FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of chenodeoxycholic acid with ciclosporin or sirolimus should be avoided.
Danish: Samtidig administration af chenodeoxycholsyre og ciclosporin eller sirolimus bør undgås.
English: Psychiatric impairment resolved, improved or stabilised in 85.7% (6/7) of patients.
Danish: Psykiatrisk funktionsnedsættelse forsvandt, blev forbedret eller blev stabiliseret hos 85,7 % (6/7) af patienterne.
English: Chenodeoxycholic acid is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Chenodeoxycholsyre anbefales ikke under graviditet og til kvinder i den fertile alder, som ikke anvender prævention.
English: In contrast, Lithocholic acid sulfate conjugation in humans prevents the overt hepatotoxicity, as seen in animal toxicity species after repeat dosing.
Danish: Lithocholsyresulfatkonjugeringen hos mennesker forhindrer derimod den tydelige levertoksicitet, som ses ved dyrestudier efter gentagen dosering.
English: Breast-feeding It is unknown whether chenodeoxycholic acid/metabolites are excreted in human milk.
Danish: Amning Det vides ikke, om chenodeoxycholsyre/metabolitter udskilles i human mælk.
English: The maximum dose for children is 15 mg per kg per day.
Danish: Maksimumdosis til børn er 15 mg pr. kg pr. dag.
English: In the pivotal study CDCA-STUK-15-001 treatment of CTX patients with chenodeoxycholic acid 7501000 mg/day in adults or 5-15 mg/kg/day in infants and children was associated with statistically significant decreases in mean serum levels of cholestanol from baseline to post-baseline in the overall population and in the two subgroups of patients aged < 21 years or ≥ 21 years at first treatment.
Danish: I det pivotale studie CDCA-STUK-15-001 var behandling med chenodeoxycholsyre 750-1000 mg/dag hos voksne og 5-15 mg/kg/dag hos spædbørn og børn associeret med statistisk signifikante fald i det gennemsnitlige serum-cholestanol fra baseline til post-baseline i den samlede CTX-population og i de 2 undergrupper af patienter i alderen <21 år og ≤21 år ved første behandling.
English: The starting dose in children is 5 mg/kg/day in three divided doses.
Danish: Startdosis hos børn er 5 mg/kg/dag fordelt på 3 doser.
English: In the supportive study CDCA-STRCH-CR-14-001 treatment of CTX patients with chenodeoxycholic acid 750 mg/day given for a median duration of 5.75 years was associated with statistically significant decreases in mean serum levels of cholestanol from baseline to any post-baseline visit.
Danish: I det supportive CTX-studie CDCA-STRCH-CR-14-001 var behandling med chenodeoxycholsyre 750 mg/dag givet i en medianvarighed på 5,75 år associeret med statistisk signifikante fald i gennemsnitlig serum-cholestanol fra baseline til ethvert post-baseline-besøg.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from chenodeoxycholic acid therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman
Danish: Det skal besluttes, om amning skal ophøre eller behandling med chenodeoxycholsyre seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Colestipol or antacid medicinal products containing aluminium hydroxide and/or smectite should be taken either 2 hours before or after taking chenodeoxycholic acid.
Danish: Colestipol og antacida, som indeholder aluminiumhydroxid og/eller smectit, bør tages enten 2 timer før eller efter chenodeoxycholsyre, se pkt.
English: Where the dose calculated is not a multiple of 250 mg, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to normalise serum cholestanol and/or urine bile alcohols.
Danish: Hvis den beregnede dosis ikke er et multiplum af 250 mg, vælges den nærmeste dosis under den maksimale dosis på 15 mg/kg/dag, forudsat at den er tilstrækkelig til at normalisere serum-cholestanol og/eller biliære alkoholer i urinen.
English: No data are available for patients with renal impairment.
Danish: Der foreligger ingen data for patienter med nedsat nyrefunktion.
English: The starting dosage in adults is 750 mg/day, in three divided doses provided that it is sufficient to normalise serum cholestanol and/or urine bile alcohols.
Danish: Startdosis hos voksne er 750 mg/dag fordelt på 3 doser, såfremt dette er tilstrækkeligt til at normalisere serum-cholestanol og/eller biliære alkoholer i urinen.
English: Ciclosporin has been shown to reduce the synthesis of chenodeoxycholic acid by inhibition of CYP27A1 and increasing the activity of HMG CoA reductase.
Danish: Det er påvist, at ciclosporin reducerer syntesen af chenodeoxycholsyre ved at hæmme CYP27A1 og øge aktiviteten af HMG-CoA-reduktase.
English: It is not recommended to take Chenodeoxycholic acid Leadiant during pregnancy and breast-feeding.
Danish: Det anbefales ikke at tage Chenodeoxycholic acid Leadiant under graviditet og amning.
English: Reduced production of cholesterol: reduces serum cholestanol (action on HMG CoA reductase).
Danish: Nedsat produktion af kolesterol: reducerer serumcholestanol (virkning på HMG-CoAreduktase).
English: If your doctor considers it necessary for you to take ciclosporin, sirolimus or phenobarbital they will closely monitor the results of blood and urine tests and adjust the dose of Chenodeoxycholic acid Leadiant if necessary.
Danish: Hvis din læge mener, at det er nødvendigt, at du tager ciclosporin, sirolimus eller phenobarbital, vil lægen nøje overvåge resultaterne af dine blod- og urinprøver og justerer dosis af Chenodeoxycholic acid Leadiant, hvis det er nødvendigt.
English: Concomitant administration of chenodeoxycholic acid with phenobarbital increases HMG CoA reductase and thus counteracts one of the pharmacodynamics effects of chenodeoxycholic acid in CTX.
Danish: Samtidig administration af chenodeoxycholsyre og phenobarbital øger HMG-CoA-reduktase og modvirker dermed en af chenodeoxycholsyres farmakodynamiske virkninger ved CTX.
English: Reduced production of atypical bile alcohols and bile acids: through restoration of feedback inhibition of primary bile acid synthesis (action on CYP7A1)
Danish: Nedsat produktion af atypiske biliære alkoholer og galdesyrer: gennem genopretning af feedback-hæmning af syntese af primære galdesyrer (virkning på CYP7A1).
English: Whereas 7-keto-lithocholic acid can be formed partially in the colon and also in the liver to chenodeoxycholic acid and ursodeoxycholic acid (3α-, 7ß-di-hydroxycholanic acid), lithocholic acid is absorbed to a small extent only and is thus largely lost with faeces.
Danish: 7-keto-lithocholsyre kan omdannes delvist i colon og også i leveren til chenodeoxycholsyre og ursodeoxycholsyre (3α-, 7ß-dihydroxycholansyre), mens lithocholsyre kun absorberes i ringe omfang og går dermed stort set tabt med fæces.
English: Deconjugation results in the free bile acid, oxidation in the 7-keto-lithocholic acid and lithocholic acid (3α-hydroxycholanic acid) is formed by elimination of the 7-hydroxy group.
Danish: Dekonjugering resulterer i den frie galdesyre, oxidation i 7-keto-lithocholsyre, og der dannes lithocholsyre (3α-hydroxycholansyre) ved eliminering af 7-hydroxy-gruppen.
English: In CTX, deficiency of chenodeoxycholic acid causes a lack of feedback of cholesterol 7 alpha hydroxylase (CYP7A1) and HMG CoA reductase, causing increased production of atypical bile acids, bile alcohols and cholestanol that lead to the pathological consequences of the condition.
Danish: Ved CTX forårsager mangel på chenodeoxycholsyre en manglende feedback af kolesterol 7-alfahydroxylase (CYP7A1) og HMG-CoA-reduktase, hvilket medfører øget produktion af atypiske galdesyrer, biliære alkoholer og cholestanol, der fører til sygdommens patologiske konsekvenser.
English: Exogenous chenodeoxycholic acid is used as replacement therapy to restore the feedback inhibition lost due to the deficiency/absence of endogenous chenodeoxycholic acid.
Danish: Eksogen chenodeoxycholsyre bruges som substitutionsbehandling til at genoprette den feedbackhæmning, der er tabt på grund af underskud af eller total mangel på endogen chenodeoxycholsyre.
English: In the intestine Chenodeoxycholic acid and its glycine or taurine conjugate are decomposed by bacteria.
Danish: I tarmen nedbrydes chenodeoxycholsyre og dets glycin- eller taurinkonjugat af bakterier.
English: Chenodeoxycholic acid Leadiant is unlikely to cause serious side effects.
Danish: Det er ikke sandsynligt, at Chenodeoxycholic acid Leadiant vil give alvorlige bivirkninger.
English: Chenodeoxycholic acid has no or negligible influence on the ability to drive and use machines.
Danish: Chenodeoxycholsyre påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Urinary bile level alcohol levels decreased.
Danish: Koncentrationen af biliære alkoholer i urinen faldt.
English: Chenodeoxycholic acid should not be administered together with colestipol or antacid medicinal products containing aluminium hydroxide and/or smectite (aluminium oxide) since these preparations bind the active substance of chenodeoxycholic acid in the intestine and thus prevent its reabsorption and efficacy.
Danish: Chenodeoxycholsyre bør ikke administreres sammen med colestipol eller antacida, som indeholder aluminiumhydroxid og/eller smectit (aluminiumoxid), da disse præparater binder det aktive stof chenodeoxycholsyre i tarmen og dermed forhindrer reabsorption og virkning.
English: Babies
Danish: Spædbørn
English: Dose calculation (Infants 1month-1yr) chenodeoxycholic acid 5 mg/mL suspension Daily dose:
Danish: Dosisberegning (børn 1 måned-1 år) chenodeoxycholsyre 5 mg/ml suspension Daglig dosis:
English: The dose range in children is 5-15 mg/kg per day.
Danish: Dosisintervallet hos børn er 5-15 mg/kg pr. dag.
English: Titanium dioxide Quinoline yellow Erythrosine
Danish: Kapslen Gelatine Titandioxid Quinolingult Erythrosin
English: Chenodeoxycholic acid Leadiant is provided as hard capsules.
Danish: Chenodeoxycholic acid Leadiant leveres som hårde kapsler.
English: Reduced production of cholestanol: reduces serum cholestanol (action on HMG CoA reductase and CYP7A1).
Danish: Nedsat produktion af cholestanol: reducerer serumcholestanol (virkning på HMG-CoAreduktase og CYP7A1).
English: It is not known if Chenodeoxycholic acid Leadiant passes into breast milk.
Danish: Det vides ikke, om Chenodeoxycholic acid Leadiant passerer over i mælken.
English: The infant's liver function normalised upon temporarily stopping treatment with Chenodeoxycholic acid.
Danish: Spædbarnets leverfunktion normaliseredes efter midlertidig seponering af chenodeoxycholsyre.
English: Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder.
Danish: 21,7 mm lang kapsel (størrelse 0) med gul underdel og orange overdel.
English: Women should use an effective contraceptive method whilst taking Chenodeoxycholic acid Leadiant.
Danish: Kvinder skal anvende effektiv prævention, mens de tager Chenodeoxycholic acid Leadiant .
English: Dose calculation (Children 1-12yr, adolescents 12-18yr and adults) chenodeoxycholic acid 10 mg/mL suspension
Danish: Dosisberegning (børn 1-12 år, unge 12-18 år og voksne) chenodeoxycholsyre 10 mg/ml suspension Daglig dosis:
English: Chenodeoxycholic acid should not be administered together with colestyramine as it binds chenodeoxycholic acid in the intestine and thus prevents its reabsorption and efficacy.
Danish: Chenodeoxycholsyre bør ikke administreres sammen med colestyramin, da det binder chenodeoxycholsyre i tarmen og dermed forhindrer reabsorption og virkning.
English: The corresponding amount of suspension to give = (5 mg x 1 ml) = 1 ml
Danish: Den tilsvarende mængde suspension, der skal gives = 5 mg ∙ 1 ml)/5 mg = 5 ml
English: In rhesus monkey and baboon studies it was demonstrated that chenodeoxycholic acid dose to pregnant animals (at 5-120 mg/kg/day for rhesus monkey; at 18-38 mg/kg/day for baboons) produced liver pathology in the developing foetus.
Danish: I studier med rhesusaber og bavianer blev det påvist, at chenodeoxycholsyre fremkaldte patologiske forandringer i leveren hos det voksende foster hos drægtige dyr (ved en dosis på 5-120 mg/kg/dag hos rhesusaber og 18-38 mg/kg/dag hos bavianer).
English: This mixture will be provided to you by your pharmacy.
Danish: Suspensionen vil blive fremstillet på apoteket.
English: (Weight in kg) x (Dose in mg/kg) = Daily dose in mg
Danish: (Vægt i kg) x (Dosis i mg/kg) = Daglig dosis i mg
English: Adverse reactions in patients (both adults and children) receiving Chenodeoxycholic acid are generally mild to moderate in severity; the main reactions observed are given in the table below.
Danish: Bivirkningerne hos patienter (både voksne og børn), som får chenodeoxycholsyre, er generelt lette til moderate.
English: Exogenous replacement with Chenodeoxycholic acid inhibits CYP7A1 (via nuclear receptor, FXR) and HMG CoA reductase, thus restoring the feedback inhibition.
Danish: Eksogen substitution med chenodeoxycholsyre hæmmer CYP7A1 (via kernereceptoren, FXR) og HMG-CoA-reduktase og genopretter dermed feedbackhæmningen.
English: Capsule contents: maize starch, magnesium stearate, silica colloidal anhydrous, water,
Danish: Kapselindhold Majsstivelse Magnesiumstearat Silica, kolloidt vandfrit Vand
English: Oral contraceptives may affect the way in which Chenodeoxycholic acid Leadiant works making it less effective.
Danish: P-piller kan påvirke den måde, Chenodeoxycholic acid Leadiant virker på, og gøre det mindre effektivt.
English: After treatment with chenodeoxycholic acid, the endogenous synthesis of the primary bile acids, cholic acid and chenodeoxycholic acid, is inhibited.
Danish: Ved behandling med chenodeoxycholsyre hæmmes den endogene syntese af primære galdesyrer, cholsyre og chenodeoxycholsyre.
English: The total daily dose = 10 kg x 15 mg/kg = 150 mg
Danish: Samlet daglig dosis = 10 kg x 15 mg/kg = 150 mg
English: The administration of oral contraceptives reduces the pool size of chenodeoxycholic acid.
Danish: Administration af orale antikonceptiva mindsker puljen af chenodeoxycholsyre.
English: Chenodeoxycholic acid Leadiant 250 mg hard capsules
Danish: Chenodeoxycholic acid Leadiant 250 mg hårde kapsler
English: Chenodeoxycholic acid Leadiant is available in blister packs containing 100 hard capsules.
Danish: Chenodeoxycholic acid Leadiant fås i blisterpakninger med 100 hårde kapsler.
English: The active substance will be dissolved in the sodium bicarbonate solution and as not all the contents of the capsule will be dissolved it appears as a mixture.
Danish: Det aktive stof opløses i natriumhydrogencarbonat-opløsningen, men ikke alle indholdsstofferne i kapslen opløses, hvorfor væsken fremstår som en blanding (en suspension).
English: - The active substance is chenodeoxycholic acid.
Danish: - Aktivt stof: chenodeoxycholsyre.
English: Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the chenodeoxycholic acid, which prevents the build-up of the fatty deposits.
Danish: Chenodeoxycholic acid Leadiant-kapsler behandler CTX ved at erstatte kroppens egen chenodeoxycholsyre og derved forhindre ophobning af fedtaflejringer.
English: The following medicines may reduce the effect of Chenodeoxycholic acid Leadiant:
Danish: Følgende lægemidler kan mindske virkningen af Chenodeoxycholic acid Leadiant:
English: Hepatic adverse reactions not known
Danish: Leverbivirkninger ikke kendt
English: A small portion of chenodeoxycholic acid is excreted with faeces.
Danish: En lille del af chenodeoxycholsyren udskilles med fæces.
English: Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid
Danish: Chenodeoxycholic acid Leadiant 250 mg hårde kapsler chenodeoxycholsyre
English: Effects of chenodeoxycholic acid with other medicinal products Co-administration with ciclosporin, sirolimus, phenobarital is not recommended, see section 4.5 for further details.
Danish: Chenodeoxycholsyre sammen med andre lægemidler Samtidig administration af ciclosporin, sirolimus og phenobarbital anbefales ikke, se pkt.
English: This includes any possible side effects not listed in this leaflet.
Danish: De væsentligste bivirkninger er anført i nedenstående tabel.
English: For infants and children who cannot swallow capsules, the capsules may be carefully opened and the content added to sodium bicarbonate solution 8.4%, see section 6.6.
Danish: Til spædbørn og børn, som ikke kan synke kapsler, kan kapslerne åbnes forsigtigt og indholdet opblandes i en 8,4 % opløsning af natriumhydrogencarbonat, se pkt.
English: What you need to know before you take Chenodeoxycholic acid Leadiant Do not take Chenodeoxycholic acid Leadiant
Danish: Det skal du vide, før du begynder at tage Chenodeoxycholic acid Leadiant Tag ikke Chenodeoxycholic acid Leadiant
English: The following medicines may affect the levels of Chenodeoxycholic acid Leadiant:
Danish: Følgende lægemidler kan påvirke niveauet af Chenodeoxycholic acid Leadiant:
English: Contents of the pack and other information - What Chenodeoxycholic acid Leadiant contains
Danish: Pakningsstørrelser og yderligere oplysninger - Chenodeoxycholic acid Leadiant indeholder:
English: Chenodeoxycholic acid given orally is absorbed in the small intestine.
Danish: Chenodeoxycholsyre givet oralt absorberes i tyndtarmen.
English: In patients with CTX, no interaction studies with chenodeoxycholic acid and concomitantly administered medicinal products have been performed.
Danish: Der er ikke udført interaktionsstudier med chenodeoxycholsyre og andre samtidigt administrerede lægemidler hos patienter med CTX.
English: If administration of ciclosporin or sirolimus is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Danish: Hvis administration af ciclosporin eller sirolimus anses for nødvendig, bør de biliære alkoholer i serum og urin monitoreres tæt og dosis af chenodeoxycholsyre justeres i henhold hertil.
English: The total daily dose = 3 kg x 5 mg/kg = 15 mg
Danish: Samlet daglig dosis = 3 kg x 5 mg/kg = 15 mg
English: Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid.
Danish: Chenodeoxycholic acid Leadiant-kapsler indeholder stoffet chenodeoxycholsyre.
English: If it is necessary to take colestyramine then chenodeoxycholic acid should be taken either one hour before colestyramine or 4-6 hours after.
Danish: Hvis det er nødvendigt at tage colestyramin, skal chenodeoxycholsyre tages enten 1 time før colestyramin eller 4-6 timer efter.
English: The starting dose will be calculated at 5 mg per kg per day.
Danish: Startdosis er 5 mg pr. kg pr. dag.
English: If administration of phenobarbital is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Danish: Hvis administration af phenobarbital anses for nødvendig, bør de biliære alkoholer i serum og urin monitoreres tæt og dosis af chenodeoxycholsyre justeres i henhold hertil.
English: The divided dose when given three times a day = 15 mg = 5 mg
Danish: Den opdelte dosis, når den gives 3 gange om dagen = 15 mg/3 = 5 mg
English: The use of oral contraceptives is not recommended in patients taking chenodeoxycholic acid, see section 4.5 for further details.
Danish: Brug of orale antikonceptiva anbefales ikke hos patienter, som tager chenodeoxycholsyre, se pkt.
English: For babies, children and those who cannot swallow capsules and/or need to take a dose below 250 mg, a capsule may be opened and the contents mixed with 8.4% sodium bicarbonate solution.
Danish: Til spædbørn, børn og andre, som ikke kan synke kapsler og/eller skal tage en dosis på under 250 mg, kan en kapsel åbnes og indholdet blandes med en 8,4 % opløsning af natriumhydrogencarbonat.
English: If you get any side effects, talk to your doctor or, pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.herunder bivirkninger, som ikke er nævnt her.
English: If you have to take colestyramine then take Chenodeoxycholic acid Leadiant either one hour before colestyramine or 4-6 hours after.
Danish: Hvis det er nødvendigt at tage colestyramin, skal du tage Chenodeoxycholic Leadiant enten 1 time før colestyramin eller 4-6 timer efter.
English: What you need to know before you take Chenodeoxycholic acid Leadiant 3.
Danish: Det skal du vide, før du begynder at tage Chenodeoxycholic acid Leadiant 3.
English: Chenodeoxycholic acid should be taken either one hour before cholestyramine or 4-6 hours after.
Danish: Chenodeoxycholsyre bør tages enten 1 time før colestyramin eller 4-6 timer efter, se pkt.
English: The divided dose when given three times a day = 150 mg = 50 mg
Danish: Den opdelte dosis, når den gives 3 gange om dagen = 150 mg/3 = 50 mg
English: Elderly patients (≥ 65 years)
Danish: Særlige populationer Ældre patienter (≤ 65 år) Dosisjustering er ikke nødvendig.
English: 10 kg patient on a dose of 15 mg/kg of chenodeoxycholic acid.
Danish: Patient på 10 kg, der skal have en dosis på 15 mg/kg chenodeoxycholsyre.
English: One instance of mild intermittent constipation occurred in an adult and another instance occurred in a child. One instance of hepatic adverse reactions occurred in a two week old infant diagnosed with CTX and is discussed in the section below.
Danish: Der forekom et tilfælde af leverbivirkninger hos et 2 uger gammelt spædbarn med diagnosen CTX, og dette tilfælde er beskrevet i nedenstående afsnit.
English: Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.
Danish: Chenodeoxycholsyre er indiceret til behandling af spædbørn, børn og unge i alderen fra 1 måned til 18 år samt voksne med medfødte fejl i den primære galdesyresyntese som følge af sterol-27-hydroxylasemangel (fremtræder som cerebrotendinøs xantomatose (CTX)).
English: 3 kg patient on a dose of 5 mg/kg of chenodeoxycholic acid.
Danish: Patient på 3 kg, der skal have en dosis på 5 mg/kg chenodeoxycholsyre.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsules may be opened and the contents added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Danish: Til børn, unge og voksne, som ikke kan synke kapsler og/eller har behov for en dosis under 250 mg, kan kapslerne åbnes og indholdet tilsættes en 25 ml 8,4 %-opløsning af natriumhydrogenkarbonat (1 mmol/ml) for at frembringe en suspension med chenodeoxycholsyre 10 mg/ml.
English: Women of childbearing potential should use an effective method of contraception, see section 4.6 for further details.
Danish: Kvinder i den fertile alder bør anvende en effektiv præventionsmetode, se pkt.
English: For infants the capsules may be opened, the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Danish: Til spædbørn kan kapslerne åbnes, indholdet tilsættes en 50 ml 8,4 %-opløsning af natriumhydrogenkarbonat (1 mmol/ml) og blandes for at frembringe en suspension, der indeholder chenodeoxycholsyre 5 mg/ml.
English: For infants the capsules may be opened and the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Danish: Til spædbørn kan kapslerne åbnes og indholdet tilsættes en 50 ml 8,4 %-opløsning af natriumhydrogenkarbonat (1 mmol/ml) for at frembringe en suspension med chenodeoxycholsyre 5 mg/ml.