FrancophonIA/ELRC3.0 huggingface dataset:
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Danish: • Milde hypoglykæmiske episoder kan behandles med oral indtagelse af glucose eller sukkerholdige produkter.
English: If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious.
Danish: Hvis du får glucagon, skal du også have glucose eller et sukkerholdigt produkt at spise, så snart du igen er ved bevidsthed.
English: The following substances may reduce the patient's insulin requirements:
Danish: Følgende stoffer kan nedsætte patientens insulinbehov:
English: The intra-individual variability in time to maximum concentration is significantly less for NovoRapid than for soluble human insulin, whereas the intraindividual variability in Cmax for NovoRapid is larger.
Danish: Den intraindividuelle variation i tiden indtil maksimal koncentration er betydeligt mindre for NovoRapid end for opløseligt humaninsulin, hvorimod den intraindividuelle variation i Cmax er større for NovoRapid.
English: • Always carry an extra pen and new needles with you, in case of loss or damage.
Danish: • Hav altid en ekstra pen og nåle på dig i tilfælde af tab eller beskadigelse.
English: Dose and when to take your insulin
Danish: Dosis og hvornår du skal tage dit insulin
English: • When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or the tubing.
Danish: • Når du fylder en ny beholder, skal du kontrollere, at der ikke er store luftbobler i hverken sprøjte eller slange.
English: • Always keep your pen with you.
Danish: • Hav altid din pen på dig.
English: Especially in children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake, physical activities and current blood glucose level in order to minimise the risk of hypoglycaemia.
Danish: Særligt hos børn skal insulindosis (specielt ved basal-bolus regimer) omhyggeligt tilpasses indtagelse af mad, fysisk aktivitet og det aktuelle blodglucoseniveau for at minimere risikoen for hypoglykæmi.
English: • Check the label to make sure that it is NovoRapid PumpCart.
Danish: • Kontrollér etiketten for at sikre, at det er NovoRapid PumpCart.
English: The duration of action is 3 to 5 hours.
Danish: Virkningsvarigheden er 3 til 5 timer.
English: Anaphylactic reactions:
Danish: Anafylaktiske reaktioner:
English: When you are using an insulin pump
Danish: Når du anvender en insulinpumpe
English: ► If you are treated with NovoRapid Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Danish: ► Hvis du behandles med NovoRapid Penfill og en anden insulin Penfill cylinderampul, skal du anvende to injektionssystemer, ét system til hver insulintype.
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 blodsukkerniveau kan enten stige eller falde.
English: NovoRapid dosing is individual and determined in accordance with the needs of the patient.
Danish: Dosering af NovoRapid er individuel og afgøres ved en vurdering af patientens behov.
English: • Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body's metabolic processes)
Danish: • Væksthormon (lægemiddel til vækststimulering af skelet og legeme med udtalt effekt på kroppens metaboliske processer)
English: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Danish: Utilstrækkelig dosering eller ophør af behandlingen kan, specielt ved type 1-diabetes, føre til hyperglykæmi og diabetisk ketoacidose.
English: • Check that the insulin in NovoRapid PumpCart is clear and colourless.
Danish: • Kontrollér, at insulinet i NovoRapid PumpCart er klart og farveløst.
English: NovoRapid will start to lower your blood sugar 10-20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours.
Danish: NovoRapid vil begynde at nedsætte dit blodsukker 10-20 minutter efter injektion, maksimal effekt ses mellem 1 og 3 timer efter injektionen, og effekten varer 3-5 timer.
English: NovoRapid (insulin aspart) can be used in pregnancy.
Danish: NovoRapid (insulin aspart) kan anvendes under graviditet.
English: Stop when the right number of units lines up with the dose pointer.
Danish: Stop når det korrekte antal enheder står ud for markøren.
English: See your pen manual for further instructions.
Danish: Se brugervejledningen til din pen for yderligere information.
English: Never use a bent or damaged needle.
Danish: Brug aldrig en bøjet eller ødelagt nål.
English: The pharmacodynamic profile of insulin aspart in children was similar to that seen in adults.
Danish: Den farmakodynamiske profil af insulin aspart hos børn lignede den, set hos voksne.
English: Basal (all-day) insulin requirements: When you use NovoRapid PumpCart in a pump, your insulin will be constantly delivered to cover your basal need for insulin.
Danish: Basal (dagligt) insulinbehov: Når du bruger NovoRapid PumpCart i en pumpe, vil dit insulin konstant indgives for at dække dit basalinsulinbehov.
English: Component of a multipack, cannot be sold separately.
Danish: Del af en multipakning, sælges ikke seperat.
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 kan tilstedeværelsen af sådanne insulinantistoffer nødvendiggøre en justering af insulindosis for at korrigere en tilbøjelighed til hyper- eller hypoglykæmi.
English: Just before use, roll the NPH insulin between your hands until the liquid is uniformly white and cloudy.
Danish: Lige før brug rulles NPH-insulinet mellem hænderne, indtil væsken er jævnt hvid og uklar.
English: If the needle is blocked, you will not inject any insulin.
Danish: Hvis nålen er blokeret, vil du ikke injicere noget insulin.
English: Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites.
Danish: Subkutan injektion i abdominalvæggen sikrer en hurtigere absorption i forhold til andre injektionssteder.
English: ► If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections.
Danish: ► Hvis du har planer om at rejse til udlandet, kan en eventuel tidsforskel påvirke insulinbehovet og injektionstidspunkterne.
English: If not, change the needle and repeat the procedure no more than 6 times.
Danish: Hvis dette ikke sker, skift da nålen og gentag proceduren, dog højst 6 gange.
English: Otherwise the liquid may leak out which can cause inaccurate dosing.
Danish: Ellers kan væsken løbe ud, hvilket kan forårsage unøjagtig dosering.
English: Bolus (meal-time) insulin requirements: NovoRapid will start to lower your blood sugar within 1020 minutes after you start a bolus delivery (see section 3, How to use NovoRapid PumpCart, for more information about how to adjust your bolus dose).
Danish: Bolus (måltids) insulinbehov: NovoRapid vil begynde at nedsætte dit blodsukker 10-20 minutter efter bolusinjektion (se punkt 3 Sådan skal du bruge NovoRapid PumpCart, for mere information om hvordan du indstiller din bolus dosis).
English: NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch
Danish: NovoRapid hætteglas/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch
English: ► If you are ill, carry on taking your insulin and consult your doctor.
Danish: ► Hvis du bliver syg skal du fortsætte med at tage insulin og kontakte din læge.
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 forskel mellem insulin aspart og humaninsulin hvad angår fertilitet.
English: Uncommon - Urticaria, rash, eruptions Very rare - Anaphylactic reactions*
Danish: Ikke almindelige - Urticaria, udslæt, eruptioner Meget sjælden - Anafylaktiske reaktioner*
English: K Remove the needle from the skin.
Danish: K Fjern nålen fra huden.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse or local authorities.
Danish: Når pennen er tom kasseres den uden nålen påsat, som din læge, sygeplejerske eller lokale myndigheder har anbefalet.
English: If necessary, clean it with mild detergent on a moistened cloth.
Danish: Hvis det er nødvendigt, kan du rengøre den med mild sæbe på en let fugtet klud.
English: Be careful only to push the push-button when injecting.
Danish: Vær påpasselig med kun at trykke på dosisknappen under injektionen.
English: • Do not drop your pen or knock it against hard surfaces.
Danish: • Tab ikke din pen, og bank den ikke imod hårde overflader.
English: What you need to know before you use NovoRapid PumpCart Do not use NovoRapid PumpCart ► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information).
Danish: Det skal du vide, før du begynder at tage NovoRapid PumpCart Tag ikke NovoRapid PumpCart ► Hvis du er allergisk over for insulin aspart eller et af de øvrige indholdsstoffer i dette lægemiddel (se punkt 6 Pakningsstørrelser og yderligere oplysninger).
English: Make sure you can see the dose counter.
Danish: Kontrollér, at du kan se dosistælleren.
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 injektionsstedet og dine hænder med vand og sæbe for at undgå infektion på infusionsstedet.
English: If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death.
Danish: Hvis langvarig alvorligt lavt blodsukker ikke behandles, kan det medføre hjerneskade (midlertidig eller varig) og i værste fald død.
English: ► Inject the insulin under the skin.
Danish: ► Injicér insulinet under huden.
English: • Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.
Danish: • Bortskaf den tomme NovoRapid PumpCart cylinderampul og det brugte infusionssæt som instrueret af din læge eller sygeplejerske.
English: When NovoRapid is mixed with NPH insulin, NovoRapid should be drawn into the syringe first, and the mixture should be injected immediately after mixing.
Danish: Når NovoRapid opblandes med NPH-insulin, skal NovoRapid trækkes ind i sprøjten først, og blandingen skal injiceres straks efter opblanding.
English: • Have not injected enough insulin.
Danish: • Ikke har injiceret nok insulin
English: You may stick yourself with the needle.
Danish: Du kan stikke dig selv med nålen.
English: • Screw the needle straight and tightly onto your InnoLet (picture 1A).
Danish: • Skru nålen lige og stramt på NovoRapid InnoLet (figur 1A).
English: • Exercise more than usual.
Danish: • Motionerer mere end normalt
English: It must be handled with care.
Danish: Den skal derfor behandles med omtanke.
English: Withdraw the needle from the skin, then release the pressure on the push-button.
Danish: Træk nålen ud af huden og slip trykket på dosisknappen.
English: Date of last renewal: 30 April 2009
Danish: Dato for første markedsføringstilladelse: 7. september 1999 Dato for seneste fornyelse: 30. april 2009
English: If necessary NovoRapid can be given directly into a vein but this must only be done by physicians or other healthcare staff.
Danish: Om nødvendigt kan NovoRapid indgives direkte i en vene, men dette må kun gøres af læger eller andet sundhedspersonale.
English: The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.
Danish: Styrken af insulinanaloger, inklusive insulin aspart, angives i enheder, hvorimod styrken af humaninsulin angives i internationale enheder.
English: NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes).
Danish: NovoRapid anvendes til at sænke det høje blodsukkerniveau hos voksne, unge og børn fra 1 år og derover med sukkersyge (diabetes mellitus).
English: The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Danish: Den evne insulin aspart har til at sænke blodglucosen, skyldes det faciliterede optag af glucose, efter at insulin er bundet til receptorer på muskel- og fedtceller, og den samtidige inhibering af glucosefrigivelse fra leveren.
English: NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially ‘sodiumfree'.
Danish: NovoRapid indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. NovoRapid er stort set natriumfrit.
English: Fig. I. Blood glucose concentrations following a single pre-meal dose of NovoRapid injected immediately before a meal (solid curve) or soluble human insulin administered 30 minutes before a meal (hatched curve) in patients with type 1 diabetes mellitus.
Danish: Fig. I. Blodglucosekoncentrationer efter en enkelt præprandial dosis af NovoRapid injiceret umiddelbart før et måltid (ubrudt linje) eller opløseligt humaninsulin indgivet 30 minutter før et måltid (stiplet linje) hos patienter med type 1-diabetes mellitus.
English: Infusion sites should be rotated.
Danish: Infusionsstedet skal varieres.
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);
Danish: Frekvensenskategorierne er defineret i henhold til den 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), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: If no drop appears after these new attempts, change the needle and repeat steps F to H once more.
Danish: Hvis en dråbe ikke kommer til syne efter disse forsøg, skiftes nålen og trin F til H gentages.
English: The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes.
Danish: De farmakokinetiske og farmakodynamiske egenskaber af NovoRapid blev undersøgt hos børn (612 år) og unge (13-17 år) med type 1-diabetes.
English: Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible.
Danish: Hurtigt forbedret glykæmisk kontrol kan være forbundet med akut, smertefuld neuropati, som sædvanligvis er reversibel.
English: • Sulphonamides (used to treat infections).
Danish: • Sulfonamider (til behandling af infektioner).
English: • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Danish: • Sympatomimetika (såsom adrenalin eller salbutamol og terbutalin til behandling af astma)
English: Always mix NovoRapid and the NPH insulin in the same sequence.
Danish: Bland altid NovoRapid og NPH-insulinet i samme rækkefølge.
English: NovoRapid is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region.
Danish: NovoRapid indgives subkutant ved injektion i abdominalvæggen, låret, overarmen, deltoid- eller glutealregionen.
English: Use the dose selector on your NovoRapid FlexTouch pen to select your dose.
Danish: Brug dosisvælgeren på din NovoRapid FlexTouch pen til at indstille din dosis.
English: Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump (see section 6.6).
Danish: Patienter, som anvender CSII, skal instrueres grundigt i brugen af pumpesystemet samt korrekt anvendelse af beholdere og slanger, som hører til pumpen (se pkt.
English: Insulin mixtures should not be administered intravenously or used with a subcutaneous insulin infusion pump.
Danish: Opblandinger af insulin bør ikke administreres intravenøst eller anvendes med en subkutan insulininfusionspumpe.
English: A number of medicinal products are known to interact with the glucose metabolism.
Danish: Et antal lægemidler har kendt indflydelse på glucosemetabolismen.
English: If necessary, NovoRapid can be administered intravenously which should be carried out by physicians or other healthcare staff.
Danish: NovoRapid kan om nødvendigt administreres intravenøst, hvilket skal udføres af læger eller andet sundhedspersonale.
English: J Insert the needle into your skin as your doctor or nurse has shown you.
Danish: J Stik nålen ind i huden som din læge eller sygeplejerske har vist dig.
English: Make sure not to turn the dial or correct the dose when the needle is inserted in the skin.
Danish: Undgå at dreje eller korrigere dosis, når nålen er indsat i huden.
English: They must not give you any food or drink due to risk of suffocation.
Danish: Du må ikke få noget at spise eller drikke, da du kan blive kvalt.
English: • If you find it hard to recognise hypoglycaemia.
Danish: • Hvis du har svært ved at vurdere, om du har hypoglykæmi.
English: This medicinal product must not be diluted or mixed with other medicinal products except for mixing with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use, or with infusion fluids as described in section 4.2.
Danish: Dette lægemiddel må ikke fortyndes eller blandes med andre lægemidler, med undtagelse af opblanding med NPH (Neutral Protamine Hagedorn) -insulin i en sprøjte til subkutan brug, eller infusionsvæsker, som beskrevet under pkt.
English: On rare occasions, injection site reactions may require discontinuation of NovoRapid.
Danish: I sjældne tilfælde kan reaktioner på injektionsstedet nødvendiggøre seponering af NovoRapid.
English: For use in an infusion pump system
Danish: Til brug i et infusionspumpesystem
English: The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower Cmax (352±240 pmol/l) and later tmax (60 (interquartile range: 50-90) minutes).
Danish: Absorptionshastigheden var noget langsommere for patienter med type 2-diabetes, hvilket resulterede i en lavere Cmax (352 ± 240 pmol/l) og senere tmax (60 (interkvartilt interval: 50-90) minutter).
English: • Follow the steps described in section 1 and 2 to prepare and insert a new NovoRapid PumpCart into your pump.
Danish: • Følg trinene beskrevet i punkt 1 og 2, for at klargøre og indsætte en ny NovoRapid PumpCart i din pumpe.
English: • Always make sure that a drop appears at the needle tip before injection (picture 1B).
Danish: • Kontrollér altid, at der kommer en dråbe til syne på nålens spids før injektion (figur 1B).
English: Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breastfeeding.
Danish: Spørg din læge, sygeplejerske eller apotekspersonalet til råds, før du tager dette lægemiddel, mens du er gravid eller ammer.
English: Data were limited in patients with moderate and severe renal impairment.
Danish: Data er begrænset hos patienter med moderat til svært nedsat nyrefunktion.
English: In addition the data from a clinical trial including 27 women with gestational diabetes randomised to treatment with insulin aspart vs. human insulin (insulin aspart: 14; human insulin: 13) showed similar safety profiles between treatments.
Danish: Yderligere data fra et klinisk studie, som inkluderede 27 kvinder med gestational diabetes randomiseret til behandling med insulin aspart vs. humaninsulin (insulin aspart: 14; humaninsulin: 13) viste lignende sikkerhedsprofiler mellem behandlingerne.
English: Your bolus (meal-time) insulin needs to be adjusted based on your blood sugar measurement and food intake.
Danish: Din bolus (måltids) insulin skal justeres ud fra dit blodsukkerniveau og madindtag.
English: In NovoRapid substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with soluble human insulin.
Danish: Udskiftning af aminosyren prolin med aspartinsyre på position B28 i NovoRapid nedsætter tendensen til at danne hexamerer, som observeret for opløseligt humaninsulin.
English: NovoRapid can be used in adolescents and children aged 1 year and above.
Danish: NovoRapid kan anvendes til unge og børn i alderen 1 år og derover.
English: The efficacy and safety of NovoRapid given as bolus insulin in combination with either insulin detemir or insulin degludec as basal insulin has been studied for up to 12 months, in two randomised controlled clinical trials in adolescents and children aged 1 to less than 18 years (n=712).
Danish: Virkningen og sikkerheden af NovoRapid givet som bolusinsulin i kombination med enten insulin detemir eller insulin degludec som basalinsulin er blevet undersøgt i op til 12 måneder i to randomiserede kontrollerede kliniske studier hos unge og børn i alderen 1 til under 18 år (n=712).
English: NovoRapid Vial, InnoLet, FlexTouch and PumpCart:
Danish: NovoRapid hætteglas, InnoLet, FlexTouch og PumpCart:
English: Insulin aspart is equipotent to soluble human insulin on a molar basis.
Danish: Insulin aspart er ækvipotent med opløseligt humaninsulin på molær basis.
English: NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect.
Danish: NovoRapid er et moderne insulin (insulinanalog) med en hurtigvirkende effekt.
English: Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Danish: Patienter med markant forbedret blodglucosekontrol, opnået f.eks. ved intensiv insulinbehandling, kan opleve ændring af de normale advarselssymptomer på hypoglykæmi og bør advares herom.
English: A mean maximum plasma concentration of 492±256 pmol/l was reached 40 (interquartile range: 30-40) minutes after a subcutaneous dose of 0.15 unit/kg bodyweight in type 1 diabetic patients.
Danish: Gennemsnitlig maksimal plasmakoncentration på 492 ± 256 pmol/l blev opnået 40 (interkvartilt interval: 30-40) minutter efter subkutan injektion af 0,15 enheder/kg legemsvægt hos patienter med type 1-diabetes.
English: b) List of other side effects
Danish: b) Oversigt over andre bivirkninger
English: Substances added to NovoRapid may cause degradation of insulin aspart.
Danish: Stoffer, der tilsættes NovoRapid, kan nedbryde insulin aspart.
English: If you use only one type of insulin
Danish: Hvis du kun tager én type insulin
English: NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Danish: NovoRapid er indiceret til behandling af diabetes mellitus hos voksne, unge og børn i alderen 1 år og opefter.
English: NovoRapid should be drawn into the syringe before you draw your NPH insulin.
Danish: NovoRapid skal trækkes ind i sprøjten før du trækker NPH-insulin ind.
English: D Screw the needle straight onto the pen.
Danish: D Skru nålen lige på pennen.
English: * see section 4.8, Description of selected adverse reactions.
Danish: 4.8, Beskrivelse af udvalgte bivirkninger.
English: It must not be used with other devices not designed for NovoRapid PumpCart, as this may result in incorrect insulin dosing and subsequent hyper- or hypoglycaemia.
Danish: Det må ikke anvendes sammen med andet udstyr, der ikke er designet til NovoRapid PumpCart, da dette kan medføre en forkert insulindosering og efterfølgende hyper- eller hypoglykæmi.
English: High blood sugar (hyperglycaemia)
Danish: Højt blodsukker (hyperglykæmi)
English: Tap the top of the pen a few times to let any air bubbles rise to the top.
Danish: Bank let på toppen af pennen et par gange, således eventuelle luftbobler kan komme op til toppen.
English: ► If the protective cap is loose or missing.
Danish: ► Hvis den beskyttende hætte er løs eller mangler.