FrancophonIA/ELRC3.0 huggingface dataset:
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: The volume of distribution of obeticholic acid is 618 L. The volume of distributions of glyco- and tauro-obeticholic acid has not been determined.
Danish: Fordelingsvolumenet for obeticholsyre er 618 l. Fordelingsvolumenet for glyko- og tauroobeticholsyre er ikke fastlagt.
English: As a precautionary measure, you should not take OCALIVA if you are pregnant.
Danish: For en sikkerheds skyld må du ikke tage OCALIVA, hvis du er gravid.
English: In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.
Danish: I tilfælde af overdosering skal patienten overvåges omhyggeligt og støttende behandling iværksættes efter behov.
English: An additional third obeticholic acid metabolite, 3-glucuronide is formed but is considered to have minimal pharmacologic activity.
Danish: Der dannes en tredje obeticholsyre-metabolit, 3-glukuronid, men den anses for at have minimal farmakologisk aktivitet.
English: Maximum Dosage
Danish: Maksimal dosis
English: All changes were reversible with discontinued dosing, and are consistent with and predict the dose-limiting toxicity in humans (systemic exposure at NOAEL was up to 24-fold higher than that seen at the maximum recommended human dose).
Danish: Alle ændringer var reversible efter seponering, og de er konsistente med og prædiktive for den dosisbegrænsende toksicitet hos mennesker (systemisk eksponering ved NOAEL var 1,4 til 19 gange højere end den, der sås ved den maksimale anbefalede dosis til mennesker ).
English: Oral administration of obeticholic acid above the NOAEL to mice, rats, and dogs in pivotal, repeat dose toxicity studies resulted primarily in effects on the hepatobiliary system.
Danish: Oral administration af obeticholsyre over NOAEL til mus, rotter og hunde i pivotale studier, der undersøgte toksicitet efter gentagne doser, resulterede primært i virkninger på det hepatobiliære system.
English: Children and adolescents This medicine is not for use in children or adolescents.
Danish: Denne medicin er ikke beregnet til brug hos børn og unge.
English: These events have occurred as early as within the first month of treatment.
Danish: Disse bivirkninger har optrådt så tidligt som inden for den første behandlingsmåned.
English: These included increased liver weights, alterations in serum chemistry parameters (ALT, AST, LDH, ALP, GGT, and/or bilirubin), and macroscopic/microscopic alterations.
Danish: Disse omfattede øget levervægt, ændringer i kemiske parametre i serum (ALAT, ASAT, LDH, ALP, GGT og/eller bilirubin) samt makroskopiske/mikroskopiske ændringer.
English: There is no relevant use of obeticholic acid in the paediatric population in the treatment of primary biliary cholangitis (PBC).
Danish: Det er ikke relevant at bruge obeticholsyre hos den pædiatriske population til behandling af primær biliær cholangitis (PBC).
English: Interventional study 747-401:
Danish: Interventionsstudie 747-401
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret<{MM/ÅÅÅÅ}><{måned ÅÅÅÅ}>.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: dOCALIVA titration and OCALIVA 10 mg versus placebo.
Danish: d OCALIVA-titrering og OCALIVA 10 mg versus placebo.
English: Mean reductions in ALP were observed as early as Week 2 and were maintained through Month 12 for patients who were maintained on the same dosage throughout 12 months.
Danish: Gennemsnitlige reduktioner i ALP blev observeret så tidligt som i uge 2, og disse blev opretholdt til og med måned 12 for patienter, som fik den samme dosis i 12 måneder.
English: Dose/Time proportionality
Danish: Dosis-tid-proportionalitet
English: The adverse reactions reported with OCALIVA in the phase III clinical study are listed in the table below by MedDRA system organ class and by frequency.
Danish: De bivirkninger, der er rapporteret for OCALIVA i det kliniske fase III-studie, er opført i tabellen nedenfor i henhold til MedDRA-systemorganklasse og hyppighed.
English: Interventional study 747-302:
Danish: Interventionsstudie 747-302
English: Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and tizanidine) is recommended.
Danish: Terapeutisk monitorering af CYP1A2-substrater med snævert terapeutisk indeks (f.eks. theophyllin og tizanidin) anbefales.
English: Obeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine.
Danish: Obeticholsyre er en selektiv og potent agonist for farnesoid X-receptoren (FXR), som er en nuklear receptor, der er udtrykt i høje niveauer i leveren og tarmen.
English: At month 3, 9 (38%) OCALIVA-treated patients achieved a response to the composite endpoint, compared to 1 (4%) placebo-treated patient.
Danish: I måned 3 opnåede 9 (38 %) OCALIVA-behandlede patienter et respons i forhold til det sammensatte endepunkt sammenlignet med 1 (4 %) placebobehandlet patient.
English: Obeticholic acid is absorbed with peak plasma concentrations (Cmax) occurring at a median time (tmax) of approximately 2 hours.
Danish: Obeticholsyre absorberes med maksimal plasmakoncentration (Cmax) efter en mediantid (tmax) på cirka 2 timer.
English: Consider discontinuing treatment with obeticholic acid for patients who continue to experience persistent, intolerable pruritus.
Danish: Overveje seponering af obeticholsyre hos patienter, som fortsat oplever persisterende intolerabel pruritus.
English: Mean baseline ALP values ranged from 316 U/L to 327 U/L.
Danish: Gennemsnitsværdierne for ALP ved baseline varierede fra 316 E/l til 327 E/l.
English: The metabolite-to -parent ratios of the glycine and taurine conjugates of obeticholic acid were 13.8 and 12.3, respectively, after daily administration.
Danish: Metabolit/moderstof-ratioerne for glycin- og taurin-konjugater af obeticholsyre var henholdsvis 13,8 og 12,3 efter daglig administration.
English: Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
Danish: Poly(vinylalkohol), delvist hydrolyseret (E1203) Titandioxid (E171)
English: Abdominal pain and discomfort
Danish: Abdominalsmerter og abdominalt ubehag
English: International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid.
Danish: International normaliseret ratio (INR) falder efter samtidig administration af warfarin og obeticholsyre.
English: The highest single dose exposure of obeticholic acid in healthy volunteers has been at the 500 mg dose.
Danish: Den højeste enkeltdosis obeticholsyre, der er givet til raske frivillige forsøgspersoner, har været 500 mg.
English: b In the trial there were 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients
Danish: b Der var 16 patienter (7 %) i studiet, som var intolerante og ikke fik samtidig UDCA: 6 patienter (8 %) i
English: Repeated doses of 250 mg have been administered for 12 consecutive days and some subjects experienced pruritus and reversible transaminase liver elevations.
Danish: Gentagne doser på 250 mg er blevet administreret i 12 konsekutive dage, og nogle forsøgspersoner fik pruritus og reversibelt forhøjede leveraminotransferaser.
English: Interaction with CYP1A2 substrates with narrow therapeutic index Obeticholic acid may increase the exposure to concomitant medicinal products that are CYP1A2 substrates.
Danish: Interaktion med CYP1A2-substrater med snævert terapeutisk indeks Obeticholsyre kan øge eksponeringen for samtidigt administrerede lægemidler, der er substrater for CYP1A2.
English: There are no data on the use of obeticholic acid in pregnant women.
Danish: Der er ingen data fra anvendelse af obeticholsyre til gravide kvinder.
English: After administration of radiolabeled obeticholic acid, greater than 87% is excreted in faeces.
Danish: Efter administration af radioaktivt mærket obeticholsyre udskilles mere end 87 % i fæces.
English: Clinical signs and symptoms of hepatic decompensation have also been observed.
Danish: Der er også set kliniske symptomer på leverdekompensation.
English: Do not take OCALIVA: - if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage OCALIVA Tag ikke OCALIVA: - hvis du er allergisk over for obeticholsyre eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Following multiple-dose administration of 5, 10, and 25 mg once daily for 14 days, systemic exposures of obeticholic acid increase dose proportionally.
Danish: Efter administration af 5, 10 og 25 mg én gang dagligt i 14 dage øges den systemiske eksponering for obeticholsyre proportionalt med dosis.
English: The majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing.
Danish: De fleste tilfælde af pruritus opstod inden for den første behandlingsmåned og tenderede til at gå over med tiden ved fortsat dosering.
English: Child-Pugh Class B or C or Decompensated Cirrhotic
Danish: Child-Pugh B eller C eller dekompenseret cirrose
English: Prior to initiation of treatment with obeticholic acid the patient's hepatic status must be known.
Danish: Inden påbegyndelse af behandling med obeticholsyre skal patientens leverstatus vurderes.
English: Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been observed in patients taking obeticholic acid.
Danish: Der er set forhøjet alanin-aminotransferase (ALAT) og aspartat-aminotransferase (ASAT) hos patienter, som tager obeticholsyre.
English: FXR is thought to be a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways.
Danish: Det menes, at FXR er en vigtig regulator af galdesyretransport og inflammatoriske, fibrotiske og metaboliske processer.
English: Your doctor may adjust your dose depending on your liver function or if you experience itching that is difficult to tolerate.
Danish: Lægen kan justere din dosis efter vurdering af din leverfunktion, eller hvis du får kløe, som du har svært ved at udholde.
English: • swelling in the hands and feet
Danish: Hævede hænder og fødder
English: Responses occurred as early as 2 weeks and were dose dependent (OCALIVA 5 mg compared with 10 mg at 6 months, p=0.0358).
Danish: Der sås respons så tidligt som efter 2 uger, og disse var dosisafhængige (OCALIVA 5 mg sammenlignet med 10 mg efter 6 måneder, p = 0,0358).
English: This medicine is used to treat adult patients with a type of liver disease known as primary biliary cholangitis (also known as primary biliary cirrhosis), either by itself or together with another medicine, ursodeoxycholic acid.
Danish: Dette lægemiddel bruges til at behandle voksne patienter med en type leversygdom, der kaldes primær biliær kolangitis (også kaldet primær biliær cirrose), enten alene eller sammen med et andet lægemiddel, der hedder ursodeoxycholsyre.
English: The recommended dose is one 5 mg film-coated tablet once daily by mouth.
Danish: Den anbefalede dosis er én 5 mg filmovertrukket tablet én gang dagligt gennem munden.
English: Rationale: to investigate the effect of obeticholic acid on clinical outcomes in subjects with PBC
Danish: Rationale: At undersøge virkningen af obeticholsyre hos patienter med PBC på grundlag af kliniske resultater
English: The most common adverse reaction leading to discontinuation was pruritus.
Danish: Den bivirkning, der hyppigst medførte seponering, var pruritus.
English: In the post marketing setting, serious liver injury and death have been reported with more frequent dosing of obeticholic acid than recommended in patients with moderate to severe decreases in liver function.
Danish: Efter markedsføring er der rapporteret om alvorlig leverskade og dødsfald ved hyppigere administration af obeticholsyre end anbefalet hos patienter med moderat til svært nedsat leverfunktion.
English: Paediatric population No pharmacokinetic studies were performed with obeticholic acid in patients less than 18 years of age.
Danish: Pædiatrisk population Der er ikke udført farmakokinetiske studier med obeticholsyre hos patienter under 18 år.
English: The majority (93%) of patients received treatment in combination with UDCA and a small number of patients (7%) unable to tolerate UDCA received placebo, OCALIVA (10 mg) or OCALIVA titration (5 mg to 10 mg) as monotherapy.
Danish: Størstedelen (93 %) af patienterne fik behandling i kombination med UDCA, og et lille antal patienter (7 %), som ikke kunne tåle UDCA, fik placebo, OCALIVA (10 mg) eller OCALIVA-titrering (5 mg til 10 mg) som monoterapi.
English: Contact a doctor or go to a hospital for advice immediately.
Danish: Kontakt straks en læge eller tag på skadestuen.
English: Therefore, a modified dose regimen for patients with moderate or severe hepatic impairment is required to achieve plasma exposure levels similar to patients with no hepatic impairment (see section
Danish: Derfor kræves et modificeret dosisregime for patienter med moderat eller svært nedsat leverfunktion for at opnå det samme plasmaniveau som hos patienter uden nedsat leverfunktion (se pkt.
English: Population pharmacokinetic analysis, developed using data from patients up to 65 years old, indicated that age is not expected to significantly influence obeticholic acid clearance from the circulation.
Danish: En farmakokinetisk populationsanalyse udviklet på grundlag af data fra patienter i alderen op til 65 år indikerede, at alder ikke kan forventes at påvirke obeticholsyre-clearance fra cirkulationen i signifikant grad.
English: The impact of mild hepatic impairment (Child-Pugh Class A) on the pharmacokinetics of obeticholic acid was negligible, therefore, no dose adjustment is necessary for patients with mild hepatic impairment.
Danish: Indvirkningen af let nedsat leverfunktion (Child-Pugh klasse A) på obeticholsyres farmakokinetik var ubetydelig, og dosisjustering er derfor ikke nødvendig hos patienter med let nedsat leverfunktion.
English: Microcrystalline cellulose (E460) Sodium starch glycolate (Type A) Magnesium stearate
Danish: Mikrokrystallinsk cellulose (E460) Natriumstivelsesglycolat (Type A) Magnesiumstearat
English: - if you have a complete blockage of the biliary tract (liver, gall bladder and bile ducts).
Danish: - hvis du har en fuldstændig blokering i galdevejene (leveren, galdeblæren og galdegangene).
English: OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Danish: OCALIVA er indiceret til behandling af primær biliær cholangitis (også betegnet primær biliær cirrose) i kombination med ursodeoxycholsyre (UDCA) til voksne med utilstrækkeligt respons på UDCA eller som monoterapi til voksne, som ikke tåler UDCA.
English: • Continue to increase the dosage to 10 mg once daily, as tolerated, to achieve optimal response.
Danish: • Fortsætte med at øge dosis til 10 mg én gang dagligt, som tolereres, for at opnå optimalt respons.
English: Further, see sections 4.4 and 5.2.
Danish: 4.2 og 5.2).
English: It is unknown whether obeticholic acid is excreted in human milk.
Danish: Det er ukendt, om obeticholsyre udskilles i human mælk.
English: The levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored by your doctor while taking OCALIVA.
Danish: Niveauerne af visse lægemidler, fx theofyllin (anvendes til behandling af åndedrætsbesvær) eller tizanidin (et lægemiddel til behandling af muskelstivhed og nedsat muskelbevægelighed), kan stige og skal overvåges af lægen, så længe du tager OCALIVA.
English: The European Medicines Agency has waived the obligation to submit the results of studies with obeticholic acid in all subsets of the paediatric population in PBC (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med obeticholsyre i alle undergrupper af den pædiatriske population med PBC (se pkt.
English: Exposures of glyco- and tauro-obeticholic acid, and total obeticholic acid increase more than proportionally with dose.
Danish: Eksponeringen for glyko- og tauro-obeticholsyre samt totalobeticholsyre øges mere end proportionalt med dosis.
English: A phase III, randomised, double-blind, placebo-controlled, parallel-group, 12-month study (POISE) evaluated the safety and efficacy of OCALIVA in 216 patients with PBC who were taking UDCA for at least 12 months (stable dose for ≥ 3 months) or who were unable to tolerate UDCA and did not receive UDCA for ≥3 months.
Danish: I et randomiseret, dobbeltblindt, placebokontrolleret, 12-måneders fase III-studie med parallelle grupper (POISE) evalueredes OCALIVAs sikkerhed og virkning hos 216 patienter med PBC, som havde taget UDCA i mindst 12 måneder (stabil dosis i ≥ 3 måneder), eller som ikke kunne tåle UDCA og ikke havde fået UDCA i ≥ 3 måneder.
English: After daily administration of obeticholic acid, there was accumulation of the glycine and taurine conjugates of obeticholic acid which have in vitro pharmacological activities similar to the parent drug.
Danish: Efter daglig administration af obeticholsyre var der en akkumulation af glycin- og taurin-konjugaterne af obeticholsyre, som har in vitro farmakologisk aktivitet svarende til moderstoffet.
English: Animal studies do not indicate any direct or indirect effects on fertility or reproduction (see section 5.3).
Danish: I dyrestudier blev der ikke observeret direkte eller indirekte virkninger på fertilitet eller reproduktion (se pkt.
English: The mean (95% CI) reduction in ALP in OCALIVA-treated patients was 246 (165, 327) U/L compared to an increase of 17 (-7, 42) U/L in the placebo-treated patients.
Danish: Den gennemsnitlige reduktion (95 % CI) i ALP hos OCALIVA-behandlede patienter var 246 (165; 327) E/l sammenlignet med en stigning på 17 (-7; 42) E/l hos de placebobehandlede patienter.
English: Warnings and precautions Talk to your doctor or pharmacist before taking OCALIVA.
Danish: Kontakt lægen eller apotekspersonalet, før du tager OCALIVA.
English: Liver-related adverse events have primarily been observed at doses higher than the maximum recommended dose of 10 mg once daily (see section 4.9).
Danish: Der er primært set leverrelaterede bivirkninger ved højere doser end den maksimale anbefalede dosis på 10 mg én gang dagligt (se pkt.
English: In particular, tell your doctor if you are taking so-called bile acid binding resins (cholestyramine, colestipol, colesevelam) used to lower blood cholesterol levels as they may lessen the effect of OCALIVA.
Danish: Du skal især fortælle lægen, hvis du tager såkaldte galdesyrebindende resiner (colestyramin, colestipol, colesevelam), som bruges til at sænke kolesterolindholdet i blodet, da de kan nedsætte virkningen af OCALIVA.
English: For patients in the OCALIVA titration arm whose OCALIVA dosage was increased from 5 mg once daily to 10 mg once daily, additional reductions in ALP were observed at Month 12 in the majority of patients.
Danish: For patienter i OCALIVAtitreringsarmen, hvor OCALIVA-dosis øgedes fra 5 mg én gang dagligt til 10 mg én gang dagligt, observeredes der yderligere reduktioner i ALP i måned 12 hos størstedelen af patienterne.
English: • dry skin, redness of the skin (eczema)
Danish: Tør hud, rødhed i huden (eksem)
English: Limited data exists in patients with mild and moderate renal impairment and no data exists in severe renal impairment.
Danish: Der foreligger begrænsede data for patienter med let og moderat nedsat nyrefunktion og ingen data for patienter med svært nedsat nyrefunktion.
English: INR should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range when co-administering obeticholic acid and warfarin.
Danish: INR bør monitoreres og warfarindosis om nødvendigt justeres for at opretholde målintervallet for INR ved samtidig administration af obeticholsyre og warfarin.
English: Pack sizes 1 bottle with 30 or 100 film-coated tablets.
Danish: Pakningsstørrelse 1 flaske med 30 eller 100 filmovertrukne tabletter
English: - Film-coat: Polyvinyl alcohol, part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172).
Danish: - Filmovertræk: Delvist hydrolyseret polyvinylalkohol(E1203), titandioxid (E171), macrogol 3350 (E1521), talcum (E553b), gul jernoxid (E172).
English: No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid.
Danish: Dosisjustering af samtidig UDCA er ikke nødvendig hos patienter, der får obeticholsyre.
English: Treatment with OCALIVA 10 mg or OCALIVA titration (5 mg to 10 mg) resulted in clinically and statistically significant increases (p < 0.0001) relative to placebo in the number of patients achieving the primary composite endpoint at all study time points (see Table 3).
Danish: Behandling med OCALIVA 10 mg eller OCALIVA-titrering (5 mg til 10 mg) resulterede i klinisk og statistisk signifikant stigning (p < 0,0001) i antallet af patienter, som nåede det primære endepunkt, på alle tidspunkter i studiet (se tabel 3).
English: Patients at an increased risk of hepatic decompensation, including those with laboratory evidence of worsening liver function and /or progression to cirrhosis, should be monitored more closely.
Danish: Patienter med øget risiko for dekompenseret leversygdom skal overvåges tættere, herunder patienter, hvis laboratorietest viser tegn på forværret leverfunktion og/eller udvikling af cirrose.
English: Mean baseline total bilirubin values ranged from 10 μmol/L to 12 μmol/L across treatment arms, with 92% of patients within normal range.
Danish: Gennemsnitsværdierne for total-bilirubin ved baseline varierede fra 10 mikromol/l til 12 mikromol/l på tværs af behandlingsgrupperne med 92 % af patienterne inden for normalområdet.
English: What OCALIVA contains The active substance is obeticholic acid.
Danish: OCALIVA indeholder: Aktivt stof: obeticholsyre.
English: The percentages of patients who required interventions (i.e, dosage adjustments, treatment interruptions, or initiation of antihistamines or bile acid binding resins) were 41% in the OCALIVA 10 mg arm, 34% in the OCALIVA titration group, and 19% in the placebo group.
Danish: Andelen af patienter, hvor intervention var nødvendig (dvs. dosisjustering, afbrydelse af behandling eller initiering af antihistaminer eller galdesyrebindende resiner), udgjorde 41 % i OCALIVA 10 mgarmen, 34 % i OCALIVA-titreringsarmen og 19 % i placebogruppen.
English: The conjugates can be deconjugated in the ileum and colon by intestinal microbiota, leading to the conversion to obeticholic acid that can be reabsorbed or excreted in faeces, the principal route of elimination.
Danish: Konjugaterne kan dekonjugeres i ileum og colon ved hjælp af tarmfloraen, hvorefter de konverteres til obeticholsyre, som kan reabsorberes eller udskilles i fæces, der er den vigtigste eliminationsvej.
English: OCALIVA Titrationc (N = 70)
Danish: OCALIVAtitreringc (N = 70)