FrancophonIA/ELRC3.0 huggingface dataset:
English: Cholic acid is one of the primary bile acids in man on which essential physiological functions depend.
Danish: Cholsyre er hos mennesket en af de primære galdesyrer, som essentielle fysiologiske funktioner afhænger af.
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State.
Danish: Før markedsføring i hver medlemsstat skal indehaveren af markedsføringstilladelsen træffe aftale om det endelige uddannelsesprogram med de nationale kompetente myndigheder.
English: If you stop taking Kolbam
Danish: Hvis du holder op med at tage Kolbam
English: Some of the primary defects include but are not limited to:
Danish: Nogle af de primære defekter er bl.a.:
English: No interaction studies with cholic acid and concomitantly administered medicinal products or food have been carried out.
Danish: Der er ikke udført interaktionsundersøgelser med cholsyre og samtidigt administrerede lægemidler eller fødemidler.
English: Do not store above 30°C.
Danish: Må ikke opbevares over 30° C.
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.
Danish: Overvågning af den langsigtede sikkerhed og virkning hos patienter behandlet med Kolbam gennem et patientregister, som nærmere beskrives i risikostyringsplanen.
English: The events were transitory and generally did not interfere with the therapy.
Danish: Bivirkningerne var forbigående og medførte sædvanligvis ikke ændringer i behandlingen.
English: The limited data from animal studies do not indicate direct reproductive toxicity (see section 5.3).
Danish: De begrænsede foreliggende data fra dyreforsøg tyder ikke på reproduktionstoksicitet (se pkt 5.3).
English: Return any unused medicine to your pharmacist for disposal
Danish: Ikke anvendt lægemiddel skal returneres til apoteket til bortskaffelse
English: See the end of section 4 for how to report side effects.
Danish: Sidst i afsnit 4 er det beskrevet, hvordan du kan indberette bivirkninger.
English: No formal preclinical safety studies have been conducted; however, data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: De tilgængelige data i litteraturen viser imidlertid ingen særlig risiko for mennesker vurderet ud fra undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Cases of severe hepatotoxicity, including cases with fatal outcome, have been reported with the use of cholic acid.
Danish: Tilfælde af svær hepatotoksicitet, herunder tilfælde med dødeligt udfald, er blevet rapporteret ved anvendelsen af cholsyre.
English: The relevance of animal data with regards to cholic acid therapy safety is uncertain due to the known high inter-animal variability of bile acid homeostasis.
Danish: Relevansen af dyreforsøg for sikkerheden af behandling med cholsyre er usikker på grund af den kendte høje variation i galdesyrehomøostase dyrene imellem.
English: Where the dose calculated is not a multiple of 50, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to suppress urinary bile acids.
Danish: Er den beregnede dosis ikke et multiplum af 50, vælges nærmeste dosis lavere end den maksimale dosis på 15 mg/kg/dag, forudsat at den er tilstrækkelig til at undertrykke galdesyrer i urinen.
English: 90 capsules.
Danish: 90 kapsler.
English: Among the subgroup of patients with CTX (n=8), 3 transitioned from CAC-91-10-10 and were on cholic acid treatment at study start.
Danish: Blandt undergruppen af patienter med CTX (n=8) overgik 3 fra CAC-91-10-10, og var i behandling med cholsyre ved undersøgelsens start.
English: The concentrations of the abnormal bile acid metabolites synthesised subsequently should be determined.
Danish: Der bør foretages bestemmelse af koncentrationerne af de abnorme galdesyremetabolitter, der efterfølgende dannes.
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.
Danish: Patienter, der tidligere er behandlet med andre galdesyrer eller andre cholsyrepræparater, bør overvåges tæt på samme måde under initiering af behandling med Kolbam.
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.
Danish: Statistisk signifikante ændringer blev observeret i analysen fra baseline til bedste værdi efter baseline for galdesyrer i urinen, med betydelige reduktioner i markante, signifikante og lette anomalier, samt forhøjelser i normale spektre.
English: There is a theoretical possibility that administration of food may increase cholic acid bioavailability and improve tolerability.
Danish: Teoretisk kan administration sammen med et måltid tænkes at øge cholsyres biotilgængelighed og forbedre tolerabiliteten.
English: Pharmacotherapeutic group: Bile and liver therapy, bile acid preparations; ATC code: A05AA03
Danish: Farmakoterapeutisk klassifikation: Galde- og leverbehandling, galdesyrepræparater, ATC-kode: A05AA03
English: The lowest dose of cholic acid that effectively reduces the bile acid metabolites to as close to zero as possible should be chosen.
Danish: Der bør vælges den laveste dosis af cholsyre, som effektivt bringer galdesyremetabolitterne så tæt på nul som muligt.
English: General improvements in the degree of atypical urine bile acids were also seen in individual defect groups.
Danish: Generel bedring i mængden af atypiske galdesyrer i urinen sås ligeledes i nogle defektgrupper.
English: Of these 85 patients, 52 presented with disorders in primary bile acid synthesis including the following 3 single enzymes:
Danish: Af de 85 patienter havde 52 forstyrrelser i den primære galdesyresyntese, herunder følgende 3 enkeltenzymer:
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).
Danish: Ved terapeutiske doser forventes ikke virkninger på det nyfødte brystbarn, da den systemiske eksponering af den ammende moder for cholsyre er ubetydelig (se pkt.
English: Mixing of the capsule contents is designed to mask any unpleasant taste which results from the capsules being opened but no data on the compatibility or palatability are available.
Danish: Iblandingen af kapslens indhold skal skjule ubehagelig smag som følge af, at kapslerne åbnes, men der foreligger ikke oplysninger om forligelighed eller velsmag.
English: In Study CAC-002-01 for patients overall with single-enzyme defects, urinary bile acids and serum transaminases did not change significantly from baseline to worst post-baseline value.
Danish: I undersøgelse CAC-002-01 hos patienter med enkeltenzymdefekter ændrede galdesyrer i urinen og serumtransaminaser sig ikke samlet set signifikant fra baseline til dårligste værdi efter baseline.
English: Biliary bile alcohols and bile acids show remarkable structural diversity across animal species.
Danish: Biliære alkoholer og galdesyrer udviser bemærkelsesværdig artsvariation hos dyr.
English: There are no data on the effects of cholic acid on fertility.
Danish: Der foreligger ingen data om virkningerne af cholsyre på fertiliteten.
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om Kolbam, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: A total of 79 patients received cholic acid treatment, 49 of these suffered from a primary enzyme defect.
Danish: I alt 79 patienter blev behandlet med cholsyre, hvoraf 49 havde en primær enzymdefekt.
English: There are limited safety data from the use of cholic acid in pregnant women.
Danish: Der foreligger kun begrænsede data om anvendelse af cholsyre hos gravide kvinder.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET
English: There are a limited number of studies that have demonstrated that cholic acid administered orally for up to 26 weeks at doses significantly greater than the therapeutic dose, was well tolerated in animals with no mortalities, no effects on bodyweight or food consumption and no evidence of significant macroscopic or microscopic findings in the liver.
Danish: Et begrænset antal undersøgelser har vist, at oral administration af cholsyre i op til 26 uger ved doser væsentligt over den terapeutiske dosis var veltolereret hos dyr uden dødsfald og uden virkning på kropsvægt eller fødeindtagelse og ikke gav anledning til nævneværdige makroskopiske eller mikroskopiske fund i leveren.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER SÆRLIGE OMSTÆNDIGHEDER
English: • CYP7A1 deficiency
Danish: • CYP7A1-mangel
English: The clinical experience reported is from a patient population with disorders in primary bile acid synthesis that includes principally infants from the age of one month, children and adolescents.
Danish: De beskrevne kliniske erfaringer omfatter en patientpopulation med forstyrrelser i syntesen af primære galdesyrer, hovedsagelig spædbørn over en måned, børn og unge.
English: Mild nausea Mild reflux Moderate diarrhoea
Danish: Let kvalme Let refluks Moderat diarré
English: Cholic acid is not mutagenic; however, co-administration of cholic acid with known carcinogens has shown increased tumour formation compared to the known carcinogen alone.
Danish: Cholsyre er ikke mutagen, men koadministration af cholsyre med kendte karcinogener har vist større tumordannelse end med det pågældende karcinogen alene.
English: These are some of the medicines that may affect the way in which Kolbam works:
Danish: Nedenfor er angivet nogle af de lægemidler, der påvirker den måde, Kolbamvirker på:
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til <
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: By replacing the missing cholic acid it stimulates the production of normal bile and helps prevent the build-up of the abnormal substances in the liver.
Danish: Ved at erstatte den manglende cholsyre stimulerer det den normale galdeproduktion og forhindrer ophobningen af de abnorme stoffer i leveren.
English: Do not take any phenobarbital while you are on cholic acid.
Danish: Tag ikke phenobarbital, når du får cholsyre.
English: Slightly increased blood pressure was evident in rats after 30 days of cholic acid at approximately 4-fold therapeutic dose with increased vasoconstrictor responses to noradrenaline, together with decreased levels of aldosterone and increased corticosterone, but no adverse clinical signs were observed.
Danish: Hos rotter sås let forhøjet blodtryk efter 30 dages behandling med cholsyre ved ca. 4 gange den terapeutiske dosis, med forhøjet vasokonstriktorrespons på noradrenalin foruden fald i aldosteron og stigning i kortikosteroider, men der blev ikke iagttaget negative kliniske tegn.
English: The effect of food on the bioavailability of cholic acid has not been studied.
Danish: Virkningen af fødeindtagelse på cholsyres biotilgængelighed er ikke undersøgt.
English: • AMACR deficiency (n=1)
Danish: • AMACR-mangel (n=1)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Kapselindhold
English: Children Cholic acid has not been studied for safety and effectiveness in babies under one month of age.
Danish: Børn Cholsyre er ikke undersøgt for sikkerhed og virkning hos spædbørn under 1 måned.
English: INFORMATION IN BRAILLE Kolbam 50 mg
Danish: INFORMATION I BRAILLESKRIFT Kolbam 50 mg
English: If your doctor considers it necessary that you keep taking ciclosporin, he will closely monitor the levels of bile acids in your blood and urine and adjust the dose of cholic acid accordingly.
Danish: Hvis lægen finder det nødvendigt, at du fortsætter med at få ciclosporin, vil han nøje overvåge indholdet af galdesyre i blod og urin og afpasse din dosis af cholsyre derefter.
English: • Slight tingling (pruritus)
Danish: • Let kløe (pruritus)
English: Cholic acid will pass to the liver in the portal blood, in which it is moderately bound to albumin.
Danish: Cholsyre tilføres leveren i portalblodet, hvor den er moderat bundet til albumin.
English: Affected patients often present with significant comorbidities, including CNS impairment, which would not be treated by addressing the bile defect effects.
Danish: De berørte patienter har ofte komorbiditet af væsentligt omfang, herunder nedsat CNS-funktion, som ikke behandles ved korrektion af virkningerne af galdesyredefekten.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter og -tiltag, der er fastsat i den vedtagne risikostyringsplan, som fremgår af modul 1.8.2 af markedsføringstilladelsen, samt alle efterfølgende vedtagne ajourføringer af risikostyringsplanen.
English: If you forget to take Kolbam
Danish: Hvis du har glemt at tage Kolbam
English: Administration of a single dose of cholic acid intravenously to pregnant ewes in late gestation demonstrated systemic exposure of cholic acid in the foetus with no effect on either the mother or the foetuses other than an increase in early deliveries.
Danish: Intravenøs administration af en enkelt dosis cholsyre til drægtige får sent i drægtighedsperioden viste systemisk eksponering for cholsyre af fostret uden virkning på hverken moderdyret eller fostret bortset fra en stigning i tidlig læmning.
English: It is recommended that the capsules are taken with food, as this may help to make the cholic acid more effective, and also reduces the likelyhood of diarrhoea.
Danish: Det anbefales at tage kapslerne med et måltid, da det kan fremme virkningen af cholsyre og mindsker sandsynligheden for diarré.
English: Gallstones have been reported after long-term therapy.
Danish: Galdesten er beskrevet efter langvarig behandling.
English: These increase cholesterol production in the liver and as a result prevent cholic acid from working properly.
Danish: Disse lægemidler øger kolesterolproduktionen i leveren og forhindrer derved cholsyre i at virke korrekt.
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.
Danish: Virkningen blev påvist på to måder: (a) Behandling med cholsyre resulterer i forbedret leverfunktion, hvilket kan påvises ved bedring i leverfunktionstest, (b) Fast Atom Bombardment-Mass Spectrometry (FAB-MS)-data viste virkning ved, at cholsyre medførte suppression af de abnorme galdesyrer i urinen, der ledte til den oprindelige diagnose.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen indsender den første PSUR for dette lægemiddel inden for seks måneder efter godkendelsen.
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.
Danish: Den anbefalede dosering af cholsyre til behandling af medfødte fejl i den primære galdesyresyntese er 10-15 mg/kg/dag, enten som en enkeltdosis eller fordelt på flere doser, både til voksne og pædiatriske patienter.
English: Elderly Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.
Danish: Ældre: Cholsyre er ikke undersøgt for sikkerhed og virkning hos personer over 65 år.
English: This mixing of the capsule contents with food should mask any unpleasant taste of the medicine.
Danish: Ved at blande kapselindholdet med føde skulle ubehagelig smag fra lægemidlet kunne undgås.
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.
Danish: Formålet med at substituere manglende cholsyre er at genoprette denne galdesyres hovedfunktioner, der består i transport af lipider som blandede miceller, aktivering af co-lipase, fedtfordøjelse og -absorption, absorption af fedtopløselige vitaminer og induktion af galdeflow og dermed forhindre kolestase.
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.
Danish: Hvid 185 ml HDPE-flaske, induktionsforseglet med 38 mm hvidt børnesikret låg bestående af riflet skruelåg af HDPE foret med induktionsforsegling (karton, voks og aluminiumfolie).
English: Mild peripheral neuropathy
Danish: Let perifer neuropati Almindelig
English: INFORMATION IN BRAILLE Kolbam 250 mg
Danish: INFORMATION I BRAILLESKRIFT Kolbam 250 mg
English: • Increase liver enzymes (serum transaminases)
Danish: • Forhøjede leverenzymer (serumtransaminaser)
English: Within the liver, cholic acid is amidated in species-specific proportions, with glycine and/or taurine, into a more hydrophilic, conjugated form.
Danish: I leveren bliver cholsyre i artsspecifikt omfang amideret med glycin og/eller taurin til en mere hydrofil, konjugeret form.
English: Pregnancies with normal outcomes have been reported in women taking cholic acid.
Danish: Der er beskrevet graviditeter med normalt udfald hos kvinder i behandling med cholsyre.
English: Study CAC-91-10-10, (Investigation in the pathogenesis of liver disease in patients with inborn errors of bile acid metabolism) was conducted from 1992-2009 to evaluate the therapeutic efficacy and safety of cholic acid to treat patients with identified inborn errors of bile acid metabolism.
Danish: Undersøgelse CAC-91-10-10, (undersøgelse af patogenesen af leversygdom hos patienter med medfødte fejl i galdesyremetabolismen) blev udført 1992-2009 med det formål at vurdere den terapeutiske virkning og sikkerhed af cholsyre ved behandling af patienter med manifeste medfødte fejl i galdesyremetabolismen.
English: In case of persistent lack of therapeutic response to cholic acid monotherapy, other treatment options should be considered, see section 4.4.
Danish: Ved vedvarende manglende terapeutisk respons på monoterapi med cholsyre bør andre behandlingsmuligheder overvejes (se pkt.
English: Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol.
Danish: Der er beskrevet forhøjet levervægt og galdesten i undersøgelser med gentagen dosering, hvor cholsyre blev koadministreret med kolesterol.
English: Adverse reactions reported in the literature are pruritus and increased serum transaminases in one or two children treated with high doses of cholic acid; however, these adverse reactions disappeared with a reduced dosage.
Danish: I litteraturen er beskrevet bivirkninger i form af pruritus og forhøjede serumtransaminaser hos et eller to børn, der blev behandlet med høje doser af cholsyre; bivirkningerne forsvandt imidlertid ved dosisreduktion.
English: Any cholic acid not absorbed will be excreted in the faeces, either unchanged or following dehydroxylation via bacterial metabolism.
Danish: Ikke-absorberet cholsyre udskilles i fæces, enten uændret eller efter dehydroxylering ved bakteriel metabolisering.
English: Concomitant use with phenobarbital (see section 4.5).
Danish: Anvendelse samtidig med phenobarbital (se pkt.
English: During the initiation of therapy and dose adjustment, serum and urine bile acid levels should be monitored intensively by using suitable analytical techniques.
Danish: Ved behandlingsstart og dosisjustering bør galdesyreindholdet i serum og urin monitoreres nøje ved at anvende en egnet analytisk teknik.
English: In the body cholic acid is naturally produced in the liver and is part of the bile, a fluid that helps digestion and absorbs fat and vitamins from the food.
Danish: I kroppen dannes cholsyre naturligt i leveren og er en del af galden, en væske, der medvirker til fordøjelse og optagelse af fedtstoffer og vitaminer fra føden.
English: In these cases, serum/bile levels of cholic acid should be closely monitored and the dose adjusted accordingly.
Danish: I sådanne tilfælde bør koncentrationen af cholsyre i serum/galde overvåges tæt, og dosis tilpasses i henhold hertil.
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.
Danish: Ved hver af de defekter i primære galdesyrer, der skyldes enzymdefekter i biosyntesen, bevirker fraværet af primære galdesyrer, at der opstår kolestase og ureguleret akkumulation af toksiske galdesyreprækursorer.
English: • CYP7A1 deficiency (n=1)
Danish: • CYP7A1-mangel (n=1)
English: Transient elevations of transaminases at the initiation of cholic acid treatment have been observed and do not indicate the need for a dose reduction if Gamma GT is not elevated and if serum bile acid levels are falling or in the normal range.
Danish: Ved initiering af behandling med cholsyre er iagttaget forbigående forhøjede transaminaser, som dog ikke nødvendiggør dosisreduktion, hvis gamma-GT ikke er forhøjet og serumværdierne af galdesyrer er faldende eller inden for normalområdet.
English: In the liver, cholic acid is extracted from portal blood by multiple mechanisms, including passive diffusion and transporters.
Danish: I leveren ekstraheres cholsyre fra portalblodet ved en række mekanismer bestående i passiv diffusion og transportproteiner.
English: In growing infants, treatment with cholic acid helps with the normal development of the liver and bile circulation system.
Danish: Hos børn fremmer behandling med cholsyre under opvæksten den normale udvikling af lever og galdeveje.
English: • AMACR deficiency
Danish: • AMACR-mangel
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.
Danish: Den havde et åbent, urandomiseret design med en enkelt forsøgsarm og omfattede egnede patienter, der tidligere var blevet behandlet med cholsyre i CAC-91-10-10 og CAC-001-01, samt nydiagnosticerede patienter.