natgillin/translations-raw huggingface dataset:
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. 
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.
The bottle may be stored at a temperature not above 25°C or in the refrigerator. 
Boca se može čuvati na temperaturi ispod 25 °C ili u hladnjaku.
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).
It is used for measuring doses of more than 3 ml. 
Upotrebljava se za mjerenje doza većih od 3 ml.
Orfadin is for oral use only. 
Orfadin je samo za peroralnu primjenu.
Before re-dispersion, the medicinal product may appear as a solid cake with a slightly opalescent supernatant. 
Prije redisperzije lijek može izgledati kao čvrsti talog s blago opalescentnim supernatantom.
Each bottle contains 90 ml oral suspension. 
Jedna boca sadrži 90 ml oralne suspenzije.
The table below shows the dose conversion (mg/ml) for the three oral syringes sizes. 
Sljedeća tablica pokazuje konverziju doza (mg/ml) za tri veličine štrcaljki za usta.
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. 
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.
Orfadin contains sodium, glycerol and sodium benzoate 
Orfadin sadrži natrij, glicerol i natrijev benzoat
How to prepare a dose of medicine 
Kako pripremiti dozu lijeka
Cleaning: 
Čišćenje:
Orfadin has minor influence on the ability to drive and use machines. 
Orfadin malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
- 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. 
- 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.
If you forget to take Orfadin 
Ako ste zaboravili uzeti Orfadin
The oral suspension is a white, slightly thicker opaque suspension. 
Oralna suspenzija je bijela, nešto gušća neprozirna suspenzija.
The dose should be administered in the mouth immediately (without dilution) in order to avoid caking in the oral syringe. 
8. Dozu treba odmah primijeniti u usta (bez razrjeđivanja) kako bi se spriječilo taloženje u štrcaljki za usta.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake “EXP“.
Turn the bottle to an upright position again. 
Bocu vratite u uspravni položaj.
The oral suspension is taken with a oral syringe directly in the mouth without dilution. 
Oralna suspenzija uzima se pomoću štrcaljke izravno u usta, bez razrjeđivanja.
How to take Orfadin 
Kako uzimati Orfadin
2 mg, 5 mg, 10 mg and 20 mg hard capsules: 
2 mg, 5 mg, 10 mg i 20 mg tvrde kapsule:
Clean the oral syringe immediately with water. 
Štrcaljku za usta odmah operite vodom.
Shake off excess water and leave the disassembled oral syringe to dry until reassemble for next dosing occasion. 
Otresite višak vode te rastavljenu štrcaljku za usta ostavite da se suši do sastavljanja za sljedeću uporabu.
Liver monitoring 
Praćenje jetre
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. 
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.
A dose of 20 ml oral suspension (10 g glycerol) or more may cause headache, stomach upset and diarrhoea. 
Doza od 20 ml oralne suspenzije (10 g glicerola) ili više može uzrokovati glavobolju, nadraženi želudac i proljev.
Therefore, it is recommended that the oral suspension is taken with food, see section 4.2. 
Stoga se preporučuje da se oralna suspenzija uzima s hranom, vidjeti dio 4.2.
Capsule shell gelatin titanium dioxide (E 171) 
Ovojnica kapsule želatina titanijev dioksid (E 171)
Orfadin is also available in 2 mg, 5 mg, 10 mg and 20 mg capsules, if considered more suitable for the patient. 
Orfadin je također dostupan u kapsulama od 2 mg, 5 mg 10 mg i 20 mg, ako se smatraju pogodnijima za bolesnika.
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.
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. 
Sigurnosni profil uglavnom se temelji na pedijatrijskog populaciji budući da je liječenje nitizinonom potrebno započeti čim se ustanovi nasljedna tirozinemija tipa 1 (HT-1).
In patients with HT-1, 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.
Three oral syringes (1 ml, 3 ml and 5 ml) are provided for accurate measurement of the prescribed dose. 
Priložene su tri štrcaljke za usta (1 ml, 3 ml i 5 ml) za točno mjerenje propisane doze.
The hard capsules are white, opaque, imprinted with “NTBC” and the strength “2 mg”, “5 mg”, “10 mg” or “20 mg”, in black. 
Tvrde kapsule su bijele, neprozirne s utisnutom crnom oznakom “NTBC” i oznakom jačine “2 mg“, “5 mg“ “10 mg“ ili “20 mg“.
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 HT-1, nitizinon sprječava nakupljanje toksičnih međuprodukata maleilacetoacetata i fumarilacetoacetata.
Each pack contains one bottle, one bottle adapter and three oral syringes. 
Jedno pakiranje sadrži jednu bocu, jedan nastavak za bocu i tri štrcaljke za usta.
Capsule shell: gelatine titanium dioxide (E 171). 
Ovojnica kapsule: želatina titanijev dioksid (E 171).
This medicinal product contains 0.7 mg (0.03 mmol) sodium per ml. 
Ovaj lijek sadrži 0,7 mg (0,03 mmol) natrija po ml.
Figure F. 
Slika F.
The liver function should be monitored regularly by liver function tests and liver imaging. 
Jetrena funkcija mora se redovito pratiti pretragama jetrene funkcije i snimanjem jetre.
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. 
Važno je pažljivo slijediti upute za pripremu i primjenu doze navedene u dijelu 6.6, kako bi se osiguralo točno doziranje.
Dose Orfadin mg ml 
Doza Orfadina mg ml
In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP3A4-mediated metabolism. 
In vitro ispitivanja na ljudskim jetrenim mikrosomima i c-DNK eksprimirajućim P450 enzimima pokazala su ograničeni metabolizam posredovan CYP 3A4.
Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1. 
Nitizinon je uzrokovao približno 30%-tno smanjenje AUC∞ klorzoksazona, što ukazuje na slabu indukciju CYP 2E1.
Capsule content Starch, pregelatinised (maize) 
Sadržaj kapsule škrob, prethodno geliran (kukuruzni)
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. 
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.
Orfadin may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin) 
- lijekovi za epilepsiju (poput fenitoina) - lijekovi protiv zgrušavanja krvi (poput varfarina).
2 mg: Store in a refrigerator. 
POSEBNE MJERE ČUVANJA 2 mg: Čuvati u hladnjaku.
Before shaking the bottle, it may look like a solid cake in the bottom and a slightly opalescent liquid. 
Prije nego protresete bocu, može izgledati kao talog na dnu boce i blago opalescentna tekućina.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway. 
Nitizinon je kompetitivni inhibitor 4-hidroskifenilpiruvat dioksigenaze, enzima koji prethodi fumarilacetoacetat hidrolazi u kataboličkom putu tirozina.
Oral suspension 1 bottle of 90 ml, 1 bottle adaptor, 3 oral syringes (1 ml, 3 ml, 5 ml). 
Oralna suspenzija 1 boca od 90 ml, 1 nastavak za bocu, 3 štrcaljke za usta (1 ml, 3 ml, 5 ml).
The active ingredient of Orfadin is nitisinone. 
Djelatna tvar u lijeku Orfadin je nitizinon.
Each capsule contains 2 mg nitisinone Each capsule contains 5 mg nitisinone Each capsule contains 10 mg nitisinone Each capsule contains 20 mg nitisinone 
Svaka kapsula sadrži 2 mg nitizinona Svaka kapsula sadrži 5 mg nitizinona Svaka kapsula sadrži 10 mg nitizinona Svaka kapsula sadrži 20 mg nitizinona
The newborn baby's blood levels of bilirubin (a substance that causes the yellowing of the skin in high levels) will be closely monitored. 
Razina bilirubina (tvari koja uzrokuje žutu boju kože kad je prisutna u visokim koncentracijama) u krvi novorođenčeta pažljivo će se pratiti.
Separate barrel and plunger and rinse both with water. 
Odvojite trup i klip štrcaljke i isperite ih vodom.
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. 
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.
Place the open bottle upright on a table. 
Otvorenu bocu odložite na stol u uspravnom položaju.
It is important that you use the correct oral syringe when taking the medicine. 
Važno je da kod uzimanja lijeka upotrebljavate odgovarajuću štrcaljku za usta.
Package leaflet: Information for the user Orfadin 4 mg/ml oral suspension nitisinone 
Uputa o lijeku: Informacije za korisnika Orfadin 4 mg/ml oralna suspenzija nitizinon
It is important to carefully follow the instructions given below for preparation and administration of the dose, in order to ensure the dosing accuracy. 
Važno je pažljivo slijediti niže navedene upute za pripremu i primjenu doze, kako bi se osiguralo točno doziranje.
Keep this medicine out of the sight and reach of children. 
Kako čuvati Orfadin Lijek čuvajte izvan pogleda i dohvata djece.
Shake the bottle vigorously for at least 5 seconds (figure D). 
Bocu snažno tresite najmanje 5 sekundi (Slika D).
The bottle should be shaken vigourously for at least 5 seconds (Figure D). 
Bocu treba snažno tresti najmanje 5 sekundi (Slika D).
Excipients with known effect: Each ml contains: sodium 0.7 mg (0.03 mmol) glycerol 500 mg sodium benzoate 1 mg 
0,7 mg (0,03 mmol) natrija 500 mg glicerola 1 mg natrijeva benzoata
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. 
Preporučuje se da zdravstveni djelatnik bolesniku ili njegovatelju objasni uporabu štrcaljke za usta kako bi se osigurala primjena ispravnog volumena.
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. 
Prije uzimanja prve doze snažno protresite bocu jer čestice uslijed dugog skladištenja na dnu boce formiraju čvrsti talog.
Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (figure A). 
Bocu snažno tresite najmanje 20 sekundi dok se čvrsti talog na dnu boce potpuno ne rasprši (Slika A).
CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
It is recommended that the oral suspension is taken with food, see section 4.5. 
Preporučuje se uzimanje oralne suspenzije zajedno s hranom, vidjeti dio 4.5.
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. 
Prije uzimanja prve doze bocu treba snažno protresti jer čestice uslijed dugog skladištenja na dnu boce formiraju čvrsti talog.
4 mg/ml oral suspension: 
4 mg/ml oralna suspenzija:
Nitisinone plasma concentration reached in clinical setting is not expected to inhibit OATP1B1, OATP1B3 mediated transport. 
Ne očekuje se da će koncentracije nitizinona u plazmi koje se postižu u kliničkoj primjeni inhibirati prijenos posredovan OATP1B1 ili OATP1B3.
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. 
CYP 1A2, 2C19 ili 3A4 ili inducirati CYP 1A2, 2B6 ili 3A4/5.
Push the plastic adapter firmly into the neck of the bottle as far as you can (figure C) and close the bottle with the child resistant screw cap. 
Plastični nastavak čvrsto gurnite u grlo boce što dublje možete (Slika C) te bocu zatvorite navojnim zatvaračem sigurnim za djecu.
If any air bubbles are observed inside the filled oral syringe, the plunger should be pushed back up until the air bubbles are expelled. 
Ako u napunjenoj štrcaljki za usta primijetite mjehuriće zraka, klip treba ponovno potisnuti prema gore dok se mjehurići ne istisnu.
Dose conversion tables respectively for the three oral syringe sizes: 
Tablice za konverziju doza za tri veličine štrcaljki za usta:
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in pre-term and full-term jaundiced neonates and develop into kernicterus (brain damage due to deposits of bilirubin in the brain). 
Natrijev benzoat može pojačati žuticu (žuta boja kože i očiju) u nedonoščadi i donošene novorođenčadi sa žuticom te dovesti do kernikterusa (oštećenja mozga zbog odlaganja bilirubina u mozgu).
It is used for measuring doses of less than or up to 1 ml. 
Upotrebljava se za mjerenje doza manjih ili jednakih 1 ml.
The open bottle should be placed upright on a table, and the plastic adapter pushed firmly into the neck of the bottle as far as possible (Figure C). 
Otvorenu bocu treba odložiti na stol u uspravnom položaju te plastični nastavak čvrsto gurnuti u grlo boce što je dublje moguće (Slika C).
Sodium Each ml contains 0.7 mg (0.03 mmol). 
Natrij Jedan ml sadrži 0,7 mg (0,03 mmol).
The medicine can be stored for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which it must be discarded. 
Lijek se može čuvati na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca (za kapsule od 2 mg) ili 3 mjeseca (za kapsule od 5 mg, 10 mg i 20 mg), nakon čega se mora baciti.
The child-resistant screw cap should be replaced directly after use. 
Navojni zatvarač siguran za djecu treba vratiti odmah nakon uporabe.
Figure A. 
Slika A.
During the shelf life, the patient may store the capsules for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which the medicinal product must be discarded. 
Unutar roka valjanosti bolesnici mogu čuvati kapsule na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca (za kapsule od 2 mg) i 3 mjeseca (za kapsule od 5 mg, 10 mg i 20 mg), nakon čega se lijek mora baciti.
Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash. 
- povećan broj bijelih krvnih stanica (leukocitoza), - svrbež (pruritus), upala kože (eksfolijativni dermatitis), osip.
Figure C. 
Slika C.
Age at start of treatment 2 years 4 years 6 years 
Dob na početku liječenja 2 godine 4 godine 6 godina ≤ 2 mjeseca ≤ 6 mjeseci > 6 mjeseci
All patients Start age months Start age months 
Dob na početku mjeseca Dob na početku mjeseca
Orfadin 4 mg/ml oral suspension Nitisinone 
Orfadin 4 mg/ml oralna suspenzija nitizinon
Bilirubin levels should be measured before start of treatment: in case of markedly elevated plasma levels of bilirubin, especially in premature patients with risk factors as acidosis and low albumin level, treatment with an appropriately weighed portion of an Orfadin capsule should be considered instead of the oral suspension until the unconjugated bilirubin plasma levels are normalised. 
U slučaju izrazito povišenih razina bilirubina u plazmi, osobito u bolesne nedonoščadi s rizičnim čimbenicima kao što su acidoza i niska razina albumina, potrebno je razmotriti liječenje odgovarajućim dozama Orfadin kapsula umjesto oralnom suspenzijom sve dok se razine nekonjugiranog bilirubina u plazmi ne normaliziraju.
If any air bubbles are observed inside the filled oral syringe, push the plunger back up until the air bubbles are expelled. 
Ako u napunjenoj štrcaljki za usta primijetite mjehuriće zraka, klip ponovno potisnite prema gore dok ne istisnete mjehuriće.
Each pack contains one bottle, one LDPE bottle adapter and 3 polypropylene (PP) oral syringes (1 ml, 3 ml and 5 ml). 
Jedno pakiranje sadrži jednu bocu, jedan LDPE nastavak za bocu i 3 polipropilenske (PP) štrcaljke za usta (1 ml, 3 ml i 5 ml).
The suspension is administered in the patient's mouth with an oral syringe without dilution. 
Način primjene Suspenzija se daje bolesniku u usta pomoću štrcaljke za usta, bez razrjeđivanja.
The bottle should be shaken vigourously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (Figure A). 
2. Bocu treba snažno tresti najmanje 20 sekundi dok se čvrsti talog na dnu boce potpuno ne rasprši (Slika A).
A 1 ml, 3 ml and 5 ml oral syringes are included in the pack to measure the dose in ml in accordance with the prescribed posology. 
U pakiranju su priložene štrcaljke za usta od 1 ml, 3 ml i 5 ml za mjerenje doze u ml u skladu s propisanim doziranjem.
Re-dispersing is required before each use by vigorous shaking. 
Važne informacije o uputama za uporabu: Prije svake uporabe lijek je potrebno redispergirati snažnim protresanjem.
The bottle should be turned to an upright position again, and the oral syringe disconnected by gently twisting it out of the bottle. 
Bocu treba vratiti u uspravni položaj te izvući štrcaljku za usta iz boce, nježno je okrećući.
Cleaning 
Čišćenje
In order to withdraw the prescribed dose (ml), pull the plunger slowly down until the top edge of the black ring is exactly level with the line marking the dose (Figure F). 
Kako biste izvukli propisanu dozu (ml), klip polako povucite prema dolje dok gornji rub crnog prstena ne bude točno u ravnini s oznakom doze (Slika F).
100 ml brown glass bottle (type III) with a white child-resistant HDPE screw cap with sealing and tamper evidence. 
Boca od smeđeg stakla (tipa III) od 100 ml s bijelim navojnim HDPE zatvaračem sigurnim za djecu, sa sigurnosnim prstenom i evidencijom otvaranja.
Each ml contains 1 mg. Increase in bilirubin following its displacement from albumin, caused by benzoic acid and its salts, may increase jaundice in pre-term and full-term jaundiced neonates and develop into kernicterus (unconjugated bilirubin deposits in the brain tissue). 
Porast bilirubina zbog njegovog istiskivanja s albumina uzrokovanog benzoatnom kiselinom i njezinim solima može pojačati žuticu u nedonoščadi i donešene novorođenčadi sa žuticom te dovesti do kernikterusa (depozita nekonjugiranog bilirubina u moždanom tkivu).
Immediately thereafter, open the bottle by removing the child resistant screw cap. 3. 
Odmah potom otvorite bocu uklanjanjem navojnog zatvarača sigurnog za djecu.
Immediately thereafter, the bottle should be opened by removing the child-resistant screw cap. 3. 
Odmah potom, bocu treba otvoriti uklanjanjem navojnog zatvarača sigurnog za djecu.
It is provided in a 100 ml brown glass bottle with a white, child resistant screw cap. Each bottle contains 90 ml supension. 
Isporučuje se u smeđoj staklenoj boci od 100 ml s bijelim navojnim zatvaračem sigurnim za djecu.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
The oral syringes are graduated in 0.01 ml, 0.1 ml and 0.2 ml steps respectively. 
Štrcaljke za usta obilježene su svakih 0,01 ml, 0,1 ml odnosno 0,2 ml.
The bottle should be removed from the refrigerator, and the date when the bottle is removed from the refrigerator should be noted on the bottle label. 
1. Bocu treba izvaditi iz hladnjaka te na naljepnici boce zabilježiti datum vađenja iz hladnjaka.
In order to withdraw the prescribed dose (ml), the plunger should be pulled down slowly until the top edge of the black ring is exactly level with the line marking the dose (Figure F). 
6. Da biste izvukli propisanu dozu (ml), trebate polako povlačiti klip prema dolje dok gornji rub crnog prstena ne bude točno u ravnini s oznakom doze (Slika F).
Figure B. 
Slika B.
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). 
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).
The bottle should be closed with the child resistant screw cap. 
Bocu treba zatvoriti navojnim zatvaračem sigurnim za djecu.
Carefully turn the bottle upside down with the oral syringe in place (Figure F). 
Bocu oprezno okrenite naopako s umetnutom štrcaljkom (slika F).
Remove the child resistant screw cap by pushing it down firmly and turning it anti-clockwise (figure B). 
Uklonite navojni zatvarač siguran za djecu tako da ga čvrsto pritisnete prema dolje i okrenete u smjeru suprotnome od kazaljke na satu (Slika B).