FrancophonIA/ELRC3.0 huggingface dataset:
English: Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:
Danish: Xigduo er indiceret til voksne til behandling af type 2-diabetes mellitus som supplement til diæt og motion:
English: Metformin (immediate- or extended-release formulations) ≥ 1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrolment.
Danish: Metformin (formuleringer med øjeblikkelig frigivelse eller depotvirkning) ≥ 1500 mg/dag plus maksimalt tolereret dosis, som skal være mindst halvdelen af den maksimale dosis, af et sulfonylurinstof i mindst 8 uger inden inklusion.
English: Most patients (98%) used one or more diabetic medications at baseline, including metformin (82%), insulin (41%) and sulfonylurea (43%).
Danish: De fleste patienter (98 %) brugte et eller flere antidiabetika ved baseline, inklusive metformin (82%), insulin (41%), og sulfonylurinstof (43%).
English: Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose-lowering drugs, ATC code: A10BD15
Danish: Farmakoterapeutisk klassifikation: Lægemidler mod diabetes, kombinationer af orale blodglukosesænkende lægemidler, ATC-kode: A10BD15
English: They have “5/850” on one side and “1067” on the other side.
Danish: De har “5/850” på den ene side og “1067” på den anden side.
English: In a separate study of pre- and postnatal development, maternal rats were dosed from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Danish: I et separat studie af præ- og postnatal udvikling blev moderrotter doseret fra gestationsdag 6 til og med postnatal dag 21, og unger blev indirekte eksponeret in utero og igennem hele dieperioden.
English: • if you are taking cimetidine, a medicine used to treat stomach problems.
Danish: • hvis du tager cimetidin, der er en medicin mod maveproblemer.
English: INNER CARTON - PART OF MULTIPACK - WITHOUT BLUE BOX
Danish: INDRE ÆSKE - DEL AF EN MULTIPAKNING - UDEN BLUE BOX
English: • if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing.
Danish: - hvis du for nylig har haft et hjerteanfald eller hvis du har hjertesvigt eller alvorlige problemer med kredsløbet eller vejrtrækningsbesvær.
English: In total, there were 30,623 patient-years of exposure to dapagliflozin.
Danish: I alt var der 30.623 patientårs eksponering af dapagliflozin.
English: These findings were associated with dose-related increases in kidney weight and macroscopic kidney enlargement observed at all doses.
Danish: Disse resultater var forbundet med dosisrelateret øgning af nyrernes vægt og makroskopisk nyreforstørrelse observeret ved alle doser.
English: The primary endpoints were time to first event of the composite of cardiovascular death, myocardial infarction or ischaemic stroke (MACE) and time to first event of the composite of hospitalisation for heart failure or cardiovascular death.
Danish: De primære endepunkter var tid til første hændelse af sammensætningen af kardiovaskulær død, myokardieinfarkt eller iskæmisk stroke (MACE) og tid til første hændelse af sammensætningen af hospitalsindlæggelse for hjertesvigt eller kardiovaskulær død.
English: Because metformin is eliminated in part by the kidney, and because elderly patients are more likely to have decreased renal function, this medicinal product should be used with caution as age increases.
Danish: Da metformin delvist udskilles af nyrerne, og da ældre patienter har større sandsynlighed for at få nedsat nyrefunktion, bør dette lægemiddel anvendes med forsigtighed efterhånden som alderen stiger.
English: The mean steady-state volume of distribution of dapagliflozin was 118 liters.
Danish: Det gennemsnitlige steady state-fordelingsvolumen af dapagliflozin var 118 liter.
English: • in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products
Danish: • i kombination med andre lægemidler til behandling af diabetes til patienter, hvor metformin og disse lægemidler ikke giver tilstrækkelig kontrol
English: • if you are taking medicines to lower blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
Danish: • hvis du tager medicin, der skal sænke dit blodtryk (antihypertensiva) og har en sygehistorie med for lavt blodtryk (hypotension).
English: All patients had type 2 diabetes mellitus and either at least two additional cardiovascular risk factors (age ≥ 55 years in men or ≥ 60 years in women and one or more of dyslipidaemia, hypertension or current tobacco use) or established cardiovascular disease.
Danish: Alle patienterne havde type 2-diabetes mellitus og enten mindst to yderligere kardiovaskulære risikofaktorer (alder ≥ 55 år hos mænd eller ≥ 60 år hos kvinder og en eller flere af dyslipidæmi, hypertension eller eksisterende tobaksbrug) eller konstateret kardiovaskulær sygdom.
English: Urticaria Erythema Pruritus
Danish: Urticaria Erytem Pruritus
English: At the usual metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/mL.
Danish: Med de almindelige metformindoser og doseringsmåder nås steady state-plasmakoncentrationer inden for 24-48 timer, og de er i reglen mindre end 1 μg/ml.
English: See corresponding subsection below for additional information.
Danish: Se det tilsvarende punkt herunder for yderligere oplysninger.
English: • Metformin works mainly by inhibiting glucose production in the liver.
Danish: • Metformin virker hovedsageligt ved at hæmme produktionen af glukose i leveren.
English: Metformin partitions into erythrocytes.
Danish: Metformin fordeler sig til erytrocytter.
English: Non-inferior to glipizide + metformin p-value < 0.0001
Danish: Non-inferioritet over for glipizid + metformin p-værdi < 0,0001
English: Randomised and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: Randomiserede og behandlede patienter med baselineværdi og mindst 1 effektmåling efter baseline.
English: Talk to your doctor, pharmacist or nurse before taking Xigduo, and during treatment:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Xigduo og under behandling:
English: In faeces, approximately 15% of the dose was excreted as parent drug.
Danish: I afføringen blev ca. 15 % af dosen udskilt som det oprindelige lægemiddel.
English: Mean HbA1c was 8.3% and mean BMI was 32.1 kg/m
Danish: Middel HbA1c var 8,3 %, og middel BMI var 32,1 kg/m
English: Due to its mechanism of action, patients taking this medicinal product will test positive for glucose in their urine.
Danish: På grund af lægemidlets virkningsmekanisme vil patienter, der tager dette lægemiddel, få et positivt analyseresultat for glukose i urinen.
English: Combination requiring precautions for use
Danish: Kombinationer, der kræver forsigtighed
English: Your doctor will decide when you must stop and when to restart your treatment with Xigduo.
Danish: Lægen vil beslutte, hvornår du skal stoppe behandlingen med Xigduo, og hvornår du kan genoptage den igen.
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Danish: Kationiske stoffer, som elimineres renalt ved tubulær sekretion (f.eks. cimetidin) kan interagere med metformin ved at konkurrere om fælles tubulære transportsystemer.
English: More information is given below under ‘Other medicines and Xigduo'.
Danish: Herom yderligere oplysninger under ”Brug af anden medicin sammen med Xigduo”.
English: There have been no therapeutic clinical trials conducted with Xigduo tablets.
Danish: Der er ikke blevet udført terapeutiske kliniske studier med Xigduo-tabletter.
English: • if you have problems with your kidneys.
Danish: • hvis du har problemer med nyrerne.
English: Metformin is excreted in human milk in small amounts.
Danish: Metformin udskilles i human mælk i små mængder.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating anti-hypertensive or diuretic therapy or when starting treatment with a NSAID.
Danish: Der skal udvises særlig omhu i situationer, hvor nyrefunktionen kan blive nedsat, f.eks. ved initiering af antihypertensiv eller diuretisk behandling, eller ved start af behandling med et NSAID.
English: This may be another medicine taken by mouth and/or a medicine given by injection, such as insulin or a GLP-1 receptor agonist (helps your body to increase the production of insulin when your blood sugar is high).
Danish: Det kan være et andet lægemiddel indtaget gennem munden, og/eller medicin indgivet ved injektion, såsom insulin eller en GLP-1-receptoragonist (hjælper kroppen med at øge produktionen af insulin, når dit blodsukker er højt).
English: To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking Xigduo.
Danish: For at undgå en overdosis, skal du stoppe med at tage dapagliflozin- og metformintabletter, hvis du tager Xigduo.
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Danish: Vurderingen bør omfatte serumelektrolytter og ketoner, blodglukose og, hvis indiceret, blod-pH-, laktat-, pyruvat- og metforminniveau.
English: These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval.
Danish: Disse forsøgspersoner havde påviselig glukose i urinen i en dosisrelateret periode (mindst 5 dage for dosis på 500 mg) uden nogen indberetninger om dehydrering, hypotension eller elektrolytubalance, og ingen klinisk relevant virkning på QTc-interval.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of this medicinal product.
Danish: De følgende redegørelser afspejler de farmakokinetiske egenskaber for de enkelte aktive indholdsstoffer i dette lægemiddel.
English: The treatment benefit of dapagliflozin over placebo was observed both in patients with and without established cardiovascular disease, with and without heart failure at baseline, and was consistent across key subgroups, including age, gender, renal function (eGFR) and region.
Danish: Fordelen i behandling med dapagliflozin i forhold til placebo blev observeret både hos patienter med og uden konstateret kardiovaskulær sygdom, med og uden hjertesvigt ved baseline, og var konsekvent på tværs af de vigtige undergrupper, herunder alder, køn, nyrefunktion (eGFR) og region.
English: The following statements reflect the preclinical safety data of the individual active substances of Xigduo.
Danish: De følgende redegørelser afspejler de prækliniske sikkerhedsdata for de individuelle aktive stoffer i Xigduo.
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Danish: • abnormiteter i leverfunktionstests, leverbetændelse (hepatitis)
English: This glucose excretion (glucuretic effect) is observed after the first dose, is continuous over the 24-hour dosing interval and is sustained for the duration of treatment.
Danish: Denne udskillelse af glukose (glucoretisk effekt) observeres efter den første dosis, fortsætter over doseringsintervallet på 24 timer og varer ved i hele behandlingsperioden.
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; - by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; - by delaying intestinal glucose absorption.
Danish: Metformin kan virke via tre mekanismer: - ved reduktion af hepatisk glukoseproduktion ved hæmning af gluconeogenese og glycogenolyse; - ved i beskedent omfang at forøge insulinfølsomheden, forbedre den perifere glukoseoptagelse og -udnyttelse i musklerne; - ved at forsinke den intestinale glukoseabsorption.
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Xigduo should be temporarily discontinued and contact with a health care professional is recommended.
Danish: I tilfælde af dehydrering (alvorlig diarré eller opkastning, feber eller nedsat væskeindtagelse) skal Xigduo-behandlingen afbrydes midlertidigt, og det anbefales, at kontakte en læge.
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and non-steroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in metformin-treated patients.
Danish: Lægemidler, som kan medføre akut nedsættelse af nyrefunktionen (såsom antihypertensiva, diuretika og non-steroide antiinflammatoriske lægemidler [NSAID'er]), bør opstartes med forsigtighed hos patienter i behandling med metformin.
English: For metformin, studies in animals have not shown reproductive toxicity (see section 5.3).
Danish: For metformin har dyrestudier ikke påvist reproduktionstoksicitet (se pkt.
English: • if you are using corticosteroids (used to treat inflammation in diseases like asthma and arthritis) that are given by mouth, as an injection, or inhaled.
Danish: • hvis du bruger kortikosteroider til behandling af betændelseslignende reaktioner i forbindelse med sygdomme som astma og leddegigt, som gives gennem munden, som en insprøjtning eller som inhalation.
English: • if you are using medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Danish: • hvis du tager lægemidler mod smerter og betændelseslignende tilstande (NSAID'er og COX-2hæmmere, såsom ibuprofen og celecoxib).
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier med metformin indikerer ingen skadelige virkninger for graviditeten, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: The SGLT2 is selectively expressed in the kidney with no expression detected in more than 70 other tissues including liver, skeletal muscle, adipose tissue, breast, bladder and brain.
Danish: SGLT2 findes selektivt i nyrerne, uden at der er påvist ekspression i over 70 andre væv inklusive lever, skeletmuskulatur, fedtvæv, bryst, blære og hjerne.
English: a) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products, including metformin)
Danish: a) i et placebokontrolleret studie af dapagliflozin i kombination med insulin (alene eller med orale glukosesænkende lægemidler, herunder metformin)
English: You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Xigduo.
Danish: Du skal eventuelt have kontrollere dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Xigduo.
English: These changes are not considered to be clinically meaningful.
Danish: Disse ændringer anses ikke for klinisk betydningsfulde.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Danish: • hvis du tager anden medicin, som sænker sukkerindholdet i blodet, såsom insulin eller et ”sulfonylurinstof”.
English: If you need to have major surgery, you must stop taking Xigduo during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Xigduo under indgrebet og i nogen tid herefter.
English: The administration of this medicinal product in healthy volunteers after a high fat meal compared to after the fasted state resulted in the same extent of exposure for both dapagliflozin and metformin.
Danish: Administration af dette lægemiddel til raske forsøgspersoner efter et måltid med højt fedtindhold sammenlignet med efter den fastende tilstand resulterede i den samme grad af eksponering for både dapagliflozin og metformin.
English: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of treatment should be considered when treating pyelonephritis or urosepsis.
Danish: Udskillelse af glukose i urinen kan være forbundet med en øget risiko for urinvejsinfektioner; derfor bør en midlertidig afbrydelse af behandlingen overvejes ved behandling af pyelonefritis eller urosepsis.
English: If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Danish: Hvis du først kommer i tanker om det, når det er tid til din næste dosis, skal du springe den glemte dosis over og tage næste dosis som planlagt.
English: Xigduo may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Xigduo kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, især hvis dine nyrer ikke fungerer korrekt.
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: De højere simvastatin- og simvastatinsyreeksponeringer betragtes ikke som klinisk relevante.
English: The steady-state inhibition of renal glucose reabsorption and the amount of urinary glucose excretion over a 24-hour period was the same for both dosing regimens.
Danish: Steady state-hæmningen af renal glukosereabsorption og mængden af udskillelse af glukose i urinen i en periode på 24 timer var den samme for begge doseringsregimer.
English: Dapagliflozin does not impair normal endogenous glucose production in response to hypoglycaemia.
Danish: Dapagliflozin hæmmer ikke den normale endogene glukoseproduktion som reaktion på hypoglykæmi.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Danish: Et studie udført med syv raske frivillige viste, at cimetidin administreret som 400 mg to gange dagligt øgede metformins systemiske eksponering (AUC) med 50 % og Cmax med 81 %.
English: BLISTERS (PERFORATED)
Danish: BLISTERE (PERFOREREDE)
English: Dapagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is > 1,400 times more selective for SGLT2 versus SGLT1, the major transporter in the gut responsible for glucose absorption.
Danish: Dapagliflozin hæmmer ikke andre glukosetransportører, som er vigtige for transport af glukose til de perifere væv, og det er > 1400 gange mere selektivt for SGLT2 end for SGLT1, den vigtigste transportør i tarmen, som er ansvarlig for glukoseabsorption.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er i det væsentlige natriumfri.
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are coadministered.
Danish: Tæt monitorering af glykæmisk kontrol, dosisjustering inden for den anbefalede dosering og ændring af diabetesbehandlingen skal derfor overvejes ved administration sammen med kationiske lægemidler, som elimineres ved tubulær sekretion.
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så tal med lægen, apotekspersonalet eller sundhedspersonalet, før du begynder at tage dette lægemiddel.
English: Hypoglycaemia The frequency of hypoglycaemia depended on the type of background therapy used in each study.
Danish: Hyppigheden af hypoglykæmi afhang af den type baggrundsbehandling, der blev anvendt i hver studie.
English: Lactic acidosis Vitamin B12 deficiency h,§
Danish: Laktatacidose Vitamin B12mangel h,§
English: Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Danish: Polyuri inkluderer de foretrukne termer: pollakisuri, polyuri, øget urinproduktion.
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Gastrointestinale symptomer såsom kvalme, opkastning, diarré, abdominalsmerter og appetitløshed forekommer hyppigst ved behandlingsstart og går spontant over i de fleste tilfælde.
English: Dapagliflozin 3-O-glucuronide or other metabolites do not contribute to the glucose-lowering effects.
Danish: Dapagliflozin 3-O-glukuronid eller andre metabolitter bidrager ikke til den glukosesænkende virkning.
English: Cardiac failure There is no experience in clinical studies with dapagliflozin in NYHA class IV.
Danish: Hjertesvigt Der er ingen erfaringer fra kliniske studier med dapagliflozin i NYHA-klasse IV.
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Disse symptomer kan være tegn på ”diabetisk ketoacidose” - en sjælden, men alvorlig, til tider livstruende komplikation, du kan få ved diabetes på grund af forhøjet niveau af ”ketonstoffer” i urinen eller blodet, som kan ses i laboratorieanalyser.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Den maksimale koncentration i blod er lavere end den maksimale koncentration i plasma og opnås på omtrent samme tid.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xigduo in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Xigduo i alle undergrupper af den pædiatriske population ved behandling af type 2-diabetes (se pkt.
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Glukokortikoider (givet ad systemiske og lokale veje), beta-2-agonister og diuretika har egen hyperglykæmisk aktivitet.
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma.
Danish: Hvis det sker for dig, kan du have behov for akut medicinsk behandling, da laktatacidose kan medføre koma.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin uafhængigt af dets virkning på glykæmi gunstige virkninger på lipidmetabolismen.
English: Multipack: 196 (2 packs of 98) film-coated tablets
Danish: Multipakning: 196 (2 pakninger a 98) filmovertrukne tabletter
English: Monitoring of renal function:
Danish: Overvågning af nyrefunktion:
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is approximately 50-60% in healthy subjects.
Danish: Efter en oral dosis af metformin nås tmax på 2,5 t. Absolut biotilgængelighed af en 500 mg eller 850 mg metformintablet er ca. 50-60 % hos raske forsøgspersoner.
English: At 1 year, mean eGFR was slightly lower, and at 4 years, mean eGFR was slightly higher in the dapagliflozin group compared with the placebo group.
Danish: Efter 1 år var middel eGFR en smule lavere, og efter 4 år var middel eGFR en smule højere i dapagliflozingruppen sammenlignet med placebogruppen.