FrancophonIA/ELRC3.0 huggingface dataset:
English: RAVICTI may be added to a small amount of apple sauce, ketchup, or squash puree and should be used within 2 hours when stored at room temperature (25° C).
Slovenian: Zdravilo RAVICTI se lahko doda manjši količini jabolčne čežane, kečapa ali bučnega pireja in ga je treba porabiti v 2 urah, če je shranjeno pri sobni temperaturi (25 °C).
English: Population pharmacokinetic modelling and dosing simulations suggest body surface area is the most significant covariate explaining the variability of PAA clearance.
Slovenian: Farmakokinetično modeliranje in simulacije odmerkov v populaciji nakazujejo, da je telesna površina najpomembnejša sospremenljivka, ki pojasnjuje variabilnost očistka PAA.
English: Further adjustment may be based on monitoring of plasma ammonia, glutamine, U-PAGN and/or plasma PAA and PAGN as well as the ratio of plasma PAA to PAGN (see section 4.2).
Slovenian: Nadaljnje prilagoditve lahko temeljijo na plazemskem amoniaku, glutaminu, U-PAGN in/ali plazemski PAA in PAGN kot tudi na razmerju med plazemsko PAA in PAGN (glejte poglavje 4.2).
English: PAA, the active metabolite of glycerol phenylbutyrate, is associated with signs and symptoms of neurotoxicity (see section 4.4) and could accumulate in patients who receive an overdose.
Slovenian: PAA, aktivni presnovek glicerol fenilbutirata, je povezan z znaki in simptomi nevrotoksičnosti (glejte poglavje 4.4) in se lahko nakopiči pri bolnikih, ki zaužijejo prevelik odmerek zdravila.
English: • 9000 microgram (mcg/ml) for patients under 2 years of age
Slovenian: • 9000 mikrogramov (μg/ml) za bolnike, mlajše od 2 let
English: In some cases such as infection or post-surgery, the amount of ammonia may go up despite treatment with this medicine and may damage the brain (hyperammonaemic encephalopathy).
Slovenian: V določenih primerih, kot je okužba ali po operaciji, se lahko raven amoniaka zviša kljub zdravljenju z glicerol fenilbutiratom in lahko poškoduje možgane (hiperamoniemična encefalopatija).
English: It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone.
Slovenian: Je triglicerid, ki vsebuje 3 molekule PBA, ki so vezane na osnovo glicerola.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo RAVICTI Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • In urea cycle disorders, the body is not able to produce enough liver enzymes to remove the extra nitrogen.
Slovenian: • Pri motnjah ciklusa sečnine telo ne zmore proizvajati zadostne količine jetrnih encimov za odstranitev odvečnega dušika.
English: One oral syringe should be used each day.
Slovenian: Vsak dan se uporabi ena peroralna brizga.
English: 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).
Slovenian: Če stopnja koncentracije U-PAGN ob posameznih meritvah pade pod te ravni, ocenite bolnikovo zmožnost jemanja zdravila in/ali učinkovitost aplikacije zdravila (npr. po cevki za hranjenje) in razmislite o zvišanju odmerka glicerol fenilbutirata pri bolnikih, ki zdravilo jemljejo ustrezno, da bi dosegli optimalen nadzor ravni amoniaka (znotraj meje normalne vrednosti za bolnike, mlajše od 2 let, in na manj kot polovici ULN pri starejših bolnikih na tešče).
English: After the last dose of the day, the oral syringe should be discarded.
Slovenian: Po zadnjem dnevnem odmerku je treba peroralno brizgo zavreči.
English: RAVICTI can be added to a small amount of soft foods, such as ketchup, medical formulas, apple sauce or squash puree.
Slovenian: Zdravilo RAVICTI lahko dodate manjšim količinam mehke hrane, kot so kečap, medicinski pripravki, jabolčna čežana ali bučni pire.
English: This corresponds to a density of 1.1 g/ml.
Slovenian: To ustreza gostoti 1,1 g/ml.
English: In these in vitro studies, a complete disappearance of glycerol phenylbutyrate did not produce molar equivalent PBA, suggesting the formation of mono- or bis-ester metabolites.
Slovenian: V tej študijah in vitro popolno izginotje glicerol fenilbutirata ni ustvarilo molarno ekvivalentne količine PBA, kar nakazuje na tvorbo mono- ali bis estrnih presnovkov.
English: RAVICTI contains the active substance ‘glycerol phenylbutyrate' which is used to treat six known ‘urea cycle disorders' (UCDs) in adults and children.
Slovenian: Zdravilo RAVICTI vsebuje učinkovino »glicerol fenilbutirat«, ki se uporablja za zdravljenje šestih znanih motenj ciklusa sečnine (UCD, urea cycle disorders) pri odraslih in otrocih.
English: 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.
Slovenian: Povprečni odstotek (SD) apliciranega PBA, ki se izloči kot PAGN, je bil približno 68,9 % (17,2) pri odraslih in 66,4 % (23,9) pri otrocih z UCD v stanju dinamičnega ravnovesja.
English: In this case, glycerol phenylbutyrate will not stop the level of ammonia in your blood from becoming seriously high.
Slovenian: V tem primeru glicerol fenilbutirat ne bo preprečil prekomernega zvišanja ravni amoniaka v krvi.
English: RAVICTI should be taken with meals and administered directly into the mouth via an oral syringe.
Slovenian: Zdravilo RAVICTI je treba zaužiti z obroki in aplicirati neposredno v usta po peroralni brizgi.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: PAA konjugira z glutaminom (ki vsebuje 2 molekuli dušika) preko acetilacije v jetrih in ledvicah in tvori PAGN, ki se izloča skozi ledvice.
English: 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).
Slovenian: 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).
English: High levels of ammonia leads to feeling sick (nausea), being sick (vomiting) or feeling confused.
Slovenian: Visoke koncentracije amoniaka vodijo do siljenja na bruhanje (navzea), bruhanja ali občutka zmedenosti.
English: 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.
Slovenian: 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.
English: • corticosteroids - used to treat inflamed areas of the body
Slovenian: • kortikosteroidi - uporabljajo se za zdravljenje vnetih mest na telesu
English: • In urea cycle disorders, the body cannot remove the nitrogen from the protein that we eat.
Slovenian: • Pri motnjah ciklusa sečnine telo ne zmore odstraniti dušika iz beljakovin, ki jih zaužijemo.
English: • increased number of platelets (tends to cause blood clot)
Slovenian: • zvišano število trombocitov (ki povzročajo strjevanje krvi)
English: • lipase in pancreatic replacement therapies
Slovenian: • lipaze pri nadomestnih zdravljenjih bolezni trebušne slinavke
English: There was one additional patient who had one venous ammonia level that exceeded 100 micromol/L which was not associated with a hyperammonemic crisis.
Slovenian: 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.
English: What you need to know before you take RAVICTI Do not take RAVICTI:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo RAVICTI Ne jemljite zdravila RAVICTI:
English: • There are no other ingredients.
Slovenian: • Drugih sestavin zdravilo ne vsebuje.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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 %.
English: Glycerol phenylbutyrate has been tested in a range of in vitro and in vivo genotoxicity studies, and shown no genotoxic activity.
Slovenian: Glicerol fenilbutirat je bil testiran v številnih študijah genotoksičnosti in vitro ter in vivo in ni izkazoval genotoksične aktivnosti.
English: 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.
Slovenian: 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,
English: No developmental abnormalities were observed in rats through day 92 postpartum following oral administration in pregnant rats, during organogenesis and lactation.
Slovenian: Razvojnih nepravilnosti niso opazili pri podganah do 92. dne po skotitvi po peroralni aplikaciji brejim podganam, v času organogeneze in dojenja.
English: 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.
Slovenian: 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.
English: • poor feeding
Slovenian: • zmanjšan vnos hrane
English: Effects of glycerol phenylbutyrate on other CYP isoenzymes have not been studied in humans and cannot be excluded.
Slovenian: Učinkov glicerol fenilbutirata na druge izoencime CYP pri ljudeh niso raziskovali, zato jih ni možno izključiti.
English: The plasma PAA to PAGN ratio may be useful in dosage monitoring.
Slovenian: Razmerje med plazemsko PAA in PAGN je lahko uporabno pri nadzorovanju odmerjanja.
English: Hereford, Herefordshire, HR3 5PG United Kingdom
Slovenian: Hay-on-Wye, Hereford, Herefordshire, HR3 5PG
English: 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.
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Open the bottle of RAVICTI by pushing down on the cap and twisting to the left.
Slovenian: Steklenico z zdravilom RAVICI odprite tako, da zamašek potisnete dol in ga obrnete v levo.
English: RAVICTI is a pro-drug of PBA.
Slovenian: Zdravilo RAVICTI je predzdravilo PBA.
English: You will need to take this medicine and follow a special low protein diet throughout your life.
Slovenian: To zdravilo boste morali jemati celo življenje in upoštevati posebno dieto z malo beljakovinami.
English: Of the 45 paediatric patients participating in the open-label treatment with glycerol phenylbutyrate, 11 patients (24%) reported a total of 22 hyperammonemic crises.
Slovenian: Od 45 pediatričnih bolnikov, ki so sodelovali v odprtem zdravljenju z glicerol fenilbutiratom, je 11 bolnikov (24 %) poročalo o skupaj 22 hiperamoniemičnih krizah.
English: 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.
Slovenian: 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.
English: • through a tube that goes through your nose to the stomach - called a ‘nasogastric tube'
Slovenian: • skozi cevko, ki gre skozi vaš nos do želodca - nazogastrična sonda
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Probenecid Probenecid may inhibit the renal excretion of metabolites of glycerol phenylbutyrate including PAGN.
Slovenian: Probenecid Probenecid lahko zavira ledvično izločanje presnovkov glicerol fenilbutirata, vključno s PAGN.
English: Even while on treatment with glycerol phenylbutyrate, acute hyperammonaemia including hyperammonaemic encephalopathy may occur in a proportion of patients.
Slovenian: Tudi v času zdravljenja z glicerol fenilbutiratom se pri določenem deležu bolnikov lahko pojavi akutna hiperamoniemija, vključno z hiperamoniemično encefalopatijo.
English: Take RAVICTI with or straight after a meal.
Slovenian: Zdravilo RAVICTI vzemite ob obroku ali takoj po njem.
English: 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.
Slovenian: 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.
English: Wye Valley Business Park, Brecon Road,
Slovenian: Wye Valley Business Park,
English: • reflux of stomach contents
Slovenian: • refluks želodčne vsebine
English: Therefore, measurement of plasma PAA and PAGN levels may be useful to guide dosing.
Slovenian: Zato je lahko meritev ravni plazemske PAA in PAGN uporabna kot vodilo pri odmerjanju.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: No studies were conducted in UCD patients with renal impairment; the safety of glycerol phenylbutyrate in patients with renal impairment is unknown.
Slovenian: Študije pri bolnikih z motnjami ciklusa sečnine in okvaro ledvic niso bile opravljene; varnost glicerol fenilbutirata pri bolnikih z okvaro ledvic ni znana.
English: The potential for interaction of glycerol phenylbutyrate as a CYP3A4 inducer and those products predominantly metabolised by the CYP3A4 pathway is possible.
Slovenian: Obstaja potencial za medsebojno delovanje glicerol fenilbutirata kot induktorja CYP3A4 in tistih zdravil, ki se pretežno presnavljajo po poti CYP3A4.
English: Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3).
Slovenian: Glicerol fenilbutirat ni vplival na plodnost ali sposobnost razmnoževanja pri podganah obeh spolov (glejte poglavje 5.3).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ne dodajte in ne mešajte zdravila v večje količine druge tekočine, saj je glicerol fenilbutirat težji od vode, kar lahko vodi do nepopolne aplikacije.
English: 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.
Slovenian: 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.
English: Dose adjustment was made to 3 subjects age < 1 month.
Slovenian: Odmerek so prilagodili pri 3 preizkušancih, starih < 1 mesec.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Measuring the dose
Slovenian: Merjenje odmerka
English: Standard pack size: 1 bottle and 1 reclosable bottle cap adapter per carton.
Slovenian: Velikost standardnega pakiranja: V škatli je ena steklenica in 1 zamašek z nastavkom za brizgo.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V spodnji preglednici so v razvrstitvah pogostosti neželeni učinki navedeni po padajoči resnosti.
English: Glycerol phenylbutyrate is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Glicerol fenilbutirata ne uporabljajte med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: If RAVICTI gets in contact with water, the liquid will become cloudy in appearance.
Slovenian: Če pride zdravilo RAVICTI v stik z vodo, bo tekočina postala motna.
English: If RAVICTI is added to water the liquid will become cloudy and you may not get the full dose.
Slovenian: Če dodate zdravilo RAVICTI vodi, tekočina postane motna in morda ne boste zaužili celotnega odmerka.
English: If you forget to take RAVICTI
Slovenian: Če ste pozabili vzeti zdravilo RAVICTI