English: Other medicines and CRYSVITA Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The burosumab dose was adjusted to target a fasting serum phosphorous concentration of 1.13 to 1.62 mmol/L.
Croatian: Doza burosumaba bila je prilagođena na ciljnu vrijednost koncentracije fosfora u serumu natašte od 1,13 do 1,62 mmol/L.
English: If you miss a dose of CRYSVITA
Croatian: Ako ste propustili primiti dozu lijeka CRYSVITA
English: What you need to know before you use CRYSVITA
Croatian: Što morate znati prije nego počnete primjenjivati lijek CRYSVITA
English: Duration of Burosumab
Croatian: Trajanje primjene burosumaba (tjedan)
English: Excipients: L-histidine, D- sorbitol E420, polysorbate 80, L-methionine, hydrochloric acid, 10%, and water for injections.
Croatian: Pomoćne tvari: L-histidin, D-sorbitol E420, polisorbat 80, L-metionin, kloridna kiselina, 10%-tna, voda za injekcije.
English: Fasting serum phosphate should also be measured 4 weeks after any dose adjustment.
Croatian: Fosfat u serumu natašte treba također mjeriti 4 tjedna nakon svake prilagodbe doze.
English: Do not use CRYSVITA if:
Croatian: Nemojte primjenjivati lijek CRYSVITA:
English: The peak serum concentration (Cmax) and area under the concentration-time curve (AUC) of serum burosumab is dose proportional over the dose range of 0.1-2.0 mg/kg.
Croatian: Vršna koncentracija u serumu (Cmax) i područje ispod krivulje koncentracija-vrijeme (AUC) za burosumab u serumu proporcionalni su dozi u rasponu doza od 0,1-2,0 mg/kg.
English: Burosumab displays time-invariant pharmacokinetics that is linear to dose over the subcutaneous dose range of 0.1 to 2.0 mg/kg.
Croatian: Burosumab pokazuje vremenski nepromjenjivu farmakokinetiku koja je linearna s dozom u rasponu supkutano primijenjene doze od 0,1 do 2,0 mg/kg.
English: In Study UX023-CL201, the RSS was scored using a predefined scale looking at specific abnormalities in the wrists and knees.
Croatian: U ispitivanju UX023-CL201, RSS se bodovao na temelju unaprijed definirane ljestvice usmjerene na specifične abnormalnosti zapešća i koljena.
English: Patient's fasting serum phosphate level should be monitored due to the risk of hyperphosphatemia.
Croatian: U bolesnika je potrebno pratiti razinu fosfata u serumu natašte zbog rizika od hiperfosfatemije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with CRYSVITA in one or more subsets of the paediatric population in treatment of X-linked hypophosphataemia.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka CRYSVITA u jednoj ili više podskupina pedijatrijske populacije u liječenju X-vezane hipofosfatemije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Ectopic mineralisation of multiple tissues and organs (e.g. kidney, heart, lung, and aorta), and associated secondary consequences (e.g. nephrocalcinosis) in some cases, due to hyperphosphataemia, was observed in normal animals at doses of burosumab that resulted in serum phosphate concentrations in animals greater than approximately 2.58 mmol/L.
Croatian: Ektopična mineralizacija više tkiva i organa (npr. bubrega, srca, pluća i aorte) te u nekim slučajevima povezane sekundarne posljedice (npr. nefrokalcinoza) zbog hiperfosfatemije, opažene su u normalnih životinja pri dozama burosumaba koje su rezultirale koncentracijama fosfata u serumu životinja većim od približno 2,58 mmol/L.
English: CRYSVITA is indicated for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
Croatian: Lijek CRYSVITA indiciran je za liječenje X-vezane hipofosfatemije s radiografski dokazanom bolesti kostiju u djece u dobi od 1 i više godina te adolescenata u kojih tjelesni rast još traje.
English: CRYSVITA is used to treat X-linked hypophosphataemia (XLH).
Croatian: CRYSVITA se primjenjuje za liječenje X-vezane hipofosfatemije.
English: Patients received burosumab at a dose of 0.8 mg/kg every two weeks.
Croatian: Bolesnici su primali burosumab u dozi od 0,8 mg/kg svaka dva tjedna.
English: The AUC for the change from baseline in serum phosphate, TmP/GFR and 1,25(OH)2D increased linearly with increasing burosumab AUC.
Croatian: AUC promjene serumskog fosfata u odnosu na početnu vrijednost te vrijednosti TmP/GFR i 1,25(OH)2D povećavale su se linearno s povećanjem AUC-a burosumaba.
English: Do not shake the vial before use.
Croatian: Nemojte tresti bočicu prije upotrebe.
English: Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia (see section 4.3).
Croatian: Kontraindicirana je istodobna primjena burosumaba i peroralnog fosfata te analoga vitamina D, jer može dovesti do povećanog rizika od hiperfosfatemije i hiperkalcijemije (vidjeti dio 4.3).
English: The patient must have fasting serum phosphate below the reference range for age to restart burosumab at approximately half of the previous dose.
Croatian: Bolesnik mora imati vrijednost fosfata u serumu natašte ispod referentnog raspona za dob da bi se liječenje burosumabom nastavilo, i to približno polovicom prijašnje doze.
English: CRYSVITA will be injected every two weeks.
Croatian: Injekcije lijeka CRYSVITA primat ćete svaka dva tjedna.
English: • you already have a high level of phosphate in your blood (“hyper-phosphataemia”)
Croatian: • ako već imate visoke razine fosfata u krvi (“hiperfosfatemija”) • ako imate tešku bolest bubrega ili zatajenje bubrega.
English: In adult clinical trials no dose limiting toxicity has been observed using doses up to 1.0 mg/kg or a maximal total dose of 128 mg every 4 weeks.
Croatian: U kliničkim ispitivanjima u odraslih, toksičnost koja ograničava dozu nije bila opažena uz primjenu doza do 1,0 mg/kg ili najviše ukupne doze od 128 mg svaka 4 tjedna.
English: Your serum parathyroid hormone level will also be checked from time to time.
Croatian: S vremena na vrijeme provjeravat će se i razina hormona doštitnih žlijezda u serumu.
English: With the subcutaneous route of administration, a direct PK-PD relationship between serum burosumab concentrations and increases in serum phosphate concentration is observed and well described by an Emax/EC50 model.
Croatian: Kod supkutanog puta primjene, opaža se izravni farmakokinetičko-farmakodinamički odnos između koncentracija serumskog burosumaba i povećanja koncentracija serumskog fosfata i dobro ga opisuje model Emax/EC50.
English: Genu varum inter-condylar distance and genu valgum inter-malleolar distance did not change from Baseline up to Week 64.
Croatian: Interkondilarni razmak kod deformacija nogu u obliku slova O, genu varum i intermaleolarni razmak kod deformacija u obliku slova X, genu valgum nisu se promijenili od početka do 64. tjedna.
English: This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Croatian: Ovaj lijek sadrži 45,91 mg sorbitola u jednoj bočici, što odgovara 45,91 mg/mL.
English: Fasting serum phosphate should be measured 4 weeks after dose adjustment.
Croatian: Fosfat u serumu natašte treba izmjeriti 4 tjedna nakon prilagodbe doze.
English: CRYSVITA contains sorbitol This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Croatian: CRYSVITA sadrži sorbitol Ovaj lijek sadrži 45,91 mg sorbitola u jednoj bočici, što odgovara 45,91 mg/mL.
English: The clearance of burosumab is dependent on body weight and estimated to be 0.290 L/day and 0.136 L/day in a typical adult (70 kg) and paediatric (30 kg) XLH patient, respectively, with corresponding disposition half-life (t1/2) in the serum of approximately 19 days.
Croatian: Klirens burosumaba ovisi o tjelesnoj težini i procjenjuje se da u tipičnog odraslog bolesnika (70 kg) iznosi 0,290 L na dan, a u pedijatrijskog bolesnika (30 kg) s XLH-om 0,136 L na dan, što odgovara poluvijeku raspoloživosti (t1/2) u serumu od približno 19 dana.
English: What CRYSVITA contains
Croatian: Što CRYSVITA sadrži
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane od veće prema manjoj ozbiljnosti.
English: The maximum dose is 90 mg. All doses should be rounded to the nearest 10 mg.
Croatian: Sve je doze potrebno zaokružiti na najbližih 10 mg.
English: Burosumab is a recombinant human monoclonal antibody (IgG1) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23).
Croatian: Burosumab je rekombinantno ljudsko monoklonsko protutijelo (IgG1) koje se veže na čimbenik rasta fibroblasta 23 (FGF23) i inhibira njegovu aktivnost.
English: What CRYSVITA looks like and contents of the pack CRYSVITA comes as a clear to slightly opalescent, colourless to pale yellow/brown solution for injection in a small glass vial.
Croatian: CRYSVITA se isporučuje kao bistra do blago opalescentna, bezbojna do blijedo žuta/smeđa otopina za injekciju u staklenoj bočici.
English: Administration should be interrupted in any patient experiencing severe injection site reactions (see section 4.8) and appropriate medical therapy administered.
Croatian: U bolesnika u kojih se pojave teške reakcije (vidjeti dio 4.8), primjenu treba prekinuti i započeti odgovarajuću medicinsku terapiju.
English: Burosumab must not be given to patients with severe or end stage renal disease (see section 4.3).
Croatian: Burosumab se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega ili u onih sa završnim stadijem bolesti bubrega (vidjeti dio 4.3).
English: Dose decrease
Croatian: Smanjenje doze
English: Periodic measurement of serum parathyroid hormone is advised.
Croatian: Savjetuje se periodički mjeriti paratireoidni hormon u serumu.
English: Serum alkaline phosphatase activity
Croatian: Aktivnost alkalne fosfataze u serumu
English: It is possible that CRYSVITA could cause dizziness and affect you being able to ride a bike, use any tools or machines or to drive.
Croatian: Upravljanje vozilima, vožnja bicikla i rad sa strojevima Lijek CRYSVITA mogao bi prouzročiti omaglicu i utjecati na Vašu sposobnost vožnje bicikla, upotrebe alata ili strojeva ili upravljanja vozilima.
English: X-Linked Hypophosphataemia (XLH) is a genetic disease.
Croatian: X-vezana hipofosfatemija genetska je bolest.
English: Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).
Croatian: Koncentracija fosfata u serumu natašte iznad normalnog raspona za dob, zbog rizika od hiperfosfatemije (vidjeti dio 4.4).
English: How CRYSVITA works
Croatian: Kako CRYSVITA djeluje
English: Twenty six of 52 patients received burosumab every two weeks (Q2W) at an average dose (min, max) of 0.73 (0.3, 1.5), 0.98 (0.4, 2.0) and 1.04 (0.4, 2.0) mg/kg at weeks 16, 40 and 60 respectively, and up to a maximum dose of 2.0 mg/kg.
Croatian: Od 52 bolesnika njih 26 je primalo burosumab svaka 4 tjedna, a 26 bolesnika svaka 2 tjedna u prosječnoj dozi (minimum, maksimum) od 0,73 (0,3; 1,5), 0,98 (0,4; 2,0) i 1,04 (0,4; 2,0) mg/kg u 16. odnosno 40. i 60. tjednu, te do najviše doze od 2,0 mg/kg.
English: In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 12 years old, the MAH should conduct and submit the results of study UX023-CL301, a randomized, open-label, phase 3 Study to assess efficacy, safety and pharmacodynamics of the anti-FGF23 antibody, KRN23, versus oral phosphate and active vitamin D in paediatric patients with XLH.
Croatian: Kako bi se potvrdile djelotvornost i sigurnost lijeka Crysvita u liječenju X-vezane hipofosfatemije (XLH) u djece u dobi između 1 i 12 godina, nositelj odobrenja treba provesti i dostaviti rezultate ispitivanja UX023-CL301, randomiziranog, otvorenog ispitivanja faze III za procjenu farmakodinamike, djelotvornosti i sigurnosti KRN23, protutijela na FGF23, naspram peroralno primjenjivanog fosfata i aktivnog oblika vitamina D u pedijatrijskih bolesnika s XLH-om.
English: In preclinical studies, ectopic mineralisation has been observed in normal animals, most frequently in the kidney, given burosumab at doses that resulted in serum phosphate concentrations greater than 2.58 mmol/L (see section 5.3).
Croatian: U nekliničkim ispitivanjima ektopična mineralizacija opažena je u normalnih životinja, najčešće u bubregu, pri dozama burosumaba koje su rezultirale koncentracijama fosfata u serumu većim od 2,58 mmol/L (vidjeti dio 5.3).