natgillin/translations-raw huggingface dataset:
In rats, embryo-foetal lethality and teratogenic effects were observed at exposure levels below human exposure at the MRHD of 150 mg twice daily. 
Pri podganah so smrtnost zarodka in ploda ter teratogene učinke opazili pri izpostavljenosti, manjši od izpostavljenosti ljudi pri največjem za ljudi priporočenem odmerku 150 mg dvakrat na dan.
See Table 2 for individual and pooled study results. 
Za posamične in združene rezultate študij glejte preglednico 2.
Two pack-sizes of Ofev 150 mg capsules are available: 
Na voljo sta dve velikosti pakiranj zdravila Ofev 150 mg kapsule:
Very common side effects (may affect more than 1 in 10 people) - Feeling sick (nausea) - Pain in the lower body (abdomen) - Abnormal liver test results. 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - siljenje na bruhanje (navzea) - bolečine v spodnjem delu telesa (trebuhu) - nenormalne vrednosti jetrnih preiskav.
Nonserious epistaxis was the most frequent bleeding event. 
Najpogostejša krvavitev je bila epistaksa, ki ni bila resna.
Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period. 
V obdobju trženja zdravila so poročali o primerih predrtja prebavil, od katerih jih je bilo nekaj s smrtnim izidom.
In the pooled analysis of the INPULSIS trials, the estimated mean change from baseline to week 52 in SGRQ total score was smaller in the nintedanib group (3.53) than in the placebo group (4.96), with a difference between the treatment groups of -1.43 (95% CI: -3.09, 0.23; p=0.0923). 
V združeni analizi preskušanj INPULSIS je bila ocenjena povprečna sprememba skupnega seštevka SGRQ od izhodišča do 52. tedna manjša v skupini z nintedanibom (3,53), kot v skupini s placebom (4,96), z razliko med skupinama zdravljenja -1,43 (95 % IZ: -3,09;
Do not store Ofev above 25°C. 
Zdravilo Ofev shranjujte pri temperaturi do 25 °C.
In case of persisting severe symptoms therapy with Ofev should be discontinued. 
Pri trdovratnih simptomih je treba zdravljenje z zdravilom Ofev ukiniti.
Printing ink shellac glaze iron oxide black (E172) propylene glycol (E1520) 
Tiskarsko črnilo glazura iz šelaka črni železov oksid (E172) propilenglikol (E1520)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/003 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/979/003
Do not take more than the recommended dose of two Ofev 150 mg capsules per day. 
Ne vzemite večjega odmerka od priporočenega, to je dveh kapsul po 150 mg zdravila Ofev na dan.
Ofev 100 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters 
Zdravilo Ofev 100 mg mehke kapsule je na voljo v naslednjih velikostih pakiranj: - 30 x 1 mehka kapsula v perforiranem enoodmernem pretisnem omotu aluminij/aluminij - 60 x 1 mehka kapsula v perforiranem enoodmernem pretisnem omotu aluminij/aluminij
No increased frequency of impaired wound healing was observed in the INPULSIS trials. 
V preskušanjih INPULSIS niso opazili večje pogostnosti slabšega celjenja ran.
There was no evidence of liver enzyme increases in rats, dogs, and Cynomolgus monkeys. 
Pri podganah, psih in opicah Cynomolgus ni dokazov o zvečanju jetrnih encimov.
Nausea and vomiting 
Navzea in bruhanje
Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism. 
Učinki prenašalca in precejšnja presnova med prvim prehodom zmanjšata absorpcijo in biološko uporabnost.
Summary of ADRs per frequency category Frequency System Organ Class 
Preglednica 1: Povzetek neželenih učinkov po kategorijah pogostnosti Pogostnost
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Hyperbilirubinaemia, Blood alkaline phosphatase (ALKP) increased 
poškodba jeter zaradi zdravila, hiperbilirubinemija, zvečana vrednost alkalne-fosfataze v krvi (ALKP)
Once transaminases have returned to baseline values, treatment with Ofev may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (see section 4.2). 
Ko se aminotransferaze vrnejo na izhodiščne vrednosti, se lahko zdravljenje z zdravilom Ofev nadaljuje s polnim odmerkom (150 mg dvakrat na dan) ali z zmanjšanim odmerkom (100 mg dvakrat na dan), nato pa postopoma zvišuje do polnega odmerka (glejte poglavje 4.2).
In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Ofev is 100 mg twice daily approximately 12 hours apart. 
Izpostavljenost se je povečala pri bolnikih z jetrno okvaro (Child Pugh A, Child Pugh B; glejte poglavje 5.2).Pri bolnikih z blago jetrno okvaro (Child Pugh A) je priporočeni odmerek zdravila Ofev 100 mg dvakrat dnevno na približno 12 ur.
Age 
Starost
Breast-feeding should be discontinued during treatment with Ofev. 
Med zdravljenjem z zdravilom Ofev je treba prenehati z dojenjem.
Diarrhoea, Nausea, Abdominal pain 
Bolezni prebavil driska, navzea, bolečine v trebuhu bruhanje pankreatitis kolitis
See Table 3 for individual and pooled study results. 
Za posamične in združene rezultate študij glejte preglednico 3.
Pruritus, Alopecia 
Bolezni kože in podkožja izpuščaj pruritus, alopecija
Due to the mechanism of action of nintedanib patients might have an increased risk of gastrointestinal perforation. 
Zaradi mehanizma delovanja nintedaniba je lahko pri bolnikih tveganje za predrtje prebavil večje.
Ofev 150 mg soft capsules 
Ofev 150 mg mehke kapsule
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer box 
PODATKI NA ZUNANJI OVOJNINI Škatla
Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats. 
Predklinične študije kažejo, da se pri podganah v obdobju laktacije v mleko izloča majhna količina nintedaniba in njegovih presnovkov (≤ 0,5 % uporabljenega odmerka).
Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set 
Preglednica 2: Letna stopnja upada FVC (ml) v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki -zdravljeni bolniki
Not known 
Neznana pogostnost
Mean (SEM) observed FVC change from baseline (mL) over time, studies INPULSIS-1 and INPULSIS-2 pooled bid = twice daily 
Povprečna (SEM) opažena sprememba FVC od izhodišča (ml) glede na čas, združeni študiji INPULSIS-1 in INPULSIS-2
Diarrhoea and vomiting accompanied by reduced food consumption and loss of body weight were observed in toxicity studies in non-rodents. 
V študijah toksičnosti pri neglodalcih so zasledili drisko in bruhanje, ki sta ju spremljala zmanjšan vnos hrane in izguba telesne mase.
How to store Ofev 
Shranjevanje zdravila Ofev
Body weight 
Telesna masa
th percentile) and decreased by 19% for a 100 kg patient th percentile) relative to a patient with the median weight of 71.5 kg. 
Vrednost AUCτ,ss se je povečala za 25 % pri 50-kilogramskem bolniku (5. percentil) in zmanjšala za 19 % pri 100-kilogramskem (95. percentil) glede na tiste s srednjo telesno maso 71,5 kg.
Ofev 100 mg soft capsules 
Ofev 100 mg mehke kapsule
Do not take more than the recommended dose of two Ofev 100 mg capsules per day. 
Ne vzemite večjega odmerka od priporočenega, to je dveh kapsul po 100 mg zdravila Ofev na dan.
Drug induced liver injury, 
Zapleti s celjenjem rane
Always take this medicine exactly as your doctor or pharmacist has told you. 
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
GERMANY 
NEMČIJA
Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set 
Preglednica 3: Delež odzivnih FVC pri 52. tednih v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki - zdravljeni bolniki
Renal function 
Delovanje ledvic
INPULSIS-1 and INPULSIS-2 pooled 
INPULSIS-1 in INPULSIS-2 združeno
Supportive evidence from the phase II trial (1199.30) Ofev 150 mg twice daily results Additional evidence of efficacy is provided by the randomised, double-blind, placebo-controlled, dose finding phase II trial including a nintedanib 150 mg twice daily dose group. 
Dodatne dokaze o učinkovitosti so pridobili z randomiziranim, dvojno slepim, s placebom nadzorovanim preskušanjem za ugotavljanje odmerka faze II, ki je vključevalo skupino, ki je prejemala nintedanib po 150 mg dvakrat na dan.
Based on the mechanism of action nintedanib may impair wound healing. 
Zaradi mehanizma delovanja lahko nintedanib poslabša celjenje ran.
The contribution of renal excretion to the total clearance was low (0.649% of dose, 26.3% gCV). 
(0,649 % odmerka, 26,3 % gCV).
Nausea and vomiting were frequently reported gastrointestinal adverse reactions (see section 4.8). 
Pogosta neželena učinka prebavil sta bila navzea in bruhanje (glejte poglavje 4.8).
Ofev may have minor influence on your ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ofev ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
All-cause mortality over 52 weeks in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set 
Preglednica 6: Smrtnost zaradi vseh razlogov v 52. tednih v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki - zdravljeni bolniki
6.1 List of excipients 
6.1 Seznam pomožnih snovi
Hepatic impairment 
Bolezni živčevja glavobol
The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). 
Zdravljenje se lahko nadaljuje z zmanjšanim odmerkom (100 mg dvakrat na dan) ali s polnim odmerkom (150 mg dvakrat na dan).
Do not take two capsules together if you have forgotten to take your earlier dose.You should take your next 150 mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist. 
Naslednji 150 mg odmerek zdravila Ofev vzemite ob naslednjem načrtovanem času, ki ga priporoča zdravnik ali farmacevt.
The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev is not recommended (see section 5.2). 
Zdravljenja bolnikov z zmerno (Child Pugh B) in hudo (Child Pugh C) jetrno okvaro z zdravilom Ofev ne priporoča (glejte poglavje 5.2).
Ofev 150 mg soft capsules nintedanib 
Ofev 150 mg mehke kapsule nintedanib
Ofev 100 mg soft capsules nintedanib 
Ofev 100 mg mehke kapsule nintedanib
Each capsule contains 100 mg nintedanib (as esilate). 
Ena kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
Ofev treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). 
Zdravljenje z zdravilom Ofev lahko nadaljujete s polnim odmerkom (150 mg dvakrat na dan) ali z zmanjšanim odmerkom (100 mg dvakrat na dan).
The event was reported to be of severe intensity in 3.3% of nintedanib treated patients. 
Pri 3,3 % bolnikov zdravljenih z nintedanibom so poročali, da je bil dogodek resen.
The likelihood of drug-drug interactions with nintedanib based on CYP metabolism is therefore considered to be low. 
Na podlagi presnove s CYP velja, da je verjetnost medsebojnega delovanja zdravil z nintedanibom majhna.
Nintedanib follows at least bi-phasic disposition kinetics. 
Nintedanib se porazdeli v najmanj dveh fazah.
Each capsule contains 150 mg nintedanib (as esilate). 
Ena kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
Headache 
Driska
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
(glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Odds ratio 
Razmerje tveganja
Reproduction toxicity 
Vpliv na sposobnost razmnoževanja
NAME OF THE MEDICINAL PRODUCT Ofev 100 mg capsules nintedanib 
IME ZDRAVILA Ofev 100 mg kapsule nintedanib
NAME OF THE MEDICINAL PRODUCT Ofev 150 mg capsules nintedanib 
IME ZDRAVILA Ofev 150 mg kapsule nintedanib
Hepatic enzyme increased 
Zvečanje vrednosti jetrnih encimov
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg nintedanib (as esilate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg nintedanib (as esilate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
Ofev 150 mg capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”. 
Zdravilo Ofev 150 mg mehke kapsule so neprozorne in podolgovate želatinske kapsule rjave barve, ki imajo na eni strani črno natisnjeno oznako podjetja Boehringer Ingelheim in številko “150”.
NAME OF THE MEDICINAL PRODUCT Ofev 100 mg soft capsules nintedanib 
IME ZDRAVILA Ofev 100 mg mehke kapsule nintedanib
NAME OF THE MEDICINAL PRODUCT Ofev 150 mg soft capsules nintedanib 
IME ZDRAVILA Ofev 150 mg mehke kapsule nintedanib
One soft capsule contains 100 mg nintedanib (as esilate) Excipient with known effect 
Ena mehka kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
Ofev 100 mg capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”. 
Zdravilo Ofev 100 mg mehke kapsule so neprozorne in podolgovate želatinske kapsule v barvi breskve, ki imajo na eni strani črno natisnjeno oznako podjetja Boehringer Ingelheim in številko “100”.
One soft capsule contains 150 mg nintedanib (as esilate) Excipient with known effect 
Ena mehka kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
Marketing Authorisation Holder 
Imetnik dovoljenja za promet z zdravilom
Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas 
Boehringer Ingelheim RCV GmbH & Co KG Lietuva
Vomiting 
Krvavitev
DATE OF REVISION OF THE TEXT 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Tabulated list of adverse reactions 
Seznam neželenih učinkov
What Ofev contains - The active substance is nintedanib. 
- Učinkovina je nintedanib.
Haemorrhage 
Predrtje prebavil
Common 
Pogosti
Hepatic function 
Delovanje jeter
- The other ingredients are: 
Pogostnosti kategorij so opredeljene po naslednjem dogovoru:
This summary was last updated in 08-2013. 
Povzetek je bil nazadnje posodobljen 08-2013.
It can be used in patients with the following forms of the disease: 
Uporablja se lahko pri bolnikih z naslednjimi oblikami bolezni:
What measures are being taken to ensure the safe and effective use of Pheburane? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pheburane?
The full EPAR for Pheburane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pheburane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Pheburane on 31 July 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Pheburane, veljavno po vsej Evropski uniji, odobrila dne 31. julija 2013.
Regular blood tests are needed to find the correct daily dose. 
Da se določi pravilni dnevni odmerek, so potrebne redne preiskave krvi.
Pheburane is available as granules (483 mg/g). 
Zdravilo Pheburane je na voljo v obliki zrnc (483 mg/g).
• 'early-onset' disease in patients who show a complete lack of one or more of these enzymes within the first month of life; 
• pri zgodnji bolezni pri bolnikih, ki izkazujejo popolno pomanjkanje enega ali več teh encimov v prvem mesecu življenja;
The granules can be sprinkled onto food immediately before being swallowed or placed in the mouth and swallowed immediately with a drink. 
Zrnca se lahko tik pred zaužitjem nasuje na hrano ali da v usta in takoj pogoltne s tekočino.
This means that it is similar to a ‘reference medicine' containing the same active substance, but Pheburane granules are available at a lower strength and contain different excipients (inactive ingredients) to mask the unpleasant taste of the active substance. 
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako zdravilno učinkovino, vendar so zrnca zdravila Pheburane na voljo v nižji jakosti in vsebujejo drugačne pomožne snovi (nedejavne sestavine), da prekrijejo neprijeten okus zdravilne učinkovine.
Patients with urea cycle disorders cannot get rid of ammonia from the body, so it can reach high levels, leading to serious problems including disability, brain damage and death. 
Bolniki z motnjami ciklusa sečnine ne morejo izločiti amonijaka iz telesa, kar pomeni, da lahko ta doseže zelo visoke ravni, ki lahko povzročijo resne težave, vključno z invalidnostjo, poškodbo možganov in smrtjo.
This is a summary of the European public assessment report (EPAR) for Pheburane. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pheburane.
What are the benefits and risks of Pheburane? 
Kakšne so koristi in tveganja, povezani z zdravilom Pheburane?
The Committee recommended that Pheburane be approved for use in the EU. 
Priporočil je, da se zdravilo Pheburane odobri za uporabo v EU.
Because Pheburane is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Pheburane hibridno zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced. 
Tako se ravni dušika v telesu znižajo, količina proizvedenega amonijaka pa se zmanjša.
The daily dose of Pheburane is adjusted for each patient individually and depends on the patient's diet, height and weight. 
Dnevni odmerek zdravila Pheburane je prilagojen za vsakega bolnika posebej in je odvisen od bolnikove prehrane, višine in telesne mase.
Pheburane is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase. 
Zdravilo Pheburane se uporablja pri bolnikih, ki jim primanjkuje enega ali več naslednjih encimov: karbamil-fosfat-sintetaze, ornitintranskarbamilaze ali argininosukcinat-sintetaze.
Pheburane may be a life-long treatment unless the patient has a successful liver transplant. 
Zdravljenje z zdravilom Pheburane je lahko potrebno celo življenje, če bolniku niso uspešno presajena jetra.
• 'late-onset' disease in patients who show a partial lack of one or more of these enzymes after the age of one month and have had high blood ammonia levels that affected the brain's activity. 
• pri bolezni z zakasnelim pojavom pri bolnikih, ki izkazujejo delno pomanjkanje enega ali več teh encimov po prvem mesecu življenja in so imeli visoke ravni amonijaka v krvi, ki so vplivale na delovanje možganov.
It can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders. 
Izdaja zdravila je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami ciklusa sečnine
It is not intended to provide practical advice on how to use Pheburane. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Pheburane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Pheburane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is used to treat patients who have urea cycle disorders. 
Uporablja se za zdravljenje bolnikov z motnjami v ciklusu sečnine.
What is Pheburane and what is it used for? 
Kaj je zdravilo Pheburane in za kaj se uporablja?
The daily dose of Pheburane should be divided into equal amounts and given with each meal. 
Dnevni odmerek zdravila Pheburane je treba razdeliti na enake dele in jih vzeti skupaj z obrokom.
Other information about Pheburane 
Druge informacije o zdravilu Pheburane
Safety information has been included in the summary of product characteristics and the package leaflet for Pheburane, including the appropriate precautions to be followed by healthcare professionals and patients. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Pheburane so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Pheburane is used with a special low-protein diet to reduce the intake of nitrogen. 
Zdravilo Pheburane se uporablja s posebno dieto z malo beljakovinami za zmanjšanje vnosa dušika.
For practical information about using Pheburane, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Pheburane naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Pheburane is a ‘hybrid medicine'. 
Zdravilo Pheburane je „hibridno zdravilo“.
Studies in patients have been limited to tests to determine that Pheburane is bioequivalent to the reference medicine, Ammonaps. 
Študije na bolnikih so bile omejene na preskuse, s katerimi se dokazuje, da je zdravilo biološko enakovredno referenčnemu zdravilu Ammonaps.
In the body, waste nitrogen is in the form of ammonia, which is toxic when it accumulates, especially for the brain. 
Odpadni dušik se v telesu nahaja v obliki amonijaka, ki je, če se kopiči, še zlasti strupen za možgane.
Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys. 
Fenilacetat se veže z aminokislino glutamin, ki vsebuje dušik, in tvori snov, ki jo lahko ledvice izločijo iz telesa.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Pheburane has been shown to have comparable quality and to be bioequivalent to Ammonaps. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da ima zdravilo Pheburane primerljivo raven kakovosti kot zdravilo Ammonaps ter da mu je biološko enakovredno.
Why is Pheburane approved? 
Zakaj je bilo zdravilo Pheburane odobreno?
Eating protein brings nitrogen into the body, which is then transformed into ammonia. 
Z uživanjem beljakovin se v telo vnese dušik, ki se nato pretvori v amonijak.
The reference medicine for Pheburane is Ammonaps. 
Referenčno zdravilo za zdravilo Pheburane je zdravilo Ammonaps.
Therefore, the CHMP's view was that, as for Ammonaps, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Ammonaps, odtehtajo znana tveganja.
Pheburane is a medicine that contains the active substance sodium phenylbutyrate. 
Pheburane je zdravilo, ki vsebuje zdravilno učinkovino natrijev fenilbutirat.
The active substance in Pheburane, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body. 
Zdravilna učinkovina zdravila Pheburane, natrijev fenilbutirat, se v telesu pretvori v snov, imenovano fenilacetat.
These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver. 
Tem bolnikom primanjkuje nekaterih encimov, ki so navadno v jetrih, in zato iz telesa ne morejo izločiti odpadnega dušika.
Pheburane sodium phenylbutyrate 
Povzetek EPAR za javnost natrijev fenilbutirat
How is Pheburane used? 
Kako se zdravilo Pheburane uporablja?
How has Pheburane been studied? 
Kako je bilo zdravilo Pheburane raziskano?
How does Pheburane work? 
Kako zdravilo Pheburane deluje?
Pharmaceutical Form 
Farmacevtska oblika
Immediate Packaging 
Skupno pakiranje:
EU Number 
Številka (EU) dovoljenja za promet
Pack size 
Pot uporabe
CHMP opinion 
Mnenje CHMP
It was considered that this should be reflected in the product information. 
Menili so, da mora biti to izraženo v informacijah o zdravilu.