FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical features were limited to pruritus and diarrhoea.
Danish: Kliniske symptomer var begrænset til pruritus og diarré.
English: • Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
Danish: • Ordinering af en supraterapeutisk dosis (MedDRA-term: lægemiddeltoksicitet) • Risiko for galdesten
English: Several patients have experienced itching and/or diarrhoea, however, it is not known how likely this is to occur (frequency cannot be estimated from the available data).
Danish: Flere patienter har oplevet kløe og/eller diarré, men det vides ikke, hvor sandsynligt det er, at det sker (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: The available literature is not sufficient to detect a difference in the safety of cholic acid within paediatric age groups or between paediatric patients and adults.
Danish: Den tilgængelige litteratur er ikke tilstrækkelig til at påvise en forskel i cholsyres sikkerhed indenfor den pædiatriske aldersgruppe eller mellem pædiatriske patienter og voksne.
English: You should never stop taking Orphacol unless your doctor advises you to do so.
Danish: Du må aldrig holde op med at tage Orphacol, medmindre lægen siger det.
English: The exposed pregnancies showed no adverse reactions to cholic acid and resulted in normal, healthy children.
Danish: De eksponerede graviditeter viste ingen bivirkninger ved brug af cholsyre og resulterede i normale, sunde børn.
English: Cholic acid and its metabolites are excreted in human milk, but at therapeutic doses of Orphacol, no effects on the breastfed newborns/infants are anticipated.
Danish: Cholsyre og dennes metabolitter udskilles i human mælk, men ved terapeutiske doser af Orphacol forventes der ingen indvirkning på ammede nyfødte/spædbørn.
English: Women of childbearing potential should conduct a pregnancy test as soon as a pregnancy is suspected.
Danish: Kvinder i den fertile alder bør få udført en graviditetstest, så snart der er mistanke om graviditet.
English: Before treatment your doctor will make an assessment from your laboratory tests to determine the correct dose for you.
Danish: Før behandlingen vurderer din læge dine laboratorieprøver for at se, hvilken dosis der passer til dig.
English: At therapeutic doses, no effect on fertility is anticipated.
Danish: Ved terapeutiske doser forventes der ingen virkning på fertiliteten.
English: In the absence of treatment, unphysiologic cholestatic and hepatotoxic bile acid metabolites are predominant in the liver, serum and urine.
Danish: Uden behandling vil ufysiologiske cholestatiske og hepatotoksiske galdesyremetabolitter dominere i lever, serum og urin.
English: Phenobarbital antagonises the effect of cholic acid.
Danish: Phenobarbital antagoniserer virkningen af cholsyre.
English: Orphacol capsules are taken by mouth with a meal at approximately the same time each day, in the morning and/or evening.
Danish: Orphacol-kapsler tages via munden sammen med et måltid og på omtrent samme tid hver dag, om morgenen og/eller om aftenen.
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 Orphacol.
Danish: Patienter, som tidligere er behandlet med andre galdesyrer eller andre cholsyrepræparater, bør nøje monitoreres på samme måde under initiering af behandling med Orphacol.
English: For several patients an increase of liver enzymes (serum transaminases) have been reported during the treatment with Orphacol (frequency cannot be estimated from the available data).
Danish: Der er rapporteret om en stigning i leverenzymer (serum transaminaser) hos flere patienter under behandling med Orphacol (hyppigheden kan ikke vurderes ud fra tilgængelige data).
English: Patients with hepatic impairment should be monitored closely.
Danish: Patienter med nedsat leverfunktion bør derfor monitoreres nøje.
English: Capsules of 50 mg cholic acid are blue and white and capsules of 250 mg cholic acid are green and white.
Danish: Kapslerne med 50 mg cholsyre er blå og hvide, og kapslerne med 250 mg cholsyre er grønne og hvide.
English: The development of pruritus and/or diarrhoea has been observed during treatment with Orphacol.
Danish: Der er observeret udvikling af pruritus og/eller diarré under behandling med Orphacol.
English: The dose must be adjusted for each patient in a specialised unit according to blood and/or urine chromatographic bile acid profiles.
Danish: Doseringen skal tilpasses den enkelte patient på en specialafdeling ifølge blod- og/eller urinkromatografiske galdesyreprofiler.
English: Capsules must be swallowed whole with water, without chewing.
Danish: Kapslerne skal sluges hele med vand og må ikke tygges.
English: Animal studies showed that cholic acid did not induce any teratogenic effect or foetal toxicity.
Danish: Dyreforsøg har vist, at cholsyre ikke fremkalder nogen teratogen virkning eller føtal toksicitet.
English: More than 90% of the primary and secondary bile acids are reabsorbed in the ileum by a specific active transporter and are recycled to the liver by the portal vein; the remainder is excreted in the faeces.
Danish: Mere end 90 % af de primære og sekundære galdesyrer reabsorberes i ileum af et specifikt aktivt transportprotein og sendes til genanvendelse i leveren via vena portae.
English: In all age groups, the minimum dose is 50 mg and the dose is adjusted in 50 mg steps.
Danish: I alle aldersgrupper er minimumsdosis 50 mg, og dosis justeres trinvist 50 mg ad gangen.
English: Pack sizes are available in 30, 60 and 120 capsules.
Danish: Kapslerne fås i pakningsstørrelser med 30, 60 og 120 kapsler.
English: Orphacol capsules must be taken with food at approximately the same time each day, in the morning and/or evening.
Danish: Orphacol-kapsler skal tages sammen med et måltid og på omtrent samme tid hver dag, om morgenen og/eller om aftenen.
English: The effect of food on the bioavailability of cholic acid has not been studied.
Danish: Virkningen af føde på cholsyres biotilgængelighed er ikke undersøgt.
English: During the initiation of therapy and dose adjustment, serum and/or urine bile acid levels should be monitored intensively (at least every three months during the first year of treatment, every six months during the second year) using suitable analytical techniques.
Danish: Ved behandlingsstart og dosisjustering skal serum- og/eller uringaldesyreniveauerne monitoreres nøje (mindst hver tredje måned i det første behandlingsår og hver sjette måned i det andet år) ved hjælp af egnede analyseteknikker.
English: Detailed long-term data on treatment with cholic acid monotherapy are available for 14 patients observed for up to 12.9 years.
Danish: Der foreligger langtidsdata vedrørende behandling med cholsyre som monoterapi for 14 patienter, der har været observeret i op til 12,9 år.
English: This reflects restoration of an effective feedback control of bile acid synthesis and a metabolic equilibrium.
Danish: Det afspejler genopretning af en effektiv feedbackstyring af galdesyresyntesen og en metabolisk ligevægt.
English: Oblong, opaque, blue and white capsule.
Danish: Aflang, uigennemsigtig, blå og hvid kapsel.
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 GGT is not elevated and if serum bile acid levels are falling or in the normal range.
Danish: Der er observeret forbigående forhøjelse af transaminaser ved initiering af behandling med cholsyre, og det indicerer ikke behov for dosisreduktion, hvis GGT ikke er forhøjet, og hvis serumgaldesyreniveauerne er faldende eller inden for normalområdet.
English: Oblong, opaque, green and white capsule.
Danish: Aflang, uigennemsigtig, grøn og hvid kapsel.
English: Cholic acid showed non-significant mutagenic activity in a battery of genotoxicity tests performed in vitro.
Danish: Cholsyre viste ingen signifikant mutagen aktivitet i en række standardgenotoksicitetstest in vitro.
English: If you have taken more Orphacol than you should, contact your doctor as soon as possible.
Danish: Hvis du har taget for mange Orphacol-kapsler, skal du henvende dig til din læge så hurtigt som muligt.
English: Other special populations Please refer to section 4.2 for use of Orphacol in special populations.
Danish: 4.2 om anvendelse af Orphacol hos særlige populationer.
English: A small fraction of bile acids is excreted in urine.
Danish: En lille del af galdesyrerne udskilles i urinen.
English: In addition, blood cholic acid concentration was normal and fat-soluble vitamins were restored to their normal range.
Danish: Desuden var blodcholsyrekoncentrationen normal, og de fedtopløselige vitaminer var indenfor normalområdet.
English: Treatment must be initiated and monitored by an experienced gastroenterologist/hepatologist or a paediatric gastroenterologist/hepatologist in the case of paediatric patients.
Danish: Behandling skal initieres og monitoreres af en erfaren gastroenterolog/hepatolog eller i tilfælde af pædiatriske patienter en pædiatrisk gastroenterolog/hepatolog.
English: There is no need for contraceptive measures in women of childbearing potential treated with cholic acid or their partners.
Danish: Der er ikke behov for antikonception til kvinder i den fertile alder, som er i behandling med cholsyre, eller til deres partnere.
English: Pharmacotherapeutic group: Bile and liver therapy, bile acid and derivatives, ATC code: A05AA03
Danish: Farmakoterapeutisk klassifikation: Galde- og leverbehandling, galdesyre og derivater, ATC-kode: A05AA03
English: These reactions abated after dose reduction and are suggestive of overdose.
Danish: Disse bivirkninger aftog efter dosisreduktion og tyder på overdosering.
English: In case of persistent lack of therapeutic response to cholic acid monotherapy, other treatment options should be considered (see section 4.4).
Danish: I tilfælde af vedvarende mangel på terapeutisk respons på cholsyre som monoterapi bør andre behandlingsmuligheder overvejes (se pkt.
English: Orphacol contains cholic acid, a bile acid which is normally produced by the liver.
Danish: Orphacol indeholder cholsyre, som er en galdesyre, der normalt produceres i leveren.
English: Liver parameters should also be monitored, preferentially more frequently than serum and/or urine bile acid levels.
Danish: Leverparametre bør også monitoreres, helst oftere end serum- og/eller uringaldesyreniveauerne.
English: If administration of ciclosporin is considered necessary, serum and urine bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly.
Danish: Hvis administration af ciclosporin anses for nødvendig, bør serum- og uringaldesyreniveauerne monitoreres nøje, og cholsyredosis justeres derefter.
English: The oral LD50 in mice is 1520 mg/kg.
Danish: Den orale LD50 hos mus er 1520 mg/kg.
English: After the initiation period, serum and/or urine bile acids (using suitable analytical techniques) and liver parameters should be determined annually, at a minimum, and the dose adjusted accordingly.
Danish: Efter initieringsperioden bør serum- og/eller uringaldesyrer (ved hjælp af egnede analyseteknikker) og leverparametre som minimum bestemmes årligt, og dosis tilpasses herefter.
English: The daily dose in infants from 1 month to 2 years of age, children and adolescents ranges from 5 to 15 mg/kg and must be adjusted individually for each patient.
Danish: Den daglige dosis hos spædbørn fra 1 måned til 2 år, børn og unge er 5-15 mg/kg og skal tilpasses individuelt.
English: A concomitant decrease of urine total bile acids should be observed.
Danish: Der bør ses et samtidigt fald i totale uringaldesyrer.
English: There is a theoretical possibility that administration with food may increase cholic acid bioavailability and improve tolerability.
Danish: Der er en teoretisk mulighed for, at administration sammen med et måltid kan øge cholsyrens biotilgængelighed og forbedre tolerabiliteten.
English: Detailed medium- to long-term data are available for 5 of these patients, of whom 1 has been treated with cholic acid monotherapy.
Danish: Der foreligger detaljerede middel- til langtidsdata for 5 af disse patienter, hvoraf 1 blev behandlet med cholsyre som monoterapi.
English: Certain medical conditions are caused by defects in bile acid production and Orphacol is used to treat infants from one month to 2 years of age, children, adolescents and adults with these medical conditions.
Danish: Nogle sygdomme skyldes fejl i galdesyreproduktionen, og Orphacol bruges til at behandle spædbørn fra 1 måned til 2 år, børn, unge og voksne med disse sygdomme.
English: Patients presenting with pruritus and/or persistent diarrhoea should be investigated for a potential overdose by a serum and/or urine bile acid assay (see section 4.9).
Danish: Patienter, som præsenterer sig med pruritus og/eller persisterende diarré, bør undersøges for en potentiel overdosis med en serum- og/eller uringaldeundersøgelse (se pkt.
English: Orphacol contains a certain sugar (lactose monohydrate).
Danish: Orphacol indeholder et bestemt sukkerstof (lactosemonohydrat).
English: Deoxycholic acid is a secondary bile acid.
Danish: Deoxycholsyre er en sekundær galdesyre.
English: Always take Orphacol exactly as your doctor has told you.
Danish: Tag altid Orphacol nøjagtigt efter lægens anvisning.
English: Orphacol is not expected to have an effect on the ability to drive and use machines.
Danish: Orphacol forventes ikke at påvirke evnen til at køre bil eller betjene maskiner.
English: Paediatric population The presented safety information is derived principally from paediatric patients.
Danish: Informationen om sikkerhed ved indtagelse af cholsyre stammer især fra pædiatriske patienter.
English: Development of gallstones associated with long-term treatment have been reported in very limited number of patients.
Danish: Der er rapporteret om udvikling af galdesten i forbindelse med langvarig behandling hos et meget begrænset antal patienter.
English: Tell your doctor if you plan to breast-feed or are breastfeeding before you take Orphacol.
Danish: Fortæl det til lægen, hvis du har planer om at amme eller ammer, før du begynder at tage Orphacol.
English: Mass spectrometry analysis of urine during cholic acid therapy shows the presence of cholic acid and a marked reduction, or even complete elimination of the toxic bile acid metabolites.
Danish: Massespektometrianalyse af urin under behandling med cholsyre viser tilstedeværelse af cholsyre og en markant reduktion, eller endog fuldstændig elimination, af de toksiske galdesyremetabolitter.
English: Increased liver weight and gallstones have been reported in repeated dose studies in which cholic acid was co-administered with cholesterol.
Danish: Forhøjet levervægt og galdesten er rapporteret i undersøgelser med gentagen dosering, hvor cholsyre blev administreret i kombination med kolesterol.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (GGT) transaminases and serum bile acid concentrations.
Danish: Laboratorietests viste forhøjelse af serumgammaglutamyltransferase (GGT), transaminaser og serumgaldesyrekoncentrationer.
English: The intravenous LD50 of cholic acid in mice is 350 mg/kg body weight.
Danish: Den intravenøse LD50 af cholsyre hos mus er 350 mg/kg legemsvægt.
English: Treatment with cholic acid should be stopped if abnormal hepatocellular function, as measured by prothrombin time, does not improve within 3 months of the initiation of cholic acid treatment.
Danish: Behandling med cholsyre bør standses, hvis der forekommer abnorm levercellefunktion målt ved protrombintid, som ikke forbedres senest 3 måneder efter initiering af behandling med cholsyre.
English: Orphacol capsules contain lactose.
Danish: Orphacol-kapsler indeholder lactose.
English: Parenteral administration may cause haemolysis and cardiac arrest.
Danish: Parenteral administration kan forårsage hæmolyse og hjertestop.
English: Cholic acid therapy has been used for infants from one month of age, and for children and adolescents.
Danish: Cholsyrebehandling har været anvendt til spædbørn fra 1-måneds-alderen og til børn og unge.
English: Administration with food may increase cholic acid bioavailability and improve tolerability.
Danish: Administration sammen med et måltid kan øge cholsyrens biotilgængelighed og forbedre tolerabiliteten.
English: In repeated-dose studies, frequently reported effects of cholic acid have included decreased body weight, diarrhoea and liver damage with elevated transaminases.
Danish: I undersøgelser med gentagen dosering har hyppigt rapporterede virkninger af cholsyre omfattet vægttab, diarré og leverskader med forhøjede transaminaser.
English: The following table lists adverse reactions reported in the literature under treatment with cholic acid.
Danish: I følgende tabel er anført de bivirkninger, som er rapporteret i litteraturen ved behandling med cholsyre.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om Orphacol på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: What you need to know before you take Orphacol Do not take Orphacol
Danish: Det skal du vide, før du begynder at tage Orphacol Tag ikke Orphacol
English: Cholic acid, a primary bile acid, is partially absorbed in the ileum.
Danish: Cholsyre, en primær galdesyre, absorberes delvist i ileum.
English: If you stop taking Orphacol
Danish: Hvis du holder op med at tage Orphacol
English: Some medicines used to lower cholesterol levels, so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines to treat heartburn that contain aluminium may lessen the effect of Orphacol.
Danish: Nogle kolesterolsænkende lægemidler, såkaldte galdesyresekvestranter (cholestyramin, colestipol, colesevelam), og lægemidler til behandling af halsbrand, som indeholder aluminium, kan mindske Orphacols virkning.
English: Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxide) bind bile acids and lead to their elimination.
Danish: Galdesyresekvestranter (cholestyramin, colestipol, colesevelam) og visse antacida (f.eks. aluminiumhydroxid) binder galdesyrer og fører til, at de elimineres.
English: Take your next dose when you would normally take it. Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The cholic acid contained in Orphacol replaces the bile acids that are missing due to the defect in bile acid production.
Danish: Cholsyren i Orphacol erstatter de galdesyrer, som mangler på grund af fejlen i galdesyreproduktionen.
English: Other medicines and Orphacol
Danish: Brug af anden medicin sammen med Orphacol
English: Orphacol is available as hard capsules (capsules) of oblong shape.
Danish: Orphacol fås som hårde kapsler (kapsler) med aflang form.
English: No data on the effects of cholic acid on fertility are available.
Danish: Der foreligger ingen data vedrørende virkningen af cholsyre på fertiliteten.
English: Tell your doctor or pharmacist if you are taking, have recently taken any or might take other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Hard capsule(capsule).
Danish: Kapsel, hård (kapsel).
English: Orphacol can be used during breast-feeding.
Danish: Orphacol kan anvendes under amning.
English: If you forget to take Orphacol
Danish: Hvis du har glemt at tage Orphacol
English: The remaining part is transformed by reduction of the 7α-hydroxy group to deoxycholic acid (3α, 12α-dihydroxy) by intestinal bacteria.
Danish: Den resterende del omdannes ved reduktion af 7α-hydroxy-gruppen til deoxycholsyre (3α, 12α-dihydroxy) ved hjælp af tarmbakterier.
English: Concurrent elevation of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose.
Danish: Samtidig forhøjelse af serumgammaglutamyltransferase (GGT), alaninaminotransferase (ALT) og/eller serumgaldesyrer over normale niveauer kan tyde på overdosering.
English: Marketing Authorisation Holder Laboratoires CTRS 63, rue de l'Est
Danish: Laboratoires CTRS 63, rue de l‘Est
English: The dose of bile acid sequestrants or antacids must be separated from the dose of cholic acid by an interval of 5 hours, regardless of which medicinal product is administered first.
Danish: Galdesyresekvestranter eller antacida skal administreres med mindst 5 timers interval, uanset hvilket lægemiddel der administreres først.
English: Your doctor will decide what to do if this happens to you.
Danish: Hvis det sker for dig, vil din læge beslutte, hvad der skal gøres.
English: Oral cholic acid therapy has been shown to: postpone or obviate the need for liver transplantation; restore normal laboratory parameters; improve histological lesions of the liver, and significantly improve all of the patient's symptoms.
Danish: Det er påvist, at oral cholsyrebehandling udsætter eller forhindrer levertransplantation, genopretter normale laboratorieparametre, forbedrer histologiske læsioner i leveren og forbedrer alle patientens symptomer væsentligt.
English: SPECIFIC OBLIGATIONS TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: Δ4-3-Oxosteroid-5β-reductase deficiency
Danish: Δ4-3-oxosteroid-5β-reduktasemangel
English: Orphacol contains lactose
Danish: Orphacol indeholder lactose
English: Gallstones have been reported after long-term therapy with Orphacol.
Danish: Der er rapporteret om galdesten efter langvarig behandling med Orphacol.
English: Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as its pharmacodynamics by inhibition of cholesterol 7α-hydroxylase.
Danish: Ciclosporin ændrer cholsyres farmakokinetik ved at hæmme leverens optagelse og den hepatobiliære sekretion af galdesyre samt dens farmakodynamik ved at hæmme cholesterol 7α-hydroxylase.
English: Cholic acid is the predominant primary bile acid in man.
Danish: Cholsyre er den dominerende primære galdesyre hos mennesket.
English: The cholic acid dose for patients with familial hypertriglyceridemia will have to be established and adjusted as described, but an elevated dose, notably higher than the 500 mg daily limit for adult patients, may be required and safe.
Danish: Cholsyredosis skal for patienter med familiær hypertriglyceridæmi fastsættes og justeres som beskrevet, men en forhøjet dosis, betydeligt højere end den daglige dosisgrænse for voksne patienter på 500 mg, kan være nødvendig og sikker.
English: Excipient(s) with known effect: Lactose monohydrate (66.98 mg per capsule).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Lactosemonohydrat (66,98 mg pr. kapsel).
English: The usual starting dose is 5 to 15 mg per kilogram body weight every day in infants, children, adolescents and adults.
Danish: Den sædvanlige startdosis er 5-15 mg pr. kilo legemsvægt hver dag til spædbørn, børn, unge og voksne.