FrancophonIA/ELRC3.0 huggingface dataset:
English: - Each Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Croatian: Orion 175 mg/43,75 mg/200 mg tableta sadrži 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
English: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Croatian: Orion 100 mg/25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Croatian: Orion 50 mg/12,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: - Each Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Croatian: Orion 125 mg/31,25 mg/200 mg tableta sadrži 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Croatian: Orion 200 mg/50 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Levodopa/Carbidopa/Entacapone Orion strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Croatian: Oriona iznosi 10 tableta na dan za jačine od 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg i 150 mg/37,5 mg/200 mg.
English: Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Croatian: Orion 150 mg/37,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: - Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of drug-induced extrapyramidal reactions.
Croatian: Orion se ne preporučuje za liječenje ekstrapiramidnih reakcija izazvanih lijekovima.
English: Tablet core:
Croatian: Orion tablete.
English: - If general anaesthesia is required, therapy with Levodopa/Carbidopa/Entacapone Orion may be continued for as long as the patient is permitted to take fluids and medicinal products by mouth.
Croatian: Orionom može se nastaviti tako dugo dok bolesnik smije uzimati tekućinu i lijekove na usta.
English: Management of acute overdose with Levodopa/Carbidopa/Entacapone Orion therapy is similar to acute overdose with levodopa.
Croatian: Zbrinjavanje akutnog predoziranja tijekom terapije Levodopa/Carbidopa/Entacapone
English: Patients taking these medicinal products with Levodopa/Carbidopa/Entacapone Orion should be carefully observed for loss of therapeutic response.
Croatian: Orionom mora se pažljivo pratiti radi gubitka terapijskog odgovora.
English: 1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
Croatian: 1 ml (125 mg/ml) 12 (4 x 3) napunjenih brizgalica (višestruko pakiranje)
English: 1 ml (125 mg/ml) 4 pre-filled pens
Croatian: 1 ml (125 mg/ml) 4 napunjene brizgalice
English: Date of first authorisation: 24 August 2017
Croatian: Datum prvog odobrenja: 24. kolovoza 2017.
English: This dose should be considered as a maximal dose for all patients.
Croatian: Ta se doza mora smatrati maksimalnom dozom za sve bolesnike.
English: Store in the original bottle in order to protect from light.
Croatian: Čuvati u originalnoj bočici radi zaštite od svjetlosti.
English: The capsules are packaged in plastic bottles.
Croatian: Kapsule su pakirane u plastične boce.
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Croatian: Podaci iz ispitivanja koji su se koristili kao povijesna kontrola (van Spronsen i sur., 1994) pokazali su sljedeće vjerojatnosti preživljenja.
English: Please contact your doctor if you plan to become pregnant.
Croatian: Obratite se svom liječniku ako planirate trudnoću.
English: No information about specific treatment of overdose is available.
Croatian: Nisu dostupne informacije o specifičnom liječenju predoziranja.
English: Do not change the dose or stop the treatment without talking to your doctor.
Croatian: Nemojte mijenjati dozu ili prekidati liječenje bez razgovora sa svojim liječnikom.
English: Do not forget to mark the date on the bottle, when removed from the refrigerator.
Croatian: Ne zaboravite naznačiti na boci datum vađenja iz hladnjaka.
English: Other pharmaceutical forms are available for paediatric patients who have difficulties swallowing capsules.
Croatian: Drugi farmaceutski oblici dostupni su za pedijatrijske bolesnike koji imaju poteškoća s gutanjem kapsula.
English: Follow-up by your doctor should be performed every 6 months.
Croatian: Vaš će liječnik provoditi kontrole svakih 6 mjeseci.
English: During the treatment, blood samples will be drawn in order for your doctor to check whether the treatment is adequate and to make sure that there are no possible side effects causing blood disorders.
Croatian: Tijekom liječenja uzimat će se uzorci Vaše krvi kako bi liječnik provjerio je li liječenje za Vas odgovarajuće te da bi se pobrinuo da nema mogućih nuspojava koje uzrokuju poremećaje krvi.
English: A dose of 2 mg/kg body weight/day may be needed based on the evaluation of all biochemical parameters.
Croatian: Možda će biti potrebna doza od 2 mg/kg tjelesne težine/dan na temelju procjene svih biokemijskih parametara.
English: Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Croatian: Posjete radi praćenja potrebno je provoditi svakih 6 mjeseci; u slučaju štetnih događaja preporučuju se kraći razmaci između posjeta.
English: Date when removed from refrigerator:
Croatian: Datum vađenja iz hladnjaka:
English: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na nitizinon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Croatian: Ako je biokemijski odgovor zadovoljavajući, doza se mora prilagođavati samo sukladno povećanju tjelesne težine.
English: These substances are accumulated in your body.
Croatian: Te se tvari nakupljaju u Vašem tijelu.
English: Age at onset of symptoms 1 year 2 years < 2 months
Croatian: Dob pri nastupu simptoma 1 godina 2 godine < 2 mjeseca
English: Each bottle contains 60 capsules.
Croatian: Jedna boca sadrži 60 kapsula.
English: Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Croatian: Analiza populacijske farmakokinetike provedena je na skupini od 207 HT-1 bolesnika.
English: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
Croatian: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Ujedinjeno Kraljevstvo
English: You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body.
Croatian: Morate se pridržavati posebne dijete dok uzimate ovaj lijek, jer će tirozin zaostati u Vašem tijelu.
English: Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Croatian: Nuspojave koje zahvaćaju oči (vidjeti dio 4.8) mogu utjecati na vid.
English: NTBC study (N=250)
Croatian: Ispitivanje NTBC (N=250)
English: However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 “Possible side effects”).
Croatian: Ipak, ako osjetite nuspojave koje utječu na vid, ne smijete upravljati vozilima ili raditi sa strojevima dok Vam vid ponovo ne postane normalan (vidjeti dio 4 „Moguće nuspojave”).
English: If you have the impression that the medicine is not working properly, talk to your doctor.
Croatian: Ako imate dojam da lijek ne djeluje ispravno, obratite se svom liječniku.
English: Your doctor will adjust the dose individually.
Croatian: Vaš će liječnik prilagoditi dozu Vašim individualnim potrebama.
English: It is recommended to administer the dose once daily.
Croatian: Preporučuje se primjenjivati dozu jednom dnevno.
English: In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
Croatian: U kliničkim ispitivanjima granulocitopenija je bila manje često teška (<0,5x109/l) i nije bila povezana s infekcijama.
English: In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
Croatian: U međunarodnom ispitivanju bolesnika s HT-1 koji se liječe samo uz ograničenja u prehrani, pronašlo se da je HCC bio dijagnosticiran u 18% svih bolesnika u dobi od 2 godine i naviše.
English: Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease.
Croatian: Liječenje svih genotipova bolesti mora se započeti čim je prije moguće, kako bi se povećalo ukupno preživljenje i izbjegle komplikacije poput zatajenja jetre, raka jetre i bolesti bubrega.
English: Concomitant use with other medicinal products
Croatian: Istodobna primjena s drugim lijekovima
English: Each carton pack contains one bottle.
Croatian: Jedno kartonsko pakiranje sadrži jednu bocu.
English: However, nitisinone has been co-administered with food during the generation of efficacy and safety data.
Croatian: Međutim, nitizinon se primjenjivao istodobno s hranom tijekom prikupljanja podataka o djelotvornosti i sigurnosti.
English: 60 capsules
Croatian: 60 kapsula
English: There are no adequate data from the use of nitisinone in pregnant women.
Croatian: Nema odgovarajućih podataka o uporabi nitizinona u trudnica.
English: The safety of this medicine has not been studied in pregnant and breast-feeding women.
Croatian: Sigurnost ovog lijeka nije ispitivana u trudnica i dojilja.
English: Eye problems could be a sign of inadequate dietary control (see section 4).
Croatian: Problemi s očima mogu biti znak neodgovarajuće kontrole prehranom (pogledajte dio 4).
English: From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Croatian: Podaci iz kliničkih ispitivanja i primjene nakon stavljanja lijeka u promet ne ukazuju na to da se sigurnosni profil razlikuje u različitih podskupina pedijatrijske populacije ili da se razlikuje od sigurnosnog profila u odraslih bolesnika.
English: If you become pregnant you should contact your doctor immediately.
Croatian: Ako zatrudnite, odmah se obratite svom liječniku.
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.
Croatian: Preporučuje se pregled očiju procjepnom svjetiljkom prije početka liječenja nitizinonom , a zatim redovito, najmanje jednom godišnje.
English: Nitisinone MDK with food and drink
Croatian: Nitisinone MDK s hranom i pićem
English: 2 - 6 months > 6 months
Croatian: 2-6 mjeseci > 6 mjeseci
English: Blepharitis
Croatian: Blefaritis
English: In 10 healthy male volunteers, after administration of a single dose of nitisinone capsules (1 mg/kg body weight) the terminal half-life (median) of nitisinone in plasma was 54 hours (ranging from 39 to 86 hours).
Croatian: U 10 zdravih muških dobrovoljaca nakon primjene pojedinačne doze kapsula nitizinona (1 mg/kg tjelesne težine) terminalni poluvijek (medijan) nitizinona u plazmi bilo je 54 sata (u rasponu od 39 do 86 sati).
English: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
Croatian: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Ujedinjena Kraljevina
English: Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Croatian: Nitizinon nije pokazao kancerogeni potencijal u 26-tjednom ispitivanju kancerogenosti na transgeničnim miševima (TgrasH2).
English: Nitisinone MDK should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Croatian: Nitisinone MDK ne smije se primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje nitizinonom.
English: Dose-adjustment of these co-administered medicinal products may be needed (see section 4.5).
Croatian: Može biti potrebna prilagodba doze tih istodobno primjenjivanih lijekova (vidjeti dio 4.5).
English: The dose recommendation in mg/kg body weight is the same in children and adults.
Croatian: Preporučena doza u mg/kg tjelesne težine jednaka je u djece i odraslih.
English: 6 years
Croatian: 6 godina
English: If you have problems with swallowing the capsules, you may open the capsule and mix the powder with a small amount of water or formula diet just before you take it.
Croatian: Ako imate problema s gutanjem kapsula, možete otvoriti kapsulu i pomiješati prašak s malo vode ili dijetetskim pripravkom neposredno prije uzimanja.
English: The study indicates that once daily administration is safe and efficacious across all ages of patients.
Croatian: Ispitivanje pokazuje da je primjena jednom dnevno sigurna i djelotvorna u svim dobnim skupinama bolesnika.
English: However, due to the limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population.
Croatian: Međutim, zbog ograničenih podataka za bolesnike tjelesne težine <20 kg, u toj se populaciji bolesnika preporučuje razdijeliti ukupnu dnevnu dozu i primijeniti je u dva dijela.
English: If you start Nitisinone MDK treatment by taking it with food, it is recommended that you carry on taking it with food throughout your course of treatment.
Croatian: Ako započnete liječenje lijekom Nitisinone MDK uzimajući ga s hranom, preporučuje se da ga nastavite uzimati s hranom tijekom liječenja.
English: It was found that the early initiation of treatment resulted in a further reduced risk for the development of hepatocellular carcinoma.
Croatian: Otkriveno je da je rani početak liječenja rezultirao u daljnjem smanjenju rizika od razvoja hepatocelularnog karcinoma.
English: 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.
Croatian: Vaše tijelo nije u stanju u potpunosti razgraditi aminokiselinu tirozin (aminokiseline su građevne jedinice naših proteina), stvarajući tako štetne tvari.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake “EXP“.
English: Elevated tyrosine levels
Croatian: Povišene razine tirozina
English: Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Croatian: Nemojte dojiti dok uzimate ovaj lijek, pogledajte dio „Trudnoća i dojenje“.
English: 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:
Croatian: 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:
English: There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Croatian: Nema specifičnih preporuka za dozu u starijih ili bolesnika s oštećenjem bubrega ili jetre.
English: 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.
Croatian: Dostupni podaci iz kliničkih studija ukazuju da se sukcinilaceton u mokraći normalizirao u više od 90% bolesnika tijekom prvog tjedna liječenja.
English: Increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment.
Croatian: Porast koncentracije alfa-fetoproteina u serumu može biti znak neodgovarajućeg liječenja.
English: The dosing frequency in the study was twice daily.
Croatian: Učestalost doziranja u ispitivanju bila je dvaput dnevno.
English: If you get red eyes or any other signs of effects on the eyes, contact your doctor immediately for an eye examination.
Croatian: Ako Vam oči postanu crvene ili uočite bilo koje druge znakove učinka na oči,odmah se obratite svom liječniku radi pregleda očiju.
English: There were no clinically important differences in AEs or other safety assessments between once and twice daily dosing.
Croatian: Nije bilo klinički značajnih razlika u štetnim događajima i drugim procjenama sigurnosti između doziranja jednom dnevno i doziranja dvaput dnevno.
English: 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
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i
English: No mutagenic but a weak clastogenic activity was observed in in vitro studies.
Croatian: Nije primijećena mutagena, već samo slaba klastogena aktivnost u in vitro studijama.
English: It is recommended to also monitor serum alpha-fetoprotein concentrations.
Croatian: Također se preporučuje praćenje koncentracija alfa-fetoproteina u serumu.
English: Patients with increasing alpha-fetoprotein or signs of nodules in the liver should always be evaluated for hepatic malignancy.
Croatian: Bolesnike s porastom alfa-fetoproteina ili znakovima čvorova u jetri mora se uvijek procijeniti na zloćudne bolesti jetre.
English: 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).
Croatian: 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).
English: Do not breast-feed while taking this medicine, see section “Do not take Nitisinone MDK”.
Croatian: Nemojte dojiti dok uzimate ovaj lijek, pogledajte dio „Nemojte uzimati Nitisinone MDK”.
English: There was no evidence of in vivo genotoxicity (mouse micronucleus assay and mouse liver unscheduled DNA synthesis assay).
Croatian: Nije bilo dokaza za in vivo genotoksičnost (test u mišjih mikronukleusa i test neplanirane sinteze DNK na jetri miša).
English: This special diet is based on low tyrosine and phenylalanine (another amino acid) content.
Croatian: Ta se posebna dijeta temelji na niskom sadržaju tirozina i fenilalanina (druge aminokiseline).
English: If the vision is affected the patient should not drive or use machines until the event has subsided.
Croatian: Ako je vid narušen, bolesnik ne smije upravljati vozilima niti raditi sa strojevima dok se ta nuspojava ne povuče.
English: Furosemide AUC∞ was increased 1.7-fold, indicating a weak inhibition of OAT1/OAT3 (see sections 4.4 and 4.5).
Croatian: AUC∞ furosemida povećao se 1,7 puta, što ukazuje na slabu inhibiciju OAT1/OAT3 (vidjeti dijelove 4.4 i 4.5).
English: Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Croatian: Nisu provedena službena ispitivanja apsorpcije, distribucije, metabolizma i eliminacije s nitizinonom.
English: This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range).
Croatian: Ovaj se lijek primjenjuje u liječenju rijetke bolesti zvane nasljedna tirozinemija tipa 1 u odraslih, adolescenata i djece (bilo koje dobi).
English: 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.
Croatian: Ne preporučuje se snižavanje koncentracije tirozina u plazmi smanjivanjem ili prekidom liječenja nitizinonom, jer metabolički defekti mogu uzrokovati pogoršanje kliničkog stanja bolesnika.
English: The capsule may be opened and the content suspended in a small amount of water or formula diet immediately before intake.
Croatian: Način primjene Kapsula se može otvoriti, a sadržaj raspršiti u maloj količini vode ili dijetalnog pripravka neposredno prije uzimanja.
English: 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.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarized in the table below.
Croatian: Vjerojatnosti preživljenja nakon 2, 4 i 6 godina liječenja nitizinonom prikazane su u sljedećoj tablici.
English: Contents of the pack and other information What Nitisinone MDK contains
Croatian: Sadržaj pakiranja i druge informacije Što Nitisinone MDK sadrži
English: Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Croatian: Ispitivanja na životinjama pokazala su štetne postnatalne učinke izlaganjem nitizinonu iz mlijeka.
English: The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Croatian: Nađeni su klirens od 0,0956 l/kg/tjelesne težine/dan i poluvijek od 52,1 sata.
English: Fertility There are no data on nitisinone affecting fertility.
Croatian: Plodnost Nema podataka o utjecaju nitizinona na plodnost.
English: 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.
Croatian: 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.
English: The capsules contain a white to off white powder.
Croatian: Kapsule sadrže bijeli do gotovo bijeli prašak.
English: If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako ste uzeli više lijeka nego što ste trebali, obratite se svom liječniku ili ljekarniku u najkraćem mogućem roku.
English: Data is, however, limited in patients with body weight <20 kg.
Croatian: Međutim, za bolesnike tjelesne težine <20 kg podaci su ograničeni.
English: Nitisinone has shown embryo-foetal toxicity in the mouse and rabbit at clinically relevant dose levels.
Croatian: Nitizinon je pokazao embrio-fetalnu toksičnost u miševa i kunića pri klinički značajnim razinama doza.
English: Monitoring of plasma tyrosine levels
Croatian: Praćenje razina tirozina u plazmi
English: (<1/10,000), not known (cannot be estimated from the available data).
Croatian: < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Treatment with this medicine should be started and supervised by a doctor experienced in the treatment of the disease (hereditary tyrosinemia type 1).
Croatian: Liječenje ovim lijekom mora započeti i nadzirati liječnik s iskustvom u liječenju ove bolesti (nasljedne tirozinemije tipa 1).