FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeated dose studies, frequently reported effects of cholic acid have included decreased body weight, diarrhoea and liver damage with elevated transaminases although are considered to be associated with the pharmacological effects of bile acid metabolism.
Danish: I undersøgelser med gentagen dosering er cholsyres hyppigt beskrevne virkninger vægttab, diarré og leverskader med forhøjede transaminaser, hvilket imidlertid anses for at hænge sammen med galdesyremetabolismens farmakologiske virkninger.
English: After the initiation period, serum and urine bile acids (using suitable analytical techniques) and liver parameters should be determined annually, at a minimum, and the dose adjusted accordingly.
Danish: Efter initieringsperioden foretages bestemmelse af galdesyre i serum og/eller urin (ved at anvende en egnet analytisk teknik) mindst én gang årligt, og dosis tilpasses i henhold hertil.
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.
Danish: Konjugeret cholsyre der ikke absorberes fra ileum, føres til tyktarmen, hvor den kan undergå bakteriel metabolisering, hovedsagelig dekonjugering og 7-dehydroxylering.
English: If you have a condition called familial hypertriglyceridaemia, your doctor may have to increase your dose of cholic acid.
Danish: Hvis du har sygdommen familiær hypertriglyceridæmi, kan lægen finde det nødvendigt at forhøje din dosis af cholsyre.
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.
Danish: Dette har ført til, at cholsyre er blevet udpeget som tumorigent, hvilket tilskrives hyperproliferation af det kolorektale epitel i tilstedeværelse af sekundære galdesyrer.
English: Cholic acid has no or negligible influence on the ability to drive and use machines.
Danish: Cholsyre påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
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.
Danish: Dekonjugeret cholsyre og deoxycholsyre (produktet af 7-dehydroxyleringen) absorberes passivt fra tyktarmen og føres med portalblodet tilbage til leveren, hvor den rekonjugeres.
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.
Danish: Kolbam er indiceret til behandling af medfødte fejl i den primære galdesyresyntese som følge af sterol 27-hydroxylase (fremtræder som cerebrotendinøs xanthomatose, CTX)-mangel, 2- (eller α-) methylacyl-CoA-racemase-(AMACR)-mangel eller kolesterol 7α-hydroxylase (CYP7A1)-mangel hos spædbørn, børn og unge i alderen 1 måned til 18 år samt hos voksne.
English: A concomitant decrease of urine total bile acids should be observed.
Danish: Samtidig bør der ses et fald i urinens totalindhold af galdesyrer.
English: Statistically significant improvements were also observed in the baseline to best postbaseline analyses of serum transaminases.
Danish: Der blev også observeret statistisk signifikante forbedringer i serumtransaminaser fra baseline til den bedste analyse efter baseline.
English: Driving and using machines This medicine is not expected to affect your ability to drive or use machines.
Danish: Dette lægemiddel forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: For infants and children who cannot swallow capsules, the capsule may be opened gently and the contents mixed with food.
Danish: Til spædbørn og børn, som ikke kan synke kapsler, kan kapslerne forsigtigt åbnes, og indholdet blandes op i føde.
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.
Danish: Gennemsnitsværdierne af totalbilirubin holdt sig stabile fra baseline til dårligste værdi efter baseline og faldt fra baseline til bedste analyse efter baseline.
English: Use within 3 months of opening.
Danish: Anvendes senest tre måneder efter anbrud.
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.
Danish: Aluminiumbaserede antacida er påvist at adsorbere galdesyrer in vitro og må forventes at nedsætte koncentrationerne af cholsyre på samme måde som galdesyresekvestranter.
English: Other medicines and Kolbam
Danish: Brug af anden medicin sammen med Kolbam
English: Treatment with cholic acid in patients with pre-existing hepatic impairment should be given under close monitoring and, for all patients should be stopped in case of abnormal hepatocellular function, as measured by prothrombin time, if hepatocellular function does not improve within 3 months of the initiation of cholic acid treatment.
Danish: Behandling med cholsyre hos patienter med eksisterende nedsat leverfuntkion skal udføres under nøje overvågning, og bør for alle patienter seponeres, hvis der forekommer abnorm levercellefunktion, målt ved protrombintid, hvis den ikke bedres efter 3 måneders behandling med cholsyre.
English: There is insufficient information on the excretion of cholic acid and its metabolites in human milk.
Danish: Amning Der foreligger ikke tilstrækkelige data om udskillelse af cholsyre og dets metabolitter i modermælk.
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.
Danish: Medfødte fejl i den primære galdesyresyntese skyldes defekter i de primære enzymer, der katalyserer de vigtigste reaktioner i syntesen af cholsyre og chenodeoxycholsyre.
English: How to store Kolbam 6.
Danish: Sådan skal du bruge Kolbam 4.
English: MedDRA System Organ Class
Danish: Systemorganklasse i henhold til
English: Packs containing 90 capsules.
Danish: Pakningerne indeholder 90 kapsler.
English: Phenobarbital has been shown to increase the pool size and turnover of cholic acid and therefore has an antagonistic effect to the desired action of cholic acid in patients.
Danish: Phenobarbital er påvist at øge poolstørrelsen og omsætningen af cholsyre og virker derfor antagonistisk på den ønskede terapeutiske virkning af cholsyre.
English: Distribution and pharmacological effects of bile acids such as cholic acid are mainly limited to the enterohepatic circulation, which includes the intestine, portal vein, liver and biliary tract.
Danish: Fordeling og farmakologiske virkninger af galdesyrer såsom cholsyre er hovedsagelig begrænset til det enterohepatiske kredsløb, der omfatter tarmene, vena portae, leveren og galdevejene.
English: Regarding primary diagnoses, shifts towards improvements in ALT and AST values were shown in individual defect groups.
Danish: For de primære diagnoser påvistes forbedringer i ALT- og AST-værdierne i nogle defektgrupper.
English: Elderly patients (older than 65 years) The safety and efficacy of cholic acid in elderly patients has not been established.
Danish: Ældre patienter (> 65 år) cholsyre sikkerhed og virkning hos ældre patienter er ikke fastlagt.
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Danish: Ved dosisreduktion svandt de kliniske symptomer, og de abnorme laboratorieparametre normaliseredes.
English: Jaundice Increased serum transaminases Gallstones
Danish: Forhøjede serumtransaminaser Galdesten
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.
Danish: Serumtransaminaser var under ULN hos de fleste patienter (71-100 %) ved baseline, og hos de fleste patienter (86 %) ved den dårligste vurdering efter baseline, og hos alle patienter (100 %) ved den bedste vurdering efter baseline.
English: 50 mg Capsule shell Gelatin
Danish: 50 mg kapsel Gelatine
English: Ciclosporin may affect the levels of cholic acid.
Danish: Ciclosporin kan påvirke koncentrationen af cholsyre.
English: Try to ensure that if any of the dose is spat out or refused, it is given again.
Danish: Hvis barnet spytter noget af lægemidlet ud eller ikke vil have det, skal du prøve at give det igen.
English: Preferred Term Frequency
Danish: Foretrukken betegnelse
English: Available data in animals have shown excretion of cholic acid in milk (see section 5.3).
Danish: De foreliggende data fra dyreforsøg har vist, at cholsyre udskilles i mælk (se pkt.
English: Pack sizes: 90 capsules.
Danish: Pakningsstørrelser: 90 kapsler.
English: Of all the patients treated in Study CAC-91-10-10, 49 patients presented with a single enzyme defect.
Danish: 49 af alle de patienter, der blev behandlet i undersøgelse CAC-91-10-10, havde en enkeltenzymdefekt.
English: See under ‘Other medicines and
Danish: Se under ”Brug af anden medicin sammen med Kolbam”
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.
Danish: Der foreligger ingen data om behandling med cholsyre hos patienter med medfødte defekter i galdesyremetabolismen og leverfunktionsnedsættelse uden sammenhæng med den primære sygdom.
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (Gamma GT) transaminases and serum bile acid concentrations.
Danish: Laboratorietest viste forhøjede serumværdier af gammaglutamyltransferase (GGT), transaminaser og galdesyrer.
English: Of the 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.
Danish: Af de 49 patienter med en enkeltenzymdefekt, der blev behandlet i undersøgelse CAC-91-10-10 og indgik i sikkerhedsanalysen, fik 42 før og efter behandlingen foretaget mindst én undersøgelse for galdesyrer i urinen og leverfunktionstest, højde og vægt indgik i den primære analyse af virkning.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det drejer sig om en sjælden sygdom.
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.
Danish: Undersøgelse CAC-002-01, (en åben, urandomiseret enkeltcenter-fortsættelsesundersøgelse af cholsyre-kapsler hos patienter med medfødte fejl i galdesyresyntesen) var fortsættelsen af undersøgelse CAC-91-10-10 og begyndte den 1. januar 2010.
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.
Danish: Behandling med oral cholsyre stimulerer galdeflow og -udskillelse, hæmmer produktion og akkumulation af hepatotoksiske og kolestatiske galdesyreprækursorer og fremmer fedtoptagelsen uden toksiske bivirkninger ved terapeutiske doser.
English: In this manner the vast majority of the bile acid pool is conserved and will cycle multiple times during feeding.
Danish: Poolen af galdesyrer bliver derved for langt størstedelen opretholdt og gennemløber en række cyklusser under fødeindtagelse.
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).
Danish: Tag ikke Kolbam - hvis du er allergisk over for cholsyre eller et af de øvrige indholdsstoffer i Kolbam (angivet i afsnit 6) - hvis du tager phenobarbital, som er et lægemiddel mod epilepsi.
English: Concurrent elevation of serum gamma glutamyltransferase (Gamma GT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose.
Danish: Hvis serumværdierne af gammaglutamyltransferase (GGT), alaninaminotransferase (ALT) og/eller serumgaldesyrer samtidig er over normalværdierne, kan det være tegn på overdosering.
English: The efficacy analysis also demonstrated that treatment with cholic acid significantly improved ALT and AST values for patients stratified by single enzyme defects.
Danish: Analysen af virkning viste ligeledes, at cholsyre medførte signifikant bedring i ALT og AST for patienter stratificeret efter enkeltenzymdefekter.
English: • Sterol 27-hydroxylase deficiency (presenting as CTX)
Danish: • Sterol 27-hydroxylasemangel (fremtræder som CTX)
English: Any medicinal products implicated in drug-induced cholestasis through inhibition of transporters could reduce the effectiveness of cholic acid treatment on coadministration.
Danish: Ethvert lægemiddel, der medvirker til kolestase ved at hæmme transportproteiner, kan ved koadministration nedsætte virkningen af cholsyre.
English: Skin and subcutaneous tissue disorders Skin lesion Pruritus
Danish: Hud og subkutane væv
English: Reflux esophagitis
Danish: Refluksøsofagitis
English: It is recommended that cholic acid is taken with food (see section 4.2).
Danish: Det anbefales, at cholsyre indtages sammen med et måltid (se pkt.
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.
Danish: Lægemiddelinteraktioner med cholsyre omfatter hovedsagelig lægemidler, der kan blokere det enterohepatiske kredsløb af galdesyrer såsom sekvestreringsmidlerne colestyramin, colestipol og colesevelam.
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.
Danish: Cholsyre nedregulerer biosyntesen af galdesyrer via aktivering af farnesoid X-receptoren, der bevirker repression af transskriptionen af CYP7A1-genet, der koder for kolesterol-7α-hydroxylase, som er det hastighedsbegrænsende enzym i galdesyresyntesen.
English: Therapeutic efficacy and safety of cholic acid treatment in patients with inborn errors of bile acid metabolism were evaluated.
Danish: I undersøgelsen vurderedes den terapeutiske virkning og sikkerhed af behandlingen med cholsyre hos patienter med medfødte fejl i galdesyremetabolismen.
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).
Danish: Af disse 53 behandlede patienter havde 41 (77 %) forstyrrelser i den primære galdesyresyntese, herunder sterol 27-hydroxylasemangel (fremtræder som CTX- (n=8) og AMACR-mangel (n=1)
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med lægen eller apotekspersonalet.
English: Kolbam'.
Danish: Se pkt.
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.
Danish: Hvis du holder op med at tage det, kan der igen blive ophobet abnorme stoffer i din galde i en mængde som før du kom i behandling.
English: • Sterol 27-hydroxylase deficiency (presenting as CTX; n=5)
Danish: • Sterol 27-hydroxylasemangel (fremtræder som CTX) (n=5)
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.
Danish: Den farmakodynamiske virkning af cholsyre er feedbackhæmning af syntesen af toksiske biosyntetiske partielle galdesyreprodukter, der dannes ved blokeringer i den normale galdesyresyntese.
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.
Danish: De fleste patienter med medfødte defekter i galdesyremetabolismen havde på diagnosetidspunktet nogen leverfunktionsnedsættelse; hos størstedelen resulterede behandlingen i, at leverfunktionsnedsættelsen bedredes eller svandt.
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.
Danish: Østrogener, orale antikonceptiva og clofibrat (og muligvis andre lipidsænkende stoffer), øger den hepatiske kolesterolsekretion, og fremmer dannelse af kolesterolgaldesten og modvirker derved virkningen af cholsyre.
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.
Danish: Ciclosporin ændrer cholsyres farmakokinetik ved at hæmme den hepatiske optagelse og hepatobiliære sekretion af galdesyrer og ændrer desuden dens farmakodynamik ved at hæmme kolesterol7α-hydroxylase.
English: Concurrent with the disappearance of atypical bile acid metabolites, there is a consistent reduction and normalization in serum liver enzymes.
Danish: Samtidig med, at de atypiske galdesyremetabolitter forsvinder, ses en tilsvarende reduktion og normalisering af leverenzymværdierne i serum.
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.
Danish: Den konjugerede cholsyre udskilles i galden og føres til tyndtarmen, hvor den sammen med de øvrige komponenter i galden varetager sin hovedfunktion i fordøjelsen.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irland
English: Silicified microcrystalline cellulose
Danish: Cellulose, mikrokrystallinsk, silicificeret Magnesiumstearat
English: Patients with newly diagnosed or a family history of familial hypertriglyceridaemia are expected to poorly absorb cholic acid from the intestine.
Danish: Patienter med nydiagnosticeret eller familiær hypertriglyceridæmi må forventes at absorbere cholsyre dårligt fra tarmen.
English: Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Danish: I perioder med hurtig vækst, sygdom eller graviditet foretages supplerende eller hyppigere undersøgelser til monitorering af behandlingen (se pkt.
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.
Danish: Hos patienter med CTX (n=3) var niveauet af galdesyrer i urinen ved baseline normalt hos 1 patient og forhøjet hos 2 patienter, forhøjet for alle patienter i analysen med dårligste værdi efter behandling og normalt i den bedste vurdering efter baseline hos alle 3 patienter.
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.
Danish: Af de 52 ovennævnte patienter, der indgik i den 17 år lange undersøgelse CAC-91-10-10, afgik de 6 ved døden, 3 viste ingen tegn på behandlingen, 4 udgik af undersøgelsen, 10 blev tabt for opfølgning, og for 1 lykkedes det ikke at skaffe oplysninger.
English: Orally administered cholic acid is absorbed by passive diffusion along the length of the gastrointestinal tract.
Danish: Oralt administreret cholsyre absorberes ved passiv diffusion fra hele mave-tarmkanalen.
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.
Danish: I undersøgelse CAC-91-10-10 viste analysen af virkning, at cholsyre medførte væsentlig bedring (i form af nedsat) galdesyreudskillelse i urinen hos patienter med enkeltenzymdefekter.
English: It is recommended that cholic acid is taken with food (see section 4.5) at approximately the same time each day, in the morning and/or evening.
Danish: 4.5) på omtrent samme klokkeslæt hver dag, morgen og/eller aften.
English: WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOLBAM
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE Kolbam
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.
Danish: Til spædbørn og børn, der ikke kan synke kapsler, skal du åbne kapslen ved at vride den forsigtigt og hælde indholdet i modermælkserstatning, udmalket modermælk eller frugtmos i en ren skål.
English: Phenobarbital may stop cholic acid from working.
Danish: Phenobarbital kan standse virkningen af cholsyre.
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.
Danish: Anvendelse af cholsyre under graviditet kan overvejes, hvis lægen skønner, at fordelene for patienten overstiger den mulige risiko.
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.
Danish: Til spædbørn kan indholdet blandes med modermælkserstatning, udmalket modermælk eller frugtmos, og til børn under seks år blandes i f.eks. kartoffelmos eller æblemos.
English: Treatment with exogenous cholic acid is intended to replace physiological bile acid in cases of inborn errors of bile acid synthesis.
Danish: Behandlingen med eksogen cholsyre har til formål at erstatte den fysiologiske galdesyre ved medfødte fejl i galdesyresyntesen.
English: Therefore use of phenobarbital in patients treated with cholic acid is contraindicated (see section 4.3).
Danish: Phenobarbital er derfor kontraindiceret ved behandling med cholsyre (se pkt.
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.
Danish: Af de 41 ovennævnte patienter, der blev behandlet i undersøgelse CAC-002-01 seponerede 13 patienter behandlingen, 8 som følge af bivirkninger, 1 som følge af manglende virkning/tab af virkning, 1 var tabt for opfølgning og 3 trak deres samtykke tilbage.
English: MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irland