FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Kolbam 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kolbam 50 mg
English: Any medicinal products implicated in drug-induced cholestasis through inhibition of transporters could reduce the effectiveness of cholic acid treatment on coadministration.
Croatian: Bilo koji lijek uključen u kolestazu induciranu lijekom zbog inhibicije transportera može rezultirati smanjenom učinkovitošću liječenja kolatnom kiselinom tijekom istovremene primjene.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Kolbam Lijek čuvajte izvan pogleda i dohvata djece.
English: Kolbam is indicated for the treatment of inborn errors in primary bile acid synthesis due to Sterol 27hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or α-) methylacylCoA racemase (AMACR) deficiency or Cholesterol 7α-hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Croatian: Kolbam je indiciran za liječenje prirođenih grešaka u sintezi primarne žučne kiseline uslijed deficijencije sterol 27-hidroksilaze (manifestira se kao cerebrotendinozna ksantomatoza, CTX), deficijencije 2- (ili α-) metilacil-CoA racemaze (AMACR) ili deficijencije kolesterol 7α- hidroksilaze (CYP7A1) u dojenčadi, djece i adolescenata u dobi od jednog mjeseca do 18 godina te odraslih osoba.
English: The safety and efficacy of cholic acid in elderly patients has not been established.
Croatian: Sigurnost i djelotvornost kolatne kiseline u starijih bolesnika nisu ustanovljeni.
English: In each of the primary bile acid deficiencies due to enzyme defects in the biosynthetic pathway, absence of primary bile acids leads to cholestasis and unregulated accumulation of toxic bile acid precursors.
Croatian: U svakom nedostatku primarne žučne kiseline zbog manjka enzima u biosintetskom putu, izostanak primarne žučne kiseline uzrokuje kolestazu i nereguliranu akumulaciju toksičnih prekursora žučne kiseline.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: • CYP7A1 deficiency (n=1)
Croatian: • deficijencija CYP7A1-a (n=1).
English: INFORMATION IN BRAILLE Kolbam 250 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kolbam 250 mg
English: - PSURs - Annual Reassessments
Croatian: - PSUR-ovi - Godišnje ponovno izvješće o dokumentaciji o lijeku
English: MedDRA System Organ Class
Croatian: Klasifikacije organskih sustava prema MedDRA
English: Any conjugated cholic acid not absorbed in the ileum will pass into the lower intestine where it may be subject to bacterial metabolism, principally deconjugation and 7-dehydroxylation.
Croatian: Konjugirana kolatna kiselina koja nije apsorbirana u ileumu odlazi u debelo crijevo, gdje ju mogu metabolizirati bakterije, prvenstveno dekonjugacijom i 7-dehidroksilacijom.
English: At therapeutic doses, no effect on fertility is anticipated.
Croatian: Ne očekuju se nikakvi učinci na plodnost pri primjeni terapijskih doza.
English: For infants and children who cannot swallow capsules, the capsule may be opened gently and the contents mixed with food.
Croatian: Za dojenčad i djecu koja ne mogu progutati kapsule, kapsula se može pažljivo otvoriti te sadržaj pomiješati s hranom.
English: At therapeutic doses, no effects on the breastfed newborn infant are anticipated since the systemic exposure of the breastfeeding mother to cholic acid is negligible (see section 5.2).
Croatian: Ne očekuju se nikakvi učinci kod novorođene djece koja se hrane majčinim mlijekom pri primjeni terapijskih doza, s obzirom na to da je sistemska izloženost kolatnoj kiselini majke koja doji zanemariva (vidjeti dio 5.2).
English: Deconjugated cholic acid and deoxycholic acid, the product of 7-dehydroxylation, are passively absorbed in the lower intestine and carried back to the liver in portal blood, where reconjugation will take place.
Croatian: Dekonjugirana kolatna kiselina i deoksikolatna kiselina, produkt 7-dehidroksilacije, pasivno se apsorbiraju u debelom crijevu i prenose se portalnom krvlju natrag u jetru, gdje nastupa ponovna konjugacija.
English: It followed an open-label, single arm, non-randomized design and included eligible subjects who had previously received cholic acid through CAC-91-10-10 and CAC-001-01, and newly diagnosed subjects.
Croatian: Ono je otvorenog , nerandomiziranog dizajna, na jednoj skupini ispitanika i uključilo je prihvatljive ispitanike koji su prethodno primili kolatnu kiselinu tijekom CAC-91-10-10 i CAC-001-01 kao i novodijagnosticirane ispitanike.
English: The safety and efficacy of cholic acid in neonates less than one month of age has not been established.
Croatian: Sigurnost i djelotvornost kolatne kiseline u novorođenčadi mlađoj od mjesec dana nisu ustanovljeni.
English: Serum transaminases were below the ULN for most patients (71-100%) at baseline and for most patients (86%) at the worst post-baseline assessment and for all patients (100%) at the best post-baseline assessment.
Croatian: Transaminaze u serumu bile su ispod GGN za većinu bolesnika (71-100%) u početnoj vrijednosti te za većinu bolesnika (86%) u procjeni najlošije vrijednosti nakon početne vrijednosti i za sve bolesnike (100%) u procjeni najbolje vrijednosti nakon početne vrijednosti.
English: A concomitant decrease of urine total bile acids should be observed.
Croatian: Treba promatrati istodobno smanjivanje ukupnih žučnih kiselina u urinu.
English: There are limited safety data from the use of cholic acid in pregnant women.
Croatian: Sigurnosni podaci o primjeni kolatne kiseline u trudnica su ograničeni.
English: • Sterol 27-hydroxylase deficiency (presenting as CTX; n=5)
Croatian: • deficijencija sterol 27-hidroksilaze (manifestira se kao CTX; n=5)
English: Do not use after the expiry date which is stated on the carton and bottle label after “EXP''.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na naljepnici boce iza oznake „Rok valjanosti“.
English: Of 49 patients with a single enzyme defect treated in Study CAC-91-10-10 and included in the safety analysis, 42 had at least one pre- and one post-treatment assessment for urine bile acids and liver function tests; height and weight and were included in the primary efficacy analysis.
Croatian: Od 49 bolesnika s defektom jednog enzima liječenih u ispitivanju CAC-91-10-10 i uključenih u sigurnosnu analizu, 42 bolesnika imalo je najmanje jednu procjenu prije i jednu poslije liječenja za žučne kiseline u urinu i testove funkcije jetre; visina i težina su bile uključene u analizu primarne djelotvornosti.
English: White 185 ml HDPE bottle induction-sealed with a 38 mm white, child-resistant closure consisting of a HDPE grooved screw cap and induction seal (cardboard, wax and aluminium foil) liner.
Croatian: Bijela boca od 185 ml, od polietilena visoke gustoće (HDPE) zatvorena s 38 mm bijelim navojnim zatvaračem sigurnim za djecu od HDPE sa zalijepljenim jastučićem (karton, vosak i aluminijska folija).
English: If you stop taking it the abnormal substances in your bile may build up again to the levels before treatment was started, potentially causing damage to your liver.
Croatian: Vašoj žuči mogu se ponovno nakupiti do razina prije početka liječenja, što može uzrokovati oštećenje jetre.
English: Of the 53 patients treated, 41 (77%) presented with disorders in primary bile acid synthesis including sterol 27-hydroxylase deficiency (presenting as CTX; n=8) and AMACR deficiency (n=1).
Croatian: Od ovih 53 liječenih bolesnika, njih 41 (77%) imalo je poremećaje u sintezi primarne žučne kiseline, uključujući deficijenciju sterol 27-hidroksilaze (manifestira se kao CTX; n=8) i deficijencija AMACR-a (n=1).
English: Phenobarbital may stop cholic acid from working.
Croatian: Fenobarbital može spriječiti djelovanje kolatne kiseline.
English: WHAT KOLBAM IS AND WHAT IT IS USED FOR
Croatian: Što se nalazi u ovoj uputi: 1. Što je Kolbam i za što se koristi
English: Statistically significant changes were seen in the baseline to the best post-baseline analysis of urinary bile acids, with substantial decreases in marked, significant, and slight abnormalities as well as increases in normal spectra.
Croatian: Statistički značajne promjene uočene su u analizi usporedbe početne vrijednosti i najbolje vrijednosti nakon početne vrijednosti za žučne kiseline u urinu uz znatna smanjenja u izraženim, značajnim i neznatnim abnormalnostima te uz povišenja u normalnim spektrima.
English: Based on clinical trial data, adverse reactions in patients (both adults and children) receiving cholic acid are generally mild to moderate in severity and are provided in the following table.
Croatian: Na temelju podataka kliničkog ispitivanja, nuspojave kod bolesnika (odraslih i djece) koji primaju kolatnu kiselinu načelno su blage do umjerene u svojoj težini i prikazane u slijedećoj tablici.
English: Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol.
Croatian: Povećana masa jetre i žučni kamenci također su prijavljeni u ispitivanjima ponovljenih doza, u kojima je kolatna kiselina primijenjena istovremeno s kolesterolom.
English: The purpose of substituting missing cholic acid is to restore the main functions of this bile acid consisting of lipid transport in the form of mixed micelles, the activation of co-lipase and fat digestion and absorption, the absorption of fat-soluble vitamins, and the induction of bile flow, thus preventing cholestasis.
Croatian: Svrha zamjene kolatne kiseline koja nedostaje jest ponovno uspostavljanje glavnih funkcija ove žučne kiseline koje se sastoje od prijenosa lipida u obliku miješanih micela, aktiviranja ko-lipaze te probave i apsorpcije masti, apsorpcije vitamina topivih u masti, te poticanje protoka žuči čime se sprječava kolestaza.
English: The pharmacodynamic action of cholic acid is feedback inhibition of the synthesis of toxic partial bile acid biosynthetic products that result from blockages in the normal bile acid synthetic pathway.
Croatian: Farmakodinamičko djelovanje kolatne kiseline je povratna inhibicija sinteze toksičnih djelomičnih biosintetskih produkata žučne kiseline koji nastaju zbog blokada u normalnom putu sinteze žučne kiseline.
English: See under ‘Other medicines and
Croatian: Pogledajte dio „Drugi lijekovi i Kolbam“.
English: Study CAC-002-01, (an open-label, single-centre, non-randomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis), was the continuation of study CAC-9110-10 and started on 1 Jan 2010.
Croatian: Ispitivanje CAC-002-01 (otvoreno, monocentrično, nerandomizirano nastavljajuće ispitivanje kapsula kolatne kiseline u ispitanika s prirođenim greškama u sintezi žučne kiseline) predstavlja nastavak ispitivanja CAC-91-10-10 i započeto je na 1. siječnja 2010. godine.
English: Kolbam'.
Croatian: I DOHVATA
English: No data regarding cholic acid treatment are available in patients with inborn errors of bile acid metabolism with hepatic impairment unrelated to their primary disease.
Croatian: Nema dostupnih podataka u vezi liječenja kolatnom kiselinom kod bolesnika s prirođenim greškama metabolizma žučne kiseline s oštećenjem jetrene funkcije koje nije povezano s primarnom bolesti.
English: The efficacy analysis also demonstrated that treatment with cholic acid significantly improved ALT and AST values for patients stratified by single enzyme defects.
Croatian: Analiza djelotvornosti također je pokazala da je liječenje kolatnom kiselinom značajno poboljšalo vrijednosti ALT-a i AST-a kod bolesnika stratificiranih prema defektima pojedinačnog enzima.
English: Concurrent with the disappearance of atypical bile acid metabolites, there is a consistent reduction and normalization in serum liver enzymes.
Croatian: Istovremeno s nestajanjem atipičnih metabolita žučne kiseline, nastupa i konzistentno smanjenje i normalizacija jetrenih enzima u serumu.
English: MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irska
English: The study was an open-label, single arm, non-randomized design.
Croatian: Ispitivanje je bilo otvorenog, nerandomiziranog dizajna provedeno na jednoj skupini.
English: For infants and children who cannot swallow capsules, the capsules may be opened and the content added to infant formula or juice.
Croatian: Za dojenčad i djecu koja ne mogu progutati kapsule, kapsule se mogu otvoriti te se sadržaj može dodati u adaptirano mlijeko ili sok.
English: To monitor the long term safety and efficacy in patients treated with Kolbam from a patient registry for which details are reflected in the risk management plan.
Croatian: Kolbam iz registra bolesnika, za koje su detalji navedeni u planu upravljanja rizikom.
English: For young infants the contents may be mixed with infant formula, expressed breast milk or fruit puree and for infants and children under 6 years, mixed with soft food such as mashed potatoes or apple puree.
Croatian: Za malu dojenčad sadržaj se može pomiješati s adaptiranim mlijekom, izdojenim majčinim mlijekom ili voćnom kašicom, a za dojenčad i djecu mlađu od 6 godina može se pomiješati s mekanom hranom poput pire krumpira ili pirea od jabuke.
English: For babies and children who cannot swallow capsules, open the capsule by gently twisting it and add the contents to infant formula, expressed breast milk or fruit puree in a suitable clean container.
Croatian: Za dojenčad i djecu koja ne mogu progutati kapsule, otvorite kapsulu lagano je uvijajući te dodajte sadržaj u adaptirano mlijeko, izdojeno majčino mlijeko ili voćnu kašicu u primjerenu čistu posudu.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irska
English: For young infants the contents may be mixed with infant formula, expressed breast milk or fruit puree and for infants and children under 6 years, mixed with soft food such as mashed potatoes or apple puree.immediately.
Croatian: Za malu dojenčad sadržaj se može pomiješati s adaptiranim mlijekom, izdojenim majčinim mlijekom ili voćnom kašicom, a za dojenčad i djecu mlađu od 6 godina može se odmah pomiješati s mekanom hranom poput pire krumpira ili pirea od jabuke.
English: Urinary bile acids were normal for all patients (100%) at baseline and worst post-baseline assessments, and for most patients (88%) at the best post-baseline assessment; 1 patient (12%) had a slight elevation of urinary bile acids at best post-baseline assessment.
Croatian: Žučne kiseline u urinu bile su normalne za sve bolesnike (100%) u procjenama početne vrijednosti i najlošije vrijednosti nakon početne vrijednosti te za većinu bolesnika (88%) u procjeni najbolje vrijednosti nakon početne vrijednosti; 1 bolesnik (12%) imao je neznatno povišene žučne kiseline u urinu u procjeni najbolje vrijednosti nakon početne vrijednosti.
English: Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as via its pharmacodynamics by inhibiting cholesterol 7α-hydroxylase.
Croatian: Ciklosporin mijenja farmakokinetiku kolatne kiseline tako što inhibira jetreni unos i jetreno-žučnu sekreciju žučnih kiselina, kao i putem svoje farmakodinamike inhibirajući kolesterol 7α-hidroksilazu.
English: These increase cholesterol production in the liver and as a result prevent cholic acid from working properly.
Croatian: Ovi lijekovi povećavaju stvaranje kolesterola u jetri, a rezultat je sprječavanje ispravnog djelovanja kolatne kiseline.
English: Pregnancies with normal outcomes have been reported in women taking cholic acid.
Croatian: Kod žena koje su uzimale kolatnu kiselinu prijavljene su trudnoće s normalnim ishodima.
English: In Study CAC-91-10-10, the efficacy analysis showed that treatment with cholic acid significantly improved (i.e., decreased) urinary bile acid excretion in patients with single enzyme defects.
Croatian: U ispitivanju CAC-91-10-10, analizom djelotvornosti utvrđeno je da je liječenje kolatnom kiselinom značajno poboljšalo, (odnosno smanjilo), izlučivanje žučne kiseline u urinu kod bolesnika s defektima pojedinačnog enzima.
English: Drug interactions with cholic acid mainly relate to medicinal products capable of interrupting the enterohepatic circulation of bile acids, such as the sequestering agents cholestyramine, colestipol, or colesevelam.
Croatian: Interakcija lijekova s kolatnom kiselinom uglavnom je povezana s lijekovima sposobnima za prekidanje enterohepatičke cirkulacije žučnih kiselina, kao što su tvari koje vežu žučne kiseline poput kolestiramina, kolestipola ili kolesevelama.
English: Once absorbed, exogenous cholic acid will enter into the body's bile acid pool and will undergo multiple cycles of enterohepatic circulation.
Croatian: Nakon što se apsorbira, egzogena kolatna kiselina ulazi u tjelesni rezervoar žučne kiseline i podvrgava se višestrukim ciklusima enterohepatičke cirkulacije.
English: Conjugated cholic acid is secreted into bile and will pass into the small intestine where, in association with other components of bile, it will perform its principal digestive function.
Croatian: Konjugirana kolatna kiselina se izlučuje u žuč te prelazi u tanko crijevo, gdje, s drugim komponentama žuči, obavlja svoju primarnu probavnu funkciju.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne žvakati.
English: Therapeutic efficacy and safety of cholic acid treatment in patients with inborn errors of bile acid metabolism were evaluated.
Croatian: Ocijenjene su terapijska djelotvornost i sigurnost liječenja kolatnom kiselinom kod bolesnika s prirođenim greškama metabolizma žučne kiseline.
English: Aluminium-based antacids have been shown to adsorb bile acids in vitro and may be expected to reduce the levels of cholic acid in the same manner as the bile acid sequestering agents.
Croatian: Utvrđeno je da antacidi bazirani na aluminiju adsorbiraju žučne kiseline in vitro te se može očekivati smanjenje razina žučne kiseline na isti način kao i kod tvari koje vežu žučne kiseline.
English: Treatment with exogenous cholic acid is intended to replace physiological bile acid in cases of inborn errors of bile acid synthesis.
Croatian: Liječenje egzogenom kolatnom kiselinom namijenjeno je kao zamjena fiziološke žučne kiseline u slučaju prirođenih grešaka sinteze žučne kiseline.
English: In patients with CTX (N=3), urinary bile acids at baseline were normal for 1 patient and elevated for 2 patients, elevated for all patients in the worst post-treatment analysis, and normal in the best postbaseline assessment for all 3 patients.
Croatian: U bolesnika s CTX-om (n=3), žučne kiseline u urinu su u početnim vrijednostima bile normalne u 1 bolesnika i povišene u 2 bolesnika, povišene za sve bolesnike u analizi najlošije vrijednosti nakon liječenja i normalne u procjeni najbolje vrijednosti nakon početne vrijednosti za sva 3 bolesnika.
English: Patients with hepatic impairment who are treated with cholic acid should be monitored closely (see section 4.4).
Croatian: Bolesnike s oštećenjem jetrene funkcije koji primaju terapiju kolatnom kiselinom potrebno je pažljivo kontrolirati (vidjeti dio 4.4).
English: Inborn errors of primary bile acid synthesis involve congenital defects in the primary enzymes responsible for catalysing key reactions in the synthesis of cholic and chenodeoxycholic acids.
Croatian: Farmakodinamički učinci Prirođene greške sinteze primarne žučne kiseline uključuju prirođene defekte u primarnim enzimima odgovornima za kataliziranje ključnih reakcija u sintezi kolatne i kenodeoksikolatne kiseline.
English: After administration of cholic acid a down-regulation of bile acid synthesis occurs and there is a strong decrease or almost complete disappearance of abnormal bile acids.
Croatian: Nakon primjene kolatne kiseline nastupa prilagodba naniže sinteze žučne kiseline te nastupa značajno snižavanje ili gotovo potpuno nestajanje abnormalnih žučnih kiselina.
English: The rationale for cholic acid therapy is improvement of bile flow and fat absorption and restoration of a physiologic feedback inhibition on bile acid synthesis, lowering the production of toxic bile acid precursors.
Croatian: Razlog za terapiju kolatnom kiselinom je poboljšanje protoka žuči i apsorpcije masti te ponovna uspostava fiziološke povratne inhibicije sinteze žučne kiseline, smanjujući proizvodnju toksičnih prekursora žučne kiseline.
English: • feeling out of sorts (malaise)
Croatian: • osjećaj iscrpljenosti (opće slabosti)
English: Statistically significant improvements were also observed in the baseline to best postbaseline analyses of serum transaminases.
Croatian: Statistički značajna poboljšanja također su bila uočena u analizi usporedbe početne vrijednosti i najbolje vrijednosti nakon početne vrijednosti za transaminaze u serumu.
English: Of the 41 patients described above that were treated in Study CAC-002-01, 13 patients discontinued: 8 due to AEs, 1 for lack/loss of efficacy, 1 was lost to follow-up, and 3 withdrew consent.
Croatian: Od 41 prethodno opisanog bolesnika koji su liječeni u sklopu ispitivanja CAC-002-01, 13 bolesnika je prekinulo ispitivanje: 8 njih zbog nuspojava, 1 zbog nedostatka/gubitka djelotvornosti, 1 je izgubljen iz praćenja i 3 ih je povuklo pristanak.
English: No data are available for patients with renal impairment.
Croatian: Nema dostupnih podataka za bolesnike s oštećenjem funkcije bubrega.
English: The effect of food on the bioavailability of cholic acid has not been studied.
Croatian: Nije ispitan učinak hrane na bioraspoloživost kolatne kiseline.
English: Conjugated cholic acid is absorbed in the ileum via transporters , passed back to the liver and enters another cycle of enterohepatic circulation.
Croatian: Konjugirana kolatna kiselina apsorbira se u ileumu putem transportera, vraća se natrag u jetru i ulazi u drugi ciklus enterohepatičke cirkulacije.
English: Cases of severe hepatotoxicity, including cases with fatal outcome, have been reported with the use of cholic acid.
Croatian: Uz primjenu kolatne kiseline prijavljeni su slučajevi teške hepatotoksičnosti, uključujući slučajeve sa smrtnim ishodom.
English: Therefore use of phenobarbital in patients treated with cholic acid is contraindicated (see section 4.3).
Croatian: Stoga je primjena fenobarbitala kontraindicirana kod bolesnika liječenih kolatnom kiselinom (vidjeti dio 4.3).
English: Of the 52 patients described above that were included in Study CAC-91-10-10 during the 17-year study period, 6 died, 3 had no evidence of treatment, 4 terminated the study, 10 were lost to follow-up, and for 1, data retrieval was unsuccessful.
Croatian: Od 52 prethodno opisana bolesnika koji su uključeni u ispitivanje CAC-91-10-10 tijekom 17godišnjeg razdoblja ispitivanja, 6 ih je preminulo, 3 nije imalo dokaza o liječenju, 4 je završilo ispitivanje, 10 je izgubljeno iz praćenja, a za 1 bolesnika nisu uspješno prikupljeni podaci.
English: Marketing Authorisation Holder Retrophin Europe Limited Palmerston House Fenian Street
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Retrophin Europe Limited Palmerston House
English: Treatment with oral cholic acid stimulates bile flow and secretion, inhibits production and accumulation of hepatotoxic and cholestatic bile acid precursors and facilitates fat absorption without toxic side effects at therapeutic doses.
Croatian: Liječenje oralnom kolatnom kiselinom stimulira protok i sekreciju žuči, inhibira stvaranje i nakupljanje hepatotoksičnih i kolestatskih prekursora žučne kiseline, te olakšava apsorpciju masti bez toksičnih nuspojava u terapijskim dozama.
English: • feeling of pins and needles (mild peripheral neuropathy)
Croatian: • osjećaj mučnine (blaga mučnina) • osjećaj bockanja i iglica (blaga periferna neuropatija)