FrancophonIA/ELRC3.0 huggingface dataset:
English: The registry will monitor accumulating data on efficacy and safety in the treatment of inborn errors in primary bile acid synthesis in infants, children, adolescents and adults due to Sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis,
Slovenian: Z registrom se bodo spremljali kumulativni podatki o učinkovitosti in varnosti pri zdravljenju prirojenih okvar sinteze primarnih žolčnih kislin pri dojenčkih, otrocih, mladostnikih in odraslih zaradi pomanjkanja sterol 27
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.
Slovenian: Pri bolnikih s CTX (N = 3) so bile žolčne kisline v urinu na izhodišču normalne za 1 bolnika in zvišane za 2 bolnika, zvišane za vse bolnike v analizi najslabših vrednosti po zdravljenju in normalne v oceni najboljših vrednosti po izhodišču za vse 3 bolnike.
English: MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irska
English: This has led to the identification of cholic acid as a tumour promoter, considered to be via the hyperproliferation of colorectal epithelium in the presence of secondary bile acids.
Slovenian: S tem so ugotovili, da je holna kislina promotor tumorjev, in menijo, da se to zgodi zaradi hiperproliferacije kolorektalnega epitelija ob prisotnosti sekundarnih žolčnih kislin.
English: • Sterol 27-hydroxylase deficiency (presenting as CTX; n=5)
Slovenian: • pomanjkanje sterol 27-hidroksilaze (ki se kaže kot CTX) (n = 5);
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.
Slovenian: Utemeljitev zdravljenja s holno kislino je izboljšanje žolčnega pretoka in absorpcije maščob ter ponovna vzpostavitev fiziološkega povratnega zaviranja sinteze žolčnih kislin, kar zmanjša tvorbo prekurzorjev toksičnih žolčnih kislin.
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.
Slovenian: Od 52 bolnikov, opisanih zgoraj, vključenih v študijo CAC-91-10-10 v 17-letnem obdobju študije, jih je šest umrlo, trije niso imeli nobenih dokazov zdravljenja, štirje so prekinili študijo, deset jih ni opravilo sledenja, pri enem pa je bilo pridobivanje podatkov neuspešno.
English: During the initiation of therapy and dose adjustment, serum and urine bile acid levels should be monitored intensively by using suitable analytical techniques.
Slovenian: Med uvajanjem zdravljenja in prilagajanjem odmerka je treba intenzivno spremljati ravni žolčnih kislin v serumu in urinu z ustreznimi analitičnimi metodami.
English: Regarding primary diagnoses, shifts towards improvements in ALT and AST values were shown in individual defect groups.
Slovenian: V primerjavi s prvotnimi diagnozami so izboljšanje vrednosti ALT in AST ugotovili pri skupinah s posameznimi okvarami.
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.
Slovenian: Farmakodinamično delovanje holne kisline poteka tako, da povratno zavira sintezo toksičnih parcialnih biosintetičnih produktov žolčnih kislin, ki jih povzročajo blokade v poti sinteze normalnih žolčnih kislin.
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.
Slovenian: Po uporabi holne kisline pride do zmanjšanja sinteze žolčnih kislin in velikega zmanjšanja ali popolnega izginotja nenormalnih žolčnih kislin.
English: CTX), 2- (or α-) methylacyl-CoA racemase (AMACR) and Cholesterol 7α hydroxylase (CYP7A1) deficiencies.
Slovenian: metilacil-CoA racemaze (AMACR) in holesterol 7α-hidroksilaze (CYP7A1).
English: Cholic acid down-regulates bile acid biosynthesis via activation of farnesoid X receptor, which represses transcription of the CYP7A1 gene encoding cholesterol 7α-hydroxylase, the rate-limiting enzyme of bile acid synthesis.
Slovenian: Holna kislina zmanjša biosintezo žolčnih kislin prek aktivacije farnezoidnega receptorja X, ki povzroča represijo transkripcije holesterol 7α-hidroksilaze (encima, ki omejuje hitrost sinteze žolčnih kislin), ki jo kodira gen CYP7A1.
English: Any cholic acid not absorbed will be excreted in the faeces, either unchanged or following dehydroxylation via bacterial metabolism.
Slovenian: Neabsorbirana holna kislina se bo izločila nespremenjena z blatom ali po dehidroksilaciji z bakterijsko presnovo.
English: Pregnancies with normal outcomes have been reported in women taking cholic acid.
Slovenian: Pri ženskah, ki so jemale holno kislino, so poročali o nosečnostih z normalnim izidom.
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.
Slovenian: Bela 185-mililitrska plastenka iz HDPE, indukcijsko zatesnjena z 38-milimetrsko belo, za otroke varno zaporko, ki vključuje navojno zaporko iz HDPE in indukcijski tesnilni vložek (karton, vosek in aluminijasta folija).
English: See under ‘Other medicines and
Slovenian: Glejte poglavje „Druga zdravila in zdravilo Kolbam“.
English: Kolbam is used to treat these ‘inborn errors of bile acid synthesis'.
Slovenian: Zdravilo Kolbam se uporablja za zdravljenje teh „prirojenih okvar sinteze žolčnih kislin“.
English: Cases of severe hepatotoxicity, including cases with fatal outcome, have been reported with the use of cholic acid.
Slovenian: Pri zdravljenju s holno kislino so poročali o primerih hude hepatotoksičnosti, vključno s primeri s smrtnim izidom.
English: Conjugated cholic acid is absorbed in the ileum via transporters , passed back to the liver and enters another cycle of enterohepatic circulation.
Slovenian: Konjugirana holna kislina se prek prenašalcev absorbira v ileumu, potuje nazaj v jetra in vstopi v še en cikel enteropatičnega obtoka.
English: A concomitant decrease of urine total bile acids should be observed.
Slovenian: Opazno mora biti sočasno zmanjšanje skupnih žolčnih kislin v urinu.
English: Patients with familial hypertriglyceridaemia
Slovenian: Posebne skupine bolnikov Bolniki z družinsko hipertrigliceridemijo
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.
Slovenian: Medsebojno delovanje zdravil s holno kislino je večinoma povezano z zdravili, ki lahko ovirajo enterohepatično cirkulacijo žolčnih kislin, kot so vezalci želodčnih kislin holestiramin, holestipol ali holesevelam.
English: Oestrogens, oral contraceptives and clofibrate (and perhaps other lipid-lowering substances) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of cholic acid.
Slovenian: Estrogeni, peroralna kontracepcijska sredstva in klofibrat (ter morda druge učinkovine za zniževanje ravni lipidov) povečajo jetrno izločanje holesterola in spodbujajo tvorbo holesterolskih žolčnih kamnov, kar lahko nevtralizira učinkovitost holne kisline.
English: It is important to give the full content of the capsule to the baby or young child where whole capsules cannot be given.
Slovenian: Pomembno je, da dojenčku ali majhnemu otroku, ki ne more pogoltniti cele kapsule, daste celotno vsebino kapsule.
English: Therapeutic efficacy and safety of cholic acid treatment in patients with inborn errors of bile acid metabolism were evaluated.
Slovenian: Ocenjevali so terapevtsko učinkovitost in varnost zdravljenja s holno kislino pri bolnikih s prirojenimi okvarami presnove žolčnih kislin.
English: Patients with newly diagnosed or a family history of familial hypertriglyceridaemia are expected to poorly absorb cholic acid from the intestine.
Slovenian: Pri bolnikih z novo diagnozo ali družinsko hipertrigliceridemijo v družinski anamnezi je pričakovana slaba absorpcija holne kisline iz črevesja.
English: This medicinal product has been authorised under ‘exceptional circumstances,' which means that, due to the rarity of the disease and for ethical reasons, it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da zaradi redkosti bolezni in iz etičnih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
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.
Slovenian: Od 49 bolnikov z okvaro posamičnega encima, zdravljenih v študiji CAC-91-10-10 in vključenih v analizo varnosti, jih je 42 imelo vsaj eno oceno žolčnih kislin v urinu, preiskav jetrnega delovanja ter telesne višine in mase pred zdravljenjem in eno oceno po njem.
English: Serum transaminases were below the ULN for 1 patient and elevated (≥2 times the ULN) for 2 patients at baseline, were elevated for 2 patients in the worst postbaseline analysis but were below the ULN for all 3 patients in the best post-treatment analysis.
Slovenian: Transaminaze v serumu so bile pod vrednostjo ULN za 1 bolnika in zvišane (≥ 2-kratna vrednost ULN) za 2 bolnika ob izhodišču, zvišane za 2 bolnika v analizi najslabših vrednosti po izhodišču, a pod vrednostjo ULN za vse 3 bolnike v analizi najboljših vrednosti po zdravljenju.
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.
Slovenian: Preglednica z neželenimi učinki Glede na podatke iz kliničnih preskušanj je resnost neželenih učinkov pri bolnikih (odraslih in otrocih), ki prejemajo holno kislino, navadno blaga do zmerna, navedeni pa so v spodnji tabeli.
English: Statistically significant improvements were also observed in the baseline to best postbaseline analyses of serum transaminases.
Slovenian: Statistično značilna izboljšanja transaminaz v serumu so opazili tudi v analizi primerjave izhodiščnih vrednosti z najboljšimi vrednosti po izhodišču.
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.
Slovenian: V študiji CAC-91-10-10 je analiza učinkovitosti pokazala, da je zdravljenje s holno kislino pomembno izboljšalo (tj. zmanjšalo), izločanje žolčne kisline v urinu pri bolnikih z okvarami posamičnih encimov.
English: Silicified microcrystalline cellulose
Slovenian: Vsebina kapsule silicizirana mikrokristalna celuloza magnezijev stearat
English: The cholic acid dose for patients with familial hypertriglyceridaemia will have to be established and adjusted as necessary; an elevated dose may be required in order to suppress urinary bile acids (see section 4.4).
Slovenian: Pri bolnikih z družinsko hipertrigliceridemijo je treba določiti odmerek holne kisline in ga po potrebi prilagoditi; morda bo za zaviranje žolčnih kislin v urinu potreben povečan odmerek (glejte poglavje 4.4).
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.
Slovenian: Od 41 bolnikov, opisanih zgoraj, zdravljenih v študiji CAC-002-01, je 13 bolnikov zdravljenje prekinilo: 8 zaradi neželenega učinka, 1 zaradi pomanjkanja/izgube učinkovitosti, pri 1 je bilo pridobivanje podatkov neuspešno, 3 pa so preklicali svoje soglasje.
English: The use of cholic acid may be considered during pregnancy if your doctor considers that the benefits to you outweigh any possible risk.
Slovenian: Holna kislina se lahko uporabi med nosečnostjo, če zdravnik meni, da so koristi za vas večje od morebitnega tveganja.
English: Marketing Authorisation Holder Retrophin Europe Limited Palmerston House Fenian Street
Slovenian: Imetnik dovoljenja za promet z zdravilom Retrophin Europe Limited Palmerston House
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.
Slovenian: Ciklosporin spremeni farmakokinetiko holne kisline z zaviranjem jetrnega privzema in hepatobiliarnega izločanja žolčnih kislin ter tudi s farmakodinamiko z zaviranjem holesterol7α-hidroksilaze.
English: Cholic acid will pass to the liver in the portal blood, in which it is moderately bound to albumin.
Slovenian: Holna kislina s portalno krvjo, v kateri se zmerno veže na albumin, potuje do jeter.
English: MARKETING AUTHORISATION NUMBER EU/1/13/895/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/13/895/001
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.
Slovenian: Konjugirana holna kislina se izloči v žolč in preide v tanko črevo, kjer skupaj z drugimi sestavinami žolča opravi svojo prvotno prebavno funkcijo.
English: Elderly Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.
Slovenian: Varnosti in učinkovitosti holne kisline niso preučevali pri osebah, starejših od 65 let.
English: The majority of patients with inborn errors of bile acid metabolism presented with some degree of hepatic impairment at the time of diagnosis; in most patients, the hepatic impairment improved or resolved with treatment.
Slovenian: Ob postavitvi diagnoze ima večina bolnikov s prirojenimi okvarami presnove žolčnih kislin tudi jetrno okvaro različnih stopenj; pri večini bolnikov se jetrna okvara omili ali izgine z zdravljenjem.
English: Return any unused medicine to your pharmacist for disposal
Slovenian: Neuporabljeno zdravilo vrnite farmacevtu, ki ga bo ustrezno zavrgel.
English: Cholic acid can be used during breastfeeding if the doctor considers that the benefits to the patient outweigh the possible risk.
Slovenian: Holna kislina se lahko uporabi med dojenjem, če zdravnik meni, da so koristi za bolnico večje od morebitnega tveganja.
English: Efficacy was demonstrated in two ways: (a) treatment with cholic acid leads to an improvement in liver function as demonstrated by improved liver function test values, (b) Fast Atom Bombardment-Mass Spectrometry (FAB-MS) data demonstrated efficacy by showing that cholic acid treatment led to a suppression of the abnormal urine bile acids that initially led to the diagnosis.
Slovenian: (a) zdravljenje s holno kislino izboljša jetrno funkcijo, kar so pokazali z izboljšanimi vrednostmi pri preiskavah jetrne funkcije, (b) podatki masne spektrometrije bombardiranja s hitrimi atomi FAB-MS (Fast Atom Bombardment-Mass Spectrometry) so pokazali učinkovitost, saj je zdravljenje s holno kislino povzročilo zaviranje nenormalnih žolčnih kislin v urinu, na podlagi katerih je bila postavljena prvotna diagnoza.
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).
Slovenian: Od teh 53 zdravljenih bolnikov jih je imelo 41 (77 %) motnje v sintezi primarnih žolčnih kislin, vključno s pomanjkanjem sterol 27-hidroksilaze (ki se kaže kot CTX) (n = 8) in pomanjkanje AMACR (n = 1).
English: Patients with newly diagnosed, or a family history of, familial hypertriglyceridaemia may have poor absorption of cholic acid from the intestine.
Slovenian: Družinska hipertrigliceridemija Bolniki z novo diagnozo ali družinsko hipertrigliceridemijo v družinski anamnezi imajo lahko slabo absorpcijo holne kisline iz črevesja.
English: Orally administered cholic acid is absorbed by passive diffusion along the length of the gastrointestinal tract.
Slovenian: Peroralna holna kislina se absorbira s pasivno difuzijo po celi dolžini prebavil.
English: MARKETING AUTHORISATION NUMBER EU/1/13/895/002
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/13/895/002
English: Driving and using machines This medicine is not expected to affect your ability to drive or use machines.
Slovenian: Ni pričakovati, da bi to zdravilo vplivalo na sposobnost vožnje in upravljanja strojev.
English: Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Black Iron Oxide (E172)
Slovenian: Tiskarsko črnilo šelak (E904) propilenglikol (E1520) koncentrirana raztopina amonijaka (E527) kalijev hidroksid (E525) črni železov oksid (E172)
English: The concentrations of the abnormal bile acid metabolites synthesised subsequently should be determined.
Slovenian: Določiti je treba koncentracije nenormalnih sintetiziranih presnovkov žolčnih kislin.
English: • heartburn (gastric reflux)
Slovenian: • zgaga (želodčni refluks),
English: The use of cholic acid may be considered during pregnancy if the doctor considers that the benefits to the patient outweigh the possible risk.
Slovenian: Holna kislina se lahko uporabi med nosečnostjo, če zdravnik meni, da so koristi za bolnico večje od morebitnega tveganja.
English: This leaflet was last revised in DDmonthYYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne DD. mesec LLLL.
English: Mean total bilirubin values remained stable in the baseline to worst post-baseline value analysis and decreased in the baseline to best post-baseline analysis.
Slovenian: Povprečne vrednosti celokupnega bilirubina so pri analizi primerjave izhodiščnih vrednosti in najslabših vrednosti po izhodišču ostale stabilne in so se zmanjšale v analizi primerjave vrednosti ob izhodišču z najboljšo vrednostjo po izhodišču.
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.
Slovenian: Zdravljenje s peroralno holno kislino pri terapevtskih odmerkih spodbuja pretok in izločanje žolča, zavira tvorbo ter kopičenje hepatotoksičnih in holestatskih prekurzorjev žolčnih kislin in omogoča absorpcijo maščob brez toksičnih neželenih učinkov.
English: Children Cholic acid has not been studied for safety and effectiveness in babies under one month of age.
Slovenian: Varnosti in učinkovitosti holne kisline niso preučevali pri dojenčkih, mlajših od enega meseca.
English: Once absorbed, exogenous cholic acid will enter into the body's bile acid pool and will undergo multiple cycles of enterohepatic circulation.
Slovenian: Ko se eksogena holna kislina absorbira, vstopi v telesno zalogo žolčnih kislin in opravi več ciklov v enterohepatičnem obtoku.
English: The 50 mg capsules are orange (black imprint “ASK001” and “50mg”).
Slovenian: 50-miligramske kapsule so oranžne (s črnima odtisnjenima oznakama "ASK001" in "50 mg").
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.
Slovenian: Žolčne kisline v urinu so bile v oceni vrednosti ob izhodišču in najslabših vrednosti po izhodišču za vse bolnike normalne (100 %), za večino bolnikov (88 %) pa so bile normalne v oceni najboljših vrednosti po izhodišču; 1 bolnik (12 %)
English: Reports on recruitment progress of the registry will be submitted with PSURs and Annual Re-assessments.
Slovenian: Poročila o napredku vključevanja v register bodo predložena skupaj s poročili
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.
Slovenian: nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis) je bila nadaljevanje študije CAC-91-10-10 in se je začela 1. januarja 2010.
English: If administration of ciclosporin is considered necessary, serum and urinary bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly.
Slovenian: Če je uporaba ciklosporina nujna, je treba pozorno spremljati ravni žolčnih kislin v serumu in urinu ter ustrezno prilagoditi odmerek holne kisline.
English: • yellowing of the skin (jaundice)
Slovenian: • rumena koža (zlatenica),
English: Kolbam contains a substance called cholic acid.
Slovenian: Zdravilo Kolbam vsebuje učinkovino, imenovano holna kislina.
English: The recommended dosage for cholic acid in the treatment of inborn errors of primary bile acid synthesis is 10-15 mg/kg per day, either as a single daily dose or in divided doses, for both adult and paediatric patients.
Slovenian: 10-15 mg/kg na dan, v enkratnem dnevnem odmerku ali v razdeljenih odmerkih, kar velja za odrasle in pediatrične bolnike.
English: Kolbam 250 mg: Each capsule contains 250 mg of cholic acid.
Slovenian: Kolbam 250 mg: ena kapsula vsebuje 250 mg holne kisline.
English: The 250 mg capsules are white (black imprint “ASK002” and “250mg”).
Slovenian: 250-miligramske kapsule so bele (s črnima odtisnjenima oznakama "ASK002" in "250 mg").
English: Do not take Kolbam - If you are allergic to cholic acid or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na holno kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če jemljete fenobarbital (zdravilo za zdravljenje epilepsije).
English: The limited data from animal studies do not indicate direct reproductive toxicity (see section 5.3).
Slovenian: Omejeni podatki iz študij na živalih niso pokazali neposrednega vpliva na sposobnost razmnoževanja
English: Preferred Term Frequency
Slovenian: Organski sistem po MedDRA Priporočeni izraz Pogostnost
English: The cholic acid dose for patients with familial triglyceridaemia will have to be established and adjusted as necessary (see section 4.2).
Slovenian: Pri bolnikih z družinsko hipertrigliceridemijo je treba določiti odmerek holne kisline in ga po potrebi prilagoditi (glejte poglavje 4.2).
English: 250 mg capsule: Size number 0 capsule with a white cap (black imprint “ASK002”) and white body (black imprint “250mg”).
Slovenian: 250-miligramska kapsula: kapsula velikosti številka 0 z belim pokrovčkom (s črno odtisnjeno oznako "ASK001") in telesom (s črno odtisnjeno oznako "250 mg").
English: Patients that have previously been treated with other bile acids or other cholic acid preparations should be closely monitored in the same manner during the initiation of treatment with Kolbam.
Slovenian: Bolnike, ki so se predhodno zdravili z drugimi žolčnimi kislinami ali drugimi pripravki holne kisline,
English: The safety and efficacy of cholic acid in neonates less than one month of age has not been established.
Slovenian: Pediatrična populacija Varnosti in učinkovitosti holne kisline niso ugotovili pri novorojenčkih, mlajših od enega meseca.
English: HOW TO STORE KOLBAM
Slovenian: KAKO JEMATI ZDRAVILO KOLBAM
English: Kolbam 50 mg: Each capsule contains 50 mg of cholic acid.
Slovenian: Kolbam 50 mg: ena kapsula vsebuje 50 mg holne kisline.
English: 50 mg capsule: Size number 2 capsule with a Swedish orange cap (black imprint “ASK001”) and body (black imprint “50mg”).
Slovenian: 50-miligramska kapsula: kapsula velikosti številka 2 z rjavo-oranžnim pokrovčkom (s črno odtisnjeno oznako "ASK001") in telesom (s črno odtisnjeno oznako "50 mg").