FrancophonIA/ELRC3.0 huggingface dataset:
English: Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
Slovenian: V študiji, v kateri so primerjali učinkovitost in varnost dodajanja linagliptina v odmerkih po 5 mg ali glimepirida (povprečni odmerek 3 mg) pri bolnikih z nezadostno urejeno glikemijo z monoterapijo z metforminom, je bilo srednje znižanje vrednosti HbA1c -0,16 % pri linagliptinu (s srednjo izhodiščno vrednostjo HbA1c 7,69 %) in -0,36 % pri glimepiridu (s srednjo povprečno vrednostjo 7,69 %) s srednjo razliko zdravljenja 0,20 % (97,5-odstotni interval zaupanja: 0,09, 0,299).
English: How to store Trajenta
Slovenian: Shranjevanje zdravila Trajenta
English: Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
Slovenian: Pomembno je izboljšal tudi raven glukoze v plazmi na tešče v primerjavi s placebom.
English: Your blood sugar levels may increase when you stop taking Trajenta.
Slovenian: Če zdravilo Trajenta prenehate jemati, se vam lahko zviša raven krvnega sladkorja.
English: Therefore, no dosage adjustment of linagliptin is necessary in patients with any degree of renal insufficiency.
Slovenian: Zato bolnikom s katero koli stopnjo ledvične odpovedi odmerka linagliptina ni treba prilagajati.
English: NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets linagliptin
Slovenian: IME ZDRAVILA Trajenta 5 mg tablete linagliptin
English: Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes.
Slovenian: Nekaj bolnikov je imelo med jemanjem zdravila Trajenta, samega ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vnetje trebušne slinavke (pankreatitis; pogostnost redka, pojavi se lahko pri največ 1 od 1.000 bolnikov).
English: Linagliptin provided significant improvements in HbA1c (-0.59 % change compared to placebo after 12 weeks), from a mean baseline HbA1c of 8.2%.
Slovenian: Linagliptin je pomembno izboljšal HbA1c (po 12 tednih -0,59 % sprememba v primerjavi s placebom) v primerjavi s srednjo izhodiščno vrednostjo HbA1c, ki je bila 8,2 %.
English: What Trajenta contains - The active substance is linagliptin
Slovenian: • Učinkovina je linagliptin.
English: Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Slovenian: Odmerka linagliptina ni treba prilagajati na podlagi indeksa telesne mase (ITM), ker ni klinično pomembno vplival na farmakokinetiko linagliptina, kar je pokazala populacijska farmakokinetična analiza podatkov I. in II.
English: Linagliptin provided significant improvements in HbA1c (-0.64 % change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Slovenian: Linagliptin je pomembno izboljšal HbA1c (-0,64 % v primerjavi s placebom po 24 tednih) v primerjavi z njeno srednjo izhodiščno vrednostjo, ki je bila 7,8 %.
English: In the placebo-controlled studies 4.9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Slovenian: Neželeni učinek hipoglikemijo je v s placebom nadzorovanih študijah med zdravljenjem z linagliptinom imelo 4,9 % bolnikov.
English: II data.
Slovenian: faze.
English: Linagliptin provided significant improvements in HbA1c (-0.65% compared to placebo) from a mean baseline HbA1c of 8.3%.
Slovenian: Linagliptin je pomembno izboljšal HbA1c (-0,65 % v primerjavi s placebom), in sicer glede na srednjo izhodiščno vrednost HbA1c 8,3 %.
English: - The other ingredients are
Slovenian: • Pomožne snovi so:
English: If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PERFORATED)
Slovenian: PRETISNI OMOTI (PERFORIRANI)
English: Bullous pemphigoid rare #
Slovenian: občasno bulozni pemfigoid redko
English: Linagliptin provided significant improvements in HbA1c, (-0.57% change compared to placebo), from a mean baseline HbA1c of 8.09%.
Slovenian: Linagliptin je pomembno izboljšal HbA1c (-0,57 % v primerjavi s placebom) glede na njegovo srednjo izhodiščno vrednost 8,09 %.
English: Linagliptin also showed significant improvements in patients fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG), compared to placebo.
Slovenian: Poleg tega je pomembno izboljšal raven glukoze v plazmi na tešče in 2 uri po jedi v primerjavi s placebom.
English: Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Slovenian: Linagliptin je pomembno izboljšal HbA1c (-0,62 % v primerjavi s placebom) glede na njegovo srednjo izhodiščno vrednost 8,14 %.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of linagliptin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg linagliptina.
English: Magnesium stearate
Slovenian: Bulozni pemfigoid
English: Linagliptin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Slovenian: Linagliptin je pomembno izboljšal HbA1c (-0,64 % v primerjavi s placebom) glede na njegovo srednjo izhodiščno vrednost 8 %.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was higher than placebo, due to an increase in asymptomatic hypoglycaemic events.
Slovenian: Pojavnost hipoglikemije je bila zaradi povečanja števila nesimptomatskih hipoglikemičnih dogodkov večja med bolniki, ki so jemali linagliptin, kot med bolniki, ki so jemali placebo.
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450 times human exposure.
Slovenian: Pri opicah vrste Cynomolgus so se pri izpostavljenosti, ki je bila več kot 450-krat večja kot pri človeku, pokazali kot tarčni organi za toksične učinke: jetra, ledvice, želodec, reproduktivni organi, priželjc, vranica in limfni vozli.
English: This summary was last updated in 01-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 01-2019.
English: What measures are being taken to ensure the safe and effective use of Ravicti?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ravicti?
English: The European Medicines Agency decided that the benefits of Ravicti are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Ravicti večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The company that markets Ravicti will set up a registry of patients to obtain further information on the long-term benefits and safety of the medicine.
Slovenian: Družba, ki trži zdravilo Ravicti, bo vzpostavila register bolnikov za pridobivanje dodatnih informacij o dolgoročnih koristih in varnosti zdravila.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila: ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
English: Regular blood tests are needed to adjust the dose.
Slovenian: Za prilagoditev odmerka so potrebne redne krvne preiskave.
English: Since proteins are a source of nitrogen, Ravicti must be used together with a special low-protein diet, and sometimes with dietary supplements (depending on the daily protein intake needed for growth and development).
Slovenian: Ker so beljakovine vir dušika, je treba zdravilo Ravicti uporabljati skupaj s posebno dieto z nizko vsebnostjo beljakovin in včasih s prehranskimi dopolnili (odvisno od dnevnega vnosa beljakovin, potrebnih za rast in razvoj).
English: The main measure of effectiveness was the change in the blood level of ammonia after 4 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni amoniaka v krvi po štirih tednih zdravljenja.
English: Data from additional studies showed a similar effect in children treated with Ravicti from birth.
Slovenian: Podatki iz podobnih študij so pokazali podoben učinek pri otrocih, ki so bili z zdravilom Ravicti zdravljeni od rojstva.
English: However, further data on the long-term safety of Ravicti are awaited.
Slovenian: Vendar pa se nadaljnji podatki o dolgoročni varnosti zdravila Ravicti še pričakujejo.
English: Other information about Ravicti
Slovenian: Druge informacije o zdravilu Ravicti
English: What is Ravicti and what is it used for?
Slovenian: Kaj je zdravilo Ravicti in za kaj se uporablja?
English: The total daily dose of Ravicti should be divided into equal amounts and given with each meal.
Slovenian: Skupni dnevni odmerek zdravila Ravicti je treba razdeliti na enake količine in jih zaužiti ob vsakem obroku.
English: Why is Ravicti authorised in the EU?
Slovenian: Zakaj je zdravilo Ravicti odobreno v EU?
English: Patients with urea cycle disorders are not able to get rid of waste nitrogen from the body because they lack some liver enzymes.
Slovenian: Bolniki z motnjami cikla sečnine ne morejo odvajati odpadnega dušika iz telesa, ker jim primanjkuje nekaterih jetrnih encimov.
English: Ravicti is available as a liquid (1.1 g/ml) to be taken by mouth, or given through a tube that goes from the nose to the stomach or through the belly into the stomach.
Slovenian: Zdravilo Ravicti je na voljo kot tekočina (1,1 g/ml), ki se jemlje peroralno ali se jo dovaja po cevki, ki poteka skozi nos do želodca oziroma skozi trebuh v želodec.
English: An overview of Ravicti and why it is authorised in the EU
Slovenian: Pregled zdravila Ravicti in zakaj je odobreno v EU
English: Additionally, the Agency considered that since Ravicti is available as a liquid this could make the medicine more palatable especially for children, compared with other medicines available as granules to be added to food; the liquid formulation also facilitates giving it through a tube to patients unable to swallow.
Slovenian: Agencija je poleg tega menila, da bi bilo lahko zdravilo Ravicti, ker je na voljo v obliki tekočine, bolj všečno predvsem otrokom, v primerjavi z drugimi razpoložljivimi zdravili, ki so na voljo v obliki zrnc, ki se dodajajo živilom; tekoča formulacija pa omogoča tudi dajanje prek cevke bolnikom, ki ne morejo požirati.
English: As for all medicines, data on the use of Ravicti are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ravicti stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ravicti have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ravicti upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Side effects reported with Ravicti are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ravicti, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Ravicti, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ravicti glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Ravicti (glycerol phenylbutyrate)
Slovenian: Ravicti (glicerol fenilbutirat)
English: Ravicti is used in patients who lack one or more of the following enzymes: carbamoyl phosphate synthase-I, ornithine carbamoyltransferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I and ornithine translocase.
Slovenian: Zdravilo Ravicti se uporablja pri bolnikih, ki jim manjka eden ali več naslednjih encimov: karbamoilfosfat sintetaza-I, ornitin karbamoiltransferaza, argininosukcinat sintetaza, argininosukcinat liaza, arginaza I in ornitin translokaza.
English: The study showed that Ravicti was at least as effective as the comparator in controlling the blood level of ammonia: the estimated average ammonia level was about 870 micromoles per litre in patients treated with Ravicti, compared with about 980 micromoles per litre in patients treated with sodium phenylbutyrate.
Slovenian: Študija je pokazala, da je zdravilo Ravicti pri uravnavanju ravni amoniaka v krvi vsaj tako učinkovito kot primerjalno zdravilo: povprečna raven amoniaka je bila ocenjena na približno 870 mikromolov na liter pri bolnikih, ki so se zdravili z zdravilom Ravicti, v primerjavi s približno 980 mikromoli na liter pri bolnikih, ki so se zdravili z natrijevim fenilbutiratom.
English: The most common side effects with Ravicti (which may affect more than 1 in 20 people) are diarrhoea, flatulence (passing gas), headache, decreased appetite, vomiting, tiredness, feeling sick and abnormal skin smell.
Slovenian: Najpogostejši neželeni učinki zdravila Ravicti (ki se lahko pojavijo pri več kot 1 od 20 oseb) so driska, flatulenca (vetrovi), glavobol, zmanjšan apetit, bruhanje, utrujenost, slabost in nenormalen vonj kože.
English: What benefits of Ravicti have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ravicti izkazalo v študijah?
English: What are the risks associated with Ravicti?
Slovenian: Kakšna tveganja so povezana z zdravilom Ravicti?
English: The side effects of Ravicti affect mainly the gut and are considered manageable.
Slovenian: Neželeni učinki zdravila Ravicti vplivajo predvsem na črevesje in veljajo za obvladljive.
English: It can only be obtained with a prescription and should be prescribed by a doctor who has experience in treating patients with urea cycle disorders.
Slovenian: Izdaja zdravila je le na recept, predpiše pa ga lahko le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami cikla sečnine.
English: Ravicti is a medicine used to manage urea cycle disorders in adults and children, when the diseases cannot be managed by changes in diet alone.
Slovenian: Ravicti je zdravilo, ki se uporablja za obvladovanje motenj cikla sečnine pri odraslih in otrocih, kadar bolezni ni mogoče obvladovati samo s spreminjanjem prehrane.
English: Urea cycle disorders are rare, and Ravicti was designated an ‘orphan medicine' (a medicine used in rare diseases) for several forms of the disease on 10 June 2010.
Slovenian: Motnje cikla sečnine so redke, zato je bilo zdravilo Ravicti 10. junija 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za več oblik bolezni.
English: For this same reason Ravicti must not be used to treat acute hyperammonaemia as more rapidly acting treatments are needed in these cases.
Slovenian: Zdravilo Ravicti se zato ne sme uporabljati za zdravljenje akutne hiperamoniemije, saj so v teh primerih potrebna hitrejša zdravljenja.
English: Ravicti must not be used to treat acute hyperammonaemia (sudden rise of blood ammonia levels).
Slovenian: Zdravilo Ravicti se ne sme uporabljati za zdravljenje akutne hiperamoniemije (nenadnega zvišanja ravni amoniaka v krvi).
English: In the body, waste nitrogen is turned into ammonia, which is harmful when it accumulates.
Slovenian: V telesu se odpadni dušik spremeni v amoniak, ki je ob nakopičenju škodljiv.
English: The dose of Ravicti depends on the patient's diet, height and weight.
Slovenian: Odmerek zdravila Ravicti je odvisen od bolnikove prehrane, telesne višine in mase.
English: This removal of proteins decreases the levels of nitrogen in the body, reducing the amount of ammonia produced.
Slovenian: Z odstranitvijo beljakovin se zmanjša količina dušika v telesu, s tem pa se zmanjša količina proizvedenega amoniaka.
English: Ravicti is effective in reducing the blood level of ammonia in patients with urea cycle disorders.
Slovenian: Zdravilo Ravicti je učinkovito pri zniževanju ravni amoniaka v krvi pri bolnikih z motnjami cikla sečnine.
English: Phenylacetate attaches to the amino acid glutamine found in proteins to form a substance that the kidneys can remove from the body.
Slovenian: Fenilacetat se veže na aminokislino glutamin, prisotno v beljakovinah, in tvori snov, ki jo lahko ledvice odstranijo iz telesa.
English: For the full list of side effects and restrictions with Ravicti, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ravicti glejte navodilo za uporabo.
English: Ravicti received a marketing authorisation valid throughout the EU on 27 November 2015 Further information on Ravicti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ravicti
Slovenian: Nadaljnje informacije za zdravilo Ravicti so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ravicti
English: How is Ravicti used?
Slovenian: Kako se zdravilo Ravicti uporablja?
English: Ravicti may be a life-long treatment unless the patient has a successful liver transplant.
Slovenian: Bolnik se mora zdraviti z zdravilom Ravicti celo življenje, razen v primeru uspešne presaditve jeter.
English: How does Ravicti work?
Slovenian: Kako zdravilo Ravicti deluje?
English: Ravicti has been compared with sodium phenylbutyrate (another medicine used to treat urea cycle disorders) in a study involving 88 adults with urea cycle disorders.
Slovenian: Zdravilo Ravicti so v študiji, v kateri je sodelovalo 88 odraslih z motnjami cikla sečnine, primerjali z natrijevim fenilbutiratom (drugim zdravilom, ki se uporablja za zdravljenje motenj cikla sečnine).
English: The active substance in Ravicti, glycerol phenylbutyrate, is converted to phenylacetate in the body.
Slovenian: Učinkovina zdravila Ravicti, glicerol fenilbutirat, se v telesu pretvori v snov, imenovano fenilacetat.
English: Ravicti contains the active substance glycerol phenylbutyrate.
Slovenian: Zdravilo Ravicti vsebuje učinkovino glicerol fenilbutirat.
English: Ravicti is a sustained-release medicine, meaning the active substance is released throughout the day.
Slovenian: Zdravilo Ravicti je zdravilo s podaljšanim sproščanjem, kar pomeni, da se učinkovina sprošča čez cel dan. Zaradi tega je nadzor nad ravnijo amoniaka v krvi skozi cel dan boljši.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orphacol on 12 September 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Orphacol, veljavno po vsej Evropski uniji, odobrila 12. septembra 2013.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove podatke in ustrezno posodobila ta povzetek.
English: This is a summary of the European public assessment report (EPAR) for Orphacol.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Orphacol.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Orphacol.
Slovenian: Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti popolnih informacij o njem.
English: It must not be taken by patients already taking phenobarbital, a medicine used to treat epilepsy.
Slovenian: Ne sme se uporabljati pri bolnikih, ki že jemljejo fenobarbital, zdravilo za zdravljenje epilepsije.
English: Orphacol has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Orphacol je pridobilo dovoljenje za promet v „izjemnih okoliščinah‟.
English: What measures are being taken to ensure the safe and effective use of Orphacol?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Orphacol?
English: Orphacol is available as capsules and should be taken every day at approximately the same time, with a meal.
Slovenian: Zdravilo Orphacol je na voljo v obliki kapsul in ga je treba jemati vsak dan z obrokom ob približno istem času.
English: Because cholic acid is a well-known substance, and its use in these enzyme deficiencies is well established, the applicant presented data from the scientific literature.
Slovenian: Ker je holna kislina dobro znana snov in je njena uporaba pri pomanjkanju tega encima dobro uveljavljena, je predlagatelj predstavil podatke iz znanstvene literature.
English: The daily dose is between 5 and 15 mg per kg body weight, adjusted for each patient according to the state of their bile acid, with a minimum daily dose of 50 mg and a maximum of
Slovenian: Dnevni odmerek je med 5 in 15 mg na kg telesne mase, ki se pri posameznem bolniku prilagodi glede na stanje žolčne kisline, pri čemer je najmanjši dnevni odmerek 50 mg, največji pa 500 mg.
English: It is used to treat adults and children from one month of age who have a genetic abnormality that makes them unable to produce bile.
Slovenian: Uporablja se za zdravljenje odraslih in otrok, starejših od enega meseca, z genetsko okvaro, zaradi katere niso zmožni tvoriti žolča.
English: A risk management plan has been developed to ensure that Orphacol is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Orphacol je bil pripravljen načrt obvladovanja tveganj.
English: Treatment should be stopped if liver function does not improve within three months.
Slovenian: Če se delovanje jeter ne izboljša v treh mesecih, je treba zdravljenje prekiniti.
English: It decided that based on the evidence from the scientific literature Orphacol's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Na podlagi dokazov iz znanstvene literature je zaključil, da so koristi zdravila Orphacol večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Orphacol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Orphacol cholic acid
Slovenian: Orphacol holna kislina
English: Other information about Orphacol
Slovenian: Druge informacije o zdravilu Orphacol
English: The Committee for Medicinal Products for Human Use (CHMP) noted that the use of cholic acid to treat inborn errors in primary bile acid synthesis was well established in medical practice and documented in the scientific literature, although the number of documented cases was low due to the rarity of the condition.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je upošteval, da je uporaba holne kisline za zdravljenje dednih napak v sintezi primarnih žolčnih kislin dobro uveljavljena v zdravstveni praksi in dokumentirana v znanstveni literaturi, čeprav je število dokumentiranih primerov majhno zaradi redkosti bolezni.
English: 500 mg. For small children who cannot swallow capsules, the contents can be mixed in with infant formula or juice.
Slovenian: Pri majhnih otrocih, ki ne morejo požirati kapsul, se lahko vsebina zmeša z začetno formulo za dojenčke ali sokom.
English: Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Orphacol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Slovenian: Ker je bolnikov z dednimi napakami v sintezi primarnih žolčnih kislin malo, velja ta bolezen za redko, zato je bilo zdravilo Orphacol 18. decembra 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).