FrancophonIA/ELRC3.0 huggingface dataset:
English: Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
Danish: Slanger, hvis indre overflade er af polyethylen eller polyolefin, er blevet analyseret og fundet velegnet til pumpeanvendelse.
English: PumpCart - without blue box)
Danish: PumpCart - uden blue box)
English: NovoRapid PumpCart is for use in a pump and covers your total daily insulin needs: both your all day (basal) and meal-time (bolus) insulin needs.
Danish: NovoRapid PumpCart anvendes i en pumpe og dækker hele dit daglige insulinbehov, både dit daglige(basal) og dit måltidsinsulinbehov (bolus).
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-studier af bl.a. binding til insulin- og IGF-1-receptorsteder samt virkning på cellevækst opførte insulin aspart sig meget lig humaninsulin.
English: If it shows less than 80, the number shown is the number of units left in your pen.
Danish: Hvis den viser færre end 80, angiver det viste tal antallet af enheder, der er tilbage i din pen.
English: You can select doses from 1 to 60 units in increments of 1 unit.
Danish: Du kan vælge en dosis på mellem 1 og 60 enheder i trin af én enhed.
English: Moreover NovoRapid can be used for continuous infusion in a pump system.
Danish: NovoRapid kan også anvendes til kontinuert infusion i et pumpesystem.
English: Dispose of it carefully and put the pen cap back on.
Danish: Kassér den omhyggeligt og sæt penhætten tilbage på.
English: Uncommon - Refraction disorders Uncommon - Diabetic retinopathy
Danish: Ikke almindelig - Refraktionsanomalier Ikke almindelig - Diabetisk retinopati
English: If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.
Danish: Hvis du taber pennen eller har mistanke om et problem, skal du altid skrue en ny engangsnål på og kontrollere insulingennemløbet, før du injicerer.
English: What NovoRapid contains
Danish: NovoRapid indeholder
English: Keep NovoRapid PumpCart in the blister until use to protect it from damage.
Danish: Opbevar NovoRapid PumpCart i blisterpakningen, indtil det skal bruges, for at beskytte den mod skader.
English: The maximum effect occurs between 1 and 3 hours after the bolus delivery and the effect lasts for 3 to 5 hours.
Danish: Maksimal virkning ses mellem 1 og 3 timer efter bolusinjektionen, og varer 3 til 5 timer.
English: In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Danish: Hos type 1-diabetikere fører ubehandlede hyperglykæmiske tilfælde i sidste instans til diabetisk ketoacidose, som kan være dødelig.
English: Do not use the pen without proper training from your doctor or nurse.
Danish: Anvend ikke pennen før du har modtaget grundig træning af din læge eller sygeplejerske.
English: Dispose of it carefully, and put the pen cap back on after every use.
Danish: Kassér nålen forsigtigt og sæt penhætten tilbage på pennen efter hver brug.
English: Injecting your dose
Danish: Injektion af din dosis
English: • Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
Danish: • Angiotensin konverteringsenzym (ACE)-hæmmere (til behandling af visse hjertelidelser eller forhøjet blodtryk)
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 af bindingen til insulinreceptoren er den samme som for humaninsulin.
English: In case of hypoglycaemia or if hypoglycaemia is suspected NovoRapid must not be injected.
Danish: I tilfælde af hypoglykæmi eller ved mistanke herom må NovoRapid ikke injiceres.
English: Adverse reactions observed in patients using NovoRapid are mainly due to the pharmacologic effect of insulin.
Danish: Hos patienter, som tager NovoRapid, er de observerede bivirkninger fortrinsvis forårsaget af insulins farmakologiske effekt.
English: In patients with hepatic impairment, absorption rate was decreased and more variable, resulting in delayed tmax from about 50 min in subjects with normal hepatic function to about 85 min in patients with moderate and severe hepatic impairment.
Danish: Hos patienter med nedsat leverfunktion var absorptionsraten nedsat og varierede mere, hvilket resulterede i en tmax, der var forsinket fra omkring 50 minutter hos personer med normal leverfunktion til omkring 85 minutter hos patienter med moderat til svært nedsat leverfunktion.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Danish: Forekomsten af generel hypersensibilitet (inklusive generel hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, palpitationer og blodtryksfald) er meget sjælden, men kan være potentielt livstruende.
English: For intravenous use, infusion systems with NovoRapid 100 units/ml at concentrations from 0.05 unit/ml to 1.0 unit/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours.
Danish: Til intravenøs brug er infusionssystemer med NovoRapid 100 enheder/ml stabilt ved stuetemperatur i 24 timer ved koncentrationer fra 0,05 enheder/ml til 1,0 enheder/ml insulin aspart i infusionsvæskerne 0,9% natriumchlorid, 5% dextrose eller 10% dextrose inklusive 40 mmol/l kaliumchlorid ved brug af polypropylen-infusionsposer.
English: Before travelling between different time zones, the patient should seek the doctor's advice since this may mean that the patient has to take the insulin and meals at different times.
Danish: Patienten skal rådføre sig med sin læge før rejse mellem forskellige tidszoner, da dette kan have indflydelse på, hvornår patienten skal tage sit insulin og mad.
English: • Danazol (medicine acting on ovulation).
Danish: • Danazol (lægemiddel, der virker på ægløsning).
English: • If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Danish: • Hvis andet og tredje skrifttegn er S6, P5, K7, R7, VG, FG eller ZF, så er fremstilleren Novo
English: If not, change the needle and repeat the procedure no more than
Danish: Hvis dette ikke sker, skift nålen og gentag proceduren, dog højst
English: If it is not in perfect condition when you get the vial, return the vial to your supplier.
Danish: Hvis den ikke er i hel stand, når du får hætteglasset, skal du returnere hætteglasset til apoteket.
English: What to do if you experience high blood sugar: ► If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
Danish: Du skal gøre følgende, hvis du får højt blodsukker: ► Hvis du oplever nogle af ovennævnte signaler: Mål dit blodsukkerniveau, kontrollér om muligt din urin for ketonstoffer og søg straks lægehjælp.
English: NovoRapid PumpCart carried as a spare can be kept for up to 2 weeks below 30°C.
Danish: NovoRapid PumpCart medbragt som reserve kan opbevares i op til 2 uger under 30°C.
English: To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.
Danish: For at få størst muligt udbytte af insulininfusionen og for at opdage eventuelle pumpesvigt, anbefales det, at du måler dit blodsukker regelmæssigt.
English: When transferring from other insulin medicinal products, adjustment of the NovoRapid dose and the dose of the basal insulin may be necessary.
Danish: Ved skift fra andre insulinpræparater kan justering af NovoRapid dosis samt dosis af basalinsulinet være nødvendigt.
English: During use: Use within 4 weeks
Danish: Under brug: Bruges inden 4 uger.
English: FlexTouch - without blue box)
Danish: FlexTouch - uden blue box)
English: SAS, 45 Avenue d'Orléans F-28000 Chartres, France.
Danish: 45 Avenue d'Orléans, F-28000 Chartres, Frankrig.
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Danish: Fortæl det til din læge hurtigst muligt, hvis du oplever tegn på hjertesvigt, såsom usædvanlig kortåndethed, hurtig vægtstigning eller lokale væskeansamlinger (ødemer).
English: ► If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
Danish: ► Hvis du får så lavt blodsukker, at du besvimer, hvis du har haft brug for en glucagoninjektion eller hvis du har haft gentagne tilfælde af lavt blodsukker, skal du tale med din læge.
English: ► NovoRapid should never be mixed with any other medicinal product including other insulin products when used in a pump.
Danish: ► NovoRapid må aldrig blandes med andre lægemidler, heller ikke andre insulinprodukter, når det bruges i en pumpe.
English: A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those four were younger than 4 years old) and a single dose PK/PD trial was performed in children (612 years) and adolescents (13-17 years).
Danish: Et klinisk studie, som sammenligner præprandial opløseligt humaninsulin med postprandial insulin aspart, blev udført med små børn (20 patienter fra 2 år og til under 6 år, undersøgt i 12 uger, blandt disse var fire under 4 år gamle) og et enkelt-dosis PK/PD forsøg blev udført med børn (6-12 år) og unge (13-17 år).
English: Each vial has a protective, tamper-proof plastic cap.
Danish: Hvert hætteglas har en beskyttende, brudsikker plastikhætte.
English: • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to 0 when you press the push-button.
Danish: • Sørg for, at du ikke blokerer for dosisvælgeren under injektion, da det er vigtigt, at den kan returnere frit til 0, når der trykkes på dosisknappen.
English: Due to the faster onset of action, NovoRapid should generally be given immediately before a meal.
Danish: På grund af den hurtigere virkning skal NovoRapid normalt gives lige før et måltid.
English: A decreased absorption rate was observed in elderly patients, resulting in a later tmax (82 (interquartile range: 60-120) minutes), whereas Cmax was similar to that observed in younger patients with type 2 diabetes and slightly lower than in patients with type 1 diabetes.
Danish: Hos ældre blev der observeret en nedsat absorptionsrate, hvilket resulterede i en senere tmax (82 (interkvartilt interval: 60120) minutter), hvorimod Cmax var i overensstemmelse med den værdi, som blev observeret hos yngre patienter med type 2-diabetes, og en smule lavere end hos patienter med type 1-diabetes.
English: Always make sure that the dose selector returns to 0 after the injection.
Danish: Kontrollér altid, at dosisvælgeren vender tilbage til 0 efter injektionen.
English: Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes og hjertesygdom eller tidligere slagtilfælde, som er blevet behandlet med pioglitazon og insulin, oplevede hjertesvigt.
English: The maximum effect is exerted between 1 and 3 hours after the injection.
Danish: Den maksimale effekt finder sted mellem 1 og 3 timer efter injektionen.
English: • Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a few times (picture 1B) to make any air bubbles collect at the top of the cartridge.
Danish: • Hold din InnoLet med nålen opad, og bank let på cylinderampullen med fingeren et par gange (figur 1B), så eventuelle luftbobler samles i toppen af cylinderampullen.
English: The maximum effect is exerted between 1 and 3 hours after injection.
Danish: Maksimal virkning opnås mellem 1 og 3 timer efter injektion.
English: A randomised, double-blind cross-over PK/PD trial comparing insulin aspart with soluble human insulin was performed in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age 70 years).
Danish: Et randomiseret, dobbeltblindet cross-over PK/PD studie, som sammenlignede insulin aspart med opløseligt humaninsulin, blev udført med ældre patienter med type 2-diabetes (19 patienter mellem 65-83 år, gennemsnitsalder 70 år).
English: Removing the needle
Danish: Fjernelse af nålen
English: Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your doctor has told you.
Danish: Tag altid dit insulin og justér din basal- (daglige) og bolus- (måltids) dosis nøjagtigt efter lægens anvisning.
English: Keep the push-button fully depressed until the needle has been withdrawn from the skin.
Danish: Hold dosisknappen helt nede, indtil nålen er trukket ud fra huden.
English: Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds.
Danish: Hold dosisknappen helt i bund og lad nålen forblive under huden i mindst 6 sekunder.
English: There are no restrictions on treatment with NovoRapid during breast-feeding.
Danish: Der er ingen restriktioner på behandling med NovoRapid under amning.
English: Store below 37°C Do not freeze
Danish: Opbevares under 37°C Må ikke fryses
English: Rare side effects May affect less than 1 in 1,000 people.
Danish: Sjældne bivirkninger Kan forekomme hos færre end 1 ud af 1.000 behandlede.
English: • If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
Danish: • Hvis andet og tredje skrifttegn er H7 eller T6, så er fremstilleren Novo Nordisk Production SAS,
English: Clinical trials in patients with type 1 diabetes have demonstrated a lower postprandial blood glucose with NovoRapid compared to soluble human insulin (Fig.
Danish: Kliniske studier hos patienter med type 1-diabetes har vist lavere postprandial blodglucose med NovoRapid i forhold til opløseligt humaninsulin (Fig. I).
English: C Take a new disposable needle, and tear off the paper tab.
Danish: C Tag en ny engangsnål og fjern papirforseglingen.
English: Before using NovoRapid PumpCart in a pump, you must have thorough training in the use of the pump and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump.
Danish: Inden brug af NovoRapid PumpCart i en pumpe, skal du have grundig træning i brug af pumpen og information om hvad du skal gøre i tilfælde af sygdom, for højt eller for lavt blodsukker eller pumpesvigt.
English: A clinical trial comparing safety and efficacy of insulin aspart vs. human insulin in the treatment of pregnant women with type 1 diabetes (322 exposed pregnancies (insulin aspart: 157; human insulin: 165)) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn.
Danish: Et klinisk studie, der sammenligner sikkerhed og effekt af insulin aspart vs. humaninsulin under behandling af gravide med type 1-diabetes (322 eksponerede graviditeter (insulin aspart: 157; humaninsulin: 165)) viser ingen bivirkninger af insulin aspart under graviditet eller på fosterets/spædbarnets helbred.
English: OTHER SPECIAL WARNINGS, IF NECESSARY Use solution only if clear and colourless For use by one person only
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Brug kun opløsning der er klar og farveløs Må kun anvendes af én person
English: Data from two randomised controlled clinical trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to human insulin (see section 5.1).
Danish: Data fra to randomiserede, kontrollerede kliniske studier (322 og 27 eksponerede graviditeter) viser ingen bivirkninger af insulin aspart under graviditet eller på fosterets/spædbarnets helbred sammenlignet med humaninsulin (se pkt.
English: Patients transferred to NovoRapid from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products.
Danish: Patienter, der skifter til NovoRapid fra en anden insulintype, skal muligvis have øget antallet af daglige injektioner eller ændret dosis i forhold til dosis af deres sædvanlige insulinpræparater.
English: NovoRapid is for injection under the skin (subcutaneously) or for continuous infusion in a pump system.
Danish: NovoRapid er beregnet til injektion under huden (subkutant) eller til kontinuert infusion i et pumpesystem.
English: You can clean your InnoLet by wiping it with a medicinal swab.
Danish: Din InnoLet kan renses udvendigt ved at tørre den med en medicinsk serviet.
English: Before use of NovoRapid 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, too high or too low blood sugar or failure of the pump system.
Danish: Før du anvender NovoRapid i et pumpesystem, skal du have modtaget grundig instruktion i brugen og information om forholdsregler i tilfælde af, at du bliver syg, får for højt eller for lavt blodsukker, eller at pumpesystemet svigter.
English: The relative differences in the pharmacodynamic properties (GIRmax,AUCGIR, 0-120 min) between insulin aspart and soluble human insulin in the elderly were similar to those seen in healthy subjects and in younger patients with diabetes.
Danish: Den relative forskel i de farmakodynamiske egenskaber (GIRmax, AUCGIR, 0-120 min) mellem insulin aspart og opløseligt humaninsulin hos ældre var i overensstemmelse med dem, som er set hos raske personer og hos yngre patienter med diabetes.
English: Make sure that you receive your full dose by always checking the insulin flow before you select and inject your dose.
Danish: Vær sikker på, at du får den rigtige dosis ved at kontrollere gennemløb af insulin, før du indstiller og injicerer din dosis.
English: EXP/ During use in pump: Use within 7 days
Danish: EXP/ Under brug i pumpe: Bruges inden 7 dage
English: If administration by infusion pump is necessary, a vial or NovoRapid PumpCart should be used.
Danish: Hvis det er nødvendigt at anvende en infusionspumpe til administrationen, bør et hætteglas eller NovoRapid PumpCart anvendes.
English: Mixing two types of insulins
Danish: Opblanding af to typer insulin
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ADMINISTRATIONSMETODE Læs indlægssedlen før brug
English: If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Danish: Hvis du skifter til en anden insulintype eller et andet insulinmærke, er det muligt, at dosis skal justeres af din læge.
English: NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal.
Danish: Virkningen af NovoRapid indtræder hurtigere sammenlignet med opløseligt humaninsulin, og samtidig er glucosekoncentrationen lavere inden for de første 4 timer efter et måltid.
English: • If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Danish: - Hvis andet og tredje skrifttegn er S6, P5, K7, R7, VG, FG eller ZF, så er fremstilleren Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danmark.
English: Make sure the needle is on tight.
Danish: Kontrollér, at nålen sidder fast.
English: F Turn the dose selector to select 2 units.
Danish: F Drej dosisvælgeren for at vælge 2 enheder.
English: The most frequently reported adverse reaction is hypoglycaemia.
Danish: Den hyppigst rapporterede bivirkning er hypoglykæmi.
English: You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.
Danish: Du kan have den med dig og opbevare den ved stuetemperatur (under 30°C) i op til 4 uger.
English: ► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section
Danish: ► 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: If you experience any problems contact your doctor.
Danish: Kontakt lægen hvis du oplever nogle problemer.
English: Small amounts of air may collect in the needle and cartridge during normal use.
Danish: Små luftbobler kan samle sig i nål og cylinderampul under normal brug.
English: Store below 30°C Do not freeze
Danish: Opbevares under 30°C Må ikke fryses
English: Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycaemia with insulin aspart compared with soluble human insulin.
Danish: Kliniske studier hos patienter med type 1-diabetes har vist, at der er en reduceret risiko for natlig hypoglykæmi med insulin aspart sammenlignet med opløseligt humaninsulin.
English: • If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans F-28000 Chartres, France.
Danish: - Hvis andet og tredje skrifttegn er H7 eller T6, så er fremstilleren Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, Frankrig.
English: Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Danish: Diabetisk retinopati (en øjensygdom med relation til sukkersyge, som kan medføre tab af synet): Hvis du har diabetisk retinopati, kan det blive værre, hvis dit blodsukkerniveau forbedres meget hurtigt.
English: If the insulin looks cloudy, do not use NovoRapid PumpCart.
Danish: Hvis insulinet ser uklart ud, må du ikke bruge NovoRapid PumpCart.
English: During use or when carried as a spare: The product must be stored for a maximum of 4 weeks.
Danish: Under brug eller medbragt som reserve: Lægemidlet må opbevares i højst 4 uger.
English: • Connect the infusion set with NovoRapid PumpCart by attaching the adapter onto your pump.
Danish: • Forbind infusionssættet med NovoRapid PumpCart ved at påsætte adapteren på din pumpe.
English: If any of these applies, do not use NovoRapid.
Danish: Hvis noget af ovenstående gør sig gældende, må du ikke tage NovoRapid.
English: NovoRapid FlexTouch contains 300 units of insulin and delivers doses from 1 to 80 units, in increments of 1 unit.
Danish: NovoRapid FlexTouch indeholder 300 enheder insulin og kan dosere fra 1 til 80 enheder i trin af 1 enhed.
English: • NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
Danish: • NovoRapid PumpCart skal beskyttes mod overdreven varme og lys under opbevaring og brug.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general population.
Danish: Baseret på erfaringer post-marketing samt kliniske studier er der ikke nogen indikation på forskel i bivirkningernes frekvens, type og sværhedsgrad i den pædiatriske population i forhold til den bredere erfaring i den generelle patientgruppe.
English: Follow the instructions and recommendations from your doctor regarding the use of NovoRapid in a pump.
Danish: Følg lægens instruktioner og anbefalinger vedrørende brug af NovoRapid i en pumpe.
English: Needles, syringes, cartridges, pre-filled pens and infusion sets must not be shared.
Danish: Nåle, sprøjter, cylinderampuller, fyldte penne og infusionssæt må ikke deles med andre.
English: Each ml contains 100 units of insulin aspart.
Danish: 1 ml indeholder 100 enheder insulin aspart.