FrancophonIA/ELRC3.0 huggingface dataset:
English: Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Danish: Som det gælder for alle diabetespatienter, er det vigtigt, at du får kontrolleret din fødder regelmæssigt og overholder en hvilken som helst rådgivning om fodpleje, som du får af din læge eller sygeplejerske.
English: Sequential add-on clinical trials Study MB102129
Danish: Sekventiel tillægsbehandling i kliniske studier Studie MB102129
English: Urine tests Because of how Qtern works, your urine will test positive for sugar while you are on this medicine.
Danish: På grund af den måde, hvorpå Qtern virker, vil en urinprøve være positiv for sukker, mens du får denne medicin.
English: If you take more Qtern tablets than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget flere Qtern-tabletter, end du skulle, skal du straks tale med lægen eller tage på skadestuen.
English: In addition, elderly patients are more likely to be treated with anti-hypertensive medicinal products that may cause volume depletion and/or changes in renal function [e.g. angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB)].
Danish: Derudover er der større sandsynlighed for, at ældre patienter er i behandling med antihypertensiva, der kan medføre volumendepletering og/eller ændringer i nyrefunktionen [fx angiotensinkonverterende enzymhæmmere (ACE-hæmmere) og angiotensin II type 1-receptorblokkere (ARB)].
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD21
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodglucosesænkende lægemidler, ATC-kode: A10BD21
English: Qtern contains lactose (milk sugar).
Danish: Qtern indeholder lactose (mælkesukker).
English: After a mean follow up of 2 years, the trial met its primary safety endpoint demonstrating saxagliptin does not increase the cardiovascular risk in patients with type 2 diabetes compared to placebo when added to current background therapy.
Danish: Efter en gennemsnitlig opfølgning på 2 år opfyldte studiet sit primære endepunkt for sikkerhed, idet det påviste, at saxagliptin ikke øger den kardiovaskulære risiko hos patienter med type 2-diabetes sammenlignet med placebo, når det føjes til eksisterende baggrundsbehandling.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Danish: Immunrelaterede fund af minimal, ikke-progressiv, lymfoid hyperplasi i milt, lymfeknuder og knoglemarv uden negative sequalae er rapporteret hos alle arter testet ved eksponeringer begyndende ved 7 gange RHD.
English: Dapagliflozin: Dapagliflozin was rapidly and well absorbed after oral administration.
Danish: Dapagliflozin: Dapagliflozin absorberes hurtigt og godt efter oral indgivelse.
English: When driving or using machines, it should be taken into account that dizziness has been reported in studies with combined use of saxagliptin and dapagliflozin.
Danish: Ved kørsel eller betjening af maskiner skal det tages i betragtning, at svimmelhed er rapporteret i studier med anvendelse af saxagliptin og dapagliflozin i kombination.
English: Mechanism of action for saxagliptin
Danish: Virkningsmekanisme for saxagliptin
English: The following reflects the pharmacokinetic properties of Qtern unless stated that the presented data are from administration of saxagliptin or dapagliflozin.
Danish: Følgende afspejler de farmakokinetiske egenskaber af Qtern, medmindre der står, at de præsenterede data stammer fra administration af saxagliptin eller dapagliflozin.
English: It is not known if DKA is more likely to occur with higher doses of dapagliflozin.
Danish: Det er ukendt, om der er højere risiko for DKA ved højere doser af dapagliflozin.
English: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections.
Danish: Behandling med SGLT2-hæmmer øger risikoen for urinvejsinfektion.
English: Urosepsis and pyelonephritis
Danish: Urosepsis og pyelonefritis
English: Taking this medicine can cause blood sugar levels to fall too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Danish: Når du tager denne medicin, kan dit blodsukker blive for lavt (hypoglykæmi) og give symptomer såsom rysten, sveden og synsændringer, hvilket kan påvirke din evne til at køre og betjene maskiner.
English: What you need to know before you take Qtern
Danish: Det skal du vide, før du begynder at tage Qtern
English: Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment.
Danish: Patienter med moderat nedsat leverfunktion bør vurderes inden behandlingsstart og under behandlingen.
English: - if you have moderate or severe kidney problems.
Danish: • hvis du har moderate eller svære nyreproblemer.
English: If a patient presents with severe joint pain, continuation of therapy should be individually assessed.
Danish: Hvis en patient oplever svære ledsmerter, skal det vurderes individuelt, om behandlingen kan fortsætte.
English: There are no data from the use of saxagliptin and dapagliflozin in pregnant women.
Danish: Der er ingen data fra anvendelse af saxagliptin og dapagliflozin til gravide kvinder.
English: The average renal clearance of saxagliptin (~230 ml/min) was greater than the average estimated glomerular filtration rate (~120 ml/min), suggesting some active renal excretion.
Danish: Den gennemsnitlige renale clearance af saxagliptin (230 ml/min) var højere end den gennemsnitlige estimerede glomerulære filtrationshastighed (120 ml/min), hvilket tyder på en vis aktiv renal udskillelse.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: DPP-4-hæmmere er blevet forbundet med en risiko for udvikling af akut pankreatitis.
English: Patients with signs and symptoms of urinary tract infections should be evaluated and promptly treated, if indicated (see section 4.8).
Danish: Patienter med symptomer på urinvejsinfektion skal evalueres og omgående behandles, hvis det er indiceret (se pkt.
English: If you forget to take Qtern
Danish: Hvis du har glemt at tage Qtern
English: The exposure of the active metabolite and the plasma DPP-4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Danish: Eksponeringen af den aktive metabolit og hæmningen af plasma-DPP-4-aktiviteten over et dosisinterval blev ikke påvirket af rifampicin (se pkt.
English: If a dose is missed and it is < 12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time.
Danish: Hvis en dosis glemmes, og der er < 12 timer til næste dosis, skal den glemte dosis springes over og næste dosis tages på det sædvanlige tidspunkt.
English: Dapagliflozin: The mean dapagliflozin AUCss in females was estimated to be about 22 % higher than in males.
Danish: Dapagliflozin: Det gennemsnitlige dapagliflozin-AUCss hos kvinder blev vurderet til at være ca. 22 % højere end hos mænd.
English: The safety and efficacy of dapagliflozin in patients with type 1 diabetes have not been established and Qtern should not be used for treatment of patients with type 1 diabetes.
Danish: Dapagliflozins sikkerhed og virkning hos patienter med type 1-diabetes er ikke klarlagt, og Qtern bør ikke anvendes til patienter med type 1-diabetes.
English: Saxagliptin and its major metabolite are removed by haemodialysis (23% of dose over four hours).
Danish: Saxagliptin og dets hovedmetabolit fjernes ved hæmodialyse (23 % af dosen i løbet af fire timer).
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: De højere simvastatin- og simvastatinsyre-eksponering betragtes ikke som klinisk relevante.
English: Administration of Qtern with a high-fat meal decreases dapagliflozin Cmax by up to 35 % and prolongs Tmax by approximately 1.5 hours, but does not alter AUC as compared with the fasted state.
Danish: Administration af Qtern sammen med et fedtrigt måltid reducerer dapagliflozin-Cmax med op til 35 % og forlænger Tmax med ca. 1,5 time, men ændrer ikke AUC ved sammenligning med fastende tilstand.
English: For more information, see section “Other medicines and Qtern” below.
Danish: Se afsnittet ”Brug af anden medicin sammen med Qtern” nedenfor for yderligere oplysninger.
English: Least squares mean adjusted for baseline value.
Danish: Mindste kvadraters gennemsnit justeret for baseline-værdi.
English: This decrease in mean absolute lymphocyte count was not associated with clinically relevant adverse reactions.
Danish: Dette fald i gennemsnitligt absolut lymfocyttal var ikke associeret med klinisk relevante bivirkninger.
English: CV deaths were balanced across the treatment groups.
Danish: Kardiovaskulær død var jævnt fordelt i behandlingsgrupperne.
English: Considering the short latency between first drug exposure and tumour diagnosis, a causal relationship to any specific tumour type is considered unlikely.
Danish: På grund af den korte latensperiode mellem første eksponering for lægemidlet og tumordiagnose anses en kausal sammenhæng med en specifik tumortype for værende usandsynlig.
English: Serum creatinine was further evaluated in those patients with events related to decreased renal function, and most observed increases in creatinine were ≤ 0.5 mg/dl from baseline.
Danish: Serumkreatinin blev vurderet yderligere hos de patienter, der havde bivirkninger, der var relateret til nedsat nyrefunktion, og de fleste observerede kreatininstigninger var ≤ 0,5 mg/dl i forhold til baseline.
English: Interference with 1,5-anhydroglucitol (1,5-AG) assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors.
Danish: Interferens med 1,5-anhydroglucitol (1,5-AG)-assay Overvågning af glykæmisk kontrol med 1,5-AG-assay kan ikke anbefales, da måling af 1,5-AG er upålidelig til vurdering af den glykæmiske kontrol hos patienter, som tager SGLT2-hæmmere.
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
Danish: Efter 24 uger varierede reduktionerne i serumurinsyre fra -48,3 til -18,3 mikromol/l (-0,87 til -0,33 mg/dl).
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1441 times the human values at the MRHD.
Danish: Hos rotter var dapagliflozin hverken embryoletalt eller teratogent ved eksponeringer op til 1.441 gange de humane værdier ved MRHD.
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1 % in the saxagliptin group and 4.6 % in the placebo group.
Danish: Et andet sekundært endepunkt, totalmortalitet, blev nået af 5,1 % i saxagliptingruppen og af 4,6 % i placebogruppen.
English: The major active metabolite of saxagliptin, 5-OH-saxagliptin, is also a selective, reversible, competitive DPP-4 inhibitor, half as potent as saxagliptin.
Danish: Saxagliptins aktive hovedmetabolit, 5-OH-saxagliptin, er også en selektiv, reversibel, kompetitiv DPP-4-hæmmer, halvt så potent som saxagliptin.
English: - Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) if used with other diabetes medicines known to cause hypoglycaemia.
Danish: - Lavt blodsukker (hypoglykæmi), meget almindeligt (kan forekomme hos flere end 1 ud af 10 patienter), hvis medicinen anvendes sammen med andre antidiabetika, som vides at forårsage hypoglykæmi.
English: Diabetic skin lesions (skin damage such as sores or ulcers) are a common complication of diabetes.
Danish: Hudlæsioner (beskadiget hud såsom sår) er en almindelig komplikation ved diabetes (diabetiske hudlæsioner).
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 såkaldte ketonstoffer i urinen eller blodet, som kan ses i laboratorieanalyser.
English: - You can take the tablet at any time of the day.
Danish: - Du kan tage tabletten når som helst på dagen, men du skal forsøge at tage den på samme tid hver dag.
English: There were no clinically relevant differences observed in saxagliptin pharmacokinetics between males and females.
Danish: Der blev ikke observeret klinisk relevante forskelle i farmakokinetikken for saxagliptin mellem kvinder og mænd.
English: If pregnancy is detected, treatment with Qtern should be discontinued.
Danish: Hvis graviditet konstateres, skal Qtern seponeres.
English: Qtern has no or negligible influence on the ability to drive and use machines.
Danish: Qtern påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The NOAEL for developmental toxicityis associated with a maternal systemic exposure 19 times the human values at the MRHD.
Danish: NOAEL for udviklingstoksicitet er forbundet med en maternel systemisk eksponering, som er 19 gange den humane værdi ved MRHD.
English: Maximum dapagliflozin plasma concentrations (Cmax) were usually attained within 2 hours after administration in the fasted state.
Danish: Den maksimale plasmakoncentration af dapagliflozin (Cmax) opnås som regel inden for 2 timer efter indgivelse ved faste.
English: Dapagliflozin: Dapagliflozin is approximately 91 % protein bound.
Danish: Dapagliflozin: Dapagliflozin er ca. 91 % proteinbundet.
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term, clinical studies with another SGLT2 inhibitor.
Danish: Der er blevet observeret en stigning i antallet af amputationer af en underekstremitet (primært af en tå) i igangværende kliniske langtidsstudier med en anden SGLT2-hæmmer.
English: Dapagliflozin dosed to maternal rats from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Danish: Dapagliflozin blev doseret til moderrotter fra gestationsdag 6 til og med dag 21 postnatalt, og unger blev indirekte eksponeret in utero og igennem hele dieperioden.
English: Saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) in cynomolgus monkeys.
Danish: Saxagliptin medførte reversible hudlæsioner (sårskorper, ulcerationer og nekrose) på ekstremiteterne (hale, fingre/tæer, skrotum og/eller næse) hos cynomolgusaber.
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19 % increase in AUC of simvastatin and 31 % increase in AUC of simvastatin acid.
Danish: Kombination af en enkelt dosis dapagliflozin på 20 mg og simvastatin (CYP3A4-substrat) resulterede i en 19 % stigning i AUC for simvastatin og en 31 % stigning i AUC af simvastatinsyre.
English: The study population included those ≥ 65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Danish: Studiepopulationen inkluderede patienter ≥ 65 år (n=8.561) og ≥ 75 år (n=2.330) og omfattede patienter med normal eller let nedsat nyrefunktion (n=13.916), med moderat (n=2.240) og med svært (n=336) nedsat nyrefunktion.
English: This results in a glucose-dependent increase in insulin secretion, thus reducing fasting and post-prandial blood glucose concentrations.
Danish: Dette resulterer i en glucoseafhængig stigning i insulinsekretion, hvilket reducerer faste og postprandial blodglucose.
English: Non-clinical studies of either saxagliptin or dapagliflozin revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity or carcinogenicity.
Danish: Hverken prækliniske studier af saxagliptin eller dapagliflozin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Danish: Den øgede sekretion af insulin fra beta-celler i pancreas og den nedsatte sekretion af glucagon fra alfa-celler i pancreas var associeret med lavere glucosekoncentrationer under faste og nedsat glucoseudsving efter en oral glucosebelastning eller et måltid.
English: However, renal function and risk of volume depletion should be taken into account in elderly patients (≥ 65 years).
Danish: Der er ingen restriktioner baseret udelukkende på alder. Nyrefunktion og risiko for volumendepletering bør imidlertid tages i betragtning hos ældre patienter (≥ 65 år).
English: The primary safety (non-inferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischemic stroke.
Danish: De primære endepunkter for sikkerhed (non-inferioritet) og virkning (superioritet) var et sammensat endepunkt bestående af tiden til første forekomst af en af følgende alvorlige kardiovaskulære bivirkninger (MACE): kardiovaskulær død, ikke-dødeligt myokardieinfarkt eller ikke-dødelig iskæmisk apopleksi.
English: Saxagliptin: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Danish: Saxagliptin: In vitro-proteinbinding af saxagliptin og dets hovedmetabolit i humant serum er ubetydelig.
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Danish: Der skal udvises forsigtighed hos patienter, hvor et dapagliflozin-udløst blodtryksfald kan udgøre en risiko, såsom patienter med kendt kardiovaskulær sygdom, patienter i antihypertensiv behandling med hypotension i anamnesen og ældre patienter.
English: Dapagliflozin's 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: Dapagliflozins glukuretiske virkning observeres efter den første dosis, er kontinuerlig over et doseringsinterval på 24 timer og opretholdes under hele behandlingens varighed.
English: - if you have had a serious allergic reaction to any other similar medicines (for example DPP-4 inhibitors like sitagliptin, linagliptin, alogliptin, or SGLT2 inhibitors like canagliflozin, empagliflozin) that you take to control your blood sugar.
Danish: - hvis du har haft en alvorlig allergisk reaktion på lignende medicin (for eksempel DPP-4-hæmmere såsom sitagliptin, linagliptin og alogliptin eller SGLT2-hæmmere såsom canagliflozin og empagliflozin), som du tager for at kontrollere blodsukkeret.
English: These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier's gangrene which destroys the tissue under the skin.
Danish: Disse symptomer kan være et tegn på en sjælden, men alvorlig og muligvis livstruende infektion (såkaldt nekrotiserende fasciitis i mellemkødet eller Fourniers gangræn), der ødelægger vævet under huden.
English: Therapeutic experience in patients 65 years and older is limited, and very limited in patients 75 years and older.
Danish: Den terapeutiske erfaring hos patienter ≥ 65 år er begrænset og meget begrænset hos patienter ≥ 75 år.
English: The majority of events were considered non-serious, mild or moderate in intensity, and resolved.
Danish: Størstedelen af bivirkningerne blev vurderet til ikke-alvorlige, lette eller moderate i sværhedsgrad og ophørte igen.
English: Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible and competitive inhibitor of DPP-4, an enzyme responsible for the breakdown of incretin hormones.
Danish: Saxagliptin er en meget potent (Ki: 1,3 nM) selektiv, reversibel og kompetitiv hæmmer af DPP-4, et enzym, der er ansvarligt for nedbrydningen af inkretinhormoner.
English: In addition, patients should be alerted to the risk of hypoglycaemia if used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. sulphonylureas).
Danish: Derudover skal patienten advares om risikoen for hypoglykæmi, hvis lægemidlet anvendes i kombination med andre antidiabetika, der er kendt for at forårsage hypoglykæmi (fx sulfonylurinstoffer).
English: Dapagliflozin: Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks.
Danish: Dapagliflozin: Eksponeringen for dapagliflozin øgedes proportionalt med stigningen i dapagliflozindosis over intervallet fra 0,1 til 500 mg, og dets farmakokinetik ændredes ikke over tid ved gentagen daglig dosis i op til 24 uger.
English: N is the number of randomised and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: N er antallet af randomiserede og behandlede forsøgspersoner med baseline-værdi og mindst 1 post-baseline effektmåling.
English: These medicinal products did not alter the pharmacokinetics of saxagliptin or its major active metabolite.
Danish: Disse lægemidler ændrede ikke farmakokinetikken af saxagliptin eller dets primære aktive metabolit.
English: In studies of embryo-foetal development in rabbits, dapagliflozin caused neither maternal nor developmental toxicities at any dose tested; the highest dose tested corresponded to a systemic exposure 1191 times the MRHD.
Danish: I studier af embryo-føtal udvikling hos kaniner medførte dapagliflozin hverken maternal eller udviklingsmæssig toksicitet ved nogen af de testede doser; den højeste testede dosis svarede til en systemisk eksponering på 1.191 gange MRHD.
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 glucosesænkende virkning.
English: Considering the lack of tumour findings in non-clinical studies as well as the short latency between first drug exposure and tumour diagnosis, a causal relationship is considered unlikely.
Danish: Under hensyntagen til de manglende tumorfund i prækliniske studier samt den korte latensperiode mellem første eksponering for lægemidlet og tumordiagnose, anses en kausal sammenhæng for værende usandsynlig.
English: 14 film-coated tablets 28 film-coated tablets 98 film-coated tablets 30 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 98 filmovertrukne tabletter 30 filmovertrukne tabletter
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in breast-feeding offspring (see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist, at dapagliflozin/metabolitter udskilles i mælk, og endvidere påvist farmakologisk fremkaldte virkninger på diende afkom (se pkt.
English: Treatment with Qtern resulted in change from baseline for systolic blood pressure ranging from -1.3 to -2.2 mm Hg and for diastolic blood pressure ranging from -0.5 to -1.2 mm Hg caused by Qtern's mild diuretic effect.
Danish: Behandling med Qtern resulterede i ændring i systolisk blodtryk i intervallet fra -1,3 til -2,2 mmHg fra baseline og i diastolisk blodtryk i intervallet fra -0,5 til -1,2 mmHg, forårsaget af Qterns lette diuretiske virkning.