natgillin/translations-raw huggingface dataset:
Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Izločanje Približno 80-100 % zdravila se izloči preko ledvic v 24 urah v obliki konjugiranega produkta,
• haloperidol (used in certain psychotic disorders),
• haloperidol (za zdravljenje nekaterih psihotičnih motenj)
PHEBURANE helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body.
Zdravilo PHEBURANE telesu pomaga odstraniti odpadni dušik in v njem zmanjšati količino amoniaka.
Common metabolic acidosis, alkalosis, decreased appetite
Pogosti metabolična acidoza, alkaloza, zmanjšan tek
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.
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.
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 %.
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 %.
Available pharmacodynamic/toxicological data in animals have shown excretion of sodium phenylbutyrate/metabolites in milk (see section 5.3).
Farmakodinamični/toksikološki podatki iz študij na živalih, ki so na voljo, kažejo izločanje natrijevega fenilbutirata/presnovkov v mleko (glejte poglavje 5.3).
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.
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.
Other medicines and PHEBURANE
Druga zdravila in zdravilo PHEBURANE
Pheburane is contra-indicated during breast-feeding (see section 4.3).
Pheburane je kontraindicirano med dojenjem (glejte poglavje 4.3).
Common renal tubular acidosis
Pogosti ledvična tubulna acidoza
• changes in taste (taste disturbances),
• sprememba v okušanju (motnje okušanja) • naglušnost
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).
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).
• corticosteroids (medicines that are used to provide relief for inflamed areas of the body),
• kortikosteroide (zdravila za lajšanje simptomov na vnetih predelih telesa)
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).
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).
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).
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).
• sleepiness, tiredness, light-headedness and less frequently confusion,
• zaspanost, utrujenost, vrtoglavica in redkeje zmedenost • glavobol
Women of childbearing potential/Contraception in males and females Effective contraceptive measures must be taken by women of child-bearing potential.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko zaščito.
If you are a woman who could get pregnant, you must use reliable contraception, during treatment with PHEBURANE.
Če lahko zanosite, morate med jemanjem zdravila PHEBURANE uporabljati zanesljivo metodo kontracepcije.
It is unknown whether sodium phenylbutyrate/metabolites are excreted in human milk.
Ni znano, ali se natrijev fenilbutirat/presnovki izločajo v materino mleko.
Uncommon aplastic anaemia, ecchymosis
Občasni aplastična anemija, ekhimoza
Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis
Pogosti anemija, trombocitopenija, levkopenija, levkocitoza, trombocitoza
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.
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.
Mechanism of action and pharmacodynamic effects Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Mehanizem delovanja in farmakodinamični učinki Natrijev fenilbutirat je predzdravilo in se hitro presnavlja v fenilacetat.
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.
Razporejanje fenilbutirata in njegovih presnovkov je bilo proučeno tudi pri bolnikih z rakom po intravenski infuziji natrijevega fenilbutirata (do 2 g/m2) ali fenilacetata.
The patient developed diarrhea, irritability and metabolic acidosis with hypokalaemia.
Bolnik je dobil drisko, postal razdražljiv in je razvil metabolično acidozo s hipokaliemijo.
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.
Ti simptomi so skladni z nakopičenjem fenilacetata, za katerega je bila dokazana nevtrotoksičnost, odvisna od intravenskega odmerka pri odmerkih 400 mg/kg/dan.
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).
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).
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
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.
Nutritional management PHEBURANE must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation.
Zdravilo PHEBURANE moramo kombinirati z omejitvami prehranskega vnosa beljakovin in v določenih primerih tudi s prehranskimi dopolnili esencialnih aminokislin in karnitina.
PHEBURANE granules are white to off-white.
Zrnca zdravila PHEBURANE so bela ali belkasta.
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.
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.
As a consequence, sodium phenylbutyrate reduces elevated plasma ammonia and glutamine levels in patients with urea cycle disorders.
Posledično natrijev fenilbutirat znižuje povišane plazemske koncentracije amoniaka in glutamina pri bolnikih z motnjami ciklusa sečnine.
PHEBURANE must be taken with a special diet reduced in protein.
Zdravilo PHEBURANE morate jemati s posebno prehrano z zmanjšano vsebnostjo beljakovin.
What you need to know before you take PHEBURANE Do not take PHEBURANE if you:
Kaj morate vedeti, preden boste vzeli zdravilo PHEBURANE Ne jemljite zdravila PHEBURANE
Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth.
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).
• are pregnant.
• nosečnost
PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders.
Zdravilo PHEBURANE vsebuje učinkovino natrijev fenilbutirat in se uporablja za zdravljenje bolnikov vseh starosti z motnjami v ciklusu sečnine.
• Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
• Med zdravljenjem je treba spremljati serumski kalij, ker utegne izločanje fenilacetilglutamina skozi ledvici povzročiti izgubo kalija z urinom.
EXP After the first opening, to be used within 45 days.
EXP Zdravilo morate porabiti v 45 dneh po prvem odprtju.
Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Povišana koncentracija alkalne fosfataze, transaminaz, bilirubina, sečne kisline, klorida, fosfata in natrija v krvi.
HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules.
Plastenke iz HDPE z za otroke varno zaporko in sušilnim sredstvom, ki vsebujejo 174 g zrnc.
PHEBURANE is unlikely to affect your ability to drive and use machines.
Malo verjetno je, da bi zdravilo PHEBURANE vplivalo na vašo sposobnost upravljanja vozil in strojev.
This may be due to the lipophilicity of sodium phenylbutyrate and consequent differences in volume of distribution.
Pojav najbrž lahko pripišemo lipofilnosti natrijevega fenilbutirata in posledičnim razlikam v volumnu porazdelitve.
Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
En gram natrijevega fenilbutirata vsebuje 124 mg (5,4 mmol) natrija in 768 mg saharoze.
• Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
Splošne ugotovitve • Pri številnih bolnikih se lahko akutna hiperamonemična encefalopatija pojavi celo med zdravljenjem.
Talk to your doctor or pharmacist before taking PHEBURANE if you:
Preden vzamete zdravilo PHEBURANE, se posvetujte s svojim zdravnikom ali farmacevtom, če:
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.
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.
Decreased blood potassium, albumin, total protein and phosphate.
Pogosti znižana koncentracija kalija, albumina, celokupnih beljakovin in fosfata v krvi.
What PHEBURANE looks like and contents of the pack
Izgled zdravila PHEBURANE in vsebina pakiranja
Each bottle contains 174g of granules.
Vsaka plastenka vsebuje 174 g zrnc.
This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
To zdravilo vsebuje 768 mg saharoze na 1 g natrijevega fenilbutirata.
FrostPharma AB Tel: +46 775 86 80 02
Tel: +46 775 86 80 02
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.
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.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
PHEBURAN vsebuje saharozo“), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.
PHEBURANE should be administered orally.
Zdravilo PHEBURANE morate jemati peroralno.
• This medicinal product contains 124 mg sodium per gram, equivalent to 6.2% of the WHO recommended maximum daily intake for sodium.
• To zdravilo vsebuje 124 mg natrija na gram, kar je enako 6,2 % največjega dnevnega vnosa natrija po priporočilu Svetovne zdravstvene organizacije Največji dnevni odmerek tega zdravila je enak 125 % največjega dnevnega vnosa natrija po priporočilu Svetovne zdravstvene organizacije.
The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose.
Dnevni odmerek zdravila PHEBURANE vam bodo določili na podlagi vaše telesne mase ali telesne površine in bo prilagojen glede na vašo toleranco za beljakovine in glede na vašo prehrano.
Uncommon arrhythmia
Občasni aritmija
After the first opening, to be used within 45 days.
3 leta Zdravilo morate porabiti v 45 dneh po prvem odprtju.
However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
Zdravilo PHEBURANE pa morate kombinirati s prehrano z nizko vsebnostjo beljakovin, ki jo posebej za vas prilagodita zdravnik in dietetik.
The granules are packaged in a plastic bottle with child-resistant closure and a dessicant.
Zrnca so pakirana v plastenke z za otroke varno zaporko in sušilnim sredstvom.
Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Na podlagi študij izločanja fenilacetilglutamina pri bolnikih z motnjami ciklusa sečnine lahko ocenimo, da se na vsak odmerjen gram natrijevega fenilbutirata proizvede med 0,12 in 0,15 g dušika v obliki fenilacetilglutamina.
Carton: One bottle with 174 g granules.
Škatla: ena plastenka s 174 g zrnc.
Only use the calibrated measuring spoon provided.
Uporabljajte le priloženo umerjeno odmerno žličko.
This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
To zdravilo vsebuje 124 mg (5,4 mmol) natrija na 1 g natrijevega fenilbutirata.
Very common amenorrhea, irregular menstruation
Motnje reprodukcije in dojk Zelo pogosti amenoreja, neredna menstruacija
PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Zdravilo PHEBURANE je indicirano kot dodatno zdravljenje pri dolgoročnem obravnavanju motenj ciklusa sečnine, ki vključujejo pomanjkanje karbamoilfosfat-sintaze, ornitin-transkarbamoilaze ali argininosukcinat-sintaze.
PHEBURANE contains sodium and sucrose
Zdravilo PHEBURANE vsebuje natrij in saharozo.
See section 4.
povidon K25.
A calibrated measuring spoon is provided.
Priložena je umerjena odmerna žlička.
Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Pri ponavljajočem se odmerjanju fenilacetata so opazili indukcijo očistka.
There are no or limited amount of data from the use of sodium phenylbutyrate in pregnant women.
Nosečnost Podatkov o uporabi natrijevega fenilbutirata pri nosečnicah ni ali so omojeni.
Because of its slow dissolution, PHEBURANE should not be administered by nasogastric or gastrostomy tubes.
Ker se zdravilo PHEBURANE raztaplja počasi, ga ne smemo dajati prek gastrostome ali nazogastrične cevke.
Studies with high intravenous doses of phenylacetate showed non-linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Študije z visokimi intravenskimi odmerki fenilacetata so odkrile nelinearno farmakokinetiko, katere značilnost je presnova v fenilacetilglutamin, pri kateri pride do nasičenja.
Phenylbutyrate is rapidly absorbed under fasting conditions.
Fenilbutirat se pri tešči osebi hitro absorbira.
You should take PHEBURANE by mouth.
Zdravilo PHEBURANE morate jemati peroralno (skozi usta).
Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Za fenilbutirat je znano, da se oksidira v fenilacetat, ki se v jetrih in ledvicah encimsko konjugira z glutaminom v fenilacetilglutamin.
In normal volunteers gender differences were found in the pharmacokinetic parameters of phenylbutyrate and phenylacetate (AUC and Cmax about 30 - 50 % greater in females), but not phenylacetylglutamine.
Pri zdravih prostovoljcih so bile med spoloma opažene razlike v farmakokinetičnih parametrih fenilbutirata in fenilacetata (vrednosti AUC in Cmaks.
Bottle: 174 g granules.
Plastenka: 174 g zrnc.
After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Po enkratnem peroralnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc se merljive količine fenilbutirata v plazmi pojavijo že po 15 minutah.
Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Za bolnike z diagnozo neonatalnega pojava pomanjkanja karbamoilfosfat-sintaze je potrebno dopolnjevanje prehrane s citrulinom v odmerku 0,17 g/kg/dan oziroma pri pomanjkljivosti ornitin transkarbamoilaze dopolnjevanje prehrane z argininom v odmerku 3,8 g/m2/dan.
More frequent monitoring of plasma ammonia levels is advised when these medicinal products have to be used.
Če se dajejo ta zdravila, svetujemo pogostejše nadzorovanje plazemskih koncentracij amoniaka.
Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Študije kancerogenosti in vpliva na sposobnost razmnoževanja z natrijevim fenilbutiratom niso bile izvedene.
In case of mixture of the granules with solid foods or liquid it is important that it is taken immediately after mixing.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Če zrnca mešate s čvrsto hrano ali pijačami, je pomembno, da jih zaužijete takoj po mešanju.
Do not use PHEBURANE if you are pregnant, because this medicine can harm your unborn baby.
Nosečnost in dojenje Ne jemljite zdravila PHEBURANE med nosečnostjo, saj lahko škoduje vašemu otroku.
Content of clinically important electrolytes
4.4 Posebna opozorila in previdnostni ukrepi Vsebnost klinično pomembnih elektrolitov
Fertility There is no evidence available on the effect of sodium phenylbutyrate on fertility.
O učinkih natrijevega fenilbutirata na plodnost ni na voljo nobenih podatkov.
How to take PHEBURANE
Kako jemati zdravilo PHEBURANE
The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Razpolovni čas izločanja je bil za fenilacetat 1,3 ure, za fenilacetilglutamin pa 2,4 ure.
Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Fenilacetat je presnovno dejavna spojina, ki se z acetilacijo konjugira z glutaminom v fenilacetilglutamin.
PHEBURANE 483 mg/g {For carton only}
PHEBURANE 483 mg/g [samo zunanja ovojnina]
If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.
Če ste negotovi o uporabi navedenih učinkovin, preverite pri svojem zdravniku ali farmacevtu.
Concurrent administration of probenecid may affect renal excretion of the conjugation product of sodium phenylbutyrate.
Sočasno dajanje probenecida lahko vpliva na izločanje konjugiranega produkta natrijevega fenilbutirata preko ledvic.
After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Po enkratnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc so se merljive količine fenilacetata pojavile po 30 minutah, merljive količine fenilacetilglutamina pa po 60 minutah po odmerjanju.
PHEBURANE 483 mg/g granules sodium phenylbutyrate
PHEBURANE 483 mg/g zrnca natrijev fenilbutirat
A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
Priložena je odmerna žlička, s katero v korakih po 250 mg odmerimo 3 g natrijevega fenilbutirata.
As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Ker telo razgradi zaužite beljakovine, se odpadni dušik v obliki amoniaka kopiči, saj ga telo ne zmore odstraniti.
Each gram of granules contains 483 mg of sodium phenylbutyrate.
En gram zrnc vsebuje 483 mg natrijevega fenilbutirata.
PHEBURANE 483 mg/g granules
PHEBURANE 483 mg/g zrnca
In case of any doubt, ask your doctor or pharmacist.
Če ste v dvomih, se posvetujte s svojim zdravnikom ali farmacevtom.
Increased weight
Povečana telesna masa
Name and address of the manufacturer(s) responsible for batch release Lucane Pharma
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
• If you get any side effects, talk to your doctor or pharmacist.
• Če opazite kateri koli neželeni učinek, se posvetujte s zdravnikom ali farmacevtom.
The active substance is sodium phenylbutyrate.
Učinkovina je natrijev fenilbutirat.
Common rash, abnormal skin odor
Pogosti izpuščaj, nenormalen telesni vonj
• PHEBURANE contains 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
• Zdravilo PHEBURANE vsebuje 124 mg (5,4 mmol) natrija na gram natrijevega fenilbutirata,
• are breast-feeding.
• Navodilo shranite.
The mean time to peak concentration was 3.55 and 3.23 hours, respectively, and the mean peak concentration was 45.3 and 62.8 μg/ml, respectively.
Povprečni čas do najvišje koncentracije je bil za fenilacetat 3,55 ure, za fenilacetilglutamin pa 3,23 ure.