FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin aspart has a low binding affinity to plasma proteins (< 10%), similar to that seen with regular human insulin.
Danish: Insulin aspart har en lav bindingsaffinitet til plasmaproteiner (< 10%), svarende til det, der ses med almindeligt humant insulin.
English: Octreotide and lanreotide - used to treat a rare condition involving too much growth hormone (acromegaly).
Danish: Octreotid og lanreotid - til behandling af en sjælden lidelse med for meget væksthormon (akromegali).
English: • The active substance is insulin aspart.
Danish: • Aktivt stof: Insulin aspart.
English: There were no microscopically confirmed episodes of infusion set occlusions in either the Fiasp (N=25) or NovoRapid (N=12) groups.
Danish: Der var ingen mikroskopisk bekræftede episoder med tilstopning af infusionssættet i hverken gruppen med Fiasp (N = 25) eller NovoRapid (N = 12).
English: Patients with renal failure necessitating dialysis treatment were not investigated.
Danish: Patienter med nyresvigt, som kræver dialysebehandling, blev ikke undersøgt.
English: • Treat your pen with care.
Danish: • Håndter din pen med forsigtighed.
English: You can select up to 80 units per dose.
Danish: Du kan vælge op til 80 enheder per dosis.
English: • Remove the needle from your skin.
Danish: • Fjern nålen fra huden.
English: • Always keep your pen and needles out of sight and reach of others, especially children.
Danish: • Opbevar altid pennen og nålene ude af syne og utilgængeligt for andre, især børn.
English: • sulphonamides - for infections
Danish: • sulfonamider - mod infektioner
English: This must be considered when prescribing Fiasp.
Danish: Dette skal tages i betragtning ved ordination af Fiasp.
English: Dosing with Fiasp is individual and determined in accordance with the needs of the patient.
Danish: Dosering af Fiasp er individuel og fastlægges ud fra en vurdering af patientens behov.
English: You may prick or injure yourself with the needle.
Danish: Du kan komme til at stikke eller skade dig selv med nålen.
English: Baseline, End of trial values are based on the mean of the observed last available values.
Danish: Baseline- og forsøgsafslutningsværdierne er baseret på gennemsnittet af de observerede seneste tilgængelige værdier.
English: No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
Danish: Der blev ikke observeret nogen overordnede forskelle mellem ældre og yngre patienter, hvad angår sikkerhed eller virkning.
English: No apparent effect of creatinine clearance values on AUC, Cmax, CL/F and Tmax of insulin aspart was found.
Danish: Der blev ikke fundet nogen tydelig effekt af kreatinin-clearance-værdier på AUC, Cmax, CL/F og Tmax for insulin aspart.
English: Do not touch the dose counter with your fingers.
Danish: Du må ikke røre ved dosistælleren med fingrene.
English: Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.
Danish: Reproduktionsstudier hos dyr har ikke vist nogen forskelle mellem insulin aspart og humant insulin, hvad angår fertilitet.
English: • Make sure you can see the dose counter.
Danish: • Kontrollér, at du kan se dosistælleren.
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: Needles are not included in the pack.
Danish: Nåle medfølger ikke i pakningen.
English: Care should be taken to ensure that the insulin is injected into the infusion bag and not simply the entry port.
Danish: Det skal omhyggeligt sikres, at insulinet injiceres i infusionsposen og ikke blot i indgangsporten.
English: • anabolic steroids - such as testosterone
Danish: • anabolske steroider - f.eks. testosteron
English: Before using Fiasp in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, high or low blood sugar or failure of the pump system.
Danish: Før du anvender Fiasp i et pumpesystem, skal du have modtaget grundig instruktion i brugen og information om, hvad du skal gøre i tilfælde af sygdom, for højt eller for lavt blodsukker eller pumpesvigt.
English: This causes swelling around your ankles and other joints.
Danish: Det giver hævelser omkring ankler og andre led.
English: Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Danish: Alkohol kan øge eller reducere den hypoglykæmiske effekt af insulin.
English: If necessary, clean it with mild detergent on a moistened cloth.
Danish: Hvis det er nødvendigt, kan den rengøres med et mildt rengøringsmiddel på en fugtig klud.
English: • get medical help straight away
Danish: • straks tilkalde lægehjælp
English: • Always keep a spare pen in case you lose your pen or it gets damaged.
Danish: • Medbring altid en ekstra pen i tilfælde af, at du mister din pen, eller den bliver beskadiget.
English: However, long-term glycaemic control decreases the risk of diabetic retinopathy and neuropathy.
Danish: Glykæmisk kontrol gennem længere tid nedsætter dog risikoen for diabetisk retinopati og neuropati.
English: • you experience difficulty in breathing
Danish: • du får åndedrætsbesvær
English: Half-life after subcutaneous administration of Fiasp is 57 minutes and comparable to NovoRapid.
Danish: Halveringstiden efter subkutan administration af Fiasp er 57 minutter og sammenlignelig med NovoRapid.
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 fået noget medicin, selvom dosistælleren har bevæget sig fra den oprindelige dosis, du valgte.
English: Talk to your doctor if:
Danish: Tal med lægen, hvis:
English: After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Danish: Efter fødslen vil insulinbehovet normalt hurtigt vende tilbage til behovet før graviditeten.
English: Time since bolus injection (min)
Danish: Tid siden bolusinjektion (min.)
English: • acetylsalicylic acid (and other salicylates) - for pain and mild fever
Danish: • acetylsalicylsyre (og andre salicylater) - mod smerter og let feber
English: Following intravenous administration of Fiasp, clearance was rapid (1.0 L/h/kg) and the elimination half-life was 10 minutes.
Danish: Efter intravenøs administration af Fiasp var clearance hurtig (1,0 l/time/kg), og halveringstiden var 10 minutter.
English: If severe low blood sugar is not treated over time, it can cause brain damage.
Danish: Hvis alvorligt lavt blodsukker ikke behandles inden for en vis tid, kan det medføre hjerneskade.
English: If the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and oedema.
Danish: Hvis kombinationsbehandlingen anvendes, skal patienterne observeres for tegn og symptomer på kongestiv hjerteinsufficiens, vægtstigning og ødemer.
English: It might lead to cross-infection.
Danish: Det kan medføre krydsinfektion.
English: Eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin.
Danish: Spiser mere eller dyrker mindre motion, end du plejer, drikker alkohol, får en infektion eller feber, ikke har brugt tilstrækkeligt insulin, gentagne gange bruger mindre insulin end du har brug for, glemmer at bruge insulin eller stopper med at bruge insulin.
English: Please read these instructions carefully before using your FlexTouch pre-filled pen.
Danish: Læs denne vejledning omhyggeligt, inden du bruger den fyldte FlexTouch pen.
English: This helps you to ensure that you get your full insulin dose.
Danish: Det er med til at sikre, at du får hele din insulindosis.
English: If there is still no drop, change the needle and repeat steps 2A to 2C once more.
Danish: Hvis der stadig ikke kommer en dråbe til syne, skiftes nålen, og trin 2A til 2C gentages en gang mere.
English: Data were limited in patients with moderate and severe renal impairment.
Danish: Data var begrænsede hos patienter med moderat og svært nedsat nyrefunktion.
English: In subjects with hepatic impairment, absorption rate was decreased and more variable.
Danish: Hos personer med nedsat leverfunktion var absorptionsraten nedsat og varierede mere.
English: Prompt identification and correction of the cause of hyperglycaemia or ketosis is necessary.
Danish: Hurtig identifikation og korrektion af årsagen til hyperglykæmi eller ketose er nødvendig.
English: Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Danish: Behandling af diabetes mellitus hos voksne, unge og børn i alderen 1 år og derover.
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements.
Danish: Anden samtidig sygdom, især infektioner og tilstande med feber, øger normalt patientens insulinbehov.
English: < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving.
Danish: Patienterne skal informeres om at tage forholdsregler for at undgå hypoglykæmi, når de kører bil.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis.
English: Keep away from the freezing element.
Danish: Må ikke komme for tæt på fryseelementet.
English: Use the injection technique advised by your doctor or nurse.
Danish: Brug den injektionsteknik, som din læge eller sygeplejerske har anbefalet dig.
English: EXP During use: Use within 4 weeks
Danish: EXP Under brug: Anvendes inden 4 uger
English: One (1) unit of Fiasp corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues.
Danish: Én (1) enhed Fiasp svarer til 1 international enhed humant insulin eller 1 enhed af andre hurtigtvirkende insulinanaloger.
English: Overall the frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the adult population.
Danish: Generelt indikerer hyppigheden, typen og alvorligheden af bivirkninger hos den pædiatriske population ingen forskelle sammenlignet med erfaringen fra den voksne population.
English: • if you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for insulin aspart eller et af de øvrige indholdsstoffer i Fiasp (angivet i punkt 6).
English: • Low blood sugar (hypoglycaemia) (very common)
Danish: • For lavt blodsukker (hypoglykæmi) (meget almindelig)
English: These are uncommon and may affect up to 1 in 100 people.
Danish: Dette er ikke almindeligt og kan forekomme hos færre end 1 ud af 100 behandlede.
English: The initial absorption rate was slower with increasing BMI while the total exposure was similar across different BMI levels.
Danish: Den initiale absorptionsrate var langsommere ved et højere BMI, mens den totale eksponering var den samme på tværs af forskellige BMI-niveauer.
English: The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions' below).
Danish: Den hyppigst rapporterede bivirkning under behandling er hypoglykæmi (se afsnittet ”Beskrivelse af udvalgte bivirkninger” nedenfor).
English: • local reactions (e.g., rash, redness and itching) spread to other parts of your body
Danish: • lokale reaktioner (f.eks. udslæt, rødme og kløe) spreder sig til resten af din krop
English: • If the needle is removed earlier, you may see a stream of insulin coming from the needle tip.
Danish: • Hvis nålen fjernes tidligere, vil du måske se en strøm af insulin, der kommer fra nålens spids.
English: Your doctor will decide together with you:
Danish: Du og din læge beslutter sammen:
English: If you have a serious allergic reaction to insulin or any of the ingredients in Fiasp, stop using this medicine and contact emergency medical service straight away.
Danish: Hvis du får en alvorlig allergisk reaktion over for insulin eller andre af indholdsstofferne i Fiasp, skal du stoppe med at bruge dette lægemiddel og straks kontakte alarmcentralen.
English: • If you do not respond to a glucagon injection, you will have to be treated in a hospital.
Danish: • Hvis du ikke reagerer på glucagon-injektionen, skal du behandles på et hospital.
English: This may lead to high blood sugar level.
Danish: Det kan medføre for højt blodsukker.
English: Interim therapy with subcutaneous injection may be required.
Danish: Midlertidig behandling med subkutan injektion kan være påkrævet.
English: Important information about some of the ingredients of Fiasp
Danish: Vigtig information om nogle af indholdsstofferne i Fiasp
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 hos patienter, der udøver øget fysisk aktivitet, ændrer deres kostvaner eller under anden samtidig sygdom.
English: Compared to NovoRapid, the influence of BMI on the absorption was less pronounced for Fiasp leading to relatively higher initial exposure.
Danish: Sammenlignet med NovoRapid var BMI's indflydelse på absorptionen mindre udtalt for Fiasp, hvilket førte til en relativt højere initial eksponering.
English: This should be kept in mind if treatment with the combination of thiazolidinediones and insulin medicinal products is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med thiazolidindioner og insulinpræparater overvejes.
English: Tell everyone you spend time with that you have diabetes.
Danish: Fortæl alle, du er sammen med, at du har sukkersyge.
English: Start by checking your pen to make sure that it contains Fiasp 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.
Danish: Begynd med at kontrollere pennen for at sikre dig, at den indeholder Fiasp 100 enheder/ml, og se derefter på nedenstående illustrationer, så du kan lære de forskellige dele af pennen og nålen at kende.
English: As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.
Danish: Som en generel regel kan 0,2-0,4 enheder insulin per kilo legemsvægt anvendes til at beregne den samlede daglige startdosis af insulin hos insulinnaive patienter med type 1-diabetes.
English: • Pioglitazone used together with insulin - This may increase the risk of heart failure, see under ‘Other medicines and Fiasp' below.
Danish: • Brug af pioglitazon sammen med insulin - Dette kan øge risikoen for hjertesvigt, se under ”Brug af anden medicin sammen med Fiasp” nedenfor.
English: Continuous subcutaneous insulin infusion (CSII)
Danish: Kontinuerlig subkutan insulininfusion (CSII)
English: • you have been given an injection of glucagon
Danish: • du har fået en glucagon-injektion
English: FlexTouch is colour-coded and accompanied by a package leaflet with detailed instructions for use to be followed.
Danish: FlexTouch er farvekodet, og der medfølger en indlægsseddel med en detaljeret brugervejledning, som skal følges.
English: • Always check the insulin flow before you start.
Danish: • Kontrollér altid insulingennemløbet, før du starter.
English: • Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted to avoid any infection at the infusion site.
Danish: • Før du indfører nålen, skal du vaske dine hænder og huden på indstiksstedet med vand og sæbe for at undgå infektioner på infusionsstedet.
English: Pioglitazone - oral anti-diabetic medicine used to treat type 2 diabetes.
Danish: Pioglitazon - oralt diabeteslægemiddel til behandling af type 2-diabetes.
English: Talk to your doctor, pharmacist or nurse before using Fiasp.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du bruger Fiasp.
English: Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes aged 2 to less than 18 years.
Danish: Sikkerhed og virkning er blevet undersøgt i et terapeutisk bekræftende studie hos børn med type 1diabetes i alderen fra 2 til mindre end 18 år.
English: Serious hypoglycaemia may cause brain damage and may be life-threatening.
Danish: Alvorlig hypoglykæmi kan forårsage hjerneskade og kan være livstruende.
English: Warning signs of high blood sugar - these normally appear gradually:
Danish: Advarselssignaler på for højt blodsukker - de kommer normalt gradvist:
English: Drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.
Danish: Drikker alkohol, bruger for meget insulin, motionerer mere end normalt, spiser for lidt eller springer et måltid over.
English: A small air bubble may remain at the needle tip, but it will not be injected.
Danish: Der kan stadig være en lille luftboble ved nålespidsen, men den injiceres ikke.
English: Octreotide/lanreotide may either increase or decrease the insulin requirement.
Danish: Octreotid/lanreotid kan enten øge eller reducere insulinbehovet.
English: Initiation
Danish: Initiering
English: Single patient use only
Danish: Kun til brug hos én patient
English: Example
Danish: Eksempel
English: 4 Draw into the syringe the same amount of air as the dose of insulin you are going to inject.
Danish: 4 Træk den samme mængde luft ind i sprøjten som den dosis insulin, du skal injicere.
English: • growth hormone - for growth hormone deficiency
Danish: • væksthormon - mod mangel på væksthormon
English: The safety profile in very elderly patients (≥ 75 years) or patients with moderate to severe renal impairment or hepatic impairment is limited.
Danish: Sikkerhedsprofilen hos ældre patienter (≥ 75 år) eller patienter med moderat til svært nedsat nyre- eller leverfunktion er begrænset.
English: No overall increased risk of severe or blood glucose confirmed hypoglycaemia was observed compared to NovoRapid.
Danish: Der blev ikke observeret nogen generel øget risiko for alvorlig eller blodglucose-bekræftet hypoglykæmi sammenlignet med NovoRapid.
English: Some conditions and activities can affect how much insulin you need.
Danish: Nogle omstændigheder og aktiviteter kan have indflydelse på dit insulinbehov.
English: The absolute bioavailability of insulin aspart after subcutaneous administration of Fiasp in the abdomen, deltoid and thigh was approximately 80%.
Danish: Den absolutte biotilgængelighed af insulin aspart efter subkutan administration af Fiasp i abdomen, deltoideus og låret var ca. 80%.
English: See section 4 under ‘What to do if you get low blood sugar'.
Danish: Se punkt 4 under ”Hvad du skal gøre, hvis du får for lavt blodsukker”.
English: • Push the needle straight onto the pen.
Danish: • Skub nålen lige ind på pennen.
English: E Statistically significant in favour of Fiasp mealtime
Danish: E Statistisk signifikant til fordel for Fiasp ved måltid
English: If the vial is not in perfect condition when you get it,
Danish: Hvis hætteglasset ikke er i perfekt stand,
English: Where to inject
Danish: Hvor du skal injicere
English: General effects from insulin treatment including Fiasp
Danish: Generelle bivirkninger ved insulinbehandling inklusive Fiasp
English: Increase dose by 1 unit
Danish: Øg dosis med 1 enhed
English: If the needle is blocked, you will not inject any insulin.
Danish: Hvis nålen er tilstoppet, injicerer du ikke noget insulin.
English: Some medicines affect your blood sugar level - this may mean your insulin dose has to change.
Danish: Nogle lægemidler påvirker blodsukkeret - og det kan betyde, at din insulindosis skal ændres.
English: There was no statistical significant difference between Fiasp and NovoRapid in the estimated odds of achieving HbA1c < 7%.
Danish: Der var ingen statistisk signifikant forskel mellem Fiasp og NovoRapid, hvad angik de estimerede odds for at opnå et HbA1c på <7%.
English: The pen can dial up to a maximum of 80 units.
Danish: Pennen kan indstilles til højst 80 enheder.
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar.
Danish: • Mild hypoglykæmi, som kan behandles med oral indtagelse af glucose eller andre sukkerholdige produkter.
English: The maximum glucose-lowering effect of Fiasp occurred between 1 and 3 hours after injection.
Danish: Den maksimale glucosesænkende effekt af Fiasp optrådte mellem 1 og 3 timer efter injektion.
English: If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall.
Danish: Hvis du drikker alkohol, kan dit behov for insulin ændres, og dit blodsukker kan enten stige eller falde.
English: Do not count the pen clicks to set the dose.
Danish: Du må ikke tælle antal klik med pennen for at vælge dosis.
English: Insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, acute painful peripheral neuropathy and peripheral oedema.
Danish: Initiering af insulin og intensivering af glucosekontrol Intensivering eller hurtig forbedring af glucosekontrollen er blevet forbundet med en forbigående, reversibel refraktionsanomali, forværring af diabetisk retinopati, akut smertefuld perifer neuropati og perifert ødem.
English: Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions.
Danish: Kontinuerligt skift af injektionssted inden for det specifikke injektionsområde kan medvirke til at reducere risikoen for udvikling af disse reaktioner.
English: Always remove the needle from your pen after each injection and store your pen without the needle attached.
Danish: Fjern altid nålen fra pennen efter hver injektion, og opbevar pennen uden nålen påsat.
English: Patients, who are blind or have poor vision, must be instructed to always get assistance from another person who has good vision and is trained in administration of insulins.
Danish: Patienter, der er blinde eller har nedsat syn, skal have besked på altid at få hjælp/assistance fra en anden person med normalt syn, som har fået undervisning i administration af insulinpræparater.
English: Do not rub the area.
Danish: Du må ikke gnide på stedet.
English: Some patients with longstanding type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin developed heart failure.
Danish: Nogle patienter med årelang type 2-diabetes og hjertesygdom eller tidligere slagtilfælde, som er blevet behandlet med pioglitazon og insulin, udviklede hjertesvigt.
English: Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people).
Danish: For lavt blodsukker (hypoglykæmi) er meget almindeligt ved insulinbehandling (kan forekomme hos flere end 1 ud af 10 behandlede).
English: Designed to be used with Novo Nordisk reusable pens
Danish: Beregnet til anvendelse sammen med Novo Nordisk flergangspenne
English: • Fiasp should never be diluted or mixed with any other insulin.
Danish: • Fiasp må aldrig fortyndes eller blandes med andre insulinpræparater.
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 insulin.
Danish: Hvis du vil ændre din sædvanlige kost, skal du først tale med lægen, apotekspersonalet eller sygeplejersken, da en kostændring kan ændre dit insulinbehov.