FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take Chenodeoxycholic acid Leadiant
Croatian: Ako zaboravite uzeti Chenodeoxycholic acid Leadiant
English: Hepatic impairment
Croatian: je inhibirana.
English: For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsules may be opened and the contents added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Croatian: Za djecu, adolescente i odrasle koji ne mogu progutati kapsule i/ili trebaju uzeti dozu manju od 250 mg, kapsule se mogu otvoriti i sadržaj dodati u 25 ml 8,4%-tne (1 mmol/ml) otopine natrijevog bikarbonata kako bi se napravila suspenzija koja sadrži 10 mg/ml kenodeoksikolatne kiseline.
English: Other medicines and Chenodeoxycholic acid Leadiant
Croatian: Drugi lijekovi i Chenodeoxycholic acid Leadiant
English: For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsule may be opened, the contents of added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Croatian: Za djecu, adolescente i odrasle koji ne mogu progutati kapsule i/ili trebaju uzeti dozu manju od 250 mg, kapsulu se može otvoriti, sadržaj dodati u 25 ml 8,4%-tne (1 mmol/ml) otopine natrijevog bikarbonata i pomiješati kako bi se napravila suspenzija koja sadrži 10 mg/ml kenodeoksikolatne kiseline.
English: The administration of oral contraceptives reduces the pool size of chenodeoxycholic acid.
Croatian: Primjena oralnih kontraceptiva smanjuje količinu kenodeoksikolatne kiseline u tijelu.
English: Chenodeoxycholic acid should be taken either one hour before cholestyramine or 4-6 hours after.
Croatian: Kenodeoksikolatnu kiselinu treba uzeti ili jedan sat prije ili 4-6 sati nakon uzimanja kolestiramina.
English: If you stop taking Chenodeoxycholic acid Leadiant
Croatian: Ako prestanete uzimati Chenodeoxycholic acid Leadiant
English: Breast-feeding It is unknown whether chenodeoxycholic acid/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se kenodeoksikolatna kiselina/metaboliti u majčino mlijeko.
English: If it is necessary to take colestyramine then chenodeoxycholic acid should be taken either one hour before colestyramine or 4-6 hours after.
Croatian: Ako je potrebno uzeti kolestiramin, onda kenodeoksikolatnu kiselinu treba uzeti ili jedan sat prije ili 4-6 sati nakon uzimanja kolestiramina.
English: MedDRA System Organ Class Preferred term
Croatian: MedDRA klasifikacija organskih sustava
English: There are no or limited amount of data from the use of chenodeoxycholic acid in pregnant women.
Croatian: Podataka o uporabi kenodeoksikolatne kiseline kod trudnica nema ili su ograničeni.
English: How to store Chenodeoxycholic acid Leadiant 6.
Croatian: Kako čuvati Chenodeoxycholic acid Leadiant 6.
English: For infants the capsules may be opened and the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Croatian: Za dojenčad kapsule se mogu otvoriti i sadržaj dodati u 50 ml 8,4%-tne otopine natrijevog bikarbonata (1 mmol/ml) kako bi se napravila suspenzija koja sadrži 5 mg/ml kenodeoksikolatne kiseline.
English: Chenodeoxycholic acid given orally is absorbed in the small intestine.
Croatian: Kenodeoksikolatna kiselina primijenjena peroralno apsorbira se u tankom crijevu.
English: For infants the capsules may be opened, the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Croatian: Za dojenčad kapsule se mogu otvoriti i sadržaj dodati u 50 ml 8,4%-tne otopine natrijevog bikarbonata (1 mmol/ml) i pomiješati kako bi se napravila suspenzija koja sadrži 5 mg/ml kenodeoksikolatne kiseline.
English: Each hard capsule contains 250 mg of chenodeoxycholic acid.
Croatian: Svaka tvrda kapsula sadrži 250 mg kenodeoksikolatne kiseline.
English: Elderly patients (≥ 65 years)
Croatian: Posebne populacije Stariji bolesnici (≤ 65 godina) Nije potrebno prilagoditi dozu.
English: - Each capsule contains 250 mg of chenodeoxycholic acid.
Croatian: - Svaka kapsula sadrži 250 mg kenodeoksikolatne kiseline.
English: Package leaflet: Information for the user Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Chenodeoxycholic acid Leadiant 250 mg tvrde kapsule kenodeoksikolatna kiselina
English: Colestyramine
Croatian: Doziranje
English: (Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg) x 1 ml = Amount of suspension to give
Croatian: Volumen za primjenu: (Podijeljena doza u mg) x 1 ml = Količina suspenzije koju treba dati
English: Each capsule contains 250 mg chenodeoxycholic acid.
Croatian: Svaka kapsula sadrži 250 mg kenodeoksikolatne kiseline.
English: In patients with CTX, no interaction studies with chenodeoxycholic acid and concomitantly administered medicinal products have been performed.
Croatian: Ispitivanja interakcija između kenodeoksikolatne kiseline i istodobno primijenjenih lijekova nisu provedena na bolesnicima koji imaju CTX.
English: (Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg x 1 ml) = Amount of suspension to give
Croatian: Volumen za primjenu: (Podijeljena doza u mg x 1 ml) = Količina suspenzije koju treba dati
English: How to take Chenodeoxycholic acid Leadiant
Croatian: Kako uzimati Chenodeoxycholic acid Leadiant
English: Concomitant administration of chenodeoxycholic acid with phenobarbital increases HMG CoA reductase and thus counteracts one of the pharmacodynamics effects of chenodeoxycholic acid in CTX.
Croatian: reduktaze i stoga poništava jedan od farmakodinamičkih učinaka kenodeoksikolatne kiseline u CTX-u.
English: How to store Chenodeoxycholic acid Leadiant
Croatian: Kako čuvati Chenodeoxycholic acid Leadiant
English: Your doctor will advise you if for any reason you have to stop treatment with Chenodeoxycholic acid Leadiant.
Croatian: Liječnik će Vam reći ako iz nekog razloga morate prestati liječenje lijekom
English: The following medicines may reduce the effect of Chenodeoxycholic acid Leadiant:
Croatian: Sljedeći lijekovi mogu umanjiti učinak lijeka Chenodeoxycholic acid Leadiant: • kolestiramin, kolestipol (takozvani sekvestranti žučne kiseline)
English: This was confirmed within the framework of this article 30 procedure.
Croatian: To je potvrđeno unutar okvira ovog postupka u skladu sa člankom 30.
English: The stability data at these testing conditions has shown that the results are within the acceptance criteria and the product is stable.
Croatian: Podaci o stabilnosti u ovim testnim uvjetima pokazali su da se rezultati nalaze unutar kriterija prihvatljivosti te da je lijek stabilan.
English: Moreover, recent trials have confirmed the benefit of Sandimmun in different forms of nephrotic syndrome in children and adults.
Croatian: Nadalje, posljednja su istraživanja potvrdila koristi lijeka Sandimmun u slučaju različitih oblika nefrotskog sindroma u djece i odraslih.
English: The registration of Sandimmun Neoral was based on efficacy and safety data from clinical studies performed with the oil-based formulation (Sandimmun), first registered in Switzerland in December 1982.
Croatian: Registracija lijeka Sandimmun Neoral temeljila se na podacima o djelotvornosti i sigurnosti iz kliničkih ispitivanja provedenih s formulacijama na bazi ulja (Sandimmun), koje su po prvi put registrirane u Švicarskoj u prosincu 1982. godine.
English: The MAH confirmed that the stability studies have been performed at the long term conditions at 25°C/60%RH and accelerated conditions also at 40°C/75% RH.
Croatian: Nositelj odobrenja potvrdio je da su ispitivanja stabilnosti provedena u dugoročnim uvjetima pri 25°C/60% RV i također u ubrzanim uvjetima pri
English: Ciclosporin is also used in a variety of conditions that are known, or may be considered, to be of autoimmune origin (endogenous uveitis, nephrotic syndrome, rheumatoid arthritis, psoriasis and atopic dermatitis).
Croatian: Ciklosporin se koristi, također, za niz stanja za koja je poznato da su, ili se mogu smatrati, autoimunog porijekla (endogeni uveitis, nefrotski sindrom, reumatoidni artritis, psoriaza i atopički dermatitis).
English: However the statement “The daily doses of Sandimmum should always be given in two divided doses” was partly endorsed by the CHMP since the word “always” should be omitted (in some cases, three times daily administration may be needed).
Croatian: „Dnevne doze lijeka Sandimmum moraju se uzimati uvijek u dvije podijeljene doze“, s obzirom da riječ „uvijek“ treba biti izostavljena (u određenim je slučajevima potrebno uzimati lijek tri puta na dan).
English: The MAH confirmed that the storage conditions in the SmPCs of Sandimmun soft gelatin capsules and oral solutions are already aligned with the requirements set in the Guideline on Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2 dated 19 Nov 2007).
Croatian: Nositelj odobrenja potvrdio je da su mjere čuvanja navedene u sažetku opisa svojstava lijeka za Sandimmun mekane želatinaste kapsule i oralne otopine već usklađene sa zahtjevima navedenima u Smjernici za deklaraciju mjera pri čuvanju lijeka (CPMP/QWP/609/96/Rev 2, od 19. studenog 2007.).
English: The dossier of Sandimmun was used as a basis of the review as the dossier supporting the approval of the new ciclosporin formulation (Sandimmun Neoral) was based on pharmacokinetics evaluation that demonstrated equivalence between the 2 forms of ciclosporin (oil-based formulation versus microemulsified formulation).
Croatian: Sandimmun upotrijebljen je kao osnova za pregled s obzirom da je dosje, koji podržava odobrenje nove formulacije ciklosporina (Sandimmun Neoral), bio temeljen na farmakokinetičkoj evaluaciji koja je dokazala ekvivalenciju 2 oblika ciklosporina (formulacije na bazi ulja u odnosu na mikoemulgiranu formulaciju).
English: It is recommended that Sandimmun be administered on a consistent schedule with regard to time of day and relation to meals.
Croatian: Preporuča se da se lijek Sandimmun uzima prema konzistentnom rasporedu s obzirom na doba dana i obroke.“
English: The MAH proposed wordings for the sub-sections “Food interactions, Drug interactions, Drugs that decrease ciclosporin levels, Drugs that increase ciclosporin levels, Other relevant drug interactions, Recommendations, Paediatric population and Other relevant drug interactions.”
Croatian: Lijekovi koji smanjuju razinu ciklosporina, Lijekovi koji povećavaju razinu ciklosporina, Druge značajne interakcije s lijekovima, Preporuke, Pedijatrijska populacija i Druge relevantne interakcije s lijekovima.“
English: Therefore, The MAH adhered to the statement on SPC and PL as “This medicinal product does not require any special temperature storage conditions” in accordance with the guideline.
Croatian: Stoga je nositelj odobrenja udovoljio izjavi o posebnim mjerama pri čuvanju lijeka i PL s obzirom da je formulacija „Ovaj lijek ne zahtjeva nikakve posebne uvjete pri čuvanju“ u skladu sa smjernicom.
English: Finally the MAH was also requested to update this section with more information concerning the inhibitory potential of ciclosporin on other transporters than P-gp.
Croatian: U konačnici od nositelja odobrenja zatraženo je da ažurira ovaj dio s više informacija u vezi inhibitorskog potencijala ciklosporina na druge transportere, uz P-glikoprotein.
English: In addition, the MAH proposed a correction in the wording of the “Special precautions for storage” in the SmPC for Sandimmun 50 mg/ml concentrate for solution for infusion, also in conformance to the above-mentioned Guideline.
Croatian: Nadalje, nositelj odobrenja predložio je ispravak u formulaciji „Posebne mjere pri čuvanju lijeka“ u sažetku opisa svojstava lijeka za Sandimmun 50 mg/ml koncentrat za otopinu za infuziju, također u skladu s prethodno navedenom smjernicom.
English: The MAH proposed the following wording for this indication: “Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.” The MAH's proposed indication wording for the Atopic dermatis is approved in 15 EU countries.
Croatian: Nositelj odobrenja predložio je sljedeću formulaciju za ovu indikaciju: „Sandimmun indiciran je u bolesnika s teškim atopičkim dermatitisom kada je potrebna sistemna terapija.“
English: Based on the above the CHMP considers the benefit/risk ratio of Sandimmun to be favourable and the harmonised PI to be approvable.
Croatian: Na temelju prethodno navedenog, CHMP smatra da je omjer koristi i rizika lijeka Sandimmun povoljan, te da se usklađene informacije o lijeku mogu odobriti.
English: Referring to the “non-transplantation indications” section, likewise, the MAH proposed a posology for each of the special populations (i.e. patients with renal impairment, patients with hepatic impairment, paediatric population, elderly population).
Croatian: doziranje za svaku posebnu populaciju (primjerice bolesnike s oštećenjem funkcije bubrega, bolesnike s oštećenjem jetre, pedijatrijsku populaciju, stariju populaciju).
English: Whilst reviewing the MAH's proposal, in view of the SmPC guideline, the CHMP considered that the category “not known” should only be used in exceptional cases; the MAH was requested to adhere to the classification according to the CSP unless adequately justified.
Croatian: CHMP smatra da se kategorija „nije poznato“ treba koristiti samo u iznimnim slučajevima; nositelj odobrenja zatražio je pridržavanje klasifikacije u skladu sa CSP-om, osim ako što drugačije nije primjereno opravdano.
English: The CHMP noted that Marketing Authorisations for Sandimmum and associated names 50mg/ml concentrate for solution for infusion are solely granted for the above-mentioned transplantation indications (namely, the solid organ transplantation and the bone marrow transplantation).
Croatian: mg/ml koncentrat za otopinu za infuziju izdano isključivo za prethodno navedene transplantacijske indikacije (odnosno transplantaciju organa i transplantaciju koštane srži).
English: The MAH therefore agreed to revise the wording, recommending that Sandimmun should be administered on a consistent schedule with regard to time of day and relation to meals, as follows: “The daily doses of Sandimmun/Sandimmun Neoral always should be given in two divided doses equally distributed throughout the day, taken at the same time of the day, e.g., in the morning and in the evening.
Croatian: Stoga je nositelj odobrenja suglasan da se formulacija revidira te preporuča da se lijek Sandimmun mora davati prema konzistentnom rasporedu s obzirom na vrijeme dana i obroke, kako slijedi: „Dnevne doze lijeka Sandimmun/Sandimmun
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun and associated names.
Croatian: List of Outstanding Issues) i nakon razmatranja Povjerenstva, CHMP je suglasan s i prihvatio je usklađene komplete dokumenata informacija o lijeku za različite oblike lijeka Sandimmun i povezane nazive.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
Croatian: • sažetak opisa svojstava lijeka, naljepnica i uputa o lijeku, koje je(su) predložio(li) nositelj(i) odobrenja, ocijenjeni su na temelju dostavljene dokumentacije i znanstvenog razmatranja unutar Povjerenstva
English: The CHMP is of the view that introducing Sandimmun for the treatment of rejection is most appropriate for cellular rather than humoral rejection, based on the mechanism of action of CNI's.
Croatian: Na temelju mehanizma djelovanja CNI-a, mišljenje je CHMP-a da je uvođenje lijeka Sandimmun u liječenje odbacivanja najprimjerenije za stanično, a ne za humoralno odbacivanje.
English: • Sandimmum and associated names 50mg/ml concentrate for solution for infusion
Croatian: • Sandimmum i povezani nazivi 50mg/ml koncentrat za otopinu za infuziju CHMP smatra da je odobrenje za stavljanje lijeka u promet za lijek Sandimmum i povezane nazive 50
English: A new wording was proposed by the MAH and agreed by the CHMP.
Croatian: Nositelj odobrenja predložio je novu formulaciju, s kojom je CHMP suglasan.
English: Ciclosporin is a potent immunosuppressive agent used in human solid organ and bone marrow transplantation to prevent graft rejection and in Graft Versus Host Disease (GVHD).
Croatian: koje se koristi u transplantaciji ljudskih organa i koštane srži kako bi se spriječilo odbacivanje presatka, te u slučaju bolesti presatka protiv primatelja (GVHD, engl.
English: The daily doses of Sandimmum should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP.
Croatian: CHMP potvrdio je izjavu nositelja odobrenja „Rasponi doze navedeni za oralnu primjenu predviđeni su samo kao smjernice“.
English: Overall summary of the scientific evaluation of Sandimmun and associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijeka Sandimmun i povezanih naziva (vidjeti Dodatak I) Sandimmun je formulacija ciklosporina na bazi ulja.
English: The maximum dose is 90 mg every two weeks.
Croatian: Najveća doza je 90 mg svaka dva tjedna.
English: What is Crysvita and what is it used for?
Croatian: Što je Crysvita i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Crysvita.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Crysvita.
English: All the children received Crysvita either every two weeks or every four weeks.
Croatian: Sva su djeca primala lijek Crysvita svaka dva tjedna ili svaka četiri tjedna.
English: The average score before treatment was 1.9 points in those given Crysvita every 2 weeks, and this fell by 1.0 point after 64 weeks of treatment; in those given the medicine every 4 weeks the baseline score of 1.7 fell by 0.8 point.
Croatian: Prosječni rezultat prije liječenja iznosio je 1,9 bodova u djece koja su primala lijek Crysvita svaka dva tjedna; ovaj je rezultat pao za 1,0 bod nakon 64 tjedna liječenja; kod djece koja su primala lijek svaka 4 tjedna početni rezultat od 1,7 pao je za 0,8 bodova.
English: What measures are being taken to ensure the safe and effective use of Crysvita?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Crysvita?
English: Side effects with Crysvita (which may affect more than 1 in 10 people) are injection site reactions (such as skin redness, itching, rash, pain and bruising), headache, pain in arms and legs, decreased vitamin D level, rash, toothache, tooth abscess, muscle pain and dizziness.
Croatian: Nuspojave lijeka Crysvita (koje se mogu javiti u više od 1 na 10 osoba) jesu reakcije na mjestu primjene injekcije (kao što su crvenilo, osip, svrbež, bol i nastanak modrice), glavobolja, bol u rukama i nogama, niska razina vitamina D, osip, zubobolja, apsces zuba, bol u mišićima i omaglica.
English: The main measure of effectiveness was a reduction in the severity of rickets (bone deformities) in the wrist and knee measured on a scale from 0 (normal) to 10 (severe).
Croatian: Glavno mjerilo djelotvornosti bilo je smanjenje težine rahitisa (deformacija kostiju) u kostima zapešća i koljena mjereno na ljestvici od 0 (normalno) do 10 (ozbiljno).
English: The recommended dose at the start of treatment is 0.4 mg per kg of body weight, and then 0.8 mg/kg every two weeks to continue treatment.
Croatian: Preporučena početna doza iznosi 0,4 mg/kg tjelesne težine, nakon čega se daje 0,8 mg/kg svaka dva tjedna tijekom nastavka liječenja.
English: The full EPAR for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Crysvita nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of patients with bone diseases caused by alterations in the body's chemical processes.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u liječenju bolesnika s bolestima kostiju uzrokovanih promjenama u kemijskim procesima organizma.
English: The European Medicines Agency therefore decided that Crysvita's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Crysvita nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: In addition, phosphate levels in the blood improved over time in both groups, particularly those given Crysvita every 2 weeks.
Croatian: Nadalje, razine fosfata u krvi s vremenom su se povećale u objema skupinama, osobito u djece koja su primala lijek Crysvita svaka 2 tjedna.
English: Crysvita has been given ‘conditional approval'.
Croatian: Za lijek Crysvita izdano je „uvjetno odobrenje”.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Crysvita nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Phosphate is essential to build bones and teeth and to maintain their strength, so patients may develop rickets and other bone deformities and growth problems.
Croatian: Fosfati su neophodni za izgradnju kostiju i zubi i održavanje njihove čvrstoće, zbog čega bolesnici mogu oboljeti od rahitisa i ostalih deformacija kostiju i imati poteškoće s rastom.
English: An additional ongoing study in 13 younger children shows that Crysvita is effective in those aged between 1 and 4 years.
Croatian: Dodatno tekuće ispitivanje provedeno na 13 mlađe djece pokazuje da je lijek Crysvita učinkovit u djece u dobi između 1 i 4 godine.
English: It is not intended to provide practical advice on how to use Crysvita.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Crysvita.
English: The medicine was assessed in one main ongoing study in 52 children aged between 5 and 12 years.
Croatian: Lijek je ocijenjen u okviru jednog tekućeg ispitivanja provedenog na 52 djece u dobi između 5 i 12 godina.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Crysvita have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Crysvita nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The company is also required to conduct and submit the results of a study comparing Crysvita with oral phosphate and vitamin D in children aged between 1 and 12 years with X-linked hypophosphataemia.
Croatian: Tvrtka također mora voditi i podnositi rezultate ispitivanja u kojem se Crysvita uspoređuje s peroralnim fosfatima i analozima vitamina D u djece između 1 i 12 godina s X-vezanom hipofosfatemijom.
English: What are the risks associated with Crysvita?
Croatian: Koji su rizici povezani s lijekom Crysvita?