natgillin/translations-raw huggingface dataset:
The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed to promote growth and development. 
Dnevnu dozu treba individualno prilagoditi prema bolesnikovoj toleranciji proteina i dnevnom unosu proteina hranom potrebnom za podržavanje rasta i razvoja djeteta.
Available pharmacodynamic/toxicological data in animals have shown excretion of sodium phenylbutyrate/metabolites in milk (see section 5.3). 
Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se natrijev fenilbutirat/metaboliti izlučuju u mlijeko (za detalje vidjeti dio 5.3).
• This medicinal product contains 768 mg sucrose per gram. 
• Lijek sadrži 768 mg saharoze po gramu.
Do not use PHEBURANE if you are breast-feeding, because this medicine can pass into the breast milk and may harm your baby. 
Nemojte uzeti PHEBURANE ako dojite, jer se ovaj lijek može izlučiti u mlijeko i tako naškoditi Vašem djetetu.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX03. 
Farmakoterapijska skupina: Ostali lijekovi za probavni trakt i metabolizam, razni lijekovi za probavni trakt i metabolizam, ATK oznaka: A16AX03.
Patients with neonatal-onset disease had a high incidence of mental retardation. 
Bolesnici s početkom bolesti u novorođenačkoj dobi imaju visoku incidenciju mentalne retardacije.
Nitrogen is a building block of proteins, which are an essential part of the food we eat. 
Dušik je sastavni dio bjelančevina, koje su osnovni sastojak naše hrane.
PHEBURANE must be taken with a special diet reduced in protein. 
PHEBURANE se mora uzimati uz posebnu dijetu s ograničenom količinom proteina.
Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine. 
Oko 80 - 100% primijenjenog lijeka izlučuje se bubrezima unutar 24 sata u obliku konjugata fenilacetilglutamina.
On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion. 
Na molarnoj osnovi, fenilacetilglutamin se može usporediti s urejom (oboje sadrže 2 mola dušika) i stoga predstavlja alternativni vehikulum za izlučivanje suvišnog dušika.
Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis 
Često anemija, trombocitopenija, leukopenija, leukocitoza, trombocitoza
Women of childbearing potential/Contraception in males and females Effective contraceptive measures must be taken by women of child-bearing potential. 
Žene reproduktivne dobi/kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije.
Fertility There is no evidence available on the effect of sodium phenylbutyrate on fertility. 
Plodnost Nema dostupnih podataka o učinku natrijevog fenilbutirata na plodnost.
The patient developed diarrhea, irritability and metabolic acidosis with hypokalaemia. 
Kod bolesnika se javio proljev, razdražljivost i metabolička acidoza s hipokalijemijom.
Prenatal exposure of rat pups to phenylacetate (the active metabolite of phenylbutyrate) produced lesions in cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number (see section 4.6). 
Izlaganje još nerođenih mladunaca štakora fenilacetatu (aktivnom metabolitu fenilbutirata) uzrokovalo je lezije na kortikalnim piramidalnim stanicama; dendritni trnovi bili su dulji, tanji i malobrojniji od normalnih (vidjeti dio 4.6).
In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recovered from hyperammonaemic encephalopathy and were then treated chronically with dietary protein restriction and sodium phenylbutyrate, the survival rate was 98 %. 
U bolesnika s kasnim početkom deficijencije, uključujući ženske heterozigote za deficijenciju ornitin transkarbamilaze, koji su se oporavili od hiperamonijemijske encefalopatije, te su potom trajno liječeni smanjenjem proteina u prehrani i natrijevim fenilbutiratom, stopa preživljenja je bila 98 %.
What you need to know before you take PHEBURANE 3. 
Što morate znati prije nego počnete uzimati PHEBURANE
This should be taken into account in patients with diabetes mellitus. 
Ovo treba uzeti u obzir kod bolesnika s dijabetesom melitusom.
PHEBURANE helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body. 
PHEBURANE pomaže tijelu izlučiti suvišni dušik smanjujući tako količinu amonijaka u Vašem organizmu.
Since the metabolism and excretion of sodium phenylbutyrate involves the liver and kidneys, PHEBURANE should be used with caution in patients with hepatic or renal insufficiency. 
Budući da se metabolizam i izlučivanje natrijevog fenilbutirata odvija preko jetre i bubrega, PHEBURANE treba primjenjivati s oprezom u bolesnika s jetrenom ili bubrežnom insuficijencijom.
PHEBURANE may be required life-long unless orthotropic liver transplantation is elected. 
Može biti potrebno uzimati PHEBURANE do kraja života ili ortotropne transplantacije jetre.
The maximum daily dose of this medicinal product is equivalent to 125% of the WHO recommended maximum daily intake for sodium. 
Maksimalna dnevna doza ovog lijeka odgovara 125 % maksimalnog dnevnog unosa natrija prema preporukama SZO.
The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 ‘PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25. 
Drugi sastojci su: kuglice šećera (saharoza i kukuruzni škrob, vidjeti dio 2 PHEBURANE sadrži saharozu), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.
The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce). 
Granule se mogu izravno progutati s pićem (voda, voćni sokovi, preparati za dojenčad koji ne sadrže proteine) ili se njima može posipati kruta hrana (pire od krumpira ili pire od jabuka) u žlici.
Common side effects (may affect more than 1 in 100 people): changes in number of blood cells (red cells, white cells and platelets), changes in the amount of bicarbonate in the blood, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), stomach ache, vomiting, nausea, constipation, abnormal skin odor, rash, abnormal kidney function, weight gain, altered laboratory test values. 
Česte nuspojave (mogu se javiti kod više od 1 na 100 ljudi): promjene u broju krvnih stanica (eritrocita, leukocita i trombocita), promjene u razini bikarbonata u krvi, smanjen apetit, depresija, razdražljivost, glavobolja, padanje u nesvijest, zadržavanje tekućine (oticanje), promjena osjeta okusa, bol u želucu, povraćanje, mučnina, zatvor, neobični miris kože, osip, poremećena funkcija bubrega, dobivanje na težini, promijenjene vrijednosti laboratorijskih pretraga.
• PHEBURANE contains 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose. 
• PHEBURANE sadrži 124 mg (5,4 mmol) natrija po gramu natrijevog fenilbutirata, što odgovara 2,5 g (108 mmol) natrija na 20 g natrijevog fenilbutirata, što predstavlja maksimalnu dnevnu dozu.
Three cirrhotic patients (out of 6) who received repeated oral administration of sodium phenylbutyrate (20 g/day in three doses) showed sustained plasma levels of phenylacetate on the third day that were five times higher than those achieved after the first dose. 
Tri bolesnika s cirozom (od 6) koji su primali ponavljane peroralne doze natrijevog fenilbutirata (20 g/dan podijeljeno u 3 doze) pokazivali su povišenu razinu fenilacetata u plazmi trećeg dana koja je bila pet puta viša od one postignute nakon prve doze.
Decreased blood potassium, albumin, total protein and phosphate. 
Snižena razina kalija, albumina, ukupnih proteina i fosfata u krvi.
HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules. 
HDPE bočica, sigurnosni zatvarač za djecu sa sredstvom za sušenje, koja sadrži 174 g granula.
PHEBURANE treatment should be supervised by a physician experienced in the treatment of urea cycle disorders. 
Liječenje PHEBURANEOM treba nadzirati liječnik koji ima iskustva u liječenju poremećaja ciklusa ureje.
Previously, neonatal-onset presentation of urea cycle disorders was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogues. 
Ranije, poremećaji ciklusa ureje koji su se manifestirali u novorođenačkoj dobi gotovo uvijek su imali letalni ishod tijekom prve godine života, čak i ako su liječeni peritonejskom dijalizom i esencijalnim aminokiselinama ili njihovim analozima bez dušika.
In patients with impaired hepatic function the conversion of phenylacetate to phenylacetylglutamine may be relatively slower. 
U bolesnika s oštećenom funkcijom jetara konverzija fenilacetata u fenilacetilglutamin može biti sporija.
The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce); in this case, it is important that it is taken immediately in order to preserve the taste-masking. 
Granule mogu biti izravno progutane s pićem (voda, voćni sokovi, pripravci za dojenčad koji ne sadrže proteine) ili njima posipati žlicu punu krute hrane (pire od krumpira, umak od jabuka); u ovom slučaju važno je da se uzme odmah kako bi se spriječilo mijenjanje okusa hrane.
Less frequent manifestations were confusion, headache, dysgeusia, hypoacusis, disorientation, impaired memory and exacerbation of a pre-existing neuropathy. 
Rjeđe se manifestirala kao konfuzija, glavobolja, poremećaj osjeta okusa, hipoakuzija, dezorijentacija, slabljenje pamćenja i pogoršanje već postojeće neuropatije.
Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth. 
Sazrijevanje sinapse u cerebralnom korteksu bilo je usporeno i broj funkcionalnih završetaka živaca u cerebrumu smanjen, što je rezultiralo poremećajem rasta mozga. (vidjeti dio 4.6).
Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium. 
Povišena razina alkalne fosfataze, transaminaza, bilirubina, mokraćne kiseline, klorida, fosfata i natrija u krvi.
Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose. 
Svaki gram natrijevog fenilbutirata sadrži 124 mg (5,4 mmol) natrija i 768 mg saharoze.
• 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults. 
450 - 600 mg/kg/dan za novorođenčad, dojenčad i djecu koja teže manje od 20 kg 9,9 - 13,0 g/m2/dan za djecu koja teže više od 20 kg, adolescente i odrasle.
Uncommon aplastic anaemia, ecchymosis 
Manje često aplastična anemija, ekhimoza
PHEBURANE should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema. 
PHEBURANE treba stoga koristiti s oprezom u bolesnika s kongestivnom insuficijencijom srca, teškom bubrežnom insuficijencijom i kliničkim stanjima u kojima postoji retencija natrija s edemima.
• This medicinal product contains 124 mg sodium per gram, equivalent to 6.2% of the WHO recommended maximum daily intake for sodium. 
• Ovaj lijek sadrži 124 mg natrija po gramu, što odgovara 6,2 % maksimalnog dnevnog unosa natrija prema preporukama Svjetske zdravstvene organizacije (SZO).
Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies). 
Koncentracije fenilbutirata i njegovih metabolita u plazmi i urinu utvrđene su u zdravih ljudi na tašte koji su primili jednokratnu dozu od 5 g natrijevog fenilbutirata, i u bolesnika s poremećajima ciklusa ureje, hemoglobinopatijama i cirozom koji su primili jednokratne i ponovljene peroralne doze od do 20 g/dan (nekontrolirana ispitivanja).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25. 
6.1 Popis pomoćnih tvari kuglice šećera (saharoza i kukuruzni škrob), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.
In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/kg/day up to 20 g/day) no plasma level of phenylacetate could be detected after overnight fasting. 
U većine bolesnika s poremećajima ciklusa ureje ili hemoglobinopatijama koji su primali različite doze fenilbutirata (300 - 650 mg/kg/dan do 20 g/dan) nije mogla biti utvrđena razina fenilacetata u plazmi nakon cjelonoćnog gladovanja.
Pheburane is contra-indicated during breast-feeding (see section 4.3). 
Pheburane je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
Repeated dosing with phenylacetate showed evidence of an induction of clearance. 
Ponavljanja doziranja fenilacetata pokazala su postojanje indukcije klirensa.
Do not use PHEBURANE after the expiry date which is stated on the carton and the bottle label after EXP. 
PHEBURANE se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
Bottle: 174 g granules. 
Bočica: 174 g granula.
PHEBURANE should be administered orally. 
PHEBURANE se primjenjuje peroralno.
PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders. 
PHEBURANE sadrži djelatnu tvar natrijev fenilbutirat koji se koristi za liječenje bolesnika svih starosnih skupina s poremećajima ciklusa ureje.
• PHEBURANE is considered high in sodium. 
• PHEBURANE se smatra lijekom s visokim sadržajem natrija.
Common rash, abnormal skin odor 
Često osip, nenormalni miris kože
These symptoms are consistent with the accumulation of phenylacetate, which showed dose-limiting neurotoxicity when administered intravenously at doses up to 400 mg/kg/day. 
Jednaki simptomi javljaju se pri akumulaciji fenilacetata koji pokazuje dozno limitirajuću neurotoksičnost ako se primijeni intravenski u dozama višim od 400 mg/kg/dan.
Because of its slow dissolution, PHEBURANE should not be administered by nasogastric or gastrostomy tubes. 
Zbog spore topivosti PHEBURANE se ne bi smio primjenjivati kroz nazogastričnu ili gastrostomsku sondu.
PHEBURANE has negligible influence on the ability to drive and use machines. 
PHEBURANE zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate. 
Ovaj lijek sadrži 768 mg saharoze po 1 g natrijevog fenilbutirata.
Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced. 
Temeljeno na ispitivanjima izlučivanja fenilacetilglutamina u bolesnika s poremećajem ciklusa ureje može se procijeniti da se po svakom gramu primijenjenog natrijevog fenilbutirata stvara između 0,12 i 0,15 g fenilacetilglutaminskog dušika.
CARTON AND BOTTLE LABEL 
OZNAKA NA KUTIJI I BOČICI
However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician. 
PHEBURANE se treba koristiti zajedno s dijetom s ograničenim unosom proteina, koju je Vaš liječnik ili dijetetičar posebno osmislio za Vas.
Studies with high intravenous doses of phenylacetate showed non-linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine. 
Ispitivanja s visokim intravenskim dozama fenilacetata pokazala su nelinearno farmakokinetičko svojstvo saturacijom njegovog metaboliziranja u fenilacetilglutamin.
Nutritional management PHEBURANE must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation. 
PHEBURANE treba kombinirati s dijetom s ograničenim unosom proteina, u nekim slučajevima uz suplementaciju esencijalnim aminokiselinama i karnitinom.
Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day. 
Suplementacija citrulina ili arginina potrebna je u bolesnika kod kojih se deficijencija karbamilfosfat sintetaze i ornitin transkarbamilaze pojavila u novorođenačkoj dobi u dozi 0,17 g/kg/dan ili 3,8 g/m2/dan,
Only use the calibrated measuring spoon provided. 
Koristiti samo priloženu kalibriranu mjernu žličicu.
• Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium. 
• Tijekom liječenja potrebno je nadzirati razinu kalija u serumu budući da izlučivanje fenilacetilglutamina putem bubrega može inducirati gubitak kalija urinom.
This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate. 
Ovaj lijek sadrži 124 mg (5,4 mmol) natrija po 1 g natrijevog fenilbutirata.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svakog grupiranja po učestalosti nuspojave se navode prema svojoj težini, od težih prema manje teškima.
PHEBURANE contains sodium and sucrose 
PHEBURANE sadrži natrij i sukrozu
There are no or limited amount of data from the use of sodium phenylbutyrate in pregnant women. 
Nema podataka ili su podaci o primjeni natrijevog fenilbutirata u trudnica ograničeni.
The disposition of phenylbutyrate and its metabolites has also been studied in cancer patients following intravenous infusion of sodium phenylbutyrate (up to 2 g/m²) or phenylacetate. 
Raspoloživost fenilbutirata i njegovih metabolita također je ispitivana na onkološkim bolesnicima koji su primili intravensku infuziju natrijevog fenilbutirata (do 2 g/m²) ili fenilacetata.
Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas. 
Manje česte nuspojave (mogu se javiti kod više od 1 na 1000 ljudi): nedostatak eritrocita zbog zatajivanja koštane srži, stvaranje modrica, promjena srčanog ritma, krvarenje iz rektuma, upala želuca (gastritis), čir želuca, upala gušterače.
Common abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon pancreatitis, peptic ulcer, rectal haemorrhage, gastritis 
Često bol u abdomenu, povraćanje, mučnina, konstipacija, disgeuzija Manje često pankreatitis, peptički ulkus, krvarenje iz rektuma, gastritis
Phenylbutyrate is rapidly absorbed under fasting conditions. 
Fenilbutirat se brzo apsorbira na tašte.
The active substance is sodium phenylbutyrate. 
Djelatna tvar je natrijev fenilbutirat.
Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys. 
Fenilacetat je metabolički aktivni spoj koji se acetilacijom konjugira s glutaminom i tvori fenilacetilglutamin, koji se potom izlučuje putem bubrega.
The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose. 
Dnevna doza PHEBURANEA temeljit će se na Vašoj tjelesnoj težini i tjelesnoj površini i bit će prilagođena prema Vašoj toleranciji na proteine i dijeti.
PHEBURANE is unlikely to affect your ability to drive and use machines. 
Malo je vjerojatno da PHEBURANE utječe na sposobnost upravljanja vozilima i rada na strojevima.
A calibrated measuring spoon is provided. 
Priložena je kalibrirana mjerna žličica.
More frequent monitoring of plasma ammonia levels is advised when these medicinal products have to be used. 
Kada se oni koriste savjetuje se češća kontrola razine amonijaka u plazmi.
PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase. 
PHEBURANE je indiciran kao pomoćna terapija u dugotrajnom liječenju poremećaja ciklusa ureje, uključujući nedostatak karbamilfosfat sintetaze, ornitin transkarbamilaze ili argininosukcinat sintetaze.
PHEBURANE 483 mg/g granules 
PHEBURANE 483 mg/g granule
PHEBURANE 483 mg/g {For carton only} 
PHEBURANE 483 mg/g {Samo na kutiji}
• Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients. 
• Unatoč liječenju kod određenog broja bolesnika može se pojaviti hiperamonijemijska encefalopatija.
In the table below all adverse reactions are listed below, by system organ class and by frequency. 
U sljedećoj tablici sve nuspojave navedene su prema klasifikaciji organskih sustava i učestalosti.
A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg. 
S lijekom se isporučuje kalibrirana mjerna žličica kojom se može dozirati do 3 g natrijevog fenilbutirata, graduirana po 250 mg.
After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing. 
Nakon jednokratne peroralne doze od 5 g natrijevog fenilbutirata, u obliku granula, mjerljive razine fenilbutirata u plazmi utvrđene su nakon 15 minuta.
• Pregnancy. 
• Dojenje.
PHEBURANE 483 mg/g granules sodium phenylbutyrate 
PHEBURANE 483 mg/g granule natrijev fenilbutirat
After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing. 
Nakon jednokratne doze od 5 g natrijevog fenilbutirata, u obliku granula, mjerljive razine fenilacetata i fenilacetilglutamina u plazmi utvrđene su nakon 30 odnosno 60 minuta.
In case of any doubt, ask your doctor or pharmacist. 
U slučaju ikakve dvojbe obratite se svom liječniku ili ljekarniku.
How to take PHEBURANE 
Kako uzimati PHEBURANE
Only use this measuring spoon to measure out the dose. 
Za doziranje koristite samo ovu mjernu žličicu.
Carton: One bottle with 174 g granules. 
Kutija: Jedna bočica sa 174 g granula.
Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test. 
Natrijev fenilbutirat bio je negativan u 2 testa mutagenosti, tj.
In case of mixture of the granules with solid foods or liquid it is important that it is taken immediately after mixing. 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom U slučaju da se granule miješaju s krutom hranom ili tekućinom važno je pripremljeno uzeti odmah nakon miješanja.
How to store PHEBURANE 
Kako čuvati PHEBURANE
Granules. 
OBLIK Granule.
• are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati PHEBURANE: ako ste alergični na natrijev fenilbutirat ili neki drugi sastojak ovog lijeka (naveden u dijelu ako ste trudni ako dojite.
Each bottle contains 174g of granules. 
Jedna bočica sadrži 174 g granula.
PHEBURANE granules are white to off-white. 
Kako PHEBURANE izgleda i sadržaj pakiranja PHEBURANE granule su bijele do gotovo bijele boje.
Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate. 
Ispitivanja kancerogenosti i ispitivanja utjecaja fenilbutirata na plodnost nisu provedena.
It is unknown whether sodium phenylbutyrate/metabolites are excreted in human milk. 
Nema dovoljno podataka o izlučivanju natrijevog fenilbutirata/metabolita u majčino mlijeko.