natgillin/translations-raw huggingface dataset:
The UCDs include deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH). 
Motnje ciklusa sečnine vključujejo pomanjkanje karbamoilfosfat sintetaze I (CPS, carbamoyl phosphate-synthetase-I), ornitin karbamoiltransferaze (OTC, ornithine carbamoyltransferase), argininosukcinat sintetaze (ASS), argininosukcinat liaze (ASL), arginaze I (ARG) in pomanjkanje ornitin translokaze (sindrom hiperornitinemija-hiperamonemija-homocitrulinurija (HHH)).
Based on prescribed dosing volume, patients should be advised to obtain CE marked oral syringes with suitable size for the dosage and compatible with the reclosable bottle cap adapter from the pharmacy. 
Na podlagi predpisanega volumna odmerka je treba bolnikom svetovati, da v lekarni dobijo peroralne brizge z oznako CE, ki so primerne velikosti za predpisani odmerek in združljive z zamaški z nastavkom za brizgo.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking RAVICTI. 
Če karkoli od naštetega velja za vas (ali pa niste prepričani), se pogovorite z zdravnikom ali farmacevtom, preden vzamete zdravilo RAVICTI.
• through a tube that goes through your tummy (‘abdomen') to the stomach - called a 
• skozi cevko, ki gre skozi vaš trebuh do želodca - gastrostoma
About urea cycle disorders 
O motnjah ciklusa sečnine
The efficacy of glycerol phenylbutyrate in paediatric patients 2 months to 17 years of age involving deficiencies of OTC, ASS, ASL, and ARG was evaluated in 2 fixed sequence, open-label, sodium phenylbutyrate to equivalent dosing of glycerol phenylbutyrate switchover studies (Studies 3 and 4). 
Klinične študije pri otrocih z motnjami ciklusa sečnine Učinkovitost glicerol fenilbutirata pri pediatričnih bolnikih, starih od 2 mesecev do 17 let z okvarami OTC, ASS, ASL in ARG so ocenjevali v dveh odprtih študijah prehoda s fiksnim zaporedjem, ki sta primerjali natrijev fenilbutirat z enakovrednimi odmerki glicerol fenilbutirata (Študija 3 in 4).
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. 
Farmakokinetično modeliranje in simulacije odmerkov v populaciji nakazujeta, da PBA vstopi v krvni obtok približno 70-75 % počasneje, kadar je peroralno zaužit kot glicerol fenilbutirat, v primerjavi z natrijevim fenilbutiratom.
• You should have the medicine with the reclosable bottle cap adapter along with an oral syringe to administer the correct amount of glycerol phenylbutyrate. 
• Imeti morate zdravilo z zamaškom z nastavkom za brizgo in peroralno brizgo, za lažjo aplikacijo ustrezne količine glicerol fenilbutirata.
• 7 ml/m2/day (8 g/m2/day) in patients with a BSA ≥ 1.3 m2 
• 7 ml/m2/na dan (8 g/m2/na dan) za bolnike s telesno površino ≥ 1,3 m2
• 8.5 ml/m2/day (9.4 g/m2/day) in patients with a body surface area (BSA) < 1.3 m2 
• 8,5 ml/m2/na dan (9,4 g/m2/na dan) za bolnike s telesno površino < 1,3 m2
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. 
Pri odraslih z UCD, ki so prejemali večkratne odmerke glicerol fenilbutirata, se je najvišja vrednost plazemske koncentracije ob stanju dinamičnega ravnovesja (Cmaxss) PBA, PAA in PAGN pojavila po 8, 12 in 10 urah po prvem dnevnem odmerku.
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. 
Zmanjšana absorpcija fenilbutirata pri pankreatični insuficienci ali črevesni malabsorpciji Eksokrini encimi trebušne slinavke hidrolizirajo glicerol fenilbutirat v tankem črevesu in ločijo aktivno molekulo, fenilbutirat, od glicerola.
Additional side effects in children less than 2 months of age 
Dodatni neželeni učinki pri otrocih, starih manj kot 2 meseca
The same reclosable bottle cap adapter can be used until a bottle is empty. 
Isti zamašek z nastavkom za brizgo injekcijske brizge se lahko uporablja, dokler ni vsebina steklenice prazna.
In healthy, fasting adult subjects receiving a single oral dose of 2.9 ml/m2 of glycerol phenylbutyrate, peak plasma levels of PBA, PAA, and PAGN occurred at 2 h, 4 h, and 4 h, respectively. 
Pri zdravih odraslih preiskovancih na tešče, ki prejemajo enkratni peroralni odmerek 2,9 ml/m2 glicerol fenilbutirata, so bile najvišje vrednosti koncentracij PBA, PAA in PAGN dosežene po 2, 4 oz. 4 urah.
RAVICTI 1.1 g/ml oral liquid Glycerol phenylbutyrate 
RAVICTI 1,1 g/ml peroralna tekočina glicerol fenilbutirat
Tabulated list of adverse reactions The adverse reactions are listed below, by system organ class and by frequency. 
Neželeni učinki so navedeni spodaj glede na organski sistem in pogostost.
Of the 49 paediatric patients who participated in these extension studies, 12 patients (25 %) reported a total of 17 hyperammonaemic crises during treatment with glycerol phenylbutyrate as compared with 38 crises in 21 patients (43 %) in the preceding 12 months prior to study entry, while they were being treated with sodium phenylbutyrate. 
Od 49 otrok, ki so sodelovali v teh podaljšanih študijah, je 12 bolnikov (25 %) poročalo o skupno 17 hiperamoniemičnih krizah v času zdravljenja z glicerol fenilbutiratom, v primerjavi z 21 bolniki (43 %), ki so poročali o skupno 38 krizah pri zdravljenju z natrijevim fenilbutiratom v obdobju 12 mesecev pred vključitvijo v študijo.
The product contains no excipients. 
Zdravilo ne vsebuje pomožnih snovi.
How to take RAVICTI 
Kako jemati zdravilo RAVICTI
Amino acid level decreased Gamma-glutamyltransferase increased Hepatic enzyme increased Transaminases increased 
Zmanjšana raven aminokisline Zvišana raven gama-glutamiltransferaze Zvišana raven jetrnega encima Zvišana raven transaminaz
Therefore, therapeutic effects and/or metabolite levels of medicinal products, including some oral contraceptives, that are substrates for this enzyme may be reduced and their full effects cannot be guaranteed, following coadministration with glycerol phenylbutyrate. 
Zato se po sočasni aplikaciji glicerol fenilbutirata terapevtski učinki in/ali ravni presnovkov zdravila, vključno z nekaterimi peroralnimi kontraceptivi, ki so substrati za ta encim, lahko znižajo in njihov polni učinek ni zagotovljen.
Three patients were treatment naïve and three additional patients were gradually discontinued from intravenous sodium benzoate and sodium phenylacetate while RAVICTI was initiated. 
Trije bolniki predhodno še niso bili zdravljeni, pri treh dodatnih bolnikih pa so postopoma prekinjali intravensko dajanje natrijevega benzoata in natrijevega fenilacetata, medtem ko so uvajali zdravilo RAVICTI.
Consistent with plasma ammonia, blood glutamine levels were lower during glycerol phenylbutyrate treatment as compared with sodium phenylbutyrate in each arm of the crossover study (decrease of 44.3 ± 154.43 micromol/L after glycerol phenylbutyrate compared with NaPBA; p = 0.064, paired t-test; p = 0.048, Wilcoxon signed-rank test). 
Skladno s plazemsko koncentracijo amoniaka so bile ravni glutamina v krvi nižje v času zdravljenja z glicerol fenilbutiratom v primerjavi z natrijevim fenilbutiratom v vsakem terapevtskem kraku navzkrižne študije (upad za 44,3 ± 154,43 mikromol/l po aplikaciji glicerol fenilbutirata v primerjavi z natrijevim fenilbutiratom; p = 0,064, parni t-test; p = 0,048, Wilcoxonov preizkus predznačenih rangov).
RAVICTI must be used with dietary protein restriction and sometimes dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements) depending on the daily dietary protein intake needed to promote growth and development. 
Zdravilo RAVICTI se uporablja skupaj s posebno dieto z malo beljakovinami in v nekaterih primerih skupaj s prehranskimi dodatki (npr. esencialne aminokisline, arginin, citrulin, kalorični dodatki brez beljakovin) glede na dnevni vnos prehranskih beljakovin, ki so potrebne za pospeševanje rasti in razvoja.
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). 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Zdravilo RAVICTI je treba pri ženskah v rodni dobi uporabljati sočasno z učinkovito kontracepcijo (glejte poglavje 4.4).
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. 
Odmerek glicerol fenilbutirata je treba prilagoditi, da pri bolnikih, starih 6 let in več, raven plazemskega amoniaka na tešče ostane pod polovico zgornje meje normalne vrednosti (ULN - upper limit of normal).
• if you have acute hyperammonaemia, which requires more rapid intervention. 
• če ste alergični na glicerol fenilbutirat • če imate akutno hiperamoniemijo, ki zahteva hitro ukrepanje.
What RAVICTI is and what it is used for What you need to know before you take RAVICTI How to take RAVICTI 
Kaj morate vedeti, preden boste vzeli zdravilo RAVICTI Kako morate jemati zdravilo RAVICTI
Two patients were treatment naïve and one additional patient was gradually discontinued from intravenous sodium benzoate and sodium phenylacetate while RAVICTI was initiated. 
Dva bolnika predhodno še nista bila zdravljena, pri enem dodatnem bolniku pa so postopoma prekinjali intravensko dajanje natrijevega benzoata in natrijevega fenilacetata, medtem ko so uvajali zdravilo RAVICTI.
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. 
Skupno 49 otrok, starih od 2 mesecev do 17 let, z okvarami OTC, ASS, ASL in ARG je bilo vključenih v študije in vsi razen enega so prešli z natrijevega fenilbutirata na glicerol fenilbutirat.
Uncommon Back pain, joint swelling, muscle spasm, pain in extremity, plantar fasciitis 
Bolečine v hrbtu, otekanje sklepov, krči mišic, bolečina v okončinah, plantarni fasciitis
Hypophagia 
Hipotiroidizem
Increased aspartate aminotransferase, alanine aminotransferase increased, increased anion gap, decreased lymphocyte count, decreased vitamin D Uncommon Blood potassium increased, blood triglycerides increased, electrocardiogram abnormal, low density lipoprotein increased, prothrombin time prolonged, white blood cell count increased, weight increased, weight decreased 
Povečana vsebnost kalija v krvi, zvišane vrednosti trigliceridov v krvi, nenormalen elektrokardiogram, zvišane vrednosti lipoproteinov majhne gostote, podaljšan protrombinski čas, povečano število levkocitov, povečanje telesne mase,
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. 
Ko so bolniki stabilizirani in je amoniak pod nadzorom, morajo bolniki, ki so prešli z natrijevega fenilacetata/natrijevega benzoata na zdravilo RAVICTI, prejeti odmerek zdravila RAVICTI na večjega koncu razpona zdravljenja (11,2 ml/m2/dan) z merjenjem plazemskega amoniaka, ki je vodilo za nadaljnje odmerjanje.
A new reclosable bottle cap should be used for each new bottle that is opened. 
Za vsako novo steklenico, ki jo odprete, je treba uporabiti nov zamašek z nastavkom za brizgo.
PHARMACEUTICAL FORM AND CONTENTS 
FARMACEVTSKA OBLIKA IN VSEBINA peroralna tekočina
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. 
Za zagotovitev pravilnega odmerjanja zdravila RAVICTI so v lekarni na voljo peroralne brizge z oznako CE, ki so primerne velikosti za dajanje vašega predpisanega odmerka in združljive z zamaški z nastavkom za brizgo.
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. 
Po peroralni aplikaciji pankreatične lipaze hidrolizirajo glicerol fenilbutirat in sprostijo PBA. PBA se pretovri v PAA z β-oksidacijo, nato konjugira z glutaminom v jetrih in ledvicah prek encima fenilacetil KoA: L-glutamin-N-acetiltransferaza, pri čemer nastane PAGN.
Intact glycerol phenylbutyrate was not detectable in plasma in UCD patients. 
Intaktnega glicerol fenilbutirata v plazmi bolnikov z UCD niso odkrili.
Use within 14 days of opening. 
POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo porabite v 14 dneh po odprtju.
How RAVICTI works 
Kako deluje zdravilo RAVICTI
Uncommon Abdominal discomfort, abnormal faeces, dry mouth, eructation, defaecation urgency, upper abdominal pain and/or lower abdominal pain, painful defaecation, steatorrhoea, stomatitis 
Nelagodje v trebuhu, nenormalno blato, suha usta, kolcanje, urgentno odvajanje blata, bolečine v zgornjem in/ali spodnjem delu trebuha, boleče odvajanje blata,
• constipation 
• zmedenost
Additional adverse reactions have been evaluated in a clinical study including 16 UCD patients less than 2 months of age. 
Dodatne neželene učinke so ocenili v klinični študiji, v katero je bilo vključenih 16 bolnikov z UCD,
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Jih ni.
Glycerol phenylbutyrate is hydrolysed by pancreatic lipases to yield, PBA, which is converted by beta oxidation to PAA, the active moiety of glycerol phenylbutyrate. 
Glicerol fenilbutirat se hidrolizira s pomočjo pankreatičnih lipaz v PBA, ki se pretvori z beta oksidacijo v PAA, aktivno molekulo glicerol fenilbutirata.
Fill the oral syringe by pulling the plunger back until the syringe is filled with the amount of medicinal product. 
Peroralno brizgo napolnite, tako da bat povlečete nazaj, da se peroralna brizga napolni z zdravilom.
• Step 1: 100% dose sodium phenylacetate/sodium benzoate and 50% dose of RAVICTI for 4-8 
100-% odmerek natrijevega fenilacetata/natrijevega benzoata in 50-%
Initial dosage in patients switching from sodium phenylbutyrate to RAVICTI: 
Začetni odmerki za bolnike, ki bodo prešli z injekcij natrijevega fenilacetata/natrijevega benzoata na zdravilo RAVICTI:
Study in Children Less Than 2 Months of Age 
Študija pri otrocih, starih 2 meseca do manj kot 2 leti
Uncommon Dysphonia, epistaxis, nasal congestion, oropharyngeal pain, throat irritation 
Disfonija, epistaksa, zamašenost nosu, bolečine v žrelu, draženje grla
The RAVICTI pack contains the medicinal product and a reclosable bottle cap adapter. 
Pakiranje zdravila RAVICTI vsebuje zdravilo in zamašek z nastavkom za brizgo.
• gallbladder, bladder or back pain 
• bolečine v žolčniku, sečnem mehurju ali hrbtu
RAVICTI must be used with a special low protein diet. - This diet will be designed for you by your doctor and dietician. 
- To dieto bosta posebej za vas pripravila vaš zdravnik in dietetik.
Store bottle and oral syringe in a clean, dry place between doses. 
Med posameznimi odmerjanji stekenico shranite na čistem in suhem mestu.
The median exposure was 10 months (range 2 to 20 months) and median exposure in the 2 months to less than 2 years of age was 9 months (range 0.2 to 20.3 months).Adverse drug reactions (ADR) are summarized below. 
Mediana izpostavljenost je bila 10 mesecev (razpon 2 do 20 mesecev), medtem ko je bila mediana izpostavljenost za starost od 2 mesecev do manj kot 2 leti 9 mesecev
• 7000 microgram (mcg/ml) for patients >2 years of age with a BSA of ≤1.3 
• 7000 mikrogramov (μg/ml) za bolnike starosti >2 let s telesno površino ≤1,3
Swallow the liquid from the oral syringe or attach the oral syringe to a gastrostomy or nasogastric tube. 
Pogoltnite tekočino iz peroralne brizge ali pritrdite peroralno brizgo na gastrostomo ali nazogastrično sondo.
Respiratory, thoracic and mediastinal disorder 
Bolezni dihal, prsnega koša in mediastinalnega prostora
• 5000 microgram (mcg/ml) for patients >2 years of age with a BSA of >1.3 
• 5000 mikrogramov (μg/ml) za bolnike starosti >2 let s telesno površino >1,3
Mean maximum concentration (Cmax) for PBA, PAA, and PAGN was 37.0 micrograms/ml, 14.9 micrograms/ml, and 30.2 micrograms/ml, respectively. 
Srednje vrednosti najvišje koncentracije (Cmax) za PBA, PAA in PAGN so bile 37,0 mikrogramov/ml,
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). 
V analizi združenih podatkov iz kratkoročnih študij pri otrocih (3. študija in 4. študija) je bila plazemska koncentracija amoniaka pomembno nižja po prehodu na glicerol fenilbutirat; površina pod krivuljo plazemskih koncentracij amoniaka (AUC0-24h) je bila 626,79 [(mikromol/l)*h ] med zdravljenjem z glicerol fenilbutiratom in in 871,72 med zdravljenjem natrijevim fenilbutiratom (n = 26, razmerje geometričnih sredin 0,79; 95-odstotni intervali zaupanja 0,647, 0,955).
Upon oral ingestion, PBA is released from the glycerol backbone in the gastrointestinal tract by pancreatic lipases. 
Po peroralnem zaužitju se PBA sprosti z osnove glicerola v prebavni trakt s pomočjo pankreatične lipaze.
• Utilising the plunger of the oral syringe, administer RAVICTI into the tube. 
• Z uporabo bata peroralne brizge aplicirajte zdravilo RAVICTI v sondo.
Glycerol phenylbutyrate is a nitrogen-binding medicinal product. 
Glicerol fenilbutirat je zdravilo, ki veže nase dušik.
CE marked oral syringes compatible with the reclosable bottle cap adapter can be obtained from a pharmacy. 
Peroralne brizge z oznako CE, ki so združljive z zamaškom z nastavkom za brizgo, so na voljo v lekarni.
It is not recommended to administer a dose of 0.5 ml or less with nasogastric, gastrostomy or nasojejunal tubes, given the low drug recovery in dosing. 
Apliciranje odmerka 0,5 ml ali manj preko nazogastrične sonde, gastrostome ali nazojejunalne sonde ni priporočljivo zaradi nizkega odstotka izkoriščenega zdravila pri takem odmerjanju.
Constipation, Flatulence, Gastrooesophageal reflux disease 
Konstipacija, flatulenca, gastrooezofagealna refluksna bolezen vsaka po 1 (6,3 %)
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. 
Dnevni odmerek je treba individualno prilagajati glede na bolnikovo ocenjeno sposobnost sinteze sečnine, v kolikor do sinteze sploh prihaja, tolerance na beljakovine in dnevni vnos prehranskih beljakovin, ki so potrebne za pospeševanje rasti in razvoja.
• If you are pregnant, tell your doctor before you start taking RAVICTI. 
Nosečnost, kontracepcija in dojenje • Če ste noseči, obvestite zdravnika, preden začnete jemati zdravilo RAVICTI.
Food aversion 
Odklanjanje hrane
• You should not take RAVICTI if you are breast-feeding. 
• Če dojite, ne smete jemati zdravila RAVICTI.
Although two patients had day 7 ammonia values of 150 micromol/L and 111 micromol/L respectively, neither had associated signs and symptoms of hyperammonemia. 
Čeprav sta imela dva bolnika vrednosti amoniaka na 7. dan 150 mikromolov/l oz.
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). 
Analiza združenih podatkov iz študij, kjer so bolniki prešli z natrijevega fenilbutirata na glicerol fenilbutirat, je bila površina pod krivuljo plazemskih koncentracij amoniaka (AUC0-24h) 774,11 [(mikromol/l)*h] med zdravljenjem z glicerol fenilbutiratom in in 991,19 med zdravljenjem z natrijevim fenilbutiratom (n = 80, razmerje geometričnih sredin 0,84; 95-odstotni interval zaupanja
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. 
Priporočeni odmerki za bolnike, ki še niso prejemali fenilbutirične kisline, in za bolnike, ki so prešli z natrijevega fenilbutirata ali injekcij natrijevega fenilacetata/natrijevega benzoata na zdravilo
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). 
Povprečne normalizirane vrednosti amoniaka v venski krvi pri pediatričnih bolnikih, starih manj kot 2 meseca, so bile znotraj normalnih mej med dolgoročnim zdravljenjem z glicerol fenilbutiratom (razpon: 35 do 94 mikromolov/l).
RAVICTI 1.1 g/ml oral liquid 
IME ZDRAVILA RAVICTI 1,1 g/ml peroralna tekočina
Skin and subcutaneous tissue disorders 
Driska Bolezni kože in podkožja
• Place the tip of the oral syringe onto the tip of the gastrostomy/nasogastric tube. 
• Položite vrh/konico peroralne brizge na vrh/konico gastrostome/nazogastrične sonde.
It is important to ensure that the oral syringe is kept clean and dry between the dosing intervals. 
Ista peroralna brizga je namenjena za vse odmerke za vsak dan. Pomembno je zagotoviti, da peroralna brizga med odmernimi intervali ostane čista in suha.
Patients switching from sodium phenylbutyrate to RAVICTI should receive the dosage of RAVICTI that contains the same amount of phenylbutyric acid. 
Začetni odmerek pri bolnikih, ki so prešli z natrijevega fenilbutirata na zdravilo RAVICTI: Bolniki, ki so prešli iz natrijevega fenilbutirata na zdravilo RAVICTI, morajo prejemati takšen odmerek zdravila RAVICTI, ki vsebuje isto količino fenilbutirične kisline.
• Each ml of liquid contains 1.1 g of glycerol phenylbutyrate. 
• En ml tekočine vsebuje 1,1 g glicerol fenilbutirata.
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). 
Povprečna vrednost AUC (0-24) za amoniak v venski krvi pri odmerjanju v stanju dinamičnega ravnovesja je bila 866 mikromol/l*h pri uporabi glicerol fenilbutirata in pri uporabi 977 mikromol/l*h natrijevega fenilbutirata (n = 44, razmerje geometričnih sredin 0,91; 95-odstotni interval zaupanja 0,799, 1,034).
Hyperammonemia may be induced by haloperidol and by valproic acid. 
Valprojska kislina in haloperidol lahko sprožita hiperamoniemijo.
Do not rinse the reclosable bottle cap or the oral syringe between daily doses, as the presence of water causes glycerol phenylbutyrate to degrade. 
Med dnevnimi odmerki ne spirajte zamaška z nastavkom za brizgo ali peroralne brizge, saj prisotnost vode povzroči razgradnjo glicerol fenilbutirata.
• by mouth 
• peroralno (skozi usta)
Dizziness, headache, tremor Uncommon Dysgeusia, lethargy, paraesthesia, psychomotor hyperactivity, somnolence, speech disorder 
Disgevzija, letargija, parestezija, psihomotorična hiperaktivnost,
Constipation Diarrhoea 
Žilne bolezni