FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor before taking this medicine if you would like to breast-feed or you are breast-feeding your baby.
Danish: Tal med din læge, før du tager dette lægemiddel, hvis du ammer eller ønsker at amme dit barn.
English: Switching to Qtrilmet
Danish: Skift til Qtrilmet
English: Modified-release tablet (tablet).
Danish: Depottablet (tablet).
English: In particular, talk to your doctor before taking Qtrilmet if you are taking any of the following medicines:
Danish: Det er især vigtigt, at du taler med din læge, inden du tager Qtrilmet, hvis du tager nogle af følgende lægemidler:
English: Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP-4 inhibitor.
Danish: Patienterne oplevede lindring af symptomerne efter seponering af lægemidlet, og nogle oplevede, at symptomerne vendte tilbage, når behandling med den samme eller en anden DPP-4
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er i det væsentlige natriumfrit.
English: Your doctor may decide to temporarily or permanently stop your treatment with Qtrilmet.
Danish: Lægen kan beslutte at stoppe behandlingen med Qtrilmet midlertidigt eller permanent.
English: Metformin hydrochloride: Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analysed according to gender (males=19, females=16).
Danish: Metforminhydrochlorid: Metformins farmakokinetiske parametre varierede ikke signifikant mellem raske personer og patienter med type 2-diabetes, når de blev analyseret efter køn (mænd = 19, kvinder = 16).
English: Elderly patients are more likely to have impaired renal function, and may be at a greater risk for volume depletion.
Danish: Ældre patienter har større sandsynlighed for at få nedsat nyrefunktion og kan have en større risiko for volumendepletering.
English: The efficacy and safety profiles of Qtrilmet in these patients have not been established.
Danish: Qtrilmets effekt og sikkerhedsprofil er ikke klarlagt hos disse patienter.
English: Administration with a high-fat meal decreases dapagliflozin Cmax by up to 50% and prolonged Tmax by approximately 1 hour, but does not alter AUC as compared with the fasted state.
Danish: Administration med et fedtholdigt måltid nedsætter dapagliflozin Cmax med op til 50 % og forlænget Tmax med ca. 1 time, men ændrer ikke AUC sammenlignet med fastende tilstand.
English: Metformin: Following a single oral dose of metformin extended-release tablet, Cmax is achieved with a median value of 7 hours and a range of 4 to 8 hours.
Danish: Metformin: Efter en enkelt oral dosis af metformin tablet med forlænget frigivelse, opnås Cmax med en medianværdi på 7 timer og et interval på 4 til 8 timer.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: It is important to check your feet regularly - and follow the advice on foot care from your health care professional.
Danish: Det er vigtigt, at du får kontrolleret din fødder regelmæssigt, og at du overholder rådgivningen om fodpleje, som du har fået af lægen eller sygeplejersken.
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 følgevirkninger er rapporteret hos alle arter testet ved eksponeringer begyndende ved 7 gange RHD.
English: The NOAEL for developmental toxicity is 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: In type 1 diabetes mellitus studies with dapagliflozin, DKA was reported with common frequency.
Danish: I type 1-diabetes mellitus-studier med dapagliflozin blev DKA rapporteret med hyppigheden ”almindelig”.
English: HbA1c change from baseline at week 24 excluding data after rescue for randomised subjects - studies MB102129 and CV181168
Danish: HbA1c-ændring fra baseline ved uge 24, eksklusive data efter nødmedicin for randomiserede forsøgspersoner - studie MB102129 og CV181168
English: 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: Overvågning af glykæmisk kontrol med 1,5-AG-analyse anbefales ikke, da målinger af 1,5-AG er upålidelige ved vurdering af glykæmisk kontrol hos patienter, der tager SGLT2-hæmmere.
English: Also, it may be dangerous to drive or use machines if your blood sugar levels fall too low (hypoglycaemia), which can cause shaking, sweating, fast heartbeat, change in vision, headache and confusion.
Danish: Det kan også være farligt at køre bil eller benytte maskiner, hvis dit blodsukker bliver for lavt (hypoglykæmi), hvilket kan give rysten, sveden, hurtig hjerterytme, synsændringer, hovedpine og forvirring.
English: Cardiovascular death, MI, and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Danish: Kardiovaskulær død, MI og slagtilfælde blev observeret med en hazard ratio på 0,77 (95 % CI: 0,54, 1,10).
English: If a daily dose is missed and it is ≥ 12 hours until the next dose, the dose should be taken.
Danish: Hvis en daglig dosis glemmes, og der er ≥ 12 timer til næste dosis, skal dosen tages.
English: Metformin passes into breast milk in small amounts.
Danish: Metformin passerer over i modermælk i små mængder.
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 plasma DPP 4-aktivitetsinhibering over et dosisinterval blev ikke påvirket af rifampicin (se pkt.
English: If you are already taking metformin, saxagliptin and dapagliflozin as single tablets or saxagliptin and dapagliflozin as a combination together with metformin, your doctor may ask you to switch to this medicine so you only need to take one tablet.
Danish: Hvis du allerede tager metformin, saxagliptin og dapagliflozin som særskilte tabletter eller saxagliptin og dapagliflozin som en kombination sammen med metformin, kan lægen bede dig om at skifte til dette lægemiddel, så du kun behøver at tage én tablet.
English: Qtrilmet is not expected to affect you being able to drive a car or use any tools or machines.
Danish: Qtrilmet forventes ikke at påvirke din evne til at køre bil eller benytte værktøj eller maskiner.
English: if you have risk factors for developing heart failure, such as problems with your kidneys.
Danish: - hvis du har risikofaktorer for at udvikle hjertesvigt, såsom nyreproblemer.
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: Qtrilmet must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Danish: Behandling med Qtrilmet skal afbrydes på tidspunktet for kirurgi under generel, spinal eller epidural anæstesi.
English: Erectile dysfunction pruritus genital vulvovaginal
Danish: Erektil dysfunktion genital pruritus vulvovaginal pruritus
English: Metformin: At steady state, the AUC and Cmax are less than dose proportional for metformin extended-release within the range of 500 to 2,000 mg administered once daily.
Danish: Metformin: Ved steady state er AUC og Cmax mindre end dosisproportionale for metformin med forlænget frigivelse i intervallet 500 til 2.000 mg administreret én gang dagligt.
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 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: Gastrointestinal symptoms (subsumed terms included nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite) occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Gastrointestinale symptomer (omfatter kvalme, opkastning, diarré, abdominalsmerter og appetitløshed) forekommer hyppigst under initiering af behandling og løses spontant i de fleste tilfælde.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Danish: * LRM = Longitudinalt gentagne målinger (ved brug af værdier før nødmedicin).
English: These may be symptoms of another rare, but very serious, sometimes life-threatening condition called diabetic ketoacidosis.
Danish: Dette kan være symptomer på en anden sjælden, men meget alvorlig og til tider livstruende, tilstand, der kaldes diabetisk ketoacidose.
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: This leads to a high level of sugar (glucose) in your blood.
Danish: Det fører til forhøjet blodsukker (glucose).
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-blodglucosekoncentrationerne.
English: Follow the recommendations for skin care from your doctor or nurse.
Danish: Følg de anbefalinger for hudpleje, som din læge eller sygeplejerske har givet dig.
English: Metformin partitions into erythrocytes.
Danish: Metformin fordeler sig til erytrocytterne.
English: Non-clinical studies of either metformin, saxagliptin or dapagliflozin revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity or carcinogenicity.
Danish: Hverken non-kliniske studier af metformin, saxagliptin eller dapagliflozin viser nogen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
English: In addition, patients should be alerted to the risk of hypoglycaemia when this medicinal product is used in combination with other glucose-lowering medicinal products known to cause hypoglycaemia (e.g. insulin and sulphonylureas).
Danish: Derudover skal patienterne være opmærksomme på risikoen for hypoglykæmi, når dette lægemiddel anvendes i kombination med andre glucosesænkende lægemidler, der vides at forårsage hypoglykæmi (for eksempel insulin og sulfonylurinstoffer).
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 [f.eks. angiotensinkonverterende enzymhæmmere (ACE-hæmmere) og angiotensin II type 1receptorblokkere (ARB)].
English: Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) if used with other diabetes medicines which cause hypoglycaemia.
Danish: - Lavt blodsukker (hypoglykæmi), meget almindelig (kan forekomme hos flere end 1 ud af 10 personer), hvis medicinen anvendes sammen med andre diabeteslægemidler, som vides at forårsage hypoglykæmi.
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 på over 5 mmol/l samt øget anion-gap og laktat/pyruvat-ratio.
English: Carmellose sodium (E466) Crospovidone (E1202) Hypromellose (E464) Lactose
Danish: Carmellosenatrium (E466) Crospovidon (E1202) Hypromellose (E464) Lactose
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD25.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodglucosesænkende lægemidler, ATC-kode: A10BD25.
English: However, subjects on saxagliptin with a history of heart failure or impaired renal function at baseline were not at an increased risk relative to placebo for the primary or secondary composite endpoints or all-cause mortality.
Danish: Forsøgspersoner i saxagliptingruppen, som havde hjertesvigt eller nedsat nyrefunktion i anamnesen ved baseline, havde imidlertid ikke en øget risiko i forhold til placebo for de primære og sekundære sammensatte endepunkter eller totalmortalitet.
English: Animal studies have shown excretion of saxagliptin and/or metabolite in milk.
Danish: Dyreforsøg har vist udskillelse af saxagliptin og/eller metabolitten i mælk.
English: Patients on glimepiride/placebo dose were up-titrated starting at 1 mg per day over 12 weeks to optimal glycaemic effect (FPG < 6.1 mmol/L) or the highest tolerable dose.
Danish: Patienterne på glimepirid/placebo-dosis blev optitreret startende med 1 mg dagligt over 12 uger til optimal glykæmisk effekt (FPG <6,1 mmol/l) eller den højest tålelige dosis.
English: Dapagliflozin: Dapagliflozin is approximately 91% protein bound.
Danish: Dapagliflozin: Dapagliflozin er ca. 91 % proteinbundet.
English: These may be symptoms of a very rare, but very serious side effect called lactic acidosis which can occur with Qtrilmet, particularly if your kidneys are not working properly.
Danish: Dette kan være symptomer på en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, der kan opstå med Qtrilmet, især hvis dine nyrer ikke fungerer korrekt.
English: The corresponding plasma Cmax values were 24 ng/mL and 47 ng/mL, respectively.
Danish: Den tilsvarende plasmaCmax var henholdsvis 24 ng/ml og 47 ng/ml.
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Danish: Der blev udført en klinisk metaanalyse af kardiovaskulære hændelser.
English: Food has relatively modest effects on the pharmacokinetics of dapagliflozin in healthy subjects.
Danish: Fødevarer har relativt beskedne virkninger på farmakokinetikken af dapagliflozin hos raske forsøgspersoner.
English: Metformin hydrochloride: Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects.
Danish: Metforminhydrochlorid: Begrænsede data fra kontrollerede farmakokinetiske studier af metformin hos raske, ældre forsøgspersoner tyder på, at total plasma clearance af metformin er nedsat, halveringstiden forlænget, og Cmax er forøget sammenlignet med raske unge forsøgspersoner.
English: Qtrilmet has no or negligible influence on the ability to drive and use machines.
Danish: Qtrilmet påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: There is no experience in clinical trials with dapagliflozin in NYHA class III-IV.
Danish: Der er ingen erfaring fra kliniske studier med dapagliflozin for NYHA-klasse III-IV.
English: The study population included those ≥ 65 years (n = 8,561) and ≥ 75 years (n = 2,330), with normal or mild renal impairment (n = 13,916) as well as moderate (n = 2,240) or severe (n = 336) renal impairment.
Danish: Studiepopulationen inkluderede patienter ≥ 65 år (n=8.561) og ≥ 75 år (n=2.330) med normal eller let nedsat nyrefunktion (n=13.916) samt moderat (n=2.240) eller svært (n=336) nedsat nyrefunktion.
English: Saxagliptin: Saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) in cynomolgus monkeys.
Danish: Saxagliptin: Saxagliptin medførte reversible hudlæsioner (sårskorper, ulcerationer og nekrose) på ekstremiteterne (hale, fingre/tæer, skrotum og/eller næse) hos cynomolgusaber.
English: PA/alu/PVC/alu blister: This medicinal product does not require any special storage conditions.
Danish: PA/alu/PVC/alublister: Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: Lactic acidosis Vitamin B12 deficiency
Danish: Vitamin B12mangel
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 20 mg og simvastatin (et CYP3A4-substrat) resulterede i en stigning på 19 % i simvastatin AUC og en stigning på 31 % i simvastatinsyre AUC.
English: In additional 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 1,191 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: Metformin may act via three mechanisms; by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle, and by delaying intestinal glucose absorption.
Danish: Metformin kan virke via tre mekanismer; ved en reduktion af hepatisk glucoseproduktion ved at hæmme gluconeogenese og glycogenolyse ved svagt at øge insulinfølsomheden, forbedre perifer glucoseoptagelse og udnyttelse i musklerne og ved at forsinke intestinal glucoseabsorption.
English: Avoid excessive alcohol intake while taking Qtrilmet since this may increase the risk of lactic acidosis (see “Warnings and precautions” and “Do not take Qtrilmet if you”).
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Qtrilmet, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler” og "Tag ikke Qtrilmet").
English: Metformin is a biguanide with anti-hyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmiske virkninger, hvilket sænker både basal og postprandial plasmaglucose.
English: The safety and efficacy of the fixed-dose combination of metformin/saxagliptin/dapagliflozin was evaluated in five randomised, double-blind, active/placebo-controlled clinical trials in adult subjects with type 2 diabetes mellitus.
Danish: Sikkerhed og virkning af fastdosis-kombinationen med metformin/saxagliptin/dapagliflozin blev evalueret i fem randomiserede, dobbeltblinde, aktiv/placebokontrollerede kliniske studier med voksne forsøgspersoner med type 2-diabetes mellitus.
English: Contact your doctor as soon as possible if you have any of the following side effects:
Danish: Kontakt lægen hurtigst muligt, hvis du får en af følgende bivirkninger:
English: Metformin is contraindicated in patients with GFR of < 30 mL/min and this treatment should be temporarily interrupted 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: Adverse reaction reported for metformin.
Danish: Bivirkninger rapporteret for metformin.
English: Use with insulin or insulin secretagogues known to cause hypoglycaemia
Danish: Anvendelse sammen med insulin eller insulinsekretionsfremmende midler kendt for at forårsage hypoglykæmi
English: The mean age was 53.8 years and 49.8% of patients were female.
Danish: Den gennemsnitlige alder var 53,8 år, og 49,8 % af patienterne var kvinder.
English: * LRM = Longitudinal repeated measures using values prior to rescue.
Danish: * LRM = Longitudinalt gentagne målinger under anvendelse af værdier før behandling med nødmedicin.
English: If a daily 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 daglig 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: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by uridine diphosphate (UDP) glucuronosyltransferase 1A9 (UGT1A9).
Danish: Metabolismen af dapagliflozin forekommer primært via glucuronidkonjugering medieret af uridindiphosphat (UDP) glucuronosyltransferase 1A9 (UGT1A9).
English: Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Danish: Kontakt straks en læge eller det nærmeste hospital, hvis du får en af følgende bivirkninger:
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: Dannelse af dapagliflozin 3-O-glukuronid medieres af UGT1A9, et enzym, der findes i lever og nyrer, og CYP-medieret metabolisme var en mindre vigtig metaboliseringsvej hos mennesker.
English: No appreciable accumulation of either saxagliptin or its major metabolite was observed with repeated once-daily dosing at any dose level.
Danish: Der er ikke observeret betydelig akkumulering af hverken saxagliptin eller hovedmetabolitten ved gentagne doseringer én gang dagligt på noget dosisniveau.
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: HbA1c (%) at week 24
Danish: HbA1c (%) ved uge 24*
English: Metformin Metformin is excreted unchanged in the urine.
Danish: Metformin Metformin udskilles uændret i urinen.
English: The reported adverse reactions of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of dapagliflozin.
Danish: De rapporterede bivirkninger i form af vulvovaginitis, balanitis og relaterede genitale infektioner fra den samlede sikkerhedsanalyse afspejlede sikkerhedsprofilen for dapagliflozin.
English: The effect in HbA1c observed at week 24 was sustained at week 52.
Danish: Effekten i HbA1c observeret i uge 24 blev opretholdt i uge 52.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Danish: Metformin stimulerer den intracellulære glycogensyntese ved at virke på glycogensyntasen.
English: Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure, such as baseline history of heart failure or impaired renal function.
Danish: Forsøgspersoner med højere risiko for hospitalsindlæggelse pga. hjertesvigt kunne uanset tildeling af behandling identificeres ved kendte risikofaktorer for hjertesvigt såsom baseline-anamnese med hjertesvigt eller nedsat nyrefunktion.
English: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections (see section 4.8).
Danish: Behandling med SGLT2-hæmmere øger risikoen for urinvejsinfektioner (se pkt.