FrancophonIA/ELRC3.0 huggingface dataset:
English: FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol, as well as, by increasing transport of bile acids out of the hepatocytes.
Danish: FXR-aktivering nedsætter koncentrationen af galdesyrer i hepatocytter ved at undertrykke de novo-syntesen af kolesterol såvel som ved at øge transporten af galdesyrer ud af hepatocytterne.
English: These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
Danish: Disse mekanismer begrænser den totale pool af cirkulerende galdesyrer og fremmer kolerese, hvorved den hepatiske eksponering for galdesyrer reduceres.
English: ALP less than 1.67-times ULN, n (%)
Danish: ALP < 1,67 gange ULN, n
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/12/2016
Danish: Dato for første markedsføringstilladelse: 12/12/2016
English: Patients were included in the trial if the alkaline phosphatase (ALP) was greater than or equal to 1.67 times upper limit of normal (ULN) and/or if total bilirubin was greater than 1 x ULN but less 2 x ULN.
Danish: Patienterne blev inkluderet i studiet, hvis alkalisk fosfatase (ALP) var ≥ 1,67 gange den øvre normalgrænse (ULN), og/eller hvis total-bilirubin (TB) var > 1 x ULN, men < 2 x ULN.
English: Urinary excretion is less than 3%.
Danish: Mindre end 3 % udskilles i urinen.
English: Relative to patients who started on 10 mg once daily in the OCALIVA 10 mg arm, patients in the OCALIVA titration arm had a lower incidence of pruritus (70% and 56% respectively) and a lower discontinuation rate due to pruritus (10% and 1%, respectively).
Danish: I forhold til patienter, som startede på 10 mg én gang dagligt i OCALIVA 10 mg-armen, havde patienter i OCALIVA-titreringsarmen en lavere forekomst af pruritus (henholdsvis 70 % og 56 %) og en lavere seponeringsrate på grund af pruritus (henholdsvis 10 % og 1 %).
English: * Adverse reactions are defined as events occurring at a rate of greater than or equal to 5% of patients on obeticholic acid treatment arm and at an incidence greater than or equal to 1% higher than in the placebo treatment arm.
Danish: * Bivirkninger defineres som hændelser, der forekommer med en hyppighed ≥ 5 % i obeticholsyre-armen og med en hyppighed ≥ 1 % højere end i placebo-armen.
English: • The other ingredients are: - Tablet core: Microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium stearate.
Danish: • Øvrige indholdsstoffer: - Tabletkerne: Mikrokrystallinsk cellulose (E460), natriumstivelsesglycolat (Type A), magnesiumstearat.
English: Tell your doctor or pharmacist if you experience itching of the skin (pruritus) or if the itch gets worse while on this medicine.
Danish: Kontakt lægen eller apotekspersonalet, hvis du oplever hudkløe, eller hvis kløen forværres, mens du tager dette lægemiddel.
English: Obeticholic acid is metabolised in the liver and intestines.
Danish: Obeticholsyre metaboliseres i leveren og tarmene.
English: High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an aluminium foil induction seal.
Danish: Flasker af højdensitetspolyethylen (HDPE) med børnesikret polypropylenlåg og forsegling af aluminiumsfolie.
English: OCALIVA contains the active substance obeticholic acid (farnesoid X-receptor agonist) which helps to improve how your liver works by reducing the production and build up of bile in the liver and also reducing inflammation.
Danish: OCALIVA indeholder det aktive stof obeticholsyre, en såkaldt farnesoid X-receptor (FXR)-agonist, som får din lever til at fungere bedre ved at reducere produktion og ophobning af galde i leveren, og som også formindsker betændelseslignende reaktioner (inflammation).
English: Patients were randomised (1:1:1) to receive once daily placebo, OCALIVA 10 mg, or OCALIVA titration (5 mg titrated to 10 mg at 6 months dependent on therapeutic response/tolerability).
Danish: Patienterne blev randomiseret (1:1:1) til placebo, OCALIVA 10 mg eller OCALIVA-titrering (5 mg titreret til 10 mg efter 6 måneder afhængigt af terapeutisk respons/tolerabilitet) én gang dagligt.
English: Obeticholic acid has minimal renal elimination with less than 3% of the dose recovered in urine.
Danish: Den renale elimination af obeticholsyre er minimal, og mindre end 3 % genfindes i urinen.
English: Mean reduction in gamma-glutamyl transferase (GGT) The mean (95% CI) reduction in GGT was 178 (137, 219) U/L in the OCALIVA 10 mg arm, 138 (102, 174) U/L in the OCALIVA titration arm, and 8 (-48, 32) U/L in the placebo arm.
Danish: Middelreduktion i gammaglutamyltransferase (GGT) Middelreduktionen (95 % CI) i GGT var 178 (137; 219) U/l i OCALIVA 10 mg-armen, 138 (102; 174) E/l i OCALIVA-titreringsarmen og 8 (-48; 32) E/l i placeboarmen.
English: If you take more OCALIVA than you should If you accidentally take too many tablets, you may experience liver related side effects such as yellowing of the skin.
Danish: Hvis du ved et uheld har taget for mange tabletter, kan du opleve leverrelaterede bivirkninger som fx gulfarvning af huden.
English: The systemic exposure of obeticholic acid, its active conjugates, and endogenous bile acids is increased in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C, respectively) when compared to healthy controls.
Danish: Den systemiske eksponering for obeticholsyre, dets aktive konjugater og endogene galdesyrer er øget hos patienter med moderat eller svært nedsat leverfunktion (hhv. Child-Pugh B og C) i forhold til raske kontrolpersoner.
English: Obeticholic acid has no or negligible influence on the ability to drive and use machines.
Danish: Obeticholsyre påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Dosing frequency should be reduced for patients who progress to advanced disease (i.e. from Child-Pugh Class A to Child-Pugh Class B or C) (see sections 4.2 and 5.2).
Danish: Doseringshyppigheden skal reduceres hos patienter, der udvikler fremskreden leversygdom (fra ChildPugh A til Child-Pugh B eller C) (se pkt.
English: Severe pruritus was reported in 23% of patients treated with OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arms.
Danish: Der er rapporteret svær pruritus hos 23 % af patienterne behandlet i OCALIVA 10 mg-armen, hos 19 % af patienterne i OCALIVA-titreringsarmen og hos 7 % af patienterne i placeboarmen.
English: INFORMATION IN BRAILLE OCALIVA 5 mg
Danish: INFORMATION I BRAILLESKRIFT OCALIVA 5 mg
English: For patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin after 6 months of treatment and the patient is tolerating obeticholic acid, titrate up to 10 mg once daily
Danish: Hos patienter, der ikke har opnået tilstrækkelig reduktion af alkalisk fosfatase (ALP) og/eller total bilirubin efter 6 måneders behandling, og som godt kan tåle obeticholsyre, titreres op til 10 mg én gang dagligt
English: • Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage.
Danish: • Midlertidig behandlingsafbrydelse af obeticholsyre i op til 2 uger med efterfølgende genoptagelse med en reduceret dosis.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1139/001
English: Fifty-one PBC patients with baseline ALP 1.67-times ULN or greater and/or total bilirubin greater than ULN were evaluated for a biochemical response to OCALIVA as monotherapy (24 patients received OCALIVA 10 mg once daily and 27 patients received placebo) in a pooled analysis of data from the phase III randomised, double-blind, placebo-controlled 12 month study (POISE) and from a randomised, double-blind, placebo-controlled, 3- month study.
Danish: 51 PBC-patienter med baseline-ALP ≥ 1,67 gange ULN og/eller total-bilirubin > ULN blev evalueret for biokemisk respons på OCALIVA som monoterapi (24 patienter fik OCALIVA 10 mg én gang dagligt, og 27 patienter fik placebo) i en puljet analyse af data fra det randomiserede, dobbeltblinde, placebokontrollerede 12-måneders fase III-studie og fra et randomiseret, dobbeltblindt, placebokontrolleret 3-måneders studie.
English: INFORMATION IN BRAILLE OCALIVA 10 mg
Danish: INFORMATION I BRAILLESKRIFT OCALIVA 10 mg
English: Pack size: 30 or 100 film-coated tablets.
Danish: Pakningsstørrelse: 30 eller 100 filmovertrukne tabletter.
English: Human plasma protein binding of obeticholic acid and its conjugates is greater than 99%.
Danish: Obeticholsyre og dets konjugater bindes mere end 99 % til humant plasmaprotein.
English: • Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage if applicable.
Danish: • Midlertidig behandlingsafbrydelse af obeticholsyre i op til 2 uger med efterfølgende genoptagelse med en reduceret dosis, hvis relevant.
English: It is not known if this medicine passes into human milk.
Danish: Det vides ikke om lægemidlet udskilles i mælken.
English: If you stop taking OCALIVA
Danish: Hvis du holder op med at tage OCALIVA
English: Yellow, 7.6 mm X 7.4 mm triangular tablet debossed with ‘INT' on one side and ‘10' on the other side.
Danish: Gul 7,6 mm x 7,4 mm trekantet tablet, præget med ‘INT' på den ene side og ‘10' på den anden side.
English: As a precautionary measure, it is preferable to avoid the use of obeticholic acid during pregnancy.
Danish: For en sikkerheds skyld bør obeticholsyre undgås under graviditet.
English: Description: In order to confirm the efficacy and safety of OCALIVA, the MAH should conduct and submit the results of study 747-401, a double-blind, randomised, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of OCALIVA in patients with PBC and moderate to severe hepatic impairment.
Danish: Beskrivelse: Med henblik på at bekræfte OCALIVAs virkning og sikkerhed skal indehaveren af markedsføringstilladelsen gennemføre og fremsende resultaterne af studie 747-401, et dobbeltblindt, randomiseret, placebokontrolleret studie til evaluering af OCALIVAs virkning, sikkerhed og farmakokinetik hos patienter med PBC og moderat til svært nedsat leverfunktion.
English: or OCALIVA titration (5 mg once daily for the initial 6 months, with the option to increase to 10 mg once daily for the last 6 months, if the patient was tolerating OCALIVA but had ALP 1.67-times the ULN or greater, and/or total bilirubin above the ULN, or less than 15% ALP reduction) or placebo.
Danish: OCALIVA-titrering (5 mg én gang dagligt i de første 6 måneder med mulighed for stigning til 10 mg én gang dagligt i de sidste 6 måneder, hvis patienten tolererede OCALIVA, men havde ALP ≥ 1,67 gange ULN og/eller total-bilirubin > ULN eller < 15 % reduktion i ALP) eller placebo.
English: Management strategies include the addition of bile acid binding resins or antihistamines, dose reduction, reduced dosing frequency, and/or temporary dose interruption (see sections 4.2 and 4.8).
Danish: Behandlingsstrategier består bl.a. af tilføjelse af galdesyrebindende resiner eller antihistaminer, dosisreduktion, nedsat doseringshyppighed og/eller midlertidig afbrydelse af behandlingen (se pkt.
English: For patients who have not achieved an adequate reduction in ALP and/or total bilirubin after 3 months of treatment and the patient is tolerating obeticholic acid, titrate up to 5 mg twice weekly (at least 3 days apart) and subsequently to 10 mg twice weekly (at least 3 days apart) based on response and tolerability
Danish: Hos patienter, der ikke har opnået tilstrækkelig reduktion af ALP og/eller total bilirubin efter 3 måneders behandling, og som godt kan tåle obeticholsyre, titreres op til 5 mg to gange ugentligt (med mindst 3 dages mellemrum) og derefter op til 10 mg to gange ugentligt (med mindst 3 dages mellemrum), alt efter respons og tolerabilitet
English: Your doctor will determine whether you should discontinue breast-feeding or discontinue/abstain from OCALIVA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Danish: Du og din læge skal sammen beslutte, om du skal fortsætte med at amme, eller om du skal ophøre/lade være med at tage OCALIVA, idet der tages hensyn for fordelene ved amning for dit barn i forhold til de behandlingsmæssige fordele for dig.
English: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce efficacy of obeticholic acid.
Danish: Galdesyrebindende resiner som f.eks. colestyramin, colestipol og colesevelam adsorberer galdesyre og reducerer galdesyreabsorptionen og kan muligvis reducere virkningen af obeticholsyre.
English: Adverse reactions leading to discontinuation were 1% in the OCALIVA titration arm and 11% in the OCALIVA 10 mg arm.
Danish: Bivirkninger medførte seponering hos 1 % i OCALIVA-titreringsarmen og 11 % i OCALIVA 10 mg-armen.
English: In general itching of the skin is a very common side effect that begins within the first month following the start of treatment with OCALIVA and usually becomes less severe over time..
Danish: Hudkløe er en meget almindelig bivirkning, og den opstår som regel inden for den første måned af behandlingen med OCALIVA.
English: In PBC patients who received OCALIVA 25 mg once daily (2.5 times the highest recommended dosage) or 50 mg once daily (5 times the highest recommended dosage), a dose-dependent increase in the incidence of liver-related adverse reactions (e.g., ascites, primary biliary cholangitis flare, new onset jaundice), and transaminase and bilirubin elevations (up to greater than 3-times upper limit of normal [ULN]) were reported.
Danish: Hos PBC-patienter, som fik OCALIVA 25 mg én gang dagligt (2,5 gange den højeste anbefalede dosis) eller 50 mg én gang dagligt (5 gange den højeste anbefalede dosis), observeredes en dosisafhængig stigning i forekomsten af leverrelaterede bivirkninger (f.eks. ascites, opblussen af primær biliær cholangitis, ny debut af ikterus) samt forhøjede aminotransferaser og bilirubin (op til mere end 3 gange den øvre normalgrænse (ULN)).
English: Driving and using machines This medicine has no or negligible influence on your ability to drive or use machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad din evne til at køre motorkøretøj og betjene maskiner.
English: If you forget to take OCALIVA
Danish: Hvis du har glemt at tage OCALIVA
English: Percentage of PBC patients achieving the primary composite endpointa at month 6 and month 12 with or without UDCAb OCALIVA 10 mgc (N = 73)
Danish: Procentdel af PBC-patienter, der nåede det primære endepunkta i måned 6 og måned 12 med eller uden UDCAb
English: In a pre- and post-natal toxicity study in rats, the tauro-conjugate of obeticholic acid was found in pups nursing from dams dosed with obeticholic acid
Danish: I et præ- og postnatalt toksicitetsstudie hos rotter fandtes tauro-konjugatet af obeticholsyre hos diende rotteunger, hvor moderdyret havde fået obeticholsyre
English: No dose adjustment is required for elderly patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Obeticholic acid is conjugated with glycine or taurine in the liver and secreted into bile.
Danish: Obeticholsyre konjugeres med glycin eller taurin i leveren og udskilles i galden.
English: Co-administration with food does not alter the extent of absorption of obeticholic acid.
Danish: Indgivelse sammen med mad ændrer ikke absorptionsfraktionen af obeticholsyre.
English: • Continue to increase the dosage to 10 mg twice weekly, as tolerated, to achieve optimal response.
Danish: • Fortsætte med at øge dosis til 10 mg to gange om ugen, hvis patienten tolererer det, for at opnå optimalt respons.
English: These glycine and taurine conjugates of obeticholic acid are absorbed in the small intestine leading to enterohepatic recirculation.
Danish: Disse glycin- og taurin-konjugater af obeticholsyre absorberes i tyndtarmen med efterfølgende enterohepatisk recirkulation.
English: The median time to onset of severe pruritus was 11, 158, and 75 days for patients in the OCALIVA 10 mg, OCALIVA titration, and placebo arms, respectively.
Danish: Mediantiden til indtræden af svær kløe var 11, 158 og 75 dage i henholdsvis OCALIVA 10 mg-, OCALIVA-titrerings- og placeboarmen.
English: P-values are obtained using the Cochran-Mantel-Haenszel General Association test stratified by intolerance to UDCA and pretreatment ALP greater than 3-times ULN and/or AST greater than 2-times ULN and/or total bilirubin greater than ULN.
Danish: Mantel-Haenszel General Association test stratificeret efter intolerans over for UDCA og ALP > 3 gange ULN og/eller ASAT > 2 gange ULN og/eller total-bilirubin > ULN før behandling.
English: Child-Pugh Class A
Danish: Ikke-cirrotisk eller Child-Pugh A
English: Your doctor may need to monitor how well your blood clots when taking medicines such as warfarin (a medicine to help your blood flow) with OCALIVA.
Danish: Lægen vil muligvis overvåge dit blods evne til at størkne, hvis du også tager lægemidler som fx warfarin (blodfortyndende medicin).
English: Treatment-emergent pruritus generally started within the first month following the initiation of treatment.
Danish: Pruritus, som opstod under behandlingen, startede almindeligvis inden for den første behandlingsmåned.
English: Medicinal products that are affected by obeticholic acid
Danish: Lægemidler, der påvirker obeticholsyre
English: • Reducing the dosage of obeticholic acid to: ▪ 5 mg every other day, for patients intolerant to 5 mg once daily ▪ 5 mg once daily, for patients intolerant to 10 mg once daily
Danish: • Dosisreduktion af obeticholsyre til: ▪ 5 mg hver anden dag til patienter, der ikke tolererer 5 mg én gang dagligt ▪ 5 mg én gang dagligt til patienter, der ikke tolererer 10 mg én gang dagligt
English: For Child-Pugh Class B or C or Decompensated Cirrhotic patients:
Danish: Hos patienter, der har Child-Pugh B eller C eller dekompenseret cirrose:
English: • pain in your joints
Danish: Smerter i leddene
English: f The mean baseline total bilirubin value was 0.65 mg/dL, and was within the normal range (i.e., less than or equal to the ULN) in 92% of the enrolled patients.
Danish: f Gennemsnitsværdien for total-bilirubin ved baseline var 0,65 mg/dl og inden for normalområdet (dvs. ≤ ULN)
English: Description: In order to confirm the efficacy and safety of OCALIVA, the MAH should conduct and submit the results of study 747-302, a confirmatory doubleblind, randomised, placebo-controlled multicentre study investigating the clinical benefit associated with OCALIVA treatment in patients with PBC who are either unresponsive or intolerant to UDCA treatment based on clinical endpoints.
Danish: Beskrivelse: Med henblik på at bekræfte OCALIVAs virkning og sikkerhed skal indehaveren af markedsføringstilladelsen gennemføre og fremsende resultaterne - baseret på kliniske endepunkter - af studie 747-302, et dobbeltblindt, randomiseret, placebokontrolleret multicenter-verifikationsstudie, der undersøger den kliniske fordel forbundet med OCALIVA-behandling hos patienter, som enten ikke responderer på eller ikke tåler UDCA-behandling .
English: Based on population pharmacokinetic analysis, renal function did not have a meaningful effect on the pharmacokinetics of obeticholic acid.
Danish: På grundlag af en farmakokinetisk populationsanalyse har nyrefunktionen ingen betydende indvirkning på obeticholsyres farmakokinetik.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Reducing the dosage of obeticholic acid to: ▪ 5 mg once weekly, for patients intolerant to 5 mg twice weekly ▪ 10 mg once weekly, for patients intolerant to 10 mg twice weekly
Danish: • Dosisreduktion af obeticholsyre til: ▪ 5 mg én gang om ugen hos patienter, der ikke tolererer 5 mg to gange om ugen ▪ 10 mg én gang om ugen hos patienter, der ikke tolererer 10 mg to gange om ugen
English: Population pharmacokinetic analysis indicated that race is not expected to influence obeticholic acid pharmacokinetics.
Danish: En populationsfarmakokinetisk analyse indikerede, at race ikke kan forventes at påvirke obeticholsyres farmakokinetik.
English: If you take bile acid binding resins, take this medicine at least 4-6 hours before or at least 4-6 hours after the bile acid binding resin (see section "Other medicines and OCALIVA").
Danish: Hvis du tager galdesyrebindende resiner, skal du tage dette lægemiddel mindst 4-6 timer før eller 4-6 timer efter det galdesyrebindende resin (se afsnittet "Brug af anden medicin sammen med OCALIVA").
English: 5 mg once weekly
Danish: 5 mg én gang om ugen
English: • fast or irregular heart beat (palpitations)
Danish: Hurtige eller uregelmæssige hjerteslag (hjertebanken) Smerter i munden og svælget
English: You should continue to take OCALIVA for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.
Danish: Hold ikke op med at tage lægemidlet uden først at tale med lægen.
English: Population pharmacokinetic analysis indicated that gender does not influence obeticholic acid pharmacokinetics.
Danish: En populationsfarmakokinetisk analyse indikerede, at køn ikke påvirker obeticholsyres farmakokinetik.
English: Severe pruritus
Danish: Svær pruritus
English: Management and dose adjustment for severe pruritus Management strategies include the addition of bile acid binding resins or antihistamines.
Danish: Behandingsstrategier omfatter tilføjelse af galdesyrebindende resiner eller antihistaminer.
English: No dose adjustment is required for patients with renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: If you take any of these medicines, take OCALIVA at least 4-6 hours before or 4-6 hours after taking bile acid binding resin, giving as much time as possible.
Danish: Hvis du tager et af disse lægemidler, skal du tage OCALIVA mindst 46 timer før eller 4-6 timer efter, at du tager det galdesyrebindende resin, så der er så lang tid som muligt imellem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/002 30 film-coated tablets EU/1/16/1139/004 100 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1139/002 30 filmovertrukne tabletter EU/1/16/1139/004 100 filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001 30 film-coated tablets EU/1/16/1139/003 100 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1139/001 30 filmovertrukne tabletter EU/1/16/1139/003 100 filmovertrukne tabletter
English: - Complete biliary obstruction.
Danish: Komplet galdeobstruktion.
English: No fertility data is available in humans.
Danish: Der foreligger ingen data for obeticholsyres indvirkning på fertiliteten hos mennesker.
English: Table 1: Dosage Regimen by PBC Patient Population Staging/Classification Non-Cirrhotic or
Danish: PBC-patientpopulation Stadie/klasse
English: See table 1 for dose recommendations.
Danish: Patienter med nedsat leverfunktion Se tabel 1 for doseringsanbefalinger.
English: Decrease in ALP of at least 15%, n (%) Total bilirubin less than or equal to 1-times ULNf, n a Percentage of subjects achieving a response, defined as an ALP less than 1.67-times the ULN, total bilirubin within the normal range, and an ALP decrease of at least 15%.
Danish: a Procentdel af forsøgspersoner, der opnåede et respons, defineret som ALP < 1,67 gange ULN, total-bilirubin inden for normalområdet og et fald i ALP på mindst 15 %.
English: - OCALIVA 10 mg is a yellow, triangular film-coated tablet with ‘INT' on one side and ‘10' on the other side of the film-coated tablet.
Danish: - OCALIVA 10 mg er en gul trekantet filmovertrukket tablet, mærket med “INT” på den ene side og “10” på den anden side.