natgillin/translations-raw huggingface dataset:
Even while on treatment with glycerol phenylbutyrate, acute hyperammonaemia including hyperammonaemic encephalopathy may occur in a proportion of patients.
Tudi v času zdravljenja z glicerol fenilbutiratom se pri določenem deležu bolnikov lahko pojavi akutna hiperamoniemija, vključno z hiperamoniemično encefalopatijo.
Take RAVICTI with or straight after a meal.
Zdravilo RAVICTI vzemite ob obroku ali takoj po njem.
Reversible clinical manifestations suggestive of neurotoxicity (e.g., nausea, vomiting, somnolence) have been reportedly associated with phenylacetate levels ranging from 499-1285 mcg/ml in cancer patients who received PAA intravenously.
O reverzibilnih kliničnih manifestacijah, ki so značilne za nevrotoksičnost (npr. slabost, bruhanje, somnolenca), so poročali v povezavi z ravnmi fenilbutirata v razponu od 499-1285 μg/ml pri bolnikih z rakom, ki so prejemali PAA intravensko.
Wye Valley Business Park, Brecon Road,
Wye Valley Business Park,
• reflux of stomach contents
• refluks želodčne vsebine
Therefore, measurement of plasma PAA and PAGN levels may be useful to guide dosing.
Zato je lahko meritev ravni plazemske PAA in PAGN uporabna kot vodilo pri odmerjanju.
The upper bound of the one-sided 95% CI for the largest placeboadjusted, baseline-corrected QTc, based on individual correction method (QTcI) for glycerol phenylbutyrate, was below 10 ms, demonstrating that glycerol phenylbutyrate had no QT/QTc prolonging effect.
Zgornja meja enostranskega 95-odstotnega intervala zaupanja za največji, s placebom prilagojeni in za izhodiščne vrednost korigirani QTc, ki temelji na individualni korekcijski metodi (QTcI) za glicerol fenilbutirat, je bila pod 10 ms, kar kaže na to, da glicerol fenilbutirat ni imel učinka na podaljšanje intervala QT/QTc.
A plasma PAA to PAGN ratio exceeding 2.5 may indicate saturation of PAA to PAGN conversion capacity and the need for reduced dosing and/or increased frequency of dosing.
Razmerje med plazemsko PAA in PAGN, ki presega 2,5, lahko nakazuje nasičenost zmožnosti pretvorbe PAA v PAGN in potrebo po znižanem odmerku in/ali povečani pogostosti odmerjanja.
No studies were conducted in UCD patients with renal impairment; the safety of glycerol phenylbutyrate in patients with renal impairment is unknown.
Študije pri bolnikih z motnjami ciklusa sečnine in okvaro ledvic niso bile opravljene; varnost glicerol fenilbutirata pri bolnikih z okvaro ledvic ni znana.
The potential for interaction of glycerol phenylbutyrate as a CYP3A4 inducer and those products predominantly metabolised by the CYP3A4 pathway is possible.
Obstaja potencial za medsebojno delovanje glicerol fenilbutirata kot induktorja CYP3A4 in tistih zdravil, ki se pretežno presnavljajo po poti CYP3A4.
Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3).
Glicerol fenilbutirat ni vplival na plodnost ali sposobnost razmnoževanja pri podganah obeh spolov (glejte poglavje 5.3).
The mean peak ratio of PAA to PAGN in UCD patients aged birth to less than 2 months was higher (mean: 1.65; range 0.14 to 7.07) than for UCD patients aged 2 months to less than 2 years (mean 0.59; range 0.17 to 1.21).
Povprečno največje razmerje PAA in PAGN pri bolnikih z UCD, starih od rojstva do manj kot 2 meseca, je bilo večje (povprečje: 1,65; razpon 0,14 do 7,07) kot pri bolnikih z UCD, starih 2 meseca do manj kot 2 leti (povprečje 0,59; razpon 0,17 do 1,21).
Because conversion of PAA to PAGN occurs in the liver, patients with severe hepatic impairment may have reduced conversion capability and higher plasma PAA and plasma PAA to PAGN ratio.
Ker se pretvorba PAA v PAGN odvija v jetrih, imajo lahko bolniki s hudo okvaro jeter zmanjšano sposobnost pretvorbe in višjo raven plazemske PAA kot tudi razmerje med PAA in PAGN.
Do not add and stir the medicinal product into a large volume of other liquid, as glycerol phenylbutyrate is heavier than water and this may result in incomplete administration.
Ne dodajte in ne mešajte zdravila v večje količine druge tekočine, saj je glicerol fenilbutirat težji od vode, kar lahko vodi do nepopolne aplikacije.
The syringe used to flush the gastrostomy or nasogastric tube shall not be used for measuring the dose of RAVICTI to avoid introduction of water into the medicinal product.
Brizge, ki ste jo uporabili za izpiranje gastrostome ali nazogastrične sonde, ne smete uporabiti za odmerjanje zdravila RAVICTI, s čimer se izognete dodajanju vode v zdravilo.
Dose adjustment was made to 3 subjects age < 1 month.
Odmerek so prilagodili pri 3 preizkušancih, starih < 1 mesec.
The effect of multiple doses of glycerol phenylbutyrate 13.2 g/day and 19.8 g/day (approximately 69% and 104% of the maximum recommended daily dosage) on QTc interval was evaluated in a randomised, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment-arm, crossover study in 57 healthy subjects.
Učinek večkratnih odmerkov glicerol fenilbutirata 13,2 g/na dan in 19,8 g/na dan (približno 69 % in 104 % največjega priporočenega dnevnega odmerka) na interval QTc, so ocenjevali v randomizirani navzkrižni študiji s štirimi terapevtskimi kraki, nadzorovani s placebom in zdravilno učinkovino (moksafloksacin 400 mg) pri 57 zdravih preiskovancih.
Upon singledose administration of glycerol phenylbutyrate, plasma concentrations of PBA were quantifiable in 15 of 22 participants at the first sample time post dose (0.25 h).
Po aplikaciji enkratnega odmerka glicerol fenilbutirata so bile plazemske koncentracije PBA količinsko določljive pri 15 od 22 udeležencev v prvem vzorcu, odvzetem po odmerku (0,25 h).
Measuring the dose
Merjenje odmerka
Standard pack size: 1 bottle and 1 reclosable bottle cap adapter per carton.
Velikost standardnega pakiranja: V škatli je ena steklenica in 1 zamašek z nastavkom za brizgo.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V spodnji preglednici so v razvrstitvah pogostosti neželeni učinki navedeni po padajoči resnosti.
Glycerol phenylbutyrate is not recommended during pregnancy and in women of childbearing potential not using contraception.
Glicerol fenilbutirata ne uporabljajte med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
If RAVICTI gets in contact with water, the liquid will become cloudy in appearance.
Če pride zdravilo RAVICTI v stik z vodo, bo tekočina postala motna.
If RAVICTI is added to water the liquid will become cloudy and you may not get the full dose.
Če dodate zdravilo RAVICTI vodi, tekočina postane motna in morda ne boste zaužili celotnega odmerka.
If you forget to take RAVICTI
Če ste pozabili vzeti zdravilo RAVICTI
What RAVICTI looks like and contents of the pack
Izgled zdravila RAVICTI in vsebina pakiranja
Given that approximately 47% of dietary nitrogen is excreted as waste and approximately 70% of an administered 4phenylbutyric acid (PBA) dose will be converted to urinary phenylacetylglutamine (U-PAGN), an initial estimated glycerol phenylbutyrate dose for a 24-hour period is 0.6 ml glycerol phenylbutyrate per gram of dietary protein ingested per 24 hour period assuming all the waste nitrogen is covered by glycerol phenylbutyrate and excreted as phenylacetylglutamine (PAGN).
Če se približno 47 % prehranskega dušika izloči kot odpadna snov in se približno 70 % aplicirane 4-fenilbutirične kisline pretvori v urinski fenilacetilglutamin (U-PAGN), je začetni odmerek glicerol fenilbutirata za 24-urno obdobje 0,6 ml glicerol fenilbutirata na gram prehranskih beljakovin, zaužitih v 24 urah, ob predpostavki, da glicerol fenilbutirat pokrije ves odpadni dušik in se izloči kot fenilacetilglutamin (PAGN).
Supplemental amino acid formulations may be necessary to maintain essential amino acids and branched chain amino acids within normal range.
Morda bo potrebno jemanje dodatnih aminokislinskih pripravkov za vzdrževanje esencialnih aminokislin in aminokislin z razvejano verigo v normalnem razponu.
Saturation of conjugation of PAA and glutamine to form PAGN was suggested by increases in the ratio of plasma PAA to PAGN with increasing dose and with increasing severity of hepatic impairment.
Zasičenost konjugacije PAA in glutamina za tvorbo PAGN je bila nakazana s povišanim razmerjem med plazemsko PAA in PAGN z večjim odmerkom in naraščajočo resnostjo okvare jeter.
Glycerol phenylbutyrate was not tumourigenic at doses up to 1000 mg/kg/day in a 26-week mouse study.
Glicerol fenilbutirat v 26-tedenski študiji na miših ni bil tumorogen pri odmerkih do 1000 mg/kg/na dan.
Nine patients successfully transitioned to RAVICTI within 4 days, followed by 3 days of observation for a total of 7 days, where successful transition was defined as no signs and symptoms of hyperammonemia and a venous ammonia value less than 100 micromol/L.
Devet bolnikov je v 4 dneh uspešno prešlo na zdravilo RAVICTI, temu obdobju je sledilo 3-dnevno opazovanje, ki je skupaj trajalo 7 dni, pri čemer so uspešen prehod opredelili kot stanje brez znakov in simptomov hiperamonemije in vrednosti amoniaka v venski krvi pod 100 mikromolov/l.
Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in UCD patients.
Natančno spremljajte ravni amoniaka, kadar je treba uporabljati valprojsko kislino ali haloperidol pri bolnikih z UCD.
One additional patient developed hyperammonemia on day 3 of dosing and experienced surgical complications (bowel perforation and peritonitis) following jejunal tube placement on day 4.
Pri enem dodatnem bolniku se je 3. dan odmerjanja razvila hiperamoniemija in 4. dan je prišlo do kirurških zapletov (perforacija črevesja in peritonitis) po namestitvi jejunalne sonde.
In vitro, the extent of human plasma protein binding for 14C-labeled metabolites was 80.6% to 98.0% for PBA (over 1-250 microgram/ml), and 37.1% to 65.6% for PAA (over 5-500 microgram /ml).
In vitro je stopnja vezave na beljakovine v plazmi za presnovke, označene s 14C, od 80,6 % do 98,0 % za PBA (prek 1-250 mikrogramov/ml) in od 37,1 % do 65,6 % za PAA (prek 5-500 mikrogramov/ml).
The effects of glycerol phenylbutyrate on cytochrome P450 (CYP) 2C9 isoenzyme and potential for interaction with celecoxib has been studied in humans with no evidence of an interaction observed.
Preučevali so učinek glicerolfenilbutirata na izoencim citokroma P450 (CYP) 2C9 in možnost medsebojnega delovanja s celekoksibom pri ljudeh; kakršnih koli dokazov za medsebojno delovanje niso opazili.
Open-Label Uncontrolled Extension Study in Adults A long-term (12-month), uncontrolled, open-label study (Study 2) was conducted to assess monthly ammonia control and hyperammonaemic crisis over a 12-month period.
Odprta nenadzorovana podaljšana študija pri odraslih Dolgoročna (12-mesečna), nenadzorovana, odprta študija (Študija 2) je bila izvedena za ocenjevanje mesečnega nadzora koncentracij amoniaka in hiperamoniemične krize v obdobju 12 mesecev.
In a rat study, glycerol phenylbutyrate caused a statistically significant increase in the incidence of pancreatic acinar cell adenoma, carcinoma, and combined adenoma or carcinoma in males and females, at a dose of 4.7 and 8.4 times the dose in adult patients, (6.87 ml/m2/day based on combined AUCs for PBA and PAA).
Kancerogenost V študiji na podganah je glicerol fenilbutirat povzročil statistično značilno zvišanje pojavnosti pankreatičnega adenoma acinarnih celic in kombiniranega adenoma ali karcinoma pri samcih in samicah pri 4,7- in 8,4-kratnem odmerku za odrasle bolnike (6,87 ml/m2/na dan na podlagi kombiniranih AUC za PBA in PAA).
• flatulence
• napenjanje (flatulenca)
All patients successfully transitioned to RAVICTI within 3 days, where successful transition was defined as no signs and symptoms of hyperammonemia and a venous ammonia value less than 100 micromol/L.
Vsi bolniki so v 3 dneh uspešno prešli na zdravilo RAVICTI, pri čemer so uspešen prehod opredelili kot stanje brez znakov in simptomov hiperamonemije in vrednostmi amoniaka v venski krvi pod 100 mikromolov/l.
If you stop taking RAVICTI
Če ste prenehali jemati zdravilo RAVICTI
It is unknown whether glycerol phenylbutyrate or its metabolites are excreted in human milk.
Ni znano, ali se fenilbutirat ali njegovi presnovki izločajo v materino mleko.
Use one oral syringe for all doses taken each day.
Ena peroralna brizga je namenjena za vse odmerke za vsak dan.
Clear, Type III glass, bottle with a high density polyethylene (HDPE) child-resistant closure.
Prozorna steklenica (steklo tipa III) z za otroke varnim zamaškom iz polietilena visoke gostote (HDPE).
If U-PAGN excretion is insufficient to cover daily dietary protein intake and the fasting ammonia is greater than half the recommended ULN, the glycerol phenylbutyrate dose should be adjusted upward.
Če izločanje U-PAGN ne zadostuje za pokritje dnevnega vnosa prehranskih beljakovin in je raven amoniaka na tešče nad priporočeno zgornjo mejo normalne vrednosti (ULN), je treba odmerek glicerol fenilbutirata prilagoditi navzgor.
Pharmacological effects
Farmakološki učinki
Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of glycerol phenylbutyrate and/or absorption of phenylbutyrate and reduced control of plasma ammonia.
Majhno število ali odsotnost encimov trebušne slinavke ali črevesna bolezen, ki povzroči malabsorpcijo maščob, lahko vodi do znižane ali odsotne prebave glicerol fenilbutirata in/ali absorpcijo fenilbutirata kakor tudi do zmanjšanega nadzora nad ravnjo plazemskega amoniaka.
Monitor ammonia levels closely when corticosteroids and glycerol phenylbutyrate are used concomitantly.
Skrbno opazujte ravni amoniaka, kadar se kortikosteroidi in glicerol fenilbutirat uporabljajo sočasno.
• probenecid - to treat high levels of uric acid in the blood which can cause gout (‘hyper uricaemia')
• probenecid - za zdravljenje visokih vrednosti sečne kisline v krvi, ki lahko povzroča protin
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.
Glicerol fenilbutirat ni imel učinka na plodnost ali sposobnost razmnoževanja pri samcih in samicah podgan pri ravneh klinične izpostavljenosti, vendar pa je bilo pri odmerkih, ki so bili do približno 7krat večji od odmerka za odrasle bolnike, opaziti toksičnost pri samcih in samicah, povečalo pa se je tudi število neviabilnih zarodkov.
Take RAVICTI by mouth unless otherwise directed by your doctor.
Zdravilo RAVICTI jemljite peroralno, razen če vam zdravnik ne predpiše drugače.
• viral infection in the gut
• virusna okužba v prebavilih
• tests show higher or lower potassium in your blood
• preiskave, ki kažejo višje ali nižje vrednosti kalija v krvi
• feeling tired, feeling dizzy, headache or tremor
• utrujenost, omotičnost, glavobol, tremor
The recommended total daily dose of RAVICTI is based on body surface area and ranges from 4.5 ml/m2/day to 11.2 ml/m2/day [5.3 g/m2/day to 12.4 g/m2/day) and should take into account the following:
4,5 ml/m2/na dan do 11,2 ml/m2/na dan [od 5,3 g/m2/na dan do 12,4 g/m2/na dan), pri čemer je treba upoštevati naslednje:
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.
Skupno 51 odraslih bolnikov s pomanjkanjem CPS, OTC, ASS, ASL, ARG in HHH je bilo vključenih v študijo in vsi razen 6 so prešli iz natrijevega fenilbutirata na enakovredne odmerke glicerol fenilbutirata.
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.
Zdravilo RAVICTI se lahko aplicira tudi s pomočjo nazogastrične sonde ali gastrostome iz medicinskega silikona z oznako CE, pri tistih bolnikih, ki zdravila niso sposobni zaužiti peroralno.
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.
Toksičnost za mater in neželeni učinki na razvoj zarodkov in plodov, vključno z zmanjšano maso zarodkov in vratnimi rebri, so opazili v študiji na podganah, ki so prejemale odmerek, ki je bil 6-krat večji od odmerka za odrasle bolnike na podlagi kombiniranih AUC za PBA in PAA.
Do not use RAVICTI after the expiry date which is stated on the carton and the bottle label after the letters “EXP”.
Zdravila RAVICTI ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na steklenici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Adjustment based on urinary phenylacetylglutamine U-PAGN measurements may be used to help guide glycerol phenylbutyrate dose adjustment and assess compliance.
Prilagoditev na podlagi fenilacetilglutamina v urinu Meritve U-PAGN se lahko uporabijo pri prilagajanju odmerka glicerol fenilbutirata in ocenjevanju kompliance.
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).
Prilagoditev na podlagi plazemskega fenilacetata in fenilacetilglutamina Simptomi, kot so bruhanje, navzea, glavobol, somnolenca, zmedenost ali zaspanost, ob odsotnosti visokih koncentracij amoniaka ali druge trenutne bolezni, so lahko znaki toksičnosti fenilocetne kisline (PAA - phenylacetic acid) (glejte poglavje 4.4 Toksičnost fenilocetne kisline).
Fill the oral syringe by pulling the plunger back until the syringe is filled with the amount of glycerol phenylbutyrate liquid that your doctor has told you to take.
Peroralno brizgo napolnite, tako da bat povlečete nazaj, da se peroralna brizga napolni s količino glicerol fenilbutirata, ki vam jo je predpisal vaš zdravnik.
The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed.
Dnevni odmerek je treba individualno prilagajati glede na bolnikovo toleranco na beljakovine in potrebni dnevni vnos prehranskih beljakovin.
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.
Pri treh bolnikih so poročali o skupaj 7 hiperamoniemičnih krizah, opredeljenih kot znaki in simptomi, skladni s hiperamoniemijo (kot so pogosto bruhanje, navzea, glavobol, letargičnost, razdražljivost,
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 aplikacija glicerol fenilbutirata v času organogeneze pri podganah in kuncih ni vplivala na razvoj zarodkov in plodov pri odmerku, ki je bil 2,7- in 1,9-krat večji od odmerka za odrasle bolnike.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking RAVICTI.
Če niste prepričani, ali se zgoraj navedeno nanaša na vas, se pogovorite z zdravnikom ali farmacevtom, preden vzamete zdravilo RAVICTI.
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%].
Neželeni učinki, ki so bili prisotni pri več otrocih kot odraslih v času dolgotrajnega zdravljenja z glicerol fenilbutiratom, so vključevali bolečine v zgornjem delu trebuha (3 od 49 pediatričnih bolnikov [6,1 %] v primerjavi z 1 od 51 odraslih [2,0 %] in zvečano anionsko vrzel (2 od 49 pediatričnih bolnikov [4,1 %] v primerjavi z 0 od 51 odraslih [0 %].
• 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
• menstruacije so prekinjene ali neredne, hripav glas, krvavitev iz nosu, zamašen nos, boleče ali vneto grlo, izguba las, močnejše potenje kot običajno, srbeč izpuščaj, neenakomeren srčni utrip, zmanjšano delovanje ščitnice
Chemical compatibility of glycerol phenylbutyrate with medical grade silicone nasogastric, gastrostomy, and nasojejunal tubes has been demonstrated.
Dokazana je bila kemična kompatibilnost glicerol fenilbutirata z medicinskimi silikonskimi nazogastričnimi sondami, gastrostomo in nazojejunalno sondo.
Further, glycerol phenylbutyrate was hydrolysed in vitro by esterases in human plasma.
Glicerol fenilbutirat je bil hidroliziran in vitro z esterazami v človeški plazmi.
However, for patients who cannot swallow liquids, a nasogastric tube or gastrostomy tube may be used to administer RAVICTI as follows:
Pri bolnikih, ki ne morejo pogoltniti tekočine, se lahko uporabi nazogastrično sondo ali gastrostomo za aplikacijo zdravila RAVICTI po naslednjem postopku:
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).
Zdravilo RAVICTI se uporablja skupaj z dieto z malo beljakovinami in v nekaterih primerih skupaj s prehranskimi dodatki (npr. esencialne aminokisline, arginin, citrulin, kalorični dodatki brez beljakovin).
• feeling of pins and needles, feeling very restless, difficulty in waking up, feeling drowsy, problems with speech, feeling confused, depressed
• občutek zbadanja ali mravljinčenja, občutek nemirnosti, težave pri zbujanju, zaspanost, težave z govorom, zmedenost, depresija
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.
Izpostavljenost in vivo glicerol fenilbutiratu je povzročila zmanjšano sistemsko izpostavljenost midazolamu za približno 32 % in zvišano izpostavljenost 1-hidroksi presnovku midazolama, kar nakazuje na to, da odmerjanje glicerol fenilbutirata v stanju dinamičnega ravnovesja povzroči indukcijo encima CYP3A4.
Glycerol phenylbutyrate was found to be non-inferior to sodium phenylbutyrate with respect to ammonia control in both of these paediatric studies.
Glicerol fenilbutirat ni bil slabši kot natrijev fenilbutirat glede na nadzor amoniaka v obeh študijah s pediatrično populacijo.
• Total daily dosage of RAVICTI (ml) = total daily dosage of sodium phenylbutyrate powder (g) x 0.81
• Skupni dnevni odmerek zdravila RAVICTI (ml) = skupni odmerek praška natrijevega fenilbutirata (g) x 0,81
• tests show increased liver enzyme levels, imbalance of salts in the blood, low levels of a type of white blood cell (‘lymphocytes') or low levels of vitamin D
• preiskave, ki kažejo na povečano raven jetrnih encimov, neravnovesje soli v krvi, nizko število določene vrste belih krvnih celic (limfocitov) ali nizke vrednosti vitamina D Občasni: lahko se pojavijo pri največ 1 od 100 ljudi
If you take more RAVICTI than you should
Če ste vzeli večji odmerek zdravila RAVICTI, kot bi smeli
• joint swelling, muscle spasms, pain in the hands and feet, heel pain
• otekanje sklepov, mišični krči, bolečine v rokah in nogah, bolečina v peti