FrancophonIA/ELRC3.0 huggingface dataset:
English: • When you are treated with Edistride, diabetic ketoacidosis can occur even if your blood sugar is normal.
Danish: • Når du behandles med Edistride, kan diabetisk ketoacidose forekomme, selvom dit blodsukkerniveau er normalt.
English: Study MB102229
Danish: Studie MB102229
English: Do not use this medicine after the expiry date, which is stated on the blister or carton after ‘EXP'.
Danish: Brug ikke Edistride efter den udløbsdato ("EXP"), der står på blisterkort og pakning.
English: • The risk of getting diabetic ketoacidosis is different in the two types diabetes: - in type 2 diabetes it is rare.
Danish: • Risikoen for at få diabetisk ketoacidose er forskellig for de to typer diabetes: - ved type 2-diabetes er det sjældent.
English: Study MB102230
Danish: Studie MB102230
English: Type 1 diabetes mellitus Treatment with Edistride is to be initiated and supervised by specialists in type 1 diabetes.
Danish: Type 1-diabetes mellitus Behandling med Edistride skal initieres og overvåges af specialister i type 1-diabetes.
English: • Dapagliflozin should only be given to patients who are able to monitor ketone levels and are educated in when it is most appropriate to do so.
Danish: • Dapagliflozin bør kun gives til patienter, der er i stand til at overvåge ketonniveauet og er uddannet i, hvornår det er mest hensigtsmæssigt at gøre det.
English: • Counsel the patient and evaluate their adherence to ketone monitoring while establishing their baseline ketone level 1 to 2 weeks before treatment initiation and ensure the patient: o Has received education/training in ketone testing, and interpreting/acting upon test results o Is willing/able to perform ketone testing as prescribed o Is adequately informed about managing sick days
Danish: • Rådgiv patienten og vurdér dennes efterlevelse af ketonmonitorering, mens deres baseline ketonniveau fastlægges 1 til 2 uger før behandlingens start, og sørg for, at patienten: o har fået undervisning/træning i måling af ketoner og tolkning/handling ifølge testresultaterne o er villig til/i stand til at udføre måling af ketoner som ordineret o er tilstrækkeligt informeret om håndtering af sygedage
English: • if you have type 2 diabetes and are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Danish: • Hvis du har type 2-diabetes og tager anden medicin, som sænker sukkerindholdet i blodet, som f.eks. insulin eller en medicin med "sulfonylurinstof".
English: Blood glucose variability
Danish: Blodglukosevariabilitet
English: The recommended actions are listed in Table 1 (see section 4.2).
Danish: De anbefalede foranstaltninger er anført i tabel 1 (se pkt.
English: • if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
Danish: • Hvis du har "type 1-diabetes" - den type, der normalt starter, når du er ung, og din krop ikke producerer noget insulin.
English: You may need to take extra insulin, drink water, and if your blood glucose is normal or low, you may need to eat carbohydrates.
Danish: Du skal måske tage ekstra insulin, drikke vand og hvis dit blodsukker er normalt eller lavt, skal du måske spise kulhydrater.
English: Subsequently, basal insulin should be adjusted based on blood glucose results.
Danish: Efterfølgende bør basal insulin justeres på baggrund af blodglukoseresultater.
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: If Fournier's gangrene is suspected, Forxiga should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Edistride seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: No reduction in basal insulin is recommended when initiating dapagliflozin.
Danish: Det anbefales ikke at reducere basal insulin ved start af dapagliflozin.
English: See “Description of selected adverse reactions” and section 4.4.
Danish: Se "Beskrivelse af udvalgte bivirkninger" og pkt.
English: Mechanism of action Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of SGLT2.
Danish: Virkningsmekanisme Dapagliflozin er en potent (Ki: 0,55 nM), selektiv og reversibel hæmmer af SGLT2.
English: Dapagliflozin must only be administered as an adjunct to insulin.
Danish: Dapagliflozin må kun administreres som supplement til insulin.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos op til 1 ud af 10 personer)
English: Patients treated with dapagliflozin exhibited continuous weight loss over the 24-week period.
Danish: Patienter behandlet med dapagliflozin udviste kontinuerligt vægttab i løbet af 24 ugers perioden.
English: There is limited experience in clinical studies in patients with hepatic impairment.
Danish: Der er begrænset erfaring fra kliniske studier med patienter med nedsat leverfunktion.
English: The educational materials are aimed at providing guidance on how to manage risk of diabetic ketoacidosis (DKA) in patients with type 1 diabetes.
Danish: Uddannelsesmaterialerne er rettet mod at vejlede om, hvordan risikoen for diabetisk ketoacidose (DKA) hos patienter med type 1-diabetes håndteres.
English: Stop taking Edistride and see a doctor as soon as possible if you notice any of the following serious side effects:
Danish: Stop med at tage Edistride og opsøg hurtigst muligt en læge, hvis du får nogen af følgende alvorlige bivirkninger:
English: Ketone monitoring during treatment:
Danish: Ketonovervågning under behandling:
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Edistride.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så tal med din læge, apotekspersonalet eller sundhedspersonalet, før du begynder at tage Edistride.
English: Edistride is used for the types of diabetes called:
Danish: Edistride anvendes til diabetestyperne kaldet:
English: The most frequently reported adverse reactions associated with dapagliflozin in patients with type 1 diabetes mellitus were genital infections, which were more frequent in females.
Danish: De hyppigst rapporterede bivirkninger forbundet med dapagliflozin hos patienter med type 1-diabetes mellitus var genitale infektioner, som var hyppigere hos kvinder.
English: - together with other medicines to treat diabetes.
Danish: - sammen med anden medicin til behandling af diabetes.
English: The following adverse reactions have been identified in the placebo-controlled clinical studies and postmarketing surveillance.
Danish: Følgende bivirkninger er identificeret i de placebokontrollerede kliniske studier og overvågning efter markedsføring.
English: • Risk factors for diabetic ketoacidosis (DKA) should be assessed (see section 4.4).
Danish: • Risikofaktorer for diabetisk ketoacidose (DKA) bør vurderes (se pkt.
English: Hence, Edistride can be administered with or without food.
Danish: Derfor kan Edistride indgives med eller uden mad.
English: • Correction of volume depletion prior to initiation of dapagliflozin is recommended in patients with this condition (see section 4.4).
Danish: • Korrektion af volumendepletering forud for initiering af dapagliflozin anbefales til patienter med denne tilstand (se pkt.
English: In both types of diabetes, this leads to a high level of sugar in your blood.
Danish: Begge typer diabetes fører til forhøjet blodsukker.
English: Other side effects when taking Edistride:
Danish: Andre bivirkninger, når du tager Edistride:
English: Restarting SGLT2 inhibitor treatment in patients experiencing a DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Danish: Genstart af behandling med SGLT2-hæmmer hos patienter, der oplever en DKA under behandling med SGLT2-hæmmer, anbefales ikke, medmindre en anden klar udløsende faktor identificeres og løses.
English: Ketone monitoring:
Danish: Ketonovervågning:
English: • Patient not on optimal insulin dose or who have recent issues with noncompliance or recurrent errors with insulin dosing and who are unlikely to maintain adequate insulin dosing.
Danish: • Patienter, som ikke er på optimal insulindosis eller som har nylige problemer med efterlevelse eller tilbagevendende fejl i insulindosering og som sandsynligvis ikke kan opretholde tilstrækkelig insulindosering.
English: • The above symptoms could be a sign of “diabetic ketoacidosis” - a serious, sometimes lifethreatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: • De ovennævnte symptomer kan være tegn på ”diabetisk ketoacidose” - en 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: Dapagliflozin should not be initiated when patients are at a higher risk of DKA, such as:
Danish: Dapagliflozin bør ikke initieres hos patienter, der har en høj risiko for DKA, såsom:
English: The guide for healthcare professionals including the prescriber's checklist should contain the following key elements:
Danish: Vejledningen til sundhedspersonale, herunder den ordinerende læges tjekliste, skal indeholde følgende hovedelementer:
English: Your doctor may ask you to take Edistride: - on its own - if you cannot tolerate metformin.
Danish: Lægen kan bede dig om at tage Edistride: - alene, hvis du ikke kan tåle metformin.
English: The patient should be advised to test their ketone level (urine or blood) if signs or symptoms of ketoacidosis occur.
Danish: Patienterne bør rådes til at teste deres ketonniveau (urin eller blod), hvis tegn eller symptomer på ketoacidose forekommer.
English: The mean steady-state volume of distribution of dapagliflozin was 118 liters.
Danish: Det gennemsnitlige steady statefordelingsvolumen af dapagliflozin var 118 liter.
English: The patient should measure blood glucose and consider taking extra carbohydrates if the glucose levels are normal or low.
Danish: Patienten skal måle blodglukose og overveje at tage ekstra kulhydrater, hvis glukoseniveauerne er normale eller lave.
English: p-values are two-sided.
Danish: p-værdier er tosidede.
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: De højere simvastatin- og simvastatinsyre-eksponeringer betragtes ikke som klinisk relevante.
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat leverfunktion.
English: • Ensure the patient is on optimal insulin therapy prior to initiation of dapagliflozin treatment.
Danish: • Sørg for, at patienten er i optimal insulinbehandling før behandling med dapagliflozin indledes.
English: • Patients who insist on maintaining caloric restriction, carbohydrate restriction or ketogenic diet or who chronically under-dose insulin (e.g. in order to remain in a lipolytic state).
Danish: • Patienter, som insisterer på opretholdelse af restriktion af kalorier og kulhydrater eller ketogen diæt eller som kronisk underdoserer insulin (f.eks. for at forblive i lipolytisk tilstand).
English: • Do not start caloric restriction or carbohydrate restriction while treated
Danish: • Begynd ikke at skære ned på kalorier eller kulhydrater under behandlingen
English: Ketone levels should be measured again after two hours.
Danish: Ketonniveauer skal måles igen efter to timer.
English: Fifty percent (50%) had mild renal impairment and 11% had moderate renal impairment.
Danish: 50 % havde let nedsat nyrefunktion, og 11 % havde moderat nedsat nyrefunktion.
English: Measure your ketone levels again in 2 hours.
Danish: Mål dine ketonniveauer igen efter 2 timer.
English: Your doctor may prescribe Edistride together with other medicine(s) to lower the amount of sugar in your blood.
Danish: Din læge kan ordinere Edistride sammen med anden medicin for at sænke sukkerindholdet i blodet.
English: Pharmacotherapeutic group: Drugs used in diabetes, Sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK01
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, natrium-glukose co-transporter 2 (SGLT2) inhibitorer, ATC-kode: A10BK01
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 glukosetransportstoffer, som er vigtige for transport af glukose til de perifere væv, og det er > 1400 gange mere selektivt for SGLT2 end for SGLT1, det vigtigste transportstof i tarmen, som er ansvarlig for glukoseabsorption.
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 en række tilfælde var præsentationen af tilstanden atypisk med kun moderat forhøjede blodglukoseværdier, under 14 mmol/l (250 mg/dl).
English: • In the event of a marked reduction of insulin need, discontinuation of dapagliflozin should be considered.
Danish: • I tilfælde af en markant reduktion af insulinbehovet, bør seponering af dapagliflozin overvejes.
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 (glukuretisk effekt) observeres efter den første dosis, fortsætter over doseringsintervallet på 24 timer og varer ved i hele behandlingsperioden.
English: Patients using a pump should also check their ketone levels with any suspected insulin interruption, regardless of blood glucose levels.
Danish: Patienter, der bruger en pumpe, bør også kontollere deres ketonniveauer ved mistænkt insulinafbrydelser, uanset blodglukoseniveauet.
English: a) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products)
Danish: a) i et placebokontrolleret studie af dapagliflozin i kombination med insulin (alene eller med orale glukosesænkende lægemidler)
English: The recommended dose is 5 mg once daily.
Danish: Den anbefalede dosis er 5 mg én gang daglig.
English: • necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Danish: • nekrotiserende fasciitis i mellemkødet (Fourniers gangræn), en alvorlig bløddelsinfektion i kønsdelene eller området mellem kønsdelene og anus, forekommer meget sjældent.
English: DPP-4 Inhibitor (sitagliptin 2) ± Metformin
Danish: DPP-4-hæmmer (sitagliptin 2) ± metformin
English: Talk to your doctor, pharmacist or nurse before taking Edistride:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du tager Edistride:
English: Subsequent bolus doses should be adjusted individually based on blood glucose results.
Danish: Efterfølgende bolusdoser bør justeres individuelt på baggrund af blodglukoseresultater.
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: 2Metformin (formulering med umiddelbar (IR) eller forlænget frigivelse (XR)) ≥1500 mg/dag plus maksimal tolereret dosis, som skal være mindst halvdelen af den maksimale dosis, af et sulfonylurinstof i mindst 8 uger inden inkludering i studiet.
English: • The recommended dose is one 10 mg tablet each day.
Danish: • Den anbefalede dosis er én 10 mg tablet hver dag.
English: • Your doctor will tell you when you may need to measure ketones in your blood or urine and what you need to do when your ketone levels are raised: - At blood ketone readings from 0.6 to 1.5 mmol/L (or urine ketones reading +) you may need to take extra insulin, drink water, and if your blood glucose is normal or low, you may need to eat carbohydrates.
Danish: • Din læge vil fortælle dig, hvornår du skal måle ketoner i dit blod eller urin, og hvad du skal gøre, når dine ketonniveauer er forhøjede: - Ved blodketonmåling fra 0,6 til 1,5 mmol/l (eller urinketonmåling +) skal du muligvis tage ekstra insulin, drikke vand og hvis dit blodsukker er normalt eller lavt, skal du måske spise kulhydrater.
English: If you are taking Edistride for type 2 diabetes:
Danish: Hvis du tager Edistride mod type 2-diabetes:
English: Precipitating factors for DKA were as expected in a type 2 diabetes mellitus population (see section 4.4).
Danish: Fremskyndende faktorer for DKA var som forventet i type 2-diabetes mellitus-populationen (se pkt.
English: No dose adjustment is required based on renal function.
Danish: Det er ikke nødvendigt at justere dosis baseret på nyrefunktionen.
English: In patients with type 1 diabetes mellitus and a known risk of frequent or severe hypoglycaemia, it may be necessary to reduce the insulin dose at the time of initiating treatment with dapagliflozin to decrease the risk of hypoglycaemia.
Danish: Hos patienter med type 1-diabetes mellitus og en kendt risiko for hyppig eller alvorlig hypoglykæmi kan det være nødvendigt at nedsætte insulindosen ved initiering af behandling med dapagliflozin for at mindske risikoen for hypoglykæmi.
English: - in type 1 diabetes the risk is higher - this is because your body hardly produces any insulin, and diabetic ketoacidosis may occur at sudden decreases in insulin dose (such as missed insulin injections, or issues with your insulin pen or pump).
Danish: - ved type 1-diabetes er risikoen højere, fordi din krop nærmest ikke producerer noget insulin, og diabetisk ketoacidose kan forekomme ved pludselige fald i insulindosis (f.eks. glemte insulinindsprøjtninger eller problemer med din insulinpen eller -pumpe).
English: Seek medical advice immediately and stop taking Edistride if levels persist and symptoms present.
Danish: Søg straks lægehjælp, og stop med at tage Edistride, hvis niveauerne fortsat er høje, og der er symptomer.
English: • How to measure ketones, how to interpret the results and what to do in case of hyperketonaemia/DKA (contact HCP immediately if BHB > 0.6 mmol/L with symptoms or if BHB > 1.5 mmol/L with or without symptoms)
Danish: • Hvordan ketoner måles, hvordan resultaterne tolkes og hvad man skal gøre i tilfælde af hyperketonæmi/DKA (kontakt straks lægen, hvis BHB > 0,6 mmol/l med symptomer eller hvis BHB > 1,5 mmol/l med eller uden symptomer)
English: Clinical stage
Danish: Klinisk stadie
English: • The patient should be informed how to recognize the risk factors which can predispose to ketosis (including starvation ketosis) and DKA and how to recognize DKA signs or symptoms.
Danish: • Patienten bør informeres om, hvordan man genkender de risikofaktorer, der kan prædisponere for ketose (herunder ”sulteketose”) og DKA og hvordan man genkender tegn og symptomer på DKA.
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Danish: SGLT2 er det vigtigste transportstof, som er ansvarlig for reabsorption af glukose fra det glomerulære filtrat tilbage i kredsløbet.
English: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of dapagliflozin 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 med dapagliflozin overvejes ved behandling af pyelonefritis eller urosepsis.
English: In patients where DKA is suspected or diagnosed, dapagliflozin treatment should be stopped immediately.
Danish: Hos patienter, hvor DKA mistænkes eller diagnosticeres, skal behandlingen med dapagliflozin straks stoppes.
English: Edistride has no or negligible influence on the ability to drive and use machines.
Danish: Edistride påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Figure 1: Time to first occurrence of hospitalisation for heart failure or cardiovascular death
Danish: Figur 1: Tid til første forekomst af hospitalsindlæggelse for hjertesvigt eller kardiovaskulær død
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 at udvikle diabetisk ketoacidose kan være forøget ved længerevarende faste, overdreven alkoholindtagelse, dehydrering, pludselig nedsættelse af insulindosis eller øget behov for insulin på grund af større operationer eller alvorlig sygdom.
English: • The risk of DKA is increased with dapagliflozin treatment.
Danish: • Risikoen for DKA er højere ved behandling med dapagliflozin.
English: • Edistride is used if your type 1 diabetes cannot be controlled with insulin alone.
Danish: • Edistride anvendes, hvis din type 1-diabetes ikke kan kontrolleres med insulin alene.
English: Although uncommon, if you see blood in your urine, tell your doctor immediately.
Danish: Hvis du ser blod i urinen, skal du straks fortælle det til din læge, dette forekommer dog sjældent.
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: En kombination af en enkeltdosis dapagliflozin 20 mg og simvastatin (et CYP3A4-substrat) resulterede i en 19 % stigning i AUC for simvastatin og en 31 % stigning i AUC for simvastatinsyre.
English: • Patient's/Carer's Guide
Danish: • Vejledning til patient/omsorgsperson
English: The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Danish: Dannelsen af dapagliflozin 3-O-glukuronid medieres af UGT1A9, et enzym i lever og nyrer, og den CYP-medierede metabolisme var en mindre clearance pathway hos mennesker.
English: • Dapagliflozin should only be given to patients with access to ketone testing materials and immediate access to a clinician if blood or urine ketones are elevated.
Danish: • Dapagliflozin bør kun gives til patienter, der har adgang til ketontestmateriale og umiddelbar adgang til en læge, hvis der opstår forhøjede ketonværdier i blod eller urin.
English: • Patients with elevated ketones levels (BHB reading is greater than 0.6 mmol/L or urine ketones one plus (+)).
Danish: • Patienter med forhøjede ketonniveauer (BHB-måling er større end 0,6 mmol/l eller urinketoner viser et plus (+)).
English: Patients should be informed about what actions to take if ketone levels are elevated.
Danish: Patienterne bør informeres om, hvilke foranstaltninger der skal træffes, hvis ketonniveauerne er forhøjede.
English: • Guidance to the physician for assessing whether the patient is eligible for dapagliflozin prescription, e.g. patient selection criteria including adherence to insulin treatment and insulin thresholds, patient's beta-hydroxybutyrate (BHB) < 0.6 mmol/L or urine ketones < 1+, BMI ≥ 27 kg/m2, absence of DKA risk factors.
Danish: • Vejledning til lægen til bedømmelse af, om patienten er egnet til ordination af dapagliflozin, f.eks. patientudvælgelseskriterner, herunder efterlevelse af insulinbehandling og insulingrænser, patientens beta-hydroxybutyrat (BHB) < 0,6 mmol/l eller urinketoner < 1+, BMI ≥ 27 kg/m fravær af risikofaktorer for DKA.