natgillin/translations-raw huggingface dataset:
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
Glycerol phenylbutyrate is not recommended during pregnancy and in women of childbearing potential not using contraception.
Ne preporučuje se koristiti lijek glicerolfenilbutirat tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
Adverse reactions reported in more paediatric than adult patients during long-term treatment with glycerol phenylbutyrate included upper abdominal pain (3 of 49 paediatric [6.1%] versus 1 of 51 adults [2.0%] and increased anion gap (2 of 49 paediatric [4.1%] versus 0 of 51 adults [0%].
Nuspojave prijavljene kod više pedijatrijskih nego odraslih bolesnika tijekom dugotrajnog liječenja glicerolfenilbutiratom uključivale su bol u gornjem dijelu abdomena (3 od 49 pedijatrijskih [6,1%] naspram 1 od 51 odraslih bolesnika [2,0%]) i povećani anionski jaz (2 od 49 pedijatrijskih bolesnika [4,1%] naspram 0 od 51 odraslih [0%]).
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
Povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti alanin aminotranferaze, povećani anionski jaz (engl. anion gap), smanjen broj limfocita, smanjena razina vitamina D Manje često Povišen kalij u krvi, povišeni trigliceridi u krvi, abnormalni elektrokardiogram, povišen lipoprotein niske gustoće, produljeno protrombinsko vrijeme, povišen broj leukocita, povećanje tjelesne težine, smanjenje tjelesne težine
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.
Nemojte dodavati niti miješati lijek u velikom volumenu druge tekućine jer je glicerolfenilbutirat teži od vode što može uzrokovati nepotpunu primjenu.
It is unknown whether glycerol phenylbutyrate or its metabolites are excreted in human milk.
Nije poznato izlučuju li se glicerolfenilbutirat ili njegovi metaboliti u majčino mlijeko.
Glycerol phenylbutyrate has been tested in a range of in vitro and in vivo genotoxicity studies, and shown no genotoxic activity.
Glicerolfenilbutirat ispitivan je u rasponu in vitro i in vivo ispitivanja genotoksičnosti i nije pokazao genotoksičnu aktivnost.
• less able to remember things
• oslabljena sposobnost pamćenja
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.
Ne preporučuje se primijeniti dozu od 0,5 ml ili manju nazogastričnom, gastrostomom ili nazojejunalnom sondom s obzirom na mali povrat lijeka kod doziranja.
In healthy subjects, after administration of 4 ml, 6 ml, and 9 ml 3 times daily for 3 days, the ratio of mean AUC0-23h of PAA to PAGN was 1, 1.25, and 1.6, respectively.
Kod zdravih ispitanika, nakon primjene 4 ml, 6 ml i 9 ml 3 puta dnevno tijekom 3 dana, omjer srednjeg AUC0-23h PAA i PAGN bio je 1, 1,25, odnosno 1,6.
Important note: Do not add or stir RAVICTI into larger volumes of liquid such as water or juice as the introduction of water causes glycerol phenylbutyrate to degrade.
Važna napomena: Nemojte dodavati ni miješati RAVICTI u većim količinama tekućine poput vode ili soka, budući da dodavanje vode uzrokuje razgradnju glicerolfenilbutirata.
• Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate powder (g) x 0.81
• Ukupna dnevna doza lijeka RAVICTI (ml) = ukupna dnevna doza praška natrijevog fenilbutirata (g) x 0,81
Glycerol phenylbutyrate was found to be non-inferior to sodium phenylbutyrate with respect to ammonia control in both of these paediatric studies.
Utvrđeno je da je glicerolfenilbutirat neinferioran natrijevom fenilbutiratu s obzirom na kontrolu amonijaka u oba ta pedijatrijska ispitivanja.
Turn the bottle upside down with the oral syringe still inserted.
Preokrenite bocu naopako dok je oralna štrcaljka još uvijek umetnuta.
Standard pack size: 1 bottle and 1 reclosable bottle cap adapter per carton.
Standardna veličina pakiranja: 1 nastavak za bocu s čepom za ponovno zatvaranje po kutiji.
After the last dose of the day, the oral syringe should be discarded.
Nakon zadnje doze u danu oralnu štrcaljku treba baciti.
Tap the oral syringe to remove air bubbles, making sure you have filled it with the correct amount of liquid.
Kucnite prstima po oralnoj štrcaljki kako biste uklonili mjehuriće zraka, pazeći da ste je napunili odgovarajućom količinom tekućine.
Ammonia levels must be monitored closely when changing the dose of glycerol phenylbutyrate.
Razine amonijaka moraju se strogo pratiti kod promjene doze glicerolfenilbutirata.
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 prilagođene doze treba biti srazmjerna količini proteina iz prehrane koja nije pokrivena, sukladno razini 24-h U-PAGN i procijenjenoj dozi glicerolfenilbutirata potrebnoj po gramu uzetih proteina iz prehrane.
• poor feeding
• slabo uzimanje hrane.
Study in Children Less Than 2 Months of Age
Ispitivanje u djece mlađe od 2 mjeseca
Do not re-use the oral syringe for measuring the dose of RAVICTI on another day.
Nemojte drugi dan ponovno koristiti istu oralnu štrcaljku za odmjeravanje doze lijeka RAVICTI.
• tests show higher triglycerides, low density lipo-protein or white cells in your blood
• nalazi pretraga pokazuju povišene trigliceride, lipoprotein niske gustoće ili bijele krvne stanice u krvi
Uncommon Gastrointestinal viral infection
Manje često Gastrointestinalna virusna infekcija
How RAVICTI works
Kako RAVICTI djeluje
Glycerol phenylbutyrate was non-inferior to sodium phenylbutyrate with respect to the 24-hour AUC for ammonia.
Glicerolfenilbutirat bio je neinferioran natrijevom fenilbutiratu s obzirom na 24-satni AUC amonijaka.
Pharmacological effects
Farmakološki učinci
Ammonia levels should be closely monitored in patients with pancreatic insufficiency or intestinal malabsorption.
Razine amonijaka treba pomno pratiti kod bolesnika s insuficijencijom gušterače ili intestinalnom malapsorpcijom.
Package leaflet: Information for the patient RAVICTI 1.1 g/ml oral liquid
Uputa o lijeku: Informacije za bolesnika RAVICTI 1,1 g/ml oralna tekućina glicerolfenilbutirat
Tell a doctor straight away if: • you are sick (vomit), which is a common side effect, more than once and this does not stop.
• povraćate, što je česta nuspojava, više od jednom i to ne prestaje.
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).
Bolesnici nisu smjeli imati kliničke dokaze hiperamonemije kod uključenja i nisu smjeli primati lijekove za koje se zna da povećavaju razinu amonijaka (npr. valproat), povećavaju katabolizam proteina (npr. kortikosteroidi),
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.
Medijan izloženosti iznosio je 10 mjeseci (raspon: 2-20 mjeseci), a medijan izloženosti u dobnoj skupini od 2 mjeseca do manje od 2 godine iznosio je 9 mjeseci (raspon: 0,2-20,3 mjeseci).
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.
Sniženje ili odsutnost enzima gušterače ili crijevna bolest koja uzrokuje malapsorpciju masti mogu rezultirati smanjenjem ili izostankom probave glicerolfenilbutirata i/ili apsorpcije fenilbutirata i smanjenom kontrolom razine amonijaka u plazmi.
Unimedic AB Storjordenvägen 2 SE-864 31 Matfors Sweden
SE-864 31 Matfors
The incidence of the following tumours was also increased in female rats: thyroid follicular cell adenoma, carcinoma and combined adenoma or carcinoma, adrenal cortical combined adenoma or carcinoma, cervical schwannoma, uterine endometrial stromal polyp, and combined polyp or sarcoma.
Incidencija sljedećih tumora također je bila veća kod ženki štakora: adenom folikularnih stanica štitnjače, karcinom i kombinirani adenom ili karcinom, kombinirani adenom ili karcinom nadbubrežne žlijezde, cervikalni švanom, uterini endometrijski stromalni polip i kombinirani polip ili sarkom.
No studies were conducted in UCD patients with renal impairment; the safety of glycerol phenylbutyrate in patients with renal impairment is unknown.
Nisu provedena ispitivanja u bolesnika s poremećajima ciklusa ureje i oštećenjem bubrega; sigurnost glicerolfenilbutirata kod bolesnika s oštećenjem bubrega nije poznata.