FrancophonIA/ELRC3.0 huggingface dataset:
English: 8,582 patients were randomised to dapagliflozin 10 mg and 8,578 to placebo, and were followed for a median of 4.2 years.
Danish: 8.582 patienter blev randomiseret til dapagliflozin 10 mg og 8.578 til placebo, og de blev fulgt i en median på 4,2 år.
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 af simvastatin og en 31 % stigning i AUC af simvastatinsyre.
English: • diarrhoea or stomach ache
Danish: • diarré eller mavepine
English: In active- and placebo-controlled clinical trials (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Danish: I aktive og placebo-kontrollerede kliniske studier (dapagliflozin, N=5.936, alle kontroller, N=3.403) var hyppigheden af udslæt den samme for henholdsvis dapagliflozin (1,4 %) og alle kontroller (1,4 %).
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Danish: SGLT2 er den vigtigste transportør, som er ansvarlig for reabsorption af glukose fra det glomerulære filtrat tilbage i kredsløbet.
English: The difference between groups was driven by reductions in events of the renal components; sustained eGFR decrease, end-stage renal disease and renal death (Figure 2).
Danish: Forskellen mellem grupperne blev drevet af reduktioner i hændelser med renale komponenter; vedvarende eGFR-fald, nyresygdom i slutstadiet og renal død (figur 2).
English: These may be medicine(s) by mouth or given by injection, such as insulin or a GLP-1 receptor agonist.
Danish: Det kan være lægemidler, som indtages via munden, eller indgivet ved injektion, såsom insulin eller en GLP-1-receptoragonist.
English: No major events of hypoglycaemia were reported.
Danish: Der blev ikke rapporteret om alvorlige tilfælde af hypoglykæmi.
English: The most effective method to remove metformin and lactate is haemodialysis.
Danish: Den mest effektive metode til at fjerne metformin og laktat er hæmodialyse.
English: OUTER CARTON - PART OF MULTIPACK - WITH BLUE BOX
Danish: YDRE ÆSKE - DEL AF MULTIPAKNING - MED BLUE BOX
English: It is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Danish: Det er 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: In the placebo group there was an increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and 104, respectively.
Danish: I placebogruppen var stigningen på 10,5 IE dagligt og 18,3 IE dagligt fra baseline (gennemsnitsdosis på 84 og 92 IE dagligt) i henholdsvis uge 48 og 104.
English: Stop taking Xigduo for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Xigduo i en kort periode, hvis du har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
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: • Metformin is contraindicated in patients with GFR of < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Danish: • Metformin er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: Metformin is a biguanide with anti-hyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmisk effekt, som sænker såvel basal som postprandial plasmaglukose.
English: Similar observations were made for the combination of dapagliflozin with metformin in drug-naive patients.
Danish: Der blev gjort lignende observationer ved kombinationen med dapagliflozin og metformin hos lægemiddelnaive patienter.
English: Prolonged-release exenatide 2 mg QW
Danish: Depotformulering af exenatid 2 mg QW
English: Placebo + insulin ± oral glucose-lowering medicinal products
Danish: Placebo + insulin ± oral glukosesænkende lægemidler
English: Reported in the cardiovascular outcomes study in patients with type 2 diabetes.
Danish: Rapporteret i studier af kardiovaskulære hændelser hos patienter med type 2-diabetes.
English: Blood creatinine increased during initial treatment
Danish: Forhøjet kreatinin i blodet under initial behandling
English: The results showed a similar mean reduction in HbA1c from baseline to Week 52, compared with glipizide, thus demonstrating non-inferiority (Table 3).
Danish: Resultaterne viste den samme gennemsnitlige reduktion i HbA1c fra baseline til uge 52 som for glipizid og påviste dermed non-inferioritet (tabel 3).
English: Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (time periods corresponding to the second and third trimesters of pregnancy with respect to human renal maturation) and lactation are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
Danish: Direkte administration af dapagliflozin i unge rotter under afvænning og indirekte eksponering i den sene graviditet (tidsperioder, der svarer til andet og tredje trimester af graviditeten, hvad angår modningen af nyrerne hos mennesker) og amning er hver især forbundet med øget forekomst og/eller sværhedsgrad af dilatation af nyrebækken og -tubuli hos afkom.
English: Most infections were mild to moderate, and subjects responded to an initial course of standard treatment and rarely resulted in discontinuation from dapagliflozin treatment.
Danish: De fleste infektioner var milde til moderate, og forsøgspersonerne responderede på det første behandlingsforløb med standardbehandling og var sjældent nødt til at stoppe behandlingen med dapagliflozin.
English: If you forget to take Xigduo
Danish: Hvis du har glemt at tage Xigduo
English: Post-prandial glucose
Danish: Postprandial glukose
English: Use in patients at risk for volume depletion and/or hypotension Due to its mechanism of action, dapagliflozin increases diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see section 5.1).
Danish: Anvendelse til patienter med risiko for volumendepletering og/eller hypotension På grund af dapagliflozins virkningsmekanisme øges diuresen, hvilket kan medføre det moderate blodtryksfald, der er observeret i kliniske studier (se pkt.
English: Urine laboratory assessments
Danish: Laboratorieanalyser af urinprøver
English: Treatment with dapagliflozin resulted in reductions in HbA1c and body weight compared with placebo (Table 9).
Danish: Behandling med dapagliflozin resulterede i reduktioner i HbA1c og kropsvægt sammenlignet med placebo (Tabel 9).
English: The hazard ratio for time to nephropathy (sustained eGFR decrease, end-stage renal disease and renal death) was 0.53 (95% CI 0.43, 0.66) for dapagliflozin versus placebo.
Danish: Hazard ratio for tid til nefropati (vedvarende eGFR-fald, nyresygdom i slutstadiet og renal død) var 0,53 (95 % CI 0,43, 0,66) for dapagliflozin versus placebo.
English: Taking this medicine
Danish: Sådan indtager du medicinen
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
Danish: Den gennemsnitlige procentvise ændring fra baseline for henholdsvis dapagliflozin 10 mg versus placebo var: Total kolesterol 2,5 % versus 0,0 %; HDL-kolesterol 6,0 % versus 2,7 %; LDL-kolesterol 2,9 % versus -1,0 %; triglycerider -2,7 % versus -0,7 %.
English: If you stop taking Xigduo
Danish: Hvis du holder op med at tage Xigduo
English: Studies in rats treated with dapagliflozin have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy (see section 5.3).
Danish: Studier med rotter, som blev behandlet med dapagliflozin, har påvist toksicitet for udviklingen af nyrerne i den tidsperiode, der svarer til andet og tredje trimester af menneskets graviditet (se pkt.
English: These are medicines taken by mouth for diabetes.
Danish: Begge stoffer er medicin mod diabetes, der indtages gennem munden.
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Danish: Den primære vurdering af sikkerhed og tolerabilitet blev udført i en planlagt puljet analyse af 13 placebokontrollerede studier af kort varighed (op til 24 uger) med 2.360 forsøgspersoner behandlet med dapagliflozin 10 mg, og 2.295 behandlet med placebo.
English: 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Danish: 14, 28, 56 og 60 filmovertrukne tabletter i ikke-perforerede blistere.
English: 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: Eksponeringen for dapagliflozin øgedes proportionalt med stigningen i dapagliflozindosis i området fra 0,1 til 500 mg, og dets farmakokinetik ændredes ikke over tid ved gentagen daglig dosering i op til 24 uger.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 mL/min.
Danish: Den gennemsnitlige totale systemiske clearance af dapagliflozin indgivet intravenøst var 207 ml/min.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund er nedsat pH i blodet (< 7,35), forhøjet laktatniveau i blodet (> 5 mmol/l) samt øget anion-gap og laktat/pyruvat-ratio.
English: BLISTERS (NON-PERFORATED)
Danish: BLISTERE (IKKE PERFOREREDE)
English: No additional adverse reactions were identified for the dapagliflozin plus metformin group compared with those reported for the individual components.
Danish: Der blev ikke identificeret nogen yderligere bivirkninger for gruppen, som fik dapagliflozin plus metformin sammenlignet med dem, som blev rapporteret for de individuelle studier.
English: Xigduo should not be initiated in patients with GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see section 4.2).
Danish: Xigduo bør ikke initieres hos patienter med GFR under 60 ml/min og skal seponeres ved GFR, der vedvarende er under 45 ml/min (se pkt.
English: Change in clinical status of patients with previously controlled type 2 diabetes As this medicinal product contains metformin, a patient with type 2 diabetes previously well-controlled on it who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Danish: Ændring i klinisk status hos patienter med tidligere kontrolleret type 2-diabetes Da dette lægemiddel indeholder metformin, skal en patient med type 2-diabetes, der tidligere har været velkontrolleret på det, og som udvikler laboratorieanomalier eller klinisk sygdom (især uklar og dårligt defineret sygdom) straks vurderes for tegn på ketoacidose eller laktatacidose.
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 ubetydelig vej til clearance hos mennesker.
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP-glucuronosyltransferase 1A9 (UGT1A9).
Danish: Dapagliflozins metabolisme foregår primært via glukuronidkonjugering medieret af UDP-glukuronyltransferase 1A9 (UGT1A9).
English: The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively.
Danish: Steady state-udskillelsen af glukose i urinen over 24 timer var stærkt afhængig af nyrefunktionen, og der blev udskilt 85, 52, 18 og 11 g glukose/dag af forsøgspersoner med type 2-diabetes mellitus og normal nyrefunktion eller henholdsvis let, moderat eller svært nedsat nyrefunktion.
English: In in vitro studies, dapagliflozin neither inhibited cytochrome P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, nor induced CYP1A2, CYP2B6 or CYP3A4.
Danish: I in vitro-studier medførte dapagliflozin hverken hæmning af CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 eller induktion af CYP1A2, CYP2B6 eller CYP3A4.
English: Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
Danish: Ældre patienter har større sandsynlighed for at få nedsat nyrefunktion og/eller for at være i behandling med antihypertensiva, der kan medføre ændringer i nyrefunktionen, såsom ACE-hæmmere og angiotensin-II type 1-receptorblokkere (ARB).
English: Xigduo combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.
Danish: Xigduo kombinerer to antihyperglykæmiske lægemidler med forskellige og komplementære virkningsmekanismer for at forbedre glykæmisk kontrol hos patienter med type 2-diabetes: dapagliflozin, en SGLT2-hæmmer og metforminhydrochlorid, et medlem af biguanidgruppen.
English: The pack sizes are 14, 28, 56 and 60 film-coated tablets in non-perforated blisters, 60x1 film-coated tablets in perforated unit dose blisters and multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelserne er 14, 28, 56 og 60 filmovertrukne tabletter i ikke-perforerede blistere, 60x1 filmovertrukne tabletter i perforerede enkeltdosisblistere og multipakning indeholdende 196 (2 pakninger a 98) filmovertrukne tabletter i ikke-perforerede blistere.
English: Vulvovaginal pruritus Pruritus genital
Danish: Vulvovaginal pruritus** Genital pruritus
English: Dapagliflozin should not be initiated.
Danish: Dapagliflozin må ikke initieres.
English: In a juvenile toxicity study, when dapagliflozin was dosed directly to young rats from postnatal day 21 until postnatal day 90, renal pelvic and tubular dilatations were reported at all dose levels; pup exposures at the lowest dose tested were ≥ 15 times the maximum recommended human dose.
Danish: I et toksicitetsstudie for unge rotter, hvor de unge rotter blev behandlet direkte med dapagliflozin fra postnatal dag 21 indtil postnatal dag 90, blev der rapporteret dilatationer af nyrebækken og -tubuli ved alle dosisniveauer; ungernes eksponering ved den lavest testede dosis var ≥ 15 gange den maksimalt anbefalede humane dosis.
English: These are signs of a severe infection of the urinary tract: - fever and/or chills - burning sensation when passing water (urinating) - pain in your back or side.
Danish: Følgende er tegn på en alvorlig urinvejsinfektion: - feber og/eller kulderystelser - brændende fornemmelse ved vandladning - smerter i ryggen eller siden.
English: Liver function disorders Hepatitis
Danish: Forstyrrelser i leverfunktionen Hepatitis
English: Adverse reactions related to increased creatinine were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Danish: Bivirkninger, relateret til øget kreatinin blev grupperet (f.eks. nedsat renal kreatininclearance, nedsat nyrefunktion, øget kreatinin i blodet og nedsat glomerulær filtrationshastighed).
English: Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks.
Danish: Der blev udskilt ca. 70 g glukose i urinen pr. dag (svarende til 280 kcal/dag) ved en dosis dapagliflozin på 10 mg/dag hos forsøgspersoner med type 2-diabetes mellitus i 12 uger.
English: Taking it with other medicines that lower the amount of sugar in your blood, such as insulin or a “sulphonylurea” medicine, can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as weakness, dizziness, increased sweating, fast heart beat, change in vision or difficulties concentrating, and may affect your ability to drive and use machines.
Danish: Hvis du tager det sammen med andre lægemidler, der nedsætter mængden af sukker i dit blod, f.eks. insulin eller et ”sulfonylurinstof”, kan dit blodsukker blive for lavt (hypoglykæmi), hvilket kan give symptomer såsom svaghed, svimmelhed, øget svedudbrud, hurtig hjerterytme, synspåvirkning eller koncentrationsbesvær og kan påvirke din evne til at færdes i trafikken eller betjene maskiner.
English: In addition, dapagliflozin reduced the new onset of sustained albuminuria (hazard ratio 0.79 [95% CI 0.72, 0.87]) and led to greater regression of macroalbuminuria (hazard ratio 1.82 [95% CI 1.51, 2.20]) compared with placebo.
Danish: I tillæg reducerede dapagliflozin den nye indtræden af vedvarende albuminuri (hazard ratio 0,79 [95% CI 0,72, 0,87]) og førte til større regression af makroalbuminuri (hazard ratio 1,82 [95% CI 1,51, 2,20]) sammenlignet med placebo.
English: Your doctor may prescribe this medicine together with other medicine(s) to lower the amount of sugar in your blood.
Danish: Din læge kan ordinere dette lægemiddel sammen med et eller flere andre lægemidler for at sænke sukkerindholdet i blodet.
English: In case of intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit and electrolytes) is recommended.
Danish: I tilfælde af tilstødende lidelser, der kan føre til volumendepletering (f.eks. mave-tarm-sygdom), monitoreres nøje for væskestatus (f.eks. objektiv undersøgelse, blodtryksmålinger, laboratorieprøver inklusive hæmatokrit og elektrolytter).
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Danish: Halvtreds procent af forsøgspersonerne tog insulin som monoterapi ved baseline; 50 % tog 1 eller 2 orale glukosesænkende lægemidler i tilgift til insulin: i denne sidste gruppe tog 80 % kun metformin, 12 % tog metformin plus sulfonylurinstofbehandling, og resten tog andre orale glukosesænkende lægemidler.
English: Avoid excessive alcohol intake while taking Xigduo since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Xigduo, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: High overdose or concomitant risks of metformin may lead to lactic acidosis.
Danish: Høj overdosering eller samtidige risici med metformin kan føre til laktatacidose.
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4).
Danish: Monitorering af nyrefunktionen er nødvendig for at forhindre metformin-associeret laktatacidose, specielt hos ældre patienter (se pkt.
English: In clinical studies where once daily doses of up to 100 mg (10 times the maximum recommended human dose) were administered for 2 weeks in healthy subjects and type 2 diabetes subjects, the incidence of hypoglycaemia was slightly higher than placebo and was not dose-related.
Danish: I kliniske studier, hvor doser én gang dagligt på op til 100 mg (10 gange den maksimale anbefalede humane dosis) blev indgivet til raske forsøgspersoner og forsøgspersoner med type 2-diabetes i 2 uger, var hyppigheden af hypoglykæmi en anelse højere end ved placebo og var ikke dosisrelateret.
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with dapagliflozin.
Danish: Der er blevet observeret forbedring i homeostasemodelvurdering for betacellefunktion (HOMA-betacelle) i kliniske studier med dapagliflozin.
English: Other medicines and Xigduo
Danish: Brug af anden medicin sammen med Xigduo
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 itype 2-diabetes mellitus-populationen (se pkt.
English: Maximum total daily dose is 10 mg.
Danish: Maksimal, total daglig dosis er 10 mg.
English: Vulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
Danish: Vulvovaginitis, balanitis og relaterede genitale infektioner omfatter f.eks. de foruddefinerede foretrukne termer: vulvovaginal mykotisk infektion, vaginal infektion, balanitis, genital svampeinfektion, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infektion, genital infektion hos mænd, penisinfektion, vulvitis, bakterieinfektion i skeden, vulva-absces.
English: Dapagliflozin 5 mg twice daily provided statistically significant reductions in HbA1c at 16 weeks compared with subjects receiving placebo (p < 0.0001; Table 4).
Danish: Dapagliflozin 5 mg to gange dagligt gav statistisk signifikant reduktion i HbA1c efter 16 uger sammenlignet med forsøgspersoner, der fik placebo (p < 0,0001; Tabel 4).
English: This medicinal product may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Danish: Dette lægemiddel kan øge den diuretiske virkning fra thiazid og loop-diuretika, hvilket kan øge risikoen for dehydrering og hypotension (se pkt.
English: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Danish: Dapagliflozin metaboliseres i udstrakt grad, primært til dapagliflozin 3-O-glukuronid, som er en inaktiv metabolit.
English: If you take more Xigduo tablets than you should, you may experience lactic acidosis.
Danish: Hvis du har taget flere Xigduo-tabletter end du skulle, kan du få laktatacidose.