natgillin/translations-raw huggingface dataset:
How to take RAVICTI
Kako uzimati RAVICTI
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).
Srednja vrijednost omjera vršnih vrijednosti PAA i PAGN u bolesnika s poremećajima ciklusa ureje u dobi od rođenja do manje od 2 mjeseca bila je viša (srednja vrijednost: 1,65; raspon 0,14-7,07) nego u bolesnika s poremećajima ciklusa ureje u dobi od 2 mjeseca do manje od 2 godine (srednja vrijednost 0,59; raspon 0,17-1,21).
Each dose should be rounded up to the nearest 0.1 ml for patients less than 2 years of age and 0.5 ml for patients 2 years of age and older.
Svaku dozu treba zaokružiti na najbližih 0,1 ml za bolesnike mlađe od
In vivo exposure to glycerol phenylbutyrate has resulted in decreased systemic exposure to midazolam of approximately 32% and increased exposure to the 1-hydroxy metabolite of midazolam, suggesting that steady-state dosing of glycerol phenylbutyrate results in CYP3A4 induction.
Izloženost glicerolfenilbutiratu in vivo rezultirala je smanjenom sistemskom izloženosti midazolamu za otprilike 32% i povećanom izloženosti 1-hidroksi metabolitu midazolama, što upućuje na to da doziranje glicerolfenilbutirata u stanju dinamičke ravnoteže rezultira indukcijom enzima CYP3A4.
• feeling of pins and needles, feeling very restless, difficulty in waking up, feeling drowsy, problems with speech, feeling confused, depressed
• osjećaj trnaca i bockanja, osjećaj jakog nemira, teško buđenje, omamljenost, problemi s govorom, smetenost, depresija
Three patients were treatment naïve and three additional patients were gradually discontinued from intravenous sodium benzoate and sodium phenylacetate while RAVICTI was initiated.
Tri bolesnika prethodno nisu bila liječena, dok su tri dodatna bolesnika postupno prekinula primanje intravenskog natrijevog benzoata i natrijevog fenilacetata dok im se uvodio RAVICTI.
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.
Farmakokinetika glicerolfenilbutirata kod bolesnika s oštećenjem funkcije bubrega, uključujući one sa završnim stadijem bolesti bubrega ili one na hemodijalizi, nije ispitivana.
In a study in patients with clinically decompensated cirrhosis and hepatic encephalopathy (Child-Pugh B and C), mean Cmax of PAA was 144 mcg/ml (range: 14-358 mcg /ml) after daily dosing of 6 ml of glycerol phenylbutyrate twice daily, while mean Cmax of PAA was 292 mcg /ml (range: 57-655 mcg/ml) after daily dosing of 9 ml of glycerol phenylbutyrate twice daily.
U ispitivanju u bolesnika s klinički dekompenziranom cirozom i hepatičkom encefalopatijom (ChildPugh B i C), srednji Cmax PAA bio je 144 μg/ml (raspon: 14-358 μg /ml) nakon dnevne doze od 6 ml glicerolfenilbutirata dvaput dnevno, dok je srednji Cmax PAA bio 292 μg /ml (raspon: 57-655 μg /ml) nakon dnevne doze od 9 ml glicerolfenilbutirata dvaput dnevno.
Uncommon Ventricular arrhythmia
Manje često Ventrikularna aritmija
• Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate tablets (g) x
• Ukupna dnevna doza lijeka RAVICTI (ml) = ukupna dnevna doza tableta natrijevog fenilbutirata (g) x 0,86
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.
U in vitro ispitivanjima,specifična aktivnost lipaza za glicerolfenilbutirat opažena je ovim padajućim slijedom: trigliceridna lipaza gušterače, karboksil ester lipaza, i protein 2 povezan s lipazom gušterače.
An open-label, long-term study (Study 5) was conducted to assess ammonia control in paediatric patients with UCD.
Otvoreno, dugoročno ispitivanje (Ispitivanje 5) provedeno je kako bi se ocjenila kontrola amonijaka u pedijatrijskih bolesnika s poremećajem ciklusa ureje.
• 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/dan (9,4 g/m2/dan) za bolesnike s površinom tijela < 1,3 m2
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 pedijatrijskih bolesnika koji su sudjelovali u tim produžecima ispitivanja, 12 bolesnika (25%) je prijavilo ukupno 17 hiperamonemijskih kriza tijekom liječenja glicerolfenilbutiratom u usporedbi s 38 kriza kod 21 bolesnika (43%) u 12 mjeseci prije ulaska u ispitivanje kada su bili liječeni natrijevim fenilbutiratom.
• menstrual periods stop or are irregular, hoarse voice, nosebleeds, stuffy nose, sore or painful throat, hair loss, sweating more than usual, itchy rash, uneven heartbeat, reduced thyroid function
• prekid ili neredovitost menstruacija, promukao glas, krvarenje iz nosa, začepljen nos, nadraženo ili bolno grlo, opadanje kose, znojenje jače nego obično, osip koji svrbi, neravnomjerni otkucaji srca, smanjena funkcija štitne žlijezde
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.
Sigurnost i djelotvornost lijeka RAVICTI za liječenje bolesnika s nedostatkom N-acetilglutamat sintaze (NAGS) i CITRINA (citrulinemija tipa 2) nisu ustanovljene.
RAVICTI is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including 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) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
RAVICTI je indiciran za primjenu kao pomoćna terapija u kroničnom liječenju bolesnika s poremećajima ciklusa ureje, uključujući nedostatak karbamoil fosfat sintetaze I (CPS), ornitin karabamoil transferaze (OTC), argininosukcinat sintetaze (ASS), argininosukcinat liaze (ASL), arginaze I (ARG) i nedostatak ornitin translokaze (sindrom hiperornitinemija-hiperamonemijahomocitrulinurija, HHH) koji se ne mogu liječiti samo ograničavanjem proteina u prehrani i/ili nadomjescima aminokiselina.
The RAVICTI pack contains the medicinal product and a reclosable bottle cap adapter.
Pakiranje lijeka RAVICTI sadrži lijek i nastavak za bocu s čepom za ponovno zatvaranje.
Of 51 adult patients participating in Study 2, 7 patients (14%) reported a total of 10 hyperammonaemic crises during treatment with glycerol phenylbutyrate as compared with 9 patients (18 %) who had reported a total of 15 crises in the 12 months prior to study entry while they were being treated with sodium phenylbutyrate.
Od 51 odraslog bolesnika koji je sudjelovao u Ispitivanju 2,7 bolesnika (14%) je prijavilo ukupno 10 hiperamonemijskih kriza tijekom liječenja glicerolfenilbutiratom u usporedbi s 9 bolesnika (18%) koji su prijavili ukupno 15 kriza u 12 mjeseci prije ulaska u ispitivanje kada su bili liječeni natrijevim fenilbutiratom.
Swallow the liquid from the oral syringe or attach the oral syringe to a gastrostomy or nasogastric tube.
Progutajte tekućinu iz oralne štrcaljke ili spojite oralnu štrcaljku za gastrostomu ili nazogastričnu sondu.
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.
RAVICTI se mora uzimati uz ograničen unos proteina prehranom i ponekad uz dodatke prehrani (npr. esencijalne aminokiseline, arginin, citrulin, kalorijske dodatke koji ne sadrže proteine) ovisno o dnevnom unosu proteina prehranom potrebnom za poticanje rasta i razvoja.
Mean blood glutamine levels were also non-significantly lower after glycerol phenylbutyrate treatment compared with sodium phenylbutyrate treatment by -45.2 ± 142.94 micromol/L (p = 0.135, paired ttest; p = 0.114, Wilcoxon signed-rank test).
Srednje razine glutamina u krvi također su bile ne značajno niže nakon liječenja glicerolfenilbutiratom u usporedbi s liječenjem natrijevim fenilbutiratom za -45,2 ± 142,94 mikromola/l (p = 0,135, upareni t-test; p = 0,114, Wilcoxonov test sume rangova).
Uncommon Back pain, joint swelling, muscle spasm, pain in extremity, plantar fasciitis
Bol u leđima, oticanje zglobova, spazmi mišića, bol u ekstremitetima, plantarni fasciitis
In vitro studies evaluating the percent recovery of total dose delivered with nasogastric or gastrostomy tubes demonstrated the percent of dose recovered was >99% for doses > 1 ml and 70% for a 0.5 ml dose.
In vitro ispitivanja za procjenu postotka povrata ukupne doze primijenjene putem nazogastrične sonde ili gastrostome pokazala su da je postotak povrata doze > 99% za doze > 1 ml, odnosno 70% za dozu od 0,5 ml.
In a separate study, in patients with hepatic impairment (Child-Pugh B and C), the ratios of mean values for PAA to PAGN among all patients dosed with 6 ml and 9 ml twice daily ranged from 0.96 to 1.28 and for patients dosed with 9 ml twice daily ranged from 1.18-3.19.
U odvojenom ispitivanju, kod bolesnika s oštećenom jetrom (Child-Pugh B i C), omjeri srednjih vrijednosti PAA i PAGN kod bolesnika koji su primali doze od 6 ml i 9 ml dvaput dnevno bile su u rasponu od 0,96 do 1,28, i za bolesnike koji su primali dozu od 9 ml dvaput dnevno, bili su u rasponu od 1,18-3,19.
Following 4 ml of glycerol phenylbutyrate for 3 days (3 times a day [TID]), mean Cmax and AUC were 66 mcg/ml and 930 mcg•h/ml for PBA and 28 microgram /ml and 942 mcg•h/ml for PAA,
Nakon davanja doze glicerolfenilbutrata od 4 ml tijekom 3 dana (3 puta dnevno), srednji Cmax i AUC bili su 66 μg/ml i 930 μg•h/ml za PBA, odnosno 28 mikrograma /ml i 942 μg•h/ml za PAA.
RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
RAVICTI se mora uzimati uz ograničen unos proteina prehranom i u nekim slučajevima, uz dodatke prehrani (npr. esencijalne aminokiseline, arginin, citrulin, kalorijske dodatke koji ne sadrže proteine).
There are limited data regarding the use of glycerol phenylbutyrate in pregnant women.
Podaci o primjeni glicerolfenilbutirata u trudnica su ograničeni.
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.
Kod zdravih odraslih bolesnika koji natašte primaju jednu oralnu dozu od 2,9 ml/m2 glicerolfenilbutirata, vršne razine PBA, PAA i PAGN u plazmi postignute su nakon 2, 4, odnosno 4 sata.
Clinical studies in paediatric patients with UCDs
Klinička ispitivanja u pedijatrijskih bolesnika s poremećajima ciklusa ureje
Clinical studies of RAVICTI did not include sufficient numbers of subjects ≥ 65 years of age to determine whether they respond differently than younger subjects.
≥ 65 godina za utvrđivanje odgovaraju li oni drugačije na terapiju od mlađih ispitanika.
Chemical compatibility of glycerol phenylbutyrate with medical grade silicone nasogastric, gastrostomy, and nasojejunal tubes has been demonstrated.
Dokazana je kemijska kompatibilnost glicerolfenilbutirata s nazogastričnim, gastrostomskim i nazojejunalnim sondama od silikona medicinskog stupnja.
RAVICTI 1.1 g/ml oral liquid
RAVICTI 1,1 g/ml oralna tekućina
The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed.
Dnevnu dozu treba individualno prilagoditi prema bolesnikovom podnošenju proteina i potrebnom dnevnom unosu proteina prehranom.
The bottle is packed with a reclosable bottle cap adapter.
Boca je pakirana s nastavkom za bocu s čepom za ponovno zatvaranje.
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).
Djelotvornost glicerolfenlbutirata u pedijatrijskih bolesnika u dobi od 2 mjeseca do 17 godina uključujući nedostatak OTC-a, ASS-a, ASL-a i ARG-a procijenjena je u 2 otvorena ispitivanja fiksnog slijeda liječenja, s natrijevim fenilbutiratom, u usporedbi s ekvivalentnim doziranjem glicerolfenilbutirata (Ispitivanja 3 i 4).
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).
U skladu s razinom amonijaka u plazmi, razine glutamina u krvi bile su niže tijekom liječenja glicerolfenilbutiratom u usporedbi s natrijevim fenilbutiratom u svakoj skupini ukriženog ispitivanja (smanjenje od 44,3 ± 154,43 mikromola/l nakon glicerolfenilbutirata u usporedbi s NaPBA; p = 0,064, upareni t-test; p = 0,048, Wilcoxonov test sume rangova).
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.
Ovisno o volumenu propisane doze bolesnicima se treba savjetovati da u ljekarni nabave oralne štrcaljke s oznakom CE, odgovarajuće veličine za dozu i kompatibilne s nastavkom za bocu s čepom za ponovno zatvaranje.
• if you have problems with your kidneys or liver - this is because glycerol phenylbutyrate is removed from your body through the kidneys and liver
• ako imate problema s bubrezima ili jetrom - zbog toga što se glicerolfenilbutirat uklanja iz
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).
Poremećaji ciklusa ureje uključuju nedostatak karbamoil fosfat sintetaze I (CPS), ornitin karbamoiltransferaze (OTC), argininosukcinat sintetaze (ASS), argininosukcinat liaze (ASL), arginaze I (ARG) i ornitin translokaze (sindrom hiperornitinemija-hiperamonemija-homocitrulinurija, HHH).
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.
Kod odraslih bolesnika s poremećajima ciklusa ureje koji su primali višestruke doze glicerolfenilbutirata, najviše koncentracije PBA, PAA i PAGN u plazmi u stanju dinamičke ravnoteže (Cmax, ss) postignute su 8, 12, odnosno 10 sati nakon prve dnevne doze.
In 4 of the 5 subjects age < 1 month, possible risk factors included infectious precipitants, hyperammonaemic crisis at baseline, and missing dose.
< 1 mjeseca, mogući rizični čimbenici uključivali su infekciju kao okidač, hiperamonemijsku krizu na početku ispitivanja i propuštenu dozu.
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.
Dugoročno (12-mjesečno), nekontrolirano, otvoreno ispitivanje (Ispitivanje 2) provedeno je za procjenu mjesečne kontrole amonijaka i hiperamonemijske krize u 12-mjesečnom razdoblju.
• Place the tip of the oral syringe onto the tip of the gastrostomy/nasogastric tube.
• Stavite vrh oralne štrcaljke na vrh gastrostome/nazogastrične sonde.
Open-Label, Uncontrolled, Extension Studies in Paediatric Patients Long-term (12-month), uncontrolled, open-label studies were conducted to assess monthly ammonia control and hyperammonaemic crisis over a 12-month period in three studies (Study 2, which also enrolled adults, and extensions of Studies 3 and 4).
Dugoročna (12-mjesečna), nekontrolirana, otvorena ispitivanja provedena su u svrhu procjene mjesečne kontrole amonijaka i hiperamonemijske krize u 12-mjesečnom razdoblju u tri ispitivanja (Ispitivanje 2 u koje su bili uključeni i odrasli, i produžeci Ispitivanja 3 i 4).
However, for patients who cannot swallow liquids, a nasogastric tube or gastrostomy tube may be used to administer RAVICTI as follows:
Međutim, bolesnici koji ne mogu gutati tekućine, mogu primati RAVICTI putem nazogastrične sonde ili gastrostome na sljedeći način:
A total of 51 adult patients involving deficiencies of CPS, OTC, ASS, ASL, ARG, and HHH were enrolled in the study and all but 6 had been converted from sodium phenylbutyrate to equivalent doses of glycerol phenylbutyrate.
U ispitivanje je uključen ukupno 51 odrastao bolesnik s nedostatkom CPS-a, OTC-a, ASS-a, ASL-a, ARG-a i HHH-om i svi osim njih 6 prešli su s natrijevog fenilbutirata na ekvivalentne doze glicerolfenilbutirata.
Venous ammonia levels were monitored monthly.
Razine amonijaka u venskoj krvi praćene su na mjesečnoj osnovi.
Although these have not been seen in clinical trials involving UCD patients, high PAA levels should be suspected in patients (particularly in children <2months) with unexplained somnolence, confusion, nausea and lethargy who have normal or low ammonia.
Iako one nisu zabilježene u kliničkim ispitivanjima u bolesnika s poremećajima ciklusa ureje, kod bolesnika s neobjašnjenom somnolencijom, konfuzijom, mučninom i letargijom koji imaju normalnu ili sniženu razinu amonijaka treba posumnjati na visoke razine PAA (osobito u djece u dobi <2 mjeseca).
Clear, colourless to pale yellow liquid.
Prozirna, bezbojna do blijedožuta tekućina.
The median exposure was 10 months (range 2 to 20 months).
Medijan izloženosti iznosio je 10 mjeseci (raspon:
Active-Controlled, 4-Week, Noninferiority, Blinded Crossover Study (Study 1) A randomised, double-blind, active-controlled, crossover, noninferiority study (Study 1) compared equivalent doses of glycerol phenylbutyrate to sodium phenylbutyrate by evaluating 24-hour venous ammonia levels in patients with UCDs who had been on sodium phenylbutyrate prior to enrolment for control of their UCD.
Randomizirano, dvostruko slijepo, ukriženo ispitivanje neinferiornosti s aktivnom kontrolom (Ispitivanje 1) uspoređivalo je ekvivalentne doze glicerolfenilbutirata sa natrijevim fenilbutiratom procjenom 24-satnih razina amonijaka u venama bolesnika s poremećajima ciklusa ureje koji su primali natrijev fenilbutirat prije uključivanja u skupinu za kontrolu svojeg poremećaja ciklusa ureje.
This process allows phenylbutyrate to be absorbed into the circulation.
Ovaj proces omogućuje apsorpciju fenilbutirata u krvotok.
• burping, stomach ache, changes in your stools such as being oily, urgent need for bowel movements, painful bowel movements
• podrigivanje, bol u želucu, promjene stolice poput uljaste stolice, potreba za hitnim pražnjenjem crijeva, bolno pražnjenje crijeva
Upon oral ingestion, PBA is released from the glycerol backbone in the gastrointestinal tract by pancreatic lipases.
Nakon peroralnog uzimanja, PBA se oslobađa s glavnog lanca glicerola u gastrointestinalni trakt lipazama gušterače.
Use an oral syringe to measure your dose.
Za mjerenje doze koristite oralnu štrcaljku.
Concomitant use of medicinal products known to inhibit lipase should be given with caution as glycerol phenylbutyrate is hydrolysed by digestive lipase into phenylbutyrate acid and glycerol.
Istodobna primjena lijekova za koje se zna da inhibiraju lipazu treba se vršiti s oprezom budući da lipaza u probavnom sustavu hidrolizira glicerolfenilbutirat u fenilbutiratnu kiselinu i glicerol.
• Step 2: 50% dose sodium phenylacetate/sodium benzoate and 100% RAVICTI for 4-8 hours;
50% doze natrijevog fenilacetata / natrijevog benzoata i 100% doze lijeka RAVICTI tijekom 4-8 sati;
• viral infection in the gut
• virusna infekcija crijeva
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.
Kako bi se osiguralo pravilno doziranje lijeka RAVICTI, u ljekarni se mogu nabaviti oralne štrcaljke s oznakom CE, u veličinama koje odgovaraju dozi, a koje su kompatibilne s nastavkom za bocu s čepom za ponovno zatvaranje.
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.
U bolesnika s rakom koji su intravenski primali PAA, reverzibilne kliničke manifestacije koje upućuju na neurotoksičnost (npr. mučnina, povraćanje, somnolencija), povezane su s razinama fenilacetata u rasponu od 499-1285 μg/ml.
Glycerol phenylbutyrate is a nitrogen-binding medicinal product.
Glicerolfenilbutirat je lijek koji veže dušik.
Uncommon Abdominal discomfort, abnormal faeces, dry mouth, eructation, defaecation urgency, upper abdominal pain and/or lower abdominal pain, painful defaecation, steatorrhoea, stomatitis
Manje često Nelagoda u abdomenu, abnormalna stolica, suhoća usta, podrigivanje, hitni nagon na stolicu, bol u gornjem i/ili donjem dijelu abdomena, bolna defekacija, steatoreja, stomatitis
Even while on treatment with glycerol phenylbutyrate, acute hyperammonaemia including hyperammonaemic encephalopathy may occur in a proportion of patients.
Kod jednog dijela bolesnika čak i na liječenju glicerolfenilbutiratom može doći do hiperamonemije uključujući hiperamonemijsku encefalopatiju.
In healthy subjects, intact glycerol phenylbutyrate was not detected in plasma.
Kod zdravih ispitanika u plazmi nije otkriven nepromijenjeni glicerolfenilbutirat.
Adjustment based on plasma phenylacetate and phenylacetylglutamine Symptoms of vomiting, nausea, headache, somnolence, confusion, or sleepiness in the absence of high ammonia or intercurrent illness may be signs of phenylacetic acid (PAA) toxicity (see section 4.4, PAA toxicity).
Simptomi povraćanja, mučnine, glavobolje, pospanosti, konfuzije ili pospanosti u odsutnosti visoke razine amonijaka ili interkurentne bolesti mogu biti znakovi toksičnosti fenilacetatne kiseline (PAA) (vidjeti dio 4.4, Toksičnost fenilacetatne kiseline).
The same reclosable bottle cap adapter can be used until a bottle is empty.
Isti nastavak za bocu s čepom za ponovno zatvaranje može se koristiti dok se boca ne isprazni.
Additional adverse reactions have been evaluated in a clinical study including 16 UCD patients less than 2 months of age.
Dodatne nuspojave procijenjene su u jednom kliničkom ispitivanju koje je uključilo 16 bolesnika s poremećajima ciklusa ureje mlađih od 2 mjeseca.
A total of 16 paediatric patients with UCDs aged less than 2 months participated in a long-term (24 months), uncontrolled, open-label study, of which 10 patients converted from sodium phenylbutyrate to RAVICTI.
Ukupno je 16 pedijatrijskih bolesnika s poremećajima ciklusa ureje mlađih od 2 mjeseca sudjelovalo u dugotrajnom (24 mjeseca), nekontroliranom, otvorenom ispitivanju, od kojih je 10 prešlo sa natrijevog fenilbutirata na lijek RAVICTI.
• feeling sleepy, tired, light-headed or sometimes confused
• pospanost, umor, ošamućenost i ponekad smetenost
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).
Primjena lijeka RAVICTI u žena reproduktivne dobi mora biti popraćena primjenom učinkovite kontracepcije (vidjeti dio 4.4).