FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent
Slovenian: IME ZDRAVILA Holoclar 79.000 - 316.000 celic/cm2 ekvivalent živega tkiva
English: Concomitant eyelids malposition, conjunctival scarring with fornix shortening, corneal anaesthesia and/or conjunctival anaesthesia or severe hypoaesthesia, pterygium and severe dry eye are potential complicating factors.
Slovenian: Možni dejavniki za zaplete so: nepravilni položaj očesnih vek, brazgotina veznice s skrajšanjem forniksa, roženična ali veznična anestezija ali huda hipestezija, pterigij in hude oblike suhega očesa.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: • vnetje roženice Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: Ask your surgeon if you have any further questions about the treatment with Holoclar.
Slovenian: Če imate dodatna vprašanja o zdravljenju z zdravilom Holoclar, se posvetujte s kirurgom.
English: At the time of product administration, the mean duration of the condition since the injury was 18 years (median 10 years), 99% of patients had corneal opacity and 90% of them had a severe impairment in visus (1/10th or less at Snellen chart).
Slovenian: V času apliciranja zdravila je bilo povprečno trajanje stanja od poškodbe 18 let (mediana 10 let), 99 %
English: Your eyelid will be taped closed for three days and your eye will be bandaged for 10 to 15 days after the implantation.
Slovenian: Veke na operiranem očesu bodo zlepljene skupaj s pomočjo posebnega lepilnega traku še tri dni po posegu, preko očesa pa boste še 10 do 15 dni po posegu nosili obvezo.
English: - If you get any side effects, talk to your surgeon.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s kirurgom.
English: If you get any side effects, talk to your surgeon.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s kirurgom.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: Holoclar is a medicine used for replacing damaged cells of the cornea (the clear layer that covers the coloured iris at the front of the eye) including limbal cells which normally help to maintain the health of your eye.
Slovenian: Roženica je prosojna plast, ki prekriva obarvano šarenico na sprednjem delu očesa, vključno z limbusnimi celicami, ki običajno pomagajo ohranjati vaše oko zdravo.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Slovenian: ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV ŠTEVILKA SERIJE:
English: Before the biopsy, the surgeon will give you eyedrops to anaesthetise your eye and surgically take the biopsy.
Slovenian: Pred biopsijo vam bo kirurg dal kapljice za oko, s katerimi bo oko omrtvičil.
English: Conventional pharmacodynamic studies for Holoclar have not been performed Clinical efficacy and safety
Slovenian: Običajnih farmakodinamičnih študij za zdravilo Holoclar niso opravili.
English: PHARMACEUTICAL FORM Living tissue equivalent.
Slovenian: FARMACEVTSKA OBLIKA ekvivalent živega tkiva prosojen, okrogel listič
English: • Infection of the cornea
Slovenian: • okužba roženice
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Slovenian: ŠTEVILKA SERIJE<, ENOTNE OZNAKE DAROVANJA IN IZDELKOV> ŠTEVILKA SERIJE:
English: Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns.
Slovenian: Zdravljenje odraslih bolnikov z zmernim do hudim pomanjkanjem limbusnih matičnih celic (opredeljeno s prisotnostjo površinske roženične neovaskularizacije v vsaj dveh roženičnih kvadrantih,
English: The surgical nature of the underlying procedure for the implantation of Holoclar has a major influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zaradi narave kirurškega posega, potrebnega za implantacijo zdravila Holoclar, ima zdravilo pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: Hepatic and renal impairment
Slovenian: Okvarjeno delovanje jeter in ledvic
English: This biopsy will then be used to make
Slovenian: Nato bo naredil biopsijo.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja podkožna krvavitev občasni
English: Name and address of the manufacturer of the biological active substance Holostem Terapie Avanzate S.R.L.
Slovenian: Holostem Terapie Avanzate S.R.L.
English: Next, the insert is fitted under the undermined conjunctiva.
Slovenian: Nato je treba implantat vstaviti pod pripravljeno veznico.
English: Two weeks after surgery, a topical corticosteroid treatment should be started with preservative-free dexamethasone 0.1% eye-drops, 1 drop three times per day for 2 weeks, then reduced to 1 drop twice daily for 1 week and 1 drop once daily for a further week.
Slovenian: Aplicira se 1 kapljico trikrat na dan za 2 tedna, nato se zmanjša na 1 kapljico dvakrat na dan za 1 teden in nato naslednji teden preide na 1 kapljico enkrat na dan. Topikalno dajanje kortikosteroida se lahko pri trdovratnem vnetju očesa nadaljuje.
English: System / organ class
Slovenian: Organski sistem
English: The container and closure should be carefully visually inspected for any derogation.
Slovenian: Skrbno vizualno preglejte vsebnik in zaporko, ali sta brezhibna.
English: Holoclar consists of a layer of your own cells which have been grown (ex vivo expanded) from a sample of limbal cells taken from your eye during a small surgical procedure called a biopsy.
Slovenian: iz vzorca limbusnih celic, ki jih zdravnik vzame iz vašega očesa s pomočjo majhnega kirurškega postopka, ki se imenuje biopsija.
English: Reporting of side effects
Slovenian: - spodbujanje vključevanja v register - poročanje o domnevnih stranskih učinkih
English: How Holoclar is stored
Slovenian: Shranjevanje zdravila Holoclar
English: Fibrin support.
Slovenian: - Navodilo shranite.
English: • The stitches break
Slovenian: • pretrganje šivov
English: Posology
Slovenian: Veznica
English: The following additional risk minimisation measures are necessary for the safe and effective use of the product:
Slovenian: Za varno in učinkovito uporabo zdravila so nujni naslednji dodatni ukrepi za zmanjševanje tveganj: Izobraževalno gradivo za zdravstvene delavce, ki bo omogočalo usposabljanje za ustrezno uporabo zdravila in zmanjševanje tveganj ter ki bo zajemalo ključne elemente za:
English: • Remove the scarred surface of the cornea
Slovenian: • odstranil zabrazgotinjeno površino roženice • jo zamenjal z zdravilom Holoclar
English: OTHER SPECIAL WARNING(S), IF NECESSARY Potentially infected biological material.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: Conjunctival haemorrhage, eye haemorrhage, corneal epithelium defect, eye pain, glaucoma/intraocular pressure increased, ulcerative keratitis
Slovenian: glavkom/zvišan očesni tlak, ulcerozni keratitis pogosti adhezija veznice, hiperemija veznice, edem roženice, perforacija roženice, draženje očesa, fotofobija občasni
English: • Severe dry eye.
Slovenian: • huda oblika suhega očesa
English: Eye disorders
Slovenian: (šarenico) očesa.
English: It is the rim surrounding the coloured centre (iris) of your eye.
Slovenian: To je obroč, ki obkroža obarvano sredino
English: Syncope vasovagal
Slovenian: Bolezni živčevja vazovagalna sinkopa občasni
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA19 Mechanism of action and pharmacodynamic effects The mechanism of action of Holoclar is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns.
Slovenian: Mehanizem delovanja zdravila Holoclar je nadomestitev roženičnega epitelija in izgubljenih limbusnih matičnih celic pri bolnikih, pri katerih je bil limbus uničen ob opeklini očesa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SCREW-CAP CONTAINER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: The recommended dose of Holoclar is 79,000 - 316,000 cells/cm², corresponding to 1 cm² of product/cm² of defect.
Slovenian: 79.000 - 316.000 celic/cm˛, kar ustreza 1 cm˛ zdravila/cm˛ okvare.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Pregnancy and breast-feeding
Slovenian: - tveganje za glavkom in blefaritis
English: Infections and infestations
Slovenian: Klinična učinkovitost in varnost
English: • Increased pressure in the eye (glaucoma)
Slovenian: • zvišan očesni tlak (glavkom) • bolečina v očesu
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
English: In small children this can be 4 to 6 times per day.
Slovenian: Pri majhnih otrocih je to lahko 4- do 6-krat na dan.
English: Make sure that there are at least 3 hours between two doses.
Slovenian: Prepričajte se, da so minile najmanj tri ure med dvema odmerkoma.
English: Your doctor will tell you the amount of granules you should take.
Slovenian: Vaš zdravnik vam bo povedal, kakšno količino zrnc morate vzeti.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja pri novorojenčkih/dojenčkih ni mogoče izključiti.
English: The patient recovered within 48 hours after symptomatic treatment.
Slovenian: Bolnik si je opomogel v 48 urah po simptomatičnem zdravljenju.
English: It is especially important to tell your doctor if you are taking medicines containing:
Slovenian: Zlasti pomembno je, da obvestite svojega zdravnika, če jemljete zdravila, ki vsebujejo:
English: Take the correct amount as prescribed by your doctor.
Slovenian: Vzemite pravilno količino, kot vam jo je predpisal vaš zdravnik;
English: The effect of food on absorption is unknown.
Slovenian: Učinek hrane na absorpcijo ni znan.
English: To measure the dose:
Slovenian: Za odmerjanje odmerka:
English: The total daily dose should be divided into equal amounts and given with each meal or feeding (e.g. 4-6 times per day in small children).
Slovenian: Celokupni dnevni odmerek naj se razdeli na enake dele in se daje z vsakim obrokom ali hranjenjem (npr. 4-6 krat dnevno pri majhnih otrocih).
English: It is important that the diagnosis is made early and treatment is initiated immediately to improve the survival and the clinical outcome.
Slovenian: Pomembno je, da se diagnoza postavi zgodaj in da se zdravljenje takoj prične, saj se s tem izboljša preživetje in klinični izid.
English: You should take a dose as soon as possible with your next meal.
Slovenian: Vzemite odmerek takoj, ko je možno, z naslednjim obrokom.
English: The safety and efficacy of doses in excess of 20 g/day have not been established.
Slovenian: Varnost in učinkovitost odmerkov, večjih od 20 g/dan, še ni bila dokazana.
English: Date of first authorisation: 31 July 2013 Date of latest renewal: 23 March 2018
Slovenian: Datum zadnjega podaljšanja: 23. marec 2018
English: Talk to your doctor for the details.
Slovenian: O podrobnostih se pogovorite s svojim zdravnikom.
English: If you mix them with food, it is important that you take it immediately.
Slovenian: Če jih zmešate s hrano, je pomembno, da jih zaužijete takoj.
English: This will keep the granules from producing any taste.
Slovenian: Tako zrnca ne bodo razvila okusa.
English: Lucane Pharma 172 rue de Charonne 75011 Paris France
Slovenian: Lucane Pharma 172 rue de Charonne 75011 Pariz Francija
English: Common depression, irritability
Slovenian: Pogosti depresija, razdražljivost
English: The elimination half-life was estimated to be 0.8 hours.
Slovenian: Ocenjeno je bilo, da je razpolovni čas izločanja 0,8 ure.
English: If this happens you will develop symptoms such as feeling sick (nausea), being sick (vomiting), confusion and will need to get urgent medical help.
Slovenian: Če pride do tega, se bodo pojavili simptomi, kot so siljenje na bruhanje (navzea), bruhanje, zmedenost, in potrebovali boste nujno medicinsko pomoč.
English: • 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults.
Slovenian: • 9,9-13,0 g/m2/dan pri otrocih, ki tehtajo več kot 20 kg, ter pri mladostnikih in odraslih.
English: Nitrogen is a building block of proteins, which are an essential part of the food we eat.
Slovenian: Dušik je gradnik beljakovin, ki so bistveni del naše prehrane.
English: If caloric supplementation is indicated, a protein-free product is recommended.
Slovenian: Če je indicirano kalorično dopolnjevanje prehrane, priporočamo izdelke brez beljakovin.
English: Talk to your doctor or pharmacist if you need 3 or more grams daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če potrebujete 3 ali več gramov dnevno v daljšem časovnem obdobju, , še posebno če so vam svetovali dieto z manjšim vnosom soli (natrija)
English: She recovered following dose reduction except for recurrent pancreatitis episodes that eventually prompted treatment discontinuation.
Slovenian: Po zmanjšanju odmerka je okrevala, z izjemo ponavljajočih se epizod pankreatitisa, zaradi katerih so zdravljenje končno prekinili.
English: In the event of an overdose, the treatment should be discontinued and supportive measures be instituted.
Slovenian: V primeru prevelikega odmerjanja je treba nemudoma prekiniti z zdravljenjem in izvesti podporne ukrepe.
English: Haemodialysis or peritoneal dialysis may be beneficial.
Slovenian: Hemodializa ali peritonealna dializa sta lahko koristni.
English: • Pour granules directly into the spoon as shown by the picture (on the outer carton and at the end of/page 2 of this leaflet)
Slovenian: • zrnca stresite neposredno na žličko, kot kaže slika (na zunanji ovojnini in na koncu strani 2 tega navodila);
English: It is indicated in all patients with neonatal-onset disease (complete enzyme deficiencies, presenting within the first 28 days of life).
Slovenian: Indicirano je pri vseh bolnikih, pri katerih se bolezen pojavi v neonatalnem obdobju (popolno pomanjkanje encimov, ki se pokaže v prvih 28 dneh življenja).
English: • suffer from congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or a decrease in your kidney function.
Slovenian: • imate kongestivno srčno popuščanje (vrsta srčnega obolenja, pri kateri srce ne more črpati zadostne količine krvi po telesu) ali če imate zmanjšano delovanje ledvic;
English: Distribution The volume of distribution of phenylbutyrate is 0.2 l/kg.
Slovenian: Porazdelitev Volumen porazdelitve fenilbutirata je 0,2 l/kg.
English: Patients with neonatal-onset disease had a high incidence of mental retardation.
Slovenian: Bolniki z neonatalnim pojavom bolezni so imeli visoko pojavnost umske zaostalosti.
English: These medicines may change the effect of PHEBURANE and you will need more frequent blood tests.
Slovenian: Ta zdravila lahko spremenijo delovanje zdravila PHEBURANE in boste morali pogosteje na krvne preiskave.
English: • 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
Slovenian: • 450-600 mg/kg/dan pri novorojenčkih, dojenčkih in otrocih, ki tehtajo manj kot 20 kg,
English: • valproate (an antiepileptic medicine),
Slovenian: • valproat (zdravilo proti epilepsiji)
English: These rare disorders are due to a deficiency of certain liver enzymes which are necessary to eliminate waste nitrogen in the form of ammonia.
Slovenian: Do teh redkih motenj prihaja zaradi pomanjkanja določenih encimov v jetrih, ki so potrebni za odstranjevanje odpadnega dušika v obliki amoniaka.
English: Plasma glutamine should be maintained at levels less than 1,000 μmol/L.
Slovenian: Plazemske koncentracije glutamina je treba vzdrževati pod 1000 µmol/l.
English: • worsening of existing neurological conditions.
Slovenian: • težave s spominom • poslabšanje obstoječih nevroloških stanj
English: If you need laboratory tests, it is important to remind your doctor that you are taking PHEBURANE, since sodium phenylbutyrate may interfere with certain laboratory test results (such as blood electrolytes or protein, or liver function tests)
Slovenian: Če boste morali opraviti laboratorijske preiskave, je pomembno, da opomnite svojega zdravnika, da jemljete zdravilo PHEBURANE, ker lahko natrijev fenilbutirat vpliva na rezultate nekaterih laboratorijskih preiskav (kot so npr. elektroliti ali beljakovine v krvi ali pa vrednosti jetrnih preiskav).
English: If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.
Slovenian: Če pri sebi opazite katerega teh simptomov, nemudoma obvestite svojega zdravnika ali najbližjo nujno medicinsko pomoč za podporno zdravljenje.
English: This should be taken into account if you have diabetes mellitus.
Slovenian: To morate upoštevati, če imate sladkorno bolezen.
English: If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see ‘Pregnancy and breast-feeding' section above) or by menopause.
Slovenian: Če se to zgodi, se posvetujete s svojim zdravnikom, ker lahko izostanek menstruacije pomeni, da ste noseči (glejte poglavje „Nosečnost in dojenje“ zgoraj).
English: • disorientation,
Slovenian: • dezorientiranost
English: Very common side effects (may affect more than 1 in 10 people): irregular menstrual periods and stopping of menstrual periods in fertile women.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): neredna menstruacija in izostanek menstruacije pri plodnih ženskah.
English: You will need to take this medicine and to follow a diet throughout your life.
Slovenian: To zdravilo in posebno prehrano boste potrebovali celo življenje.
English: If you are sexually active and your period stops altogether, do not assume that this is caused by PHEBURANE.
Slovenian: Če ste spolno dejavni in vam menstruacija izostane, ne domnevajte, da gre za učinke zdravila PHEBURANE.
English: <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena kot zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥ 1/10.000 do < 1/1 000), zelo redki (< 1/10 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Women of childbearing potential must use effective contraception during treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
English: If persistent vomiting occurs, you should contact your doctor immediately.
Slovenian: Če pride do trdovratnega bruhanja, nemudoma obvestite svojega zdravnika.
English: • are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na natrijev fenilbutirat ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Phenylacetate is also hydrolysed by esterases in liver and blood.
Slovenian: Fenilacetat hidrolizirajo tudi esteraze v jetrih in krvi.
English: Therapeutic monitoring
Slovenian: Nadzorovanje zdravljenja
English: Manifestations of neurotoxicity were predominantly somnolence, fatigue and light-headedness.
Slovenian: Znaki nevrotoksičnosti so bili predvsem somnolenca, utrujenost in omotičnost.
English: • Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary
Slovenian: • enkrat potolcite z žličko po mizi, da se bodo zrnca vodoravno poravnala in po potrebi nadaljujte polnjenje.
English: • probenecid (for treatment of hyperuricaemia, high levels of uric acid in the blood, associated with gout)
Slovenian: • probenecid (za zdravljenje hiperurikemije, visokih ravni sečne kisline v krvi, ki so povezane s protinom).
English: Adverse reactions mainly involved the reproductive and gastrointestinal system.
Slovenian: Neželeni učinki so prizadeli predvsem reproduktivni in prebavni sistem.
English: The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed to promote growth and development.
Slovenian: Dnevni odmerek je treba prilagoditi individualno glede na bolnikovo toleranco za beljakovine in na potreben dnevni vnos beljakovin za pospeševanje rasti in razvoja.
English: Each carton contains 1 bottle.
Slovenian: Vsaka škatlica vsebuje 1 plastenko.
English: PHEBURANE will not prevent the occurrence of an acute excess of ammonia in the blood, a condition which usually constitutes a medical emergency.
Slovenian: Zdravilo PHEBURANE ne prepreči nastanka akutnega presežka amonijaka v krvi, stanja, ki običajno pomeni nujno medicinsko pomoč.
English: • PHEBURANE is not recommended for the management of acute hyperammonaemia, which is a medical emergency.
Slovenian: • Zdravila PHEBURANE ne priporočajo za zdravljenje akutne hiperamonemije, ki je medicinski nujen primer.
English: Less frequent manifestations were confusion, headache, dysgeusia, hypoacusis, disorientation, impaired memory and exacerbation of a pre-existing neuropathy.
Slovenian: Manj pogosti znaki nevrotoksičnosti pa so bili zmedenost, glavobol, disgevsija, hipakuza, dezorientacija, poslabšanje spomina in poslabšanje že obstoječih nevropatij.
English: Reversal of pre-existing neurologic impairment is not likely to occur with treatment, and neurologic deterioration may continue in some patients.
Slovenian: Z zdravljenjem ni verjetno, da bi prišlo do izboljšanja obstoječih nevroloških motenj, pri nekaterih bolnikih pa se lahko tudi nadaljuje slabšanje nevroloških stanj.
English: Do not use PHEBURANE after the expiry date which is stated on the carton and the bottle label after EXP.
Slovenian: Zdravila PHEBURANE ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na plastenki poleg oznake “EXP”.
English: PHEBURANE may be required life-long unless orthotropic liver transplantation is elected.
Slovenian: Zdravljenje z zdravilom PHEBURANE je lahko potrebno celo življenje, če ne pride do odločitve za ortotopično presaditev jeter.
English: • Lines on the spoon indicate the amount (in gram of sodium phenylbutyrate).
Slovenian: • črtice na žlički prikazujejo količino (v gramih natrijevega fenilbutirata).
English: In patients diagnosed during gestation and treated prior to any episode of hyperammonaemic encephalopathy, survival was 100 %, but even in these patients, many subsequently demonstrated cognitive impairment or other neurologic deficits.
Slovenian: Pri bolnikih, katerim so diagnozo postavili v času nosečnosti in so bili zdravljeni pred epizodo hiperamoniemične encefalopatije, je bilo preživetje 100 %, toda tudi pri velikem deležu teh bolnikov so kasneje odkrili kognitivne motnje ali druge nevrološke pomanjkljivosti.
English: One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Slovenian: Do prevelikega odmerjanja je prišlo pri petmesečnem dojenčku z naključnim zaužitjem enkratnega odmerka 10 g (1 370 mg/kg).
English: You must follow this diet carefully.
Slovenian: Navodila glede prehrane morate zelo skrbno upoštevati.
English: The usual total daily dose of sodium phenylbutyrate in clinical experience is:
Slovenian: Običajni celokupni dnevni odmerek natrijevega fenilbutirata je po kliničnih izkušnjah:
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX03.
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16AX03.