FrancophonIA/ELRC3.0 huggingface dataset:
English: Micronucleus test results indicate that sodium phenylbutyrate was considered not to have produced any clastogenic effect in rats treated at toxic or non-toxic dose levels (examined 24 and 48 hours after a single oral administration of 878 to 2800 mg/kg).
Slovenian: Rezultati mikronukleusnega preskusa kažejo, da natrijev fenilbutirat ni proizvedel klastogenih učinkov pri podganah, katerim je bil dajan v toksičnih in netoksičnih odmerkih (preverjano po 24 in 48 urah po enkratnem peroralnem odmerku 878 do 2 800 mg/kg).
English: You should take PHEBURANE with each meal or feeding.
Slovenian: Zdravilo PHEBURANE morate vzeti ob vsakem obroku oz. prehranjevanju.
English: There have been published reports of hyperammonaemia being induced by haloperidol and by valproate.
Slovenian: Objavljena so poročila o hiperamonemiji, sproženi s haloperidolom in z valproatom.
English: Common syncope, headache
Slovenian: Pogosti sinkopa, glavobol
English: Do not use PHEBURANE if you are breast-feeding, because this medicine can pass into the breast milk and may harm your baby.
Slovenian: Ne jemljite zdravila PHEBURANE, če dojite, ker lahko prehaja v mleko in lahko škoduje vašemu otroku.
English: Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test.
Slovenian: Natrijev fenilbutirat je dal negativne rezultate v dveh preskusih mutagenosti, tj. v Amesovem preskusu in v mikronukleusnem preskusu.
English: Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Slovenian: Njihove kognitivne sposobnosti pa so med zdravljenjem z fenilbutiratom ostajale sorazmerno stabilne.
English: Contents of the pack and other information What PHEBURANE contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo PHEBURANE
English: • This medicinal product contains 768 mg sucrose per gram.
Slovenian: • To zdravilo vsebuje 768 mg saharoze na gram.
English: With haemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth (but within the first month of life) increased to almost 80 % with most deaths occurring during an episode of acute hyperammonaemic encephalopathy.
Slovenian: S hemodializo, uporabo alternativnih poti izločanja odpadnega dušika (natrijev fenilbutirat, natrijev benzoat in natrijev fenilacetat), omejevanjem prehranskega vnosa beljakovin in (v določenih primerih) dopolnili esencialnih aminokislin se je stopnja preživetja pri novorojenčkih s postavitvijo diagnoze v prvem mesecu življenja povečala na skoraj 80 %, pri čemer do večine smrti pride med epizodo hiperamoniemične encefalopatije.
English: Pheburane is contra-indicated during pregnancy (see section 4.3).
Slovenian: Zdravilo Pheburane je kontraindicirano v nosečnosti (glejte poglavje 4.3).
English: In clinical trials with sodium phenylbutyrate, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to sodium phenylbutyrate.
Slovenian: V kliničnih preskušanjih z natrijevim fenilbutiratom je 56 % bolnikov doživelo najmanj en neželeni učinek, vendar se za 78 % teh neželenih učinkovšteje, da niso povezani z natrijevim fenilbutirat.
English: The mean time to peak concentration was 1 hour and the mean peak concentration 195 μg/ml.
Slovenian: Povprečni čas do najvišje koncentracije je bil 1 ura, povprečna najvišja koncentracija pa 195 µg/ml.
English: It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Slovenian: Indicirano je tudi pri bolnikih, pri katerih se bolezen pojavi s t.i. zakasnjenim pojavom (delno pomanjkanje encimov, ki se pokaže po prvem mesecu življenja) in imajo anamnezo hiperamonemične encefalopatije.
English: • have decreased kidney or liver function, since PHEBURANE is eliminated from the body through the kidney and liver.
Slovenian: • imate zmanjšano delovanje ledvic ali jeter, ker se zdravilo PHEBURANE odstranjuje iz telesa prek ledvic in jeter.
English: Plasma levels of ammonia, arginine, essential amino acids (especially branched chain amino acids), carnitine and serum proteins should be maintained within normal limits.
Slovenian: Plazemske koncentracije amoniaka, arginina, esencialnih aminokislin (predvsem aminokislin z razvejano verigo), karnitina in serumskih beljakovin je treba vzdrževati v normalnih mejah.
English: Results indicate that sodium phenylbutyrate did not induce any mutagenic effects in the Ames test with or without metabolic activation.
Slovenian: Rezultati kažejo, da natrijev fenilbutirat ni sprožil mutagenih učinkov v Amesovem preskusu niti s presnovno aktivacijo niti brez nje.
English: What PHEBURANE is and what it is used for
Slovenian: Kaj je zdravilo PHEBURANE in za kaj ga uporabljamo
English: On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion.
Slovenian: Po molskih razmerjih je fenilacetilglutamin primerljiv s sečnino (oba vsebujeta 2 mola dušika) in je zato lahko alternativen nosilec za izločanje odpadnega dušika.
English: In patients with impaired hepatic function the conversion of phenylacetate to phenylacetylglutamine may be relatively slower.
Slovenian: Pri bolnikih z motnjami v delovanju jeter je lahko pretvorba fenilacetata v fenilacetilglutamin sorazmerno počasnejša.
English: This should be particularly taken into account for those on a low salt diet.
Slovenian: To je treba posebej skrbno upoštevati pri bolnikih na dieti z zmanjšanim vnosom soli.
English: Only use this measuring spoon to measure out the dose.
Slovenian: Za odmerjanje odmerka uporabljajte le to odmerno žličko.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Slovenian: To je treba upoštevati pri bolnikih s sladkorno boleznijo.. Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: PHEBURANE has negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo PHEBURANE ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: PHEBURANE treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.
Slovenian: Zdravljenje z zdravilom PHEBURANE naj nadzoruje zdravnik, ki je izkušen pri zdravljenju motenj ciklusa sečnine.
English: The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range.
Slovenian: Vrednosti IQ večine bolnikov, ki so bili testirani, so bile v območju povprečja do nizkega povprečja oz. mejnih vrednosti umske zaostalosti.
English: Corticosteroids may cause the breakdown of body protein and thus increase plasma ammonia levels.
Slovenian: Kortikosteroidi lahko povzročijo razgradnjo telesnih beljakovin in s tem povečanje plazemskih koncentracij amoniaka.
English: Contains sodium and sucrose.
Slovenian: Vsebuje natrij in saharozo.
English: A probable case of toxic reaction to sodium phenylbutyrate (450 mg/kg/d) was reported in an 18year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Slovenian: Poročali so o verjetnem primeru toksične reakcije na natrijev febilbutirat (450 mg/kg/d) pri 18-letni anorektični bolnici, pri kateri se je razvila metabolična encefalopatija, povezana z laktično acidozo, težko hipokaliemijo, pancitopenijo, periferno nevropatijo in pankreatitisom.
English: Previously, neonatal-onset presentation of urea cycle disorders was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogues.
Slovenian: Včasih so bile motnje ciklusa sečnine z neonatalnim pojavom skoraj brez izjeme smrtne v prvem letu življenja, navkljub zdravljenju s peritonealno dializo in esencialnimi aminokislinami ali njihovimi analogi brez dušika.
English: If you forget to take PHEBURANE
Slovenian: Če ste pozabili vzeti zdravilo PHEBURANE
English: In the table below all adverse reactions are listed below, by system organ class and by frequency.
Slovenian: Neželeni učinki so navedeni v spodnji preglednici, razvrščeni po organskih sistemih in pogostnosti.
English: Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Slovenian: Izločanje Približno 80-100 % zdravila se izloči preko ledvic v 24 urah v obliki konjugiranega produkta,
English: • haloperidol (used in certain psychotic disorders),
Slovenian: • haloperidol (za zdravljenje nekaterih psihotičnih motenj)
English: PHEBURANE helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body.
Slovenian: Zdravilo PHEBURANE telesu pomaga odstraniti odpadni dušik in v njem zmanjšati količino amoniaka.
English: Common metabolic acidosis, alkalosis, decreased appetite
Slovenian: Pogosti metabolična acidoza, alkaloza, zmanjšan tek
English: Arginine supplementation is required for patients diagnosed with deficiency of argininosuccinate synthetase at a dose of 0.4 - 0.7 g/kg/day or 8.8 - 15.4 g/m2/day.
Slovenian: Dopolnjevanje prehrane z argininom je potrebno za bolnike z diagnozo pomanjkljivosti argininosukcinat-sintaze, in sicer z odmerki 0,4-0,7 g/kg/dan ali 8,8-15,4 g/m2/dan.
English: In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recovered from hyperammonaemic encephalopathy and were then treated chronically with dietary protein restriction and sodium phenylbutyrate, the survival rate was 98 %.
Slovenian: Pri bolnikih z zakasnjenim pojavom bolezni (vključno z ženskami, heterozigotnimi za pomanjkanje ornitin transkarbamoilaze), ki so si opomogli od hiperamoniemične encefalopatije ter so bili kasneje kronično zdravljeni z omejevanjem prehranskega vnosa beljakovin in natrijevim fenilbutiratom, je bila stopnja preživetja 98 %.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of sodium phenylbutyrate/metabolites in milk (see section 5.3).
Slovenian: Farmakodinamični/toksikološki podatki iz študij na živalih, ki so na voljo, kažejo izločanje natrijevega fenilbutirata/presnovkov v mleko (glejte poglavje 5.3).
English: Common side effects (may affect more than 1 in 100 people): changes in number of blood cells (red cells, white cells and platelets), changes in the amount of bicarbonate in the blood, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), stomach ache, vomiting, nausea, constipation, abnormal skin odor, rash, abnormal kidney function, weight gain, altered laboratory test values.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 100 bolnikov): spremembe v številu krvničk (rdečih krvničk, belih krvničk, krvnih ploščic), spremembe v količini hidrogenkarbonata v krvi, zmanjšan tek, depresivnost, razdražljivost, glavobol, omedlevica, zastoj tekočin (otekanje), spremembe v okušanju (motnje okušanja), želodčne bolečine, bruhanje, slabost s siljenjem na bruhanje (navzea), zapeka, nenormalen telesni vonj, izpuščaj, nenormalno delovanje ledvic, povišana telesna masa, nenormalni rezultati laboratorijskih preiskav.
English: Other medicines and PHEBURANE
Slovenian: Druga zdravila in zdravilo PHEBURANE
English: Pheburane is contra-indicated during breast-feeding (see section 4.3).
Slovenian: Pheburane je kontraindicirano med dojenjem (glejte poglavje 4.3).
English: Common renal tubular acidosis
Slovenian: Pogosti ledvična tubulna acidoza
English: • changes in taste (taste disturbances),
Slovenian: • sprememba v okušanju (motnje okušanja) • naglušnost
English: Because it dissolves slowly, PHEBURANE should not be administered through a gastrostomy (tube that goes through the abdomen to the stomach) or through a nasogastric tube (tube that goes through the nose to the stomach).
Slovenian: Ker se zdravilo PHEBURANE raztaplja počasi, ga ne smemo dajati prek gastrostome (cevke, ki poteka skozi trebuh v želodec) ali nazogastrične cevke (cevke, ki poteka skozi nos v želodec).
English: info@frostpharma.com info@frostpharma.com
Slovenian: info@frostpharma.com
English: • corticosteroids (medicines that are used to provide relief for inflamed areas of the body),
Slovenian: • kortikosteroide (zdravila za lajšanje simptomov na vnetih predelih telesa)
English: Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies).
Slovenian: Plazemske in urinske koncentracije fenilbutirata ter njegovih presnovkov so bile določene pri teščih normalnih odraslih osebah, ki so prejele enkratni odmerek 5 g natrijevega fenilbutirata, in pri bolnikih z motnjami v ciklusu sečnine, hemoglobinopatijami ter cirozo, ki so prejeli enkratni odmerek ali ponavljajoče peroralne odmerke do 20 g/dan (nekontrolirane študije).
English: Prenatal exposure of rat pups to phenylacetate (the active metabolite of phenylbutyrate) produced lesions in cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number (see section 4.6).
Slovenian: Pri izpostavitvi podganjih mladičev fenilacetatu (aktivnemu presnovku fenilbutirata) pred rojstvom je prišlo do lezij v piramidnih kortikalnih celicah; dendriti pa so bili daljši in tanjši kot običajno ter prisotni v manjšem številu (glejte poglavje 4.6).
English: • sleepiness, tiredness, light-headedness and less frequently confusion,
Slovenian: • zaspanost, utrujenost, vrtoglavica in redkeje zmedenost • glavobol
English: Women of childbearing potential/Contraception in males and females Effective contraceptive measures must be taken by women of child-bearing potential.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko zaščito.
English: If you are a woman who could get pregnant, you must use reliable contraception, during treatment with PHEBURANE.
Slovenian: Če lahko zanosite, morate med jemanjem zdravila PHEBURANE uporabljati zanesljivo metodo kontracepcije.
English: It is unknown whether sodium phenylbutyrate/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se natrijev fenilbutirat/presnovki izločajo v materino mleko.
English: Uncommon aplastic anaemia, ecchymosis
Slovenian: Občasni aplastična anemija, ekhimoza
English: Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis
Slovenian: Pogosti anemija, trombocitopenija, levkopenija, levkocitoza, trombocitoza
English: Three cirrhotic patients (out of 6) who received repeated oral administration of sodium phenylbutyrate (20 g/day in three doses) showed sustained plasma levels of phenylacetate on the third day that were five times higher than those achieved after the first dose.
Slovenian: Trije bolniki s cirozo (od šestih), ki so prejemali ponavljajoče se peroralne odmerke natrijevega fenilbutirata (20 g/dan v treh odmerkih), so imeli na tretji dan konstantne plazemske koncentracije fenilacetata petkrat višje od koncentracij, ki so bile dosežene po prvem odmerku.
English: Mechanism of action and pharmacodynamic effects Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Natrijev fenilbutirat je predzdravilo in se hitro presnavlja v fenilacetat.
English: The disposition of phenylbutyrate and its metabolites has also been studied in cancer patients following intravenous infusion of sodium phenylbutyrate (up to 2 g/m²) or phenylacetate.
Slovenian: Razporejanje fenilbutirata in njegovih presnovkov je bilo proučeno tudi pri bolnikih z rakom po intravenski infuziji natrijevega fenilbutirata (do 2 g/m2) ali fenilacetata.
English: The patient developed diarrhea, irritability and metabolic acidosis with hypokalaemia.
Slovenian: Bolnik je dobil drisko, postal razdražljiv in je razvil metabolično acidozo s hipokaliemijo.
English: These symptoms are consistent with the accumulation of phenylacetate, which showed dose-limiting neurotoxicity when administered intravenously at doses up to 400 mg/kg/day.
Slovenian: Ti simptomi so skladni z nakopičenjem fenilacetata, za katerega je bila dokazana nevtrotoksičnost, odvisna od intravenskega odmerka pri odmerkih 400 mg/kg/dan.
English: The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce).
Slovenian: Zrnca lahko zaužijete neposredno s pijačo (voda, sadni sokovi, tekoči pripravki brez beljakovin za dojenčke) ali pa jih nasujete na žlico čvrste hrane (pire krompir ali čežana).
English: When high doses of phenylacetate (190 - 474 mg/kg) were given subcutaneously to rat pups, decreased proliferation and increased loss of neurons were observed, as well as a reduction in CNS
Slovenian: Pri podganjih mladičih, ki so podkožno prejemali velike odmerke fenilacetata (190-474 mg/kg), so poročali o zmanjšani proliferaciji in povečani izgubi nevronov ter zmanjšanju mielina v centralnem živčnem sistemu.
English: Nutritional management PHEBURANE must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation.
Slovenian: Zdravilo PHEBURANE moramo kombinirati z omejitvami prehranskega vnosa beljakovin in v določenih primerih tudi s prehranskimi dopolnili esencialnih aminokislin in karnitina.
English: PHEBURANE granules are white to off-white.
Slovenian: Zrnca zdravila PHEBURANE so bela ali belkasta.
English: In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/kg/day up to 20 g/day) no plasma level of phenylacetate could be detected after overnight fasting.
Slovenian: Pri večini bolnikov z motnjami ciklusa sečnine ali hemoglobinopatijami, ki so prejemali različne odmerke fenilbutirata (300-650 mg/kg/dan do 20 g/dan), ni bilo moč zaznati plazemskih koncentracij fenilacetata po prekonočnem postu.
English: FrostPharma AB Tlf: +47 815 03 175
Slovenian: Tlf: +47 815 03 175
English: As a consequence, sodium phenylbutyrate reduces elevated plasma ammonia and glutamine levels in patients with urea cycle disorders.
Slovenian: Posledično natrijev fenilbutirat znižuje povišane plazemske koncentracije amoniaka in glutamina pri bolnikih z motnjami ciklusa sečnine.
English: PHEBURANE must be taken with a special diet reduced in protein.
Slovenian: Zdravilo PHEBURANE morate jemati s posebno prehrano z zmanjšano vsebnostjo beljakovin.
English: What you need to know before you take PHEBURANE Do not take PHEBURANE if you:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo PHEBURANE Ne jemljite zdravila PHEBURANE
English: Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth.
Slovenian: Možganska sinapsa je dozorela zapoznelo in zmanjšano je bilo število delujočih živčnih končičev v možganih, kar je povzročilo slabšo rast možganov (glejte poglavje 4.6).
English: • are pregnant.
Slovenian: • nosečnost
English: PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders.
Slovenian: Zdravilo PHEBURANE vsebuje učinkovino natrijev fenilbutirat in se uporablja za zdravljenje bolnikov vseh starosti z motnjami v ciklusu sečnine.
English: • Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
Slovenian: • Med zdravljenjem je treba spremljati serumski kalij, ker utegne izločanje fenilacetilglutamina skozi ledvici povzročiti izgubo kalija z urinom.
English: EXP After the first opening, to be used within 45 days.
Slovenian: EXP Zdravilo morate porabiti v 45 dneh po prvem odprtju.
English: Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Slovenian: Povišana koncentracija alkalne fosfataze, transaminaz, bilirubina, sečne kisline, klorida, fosfata in natrija v krvi.
English: HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules.
Slovenian: Plastenke iz HDPE z za otroke varno zaporko in sušilnim sredstvom, ki vsebujejo 174 g zrnc.
English: PHEBURANE is unlikely to affect your ability to drive and use machines.
Slovenian: Malo verjetno je, da bi zdravilo PHEBURANE vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: This may be due to the lipophilicity of sodium phenylbutyrate and consequent differences in volume of distribution.
Slovenian: Pojav najbrž lahko pripišemo lipofilnosti natrijevega fenilbutirata in posledičnim razlikam v volumnu porazdelitve.
English: Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
Slovenian: En gram natrijevega fenilbutirata vsebuje 124 mg (5,4 mmol) natrija in 768 mg saharoze.
English: • Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
Slovenian: Splošne ugotovitve • Pri številnih bolnikih se lahko akutna hiperamonemična encefalopatija pojavi celo med zdravljenjem.
English: Talk to your doctor or pharmacist before taking PHEBURANE if you:
Slovenian: Preden vzamete zdravilo PHEBURANE, se posvetujte s svojim zdravnikom ali farmacevtom, če:
English: Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri več kot 1 od 1 000 bolnikov): zmanjšanje števila rdečih krvničk zaradi zmanjšane dejavnosti kostnega mozga, modrice, spremenjen srčni ritem, krvavitev iz danke, vnetje želodčne sluznice, želodčna razjeda, vnetje trebušne slinavke.
English: Decreased blood potassium, albumin, total protein and phosphate.
Slovenian: Pogosti znižana koncentracija kalija, albumina, celokupnih beljakovin in fosfata v krvi.
English: What PHEBURANE looks like and contents of the pack
Slovenian: Izgled zdravila PHEBURANE in vsebina pakiranja
English: Each bottle contains 174g of granules.
Slovenian: Vsaka plastenka vsebuje 174 g zrnc.
English: This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
Slovenian: To zdravilo vsebuje 768 mg saharoze na 1 g natrijevega fenilbutirata.
English: FrostPharma AB Tel: +46 775 86 80 02
Slovenian: Tel: +46 775 86 80 02
English: Since the metabolism and excretion of sodium phenylbutyrate involves the liver and kidneys, PHEBURANE should be used with caution in patients with hepatic or renal insufficiency.
Slovenian: Ker presnova in izločanje natrijevega fenilbutirata vključuje jetra in ledvice, je potrebna previdnost pri predpisovanju zdravila PHEBURANE bolnikom z motnjami v delovanju jeter in ledvic.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Slovenian: PHEBURAN vsebuje saharozo“), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.
English: PHEBURANE should be administered orally.
Slovenian: Zdravilo PHEBURANE morate jemati peroralno.