FrancophonIA/ELRC3.0 huggingface dataset:
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Den maksimale koncentration i blod er lavere end den maksimale koncentration i plasma og viser sig på omtrent samme tid.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Danish: Langtidsbehandling med metformin er blevet sat i forbindelse med nedsat vitamin B12-absorption, som meget sjældent kan resultere i klinisk signifikant vitamin B12-mangel (f.eks. megaloblastær anæmi).
English: If you take more Komboglyze than you should If you take more Komboglyze tablets than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget flere Komboglyze-tabletter, end du skulle, skal du tale med en læge eller straks tage til et hospital.
English: Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
Danish: Symptomerne kan omfatte, men er ikke begrænset til, tiltagende kortåndethed, hurtig vægtstigning og hævede fødder (ødem).
English: • infection of your sinuses, sometimes with a feeling of pain and fullness behind your cheeks and eyes (sinusitis)
Danish: • infektion i bihulerne, undertiden med smertefornemmelse eller fornemmelse af at være stoppet bag ved kinderne og øjnene (sinuitis)
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Danish: Primært sammensat endepunkt: MACE Sekundært sammensat endepunkt: MACE plus
English: Food decreases the extent and slightly delays the absorption of metformin.
Danish: Fødevarer nedsætter omfanget af metforminabsorption og forsinker den let.
English: Do not take this medicine if you are pregnant or might become pregnant.
Danish: Tag ikke dette lægemiddel, hvis du er gravid eller planlægger at blive gravid.
English: Tablet core Povidone K30
Danish: Tabletkerne Povidon K30
English: In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour period.
Danish: Hos patienter med type 2-diabetes resulterede administration af saxagliptin i hæmning af DPP-4-enzymaktivitet i en periode på 24 timer.
English: The adverse reactions are listed by system organ class and absolute frequency.
Danish: Bivirkningerne er opført efter systemorganklasse og absolut hyppighed.
English: Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Danish: Saxagliptin er en højpotent (Ki: 1,3 nM), selektiv, reversibel, kompetitiv DPP-4-hæmmer.
English: No animal studies have been conducted with the combination of products in Komboglyze to evaluate carcinogenesis, mutagenesis, or impairment of fertility.
Danish: Der er ikke udført dyrestudier med kombinationen af produkterne i Komboglyze for at vurdere karcinogenese, mutagenese eller nedsat fertilitet.
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than 12%.
Danish: De intrapersonelle variationskoefficienter for saxagliptins Cmax og AUC var mindre end 12 %.
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the saxagliptin clinical program.
Danish: Patienter med nedsat immunforsvar, såsom patienter som har fået foretaget organtransplantation, eller patienter der har fået stillet diagnosen humant immundefektsyndrom, er ikke blevet undersøgt i det kliniske udviklingsprogram for saxagliptin.
English: As this medicinal product contains saxagliptin, it should not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase 4 (DPP4) inhibitor.
Danish: Da dette lægemiddel indeholder saxagliptin, må det ikke anvendes til patienter, som har haft en alvorlig overfølsomhedsreaktion over for en dipeptidylpeptidase-4-hæmmer (DPP4-hæmmer).
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Danish: Metformin blev optitreret fra 500 til 2000 mg dagligt, alt efter hvordan det blev tålt.
English: p< 0.0001 compared to placebo.
Danish: p<0,0001 sammenlignet med placebo.
English: The corresponding plasma Cmax values were 24 ng/mL and 47 ng/mL, respectively.
Danish: De tilsvarende plasma-Cmaxværdier var henholdsvis 24 ng/ml og 47 ng/ml.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a NSAID.
Danish: Der skal udvises særlig omhu i situationer, hvor nyrefunktionen kan blive nedsat, f.eks. ved påbegyndelse af antihypertensiv eller diuretisk behandling, eller ved start af behandling med et NSAID.
English: There appeared to be no difference in percentage responders: 37.9% (saxagliptin) and 38.2% (glimepiride) achieved the primary endpoint.
Danish: Der forekom ikke at være nogen forskel i procentdelen af respondenter: 37,9 % i saxagliptingruppen og 38,2 % i glimepiridgruppen nåede det primære endepunkt.
English: Adjusted mean change from baseline adjusted for baseline value (ANCOVA).
Danish: Korrigeret middelændring fra baseline korrigeret for baseline-værdi (ANCOVA).
English: To control your diabetes, you still need to diet and exercise, even when you are taking this medicine.
Danish: For at kontrollere din diabetes har du stadig brug for at holde diæt og motionere, selv om du tager denne medicin.
English: • Lactic acidosis, Komboglyze may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: • Laktatacidose, Komboglyze kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 brugere), men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Danish: Eksponeringen for den aktive metabolit og hæmningen af plasma DPP4-aktiviteten over et dosisinterval blev ikke påvirket af rifampicin (se punkt 4.4).
English: There have been no formal interaction studies for Komboglyze.
Danish: Der er ikke udført interaktionsstudier af Komboglyze.
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Prækliniske data for metformin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
English: In addition, some patients have reported rash and skin reactions (hypersensitivity) while taking saxagliptin.
Danish: Desuden har nogle patienter rapporteret udslæt og hudreaktioner (overfølsomhed), mens de tog saxagliptin.
English: p-value = 0.0063 (between group comparisons significant at α = 0.05).
Danish: p-værdi = 0,0063 (mellem-gruppe-sammenligninger, der er signifikante ved a α = 0,05).
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Gastrointestinale symptomer såsom kvalme, opkastning, diarré, abdominalsmerter og appetitløshed forekommer hyppigst under påbegyndelse af behandlingen og svinder i de fleste tilfælde spontant.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Danish: I overensstemmelse med rutinebehandling af diabetespatienter anbefales det derfor at monitorere for hudreaktioner, såsom blæredannelse, ulceration eller udslæt.
English: Arthralgia has also been reported during postmarketing surveillance (see section 4.4).
Danish: Artralgi er også rapporteret under postmarketing-overvågning (se pkt.
English: The following data are based on the findings in the studies with saxagliptin and metformin individually.
Danish: De følgende data er baseret på fundene i studierne med saxagliptin og metformin enkeltvist.
English: Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.
Danish: Patienterne oplevede lindring af symptomerne efter seponering af lægemidlet, og nogle oplevede, at symptomerne vendte tilbage, når behandling med den samme eller en anden DPP4-hæmmer blev genoptaget.
English: - In patients with moderate renal impairment that have GFR ≥ 30 to < 45 mL/min, in the absence of other conditions that may increase the risk of lactic acidosis, the dose is 2.5 mg/1000 mg or 2.5 mg/850 mg once daily.
Danish: - Hos patienter med moderat nedsat nyrefunktion, som har GFR ≥ 30 til <45 ml/min, i fravær af andre tilstande, der kan øge risikoen for laktatacidose, er dosis 2,5 mg/1000 mg eller 2,5 mg/850 mg én gang dagligt.
English: The inhibition of plasma DPP4 activity by saxagliptin for at least 24 hours after oral administration of saxagliptin is due to high potency, high affinity, and extended binding to the active site.
Danish: Saxagliptins hæmningen af plasma-DPP-4-aktivitet i mindst 24 timer efter oral administration af saxagliptin skyldes høj potens, høj affinitet og udstrakt binding til det aktive sted.
English: Do not use this medicine if the package 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: Komboglyze with alcohol
Danish: Brug af Komboglyze sammen med alkohol
English: Co-administration of saxagliptin and metformin
Danish: Co-administration af saxagliptin og metformin
English: The average renal clearance of saxagliptin (230 mL/min) was greater than the average estimated glomerular filtration rate (120 mL/min), suggesting some active renal excretion.
Danish: Saxagliptins gennemsnitlige renale clearance (230 ml/min) var større end den gennemsnitlige beregnede glomerulære filtrationsrate (120 ml/min), hvilket tyder på en vis aktiv renal udskillelse.
English: Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when saxagliptin was used alone or in combination.
Danish: Nogle patienter har fået en lille reduktion i antallet af én type hvide blodlegemer (lymfocytter) påvist i en blodprøve ved anvendelse af saxagliptin alene eller sammen med andre lægemidler.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Danish: • Kraftige og vedvarende mavesmerter, der eventuelt stråler ud til ryggen, samt kvalme og opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pancreatitis).
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Danish: Tæt monitorering af glykæmisk kontrol, dosisjustering inden for den anbefalede dosering og ændring af diabetesbehandlingen skal derfor overvejes ved administration sammen med kationiske lægemidler, som elimineres ved tubulær sekretion.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 μg/mL.
Danish: Med de almindelige metformindoser og doseringsmåder nås steady state-plasmakoncentrationer inden for 24-48 t, og de er i reglen mindre end 1 μg/ml.
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4.
Danish: I in vitro-studier inhiberede saxagliptin og hovedmetabolitten hverken CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A4 og inducerede ikke CYP1A2, 2B6, 2C9 eller 3A4.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmisk effekt, som sænker såvel basal som postprandial plasma-glucose.
English: Posology Adults with normal renal function (GFR ≥ 90 mL/min)
Danish: Dosering Voksne med normal nyrefunktion (GFR ≥90 ml/min)
English: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Danish: In vitro-proteinbinding af saxagliptin og hovedmetabolitten i humant serum er ubetydelig.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg med metformin indikerer ingen skadelige virkninger for graviditeten, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Some patients have experienced constipation at a frequency not known (cannot be determined from the available data) when saxagliptin was used alone or in combination.
Danish: Nogle patienter har haft forstoppelse i en ikke kendt hyppighed (kan ikke vurderes ud fra forhåndenværende data) ved anvendelse af saxagliptin alene eller sammen med andre lægemidler.
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Danish: Efter administration af en dosis på 850 mg sås en 40 % lavere maksimal plasmakoncentration, en 25 % reduktion i AUC og en 35 min forlængelse af tiden indtil maksimal plasmakoncentration.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Danish: Immunrelaterede fund af minimal, ikke-progredierende lymfoid hyperplasi i milten, lymfeknuder og knoglemarv uden alvorlige sequelae er blevet rapporteret hos alle testede arter ved eksponeringer begyndende ved 7 gange RHD.
English: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin.
Danish: I randomiserede, kontrollerede, dobbeltblindede kliniske studier (herunder erfaring under udvikling og efter markedsføring) er mere end 17.000 patienter med type 2-diabetes blevet behandlet med saxagliptin.
English: A small decrease in absolute lymphocyte count was observed.
Danish: Der sås et lille fald i absolut lymfocyttal.
English: Studies in animals have shown reproductive toxicity at high doses of saxagliptin alone or in combination with metformin (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet på høje doser af saxagliptin alene eller i kombination med metformin (se punkt 5.3).
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Danish: Efter en oral dosis er den tilsyneladende terminale eliminationshalveringstid ca. 6,5 t. Når nyrefunktionen er nedsat, reduceres renal clearance proportionalt med kreatinin, og eliminationshalveringstiden forlænges således, hvilket resulterer i forhøjede niveauer af metformin i plasma.
English: If your doctor prescribes this medicine together with a sulphonylurea or insulin, remember to take this other medicine as directed by your doctor to achieve the best results for your health.
Danish: Hvis din læge ordinerer dette lægemiddel sammen med et sulfonylurinstof eller insulin, skal du huske at tage insulinen efter lægens anvisning for at opnå den bedst mulige behandling.
English: • inflamed nose or throat such as with a cold or sore throat
Danish: • betændelsestilstand i næse eller svælg som ved en forkølelse eller ondt i halsen
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Glukokortikoider (givet ad systemisk og lokal vej), beta-2-agonister og diuretika har egen hyperglykæmisk aktivitet.
English: You should call your doctor if you experience the following side effect: • severe joint pain.
Danish: Kontakt lægen, hvis du får følgende bivirkning: • svære ledsmerter.
English: If a patient presents with severe joint pain, continuation of drug therapy should be individually assessed.
Danish: Hvis en patient oplever svære ledsmerter, skal det vurderes individuelt, om behandling med lægemidlet bør fortsatte.
English: The effect on offspring body weights were noted until postnatal day 92 and 120 in females and males, respectively.
Danish: Virkningen på kropsvægten hos afkom blev bemærket indtil dag 92 og 120 postnatalt hos henholdsvis hunner og hanner.
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Danish: Stigningen i insulin fra beta-celler i pancreas og faldet i glukagon fra alfa-celler i pancreas blev sat i forbindelse med lavere koncentrationer af faste-glucose og reduceret glucoseudsving efter en oral glucosebelastning eller et måltid.
English: Placebo-corrected mean change in HbA1c (%) (95% CI)
Danish: Placebo-korrigeret middelændring i HbA1c (%) (95 % CI)
English: Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure such as baseline history of heart failure or impaired renal function.
Danish: Forsøgspersoner med højere risiko for hospitalsindlæggelse pga. hjertesvigt, uanset tildeling af behandling, kunne identificeres ved kendte risikofaktorer for hjertesvigt, såsom baseline-anamnese med hjertesvigt eller nedsat nyrefunktion.
English: Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
Danish: Saxagliptin og hovedmetabolitten kan fjernes ved hæmodialyse (23 % af dosen i løbet af 4 timer).
English: The major metabolite of saxagliptin is also a selective, reversible, competitive DPP4 inhibitor, half as potent as saxagliptin.
Danish: Saxagliptins hovedmetabolit er også en selektiv, reversibel, kompetitiv DPP-4-hæmmer, der er halvt så potent som saxagliptin.
English: Saxagliptin has been shown to be well-tolerated with no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose).
Danish: Det er blevet vist, at saxagliptin er veltålt uden klinisk betydende effekt på QTc-intervallet eller hjertefrekvensen på orale doser op til 400 mg dagligt i 2 uger (80 gange den anbefalede dosis).
English: - Metformin is contraindicated in patients with a GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Danish: - Metformin er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: • in patients already being treated with the combination of saxagliptin and metformin as separate tablets.
Danish: • hos patienter, der allerede er i behandling med kombinationen af saxagliptin og metformin som separate tabletter.
English: Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
Danish: Saxagliptin forbedrer glykæmisk kontrol ved at reducere fastende og postprandiale glucosekoncentrationer hos patienter med type 2-diabetes.
English: GENERATION was a 52-week glycaemic control study in 720 elderly patients, the mean age was 72.6 years; 433 subjects (60.1%) were < 75 years of age, and 287 subjects (39.9%) were ≥ 75 years of age.
Danish: GENERATION var et 52-ugers studie af glykæmisk kontrol hos 720 ældre patienter, hvor den gennemsnitlige alder var 72,6 år; 433 forsøgspersoner (60,1 %) var <75 år, og 287 forsøgspersoner (39,9 %) var ≥75 år.
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis in muscle; - by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; - by delaying intestinal glucose absorption.
Danish: Metformin kan virke via tre mekanismer: - ved reduktion af hepatisk glucoseproduktion ved hæmning af glukoneogenese og glykogenolyse i musklerne - ved i beskedent omfang at forøge insulinfølsomheden, forbedre den perifere glucoseoptagelse og -udnyttelse - ved at forsinke den intestinale glucoseabsorption.
English: Includes saxagliptin in add-on to metformin and initial combination with metformin.
Danish: Omfatter saxagliptin som tillæg til metformin og initial kombination med metformin.
English: Saxagliptin plus metformin was not associated with significant changes from baseline in fasting serum lipids compared to metformin alone.
Danish: Saxagliptin plus metformin blev ikke sat i forbindelse med signifikante ændringer i forhold til baseline i faste-serum-lipider sammenlignet med metformin alene.
English: Skin lesions were not observed at an increased incidence in clinical trials.
Danish: Der blev ikke set hudlæsioner med en forøget incidens i kliniske forsøg.
English: If you have severely reduced kidney function or problems with your liver; If you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems; If you have a severe infection or are dehydrated (have lost a lot of water from your body); If you are breast-feeding (see also “Pregnancy and breast-feeding”); If you drink a large amount of alcohol (either every day or only from time to time) (please see section “Komboglyze with alcohol”);
Danish: - Hvis du har alvorligt nedsat nyrefunktion eller problemer med din lever - Hvis du for nylig har haft et hjerteanfald, eller hvis du har hjertesvigt eller alvorlige problemer med kredsløbet eller åndedrætsbesvær, som kunne være et tegn på hjerteproblemer - Hvis du har en svær infektion eller er dehydreret (har mistet en masse vand fra kroppen) - Hvis du ammer (se også "Graviditet og amning") - Hvis du drikker en stor mængde alkohol (enten hver dag eller kun fra tid til anden) (se punktet "Komboglyze sammen med alkohol")
English: The primary safety (noninferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischaemic stroke.
Danish: De primære endepunkter for sikkerhed (non-inferioritet) og virkning (superioritet) var et sammensat endepunkt bestående af tiden til første forekomst af en af følgende svære kardiovaskulære bivirkninger (MACE): kardiovaskulær død, ikke dødeligt myokardieinfarkt eller ikke dødelig iskæmisk apopleksi.
English: In the confirmatory full analysis set, mean reductions were -0.4% and -0.6% respectively for saxagliptin and sitagliptin, with median reductions of -0.5% for both groups.
Danish: I det konfirmative fulde analysesæt var middelreduktionerne henholdsvis -0,4 % og -0,6 % for saxagliptin og sitagliptin, hvor de mediane reduktioner var -0,5 % for begge grupper.