natgillin/translations-raw huggingface dataset:
For patients who can swallow liquids take RAVICTI should be taken orally, even those with a nasogastric and/or gastrostomy tube. 
Bolesnici koji mogu gutati tekućine, RAVICTI trebaju uzeti peroralno, čak i oni s nazogastričnom sondom i/ili gastrostomom.
Glycerol phenylbutyrate was not tumourigenic at doses up to 1000 mg/kg/day in a 26-week mouse study. 
Glicerolfenilbutirat nije bio tumorogen u dozama do 1000 mg/kg/dan u 26-tjednom ispitivanju na miševima.
Amino acid level decreased Gamma-glutamyltransferase increased Hepatic enzyme increased Transaminases increased 
Pretrage snižena razina aminokiselina povišena gama-glutamil transferaza povišeni jetreni enzimi povišene transaminaze
Patients were required to have a diagnosis of UCD involving deficiencies of CPS, OTC, or ASS, confirmed via enzymatic, biochemical, or genetic testing. 
Bolesnici su trebali imati dijagnosticirani poremećaj ciklusa ureje koji uključuje nedostatak CPS-a, OTC-a ili ASS-a, potvrđen enzimatskim, biokemijskim ili genetičkim testovima.
The medicinal product may be mixed with medical formulas (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree and Citrulline) and used within 2 hours when stored at 25° C, or up to 24 hours, refrigerated. 
Lijek se može miješati s medicinskim formulacijama (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree i Citrulline) i uzeti unutar 2 sata ako se čuva na 25° C ili unutar 24 sata, ako se čuva u hladnjaku.
In patients with a PAA to PAGN ratio exceeding 2.5, a further increase in glycerol phenylbutyrate dose may not increase PAGN formation, even if plasma PAA concentrations are increased, due to saturation of the conjugation reaction. 
Kod bolesnika s omjerom PAA i PAGN iznad 2,5, daljnje povećanje doze glicerolfenilbutirata možda neće povećati stvaranje PAGN, čak i ako se povećaju koncentracije PAA u plazmi zbog zasićenja reakcije konjugacije.
Hyperammonemic crises were precipitated by vomiting, upper respiratory tract infection, gastroenteritis, decreased caloric intake or had no identified precipitating event (3 events). 
Hiperamonemijske krize bile su izazvane povraćanjem, infekcijom gornjih dišnih putova, gastroenteritisom, smanjenim kalorijskim unosom ili događaj koji je izazvao hiperamonemijsku krizu nije bio utvrđen (3 događaja).
The effects of glycerol phenylbutyrate on cytochrome P450 (CYP) 2C9 isoenzyme and potential for interaction with celecoxib has been studied in humans with no evidence of an interaction observed. 
Učinci glicerolfenilbutirata na izoenzim 2C9 citokroma P450 (CYP) i mogućnost interakcije s celekoksibom ispitani su u ljudi, no nisu opaženi dokazi interakcije.
There was one additional patient who had one venous ammonia level that exceeded 100 micromol/L which was not associated with a hyperammonemic crisis. 
Jedan dodatni bolesnik jedanput je imao razinu amonijaka u venskoj krvi koja je bila viša od 100 mikromol/l, ali nije bila povezana s hiperamonemijskom krizom.
You will need to take this medicine and follow a special low protein diet throughout your life. 
Tijekom svog života trebat ćete uzimati ovaj lijek uz posebnu prehranu s niskim udjelom proteina.
Use one oral syringe for all doses taken each day. 
Koristite jednu oralnu štrcaljku za sve doze koje se uzimaju u jednom danu.
The dose of glycerol phenylbutyrate should be adjusted to produce a fasting plasma ammonia level that is less than half the upper limit of normal (ULN) in patients 6 years and older. 
Dozu glicerolfenilbutirata treba prilagoditi kako bi se postigla razina amonijaka u plazmi natašte, koja je niža od polovice gornje granice normale (GGN) u bolesnika u dobi od 6 godina i starijih.
In vitro, the extent of human plasma protein binding for 14C-labeled metabolites was 80.6% to 98.0% for PBA (over 1-250 microgram/ml), and 37.1% to 65.6% for PAA (over 5-500 microgram /ml). 
In vitro, opseg vezanja na proteine ljudske plazme za 14C-označene metabolite iznosio je 80,6% do 98,0% za PBA (više od 1-250 mikrograma/ml), i 37,1% do 65,6% za PAA (više od 5-500 mikrograma/ml).
• 9000 microgram (mcg/ml) for patients under 2 years of age 
• 9000 mikrograma (μg/ml) za bolesnike ispod 2 godine starosti
In 7 paediatric patients aged 2 months to under 2 years of age who received RAVICTI for up to 12 months, the concentrations of PAA, PBA, and PAGN did not increase over the treatment period and the overall median PAA, PBA, and PAGN concentrations in these patients were similar to those observed in older paediatric age groups. 
Kod 7 pedijatrijskih bolesnika u dobi od 2 mjeseca do manje od 2 godine koji su primali lijek RAVICTI do 12 mjeseci, koncentracije PAA, PBA i PAGN nisu se povećavale u razdoblju liječenja a ukupni medijani koncentracija PAA, PBA i PAGN kod tih bolesnika bili su slični onima zabilježenima kod starijih pedijatrijskih dobnih skupina.
• if you have acute hyperammonaemia, which requires more rapid intervention. 
• ako ste alergični na glicerolfenilbutirat • ako imate akutnu hiperamonemiju koja zahtijeva bržu intervenciju.
It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone. 
On je triglicerid koji sadrži 3 molekule PBA vezane za glavni lanac glicerola.
Open the bottle of RAVICTI by pushing down on the cap and twisting to the left. 
Otvorite bocu lijeka RAVICTI pritiskom na zatvarač i odvrtanjem u lijevu stranu.
Any adverse reaction reported in one patient met the uncommon criteria. 
Bilo koja nuspojava prijavljena kod jednog bolesnika zadovoljila je kriterije za kategoriju „manje često“.
Multi-centre prospective non-interventional registry in patients with urea cycle disorders on treatment with glycerol phenylbutyrate to characterise patients` demographics, and to document long-term safety and clinical outcomes 
Multicentričan, prospektivan, neintervencijski registar bolesnika s poremećajima ciklusa ureje koji se liječe glicerolfenilbutiratom kako bi se ustanovile demografske karakteristike bolesnika, i kako bi se prikupili podaci o dugoročnoj sigurnosti i kliničkim ishodima
EU/1/15/1062/001 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1062/001
No PAA toxicity was observed in the subjects age < 2 months. 
U ispitanika u dobi < 2 mjeseca nije opažena PAA toksičnost.
Oral or gastroenteral use. 
Peroralna ili gastroenteralna primjena.
PAA conjugates with glutamine (which contains 2 molecules of nitrogen) via acetylation in the liver and kidneys to form PAGN, which is excreted by the kidneys. 
PAA se konjugira s glutaminom (koji sadrži 2 molekule dušika) acetilacijom u jetri i bubrezima kako bi nastao PAGN, koji se izlučuje putem bubrega.
Food aversion 
Odbojnost prema hrani
On a molar basis, PAGN, like urea, contains 2 moles of nitrogen and provides an alternate vehicle for waste nitrogen excretion. 
PAGN, poput ureje, na molarnoj bazi sadrži 2 mola dušika i omogućuje alternativan put izlučivanja otpadnog dušika.
UCDs are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+). 
Poremećaji ciklusa ureje su nasljedni nedostaci enzima ili prijenosnika potrebnih za sintezu ureje iz amonijaka (NH3, NH4+).
Assessment of adverse reactions was based on exposure in 114 UCD patients (65 adults and 49 children between the ages of 2 months and 17 years) with deficiencies in CPS, OTC, ASS, ASL, ARG, or HHH across 4 short term and 3 long term clinical studies, in which 90 patients completed 12 months duration (median exposure = 51 weeks). 
Ocjena nuspojava temeljila se na izloženosti 114 bolesnika s poremećajima ciklusa ureje (65 odraslih i 49 djece u dobi od 2 mjeseca do 17 godina) s nedostatkom CPS-a, OTC-a, ASS-a, ASL-a, ARG-a ili HHH-om tijekom 4 kratkoročna i 3 dugoročna klinička ispitivanja, u kojima je 90 bolesnika završilo 12-mjesečno ispitivanje (medijan izloženosti = 51 tjedan).
RAVICTI should not be used during pregnancy and in women of childbearing potential not using contraception unless the clinical condition of the woman requires treatment with glycerol phenylbutyrate, see section 4.6. 
RAVICTI se ne smije primjenjivati tijekom trudnoće ni u žena reproduktivne dobi koje ne koriste kontracepciju osim ako kliničko stanje žene ne zahtijeva liječenje glicerolfenilbutiratom, vidjeti dio
• Hypersensitivity to the active substance. 
• Preosjetljivost na djelatnu tvar.
The plasma PAA to PAGN (both measured in mcg/ml) ratio has been observed to be generally less than 1 in patients without PAA accumulation. 
Opaženo je da je omjer PAA i PAGN u plazmi (oboje mjereno u μg/ml) općenito manji od 1 kod bolesnika bez nakupljanja PAA.
PAA clearance was 7.1 L/h, 10.9 L/h, 16.4 L/h, and 24.4 L/h, respectively, for UCD patients ages ≤ 2, 3 to 5, 6 to 11, and 12 to 17 years. 
Klirens PAA bio je 7,1 l/h, 10,9 l/h, 16,4 l/h odnosno 24,4 l/h za bolesnike s poremećajima ciklusa ureje u dobi ≤ 2, 3 do 5, 6 do 11 odnosno 12 do 17 godina.
Patients switching from sodium phenylbutyrate to RAVICTI should receive the dosage of RAVICTI that contains the same amount of phenylbutyric acid. 
Bolesnici koji prelaze s natrijevog fenilbutirata na RAVICTI trebaju primati dozu lijeka RAVICTI koja sadrži istu količinu fenilbutiratne kiseline.
The syringe used to flush the gastrostomy or nasogastric tube shall not be used for measuring the dose of RAVICTI to avoid introduction of water into the medicinal product. 
Štrcaljka koju ste koristili za ispiranje gastrostome ili nazogastrične sonde ne smije se koristiti za odmjeravanje doze lijeka RAVICTI kako bi se izbjegao ulazak vode u lijek.
Therefore, measurement of plasma PAA and PAGN levels may be useful to guide dosing. 
Stoga, mjerenje razine PAA i PAGN u plazmi može biti korisno kao vodič za doziranje.
RAVICTI contains the active substance ‘glycerol phenylbutyrate' which is used to treat six known ‘urea cycle disorders' (UCDs) in adults and children. 
RAVICTI sadrži djelatnu tvar glicerolfenilbutirat koja se koristi za liječenje šest poznatih poremećaja ciklusa ureje u odraslih i djece.
If U-PAGN excretion is insufficient to cover daily dietary protein intake and the fasting ammonia is greater than half the recommended ULN, the glycerol phenylbutyrate dose should be adjusted upward. 
Ako je izlučivanje U-PAGN nedostatno za pokrivanje dnevnog unosa proteina iz prehrane, a amonijak natašte je iznad polovice preporučene GGN, dozu glicerolfenilbutirata treba prilagoditi prema više.
RAVICTI should be used with caution in patients with severe renal impairment. 
RAVICTI treba primjenjivati s oprezom kod bolesnika s teškim oštećenjem bubrega.
In healthy female volunteers, mean Cmax for PAA was 51% and 120% higher than in male volunteers after administration of 4 ml and 6 ml 3 times daily for 3 days, respectively. 
Kod zdravih dobrovoljaca ženskog spola, srednji Cmax za PAA bio je 51% i 120% viši nego kod dobrovoljaca muškog spola nakon primjena doze od 4 ml odnosno 6 ml 3 puta dnevno tijekom 3 dana.
• probenecid - to treat high levels of uric acid in the blood which can cause gout (‘hyper uricaemia') 
• probenecid - za liječenje visokih razina mokraćne kiseline u krvi koje mogu uzrokovati giht
If there is a need to administer a dose of 0.5 ml or less with such nasogastric, gastrostomy or nasojejunal tubes, consideration should be given to the low drug recovery in dosing. 
Ako postoji potreba za primjenom doze od 0,5 ml ili manje takvim nazogastričnim, gastrostomskim ili nazojejunalnim sondama, treba uzeti u obzir niski povrat lijeka kod doziranja.
The mean (SD) percentage of administered PBA eliminated as PAGN was approximately 68.9% (17.2) in adults and 66.4% (23.9) in paediatric UCD patients at steady state. 
Srednji (SD) postotak primijenjenog PBA izlučenog kao PAGN bio je približno 68,9% (17,2) u odraslih i 66,4% (23,9) kod pedijatrijskih bolesnika s poremećajima ciklusa ureje u stanju dinamičke ravnoteže.
Effects of glycerol phenylbutyrate on other CYP isoenzymes have not been studied in humans and cannot be excluded. 
Učinci glicerolfenilbutirata na druge CYP izoenzime nisu ispitivani kod ljudi i ne mogu se isključiti.
The upper bound of the one-sided 95% CI for the largest placeboadjusted, baseline-corrected QTc, based on individual correction method (QTcI) for glycerol phenylbutyrate, was below 10 ms, demonstrating that glycerol phenylbutyrate had no QT/QTc prolonging effect. 
Gornja granica jednostranog 95%-tnog intervala pouzdanosti za najdulji QTc prilagođen za placebo i korigiran za početnu vrijednost, temeljem individualne metode korekcije (QTcI) za glicerolfenilbutirat, bio je ispod 10 ms, pokazujući da glicerolfenilbutirat nije imao učinak produljenja QT/QTc intervala.
Of the 45 paediatric patients participating in the open-label treatment with glycerol phenylbutyrate, 11 patients (24%) reported a total of 22 hyperammonemic crises. 
Od 45 pedijatrijskih bolesnika koji su sudjelovali u otvorenom liječenju glicerolfenilbutiratom, 11 bolesnika (24 %) prijavilo je ukupno 22 hiperamonemijske krize.
If spot U-PAGN concentrations fall below these levels, assess compliance with medicinal product and/or effectiveness of medicinal product administration (e.g., via feeding tube) and consider increasing the glycerol phenylbutyrate dose in compliant patients to achieve optimal ammonia control (within normal limit for patients under 2 years of age and less than half ULN in older patients when fasted). 
Ako koncentracije U-PAGN u slučajnom pojedinačnom uzorku urina padnu ispod tih razina, procijenite suradljivost bolesnika u uzimanju lijeka i/ili učinkovitost primjene lijeka (npr. preko cjevčice za hranjenje) i razmotrite povećanje doze glicerolfenilbutirata kod suradljivih bolesnika kako bi se postigla optimalna kontrola amonijaka (unutar granice normale za bolesnike ispod 2 godine starosti i manje od polovice GGN kod starijih bolesnika natašte).
In such cases, increasing the dosing frequency may result in a lower plasma PAA level and PAA to PAGN ratio. 
U tim slučajevima, povećanje učestalosti doziranja može rezultirati nižom razinom PAA u plazmi i omjerom PAA i PAGN.
Because conversion of PAA to PAGN occurs in the liver, patients with severe hepatic impairment may have reduced conversion capability and higher plasma PAA and plasma PAA to PAGN ratio. 
Budući da do pretvaranja PAA u PAGN dolazi u jetri, bolesnici s teškim oštećenjem jetre mogu imati smanjenu sposobnost pretvorbe i višu razinu PAA u plazmi i viši omjer PAA i PAGN u plazmi.
Do not use RAVICTI after the expiry date which is stated on the carton and the bottle label after the letters “EXP”. 
RAVICTI se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici boce iza oznake „Rok valjanosti“.
Oral liquid. 
OBLIK Oralna tekućina.
Further, glycerol phenylbutyrate was hydrolysed in vitro by esterases in human plasma. 
Nadalje, glicerolfenilbutirat se hidrolizirao in vitro esterazama u ljudskoj plazmi.
Mean maximum concentration (Cmax) for PBA, PAA, and PAGN was 37.0 micrograms/ml, 14.9 micrograms/ml, and 30.2 micrograms/ml, respectively. 
Srednja najviša koncentracija (Cmax) za PBA, PAA i PAGN bila je 37,0 mikrograma/ml, 14,9 mikrograma/ml, odnosno 30,2 mikrograma/ml.
The effect of multiple doses of glycerol phenylbutyrate 13.2 g/day and 19.8 g/day (approximately 69% and 104% of the maximum recommended daily dosage) on QTc interval was evaluated in a randomised, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment-arm, crossover study in 57 healthy subjects. 
Učinak višestrukih doza glicerolfenilbutirata u dozi od 13,2 g/dan i 19,8 g/dan (oko 69% odnosno 104% maksimalne preporučene dnevne doze) na QTc interval procijenjen je u ukriženom, randomiziranom ispitivanju s placebom i aktivnom kontrolom (moksifloksacin od 400 mg), s četiri terapijske skupine, na 57 zdravih ispitanika.
However, maternal toxicity and adverse effects on embryo-foetal development including reduced foetal weights and cervical ribs were observed in a rat study with a dose approximately 6 times the dose in adult patients, based on combined AUCs for PBA and PAA. 
Međutim, toksičnost za majke i štetni učinci na embrio-fetalni razvoj uključujući smanjenu težinu ploda i razvoj cervikalnih rebara zabilježeni su u ispitivanju na štakorima s dozom približno 6 puta većom od doze za odrasle bolesnike temeljem kombiniranih AUC-ova za PBA i PAA.
Three patients reported a total of 7 hyperammonemic crises defined as having signs and symptoms consistent with hyperammonemia (such as frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high venous ammonia levels and requiring medical intervention. 
U tri je bolesnika zabilježeno ukupno 7 hiperamonemijskih kriza definiranih kao znakovi i simptomi sukladni s hiperamonemijom (kao što su učestalo povraćanje, mučnina, glavobolja, letargija, razdražljivost, ratobornost i/ili somnolencija) povezanom s visokim razinama amonijaka u venskoj krvi, zbog čega je bila potrebna medicinska intervencija.
Fatigue, oedema peripheral Uncommon Hunger, Pyrexia 
Umor, periferni edem Manje često Glad, pireksija
• through a tube that goes through your tummy (‘abdomen') to the stomach - called a 
• kroz cjevčicu koja prolazi kroz Vaš trbuh (abdomen) do želuca - ona se zove „gastrostoma“
Glycerol phenylbutyrate and/or its metabolites, PAA and PBA, have been shown to be weak inducers of CYP3A4 enzyme in vivo. 
Pokazalo se da su glicerolfenilbutirat i/ili njegovi metaboliti, PAA i PBA, slabi induktori enzima CYP3A4 in vivo.
In a rat study, glycerol phenylbutyrate caused a statistically significant increase in the incidence of pancreatic acinar cell adenoma, carcinoma, and combined adenoma or carcinoma in males and females, at a dose of 4.7 and 8.4 times the dose in adult patients, (6.87 ml/m2/day based on combined AUCs for PBA and PAA). 
U ispitivanju na štakorima, glicerolfenilbutirat uzrokovao je statistički značajno povećanje incidencije adenoma acinarnih stanica gušterače i kombiniranog adenoma ili karcinoma u mužjaka i ženki pri dozi od 4,7 odnosno 8,4 puta višoj od doze za odrasle bolesnike, (6,87 ml/m2/dan temeljem kombiniranih AUC-ova za PBA i PAA).
If symptoms of vomiting, nausea, headache, somnolence, confusion, or sleepiness are present in the absence of high ammonia or other intercurrent illnesses, measure plasma PAA and plasma PAA to PAGN and consider reduction of glycerol phenylbutyrate dosage or increase the frequency of dosing if the PAA level exceeds 500 mcg/L and the plasma PAA to PAGN ratio exceeds 2.5. 
Ako su simptomi povraćanja, mučnine, glavobolje, somnolencije, konfuzije ili pospanosti prisutni u odsutstvu visoke razine amonijaka ili interkurentnih bolesti, treba izmjeriti PAA u plazmi i omjer PAA i PAGN u plazmi i razmotriti smanjenje doze glicerolfenilbutirata ili povećanje učestalosti doziranja ako razina PAA prelazi 500 μg/l, a omjer PAA i PAGN u plazmi prelazi 2,5.
The potential for interaction of glycerol phenylbutyrate as a CYP3A4 inducer and those products predominantly metabolised by the CYP3A4 pathway is possible. 
Postoji potencijal za interakciju glicerolfenilbutirata kao induktora CYP3A4 i onih lijekova koji se uglavnom metaboliziraju putem enzima CYP3A4.
Population pharmacokinetic modelling and dosing simulations suggest that PBA enters the circulation about 70-75% more slowly when given orally as glycerol phenylbutyrate as compared with sodium phenylbutyrate and further indicate that body surface area is the most significant covariate explaining the variability of PAA clearance. 
Populacijsko farmakokinetičko modeliranje i simulacija doziranja upućuju na zaključak da PBA ulazi u krvotok 70-75% polaganije kod peroralnog davanja u obliku glicerolfenilbutirata u usporedbi s natrijevim fenilbutiratom i nadalje upućuju na zaključak da je površina tijela najznačajnija kovarijanca koja pojašnjava varijabilnost klirensa PAA.
Compatibility studies have demonstrated glycerol phenylbutyrate chemical and physical in-use stability with the following foods and nutritional supplements: apple sauce, ketchup, squash puree, and five medical formulas (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree and Citrulline) typically consumed by UCD patients (see section 4.2). 
Ispitivanja kompatibilnosti su dokazala kemijsku i fizikalnu stabilnost glicerolfenilbutirata u primjeni sa sljedećom hranom i nadomjescima prehrane: pire od jabuke, kečap, pire od bundeve i pet medicinskih formulacija (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree i Citrulline)
Fill the oral syringe by pulling the plunger back until the syringe is filled with the amount of medicinal product. 
Napunite oralnu štrcaljku povlačenjem klipa dok se štrcaljka ne napuni količinom lijeka.
Given that approximately 47% of dietary nitrogen is excreted as waste and approximately 70% of an administered 4phenylbutyric acid (PBA) dose will be converted to urinary phenylacetylglutamine (U-PAGN), an initial estimated glycerol phenylbutyrate dose for a 24-hour period is 0.6 ml glycerol phenylbutyrate per gram of dietary protein ingested per 24 hour period assuming all the waste nitrogen is covered by glycerol phenylbutyrate and excreted as phenylacetylglutamine (PAGN). 
Pod pretpostavkom da se oko 47% dušika iz prehrane izluči kao otpadna tvar, i da će se oko 70% primijenjene doze 4-fenilbutiratne kiseline (PBA) pretvoriti u urinarni fenilacetilglutamin (U-PAGN), početna procijenjena doza glicerolfenilbutirata za 24-satno razdoblje je 0,6 ml glicerolfenilbutirata po gramu proteina iz prehrane uzetog tijekom 24 sata pod pretpostavkom da se sav otpadni dušik pokrije glicerolfenilbutiratom i izluči kao fenilacetilglutamin (PAGN).
If you forget to take RAVICTI 
Ako ste zaboravili uzeti RAVICTI
RAVICTI should be prescribed by a physician experienced in the management of UCDs. 
RAVICTI treba propisati liječnik iskusan u liječenju poremećaja ciklusa ureje.
Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats at clinical exposure levels, however at oral doses up to approximately 7 times the dose in adult patients, maternal as well as male toxicity was observed and the number of nonviable embryos was increased. 
Glicerolfenilbutirat nije imao učinak na plodnost ni reproduktivnu funkciju mužjaka i ženki štakora pri razinama jednakim kliničkoj izloženosti, međutim, u oralnim dozama do oko 7 puta višima od doza za odrasle bolesnike, zabilježena je toksičnost za majke kao i za mužjake, a broj nevijabilnih embrija se povećao.
The study enrolled a total of 45 paediatric patients between the ages of 1 and 17 years with UCD who had completed Study 2 and the safety extensions of Studies 3 and 4. 
Ispitivanje je uključilo ukupno 45 pedijatrijskih bolesnika s poremećajem ciklusa ureje u dobi između 1 i 17 godina koji su završili Ispitivanje 2 te sigurnosne produžetke Ispitivanja 3 i 4.
RAVICTI may also be administered by CE marked medical grade silicone nasogastric or gastrostomy tube for those patients unable to take the medicinal product by mouth. 
RAVICTI se može primjenjivati i putem nazogastrične sonde ili gastrostome od silikona medicinskog stupnja s oznakom CE za one bolesnike koji ne mogu uzimati lijek kroz usta.
In 16 paediatric UCD patients aged less than 2 months, PAA clearance was 3.8 L/h. 
U 16 pedijatrijskih bolesnika s poremećajima ciklusa ureje mlađima od 2 mjeseca, klirens PAA iznosio je 3,8 l/h.
Upon singledose administration of glycerol phenylbutyrate, plasma concentrations of PBA were quantifiable in 15 of 22 participants at the first sample time post dose (0.25 h). 
Nakon primjene jedne doze glicerolfenilbutirata, koncentracije PBA u plazmi mogle su se odrediti u 15 od 22 ispitanika kod prvog uzorkovanja nakon doze (0,25 sati).
Oral administration of glycerol phenylbutyrate during the period of organogenesis in rats and rabbits had no effects on embryo-foetal development at 2.7 and 1.9 times the dose in adult patients, respectively. 
Peroralna primjena glicerolfenilbutirata u razdoblju organogeneze štakora i kunića nije imalo učinka na embrio-fetalni razvoj u dozi 2,7 i 1,9 puta višoj od doze za odrasle bolesnike.
System Organ Class Preferred Term 
Klasifikacija organskih sustava Preporučeni pojam