FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the population pharmacokinetic analysis, the apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 l/hour.
Danish: Baseret på den farmakokinetiske populationsanalyse blev den tilsyneladende terminale halveringstid for elimination anslået til at være 12,4 timer, og tilsyneladende oral clearance var 10,6 l/time.
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%,
Danish: Variabiliteten mellem patienter og restvariabiliteten for oral clearance af empagliflozin var henholdsvis 39,1 % og 35,8 %.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertiliteten (se pkt.
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent on blood glucose concentration and GFR.
Danish: Mængden af glucose, der fjernes af nyrerne gennem denne glukuretiske mekanisme, afhænger af blodglucosekoncentrationen og GFR.
English: Patients (%)
Danish: Patienter (%), der opnåede
English: If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Danish: Hvis du har type 2-diabetes, danner din bugspytkirtel ikke insulin nok til at kontrollere dit blodsukker, og din krop kan ikke udnytte sin egen insulin effektivt.
English: • Swallow the tablet whole with water
Danish: • Synk tabletten hel med vand.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter, skal du kontakte lægen, før du tager dette lægemiddel.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret på følgende måde: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with drugs that are P-gp substrates.
Danish: Baseret på in vitro-studier betragtes det som usandsynligt, at empagliflozin forårsager interaktioner med lægemidler, der er P-gp-substrater.
English: Dehydration, seen uncommonly (may affect up to 1 in 100 people) The signs of dehydration are not specific, but may include:
Danish: Dehydrering er en ikke almindelig bivirkning (kan forekomme hos op til 1 ud af 100 brugere) Tegnene på dehydrering er ikke specifikke, men kan omfatte:
English: Difference from glimepiride1 (97.5% CI)
Danish: Forskel fra glimepirid1 (97,5 % CI)
English: The relevance of this finding to humans is unclear.
Danish: Relevansen af dette fund for mennesker er uvis.
English: The majority of drug-related radioactivity recovered in faeces was unchanged parent drug and approximately half of drug related radioactivity excreted in urine was unchanged parent drug.
Danish: Hovedparten af den lægemiddelrelaterede radioaktivitet, der blev genfundet i fæces, var uforandret lægemiddelstof og ca. halvdelen af den lægemiddelrelaterede radioaktivitet, der blev genfundet i urin, var uforandret lægemiddelstof.
English: The frequency of reported nocturia was similar for placebo and empagliflozin (<1%).
Danish: Hyppigheden af indberettet nocturi var den samme for placebo og empagliflozin (<1 %).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel og under behandlingen:
English: • if you have a serious infection of the kidney or the urinary tract with fever.
Danish: • hvis du har en alvorlig nyre- eller urinvejsinfektion med feber.
English: Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development.
Danish: Dyrestudier viser, at empagliflozin passerer placenta sent i graviditeten i meget begrænset omfang, men indikerer hverken direkte eller indirekte skadelige virkninger hvad angår den tidlige fosterudvikling.
English: Jardiance should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Jardiance bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Empagliflozin administered during the period of organogenesis was not teratogenic.
Danish: Empagliflozin administreret under organogenesen var ikke teratogent.
English: No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O glucuronide).
Danish: Der blev ikke påvist nogen større metabolitter af empagliflozin i humant plasma, og de hyppigste metabolitter var tre glucuronidkonjugater (2-, 3- og 6-O-glucuronid).
English: If you stop taking Jardiance
Danish: Hvis du holder op med at tage Jardiance
English: Co-medication with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Danish: Samtidig medicinering med kendte UGT-enzym-induktorer bør undgås på grund af en potentiel risiko for nedsat virkning.
English: The tablet is 11.1 mm long and has a width of 5.6 mm.
Danish: Tabletterne er 11,1 mm lange og 5,6 mm brede.
English: No such effect was seen at systemic exposure equal to the maximal clinical exposure to empagliflozin.
Danish: En sådan virkning blev ikke observeret ved en systemisk eksponering lig med den maksimale kliniske eksponering for empagliflozin.
English: However, temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Danish: Midlertidig afbrydelse af empagliflozin skal dog overvejes hos patienter med komplicerede urinvejsinfektioner.
English: Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden empagliflozin-behandling påbegyndes, skal der tages højde for faktorer i patientens sygehistorie, som kan prædisponere for ketoacidose.
English: • If it is less than 12 hours until your next dose, skip the missed dose.
Danish: • Hvis der er mindre end 12 timer til næste dosis, så spring den glemte dosis over.
English: Increased urinary glucose excretion was maintained at the end of the 4-week treatment period, averaging approximately 78 g/day.
Danish: Den øgede udskillelse af glucose i urinen var opretholdt ved afslutningen af den 4 uger lange behandlingsperiode og var gennemsnitligt 78 g/dag.
English: Body Mass Index
Danish: Body Mass Index (BMI)
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Danish: Det er, som det dominerende transportprotein, ansvarligt for reabsorption af glucose fra glomerulusfiltratet til cirkulationen.
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 ** p-værdi <0,0001
English: The glucosuria observed with empagliflozin is accompanied by mild diuresis which may contribute to sustained and moderate reduction of blood pressure.
Danish: Den glucosuri, der er observeret med empagliflozin, er ledsaget af mild diurese, som kan bidrage til en vedvarende og moderat blodtryksreduktion.
English: This may occur regardless of blood glucose level.
Danish: Disse symptomer kan forekomme uanset blodsukkerniveau.
English: Hypoglycaemia (when used with sulphonylurea or insulin)a
Danish: Hypoglykæmi (ved anvendelse sammen med sulfonylurinstof eller insulin)a
English: The tablets are 9.1 mm in diameter.
Danish: Tabletternes diameter er 9,1 mm.
English: Temporary interruption of treatment with empagliflozin should be considered until the fluid loss is corrected.
Danish: Midlertidig afbrydelse af behandlingen med empagliflozin, indtil væsketabet er korrigeret, skal overvejes.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Jardiance.
English: The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food.
Danish: Den observerede virkning af mad på empagliflozins farmakokinetik blev ikke betragtet som værende klinisk relevant, og empagliflozin kan administreres med eller uden mad.
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 fremstod tilstanden atypisk med kun moderat forhøjet blodglucose, under 14 mmol/l (250 mg/dl).
English: If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice.
Danish: Hvis du får symptomer på for lavt blodsukker, skal du spise druesukker eller et sukkerrigt mellemmåltid eller drikke frugtjuice.
English: The maximum daily dose is 25 mg (see below and section 4.4).
Danish: Den højeste daglige dosis er 25 mg (se nedenfor og pkt.
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 efter EXP på blister og efter Anvendes inden på pakning.
English: Furthermore, empagliflozin resulted in a reduction in FPG, body weight, and blood pressure.
Danish: Desuden medførte empagliflozin et fald i FPG, kropsvægt og blodtryk.
English: Risk for volume depletion
Danish: Risiko for volumendepletering
English: Uncommon • straining or pain when emptying the bladder
Danish: Ikke almindeligt forekomne • anstrengelse eller smerte ved tømning af blæren
English: Patients aged 75 years and older may be at an increased risk of volume depletion.
Danish: Patienter på 75 år og derover kan have forhøjet risiko for volumendepletering.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
Danish: Din læge vil måske sænke din dosis af disse lægemidler for at forhindre, at dit blodsukker bliver for lavt (hypoglykæmi).
English: Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies.
Danish: Hypoglykæmi Hyppigheden af hypoglykæmi afhang af baggrundsbehandlingen i de respektive studier.
English: Possible signs are listed in section 4, ‘Possible side effects' under ‘dehydration'.
Danish: Tegn på dehydrering er anført i afsnit 4, ‘Bivirkninger' under ‘dehydrering'.
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Danish: Højere baseline-HbA1c var forbundet med en større reduktion i HbA1c.relevante
English: In 5 placebo-controlled trials of 18 to 24 weeks duration, 2,971 patients were included of which 995 were treated with placebo and 1,976 with empagliflozin.
Danish: I 5 placebokontrollerede studier af 18 op til 24 uger inkluderedes 2.971 patienter, hvor af 995 blev behandlet med placebo og 1.976 med empagliflozin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters (perforated)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blistere (perforerede)
English: What you need to know before you take Jardiance 3.
Danish: Det skal du vide, før du begynder at tage Jardiance 3.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, fertilitet og tidlig fosterudvikling.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Jardiance in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Jardiance i en eller flere undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Following administration of an oral [14C]-empagliflozin solution to healthy volunteers, approximately 96% of the drug-related radioactivity was eliminated in faeces (41%) or urine (54%).
Danish: Efter administration af en oral dosis [14C]-empagliflozin til raske frivillige blev ca. 96 % af den lægemiddelrelaterede radioaktivitet udskilt i fæces (41 %) eller urin (54 %).
English: Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Danish: Brug ikke dette lægemiddel, hvis pakningen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: These symptoms could be a sign of “diabetic ketoacidosis” - a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Disse symptomer kan være tegn på diabetisk ketoacidose - en komplikation, du kan få ved diabetes som følge af forhøjet niveau af ketonstoffer i urinen eller blodet, målt ved laboratorieanalyser.
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
Danish: Ved eksponeringer, der i tilstrækkelig grad oversteg eksponeringen hos mennesker efter terapeutiske doser, havde empagliflozin ingen utilsigtede virkninger på fertilitet eller tidlig fosterudvikling.
English: • Jardiance can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
Danish: • Jardiance kan bruges som det eneste diabetesmedicin hos patienter, der ikke tåler metformin (en anden diabetesmedicin).
English: • Jardiance is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
Danish: • Jardiance bruges til at behandle voksne patienter med type 2-diabetes (18 år og derover), når diæt og motion alene ikke er tilstrækkelig.
English: • if you are 75 years old or older, as increased passing of urine due to the medicine may affect fluid balance in your body and increase your risk of dehydration.
Danish: • hvis du er 75 år gammel eller derover, da medicinen øger urinafgang og kan øge din risiko for dehydrering.
English: During the initial 18 weeks the insulin dose was kept stable, but was adjusted to achieve a FPG <110 mg/dl in the following 60 weeks.
Danish: Under de første 18 uger blev insulindosen holdt stabil, mens den i de følgende 60 uger blev justeret for at opnå et FPG <110 mg/dl.
English: It is not known if DKA is more likely to occur with higher doses of empagliflozin.
Danish: Det vides ikke, om der er større sandsynlighed for diabetisk ketoacidose ved højere doser af empagliflozin.
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Hydroxypropylcellulose Croscarmellosenatrium Kolloid vandfri silica Magnesiumstearat
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Danish: Når diæt og motion alene ikke giver tilstrækkelig glykæmisk kontrol og metformin ikke betragtes som hensigtsmæssigt på grund af intolerance.
English: What Jardiance contains - The active substance is empagliflozin.
Danish: Jardiance indeholder: - Aktivt stof: Empagliflozin.
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Danish: Empagliflozin er en reversibel, yderst potent (IC50 på 1,3 nmol) og selektiv kompetitiv hæmmer af natrium-glucose-co-transporter 2 (SGLT2).
English: It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.
Danish: Det er vigtigt, at du fortsætter med din diæt- og motionsplan, som din læge, apotekspersonalet eller sundhedspersonalet har anvist.
English: SGLT2 is highly expressed in the kidney, whereas expression in other tissues is absent or very low.
Danish: SGLT2 er i stort omfang udbredt i nyrerne, modsat i andre væv hvor udbredelsen er ikke-eksisterende eller meget lav.
English: By blocking this protein, the medicine causes glucose (blood sugar), to be removed via the urine and blood glucose levels, which are too high because of your type 2 diabetes, are thereby reduced.
Danish: Når medicinen blokerer dette protein fjernes glucose (blodsukker) i højere grad via urinen og blodsukkertallet som er for højt på grund af din type 2-diabetes, sænkes.
English: Jardiance contains the active substance empagliflozin which works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: Jardiance indeholder det aktive stof empagliflozin, som virker ved at blokere et protein i nyrerne, der hedder natrium-glucose-co-transporter 2 (SGLT2).
English: With once-daily dosing, steady-state plasma concentrations of empagliflozin were reached by the fifth dose.
Danish: Ved dosering en gang dagligt blev steady state med hensyn til plasmakoncentrationer af empagliflozin nået efter den femte dosis.
English: Only at maternally toxic doses, empagliflozin also caused bent limb bones in the rat and increased embryofetal loss in the rabbit.
Danish: Kun ved maternelt toksiske doser forårsagede empagliflozin også bøjede knogler i ekstremiteter hos rotter og øget embryoføtalt tab hos kaniner.
English: Empagliflozin as add on to basal insulin
Danish: Empagliflozin som supplement til basal insulin
English: The male mouse renal tumours are considered not relevant to humans.
Danish: Hanmusenes nyretumorer betragtes ikke som værende relevante for mennesker.
English: Consistent with the half-life, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state.
Danish: I overensstemmelse med halveringstiden blev der observeret 22 % akkumulering med hensyn til plasma-AUC i steady state.
English: Following administration of an oral [14C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Danish: Efter administration af en oral [14C]-empagliflozinopløsning til raske frivillige var fordelingen til røde blodceller ca. 37 % og plasmaproteinbindingen var 86 %.
English: Body weight
Danish: Kropsvægt
English: The genital tract infections were mild or moderate in intensity.
Danish: Disse genitale infektioner var af mild eller moderat intensitet.
English: After oral administration, empagliflozin was rapidly absorbed with peak plasma concentrations occurring at a median tmax of 1.5 hours post-dose.
Danish: Efter oral administration absorberedes empagliflozin hurtigt, og peakplasmakoncentrationer forekom med en median tmax på 1,5 time efter dosering.
English: No studies on the effect on human fertility have been conducted for Jardiance.
Danish: Der er ikke gennemført undersøgelser af Jardiances virkning på human fertilitet.
English: Jardiance has minor influence on the ability to drive and use machines.
Danish: Jardiance påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: (95% CI) 24 hour DBP at week 123
Danish: (95 % CI) 24 timers DBP ved uge 123
English: (95% CI) 24 hour SBP at week 123
Danish: (95 % CI) 24 timers SBP ved uge 123
English: Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid.
Danish: Din læge vil måske sige, at du skal holde op med at tage Jardiance, indtil du er blevet rask, for at forhindre at du mister for meget kropsvæske.
English: Body Weight (kg)
Danish: Kropsvægt (kg)
English: Body Weight (kg) at week 522
Danish: Kropsvægt (kg) ved uge 522
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away.
Danish: • hvis du oplever hurtigt vægttab, kvalme eller opkastning, mavesmerter, udtalt tørst, hurtig og dyb vejrtrækning, forvirring, usædvanlig søvnighed eller træthed, din ånde lugter sødligt, en sød eller metallisk smag i munden eller en unormal lugt fra din urin eller sved, skal du straks kontakte en læge eller det nærmeste hospital.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not OAT1 and OCT2.
Danish: Empagliflozin er et substrat for de humane optagtransportere OAT3, OATP1B1 og OATP1B3, men ikke OAT1 og OCT2.
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 glucosetransportproteiner med betydning for transport af glucose ind i perifere væv og er 5000 gange mere selektiv for SGLT2 end for SGLT1, det vigtigste transportprotein med ansvar for absorption af glucose i tarmen.
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 øges udskillelsen af glucose i urinen øjeblikkeligt efter første dosis empagliflozin og er vedvarende over det 24 timer lange doseringsinterval.
English: Jardiance 10 mg film-coated tablets EU/1/14/930/010
Danish: Jardiance 10 mg filmovertrukne tabletter EU/1/14/930/010
English: The population pharmacokinetic analysis showed that the apparent oral clearance of empagliflozin decreased with a decrease in eGFR leading to an increase in drug exposure.
Danish: Den farmakokinetiske populationsanalyse viste, at oralt administreret empagliflozins tilsyneladende clearance faldt med et fald i eGFR, der førte til øget lægemiddeleksponering.
English: Similar to placebo, urinary tract infection was reported more frequently for empagliflozin in patients with a history of chronic or recurrent urinary tract infections.
Danish: Ligesom for placebo blev urinvejsinfektion indberettet hyppigere for empagliflozin hos patienter med kronisk eller recidiverende urinvejsinfektion i anamnesen.
English: Available toxicological data in animals have shown excretion of empagliflozin in milk.
Danish: De tilgængelige toksikologiske data fra dyrestudier viser, at empagliflozin udskilles i mælk.
English: Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
Danish: Urinvejsinfektion er en almindelig bivirkning (kan forekomme hos op til 1 ud af 10 brugere) Tegnene på urinvejsinfektion er:
English: Jardiance 25 mg film-coated tablets EU/1/14/930/001
Danish: Jardiance 25 mg filmovertrukne tabletter EU/1/14/930/001
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infectiona Urinary tract infectiona
Danish: Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infektionera Urinvejsinfektiona