FrancophonIA/ELRC3.0 huggingface dataset:
English: Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to diabetic precoma.
Danish: Ketoacidose er en tilstand, hvor såkaldte ketonstoffer ophobes i blodet, hvilket kan medføre diabetisk koma.
English: * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Danish: * p-værdi < 0,0001 for non-inferioritet og p-værdi = 0,0153 for superioritet.
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5000-times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Danish: Empagliflozin hæmmer ikke andre glukosetransportører med betydning for transport af glukose ind i perifere væv, og det er 5.000 gange mere selektivt for SGLT2 end for SGLT1, der er den vigtigste transportør med betydning for absorption af glukose i tarmen.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmiske virkninger, som nedsætter både basal og postprandial plasmaglukose.
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m2.
Danish: Ved denne analyse blev AUC estimeret til at være 5,82 %, 10,4 % og 17,3 % lavere hos patienter med et BMI på henholdsvis 30, 35 og 45 kg/m2 sammenlignet med patienter med et BMI på 25 kg/m2.
English: This medicinal product must not be used in patients with moderate or severe renal impairment (creatinine clearance <60 ml/min) (see sections 4.3 and 4.4).
Danish: Dette lægemiddel må ikke bruges til patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 60 ml/min) (se pkt.
English: Taste disturbance3
Danish: Smagsforstyrrelser3
English: Physicians should alert the patients on the risk and on the symptoms of lactic acidosis.
Danish: Lægen skal informere patienten om risikoen for og symptomerne på laktatacidose.
English: The frequency of reported nocturia was comparable between placebo and empagliflozin (<1%).
Danish: Hyppigheden af nykturi var sammenlignelig for placebo og empagliflozin (< 1 %).
English: Available animal data have shown excretion of empagliflozin and metformin in milk.
Danish: Dyrestudier har påvist udskillelse af både empagliflozin og metformin i mælken.
English: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with renal failure or acute worsening of renal function.
Danish: De indberettede tilfælde af laktatacidose i forbindelse med metformin er primært forekommet hos diabetespatienter med nedsat nyrefunktion eller med akut forværring af nyrefunktionen.
English: It particularly affects patients whose kidneys are not working properly.
Danish: Dette gælder især, hvis nyrerne ikke fungerer godt nok.
English: • in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization,
Danish: • forøgelse af insulinfølsomheden i musklerne og derved forbedring af den perifere optagelse og udnyttelse af glukose.
English: Of these, a total of 530 patients received empagliflozin as add-on to metformin plus insulin, of which 266 patients were treated with empagliflozin 10 mg and 264 with empagliflozin 25 mg.
Danish: Af disse fik i alt 530 patienter empagliflozin som tillæg til metformin plus insulin, hvoraf 266 patienter blev behandlet med empagliflozin 10 mg og 264 med empagliflozin 25 mg.
English: You will need to tell your doctor and stop taking this medicine before, or at the time of the X-ray and for 2 or more days after depending on how your kidneys are working.
Danish: Du skal fortælle det til lægen og holde pause med Synjardy i en periode fra før undersøgelsen og i mindst 2 dage efter, afhængigt af hvordan dine nyrer fungerer.
English: • Diabetic ketoacidosis, diabetic pre-coma.
Danish: • Diabetisk ketoacidose eller diabetisk prækoma.
English: This may induce metformin accumulation and may increase the risk for lactic acidosis.
Danish: Dette kan inducere akkumulation af metformin og øge risikoen for laktatacidose.
English: Treatment with empagliflozin once daily resulted in statistically significant improvement in HbA1c, and 24 hour mean systolic and diastolic blood pressure as determined by ambulatory blood pressure monitoring (Table 6).
Danish: Behandling med empagliflozin én gang daglig medførte et statistisk signifikant fald i HbA1c og i 24-timers gennemsnitligt systolisk og diastolisk blodtryk målt ved ambulant blodtrykskontrol (Tabel 6).
English: Dysuria2
Danish: Dysuri2
English: Lactic acidosis is characterised by acidotic dyspnea, abdominal pain and hypothermia followed by coma.
Danish: Laktatacidose er karakteriseret ved acidotisk dyspnø, mavesmerter og hypotermi efterfulgt af koma.
English: Increased urination1, 2
Danish: Øget vandladning1, 2
English: Complicated urinary tract infection (e.g. pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Danish: Komplicerede urinvejsinfektioner (f.eks. pyelonefritis eller urosepsis) forekom med samme hyppighed hos patienter behandlet med empagliflozin sammenlignet med placebo.
English: Other medicines and Synjardy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Synjardy Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: No additional adverse reactions were identified in clinical trials with empagliflozin as add-on to metformin compared to the side effects of the single components.
Danish: Der blev ikke påvist yderligere bivirkninger i kliniske studier med empagliflozin som tillæg til metformin sammenlignet med bivirkningerne fra de enkelte komponenter.
English: Synjardy combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: empagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), and metformin hydrochloride, a member of the biguanide class.
Danish: Synjardy kombinerer to antihyperglykæmiske lægemidler med komplementære virkningsmekanismer for at forbedre den glykæmiske kontrol hos patienter med type 2-diabetes: empagliflozin, der er en hæmmer af natrium-glukose co-transportør 2 (SGLT2-hæmmer), og metforminhydrochlorid, der er et medlem af biguanidklassen.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund viser nedsat pH i blodet, plasmalaktat > 5 mmol/l og øget anion gap og laktat/pyruvatratio.
English: Synjardy is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control
Danish: Synjardy er indiceret til patienter på 18 år og derover med type 2-diabetes mellitus som tillæg til kostomlægning og motion for at forbedre den glykæmiske kontrol
English: In patients with type 2 diabetes, urinary glucose excretion increased immediately following the first dose of empagliflozin and is continuous over the 24 hour dosing interval.
Danish: Hos patienter med type 2-diabetes blev udskillelsen af glukose i urinen øget umiddelbart efter den første dosis empagliflozin, og dette varede ved i doseringsintervallet på 24 timer.
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Danish: Toksiciteten var for det meste forenelig med en sekundær farmakologisk virkning med relation til tab af glukose via urinen og elektrolytforstyrrelser, herunder nedsat legemsvægt og kropsfedt, øget fødeindtagelse, diarré, dehydrering, nedsat serumglukose og stigninger i andre serumparametre, der afspejler øget proteinmetabolisme og glukoneogenese, ændringer i vandladningen (f.eks. polyuri) og i urinen (f.eks. glukosuri) og mikroskopiske forandringer, herunder mineralisering i nyrerne og visse bløddele og vaskulære væv.
English: It is not known whether empagliflozin passes into human breast milk.
Danish: Det vides ikke, om empagliflozin udskilles i modermælken hos mennesker.
English: The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding maximum recommended daily dose of metformin.
Danish: Dosis er individuel og tilpasses patientens aktuelle behandling samt virkning og tolerabilitet ved brug af den anbefalede dosis på 10 mg eller 25 mg empagliflozin daglig samtidig med at den anbefalede, højeste daglige dosis af metformin ikke overskrides.
English: Due to the metformin component, Synjardy may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly.
Danish: På grund af metforminindholdet kan Synjardy give en meget sjælden, men meget alvorlig bivirkning, der kaldes mælkesyreforgiftning, især hvis du har nedsat nyrefunktion.
English: Increased urinary glucose excretion resulted in an immediate reduction in plasma glucose levels in patients with type 2 diabetes.
Danish: Øget udskillelse af glukose i urinen medførte et omgående fald i plasmaglukose hos patienter med type 2-diabetes.
English: Therapy should usually not be resumed earlier than 48 hours following surgery and only after renal function has been reevaluated and found to be normal.
Danish: Behandling må normalt ikke genoptages før 48 timer efter operationen, og først når nyrefunktionen er blevet kontrolleret igen og fundet normal.
English: Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component.
Danish: Behandling med jodholdige kontraststoffer kan nedsætte din nyrefunktion og øge risikoen for bivirkninger, hvilket skyldes metformin.
English: Add-on to pioglitazone + metformin therapyb Placebo
Danish: Tillæg til pioglitazon + metforminbehandlingb Placebo
English: Treatment with empagliflozin in combination with metformin with or without other antidiabetic medicinal products (pioglitazone, sulfonylurea, DPP-4 inhibitors, and insulin) led to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, systolic and diastolic blood pressure.
Danish: Behandling med empagliflozin i kombination med metformin med eller uden andre antidiabetika (pioglitazon, sulfonylurinstof, DPP-4-hæmmere og insulin) medførte klinisk betydende fald i HbA1c, faste-plasmaglukose (FPG), legemsvægt og systolisk og diastolisk blodtryk.
English: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect hydration status of patients age 75 years and older.
Danish: Empagliflozins virkning på udskillelsen af glukose i urinen er forbundet med osmotisk diurese, hvilket kan påvirke hydreringsstatus for patienter på 75 år og derover.
English: Due to the limited therapeutic experience with empagliflozin in patients aged 85 years and older, initiation of therapy in this population is not recommended (see section 4.4).
Danish: Den kliniske erfaring med empagliflozin til patienter på 85 år og derover er begrænset, og behandling af denne population bør ikke indledes (se pkt.
English: Your doctor may ask you to stop taking Synjardy until you have recovered;
Danish: Din læge beder dig måske stoppe med at tage Synjardy, indtil du er blevet rask
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: • iodinated contrast agents (medicines used during an X-ray, see section 2 ‘Warnings and precautions'.
Danish: • kontraststoffer, der indeholder jod (lægemidler, der bruges ved en røntgenundersøgelse, se 'Advarsler og forsigtighedsregler')
English: SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys.
Danish: SGLT2 forhindrer glukose (blodsukker) i at blive udskilt med urinen ved at transportere glukose tilbage til blodet.
English: Increased urinary glucose excretion was maintained at the end of the 4-week treatment period, averaging approximately 78 g/day with empagliflozin 25 mg.
Danish: Der var stadig en øget udskillelse af glukose ved ophør af den 4 uger varende behandlingsperiode (i gennemsnit 78 g/dag med empagliflozin 25 mg).
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Danish: Mælkesyreforgiftning er en akut tilstand, der kræver behandling på et hospital.
English: N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Danish: N HbA1c (%) Baseline (middelværdi) Ændring fra baseline1 Forskel til placebo1 (97,5 % CI) N Patienter (%) der opnåede HbA1c < 7 % efter et baseline-HbA1c ≥ 7 %2 N Legemsvægt (kg) Baseline (middelværdi) Ændring fra baseline1 Forskel til placebo1 (97,5 % CI) N SBP (mmHg)2 Baseline (middelværdi) Ændring fra baseline1 Forskel til placebo1 (95 % CI)
English: Table 6 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressurea
Danish: Tabel 6: Effektresultater efter 12 uger i et placebokontrolleret studie med empagliflozin til patienter med type 2-diabetes og dårligt kontrolleret blodtryka
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 4).
Danish: Du skal omgående stoppe med at tage Synjardy og straks kontakte en læge eller tage til det nærmeste hospital (se afsnit 4).
English: A greater proportion of patients treated with empagliflozin and with a baseline HbA1c ≥7.0% achieved a target HbA1c of <7% compared to placebo (Table 5).
Danish: En højere andel af patienter behandlet med empagliflozin og med baseline-HbA1c ≥ 7,0 % opnåede en HbA1c-målværdi på < 7 % sammenlignet med placebo (Tabel 5).
English: • reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
Danish: • nedsat glukoseproduktion i leveren ved at hæmme glukoneogenese og glykogenolyse.
English: In patients with type 2 diabetes and hyperglycaemia a higher amount of glucose is filtered and reabsorbed.
Danish: Hos patienter med type 2-diabetes og hyperglykæmi er mængden af filtreret og reabsorberet glukose højere.
English: It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis.
Danish: Det er vigtigt, at du tager Synjardy som foreskrevet, følger din diæt og dit motionsprogram, da det kan nedsætte risikoen for mælkesyreforgiftning.
English: • if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, dehydration, rapid weight loss or ketoacidosis.
Danish: • hvis du lider af sukkersyge (diabetes), der ikke er under kontrol, f.eks. med for højt blodsukker (alvorlig hyperglykæmi), kvalme, opkastning, dehydrering, hurtigt vægttab eller ketoacidose.
English: Stop taking Synjardy immediately and contact a doctor or the nearest hospital straight away.
Danish: Du skal omgående stoppe med at tage Synjardy, og du skal straks kontakte en læge eller tage til det nærmeste hospital.
English: Table 3: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Danish: Tabel 3: Effektresultater i uge 104 i et aktivt kontrolleret studie med sammenligning af empagliflozin og glimepirid som tillæg til metformina
English: 2 Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored
Danish: 2 Ikke undersøgt for statistisk signifikans som led i den sekventielle, bekræftende testprocedure.
English: The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Danish: Iodholdige kontraststoffer givet intravaskulært i forbindelse med radiologiske undersøgelser kan medføre nyresvigt, der resulterer i akkumulation af metformin og risiko for laktatacidose.
English: Empagliflozin increased urine glucose excretion leading to an increase in urine volume.
Danish: Empagliflozin øgede udskillelsen af glukose i urinen og førte dermed til øget urinvolumen.
English: Administration of empagliflozin 25 mg resulted in a higher proportion of patients achieving HbA1c goal of less than 7% and fewer patients needing glycaemic rescue compared to empagliflozin 10 mg and placebo.
Danish: Administration af empagliflozin 25 mg medførte, at en højere andel af patienterne opnåede en HbA1c-målværdi på under 7 %, og at færre patienter havde brug for blodsukkerregulerende behovsbehandling sammenlignet med empagliflozin 10 mg og placebo.
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: Hvis patienten planlægger graviditet, og under graviditet, bør Synjardy seponeres og hurtigst muligt erstattes af insulin til at holde blodsukkerværdierne så tæt på normalen som muligt.
English: N HbA1c (%) at week 18a
Danish: N HbA1c (%) i uge 18a
English: Symptoms include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath;
Danish: Symptomerne omfatter hurtigt vægttab, opkastning eller kvalme, mavesmerter, hurtig og dyb vejrtrækning, søvnighed eller usædvanlig, frugtagtig ånde.
English: • in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin (see sections 4.5 and 5.1 for available data on different combinations)
Danish: • hvis patienten har utilstrækkelig glykæmisk kontrol med metformin i kombination med andre glukosesænkende lægemidler, herunder insulin (se tilgængelige data om de forskellige kombinationer i pkt.
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Kombinationsbehandlinger der kræver forsigtighed Glukokortikoider (til systemisk og lokal anvendelse), beta-2-agonister og diuretika har en selvstændig hyperglykæmisk virkning.
English: The intravascular administration of iodinated contrast materials in radiologic studies can lead to renal failure.
Danish: Iodholdige kontraststoffer givet intravaskulært i forbindelse med radiologiske undersøgelser kan medføre nyresvigt.
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to coma.
Danish: Hvis dette sker for dig, kan du have brug for omgående behandling på et hospital, da mælkesyreforgiftning kan føre til koma.
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Danish: Interaktionsstudier med raske frivillige tyder på, at empagliflozin ikke har nogen klinisk betydende virkning på farmakokinetikken for metformin, glimepirid, pioglitazon, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretika og orale kontraceptiva.
English: Empagliflozin 24 months data, as add-on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 3), and a clinically meaningful reduction in FPG, compared to glimepiride.
Danish: 24 måneders data for empagliflozin som tillæg til metformin sammenlignet med glimepirid I et studie, hvor man sammenlignede virkning og sikkerhed af empagliflozin 25 mg over for glimepirid (op til 4 mg per dag) hos patienter med utilstrækkelig glykæmisk kontrol på metformin alene, medførte daglig behandling med empagliflozin et større fald i HbA1c (Tabel 3) og et klinisk betydende fald i FPG sammenlignet med glimepirid.
English: Empagliflozin improves both fasting and post-prandial plasma glucose levels.
Danish: Empagliflozin nedsætter både faste-plasmaglukose og den postprandiale plasmaglukose.
English: N HbA1c (%) at week 121
Danish: N HbA1c (%) i uge 121
English: Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-dministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Danish: Interaktionsstudier med raske frivillige tyder på, at empagliflozins farmakokinetik ikke påvirkes ved samtidig administration af metformin, glimepirid, pioglitazon, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemid eller hydrochlorthiazid.
English: During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Danish: I de første 18 uger og de sidste 12 uger blev insulindosis holdt konstant, men mellem uge 19 og 40 blev dosis justeret for at opnå præprandiale glukoseværdier < 100 mg/dl [5,5 mmol/l] og postprandiale glukoseværdier < 140 mg/dl [7,8 mmol/l].
English: A total of 7052 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 4740 patients were treated with empagliflozin as add-on to metformin.
Danish: I alt har 7.052 patienter med type 2-diabetes fået behandling i kliniske studier, hvoraf 4.740 patienter fik empagliflozin som tillæg til metformin.
English: Add-on to metformin and a sulphonylurea therapya Placebo
Danish: Tillæg til metformin og en sulfonylurinstofbehandlinga Placebo
English: • Take the tablet twice daily by mouth.
Danish: • Tag Synjardy to gange daglig sammen morgenmaden og aftensmaden.
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Danish: Udskillelse af glukose i urinen medfører endvidere et kalorietab, der er ledsaget af tab af kropsfedt og vægttab.
English: You should stop taking Synjardy at least 48 hours before planned surgery with general, spinal or peridural anaesthesia and should not start again until at least 48 hours afterwards.
Danish: Du skal holde pause med Synjardy i en periode på mindst 48 timer før en planlagt operation med helbedøvelse og til mindst 48 timer efter operationen.
English: At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 4).
Danish: I uge 18 var der et statistisk signifikant fald i HbA1c med empagliflozin sammenlignet med placebo (Tabel 4).