FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical study protocol provided for all patients to receive aspirin and a daily maintenance dose of prasugrel.
Danish: Transfusion (≥4 enheder) påkrævet TIMI mindre blødninge aAndre standardbehandlinger blev brugt, når det var nødvendigt.Protokollen for det kliniske studie foreskrev, at alle patienter fik acetylsalicylsyre og en daglig vedligeholdelsesdosis af prasugrel.
English: treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed.
Danish: 4.4), bør det ordineres som en 60 mg loading-dosis efterfulgt af en lavere vedligeholdelsesdosis på 5 mg. o Patienter med en vægt < 60 kg bør have en reduceret vedligeholdelsesdosis på 5 mg.
English: Eye haemorrhage
Danish: Nyrer og urinveje
English: TIMI minor bleeding f
Danish: TIMI større blødningb
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg.
Danish: I et studie med patienter med stabil aterosklerose var det gennemsnitlige AUC for den aktive metabolit 38% lavere hos patienter < 60 kg,
English: Requiring surgical intervention
Danish: Operation påkrævet
English: 1.3% (0.1% fatal)
Danish: 1,3% (0,1% dødelige)
English: • Nose bleeds
Danish: • Næseblod
English: Post-procedural haemorrhage
Danish: • Hududslæt
English: Efient 10 mg: Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other.
Danish: Beige tabletter med form som en aflang sekskant, præget med ”10 MG” på den ene side og ”4759” på den anden.
English: (see sections 4.2 and 4.4).
Danish: 4.2 og 4.4).
English: Efient 5 mg: Yellow and double-arrow shaped tablets, debossed with “5 MG” on one side and “4760” on the other.
Danish: Gule tabletter med form som en aflang sekskant, præget med ”5 MG” på den ene side og ”4760” på den anden.
English: If you take more Efient than you should
Danish: Hvis du har taget for meget Efient
English: Renal impairment:
Danish: Nedsat nyrefunktion:
English: Life-threateningc
Danish: Livstruendec
English: What Efient looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Rash Ecchymosis
Danish: Lactosemonohydrat
English: Posology
Danish: Letale
English: Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of prasugrel.
Danish: Der er indberettet TTP ved brug af prasugrel.
English: TIMI Major bleedingb
Danish: TIMI større blødningc
English: Be especially aware of the following:
Danish: Vær specielt opmærksom på følgende:
English: This could be dangerous to yourself or others.
Danish: Det kan være farligt for dig selv og andre.
English: Date of first authorisation: 09 January 2017
Danish: Dato for første markedsføringstilladelse: 09. januar 2017
English: You may then hear or feel a click.
Danish: Du kan måske høre eller mærke et klik.
English: Travelling between time zones
Danish: Rejser mellem tidszoner
English: The reactions usually disappear after a few days.
Danish: Reaktionerne forsvinder normalt efter få dage.
English: This is normal and does not affect your dose.
Danish: Dette er normalt og påvirker ikke din dosis.
English: • how much Fiasp you will need at each meal
Danish: • hvor meget Fiasp du har behov for ved hvert måltid
English: Race and Ethnicity
Danish: Race og etnicitet
English: Component of a multipack, cannot be sold separately
Danish: Del af en multipakning, må ikke sælges separat
English: Time (min)
Danish: Tid (min.)
English: Ask your doctor for advice on these situations.
Danish: Spørg din læge til råds omkring sådanne situationer.
English: less than 71
Danish: under 71
English: Very common Common Uncommon Not known
Danish: Almindelig Ikke almindelig Ikke kendt
English: This may constitute a risk in situations where these abilities are of special importance (e.g., driving a car or using machines).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af speciel vigtighed (f.eks. ved bilkørsel eller brug af maskiner).
English: However, the dosage may need to be adjusted.
Danish: Det kan dog være nødvendigt at justere dosis.
English: Other side effects include:
Danish: Andre bivirkninger inkluderer:
English: Look through the insulin window.
Danish: Kig igennem insulinvinduet.
English: Signs of a serious allergic reaction may include:
Danish: Tegn på en alvorlig allergisk reaktion kan omfatte, at:
English: • Do not leave the pen in a car or other place where it can get too hot or too cold.
Danish: • Du må ikke efterlade pennen i bilen eller andre steder, hvor den kan blive for varm eller for kold.
English: Unit No adjustment
Danish: Enhed Ingen justering
English: • turn you on your side to avoid choking
Danish: • vende dig om på siden for at undgå, at du bliver kvalt
English: This medicine can be used in elderly patients.
Danish: Dette lægemiddel kan bruges til ældre patienter.
English: What others need to do if you pass out
Danish: Hvad andre skal gøre, hvis du besvimer
English: Talk to your doctor about changes in your dose.
Danish: Tal med lægen om ændringer i din dosis.
English: Fiasp which has been frozen must not be used.
Danish: Fiasp, som har været frosset, må ikke anvendes.
English: Make sure you select the full dose you need.
Danish: Sørg for, at du vælger den fulde dosis, du har behov for.
English: Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter ”EXP”.
English: more than 108
Danish: over 108
English: • Test your urine for ketones.
Danish: • Test urinen for ketoner.
English: This is usually only short-lasting.
Danish: Det er normalt kun kortvarigt.
English: See a doctor if the symptoms worsen or you see no improvement in a few weeks.
Danish: Kontakt lægen hvis symptomerne forværres eller hvis de ikke forbedres indenfor få uger.
English: The observed effects and the safety profiles were comparable between all age groups.
Danish: De observerede virknings- og sikkerhedsprofiler var sammenlignelige mellem alle aldersgrupper.
English: The advisability of driving should be considered in these circumstances.
Danish: Det skal overvejes, om bilkørsel er tilrådeligt under disse omstændigheder.
English: Careful control of your diabetes is needed in pregnancy.
Danish: Nøje kontrol med din diabetes er nødvendig under graviditeten.
English: Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Glucose skal gives intravenøst, hvis patienten ikke reagerer på glucagon inden for 10 til 15 minutter.
English: Your medicine might be harmful to them.
Danish: Din medicin kan være skadelig for andre.
English: If you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets.
Danish: Hvis du bliver ved med at injicere det samme sted, kan disse reaktioner blive mere alvorlige og påvirke den mængde medicin, kroppen får.
English: • Give a correction dose of insulin if you have been taught how to do this.
Danish: • Indgiv en korrigerende dosis insulin, hvis du har lært, hvordan man gør dette.
English: Push the air out of the syringe and check that the dose is correct.
Danish: Skub luften ud af sprøjten, og kontrollér, at dosis er korrekt.
English: This is especially important if you take more than one type of insulin.
Danish: Det er især vigtigt, hvis du tager flere typer insulin.
English: In the trial, 519 patients were treated with Fiasp.
Danish: I studiet blev 519 patienter behandlet med Fiasp.
English: • you suddenly feel unwell with sweating
Danish: • du pludselig føler dig dårlig og sveder
English: Then carry on with your insulin treatment as usual.
Danish: Derefter kan du fortsætte med din insulinbehandling, som du plejer.
English: 6 How much insulin is left?
Danish: 6 Hvor meget insulin er der tilbage?
English: Follow the instructions and recommendations from your doctor regarding the use of Fiasp in a pump.
Danish: Følg din læges instruktioner og anbefalinger med hensyn til anvendelse af Fiasp i en pumpe.
English: Patients should resume their usual dosing schedule at the next meal.
Danish: Patienterne skal genoptage deres sædvanlige doseringsplan ved næste måltid.
English: • when to check your blood sugar level and if you need a higher or lower dose.
Danish: • hvornår du skal kontrollere dit blodsukker, og om du har behov for en højere eller lavere dosis.
English: Let them know that if you pass out, they must:
Danish: Fortæl dem, at hvis du besvimer, skal de:
English: Dose counter stopped: 16 units left
Danish: Dosistæller stoppet: 16 enheder tilbage
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Danish: Insulinbehovet falder normalt i første trimester og stiger siden i løbet af andet og tredje trimester.
English: • not give you any food or drink because you may choke.
Danish: • ikke give dig noget at spise eller drikke, da du kan risikere at blive kvalt.
English: Be very careful to calculate correctly if splitting your dose.
Danish: Vær omhyggelig med at regne rigtigt, hvis du opdeler din dosis.
English: Fiasp can be used in pregnancy.
Danish: Fiasp kan anvendes under graviditet.
English: • Check that the insulin in your pen is clear and colourless.
Danish: • Kontrollér, at insulinet i pennen er klart og farveløst.
English: Summary of safety profile
Danish: Opsummering af sikkerhedsprofilen
English: This is normal, but you must still check the insulin flow.
Danish: Dette er normalt, men du skal stadig kontrollere insulingennemløbet.
English: It can be administered in accordance with the instructions provided by the pump manufacturer, preferably in the abdomen.
Danish: Det indgives i henhold til pumpefabrikantens instruktioner, fortrinsvis i abdomen.
English: Bodyweight (kg)
Danish: Legemsvægt (kg)
English: No children below the age of 2 years were randomised in the trial.
Danish: Ingen børn under 2 år blev randomiseret i studiet.
English: Once empty, it must be disposed of.
Danish: Når den er tom, skal den kasseres.
English: Remove the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle.
Danish: Fjern nålen som beskrevet i punkt 5, og gentag alle trin med start fra punkt 1: Klargør pennen med en ny nål.
English: Reduce dose by 1 unit No dose adjustment more than 6.0
Danish: Reducér dosis med 1 enhed Ingen dosisjustering over 6,0
English: If in doubt, take the full dose with a new pen.
Danish: Hvis du er i tvivl, skal du tage hele din dosis med en ny pen.
English: Elderly patients (≥ 65 years old)
Danish: Ældre patienter (≥ 65 år)
English: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia.
Danish: Patientens evne til at koncentrere sig og reagere kan være svækket på grund af hypoglykæmi.
English: Take it back to your supplier.
Danish: Levér den tilbage til leverandøren.
English: If necessary, Fiasp can be administered intravenously by health care professionals.
Danish: Om nødvendigt kan Fiasp indgives intravenøst af sundhedspersonale.
English: Suggested initial dose is 4 units at one or more meals.
Danish: Den foreslåede startdosis er 4 enheder ved et eller flere måltider.
English: You should therefore monitor your blood sugar level more often than usual.
Danish: Du skal derfor kontrollere dit blodsukker oftere end normalt.
English: Ask your doctor whether you can drive if:
Danish: Spørg din læge, om du må køre bil:
English: Never use a bent or damaged needle.
Danish: Brug aldrig en bøjet eller beskadiget nål.
English: • If you need more insulin than the units left in your pen, you can split your dose between two pens.
Danish: • Hvis du skal bruge mere insulin end det antal enheder, der er tilbage i pennen, kan du opdele dosis mellem to penne.
English: • Change the place within the area where you inject each day to reduce the risk of developing changes under the skin (see section 4).
Danish: • Skift sted hver dag inden for det område, hvor du injicerer, for at nedsætte risikoen for at få forandringer under huden (se punkt 4).
English: There were two patients from the Fiasp group who each reported two treatment-emergent infusion site reactions.
Danish: Der var to patienter i gruppen med Fiasp, som hver rapporterede to behandlingsrelaterede reaktioner på infusionsstedet.
English: The dose selector clicks differently when turned forwards, backwards or past the number of units left.
Danish: Dosisvælgeren klikker forskelligt, når den drejes frem, tilbage eller forbi det antal enheder, der er tilbage.
English: Tell them what could happen if your blood sugar gets too low, including the risk of passing out.
Danish: Fortæl dem, hvad der kan ske, hvis dit blodsukker bliver for lavt, herunder risikoen for, at du besvimer.
English: Treatment with Fiasp helps to prevent complications from your diabetes.
Danish: Behandling med Fiasp hjælper med at forhindre komplikationer fra din sukkersyge.
English: Talk to your doctor:
Danish: Tal med din læge:
English: Insulin appeared in the circulation approximately 4 minutes after administration (Figure 1).
Danish: Insulin blev frigivet i kredsløbet ca. 4 minutter efter administration (figur 1).
English: Adverse reactions listed below (Table 2) are based on data from 6 completed therapeutic confirmatory trials in adults.
Danish: Bivirkningerne anført nedenfor (tabel 2) er baseret på data fra 6 afsluttede terapeutiske bekræftende forsøg hos voksne.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Pay special attention to these notes as they are important for correct use of the pen.
Danish: Vær særligt opmærksom på denne information, da den er vigtig for at kunne anvende pennen korrekt.
English: • you have had too low blood sugar a few times recently.
Danish: • du har haft for lavt blodsukker nogle gange inden for den seneste tid.
English: • High blood sugar (hyperglycaemia) frequency not known (cannot be estimated from the available data)
Danish: • For højt blodsukker (hyperglykæmi) hyppigheden er ikke kendt (kan ikke beregnes ud fra tilgængelige data)
English: The safety and efficacy of Fiasp have been established in elderly patients aged 65 to 75 years.
Danish: Sikkerhed og virkning af Fiasp er klarlagt hos ældre patienter i alderen 65 til 75 år.
English: If blood appears at the injection site, press lightly on the skin for a few minutes to stop the bleeding.
Danish: Hvis der kommer blod til syne ved injektionsstedet, skal du trykke let på huden i et par minutter for at stoppe blødningen.
English: • if you are ill, carry on taking your insulin and talk to your doctor.
Danish: • Hvis du bliver syg, skal du fortsætte med at tage insulin og kontakte din læge.
English: When using other medicines, ask your doctor if your treatment needs to be adjusted.
Danish: Når du bruger anden medicin, skal du spørge lægen, om behandlingen skal justeres.
English: Do not attach a new needle to your pen until you are ready for your injection.
Danish: Sæt ikke en ny nål på pennen, før du er klar til din injektion.
English: The therapeutic experience in patients ≥ 75 years of age is limited.
Danish: Erfaringen med behandling af patienter ≥ 75 år er begrænset.
English: Insulin treatment of the nursing mother presents no risk to the baby.
Danish: Insulinbehandling af moderen udgør ingen risiko for det ammede barn.
English: This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.
Danish: Lægemidlet har sin maksimale virkning mellem 1 og 3 timer efter injektionen, og virkningen varer i 3-5 timer.
English: Speak to your doctor if you need to inject your insulin by another method.
Danish: Tal med lægen, hvis du har behov for at indsprøjte din insulin på en anden måde.
English: Inject the air into the vial.
Danish: Injicér luften ind i hætteglasset.
English: If you have kidney or liver problems
Danish: Hvis du har nyre- eller leverproblemer
English: Diabetes is a disease where your body does not produce enough insulin to control the level of blood sugar.
Danish: Sukkersyge er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at kontrollere blodsukkerniveauet.
English: Administration in a pump will require a comprehensive instruction by your healthcare professional.
Danish: Indgivelse med en pumpe kræver grundig instruktion fra sundhedspersonale.
English: Dose for type 1 and type 2 diabetes Your doctor will decide together with you:
Danish: Dosis ved type 1- og type 2-diabetes Du og din læge beslutter sammen:
English: *Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Danish: * Insulin aspart er fremstillet i Saccharomyces cerevisiae ved rekombinant DNA-teknologi.
English: Do not stop using your insulin without talking to your doctor.
Danish: Du må ikke holde op med at bruge insulin uden først at have talt med din læge om det.
English: • Do not try to refill your pen.
Danish: • Forsøg ikke at genfylde din pen.
English: • if the protective cap on the vial is loose or missing.
Danish: • Hvis beskyttelseshætten på hætteglasset er løs eller mangler.
English: • if you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
Danish: • Hvis du dyrker mere motion, end du plejer, eller ønsker at ændre din kost, da dette kan påvirke dit blodsukker.
English: Listed below are the most common medicines which may affect your insulin treatment.
Danish: Nedenstående liste omfatter de mest kendte lægemidler, som kan påvirke din insulinbehandling.
English: The dose selector changes the number of units.
Danish: Dosisvælgeren ændrer antallet af enheder.
English: Concomitant illness
Danish: Samtidig sygdom
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 har hyppige episoder med hypoglykæmi.
English: The symptoms of hypoglycaemia usually occur suddenly.
Danish: Symptomerne på hypoglykæmi opstår normalt pludseligt.
English: Use in elderly patients (65 years or older)
Danish: Brug til ældre patienter (65 år eller derover)
English: There is no clinical experience with the use of Fiasp in children below the age of 2 year.
Danish: Der er ingen klinisk erfaring med brugen af Fiasp hos børn under 2 år.
English: The 95% confidence interval is stated in ‘[]' A Meal test
Danish: 95%konfidensintervallet er anført i ”[]”
English: Number of injections and subsequent titration will depend on the individual glycaemic target and the size and composition of the meals.
Danish: Antallet af injektioner og den efterfølgende titrering afhænger af det individuelle glykæmiske mål samt af måltidernes størrelse og sammensætning.
English: This medicine can be used during pregnancy; however your insulin dose may need to be changed during pregnancy and after delivery.
Danish: Dette lægemiddel kan anvendes under graviditet, dog skal din insulindosis eventuelt ændres under graviditet og efter fødsel.
English: Usual warning symptoms may disappear in patients with long-standing diabetes.
Danish: Sædvanlige advarselssymptomer kan udeblive hos patienter med mangeårig diabetes.
English: Tap the top of the pen gently a few times to let any air bubbles rise to the top.
Danish: Bank let på toppen af pennen et par gange, så eventuelle luftbobler stiger op til toppen af pennen.
English: They may increase or decrease your blood sugar level.
Danish: De kan enten øge eller reducere dit blodsukker.
English: • difficulty in concentrating
Danish: • koncentrationsbesvær
English: It is therefore recommended that the diabetic patient always carries glucosecontaining products.
Danish: Det anbefales derfor, at diabetespatienter altid bærer sukkerholdige produkter på sig.
English: Estimated rate ratio
Danish: Estimeret rate-ratio
English: This medicine can also be used for continuous infusion in a pump system.
Danish: Lægemidlet kan også gives som kontinuerlig infusion i et pumpesystem.
English: 6 Inject the insulin under the skin.
Danish: 6 Injicér insulinet under huden.
English: This is a build-up of acid in the blood because the body is breaking down fat instead of sugar.
Danish: Det er en ophobning af syre i blodet, da kroppen nedbryder fedt i stedet for sukker.
English: This means that this medicine is essentially ‘sodium-free'.
Danish: Det betyder, at lægemidlet stort set er natriumfrit.
English: For Fiasp no difference in exposure was found between the racial and ethnic groups investigated.
Danish: For Fiasp blev der ikke fundet nogen eksponeringsforskel mellem de undersøgte racegrupper og etniske grupper.
English: 5 After your injection
Danish: 5 Efter injektionen
English: Avoiding low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Danish: Forebyggelse af lavt blodsukker (hypoglykæmi) er især vigtigt for dit barns helbred.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 18.
English: If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
Danish: Hvis du vælger en forkert dosis, kan du dreje dosisvælgeren frem eller tilbage til den rigtige dosis.
English: Monitoring of blood glucose is necessary during insulin infusion.
Danish: Monitorering af blodglucose er nødvendig under insulininfusion.
English: If no drop appears, repeat steps 2A to 2C up to 6 times.
Danish: Hvis der ikke kommer nogen dråbe til syne, gentages trin 2A til 2C op til 6 gange.
English: • Caregivers must be very careful when handling used needles - to reduce the risk of needle injury and cross-infection.
Danish: • Omsorgspersoner skal håndtere brugte nåle meget forsigtigt - for at reducere risikoen for stikuheld og krydsinfektion.
English: • Always carry something to show you have diabetes.
Danish: • Medbring altid noget, der viser, at du har sukkersyge.
English: The individual total daily insulin requirement in adults, adolescents and children may vary and is usually between 0.5 and 1.0 unit/kg/day.
Danish: Det individuelle samlede daglige insulinbehov hos voksne, unge og børn kan variere, men ligger normalt mellem 0,5 og 1,0 enheder/kg/dag.
English: Three simple steps to avoid low or high blood sugar are:
Danish: Tre enkle trin til at undgå for lavt eller for højt blodsukker:
English: Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when contemplating pregnancy.
Danish: Intensiveret blodglucosekontrol og monitorering af gravide kvinder med diabetes (type 1-diabetes, type 2-diabetes eller gestationel diabetes) anbefales gennem hele graviditeten, og når graviditet påtænkes.
English: Table 1 Dose adjustment SMPG (see above)
Danish: Tabel 1 Dosisjustering SMPG (se ovenfor)
English: Close monitoring of blood glucose levels is recommended if administering this medicine after the start of the last meal of the day, in order to avoid nocturnal hypoglycaemia.
Danish: Nøje monitorering af blodglucose-niveauer anbefales, hvis dette lægemiddel administreres efter påbegyndelsen af dagens sidste måltid, for at undgå natlig hypoglykæmi.
English: DK-2880 Bagsværd, Denmark
Danish: DK-2880 Bagsværd, Danmark
English: During use: Use within 4 weeks
Danish: Under brug: Anvendes inden 4 uger
English: The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Danish: Virkningsvarigheden varierer alt efter dosis, injektionssted, blodgennemstrømning, temperatur og fysisk aktivitetsniveau.
English: • fruity (acetone) breath
Danish: • frugtagtig (acetonelugtende) ånde