FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, mothers receiving nitisinone must not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
Croatian: Stoga majke koje uzimaju nitizinon ne smiju dojiti, jer se rizik za dojenče ne može isključiti (vidjeti dijelove 4.3 i 5.3).
English: - The active substance is nitisinone.
Croatian: - Djelatna tvar je nitizinon.
English: Exfoliative dermatitis may occur uncommonly.
Croatian: Eksfolijativni dermatitis može se pojaviti manje često.
English: Succinylacetone inhibits the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate.
Croatian: Sukcinilaceton inhibira put sinteze porfirina što dovodi do nakupljanja 5-aminolevulinata.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOCI
English: Mothers receiving nitisinone must not breast-feed (see sections 4.6 and 5.3).
Croatian: Majke koje uzimaju nitizinon ne smiju dojiti (vidjeti dijelove 4.6 i 5.3).
English: It should be established that the patient is adhering to his/her dietary regimen and the plasma tyrosine concentration should be measured.
Croatian: Potrebno je utvrditi pridržava li se bolesnik dijetetskog režima i mjeriti koncentracije tirozina u plazmi.
English: Based on in vitro studies, nitisinone is not expected to inhibit CYP1A2, 2C19 or 3A4-mediated metabolism or to induce CYP1A2, 2B6 or 3A4/5.
Croatian: Na temelju ispitivanja in vitro ne očekuje se da će nitizinon inhibirati metabolizam posredovan CYP 1A2, 2C19 ili 3A4 ili inducirati CYP 1A2, 2B6 ili 3A4/5.
English: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism.
Croatian: In vitro studije na ljudskim jetrenim mikrosomima i c-DNK eksprimirajućim P450 enzimima pokazali su ograničeni metabolizam posredovan CYP 3A4.
English: What Nitisinone MDK is and what it is used for
Croatian: Što je Nitisinone MDK i za što se koristi
English: Elevated tyrosine levels have been associated with toxicity to eyes, skin, and the nervous system.
Croatian: Povišene razine tirozina povezane su s toksičnim učincima na očima, koži i živčanom sustavu.
English: During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Croatian: Tijekom redovitog nadzora dobro je pratiti sukcinilaceton u mokraći, vrijednosti pretraga jetrene funkcije i razine alfa-fetoproteina (vidjeti dio 4.4).
English: Succinylacetone should not be detectable in urine or plasma when the nitisinone dose is properly adjusted.
Croatian: Sukcinilacetat ne bi smio biti mjerljiv u mokraći ili plazmi kad se doza nitizinona ispravno prilagodi.
English: If you notice any side effects relating to the eyes, talk to your doctor immediately to have an eye examination.
Croatian: Ako primijetite bilo koje nuspojave povezane s očima, obratite se odmah svom liječniku radi pregleda očiju.
English: Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Croatian: Liječenje odraslih i pedijatrijskih bolesnika (bilo koje dobi) s potvrđenom dijagnozom nasljedne tirozinemije tipa 1 (HT-1) u kombinaciji s ograničenjem unosa tirozina i fenilalanina hranom.
English: The safety profile is mainly based on the paediatric population since nitisinone treatment should be started as soon as the diagnosis of hereditary tyrosinemia type 1 (HT-1) has been established.
Croatian: Pedijatrijska populacija Sigurnosni profil uglavnom se temelji na pedijatrijskoj populaciji budući da je liječenje nitizinonom potrebno započeti čim se ustanovi nasljedna tirozinemija tipa 1 (HT-1).
English: In rats, exposure via milk resulted in reduced mean pup weight and corneal lesions.
Croatian: U štakora, izloženost putem mlijeka rezultirala je smanjenjem prosječne težine mladunčadi i lezijama rožnice.
English: Nitisinone MDK blocks the breakdown of tyrosine and the harmful substances are not formed.
Croatian: Nitisinone MDK blokira razgradnju tirozina te ne nastaju štetne tvari.
English: Treatment with nitisinone leads to higher levels of tyrosine in the blood which can cause eye related symptoms.
Croatian: Liječenje nitizinonom povećava razine tirozina u krvi što može uzrokovati simptome povezane s očima.
English: It is unknown whether nitisinone is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se nitizinon u majčino mlijeko.
English: Nitisinone is a moderate CYP2C9 inhibitor.
Croatian: Nitizinon je umjereno jak inhibitor CYP 2C9.
English: Other common side effects - Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).
Croatian: Ostale česte nuspojave smanjeni broj krvnih pločica (trombocitopenija) i bijelih krvnih stanica (leukopenija), manjak određenih vrsta bijelih krvnih stanica (granulocitopenija).
English: Treatment with nitisinone was also found to result in reduced risk for the development of hepatocellular carcinoma compared to historical data on treatment with dietary restriction alone.
Croatian: Otkriveno je da liječenje nitizinonom rezultira smanjenjem rizika od razvoja hepatocelularnog karcinoma (HCC) u usporedbi s povijesnim podacima o liječenju samo uz ograničenja u prehrani.
English: 60 hard capsules
Croatian: 60 tvrdih kapsula
English: In the rabbit, nitisinone induced a dose-related increase in malformations (umbilical hernia and gastroschisis) from a dose level 2.5-fold higher than the maximum recommended human dose (2 mg/kg/day).
Croatian: U kunića je nitizinon inducirao porast malformacija ovisan o dozi (umbilikalna hernija i gastroshiza) uz razinu doze 2,5 puta veću od maksimalne preporučene doze u ljudi (2 mg/kg/dan).
English: Common eye related side effects (may affect more than 1 in 10 people) caused by higher tyrosine levels are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain.
Croatian: Česte nuspojave na očima (javljaju se u više od 1 na 10 osoba) uzrokovane povišenim razinama tirozina su upala oka (konjunktivitis), zamućenje i upala rožnice (keratitis), osjetljivost na svjetlo (fotofobija) i bol u očima.
English: No formal food interactions studies have been performed with Nitisinone MDK hard capsules.
Croatian: Nisu provedena službena ispitivanja interakcija Nitisinone MDK tvrdih kapsula s hranom.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Drugi lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16A X04.
English: It is recommended that platelet and WBC counts are monitored regularly, as a few cases of reversible thrombocytopenia and leucopenia were observed during clinical evaluation.
Croatian: Preporučuje se redovito praćenje broja trombocita i leukocita, jer je tijekom kliničkih procjena zabilježeno nekoliko slučajeva reverzibilne trombocitopenije i leukopenije.
English: Nitisinone is metabolised in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Croatian: Nitizinon se in vitro metabolizira pomoću CYP 3A4 te stoga može biti potrebna prilagodba doze kad se nitizinon primjenjuje istodobno s inhibitorima ili induktorima ovog enzima.
English: This medicine has minor influence on the ability to drive and use machines.
Croatian: Ovaj lijek malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids.
Croatian: Liječenje nitizinonom dovodi do normaliziranja metabolizma porfirina, uz normalnu aktivnost porfobilinogen sintaze u eritrocitima i 5-aminolevulinata u mokraći, smanjenja izlučivanja sukcinilacetona mokraćom, porasta koncentracije tirozina u plazmi i povećanog izlučivanja fenolnih kiselina mokraćom.
English: The capsule contains a white to off-white powder.
Croatian: Kapsula sadrži bijeli do gotovo bijeli prašak.
English: The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Croatian: Preporučena početna dnevna doza u pedijatrijskoj i odrasloj populaciji iznosi 1 mg/kg tjelesne težine koja se primjenjuje peroralno.
English: Nitisinone has minor influence on the ability to drive and use machines.
Croatian: Nitisinone malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: What Nitisinone MDK looks like and contents of the pack
Croatian: Kako Nitisinone MDK izgleda i sadržaj pakiranja
English: The liver function should be monitored regularly by liver function tests and liver imaging.
Croatian: Praćenje jetre Jetrena funkcija mora se redovito pratiti pretragama jetrene funkcije i snimanjem jetre.
English: Nitisinone treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolized through CYP2C9, such as warfarin and phenytoin, should be carefully monitored.
Croatian: Bolesnike liječene nitizinonom koji se istodobno liječe lijekovima uskog terapijskog indeksa, a koji se metaboliziraju putem CYP 2C9, kao što su varfarin i fenitoin, potrebno je pažljivo pratiti.
English: Capsule content ˗ Pregelatinised starch (maize)
Croatian: Sadržaj kapsule - prethodno geliran škrob (kukuruzni)
English: If you experience any side effects, shorter intervals are recommended.
Croatian: U slučaju pojave nuspojava, preporučuju se kraći razmaci.
English: Nitisinone is a weak inducer of CYP2E1 (30% decrease in chlorzoxazone AUC) and a weak inhibitor of OAT1 and OAT3 (1.7-fold increase in AUC of furosemide), whereas nitisinone did not inhibit CYP2D6 (see section 5.2).
Croatian: Nitizinon je slab induktor CYP 2E1 (smanjenje AUC-a klorzoksazona za 30%) i slab inhibitor OAT1 i OAT3 (povećanje AUC-a furosemida 1,7 puta), ali nitizinon nije inhibirao CYP 2D6 (vidjeti dio 5.2).
English: Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8).
Croatian: Pored liječenja nitizinonom potrebna je dijeta siromašna fenilalaninom i tirozinom, uz praćenje aminokiselina u plazmi (vidjeti dijelove 4.4 i 4.8).
English: If you forget to take a dose, contact your doctor or pharmacist.
Croatian: Ako ste zaboravili uzeti dozu, obratite se svom liječniku ili ljekarniku.
English: MedDRA system organ class Frequency
Croatian: MedDRA organski sustav Učestalost
English: Restriction of tyrosine and phenylalanine in the diet should limit the toxicity associated with this type of tyrosinemia by lowering tyrosine levels (see section 4.4).
Croatian: Ograničenje unosa tirozina i fenilalanina hranom trebalo bi ograničiti toksičnost povezanu s ovim tipom tirozinemije snižavanjem razine tirozina (vidjeti dio 4.4).
English: HDPE plastic bottle with LDPE plastic cap containing 60 capsules.
Croatian: Plastična boca od polietilena visoke gustoće s plastičnim poklopcem od polietilena niske gustoće, koja sadrži 60 kapsula.
English: Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment.
Croatian: Nuspojave koje zahvaćaju organski sustav "Poremećaji krvi i limfnog sustava" prema MedDRA-klasifikaciji organskih sustava povukle su se tijekom kontinuiranog liječenja nitizinonom.
English: By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Croatian: Inhibicijom normalnog katabolizma tirozina u bolesnika s HT1, nitizinon sprječava nakupljanje toksičnih međuprodukata maleilacetoacetata i fumarilacetoacetata.
English: Nitisinone is not expected to inhibit P-gp, BCRP or OCT2-mediated transport.
Croatian: Ne očekuje se da će nitizinon inhibirati prijenos posredovan P-gp-om, BCRP-om ili prijenosnikom OCT2.
English: Therefore, it is recommended that if nitisinone treatment with Nitisinone MDK hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Croatian: Stoga se preporučuje da se, ako se liječenje Nitisinone MDK tvrdim kapsulama započne s hranom, takav režim liječenja održava rutinski, vidjeti dio 4.2.
English: NTBC study (N=250) Age at start of treatment
Croatian: Ispitivanje NTBC (N=250) Broj bolesnika
English: Imprint ˗ Black iron oxide (E172) ˗ Shellac
Croatian: Oznaka - željezov oksid, crni (E 172) - šelak
English: By its mode of action, nitisinone increases tyrosine levels in all nitisinone treated patients.
Croatian: Zbog načina djelovanja nitizinon povećava razine tirozina u svih bolesnika liječenih nitizinonom.
English: The dose of nitisinone should be adjusted individually.
Croatian: Doza nitizinona mora se prilagoditi pojedinom bolesniku.
English: Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with this type of tyrosinemia.
Croatian: Ograničenje unosa tirozina i fenilalanina hranom trebalo bi ograničiti toksičnost povezanu s ovim tipom tirozinemije.
English: Can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Croatian: Može se čuvati na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca, nakon čega se mora baciti.
English: Other medicines and Nitisinone MDK
Croatian: Drugi lijekovi i Nitisinone MDK
English: In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Croatian: U bolesnika s HT-1, ti se međuprodukti pretvaraju u toksične metabolite sukcinilaceton i sukcinilacetoacetat.
English: Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Croatian: Konjunktivitis, zamućenje rožnice, keratitis, fotofobija, bol u oku
English: Nitisinone treatment leads to elevated tyrosine levels.
Croatian: Liječenje nitizinonom uzrokuje povišene razine tirozina.
English: The active ingredient of Nitisinone MDK is nitisinone.
Croatian: Djelatna tvar u lijeku Nitisinone MDK je nitizinon.
English: Thrombocytopenia, leucopenia, granulocytopenia
Croatian: Trombocitopenija, leukopenija, granulocitopenija
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone caused a 2.3-fold increase in AUC∞ of the CYP2C9 substrate tolbutamide, which is indicative of a moderate inhibition of CYP2C9.
Croatian: Na temelju podataka kliničkog ispitivanja interakcija 80 mg nitizinona u stanju dinamičke ravnoteže, nitizinon je uzrokovao povećanje AUC∞ supstrata CYP 2C9 tolbutamida 2,3 puta, što ukazuje na umjerenu inhibiciju CYP 2C9.
English: The recommended total daily dose is 1 mg/kg body weight administered orally.
Croatian: Preporučena ukupna dnevna doza je 1 mg/kg tjelesne težine i uzima se kroz usta.
English: Capsule shell ˗ Gelatin ˗ Titanium dioxide (E171)
Croatian: Ovojnica kapsule - želatina - titanijev dioksid (E 171)
English: Tabulated list of adverse reactions The adverse reactions listed below by MedDRA system organ class and absolute frequency, are based on data from a clinical trial and post-marketing use.
Croatian: Nuspojave navedene u nastavku prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti temelje se na podacima iz kliničkog ispitivanja i primjene nakon stavljanja lijeka u promet.
English: Capsule content: pregelatinised maize starch Capsule shell: gelatin, titanium dioxide (E171) Printing ink: black iron oxide (E172), shellac glaze
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171) Tinta za označivanje: željezov oksid, crni (E 172), šelak glazura
English: The clinical study was open-labelled and uncontrolled.
Croatian: Klinička djelotvornost i sigurnost Kliničko je ispitivanje bilo otvorenog tipa i bez kontrolne skupine.
English: If you take more Nitisinone MDK than you should
Croatian: Ako uzmete više lijeka Nitisinone MDK nego što ste trebali
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Croatian: Na temelju podataka kliničkog ispitivanja interakcija 80 mg nitizinona u stanju dinamičke ravnoteže, nitizinon je umjereno jak inhibitor CYP 2C9 (povećanje AUC-a tolbutamida 2,3 puta) pa stoga liječenje nitizinonom može rezultirati povišenim plazmatskim koncentracijama istodobno primijenjenih lijekova koji se primarno metaboliziraju putem CYP 2C9 (vidjeti dio 4.4).
English: Nitisinone MDK may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Croatian: - lijekovi za epilepsiju (poput fenitoina) - lijekovi protiv zgrušavanja krvi (poput varfarina)
English: Eye-related adverse reactions, such as conjunctivitis, corneal opacity, keratitis, photophobia, and eye pain, related to elevated tyrosine levels are therefore common.
Croatian: Stoga su nuspojave na očima poput konjunktivitisa, zamućenja rožnice, keratitisa, fotofobije i boli u očima povezane s povišenim razinama tirozina česte.
English: Other common adverse reactions include thrombocytopenia, leucopenia, and granulocytopenia.
Croatian: Druge česte nuspojave uključuju trombocitopeniju, leukopeniju i granulocitopeniju.
English: Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
Croatian: 4.2 Doziranje i način primjene Liječenje nitizinonom mora započeti i nadzirati liječnik iskusan u liječenju bolesnika s HT-1.
English: Nitisinone plasma concentration reached in clinical setting is not expected to inhibit OATP1B1, OATP1B3 mediated transport.
Croatian: Ne očekuje se da će koncentracije nitizinona u plazmi koje se postižu u kliničkoj primjeni inhibirati prijenos posredovan OATP1B1 ili
English: What you need to know before you take Nitisinone MDK 3.
Croatian: Što morate znati prije nego počnete uzimati Nitisinone MDK
English: Nitisinone MDK capsules are 15.7 mm long, white, opaque, hard gelatin capsules, imprinted with “Nitisinone” and the strength “2 mg”, “5 mg” or “10 mg”, in black.
Croatian: Kapsule Nitisinone MDK duge su 15,7 mm, bijele, neprozirne, tvrde želatinozne kapsule s utisnutom crnom oznakom „Nitisinone” i oznakom jačine „2 mg”, „5 mg” ili „10 mg”.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog/proizvođača odgovornih za puštanje serije lijeka u promet
English: The medicine can be stored for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which it must be discarded.
Croatian: Lijek se može čuvati na temperaturi ispod 25°C u razdoblju od 2 mjeseca, nakon prvog otvaranja boca, nakon čega se mora baciti.
English: Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Croatian: 4-hidroskifenilpiruvat dioksigenaze, enzima koji prethodi fumarilacetoacetat hidrolazi u kataboličkom putu tirozina.
English: 2 years 4 years 6 years
Croatian: 2 godine 4 godine
English: A study to evaluate the PK, efficacy and safety of once daily dosing compared to twice daily dosing was performed in 19 patients with HT-1.
Croatian: Provedeno je ispitivanje u 19 bolesnika s HT-1 da bi se procijenila farmakokinetika, djelotvornost i sigurnost doziranja jednom dnevno u usporedbi s doziranjem dvaput dnevno.
English: Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).
Croatian: Upala očnog kapka (blefaritis) je manje česta nuspojava (javlja se u do 1 na
English: Exfoliative dermatitis, erythematous rash, pruritus
Croatian: Eksfolijativni dermatitis, eritematozni osip, pruritus
English: It is recommended that if nitisinone treatment is initiated with food, this should be maintained on a routine basis, see section 4.5.
Croatian: Ako se liječenje nitizinonom započne s hranom, preporučuje se da se takav režim liječenja održava rutinski, vidjeti dio 4.5.
English: Elevated levels of tyrosine have been associated with eye-related adverse reactions, such as e.g. corneal opacities and hyperkeratotic lesions.
Croatian: Povišene razine tirozina povezane su s nuspojavama na očima kao npr. zamućenje rožnice i hiperkeratotičke lezije.
English: Nitisinone does not inhibit CYP2D6 since metoprolol AUC∞ was not affected by the administration of nitisinone.
Croatian: Budući da primjena nitizinona nije utjecala na AUC∞ metoprolola, nitizinon ne inhibira CYP 2D6.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN/PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE
English: A pre- and postnatal development study in the mouse showed statistically significant reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher,
Croatian: Studije prenatalnog i postnatalnog razvoja u miševa pokazale su statistički značajna smanjenja preživljenja mladunčadi te njihovog rasta tijekom razdoblja odbijanja od sise pri razinama doza 125, odnosno 25 puta većim od maksimalnih preporučenih doza u ljudi, s trendom negativnog učinka na preživljenje mladunčeta počevši od doze 5 mg/kg/dan.
English: Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9.
Croatian: Stoga liječenje nitizinonom može rezultirati povišenim plazmatskim koncentracijama istodobno primijenjenih lijekova koji se primarno metaboliziraju putem
English: No patient had detectable succinylacetone (SA) levels at the end of the once-daily treatment period.
Croatian: Nijedan bolesnik nije imao mjerljive razine sukcinilacetona (SA)
English: If you stop taking Nitisinone MDK
Croatian: Ako prestanete uzimati Nitisinone MDK
English: The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway.
Croatian: Biokemijski defekt u nasljednoj tirozinemiji tipa 1 (HT-1) je nedostatak fumarilacetoacetat hidrolaze,
English: If you forget to take Nitisinone MDK
Croatian: Ako ste zaboravili uzeti Nitisinone MDK
English: Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels.
Croatian: Ako pojedinci čija prehrana ne uključuje ograničenje tirozina i fenilalanina slučajno progutaju nitizinon, dolazi do porasta razine tirozina.
English: Your liver will be checked at regular intervals because the disease affects the liver.
Croatian: S obzirom da bolest zahvaća jetru, provodit će se redovne pretrage Vaše jetre.
English: Package leaflet: Information for the user Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone
Croatian: Uputa o lijeku: Informacije za korisnika Nitisinone MDK 2 mg tvrde kapsule Nitisinone MDK 5 mg tvrde kapsule Nitisinone MDK 10 mg tvrde kapsule nitizinon
English: Number of patients at
Croatian: Svi bolesnici
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/L.
Croatian: U slučaju razina tirozina u plazmi iznad 500 mikromola/l mora se uvesti restriktivna dijeta bez tirozina i fenilalanina.
English: Nitisinone MDK 2 mg: Each capsule contains 2 mg nitisinone.
Croatian: Nitisinone MDK 2 mg: jedna kapsula sadrži 2 mg nitizinona.