FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
Danish: Den normale startdosis er 10 mg empagliflozin én gang daglig til monoterapi og i kombination med andre glucosesænkende lægemidler, herunder insulin.
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m2.
Danish: I den farmakokinetiske populationsanalyse blev AUC anslået til at være 13,5 % højere hos asiater med et BMI på 25 kg/m2 sammenlignet med ikke-asiater med et BMI på 25 kg/m2.
English: This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.
Danish: Det medfører et for højt sukkerindhold i dit blod, som kan give helbredsproblemer som hjertesygdom, nyresygdom, blindhed og dårligt blodomløb i dine lemmer.
English: The safety and efficacy of empagliflozin in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with type 1 diabetes.
Danish: Empagliflozins sikkerhed og virkning hos patienter med type 1-diabetes er ikke klarlagt, og empagliflozin bør ikke anvendes til patienter med type 1-diabetes.
English: The mode of action for these tumours is dependent on the natural predisposition of the male mouse to renal pathology and a metabolic pathway not reflective of humans.
Danish: Disse tumorers virkningsmekanisme afhænger af hanmusens naturlige disponering for nyrepatologi og en metabolisk signalvej, der ikke afspejler menneskers.
English: N HbA1c (%) at week 121
Danish: N HbA1c (%) ved uge 121
English: Titanium dioxide (E171)
Danish: Filmovertræk Hypromellose Titandioxid (E171) Talcum
English: Change from baseline1
Danish: Ændring fra baseline1
English: The effect of UGT induction on empagliflozin has not been studied.
Danish: Virkningen af UGT-induktion på empagliflozin er ikke undersøgt.
English: Do not take Jardiance: - if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Jardiance - hvis du er allergisk over for empagliflozin eller et af de øvrige indholdsstoffer i Jardiance
English: Body Weight (kg)2
Danish: N Kropsvægt (kg)2
English: The improvement in HbA1c, body weight, and blood pressure was sustained up to 52 weeks.
Danish: Forbedringen i HbA1c, kropsvægt og blodtryk blev bevaret op til 52 uger.
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - 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.
Danish: Diabetisk ketoacidose, ses sjældent (kan forekomme hos op til 1 ud af 1.000 patienter) Følgende symptomer er tegn på diabetisk ketoacidose (se også afsnit 2, 'Advarsler og forsigtighedsregler'): - forhøjet niveau af ketonstoffer i urinen eller blodet - 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.
English: Four studies had treatment durations of 24 weeks; extensions of those and other studies had patients exposed to empagliflozin for up to 102 weeks.
Danish: I forlængelser af disse og andre studier blev patienter eksponeret for empagliflozin i op til 102 uger.
English: It is not known if Jardiance passes into human breast milk.
Danish: Det vides ikke, om Jardiance går over i modermælken.
English: 2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure
Danish: 2 Ikke evalueret med hensyn til statistisk signifikans på grund af den sekventielt bekræftende testprocedure
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 stemte for det meste overens med sekundær farmakologi med relation til tab af glucose via urin og elektrolytubalancer, herunder nedsat kropsvægt og kropsfedt, øget fødeindtagelse, diarré, dehydrering, nedsat serumglucose og stigninger i andre serumparametre, der afspejler øget proteinmetabolisme og gluconeogenese, urinforandringer som for eksempel polyuri og glucosuri og mikroskopiske forandringer, herunder mineralisering i nyrerne og visse bløddele og vaskulære væv.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Danish: Begrænsede data fra kliniske studier tyder på, at diabetisk ketoacidose optræder med hyppigheden almindelig, når patienter med type 1-diabetes behandles med SGLT2-hæmmere.
English: Placebo Empagliflozin 25 mg eGFR ≥60 to <90 ml/min/1.73 m²
Danish: Placebo Empagliflozin 25 mg eGFR ≥60 til <90 ml/min/1,73 m²
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Danish: Risikoen for diabetisk ketoacidose skal overvejes ved ikke-specifikke symptomer som f.eks. kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, konfusion, usædvanlig træthed eller søvnighed.
English: • shaking, sweating, feeling very anxious or confused, fast heart beat
Danish: • rysteture, svedtendens, ængstelse eller forvirring, hurtig hjerterytme
English: Initiation of empagliflozin therapy in this population is not recommended (see section 4.2).
Danish: Intitiering af behandling med empagliflozin hos denne population anbefales ikke (se pkt.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Danish: I kontrollerede kliniske studier viste enkeltdoser på op til 800 mg empagliflozin (svarende til 32 gange den højeste anbefalede daglige dosis) hos raske frivillige og gentagen administration af daglige doser på op til 100 mg empagliflozin (svarende til 4 gange den højeste anbefalede daglige dosis) hos patienter med type 2-diabetes ingen toksicitet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE PAKNING
English: There were no clinically relevant differences in empagliflozin pharmacokinetics between healthy volunteers and patients with type 2 diabetes.
Danish: Der var ingen klinisk relevante forskelle i empagliflozins farmakokinetik mellem raske frivillige og patienter med type 2-diabetes.
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 filtreres og reabsorberes en større mængde glucose.
English: The mechanism of action of empagliflozin is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Danish: Empagliflozins virkningsmekanisme er uafhængig af beta-cellefunktion og insulinsystemet, og det er medvirkende til, at risikoen for hypoglykæmi er lav.
English: Patients with high baseline HbA1c >10%
Danish: Patienter med højt baseline-HbA1c >10 %
English: Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received empagliflozin in placebo-controlled studies are presented in the table below (Table 1).
Danish: Bivirkninger klassificeret efter systemorganklasse og foretrukken MedDRA-betegnelse, som er indberettet i placebokontrollerede studier, er angivet i nedenstående tabel (tabel 1).
English: Cases of hepatic injury have been reported with empagliflozin in clinical trials.
Danish: Tilfælde af leverskade er blevet rapporteret i kliniske studier.
English: Jardiance contains lactose (milk sugar).
Danish: Jardiance indeholder lactose (mælkesukker).
English: 2856 patients received empagliflozin 10 mg and 3,738 patients received empagliflozin 25 mg for at least 24 weeks and 601 or 881 patients for at least 76 weeks, either alone or in combination with metformin, a sulphonylurea, pioglitazone, DPP-4 inhibitors, or insulin.
Danish: 2.856 patienter fik empagliflozin 10 mg og 3.738 patienter fik empagliflozin 25 mg i mindst 24 uger og 601 henholdsvis 881 patienter i mindst 76 uger, enten alene eller i kombination med metformin, et sulfonylurinstof, pioglitazon, DPP-4-hæmmere eller insulin.
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), cellulose microcrystalline, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Danish: - Øvrige indholdsstoffer: - tabletkerne: lactosemonohydrat (se sidst i afsnit 2 under ‘Jardiance indeholder lactose'), mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmellosenatrium, kolloid vandfri silica, magnesiumstearat - filmovertræk: hypromellose, titandioxid (E171), talcum, macrogol (400), jernoxid gul (E172)
English: In addition it resulted in a clinically meaningful reduction in FPG, systolic and diastolic blood pressure compared to placebo.
Danish: Der sås også klinisk relevante reduktioner i FPG, i systolisk og diastolisk blodtryk sammenlignet med placebo.
English: Co-administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and 14% increase in Cmax of digoxin.
Danish: Samtidig administration af digoxin, et P-gp-substrat, og empagliflozin medførte en 6 % stigning i AUC og en 14 % stigning i Cmax for digoxin.
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: I denne analyse blev AUC anslået til at være henholdsvis 5,82 %, 10,4 % og 17,3 % lavere hos patienter med et BMI på 30, 35 og 45 kg/m2 sammenlignet med patienter med et BMI på 25 kg/m2.
English: Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
Danish: Empagliflozin hæmmer ikke humane optagstransportproteiner som OAT3, OATP1B1 og OATP1B3 in vitro ved klinisk relevante plasmakoncentrationer, og lægemiddel-lægemiddelinteraktioner med substrater for disse optagstransportproteiner betragtes således som usandsynlige.
English: In long term toxicity studies in rodents and dogs, signs of toxicity were observed at exposures greater than or equal to 10-times the clinical dose of empagliflozin.
Danish: I langsigtede toksicitetsstudier hos gnavere og hunde blev der observeret tegn på toksicitet ved eksponeringer, der var større end eller lig med 10 gange den kliniske dosis empagliflozin.
English: A total of 13,076 patients with type 2 diabetes were included in clinical studies to evaluate the safety of empagliflozin.
Danish: I alt 13.076 patienter med type 2-diabetes indgik i kliniske studier.
English: Your doctor may ask you to stop taking Jardiance.
Danish: Din læge vil måske sige, at du skal holde op med at tage Jardiance.
English: The adverse reactions are listed by absolute frequency.
Danish: Bivirkningerne er opdelt efter hyppighed.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Danish: Risikoen for at udvikle diabetisk ketoacidose kan være øget ved længerevarende faste, stort alkoholforbrug, dehydrering, pludselig nedsættelse af insulindosis eller et større behov for insulin på grund af et større kirurgisk indgreb eller alvorlig sygdom.
English: Empagliflozin 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: Empagliflozin kan potensere den diuretiske virkning af thiazid- og loop-diuretika og dermed øge risikoen for dehydrering og hypotension (se pkt.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Danish: • hvis du tager andre lægemidler, der sænker blodsukkeret, som for eksempel insulin eller et
English: A causal relationship between empagliflozin and hepatic injury has not been established.
Danish: Der er ikke fastslået en årsagssammenhæng mellem empagliflozin og leverskade.
English: A total of 11,250 patients with type 2 diabetes were treated in 10 double-blind, placebo- and active-controlled clinical studies, of which 7,015 received empagliflozin (empagliflozin 10 mg: 3021 patients; empagliflozin 25 mg: 3994 patients).
Danish: I alt 11.250 patienter med type 2-diabetes blev behandlet i 10 dobbeltblindede, placebo- og aktivkontrollerede kliniske studier, hvoraf 7.015 fik empagliflozin (empagliflozin 10 mg: 3.021 patienter; empagliflozin 25 mg: 3.994 patienter).
English: How to store Jardiance 6.
Danish: Sådan skal du tage Jardiance 4.
English: • passing more urine than usual or needing to pass urine more often
Danish: • større vandladningsmængde eller hyppigere trang til at lade vandet
English: As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy.
Danish: For en sikkerheds skyld bør Jardiance undgås i graviditeten.
English: Increased urination was mostly mild or moderate in intensity.
Danish: Øget vandladning var for det meste af mild til moderat grad.
English: Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population (see section
Danish: Den kliniske erfaring ved svær nedsat leverfunktion er begrænset, og anvendelse kan derfor ikke anbefales hos denne population (se pkt.
English: Studies characterising the pharmacokinetics of empagliflozin in paediatric patients have not been performed.
Danish: Der er ikke gennemført undersøgelser til karakterisering af empagliflozins farmakokinetik hos pædiatriske patienter.
English: Jardiance should not be used during breast-feeding.
Danish: Jardiance må ikke anvendes under amning.
English: HbA1c (%) at week 522
Danish: HbA1c (%) ved uge 522
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 8).
Danish: Behandling med empagliflozin én gang dagligt medførte en statistisk signifikant forbedring i HbA1c og i 24 timers systolisk og diastolisk middelblodtryk bestemt ved ambulatorisk blodtryksmonitorering (tabel 8).
English: These infections were reported more frequently in females treated with empagliflozin compared to placebo, and the difference in frequency was less pronounced in males.
Danish: Infektionerne blev indberettet hyppigere hos empagliflozinbehandlede kvinder, sammenlignet med placebo, og forskellen i hyppighed var mindre udtalt hos mænd.
English: Increased urinary glucose excretion resulted in an immediate reduction in plasma glucose levels in patients with type 2 diabetes.
Danish: Forhøjet udskillelse af glucose i urinen medførte en øjeblikkelig nedsættelse af plasmaglucosekoncentrationerne hos patienter med type 2-diabetes.
English: The single-dose and steady-state pharmacokinetic parameters of empagliflozin were similar suggesting linear pharmacokinetics with respect to time.
Danish: De farmakokinetiske parametre for empagliflozin ved enkelt dosering og i steady state var de samme, hvilket tyder på en lineær farmakokinetik i forhold til tid.
English: Other medicines and Jardiance 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 Jardiance Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
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 frekvens hos patienter, der blev behandlet med empagliflozin sammenlignet med placebo.
English: • lightheadedness or dizziness upon standing
Danish: • ørhed eller svimmelhed, når du rejser dig op
English: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Danish: I kombination med andre glucosesænkende lægemidler, herunder insulin, når disse sammen med diæt og motion, ikke giver tilstrækkelig glykæmisk kontrol (se tilgængelige data om de forskellige kombinationer i pkt.
English: In patients with mild, moderate or severe renal impairment (eGFR <30 - <90 ml/min/1.73 m2) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Danish: Hos patienter med mild, moderat eller svær nedsat nyrefunktion (eGFR <30 - <90 ml/min/1,73 m2) og patienter med nyresvigt/terminal nyresygdom (ESRD) steg empagliflozins AUC med henholdsvis ca. 18 %, 20 %, 66 % og 48 % sammenlignet med patienter med normal nyrefunktion.
English: When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and
Danish: Når empagliflozin anvendes i kombination med et sulfonylurinstof eller med insulin, kan en lavere dosis af sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT-2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Danish: Det anbefales ikke at genoptage behandling med en SGLT2-hæmmer hos patienter, der tidligere har haft diabetisk ketoacidose under behandling med en SGLT2-hæmmer, medmindre en anden uomtvistelig medvirkende faktor identificeres og afhjælpes.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Danish: Der er forhøjet risiko for diabetisk ketoacidose hos patienter med lav restfunktion af betaceller (f.eks. voksne patienter med type 2-diabetes og lavt C-peptid-niveau eller latent autoimmun diabetes (LADA) eller patienter med pankreatitis i anamnesen), patienter med tilstande, der medfører begrænset fødeindtagelse eller svær dehydrering, patienter, hvis insulindoser er reduceret, samt patienter med øget insulinbehov som følge af akutte medicinske sygdomme, kirurgi eller alkoholmisbrug.
English: Minor hypoglycaemia
Danish: Mild hypoglykæmi
English: Empagliflozin daily resulted in a statistically significant reduction in body weight, systolic and diastolic blood pressure and a statistically significantly lower proportion of patients with hypoglycaemic events compared to glimepiride (2.5% for empagliflozin, 24.2% for glimepiride, p<0.0001).
Danish: Kontinuerlig behandling med empagliflozin gav en statistisk signifikant reduktion i kropsvægt og systolisk og diastolisk blodtryk og en statistisk signifikant lavere andel af patienter med hypoglykæmiske hændelser sammenlignet med glimepirid (2,5 % for empagliflozin, 24,2 % for glimepirid, p<0,0001).
English: In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Danish: Hos patienter med mild, moderat og svær nedsat leverfunktion ifølge Child-Pugh-klassifikationen steg empagliflozins AUC med ca. 23 %, 47 % og 75 % og Cmax med henholdsvis ca. 4 %, 23 % og 48 % sammenlignet med patienter med normal leverfunktion.
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Danish: Hvis du tager Jardiance i kombination med lægemidler, der hedder sulfonylurinstoffer, eller med insulin, kan du få for lavt blodsukker (hypoglykæmi), og det kan give symptomer som rysteture, svedtendens og synsforstyrrelser, som kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: They have “S10” on one side and the Boehringer Ingelheim logo on the other side.
Danish: De har “S10” på den ene side og Boehringer Ingelheims logo på den anden side.
English: Table 1: Adverse reactions reported in placebo-controlled studies System organ class
Danish: Tabel 1: Bivirkninger indberettet i placebokontrollerede studier Systemorganklasse Meget almindelig Almindelig
English: Empagliflozin improves both fasting and post-prandial plasma glucose levels.
Danish: Empagliflozin forbedrer både faste-plasmaglucosekoncentrationen og den postprandiale plasmaglucosekoncentration.
English: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status.
Danish: Empagliflozins virkning på udskillelse af glucose i urinen er forbundet med osmotisk diurese, hvilket kan påvirke patientens hydreringsstatus.
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: Under de første 18 uger og de sidste 12 uger blev insulindosen holdt stabil, mens den blev justeret for at opnå præprandiale glucoseværdier <100 mg/dl [5,5 mmol/l] og postprandiale glucoseværdier <140 mg/dl [7,8 mmol/l] mellem uge 19 og 40.
English: The overall incidence of adverse events in patients treated with empagliflozin was similar to placebo.
Danish: Den overordnede forekomst af utilsigtede hændelser hos empagliflozin-behandlede patienter, var den samme som for placebo.
English: Add-on to pioglitazone +/- metformin therapy Placebo
Danish: Supplement til pioglitazon +/- metforminbehandling Placebo
English: What you need to know before you take Jardiance
Danish: Det skal du vide, før du begynder at tage Jardiance