FrancophonIA/ELRC3.0 huggingface dataset:
English: The renal composite endpoint and all-cause mortality were therefore not tested as part of the confirmatory testing procedure.
Danish: Det renale komposit-endepunkt og død uanset årsag blev derfor ikke testet som led i den bekræftende testprocedure.
English: During treatment with Xigduo, your doctor will check your kidney function at least once every year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Xigduo vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: Possible signs of dehydration are listed at the top of section 4.
Danish: Mulige tegn på dehydrering er anført øverst i punkt 4.
English: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Danish: Race Der var ingen klinisk relevant forskel i systemiske eksponering mellem hvid, sort eller asiatisk race.
English: Vulvovaginitis, balanitis and related genital infections
Danish: Vulvovaginitis, balanitis og relaterede genitale infektioner
English: At baseline, 10.0% of patients had a history of heart failure.
Danish: Ved baseline havde 10,0 % af patienterne hjertesvigt i anamnesen.
English: • if you have very high levels of glucose in your blood which may make you dehydrated (lose too much body fluid).
Danish: • hvis du har meget høje niveauer af glukose (sukker) i blodet, som kan gøre dig dehydreret (få dig til at tabe for meget kropsvæske).
English: A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital malformations.
Danish: En begrænset datamængde fra brugen af metformin til gravide kvinder indikerer ikke en øget risiko for medfødte misdannelser.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Danish: Patienterne skal straks vurderes for ketoacidose, hvis disse symptomer opstår, uanset blodglukoseniveau.
English: Remember to take these other medicine(s) as your doctor has told you.
Danish: Husk at tage disse andre lægemidler, som din læge har fortalt dig.
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.
Danish: Især hvis du følger en diabetesdiæt med vægtkontrol, skal du fortsat følge denne, mens du tager dette lægemiddel.
English: Frequency categories are defined according to the following 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: Hyppighedskategorier inddeles efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Danish: Du skal omgående stoppe med at tage dette lægemiddel og straks kontakte en læge eller nærmeste hospital (se punkt 2).
English: If no adequate strength of Xigduo is available, individual mono-components should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Xigduo, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: • If you are already taking both dapagliflozin and metformin as single tablets, your doctor may ask you to switch to this medicine.
Danish: • Hvis du allerede tager både dapagliflozin og metformin som særskilte tabletter kan lægen bede dig om at skifte til dette lægemiddel.
English: • Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter.
Danish: • Før start på behandling med samtidige lægemidler, der kan nedsætte nyrefunktionen, og periodisk derefter.
English: In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss.
Danish: I kliniske studier var anvendelse af metformin forbundet med enten en stabil kropsvægt eller et beskedent vægttab.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Danish: Det antages, at farmakokinetikken for metforminabsorption er ikke-lineær.
English: • The recommended dose is one tablet twice a day.
Danish: • Den anbefalede dosis er 1 tablet to gange dagligt.
English: There are no data from the use of Xigduo or dapagliflozin in pregnant women.
Danish: Der er ingen data fra anvendelse af Xigduo eller dapagliflozin til gravide kvinder.
English: The patient should be informed and more frequent blood glucose monitoring perfomed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres, og der skal foretages hyppigere blodglukosemonitorering, især i begyndelsen af behandlingen med den slags lægemidler.
English: • Dapagliflozin works by removing excess sugar from your body via your urine and lowers the amount of sugar in your blood.
Danish: • Dapagliflozin virker ved at fjerne det overskydende sukker fra din krop via urinen og nedsætter mængden af sukker i dit blod.
English: Body weight reductions were sustained in long-term extensions up to 208 weeks.
Danish: Fald i legemsvægt blev opretholdt i langtidsstudier i op til 208 uger.
English: • if you drink large amounts of alcohol, either every day or only from time to time (please see section “Xigduo with alcohol”).
Danish: - hvis du indtager større mængder alkohol (enten hver dag eller kun ind imellem) (se afsnittet “Brug af Xigduo sammen med alkohol”).
English: UNIQUE IDENTIFIER 2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Danish: Det stimulerer ikke insulinsekretionen og giver derfor ikke hypoglykæmi.
English: No interaction studies have been performed for Xigduo.
Danish: Der er ikke udført interaktionsstudier for Xigduo.
English: CARTON - WITH BLUE BOX
Danish: ÆSKE - MED BLUE BOX
English: C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces.
Danish: C]-dapagliflozin blev 96 % genfundet, 75 % i urinen og 21 % i afføringen.
English: • The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of dapagliflozin and metformin.
Danish: • Den mængde af dette lægemiddel, som du skal tage, afhænger af din tilstand og de doser, du på nuværende tidspunkt tager af metformin og/eller separate tabletter af dapagliflozin og metformin.
English: It may be more pronounced in patients with high blood glucose concentrations.
Danish: Det kan være mere udtalt hos patienter med meget høje koncentrationer af glukose i blodet.
English: Xigduo is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older.
Danish: Xigduo anvendes til en type diabetes, der hedder “type 2-diabetes” hos voksne patienter (18 år og derover) som sædvanligvis opstår når du er blevet ældre.
English: • This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes.
Danish: • Dette lægemiddel anvendes, hvis din diabetes ikke kan kontrolleres med andre lægemidler til behandling af diabetes.
English: It is unknown whether this medicinal product or dapagliflozin (and/or its metabolites) are excreted in human milk.
Danish: Det vides ikke, om dette lægemiddel eller dapagliflozin (og/eller dets metabolitter) udskilles i human mælk.
English: This medicine may cause urinary tract infections and your doctor may want to monitor you more closely.
Danish: Denne medicin kan give dig urinvejsinfektioner, og lægen vil måske overvåge dig mere intenst.
English: The safety and efficacy of Xigduo in patients with type 1 diabetes have not been established and Xigduo should not be used for treatment of patients with type 1 diabetes.
Danish: Xigduos sikkerhed og virkning hos patienter med type 1-diabetes er ikke klarlagt, og Xigduo bør ikke anvendes til patienter med type 1-diabetes.
English: The following statements reflect the information available on the individual active substances.
Danish: De følgende redegørelser afspejler de oplysninger, der er tilgængelige for de enkelte aktive stoffer.
English: • if you have severely reduced kidney function.
Danish: - hvis du har alvorligt nedsat nyrefunktion.
English: • if you are using bronchodilators (beta-2 agonists) which are used to treat asthma.
Danish: • hvis du tager bronchodilatorer (beta-2 agonister), der bruges til behandling af astma.
English: The reductions in HbA1c observed at Week 24 were sustained in the add-on combination studies.
Danish: Reduktionen i HbA1c observeret i uge 24 var vedvarende i tillægskombinationsstudierne.
English: Superiority of dapagliflozin over placebo was not demonstrated for MACE (p= 0.172).
Danish: Overlegenheden af dapagliflozin over placebo blev ikke påvist for MACE (p = 0,172).
English: Heart failure or cardiovascular death
Danish: Hjertesvigt eller kardiovaskulær død
English: If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice.
Danish: Hvis du har symptomer på lavt blodsukker, skal du spise nogle glukosetabletter, et mellemmåltid med højt sukkerindhold eller drikke noget frugtjuice.
English: HbA1c reductions were seen across subgroups including gender, age, race, duration of disease, and baseline body mass index (BMI).
Danish: HbA1c-reduktionen blev set på tværs af subgrupper, herunder køn, alder, race, sygdomsvarighed og baseline body mass index (BMI).
English: When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Danish: Når patienten planlægger at blive gravid og under graviditeten anbefales det, at diabetes ikke behandles med dette lægemiddel, men at insulin anvendes til at opretholde blodglukoseniveauerne så tæt på normal som muligt, for at reducere risikoen for misdannelser af føtus, som er forbundet med abnorme blodglukoseniveauer.
English: In type 1 diabetes mellitus studies, DKA was reported with common frequency.
Danish: I studier med type 1-diabetes mellitus blev DKA rapporteret med hyppigheden ”almindelig”.
English: The meal resulted in a delay of 1 to 2 hours in the peak concentrations and a decrease in the maximum plasma concentration of 29% of dapagliflozin and 17% of metformin.
Danish: Måltidet medførte en forsinkelse på 1 til 2 timer i peakkoncentrationerne og et fald i den maksimale plasmakoncentration på 29 % af dapagliflozin og 17 % af metformin.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Metformin forøger transportkapaciteten hos specifikke typer af membranglukosetransportører (GLUT-1 og GLUT-4).
English: • Your doctor may ask you to take this medicine on its own or together with other medicines to treat diabetes.
Danish: • Lægen kan bede dig om at tage dette lægemiddel alene eller sammen med anden medicin til behandling af diabetes.
English: • If renal function falls persistently below GFR 45 mL/min, treatment should be discontinued.
Danish: • Hvis nyrefunktionen vedvarende falder til under GFR 45 ml/min, skal behandlingen seponeres.
English: The amount of glucose removed by the kidney through this mechanism is dependent upon the blood glucose concentration and GFR.
Danish: Mængden af glukose elimineret af nyrerne via denne mekanisme afhænger af glukosekoncentrationen i blodet og af GFR.
English: Patients should be alerted to the risk of hypoglycaemia when this medicinal product is used in combination with other glucose-lowering medicinal products known to cause hypoglycaemia.
Danish: Patienterne bør advares om risikoen for hypoglykæmi, når dette lægemiddel anvendes i kombination med andre glukosesænkende lægemidler, som er kendt for at forårsage hypoglykæmi.
English: • if you have problems with your liver.
Danish: - hvis du har problemer med din lever.
English: Despite the presence of hyperglycaemia in type 2 diabetes, reabsorption of filtered glucose continues.
Danish: På trods af tilstedeværelsen af hyperglykæmi i type 2-diabetes fortsætter reabsorptionen af filtreret glukose.
English: Of 17,160 randomised patients, 6,974 (40.6%) had established cardiovascular disease and 10,186 (59.4%) did not have established cardiovascular disease.
Danish: Ud af 17.160 randomiserede patienter havde 6.974 (40,6 %) fået konstateret kardiovaskulær sygdom, og 10.186 (59,4 %) havde ikke fået konstateret kardiovaskulær sygdom.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 μg/mL, even at maximum doses.
Danish: I kontrollerede kliniske studier oversteg de maksimale metformin-plasmaniveauer (Cmax) ikke 5 μg/ml, selv ved maksimumdoser.
English: Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Metformin Det prospektive randomiserede studie (UKPDS) har fastslået fordelen på langt sigt ved intensiv blodglukosekontrol ved type 2-diabetes.
English: Body weight (kg)
Danish: Kropsvægt (kg)
English: The difference in treatment effect was driven by hospitalisation for heart failure, with no difference in cardiovascular death (Figure 2).
Danish: Forskellen i behandlingsvirkningen blev drevet af hospitalsindlæggelse for hjertesvigt uden forskel i kardiovaskulær død (figur 2).
English: p-values for the secondary endpoints and for single components are nominal.
Danish: p-værdier er tosidede, p-værdier for det sekundære endepunkt og for enkeltkomponenter er nominelle.
English: Furthermore, two 12-week, placebo-controlled studies were conducted in patients with inadequately controlled type 2 diabetes and hypertension.
Danish: Desuden blev to 12-ugers placebokontrollerede studier udført med patienter med utilstrækkeligt kontrolleret type 2-diabetes og hypertension.
English: Your doctor may want to lower the dose of these other medicines, to prevent you from getting blood sugar levels that are too low (hypoglycaemia).
Danish: Din læge kan ønske at nedsætte dosen af disse andre lægemidler for at undgå, at du får et for lavt blodsukkerniveau (hypoglykæmi).
English: Temporary interruption of treatment with this medicinal product is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8).
Danish: Midlertidig afbrydelse af behandlingen med dette lægemiddel anbefales hos patienter, som udvikler volumendepletering, indtil volumendepleteringen er blevet korrigeret (se pkt.
English: A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter.
Danish: GFR skal bestemmes, inden behandling med metforminholdige lægemidler iværksættes og derefter mindst én gang om året.
English: What Xigduo contains
Danish: Xigduo indeholder
English: • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
Danish: • til patienter, der allerede er i behandling med kombinationen af dapagliflozin og metformin som separate tabletter.
English: • if you often get infections of the urinary tract.
Danish: • hvis du ofte får urinvejsinfektioner.
English: Therefore, this medicinal product is not expected to alter the metabolic clearance of coadministered medicinal products that are metabolised by these enzymes.
Danish: Dette lægemiddel forventes således ikke at ændre den metaboliske clearance af samtidigt administrerede lægemidler, der metaboliseres af disse enzymer.
English: Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Danish: Både forbedring af glykæmisk kontrol og reduktion af kardiovaskulær morbiditet og mortalitet er en integreret del af behandlingen af type 2-diabetes.
English: All treatment groups had a reduction in HbA1c compared to baseline.
Danish: Alle behandlingsgrupper havde en reduktion af HbA1c sammenlignet med baseline.
English: • The active substances are dapagliflozin and metformin hydrochloride (metformin HCl).
Danish: • Aktive stoffer: dapagliflozin og metforminhydrochlorid (metformin HCl).
English: Maximum dapagliflozin plasma concentrations (Cmax) were usually attained within 2 hours after administration in the fasted state.
Danish: De maksimale plasmakoncentrationer af dapagliflozin (Cmax) blev som regel opnået inden for 2 timer efter administration i fastende tilstand.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Danish: Dette er påvist på terapeutiske doser i kontrollerede mellemlange og lange kliniske studier: Metformin reducerer niveauerne af totalt kolesterol, LDL-kolesterol og triglycerider.
English: This medicine contains two different substances called dapagliflozin and metformin.
Danish: Dette lægemiddel indeholder to forskellige stoffer, der hedder dapagliflozin og metformin.
English: In the clinical studies in type 2 diabetes, more than 15,000 patients have been treated with dapagliflozin.
Danish: I de kliniske studier i type 2-diabetes er mere end 15.000 patienter blevet behandlet med dapagliflozin.
English: Dapagliflozin did not induce tumours in either mice or rats at any of the doses evaluated in two-year carcinogenicity studies.
Danish: Dapagliflozin inducerede hverken tumorer hos mus eller rotter ved nogen af de doser, der blev evalueret i toårige karcinogenicitetsstudier.
English: Your doctor may decide to temporarily or permanently stop your treatment with Xigduo.
Danish: Lægen kan beslutte at stoppe behandlingen med Xigduo midlertidigt eller permanent.
English: The increase in urinary volume was associated with a small and transient increase in urinary sodium excretion that was not associated with changes in serum sodium concentrations.
Danish: Øgningen af urinmængden var forbundet med en lille og forbigående øgning i udskillelsen af natrium i urinen, som ikke var forbundet med ændringer i serumnatriumkoncentrationen.
English: Dapagliflozin Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of SGLT2.
Danish: Dapagliflozin Dapagliflozin er en meget potent (Ki: 0,55 nM), selektiv og reversibel hæmmer af SGLT2.
English: Events were generally balanced between treatment groups across subgroups of age, diuretic use, blood pressure and ACE-I/ARB use.
Danish: Bivirkningerne var generelt ligeligt fordelt mellem behandlingsgrupperne på tværs af undergrupperne af alder, brug af diuretika, blodtryk og brug af ACE-I/ARB.
English: Xigduo has no or negligible influence on the ability to drive and use machines.
Danish: Xigduo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin er > 400 ml/min, hvilket viser, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: Xigduo with alcohol
Danish: Brug af Xigduo sammen med alkohol
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Danish: I et antal tilfælde fremstod tilstanden atypisk, idet der kun var moderat forhøjet blodglukose, under 14 mmol/l (250 mg/dl).
English: Clinically relevant glycaemic effects were sustained in long-term extensions up to 104 weeks.
Danish: Klinisk relevante glykæmiske virkninger blev opretholdt i langtidsstudier i op til 104 uger.
English: The effect of this medicinal product or dapagliflozin on fertility in humans has not been studied.
Danish: Virkningen af dette lægemiddel eller dapagliflozin på fertiliteten hos mennesker er ikke undersøgt.
English: Volume depletion includes, e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension.
Danish: Volumendepletering omfatter de foruddefinerede foretrukne termer: Dehydrering, hypovolæmi, hypotension.
English: Biotransformation Metformin is excreted unchanged in the urine.
Danish: Biotransformation Metformin udskilles uomdannet i urinen.
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Danish: Nedsat nyrefunktion er hyppig og asymptomatisk hos ældre patienter.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Danish: Langvarig behandling med metformin har været associeret med nedsat absorption af vitamin B12, som i meget sjældne tilfælde kan resultere i klinisk signifikant vitamin B12-mangel (f.eks. megaloblastisk anæmi).
English: • changes in taste
Danish: • smagsændringer
English: Figure 1: Time to first occurrence of hospitalisation for heart failure or cardiovascular death
Danish: Figur 1: Tid til første forekomst af hospitalsindlæggelse pga. hjertesvigt og kardiovaskulær død
English: After administration of a 50 mg [
Danish: Efter indgivelse af en dosis på 50 mg [
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Xigduo before or at the time of the injection.
Danish: Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Xigduo forud for eller på tidspunktet for injektionen.
English: Xigduo should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Xigduo gives to gange dagligt sammen med måltider for at reducere de gastrointestinale bivirkninger, der er forbundet med metformin.
English: Mean difference in change from baseline between combination and single active agent (95% CI)
Danish: Gennemsnitlig forskel i ændring fra baseline mellem kombination og enkelt-aktivt stof (95% CI)
English: If Fournier's gangrene is suspected, Xigduo should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Xigduo seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.
Danish: - hvis du har mistet meget væske fra kroppen (dehydrering), f.eks. på grund af langvarig eller alvorlig diarre, eller hvis du har kastet op flere gange i træk.
English: If necessary, the dose of the glucose-lowering medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt skal dosen af det glukosesænkende lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af det.
English: Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to a diabetic pre-coma.
Danish: Ketoacidose er en tilstand, hvor såkaldte ketonstoffer ophobes i blodet, hvilket kan føre til diabetisk prækoma.
English: Analyses exclude measurements post rescue therapy and post premature discontinuation of study medicinal product.
Danish: Analyser udelukker målinger efter rescue-medicin og efter for tidlig seponering af studiemedicin.
English: Possible signs of losing too much fluid from your body are listed at the top of section 4.
Danish: Mulige tegn på overdrevent væsketab fra kroppen er anført øverst i punkt 4.