FrancophonIA/ELRC3.0 huggingface dataset:
English: Some responses were increased by the combination treatment, such as effects on renal physiology, electrolyte balance and acid/base state.
Danish: Visse former for respons blev øget ved kombinationsbehandlingen, f.eks. på nyrefysiologi, elektrolytbalance og syre/base-tilstand.
English: In the EMPA-REG OUTCOME study, 10.1% of the patients were reported with cardiac failure at baseline.
Danish: I EMPAREG OUTCOME-studiet havde 10,1 % af patienterne hjerteinsufficiens ved baseline.
English: • Take the tablets with meals to lower your chance of an upset stomach.
Danish: • Tag tabletterne i forbindelse med måltider for at nedsætte risikoen for bivirkninger fra maven.
English: Basal insulin dose (IU/day) at week 78
Danish: Dosis af basal insulin (IE/dag) i uge 78
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 lavt blodsukker, skal du spise druesukker eller et sukkerrigt mellemmåltid eller drikke frugtjuice.
English: The clinical relevance of these decreases is unknown.
Danish: Den kliniske betydning af dette er ukendt.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with medicinal products that are P-gp substrates.
Danish: Ud fra in vitro-studier betragtes det som usandsynligt, at empagliflozin interagerer med lægemidler, der er P-gp-substrater.
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, der svarede til den maksimale kliniske eksponering for empagliflozin.
English: • unusual thirst
Danish: • En usædvanlig tørst
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (perforated)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister (perforerede)
English: • in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
Danish: • i kombination med andre antidiabetika, hvis patienten er utilstrækkeligt kontrolleret med metformin og disse lægemidler
English: Synjardy is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
Danish: Synjardy er indiceret til behandling af voksne med type 2-diabetes mellitus som supplement til diæt og motion:
English: Consistent with the half-life, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state.
Danish: Foreneligt med halveringstiden blev der observeret op til 22 % akkumulation med hensyn til plasma-AUC ved steady state.
English: Similar results were obtained when Synjardy (empagliflozin/metformin) combination tablets were administered with high-fat and high calorie meal.
Danish: Tilsvarende resultater blev opnået, når Synjardy kombinationstabletter (empagliflozin/metformin) blev givet sammen med et fedt- og kalorierigt måltid.
English: The efficacy for preventing cardiovascular mortality has not been conclusively established in patients using empagliflozin concomitantly with DPP-4 inhibitors or in Black patients because the representation of these groups in the EMPA-REG OUTCOME study was limited.
Danish: Virkning med hensyn til forebyggelse af kardiovaskulær mortalitet er ikke blevet fastslået konklusivt for patienter, der brugte empagliflozin samtidigt med DPP-4-hæmmere, eller for sorte patienter, da disse grupper var begrænset repræsenteret i EMPA-REG OUTCOME-studiet.
English: - Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.
Danish: Filmovertræk: hypromellose, macrogol 400, titandioxid (E171), talcum.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Danish: I kontrollerede kliniske studier oversteg de maksimale plasmakoncentrationer af metformin (Cmax) ikke 5 mikrogram/ml, selv ved de højeste doser.
English: By blocking this protein, the medicine causes blood sugar, sodium (salt) and water to be removed via the urine.
Danish: Når medicinen blokerer dette protein, fjernes glukose (blodsukker), natrium (salt) og vand i højere grad via urinen.
English: Co-medication with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Danish: Samtidig behandling med kendte induktorer af UGT-enzymer bør undgås på grund af en mulig risiko for nedsat virkning.
English: SGLT2 is highly expressed in the kidney, whereas expression in other tissues is absent or very low.
Danish: SGLT2 udtrykkes i udtalt grad i nyrerne, hvorimod det udtrykkes i meget lille grad, eller slet ikke, i andre væv.
English: In the double-blind placebo-controlled extension of these studies, reduction of HbA1c, body weight and blood pressure were sustained up to Week 76.
Danish: I den dobbeltblindede, placebokontrollerede forlængelse af disse studier varede faldet i HbA1c, legemsvægt og blodtryk ved til uge 76.
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Danish: C]-opløsning af empagliflozin til raske frivillige var fordelingen til røde blodlegemer ca. 37 % og plasmaproteinbindingen var 86 %.
English: Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Danish: Både forbedring af glykæmisk kontrol og reduktion af kardiovaskulær morbiditet og mortalitet er integrerede dele af behandlingen for type 2-diabetes.
English: • and delay of intestinal glucose absorption.
Danish: • forsinkelse af den intestinale absorption af glucose.
English: In the EMPA-REG Outcome study, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop.
Danish: I EMPA-REG Outcome-studiet returnerede hæmatokritværdierne til baseline-niveau efter en opfølgningsperiode på 30 dage efter behandlingsophør.
English: Hypoglycaemia has not been seen with metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances.
Danish: Der er ikke set hypoglykæmi ved metformin i doser på op til 85 g, selvom der er forekommet laktatacidose i sådanne tilfælde.
English: No major metabolites of empagliflozin were detected in human plasma, as defined by at least 10% of total drug-related material, and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Danish: Der blev ikke påvist nogen betydende metabolitter af empagliflozin i humant plasma, defineret ved mindst 10 % af det samlede lægemiddelrelaterede materiale, og de primære metabolitter var tre glukuronidkonjugater (2-, 3- og 6-O-glukuronid).
English: Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine.
Danish: En test for sukker i urinen vil være positiv, mens du tager dette lægemiddel.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Synjardy in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultater af studier med Synjardy i alle undergrupper af den pædiatriske population ved type 2-diabetes (se pkt.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Danish: Efter en oral dosis er den tilsyneladende, terminale eliminationshalveringstid ca. 6,5 timer.
English: If you have reduced kidney function, your doctor may prescribe a lower dose.
Danish: Hvis du har nedsat nyrefunktion, vil lægen eventuelt ordinere en lavere dosis.
English: • about what you can do to prevent dehydration;
Danish: • så I kan drøfte, hvad du kan gøre for at forebygge væskemangel (dehydrering)
English: • medicines that contain alcohol (see section ‘Synjardy with alcohol').
Danish: • lægemidler der indeholder alkohol (se 'Brug af Synjardy sammen med alkohol')
English: Furthermore, empagliflozin resulted in a reduction in FPG, body weight and blood pressure.
Danish: Endvidere medførte empagliflozin et fald i FPG, legemsvægt og blodtryk.
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: Ved den populationsfarmakokinetiske analyse blev den tilsyneladende terminale eliminationshalveringstid for empagliflozin estimeret til 12,4 timer, og den tilsyneladende oral clearance var 10,6 l/time.
English: Your doctor may ask you to stop taking Synjardy.
Danish: Din læge beder dig måske stoppe med at tage Synjardy.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection (including pyelonephritis and urosepsis)
Danish: Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infektioner Urinvejsinfektion (herunder pyelonefritis og urosepsis)
English: Hypoglycaemia (when used with sulphonylurea or insulin)
Danish: Hypoglykæmi (ved brug sammen med sulfonylurinstof eller insulin)
English: Your doctor may decide to temporarily or permanently stop your treatment with Synjardy.
Danish: Lægen kan beslutte at standse din behandling med Synjardy midlertidigt eller permanent.
English: • diarrhoea or stomach ache
Danish: • Diarré eller mavesmerter
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 øget risiko for volumendepletering.
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: Virkningsmekanismen for forekomst af disse tumorer afhænger af hanmusens naturlige prædisposition for nyrepatologi og en metabolisk reaktionsvej, der ikke afspejler menneskers.
English: The observed effect of food on empagliflozin and metformin is not considered to be clinically relevant.
Danish: Den observerede virkning af føde på empagliflozin og metformin anses ikke for klinisk betydende.
English: Do not drive or use any tools or machines if you feel dizzy while taking Synjardy.
Danish: Lad være med at køre selv eller bruge værktøj eller betjene maskiner, hvis du føler dig svimmel.
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 i meget begrænset omfang sent i graviditeten, men de tyder hverken på direkte eller indirekte skadelige virkninger på den tidlige fosterudvikling.
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-sukkersyge, danner din bugspytkirtel ikke insulin nok til at styre dit blodsukker, og din krop kan ikke udnytte sin egen insulin godt nok.
English: Therefore, caution should be exercised in patients for whom a empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older.
Danish: Der skal derfor udvises forsigtighed hos patienter, hvor empagliflozin-induceret blodtryksfald kan udgøre en risiko, f.eks. patienter med kendt hjerte-kar-sygdom, patienter i antihypertensiv behandling og hypotension i anamnesen eller patienter på 75 år og derover.
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 den kost- og motionsplan, som din læge, apotekspersonalet eller sundhedspersonalet har anvist.
English: Mean eGFR returned to baseline after treatment discontinuation suggesting acute haemodynamic changes may play a role in these renal function changes.
Danish: Den gennemsnitlige eGFR vendte tilbage til baseline efter behandlingen blev seponeret, hvilket tyder på, at akutte hæmodynamiske ændringer kan spille en rolle for disse ændringer af nyrefunktionen.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2).
Danish: • Empagliflozin virker ved at blokere et protein i nyrerne, der hedder natrium-glukoseco-transportør 2 (SGLT2).
English: • blood tests may show changes related to kidney function (creatinine or urea)
Danish: • Blodprøver kan vise ændringer relateret til nyrefunktionen (kreatinin eller urinstof)
English: Empagliflozin and metformin
Danish: Empagliflozin plus metformin
English: • passing more urine than usual or needing to pass urine more often
Danish: • Større mængder urin end sædvanligt eller hyppigere vandladningstrang
English: • Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver.
Danish: • Metformin sænker blodsukkeret på en anden måde, hovedsagelig ved at hæmme produktionen af glukose i leveren
English: See subsections below for additional information
Danish: Se nedenstående underpunkter for nærmere information.
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: Størstedelen af den lægemiddelrelaterede radioaktivitet, der blev genfundet i fæces, stammede fra uomdannet modersubstans, og ca. halvdelen af den lægemiddelrelaterede radioaktivitet, der blev genfundet i urin, var uomdannet modersubstans.
English: • straining or pain when emptying the bladder
Danish: • Besvær med eller smerte ved tømning af blæren
English: An urge to pass urine or more frequent urination may be due to the way Synjardy works, but they can also be signs of urinary tract infection.
Danish: Stærk vandladningstrang eller hyppigere vandladning kan skyldes den måde, som Synjardy virker på, men det kan også være tegn på urinvejsinfektion.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive, randomiserede studie (UKPDS) har påvist en positiv langtidsvirkning af tæt blodglucosekontrol ved type 2-diabetes.
English: Your doctor will decide when you must stop and when to restart your treatment with Synjardy.
Danish: Lægen vil beslutte, hvornår du skal stoppe behandlingen med Synjardy, og hvornår du kan genoptage den igen.
English: What you need to know before you take Synjardy 3.
Danish: Det skal du vide, før du begynder at tage Synjardy 3.
English: Empagliflozin administered during the period of organogenesis was not teratogenic.
Danish: Empagliflozin givet under organogenesen var ikke teratogent.
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 væsentlig grad oversteg eksponeringen hos mennesker efter terapeutiske doser, havde empagliflozin ingen utilsigtede virkninger på fertilitet eller tidlig fosterudvikling.
English: Do not stop taking Synjardy without first consulting your doctor.
Danish: Du må ikke holde op med at tage Synjardy, før du har talt med din læge.
English: Table 9: Treatment effect for the primary composite endpoint, its components and mortality Placebo
Danish: Tabel 9: Behandlingens virkning, hvad angår det primære sammensatte endepunkt, endepunktets komponenter og mortalitet
English: Synjardy is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Danish: Synjardy er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: With once-daily dosing, steady-state plasma concentrations of empagliflozin were reached by the fifth dose.
Danish: Ved dosering én gang daglig blev steady state plasmakoncentrationer af empagliflozin opnået efter den femte dosis.
English: The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.
Danish: Den glukosuri, natriurese og osmotiske diurese, der er observeret med empagliflozin, bidrager muligvis til de forbedrede kardiovaskulære resultater.
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Danish: • lægemidler mod smerter og betændelseslignende tilstande (NSAID'er og COX-2-hæmmere, såsom ibuprofen og celecoxib)
English: General toxicity studies in rats of up to 13 weeks were performed with the combination of empagliflozin and metformin and did not reveal any additional target organs when compared to empagliflozin or metformin alone.
Danish: Der er udført generelle toksicitetsstudier på rotter, der varede op til 13 uger, med kombinationen af empagliflozin og metformin, og de påviste ingen yderligere målorganer ved sammenligning med empagliflozin eller metformin alene.
English: The glucosuria observed with empagliflozin is accompanied by mild diuresis which may contribute to sustained and moderate reduction of blood pressure.
Danish: Den glukosuri, der er observeret med empagliflozin, er ledsaget af en let diurese, der kan bidrage til et vedvarende og moderat blodtryksfald.
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 blev empagliflozin absorberet hurtigt, og de maksimale plasmakoncentrationer forekom ved en median tmax på 1,5 time efter dosering.
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 rapporteret hyppigere for empagliflozin hos patienter med kronisk eller recidiverende urinvejsinfektion i anamnesen.
English: Patients with heart failure are more at risk of hypoxia and renal insufficiency.
Danish: Patienter med hjerteinsufficiens har større risiko for hypoksi og nedsat nyrefunktion.
English: Synjardy should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Synjardy tages to gange daglig i forbindelse med et måltid for at mindske de gastrointestinale bivirkninger af metformin.
English: Table 2: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience
Danish: Tabel 2: Tabel over bivirkninger (MedDRA)indberettet fra placebokontrollerede studier og rapporter efter markedsføring
English: • if you have a severe infection such as an infection affecting your lung or bronchial system or your kidney.
Danish: • hvis du har en svær infektion som f.eks. en infektion, der påvirker dine lunger, bronkier eller nyrer.
English: Consistently, in the EMPA-REG OUTCOME study, patients treated with empagliflozin experienced an initial fall in eGFR (mean: 3 ml/min/1.73 m2).
Danish: I EMPA-REG OUTCOME-studiet oplevede patienterne, der blev behandlet med empagliflozin, konsistent et indledende fald i eGFR (gennemsnit: 3 ml/min/1,73 m2).
English: • other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Danish: • andre lægemidler der sænker blodsukkeret, som f.eks. insulin eller et “sulfonylurinstof”.
English: Your doctor may ask you to stop taking Synjardy until you have recovered.
Danish: Din læge beder dig måske stoppe med at tage Synjardy, indtil du er blevet rask
English: • necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Danish: • Nekrotiserende fasciitis i mellemkødet (Fourniers gangræn), en alvorlig bløddelsinfektion i kønsdelene eller området mellem kønsdelene og anus
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development.
Danish: Ikke-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, fertilitet og tidlig fosterudvikling.
English: Synjardy has minor influence on the ability to drive and use machines.
Danish: Synjardy påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: There are no data from the use of this medicinal product or empagliflozin in pregnant women.
Danish: Der foreligger ingen data om brug af Synjardy eller empagliflozin til gravide kvinder.
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Danish: Du skal omgående stoppe med at tage Synjardy og straks kontakte en læge eller tage til det nærmeste hospital (se afsnit 2).
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 betydende, og empagliflozin kan tages med eller uden mad.
English: • pain in the pelvis, or mid-back pain (when kidneys are infected)
Danish: • Smerter i bækkenet eller i siden (hvis nyrerne er påvirkede)
English: Stop taking Synjardy for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Synjardy i en kort periode, hvis du har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
English: 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 glucosetransportører med betydning for transport af glucose ind i perifere væv, og det er 5.000 gange mere selektivt for SGLT2 end for SGLT1, der er den vigtigste transportør med betydning for absorption af glucose i tarmen.
English: Animal studies with empagliflozin and metformin do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier med empagliflozin og metformin tyder hverken på direkte eller indirekte skadelige virkninger på fertiliteten (se pkt.
English: Compared to linagliptin 5 mg, both doses of empagliflozin plus linagliptin 5 mg provided statistically significant reductions in FPG and blood pressure.
Danish: Sammenlignet med linagliptin 5 mg medførte begge doser empagliflozin plus linagliptin 5 mg statistisk signifikante fald i FPG og blodtryk.
English: Overweight patients should continue their energy restricted diet.
Danish: Overvægtige patienter skal fortsætte med deres lavenergi-kost.
English: Empagliflozin should not be initiated.
Danish: Behandling med empagliflozin bør ikke påbegyndes.
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 transportører OAT3, OATP1B1 og OATP1B3, men ikke for OAT1 og OCT2.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmiske virkninger, som nedsætter både basal og postprandial plasmaglucose.
English: Metformin is excreted into human milk.
Danish: Metformin udskilles i human mælk.