natgillin/translations-raw huggingface dataset:
During the initiation of therapy and dose adjustment, serum and/or urine bile acid levels should be monitored intensively (at least every three months during the first year of treatment, every six months during the second year) using suitable analytical techniques. 
U početnoj fazi terapije i fazi prilagođavanja terapije razine žučne kiseline u serumu i/ili urinu moraju se intenzivno pratiti (najmanje svaka tri mjeseca tijekom prve godine liječenja te svakih šest mjeseci tijekom druge godine).
Concurrent elevation of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose. 
Istodobno povišene vrijednosti serumske gama glutamiltransferaze (GGT), alanin aminotransferaze (ALT) i/ili žučnih kiselina u serumu iznad normalnih razina može biti indikacija predoziranja.
There is no need for contraceptive measures in women of childbearing potential treated with cholic acid or their partners. 
Ne postoji potreba za mjerama kontracepcije u žena reproduktivne dobi, a koje su liječene kolatnom kiselinom, ili u njihovih partnera.
A small fraction of bile acids is excreted in urine. 
Mali dio žučnih kiselina izlučuje se u urinu.
If you stop taking Orphacol 
Ako prestanete uzimati Orphacol
There is a theoretical possibility that administration with food may increase cholic acid bioavailability and improve tolerability. 
Postoji teorijska mogućnost da primjena lijeka s hranom može povećati bioraspoloživost kolatne kiseline te poboljšati toleranciju.
Parenteral administration may cause haemolysis and cardiac arrest. 
Parenteralna primjena može uzrokovati hemolizu i srčani zastoj.
The cholic acid contained in Orphacol replaces the bile acids that are missing due to the defect in bile acid production. 
Kolna kiselina sadržana u lijeku Orphacol zamjenjuje žučne kiseline koje nedostaju zbog poremećaja u stvaranju žučne kiseline.
After the initiation period, serum and/or urine bile acids (using suitable analytical techniques) and liver parameters should be determined annually, at a minimum, and the dose adjusted accordingly. 
Po završetku početnog vremenskog razdoblja parametri žučnih kiselina u serumu i/ili urinu (pomoću odgovarajućih analitičkih metoda) i jetreni parametri trebaju se određivati najmanje jednom godišnje, te se doze moraju primjereno uskladiti.
Do not use Orphacol after the expiry date which is stated on the carton and blister after EXP. 
Orphacol se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“.
No data on the effects of cholic acid on fertility are available. 
Nisu dostupni podaci o utjecaju kolatne kiseline na plodnost.
Cholic acid and its metabolites are excreted in human milk, but at therapeutic doses of Orphacol, no effects on the breastfed newborns/infants are anticipated. 
Kolatna kiselina i njezini metaboliti se izlučuju u majčino mlijeko, ali se pri terapijskoj dozi lijeka Orphacol ne očekuju učinci na dojenu novorođenčad/dojenčad.
Administration of these medicinal products is expected to reduce the effect of cholic acid. 
Primjena ovih lijekova može smanjiti djelovanje kolatne kiseline.
Administration with food may increase cholic acid bioavailability and improve tolerability. 
Uzimanje lijeka s hranom može povećati bioraspoloživost i poboljšati toleranciju.
Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxide) bind bile acids and lead to their elimination. 
Sekvestranti žučne kiseline (kolestiramin, kolestipol, kolesevelam) i određeni antacidi (primjerice aluminijev hidroksid) vežu žučne kiseline i uzrokuju njihovu eliminaciju iz tijela.
Progress and results from the database will form the basis of the annual reassessments of the benefit/risk profile of Orphacol. 
Napredak i rezultati baze podataka tvore osnovu za godišnju ponovnu ocjenu omjera koristi i rizika lijeka Orphacol.
If you forget to take Orphacol 
Ako zaboravite uzeti Orphacol
The following table lists adverse reactions reported in the literature under treatment with cholic acid. 
Sljedeća tablica navodi nuspojave prijavljene u literaturi za liječenje kolatnom kiselinom.
What you need to know before you take Orphacol Do not take Orphacol 
Što morate znati prije nego počnete uzimati Orphacol
Regular and fixed times of administration support the patient's or caregiver's compliance. 
Redovita i utvrđena vremena za uzimanje lijeka potiču suradljivost bolesnika i pružatelja skrbi.
The intravenous LD50 of cholic acid in mice is 350 mg/kg body weight. 
Intravenozni LD50 kolatne kiseline u miševa iznosi 350 mg/kg tjelesne mase.
Liver parameters should also be monitored, preferentially more frequently than serum and/or urine bile acid levels. 
Potrebno je pratiti i parametre jetre, i to po mogućnosti češće od razina žučne kiseline u serumu i/ili urinu.
SPECIFIC OBLIGATIONS TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
Patients with hepatic impairment should be monitored closely. 
Bolesnici s oštećenjem funkcije jetre trebaju se pažljivo pratiti.
- The active substance is cholic acid. 
- Djelatna tvar je kolatna kiselina.
More than 90% of the primary and secondary bile acids are reabsorbed in the ileum by a specific active transporter and are recycled to the liver by the portal vein; the remainder is excreted in the faeces. 
Specifični aktivni prijenosnici ponovno apsorbiraju više od 90 % primarnih i sekundarnih žučnih kiselina u ileumu koje se vraćaju portalnom venom u jetru.
The cholic acid dose for patients with familial hypertriglyceridemia will have to be established and adjusted as described, but an elevated dose, notably higher than the 500 mg daily limit for adult patients, may be required and safe. 
Doza kolatne kiseline za bolesnike s obiteljskom hipertrigliceridemijom treba se utvrditi i prilagoditi kako je opisano, no povećana doza, odnosno doza veća od 500 mg, što predstavlja dnevno ograničenje za odrasle bolesnike, može biti potrebna i sigurna.
A concomitant decrease of urine total bile acids should be observed. 
Treba biti zabilježeno istodobno smanjivanje ukupnih žučnih kiselina u urinu.
Deoxycholic acid is a secondary bile acid. 
Deoksikolna kiselina jest sekundarna žučna kiselina.
Cholic acid, a primary bile acid, is partially absorbed in the ileum. 
Kolna kiselina, primarna žučna kiselina, djelomično se apsorbira u ileumu.
Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as its pharmacodynamics by inhibition of cholesterol 7α-hydroxylase. 
Ciklosporin mijenja farmakokinetiku kolatne kiseline tako što inhibira jetreni unos i hepatobilijarnu sekreciju žučnih kiselina, kao i farmakodinamiku kolatne kiseline tako što inhibira kolesterol 7α-hidroksilazu.
The rational basis for treatment consists of restoration of the bile aciddependent component of bile flow enabling restoration of biliary secretion and biliary elimination of toxic metabolites; inhibition of the production of the toxic bile acid metabolites by negative feedback on cholesterol 7α-hydroxylase, which is the rate-limiting enzyme in bile acid synthesis; and improvement of the patient's nutritional status by correcting intestinal malabsorption of fats and fat-soluble vitamins. 
Racionalna osnova za liječenje sastoji se od obnavljanja komponente protoka žuči ovisne o žučnoj kiselini čime se omogućuje obnova žučne sekrecije i bilijarne eliminacije toksičnih metabolita, inhibicija nastanka toksičnih metabolita žučne kiseline negativnom povratnom spregom na kolesterol 7α-hidroksilazu, enzim koji ograničava brzinu sinteze žučne kiseline i poboljšanje nutritivnog statusa bolesnika ispravljanjem intestinalne malapsorpcije masti i vitamina topivih u mastima.
The development of pruritus and/or diarrhoea has been observed during treatment with Orphacol. 
Uočen je razvoj svrbeža i/ili proljeva tijekom liječenja lijekom Orphacol.
Patients are expected to present with some degree of hepatic impairment at diagnosis, which improves under cholic acid therapy. 
Očekuje se da bolesnici imaju određeni stupanj oštećenja funkcije jetre prilikom postavljanja dijagnoze, što se poboljšava promjenom terapije kolatnom kiselinom.
There is a limited amount of data (less than 20 pregnancy outcomes) from the use of cholic acid in pregnant women. 
Podaci o primjeni kolatne kiseline u trudnica su ograničeni (manje od 20 slučajeva trudnoća).
Patients presenting with pruritus and/or persistent diarrhoea should be investigated for a potential overdose by a serum and/or urine bile acid assay (see section 4.9). 
U bolesnika sa svrbežom i/ili perzistirajućim proljevom treba provjeriti potencijalno predoziranje pomoću testa za žučne kiseline u serumu i/ili urinu (vidjeti dio 4.9.).
If administration of ciclosporin is considered necessary, serum and urine bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly. 
Ako se primjena ciklosporina smatra potrebnom, razine žučne kiseline u serumu i/ili urinu moraju se pozorno pratiti te se doza kolatne kiseline treba prilagoditi prema potrebi.
Orphacol contains lactose 
Orphacol sadrži laktoze
Both inborn diseases are extremely rare, with a prevalence in Europe of about 3 to 5 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency per 10 million inhabitants, and an estimated ten-fold lower prevalence for Δ4-3-Oxosteroid-5β-reductase deficiency. 
Obje prirođene bolesti iznimno su rijetke s prevalencijom u Europi od otprilike 3 do 5 bolesnika s deficijencijom 3β-hidroksiΔ5-C27-steroid oksidoreduktaze na 10 milijuna stanovnika i procijenjenom deseterostruko manjom prevalencijom deficijencije Δ4-3-oksosteroid-5β-reduktaze.
The usual starting dose is 5 to 15 mg per kilogram body weight every day in infants, children, adolescents and adults. 
Uobičajena početna doza iznosi 5 do 15 mg po kilogramu tjelesne težine svaki dan u dojenčadi, djece, adolescenata i odraslih osoba.
Detailed medium- to long-term data are available for 5 of these patients, of whom 1 has been treated with cholic acid monotherapy. 
Detaljni srednjoročni i dugoročni podaci dostupni su za 5 od navedenih 7 bolesnika, od kojih je 1
The dose of cholic acid in such patients should be established and adjusted as described, but an elevated dose, notably higher than the 500 mg daily limit for adult patients, may be required. 
Doza kolatne kiseline u takvih bolesnika treba se utvrditi i prilagoditi kako je opisano, no povećana doza, odnosno doza veća od 500 mg, što predstavlja dnevno ograničenje za odrasle bolesnike, može biti potrebna.
Δ4-3-Oxosteroid-5β-reductase deficiency 
Δ4-3-oksosteroid-5β-reduktaze.
At therapeutic doses, no effect on fertility is anticipated. 
Ne očekuju se učinci na plodnost pri terapijskoj dozi lijeka.
The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency and to inform on expected and potential risks associated with the treatment. 
U dogovoru s nadležnim tijelima u državama članicama, nositelj odobrenja za stavljanje lijeka u promet treba prije stavljanja lijeka na tržište provesti edukacijski program za liječnike sa ciljem osiguravanja edukacijskih materijala o ispravnom postavljanju dijagnoze i terapijskom upravljanju za liječenje prirođenih pogrešaka u primarnoj sintezi žučne kiseline zbog deficijencije 3β-hidroksi-Δ5-C27-steroid oksidoreduktaze ili deficijencije Δ4-3-oksosteroid-5β-reduktaze te treba izvijestiti o očekivanim i mogućim rizicima povezanim s liječenjem.
In the absence of treatment, unphysiologic cholestatic and hepatotoxic bile acid metabolites are predominant in the liver, serum and urine. 
U slučaju izostanka liječenja, u jetri, serumu i urinu prevladavaju nefiziološki kolestatični i hepatotoksični metaboliti žučne kiseline.
These reactions abated after dose reduction and are suggestive of overdose. 
Ove nuspojave se povlače nakon smanjivanja doze i upućuju na predoziranje.
How to take Orphacol 
Kako uzimati Orphacol
3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency The daily dose ranges from 5 to 15 mg/kg in infants, children, adolescents and adults. 
Deficijencija 3β-hidroksi-Δ5-C27-steroid oksidoreduktaze Raspon dnevne doze kreće se od 5 do 15 mg/kg u dojenčadi, djece, adolescenata i odraslih osoba.
Lactose monohydrate, Colloidal anhydrous silica, Magnesium stearate. 
Sadržaj kapsule: laktoza hidrat, silicijev dioksid, koloidni, bezvodni magnezijev stearat.
MedDRA System Organ Class 
Klasifikacija organskih sustava MedDRA Nuspojava
For infants and children who cannot swallow capsules, the capsules may be opened and the content added to infant formula or juice. 
Za dojenčad i djecu koja ne mogu progutati kapsule, kapsule se mogu otvoriti te se sadržaj može dodati u pripravke za dojenčad ili sok.
The objectives of this surveillance programme is to monitor accumulating data on efficacy and safety in the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency with Orphacol in infants, children, adolescents and adults. 
Cilj ovog programa nadziranja jest praćenje akumulirajućih podataka o djelotvornosti i sigurnosti u liječenju prirođenih grešaka u primarnoj sintezi žučne kiseline zbog deficijencije 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ili deficijencije Δ4-3-oksosteroid-5β-reduktaze lijekom Orphacol u dojenčadi, djece, adolescenata i odraslih osoba.
Transaminases increased Gallstones 
Povećane razine transaminaza
Cholic acid therapy has been used for infants from one month of age, and for children and adolescents. 
Terapija kolatnom kiselinom primjenjuje se u dojenčadi u dobi od jednog mjeseca te u djece i adolescenata.
The daily dose ranges from 5 to 15 mg/kg in infants, children, adolescents and adults. 
Raspon dnevne doze kreće se od 5 do 15 mg/kg u dojenčadi, djece, adolescenata i odraslih osoba.
Clinical experience has been reported in the literature from small cohorts of patients and single case reports; absolute patient numbers are small due to the rarity of the conditions. 
U literaturi je prijavljeno kliničko iskustvo s malim kohortama bolesnika i izvještaji pojedinačnih slučajeva.
Certain medical conditions are caused by defects in bile acid production and Orphacol is used to treat infants from one month to 2 years of age, children, adolescents and adults with these medical conditions. 
Orphacol se koristi za liječenje dojenčadi u dobi od jednog mjeseca starosti do 2 godine, djece, adolescenata i odraslih osoba s ovim medicinskim stanjima.
The clinical experience reported in the literature is from a patient population with inborn deficiency of 3β-Hydroxy-Δ5-C27-steroid oxidoreductase or Δ4-3-Oxosteroid-5β-reductase that includes principally infants from the age of one month, children and adolescents. 
Kliničko iskustvo prijavljeno u literaturi prikupljeno je iz populacije bolesnika s prirođenim deficijencijom 3β-hidroksi-Δ5-C27-steroid oksidoreduktaze ili Δ4-3-oksosteroid-5β-reduktaze, koja obuhvaća uglavnom dojenčad u dobi od jednog mjeseca, djecu i adolescente.
PACKAGE LEAFLET: INFORMATION FOR THE USER Orphacol 50 mg hard capsules Orphacol 250 mg hard capsules 
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA Orphacol 50 mg tvrde kapsule Orphacol 250 mg tvrde kapsule kolatna kiselina
For babies and children who cannot swallow capsules, the capsule can be opened and its contents added to baby formula or apple/orange or apple/apricot juice adapted for small children. 
Za dojenčad i djecu koja ne mogu progutati kapsule, kapsule se mogu otvoriti, a sadržaj se može dodati u pripravak za dojenčad ili u sok od jabuke/naranče ili jabuke/marelice, koji su prilagođeni maloj djeci.
Ciclosporin (a medicine used to suppress the immune system) may also change the effect of Orphacol. 
Ciklosporin (lijek koji se koristi za supresiju imunološkog sustava)
The remaining part is transformed by reduction of the 7α-hydroxy group to deoxycholic acid (3α, 12α-dihydroxy) by intestinal bacteria. 
Intestinalne bakterije pretvaraju preostali dio redukcijom 7α-hidroksi grupe u deoksikolnu kiselinu (3α, 12α-dihidroksi).
How to store Orphacol 
Kako čuvati Orphacol
Orphacol 250 mg: Each hard capsule contains 250 mg of cholic acid. 
Orphacol 250 mg: jedna tvrda kapsula sadrži 250 mg kolatne kiseline.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. 
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu . Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i njihovom liječenju.
3β, 7α, 12α-trihydroxy-5-cholenoic acids) or in Δ4-3-Oxosteroid-5β-reductase deficiency (3-oxo-7α-hydroxy- and 3-oxo-7α, 12α-dihydroxy-4-cholenoic acids) should be determined. 
steroid oksidoreduktaze (3β, 7α-dihidroksi- i 3β, 7α, 12α-trihidroksi-5-kolanske kiseline) ili u deficijenciji Δ4-3-oksosteroid-5β-reduktaze (3-okso-7α-hidroksi- i 3-okso-7α, 12α-dihidroksi-4-kolanske kiseline).
Cholic acid has no or negligible influence on the ability to drive and use machines. 
Kolatna kiselina nema utjecaj na sposobnost upravljanja vozilima i rada sa strojevima ili je taj utjecaj zanemariv.
Orphacol 250 mg: gelatin, titanium dioxide (E171), carmine blue (E132), yellow iron oxide (E172). 
Orphacol 50 mg: želatina, titanijev dioksid (E171), carmine blue (E132); Orphacol 250 mg: želatina, titanijev dioksid (E171), carmine blue (E132), žuti željezov oksid (E172).
Orphacol 50 mg: Each hard capsule contains 50 mg of cholic acid. 
Orphacol 50 mg: jedna tvrda kapsula sadrži 50 mg kolatne kiseline.
EU/1/13/870/004 [30 hard capsules] EU/1/13/870/005 [60 hard capsules] EU/1/13/870/006 [120 hard capsules] 
EU/1/13/870/004 [30 tvrdih kapsula] EU/1/13/870/005 [60 tvrdih kapsula] EU/1/13/870/006 [120 tvrdih kapsula]
EU/1/13/870/001 [30 hard capsules] EU/1/13/870/002 [60 hard capsules] EU/1/13/870/003 [120 hard capsules] 
EU/1/13/870/001 [30 tvrdih kapsula] EU/1/13/870/002 [60 tvrdih kapsula] EU/1/13/870/003 [120 tvrdih kapsula]
Gelatin (bovine origin), Titanium dioxide (E171), Carmine blue (E132). 
titanijev dioksid (E171), carmine blue (E132).
Limited data are available for patients with minor to severe hepatic impairment related to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency. 
Dostupni su ograničeni podaci u bolesnika s manjim do teškim oštećenjem jetre povezanim s pomanjkanjem 3β-hidroksi-Δ5-C27-steroid oksidoreduktaze ili pomanjkanjem
Gelatin (bovine origin), Titanium dioxide (E171), Carmine blue (E132), Yellow Iron Oxide (E172). 
titanijev dioksid (E171), carmine blue (E132). željezov oksid, žuti (E172).
Overall, cholic acid treatment results for about 60 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency are reported in the literature. 
Sveukupno su u literaturi prijavljeni rezultati liječenja kolatnom kiselinom za otprilike 60 bolesnika s pomanjkanjem 3β-hidroksi-Δ5-C27
Some medicines used to lower cholesterol levels, so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines to treat heartburn that contain aluminium may lessen the effect of Orphacol. 
(kolestiramin, kolestipol, kolesevelam), i lijekovi protiv žgaravice koji sadrže aluminij, mogu umanjiti djelovanje lijeka Orphacol.
Cholic acid treatment results for seven patients with Δ4-3-Oxosteroid-5β-reductase deficiency for up to 14 years are reported in the literature. 
U literaturi su prijavljeni rezultati liječenja kolatnom kiselinom do 14 godina za sedam bolesnika s pomanjkanjem Δ4-3-oksosteroid-5β-reduktaze.
Each hard capsule contains 250 mg of cholic acid. 
Jedna tvrda kapsula sadrži 250 mg kolatne kiseline.
Marketing Authorisation Holder Laboratoires CTRS 63, rue de l'Est 
63, rue de l'Est
Orphacol 50 mg hard capsules 
Orphacol 50 mg tvrde kapsule
Orphacol 250 mg hard capsules 
Orphacol 250 mg tvrde kapsule
Each hard capsule contains 50 mg of cholic acid. 
Jedna tvrda kapsula sadrži 50 mg kolatne kiseline.
Patients with newly diagnosed or a family history of familial hypertriglyceridemia are expected to poorly absorb cholic acid in the intestine. 
Očekuje se slaba apsorpcija kolatne kiseline u crijevima u bolesnika s novodijagnosticiranom ili s anamnezom obiteljske hipertrigliceridemije.
The concentrations of the abnormal bile acid metabolites synthesised in 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency (3β, 7α-dihydroxy- and 
Potrebno je utvrditi koncentracije abnormalnih metabolita žučne kiseline sintetiziranih u deficijenciji 3β-hidroksi-Δ5-C27
For infants and children who cannot swallow capsules, the capsules may be opened and the content added to infant formula or infant-adapted apple/orange or apple/apricot juice. 
Vidjeti također dio 4.2. Za dojenčad i djecu koja ne mogu progutati kapsule, kapsule se mogu otvoriti te se sadržaj može dodati u formulu za dojenčad ili sok od jabuke/naranče ili sok od jabuke/marelice koji su prilagođeni dojenčadi.
Orphacol 250 mg capsules Cholic acid 
Orphacol 250 mg kapsule kolatna kiselina
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Orphacol. 
Ako Vam je liječnik rekao da ne podnosite neke šećere,
Orphacol 50 mg capsules Cholic acid 
Orphacol 50 mg kapsule kolatna kiselina
No experience exists in patients with hepatic impairment from causes other than 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency and no dose recommendation can be given. 
Nema iskustva u liječenju bolesnika s oštećenjem funkcije jetre koje je uzrokovano drugim uzrocima, a ne pomanjkanjem 3β-hidroksi-Δ5-C27-steroid-oksidoreduktaze ili pomanjkanjem
Hepatic impairment 
Poremećaji probavnog sustava
Orphacol 250 mg hard capsules Cholic acid 
Orphacol 250 mg tvrde kapsule kolatna kiselina
Orphacol 50 mg hard capsules Cholic acid 
Orphacol 50 mg tvrde kapsule kolatna kiselina
Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults. 
3β-hidroksi-Δ5-C27-steroid oksidoreduktaze ili deficijencije Δ4-3-oksosteroid-5β-reduktaze u dojenčadi, djece i adolescenata u dobi od 1 mjeseca do 18 godina te odraslih osoba.
Use of phenobarbital in patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency treated with cholic acid is contraindicated (see section 4.3). 
Δ4-3-oksosteroid-5β-reduktaze liječenih kolatnom kiselinom (vidjeti dio 4.3.).
: + 33 (0)1 707 60 637 ctrs@ctrs.fr 
Laboratoires CTRS Teл.: + 33 (0)1 707 60 637 ctrs@ctrs.fr
• yellowing of the skin and/or eyes 
• žutilo kože i/ili očiju
Date of latest renewal: 11.11.2016 
Datum posljednje obnove odobrenja: 11.11.2016
Keep the bottle tightly closed in order to protect from light. 
Čuvati bocu čvrsto zatvorenom radi zaštite od svjetlosti.
Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. 2600 Dupnitsa Bulgaria 
Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. 2600 Dupnitsa Bugarska
OPA/Aluminium/PVC-Aluminium blisters. 
OPA/aluminij/PVC-aluminijski blisteri.
If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away. 
Ako primijetite bilo koju od ovih ozbiljnih nuspojava, prestanite uzimati lijek i odmah potražite hitni medicinski savjet.
to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). 
1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).