FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-interventional PASS: In order to estimate the incidence of DKA in T1DM dapagliflozin users following implementation of RMMs in Europe, the MAH should conduct and submit the results from an observational cohort study using existing data sources in European countries where dapagliflozin will be launched for T1DM.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): For at estimere forekomsten af DKA hos T1DM dapagliflozin brugere, efter implementering af risikominimeringsforanstaltninger i Europa, skal indehaveren af markedsføringstilladelsen udføre og indsende resultater fra et observationskohortestudie under anvendelse af eksisterende datakilder i europæiske lande, hvor dapagliflozon lanceres for T1DM.
English: Measurement of blood ketone levels is preferred to urine.
Danish: Måling af ketonniveauer i blod foretrækkes frem for i urin.
English: The percentage of patients achieving ≥ 0.5% reductions in HbA1c without severe hypoglycaemia was significantly higher in patients treated with dapagliflozin compared with placebo (Table 11).
Danish: Andelen af patienter, der opnåede ≥ 0,5 % reduktion i HbA1c uden alvorlig hypoglykæmi, var signifikant højere hos patienter behandlet med dapagliflozin sammenlignet med placebo (tabel 11).
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, "Edistride indeholder").
English: Mean difference in change from baseline between combination and single medicinal product (95% CI)
Danish: Gennemsnitlig forskel i ændring fra baseline mellem kombination og enkelt lægemiddel (95% CI)
English: • Patients should be informed, in a dedicated education session, on the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take at elevated ketone readings (see section 4.4).
Danish: • Patienterne bør under en særlig uddannelsessession informeres om risikoen for DKA, hvordan man genkender DKA-risikofaktorer, -tegn og -symptomer, hvordan og hvornår man skal overvåge ketonniveauerne og hvilke foranstaltninger der skal træffes ved forhøjede ketonmålinger (se pkt.
English: Edistride contains the active substance dapagliflozin.
Danish: Edistride indeholder det aktive stof dapagliflozin.
English: • Patient Alert Card
Danish: • Patientoplysningskort
English: In the two placebo-controlled clinical studies of dapagliflozin in type 1 diabetes mellitus, patients were advised to monitor blood ketones in case of suspected symptoms of DKA and seek medical advice/attention if their self-measured blood ketone reading was ≥ 0.6 mmol/L.
Danish: I de to placebo-kontrollerede kliniske studier med dapagliflozin ved type 1-diabetes mellitus blev patienterne anbefalet at overvåge blodketoner i tilfælde af formodede symptomer på DKA og søge lægelig råd/hjælp, hvis deres selvmålte blodketonmåling var ≥ 0,6 mmol/l.
English: Frequency of adverse reaction was identified from the full study population in 2 placebo-controlled studies in subjects with type 1 diabetes mellitus.
Danish: Hyppigheden af bivirkninger blev identificeret fra den samlede studiepopulation i to placebokontrollerede studier med forsøgspersoner med type 1-diabetes mellitus.
English: • For pump users: restrict dapagliflozin prescription to patients experienced in pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur in case of pump failure.
Danish: • Til pumpebrugere: begræns ordination af dapagliflozin til patienter, der har erfaring med brug af pumpe samt løsning af almindelige problemer, når insulinleveringen via pumpe afbrydes i tilfælde af, at pumpen svigter.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal aflevere medicinrester.
English: Obligation to conduct post-authorisation measures: The MAH shall complete, within the stated timeframe, the below measures: Description
Danish: Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Adverse reactions in placebo-controlled clinical studies a and postmarketing experience
Danish: Bivirkninger i placebokontrollerede kliniske studier a og erfaring efter markedsføring
English: In type 1 diabetes mellitus studies with dapagliflozin, DKA was reported with common frequency.
Danish: I studier af type 1-diabetes mellitus med dapagliflozin blev DKA rapporteret med almindelig frekvens.
English: Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin.
Danish: Sjældne tilfælde af DKA, herunder livstruende og letale tilfælde, er blevet rapporteret hos patienter behandlet med SGLT2-hæmmere, herunder dapagliflozin.
English: • The Patient Alert Card should be presented to any HCP consulted.
Danish: • Patientoplysningskortet skal vises til alle læger, som konsulteres
English: Hypoglycaemia (when used with SU or insulin)
Danish: Hypoglykæmi (ved samtidig anvendelse af SU eller insulin)
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Danish: Den primære vurdering af sikkerhed og tolerabilitet blev udført i en planlagt puljet analyse af 13 placebo-kontrollerede studier af kort varighed (op til 24 uger) med 2.360 forsøgspersoner behandlet med dapagliflozin 10 mg, og 2.295 blev behandlet med placebo.
English: Taking this medicine with other medicines called sulphonylureas or with insulin can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Danish: Hvis du tager 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: - in addition to other medicinal products for the treatment of type 2 diabetes.
Danish: - som tillægsbehandling til andre lægemidler til behandling af type 2-diabetes.
English: Reported in the cardiovascular outcomes study in patients with type 2 diabetes.
Danish: Rapporteret i studier med kardiovaskulære hændelser hos patienter med type 2-diabetes.
English: Patients must be informed about what actions to take if ketone levels are elevated.
Danish: Patienterne skal informeres om, hvilke foranstaltninger der skal træffes, hvis ketonniveauet er forhøjet.
English: Urine laboratory assessments Due to its mechanism of action, patients taking Edistride will test positive for glucose in their urine.
Danish: På grund af lægemidlets virkningsmekanisme vil patienter, der tager Edistride, få et positivt analyseresultat for glukose i urinen.
English: • type 1 diabetes - where your body hardly produces any insulin.
Danish: • type 1-diabetes - hvor din krop nærmest ikke producerer noget insulin.
English: Edistride 10 mg Tablets Type 2 diabetes: Medicinal product subject to medical prescription.
Danish: Edistride 10 mg: Type 2-diabetes: Lægemidlet er receptpligtigt.
English: Ketones should be monitored on a regular basis during the initial one to two weeks, then the frequency of ketone level testing should be individualised, according to the patient's lifestyle and/or risk factors (see section 4.2).
Danish: Ketoner bør monitoreres regelmæssigt i løbet af de indledende 1-2 uger, og derefter bør hyppigheden af ketonniveautest individualiseres efter patientens livsstil og/eller risikofaktorer (se pkt.
English: Edistride has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Danish: Edistride er ikke undersøgt ved alvorlig nedsat nyrefunktion (GFR <30 ml/min) eller hos patienter i terminal nyresygdom (ESRD).
English: • The other ingredients are: tablet core: microcrystalline cellulose (E460i), lactose (see section 2 ‘Edistride contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Danish: • Øvrige indholdsstoffer: tabletkerne: mikrokrystallinsk cellulose (E460i), laktose (se punkt 2 "Edistride indeholder laktose"), crospovidon (E1202), siliciumdioxid (E551), magnesiumstearat (E470b).
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with a sulphonylurea or insulin
Danish: • lavt blodsukker (hypoglykæmi) - når Edistride tages sammen med et sulfonylurinstof eller insulin
English: Edistride is used for the type of diabetes called type 2 diabetes - where your body does not make enough insulin or is not able to use the insulin it produces properly.
Danish: Edistride anvendes til den type diabetes, som kaldes type 2-diabetes - hvor din krop ikke producerer nok insulin, eller kroppen ikke kan udnytte det insulin, som den producerer, godt nok.
English: Metformin or metformin hydrochloride were part of the usual care in 69.4% and 64.0% of the patients for the dapagliflozin and placebo groups, respectively.
Danish: Metformin eller metforminhydrochlorid var en del af den normale behandling for henholdsvis 69,4% og 64,0% af patienterne i dapagliflozin-gruppen og placebo-gruppen.
English: Use in patients at risk for volume depletion and/or hypotension Due to its mechanism of action, dapagliflozin increases diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see section 5.1).
Danish: Anvendelse til patienter med risiko for volumendepletering og/eller hypotension Dapagliflozins virkningsmekanisme øger diuresen, hvilket kan medføre det moderate blodtryksfald, der er observeret i kliniske studier (se pkt.
English: In two placebo-controlled studies in subjects with type 1 diabetes mellitus, 548 subjects were treated with dapagliflozin 5 mg plus adjustable insulin and 532 were treated with placebo plus adjustable insulin.
Danish: I to placebokontrollerede studier hos patienter med type 1-diabetes mellitus blev 548 forsøgspersoner behandlet med dapagliflozin 5 mg plus justerbart insulin, og 532 blev behandlet med placebo plus justerbart insulin.
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
Danish: Den gennemsnitlige procentvise ændring fra baseline for dapagliflozin 10 mg versus placebo var hhv.: Total kolesterol 2,5 % versus 0,0 %; HDL-kolesterol 6,0 % versus 2,7 %; LDL-kolesterol 2,9 % versus -1,0 %; triglycerider -2,7 % versus -0,7 %.
English: • increases in the amount of red blood cells in your blood (shown in tests)
Danish: • øgning af antal røde blodlegemer i blodet (påvist i blodprøver)
English: • Dapagliflozin should be temporarily stopped before surgical procedures or hospitalisation for acute serious illness.
Danish: • Dapagliflozin skal midlertidigt stoppes før kirurgi eller indlæggelse for akut alvorlig sygdom
English: 6 of 23 events of DKA in the dapagliflozin 5 mg group occurred in patients with blood glucose in the euglycaemic range (< 14 mmol/L or 250 mg/dL).
Danish: 6 ud af 23 hændelser af DKA i gruppen med dapagliflozin 5 mg forekom hos patienter med blodglukose i det euglykæmiske område (<14 mmol/l eller 250 mg/dl).
English: Prolonged-release exenatide 2 mg QW
Danish: Depot formulering af exenatid 2 mg QW
English: Results at Week 24 of two placebo-controlled clinical studies of dapagliflozin as an adjunct to insulin in adults with type 1 diabetes mellitus
Danish: Resultater ved uge 24 af to placebokontrollerede kliniske studier med dapagliflozin som et supplement til insulin hos voksne med type 1-diabetes mellitus
English: Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure.
Danish: Patienter, som bruger en infusionspumpe til insulin, har en højere risiko for DKA og bør have erfaring med brug af pumpe, løsning af almindelige problemer, hvis der forekommer afbrydelser af insulinlevering via pumpen (problemer med indsættelsesstedet, stoppet slange, tom beholder etc.) og brug af supplerende insulininjektioner med pen eller sprøjte efter behov i tilfælde af, at pumpen ikke virker.
English: Prior to launch of the new adult indication for dapagliflozin, for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Yderligere risikominimeringsforanstaltninger Før lancering af den nye indikation for dapagliflozin for voksne til behandling af utilstrækkeligt kontrolleret type 1-diabetes mellitus som supplement til insulin til patienter med BMI ≥ 27 kg/m2, når insulin alene ikke giver tilstrækkelig glykæmisk kontrol på trods af optimal insulinbehandling, skal indehaveren af markedsføringstilladelsen (MAH) i hvert medlemsland blive enige med de nationale kompetente myndigheder om indhold og format af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmåder og eventuelt andre aspekter af programmet.
English: These are signs of dehydration: - very dry or sticky mouth, feeling very thirsty - feeling very sleepy or tired - passing little or no water (urine) - fast heartbeat.
Danish: Følgende er tegn på dehydrering: - meget tør eller klæbrig mund, at du føler dig meget tørstig - at du føler dig meget søvnig eller træt - at du lader meget lidt eller intet vand (urin) - hurtig hjerterytme.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 1 diabetes patients, 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 beta-cellefunktionsreserve (f.eks. type 1-diabetespatienter, type 2-diabetespatienter med lavt C-peptid eller latent autoimmun diabetes hos voksne (LADA) og patienter med pankreatitis i anamnesen) , patienter med tilstande, der fører til begrænset fødeindtag eller alvorlig dehydrering, patienter for hvem insulindoserne er reduceret, og patienter med øget insulinbehov på grund af akut medicinsk sygdom, kirurgi eller alkoholmisbrug.
English: In active- and placebo-controlled clinical studies (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Danish: I aktive og placebokontrollerede kliniske studier (dapagliflozin, N=5.936, alle kontroller, N=3.403) var hyppigheden af udslæt den samme for henholdsvis dapagliflozin (1,4 %) og alle kontroller (1,4 %).
English: • Contact details of the dapagliflozin prescriber' and ‘Name of patient'.
Danish: • Kontaktinformation på lægen, der har ordineret dapagliflozin og patientens navn.
English: A cardiovascular outcomes study (DECLARE) was conducted with dapagliflozin 10 mg compared with placebo in 17,160 patients with type 2 diabetes mellitus with or without established cardiovascular disease to evaluate the effect on cardiovascular and renal events.
Danish: Der blev udført et studie med kardiovaskulære hændelser (DECLARE) med dapagliflozin 10 mg sammenlignet med placebo hos 17.160 patienter med type 2-diabetes mellitus med eller uden konstateret kardiovaskulær sygdom for at evaluere virkningen på kardiovaskulære og renale bivirkninger.
English: • diabetic ketoacidosis - this is common in patients with type 1 diabetes (may affect up to 1 in 10 people) and rare in patients with type 2 diabetes (may affect up to 1 in 1,000 people).
Danish: • diabetisk ketoacidose, dette er almindeligt hos patienter med type 1-diabetes (kan forekomme hos op til 1 ud af 10 personer) og sjældent hos patienter med type 2-diabetes (kan forekomme hos op til 1 ud af 1.000 personer)
English: Edistride and other diabetes medicines Edistride is used if your type 2 diabetes cannot be controlled with diet and exercise.
Danish: Edistride og anden diabetesmedicin Edistride anvendes, hvis din type 2-diabetes ikke kan kontrolleres med diæt og motion.
English: What Edistride contains
Danish: Edistride indeholder
English: Edistride is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance.
Danish: Edistride er indiceret til voksne til behandling af utilstrækkelig kontrolleret type 2-diabetes mellitus i tillæg til diæt og motion - som monoterapi når metformin ikke anses for velegnet på grund af intolerance.
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5%, 4.3% and 5.0%, respectively) experienced at least one event of hypoglycaemia compared to the group treated with glipizide (40.8%, 47.0% and 50.0%, respectively).
Danish: Ved uge 52, 104 og 208 havde en betydeligt lavere andel af forsøgspersonerne i dapagliflozin-gruppen (hhv. 3,5 %, 4,3 % og 5,0 %) oplevet mindst ét tilfælde af hypoglykæmi sammenlignet med med glipizid-gruppen (hhv. 40,8 %, 47,0 % og 50,0 %).
English: The safety profile of dapagliflozin in subjects with type 1 diabetes mellitus was similar to the known safety profile of dapagliflozin in subjects with type 2 diabetes mellitus, with the exception of a higher number of DKA events in dapagliflozin-treated subjects in the type 1 diabetes mellitus studies.
Danish: Sikkerhedsprofilen for dapagliflozin hos personer med type 1-diabetes mellitus svarede til den kendte sikkerhedsprofil for dapagliflozin hos personer med type 2-diabetes mellitus med undtagelse af et højere antal DKA-hændelser hos dapagliflozin-behandlede forsøgspersoner i type 1-diabetes mellitusstudierne.
English: The MAH shall ensure that in each Member State where dapagliflozin is marketed for type 1 diabetes, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use the product have access to:
Danish: MAH skal sikre, at alt sundhedspersonale og patienter/omsorgspersoner, som forventes at ordinere, administrere eller bruge produktet, i hvert medlemsland, hvor dapagliflozin markedsføres til type 1-diabetes, har adgang til:
English: The patient should immediately seek medical advice and stop taking dapagliflozin if levels persist and symptoms present.
Danish: Patienten skal straks søge lægehjælp og stoppe med at tage dapagliflozin, hvis niveauerne er vedvarende og der er symptomer.
English: The number of patients with severe hypoglycaemia was balanced across treatment groups (6.9% and 7.5% at Week 24 in the dapagliflozin 5 mg and placebo groups, respectively).
Danish: Antallet af patienter med svær hypoglykæmi var afbalanceret på tværs af behandlingsgrupper (henholdsvis 6,9 % og 7,5 % ved uge 24 i dapagliflozin 5 mg og placebogruppen).
English: • type 2 diabetes - where your body does not make enough insulin or is not able to use the insulin it produces properly.
Danish: • type 2-diabetes - hvor din krop ikke producerer nok insulin eller kroppen ikke kan udnytte det insulin, som den producerer, godt nok.
English: • decreases in creatinine renal clearance (shown in tests) in the beginning of treatment
Danish: • nedsat kreatininclearance (påvist i prøver) i starten af behandlingen
English: Results of one 28-week study of dapagliflozin and prolonged-release exenatide versus dapagliflozin alone and prolonged-release exenatide alone, in combination with metformin (intent to treat patients)
Danish: Resultater af et 28-ugers studie med dapagliflozin og depotformulering af exenatid versus dapagliflozin alene og depotformulering af exenatid alene i kombination med metformin (intent-to-treat patienter)
English: Actions
Danish: Foranstaltninger
English: During the initial one to two weeks of treatment with dapagliflozin, ketones should be monitored on a regular basis, then the frequency of ketone level testing should be individualized, according to the patient's lifestyle and/or risk factors (see section 4.4).
Danish: Under de første 1-2 uger af behandling med dapagliflozin bør ketoner monitoreres regelmæssigt, og derefter bør hyppigheden af test af ketonniveau individualiseres i overensstemmelse med patientens livsstil og/eller risikofaktorer (se pkt.
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/mL and 628 ng h/mL, respectively.
Danish: De geometriske gennemsnitlige steady state Cmax- og AUCτ-værdier for dapagliflozin efter én daglig 10 mg dosis dapagliflozin var henholdsvis 158 ng/ml og 628 ng t/ml.
English: Crospovidone (E1202) Silicon dioxide (E551) Magnesium stearate (E470b)
Danish: Crospovidon (E1202) Siliciumdioxid (E551) Magnesiumstearat (E470b)
English: Type 1 diabetes: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Type 1-diabetes: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Results at Week 24 (LOCF a) of a placebo-controlled study of dapagliflozin as monotherapy
Danish: Resultaterne ved uge 24 (LOCF a) af et placebo-kontrolleret studie af dapagliflozin som monoterapi
English: Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Danish: Edistride er indiceret til voksne til behandling af utilstrækkeligt kontrolleret type 1-diabetes mellitus i tillæg til insulin til patienter med BMI ≥ 27 kg/m2, når insulin alene ikke giver tilstrækkelig glykæmisk kontrol på trods af optimal insulinbehandling.
English: If you forget to take Edistride
Danish: Hvis du har glemt at tage Edistride
English: • increases in urea (shown in laboratory blood tests)
Danish: • forhøjet urea (viser sig ved laboratorieblodprøver)
English: If you stop taking Edistride
Danish: Hvis du holder op med at tage Edistride
English: Following an 8-week lead-in period to optimise each patient's diabetes management (glycaemic control including hyperglycaemia and hypoglycaemia, diet and exercise patterns), a total of 1,646 patients with HbA1c ≥ 7.5% and ≤ 10.5% were randomised to 5 mg dapagliflozin once daily, 10 mg dapagliflozin once daily or placebo once daily.
Danish: Efter en 8 ugers indledningsperiode for at optimere hver patients diabetesbehandling (glykæmisk kontrol inklusive hyperglykæmi og hypoglykæmi, diæt- og motionsmønstre) blev der i alt randomiseret 1.646 patienter med HbA1c ≥ 7,5 % og ≤10,5 % til enten 5 mg dapagliflozin en gang dagligt, 10 mg dapagliflozin en gang dagligt eller placebo en gang dagligt.
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350
Danish: Filmovertræk Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 3350