FrancophonIA/ELRC3.0 huggingface dataset:
English: C-cell hyperplasia and adenoma were seen at all doses in rats and a no observed adverse effect level (NOAEL) could be not defined.
Danish: C-cellehyperplasi og adenomer sås hos rotter og mus uanset dosisniveau og nul-bivirknings-niveauet (NOAEL) kunne ikke defineres.
English: The green 10 micrograms Lyxumia pen is empty when the black plunger has reached ‘0' on the dose scale and the injection button cannot be pulled out fully.
Danish: Den grønne 10 mikrogram Lyxumia-pen er tom, når det sorte stempel har nået ”0” på dosisskalaen, og injektionsknappen ikke kan trækkes helt ud.
English: These side effects were mostly mild and usually go away over time.
Danish: Disse bivirkninger var oftest milde, og forsvinder normalt med tiden.
English: For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before or 4 hours after lixisenatide injection.
Danish: For orale lægemidler, hvis effekt er særlig afhængig af tærskelkoncentrationer, så som antibiotika, bør patienterne rådes til at tage disse lægemidler mindst 1 time før eller 4 timer efter injektion af lixisenatid.
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
Danish: • Kraftige eller vedholdende mavesmerter, som kan stråle ud i ryggen, samt kvalme og opkastning, da det kan være et tegn på infektion i bugspytkirtlen (pancreatitis).
English: If you use more Lyxumia than you should, talk to your doctor immediately.
Danish: Hvis du har taget for meget Lyxumia, skal du omgående kontakte din læge.
English: Lixisenatide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in intracellular cyclic adenosine monophosphate (cAMP).
Danish: Lixisenatids virkning medieres via en specifik interaktion med GLP-1-receptorer, som medfører en forøgelse af intracellulært cyklisk adenosinmonophosphat (cAMP).
English: • Protect your Lyxumia pens from dust and dirt.
Danish: • Beskyt dine Lyxumia-penne mod støv og snavs.
English: • The starting dose is 10 micrograms once a day for the first 14 days - injected using the green pen.
Danish: • Startdosis er 10 mikrogram én gang dagligt i de første 14 dage - injiceret med den grønne pen.
English: After stopping the treatment, few antibody positive patients were followed up for antibody status; the percentage decreased to approximately 90% within 3 months and 30% at 6 months or beyond.
Danish: Efter behandlingsophør blev nogle få antistofpositive patienter fulgt op med hensyn til antistofstatus; andelen faldt til omtrent 90 % indenfor tre måneder, og 30 % efter seks måneder og derover.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lyxumia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om at fremlægge resultater af studier med Lyxumia i en eller flere undergrupper af den pædiatriske population i type 2-diabetes mellitus (se pkt.
English: If it is still hard to press the injection button, your Lyxumia pen may be damaged.
Danish: Hvis det stadig er svært at trykke injektionsknappen ind, kan din Lyxumia-pen være beskadiget.
English: • You can clean the outside of your Lyxumia pen by wiping it with a damp cloth.
Danish: • Du kan rengøre ydersiden af Lyxumia-pennen ved at tørre den af med en fugtig klud.
English: Lixisenatide provided significant improvements in HbA1c (-0.64% change compared to placebo; 95% CI: -0.810% to -0.464%; p<0.0001), from a mean baseline HbA1c of 8.0%.
Danish: Lixisenatid medførte signifikante forbedringer i HbA1c (-0,64 % ændring sammenlignet med placebo; 95 % KI: -0,810 % til -0,464 %; p<0,0001), fra en gennemsnitlig baseline HbA1c på 8,0 %.
English: The most common adverse reactions which led to treatment discontinuation in the lixisenatide group were nausea (3.1%) and vomiting (1.2%).
Danish: De mest almindelige bivirkninger, der førte til behandlingsophør i lixisenatidgruppen, var kvalme (3,1 %) og opkastning (1,2 %).
English: Patients treated with lixisenatide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Danish: Patienter behandlet med lixisenatid bør informeres om den potentielle risiko for dehydrering i forbindelse med gastrointestinale bivirkninger og træffe foranstaltninger for at undgå væskemangel.
English: Keep this leaflet for future reference.
Danish: Gem denne vejledning til fremtidig brug.
English: Gastro-resistant formulations containing substances sensitive to stomach degradation, should be administered 1 hour before or 4 hours after lixisenatide injection.
Danish: Gastro-resistente formuleringer, der indeholder stoffer, som er følsomme over for nedbrydning i mavesækken, bør administreres 1 time før eller 4 timer efter injektion af lixisenatid.
English: Efficacy of Lyxumia was also assessed in two randomised, open-label, active-controlled study (versus exenatide or versus insulin glulisine) and in a meal time study (in total 1,067 patients randomised to lixisenatide).
Danish: Lyxumias virkning blev også vurderet i to randomiserede, åbne, aktivt kontrollerede studier (versus exenatid eller versus insulin glulisin) og i et måltidsstudium (totalt 1.067 patienter randomiseret til lixisenatid).
English: The HbA1c reduction was significant with once daily administration, whether administered morning or evening.
Danish: HbA1c -reduktionen var signifikant ved administration én gang dagligt, uanset om Lyxumia blev givet morgen eller aften.
English: The incidence of hypoglycaemia was mainly increased in the lixisenatide group during the first 6 weeks of treatment and thereafter, was similar to the placebo group.
Danish: Forekomsten af hypoglykæmi var især øget i lixisenatidgruppen i de første 6 uger af behandlingen og herefter svarede den til placebogruppen.
English: The table presents adverse reactions that occurred with an incidence >5% if the frequency was higher among Lyxumia treated patients than patients treated with all comparators.
Danish: Tabellen præsenterer bivirkninger, der forekom med en incidens på > 5 %, dersom frekvensen var højere blandt Lyxumia-behandlede patienter end blandt patienter behandlet med alle komparatorpræparater.
English: How much to inject
Danish: Hvor meget der skal injiceres
English: No dose adjustment is required for patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat nyrefunktion.
English: • Do not activate the purple 20 microgram Lyxumia pen until you have finished the green pen.
Danish: • Aktiver ikke den lilla 20 mikrogram Lyxumia-pen før du har opbrugt den grønne pen.
English: Hypoglycaemia (in combination with metformin alone)
Danish: Hypoglykæmi (i kombination med metformin alene)
English: Lyxumia comes as a pre-filled pen for injection.
Danish: Lyxumia leveres som en fyldt pen til injektion.
English: - you are taking other medicines, as there are other medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach (see section Other medicines and Lyxumia)
Danish: - du tager anden medicin, idet der er anden medicin, så som antibiotika eller mavesyreresistente tabletter eller kapsler, som ikke bør opholde sig for længe i din mavesæk (se punktet Brug af anden medicin sammen med Lyxumia)
English: Contact your doctor, pharmacist or nurse for advice on checking your blood sugar.
Danish: Kontakt din læge, apotekspersonalet eller sundhedspersonalet for at få råd om kontrol af dit blodsukker.
English: It is preferable that the prandial injection of Lyxumia is performed before the same meal every day, when the most convenient meal has been chosen.
Danish: Den prandiale injektion af Lyxumia bør tages før det samme måltid hver dag, når først det mest hensigtsmæssige måltid er valgt.
English: This helps prevent contamination and potential needle blockage.
Danish: Dette medvirker til at forebygge kontaminering og potentiel tilstopning af nålen.
English: Sulfonylureas or glinides were not used with basal insulin as background therapy.
Danish: Sulfonylurinstoffer eller glinider blev ikke brugt med basalinsulin som baggrundsbehandling.
English: When administered once daily, lixisenatide improves glycaemic control through the immediate and sustained effects of lowering both post-prandial and fasting glucose concentrations in patients with type 2 diabetes.
Danish: Ved administration én gang dagligt forbedrer lixisenatid den glykæmiske kontrol via umiddelbar og vedvarende sænkning af både postprandiale og fastende glucosekoncentrationer hos patienter med type 2-diabetes.
English: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Danish: Forsinkelsen af gastrisk tømning med lixisenatid kan reducere absorptionshastigheden af oralt administrerede lægemidler.
English: In 2-year subcutaneous carcinogenicity study in mice, 3 cases of adenocarcinoma in the endometrium were seen in the mid dose group with a statistically significant increase, corresponding to an exposure ratio of 97-fold.
Danish: I 2-årige subkutane karcinogenicitetsstudier hos mus sås 3 tilfælde af adenokarcinomer i endometriet i middeldosis-gruppen med en signifikant stigning svarende til eksponeringsratio på 97-fold.
English: In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
Danish: I embryo-føtale udviklingsstudier sås misdannelser, væksthæmning, forsinket ossifikation og skeletale påvirkninger i rotter ved alle doser (5 gange eksponeringsratio sammenlignet med humaneksponering) og hos kaniner ved høje doser (32 gange eksponeringsratio sammenlignet med humaneksponering) af lixisenatid.
English: Of lixisenatide-treated patients with HbA1c measurement, 79.3% had either a negative antibody status or an antibody concentration below the lower limit of quantification and the other 20.7% of patients had a quantified antibody concentration.
Danish: Af de lixisenatidbehandlede patienter med HbA1c-måling, havde 79,3 % enten en negativ antistofstatus eller en antistofkoncentration under den nedre kvantificeringsgrænse, og de resterende 20,7 % af patienterne havde en kvantificeret antistofkoncentration.
English: Keep the injection button pressed in and slowly count to 5 to get the full dose.
Danish: Hold injektionsknappen trykket ind og tæl langsomt til 5 for at få en fuld dosis.
English: • Cold (upper respiratory tract infection)
Danish: • Forkølelse (øvre luftvejsinfektion)
English: Very common side effects: may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger: kan forekomme hos flere end 1 ud af 10 patienter
English: Lyxumia can be used with 29 to 32 gauge disposable pen needles.
Danish: Lyxumia kan bruges med 29 til 32 gauge engangs-pennåle.
English: Patients received stable dose(s) of oral antidiabetic drug(s) (OAD) and/or basal insulin as background therapy.
Danish: Patienterne fik fast/-e dose(r) af orale antidiabetika (OAD) og/eller basalinsulin som baggrundsbehandling.
English: The plunger will move along the dose scale after each injection.
Danish: Stemplet flytter sig langs med skalaen efter hver injektion.
English: Table 1: Adverse reactions reported in placebo- and active-controlled phase III studies during the entire treatment period (including the period beyond the main 24-week treatment period in studies with ≥76 weeks of total treatment).
Danish: Tabel 1: Bivirkninger rapporteret i placebo- og aktivt-kontrollerede fase III-studier i hele behandlingsperioden (inklusiv perioden udover den 24-ugers behandlingsperiode i studier med ≥ 76 ugers samlet behandling).
English: Restoration of first phase insulin secretion and improved second phase insulin secretion in response to an intravenous bolus of glucose were demonstrated in patients with type 2 diabetes (n=20) after a single dose of Lyxumia.
Danish: Retablering af første fase insulinsekretion og forbedret anden fase insulinsekretion efter intravenøs bolus af glucose blev påvist efter en enkelt dosis Lyxumia hos patienter med type 2-diabetes (n=20).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere informationer om dette produkt findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: There are no clinically relevant differences in the rate of absorption when lixisenatide is administered subcutaneously in the abdomen, thigh, or arm.
Danish: Der er ingen kliniske relevante forskelle i absorptionshastigheden, om lixisenatid administreres subkutant i abdomen, låret eller armen.
English: Allergic reactions possibly associated with lixisenatide (such as anaphylactic reaction, angioedema and urticaria) have been reported in 0.4% of lixisenatide patients while possibly associated allergic reactions occurred in less than 0.1% of placebo patients during the main 24-week treatment period.
Danish: Allergiske reaktioner muligvis associeret med lixisenatid (så som anafylaktisk reaktion, angioødem og urticaria) er rapporteret hos 0,4 % af lixisenatidpatienterne, mens muligt associerede allergiske reaktioner forekom hos mindre end 0,1 % af placebopatienterne under den 24-ugers behandlingsperiode.
English: Treatment Initiation pack - Contains two pre-filled pens each with 14 doses.
Danish: Behandlingsopstartspakning - indeholder to fyldte penne hver med 14 doser.
English: If you miss a dose of Lyxumia, you can inject it in the hour before your next meal.
Danish: Hvis du glemmer en dosis Lyxumia, kan du injicere den inden for en time før dit næste måltid.
English: If still no liquid comes out, your Lyxumia pen may be damaged.
Danish: Hvis der stadig ikke kommer væske ud, kan din Lyxumia-pen være beskadiget.
English: Neonatal growth was reduced in male rats exposed to high doses of lixisenatide during late gestation and lactation, with a slightly increased pup mortality observed.
Danish: Den neonatale vækst var reduceret hos hanrotter, der blev eksponeret for høje doser af lixisenatid under den sene drægtighedsperiode og laktationen, og der observeredes en let forhøjet mortalitet blandt ungerne.
English: This helps prevent contamination of Lyxumia or possible needle blockage.
Danish: Dette medvirker til at forebygge forurening af Lyxumia eller blokering af nålen.
English: Mean HbA1c (±SD) in the lixisenatide and placebo groups was 7.72 (±1.32)% and 7.64 (±1.28)% at baseline and 7.46 (±1.51)% and 7.61 (±1.48)% at 24 months, respectively.
Danish: Gennemsnitlig HbA1c (±SD) i lixisenatid- og placebogrupperne var 7,72 (±1,32) % og 7,64 (±1,28) % ved baseline og 7,46 (±1,51) % og 7,61 (±1,48) % efter 24 måneder.
English: Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-lixisenatide antibodies following treatment with Lyxumia and, at the end of the main 24-week treatment period in placebo-controlled studies, 69.8% of lixisenatide patients had a positive antibody status.
Danish: I overensstemmelse med de potentielt immunogene egenskaber ved lægemidler, der indeholder proteiner eller peptider, kan patienterne udvikle anti-lixisenatid antistoffer efter behandling med Lyxumia, og i slutningen af den 24-ugers behandlingsperiode i de placebokontrollerede studier havde 69,8 % af lixisenatidpatienterne en positiv antistofstatus.
English: The injection is administered once daily, within the hour prior to any meal of the day.
Danish: Injektionen administreres én gang dagligt inden for en time før et vilkårligt måltid.
English: • Injection site reactions (such as itching).
Danish: • Reaktioner på injektionsstedet (såsom kløe).
English: One case of anaphylactoid reaction was reported during clinical trials with lixisenatide.
Danish: Der blev rapporteret ét tilfælde af anafylaktoid reaktion under de kliniske studier med lixisenatid.
English: The percentage of patients who were antibody positive was similar at the end of the entire 76-week treatment period.
Danish: En tilsvarende andel af patienter var antistofpositive efter den samlede 76-ugers behandlingsperiode.
English: If not, do not use this pen.
Danish: Er den ikke det, må pennen ikke bruges.
English: Add-on combination therapy with oral antidiabetics
Danish: Tillægsbehandling i kombination med orale antidiabetika
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Danish: Efter samtidig administration af lixisenatid 20 µg og digoxin 0,25 mg ved steady state påvirkedes AUC for digoxin ikke.
English: • The dose from then onwards will be 20 micrograms once a day -using the purple pen.
Danish: • Dosis vil herefter være 20 mikrogram én gang dagligt - ved brug af den lilla pen.
English: The ELIXA study was a randomized, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Danish: ELIXA-studiet var et randomiseret, dobbeltblindet, placebokontrolleret, multinationalt studium, der evaluerede kardiovaskulære (CV) hændelser under behandling med lixisenatid hos patienter med type 2-diabetes mellitus efter nyligt akut koronarsyndrom.
English: The addition of lixisenatide led to a significantly greater HbA1c decrease of 0.71% in the lixisenatide group compared to 0.40% in the placebo group.
Danish: Tillæg af lixisenatid førte til en signifikant større HbA1c-reduktion på 0,71 % i lixisenatidgruppen sammenlignet med 0,4 % i placebogruppen.
English: • Activate the pen on the same day as your first injection.
Danish: • Aktiver pennen samme dag som du får din første injektion.
English: Type I glass cartridge with a (bromobutyl) rubber plunger, flanged caps (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the inside and polyisoprene on the outside).
Danish: Cylinderampul af type I glas med et (brombutyl) gummistempel, beskyttelseshætte (aluminium) med indsatte laminerede tætningsskiver (brombutylgummi på indersiden og polyisopren på ydersiden).
English: Learning how to use the pre-filled pens Before you use the pen for the first time, your doctor or nurse will show how to inject Lyxumia.
Danish: Før du bruger pennen for første gang, vil din læge eller sygeplejerske vise dig, hvordan du injicerer Lyxumia.
English: Nausea was reported in 14.7% and 15.5% of patients, and symptomatic hypoglycaemia in 5.8% and 2.2% of patients, main meal group and breakfast group, respectively.
Danish: Kvalme blev rapporteret hos 14,7 % og 15,5 % af patienterne, og symptomatisk hypoglykæmi hos 5,8 % og 2,2 % af patienterne i henholdsvis hovedmåltidsgruppen og morgenmadsgruppen.
English: Over 2,600 patients have received Lyxumia either alone or in combination with metformin, a sulphonylurea (with or without metformin) or a basal insulin (with or without metformin, or with or without a sulphonylurea) in 8 large placebo- or active-controlled phase III studies.
Danish: Over 2.600 patienter har fået Lyxumia enten som monoterapi eller i kombination med metformin, et sulfonylurinstof (med eller uden metformin) eller basalinsulin (med eller uden metformin, eller med eller uden et sulfonylurinstof) i otte store placebo- eller aktivt-kontrollerede fase III-studier.
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells.
Danish: GLP-1-receptoren er mål for naturligt forekommende GLP-1, et endogent inkretinhormon, som potenserer glucose-afhængig insulinsekretion fra pancreas' betaceller.
English: Table 5: Active-controlled study in combination with basal insulin with or without metformin (26-week results) - (mITT) and safety population
Danish: Tabel 5: Aktivt-kontrolleret studie ved kombination med basalinsulin med eller uden metformin (26 ugers resultater) - (mITT) og sikkerhedspopulation
English: A total of 350 patients were randomized (randomization ratio
Danish: Totalt blev 350 patienter randomiseret (randomiseringsratio 1:1).
English: These reactions were mostly mild and transient.
Danish: Disse bivirkninger var i reglen milde og forbigående.
English: Following administration of a single dose of an oral contraceptive medicinal product (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) 1 hour before or 11 hours after 10 mcg lixisenatide, the Cmax, AUC, t1/2 and tmax of ethinylestradiol and levonorgestrel were unchanged.
Danish: Efter administration af en enkelt dosis af et oralt kontraceptiva (ethinylestradiol 0,03 mg/levonorgestrel 0,15 mg) 1 time før eller 11 timer efter 10 µg lixisenatid var Cmax, AUC, t1/2 og tmax for ethinylestradiol og levonorgestrel uændrede.
English: Use 29 to 32 gauge disposable pen needles with your Lyxumia pen.
Danish: Brug 29 til 32 gauge engangsnåle til din Lyxumia-pen.
English: Inject Lyxumia in the hour before any meal of the day.
Danish: Injicer Lyxumia inden for en time før et hvilket som helst måltid i løbet af dagen.
English: Inject Lyxumia into the skin (subcutaneously) of your stomach area (abdomen), upper leg (thigh) or upper arm.
Danish: Lyxumia injiceres i huden (subkutant) på din mave (abdomen), øverste del af benet (låret) eller overarmen.
English: • Only inject one dose per day.
Danish: • Injicer kun én dosis per dag.
English: Some medicines such as antibiotics or stomach resistant tablets or capsules that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Lyxumia injection.
Danish: Visse lægemidler, som f.eks. antibiotika eller mavesyreresistente tabletter eller kapsler, som ikke bør opholde sig for længe i din mavesæk, skal muligvis tages en time før eller fire timer efter injektionen med Lyxumia.
English: Pull the needle out of your skin.
Danish: Træk nålen ud af huden.
English: This study consisted of a 12-week run-in period with introduction and titration of insulin glargine and of a 24-week treatment period during which patients receive either lixisenatide or placebo in combination with insulin glargine and metformin with or without thiazolidinediones.
Danish: Dette studium bestod af en 12-ugers run-in periode med initiering og titrering af insulin glargin, og en 24-ugers behandlingsperiode under hvilken patienterne enten fik lixisenatid eller placebo i kombination med insulin glargin og metformin med eller uden thiazolidinedioner.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis og er i det væsentligste ”natriumfrit”.
English: - you are also taking a sulphonylurea or a basal insulin.
Danish: - du også tager et sulfonylurinstof eller basalinsulin.
English: In case of air bubbles see the “Questions and answers” section.
Danish: Se afsnittet ”Spørgsmål og svar”, hvis der er luftbobler.
English: Treatment initiation pack
Danish: Behandlingsopstartspakning
English: The tmax of digoxin was delayed by 1.5 hour and the Cmax was reduced by
Danish: tmax for digoxin blev forsinket 1,5 time og Cmax reduceredes med 26 %.
English: Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Back
Danish: Bagpå
English: To inject a dose with the purple 20 micrograms Lyxumia pen, follow all steps in Section 3.
Danish: For at injicere en dosis med den lilla 20 mikrogram Lyxumia-pen, følg alle trinene i Afsnit 3.