FrancophonIA/ELRC3.0 huggingface dataset:
English: A high variability (% CV range of 18% to 99%) in telotristat ethyl and its active metabolite parameters was observed within the overall PK.
Danish: Der blev observeret en høj variabilitet (% CVinterval på 18 % til 99 %) i parametrene for telotristatethyl og dets aktive metabolit inden for den samlede PK.
English: Depression, depressed mood and decreased interest have been reported in clinical trials and from postmarketing in some patients treated with telotristat (see section 4.8).
Danish: Depression, nedtrykthed og nedsat interesse er blevet rapporteret i kliniske studier og fra post-marketing hos nogle patienter, som blev behandlet med telotristat (se pkt.
English: Constipation was reported in patients using a higher dose (500 mg).
Danish: Forstoppelse blev rapporteret hos patienter, som brugte en højere dosis (500 mg).
English: Effect of Xermelo on other medicinal products
Danish: Effekt af Xermelo på andre lægemidler
English: The recommended dose is one tablet (250 mg) three times a day.
Danish: Den anbefalede dosis er 1 tablet (250 mg) 3 gange dagligt.
English: Pack sizes of 90 and 180 tablets.
Danish: Pakningsstørrelser med 90 og 180 tabletter.
English: The use of Xermelo is not recommended in patients with end-stage renal disease requiring dialysis (eGFR < 15 mL/min requiring dialysis) because efficacy and safety of Xermelo in these patients has not been established.
Danish: Anvendelse af Xermelo frarådes til patienter med nyresygdom i sidste stadie, der kræver dialyse (eGFR < 15 ml/min, dialysekrævende), da effekt og sikkerhed af Xermelo til disse patienter ikke er blevet fastslået.
English: You may feel sick or be sick, have diarrhoea or stomach ache.
Danish: Du kan få kvalme eller kaste op, få diarré eller mavesmerter.
English: Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects taking a single dose of 1,500 mg in a phase 1 study.
Danish: Gastrointestinale lidelser, herunder kvalme, diarré, mavesmerter og opkastning er blevet rapporteret hos raske forsøgspersoner, der fik en enkeltdosis på 1.500 mg i et fase 1 forsøg.
English: These studies confirmed that telotristat did not increase the incidence of tumors in both species and sexes, at doses corresponding to an exposure of approximately 10- to 15-fold and 2- to 4.5-fold the human exposure to the active metabolite at the MRHD in mice and rats, respectively.
Danish: Disse undersøgelser bekræftede, at telotristat ikke øgede forekomsten af tumorer hos nogen af arterne eller kønnene ved doser svarende til en eksponering på henholdsvis ca. 10-15 gange og 2-4,5 gange den humane eksponering for den aktive metabolit ved MRHD hos mus og rotter.
English: You should not breast-feed if you are taking Xermelo, as this medicine may be passed on to your baby.
Danish: Du må ikke amme, når du tager Xermelo, da lægemidlet kan passere videre til dit barn.
English: This is because this medicine has not been tested in patients with end-stage kidney disease, requiring dialysis.
Danish: Dette er fordi denne medicin ikke er afprøvet hos patienter med en nyresygdom i slutstadiet, der er dialysekrævende.
English: In patients with carcinoid syndrome on long-acting SSA therapy, there was also a rapid conversion of telotristat ethyl to its active metabolite.
Danish: Hos patienter med karcinoid syndrom i behandling med langtidsvirkende SSA var der også en hurtig omdannelse af telotristatethyl til dets aktive metabolit.
English: At doses of 200 and 500 mg/kg/day degeneration/necrosis in the nonglandular and/or glandular portions of the stomach and/or increased protein droplets in the glandular portions were observed.
Danish: Ved doser på 200 og 500 mg/kg/dag blev der observeret degenerering/nekrose i de nonglandære og/eller glandulære dele af maven og/eller øgede dannelse af proteindråber i de glandulære dele.
English: This could mean that your doctor needs to change the dose(s) that you take.
Danish: Dette kan betyde, at din læge skal ændre den dosis/de doser, som du tager.
English: During the study, patients were allowed to use rescue medication (short-acting SSA therapy) and anti-diarrhoeals for symptomatic relief but were required to be on stable-dose long-acting SSA therapy for the duration of the DBT period.
Danish: I løbet af studiet fik patienterne lov til at anvende rescue-medicin (korttidsvirkende SSA-behandling) og anti-diarré behandling til symptomatisk lindring, men fast dosering af langtidsvirkende SSA-behandling var et krav under den dobbeltblindede behandlingsperiode.
English: It is unknown whether telotristat ethyl and its metabolite are excreted in human breast milk.
Danish: Det er uvist, om telotristatethyl, og dets metabolitter udskilles i human modermælk.
English: Beaufour Ipsen Industrie Rue Ethé Virton 28100 Dreux France
Danish: Beaufour Ipsen Industrie Rue Ethé Virton 28100 Dreux Frankrig
English: • medicines used to treat your neuroendocrine tumour, such as sunitinib or everolimus.
Danish: • medicin til behandling af neuroendokrin tumor, såsom sunitinib eller everolimus.
English: Elevations in ALT >3 × upper limit of normal (ULN) or ALP>2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg).
Danish: Der er rapporteret en stigning i ALT >3 × øvre grænse for normal (ULN) eller ALP >2 ULN hos patienter, der fik behandling med telotristat, hvoraf de fleste tilfælde blev rapporteret ved en højere dosis (500 mg).
English: b. Defined as the proportion of responders with ≥30% reduction in daily number of BMs for ≥50%
Danish: b. Defineret som andel af respondenter med ≥30 % reduktion i daglige antal afføringer for ≥50 % af tiden over den dobbelt-blindede behandlingsperiode.
English: Telotristat induced CYP2B6 in vitro (see section 5.2).
Danish: Telotristat inducerer CYP2B6 in vitro (se pkt.
English: Oedema peripheral, Pyrexia a Abdominal pain (including upper and lower abdominal pain) b Gamma-glutamyl transferase increased (including preferred terms of gamma-glutamyl transferase increased, gamma-glutamyl transferase, and liver function test abnormal / hepatic enzyme increased for which gamma-glutamyl transferase was increased).
Danish: Perifert ødem, Pyreksi a Mavesmerter (inklusive smerter i øvre og nedre del af maven) b Forhøjet gamma-glutamyl transferase (inklusive foretrukken term for forhøjet gamma-glutamyl transferase, gamma-glutamyl transferase, og anormal leverfunktionstest / forhøjet leverenzymer for hvilken gamma-glutamyl transferase var forhøjet).
English: A pre-specified patient exit interview substudy was conducted to assess relevance and clinical meaningfulness of symptom improvements in 35 patients.
Danish: Et pre-defineret substudie, hvor 35 patienter blev interviewet ved afslutningen af studiet blev udført for at vurdere, om symptomforbedringer var relevante og klinisk meningsfulde.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Swollen stomach
Danish: • Oppustet mave
English: • medicines used to treat high blood pressure, such as amlodipine.
Danish: • medicin til behandling af forhøjet blodtryk, såsom amlodipin.
English: Laboratory monitoring of hepatic enzymes prior to and during telotristat therapy is recommended as clinically indicated.
Danish: Det anbefales at udføre laboratorieundersøgelser af leverenzymer før og under behandling med telotristat som klinisk indiceret.
English: Following administration of 500 mg tid, the apparent terminal half-life was approximately 11 hours.
Danish: Efter indgivelse af 500 mg 3 gange dagligt var den tilsyneladende halveringstid ca. 11 timer.
English: After oral administration to healthy volunteers, telotristat ethyl was rapidly absorbed, and almost completely converted to its active metabolite.
Danish: Efter oral administration til raske frivillige, absorberes telotristatethyl hurtigt og omdannes næsten fuldstændigt til dets aktive metabolit.
English: In vitro telotristat ethyl inhibited BCRP (IC50 = 20 µM), but its active metabolite telotristat did not show any significant inhibition of BCRP activity (IC50 > 30 µM).
Danish: In vitro inhiberer telotristatethyl BCRP (IC50 = 20 µM), men den aktive metabolit telotristat viste ikke signifikant inhibering af BCRP aktiviteten (IC50 > 30 µM).
English: If you forget to take a dose, take your next dose when it is due, skipping the missed dose.
Danish: Hvis du glemmer at tage en dosis, så tag den næste dosis som planlagt og hop den manglende dosis over.
English: Your doctor may decide to decrease your daily dose of Xermelo.
Danish: Din læge kan beslutte at nedsætte din daglige Xermelo dosis.
English: The European Medicines Agency has waived the obligation to submit the results of studies with telotristat in all subsets of the paediatric population in the treatment of carcinoid syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med telotristat i alle undergrupper af den pædiatriske population ved behandling af karcinoid syndrom (se pkt.
English: The most frequently reported adverse reaction leading to discontinuation of telotristat was abdominal pain in 7.1% of patients (5/70).
Danish: Den hyppigst rapporterede bivirkning, der førte til seponering af telotristat, var mavesmerter hos 7,1 % af patienterne (5/70).
English: Telotristat ethyl 250 mg tid u5-HIAA excretion (mg/24 hours) at baseline
Danish: Telotristatethyl 250 mg tid u5-HIAA ekskretion (mg/24 timer) ved baseline
English: After oral administration, telotristat ethyl undergoes hydrolysis via carboxylesterases to its active and major metabolite.
Danish: Efter oral administration undergår telotristatethyl hydrolyse via carboxylesteraser til dets aktive hovedmetabolit.
English: Each tablet is approximately 17 mm long by 7.5 mm wide with ‘T-E' debossed on one side and ‘250' debossed on the other.
Danish: Hver tablet er cirka 17 mm lang og 7,5 mm bred og præget med ”T-E” præget på den ene side og ”250” præget på den anden side.
English: In vitro telotristat (active metabolite) caused a concentration dependent increase in CYP2B6 mRNA levels (>2-fold increase and > 20% of the positive control, with a maximum observed effect similar to the positive control), suggesting possible CYP2B6 induction (see section 4.5).
Danish: In vitro telotristat (aktive metabolit) forårsagede en koncentrationsafhængig forøgelse i CYP2B6 mRNA niveauer (> dobbelt forøgelse og >20 % i forhold til den positive kontrol, med en maksimum observeret effekt svarende til den positive kontrol), hvilket tyder på en mulig CYP2B6 induktion (se pkt.
English: Administration of a single dose of 250 mg was well tolerated in subjects with severe to moderate renal impairment.
Danish: Administration af en enkelt dosis på 250 mg var veltolereret hos forsøgspersoner med svært til moderat nedsat nyrefunktion.
English: The use of telotristat is not recommended in patients with severe hepatic impairment as no data are available.
Danish: Brug af telotristat anbefales ikke til patienter med svært nedsat leverfunktion, da der ikke foreligger data.
English: Xermelo contains lactose (a type of sugar).
Danish: Xermelo indeholder lactose (en sukkerart).
English: • if you have signs of constipation, as telotristat reduces the number of your bowel movements.
Danish: • hvis du har symptomer på forstoppelse, da telotristat nedsætter tarmbevægelserne (antal afføringer).
English: Percent change from baseline in u5-HIAA excretion (mg/24 hours) at week 12
Danish: Procent ændring fra baseline i u5-HIAA ekskretion (mg/24 timer) ved uge 12
English: • You should keep having injections of somatostatin analogues (lanreotide or octreotide) when taking
Danish: • Du skal fortsat have injektioner med somatostatinanaloger (lanreotid eller octreotid), når du tager Xermelo.
English: The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%).
Danish: De hyppigst rapporterede bivirkninger hos patienter behandlet med telotristat var mavesmerter (26 %), øget gamma-glutamyltransferase (11 %) og træthed (10 %).
English: In a 39-week repeat-dose toxicity study in dogs NOAEL of 300 mg/kg/day was determined.
Danish: I et 39-ugers gentagen dosisstudie blev toksiciteten undersøgt hos hunde og NOAEL på 300 mg/kg/dag bestemt.
English: Telotristat ethyl 250 mg tid
Danish: Telotristatethyl 250 mg tid
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products: Various alimentary tract and metabolism products, ATC code: A16AX15
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte: div. midler til fordøjelsesorganer og stofskifte, ATC-kode: A16AX15
English: A study was conducted to investigate the impact of renal impairment on the pharmacokinetics of a single dose of telotristat ethyl 250 mg.
Danish: Et studie blev udført for at undersøge påvirkningen af nedsat nyrefunktion på farmakokinetikken af en enkelt dosis på 250 mg telotristatethyl.
English: The percent change from baseline in u5-HIAA excretion at week 12 was +97.7% in the placebo group versus -33.2% in the 250 mg group.
Danish: Den procentvise ændring fra baseline i u5-HIAA udskillelse i uge 12 var + 97,7 % i placebogruppen versus -33,2 % i 250 mg gruppen.
English: Alanine aminotransferase increased (ALT), Aspartate aminotransferase increased (AST),
Danish: Forhøjet alanin aminotransferase (ALT), Forhøjet aspartat aminotransferase (AST), Forhøjet alkalisk fosfatase (ALP) i blodet
English: c Faecaloma has only been observed in a clinical study at a dosage of 500mg tid (twice the recommended dose).
Danish: c Fækalom er kun observeret i et klinisk studie ved en dosis på 500 mg tre gange dagligt (to gange den anbefalede dosis).
English: P-glycoprotein (P-gp) and Multi-drug Resistance associated Protein 2 (MRP-2) In vitro telotristat ethyl inhibited P-gp, but its active metabolite did not at the clinically relevant concentrations.
Danish: P-glycoprotein (P-gp) og ”Multidrug resistance-associated protein 2” (MRP2) Telotristatethyl inhiberer P-gp in vitro, men det gjorde dens aktive metabolit ikke ved klinisk relevante koncentrationer.
English: In vitro, telotristat ethyl inhibited CES2 with an IC50 approximately of 6.4 μM.
Danish: Telotristatethyl hæmmede CES2 in vitro med en IC50 på ca. 6,4 µM.
English: This medicine is used in adults with a condition called ‘carcinoid syndrome'.
Danish: Xermelo anvendes hos voksne til en tilstand, der kaldes ”karcinoid syndrom”.
English: Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Danish: Xermelo er indiceret til behandling af karcinoid syndrom diarré i kombination med somatostatinanalog (SSA) af voksne, hvor SSA behandling alene ikke er tilstrækkelig.
English: All patients had well-differentiated metastatic neuroendocrine tumours and carcinoid syndrome.
Danish: Alle patienter havde veldifferentierede metastaserede neuroendokrine tumorer og karcinoid syndrom.
English: Taking this medicine
Danish: Sådan tager du lægemidlet
English: Effect of other medicinal products on Xermelo
Danish: Effekt af andre lægemidler på Xermelo
English: Telotristat had no effect on fertility in animal studies (see section 5.3).
Danish: Telotristat havde ingen effekt på fertiliteten i dyreforsøg (se pkt.
English: At the conclusion of the 12-week DBT period, 115 patients (85.2%) entered the 36-week open-label extension period, where all patients were titrated to receive a higher dose of telotristat ethyl (500 mg) tid.
Danish: Ved afslutningen af den 12-ugers dobbeltblinde periode gik 115 patienter (85,2 %) videre i den 36-ugers åbne forlængelsesperiode, hvor alle patienter blev titreret til at modtage en højere dosis telotristatethyl (500 mg) 3 gange dagligt.
English: Following a single oral 250 mg dose of telotristat ethyl to heathy volunteers, urine concentrations of telotristat ethyl were close to or below the limit of quantification (<0.1 ng/mL).
Danish: Efter en enkelt oral dosis på 250 mg telotristatethyl til raske frivillige, var urinkoncentrationen af telotristatethyl tæt på eller under kvantificeringsgrænsen (<0,1 ng/ml).
English: Abdominal distension, Constipation, Flatulence
Danish: Abdominal udspiling, Forstoppelse, Flatulens
English: The use of telotristat is not recommended in patients with severe hepatic impairment (Child Pugh score C) as no data are available (see section 5.2).
Danish: Anvendelsen af telotristat anbefales ikke til patienter med stærkt nedsat leverfunktion (Child-Pugh score C), da der ikke findes tilgængelige data (se pkt.
English: Adverse reactions reported in a pooled safety dataset of 70 patients with carcinoid syndrome receiving telotristat ethyl 250 mg tid in combination with SSA therapy in placebo-controlled clinical trials are listed in Table 1.
Danish: Bivirkninger rapporteret i et poolet sikkerhedsdatasæt med 70 patienter med karcinoid syndrom, som tog telotristatethyl 250 mg tid i kombination med SSA-behandling i placebokontrollerede kliniske forsøg, er anført i Tabel 1.
English: In phase 3 clinical trials, telotristat was routinely combined with loperamide with no evidence of safety concerns.
Danish: I fase III kliniske studier, hvor telotristat og loperamid rutinemæssigt blev kombineret, sås ingen evidens for nedsættelse af sikkerheden.
English: Eight subjects with severe to moderate renal impairment not requiring dialysis [eGFR ≤ 33 mL/min at screening and ≤40 mL/min at the day prior to dosing] and eight healthy to mildly impaired subjects [eGFR ≥88 mL/min at screening and ≥83 mL/min at the day prior to dosing] were included in this study.
Danish: Otte personer med svært til moderat nedsat nyrefunktion, der ikke krævede dialyse [eGFR ≤ 33 ml/min ved screening og ≤40 ml/min dagen inden dosering] og otte forsøgspersoner, der var raske eller havde let nedsat nyrefunktion [eGFR ≥88 ml/min ved screening og ≥83 ml/min dagen inden dosering] deltog i studiet.
English: Statistically significant reductions in u5-HIAA were seen for telotristat ethyl 250 mg tid compared with placebo in both Phase 3 studies.
Danish: Statistisk signifikante reduktioner i u5-HIAA blev set for telotristatethyl 250 mg 3 gange dagligt sammenlignet med placebo i begge fase 3 forsøg.
English: In patients with mild hepatic impairment (Child Pugh score A), it may be necessary to reduce the dose to 250 mg twice daily according to tolerability.
Danish: Hos patienter med let nedsat leverfunktion (Child-Pugh score A), kan det være nødvendigt at reducere dosis til 250 mg to gange dagligt afhængigt af tolerabilitet.
English: The mean Cmax and AUC0-inf were 610 ng/mL and 2320 ng•hr/mL, respectively for telotristat.
Danish: Den gennemsnitlige Cmax og AUC0-inf var henholdsvis 610 ng/ml og 2320 ng∙t/ml for telotristat.
English: • The other ingredients are: lactose anhydrous (see section 2 under ‘Xermelo contains lactose'), hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, colloidal anydrous silica, polyvinyl alcohol (partially hydrolysed) (E1203), titanium dioxide (E171), macrogol 3350 (E1521) and talc (E553b).
Danish: 2 under "Xermelo indeholder lactose"), hydroxypropylcellulose, croscarmellosenatrium, magnesiumstearat, vandfri kolloid silica, polyvinylalkohol - delvist hydrolyseret (E1203), titandioxid (E171), macrogol 3350 (E1521) og talcum (E553b).
English: In a food effect study administration of telotristat ethyl 500 mg with a high-fat meal resulted in higher exposure to the parent compound (Cmax, AUC0-tlast, and AUC0-∞ being 112%, 272%, and 264% higher, respectively compared with the fasted state) and its active metabolite (Cmax, AUC0-tlast, and AUC0-∞, 47%, 32%, and 33% higher, respectively compared with the fasted state).
Danish: I et studie blev fødevareeffekten undersøgt ved administration af telotristatethyl 500 mg sammen med et fedtrigt måltid, det resulterede i en højere eksponering over for prodrug (Cmax, AUC0-tlast og AUC0-∞ var henholdsvis 112 %, 272 % og 264 % højere sammenlignet med fastende tilstand) og dets aktive metabolit (Cmax, AUC0-tlast og AUC0-∞ var henholdsvis 47 %, 32 % og 33 % højere sammenlignet med den fastende tilstand).
English: Ipsen Farmaceutica B.V. Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
Danish: Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
English: Short acting octreotide
Danish: Korttidsvirkende octreotid
English: Based on the high inter-subject variability observed, accumulation in a subset of patients with carcinoid syndrome cannot be excluded.
Danish: Baseret på den høje variabilitet imellem forsøgspersonerne, kan akkumulering i en undergruppe af patienter med karcinoid syndrom ikke udelukkes.
English: In patients with moderate hepatic impairment (Child Pugh score B), it may be necessary to reduce the dose to 250 mg once daily according to tolerability.
Danish: Hos patienter med moderat nedsat leverfunktion (Child-Pugh score B), kan det være nødvendigt at reducere dosis til 250 mg én gang dagligt afhængigt af tolerabilitet.
English: A post-hoc analysis showed that the average number of daily short-acting SSA injections used for rescue therapy over the 12-week DBT period was 0.3 and 0.7 in the telotristat ethyl 250 mg and placebo groups, respectively.
Danish: En post-hoc-analyse viste, at det gennemsnitlige antal daglige korttidsvirkende SSA-injektioner anvendt som rescue-medicin over 12-ugers DBT-perioden var 0,3 og 0,7 i henholdsvis telotristatethyl 250 mg og placebogruppen.
English: Figure 1 - Mean change from baseline in BMs by study week during the DBT period, Intent-toTreat Population
Danish: Figur 1: Gennemsnitlig ændring fra baseline i antal afføringer per studieuge i løbet af den dobbeltblindede behandlingsperiode, Intent-to-Treat population
English: The study included a 12-week double-blind treatment (DBT) period, in which patients initially received placebo (n=45), telotristat ethyl 250 mg (n=45) or a higher dose (telotristat ethyl 500 mg; n=45) tid.
Danish: Studiet omfattede en 12-ugers dobbeltblind behandlingsperiode, hvor patienterne indledningsvis tog placebo (n = 45), telotristatethyl 250 mg (n = 45) eller en højere dosis (telotristatethyl 500 mg; n = 45)
English: The apparent half-life of telotristat ethyl in normal healthy volunteers following a single 500 mg oral dose 14C-telotristat ethyl was approximately 0.6 hour and that of its active metabolite was 5 hours.
Danish: Den tilsyneladende halveringstid for telotristatethyl hos normale, raske frivillige forsøgspersoner var efter en enkelt 500 mg oral dosis 14C-telotristatethyl ca. 0,6 time, og for dets aktive metabolit var den 5 timer.
English: In patients with hepatic impairment, continuous monitoring for adverse events and worsening of liver function is recommended.
Danish: Hos patienter med nedsat leverfunktion anbefales kontinuerlig overvågning for bivirkninger og forværring af leverfunktionen.
English: Variability of the main plasma telotristat PK parameters was higher in subjects with severe to moderate renal impairment, with CV% ranging from 53.3% for Cmax to 77.3% for AUC as compared to 45.4% for Cmax and 39.7% for AUC in healthy to mildly impaired subjects, respectively.
Danish: Variabiliteten af de væsentligste plasma LP-778902 PK-parametre var højere hos forsøgspersoner med svært til moderat nedsat nyrefunktion med CV% i intervallet fra 53,3 % for Cmax til 77,3 % for AUC sammenlignet med henholdsvis 45,4 % for Cmax og 39,7 % for AUC hos forsøgspersoner, der var raske eller havde let nedsat nyrefunktion.
English: • feeling or being sick, abnormally dark urine, yellow skin or eyes, pain in the upper right belly.
Danish: • kvalme eller opkastning, unormalt mørk urin, gul hud eller gule øjne, smerte øverst til højre i maven.