FrancophonIA/ELRC3.0 huggingface dataset:
English: Xermelo was taken within 15 minutes before, or within 1 hour after food.
Danish: Xermelo blev taget inden for intervallet max.15 minutter før eller højst 1 time efter mad.
English: The potential for in vivo drug interaction via inhibition of BCRP is considered low.
Danish: Potentialet for in vivo lægemiddel interaktion via inhibering af BCRP anses for værende lavt.
English: Your doctor will prescribe this medicine if your diarrhoea is not well controlled with injections of other medicines called ‘somatostatin analogues' (lanreotide or octreotide).
Danish: Din læge vil give dig dette lægemiddel, hvis din diarré ikke er velkontrolleret med injektioner af anden medicin, som kaldes ”somatostatinanaloger” (lanreotid eller octreotid).
English: This is because Xermelo can affect the way some other medicines work, or other medicines can affect the way Xermelo works.
Danish: Det skyldes at Xermelo kan påvirke den måde anden medicin virker på, eller anden medicin kan påvirke den måde Xermelo virker på.
English: There are no data from the use of telotristat in pregnant women.
Danish: Der er ingen data om brugen af telotristat hos gravide kvinder.
English: CLs were based on the HodgesLehmann estimator of the median paired difference.
Danish: CLer var baseret på Hodges-Lehmann estimatoren for den medianparrede forskel.
English: Carboxylesterase (CES) inhibitors
Danish: Carboxylesterase (CES) inhibitorer
English: The microscopic changes in the gastrointestinal tract reversed with a 4-week recovery period.
Danish: De mikroskopiske ændringer i det gastrointestinale område restitueredes i løbet af en 4-ugers periode.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Your doctor may need to change the dose of your medicines.
Danish: Din læge kan være nødt til at ændre dosis af din medicin.
English: The secondary objective of this study was to evaluate changes in patients' quality of life (QOL) through Week 84.
Danish: Det sekundære formål med dette studie var at evaluere ændringer i patienternes livskvalitet til og med uge 84.
English: Elderly patients (65 years of age and above) No specific dose recommendations are available for elderly patients (see section 5.2).
Danish: Ældre patienter (65 år og ældre) Der er ingen specielle dosisanbefalinger tilgængelige for ældre patienter (se pkt.
English: Most events were mild or moderate and did not limit study treatment.
Danish: De fleste bivirkninger var milde eller moderate og begrænsede ikke forsøgsbehandlingen.
English: The renal clearance of telotristat was 0.126 L/h.
Danish: Den renale clearance af telotristat var 0,126 l/time.
English: This medicine works by reducing the amount of serotonin made by the tumour.
Danish: Denne medicin virker ved at nedsætte den mængde af serotonin, som tumoren producerer.
English: There is limited clinical experience with telotristat overdose in humans.
Danish: Der er begrænset klinisk erfaring med overdosering af telotristat hos mennesker.
English: Food effect
Danish: Fødevareeffekt
English: • if you have end-stage kidney disease or are on dialysis.
Danish: • hvis du har en nyresygdom i slutstadiet eller er i dialyse.
English: Oral use.
Danish: Til oral brug.
English: In the event of a missed dose, patients should take their subsequent dose at the next scheduled time point.
Danish: Hvis en dosis glemmes bør patienten tage den efterfølgende dosis på det næste planlagte tidspunkt.
English: The long-term safety and tolerability of telotristat was evaluated in a nonpivotal (nonrandomized), phase 3, multicentre, open-label, long-term extension study.
Danish: Telostristats langsigtede sikkerhed og tolerabilitet blev evalueret i et ikke-pivotalt (ikke-randomiseret), fase 3, multicenter, åbent, længerevarende forlængelsesstudie.
English: Your doctor will also monitor your liver.
Danish: Din læge vil også overvåge, om din lever påvirkes.
English: The adverse event was observed in clinical trials with frequency “very common” and is being reported from post-marketing setting.
Danish: Bivirkningen blev observeret i kliniske studier med hyppigheden "meget almindelig" og er blevet rapporteret efter markedsføring.
English: Administration of a single dose of 500 mg was well tolerated.
Danish: Administration af en enkeltdosis på 500 mg tolereredes godt.
English: Based on the small increase observed, clinically meaningful interactions with P-gp and MRP-2 substrates are unlikely.
Danish: Baseret på den lille stigning, som blev observeret, er klinisk relevant interaktion med P-gp og MRP2-substrater usandsynlig.
English: Your doctor will decide for how long you should take Xermelo.
Danish: Lægen vil bestemme, hvor længe du skal tage Xermelo.
English: Therefore, intake of higher doses is not recommended (see section 5.2).
Danish: Derfor kan indtagelse af højere doser ikke anbefales (se pkt.
English: No studies on the effect of telotristat on human fertility have been conducted.
Danish: Der er ikke foretaget undersøgelser af virkningen af telotristat på human fertilitet.
English: Table 2: BM response (TELESTAR Study) Parameter
Danish: Tabel 2: Afføringer respons (TELESTAR studiet) Parameter
English: When the tumour releases too much serotonin into your bloodstream you can get diarrhoea.
Danish: Når tumoren frigiver for meget serotonin ud i blodbanen, kan du få diarré.
English: You should tell your doctor about every medicine.
Danish: Du skal fortælle din læge om al medicin, som du tager.
English: This is when a tumour, called a ‘neuroendocrine tumour', releases a substance called serotonin into your bloodstream.
Danish: Det er når en tumor, kaldet en ”neuroendokrin tumor”, frigiver et stof, som hedder serotonin, ud i blodbanen.
English: The tablets are packaged in a PVC/PCTFE/PVC/Al blister.
Danish: Tabletterne er pakket i et PVC/PCTFE/PVC/Alu-blisterkort.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for telotristat, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for telotristat er CHMP nået frem til følgende videnskabelige konklusioner:
English: Telotristat ethyl and telotristat have a low renal elimination following oral administration (less than 1% of the dose recovered from the urine).
Danish: Telotristatethyl og telotristat har lav renal eliminering efter oral administration (under 1 % af dosis genfindes i urinen).
English: Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome.
Danish: Serotonin spiller en kritisk rolle i reguleringen af flere væsentlige fysiologiske processer, herunder sekretion, motilitet, inflammation og følsomhed af mave-tarmkanalen, og udskilles i for stor en mængde hos patienter med karcinoid syndrom.
English: BMs/day at baseline
Danish: Afføringer/dag ved baseline
English: Number of Patients Percent Change at Week 12: Mean (SD) Estimate of Treatment Difference (95% CL)b
Danish: Antal patienter Procent ændring ved uge 12: gennemsnit (SD) Estimat af behandling forskel (95 % CL)b
English: There is no relevant use of telotristat in the paediatric population in the indication of carcinoid syndrome.
Danish: Der er ingen relevant anvendelse af telotristat i den pædiatriske population inden for indikationen karcinoid syndrom.
English: Distribution Both telotristat ethyl and its active metabolite are > 99% bound to human plasma proteins.
Danish: Fordeling Både telotristatethyl og dets aktive metabolit er > 99 % bundet til humane plasmaproteiner.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential, toxicity to 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: Least Square mean difference 97.5% CL for difference p value
Danish: Difference i mindste kvadraters gennemsnit 97,5 % CL for difference p værdi
English: There was no significant difference between treatment groups for the endpoints of flushing and abdominal pain.
Danish: Der var ingen signifikant forskel mellem behandlingsgrupper for effektmålene for flushing og mavesmerter.
English: Clinical signs were limited to increase in frequency of liquid faeces at all doses.
Danish: Kliniske tegn var begrænset til stigning i frekvensen af flydende fæces ved alle doser.
English: Do not stop taking Xermelo without talking with your doctor.
Danish: Du må ikke stoppe med at tage Xermelo uden aftale med lægen.
English: No decrease in brain 5-HT and 5-HIAA levels were observed after intravenous application of active metabolite.
Danish: Der blev ikke observeret noget fald i hjernens 5-HT- og 5-HIAA-niveauer efter intravenøs indgift af den aktive metabolit.
English: The maximum dose of Xermelo is 750 mg in 24 hours.
Danish: Den maksimale dosis af Xermelo er 750 mg pr. døgn.
English: Other transporters Based on in vitro findings, no clinically-relevant interaction is expected with other transporters.
Danish: Andre transportører Baseret på in vitro-data, forventes der ingen kliniske relevante interaktioner med andre transportører.
English: Prenatal development in rats and rabbits was affected by increased prenatal lethality (increased early and late resorptions), while no adverse effects were noted on postnatal development in rats.
Danish: Den prænatale udvikling hos rotter og kaniner blev påvirket med øgning i den prænatale dødelighed (øget tidlig og sen resorption), mens der ikke sås bivirkninger på rotternes postnatale udvikling.
English: Telotristat ethyl inhibited MRP2-mediated transport (98% inhibition).
Danish: Telotristatethyl inhiberer MRP2-medieret transport (98 % inhibition).
English: Xermelo is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Xermelo anbefales ikke til gravide eller til kvinder i den fødedygtige alder, som ikke anvender antikonception.
English: Moreover, in the long-term safety study (LX1606.1-302-CS), the incidence of depression was 21% and there is a probable biological mechanism that telotristat reduces the production of serotonin that may lead to symptoms of depression.
Danish: Derudover var forekomsten af depression 21 % i langtidssikkerhedsstudiet (LX1606.1-302-CS), og der er en sandsynlig biologisk mekanisme, hvor telotristat reducerer produktionen af serotonin, hvilket kan føre til symptomer på depression.
English: If you need treatment with octreotide subcutaneous injections, you should have your injection at least 30 minutes after taking Xermelo.
Danish: Hvis du har behov for behandling med subkutane injektioner af octreotid, skal du have din injektion mindst 30 minutter efter du har taget Xermelo.
English: Patients should be monitored for signs and symptoms of constipation.
Danish: Patienterne bør overvåges for tegn og symptomer på forstoppelse.
English: You should keep having injections of these other medicines when taking Xermelo.
Danish: Du skal fortsat have injektioner med disse andre lægemidler, når du tager Xermelo.
English: Brain 5-HIAA levels were unchanged at all doses of telotristat ethyl examined.
Danish: Hjerne-5-HIAA-niveauerne var uændrede i alle undersøgte doser af telotristatethyl.
English: • Depression, you may experience decreased self-esteem, lack of motivation, sadness or low mood
Danish: • Depression; du kan få nedsat selvværd, mangle motivation, blive trist eller i dårligt humør
English: Talk to your doctor or pharmacist:
Danish: Tal med lægen eller apotekspersonalet:
English: Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.
Danish: Ved hæmning af perifer TPH1 reducerer telotristat produktionen af serotonin, hvilket lindrer symptomer forbundet med karcinoid syndrom.
English: They were on SSA therapy and had ≥4 daily BM.
Danish: De var på SSA-behandling og havde afføring ≥4 dagligt.
English: Tell your doctor straight away if you notice any of the following signs and symptoms that suggest that your liver may not be working properly:
Danish: Fortæl det straks til lægen, hvis du bemærker et af følgende tegn eller symptomer på, at din lever måske ikke fungerer rigtigt:
English: Table 1 - Adverse reactions reported in patients treated with Xermelo System organ class
Danish: Tabel 1: Bivirkninger rapporteret hos patienter behandlet med Xermelo System organ klasse Meget almindelig
English: Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous
Danish: Lactose, vandfri Hydroxypropylcellulose Croscarmellosenatrium Magnesiumstearat Silica, kolloid vandfri
English: Systemic exposure to LP-951757 was about 35% of the systemic exposure to telotristat (active metabolite) in the mass balance study.
Danish: Systemisk eksponering for LP-951757 var omkring 35 % af den systemiske eksponering for telotristat (aktive metabolit) i massebalancestudiet.
English: The tablets are white to off-white, film-coated and oval shaped.
Danish: Tabletterne er hvide til råhvide, filmovertrukne og har oval form.
English: If you feel tired, you should wait until you feel better before driving or using any tools or machines.
Danish: Hvis du føler dig træt, bør du vente med at køre bil eller bruge værktøj eller maskiner til du har det bedre.
English: This might also be shown by changes in your blood test results, such as an increase of liver enzymes: gamma-glutamyl transferase (very common, may affect more than 1 in 10 people), transaminases and blood alkaline phosphatase (common, may affect up to 1 in 10 people).
Danish: Dette kan også vise sig ved ændringer i blodprøver som en stigning i leverenzymer: gamma-glutamyltransferase (meget almindelig, kan forekomme hos mere end 1 ud af 10 personer), transaminaser og alkalisk phosphatase i blodet (almindelig, kan forekomme hos op til 1 ud af 10 personer).
English: Faecalomac, intestinal obstruction
Danish: Fækalomc, intestinal obstruktion
English: In patients with carcinoid syndrome, telotristat resulted in reductions in u5-HIAA (refer to Table 3 for TELESTAR and information provided for TELECAST).
Danish: Hos patienter med karcinoid syndrom resulterede telotristat i reduktioner af u5-HIAA (se Tabel 3 for TELESTAR og oplysninger opgivet til TELECAST).
English: The mean PK parameters for telotristat ethyl and the active metabolite appeared unchanged between week 24 and week 48, suggesting the achievement of steady-state conditions at or prior to week 24.
Danish: De gennemsnitlige PK-parametre for telotristatethyl og den aktive metabolit forekom uændret mellem uge 24 og uge 48, hvilket tyder på opnåelse af steady-state tilstande ved eller før uge 24.
English: The mean Cmax, and AUC0-inf for the active metabolite, 1'-hydroxymidazolam, were also decreased by 34%, and 48%, respectively.
Danish: Den gennemsnitlige Cmax og AUC0-inf for den aktive metabolit, 1'hydroxymidazolam var også nedsat med henholdsvis 34 % og 48 %.
English: Overall, severe to moderate renal impairment did not result in a clinically meaningful change in the PK profile or safety of telotristat ethyl and its metabolite telotristat.
Danish: Samlet set resulterede svært til moderat nedsat nyrefunktion ikke i en klinisk relevant ændring i PK-profilen eller sikkerheden af telotristatethyl og metabolitten telotristat.
English: • Swelling (build-up of fluid in the body)
Danish: • Hævelse (ophobning af væske i kroppen)
English: This is because this medicine has not been tested in patients with severe liver problems.
Danish: Dette er fordi, denne medicin ikke er blevet afprøvet hos patienter med alvorlige leverproblemer.
English: Talk to your doctor or pharmacist before taking Xermelo:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Xermelo:
English: Carboxylesterases
Danish: Carboxylesteraser
English: The pharmacokinetics of telotristat ethyl and its active metabolite have been characterised in healthy volunteers and patients with carcinoid syndrome.
Danish: Farmakokinetikken af telotristatethyl og dets aktive metabolit er blevet karakteriseret hos raske frivillige og patienter med karcinoid syndrom.
English: Patients should be advised to report any symptoms of depression, depressed mood and decreased interest to their physicians.
Danish: Patienterne bør opfordres til at oplyse om eventuelle symptomer på depression, nedtrykthed og nedsat interesse til lægen.
English: b. Statistical tests used a blocked 2-sample Wilcoxon Rank Sum statistic (van Elteren test) stratified by the u5-HIAA stratification at randomization.
Danish: b. Statistisk test anvendte Wilcoxon Rank Sum statistik med 2 prøveblokke (van Elteren test) stratificeret for u5-HIAA-stratifikationen ved randomisering.
English: What Xermelo is used for
Danish: Hvad Xermelo anvendes til
English: On the basis of the scientific conclusions for telotristat the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing telotristat is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for telotristat er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder telotristat, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: • Breathing problems, rapid heartbeat, fever, incontinence (uncontrollable urination), confusion, dizziness or agitation.
Danish: • Åndedrætsbesvær, hurtigt hjerteslag, feber, inkontinens (ukontrollerbar vandladning), forvirring, svimmelhed eller rastløs uro.
English: QOL was generally stable over the course of the study.
Danish: Patienternes livskvalitet var generelt stabil gennem studieforløbet.
English: The mean age was 63 years (range 35 to 84 years), 55% were male and 97% were white.
Danish: Den gennemsnitlige alder var 63 år (interval 35 til 84 år), 55 % var mænd og 97 % var hvide.
English: Any unused medicinal product or waste should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The only metabolite of telotristat (active metabolite) representing consistently > 10% of total plasma drug-related material was its oxidative decarboxylated deaminated metabolite, LP-951757.
Danish: Den eneste telotristat metabolit (aktive metabolit), som konsekvent repræsenterer > 10 % af det totale lægemiddelrelateret materiale i plasma, var dens oxidativt decarboxyleret og deaminerede metabolit, LP-951757.
English: Following a single 500 mg oral dose of 14C-telotristat ethyl, approximately 93% of the dose was recovered.
Danish: Efter en enkelt 500 mg oral dosis af 14C-telotristatethyl blev ca. 93 % af dosen genfundet.
English: Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes tested and telotristat should be discontinued if liver injury is suspected.
Danish: Patienter, som udvikler symptomer, der tyder på hepatisk dysfunktion, bør få foretaget en leverenzymtest og telotristat bør afbrydes, hvis der er mistanke om leverskade.
English: 90 film-coated tablets 180 film-coated tablets
Danish: 90 filmovertrukne tabletter 180 filmovertrukne tabletter
English: CL=confidence limit; tid=three times daily; SD=standard deviation; u5-HIAA = urinary 5--hydroxyindoleacetic acid.
Danish: CL= konfidensgrænse; tid=tre gange dagligt SD=standardafvigelse; u5-HIAA = urin 5-hydroxyindoleacetic acid.
English: Telotristat ethyl 250 mg showed that stool consistency, as measured by Bristol Stool Form Scale, was improved compared with placebo.
Danish: Telotristatethyl 250 mg viste, at afføringskonsistensen målt ved Bristol Stool Form Scale blev forbedret sammenlignet med placebo.
English: • medicines used to avoid transplant rejection, such as cyclosporine.
Danish: • medicin, der bruges for at undgå transplantatafstødning, såsom cyclosporin.
English: • medicines to treat depression, such as bupropion or sertraline.
Danish: • medicin til behandling af depression, såsom bupropion eller sertralin.
English: Shortacting octreotide should be administered at least 30 minutes after administration of Xermelo if treatment with short-acting octreotide is needed in combination with Xermelo.
Danish: Korttidsvirkende octreotid skal administreres mindst 30 minutter efter Xermelo, hvis behandling med korttidsvirkende octreotid i kombination med Xermelo er nødvendig.
English: Peak plasma levels of telotristat ethyl were achieved in 0.53 to 2.00 hours and those of the active metabolite in 1.50 to 3.00 hours after oral administration.
Danish: Peak plasmaniveauer af telotristatethyl blev opnået på 0,53 til 2,00 timer og for den aktive metabolit på 1,50 til 3,00 timer efter oral administration.
English: Since telotristat ethyl is rapidly converted to its active metabolite, which is > 25× more active than telotristat ethyl, no dose adjustments are required when using Xermelo with acid reducers.
Danish: Da telotristatethyl hurtigt omdannes til dets aktive metabolit, som er > 25× mere aktiv end telotristatethyl, er ingen dosisjustering nødvendig ved anvendelse af Xermelo samtidig med syrereducerende lægemidler.
English: The influence of age on the pharmacokinetics of telotristat ethyl and its active metabolite has not been conclusively evaluated.
Danish: Den indflydelse alderen har på farmakokinetikken for telotristatethyl og dens aktive metabolit telotristat er ikke endegyldigt evalueret.
English: Table 3: u5-HIAA excretion at baseline and week 12 (TELESTAR Study) Parameter
Danish: Tabel 3: u5-HIAA ekskretion ved baseline og uge 12 (TELESTAR Studie) Parameter
English: If you have liver problems, your doctor may decide to reduce your daily dose of Xermelo.
Danish: Hvis du har leverproblemer kan lægen beslutte at nedsætte din daglige dosis af Xermelo.
English: The primary endpoint was the percent change from Baseline in u5-HIAA at Week 12.
Danish: Den primære effektparameter var den procentvise ændring fra baseline i u5-HIAA i uge 12.
English: The mean age was 64 years (range 37 to 88 years), 52% were male and 90% were white.
Danish: Den gennemsnitlige alder var 64 år (interval 37 til 88 år), 52 % var mænd og 90 % var hvide.
English: Depressive disorders
Danish: Depressive forstyrrelser
English: • oral contraceptives, such as ethinyloestradiol.
Danish: • oralt præventionsmiddel, såsom ethinylestradiol.
English: Telotristat may have a small effect on your ability to drive or use any tools or machines.
Danish: Telotristat påvirker i mindre grad din evne til at køre bil eller bruge værktøj eller maskiner.
English: Patients having participated in any Xermelo phase 2 or phase 3 carcinoid syndrome study were eligible to enter the study at the same dose level and regimen as identified in their original study, for at least 84 weeks of treatment.
Danish: Patienter, der tidligere havde deltaget i et Xermelo-studie med karcinoid syndrom i fase 2 eller fase 3 var egnede til at indgå i studiet (på samme dosisniveau og -regime som i deres oprindelige studie) med mindst 84 ugers behandling.
English: The efficacy and safety in patients with end-stage renal disease who require dialysis (eGFR < 15 mL/min/1.73 m² requiring dialysis) has not been established.
Danish: Effekten og sikkerheden hos patienter med nyresygdom i sidste stadie, der kræver dialyse (eGFR < 15 ml/min/1,73 m2, dialysekrævende) er ikke blevet fastslået.
English: If constipation develops, the use of telotristat and other concomitant therapies affecting bowel motility should be re-evaluated.
Danish: Hvis der opstår forstoppelse, bør anvendelse af telotristat, og anden samtidig behandling med medicin som påvirker tarmens motilitet, revurderes.