FrancophonIA/ELRC3.0 huggingface dataset:
English: However, if you take more Neoclarityn than you were told to, tell your doctor, pharmacist or nurse immediately.
Croatian: Vam je propisano, odmah o tome obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: Taking Neoclarityn oral solution is not recommended if you are pregnant or nursing a baby.
Croatian: Ako ste trudni ili dojite, nije preporučljivo uzimati Neoclarityn oralnu otopinu.
English: SE-141 75 Kungens Kurva Sweden
Croatian: SE-141 75 Kungens Kurva Švedska
English: How to prepare a new bottle of medicine for first time use:
Croatian: Kako pripremiti novu bocu lijeka za prvu uporabu:
English: Follow the instructions below:
Croatian: Slijedite niže navedene upute:
English: What Orfadin is and what it is used for
Croatian: Što je Orfadin i za što se koristi
English: Orfadin must not be injected.
Croatian: Orfadin se ne smije ubrizgavati.
English: Talk to your doctor or pharmacist before taking Orfadin.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Orfadin.
English: - This medicine has been prescribed for you.
Croatian: - Ovaj je lijek propisan Vama.
English: If you start 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 uzimajući ga s hranom, preporučuje se da ga nastavite uzimati s hranom tijekom liječenja.
English: If you take more Orfadin than you should
Croatian: Ako uzmete više Orfadina nego što ste trebali
English: Orfadin with food
Croatian: Orfadin s hranom
English: Each pack contains 1 bottle.
Croatian: Svako pakiranje sadrži 1 bocu.
English: Each bottle contains 60 capsules.
Croatian: Svaka boca sadrži 60 kapsula.
English: Date of first authorisation: 21 February 2005 Date of latest renewal: 19 January 2010
Croatian: Datum prvog odobrenja: 21. veljače 2005.
English: A 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: Other medicines and Orfadin
Croatian: Drugi lijekovi i Orfadin
English: Contents of the pack and other information What Orfadin contains
Croatian: Sadržaj pakiranja i druge informacije Što Orfadin sadrži
English: What Orfadin looks like and contents of the pack
Croatian: Kako Orfadin izgleda i sadržaj pakiranja
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 (pogledajte dio 4 „Moguće nuspojave“).
English: The dose should be withdrawn and administered immediately after re-dispersion.
Croatian: Dozu treba izvući i primijeniti odmah nakon redisperzije.
English: Orfadin should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Croatian: Orfadin se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje nitizinonom.
English: Do not attach a needle to the syringe.
Croatian: Nemojte spajati iglu na štrcaljku.
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: Age at onset of symptoms 1 year 2 years < 2 months > 2-6 months > 6 months
Croatian: Dob pri nastupu simptoma 1 godina 2 godine < 2 mjeseca > 2-6 mjeseci > 6 mjeseci
English: No formal food interactions studies have been performed with Orfadin hard capsules.
Croatian: Nisu provedena službena ispitivanja interakcija Orfadin tvrdih kapsula s hranom.
English: Oral suspension 90 ml
Croatian: Oralna suspenzija 90 ml
English: Do not breast-feed while taking this medicine, see section “Do not take Orfadin”.
Croatian: Nemojte dojiti dok uzimate ovaj lijek, pogledajte dio „Nemojte uzimati Orfadin“.
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 bio je 54 sata (u rasponu od 39 do 86 sati).
English: The bottle may be stored at room temperature (not above 25°C).
Croatian: Boca se može čuvati na sobnoj temperaturi (ne iznad 25 °C).
English: It is recommended that the oral suspension is taken with food.
Croatian: Preporučuje se uzimati oralnu suspenziju s hranom.
English: The capsules are packaged in plastic bottles with tamper-proof closures.
Croatian: Kapsule su pakirane u plastične boce sa zaštitnim zatvaračima s evidencijom otvaranja.
English: Orfadin is also available as a 4 mg/ml oral suspension for paediatric patients who have difficulties swallowing capsules.
Croatian: Orfadin je također dostupan u obliku oralne suspenzije od 4 mg/ml za pedijatrijske bolesnike koji imaju poteškoća s gutanjem kapsula.
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: Remove the bottle from the refrigerator.
Croatian: Bocu izvadite iz hladnjaka.
English: Orfadin blocks the breakdown of tyrosine and the harmful substances are not formed.
Croatian: Orfadin blokira razgradnju tirozina te ne nastaju štetne tvari.
English: NTBC study (N=250) Number of patients at
Croatian: Ispitivanje NTBC (N=250) Broj bolesnika
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 ispitivanja ukazuju da se sukcinilaceton u mokraći normalizirao u više od 90% bolesnika tijekom prvog tjedna liječenja.
English: The bottle adapter should not be removed.
Croatian: Nastavak za bocu ne smije se uklanjati.
English: Your doctor, pharmacist or nurse will advise which oral syringe to use depending on the dose that has been prescribed.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra savjetovat će Vam koju štrcaljku za usta da koristite, ovisno o dozi koja Vam je propisana.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
Croatian: Farmakoterapijska skupina: Drugi lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16A X04.
English: A close monitoring of the plasma levels of bilirubin in the newborn patient is therefore of great importance.
Croatian: Zbog toga je od velike važnosti pažljivo praćenje razine bilirubina u plazmi bolesne novorođenčadi.
English: 5 mg, 10 mg, 20 mg: Store in a refrigerator.
Croatian: 5 mg, 10 mg, 20 mg: Čuvati u hladnjaku.
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 ispitivanjima.
English: If you stop taking Orfadin
Croatian: Ako prestanete uzimati Orfadin
English: White, slightly viscous opaque suspension.
Croatian: Bijela, blago viskozna neprozirna suspenzija.
English: What you need to know before you take Orfadin Do not take Orfadin
Croatian: Što morate znati prije nego počnete uzimati Orfadin
English: Food does not influence the bioavailability of nitisinone oral suspension, but intake together with food decreases the absorption rate and consequently leads to lower fluctuations in serum concentrations within a dosage interval.
Croatian: Hrana ne utječe na bioraspoloživost nitizinona iz oralne suspenzije, ali uzimanje zajedno s hranom usporava apsorpciju i posljedično dovodi do manje fluktuacije serumskih koncentracija tijekom intervala između doza.
English: The bottle may be stored at a temperature not above 25°C or in the refrigerator.
Croatian: Boca se može čuvati na temperaturi ispod 25 °C ili u hladnjaku.
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: It is used for measuring doses of more than 3 ml.
Croatian: Upotrebljava se za mjerenje doza većih od 3 ml.
English: Orfadin is for oral use only.
Croatian: Orfadin je samo za peroralnu primjenu.
English: Before re-dispersion, the medicinal product may appear as a solid cake with a slightly opalescent supernatant.
Croatian: Prije redisperzije lijek može izgledati kao čvrsti talog s blago opalescentnim supernatantom.
English: Each bottle contains 90 ml oral suspension.
Croatian: Jedna boca sadrži 90 ml oralne suspenzije.
English: The table below shows the dose conversion (mg/ml) for the three oral syringes sizes.
Croatian: Sljedeća tablica pokazuje konverziju doza (mg/ml) za tri veličine štrcaljki za usta.
English: Precautions to be taken before handling or administering the medicinal product No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Croatian: Mjere opreza koje se provode prije rukovanja ili primjene lijeka Na štrcaljku za usta ne smiju biti spojeni ni igla, ni intravenska kanila niti bilo koje drugo pomagalo za parenteralnu primjenu.
English: Orfadin contains sodium, glycerol and sodium benzoate
Croatian: Orfadin sadrži natrij, glicerol i natrijev benzoat
English: How to prepare a dose of medicine
Croatian: Kako pripremiti dozu lijeka
English: Cleaning:
Croatian: Čišćenje:
English: Orfadin has minor influence on the ability to drive and use machines.
Croatian: Orfadin malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - The other ingredients are hydroxypropylmethylcellulose, glycerol (see section 2), polysorbate 80, sodium benzoate (E211) (see section 2), citric acid monohydrate, sodium citrate (see section 2), strawberry aroma (artificial) and purified water.
Croatian: - Pomoćne tvari su hidroksipropilmetilceluloza, glicerol (pogledajte dio 2), polisorbat 80, natrijev benzoat (E211) (pogledajte dio 2), citratna kiselina hidrat, natrijev citrat (pogledajte dio 2), aroma jagode (umjetna) i pročišćena voda.
English: If you forget to take Orfadin
Croatian: Ako ste zaboravili uzeti Orfadin
English: The oral suspension is a white, slightly thicker opaque suspension.
Croatian: Oralna suspenzija je bijela, nešto gušća neprozirna suspenzija.
English: The dose should be administered in the mouth immediately (without dilution) in order to avoid caking in the oral syringe.
Croatian: 8. Dozu treba odmah primijeniti u usta (bez razrjeđivanja) kako bi se spriječilo taloženje u štrcaljki za usta.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake “EXP“.
English: Turn the bottle to an upright position again.
Croatian: Bocu vratite u uspravni položaj.
English: The oral suspension is taken with a oral syringe directly in the mouth without dilution.
Croatian: Oralna suspenzija uzima se pomoću štrcaljke izravno u usta, bez razrjeđivanja.
English: How to take Orfadin
Croatian: Kako uzimati Orfadin
English: 2 mg, 5 mg, 10 mg and 20 mg hard capsules:
Croatian: 2 mg, 5 mg, 10 mg i 20 mg tvrde kapsule:
English: Clean the oral syringe immediately with water.
Croatian: Štrcaljku za usta odmah operite vodom.
English: Shake off excess water and leave the disassembled oral syringe to dry until reassemble for next dosing occasion.
Croatian: Otresite višak vode te rastavljenu štrcaljku za usta ostavite da se suši do sastavljanja za sljedeću uporabu.
English: Liver monitoring
Croatian: Praćenje jetre
English: If the levels are markedly higher than they should be, especially in prematures babies with risk factors as acidosis (too low pH in the blood) and low albumin level (a protein in the blood) treatment with Orfadin capsules will be considered instead of the oral suspension until the bilirubin plasma levels are normalised.
Croatian: Ako razine budu izrazito više nego što bi trebale biti, osobito u nedonoščadi s rizičnim čimbenicima kao što su acidoza (prenizak pH krvi) i niska razina albumina (jednog proteina u krvi), razmotrit će se liječenje Orfadin kapsulama umjesto oralnom suspenzijom sve dok se razine bilirubina u plazmi ne normaliziraju.
English: A dose of 20 ml oral suspension (10 g glycerol) or more may cause headache, stomach upset and diarrhoea.
Croatian: Doza od 20 ml oralne suspenzije (10 g glicerola) ili više može uzrokovati glavobolju, nadraženi želudac i proljev.
English: Therefore, it is recommended that the oral suspension is taken with food, see section 4.2.
Croatian: Stoga se preporučuje da se oralna suspenzija uzima s hranom, vidjeti dio 4.2.
English: Capsule shell gelatin titanium dioxide (E 171)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E 171)
English: Orfadin is also available in 2 mg, 5 mg, 10 mg and 20 mg capsules, if considered more suitable for the patient.
Croatian: Orfadin je također dostupan u kapsulama od 2 mg, 5 mg 10 mg i 20 mg, ako se smatraju pogodnijima za bolesnika.
English: 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: 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: Sigurnosni profil uglavnom se temelji na pedijatrijskog populaciji budući da je liječenje nitizinonom potrebno započeti čim se ustanovi nasljedna tirozinemija tipa 1 (HT-1).
English: In patients with HT-1, 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: Three oral syringes (1 ml, 3 ml and 5 ml) are provided for accurate measurement of the prescribed dose.
Croatian: Priložene su tri štrcaljke za usta (1 ml, 3 ml i 5 ml) za točno mjerenje propisane doze.
English: The hard capsules are white, opaque, imprinted with “NTBC” and the strength “2 mg”, “5 mg”, “10 mg” or “20 mg”, in black.
Croatian: Tvrde kapsule su bijele, neprozirne s utisnutom crnom oznakom “NTBC” i oznakom jačine “2 mg“, “5 mg“ “10 mg“ ili “20 mg“.
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 HT-1, nitizinon sprječava nakupljanje toksičnih međuprodukata maleilacetoacetata i fumarilacetoacetata.
English: Each pack contains one bottle, one bottle adapter and three oral syringes.
Croatian: Jedno pakiranje sadrži jednu bocu, jedan nastavak za bocu i tri štrcaljke za usta.
English: Capsule shell: gelatine titanium dioxide (E 171).
Croatian: Ovojnica kapsule: želatina titanijev dioksid (E 171).
English: This medicinal product contains 0.7 mg (0.03 mmol) sodium per ml.
Croatian: Ovaj lijek sadrži 0,7 mg (0,03 mmol) natrija po ml.
English: Figure F.
Croatian: Slika F.
English: The liver function should be monitored regularly by liver function tests and liver imaging.
Croatian: Jetrena funkcija mora se redovito pratiti pretragama jetrene funkcije i snimanjem jetre.
English: It is important to carefully follow the instructions given in section 6.6 for preparation and administration of the dose, in order to ensure the dosing accuracy.
Croatian: Važno je pažljivo slijediti upute za pripremu i primjenu doze navedene u dijelu 6.6, kako bi se osiguralo točno doziranje.
English: Dose Orfadin mg ml
Croatian: Doza Orfadina mg ml
English: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP3A4-mediated metabolism.
Croatian: In vitro ispitivanja na ljudskim jetrenim mikrosomima i c-DNK eksprimirajućim P450 enzimima pokazala su ograničeni metabolizam posredovan CYP 3A4.
English: Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1.
Croatian: Nitizinon je uzrokovao približno 30%-tno smanjenje AUC∞ klorzoksazona, što ukazuje na slabu indukciju CYP 2E1.
English: Capsule content Starch, pregelatinised (maize)
Croatian: Sadržaj kapsule škrob, prethodno geliran (kukuruzni)
English: A pre- and postnatal development study in the mouse showed statistically significantly reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, respectively, than the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day.
Croatian: Ispitivanja prenatalnog i postnatalnog razvoja u miševa pokazala 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: Orfadin 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: 2 mg: Store in a refrigerator.
Croatian: POSEBNE MJERE ČUVANJA 2 mg: Čuvati u hladnjaku.
English: Before shaking the bottle, it may look like a solid cake in the bottom and a slightly opalescent liquid.
Croatian: Prije nego protresete bocu, može izgledati kao talog na dnu boce i blago opalescentna tekućina.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Croatian: Nitizinon je kompetitivni inhibitor 4-hidroskifenilpiruvat dioksigenaze, enzima koji prethodi fumarilacetoacetat hidrolazi u kataboličkom putu tirozina.
English: Oral suspension 1 bottle of 90 ml, 1 bottle adaptor, 3 oral syringes (1 ml, 3 ml, 5 ml).
Croatian: Oralna suspenzija 1 boca od 90 ml, 1 nastavak za bocu, 3 štrcaljke za usta (1 ml, 3 ml, 5 ml).
English: The active ingredient of Orfadin is nitisinone.
Croatian: Djelatna tvar u lijeku Orfadin je nitizinon.
English: Each capsule contains 2 mg nitisinone Each capsule contains 5 mg nitisinone Each capsule contains 10 mg nitisinone Each capsule contains 20 mg nitisinone
Croatian: Svaka kapsula sadrži 2 mg nitizinona Svaka kapsula sadrži 5 mg nitizinona Svaka kapsula sadrži 10 mg nitizinona Svaka kapsula sadrži 20 mg nitizinona
English: The newborn baby's blood levels of bilirubin (a substance that causes the yellowing of the skin in high levels) will be closely monitored.
Croatian: Razina bilirubina (tvari koja uzrokuje žutu boju kože kad je prisutna u visokim koncentracijama) u krvi novorođenčeta pažljivo će se pratiti.
English: Separate barrel and plunger and rinse both with water.
Croatian: Odvojite trup i klip štrcaljke i isperite ih vodom.
English: It is recommended that the healthcare professional advises the patient or care giver how to use the oral syringes to ensure that the correct volume is administered and that the prescription is given in ml.
Croatian: Preporučuje se da zdravstveni radnik bolesniku ili njegovatelju objasni uporabu štrcaljke za usta kako bi se osigurala primjena ispravnog volumena te da je lijek propisan u ml.
English: Place the open bottle upright on a table.
Croatian: Otvorenu bocu odložite na stol u uspravnom položaju.
English: It is important that you use the correct oral syringe when taking the medicine.
Croatian: Važno je da kod uzimanja lijeka upotrebljavate odgovarajuću štrcaljku za usta.
English: Package leaflet: Information for the user Orfadin 4 mg/ml oral suspension nitisinone
Croatian: Uputa o lijeku: Informacije za korisnika Orfadin 4 mg/ml oralna suspenzija nitizinon
English: It is important to carefully follow the instructions given below for preparation and administration of the dose, in order to ensure the dosing accuracy.
Croatian: Važno je pažljivo slijediti niže navedene upute za pripremu i primjenu doze, kako bi se osiguralo točno doziranje.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Orfadin Lijek čuvajte izvan pogleda i dohvata djece.
English: Shake the bottle vigorously for at least 5 seconds (figure D).
Croatian: Bocu snažno tresite najmanje 5 sekundi (Slika D).
English: The bottle should be shaken vigourously for at least 5 seconds (Figure D).
Croatian: Bocu treba snažno tresti najmanje 5 sekundi (Slika D).
English: Excipients with known effect: Each ml contains: sodium 0.7 mg (0.03 mmol) glycerol 500 mg sodium benzoate 1 mg
Croatian: 0,7 mg (0,03 mmol) natrija 500 mg glicerola 1 mg natrijeva benzoata
English: It is recommended that the healthcare professional advises the patient or carer giver how to use the oral syringes to ensure that the correct volume is administered.
Croatian: Preporučuje se da zdravstveni djelatnik bolesniku ili njegovatelju objasni uporabu štrcaljke za usta kako bi se osigurala primjena ispravnog volumena.
English: Before you take the first dose, shake the bottle vigorously since during long-term storage the particles will form a solid cake at the bottom of the bottle.
Croatian: Prije uzimanja prve doze snažno protresite bocu jer čestice uslijed dugog skladištenja na dnu boce formiraju čvrsti talog.
English: Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (figure A).
Croatian: Bocu snažno tresite najmanje 20 sekundi dok se čvrsti talog na dnu boce potpuno ne rasprši (Slika A).
English: CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: It is recommended that the oral suspension is taken with food, see section 4.5.
Croatian: Preporučuje se uzimanje oralne suspenzije zajedno s hranom, vidjeti dio 4.5.
English: Before taking the first dose, the bottle should be shaken vigorously since during long-term storage the particles will form a solid cake at the bottom of the bottle.
Croatian: Prije uzimanja prve doze bocu treba snažno protresti jer čestice uslijed dugog skladištenja na dnu boce formiraju čvrsti talog.
English: 4 mg/ml oral suspension:
Croatian: 4 mg/ml oralna suspenzija:
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 OATP1B3.
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: CYP 1A2, 2C19 ili 3A4 ili inducirati CYP 1A2, 2B6 ili 3A4/5.