FrancophonIA/ELRC3.0 huggingface dataset:
English: Single supratherapeutic oral doses of eluxadoline up to 1,000 mg and single intranasal doses up to 200 mg were associated with a higher incidence of adverse events than a 100 mg single dose, especially gastrointestinal and central nervous system events.
Danish: Supraterapeutiske orale enkeltdoser af eluxadolin på op til 1.000 mg og intranasale enkeltdoser på op til 200 mg var forbundet med en højere forekomst af bivirkninger end en enkelt 100 mg dosis, især bivirkninger fra mave-tarm-kanalen og centralnervesystemet.
English: Film-coated tablets 28 tablets
Danish: Filmovertrukne tabletter 28 tabletter
English: Placebo n=382
Danish: Placeb o n=382
English: In participants with end stage renal disease (ESRD) not yet on dialysis, exposure of eluxadoline was significantly increased compared with matched, healthy participants with normal renal function.
Danish: Hos deltagere med terminalt nyresvigt (end stage renal disease (ESRD)), der endnu ikke var i dialyse, var eksponeringen for eluxadolin signifikant forhøjet sammenlignet med tilsvarende, raske deltagere med normal nyrefunktion.
English: Since bioavailability is limited, the pharmacodynamic activity of eluxadoline is based predominantly on local action within the GI tract.
Danish: Da biotilgængeligheden er begrænset, er eluxadolins farmakodynamiske aktivitet fortrinsvist baseret på en lokal virkning i mave-tarm-kanalen.
English: Eluxadoline may cause constipation.
Danish: Eluxadolin kan forårsage obstipation.
English: Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, eluxadoline has some potential for the metabolism based inactivation of CYP3A4.
Danish: Eluxadolin virker ikke inducerende eller hæmmende på de vigtigste CYP-enzymer, men har dog et vist potentiale for metabolisme-baseret inaktivering af CYP3A4.
English: Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.
Danish: Der kan optræde tab af virkning, især når lægemidler med lav dosis og smalt terapeutisk indeks (fx alfentanil, dihydroergotamin, ergotamin, fentanyl, pimozid, kinidin, sirolimus, tacrolimus) indgives samtidig med eluxadolin.
English: These symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).
Danish: Disse symptomer forekommer kun sjældent (kan ramme op til 1 ud af 100 personer) og kan være tegn på problemer i bugspytkirtlen eller galdegangen (for eksempel betændelse i bugspytkirtlen eller kramper i sphincter Oddi).
English: 3 “Sphincter of Oddi spasm” term includes: manifestation as pancreatitis (terms include alcoholic pancreatitis, pancreatitis, and pancreatitis acute) and hepatic enzyme elevations with abdominal pain (terms include abdominal pain, abdominal pain upper, dyspepsia, and sphincter of Oddi dysfunction).
Danish: 3Termen “spasmer i sphincter Oddi” omfatter: manifestation som pancreatitis (alkoholisk pancreatitis, pancreatitis og akut pancreatitis) og forhøjede leverenzymer med abdominalsmerter (abdominalsmerter, øvre abdominalsmerter, dyspepsi og sphincter Oddi dysfunktion).
English: 6”Hypersensitivity” term includes: anaphylaxis, angioedema, (e.g. swollen face and/or throat), dyspnea, throat tightness and chest pain/tightness - spontaneously reported in the post-marketing period.
Danish: 6Termen “overfølsomhed” omfatter: anafylaksi, angioødem (fx hævet ansigt og/eller svælg), dyspnø, sammensnøring i halsen og smerter i/trykken for brystet - indberettet spontant i perioden efter markedsføring.
English: Eluxadoline is also an agonist at the kappa opioid receptor (κOR).
Danish: Eluxadolin er desuden en kappa-opioidreceptor- (κOR-) agonist.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of eluxadoline in milk (for details see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at eluxadolin udskilles i mælk (se pkt.
English: OATP1B1 substrates
Danish: OATP1B1-substrater
English: Considering the short half-life of naloxone, repeated administration may be necessary.
Danish: Gentagen indgift kan være nødvendig i betragtning af naloxons korte halveringstid.
English: Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder.
Danish: Der er efter markedsføring indberettet alvorlige bivirkninger i form af spasme i sphincter Oddi med eller uden pancreatitis, som medførte hospitalsindlæggelse, især hos patienter uden galdeblære.
English: Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor
Danish: Eluxadolin er en lokalt virkende blandet my-opioidreceptor-agonist (μOR-agonist) og deltaopioidreceptor-antagonist (δOR-antagonist).
English: Eluxadoline is primarily excreted in the feces, either as unabsorbed active substance or via the biliary system with the kidney playing a minimal role in elimination.
Danish: Eluxadolin udskilles primært i fæces - enten som uabsorberet aktivt stof eller via galdesystemet; nyrerne spiller en minimal rolle i eliminationen.
English: Avoid taking Truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]).
Danish: Undgå at tage Truberzi sammen med andre lægemidler, som kan forårsage forstoppelse, såsom opioider (fx fentanyl [bruges til behandling af smerter]) eller antikolinerge midler (fx atropin [bruges blandt andet til behandling af hjertesygdomme]).
English: Eluxadoline should not be administered concomitantly with such medicinal products (see section 4.3).
Danish: Eluxadolin må ikke indgives samtidig med sådanne lægemidler (se pkt.
English: Patients should be informed of and monitored for signs and symptoms suggestive of pancreatitis e.g. abdominal pain, that may radiate to the back or shoulder, nausea and vomiting.
Danish: Patienter skal oplyses om og overvåges for tegn og symptomer, der indikerer pancreatitis, fx mavesmerter, der kan udstråle til ryg eller skulder, kvalme og opkastning.
English: The main symptoms of IBS-D include: - stomach ache; - stomach discomfort; - diarrhoea; - urgent bowel movements.
Danish: De mest fremtrædende symptomer på IBS-D er: - mavesmerter - ubehag i maven - diaré - pludselig afføringstrang.
English: Truberzi may decrease the level of some medicines in the blood.
Danish: Truberzi kan sænke indholdet af nogle lægemidler i blodet.
English: In both studies, the proportion of patients who were composite responders to Truberzi 100 mg twice daily was statistically significantly higher than placebo.
Danish: I begge studier var andelen af patienter, som var kombinerede respondenter på Truberzi 100 mg to gange dagligt, statistisk signifikant højere end for placebo.
English: Eluxadoline's systemic exposure following oral administration is low and is consistent with its local action in the GI tract.
Danish: Eluxadolins systemiske eksponering efter oral indgift er lav og i overensstemmelse med lægemidlets lokale virkning i mave-tarm-kanalen.
English: Truberzi should not be taken whilst pregnant or breast-feeding.
Danish: Du må ikke tage Truberzi, hvis du er gravid eller ammer.
English: The following adverse reactions considered related to eluxadoline treatment from clinical trials and spontaneous reporting are presented according to the MedDRA System Organ Classification and frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Følgende bivirkninger, fra kliniske studier og spontane indberetninger, og som anses for at være relateret til eluxadolin-behandling, er klassificeret i henhold til MedDRA's systemorganklasse og hyppighedskonvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig
English: Patients should be instructed to stop the treatment immediately and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain (e.g. acute epigastric or biliary [i.e., right upper quadrant] pain) that may radiate to the back or shoulder, with or without nausea and vomiting.
Danish: Patienterne skal informeres om straks at seponere behandlingen og søge læge, hvis de får symptomer, der kan tyde på spasmer i sphincter Oddi, såsom akut forværring af abdominalsmerter (fx akutte epigastriske eller biliære [dvs. højre øvre kvadrant] smerter), som kan stråle ud til ryg eller skulder, med eller uden kvalme og opkastning.
English: Hepatic impairment or coadministration with cysclosporine results in significant increases in plasma concentrations of eluxadoline.
Danish: Nedsat leverfunktion eller samtidig indgift af ciclosporin medfører signifikant stigning i plasmakoncentrationen af eluxadolin.
English: (see sections 4.2 and 4.4).
Danish: 4.2 and 4.4).
English: The recommended dose is one 100 mg tablet twice a day.
Danish: Den anbefalede dosis er én 100 mg tablet to gange dagligt.
English: However, patients 65 years of age and older, treated with the 75 mg dose twice daily experienced a reduced rate of serious adverse events as well as adverse events leading to discontinuation compared to patients treated with 100 mg dose twice daily (see section 4.8).
Danish: Patienter ≥ 65 år, som fik en dosis på 75 mg to gange dagligt, havde imidlertid færre alvorlige bivirkninger og bivirkninger, som medførte seponering, sammenlignet med patienter, der fik 100 mg to gange dagligt (se pkt.
English: When the threshold for abdominal pain response was increased to ≥40% or ≥50% improvement from baseline in daily worst abdominal pain, the proportion of abdominal pain responders was 6%-7% higher for eluxadoline 100 mg twice daily compared to placebo which was statistically significant (P ≤ 0.009) for the pooled (Study 1 and Study 2) data.
Danish: Da tærsklen for abdominalsmerte-respons i værste daglige abdominalsmerter blev forhøjet til en forbedring på ≥ 40 % eller ≥ 50 % i forhold til baseline, var andelen af abdominalsmerte-respondenter 6-7 % højere for eluxadolin 100 mg to gange dagligt end for placebo.
English: Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) and iron oxide red (E172).
Danish: Filmovertræk: polyvinylalkohol (E 1203), titandioxid (E 171), macrogol 3350 (E 1521), talcum (E 553B), gul jernoxid (E 172) og rød jernoxid (E 172).
English: Co-administration of eluxadoline with rosuvastatin (an OATP1B1 substrate) resulted in an up to 1.4-fold increase in exposure of rosuvastatin and the major active metabolite, n-desmethyl rosuvastatin compared to administration of rosuvastatin alone.
Danish: Samtidig indgift af eluxadolin og rosuvastatin (et OATP1B1-substrat) medførte en stigning i eksponeringen for rosuvastatin og den vigtigste aktive metabolit, n-desmethyl-rosuvastatin, på op til 1,4 gange sammenlignet med indgift af rosuvastatin alene.
English: Macrogol 3350 (E1521);
Danish: Macrogol 3350 (E 1521) Talcum (E 553B)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - 100 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER - 100 mg
English: Truberzi may increase the level of some medicines in the blood.
Danish: Truberzi kan øge indholdet af nogle lægemidler i blodet.
English: In vitro studies indicated that eluxadoline is a substrate and an inhibitor of the hepatic uptake transporter OATP1B1; a substrate for the hepatic efflux transporter MRP2 and is not a substrate or inhibitor of the P-gp and BCRP transporters.
Danish: In vitro studier indikerede, at eluxadolin er substrat for og hæmmer af leveroptagelsestransportøren OATP1B1 og substrat for levereffluxtransportøren MRP2, men ikke substrat for eller hæmmer af Pgp- og BCRP-transportørerne.
English: Eluxadoline has very low oral bioavailability and exerts no detectable central nervous system (CNS)-mediated effects when administered orally to animals at effective doses.
Danish: Eluxadolin har meget lav oral biotilgængelighed og udviser ingen påviselige CNSmedierede virkninger hos dyr efter oral indgift af effektive doser.
English: Truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets.
Danish: Truberzi fås i pakninger, der indeholder 28 eller 56 filmovertrukne tabletter og i multipakninger med 168 filmovertrukne tabletter, der består af 3 æsker, der hver indeholder 56 filmovertrukne tabletter.
English: Eluxadoline has demonstrated efficacy in normalizing GI transit and defecation in several models of stress induced or post GI inflammation-altered GI function in animals.
Danish: Eluxadolin har udvist virkning i normaliseringen af den gastrointestinale passage og defækation i flere dyremodeller af ændret gastrointestinal funktion - enten stressinduceret eller efter gastrointestinal inflammation.
English: The apparent clearance of eluxadoline is markedly reduced and half-life increases in hepatic-impaired patients (see sections 4.3 and 4.4).
Danish: Den tilsyneladende clearance af eluxadolin er markant reduceret og halveringstiden øget hos patienter med nedsat leverfunktion (se pkt.
English: Patients receiving eluxadoline reported significant increases in urgency-free days both for ≥50% urgency-free days as well as ≥75% urgency free days.
Danish: Patienter, der fik eluxadolin, rapporterede signifikant stigning i dage uden afføringstrang både for ≥ 50 % dage uden afføringstrang og ≥ 75 % dage uden afføringstrang.
English: • Hypersensitivity to eluxadoline or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for eluxadolin eller over for et eller flere af hjælpestofferne anført i pkt.
English: Taken together these results suggest that when using the medicinal product as directed at therapeutic doses patients will not experience significant central nervous system effects or adverse events consistent with a drug of abuse.
Danish: Samlet set tyder disse resultater på, at patienter ikke vil opleve signifikante bivirkninger i centralnervesystemet eller samme bivirkninger som ved et misbrugsstof, når lægemidlet tages efter anvisningerne og i terapeutiske doser.
English: • Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction.
Danish: • Kendt eller mistanke om obstruktion i galdeveje og/eller pancreasgangen (fx galdesten, tumor, periampullær duodenaldivertikel) eller sygdom i eller dysfunktion af sphincter Oddi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - 75 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER - 75 mg
English: Eluxadoline is primarily cleared as such via the biliary system with the kidney playing a minimal role in elimination.
Danish: Eluxadolin udskilles fortrinsvis via galdesystemet, og nyrerne spiller en minimal rolle i eliminationen.
English: Film-coated tablets 56 tablets.
Danish: Filmovertrukne tabletter 56 tabletter.
English: Each tablet contains 100 mg of eluxadoline.
Danish: Hver tablet indeholder 100 mg eluxadolin.
English: Caution should be exercised when administering eluxadoline in IBS patients whose bowel habits vary over time.
Danish: Der skal udvises forsigtighed ved ordination af eluxadolin til IBS-patienter med et varierende afføringsmønster.
English: Truberzi should not be restarted in patients who developed biliary duct obstruction or sphincter of Oddi spasm while taking Truberzi (see section 4.3).
Danish: Behandling med Truberzi bør ikke genstartes hos patienter, der har udviklet galdevejsobstruktion eller spasmer i sphincter Oddi, mens de har fået Truberzi (se pkt.
English: Each tablet contains 75 mg of eluxadoline.
Danish: Hver tablet indeholder 75 mg eluxadolin.
English: Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572).
Danish: Tabletkerne: silicificeret mikrokrystallinsk cellulose (E 460), kolloid vandfri silica (E 551), crospovidon, type B (E 1202), mannitol (E 421) og magnesiumstearat (E 572).
English: Therefore, in this population, the 75 mg dose twice daily can be used.
Danish: Derfor kan en dosis på 75 mg to gange dagligt bruges i denne population (se pkt.
English: Serious adverse reactions of pancreatitis (0.2% and 0.3% of patients receiving 75 mg and 100 mg respectively) and sphincter of Oddi spasm (0.2% of patients receiving 75 mg and 0.8% of patients receiving 100 mg) may also occur.
Danish: Der kan desuden opstå alvorlige bivirkninger i form af pancreatitis (0,2 % og 0,3 % ved henholdsvis 75 mg og 100 mg) samt spasmer i sphincter Oddi (0,2 % og 0,8 % ved henholdsvis 75 mg og 100 mg).
English: Co-administration of OATP1B1 inhibitors (cyclosporine, gemfibrozil, antiretrovirals [atazanavir, lopinavir, ritonavir, saquinavir, tipranavir], rifampin) with eluxadoline may increase exposure to eluxadoline (see section 5.2).
Danish: Samtidig indgift af OATP1B1-hæmmere (ciclosporin, gemfibrozil, antiretrovirale midler [atazanavir, lopinavir, ritonavir, saquinavir, tipranavir], rifampin) og eluxadolin kan øge eksponeringen for eluxadolin (se pkt.
English: • these symptoms are uncommon and may indicate pancreas or bile duct system problems (i.e. inflammation of the pancreas or spasm of the sphincter of Oddi); o your risk of developing pancreas or bile duct system problems may be higher if you drink alcohol in excess, o the spasm of the sphincter of Oddi usually goes away when you stop Truberzi.
Danish: • Disse symptomer er ikke almindelige og kan være tegn på problemer i bugspytkirtlen eller galdegangen (for eksempel betændelse i bugspytkirtlen eller kramper i sphincter Oddi) o din risiko for at få problemer i bugspytkirtlen eller galdegangen kan være højere, hvis du drikker meget alkohol, o kramper i sphincter Oddi forsvinder normalt, når man holder op med at tage Truberzi - svær forstoppelse.
English: 2“Abdominal pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper.
Danish: 1Termen “døsighed” omfatter: døsighed og sedation 2Termen “abdominalsmerter" omfatter: abdominalsmerter, nedre abdominalsmerter og øvre abdominalsmerter.
English: Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies.
Danish: I kliniske studier blev der også rapporteret tilfælde af pancreatitis, som ikke var forbundet med spasmer i sphincter Oddi.
English: Common: may affect up to 1 in 10 people - dizziness; - sleepiness; - constipation; - feeling sick (nausea); - stomach ache; - being sick (vomiting); - gas (flatulence); - feeling bloated; - heartburn or acid reflux; - rash; - abnormal blood test results (increased levels of certain liver enzymes).
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 personer - svimmelhed - søvnighed - forstoppelse - kvalme - mavesmerter - opkastning - luft i maven (flatulens) - oppustethed - halsbrand eller sure opstød - udslæt - unormale resultater af blodprøver (forhøjet indhold af bestemte leverenzymer).
English: Sphincter of Oddi spasm3
Danish: Spasmer i sphincter Oddi3
English: Adequate Relief Response
Danish: Respons, tilstrækkelig lindring
English: No dose adjustment is necessary for co-administered OATP1B1 substrates.
Danish: Dosisjustering er ikke nødvendig ved samtidig indgift af OATP1B1-substrater.
English: Patients should be instructed to stop the medicinal product and seek medical attention if they develop severe constipation (see section 4.4).
Danish: Patienterne skal informeres om at afbryde behandlingen og søge læge, hvis de får alvorlig obstipation (se pkt.
English: Co-administration of eluxadoline with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to eluxadoline.
Danish: Samtidig indgift af eluxadolin og probenecid (en MRP2-hæmmer) medførte en stigning i eksponeringen for eluxadolin på cirka 1,4 gange.
English: Given the mu opioid receptor agonism of eluxadoline, there is a potential for increased risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking eluxadoline, especially in patients without a gallbladder (see sections 4.3 and 4.8).
Danish: På grund af eluxadolins antagonistiske virkning på my-opioidreceptoren er der potentielt en øget risiko for spasmer i sphincter Oddi, som kan medføre pancreatitis eller forhøjede leverenzymer forbundet med akutte abdominalsmerter (fx galdestens-lignende smerter) hos patienter, der får eluxadolin - især patienter uden galdeblære (se pkt.
English: - if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum); - if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);
Danish: - hvis du er allergisk over for eluxadolin eller et af de øvrige indholdsstoffer i Truberzi (angivet i afsnit 6) - hvis du har eller har haft betændelse i bugspytkirtlen (pancreatitis) - hvis du fra fødslen ikke har nogen galdeblære, eller din galdeblære er blevet fjernet kirurgisk - hvis du har eller har haft problemer med alkoholmisbrug, alkoholafhængighed, eller hvis du har et alkoholforbrug - hvis du har eller har haft en hvilken som helst form for blokering i galdeblæren, galdegangene eller bugspytkirtlen (såsom galdesten, tumor, divertikel på tolvfingertarmen) - hvis du har eller har haft sygdom i sphincter Oddi (en lille rund muskel i den øverste del af maven, der regulerer strømmen af galde og bugspyt ind i den øverste del af tarmene), eller hvis sphincter Oddi ikke fungerer korrekt
English: These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm (see section 4.4).
Danish: Disse patienter har øget risiko for at udvikle alvorlige bivirkninger i form af pancreatitis og/eller spasmer i sphincter Oddi (se pkt.
English: Patients with renal impairment No dose adjustment is necessary based on renal function (see sections 4.4 and 5.2).
Danish: Patienter med nedsat nyrefunktion Dosisjustering på baggrund af nyrefunktion er ikke nødvendig (se pkt.
English: Truberzi 100 mg film-coated tablets Each film-coated tablet contains 100 mg of eluxadoline.
Danish: Truberzi 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg eluxadolin.
English: These patients are at increased risk for acute pancreatitis (see section 4.4).
Danish: Disse patienter har forhøjet risiko for akut pancreatitis (se pkt.
English: The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).
Danish: Den anbefalede dosis er 200 mg dagligt (én 100 mg tablet to gange dagligt).
English: Additionally, the proportion of patients who were composite responders to eluxadoline at each 4-week interval for months 1 through 6 was higher than placebo for both doses in both Phase 3 studies demonstrating that efficacy is maintained with continuous eluxadoline treatment.
Danish: Desuden var andelen af patienter, som var kombinerede respondenter på eluxadolin ved hvert 4 ugers interval i måned 1 til og med måned 6, højere end ved placebo for begge dosers vedkommende i begge fase 3-studier.