FrancophonIA/ELRC3.0 huggingface dataset:
English: In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
Danish: I et todages studie med raske forsøgspersoner øgede sitagliptin alene den aktive GLP-1koncentration, hvorimod metformin alene øgede den aktive og totale GLP-1-koncentration i tilsvarende grad.
English: In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour haemodialysis session.
Danish: I kliniske studier blev ca. 13,5% af dosis fjernet i løbet af en hæmodialysesession på 3-4 timer.
English: • Steglujan lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
Danish: • Steglujan sænker blodsukkerniveauet hos voksne patienter (i alderen 18 år eller derover) med type 2-diabetes.
English: • bullous pemphigoid (a type of skin blister)
Danish: • bulløs pemfigoid (en type blærer på huden)
English: Steglujan has been shown to be bioequivalent to coadministration of corresponding doses of ertugliflozin and sitagliptin tablets.
Danish: Steglujan har vist sig at være bioækvivalent med samtidig administration af tilsvarende doser af ertugliflozin- og sitagliptin-tabletter.
English: The safety and efficacy of Steglujan in children under 18 years of age have not been established.
Danish: Pædiatrisk population Steglujans sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: • arm or leg pain
Danish: • smerter i arme eller ben
English: Some adverse reactions were observed more frequently in studies of combination use of sitagliptin with other anti-diabetic medicinal products than in studies of sitagliptin monotherapy.
Danish: Nogle bivirkninger blev observeret hyppigere i studier med sitagliptin i kombination med andre antidiabetika end i studier med sitagliptin som monoterapi.
English: • if you are taking medicines which increase urine production (diuretics).
Danish: • hvis du tager medicin, der øger urinproduktionen (vanddrivende medicin [diuretika]).
English: Consideration may also be given to stopping treatment with ertugliflozin/sitagliptin in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Danish: Det kan også overvejes at afbryde behandlingen med ertugliflozin/sitagliptin hos patienter, der udvikler lidelser, der kan være forløbere for amputation, som f.eks. sår på underekstremitet, infektion, osteomyelitis eller gangræn.
English: Patients with an eGFR < 30 ml/min/1.73 m2 were not to be enrolled in the study.
Danish: Patienter med eGFR < 30 ml/min/1,73 m2 blev ikke inkluderet i studiet.
English: The effects of a high-fat meal on the pharmacokinetics of ertugliflozin and sitagliptin when administered as Steglujan tablets are comparable to those reported for the individual tablets.
Danish: Virkningerne af et måltid med højt fedtindhold på farmakokinetikken for ertugliflozin og sitagliptin ved administration som Steglujan-tabletter er sammenlignelige med de virkninger, der blev rapporteret for de enkelte tabletter.
English: In patients with type 2 diabetes treated with ertugliflozin in combination with sitagliptin, the improvement in HbA1c was similar across subgroups defined by age, sex, and race, and duration of type 2 diabetes mellitus.
Danish: Hos patienter med type 2-diabetes, som blev behandlet med ertugliflozin i kombination med sitagliptin, var forbedringen i HbA1c den samme i subgrupperne defineret i henhold til alder, køn og race og varighed af type 2-diabetes mellitus.
English: Hypoglycaemia has been reported in combination with sulphonylurea (4.7%-13.8%) and insulin (9.6%) (see section 4.4).
Danish: Hypoglykæmi er rapporteret sammen med sulfonylurinstof (4,7%-13,8%) og insulin (9,6%) (se pkt.
English: It is not known if sitagliptin is dialysable by peritoneal dialysis.
Danish: Det er ukendt, om sitagliptin er dialyserbart ved peritonealdialyse.
English: Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD).
Danish: Metabolisering kan spille en mere betydningsfuld rolle ved eliminationen af sitagliptin ved svært nedsat nyrefunktion eller terminal nyresygdom (ESRD).
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased modestly in patients with GFR ≥ 45 to < 90 mL/min.
Danish: Sammenlignet med normale raske kontrolpersoner steg sitagliptins plasma-AUC en anelse hos patienter med GFR ≥ 45 til < 90 ml/min.
English: Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Danish: Reproduktive toksicitetsstudier viste en let behandlingsrelateret øget forekomst af føtale ribbensdefekter (manglende, hypoplastiske og takkede ribben) hos rotteafkom ved en systemisk eksponering på mere end 29 gange eksponeringen hos mennesker.
English: In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Danish: Hos rotter var der en øget forekomst af hepatiske adenomer og karcinomer ved en systemisk eksponering, der var 58 gange højere end eksponeringen hos mennesker.
English: • A serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Danish: • En alvorlig allergisk reaktion (hyppighed ikke kendt), herunder udslæt, nældefeber, blærer på huden/hudafskalning og hævelse af ansigt, læber, tunge og svælg, som kan medføre vejrtræknings- eller synkebesvær.
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of P-gp.
Danish: I et klinisk studie havde sitagliptin en lille effekt på digoxinkoncentrationerne i plasma, hvilket tyder på, at sitagliptin kan være en svag hæmmer af P-gp.
English: If you forget to take Steglujan
Danish: Hvis du har glemt at tage Steglujan
English: These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Danish: Disse omfattede hypoglykæmi (hyppighed: meget almindelig ved kombinationsbehandling med sulfonylurinstof og metformin), influenza (almindelig med insulin (med eller uden metformin)), kvalme og opkastning (almindelig med metformin), flatulens (almindelig med metformin eller pioglitazon), obstipation (almindelig ved kombinationsbehandling med sulfonylurinstof og metformin), perifert ødem (almindelig med pioglitazon eller ved kombinationsbehandling med pioglitazon og metformin), døsighed og diarré (ikke almindelig med metformin) og mundtørhed (ikke almindelig med insulin (med eller uden metformin)).
English: • The active substances are ertugliflozin and sitagliptin.
Danish: • Aktive stoffer: ertugliflozin og sitagliptin.
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signalling pathways involving cyclic AMP.
Danish: Når blodglucosekoncentrationen er normal eller forhøjet, bevirker GLP-1 og GIP en øget insulinsyntese og frigørelsen af insulin fra de pankreatiske betaceller via intracellulære signaleringsveje, som inddrager cyklisk AMP.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på blister og karton efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Danish: SGLT2 er det dominerende transportprotein, der er ansvarligt for reabsorption af glucose fra det glomerulære filtrat tilbage i kredsløbet.
English: Because renal function abnormalities can occur after initiating ertugliflozin, and sitagliptin is known to be substantially excreted by the kidneys, renal function should be assessed more frequently in elderly patients.
Danish: Da der kan forekomme unormal nyrefunktion efter initiering af behandling med ertugliflozin, og da sitagliptin vides at blive udskilt hovedsageligt via nyrerne, skal nyrefunktionen vurderes hyppigere hos ældre patienter.
English: Administration of Steglujan with food decreased ertugliflozin Cmax by 29% and had no meaningful effect on ertugliflozin AUCinf, or on sitagliptin AUCinf and Cmax.
Danish: Administration af Steglujan med mad nedsatte Cmax for ertugliflozin med 29% og havde ikke nogen betydningsfuld indvirkning på AUCinf for ertugliflozin, eller på AUCinf og Cmax for sitagliptin.
English: Taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating or changes in vision and may affect your ability to drive and use machines.
Danish: Hvis du tager dette lægemiddel sammen med insulin eller lægemidler, der øger insulinfrigivelsen fra bugspytkirtlen, kan det medføre, at blodsukkerniveauet bliver for lavt (hypoglykæmi), hvilket kan give symptomer såsom rysten, svedtendens eller ændret syn, og kan påvirke evnen til at køre bil og betjene maskiner.
English: The effect of Steglujan on fertility in humans has not been studied.
Danish: Steglujans indvirkning på fertilitet hos mennesker er ikke blevet undersøgt.
English: The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 ml/min/1.73 m
Danish: Studiepopulationen bestod af 2.004 patienter ≥ 75 år og 3.324 patienter med nedsat nyrefunktion (eGFR < 60 ml/min/1,73 m
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD24.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodglucosesænkende midler, ATC-kode: A10BD24.
English: The mean steady-state volume of distribution of ertugliflozin following an intravenous dose is 86 l. Plasma protein binding of ertugliflozin is 93.6% and is independent of ertugliflozin plasma concentrations.
Danish: Det gennemsnitlige fordelingsvolumen ved steady state for ertugliflozin efter en intravenøs dosis er 86 l. Plasmaproteinbindingen af ertugliflozin er 93,6% og er uafhængig af ertugliflozins plasmakoncentration.
English: Most toxicity was consistent with pharmacology related to urinary glucose loss and included decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism, gluconeogenesis and electrolyte imbalances, and urinary changes such as polyuria, glucosuria, and calciuria.
Danish: Størstedelen af toksiciteten svarede til farmakologien vedrørende glucosetab i urinen og omfattede reduceret legemsvægt og kropsfedt, øget fødeindtagelse, diarré, dehydrering, nedsat serumglucose og stigninger i andre serumparametre, der afspejler øget proteinmetabolisering, gluconeogenese og forstyrrelser i elektrolytubalancen samt urinændringer som f.eks. polyuri, glukosuri og kalkariuri.
English: There are no data from the use of Steglujan in pregnant women.
Danish: Der er ingen data fra anvendelse af Steglujan til gravide kvinder.
English: Sitagliptin is not a substrate for OCT2 or OAT1 or peptide transporter 1/2 (PEPT1/2) transporters.
Danish: Sitagliptin er ikke et substrat for OCT2 eller OAT1 eller peptidtransporter 1/2 (PEPT1/2) transportere.
English: The safety and efficacy of Steglujan in patients with type 1 diabetes have not been established and Steglujan should not be used for treatment of patients with type 1 diabetes.
Danish: Steglujans sikkerhed og virkning hos patienter med type 1-diabetes er ikke klarlagt, og Steglujan bør ikke anvendes til behandling af patienter med type 1-diabetes.
English: Based on a population pharmacokinetic analysis, age, body weight, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of ertugliflozin.
Danish: På baggrund af en farmakokinetisk populationsanalyse har alder, legemsvægt, køn og race ingen klinisk betydningsfuld indvirkning på farmakokinetikken for ertugliflozin.
English: Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29% (0.01), 95% CI (-0.32, -0.27); p< 0.001.
Danish: I løbet af studiet var den samlede estimerede gennemsnitlige forskel (standardafvigelse (SD)) i HbA1c mellem sitagliptingruppen og placebogruppen 0,29% (0,01), 95% CI (-0,32; -0,27); p < 0,001.
English: Because of how Steglujan works, your urine will test positive for sugar (glucose) while you are on this medicine.
Danish: På grund af Steglujans virkemåde vil en urinprøve vise, at du har sukker (glucose) i urinen, mens du tager dette lægemiddel.
English: These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase 1 pharmacokinetic data and on a population pharmacokinetic analysis of Phase 1 and Phase 2 data.
Danish: Disse karakteristika havde ingen klinisk relevant virkning på sitagliptins farmakokinetik på basis af en sammensat analyse af farmakokinetiske fase 1-data og en farmakokinetisk populationsanalyse af fase 1- og fase 2-data.
English: Sitagliptin is also a substrate of P-gp, which may also be involved in mediating the renal elimination of sitagliptin.
Danish: Sitagliptin er også et substrat for P-gp, som også kan være involveret i sitagliptins renale elimination.
English: These medical conditions can increase your chance of getting pancreatitis (see section 4).
Danish: Disse sygdomme kan øge risikoen for at få pankreatitis (se punkt 4).
English: Temporary interruption of treatment with Steglujan should be considered until the fluid loss is corrected.
Danish: Midlertidig afbrydelse af behandlingen med Steglujan skal overvejes, indtil væsketabet er afhjulpet.
English: An increase in cases of lower limb amputation (primarily of the toe) has also been observed in long-term clinical studies with another SGLT2 inhibitor.
Danish: Der er også observeret en stigning i antallet af amputationer af en underekstremitet (primært en tå) i kliniske langtidsstudier med en anden SGLT2-hæmmer.
English: In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and post-prandial glucose concentrations.
Danish: Hos patienter med type 2-diabetes med hyperglykæmi fører disse ændringer i insulin- og glucagonniveauer til lavere hæmoglobin A1c (HbA1c) samt lavere koncentration af faste plasmaglucose (FPG) og postprandial glucose (PPG).
English: No effects of ertugliflozin or sitagliptin on fertility were observed in animal studies (see section 5.3).
Danish: Der blev ikke observeret nogen virkning af ertugliflozin eller sitagliptin på fertiliteten i dyreforsøg (se pkt.
English: Insulin and insulin secretagogues, such as sulphonylureas, cause hypoglycaemia.
Danish: Insulin og insulinsekretionsfremkaldende stoffer, som f.eks. sulfonylurinstoffer, forårsager hypoglykæmi.
English: The overall incidence of serious adverse events in patients receiving sitagliptin was similar to that in patients receiving placebo.
Danish: Den samlede incidens af alvorlige bivirkninger hos patienter i sitagliptin-armen var den samme som hos patienter i placebo-armen.
English: Plasma Cmax and AUC of ertugliflozin increase in a dose-proportional manner following single doses from 0.5 mg to 300 mg and following multiple doses from 1 mg to 100 mg.
Danish: Plasma-Cmax og AUC for ertugliflozin stiger dosisproportionalt efter enkelte doser fra 0,5 mg til 300 mg og efter flere doser fra 1 mg til 100 mg.
English: †, 95% CI) * N includes all patients who received at least one dose of study medication and had at least one measurement of the outcome variable.
Danish: †, (95% CI) * N omfatter alle patienter, som fik mindst en dosis af studiemedicinen og havde mindst en måling af udfaldsvariablen.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase 1 and Phase 2 data.
Danish: Alder havde ingen klinisk relevant indflydelse på sitagliptins farmakokinetik baseret på en farmakokinetisk populationsanalyse af fase 1- og fase 2data.
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Danish: Hypoglykæmi er observeret, når sitagliptin blev anvendt i kombination med insulin eller et sulfonylurinstof.
English: (listed in section 6).
Danish: Steglujan (angivet i punkt 6).
English: If a hypersensitivity reaction is suspected, Steglujan should be discontinued.
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, skal Steglujan seponeres.
English: You should not use this medicine if you are breast-feeding or plan to breast-feed.
Danish: Du må ikke tage dette lægemiddel, hvis du ammer eller planlægger at amme.
English: Ertugliflozin in combination with sitagliptin
Danish: Ertugliflozin i kombination med sitagliptin
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Danish: Risikoen for udvikling af diabetisk ketoacidose kan øges ved langvarig faste, meget stort alkoholforbrug, dehydrering, pludselige nedsættelser af insulindosis eller et større behov for insulin på grund af større operation eller alvorlig sygdom.
English: p< 0.001 compared to corresponding dose of ertugliflozin or sitagliptin (based on adjusted odds ratio comparisons from a logistic regression model using multiple imputation for missing data values).
Danish: p < 0,001 sammenlignet med tilsvarende dosis ertugliflozin eller sitagliptin (baseret på justerede odds ratiosammenligninger fra en logistisk regressionsmodel med multipel imputation for manglende dataværdier).
English: If you notice any of the serious side effects above, stop taking this medicine and contact a doctor straight away.
Danish: Hvis du bemærker en eller flere af ovenstående alvorlige bivirkninger, skal du straks stoppe med at tage dette lægemiddel og kontakte en læge.
English: Before initiating Steglujan, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden initiering af behandlingen med Steglujan skal der tages højde for faktorer i patientens anamnese, der kan prædisponere for ketoacidose.
English: Monitoring of renal function is recommended as follows: - Prior to Steglujan initiation and periodically during treatment (see section 4.2).
Danish: Monitorering af nyrefunktionen anbefales som følger: - Inden initiering af behandling med Steglujan og periodisk under behandlingen (se pkt.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Danish: Begrænsede data fra kliniske studier tyder på, at diabetisk ketoacidose forekommer med hyppigheden almindelig, når patienter med type 1-diabetes behandles med SGLT2-hæmmere.
English: Before initiating ertugliflozin/sitagliptin, consider factors in the patient history that may increase the risk for amputation.
Danish: Før behandling med ertugliflozin/sitagliptin initieres, skal faktorer i patientens anamnese, som kan forøge risikoen for amputation, tages i betragtning.
English: • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2)
Danish: • Ertugliflozin tilhører en lægemiddelklasse kaldet natrium-glucose-co-transporter 2 (SGLT2)hæmmere.
English: After a median follow up of 3 years, sitagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or the risk of hospitalisation for heart failure compared to usual care without sitagliptin in patients with type 2 diabetes (see Table 5).
Danish: Med en median opfølgningstid på 3 år øgede sitagliptin som supplement til standardbehandling ikke risikoen for alvorlige uønskede kardiovaskulære hændelser (major adverse cardiovascular eventsMACE) eller hospitalsindlæggelse på grund af hjertesvigt sammenlignet med standardbehandling uden sitagliptin hos patienter med type 2-diabetes (se tabel 5).
English: • take medicines that increase your urine production (diuretics) or lower blood pressure
Danish: • tager medicin, der øger urinproduktionen (vanddrivende medicin [diuretika]) eller sænker blodtrykket
English: Blood creatinine increased/Glomerular filtration rate decreased and renal-related events (ertugliflozin)
Danish: Forhøjet kreatinin i blodet/nedsat glomerulær filtrationsrate og nyrerelaterede hændelser (ertugliflozin)
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Danish: Nekrotiserende fasciitis i perineum (Fourniers gangræn) Der er efter markedsføring rapporteret om tilfælde af nekrotiserende fasciitis i perineum (også kendt som Fourniers gangræn) hos kvindelige og mandlige patienter, der behandles med SGLT2hæmmere.
English: Stop taking Steglujan and contact a doctor straight away if you notice any of the following serious side effects:
Danish: Stop med at tage Steglujan og kontakt straks lægen, hvis du får et eller flere af følgende alvorlige bivirkninger:
English: †, 95% CI) * N includes all randomised, treated patients who had at least one measurement of the outcome variable.
Danish: †, (95% CI) * N omfatter alle randomiserede, behandlede patienter, som har mindst en måling af udfaldsvariablen.
English: Acute pancreatitis a,*,b,2
Danish: Akut pankreatitis a,*,b,2
English: The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 l. The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).
Danish: Det gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs dosis sitagliptin på 100 mg til raske forsøgspersoner er ca. 198 l. Den fraktion af sitagliptin, som er reversibelt bundet til plasmaproteiner, er lav (38%).
English: Effects on bone (shorter femur length, increased trabecular bone in the femur) as well as effects of delayed puberty were observed at an exposure 817 times the MRHD of 15 mg/day based on AUC.
Danish: Virkninger på knogler (kortere lårbenslængde, længere trabekulær lårbensknogle) samt virkninger i form af forsinket pubertet blev observeret ved en eksponering på 817 gange MRHD på 15 mg/dag baseret på AUC.
English: Across the clinical program for ertugliflozin, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients (see section 4.4).
Danish: I det kliniske program for ertugliflozin blev der identificeret ketoacidose hos 3 ud af 3.409 (0,1%) ertugliflozin-behandlede patienter og 0,0% patienter i komparatorgruppen (se pkt.