FrancophonIA/ELRC3.0 huggingface dataset:
English: If a drop of insulin still does not appear, dispose of the pen and use a new one.
Danish: Hvis der stadig ikke kommer en dråbe insulin til syne, skal du kassere pennen og tage en ny i brug.
English: Needles and syringes must not be shared.
Danish: Nåle og sprøjter må ikke deles med andre.
English: The total insulin exposure was comparable between Fiasp and NovoRapid.
Danish: Den totale insulineksponering var sammenlignelig for Fiasp og NovoRapid.
English: • Severe hypoglycaemic episodes, where the patient is not able to treat him/herself, 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: • The insulin scale shows you approximately how much insulin is left in your pen.
Danish: • Insulinskalaen viser, cirka hvor meget insulin der er tilbage i pennen.
English: • Always carry products containing sugar with you.
Danish: • Medbring altid sukkerholdige produkter.
English: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Danish: Orale kontraceptiva, thiazider, glukokortikoider, thyreoideahormoner, sympatomimetika, væksthormon og danazol.
English: Blood glucose levels should be monitored adequately under these conditions.
Danish: Under sådanne betingelser skal blodglucose monitoreres i tilstrækkelig grad.
English: The total glucose-lowering effect and maximum (GIRmax) glucose-lowering effect were comparable between Fiasp and NovoRapid.
Danish: Den samlede glucosesænkende effekt og den maksimale (GIRmax) glucosesænkende effekt var sammenlignelige for Fiasp og NovoRapid.
English: If you forget to use your insulin your blood sugar may get too high (hyperglycaemia).
Danish: Hvis du glemmer at bruge din insulin, kan dit blodsukker blive for højt (hyperglykæmi).
English: Close glucose monitoring is recommended during the transfer from other mealtime insulins and in the initial weeks thereafter.
Danish: Nøje monitorering af glucose anbefales ved skift fra andre måltidsinsulinpræparater og i de første uger herefter.
English: The pre-filled pen delivers 1-80 units in steps of 1 unit.
Danish: Den fyldte pen leverer 1-80 enheder i trin på 1 enhed.
English: Subcutaneous injection
Danish: Subkutan injektion
English: Insulin administration may cause insulin antibodies to form.
Danish: Insulinadministration kan forårsage dannelse af insulinantistoffer.
English: If your blood sugar level falls too much you may become unconscious.
Danish: Hvis dit blodsukker falder for meget, kan du besvime.
English: The medicinal product must not be diluted or mixed with any other medicinal products except infusion fluids as described in section 4.2.
Danish: Lægemidlet må ikke fortyndes eller blandes med andre lægemidler end de infusionsvæsker, der er anført under pkt.
English: Fiasp with alcohol
Danish: Brug af Fiasp sammen med alkohol
English: If it shows less than 80, the number shown is the number of units left in your pen.
Danish: Hvis den viser mindre end 80, er det viste tal antallet af enheder, der er tilbage i pennen.
English: If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Danish: Hvis du er blind eller har nedsat syn og ikke kan aflæse dosistælleren på pennen, må du ikke bruge denne pen uden hjælp.
English: Figure 1 Mean insulin profile in patients with type 1 diabetes after subcutaneous injection.
Danish: Figur 1 Gennemsnitlig insulinprofil hos patienter med type 1-diabetes efter subkutan injektion.
English: • Do not inject into a vein or muscle.
Danish: • Injicér ikke lægemidlet i en blodåre eller muskel.
English: • Check the name and strength on the label of the cartridge (Penfill) to make sure it is Fiasp.
Danish: • Kontrollér navnet og styrken på cylinderampullens etiket (Penfill) for at sikre dig, at det er
English: Before first use:
Danish: Før ibrugtagning:
English: Do not use Fiasp
Danish: Brug ikke Fiasp
English: • oral contraceptives (birth control pills)
Danish: • oral prævention (f.eks. p-piller)
English: Before you use Fiasp for the first time, your doctor or nurse will show you how to use it. 1 Check the name and strength on the label of the vial to make sure it is Fiasp.
Danish: Før du bruger Fiasp første gang, viser lægen eller sygeplejersken dig, hvordan du skal bruge det. 1 Kontrollér navnet og styrken på hætteglassets etiket for at sikre dig, at det er Fiasp.
English: • Insert the needle into your skin as your doctor or nurse has shown you.
Danish: • Stik nålen ind i huden, som lægen eller sygeplejersken har vist dig.
English: Allergic skin manifestations reported with Fiasp (1.8% vs. 1.5% for comparator) include eczema, rash, rash pruritic, urticaria and dermatitis.
Danish: Allergiske hudmanifestationer rapporteret med Fiasp (1,8% versus 1,5% for komparator) omfatter eksem, udslæt, kløende udslæt, urticaria og dermatitis.
English: 5 Turn the vial and syringe upside down and draw the correct insulin dose into the syringe.
Danish: 5 Vend hætteglasset og sprøjten på hovedet, og træk den korrekte dosis insulin ind i sprøjten.
English: If no drop appears, no insulin will be injected, 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: Read the package leaflet before use Subcutaneous or intravenous use
Danish: Læs indlægssedlen inden brug Subkutan eller intravenøs anvendelse
English: • tremor or feeling nervous or worried
Danish: • ufrivillig rysten eller nervøsitet eller bekymring
English: What to do if you get high blood sugar
Danish: Hvad du skal gøre, hvis du får for højt blodsukker
English: • The best places to inject are the front of your waist (abdomen) or upper arms.
Danish: • De bedste steder til injektion er foran på maveskindet eller på overarmen.
English: Figure 2 Mean insulin profiles in patients with type 1 diabetes in a CSII setting (0-5 hours) corrected for basal insulin infusion
Danish: Figur 2 Gennemsnitlige insulinprofiler hos patienter med type 1-diabetes ved CSIIadministration (0-5 timer) korrigeret for infusion af basalinsulin
English: Fiasp is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above.
Danish: Fiasp er en injektionsvæske, opløsning, der indeholder insulin aspart og anvendes til at behandle sukkersyge (diabetes mellitus) hos voksne, unge og børn i alderen 1 år og derover.
English: Fiasp has been studied in 2,068 adult patients with type 1 diabetes (1,143 patients) and type 2 diabetes (925 patients) in 3 randomised efficacy and safety trials (18-26 weeks of treatment).
Danish: Fiasp er blevet undersøgt hos 2.068 randomiserede voksne patienter med type 1-diabetes (1.143 patienter) og type 2-diabetes (925 patienter) i tre randomiserede virknings- og sikkerhedsforsøg (18-26 ugers behandling).
English: (0.56→0.53 units/kg/day) and NovoRapid (0.52→0.48 units/kg/day).
Danish: (0,56→0,53 enheder/kg/dag) og NovoRapid (0,52→0,48 enheder/kg/dag).
English: C Count slowly:
Danish: C Tæl langsomt:
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Danish: Dette reducerer risikoen for urenheder, infektion, udsivning af insulin, tilstoppede nåle og upræcis dosering.
English: • thiazides - for high blood pressure or if your body is keeping too much water (water retention).
Danish: • thiazider - mod forhøjet blodtryk eller for meget vand i kroppen (væskeophobning).
English: Make sure the dose counter shows 2.
Danish: Du skal sikre dig, at dosistælleren viser 2.
English: The daily dose should be based on your blood sugar level at mealtimes and bedtime from the previous day.
Danish: Den daglige dosis skal baseres på dit blodsukker ved måltiderne og ved sengetid den foregående dag.
English: In a basal-bolus treatment regimen approximately 50% of this requirement may be provided by Fiasp and the remaining by intermediate-acting or long-acting insulin.
Danish: I et basal-bolus-behandlingsregimen vil ca. 50% af behovet være dækket af Fiasp og resten af insulin med middellang eller lang virkningsvarighed.
English: If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
Danish: Hvis det er nødvendigt at anvende en sprøjte, intravenøs injektion eller infusionspumpe til administrationen, bør et hætteglas anvendes.
English: The day-to-day variability within-patients in glucose-lowering effect was low for Fiasp both for early (AUCGIR, 0-1h, CV~26%), total (AUCGIR, 0-12h, CV~18%) and maximum glucose-lowering effect (GIRmax, CV~19%).
Danish: Dag-til-dag-variationen i den glucosesænkende effekt hos den enkelte patient var lav for Fiasp, både med hensyn til den tidlige (AUCGIR, 0-1 time, CV ~26%), den samlede (AUCGIR, 0-12 timer, CV ~18%) og den maksimale glucosesænkende effekt (GIRmax, CV ~19%).
English: The efficacy and safety of Fiasp have been studied in a 1:1:1 randomised active controlled clinical trial in children and adolescents with type 1 diabetes, aged 1 to 18 years, for a period of 26 weeks (N=777).
Danish: Virkningen og sikkerheden af Fiasp er blevet undersøgt i et 1:1:1 randomiseret aktivt kontrolleret klinisk studie hos børn og unge i alderen 1 til 18 år med type 1-diabetes over en periode på 26 uger (N=777).
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 i henhold til de anvisninger, du har fået fra lægen, sygeplejersken, apotekspersonalet eller de lokale sundhedsmyndigheder.
English: If hypoglycaemia occurs, you may experience it earlier after an injection with Fiasp.
Danish: Hvis der opstår hypoglykæmi, kan du opleve, at det opstår hurtigere efter en injektion med Fiasp.
English: • Wait until the signs of 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: The following substances may increase insulin requirement:
Danish: Følgende præparater kan øge insulinbehovet:
English: The pre-filled pen can provide a dose of 1-80 units in one injection in steps of 1 unit.
Danish: Den fyldte pen kan levere en dosis på 1-80 enheder i én injektion i trin på 1 enhed.
English: In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin.
Danish: I in vitro-undersøgelser af bl.a. binding til insulin og IGF-1receptorsteder samt virkning på cellevækst opførte insulin aspart sig meget lig humant insulin.
English: • Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.
Danish: • Skift af infusionssættet (slange og nål) skal ske i overensstemmelse med instruktionerne i produktinformationen, der følger med infusionssættet.
English: Intravenous use
Danish: Intravenøs anvendelse
English: Fiasp has been shown to be stable at room temperature for 24 hours in the infusion fluids such as sodium chloride 9 mg/mL (0.9%) solution or 5% glucose solution.
Danish: Det er vist, at Fiasp er stabilt ved stuetemperatur i 24 timer i infusionsvæsker såsom natriumchlorid 9 mg/ml (0,9%) opløsning eller 5% glucoseopløsning.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent a relapse.
Danish: Når patienten er kommet til bevidsthed, anbefales det at give kulhydrater oralt for at forhindre et tilbagefald.
English: This medicine is for injection under the skin (subcutaneous injection) or for continuous infusion in pumps.
Danish: Fiasp er beregnet til injektion under huden (subkutan injektion) eller til kontinuerlig infusion i pumper.
English: • you often get low blood sugar
Danish: • hvis du ofte har for lavt blodsukker
English: There are no restrictions on treatment with Fiasp during breast-feeding.
Danish: Der er ingen restriktioner for behandling med Fiasp under amning.
English: Get help from a person with good eyesight who is trained to use the pen.
Danish: Få hjælp af en person med normalt syn, som har fået undervisning i at bruge pennen.
English: Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Danish: Brug altid dosistælleren og dosismarkøren til at se, hvor mange enheder du har valgt, før du injicerer insulinet.
English: If the insulin looks cloudy, do not use the pen.
Danish: Hvis insulinet virker uklart, må du ikke bruge pennen.
English: Always check the flow before you inject.
Danish: Kontrollér altid gennemløbet, før du injicerer.
English: D The difference is for Fiasp postmeal - NovoRapid mealtime
Danish: D Forskellen er for Fiasp efter måltid - NovoRapid ved måltid
English: • Switching from other insulin medicinal products - The insulin dose may need to be changed if you switch from another insulin.
Danish: • Skift fra andre insulinpræparater - Hvis du skifter fra et andet insulinpræparat, kan det være nødvendigt at ændre din insulindosis.
English: Fiasp is a mealtime insulin with a fast-acting blood sugar lowering effect.
Danish: Fiasp er et måltidsinsulin med en hurtig blodsukkersænkende virkning.
English: Table 1 Dose adjustment Mealtime or bedtime blood sugar
Danish: Tabel 1 Dosisjustering Blodsukker ved måltid eller sengetid
English: The vial is to be used with insulin syringes with the corresponding unit scale (U-100 or 100 U/mL).
Danish: Hætteglasset skal anvendes sammen med insulinsprøjter, der har en tilsvarende enhedsskala (E-100 eller 100 E/ml).
English: If your blood sugar is low, your ability to concentrate or react might be affected.
Danish: Hvis dit blodsukker er for lavt, kan det påvirke din koncentrations- og reaktionsevne.
English: • if you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
Danish: • Hvis du har problemer med nyrer eller lever, eller med binyrer, hypofyse eller skjoldbruskkirtel.
English: The onset of appearance was twice as fast (corresponding to 5 minutes earlier), time to 50% maximum concentration was 9 minutes shorter with Fiasp compared to NovoRapid with four times as much insulin available during first 15 minutes and with twice as much insulin available during the first 30 minutes.
Danish: Virkningen indtrådte dobbelt så hurtig (svarende til 5 minutter tidligere), tid til 50% maksimal koncentration var 9 minutter kortere med Fiasp end med NovoRapid, og der var fire gange så meget insulin tilgængeligt i de første 15 minutter og dobbelt så meget insulin tilgængeligt i de første 30 minutter.
English: The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.
Danish: Infusionssættet (slange og kanyle) skal skiftes i henhold til instruktionerne i produktinformationen, der følger med infusionssættet.
English: • Pull off the outer needle cap and keep it for later.
Danish: • Fjern den ydre nålehætte, og gem den til senere brug.
English: The reduction in HbA1c from baseline to end of trial was confirmed to be non-inferior to that obtained with NovoRapid (Table 4).
Danish: Det blev bekræftet, at reduktionen af HbA1c fra baseline til forsøgsafslutning var non-inferiørt i forhold til den reduktion, der blev opnået med NovoRapid (tabel 4).
English: Do not freeze During use: Can be stored in the refrigerator.
Danish: Må ikke fryses Under brug: Kan opbevares i køleskab.
English: 33.3% of patients treated with mealtime Fiasp reached a target HbA1c of < 7% compared to 23.3% of patients treated with postmeal Fiasp and 28.2% of patients treated with mealtime NovoRapid.
Danish: 33,3% af de patienter, der blev behandlet med Fiasp i forbindelse med et måltid, opnåede target-HbA1c på < 7% sammenlignet med 23,3% af de patienter, der blev behandlet med Fiasp efter et måltid, og 28,2% af de patienter, der blev behandlet med NovoRapid i forbindelse med et måltid.
English: Fiasp must not be used if the solution does not appear clear and colourless.
Danish: Fiasp må ikke anvendes, hvis injektionsvæsken ikke er klar og farveløs.
English: Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver.
Danish: Receptorbundet insulin sænker blodglucose ved at lette cellulær optagelse af glucose i skeletmuskulaturen og fedtvævet og ved at hæmme glucosefrigivelsen fra leveren.
English: How to handle a blocked needle?
Danish: Sådan håndteres en tilstoppet nål
English: Patients must visually verify the units of the dose prior to administering.
Danish: Patienterne skal kontrollere antallet af dosisenhederne inden indgivelse.
English: You should always have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector or syringes) in case the pump system fails.
Danish: Du skal altid medbringe et alternativt insulindispenseringssystem, således at injektionen kan udføres under huden (f.eks. en injektionspen eller sprøjter), hvis der opstår pumpesvigt.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apotekspersonalet, hvordan du skal bortskaffe medicinrester.
English: Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.
Danish: Du må ikke bruge insulinskalaen, den viser ikke nøjagtigt, hvor meget insulin der er tilbage i pennen.
English: Pump or infusion set malfunctions can lead to a fast onset of hyperglycaemia and ketosis.
Danish: Funktionsfejl i pumper eller infusionssæt kan føre til hurtig indtræden af hyperglykæmi og ketose.
English: • It is recommended that you retest your blood glucose levels after 15-20 minutes and re-treat if your blood glucose levels are still less than 4 mmol/L.
Danish: • Det anbefales, at du måler dit blodsukker igen efter 15-20 minutter og hvis dit blodsukker stadig er under 4 mmol/l, skal du igen tage et sukkerholdigt produkt.
English: Contents of the pack and other information What Fiasp contains
Danish: Pakningsstørrelser og yderligere oplysninger Fiasp indeholder:
English: 3 Select your dose • Make sure the dose counter shows 0 before you start.
Danish: 3 Indstil dosis • Kontrollér, at dosistælleren står på 0, før du starter.
English: Table 4 Results from 26 week basal-bolus clinical trial in patients with type 2 diabetes
Danish: Tabel 4 Resultater fra et 26-ugers basal-bolus klinisk forsøg hos patienter med type 2-diabetes
English: Pull the needle out of the vial.
Danish: Træk nålen ud af hætteglasset.
English: If you do not check the flow, you may get too little insulin or no insulin at all.
Danish: Hvis ikke du kontrollerer gennemløbet, kan du risikere at få for lidt eller slet ingen insulin.
English: Instructions on how to use Fiasp FlexTouch
Danish: Vejledning i brugen af Fiasp FlexTouch
English: Total and maximum glucose-lowering effect of Fiasp increase linearly with increasing dose within the therapeutic dose range.
Danish: Den samlede og maksimale glucosesænkende effekt af Fiasp stiger lineært med en stigende dosis inden for det terapeutiske dosisområde.
English: Your blood sugar level may rise (hyperglycaemia) if you take:
Danish: Dit blodsukker kan stige (hyperglykæmi), hvis du tager:
English: Pharmacotherapeutic group: Drugs used in diabetes.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika.
English: • Take a new needle and tear off the paper tab.
Danish: • Tag en ny nål, og riv papirforseglingen af.
English: The onset of action was 5 minutes earlier and time to maximum glucose infusion rate was 11 minutes earlier with Fiasp than with NovoRapid.
Danish: Virkningen indtrådte 5 minutter tidligere, og tid til maksimal glucoseinfusionsrate (GIR) var 11 minutter tidligere for Fiasp end for NovoRapid.
English: Fiasp given by subcutaneous injection should be used in combination with intermediate-acting or longacting insulin given at least once a day.
Danish: Fiasp givet som subkutan injektion skal anvendes i kombination med et insulinpræparat med middellang eller lang virkningsvarighed, som gives mindst én gang dagligt.
English: Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Danish: Studier viser også, at insulin asparts dissociation fra bindingen til insulinreceptoren er den samme som for humant insulin.
English: (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Danish: Frekvenskategorierne 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
English: The onset of exposure in a CSII setting (time to reach maximum concentration) was 26 minutes shorter with Fiasp compared to NovoRapid resulting in approximately three times as much insulin available during the first 30 minutes (Figure 2).
Danish: Eksponeringens indtræden (tid til opnåelse af maksimal koncentration) ved CSII-administration var 26 minutter kortere med Fiasp end med NovoRapid, hvilket resulterede i ca. tre gange så meget tilgængeligt insulin i de første 30 minutter (figur 2).
English: Time to maximum concentration and total insulin aspart exposure were all comparable between the abdomen, upper arm and the thigh.
Danish: Tiden til maksimal koncentration og den totale eksponering for insulin aspart var sammenlignelige for abdomen, overarm og lår.
English: Do not use the pen without proper training from your doctor or nurse.
Danish: Tag ikke pennen i brug, før du har fået undervisning af lægen eller sygeplejersken.
English: If cartridge is carried as a spare and unused, the cartridge should be kept in the outer carton in order to protect from light.
Danish: Hvis cylinderampullen medbringes som reserve og er ubrugt, skal den opbevares i den ydre karton for at beskytte mod lys.
English: The early onset of action must be considered when prescribing Fiasp (see section 5.1).
Danish: Den tidlige indsættende virkning skal tages i betragtning ved ordinering af Fiasp (se pkt.
English: Whites and Hispanics vs. non-Hispanics) on the total insulin exposure of Fiasp was based on results from a population pharmacokinetic analysis in patients with type 1 diabetes.
Danish: Indflydelsen af race og etnicitet (sorte versus hvide og latinamerikanere versus ikke-latinamerikanere) på den totale insulineksponering af Fiasp var baseret på resultater fra en populationsfarmakokinetisk analyse hos patienter med type 1-diabetes.
English: Fiasp may be used in an infusion pump (CSII) for a maximum of 6 days, as described in section 4.2 and in the package leaflet.
Danish: Fiasp kan anvendes i en infusionspumpe (CSII) i højst 6 dage, som beskrevet i pkt.
English: This may indicate a blocked or damaged needle.
Danish: Det kan betyde, at nålen er tilstoppet eller beskadiget.
English: Use only clear, colourless solution Single patient use only
Danish: Brug kun en klar, farveløs injektionsvæske Kun til brug hos én patient
English: • feeling sleepy or tired
Danish: • døsighed eller træthed
English: Before you use Fiasp for the first time, your doctor or nurse will show you how to use it.
Danish: Før du bruger Fiasp første gang, viser lægen eller sygeplejersken dig, hvordan du skal bruge det.
English: Before opening: Store in a refrigerator.
Danish: Før ibrugtagning: Opbevares i køleskab.
English: • you experience rapid heartbeat or feeling dizzy.
Danish: • du får hurtige hjerteslag (puls) eller føler dig svimmel.