natgillin/translations-raw huggingface dataset:
In this disease your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances.
Vaše tijelo nije u stanju u potpunosti razgraditi aminokiselinu tirozin (aminokiseline su građevne jedinice naših proteina), stvarajući tako štetne tvari.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake “EXP“.
Elevated tyrosine levels
Povišene razine tirozina
Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Nemojte dojiti dok uzimate ovaj lijek, pogledajte dio „Trudnoća i dojenje“.
The 2-, 4-, and 6-year probability of no occurrence of HCC during nitisinone treatment for patients aged 24 months or younger at the start of treatment and for those older than 24 months at the start of treatment is shown in the following table:
Dvogodišnja, četverogodišnja i šestogodišnja vjerojatnost da se HCC neće pojaviti tijekom liječenja nitizinonom u bolesnika u dobi od 24 mjeseca ili mlađih na početku liječenja te u bolesnika starijih od 24 mjeseca na početku liječenja prikazana je u sljedećoj tablici:
There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Nema specifičnih preporuka za dozu u starijih ili bolesnika s oštećenjem bubrega ili jetre.
Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment.
Dostupni podaci iz kliničkih studija ukazuju da se sukcinilaceton u mokraći normalizirao u više od 90% bolesnika tijekom prvog tjedna liječenja.
Increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment.
Porast koncentracije alfa-fetoproteina u serumu može biti znak neodgovarajućeg liječenja.
The dosing frequency in the study was twice daily.
Učestalost doziranja u ispitivanju bila je dvaput dnevno.
If you get red eyes or any other signs of effects on the eyes, contact your doctor immediately for an eye examination.
Ako Vam oči postanu crvene ili uočite bilo koje druge znakove učinka na oči,odmah se obratite svom liječniku radi pregleda očiju.
There were no clinically important differences in AEs or other safety assessments between once and twice daily dosing.
Nije bilo klinički značajnih razlika u štetnim događajima i drugim procjenama sigurnosti između doziranja jednom dnevno i doziranja dvaput dnevno.
Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i
No mutagenic but a weak clastogenic activity was observed in in vitro studies.
Nije primijećena mutagena, već samo slaba klastogena aktivnost u in vitro studijama.
It is recommended to also monitor serum alpha-fetoprotein concentrations.
Također se preporučuje praćenje koncentracija alfa-fetoproteina u serumu.
Patients with increasing alpha-fetoprotein or signs of nodules in the liver should always be evaluated for hepatic malignancy.
Bolesnike s porastom alfa-fetoproteina ili znakovima čvorova u jetri mora se uvijek procijeniti na zloćudne bolesti jetre.
However, in addition to the tests above, during the initiation of therapy, switch from twice daily to once daily dosing or if there is a deterioration, it may be necessary to follow more closely all available biochemical parameters (i.e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Međutim, pored gore navedenih pretraga, tijekom započinjanja terapije, prelaska s doziranja dvaput dnevno na doziranje jednom dnevno ili u slučaju pogoršanja, može biti potrebno pomnije pratiti sve dostupne biokemijske parametre (tj. sukcinilaceton u plazmi, 5-aminolevulinat (ALA) u mokraći i aktivnost sintaze porfobilinogena (PBG) u eritrocitima).
Do not breast-feed while taking this medicine, see section “Do not take Nitisinone MDK”.
Nemojte dojiti dok uzimate ovaj lijek, pogledajte dio „Nemojte uzimati Nitisinone MDK”.
There was no evidence of in vivo genotoxicity (mouse micronucleus assay and mouse liver unscheduled DNA synthesis assay).
Nije bilo dokaza za in vivo genotoksičnost (test u mišjih mikronukleusa i test neplanirane sinteze DNK na jetri miša).
This special diet is based on low tyrosine and phenylalanine (another amino acid) content.
Ta se posebna dijeta temelji na niskom sadržaju tirozina i fenilalanina (druge aminokiseline).
If the vision is affected the patient should not drive or use machines until the event has subsided.
Ako je vid narušen, bolesnik ne smije upravljati vozilima niti raditi sa strojevima dok se ta nuspojava ne povuče.
Furosemide AUC∞ was increased 1.7-fold, indicating a weak inhibition of OAT1/OAT3 (see sections 4.4 and 4.5).
AUC∞ furosemida povećao se 1,7 puta, što ukazuje na slabu inhibiciju OAT1/OAT3 (vidjeti dijelove 4.4 i 4.5).
Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Nisu provedena službena ispitivanja apsorpcije, distribucije, metabolizma i eliminacije s nitizinonom.
This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range).
Ovaj se lijek primjenjuje u liječenju rijetke bolesti zvane nasljedna tirozinemija tipa 1 u odraslih, adolescenata i djece (bilo koje dobi).
It is not recommended to lower the plasma tyrosine concentration by reduction or discontinuation of nitisinone, since the metabolic defect may result in deterioration of the patient's clinical condition.
Ne preporučuje se snižavanje koncentracije tirozina u plazmi smanjivanjem ili prekidom liječenja nitizinonom, jer metabolički defekti mogu uzrokovati pogoršanje kliničkog stanja bolesnika.
The capsule may be opened and the content suspended in a small amount of water or formula diet immediately before intake.
Način primjene Kapsula se može otvoriti, a sadržaj raspršiti u maloj količini vode ili dijetalnog pripravka neposredno prije uzimanja.
The 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.
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 odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarized in the table below.
Vjerojatnosti preživljenja nakon 2, 4 i 6 godina liječenja nitizinonom prikazane su u sljedećoj tablici.
Contents of the pack and other information What Nitisinone MDK contains
Sadržaj pakiranja i druge informacije Što Nitisinone MDK sadrži
Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Ispitivanja na životinjama pokazala su štetne postnatalne učinke izlaganjem nitizinonu iz mlijeka.
The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Nađeni su klirens od 0,0956 l/kg/tjelesne težine/dan i poluvijek od 52,1 sata.
Fertility There are no data on nitisinone affecting fertility.
Plodnost Nema podataka o utjecaju nitizinona na plodnost.
If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.
Ako je sukcinilaceton u mokraći još uvijek mjerljiv mjesec dana nakon početka liječenja nitizinonom, doza nitizinona mora se povisiti na 1,5 mg/kg tjelesne težine/dan.
The capsules contain a white to off white powder.
Kapsule sadrže bijeli do gotovo bijeli prašak.
If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Ako ste uzeli više lijeka nego što ste trebali, obratite se svom liječniku ili ljekarniku u najkraćem mogućem roku.
Data is, however, limited in patients with body weight <20 kg.
Međutim, za bolesnike tjelesne težine <20 kg podaci su ograničeni.
Nitisinone has shown embryo-foetal toxicity in the mouse and rabbit at clinically relevant dose levels.
Nitizinon je pokazao embrio-fetalnu toksičnost u miševa i kunića pri klinički značajnim razinama doza.
Monitoring of plasma tyrosine levels
Praćenje razina tirozina u plazmi
(<1/10,000), not known (cannot be estimated from the available data).
< 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Treatment with this medicine should be started and supervised by a doctor experienced in the treatment of the disease (hereditary tyrosinemia type 1).
Liječenje ovim lijekom mora započeti i nadzirati liječnik s iskustvom u liječenju ove bolesti (nasljedne tirozinemije tipa 1).
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).
Stoga majke koje uzimaju nitizinon ne smiju dojiti, jer se rizik za dojenče ne može isključiti (vidjeti dijelove 4.3 i 5.3).
- The active substance is nitisinone.
- Djelatna tvar je nitizinon.
Exfoliative dermatitis may occur uncommonly.
Eksfolijativni dermatitis može se pojaviti manje često.
Succinylacetone inhibits the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate.
Sukcinilaceton inhibira put sinteze porfirina što dovodi do nakupljanja 5-aminolevulinata.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOCI
Mothers receiving nitisinone must not breast-feed (see sections 4.6 and 5.3).
Majke koje uzimaju nitizinon ne smiju dojiti (vidjeti dijelove 4.6 i 5.3).
It should be established that the patient is adhering to his/her dietary regimen and the plasma tyrosine concentration should be measured.
Potrebno je utvrditi pridržava li se bolesnik dijetetskog režima i mjeriti koncentracije tirozina u plazmi.
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.
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.
In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism.
In vitro studije na ljudskim jetrenim mikrosomima i c-DNK eksprimirajućim P450 enzimima pokazali su ograničeni metabolizam posredovan CYP 3A4.
What Nitisinone MDK is and what it is used for
Što je Nitisinone MDK i za što se koristi
Elevated tyrosine levels have been associated with toxicity to eyes, skin, and the nervous system.
Povišene razine tirozina povezane su s toksičnim učincima na očima, koži i živčanom sustavu.
During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Tijekom redovitog nadzora dobro je pratiti sukcinilaceton u mokraći, vrijednosti pretraga jetrene funkcije i razine alfa-fetoproteina (vidjeti dio 4.4).
Succinylacetone should not be detectable in urine or plasma when the nitisinone dose is properly adjusted.
Sukcinilacetat ne bi smio biti mjerljiv u mokraći ili plazmi kad se doza nitizinona ispravno prilagodi.
If you notice any side effects relating to the eyes, talk to your doctor immediately to have an eye examination.
Ako primijetite bilo koje nuspojave povezane s očima, obratite se odmah svom liječniku radi pregleda očiju.
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.
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.
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.
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).
In rats, exposure via milk resulted in reduced mean pup weight and corneal lesions.
U štakora, izloženost putem mlijeka rezultirala je smanjenjem prosječne težine mladunčadi i lezijama rožnice.
Nitisinone MDK blocks the breakdown of tyrosine and the harmful substances are not formed.
Nitisinone MDK blokira razgradnju tirozina te ne nastaju štetne tvari.
Treatment with nitisinone leads to higher levels of tyrosine in the blood which can cause eye related symptoms.
Liječenje nitizinonom povećava razine tirozina u krvi što može uzrokovati simptome povezane s očima.
It is unknown whether nitisinone is excreted in human breast milk.
Nije poznato izlučuje li se nitizinon u majčino mlijeko.
Nitisinone is a moderate CYP2C9 inhibitor.
Nitizinon je umjereno jak inhibitor CYP 2C9.
Other common side effects - Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).
Ostale česte nuspojave smanjeni broj krvnih pločica (trombocitopenija) i bijelih krvnih stanica (leukopenija), manjak određenih vrsta bijelih krvnih stanica (granulocitopenija).
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.
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.
60 hard capsules
60 tvrdih kapsula
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).
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).
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.
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.
No formal food interactions studies have been performed with Nitisinone MDK hard capsules.
Nisu provedena službena ispitivanja interakcija Nitisinone MDK tvrdih kapsula s hranom.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Drugi lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16A X04.
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.
Preporučuje se redovito praćenje broja trombocita i leukocita, jer je tijekom kliničkih procjena zabilježeno nekoliko slučajeva reverzibilne trombocitopenije i leukopenije.
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.
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.
This medicine has minor influence on the ability to drive and use machines.
Ovaj lijek malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
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.
The capsule contains a white to off-white powder.
Kapsula sadrži bijeli do gotovo bijeli prašak.
The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally.
Preporučena početna dnevna doza u pedijatrijskoj i odrasloj populaciji iznosi 1 mg/kg tjelesne težine koja se primjenjuje peroralno.
Nitisinone has minor influence on the ability to drive and use machines.
Nitisinone malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
What Nitisinone MDK looks like and contents of the pack
Kako Nitisinone MDK izgleda i sadržaj pakiranja
The liver function should be monitored regularly by liver function tests and liver imaging.
Praćenje jetre Jetrena funkcija mora se redovito pratiti pretragama jetrene funkcije i snimanjem jetre.
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.
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.
Capsule content ˗ Pregelatinised starch (maize)
Sadržaj kapsule - prethodno geliran škrob (kukuruzni)
If you experience any side effects, shorter intervals are recommended.
U slučaju pojave nuspojava, preporučuju se kraći razmaci.
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).
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).
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).
Pored liječenja nitizinonom potrebna je dijeta siromašna fenilalaninom i tirozinom, uz praćenje aminokiselina u plazmi (vidjeti dijelove 4.4 i 4.8).
If you forget to take a dose, contact your doctor or pharmacist.
Ako ste zaboravili uzeti dozu, obratite se svom liječniku ili ljekarniku.
MedDRA system organ class Frequency
MedDRA organski sustav Učestalost
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).
Ograničenje unosa tirozina i fenilalanina hranom trebalo bi ograničiti toksičnost povezanu s ovim tipom tirozinemije snižavanjem razine tirozina (vidjeti dio 4.4).
HDPE plastic bottle with LDPE plastic cap containing 60 capsules.
Plastična boca od polietilena visoke gustoće s plastičnim poklopcem od polietilena niske gustoće, koja sadrži 60 kapsula.
Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment.
Nuspojave koje zahvaćaju organski sustav "Poremećaji krvi i limfnog sustava" prema MedDRA-klasifikaciji organskih sustava povukle su se tijekom kontinuiranog liječenja nitizinonom.
By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Inhibicijom normalnog katabolizma tirozina u bolesnika s HT1, nitizinon sprječava nakupljanje toksičnih međuprodukata maleilacetoacetata i fumarilacetoacetata.
Nitisinone is not expected to inhibit P-gp, BCRP or OCT2-mediated transport.
Ne očekuje se da će nitizinon inhibirati prijenos posredovan P-gp-om, BCRP-om ili prijenosnikom OCT2.
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.
Stoga se preporučuje da se, ako se liječenje Nitisinone MDK tvrdim kapsulama započne s hranom, takav režim liječenja održava rutinski, vidjeti dio 4.2.
NTBC study (N=250) Age at start of treatment
Ispitivanje NTBC (N=250) Broj bolesnika
Imprint ˗ Black iron oxide (E172) ˗ Shellac
Oznaka - željezov oksid, crni (E 172) - šelak
By its mode of action, nitisinone increases tyrosine levels in all nitisinone treated patients.
Zbog načina djelovanja nitizinon povećava razine tirozina u svih bolesnika liječenih nitizinonom.
The dose of nitisinone should be adjusted individually.
Doza nitizinona mora se prilagoditi pojedinom bolesniku.
Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with this type of tyrosinemia.
Ograničenje unosa tirozina i fenilalanina hranom trebalo bi ograničiti toksičnost povezanu s ovim tipom tirozinemije.
Can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Može se čuvati na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca, nakon čega se mora baciti.
Other medicines and Nitisinone MDK
Drugi lijekovi i Nitisinone MDK
In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
U bolesnika s HT-1, ti se međuprodukti pretvaraju u toksične metabolite sukcinilaceton i sukcinilacetoacetat.
Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Konjunktivitis, zamućenje rožnice, keratitis, fotofobija, bol u oku
Nitisinone treatment leads to elevated tyrosine levels.
Liječenje nitizinonom uzrokuje povišene razine tirozina.
The active ingredient of Nitisinone MDK is nitisinone.
Djelatna tvar u lijeku Nitisinone MDK je nitizinon.
Thrombocytopenia, leucopenia, granulocytopenia
Trombocitopenija, leukopenija, granulocitopenija
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.
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.
The recommended total daily dose is 1 mg/kg body weight administered orally.
Preporučena ukupna dnevna doza je 1 mg/kg tjelesne težine i uzima se kroz usta.
Capsule shell ˗ Gelatin ˗ Titanium dioxide (E171)
Ovojnica kapsule - želatina - titanijev dioksid (E 171)
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.
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.
Capsule content: pregelatinised maize starch Capsule shell: gelatin, titanium dioxide (E171) Printing ink: black iron oxide (E172), shellac glaze
Ovojnica kapsule: želatina, titanijev dioksid (E 171) Tinta za označivanje: željezov oksid, crni (E 172), šelak glazura
The clinical study was open-labelled and uncontrolled.
Klinička djelotvornost i sigurnost Kliničko je ispitivanje bilo otvorenog tipa i bez kontrolne skupine.
If you take more Nitisinone MDK than you should
Ako uzmete više lijeka Nitisinone MDK nego što ste trebali