natgillin/translations-raw huggingface dataset:
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). 
Študije o združljivosti so pokazale kemično in fizično stabilnost glicerol fenilbutirata z naslednjimi živili in prehranskimi dopolnili: jabolčna čežana, kečap, bučni pire in pet medicinskih pripravkov (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree in Citrulline), ki jih običajno uživajo bolniki z UCD (glejte poglavje 4.2).
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 konjugira z glutaminom (ki vsebuje 2 molekuli dušika) preko acetilacije v jetrih in ledvicah in tvori PAGN, ki se izloča skozi ledvice.
The most frequently reported adverse reactions (>5%) during glycerol phenylbutyrate treatment were diarrhoea, flatulence, and headache (8.8% each); decreased appetite (7.0%), vomiting (6.1%); and fatigue, nausea and, skin odour abnormal (5.3% each). 
Najpogostejši neželeni učinki (> 5 %) v času zdravljenja s fenilbutiratom so bili driska, flatulenca in glavobol (8,8 % vsak), zmanjšan apetit (7,0 %), bruhanje (6,1 %) in utrujenost, slabost in nenavaden telesni vonj (5,3 % vsak).
High levels of ammonia leads to feeling sick (nausea), being sick (vomiting) or feeling confused. 
Visoke koncentracije amoniaka vodijo do siljenja na bruhanje (navzea), bruhanja ali občutka zmedenosti.
N-acetylglutamate synthase (NAGS) and CITRIN (citrullinaemia type 2) deficiency The safety and efficacy of RAVICTI for the treatment of patients with N-acetylglutamate synthase (NAGS) and CITRIN (citrullinaemia type 2) deficiency have not been established. 
Pomanjkanje N-acetilglutamat sintaze (NAGS )in CITRIN (citrulinemija tipa 2) Varnost in učinkovitost zdravila RAVICTI pri zdravljenju bolnikov s pomanjkanjem N-acetilglutamat sintaze in citrulinemijo tipa 2 nista bili dokazani.
• corticosteroids - used to treat inflamed areas of the body 
• kortikosteroidi - uporabljajo se za zdravljenje vnetih mest na telesu
• In urea cycle disorders, the body cannot remove the nitrogen from the protein that we eat. 
• Pri motnjah ciklusa sečnine telo ne zmore odstraniti dušika iz beljakovin, ki jih zaužijemo.
• increased number of platelets (tends to cause blood clot) 
• zvišano število trombocitov (ki povzročajo strjevanje krvi)
• lipase in pancreatic replacement therapies 
• lipaze pri nadomestnih zdravljenjih bolezni trebušne slinavke
There was one additional patient who had one venous ammonia level that exceeded 100 micromol/L which was not associated with a hyperammonemic crisis. 
Pri enem dodatnem bolniku so opazili eno raven amoniaka v venski krvi, ki je bila višja od 100 mikromolov/l, in ni bila povezana s hiperamoniemično krizo.
What you need to know before you take RAVICTI Do not take RAVICTI: 
Kaj morate vedeti, preden boste vzeli zdravilo RAVICTI Ne jemljite zdravila RAVICTI:
• There are no other ingredients. 
• Drugih sestavin zdravilo ne vsebuje.
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. 
Pri bolnikih, pri katerih razmerje med PAA in PAGN presega 2,5, nadaljnje zvišanje odmerka glicerol fenilbutirata ne sme zvišati tvorbe PAGN, četudi so koncentracije PAA povečane zaradi nasičenosti konjugacijske reakcije.
Therefore, dosage for adult and paediatric patients with mild, moderate or severe hepatic impairment should be started at the lower end of the recommended dosing range (4.5 ml/m2/day) and kept at the lowest dose necessary to control the patient's ammonia levels. 
Zato mora biti začetni odmerek za odrasle in otroke z blago, zmerno ali hudo okvaro jeter na spodnji ravni priporočenega razpona odmerjanja (4,5 ml/m2/na dan) ter ga je treba obdržati na najnižji ravni, ki je potrebna za nadzor ravni amoniaka.
In a juvenile rat study with daily oral dosing performed on postpartum day 2 through mating and pregnancy after maturation, terminal body weight was dose-dependently reduced in males and females, by up to 16% and 12% respectively. 
V študiji na mladičih živalih z dnevnimi peroralnimi odmerki od 2. dne po skotitvi do parjenja in brejosti po doseganju zrelosti, se je končna telesna masa zmanjšala odvisno od odmerka, pri samcih do 16 % in pri samicah do 12 %.
Glycerol phenylbutyrate has been tested in a range of in vitro and in vivo genotoxicity studies, and shown no genotoxic activity. 
Glicerol fenilbutirat je bil testiran v številnih študijah genotoksičnosti in vitro ter in vivo in ni izkazoval genotoksične aktivnosti.
Hyperammonaemia was reported in 5 (50%) subjects age < 1 month (all serious but non-fatal) and 1 subject (16.7%) age 1-2 months (non-serious), which is consistent with more severe disease types diagnosed in the neonatal period. 
O hiperamonemiji so poročali pri 5 (50 %) preizkušancih, starih < 1 mesec (vsi resni, a ne smrtni) in pri 1 preizkušancu (16,7 %), starem 1-2 meseca (neresen), kar je skladno z bolj resno obliko bolezni,
No developmental abnormalities were observed in rats through day 92 postpartum following oral administration in pregnant rats, during organogenesis and lactation. 
Razvojnih nepravilnosti niso opazili pri podganah do 92. dne po skotitvi po peroralni aplikaciji brejim podganam, v času organogeneze in dojenja.
The amount of dose adjustment should factor in the amount of dietary protein that has not been covered, as indicated by the 24-h U-PAGN level and the estimated glycerol phenylbutyrate dose needed per gram of dietary protein ingested. 
Količina prilagoditve odmerka mora upoštevati količino prehranskih beljakovin, ki ni bila pokrita, kot je določeno za raven U-PAGN v 24 urah, in ocenjen odmerek glicerol fenilbutirata, ki je potreben na gram zaužitih prehranskih beljakovin.
• poor feeding 
• zmanjšan vnos hrane
Effects of glycerol phenylbutyrate on other CYP isoenzymes have not been studied in humans and cannot be excluded. 
Učinkov glicerol fenilbutirata na druge izoencime CYP pri ljudeh niso raziskovali, zato jih ni možno izključiti.
The plasma PAA to PAGN ratio may be useful in dosage monitoring. 
Razmerje med plazemsko PAA in PAGN je lahko uporabno pri nadzorovanju odmerjanja.
Hereford, Herefordshire, HR3 5PG United Kingdom 
Hay-on-Wye, Hereford, Herefordshire, HR3 5PG
In in vitro studies, the specific activity of lipases for glycerol phenylbutyrate was seen in the following decreasing order: pancreatic triglyceride lipase, carboxyl ester lipase, and pancreatic lipase-related protein 2. 
V študijah in vitro je bila specifična aktivnost lipaz za glicerol fenilbutirat opažena v naslednjem padajočem vrstnem redu: pankreatična trigliceridna lipaza, karboksil ester lipaza in lipaze trebušne slinavke PLRP2 (pancreatic lipase-related protein 2).
Patients had to have no clinical evidence of hyperammonaemia at enrolment and were not allowed to receive medicinal products known to increase ammonia levels (e.g., valproate), increase protein catabolism (e.g., corticosteroids), or significantly affect renal clearance (e.g., probenecid). 
Ob vključitvi bolniki niso smeli imeti klinično potrjene hiperamoniemije in niso smeli jemati zdravil, ki zvišujejo raven amoniaka (npr. valproat), pospešujejo razgradnjo beljakovin (npr. kortikosteroidi) ali pomembno vplivajo na ledvični očistek (npr. probenecid).
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. 
Če so simptomi, kot so bruhanje, slabost, glavobol, somnolenca, zmedenost ali zaspanost, prisotni ob odsotnosti visokih ravni amoniaka ali drugih trenutnih bolezni, izmerite plazemsko PAA in plazemsko pretvorbo PAA v PAGN ter razmislite o znižanju odmerka glicerol fenilbutirata oziroma povečanju pogostnosti odmerjanja, če raven PAA preseže 500 μg/ml in razmerje med PAA in PAGN preseže 2,5.
Open the bottle of RAVICTI by pushing down on the cap and twisting to the left. 
Steklenico z zdravilom RAVICI odprite tako, da zamašek potisnete dol in ga obrnete v levo.
RAVICTI is a pro-drug of PBA. 
Zdravilo RAVICTI je predzdravilo PBA.
You will need to take this medicine and follow a special low protein diet throughout your life. 
To zdravilo boste morali jemati celo življenje in upoštevati posebno dieto z malo beljakovinami.
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 pediatričnih bolnikov, ki so sodelovali v odprtem zdravljenju z glicerol fenilbutiratom, je 11 bolnikov (24 %) poročalo o skupaj 22 hiperamoniemičnih krizah.
The pharmacokinetics of glycerol phenylbutyrate in patients with impaired renal function, including those with end-stage renal disease (ESRD) or those on haemodialysis, have not been studied. 
Farmakokinetične lastnosti glicerol fenilbutirata pri bolnikih z okvaro ledvic, vključno s tistimi s končno odpovedjo ledvic (ESRD, end-stage renal disease), ali tistimi na hemodializi, niso bile raziskane.
• through a tube that goes through your nose to the stomach - called a ‘nasogastric tube' 
• skozi cevko, ki gre skozi vaš nos do želodca - nazogastrična sonda
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. 
To zdravilo se lahko meša z medicinskimi pripravki (Cyclinex-1, Cyclinex-2, UCD-1, UCD-2, Polycose, Pro Phree in Citrulline) in ga je treba uporabiti v 2 urah, če je shranjeno pri sobni temperaturi 25 °C, ali v 24 urah, če je shranjeno v hladilniku.
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. 
Pri zdravih ženskih prostovoljkah je bila povprečna vrednost Cmax PAA za 51 % oz. 120 % višja kot pri moških prostovoljcih po aplikaciji 4 ml in 6 ml trikrat na dan.
Probenecid Probenecid may inhibit the renal excretion of metabolites of glycerol phenylbutyrate including PAGN. 
Probenecid Probenecid lahko zavira ledvično izločanje presnovkov glicerol fenilbutirata, vključno s PAGN.
Even while on treatment with glycerol phenylbutyrate, acute hyperammonaemia including hyperammonaemic encephalopathy may occur in a proportion of patients. 
Tudi v času zdravljenja z glicerol fenilbutiratom se pri določenem deležu bolnikov lahko pojavi akutna hiperamoniemija, vključno z hiperamoniemično encefalopatijo.
Take RAVICTI with or straight after a meal. 
Zdravilo RAVICTI vzemite ob obroku ali takoj po njem.
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. 
O reverzibilnih kliničnih manifestacijah, ki so značilne za nevrotoksičnost (npr. slabost, bruhanje, somnolenca), so poročali v povezavi z ravnmi fenilbutirata v razponu od 499-1285 μg/ml pri bolnikih z rakom, ki so prejemali PAA intravensko.
Wye Valley Business Park, Brecon Road, 
Wye Valley Business Park,
• reflux of stomach contents 
• refluks želodčne vsebine
Therefore, measurement of plasma PAA and PAGN levels may be useful to guide dosing. 
Zato je lahko meritev ravni plazemske PAA in PAGN uporabna kot vodilo pri odmerjanju.
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. 
Zgornja meja enostranskega 95-odstotnega intervala zaupanja za največji, s placebom prilagojeni in za izhodiščne vrednost korigirani QTc, ki temelji na individualni korekcijski metodi (QTcI) za glicerol fenilbutirat, je bila pod 10 ms, kar kaže na to, da glicerol fenilbutirat ni imel učinka na podaljšanje intervala QT/QTc.
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. 
Razmerje med plazemsko PAA in PAGN, ki presega 2,5, lahko nakazuje nasičenost zmožnosti pretvorbe PAA v PAGN in potrebo po znižanem odmerku in/ali povečani pogostosti odmerjanja.
No studies were conducted in UCD patients with renal impairment; the safety of glycerol phenylbutyrate in patients with renal impairment is unknown. 
Študije pri bolnikih z motnjami ciklusa sečnine in okvaro ledvic niso bile opravljene; varnost glicerol fenilbutirata pri bolnikih z okvaro ledvic ni znana.
The potential for interaction of glycerol phenylbutyrate as a CYP3A4 inducer and those products predominantly metabolised by the CYP3A4 pathway is possible. 
Obstaja potencial za medsebojno delovanje glicerol fenilbutirata kot induktorja CYP3A4 in tistih zdravil, ki se pretežno presnavljajo po poti CYP3A4.
Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3). 
Glicerol fenilbutirat ni vplival na plodnost ali sposobnost razmnoževanja pri podganah obeh spolov (glejte poglavje 5.3).
The mean peak ratio of PAA to PAGN in UCD patients aged birth to less than 2 months was higher (mean: 1.65; range 0.14 to 7.07) than for UCD patients aged 2 months to less than 2 years (mean 0.59; range 0.17 to 1.21). 
Povprečno največje razmerje PAA in PAGN pri bolnikih z UCD, starih od rojstva do manj kot 2 meseca, je bilo večje (povprečje: 1,65; razpon 0,14 do 7,07) kot pri bolnikih z UCD, starih 2 meseca do manj kot 2 leti (povprečje 0,59; razpon 0,17 do 1,21).
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. 
Ker se pretvorba PAA v PAGN odvija v jetrih, imajo lahko bolniki s hudo okvaro jeter zmanjšano sposobnost pretvorbe in višjo raven plazemske PAA kot tudi razmerje med PAA in PAGN.
Do not add and stir the medicinal product into a large volume of other liquid, as glycerol phenylbutyrate is heavier than water and this may result in incomplete administration. 
Ne dodajte in ne mešajte zdravila v večje količine druge tekočine, saj je glicerol fenilbutirat težji od vode, kar lahko vodi do nepopolne aplikacije.
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. 
Brizge, ki ste jo uporabili za izpiranje gastrostome ali nazogastrične sonde, ne smete uporabiti za odmerjanje zdravila RAVICTI, s čimer se izognete dodajanju vode v zdravilo.
Dose adjustment was made to 3 subjects age < 1 month. 
Odmerek so prilagodili pri 3 preizkušancih, starih < 1 mesec.
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. 
Učinek večkratnih odmerkov glicerol fenilbutirata 13,2 g/na dan in 19,8 g/na dan (približno 69 % in 104 % največjega priporočenega dnevnega odmerka) na interval QTc, so ocenjevali v randomizirani navzkrižni študiji s štirimi terapevtskimi kraki, nadzorovani s placebom in zdravilno učinkovino (moksafloksacin 400 mg) pri 57 zdravih preiskovancih.
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). 
Po aplikaciji enkratnega odmerka glicerol fenilbutirata so bile plazemske koncentracije PBA količinsko določljive pri 15 od 22 udeležencev v prvem vzorcu, odvzetem po odmerku (0,25 h).
Measuring the dose 
Merjenje odmerka
Standard pack size: 1 bottle and 1 reclosable bottle cap adapter per carton. 
Velikost standardnega pakiranja: V škatli je ena steklenica in 1 zamašek z nastavkom za brizgo.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
V spodnji preglednici so v razvrstitvah pogostosti neželeni učinki navedeni po padajoči resnosti.
Glycerol phenylbutyrate is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Glicerol fenilbutirata ne uporabljajte med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
If RAVICTI gets in contact with water, the liquid will become cloudy in appearance. 
Če pride zdravilo RAVICTI v stik z vodo, bo tekočina postala motna.
If RAVICTI is added to water the liquid will become cloudy and you may not get the full dose. 
Če dodate zdravilo RAVICTI vodi, tekočina postane motna in morda ne boste zaužili celotnega odmerka.
If you forget to take RAVICTI 
Če ste pozabili vzeti zdravilo RAVICTI
What RAVICTI looks like and contents of the pack 
Izgled zdravila RAVICTI in vsebina pakiranja
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). 
Če se približno 47 % prehranskega dušika izloči kot odpadna snov in se približno 70 % aplicirane 4-fenilbutirične kisline pretvori v urinski fenilacetilglutamin (U-PAGN), je začetni odmerek glicerol fenilbutirata za 24-urno obdobje 0,6 ml glicerol fenilbutirata na gram prehranskih beljakovin, zaužitih v 24 urah, ob predpostavki, da glicerol fenilbutirat pokrije ves odpadni dušik in se izloči kot fenilacetilglutamin (PAGN).
Supplemental amino acid formulations may be necessary to maintain essential amino acids and branched chain amino acids within normal range. 
Morda bo potrebno jemanje dodatnih aminokislinskih pripravkov za vzdrževanje esencialnih aminokislin in aminokislin z razvejano verigo v normalnem razponu.
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. 
Zasičenost konjugacije PAA in glutamina za tvorbo PAGN je bila nakazana s povišanim razmerjem med plazemsko PAA in PAGN z večjim odmerkom in naraščajočo resnostjo okvare jeter.
Glycerol phenylbutyrate was not tumourigenic at doses up to 1000 mg/kg/day in a 26-week mouse study. 
Glicerol fenilbutirat v 26-tedenski študiji na miših ni bil tumorogen pri odmerkih do 1000 mg/kg/na dan.
Nine patients successfully transitioned to RAVICTI within 4 days, followed by 3 days of observation for a total of 7 days, where successful transition was defined as no signs and symptoms of hyperammonemia and a venous ammonia value less than 100 micromol/L. 
Devet bolnikov je v 4 dneh uspešno prešlo na zdravilo RAVICTI, temu obdobju je sledilo 3-dnevno opazovanje, ki je skupaj trajalo 7 dni, pri čemer so uspešen prehod opredelili kot stanje brez znakov in simptomov hiperamonemije in vrednosti amoniaka v venski krvi pod 100 mikromolov/l.
Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in UCD patients. 
Natančno spremljajte ravni amoniaka, kadar je treba uporabljati valprojsko kislino ali haloperidol pri bolnikih z UCD.
One additional patient developed hyperammonemia on day 3 of dosing and experienced surgical complications (bowel perforation and peritonitis) following jejunal tube placement on day 4. 
Pri enem dodatnem bolniku se je 3. dan odmerjanja razvila hiperamoniemija in 4. dan je prišlo do kirurških zapletov (perforacija črevesja in peritonitis) po namestitvi jejunalne sonde.
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 je stopnja vezave na beljakovine v plazmi za presnovke, označene s 14C, od 80,6 % do 98,0 % za PBA (prek 1-250 mikrogramov/ml) in od 37,1 % do 65,6 % za PAA (prek 5-500 mikrogramov/ml).
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. 
Preučevali so učinek glicerolfenilbutirata na izoencim citokroma P450 (CYP) 2C9 in možnost medsebojnega delovanja s celekoksibom pri ljudeh; kakršnih koli dokazov za medsebojno delovanje niso opazili.
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. 
Odprta nenadzorovana podaljšana študija pri odraslih Dolgoročna (12-mesečna), nenadzorovana, odprta študija (Študija 2) je bila izvedena za ocenjevanje mesečnega nadzora koncentracij amoniaka in hiperamoniemične krize v obdobju 12 mesecev.
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). 
Kancerogenost V študiji na podganah je glicerol fenilbutirat povzročil statistično značilno zvišanje pojavnosti pankreatičnega adenoma acinarnih celic in kombiniranega adenoma ali karcinoma pri samcih in samicah pri 4,7- in 8,4-kratnem odmerku za odrasle bolnike (6,87 ml/m2/na dan na podlagi kombiniranih AUC za PBA in PAA).
• flatulence 
• napenjanje (flatulenca)
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. 
Vsi bolniki so v 3 dneh uspešno prešli na zdravilo RAVICTI, pri čemer so uspešen prehod opredelili kot stanje brez znakov in simptomov hiperamonemije in vrednostmi amoniaka v venski krvi pod 100 mikromolov/l.
If you stop taking RAVICTI 
Če ste prenehali jemati zdravilo RAVICTI
It is unknown whether glycerol phenylbutyrate or its metabolites are excreted in human milk. 
Ni znano, ali se fenilbutirat ali njegovi presnovki izločajo v materino mleko.
Use one oral syringe for all doses taken each day. 
Ena peroralna brizga je namenjena za vse odmerke za vsak dan.
Clear, Type III glass, bottle with a high density polyethylene (HDPE) child-resistant closure. 
Prozorna steklenica (steklo tipa III) z za otroke varnim zamaškom iz polietilena visoke gostote (HDPE).
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. 
Če izločanje U-PAGN ne zadostuje za pokritje dnevnega vnosa prehranskih beljakovin in je raven amoniaka na tešče nad priporočeno zgornjo mejo normalne vrednosti (ULN), je treba odmerek glicerol fenilbutirata prilagoditi navzgor.
Pharmacological effects 
Farmakološki učinki
Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of glycerol phenylbutyrate and/or absorption of phenylbutyrate and reduced control of plasma ammonia. 
Majhno število ali odsotnost encimov trebušne slinavke ali črevesna bolezen, ki povzroči malabsorpcijo maščob, lahko vodi do znižane ali odsotne prebave glicerol fenilbutirata in/ali absorpcijo fenilbutirata kakor tudi do zmanjšanega nadzora nad ravnjo plazemskega amoniaka.