natgillin/translations-raw huggingface dataset:
In adult UCD patients receiving multiple doses of glycerol phenylbutyrate, maximum plasma concentrations at steady state (Cmaxss) of PBA, PAA, and PAGN occurred at 8 h, 12 h, and 10 h, respectively, after the first dose in the day. 
Kod odraslih bolesnika s poremećajima ciklusa ureje koji su primali višestruke doze glicerolfenilbutirata, najviše koncentracije PBA, PAA i PAGN u plazmi u stanju dinamičke ravnoteže (Cmax, ss) postignute su 8, 12, odnosno 10 sati nakon prve dnevne doze.
In 4 of the 5 subjects age < 1 month, possible risk factors included infectious precipitants, hyperammonaemic crisis at baseline, and missing dose. 
< 1 mjeseca, mogući rizični čimbenici uključivali su infekciju kao okidač, hiperamonemijsku krizu na početku ispitivanja i propuštenu dozu.
Open-Label Uncontrolled Extension Study in Adults A long-term (12-month), uncontrolled, open-label study (Study 2) was conducted to assess monthly ammonia control and hyperammonaemic crisis over a 12-month period. 
Dugoročno (12-mjesečno), nekontrolirano, otvoreno ispitivanje (Ispitivanje 2) provedeno je za procjenu mjesečne kontrole amonijaka i hiperamonemijske krize u 12-mjesečnom razdoblju.
• Place the tip of the oral syringe onto the tip of the gastrostomy/nasogastric tube. 
• Stavite vrh oralne štrcaljke na vrh gastrostome/nazogastrične sonde.
Open-Label, Uncontrolled, Extension Studies in Paediatric Patients Long-term (12-month), uncontrolled, open-label studies were conducted to assess monthly ammonia control and hyperammonaemic crisis over a 12-month period in three studies (Study 2, which also enrolled adults, and extensions of Studies 3 and 4). 
Dugoročna (12-mjesečna), nekontrolirana, otvorena ispitivanja provedena su u svrhu procjene mjesečne kontrole amonijaka i hiperamonemijske krize u 12-mjesečnom razdoblju u tri ispitivanja (Ispitivanje 2 u koje su bili uključeni i odrasli, i produžeci Ispitivanja 3 i 4).
However, for patients who cannot swallow liquids, a nasogastric tube or gastrostomy tube may be used to administer RAVICTI as follows: 
Međutim, bolesnici koji ne mogu gutati tekućine, mogu primati RAVICTI putem nazogastrične sonde ili gastrostome na sljedeći način:
A total of 51 adult patients involving deficiencies of CPS, OTC, ASS, ASL, ARG, and HHH were enrolled in the study and all but 6 had been converted from sodium phenylbutyrate to equivalent doses of glycerol phenylbutyrate. 
U ispitivanje je uključen ukupno 51 odrastao bolesnik s nedostatkom CPS-a, OTC-a, ASS-a, ASL-a, ARG-a i HHH-om i svi osim njih 6 prešli su s natrijevog fenilbutirata na ekvivalentne doze glicerolfenilbutirata.
Venous ammonia levels were monitored monthly. 
Razine amonijaka u venskoj krvi praćene su na mjesečnoj osnovi.
Although these have not been seen in clinical trials involving UCD patients, high PAA levels should be suspected in patients (particularly in children <2months) with unexplained somnolence, confusion, nausea and lethargy who have normal or low ammonia. 
Iako one nisu zabilježene u kliničkim ispitivanjima u bolesnika s poremećajima ciklusa ureje, kod bolesnika s neobjašnjenom somnolencijom, konfuzijom, mučninom i letargijom koji imaju normalnu ili sniženu razinu amonijaka treba posumnjati na visoke razine PAA (osobito u djece u dobi <2 mjeseca).
Clear, colourless to pale yellow liquid. 
Prozirna, bezbojna do blijedožuta tekućina.
The median exposure was 10 months (range 2 to 20 months). 
Medijan izloženosti iznosio je 10 mjeseci (raspon:
Active-Controlled, 4-Week, Noninferiority, Blinded Crossover Study (Study 1) A randomised, double-blind, active-controlled, crossover, noninferiority study (Study 1) compared equivalent doses of glycerol phenylbutyrate to sodium phenylbutyrate by evaluating 24-hour venous ammonia levels in patients with UCDs who had been on sodium phenylbutyrate prior to enrolment for control of their UCD. 
Randomizirano, dvostruko slijepo, ukriženo ispitivanje neinferiornosti s aktivnom kontrolom (Ispitivanje 1) uspoređivalo je ekvivalentne doze glicerolfenilbutirata sa natrijevim fenilbutiratom procjenom 24-satnih razina amonijaka u venama bolesnika s poremećajima ciklusa ureje koji su primali natrijev fenilbutirat prije uključivanja u skupinu za kontrolu svojeg poremećaja ciklusa ureje.
This process allows phenylbutyrate to be absorbed into the circulation. 
Ovaj proces omogućuje apsorpciju fenilbutirata u krvotok.
• burping, stomach ache, changes in your stools such as being oily, urgent need for bowel movements, painful bowel movements 
• podrigivanje, bol u želucu, promjene stolice poput uljaste stolice, potreba za hitnim pražnjenjem crijeva, bolno pražnjenje crijeva
Upon oral ingestion, PBA is released from the glycerol backbone in the gastrointestinal tract by pancreatic lipases. 
Nakon peroralnog uzimanja, PBA se oslobađa s glavnog lanca glicerola u gastrointestinalni trakt lipazama gušterače.
Use an oral syringe to measure your dose. 
Za mjerenje doze koristite oralnu štrcaljku.
Concomitant use of medicinal products known to inhibit lipase should be given with caution as glycerol phenylbutyrate is hydrolysed by digestive lipase into phenylbutyrate acid and glycerol. 
Istodobna primjena lijekova za koje se zna da inhibiraju lipazu treba se vršiti s oprezom budući da lipaza u probavnom sustavu hidrolizira glicerolfenilbutirat u fenilbutiratnu kiselinu i glicerol.
• Step 2: 50% dose sodium phenylacetate/sodium benzoate and 100% RAVICTI for 4-8 hours; 
50% doze natrijevog fenilacetata / natrijevog benzoata i 100% doze lijeka RAVICTI tijekom 4-8 sati;
• viral infection in the gut 
• virusna infekcija crijeva
In order to ensure correct dosing of RAVICTI, CE-marked oral syringes with suitable size for the dosage and compatible with the reclosable bottle cap adapter can be obtained from the pharmacy. 
Kako bi se osiguralo pravilno doziranje lijeka RAVICTI, u ljekarni se mogu nabaviti oralne štrcaljke s oznakom CE, u veličinama koje odgovaraju dozi, a koje su kompatibilne s nastavkom za bocu s čepom za ponovno zatvaranje.
Reversible clinical manifestations suggestive of neurotoxicity (e.g., nausea, vomiting, somnolence) have been reportedly associated with phenylacetate levels ranging from 499-1285 mcg/ml in cancer patients who received PAA intravenously. 
U bolesnika s rakom koji su intravenski primali PAA, reverzibilne kliničke manifestacije koje upućuju na neurotoksičnost (npr. mučnina, povraćanje, somnolencija), povezane su s razinama fenilacetata u rasponu od 499-1285 μg/ml.
Glycerol phenylbutyrate is a nitrogen-binding medicinal product. 
Glicerolfenilbutirat je lijek koji veže dušik.
Uncommon Abdominal discomfort, abnormal faeces, dry mouth, eructation, defaecation urgency, upper abdominal pain and/or lower abdominal pain, painful defaecation, steatorrhoea, stomatitis 
Manje često Nelagoda u abdomenu, abnormalna stolica, suhoća usta, podrigivanje, hitni nagon na stolicu, bol u gornjem i/ili donjem dijelu abdomena, bolna defekacija, steatoreja, stomatitis
Even while on treatment with glycerol phenylbutyrate, acute hyperammonaemia including hyperammonaemic encephalopathy may occur in a proportion of patients. 
Kod jednog dijela bolesnika čak i na liječenju glicerolfenilbutiratom može doći do hiperamonemije uključujući hiperamonemijsku encefalopatiju.
In healthy subjects, intact glycerol phenylbutyrate was not detected in plasma. 
Kod zdravih ispitanika u plazmi nije otkriven nepromijenjeni glicerolfenilbutirat.
Adjustment based on plasma phenylacetate and phenylacetylglutamine Symptoms of vomiting, nausea, headache, somnolence, confusion, or sleepiness in the absence of high ammonia or intercurrent illness may be signs of phenylacetic acid (PAA) toxicity (see section 4.4, PAA toxicity). 
Simptomi povraćanja, mučnine, glavobolje, pospanosti, konfuzije ili pospanosti u odsutnosti visoke razine amonijaka ili interkurentne bolesti mogu biti znakovi toksičnosti fenilacetatne kiseline (PAA) (vidjeti dio 4.4, Toksičnost fenilacetatne kiseline).
The same reclosable bottle cap adapter can be used until a bottle is empty. 
Isti nastavak za bocu s čepom za ponovno zatvaranje može se koristiti dok se boca ne isprazni.
Additional adverse reactions have been evaluated in a clinical study including 16 UCD patients less than 2 months of age. 
Dodatne nuspojave procijenjene su u jednom kliničkom ispitivanju koje je uključilo 16 bolesnika s poremećajima ciklusa ureje mlađih od 2 mjeseca.
A total of 16 paediatric patients with UCDs aged less than 2 months participated in a long-term (24 months), uncontrolled, open-label study, of which 10 patients converted from sodium phenylbutyrate to RAVICTI. 
Ukupno je 16 pedijatrijskih bolesnika s poremećajima ciklusa ureje mlađih od 2 mjeseca sudjelovalo u dugotrajnom (24 mjeseca), nekontroliranom, otvorenom ispitivanju, od kojih je 10 prešlo sa natrijevog fenilbutirata na lijek RAVICTI.
• feeling sleepy, tired, light-headed or sometimes confused 
• pospanost, umor, ošamućenost i ponekad smetenost
Women of childbearing potential/contraception in males and females The use of RAVICTI in women of childbearing potential must be accompanied by the use of effective contraception (see section 4.4). 
Primjena lijeka RAVICTI u žena reproduktivne dobi mora biti popraćena primjenom učinkovite kontracepcije (vidjeti dio 4.4).
Initial dosage in patients switching from sodium phenylacetate/sodium benzoate injection to RAVICTI: Once stable with controlled ammonia, patients switching from sodium phenylacetate/sodium benzoate to RAVICTI should receive a dose of RAVICTI at the higher end of the treatment range (11.2 ml/m2/day) with measurements of plasma ammonia to guide further dosing. 
Nakon što im se stanje stabilizira i amonijak bude pod kontrolom, bolesnici koji prelaze s natrijevog fenilacetata / natrijevog benzoata na lijek RAVICTI trebaju primati dozu lijeka RAVICTI iz gornjih vrijednosti terapijskog raspona (11,2 ml/m2/dan) uz mjerenje amonijaka u plazmi prema kojem se usmjerava daljnje doziranje.
A total of 49 children ages 2 months to 17 years with deficiencies of OTC, ASS, ASL, and ARG were enrolled, and all but 1 had been converted from sodium phenylbutyrate to glycerol phenylbutyrate. 
Bilo je uključeno ukupno 49 djece u dobi od 2 mjeseca do 17 godina s nedostatkom OTC-a, ASS-a, ASL-a i ARG-a, a sva osim 1 prešla su s natrijevog fenilbutirata na glicerolfenilbutirat.
About urea cycle disorders 
O poremećajima ciklusa ureje
In an additional long term (24 month), uncontrolled, open-label clinical study the safety of RAVICTI has been evaluated in 16 UCD patients less than 2 months of age and 10 pediatric patients with UCDs aged 2 months to less than 2 years. 
U dodatnom dugotrajnom (24 mjeseca), nekontroliranom, otvorenom kliničkom ispitivanju, sigurnost lijeka RAVICTI procijenjena je u 16 bolesnika s poremećajima ciklusa ureje mlađih od 2 mjeseca i
• tests show higher or lower potassium in your blood 
• nalazi pretraga pokazuju povišen ili snižen kalij u krvi
Study in Children 2 Months to Less than 2 Years of Age A total of 10 paediatric patients with UCDs aged 2 months to less than 2 years participated in a long term (24 months) uncontrolled, open label study, of which 6 patients converted from sodium phenylbutyrate to RAVICTI and 1 patient converted from sodium phenylbutyrate and sodium benzoate. 
Ukupno je 10 pedijatrijskih bolesnika s poremećajima ciklusa ureje u dobi od 2 mjeseca do manje od 2 godine sudjelovalo u dugotrajnom (24 mjeseca), nekontroliranom, otvorenom ispitivanju, od kojih je 6 bolesnika prešlo s natrijevog fenilbutirata na RAVICTI, a jedan je bolesnik prešao s natrijevog fenilbutirata i natrijevog benzoata.
Probenecid Probenecid may inhibit the renal excretion of metabolites of glycerol phenylbutyrate including PAGN. 
Probenecid može inhibirati izlučivanje metabolita glicerolfenilbutirata, uključujući PAGN, putem bubrega.
Two patients were treatment naïve and one additional patient was gradually discontinued from intravenous sodium benzoate and sodium phenylacetate while RAVICTI was initiated. 
Dva bolesnika prethodno nisu bila liječena, a jedan dodatni bolesnik postupno je prekinuo primati intravenski natrijev benzoat i natrijev fenilacetat dok se uvodio
In the pooled analysis of the short-term studies in children (Study 3 and Study 4), plasma ammonia was significantly lower after switching to glycerol phenylbutyrate; ammonia AUC0-24h was 626.79 and 871.72 (micromol/L)*hour during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 26, ratio of geometric means 0.79; 95% confidence intervals 0.647, 0.955). 
U združenoj analizi kratkoročnih ispitivanja na djeci (Ispitivanje 3 i Ispitivanje 4), razina amonijaka u plazmi bila je značajno niža nakon prelaska na glicerolfenilbutrat; AUC0-24 amonijak bio je 626,79 odnosno 871,72 (mikromol/l)*sat tijekom liječenja glicerolfenilbutiratom odnosno natrijevim fenilbutiratom (n = 26, omjer geometrijskih sredina 0,79; 95% interval pouzdanosti 0,647; 0,955).
The reclosable bottle cap adapter can be used until the bottle is empty. 
Nastavak za bocu s čepom za ponovno zatvaranje može se koristiti dok se boca ne isprazni.
Adjustment based on urinary phenylacetylglutamine U-PAGN measurements may be used to help guide glycerol phenylbutyrate dose adjustment and assess compliance. 
Mjerenja U-PAGN se mogu koristiti kao pomoć za određivanje prilagodbe doze glicerolfenilbutirata i procjenu suradljivosti.
• 7000 microgram (mcg/ml) for patients >2 years of age with a BSA of ≤1.3 
• 7000 mikrograma (μg/ml) za bolesnike >2 godine starosti s površinom tijela ≤1,3
Constipation, Flatulence, Gastrooesophageal reflux disease 
Poremećaji probavnog sustava proljev, konstipacija, vjetrovi, gastroezofagealna refluksna bolest
The daily dose should be individually adjusted according to the patient's estimated urea synthetic capacity, if any, amino acid profile, protein tolerance and the daily dietary protein intake needed to promote growth and development. 
Dnevnu dozu treba individualno prilagoditi sukladno procijenjenom kapacitetu sinteze ureje bolesnika, ukoliko je ima, profilu aminokiselina, toleranciji proteina i dnevnom unosu proteina prehranom, potrebnom za poticanje rasta i razvoja.
How to store RAVICTI 
Kako čuvati RAVICTI
In the pooled analysis of studies where patients switched from sodium phenylbutyrate to glycerol phenylbutyrate, ammonia AUC0-24h was 774.11 and 991.19 [(micromol/L)*hour] during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 80, ratio of geometric means 0.84; 95% confidence intervals 0.740, 0.949). 
U združenoj analizi ispitivanja u kojima su bolesnici prešli s natrijevog fenilbutirata na glicerolfenilbutrat, AUC0-24 amonijaka bio je 774,11 odnosno 991,19 [(mikromol/l)*sat] tijekom liječenja glicerolfenilbutiratom odnosno natrijevim fenilbutiratom (n=80, omjer geometrijskih sredina 0,84; 95%-tni interval pouzdanosti 0,740; 0,949).
The product contains no excipients. 
Lijek ne sadrži pomoćne tvari.
Flatulence, diarrhoea, vomiting, nausea, abdominal pain, dyspepsia, abdominal distension, constipation, oral discomfort, retching 
Flatulencija, proljev, povraćanje, mučnina, bol u abdomenu, dispepsija, distenzija abdomena, konstipacija, nelagoda u ustima, dizanje želuca
• joint swelling, muscle spasms, pain in the hands and feet, heel pain 
• oticanje zglobova, grčevi mišića, bol u šakama i stopalima, bol u peti
Women of childbearing potential/contraception in males and females Effective contraceptive measures must be taken by women of child-bearing potential (see section 4.6). 
Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju (vidjeti dio 4.6).
• stomach bloating or pain, constipation, diarrhoea, heartburn, wind, feeling sick (nausea), pain in the mouth, retching 
• nadutost ili bol u želucu, zatvor, proljev, žgaravica, vjetrovi, mučnina, bol u ustima, dizanje želuca
A new reclosable bottle cap adapter should be used for each new bottle that is opened. 
Novi nastavak za bocu s čepom za ponovno zatvaranje treba se koristiti za svaku novootvorenu bocu.
Hyperammonemia may be induced by haloperidol and by valproic acid. 
Haloperidol i valproatna kiselina mogu potaknuti hiperamonemiju.
• 5000 microgram (mcg/ml) for patients >2 years of age with a BSA of >1.3 
• 5000 mikrograma (μg/ml) za bolesnike >2 godine starosti s površinom tijela >1,3
The daily dose should be individually adjusted according to the patient's estimated urea synthetic capacity, if any, protein tolerance and the daily dietary protein intake needed to promote growth and development. 
Dnevnu dozu treba individualno prilagoditi prema procijenjenom kapacitetu sinteze ureje u bolesnika, ukoliko je ima, toleranciji proteina i dnevnom unosu proteina prehranom potrebnom za poticanje rasta i razvoja.
Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in UCD patients. 
Pomno pratite razine amonijaka kada je kod bolesnika s poremećajima ciklusa ureje potrebna primjena valproatne kiseline ili haloperidola.
High levels of ammonia leads to feeling sick (nausea), being sick (vomiting) or feeling confused. 
Visoke razine amonijaka uzrokuju mučninu, povraćanje ili smetenost.
• lipase in pancreatic replacement therapies 
• lipaza kod nadomjestne terapije enzima gušterače
Clear, Type III glass, bottle with a high density polyethylene (HDPE) child-resistant closure. 
Boca od prozirnog stakla tipa III sa zatvaračem sigurnim za djecu od polietilena visoke gustoće
Monitor ammonia levels closely when corticosteroids and glycerol phenylbutyrate are used concomitantly. 
Pomno pratite razine amonijaka kod istodobne primjene kortikosteroida i glicerolfenilbutirata.
• feeling tired, feeling dizzy, headache or tremor 
• osjećaj umora, omaglica, glavobolja ili nevoljno drhtanje
• The active substance is glycerol phenylbutyrate. 
• Djelatna tvar je glicerolfenilbutirat.
Recommended starting dosage in phenylbutyrate-naïve patients: 
Preporučena početna doza za bolesnike koji prethodno nisu primali fenilbutirat:
Glycerol phenylbutyrate is hydrolysed by pancreatic lipases to yield, PBA, which is converted by beta oxidation to PAA, the active moiety of glycerol phenylbutyrate. 
Glicerolfenilbutirat se hidrolizira lipazama gušterače do PBA koja se pretvara beta oksidacijom u PAA, aktivni dio glicerolfenilbutirata.
The plasma PAA to PAGN ratio may be useful in dosage monitoring. 
Omjer PAA i PAGN u plazmi može biti koristan u praćenju doze. (vidjeti dio 5.2).
The recommended dosages for patients naïve to phenylbutyric acid and for patients switching from sodium phenylbutyrate or from sodium phenylacetate/sodium benzoate injection to RAVICTI are different. 
Preporučene doze za bolesnike koji prethodno nisu liječeni fenilbutiratnom kiselinom i za bolesnike koji prelaze s natrijevog fenilbutirata ili injekcija natrijevog fenilacetata / natrijevog benzoata na
Mean 24-hour AUCs for venous ammonia during steady-state dosing were 866 micromol/L*hour and 977 micromol/L*hour with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 44, ratio of geometric means 0.91; 95% confidence intervals 0.799, 1.034). 
Srednji 24-satni AUC-ovi amonijaka u venskoj krvi tijekom doziranja u stanju dinamičke ravnoteže bili su 866 mikromola/l*sat odnosno 977 mikromola/l*sat s glicerolfenilbutiratom, odnosno natrijevim fenilbutiratom (n=44, omjer geometrijskih sredina 0,91; 95% intervali pouzdanosti 0,799; 1,034).
Uncommon Hypothyroidism 
Manje često Hipotireoza
Uncommon Dysphonia, epistaxis, nasal congestion, oropharyngeal pain, throat irritation 
Manje često Disfonija, epistaksa, začepljenje nosa, orofaringealna bol, nadraženo grlo
PBA derived from glycerol phenylbutyrate is further converted by β-oxidation to PAA. 
PBA dobiven iz glicerolfenilbutirata dalje prelazi u PAA
ADRs in patients 2 months to less than 2 years of age 
Ispitivanje u djece u dobi od 2 mjeseca do manje od 2 godine
• Step 1: 100% dose sodium phenylacetate/sodium benzoate and 50% dose of RAVICTI for 4-8 
100% doze natrijevog fenilacetata / natrijevog benzoata i 50% doze lijeka RAVICTI tijekom 4-8 sati;
All patients successfully transitioned to RAVICTI within 3 days, where successful transition was defined as no signs and symptoms of hyperammonemia and a venous ammonia value less than 100 micromol/L. 
Uspješan prelazak definiran je kao izostanak znakova i simptoma hiperamonemije i vrijednost amonijaka u venskoj krvi manja od 100 mikromol/l.
Saturation of conjugation of PAA and glutamine to form PAGN was suggested by increases in the ratio of plasma PAA to PAGN with increasing dose and with increasing severity of hepatic impairment. 
Povećanje omjera PAA i PAGN u plazmi s povećanjem doze i s povećanjem težine oštećenja jetre ukazuje na zasićenje konjugacije PAA s glutaminom kako bi se stvorio PAGN.
1 reclosable bottle cap adapter. 
1 nastavak za bocu s čepom za ponovno zatvaranje.
RAVICTI 1.1 g/ml oral liquid Glycerol phenylbutyrate 
RAVICTI 1,1 g/ml oralna tekućina glicerolfenilbutirat
Upon oral administration, pancreatic lipases hydrolyse glycerol phenylbutyrate and release PBA. PBA undergoes β-oxidation to PAA, which is conjugated with glutamine in the liver and in the kidney through the enzyme phenylacetyl-CoA: Lglutamine- N-acetyltransferase to form PAGN. 
PBA prolazi β-oksidaciju do PAA koja se konjugira s glutaminom u jetri i bubrezima putem enzima fenilacetil-CoA: Lglutamin - N-acetiltransferaze, te nastaje PAGN.
Reduced phenylbutyrate absorption in pancreatic insufficiency or intestinal malabsorption Exocrine pancreatic enzymes hydrolyse glycerol phenylbutyrate in the small intestine, separating the active moiety, phenylbutyrate, from glycerol. 
Egzokrini enzimi gušterače hidroliziraju glicerolfenilbutirat u tankom crijevu odvajajući aktivni dio molekule, fenilbutirat, od glicerola.
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava anemija, trombocitoza
A plasma PAA to PAGN ratio exceeding 2.5 may indicate saturation of PAA to PAGN conversion capacity and the need for reduced dosing and/or increased frequency of dosing. 
može ukazivati na zasićenje sposobnosti pretvorbe PAA u PAGN i potrebu za smanjenjem doze i/ili povećanjem učestalosti doziranja.
A new reclosable bottle cap adapter should be used when a new bottle is opened. 
Novi nastavak za bocu s čepom za ponovno zatvaranje treba koristiti od otvaranja nove boce.
• Each ml of liquid contains 1.1 g of glycerol phenylbutyrate. 
• Jedan ml tekućine sadrži 1,1 g glicerolfenilbutirata.
Do not drive or use machines whilst experiencing these side effects. 
Kada osjećate te nuspojave nemojte voziti ni upravljati strojevima.
The mean normalized venous ammonia values in pediatric patients aged less than 2 months were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 35 to 94 micromol/L). 
Srednje vrijednosti normaliziranih vrijednosti amonijaka u venskoj krvi u pedijatrijskih bolesnika mlađih od 2 mjeseca bile su unutar normalnih granica tijekom dugotrajnog liječenja glicerol fenilbutiratom (raspon: 35-94 mikromol/l).
Intact glycerol phenylbutyrate was not detectable in plasma in UCD patients. 
Nepromijenjeni glicerolfenilbutirat nije se mogao otkriti u plazmi bolesnika s poremećajima ciklusa ureje.
Preparation for nasogastric tube or gastrostomy tube administration: In vitro studies evaluating the percent recovery of total dose delivered with nasogastric, nasojejunal or gastrostomy tubes demonstrated the percent of dose recovered was > 99% for doses > 1 ml and 70% for a 0.5 ml dose. 
In vitro ispitivanja za procjenu postotka povrata ukupne doze primijenjene putem nazogastrične, nazojejunalne sonde ili gastrostome pokazala su postotak povrata doze > 99% za doze > 1 ml, odnosno 70% za dozu od 0,5 ml.
Place the tip of the oral syringe into the reclosable bottle cap adapter. 
Stavite vrh oralne štrcaljke u nastavak za bocu s čepom za ponovno zatvaranje.
Do not rinse the reclosable bottle cap or the oral syringe between daily doses, as the presence of water causes glycerol phenylbutyrate to degrade. 
Nemojte ispirati nastavak za bocu s čepom za ponovno zatvaranje niti oralnu štrcaljku između dnevnih doza jer prisutnost vode uzrokuje razgradnju glicerolfenilbutirata.