FrancophonIA/ELRC3.0 huggingface dataset:
English: Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Danish: Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italien
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy (see section 5.3).
Danish: Studier med rotter har påvist toksicitet for udviklingen af nyrerne i den tidsperiode, der svarer til andet og tredje trimester af menneskets graviditet (se pkt.
English: “Type 2 diabetes mellitus” is the type of diabetes that usually starts when you are older.
Danish: Type 2-diabetes er den type diabetes, som sædvanligvis starter hos ældre personer.
English: • If it is less than 12 hours until your next dose, skip the missed dose.
Danish: • Hvis der er mindre end 12 timer til den næste dosis: Spring den glemte tablet over.
English: Kidney function Your kidneys should be checked before you start taking and whilst you are on this medicine.
Danish: Nyrefunktionen Dine nyrer skal kontrolleres, før du begynder at tage denne medicin og mens du tager den.
English: • if you have a liver problem - your doctor may start you on a lower dose.
Danish: • Hvis du har et leverproblem - din læge vil måske give dig en lavere startdosis.
English: Your doctor may prescribe Forxiga together with other medicine(s) to lower the amount of sugar in your blood.
Danish: Din læge kan ordinere Forxiga sammen med anden medicin for at sænke sukkerindholdet i blodet.
English: Contact your doctor as soon as possible if you have any of the following side effects:
Danish: Kontakt snarest muligt din læge, hvis du får en af følgende bivirkninger:
English: Pyelonephritis was uncommon and occurred at a similar frequency to control.
Danish: Pyelonefritis var ikke almindelig og forekom med samme hyppighed som i kontrolgruppen.
English: Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Danish: Dapagliflozin er en potent (Ki: 0,55 nM), selektiv og reversibel hæmmer af natriumglucose cotransportstof 2 (SGLT2).
English: Difference from placebo c
Danish: Forskel fra placebo c
English: Before initiating dapagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden behandlingen med dapagliflozin påbegyndes, skal faktorer i patientens anamnese, der kan prædisponere for ketoacidose, vurderes.
English: Maternal toxicity was evident only at the highest dose tested, and limited to transient reductions in body weight and food consumption at dose.
Danish: Maternel toksicitet blev kun påvist ved højeste testdosis og var begrænset til forbigående reduktion i legemsvægt og foderindtagelse ved dosering.
English: The mean steady-state volume of distribution of dapagliflozin was 118 l.
Danish: Det gennemsnitlige steady-statefordelingsvolumen af dapagliflozin var 118 l.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og fertilitet.
English: Fifty-two percent (52%) had mild renal impairment and 11% had moderate renal impairment.
Danish: 52 % havde let nedsat nyrefunktion, og 11 % havde moderat nedsat nyrefunktion.
English: Available epidemiological data for pioglitazone suggest a small increased risk of bladder cancer in diabetic patients treated with pioglitazone.
Danish: De foreliggende epidemiologiske data for pioglitazon tyder på en mindre stigning i risikoen for blærekræft hos patienter med diabetes, der får pioglitazon.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: The SGLT2 is selectively expressed in the kidney with no expression detected in more than 70 other tissues including liver, skeletal muscle, adipose tissue, breast, bladder and brain.
Danish: SGLT2 findes selektivt i nyrerne, uden at der er påvist ekspression i over 70 andre væv inklusive lever, skeletmuskulatur, fedtvæv, bryster, blære og hjerne.
English: AstraZeneca Czech Republic s.r.o.
Danish: Česká republika AstraZeneca Czech Republic s.r.o.
English: In an add-on to metformin and a sulphonylurea study, up to 24 weeks, no episodes of major hypoglycaemia were reported.
Danish: I et studie med tillægsbehandling til metformin og et sulfonylurinstof i op til 24 uger blev der ikke rapporteret nogen tilfælde af svær hypoglykæmi.
English: The primary end point was the time-to-first event of one of the following outcomes: cardiovascular death, stroke, myocardial infarction (MI) or hospitalisation for unstable angina.
Danish: Det primære endepunkt var tidspunktet til første forekomst af et af følgende: kardiovaskulært dødsfald, stroke, myokardieinfarkt (MI) eller indlæggelse som følge af ustabil angina pectoris.
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2% as unchanged dapagliflozin.
Danish: Dapagliflozin og relaterede metabolitter elimineres primært via udskillelse i urinen med mindre end 2 % som uændret dapagliflozin.
English: Dapagliflozin does not impair normal endogenous glucose production in response to hypoglycaemia.
Danish: Dapagliflozin hæmmer ikke den normale endogene glucoseproduktion som reaktion på hypoglykæmi.
English: Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose).
Danish: Dapagliflozin viste ingen toksicitet hos raske forsøgspersoner ved orale enkeltdoser op til 500 mg (50 gange den maksimale anbefalede humane dosis).
English: Pruritus genital
Danish: Genital pruritus
English: Protein binding was not altered in various disease states (e.g. renal or hepatic impairment).
Danish: Proteinbindingen blev ikke ændret i forskellige sygdomstilstande (f.eks. nedsat nyre- eller leverfunktion).
English: Increased creatinine
Danish: Øget kreatinin
English: Dapagliflozin 3-O-glucuronide or other metabolites do not contribute to the glucose-lowering effects.
Danish: Dapagliflozin 3-O-glucuronid eller andre metabolitter bidrager ikke til den glucosesænkende virkning.
English: Adverse drug reactions related to increased creatinine were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Danish: Bivirkninger, relateret til øget kreatinin blev grupperet (f.eks. nedsat renal kreatininclearance, nedsat nyrefunktion, øget kreatinin i blodet og nedsat glomerulær filtrationshastighed).
English: What Forxiga contains
Danish: Forxiga indeholder
English: These infections were more frequent in females (8.4% and 1.2% for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Danish: Disse infektioner sås hyppigere hos kvinder (hhv. 8,4 % og 1,2 % for dapagliflozin og placebo), og forsøgspersoner med tidligere infektion var mere tilbøjelige til at få en recidiverende infektion.
English: fPolyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Danish: Polyuri inkluderer de foretrukne termer: pollakisuri, polyuri, øget urinproduktion.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dapagliflozin in one or more subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om at fremlægge resultaterne af studier med dapagliflozin i en eller flere undergrupper af den pædiatriske population til behandling af type 2diabetes (se pkt.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer)
English: Bone mineral density measurements in patients with normal or mildly impaired renal function did not indicate bone loss over a treatment period of two years.
Danish: Målinger af knoglemineraldensiteten hos patienter med normal og let nedsat nyrefunktion viste ingen tegn på knogletab i løbet af behandlingsperioden på to år.
English: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis.
Danish: Udskillelse af glucose i urinen kan være forbundet med en øget risiko for urinvejsinfektioner; derfor bør en midlertidig afbrydelse af behandlingen med dapagliflozin overvejes ved behandling af pyelonefritis eller urosepsis.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring (see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist udskillelse af dapagliflozin/metabolitter i mælk, såvel som farmakologisk fremkaldte virkninger på diende afkom (se pkt.
English: The no observed adverse effect level (NOAEL) for developmental toxicity, the lowest dose tested, is associated with a maternal systemic exposure multiple that is approximately 19 times the human value at the maximum recommended human dose.
Danish: No observed adverse effect level, (NOAEL) for udviklingsmæssig toksicitet, den laveste dosis testet, er forbundet med en multipel af moderdyrets systemiske eksponering, som er ca. 19 gange den humane værdi ved den maksimale anbefalede humane dosis.
English: Administration with a high-fat meal decreased dapagliflozin Cmax by up to 50% and prolonged Tmax by approximately 1 hour, but did not alter AUC as compared with the fasted state.
Danish: Indgivelse med et fedtrigt måltid reducerede dapagliflozin Cmax med op til 50 % og forlængede Tmax med ca. 1 time, men ændrede ikke AUC i sammenligning med den fastende tilstand.
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19% increase in AUC of simvastatin and 31% increase in AUC of simvastatin acid.
Danish: En kombination af en enkeltdosis dapagliflozin 20 mg og simvastatin (et CYP3A4-substrat) resulterede i en 19 %-forøgelse i AUC for simvastatin og en 31 %-forøgelse i AUC for simvastatinsyre.
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 DKA optræder med hyppigheden ”almindelig”, når patienter med type 1-diabetes behandles med SGLT2-hæmmere.
English: The effect of dapagliflozin on fertility in humans has not been studied.
Danish: Virkningen af dapagliflozin på fertiliteten hos mennesker er ikke undersøgt.
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 times the maximum recommended human dose.
Danish: Hos rotter var dapagliflozin hverken embryoletal eller teratogen ved eksponeringer op til 1.441 gange den maksimale anbefalede humane dosis.
English: The results showed a similar mean reduction in HbA1c from baseline to Week 52, compared to glipizide, thus demonstrating non-inferiority (Table 3).
Danish: Resultaterne viste den samme gennemsnitlige reduktion i HbA1c fra baseline til uge 52 som for glipizid og påviste dermed non-inferioritet (tabel 3).
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Danish: SGLT2 er det vigtigste transportstof, som er ansvarlig for reabsorption af glucose fra det glomerulære filtrat tilbage i kredsløbet.
English: The incidence of hypoglycaemia was similar to placebo.
Danish: Hyppigheden af hypoglykæmi var den samme som med placebo.
English: • if you are allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for dapagliflozin eller et af de øvrige indholdsstoffer (se listen under punkt 6, "Forxiga indeholder").
English: Most infections were mild to moderate, and subjects responded to an initial course of standard treatment and rarely resulted in discontinuation from dapagliflozin treatment.
Danish: De fleste infektioner var milde til moderate, og forsøgspersonerne responderede på standardbehandling og var sjældent nødt til at stoppe behandlingen med dapagliflozin.
English: Although uncommon, if you see blood in your urine, tell your doctor immediately.
Danish: Hvis du ser blod i urinen, skal du straks fortælle det til din læge; dette forekommer dog sjældent.
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: Patienter, der kan have højere risiko for DKA, omfatter patienter med lav restfunktion af betaceller (f.eks. type 2-diabetespatienter med lavt C-peptid, latent autoimmun diabetes hos voksne (LADA) eller patienter med pankreatitis i anamnesen), patienter med tilstande, der medfører lav fødeindtagelse eller alvorlig dehydrering, patienter, hvis insulindosis er reduceret, samt patienter med øget behov for insulin på grund af akut sygdom, operation eller alkoholmisbrug.
English: Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Danish: Kontakt straks en læge eller nærmeste skadestue, hvis du får nogen af følgende bivirkninger:
English: Rates of adverse events including dehydration or hypotension were similar to placebo, and there were no clinically meaningful dose-related changes in laboratory parameters, including serum electrolytes and biomarkers of renal function.
Danish: Hyppigheden af bivirkninger inklusive dehydrering eller hypotension var de samme som ved placebo, og der var ingen klinisk relevante dosisrelaterede ændringer i laboratorieparametre, inklusive serumelektrolytter og biomarkører for nyrefunktion.
English: Volume depletion
Danish: Volumendepletering
English: The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Danish: Dannelsen af dapagliflozin 3-O-glucuronid medieres af UGT1A9, et enzym i lever og nyrer, og den CYP-medierede metabolisme var en mindre clearance pathway hos mennesker.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: Diabetic Ketoacidosis i
Danish: Diabetisk ketoacidose i
English: The most commonly reported adverse reaction related to renal function was increased serum creatinine.
Danish: De mest almindeligt rapporterede bivirkninger relateret til nyrefuntionen var stigning i serum kreatinin.
English: However, the differences in exposure were not considered clinically meaningful.
Danish: Forskellene i eksponering blev dog ikke betragtet som klinisk relevante.
English: Forxiga contains the active substance dapagliflozin.
Danish: Forxiga indeholder det aktive stof dapagliflozin.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer)
English: When considering the cases of tumours occurring in the different organ systems, the relative risk associated with dapagliflozin was above 1 for some tumours (bladder, prostate, breast) and below 1 for others (e.g. blood and lymphatic, ovary, renal tract), not resulting in an overall increased tumour risk associated with dapagliflozin.
Danish: Ved vurdering af tilfældene af tumorer, der forekom i de forskellige organsystemer, var den relative risiko associeret med dapagliflozin over 1 for nogle tumorer (blære, prostata, bryst) og under 1 for andre (f.eks. blod og lymfesystemet, ovarier, nyrer), hvilket ikke resulterede i en samlet øget risiko for tumorer associeret med dapagliflozin.
English: • changes in the amount of cholesterol or fats in your blood (shown in tests)
Danish: • ændringer i mængden af kolesterol eller fedtstoffer i blodet (påvist i blodprøver)
English: The safety and efficacy of dapagliflozin in patients with type 1 diabetes have not been established and dapagliflozin should not be used for treatment of patients with type 1 diabetes.
Danish: Dapagliflozins sikkerhed og virkning hos patienter med type 1-diabetes er ikke klarlagt, og dapagliflozin bør ikke anvendes til patienter med type 1-diabetes.
English: The reductions in HbA1c observed at Week 24 were sustained in add-on combination studies (glimepiride and insulin) with 48-week data (glimepiride) and up to 104-week data (insulin).
Danish: Reduktionen i HbA1c efter uge 24 var vedvarende i tillægskombinationsstudier (glimepirid og insulin) med 48 ugers data (glimepirid) og op til 104 ugers data (insulin).
English: Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (time periods corresponding to the second and third trimesters of pregnancy with respect to human renal maturation) and lactation are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
Danish: Direkte indgivelse af dapagliflozin i unge rotter under afvænning og indirekte eksponering i den sene graviditet (tidsperiode, der svarer til andet og tredje trimester af graviditeten hvad angår modningen af nyrerne hos mennesker) og amning er hver især forbundet med øget forekomst af og/eller sværhedsgrad af dilatation af nyrebækken og -tubuli hos afkom.
English: There is limited experience in clinical trials in patients with hepatic impairment.
Danish: Der er begrænset erfaring fra kliniske studier med patienter med nedsat leverfunktion.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 ml/min.
Danish: Den gennemsnitlige totale systemiske clearance af dapagliflozin indgivet intravenøst var 207 ml/min.
English: The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively.
Danish: Steady-state-udskillelsen af glucose i urinen over 24 timer var stærkt afhængig af nyrefunktionen, og der blev udskilt 85, 52, 18 og 11 g glucose/dag af forsøgspersoner med type 2-diabetes mellitus og normal nyrefunktion eller henholdsvis let, moderat eller svært nedsat nyrefunktion.
English: • Forxiga is used if your diabetes cannot be controlled with other medicines for diabetes, diet and exercise.
Danish: • Forxiga anvendes, hvis din diabetes ikke kan kontrolleres med andre antidiabetiske lægemidler,
English: In two 12-week, placebo-controlled studies a total of 1,062 patients with inadequately controlled type 2 diabetes and hypertension (despite pre-existing stable treatment with an ACE-I or ARB in one study and an ACE-I or ARB plus one additional antihypertensive treatment in another study) were treated with dapagliflozin 10 mg or placebo.
Danish: I to 12-ugers placebokontrollerede studier med i alt 1.062 patienter med utilstrækkeligt kontrolleret type 2-diabetes og hypertension (på trods af eksisterende stabil behandling med en ACE-hæmmer eller en ARB i det ene studie og en ACE-hæmmer eller en ARB plus yderligere antihypertensiv behandling i det andet studie) blev patienter behandlet med dapagliflozin 10 mg eller placebo.
English: The mean plasma terminal half-life (t1/2) for dapagliflozin was 12.9 hours following a single oral dose of dapagliflozin 10 mg to healthy subjects.
Danish: Den gennemsnitlige endelige halveringstid i plasma (t1/2) for dapagliflozin var 12,9 timer efter en enkelt oral dosis af dapagliflozin 10 mg til raske forsøgspersoner.
English: In in vitro studies, dapagliflozin neither inhibited cytochrome P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, nor induced CYP1A2, CYP2B6 or CYP3A4.
Danish: I in vitro-studier medførte dapagliflozin hverken hæmning af CYP 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 eller induktion af CYP1A2, CYP2B6 eller CYP3A4.
English: Taking this medicine with other medicines called sulphonylureas or with insulin can cause too low blood sugar levels (hypo-glycaemia), 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 dette lægemiddel sammen med visse andre lægemidler såsom sulfonylurinstoffer eller insulin, kan dit blodsukker blive for lavt (hypoglykæmi), hvilket kan give symptomer såsom rysten, svedudbrug eller synspåvirkning og kan påvirke din evne til at færdes i trafikken eller betjene maskiner.
English: Reproductive and developmental toxicity
Danish: Reproduktions- og udviklingstoksicitet
English: Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks.
Danish: Eksponeringen for dapagliflozin øgedes proportionalt med stigningen i dapagliflozindosis over området fra 0,1 til 500 mg, og dets farmakokinetik ændredes ikke over tid ved gentagen daglig dosis i op til 24 uger.
English: • The active substance is dapagliflozin.
Danish: • Aktivt stof: dapagliflozin.
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 i tilfælde af ikke-specifikke symptomer, såsom kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, konfusion, usædvanlig træthed eller søvnighed.
English: A double-blind, placebo-controlled study of 24-week duration (with an additional extension period) was conducted to evaluate the safety and efficacy of monotherapy with Forxiga in subjects with inadequately controlled type 2 diabetes mellitus.
Danish: Der blev udført et dobbeltblindt, placebokontrolleret studie af 24 ugers varighed (med en yderligere forlængelsesperiode) for at vurdere virkning og sikkerhed af Forxiga i monoterapi hos forsøgspersoner med utilstrækkeligt kontrolleret type 2-diabetes mellitus.
English: • changes in the amount of red blood cells in your blood (shown in tests)
Danish: • ændringer i mængden af røde blodlegemer i blodet (påvist i blodprøver)
English: The recommended dose is 10 mg dapagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
Danish: Den anbefalede dosis er 10 mg dapagliflozin én gang dagligt som monoterapi eller som tillægsbehandling i kombination med andre glucosesænkende midler inklusive insulin.