FrancophonIA/ELRC3.0 huggingface dataset:
English: Tresiba is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments.
Danish: Tresiba skal anvendes én gang dagligt sammen med måltidsinsulin og kræver efterfølgende individuelle dosisjusteringer.
English: If you have kidney or liver problems, you may need to check your blood sugar level more often.
Danish: Hvis du har nyre- eller leverproblemer, kan det være nødvendigt at kontrollere blodsukkerniveauet oftere.
English: Very common Hypoglycaemia
Danish: Meget almindelig Hypoglykæmi
English: The duration of action of Tresiba is beyond 42 hours within the therapeutic dose range.
Danish: Virkningen af Tresiba varer mere end 42 timer inden for det terapeutiske dosisområde.
English: Before you use Tresiba for the first time, your doctor or nurse will show you how to use it.
Danish: Før du tager Tresiba første gang, viser lægen eller sygeplejersken dig, hvordan du skal bruge det.
English: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Danish: Insulin degludecs affinitet til serumalbumin svarer til en plasmaproteinbinding på >99% i humant plasma.
English: Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect more than 1 in 10 people).
Danish: Hypoglykæmi (for lavt blodsukker) kan forekomme med insulinbehandling (kan forekomme hos flere end 1 ud af 10 behandlede).
English: No metabolic effects are anticipated in the breast-fed newborn/infant.
Danish: Der forventes ingen metabolisk påvirkning af nyfødte/spædbørn, der ammes.
English: A numerically higher rate of severe hypoglycaemia in children aged 6-11 years in the Tresiba arm was observed.
Danish: Der blev observeret en numerisk højere hyppighed af alvorlig hypoglykæmi hos børn i alderen 6 til 11 år, der var i armen med Tresiba.
English: How to inject
Danish: Hvordan du skal injicere
English: If you forget a dose, inject the missed dose when discovering the mistake, ensuring a minimum of 8 hours between doses.
Danish: Hvis du glemmer en dosis, skal du injicere den glemte dosis, når du opdager forglemmelsen, men med mindst 8 timer mellem doserne.
English: Figure 2 Forest plot of analysis of the composite 3-point MACE and individual cardiovascular endpoints in DEVOTE
Danish: Figur 2 Forest plot af den sammensatte 3-punkts MACE-analyse og individuel kardiovaskulær virkningsendepunkt i DEVOTE.
English: There is no clinically relevant development of insulin antibodies after long-term treatment with Tresiba.
Danish: Der er ingen klinisk relevant udvikling af insulinantistoffer efter langvarig behandling med Tresiba.
English: • Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case).
Danish: • Spis glucosetabletter (druesukker) eller et andet meget sukkerholdigt produkt, såsom slik, kiks eller frugtjuice (medbring for en sikkerheds skyld altid glucosetabletter eller et meget sukkerholdigt produkt).
English: During a period of 24 hours with once-daily treatment, the exposure of insulin degludec was evenly distributed between the first and second 12 hours.
Danish: I en periode på 24 timer med behandling én gang dagligt var eksponeringen for insulin degludec jævnt fordelt mellem den første og den anden 12-timers periode.
English: The cardiovascular safety of Tresiba as compared to insulin glargine was confirmed (HR 0.91 [0.78; 1.06]) (Figure 2).
Danish: Den kardiovaskulære sikkerhed af Tresiba sammenlignet med insulin glargin blev bekræftet (HR 0,91 [0,78; 1,06]) (Figur 2).
English: The half-life after subcutaneous administration of Tresiba is determined by the rate of absorption from the subcutaneous tissue.
Danish: Halveringstiden efter subkutan administration af Tresiba bestemmes af absorptionshastigheden fra det subkutane væv.
English: The dose steps, however, differ between the two strengths of Tresiba.
Danish: Dosistrinene er dog forskellige for de to styrker af Tresiba.
English: If you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets from the pen.
Danish: Hvis du bliver ved med at injicere det samme sted, kan disse reaktioner blive mere alvorlige og påvirke den mængde medicin, kroppen får fra pennen.
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma
Danish: • sympatomimetika såsom adrenalin, salbutamol eller terbutalin, mod astma
English: Close glucose monitoring is recommended during the transfer and in the following weeks.
Danish: Hyppig blodglucosekontrol anbefales i overgangsperioden og i de følgende uger.
English: • Insert the needle into your skin as your doctor or nurse has shown you.
Danish: • Stik nålen ind under huden, som lægen eller sygeplejersken har vist dig.
English: AUCGIR,2-24h: metabolic effect in last 22 hours of dosing interval (i.e., not influenced by i.v.
Danish: AUCGIR,2-24h: metabolisk effekt i de sidste 22 timer af doseringsinterval (dvs. ikke påvirket af i.v.insulin i clampindkøringsperioden).
English: They may make it harder to recognise the warning signs of too low blood sugar (see section 4 ‘Warning signs of too low blood sugar')
Danish: De kan gøre det vanskeligere at genkende advarselssignalerne på for lavt blodsukker (se punkt 4 "Advarselssignalerne på for lavt blodsukker")
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 lægen, sygeplejersken, apotekspersonalet eller de lokale sundhedsmyndigheder har fortalt dig.
English: Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
Danish: Reproduktionsstudier med dyr har ikke vist nogen forskelle mellem insulin degludec og humant insulin med hensyn til embryotoksicitet og teratogenicitet.
English: Do not use this medicine after the expiry date which is stated on the Penfill label and carton, after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pennens etiket og karton efter ”EXP”.
English: This medicinal product must not be used in insulin infusion pumps.
Danish: Dette lægemiddel må ikke anvendes i insulininfusionspumper.
English: It is unknown whether insulin degludec is excreted in human milk.
Danish: Det er ukendt, om insulin degludec udskilles i humant mælk.
English: • Always keep your pen with you.
Danish: • Hav altid pennen på dig.
English: Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement.
Danish: Anden samtidig sygdom, især infektioner og tilstande med feber, øger normalt patientens insulinbehov.
English: It is not known if Tresiba affects the baby in pregnancy or during breast-feeding.
Danish: Det vides ikke, om Tresiba påvirker barnet under graviditeten eller amning.
English: Nocturnal
Danish: Natlig
English: Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
Danish: Insulin degludec bindes specifikt til humaninsulinreceptoren og medfører samme farmakologiske virkninger som humant insulin.
English: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Prækliniske data viser ingen risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
Danish: Skift af en patient til en anden type, et andet mærke eller en anden fabrikant af insulin må kun ske under lægekontrol og kan medføre et behov for ændring af dosis.
English: For more information, see ‘serious allergic reaction' above.
Danish: Se "alvorlig allergisk reaktion" ovenfor for mere information.
English: • if the insulin does not appear clear and colourless.
Danish: • hvis insulinet ikke er klart og farveløst.
English: While improvements in HbA1c were non-inferior compared to other insulin products, against sitagliptin Tresiba was statistically significantly superior in reducing HbA1c (Table 5).
Danish: Mens forbedringerne i HbA1c var non-inferiore sammenlignet med andre insulinpræparater, var nedsættelsen af HbA1c af Tresiba statistisk signifikant bedre end sitagliptin (tabel 5).
English: Nocturnal confirmed hypoglycaemia was defined as episodes between midnight and 6 a.m. 5 The difference is for Tresiba Flex - Tresiba
Danish: Bekræftet natlig hypoglykæmi blev defineret som episoder mellem midnat og kl. 6 5 Differencen er for Tresiba Flex - Tresiba
English: Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Danish: Efter at bevidstheden er genvundet, anbefales det at give patienten kulhydrater oralt for at forhindre et tilbagefald.
English: The dose steps, however, differ between the two strengths of the medicinal product.
Danish: Dosistrinene er dog forskellige for de to styrker af lægemidlet.
English: This may indicate a blocked or damaged needle.
Danish: Dette kan betyde, at nålen er tilstoppet eller beskadiget.
English: Some medicines affect your blood sugar level, this may mean your insulin dose has to be changed.
Danish: Nogle lægemidler påvirker blodsukkeret, hvilket kan betyde, at din insulindosis skal ændres.
English: You may stick yourself with the needle.
Danish: Du kan komme til at stikke dig på nålen.
English: Flexibility in dosing time
Danish: Fleksibelt doseringstidspunkt
English: The dose selector changes the number of units.
Danish: Dosisvælgeren ændrer antal enheder.
English: Look through the insulin window.
Danish: Kig i insulinvinduet.
English: Hypoglycaemia Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
Danish: Hypoglykæmi Udeladelse af et måltid eller ikke planlagt anstrengende fysisk aktivitet kan medføre hypoglykæmi.
English: • Leave the needle under the skin for at least 6 seconds to make sure you get your full dose.
Danish: • Lad nålen forblive under huden i mindst 6 sekunder.
English: In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet (see section 6.6).
Danish: I tilfælde af blokerede nåle, skal patienter følge instruktionerne beskrevet i brugervejledningen, som findes sammen med indlægssedlen (se punkt 6.6).
English: Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis.
Danish: Utilstrækkelig dosering og/eller afbrydelse af behandlingen hos patienter, som har behov for insulin, kan føre til hyperglykæmi og potentielt til diabetisk ketoacidose.
English: Tresiba dosed once daily showed similar reduction in HbA1c at week 52 and greater reduction in FPG from baseline versus the comparator insulin detemir dosed once or twice daily.
Danish: Administration af Tresiba en gang dagligt viste lignende reduktion i HbA1c i uge 52 og større reduktion i FPG fra baseline versus komparatoren insulin detemir, der blev doseret en eller to gange dagligt.
English: Treat your pen with care.
Danish: Vedligeholdelse af din pen Håndtér din pen med forsigtighed.
English: Pharmacokinetic properties of insulin degludec in children (1-11 years) and adolescents (12-18 years) were at steady state comparable to those observed in adults with type 1 diabetes mellitus.
Danish: Insulin degludecs farmakokinetiske egenskaber er undersøgt hos børn (1-11 år) og unge (12-18 år) og var ved steady state sammenlignelige med dem, som var observeret hos voksne med type 1-diabetes mellitus.
English: The educational pack should contain: - Direct Healthcare Professional Communication letter as described below; - Summary of Product Characteristics and Package Leaflet; - Poster for display in pharmacies/diabetic units; - Patient Brochures.
Danish: Uddannelsespakken skal indeholde: - Ledende sundhedspersonale kommunikationsbrev, som beskrevet nedenfor - Produktresumé og indlægsseddel - Poster til fremvisning i apoteker/diabetes-klinikker - Patient-brochure
English: This was achieved with 30% lower daily doses of Tresiba compared to insulin detemir.
Danish: Dette blev opnået med en 30% lavere daglig dosis af Tresiba sammenlignet med insulin detemir.
English: • Always follow your doctor's recommendation for dose.
Danish: • Følg altid lægens anbefalede dosis.
English: If no drop appears, you will not inject any insulin, even though the dose counter may move.
Danish: Hvis der ikke kommer en dråbe til syne, injicerer du ikke noget insulin, heller ikke selvom dosistælleren måske bevæger sig.
English: Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.
Danish: Umiddelbare allergiske reaktioner mod enten insulin eller hjælpestofferne kan potentielt være livstruende.
English: • If you are given glucagon, you will need sugar or a sugary snack as soon as you come round.
Danish: • Hvis du får glucagon, skal du også have glucose eller et sukkerholdigt produkt at spise, så snart du igen er ved bevidsthed.
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Danish: Hyppighedskategorierne er defineret i henhold til følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: • Wait until the signs of too low blood sugar have gone or when your blood sugar level has settled.
Danish: • Vent, indtil symptomerne på for lavt blodsukker er forsvundet, eller dit blodsukker er stabiliseret.
English: Tresiba pre-filled pen and needle (example) (FlexTouch)
Danish: Tresiba fyldt pen og nål (eksempel) (FlexTouch)
English: Always remove the needle after each injection and store your pen without the needle attached.
Danish: Fjern altid nålen efter hver injektion og opbevar pennen uden påsat nål.
English: • oral contraceptives (birth control pills)
Danish: • oral prævention (p-piller)
English: Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.
Danish: Desuden kan samtidig sygdom, især infektioner, føre til hyperglykæmi og derved et øget insulinbehov.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Danish: I sjældne tilfælde vil tilstædeværelsen af insulinantistoffer nødvendiggøre justering af insulindosis for at korrigere en tendens til hyper- eller hypoglykæmi.
English: • Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Danish: • Alvorlig hypoglykæmi, hvor patienten ikke er i stand til at behandle sig selv, kan behandles med glucagon (0,5 til 1 mg) administreret intramuskulært eller subkutant af en instrueret person eller med glucose administreret intravenøst af sundhedspersonale.
English: Detailed instructions accompanying the delivery system must be followed.
Danish: Den detaljerede vejledning, som er vedlagt dispenseringssystemet, skal følges.
English: It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.
Danish: Det anbefales at optimere den glykæmiske kontrol via dosisjustering baseret på faste-plasmaglucose.
English: On occasions when you cannot follow your regular dosing schedule, you can change the time of dosing because Tresiba has a long blood sugar-lowering effect (see section 3 for ‘Flexibility in dosing time').
Danish: I situationer, hvor du ikke kan følge din sædvanlige doseringsplan, kan du ændre administrationstidspunktet, fordi Tresiba har en langvarig blodsukkersænkende virkning (se punkt 3 ”Fleksibelt doseringstidspunkt”).
English: Efficacy and safety data for adolescent patients with type 2 diabetes mellitus have been extrapolated from data for adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Danish: Data for virkning og sikkerhed hos unge patienter med type 2-diabetes mellitus er blevet ekstrapoleret fra data fra unge og voksne patienter med type 1-diabetes mellitus og voksne patienter med type 2-diabetes mellitus.
English: On occasions when administration at the same time of the day is not possible, Tresiba allows for flexibility in the timing of insulin administration (see section 5.1).
Danish: I situationer, hvor administration på samme tidspunkt af dagen ikke er mulig, tillader Tresiba fleksibilitet med hensyn til tidspunktet for administration af insulin (se pkt.
English: Tresiba with alcohol
Danish: Brug af Tresiba sammen med alkohol
English: Only the dose counter and dose pointer will show how many units you select per dose.
Danish: Kun dosistælleren og dosismarkøren viser, hvor mange enheder du vælger pr. dosis.
English: If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not inject a double dose, but resume your once-daily dosing schedule.
Danish: Hvis du opdager, at du har glemt din tidligere dosis, når det er tid til din næste planmæssige dosis, må du ikke injicere en dobbeltdosis, men fortsætte med at tage Tresiba én gang dagligt.
English: The rate of hypoglycaemic episodes (per patient year of exposure) was statistically significantly lower when adding liraglutide compared to adding a single dose of insulin aspart (1.0 vs 8.15; ratio: 0.13; 95% CI: 0.08 to 0.21).
Danish: Hyppigheden af hypoglykæmiske episoder (per eksponeringsår) var statistisk signifikant lavere, når liraglutid blev givet i tillæg, i forhold til når en enkelt dosis insulin aspart blev tilføjet (1,0 versus 8,15; ratio: 0,13; 95% CI: 0,08 til 0,21).
English: The MAH shall agree on the final text of the Direct Healthcare Professional Communication letter and the content of the patient brochure together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational pack in the Member State.
Danish: Indehaveren af markedsføringstilladelsen skal blive enig om den færdige tekst af Ledende sundhedspersonale kommunikationsbrevet og indholdet af patient-brochuren, samt en komminukationsplan med den pågældende myndighed i hvert medlemsland før distribution af uddannelsespakken.
English: Combination of pioglitazone and insulin medicinal products Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac failure.
Danish: Kombinationsbehandling med pioglitazon og insulinpræparater Tilfælde af hjerteinsufficiens er blevet rapporteret, når pioglitazon har været brugt i kombination med insulin, særligt hos patienter med risikofaktorer for udvikling af hjerteinsufficiens.
English: Detailed instructions for use are provided on the other side of this leaflet.
Danish: Der er en detaljeret vejledning på den anden side af denne indlægsseddel.
English: N: Number of subjects with a first EAC confirmed event during trial.
Danish: N: Antal personer med et førstegangstilfælde bekræftet under forsøget via afgørelse fra en hændelseskommite.
English: CV: within-patient coefficient of variation in %
Danish: CV: intra-individuel variationskoefficient i %
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency 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: If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Danish: Hvis du har symptomer på for lavt blodsukker, skal du straks sørge for at øge dit blodsukker.
English: Addition of liraglutide resulted in a statistically significantly greater reduction of HbA1c (-0.73% for liraglutide vs -0.40% for comparator, estimated means) and body weight (-3.03 vs 0.72 kg, estimated means).
Danish: Tillæg af liraglutid resulterede i en statistisk signifikant større reduktion af HbA1c (-0,73% for liraglutid versus -0,40% for komparator, estimerede gennemsnitsværdier) og legemsvægt (-3,03 kg versus 0,72 kg, estimerede gennemsnitsværdier).
English: Tresiba must not be added to infusion fluids.
Danish: Tresiba må ikke tilsættes infusionsvæsker.
English: The efficacy and safety of Tresiba have been studied in a 1:1 randomised controlled clinical trial in children and adolescents with type 1 diabetes mellitus for a period of 26 weeks (n=350), followed by a 26-week extension period (n=280).
Danish: Virkningen og sikkerheden af Tresiba er blevet undersøgt i et 1:1 randomiseret, kontrolleret klinisk studie hos børn og unge med type 1-diabetes mellitus over en periode på 26 uger (n=350) efterfulgt af en 26-ugers udvidelsesperiode (n=280).
English: Antibody development was sparse and had no clinical impact.
Danish: Der blev kun set få tilfælde af antistofudvikling og dette havde ikke nogen klinisk betydning.
English: In the insulin degludec + liraglutide arm, the insulin dose was reduced by 20% in order to minimise the risk of hypoglycaemia.
Danish: I armen med insulin degludec + liraglutid blev insulindosis reduceret med 20% for at minimere risikoen for hypoglykæmi.
English: Fertility Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Danish: Fertilitet Reproduktionsstudier med insulin degludec hos dyr har ikke vist nogen bivirkninger på fertiliteten.
English: With Tresiba, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Danish: Med Tresiba blev overfølsomhed (manifesteret ved hævelse af tunge og læber, diarré, kvalme, træthed og kløe) og urticaria rapporteret sjældent.
English: When adding GLP-1 receptor agonists to Tresiba, it is recommended to reduce the dose of Tresiba by 20% to minimise the risk of hypoglycaemia.
Danish: Når GLP-1-receptoragonister gives i tillæg til Tresiba, anbefales det at reducere dosis af Tresiba med 20% for at minimere risikoen for hypoglykæmi.
English: Tresiba can be used in adolescents and children aged 1 year and above.
Danish: Tresiba kan bruges af unge og børn i alderen 1 år og opefter.
English: Insulin administration may cause insulin antibodies to form.
Danish: Insulin administration kan forårsage dannelse af insulinantistoffer.
English: End of treatment FPG (mmol/L)
Danish: Behandlingsafslutning FPG (mmol/l)
English: • Neonates and infants from birth to less than 12 months of age with type 1 diabetes mellitus and children from birth to less than 10 years of age with type 2 diabetes mellitus on the grounds that the disease or condition for which the specific medicinal product is intended does not occur in the specified paediatric subset (see section 4.2 for information on paediatric use).
Danish: • Nyfødte og spædbørn fra fødslen og op til 12 måneder med type 1-diabetes mellitus og børn fra fødslen og op til 10 år med type 2-diabetes mellitus, da den sygdom eller tilstand, det specifikke lægemiddel er beregnet til, ikke forekommer i den specificerede pædiatriske undergruppe (se pkt.
English: If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Danish: Hvis dosistælleren stopper, før den når 0, er den fulde dosis ikke blevet injiceret, hvilket kan føre til et for højt blodsukkerniveau.