FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the liquid you can see through the pen window does not look clear and colourless.
Danish: • Hvis den væske, du kan se gennem pennens vindue, ikke ser klar og farveløs ud.
English: If you drink alcohol, your need for Xultophy may change.
Danish: Hvis du drikker alkohol, kan dit behov for Xultophy ændres.
English: The Xultophy clinical development programme included approximately 1,900 patients treated with Xultophy.
Danish: Det kliniske udviklingsprogram for Xultophy omfattede ca. 1.900 patienter, der blev behandlet med Xultophy.
English: Pay special attention to these notes as they are important for safe use of the pen.
Danish: Vær særligt opmærksom på denne information, da den er vigtig for at kunne anvende pennen sikkert.
English: No interaction study has been performed.
Danish: Der er ikke udført interaktionsstudier.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Danish: Justering af dosis kan blive nødvendig, hvis patienter udøver øget fysisk aktivitet, ændrer deres kostvaner eller under samtidig anden sygdom.
English: It might lead to crossinfection.
Danish: Det kan føre til krydsinfektion.
English: • have not used enough Xultophy, keep using less Xultophy than you need, forget to use Xultophy or stop using Xultophy without talking to your doctor.
Danish: • ikke har brugt tilstrækkeligt Xultophy, gentagne gange bruger mindre Xultophy end du har brug for, glemmer at bruge Xultophy, eller stopper med at tage Xultophy uden at tale med din læge.
English: • eat more than usual
Danish: • spiser mere end normalt
English: • Never share your needles with other people.
Danish: • Du må aldrig dele dine nåle med andre.
English: The educational materials should contain: - Summary of product characteristics and package leaflet; - Healthcare professional brochure that should contain the following key elements:
Danish: Undervisningspakken skal indeholde: - Produktresumé og indlægsseddel - Sundhedspersonale-brochure, som skal indeholde følgende nøgleelementer:
English: These may be signs of a very serious condition called ‘ketoacidosis'.
Danish: Disse symptomer kan betyde, at du har en meget alvorlig tilstand kaldet "ketoacidose".
English: This means that the medicine is essentially ‘sodium-free'.
Danish: Det betyder, at lægemidlet er stort set natriumfrit.
English: • Do not leave the pen in a car or other place where it can get too hot or too cold.
Danish: Vedligeholdelse af din pen • Du må ikke efterlade pennen i bilen eller andre steder, hvor den kan blive for varm eller for kold.
English: Do not do any conversion of your dose.
Danish: Lav ikke nogen ændring af din dosis.
English: • Low blood sugar (very common: may affect more than 1 in 10 people).
Danish: • Lavt blodsukker (meget almindelig: kan forekomme hos flere end 1 ud af 10 behandlede).
English: • Cardiovascular Safety
Danish: • Kardiovaskulær sikkerhed
English: Mean change Estimated difference
Danish: ændring Estimeret forskel
English: If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
Danish: Hvis du taber den eller har mistanke om et problem, skal du sætte en ny nål på og kontrollere gennemløbet, før du injicerer.
English: Exposure was significantly lower (44%) in patients with severe hepatic impairment (Child Pugh score >9).
Danish: Eksponeringen var signifikant lavere (44%) hos patienter med alvorlig nedsat leverfunktion (Child Pugh-score >9).
English: It is not known if Xultophy affects the baby.
Danish: Det vides ikke, om Xultophy påvirker barnet.
English: The MAH shall agree the final content and modality of distribution for the educational materials together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational materials in the Member State.
Danish: Indehaveren af markedsføringstilladelsen skal blive enig om det endelige indhold og modaliteten af distribution af undervisningspakken, samt en kommunikationsplan med den pågældende myndighed i hvert medlemsland før distribution af uddannelsespakken.
English: Dose counter stopped: 42 dose steps left
Danish: Dosistæller stoppet: 42 dosistrin tilbage
English: The frequency of nausea and diarrhoea was ‘Common' for Xultophy and ‘Very common' for liraglutide.
Danish: Hyppigheden af kvalme og diarré var "Almindelig" for Xultophy og "Meget almindelig" for liraglutid.
English: • if you have a severe stomach ache which does not go away, tell your doctor - this could be a sign of inflamed pancreas (acute pancreatitis).
Danish: • Hvis du har alvorlig mavepine, der ikke går væk, skal du fortælle det til lægen - det kan være et tegn på betændelse i bugspytkirtlen (akut pankreatitis).
English: • You do not have to use Xultophy with a meal.
Danish: • Det er ikke nødvendigt at bruge Xultophy sammen med et måltid.
English: Xultophy can be used in elderly patients but if you are elderly you may need to check your blood sugar level more often.
Danish: Xultophy kan bruges til ældre patienter, men hvis du er ældre, kan det være nødvendigt at kontrollere blodsukkerniveauet oftere.
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Xultophy should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, eller der konstateres graviditet, bør behandling med Xultophy seponeres.
English: Tell your doctor if you are taking warfarin or other blood thinners as you might need to have blood tests more often to measure how thick your blood is (called ‘International Normalised Ratio' or INR test).
Danish: Fortæl det til lægen, hvis du tager warfarin eller andre blodfortyndende lægemidler, da du muligvis skal have taget blodprøver oftere for at få målt, hvor tykt dit blod er (kaldet "International Normalised Ratio" eller INR-test).
English: This should be kept in mind if treatment with the combination of pioglitazone and Xultophy is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Xultophy overvejes.
English: If the dose counter does not return to 0, the full dose has not been delivered, which may lead to high blood sugar level.
Danish: Hvis dosistælleren ikke går tilbage til 0, er den fulde dosis ikke blevet leveret, og det kan føre til for højt blodsukkerniveau.
English: It is unknown whether the reduced pup growth is caused by reduced pup milk intake due to a direct GLP-1 effect or reduced maternal milk production due to decreased caloric intake.
Danish: Det er ukendt, hvorvidt ungernes reducerede vækst skyldes nedsat modermælkeindtag på grund af en direkte virkning af GLP-1 eller reduceret mælkeproduktion hos moderen på grund af nedsat kalorieindtag.
English: Warfarin or other blood thinners - medicines used to prevent clotting of the blood.
Danish: Warfarin eller andre blodfortyndende lægemidler - til forebyggelse af blodpropper.
English: These findings in rodents are caused by a non-genotoxic, specific GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Danish: Resultaterne hos gnaverne skyldes en ikke-genotoksisk, specifik GLP-1 receptormedieret mekanisme, som gnavere er særligt følsomme overfor.
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Det er især vigtigt for personer, som har nedsat eller manglende fornemmelse af advarselssymptomer på hypoglykæmi eller hyppige episoder med hypoglykæmi.
English: The dose selector clicks differently when turned forward, backward or past the number of dose steps left.
Danish: Dosisvælgeren klikker forskelligt, når den drejes frem, tilbage eller forbi det antal dosistrin, der er tilbage.
English: N: Number of subjects with a first EAC confirmed event during trial.
Danish: N: Antal forsøgspersoner med en første EAC-bekræftet hændelse under studiet.
English: IDegLira Unchanged GLP-1 RA
Danish: IDegLira Uændret GLP-1 RA
English: MI: Myocardial infarction.
Danish: MI: Myokardieinfarkt.
English: In rats, a no observed adverse effect level (NOAEL) was not observed.
Danish: Hos rotter blev et "niveau, der ikke medfører observeret skadelig virkning" (no observed adverse effect level - NOAEL) ikke observeret.
English: It is important always to check the flow before you inject.
Danish: Det er vigtigt altid at kontrollere gennemløbet, før du injicerer.
English: • Check that the solution in your pen is clear and colourless.
Danish: • Kontrollér, at opløsningen i pennen er klar og farveløs.
English: Use only clear, colourless solution For use by one person only Do not withdraw solution from the pen
Danish: Brug kun en klar, farveløs opløsning Kun beregnet til én person Udtag ikke opløsning fra pennen
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: • Do not try to refill your pen.
Danish: • Forsøg ikke at genopfylde din pen.
English: • liraglutide - a ‘GLP-1 analogue' that helps your body make more insulin during meals and lowers the amount of sugar made by your body.
Danish: • liraglutid - en ‘GLP-1-analog', som hjælper din krop med at danne mere insulin under måltider og sænker den mængde sukker, din krop danner.
English: Anaphylactic reactions may potentially be life threatening.
Danish: Anafylaktiske reaktioner kan være potentielt livstruende.
English: • does not make enough insulin to control the level of sugar in your blood or
Danish: • ikke danner insulin nok til at kontrollere blodsukkerniveauet, eller
English: A small drop may remain at the needle tip, but it will not be injected.
Danish: En lille dråbe kan forblive ved nålespidsen, men den injiceres ikke.
English: Warning signs of high blood sugar - these normally appear gradually
Danish: Advarselssignaler på højt blodsukker - disse kommer normalt gradvist
English: Insulin degludec and liraglutide are extensively bound to plasma proteins (>99% and >98%, respectively).
Danish: Insulin degludec og liraglutid bindes i udstrakt grad til plasmaproteiner (henholdsvis >99% og >98%).
English: Important things to know while you are using this medicine:
Danish: Vigtige ting, du bør vide, mens du bruger dette lægemiddel:
English: If you select a wrong dose, you can turn the dose selector forward or backward to the correct dose.
Danish: Hvis du vælger en forkert dosis, kan du dreje dosisvælgeren frem eller tilbage til den rigtige dosis.
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia.
Danish: Patientens koncentrations- og reaktionsevne kan være svækket på grund af hypoglykæmi.
English: Figure 7 Forest plot of analysis of the composite 3-point MACE and individual cardiovascular endpoints in DEVOTE
Danish: Figur 7: Forest-plot af analyse af den sammensatte 3-punkts MACE og individuelle kardiovaskulære endepunkter i DEVOTE
English: They may make it harder to recognise the warning signs of low blood sugar (see section 4 ‘Warning signs of low blood sugar - these may come on suddenly')
Danish: De kan gøre det vanskeligere at genkende advarselssignalerne på lavt blodsukker (se punkt 4 "Advarselssignaler på lavt blodsukker - disse kan komme pludseligt")
English: Xultophy can be used in elderly patients.
Danish: Xultophy kan anvendes til ældre patienter.
English: All cause death
Danish: Død uanset årsag
English: EXP After first opening: Use within 21 days
Danish: EXP Efter ibrugtagning: Anvendes inden 21 dage
English: Octreotide/lanreotide may either increase or decrease the Xultophy requirement.
Danish: Octreotid/lanreotid kan enten øge eller reducere behovet for Xultophy.
English: The trials were of 26 weeks duration randomising between 199 and 833 patients to Xultophy.
Danish: Studierne var af 26 ugers varighed, og mellem 199 og 833 patienter blev randomiseret til Xultophy.
English: Xultophy can be added to existing oral antidiabetic treatment.
Danish: Xultophy kan anvendes som supplement til en eksisterende oral antidiabetisk behandling.
English: • Allergic reactions (hypersensitivity) such as rash, itching and swelling of the face.
Danish: • Allergiske reaktioner (overfølsomhed), såsom udslæt, kløe og hævelse i ansigtet.
English: • Once the needle is covered, carefully push the outer needle cap completely on.
Danish: • Når nålen er dækket, skubbes den ydre nålehætte omhyggeligt helt på.
English: Talk to your doctor if:
Danish: Tal med din læge, hvis:
English: Xultophy is to be dosed in accordance with the individual patient's needs.
Danish: Xultophy skal doseres i overensstemmelse med patientens individuelle behov.
English: • Wait until the signs of low blood sugar have gone or when your blood sugar level has settled.
Danish: • Vent indtil symptomerne på lavt blodsukker er forsvundet, eller dit blodsukker er stabiliseret.
English: • In this case - you have not received any medicine - even though the dose counter has moved from the original dose that you have set.
Danish: • I så fald har du ikke modtaget noget medicin, selv om dosistælleren har bevæget sig fra den oprindelige dosis, du valgte.
English: • If you are also taking a sulfonylurea (such as glimepiride or glibenclamide), your doctor may tell you to lower your sulfonylurea dose depending on your blood sugar levels.
Danish: • Hvis du også tager et sulfonylurinstof (såsom glimepirid eller glibenclamid), vil din læge måske bede dig om at reducere din dosis af sulfonylurinstof afhængigt af dit blodsukkerniveau.
English: Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby.
Danish: Fortæl det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: • use too much Xultophy.
Danish: • bruger for meget Xultophy.
English: There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and Xultophy is therefore not recommended for use in these patients.
Danish: Der er ingen erfaring med behandling af patienter med kongestiv hjerteinsufficiens, New York Heart Association (NYHA)-klasse IV, og anvendelse af Xultophy anbefales derfor ikke til disse patienter.
English: Figure 6 Forest plot of analyses of individual cardiovascular event types - FAS population
Danish: Figur 6: Forest-plot af analyser af individuelle kardiovaskulære hændelsestyper - FASpopulation
English: Always check the pen label before you inject your medicine to ensure that you use the correct pen.
Danish: Kontrollér altid etiketten på pennen, før du injicerer medicinen for at sikre, at du bruger den korrekte pen.
English: • Xultophy is given as an injection under the skin (subcutaneously).
Danish: • Xultophy gives som en injektion under huden (subkutant).
English: They may increase or decrease your blood sugar level.
Danish: De kan øge eller reducere dit blodsukkerniveau.
English: • acetylsalicylic acid (and medicines called ‘salicylates') - for pain and mild fever
Danish: • acetylsalicylsyre (og lægemidler, der kaldes salicylater) - mod smerter og mild feber
English: Gastrointestinal adverse reactions may occur more frequently at the beginning of Xultophy therapy and usually diminish within a few days or weeks on continued treatment.
Danish: Gastrointestinale bivirkninger kan forekomme hyppigere i starten af behandlingen med Xultophy og aftager normalt inden for få dage eller uger ved fortsat behandling.
English: If your blood sugar level gets low you may pass out (become unconscious).
Danish: Hvis dit blodsukkerniveau bliver lavt, kan du besvime (blive bevidstløs).
English: Do not use Xultophy if you are pregnant or plan to become pregnant.
Danish: Brug ikke Xultophy, hvis du er gravid eller planlægger at blive gravid.
English: See also section 2 ‘Important information about some of the ingredients of Xultophy' for information on sodium.
Danish: Se også punkt 2 'Vigtig information om nogle af indholdsstofferne i Xultophy' for yderligere information om natrium.
English: • If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for Xultophy.
Danish: • Hvis du vil ændre din sædvanlige kost, skal du først tale med lægen, apotekspersonalet eller sygeplejersken, da en kostændring kan ændre dit behov for Xultophy.
English: If the needle is blocked, you will not inject any medicine.
Danish: Hvis nålen er tilstoppet, injicerer du ikke noget medicin.
English: If there is still no drop, change the needle and repeat steps 2A to 2C once more.
Danish: Hvis der stadig ikke kommer nogen dråbe til syne, skiftes nålen, og trin 2A til 2C gentages én gang mere.
English: Xultophy is therefore not recommended in these patients.
Danish: Xultophy anbefales derfor ikke til disse patienter.
English: Upon initiation of Xultophy treatment in patients on warfarin or other coumarin derivatives more frequent monitoring of INR (International Normalised Ratio) is recommended.
Danish: Ved initiering af behandling med Xultophy hos patienter i behandling med warfarin eller andre coumarinderivater anbefales hyppigere overvågning af INR (International Normalised Ratio).
English: Liraglutide (Victoza)
Danish: Liraglutid (Victoza)
English: If you select and inject the wrong dose, your blood sugar level may get high or low.
Danish: Hvis du vælger og injicerer en forkert dosis, kan dit blodsukkerniveau blive for højt eller for lavt.
English: Do not use Xultophy:
Danish: Brug ikke Xultophy:
English: Liraglutide reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.
Danish: Liraglutid reducerer legemsvægt og kropsfedtmasse gennem mekanismer, der involverer reduceret sult og nedsat energiindtag.
English: You will need it after the injection, to safely remove the needle from the pen.
Danish: Du skal bruge den efter injektionen, når du skal fjerne nålen sikkert fra pennen.
English: The half-life of insulin degludec is approximately 25 hours and the half-life of liraglutide is approximately 13 hours.
Danish: Halveringstiden for insulin degludec er ca. 25 timer, og halveringstiden for liraglutid er ca. 13 timer.
English: If you split the dose wrongly, you will inject too little or too much medicine.
Danish: Hvis du deler din dosis forkert, injicerer du for lidt eller for meget medicin.
English: • Increase of pancreatic enzymes, such as lipase and amylase.
Danish: • Forhøjet niveau af enzymer i bugspytkirtlen, såsom lipase og amylase.
English: The long-term improvements in blood sugar control may ease the eye problems.
Danish: Langvarigt forbedret blodsukkerkontrol kan lette øjenproblemerne.
English: • have or have had a thyroid disease.
Danish: • har eller har haft en sygdom i skjoldbruskkirtlen.
English: Patients whose blood glucose control is greatly improved (e.g. by intensified therapy) may experience a change in their usual warning symptoms of hypoglycaemia and must be advised accordingly.
Danish: Patienter, hvis blodglucosekontrol er væsentligt forbedret (f.eks. ved intensiveret behandling), kan opleve ændringer i deres sædvanlige advarselssymptomer på hypoglykæmi og skal orienteres herom.
English: Important things to know before you use this medicine:
Danish: Vigtige ting, du bør vide, før du bruger dette lægemiddel:
English: This is because improvement in your blood sugar may not happen straight away.
Danish: Det skyldes, at dit blodsukker måske ikke stiger lige med det samme.
English: Liraglutide is a Glucagon-Like Peptide-1 (GLP-1) analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor (GLP-1R).
Danish: Liraglutid er en GLP-1-analog (glucagon-lignende peptid-1-analog) med 97% sekvenshomologi til humant GLP-1, der bindes til og aktiverer GLP-1 receptoren (GLP-1R).
English: In rare cases, the presence of such antibodies may necessitate adjustment of the Xultophy dose in order to correct a tendency to hyper- or hypoglycaemia.
Danish: I sjældne tilfælde vil tilstedeværelsen af sådanne antistoffer nødvendiggøre dosisjustering af Xultophy for at korrigere en tendens til hyper- eller hypoglykæmi.
English: Mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed in clinical trials with Xultophy.
Danish: En gennemsnitlig stigning i hjertefrekvensen fra baseline på 2 til 3 slag i minuttet er blevet observeret i kliniske studier med Xultophy.
English: Comparator treatments comprised basal insulin, GLP-1 RA therapy, placebo and a basal bolus regimen.
Danish: Komparatorbehandlinger omfattede basalinsulin, GLP-1 RA-terapi, placebo og et basalt bolus regime.
English: Dose adjustments of griseofulvin and other compounds with low solubility and high permeability are not required.
Danish: Dosisjustering af griseofulvin og andre forbindelser med lav opløselighed og høj permeabilitet er ikke nødvendig.
English: • a clear explanation of the posology of the product and the meaning of ‘dose steps' - with reference to dose of each component for each dose step
Danish: • En tydelig forklaring af dosering af lægemidlet og betydningen af ”dosistrin” - med henvisning til dosis af hvert lægemiddelstof for hver dosistrin.
English: • Do not use Xultophy if you have type 1 diabetes mellitus or if you have ‘ketoacidosis' (a condition with a build-up of acid in the blood).
Danish: • Brug ikke Xultophy, hvis du har type 1-diabetes mellitus, eller hvis du har ketoacidose (en tilstand, hvor syre ophobes i blodet).
English: Xultophy is for subcutaneous use only.
Danish: Xultophy er kun til subkutan anvendelse.
English: During 24 hours following administration of a single radiolabelled [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide.
Danish: I løbet af de 24 timer efter administration af én enkelt dosis radioaktivt mærket [3H]-liraglutid hos raske forsøgspersoner var den største bestanddel i plasma intakt liraglutid.
English: Xultophy should therefore be used with caution in these patients.
Danish: Xultophy skal derfor anvendes med forsigtighed hos disse patienter.
English: Hallas Alle, Kalundborg, 4400, Denmark Novo Nordisk A/S
Danish: Hallas Allé, DK-4400 Kalundborg, Danmark Novo Nordisk A/S
English: After first opening: Use within 21 days
Danish: Efter ibrugtagning: Anvendes inden 21 dage
English: If you have a serious allergic reaction to any of the ingredients in Xultophy, stop using Xultophy and see a doctor straight away.
Danish: Hvis du får en alvorlig allergisk reaktion over for et af indholdsstofferne i Xultophy, skal du stoppe med at tage Xultophy og straks kontakte lægen.
English: • Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Danish: • Omsorgspersoner skal håndtere brugte nåle meget forsigtigt - for at undgå stikuheld og krydsinfektioner.
English: Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: hvis patienten ikke reagerer på glucagon inden for 10 til 15 minutter.
English: If transferring from a long-acting GLP-1 receptor agonist (e.g. onceweekly dosing), the prolonged action should be considered.
Danish: Hvis der skiftes fra en langtidsvirkende GLP-1-receptoragonist (f.eks. dosering én ugentlig doseringt), skal den langvarige effekt tages i betragtning.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Danish: Når pennen er tom, kasserer du den uden en nål påsat, som anvist af lægen, sygeplejersken, apotekspersonalet eller de lokale sundhedsmyndigheder.
English: Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased requirement for antidiabetic treatment.
Danish: Desuden kan samtidig sygdom, især infektioner, føre til hyperglykæmi og derved forårsage et øget behov for diabetesbehandling.
English: Treatment with Xultophy should be initiated at the moment the next dose of the long-acting GLP-1 receptor agonist would have been taken.
Danish: Behandling med Xultophy skal initieres på det tidspunkt, hvor den næste dosis langtidsvirkende GLP-1-receptoragonist skulle have været indgivet.