FrancophonIA/ELRC3.0 huggingface dataset:
English: During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Danish: I de første 18 uger og de sidste 12 uger blev insulindosis holdt konstant, men mellem uge 19 og 40 blev dosis justeret for at opnå præprandiale glucoseværdier < 100 mg/dl [5,5 mmol/l] og postprandiale glucoseværdier < 140 mg/dl [7,8 mmol/l].
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 langtids-toksicitetsstudier med gnavere og hunde blev der observeret tegn på toksicitet ved eksponeringer, der var ≥ 10 gange den kliniske dosis empagliflozin.
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases).
Danish: Der er også øget risiko for at udvikle laktatacidose ved ukontrolleret diabetes, alvorlige infektioner, langvarig faste eller alkoholindtagelse, dehydrering (væskemangel - se yderligere oplysninger nedenfor), leverproblemer og enhver tilstand med nedsat iltforsyning til en legemsdel (såsom akut alvorlig hjertesygdom).
English: Empagliflozin was superior in preventing the primary combined endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, as compared with placebo.
Danish: Empagliflozin var superiort i forhold til placebo med hensyn til at forhindre det primære sammensatte endepunkt (kardiovaskulær død, ikke-dødeligt myokardieinfarkt eller ikke-dødelig apopleksi).
English: Microscopic evidence of the effects of exaggerated pharmacology on the kidney observed in some species included tubular dilatation, and tubular and pelvic mineralisation at approximately 4-times the clinical AUC exposure of empagliflozin associated with the 25 mg dose.
Danish: Den mikroskopiske evidens for virkningerne af en øget farmakologisk virkning på nyrerne, der blev observeret hos visse arter, omfattede tubulær dilatation og mineralisering i tubuli og nyrebækken ved ca. 4 gange den kliniske AUC-eksponering for empagliflozin, der er forbundet med en dosis på 25 mg.
English: In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Danish: Hos patienter på 75 år og derover skal der tages højde for den øgede risiko for volumendepletering (se pkt.
English: The overall frequency of urinary tract infection adverse events was higher in metformin-treated patients who received empagliflozin 10 mg (8.8%) compared to empagliflozin 25 mg (6.6%) or placebo (7.8%).
Danish: Den overordnede hyppighed af urinvejsinfektion var højere ved behandling med metformin plus empagliflozin 10 mg (8,8 %) end med empagliflozin 25 mg (6,6 %) eller placebo (7,8 %).
English: In the EMPA-REG OUTCOME study, for time to first nephropathy event, the HR was 0.61 (95 % CI 0.53, 0.70) for empagliflozin (12.7 %) vs placebo (18.8 %).
Danish: I EMPA-REG OUTCOME-studiet var HR 0,61 (95 % CI 0,53; 0,70) for tiden til den første nefropatihændelse, for empagliflozin (12,7 %) vs. placebo (18,8 %).
English: Synjardy may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Synjardy kan forårsage en meget sjælden, men meget alvorlig bivirkning, der kaldes laktatacidose (mælkesyreforgiftning), især hvis du har nedsat nyrefunktion.
English: Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
Danish: • induktorer af OCT1 (f.eks. rifampicin) kan øge absorptionen i mave-tarm-kanalen og virkningen af metformin
English: The pharmacokinetics of empagliflozin have been extensively characterised in healthy volunteers and patients with type 2 diabetes.
Danish: Empagliflozins farmakokinetik er grundigt undersøgt hos raske frivillige og hos patienter med type 2diabetes.
English: Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26% increase in peak empagliflozin plasma concentrations (Cmax) and a 53% increase in area under the concentration-time curve (AUC).
Danish: Samtidig behandling med empagliflozin og probenecid (en hæmmer af UGT-enzymer og OAT3) medførte en 26 % forøgelse af de maksimale plasmakoncentrationer af empagliflozin (Cmax) og en 53 % forøgelse af arealet under koncentration-tid kurven (AUC).
English: At dose levels of 500 mg/kg/day administered to Wistar Hannover rats, associated with 7-times the maximum recommended human dose (MRHD) of metformin, teratogenicity of metformin was observed, mostly evident as an increase in the number of skeletal malformations.
Danish: Ved doser på 500 mg/kg/dag, der svarer til 7 gange den maksimalt anbefalede dosis metformin til mennesker (MRHD), blev der observeret teratogenicitet af metformin hos Wistar Hannover-rotter i form af et øget antal skeletmisdannelser.
English: Due to the limited therapeutic experience with empagliflozin in patients aged 85 years and older, initiation of therapy in this population is not recommended (see section 4.4).
Danish: Den kliniske erfaring med empagliflozin til patienter på 85 år og derover er begrænset, og behandling bør ikke indledes hos denne population (se pkt.
English: Very rare
Danish: Meget sjældne:
English: Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Danish: Interaktionsstudier tyder på, at empagliflozins farmakokinetik ikke påvirkes ved samtidig administration af metformin, glimepirid, pioglitazon, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemid eller hydrochlorthiazid.
English: Major hypoglycaemic events occurred in 0.5%, 0% and 0.5% of patients treated with empagliflozin 10 mg, empagliflozin 25 mg and placebo when added on to metformin and insulin, respectively.
Danish: Svær hypoglykæmi forekom hos 0,5 %, 0 % og 0,5 % af patienterne behandlet med henholdsvis empagliflozin 10 mg, empagliflozin 25 mg og placebo som supplement til metformin plus insulin.
English: As Synjardy contains empagliflozin it 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 thiazider og loop-diuretika og dermed kan risikoen for dehydrering og hypotension øges (se pkt.
English: It is important to stay on the diet and exercise program recommended by your doctor while taking Synjardy.
Danish: Det er vigtigt, at du stadig følger det kost- og motionsprogram, som din læge har anbefalet.
English: Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Danish: • hæmmere af både OCT1 og OCT2 (f.eks. crizotinib, olaparib) kan ændre virkningen af metformin og dens elimination i nyrerne.
English: The pharmacokinetics of 5 mg empagliflozin twice daily and 10 mg empagliflozin once daily were compared in healthy subjects.
Danish: Farmakokinetikken for 5 mg empagliflozin to gange daglig og 10 mg empagliflozin én gang daglig blev sammenlignet hos raske frivillige.
English: Empagliflozin improves both fasting and post-prandial plasma glucose levels.
Danish: Empagliflozin nedsætter både faste-plasmaglucose og den postprandiale plasmaglucose.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin en gunstig virkning på lipidmetabolismen, uafhængigt af dets virkning på glykæmi.
English: If this happens you must stop taking Synjardy and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for dig, skal du omgående stoppe med at tage Synjardy, og kontakte en læge eller nærmeste hospital, da laktatacidose kan føre til koma.
English: At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in body weight.
Danish: I uge 52 var der et statistisk signifikant fald i HbA1c og en insulinbesparelse med empagliflozin sammenlignet med placebo og et vægttab.
English: Empagliflozin 24 months data, as add-on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 6), and a clinically meaningful reduction in FPG, compared to glimepiride.
Danish: 24 måneders data for empagliflozin som supplement til metformin sammenlignet med glimepirid I et studie, hvor man sammenlignede virkning og sikkerhed af empagliflozin 25 mg over for glimepirid (op til 4 mg per dag) hos patienter med utilstrækkelig glykæmisk kontrol på metformin alene, medførte daglig behandling med empagliflozin et større fald i HbA1c (Tabel 6) og et klinisk betydende fald i FPG sammenlignet med glimepirid.
English: The frequency of hypoglycaemia depended on the background therapy in the respective studies and was similar for empagliflozin and placebo as add-on to metformin, as add-on to linagliptin and metformin, for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
Danish: Hyppigheden af hypoglykæmi afhang af baggrundsbehandlingen i de respektive studier og var den samme for empagliflozin og placebo som supplement til metformin, som supplement til linagliptin og metformin, for kombinationen empagliflozin plus metformin hos behandlingsnaive patienter sammenlignet med patienter, der blev behandlet med empagliflozin og metformin som særskilte lægemidler, samt som supplement til standardbehandling.
English: At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 7).
Danish: I uge 18 var der et statistisk signifikant fald i HbA1c med empagliflozin sammenlignet med placebo (Tabel 7).
English: Empagliflozin increased urine glucose excretion leading to an increase in urine volume.
Danish: Empagliflozin øgede udskillelsen af glucose i urinen og førte dermed til øget urinvolumen.
English: Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions').
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Synjardy, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Danish: Kombinationsbehandlinger der kræver forsigtighed Visse lægemidler kan påvirke nyrefunktionen negativt, hvilket kan øge risikoen for laktatacidose, f.eks. NSAID'er, herunder selektive cyklooxygenase (COX) II-hæmmere, ACE-hæmmere, angiotensin II-receptorantagonister og diuretika, især loop-diuretika.
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Danish: Laktatacidose er en akut medicinsk tilstand, der kræver behandling på hospital.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD20
Danish: af orale blod-glucose sænkende midler, ATCkode: A10BD20
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Danish: Udskillelse af glucose i urinen medfører endvidere et kalorietab, der er ledsaget af tab af kropsfedt og vægttab.
English: Table 8: Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin Placebo
Danish: Tabel 8: Effektresultater efter 18 og 78 uger i et placebokontrolleret studie af empagliflozin som supplement til basal insulin med samtidig metforminbehandling Placebo
English: In addition it resulted in a clinically meaningful reduction in FPG, systolic and diastolic blood pressure compared to placebo.
Danish: Endvidere blev der set klinisk betydende fald i FPG og systolisk og diastolisk blodtryk sammenlignet med placebo.
English: • rash or red skin- this this may be itchy and include raised bumps, oozing fluid or blisters
Danish: • Udslæt eller rød hud, som muligvis klør og omfatter knopper, sivende væske eller blærer
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h/l and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h/l and 687 nmol/l with empagliflozin 25 mg once daily.
Danish: Den gennemsnitlige plasma-AUC og Cmax ved steady state var henholdsvis 1.870 nmol x time/l og 259 nmol/l for empagliflozin 10 mg én gang daglig og henholdsvis 4.740 nmol x time/l og 687 nmol/l for empagliflozin 25 mg én gang daglig.
English: Peak plasma levels of empagliflozin were similar in subjects with moderate renal impairment and kidney failure/ESRD compared to patients with normal renal function.
Danish: De maksimale plasmakoncentrationer af empagliflozin var de samme hos patienter med moderat nedsat nyrefunktion og nyresvigt/ESRD sammenlignet med patienter med normal nyrefunktion.
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) in metformin-treated patients who received empagliflozin was low: 0.6% for empagliflozin 10 mg, 0.3% for empagliflozin 25 mg and 0.1% for placebo.
Danish: Den overordnede hyppighed af volumendepletering (inklusive de foruddefinerede betegnelser nedsat blodtryk (ambulant), nedsat systolisk blodtryk, dehydrering, hypotension, hypovolæmi, ortostatisk hypotension og synkope) var lav hos patienter, der fik metformin plus empagliflozin (empagliflozin 10 mg: 0,6 %; empagliflozin 25 mg: 0,3 % og placebo 0,1 %).
English: About half of the patients (52.2%) had an eGFR of 60-90 ml/min/1.73 m2, 17.8% of
Danish: Ca. halvdelen af patienterne (52,2 %) havde eGFR 60-90 ml/min/1,73 m 17,8 % havde eGFR 45-60 ml/min/1,73 m2, og 7,7 % havde eGFR 30-45 ml/min/1,73 m
English: Your doctor will normally start Synjardy treatment by prescribing the strength of tablet that supplies the same dose of metformin you are already taking (850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozin (5 mg twice a day).
Danish: Startdosis af Synjardy vil supplere den dosis metformin, du allerede tager (850 mg eller 1.000 mg to gange daglig), og laveste dosis empagliflozin
English: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status.
Danish: Empagliflozins virkning på udskillelsen af glucose i urinen er forbundet med osmotisk diurese, hvilket kan påvirke patientens hydreringsstatus.
English: Pruritus (generalised) Rash
Danish: Kløe (generaliseret) Udslæt
English: The efficacy and safety of empagliflozin as add on to basal insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Danish: Virkning og sikkerhed af empagliflozin som supplement til basal insulin med samtidig metforminbehandling blev undersøgt i et 78 uger varende, dobbeltblindet placebokontrolleret studie.
English: In patients ≥75 years of age volume depletion events have been reported in a single patient treated with empagliflozin 25 mg as add-on to metformin therapy.
Danish: Volumendepletering er rapporteret hos en enkelt patient i gruppen på 75 år og derover ved behandling med empagliflozin 25 mg som supplement til metformin.
English: Glimepiride
Danish: Glimepirid
English: (empagliflozin 10 mg: 2345, empagliflozin 25 mg: 2342, placebo: 2333) and followed for a median of 3.1 years.
Danish: I alt 7.020 patienter blev behandlet (empagliflozin 10 mg: 2.345, empagliflozin 25 mg: 2.342, placebo: 2.333) og fulgt i en median periode på 3,1 år.
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021),
Danish: • Et signifikant fald i den absolutte risiko for mortalitet af alle årsager: metformin 13,5 tilfælde/1.000 patientår i forhold til diæt alene 20,6 tilfælde/1.000 patientår, (p= 0,011) og i forhold til de kombinerede grupper med sulfonylurinstof alene og insulin alene 18,9 tilfælde/1.000 patientår (p= 0,021).
English: In vitro studies suggested that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9.
Danish: In vitro-studier tyder på, at den primære metaboliseringsvej for empagliflozin hos mennesker er glukuronidering ved hjælp af uridin5'-difosfoglukuronosyltransferaserne UGT2B7, UGT1A3, UGT1A8 og UGT1A9.
English: • a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017,
Danish: • Et signifikant fald i den absolutte risiko for enhver diabetesrelateret mortalitet: metformin 7,5 tilfælde/1.000 patientår, diæt alene 12,7 tilfælde/1.000 patientår, p= 0,017.
English: Peak plasma levels of empagliflozin were roughly 20% higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function.
Danish: De maksimale plasmakoncentrationer af empagliflozin var omtrent 20 % højere hos patienter med let og svært nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: • Take the tablet twice daily by mouth.
Danish: • Tag Synjardy to gange daglig sammen med morgenmaden og aftensmaden.
English: Increased urination
Danish: Øget vandladning
English: How to store Synjardy 6.
Danish: Sådan skal du tage Synjardy 4.
English: Synjardy is a diabetes medicine that contains two active substances called empagliflozin and metformin.
Danish: Synjardy indeholder de to aktive stoffer empagliflozin og metformin:
English: Do not take a double dose of this medicine.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Major hypoglycaemia (events requiring assistance) The overall frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
Danish: Svær hypoglykæmi (hændelser, hvor der er behov for assistance) Den samlede hyppighed af svære hypoglykæmiske tilfælde var lav (< 1 %) og den samme for empagliflozin og placebo som supplement til metformin samt for kombinationen empagliflozin plus metformin hos behandlingsnaive patienter sammenlignet med patienter, der blev behandlet med empagliflozin og metformin som særskilte lægemidler, samt som supplement til standardbehandling.
English: Elevated haematocrit Haematocrit increase was observed with empagliflozin treatment (see section 4.8).
Danish: Der er set forhøjet hæmatokrit ved behandling med empagliflozin (se pkt.
English: For metformin, AUC decreased by 12% and Cmax decreased by 26% compared to fasting conditions.
Danish: Metformin medførte et fald i AUC og Cmax på henholdsvis 12 % og 26 % sammenlignet med fastetilstand.
English: In addition it resulted in clinically meaningful reductions in FPG, systolic and diastolic blood pressure compared to placebo.
Danish: Denne behandling medførte desuden klinisk relevante reduktioner i FPG samt systolisk og diastolisk blodtryk sammenlignet med placebo.
English: Cases of hepatic injury have been reported with empagliflozin in clinical trials.
Danish: I kliniske studier med empagliflozin er der rapporteret om tilfælde med leverskade.
English: Table 1: Posology for renally impaired patients GFR ml/min Metformin
Danish: Tabel 1: Dosering til patienter med nedsat nyrefunktion GFR ml/min Metformin
English: Empagliflozin twice daily versus once daily as add on to metformin therapy The efficacy and safety of empagliflozin twice daily versus once daily (daily dose of 10 mg and 25 mg) as add-on therapy in patients with in sufficient glycemic control on metformin monotherapy was evaluated in a double blind placebo-controlled study of 16 weeks duration.
Danish: Empagliflozin to gange daglig eller én gang daglig som supplement til metforminbehandling Virkning og sikkerhed af empagliflozin to gange daglig eller én gang daglig (daglig dosis på 10 mg og 25 mg) som tillægsbehandling til patienter med utilstrækkelig glykæmisk kontrol på metformin alene blev undersøgt i et 16 uger varende dobbeltblindet placebokontrolleret studie.
English: Metformin passes into human milk in small amounts.
Danish: Metformin udskilles i små mængder i modermælken hos mennesker.
English: Iron oxide black (E172) Iron oxide red (E172)
Danish: Jernoxid, sort (E172) Jernoxid, rød (E172)
English: No studies on the effect on human fertility have been conducted for this medicinal product or empagliflozin.
Danish: Der er ikke udført studier af Synjardys eller empagliflozins virkning på menneskers fertilitet.
English: • burning sensation when passing urine
Danish: • En sviende fornemmelse ved vandladning
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Danish: • Et signifikant fald i den absolutte risiko for myokardieinfarkt: metformin 11 tilfælde/1.000 patientår, diæt alene 18 tilfælde/1.000 patientår (p= 0,01).
English: How to take Synjardy
Danish: Sådan skal du tage Synjardy
English: Empagliflozin exposure was similar with and without co-administration with verapamil, a P-gp inhibitor, indicating that inhibition of P-gp does not have any clinically relevant effect on empagliflozin.
Danish: Samtidig administration af verapamil (en P-gp-hæmmer) ændrede ikke eksponeringen for empagliflozin, hvilket tyder på, at hæmning af P-gp ikke er klinisk betydende.
English: A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Danish: En højere andel af patienter behandlet med empagliflozin plus linagliptin og med baseline-HbA1c ≥ 7,0 % opnåede en HbA1c-målværdi på < 7 % sammenlignet med linagliptin 5 mg. Klinisk betydende fald i HbA1c varede ved i 52 uger.
English: In a prespecified subgroup of patients with baseline HbA1c greater or equal than 8.5% the reduction from baseline in HbA1c was -1.3% with empagliflozin 10 mg or 25 mg at 24 weeks (p<0.0001) compared to placebo.
Danish: I en prædefineret undergruppe af patienter med baseline-HbA1c ≥ 8,5 % var reduktionen i forhold til baseline -1,3 % med empagliflozin 10 mg eller 25 mg efter 24 uger (p < 0,0001) sammenlignet med placebo.