FrancophonIA/ELRC3.0 huggingface dataset:
English: The events were transitory and did not interfere with the therapy.
Danish: Bivirkningerne var forbigående og påvirkede ikke behandlingen.
English: The correct volumes should preferably be marked on the oral syringe.
Danish: Det korrekte volumen skal helst være markeret på den orale sprøjte.
English: Packs size: 100 capsules
Danish: Pakningsstørrelse: 100 kapsler
English: Disease signs and symptoms resolved, improved or stabilised in a majority of patients over the course of the study.
Danish: Sygdomstegn og symptomer forsvandt, blev forbedret eller blev stabiliseret hos de fleste patienter i løbet af studiet.
English: The hard capsules should be taken whole with sufficient water at approximately the same time each day.
Danish: Kapslerne skal synkes hele med tilstrækkeligt vand på omtrent samme tidspunkt hver dag.
English: The doctor will decide how many times and when your child should receive the dose(s) to make up the total dose for the day.
Danish: Lægen beslutter, hvor mange gange og hvornår dit barn skal have dosen eller doserne for at få en hel dagsdosis.
English: Constipation not known
Danish: Obstipation ikke kendt
English: No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Der er ikke udført formelle prækliniske sikkerhedsstudier, men data fra litteraturen viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter enkeltdosis og efter gentagne doser, genotoksicitet og karcinogenicitet.
English: The capsules should be swallowed whole with water at approximately the same time each day.
Danish: Kapslerne skal synkes hele med vand på omtrent samme tidspunkt på dagen.
English: Two intrauterine deaths in a mother with CTX have been reported in the literature.
Danish: 2 intrauterine dødsfald hos mødre med CTX er beskrevet i litteraturen.
English: 80538 Munich
Danish: 80538 München
English: Neonates less than one month of age
Danish: Nyfødte under 1 måned
English: The doctor should provide information on the dose to be received according to the weight of the child.
Danish: Lægen skal oplyse om den dosis, der skal gives i henhold til barnets vægt.
English: • phenobarbital (a medicine used for epilepsy)
Danish: • phenobarbital (et lægemiddel mod epilepsi)
English: Due to the rarity of CTX, the available literature is not sufficient to detect a difference in the safety of chenodeoxycholic acid within paediatric age groups or between paediatric patients and adults.
Danish: Da CTX er sjælden, er den tilgængelige litteratur ikke tilstrækkelig til at påvise en forskel i sikkerheden af chenodeoxycholsyre inden for pædiatriske aldersgrupper eller mellem pædiatriske patienter og voksne.
English: However, cholic acid is still formed via an alternate microsomal pathway.
Danish: Der dannes dog stadig cholsyre via en alternativ mikrosomal vej.
English: Diarrhoea improved or disappeared in 64.3% of the patients who had this symptom present at baseline.
Danish: Diarré blev forbedret eller forsvandt hos 64,3 % af de patienter, som havde dette symptom ved baseline.
English: The only infant enrolled presented with raised liver function tests within six weeks of treatment start.
Danish: Det eneste spædbarn i studiet havde forhøjede leverfunktionstests inden for 6 uger efter behandlingsstart.
English: Colestyramine
Danish: Colestyramin
English: None of the patients had treatment-related adverse events and chenodeoxycholic acid exhibited a satisfactory safety profile in relation to routine safety laboratory parameters (haematology and clinical chemistry).
Danish: Ingen af patienterne havde behandlingsrelaterede bivirkninger, og chenodeoxycholsyre viste en tilfredsstillende sikkerhedsprofil i forhold til rutinemæssige laboratorieparametre (hæmatologi og klinisk kemi).
English: Rankin and EDSS scores remained stable in 61.5% and 50% of patients respectively, however there was an overall worsening of the mean score from baseline.
Danish: Rankin- og EDSS-scorer forblev stabile hos henholdsvis 61,5 % og 50 % af patienterne, men der var en samlet forværring af den gennemsnitlige score fra baseline.
English: During your treatment, your doctor will carry out blood and urine tests to monitor your response to this medicine, and adjust your dose if necessary.
Danish: Under behandlingen tager lægen blod- og urinprøver for at overvåge din reaktion på lægemidlet og justere dosis, hvis det er nødvendigt.
English: It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food.
Danish: Det er en del af galden, som er en væske, der hjælper med at fordøje fedt og vitaminer fra maden.
English: • medicines to treat heartburn (antacids) containing aluminium hydroxide and/or smectite
Danish: • lægemidler mod halsbrand (antacida), som indeholder aluminiumhydroxid og/eller smectit
English: The mean levels of 7α-hydroxy-4-cholesten-3one significantly decreased from baseline to post-baseline Visits 1 and 2.
Danish: Det gennemsnitlig niveau af 7α-hydroxy-4-cholesten-3on faldt signifikant fra baseline til post-baseline-besøg 1 og 2.
English: The suspension is formed quite easily and is ready when there are no visible lumps or powder left.
Danish: Suspensionen dannes ret nemt og er færdig, når der ikke er synlige klumper eller synligt pulver tilbage.
English: Additional or more frequent investigations may need to be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Danish: Der kan være behov for supplerende eller hyppigere undersøgelser for at monitorere behandlingen i perioder med hurtig vækst, samtidig sygdom eller graviditet (se pkt.
English: Pyramidal dysfunction improved or stabilised in 60% (10/15) and cerebellar dysfunction in 88.7% (12/14).
Danish: Pyramidal dysfunktion blev forbedret eller stabiliseret hos 60 % (10/15) og cerebellar dysfunktion hos 88,7 % (12/14).
English: There are no or limited amount of data from the use of chenodeoxycholic acid in pregnant women.
Danish: Der foreligger ingen eller begrænsede data fra anvendelse af chenodeoxycholsyre til gravide kvinder.
English: It is recommended that this suspension is prepared at the pharmacy and instructions given to the parent on how to administer the suspension.
Danish: Det anbefales, at denne suspension fremstilles på apoteket, og at forældrene instrueres i, hvordan suspensionen administreres.
English: This deficiency blocks the synthesis of primary bile acids via the classical (neutral pathway) and the alternative (acidic) pathway.
Danish: Denne defekt blokerer for syntesen af primære galdesyrer via den klassiske (neutrale) og den alternative (sure) syntesevej.
English: 22 80538 Munich Germany
Danish: 22 80538 München Tyskland
English: All paediatric patients received 15 mg/kg/day as their starting dose.
Danish: Alle pædiatriske patienter fik 15 mg/kg/dag som startdosis.
English: Women of childbearing potential should use an effective method of contraception.
Danish: Kvinder i den fertile alder bør anvende en effektiv præventionsmetode.
English: A similar effect on CYP27A1, albeit at higher doses, is also seen with sirolimus.
Danish: En tilsvarende virkning på CYP27A1 ses også med sirolimus, men dog først ved højere doser.
English: Increases in bone mineral density (Z-score) were observed at lumbar spine at both post-treatment visits and at total hip at post-treatment at post-treatment Visit 2.
Danish: Der blev observeret stigning i knoglemineraltætheden (Z-score) i lænderygsøjlen ved begge post-behandlingsbesøg og i total hofte ved post-behandlingsbesøg 2.
English: Patients with CTX and high cholestanol have been shown to have adverse outcomes during pregnancy.
Danish: Det er påvist, at patienter med CTX og forhøjet cholestanol kan have negativt udfald af graviditet.
English: In two non-interventional studies with chenodeoxycholic acid a total of three adverse reactions were reported in three out of 63 patients (safety population).
Danish: I 2 ikke-interventionsstudier med chenodeoxycholsyre blev der i alt rapporteret 3 bivirkninger hos 3 ud af 63 patienter (sikkerhedspopulation).
English: Maternal effects in the rhesus monkeys, but not baboons, included diarrhoea, emesis, weight loss and reduction in food consumption.
Danish: Den maternelle virkning hos rhesusaber, men ikke bavianer, var diarré, emesis, vægttab og reduceret fødeindtagelse.
English: Your doctor may change the dose depending on how your child responds to treatment.
Danish: Lægen kan ændre dosis, alt efter hvordan dit barn reagerer på behandlingen.
English: The potential for harm from overdose is considered extremely low, as accumulation of chenodeoxycholic acid is unlikely due to an efficient endogenous mechanism of elimination and excretion.
Danish: Den potentielle skadevirkning ved overdosering betragtes som ekstremt lav, da akkumulering af chenodeoxycholsyre er usandsynlig på grund af en effektiv endogen mekanisme til elimination og ekskretion.
English: Please discuss suitable contraceptive methods with your doctor.
Danish: Tal med din læge om egnet prævention.
English: Two pregnancies in mothers with CTX resulted in premature infants with evidence of intrauterine growth retardation also reported in the literature.
Danish: 2 graviditeter hos mødre med CTX, der resulterede i præmature børn med tegn på intrauterin væksthæmning, er også beskrevet i litteraturen.
English: Colestipol and antacid medicinal products
Danish: Colestipol og antacida
English: In two-non interventional studies with chenodeoxycholic acid, a total of 14 paediatric patients with CTX were treated with Chenodeoxycholic acid: 1 infant (0 to < 2 years), 6 children (2 to < 12 years) and 7 adolescents (12 to < 18 years).
Danish: I 2 ikke-inventionsstudier med chenodeoxycholsyre blev i alt 14 pædiatriske patienter med CTX behandlet med chenodeoxycholsyre: 1 spædbarn (0 til <2 år), 6 børn (2 til <12 år) og 7 unge (12 til <18 år).
English: Co-administration with oral contraceptives is not recommended.
Danish: Samtidig administration med orale antikonceptiva anbefales ikke.
English: Treatment must be initiated and monitored by physicians experienced in the management of CTX or inborn errors of primary bile acid synthesis.
Danish: Behandling skal initieres og monitoreres af læger med erfaring i behandling af CTX eller medfødte fejl i den primære galdesyresyntese.
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The lowest dose of chenodeoxycholic acid that effectively reduces the serum cholestanol and/or urine bile alcohols levels to within the normal range should be chosen.
Danish: Den laveste dosis chenodeoxycholsyre, som effektivt reducerer serum-cholestanol og/eller biliære alkoholer i urinen til normalområdet, vælges.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER PACKS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERPAKNINGER
English: The mixture is ready when there are no visible lumps or powder.
Danish: Suspensionen er færdig, når der ikke er synlige klumper eller synligt pulver.
English: Mean Rankin and EDSS scores showed a very small increase (worsening) from baseline to clinical current visit at 0.08 ± 0.74 and 0.27 ± 1.24 in the overall population and this increase was not statistically significant.
Danish: De gennemsnitlige Rankin- og EDSS-scorer viste en meget lille stigning (forværring) på 0,08 ±0,74 og 0,27 ±1,24 fra baseline til det aktuelle kliniske besøg i den samlede population, og denne stigning var ikke statistisk signifikant.
English: The pharmacy should provide oral dose syringes of appropriate volume and grading for administering the suspension.
Danish: Apoteket skal levere orale doseringssprøjter med passende volumen og måleinddelinger til administration af suspensionen.
English: There was a resolution, improvement or stabilisation in 88.9% (16/18) of patients with cognitive impairment.
Danish: Der var helbredelse, forbedring eller stabilisering hos 88,9 % (16/18) af patienterne med nedsat kognitiv funktion.
English: Your doctor or pharmacist will give you instructions on how much and how often your child needs to take the mixture.
Danish: Lægen og apotekspersonalet vil instruere dig i, hvor meget af suspensionen dit barn skal have, og hvor ofte.
English: Do not stop taking Chenodeoxycholic acid Leadiant without first speaking with your doctor.
Danish: Du må ikke holde op med at tage Chenodeoxycholic acid Leadiant uden først at tale med din læge.
English: This instance of hepatic adverse reactions in an infant presented with multiple confounders, such as concomitant parechovirus infection, co-administration of medicinal products known to affect liver function (acyclovir and phenobarbital) and presence of hyperbilirubinemia at birth.
Danish: Dette tilfælde af leverbivirkninger hos et spædbarn præsenterede med flere confoundere, f.eks. samtidig infektion med parechovirus, samtidig administration af lægemidler med dokumenteret påvirkning af leverfunktionen (aciclovir og phenobarbital) og tilstedeværelse af hyperbilirubinæmi ved fødslen.
English: Vitamin D and PTH levels decreased from baseline to both post-treatment visits and mean pyruvate levels decrease from baseline to the first post-treatment visit.
Danish: Dvitamin- og PTH-niveau faldt fra baseline til begge post-behandlingsbesøg, og det gennemsnitlige pyruvatniveau faldt fra baseline til det første post-behandlingsbesøg.
English: The safety and efficacy of Chenodeoxycholic acid Leadiant has not been studied in babies less than one month of age.
Danish: Sikkerheden og virkningen af Chenodeoxycholic acid Leadiant er ikke undersøgt hos børn under 1 måned.
English: In case of persistent lack of therapeutic response to chenodeoxycholic acid monotherapy, other treatment options should be considered.
Danish: Ved vedvarende mangel på terapeutisk respons på chenodeoxycholsyre som monoterapi bør andre behandlingsmuligheder overvejes.
English: The primary pharmacodynamic effects of chenodeoxycholic acid are: 1.
Danish: De primære farmakodynamiske virkninger af chenodeoxycholsyre er: 1.
English: Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes.
Danish: Kapslerne findes i PVC-blister forseglet med aluminiumsfolie og pakket i papæsker.
English: The capsules consist of a yellow body and an orange cap containing a white compressed powder.
Danish: Kapslerne består af en gul underdel og en orange overdel og indeholder et komprimeret hvidt pulver.
English: Neurological disability scale scores (Rankin and EDSS) stabilised or improved by the clinical current visit in 84.6% and 76.9% of patients respectively.
Danish: Scorer for neurologisk funktionsnedsættelse (Rankin og EDSS) var stabiliseret eller forbedret hos henholdsvis 84,6 % og 76,9 % af patienterne ved det aktuelle kliniske besøg.
English: The active substance itself will be dissolved in the sodium bicarbonate solution and it appears as a suspension because not all components of the capsule contents will be dissolved.
Danish: Det aktive stof opløses i natriumhydrogencarbonatopløsningen og fremstår som en suspension, da ikke alle indholdsstoffer i kapslen opløses.
English: Pathological effects on adrenals and kidneys were also seen in rhesus monkey foetuses.
Danish: Der sås også patologiske virkninger på binyrer og nyrer hos rhesusabefostre.
English: The mean age of the patient population in the pivotal study was younger at 25.8 years than the supporting study population at 35 years which also reflected the level of disability present in the two cohorts prior to treatment start, with the supporting study having a higher disability score at baseline.
Danish: Gennemsnitsalderen i det pivotale studie var lavere (25,8 år) end i det supportive studie (35 år), hvilket også afspejlede niveauet af funktionsnedsættelse før behandlingsstart i de 2 kohorter, hvor patienterne i det supportive studie havde en højere score for funktionsnedsættelse ved baseline.
English: Package leaflet: Information for the user Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Chenodeoxycholic acid Leadiant 250 mg hårde kapsler chenodeoxycholsyre Dette lægemiddel er underlagt supplerende overvågning.
English: Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127)
Danish: Kapselindhold: majsstivelse, magnesiumstearat, kolloid vandfri silica, vand, Kapsel: gelatine, titandioxid (E 171), quinolingult (E 104), erythrosin (E 127)
English: The corresponding amount of suspension to give = (50 mg x 1 ml) = 5 ml 10 mg *number of divided doses dependant on advice from doctor.
Danish: Den tilsvarende mængde suspension, der skal gives = 50 mg ∙ 1 ml)/10 mg = 5 ml *antal delte doser afhængigt af lægens anbefaling.
English: Chenodeoxycholic acid is an endogenous bile acid in humans, which is tightly regulated by its secretion into bile via exporter pumps and detoxification by sulfation.
Danish: Chenodeoxycholsyre er en endogen galdesyre hos mennesker, som er stramt reguleret af dens sekretion til galden via eksportpumper og afgiftning ved sulfatering.
English: After reabsorption in the intestine, the bile acid is nearly completely conjugated to the amino acids glycine and taurine and then excreted again in the bile.
Danish: Efter reabsorption i tarmen konjugeres galdesyren næsten fuldstændigt til aminosyrerne glycin og taurin og udskilles derefter igen i galden.
English: Chenodeoxycholic acid is an endogenous bile acid used for replacement therapy and it is anticipated to have no effects on fertility at therapeutic doses.
Danish: Chenodeoxycholsyre er en endogen galdesyre, der anvendes til substitutionsbehandling, og den forventes ikke at have nogen indvirkning på fertilitet ved terapeutiske doser.
English: The usual starting dose in adults is one 250 mg capsule three times a day.
Danish: Den sædvanlige startdosis hos voksne er en kapsel på 250 mg 3 gange dagligt.
English: For the other medicines in this list, take them either 2 hours before or 2 hours after taking Chenodeoxycholic acid Leadiant.
Danish: De øvrige lægemidler på denne liste kan du tage enten 2 timer før eller 2 timer efter Chenodeoxycholic acid Leadiant.
English: Information for healthcare professionals only Patients who are unable to swallow capsules
Danish: Nedenstående oplysninger er til læger og sundhedspersonale Patienter, som ikke kan synke kapsler
English: In CTX, a defect in the CYP27A1 gene results in a deficient mitochondrial sterol 27-hydroxylase enzyme.
Danish: Ved CTX medfører en defekt i CYP27A1-genet et defekt mitokondrielt sterol 27-hydroxylase-enzym.
English: The maximum dose is one 250 mg capsule four times a day.
Danish: Maksimumdosis er en kapsel på 250 mg 4 gange dagligt.
English: The net result is a total bile acid pool that is severely deficient in chenodeoxycholic acid but relatively enriched with cholic acid.
Danish: Nettoresultatet er en pulje af total-galdesyre, som er i stærkt underskud af chenodeoxycholsyre, men relativt beriget med cholsyre.
English: During the initiation of therapy and dose adjustment, serum cholestanol levels and/or urine bile alcohols should be monitored every 3 months till metabolic control and then annually.
Danish: I forbindelse med behandlingsstart og dosisjustering skal serum-cholestanol og/eller biliære alkoholer i urinen monitoreres hver 3. måned, indtil der er opnået metabolisk kontrol, og derefter årligt.
English: Your doctor will advise you if for any reason you have to stop treatment with Chenodeoxycholic acid Leadiant.
Danish: Lægen vil fortælle dig, hvis du af en eller anden grund er nødt til at stoppe behandlingen med Chenodeoxycholic acid Leadiant.
English: Concurrent elevation of liver enzymes above normal levels may indicate overdose.
Danish: Hvis leverenzymerne samtidig er over normalværdierne, kan det være tegn på overdosering.
English: In addition to sulfation, bile acid can also be detoxified through glucronidation.
Danish: Ud over sulfatering kan galdesyre afgiftes via glukuronidering.
English: • colestyramine, colestipol (so called bile acid sequestrants)
Danish: • colestyramin, colestipol (såkaldte galdesyre-bindende lægemidler)
English: If it is necessary to take a medicinal product containing one of these active substances it should be taken either 2 hours before or after taking chenodeoxycholic acid.
Danish: Hvis det er nødvendigt at tage et lægemiddel med et af disse aktive stoffer, skal det tages enten 2 timer før eller efter chenodeoxycholsyre.
English: Biological half-life of chenodeoxycholic acid is about 4 days.
Danish: Chenodeoxycholsyres biologiske halveringstid er ca. 4 dage.
English: Pharmacotherapeutic group: Alimentary tract and metabolism - Bile therapy - Bile acid preparations, ATC code: A05AA01
Danish: Farmakoterapeutisk klassifikation: Fordøjelsesorganer og stofskifte - GaldeterapiGaldesyrepræparater, ATC-kode: A05AA01
English: Chenodeoxycholic acid supplementation was re-started and maintained at a lower dose of 5 mg/kg/day with no further complications.
Danish: Behandlingen blev genoptaget og opretholdt ved en lavere dosis på 5 mg/kg/dag uden yderligere komplikationer.
English: Your doctor may decide to increase your dose depending on how your body responds to treatment.
Danish: Lægen kan beslutte at øge dosis, alt efter hvordan du reagerer på behandlingen.
English: Further information is provided in the package leaflet under Information for Healthcare Professionals Only.
Danish: Yderligere oplysninger gives i indlægssedlen under ”Nedenstående oplysninger er til læger og sundhedspersonale”.
English: The suspension should be stored in a glass bottle.
Danish: Suspensionen skal opbevares i en glasflaske og må ikke sættes i køleskab eller fryses.
English: Chenodeoxycholic acid capsules can be taken without regards to food.
Danish: Chenodeoxycholsyre-kapsler kan tages uden hensyntagen til måltider.
English: Oral contraceptives therefore may worsen the underlying deficiency and counteract the effectiveness of chenodeoxycholic acid in CTX.
Danish: Orale antikonceptiva kan derfor forværre den underliggende mangel og modvirke effekten af chenodeoxycholsyre på CTX.
English: Rodent and primate toxicity species lack efficient-sulfating capacity for conjugation of lithocholic acid, and therefore have shown hepatotoxicity.
Danish: De gnaver- og primatarter, der er undersøgt i toksicitetsstudier, mangler effektiv sulfateringskapacitet til konjugering af lithocholsyre og har derfor udvist levertoksicitet.
English: After the initiation period, cholestanol, urine bile alcohols and liver function should be determined annually, at a minimum, and the dose adjusted accordingly.
Danish: Efter initieringsperioden skal cholestanol, biliære alkoholer i urinen og leverfunktionen monitoreres mindst én gang årligt og dosis tilpasses i henhold hertil.
English: Patients with a rare condition known as cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid and this causes a buildup of fatty deposits in various areas of the body.
Danish: Patienter med den sjældne sygdom cerebrotendinøs xantomatose (CTX) kan ikke producere chenodeoxycholsyre, hvilket medfører ophobning af fedtaflejringer forskellige steder i kroppen.
English: Chenodeoxycholic acid Leadiant is not expected to affect your ability to drive or use machines.
Danish: Chenodeoxycholic acid Leadiant forventes ikke at påvirke din evne til at køre bil eller betjene maskiner.
English: • Constipation • Abnormal liver test values
Danish: • Forstoppelse • Unormale prøver for leverfunktionen
English: The daily dose can be subsequently increased in 250 mg increments to a maximum of 1000 mg/ day if the serum cholestanol and/or urine bile alcohols remain elevated.
Danish: Den daglige dosis kan efterfølgende sættes op i trin på 250 mg til maksimalt 1.000 mg/dag, hvis serum-cholestanol og/eller biliære alkoholer i urinen fortsat er forhøjet.