FrancophonIA/ELRC3.0 huggingface dataset:
English: • If no drop appears, you will not inject any insulin, even though the dose selector may move.
Danish: • Hvis ikke der kommer en dråbe til syne, injicerer du ikke noget insulin, selvom dosisvælgeren bevæger sig.
English: When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Danish: Når nålen er dækket, skubbes den store ydre nålehætte forsigtigt helt på, og nålen skrues derefter af.
English: Actraphane with alcohol
Danish: Brug af Actraphane sammen med alkohol
English: If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
Danish: Hvis der stadig ikke kommer en dråbe insulin til syne, er pennen defekt, og du skal tage en ny i brug.
English: The dose can be corrected by turning the dial either way.
Danish: Dosis kan korrigeres ved at dreje dosisvælgeren begge veje.
English: Low blood sugar may occur if you:
Danish: Lavt blodsukker kan forekomme, hvis du:
English: • If you find it hard to recognise hypoglycaemia.
Danish: • Hvis du har svært ved at opdage symptomerne på hypoglykæmi.
English: High blood sugar may occur if you:
Danish: Højt blodsukker kan forekomme, hvis du:
English: Actraphane can be used in children and adolescents.
Danish: Actraphane kan anvendes til børn og unge.
English: Do not use the pen if the resuspended insulin does not look uniformly white and cloudy.
Danish: Anvend ikke pennen, hvis det opblandede insulin ikke ser ensartet hvidt og uklart ud.
English: Actraphane 30 Penfill/Actraphane 30 InnoLet/Actraphane 30 FlexPen During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Danish: Actraphane 30 Penfill/Actraphane 30 InnoLet/Actraphane 30 FlexPen Under brug eller medbragt som reserve: Lægemidlet kan opbevares i højst 6 uger.
English: Actraphane is administered by injection under the skin (subcutaneously).
Danish: Actraphane administreres ved injektion under huden (subkutant).
English: Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose.
Danish: Samtidige sygdomme i nyrer eller lever, eller sygdomme der påvirker binyrer, hypofyse eller thyreoidea, kan nødvendiggøre ændring af insulindosis.
English: Remove the paper tab from a new disposable needle.
Danish: Fjern papirforseglingen fra en ny engangsnål.
English: * see Description of selected adverse reactions
Danish: * Se Beskrivelse af udvalgte bivirkninger nedenfor.
English: Pull off the pen cap (see A).
Danish: Dette gør opblandingen lettere.Træk penhætten af (se A).
English: Move the pen up and down twenty times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Danish: Vend pennen, som vist, op og ned 20 gange mellem de to positioner, så glaskuglen i cylinderampullen bevæger sig fra den ene til den anden ende.
English: This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis.
Danish: Manglende insulin kan føre til meget højt blodsukker (alvorlig hyperglykæmi) og ketoacidose.
English: • Remove the paper tab from a new disposable needle.
Danish: • Fjern papirforseglingen fra en ny engangsnål.
English: If you suspect that the cartridge is damaged, take it back to your supplier.
Danish: Hvis du har en mistanke om, at cylinderampullen er beskadiget, skal den returneres til apoteket.
English: When turning the dose selector, be careful not to push the pushbutton as insulin will come out.
Danish: Vær forsigtig med ikke at trykke på trykknappen, når du drejer dosisvælgeren, da der så vil sive insulin ud.
English: Changing the site with each injection may help to reduce the risk of developing such skin changes.
Danish: Hvis man skifter injektionssted hver gang, kan det være med til at nedsætte risikoen for at udvikle disse hudforandringer.
English: If you do not treat it, this could lead to diabetic coma and eventually death.
Danish: Denne tilstand kan ubehandlet resultere i diabetisk koma og i værste fald død.
English: Consult your doctor: ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
Danish: Tal med din læge: ► Hvis du har problemer med nyrer, lever, binyrer, hypofyse eller skjoldbruskkirtel.
English: - If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Danish: - Hvis andet og tredje skrifttegn er S6 eller ZF, så er fremstilleren Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danmark.
English: A drop of insulin should appear at the needle tip.
Danish: En dråbe insulin skal nu komme til syne på nålens spids.
English: Needles, syringes, cartridges and pre-filled pens must not be shared.
Danish: Nåle, sprøjter, cylinderampuller og fyldte penne må ikke deles.
English: Actraphane Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: Actraphane Penfill er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist engangsnåle.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulty in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Danish: Generel overfølsomhed (inklusive generaliseret hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioødem, åndedrætsbesvær, palpitationer og blodtryksfald) er meget sjælden, men kan være potentielt livstruende.
English: - If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Danish: - Hvis andet og tredje skrifttegn er T6, så er fremstilleren Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, Frankrig.
English: Check the name and coloured label of your pen to make sure that it contains the correct type of insulin.
Danish: Kontrollér navnet og farven på etiketten af din pen for at sikre, at den indeholder den korrekte insulintype.
English: Turn the dose selector to select 2 units.
Danish: Indstil dosisvælgeren på 2 enheder.
English: SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Danish: Avenue d'Orléans, F-28000 Chartres, Frankrig.
English: Each vial has a protective, tamper-proof plastic cap.
Danish: Hvert hætteglas har en brudsikker plastikbeskyttelseshætte.
English: The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Danish: De bedste steder til injektion er: Foran på maven, ballen, foran på låret eller overarmen.
English: Your blood sugar level may fall (hypoglycaemia) if you take:
Danish: Dit blodsukkerniveau kan falde (hypoglykæmi), hvis du tager:
English: Before using Actraphane
Danish: Før du tager Actraphane
English: 4.2 Posology and method of administration Posology
Danish: 4.2 Dosering og administration Dosering
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dose.
Danish: Ændringer i styrke, mærke (fremstiller), type, oprindelse (animalsk insulin, humant insulin eller insulinanalog) og/eller fremstillingsmetode (rekombinant DNA i modsætning til insulin af animalsk oprindelse) kan medføre et behov for dosisændring.Patienter, der skifter til Actraphane fra en anden insulintype, skal muligvis have øget antallet af daglige injektioner eller ændret dosis i forhold til dosis af deres sædvanlige insulinpræparater.
English: After resuspending, complete all of the following stages of injection without delay.
Danish: Efter opblanding gennemføres følgende injektionsprocedure uden forsinkelse.
English: • Deliver the dose by pressing the push-button fully down (picture 3).
Danish: • Injicér dosis ved at trykke trykknappen helt i bund (figur 3).
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: Erfaringer post-marketing og samt fra kliniske studier indikerer ikke nogen forskel i bivirkningernes frekvens, type og sværhedsgrad i den pædiatriske population i forhold til den bredere erfaring i den generelle patientpopulation.
English: Pointer
Danish: Markør
English: You will hear clicks as the dose selector returns to 0.
Danish: Der høres en klikkende lyd, når dosisvælgeren stilles tilbage på 0.
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 diabetes, som kan medføre synstab): Hvis du lider af diabetisk retinopati, kan dette forværres, hvis dit blodsukkerniveau forbedres meget hurtigt.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Danish: Erfaringer post-marketing og samt fra kliniske studier indikerer ikke nogen forskel i bivirkningernes frekvens, type og sværhedsgrad hos ældre patienter og hos patienter med nedsat nyre- eller leverfunktion i forhold til den bredere erfaring i den generelle patientpopulation.
English: ► Keep the needle under your skin for at least 6 seconds.
Danish: ► Nålen skal forblive under huden i mindst 6 sekunder.
English: Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Danish: Din InnoLet er en kompakt, fyldt pen, som kan afgive en dosis på mellem 1 og 50 enheder i spring på 1 enhed.
English: This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
Danish: Dette vil sikre korrekt injektion og begrænse eventuelt tilbageløb af blod til nålen og insulinkammeret.
English: These usually disappear after a few weeks of taking your insulin.
Danish: Symptomerne forsvinder normalt inden for få uger ved fortsat insulinbehandling.
English: Turn the vial and syringe upside down and draw the correct insulin dose into the syringe.
Danish: Vend hætteglasset og sprøjten på hovedet, og træk den korrekte insulindosis ind i sprøjten.
English: Check the name and coloured label of your InnoLet to make sure that it contains the correct type of insulin.
Danish: Kontrollér navnet og farven på etiketten af din InnoLet for at sikre, at den indeholder den korrekte insulintype.
English: • Danazol (medicine acting on ovulation).
Danish: • Danazol (lægemiddel, der påvirker ægløsning).
English: If administration by syringe is necessary, a vial should be used.
Danish: Hvis det er nødvendigt at anvende en sprøjte, bør et hætteglas anvendes.
English: Draw into the syringe the same amount of air as the dose of insulin you are going to inject.
Danish: Træk en mængde luft ind i sprøjten, som svarer til den insulindosis, du skal injicere.
English: ► Actraphane Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: ► Actraphane Penfill cylinderampuller er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist engangsnåle.
English: Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.
Danish: Brug altid dosisvælgeren og markøren til at se hvor mange enheder du har valgt, før du injicerer insulinet.
English: If you take too much insulin your blood sugar gets too low (hypoglycaemia).
Danish: Hvis du tager for meget insulin, bliver dit blodsukker for lavt (hypoglykæmi).
English: Roll the vial between your hands until the liquid is uniformly white and cloudy.
Danish: Rul hætteglasset mellem hænderne, indtil væsken er ensartet hvid og uklar.
English: • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Danish: • Bevæg pennen op og ned mellem position A og B, så glaskuglen bevæger sig fra den ene ende af cylinderampullen til den anden (figur 1A) mindst 20 gange.
English: After removing Actraphane vial, cartridge or pre-filled pen from the refrigerator, it is recommended to allow the Actraphane vial, cartridge or pre-filled pen to reach room temperature before resuspending the insulin as instructed for first time use.
Danish: Efter at Actraphane hætteglas, cylinderampul eller fylt pen er taget ud af køleskabet, anbefales det at lade Actraphane hætteglas, cylinderampul eller fylt pen opnå stuetemperatur, inden insulinet opblandes som beskrevet første gang.
English: If no drop appears, you will not inject any insulin, even though the dose selector may move.
Danish: Hvis ikke der kommer en dråbe til syne, injicerer du ikke noget insulin, heller ikke selvom dosisvælgeren måske bevæger sig.
English: • Insert the needle into your skin.
Danish: • Stik nålen ind under huden.
English: Insulin medicinal products should only be added to compounds with which it is known to be compatible.
Danish: Insulinpræparater må generelt kun tilsættes til kemiske forbindelser, hvor der er påvist kompatibilitet.
English: This could be the result of an insulin leakage.
Danish: Dette kan være forårsaget af insulinlækage.
English: • Thiazides (used to treat high blood pressure or excessive fluid retention)
Danish: • Thiazider (til behandling af forhøjet blodtryk eller ved væskeophobning)
English: Actraphane 30 InnoLet, Actraphane 40 and 50 Penfill:
Danish: Actraphane 30 InnoLet, Actraphane 40 og 50 Penfill:
English: You must use the pen as described in the Instructions on how to use Actraphane 30 InnoLet.
Danish: Du skal bruge pennen som beskrevet i brugervejledningen til Actraphane 30 InnoLet.
English: • Keeping the needle upwards, press the push-button and the dose selector returns to 0.
Danish: • Hold fortsat nålen opad, og tryk trykknappen ind, hvorved dosisvælgeren stilles tilbage til 0.
English: • Salicylates (used to relieve pain and lower fever)
Danish: • Salicylater (smertestillende og febernedsættende)
English: Do not soak, wash or lubricate it.
Danish: Den må ikke lægges i blød, vaskes eller smøres.
English: Always use the dose scale and the dose selector to see how many units you have selected before injecting the insulin.
Danish: Brug altid dosisskalaen og dosisvælgeren til at se, hvor mange enheder du har indstillet, før du injicerer insulinet.
English: • Exercise less than usual.
Danish: • Dyrker mindre motion, end du plejer.
English: Injecting the insulin
Danish: Injektion af insulin
English: Always remove the needle after each injection and store your FlexPen without the needle attached.
Danish: Fjern altid nålen efter hver injektion, og opbevar din FlexPen uden påsat nål.
English: Attaching the needle C
Danish: Påsætning af nålen C
English: After removing Actraphane Penfill from the refrigerator, it is recommended to allow the Actraphane Penfill to reach room temperature before resuspending the insulin as instructed for first time use.
Danish: Efter at Actraphane Penfill er taget ud af køleskabet, bør Actraphane Penfill opnå stuetemperatur, inden insulinet opblandes som beskrevet første gang.
English: Continuous rotation of the injection site within a given area reduces the risk of developing these reactions.
Danish: Fortsat skift af injektionsstedet inden for et givet område reducerer risikoen for udvikling af disse reaktioner.
English: Uncommon - Injection site reactions
Danish: Ikke almindelig - Reaktioner på injektionsstedet
English: You can also report side effects via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Turn the dose selector to select the number of units you need to inject.
Danish: Indstil dosisvælgeren til det antal enheder, du skal injicere.
English: Suspension for injection 1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens
Danish: Injektionsvæske, suspension 1 x 3 ml fyldt pen 5 x 3 ml fyldte penne 10 x 3 ml fyldte penne
English: Removing the needle • Replace the big outer needle cap and unscrew the needle (picture 4).
Danish: Fjern nålen • Sæt den store ydre nålehætte på nålen, og skru nålen af (figur 4).
English: Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
Danish: Injicér dosis ved at trykke på trykknappen, indtil der står 0 ud for markøren.
English: ► Always use a new needle for each injection to prevent contamination.
Danish: ► Brug altid en ny nål til hver injektion for at undgå forurening.
English: Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulfate
Danish: Dinatriumphosphatdihydrat Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering) Protaminsulfat
English: May affect less than 1 in 100 people.
Danish: Kan forekomme hos færre end 1 ud af 100 behandlede.
English: Prior to each injection small amounts of air may collect in the cartridge during normal use.
Danish: Under normal brug kan der før hver injektion samle sig små luftbobler i cylinderampullen.
English: You can clean the exterior of your FlexPen by wiping it with a medicinal swab.
Danish: Du kan rense din FlexPen udvendigt med en alkoholserviet.
English: Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even resuspension.
Danish: Kontrollér altid, om der er nok insulin tilbage (mindst 12 enheder) i cylinderampullen for at sikre en ensartet opblanding.
English: Do not freeze During use: Store below 25°C.
Danish: Må ikke fryses Under brug: Opbevares under 25°C.
English: There is no restriction on treatment with Actraphane during breast-feeding.
Danish: Der er ingen restriktioner for behandling med Actraphane under amning.
English: Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Danish: Tegn på lavt blodsukker: Koldsved, kold bleg hud, hovedpine, hjertebanken, kvalme, usædvanlig stor sultfornemmelse, midlertidige synsforstyrrelser, døsighed, unormal træthed og svaghed, nervøsitet eller rysten, bekymring, forvirring og koncentrationsbesvær.
English: Instructions on how to use Actraphane 30 suspension for injection in InnoLet Read the instructions carefully before using your InnoLet.
Danish: Brugervejledning til Actraphane 30 injektionsvæske, suspension i InnoLet Læs denne brugervejledning omhyggeligt, inden du tager din InnoLet i brug.
English: If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Danish: Hvis ikke du følger denne brugervejledning omhyggeligt, kan du få for lidt eller for meget insulin, som kan føre til et for højt eller for lavt blodsukkerniveau.
English: Instructions on how to use Actraphane 30 suspension for injection in FlexPen Read the following instructions carefully before using your FlexPen.
Danish: Brugervejledning til Actraphane 30 injektionsvæske, suspension i FlexPen Læs denne brugervejledning omhyggeligt, inden du tager din FlexPen i brug.
English: Subcutaneous use Read the package leaflet before use
Danish: Subkutan anvendelse Læs indlægssedlen inden brug
English: Make sure not to turn the dial or correct the dose when the needle is inserted in the skin.
Danish: Dosisvælgeren må ikke drejes, og dosis må ikke indstilles, når nålen er indsat i huden.
English: During use or when carried as a spare: Store below 25°C.
Danish: Under brug eller medbragt som reserve: Opbevares under 25°C.
English: - The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.
Danish: - Øvrige indholdsstoffer: Zinkchlorid, glycerol, metacresol, phenol, dinatriumphosphatdihydrat, natriumhydroxid, saltsyre, protaminsulfat og vand til injektionsvæsker.
English: In elderly patients, glucose monitoring should be intensified and the insulin dose adjusted on an individual basis.
Danish: Monitorering af glucose skal intensiveres og insulindosis justeres individuelt hos ældre patienter.
English: Continuous rotation of the injection site within the particular injection area reduces the risk of developing these reactions.
Danish: Kontinuerligt skift af injektionssted inden for det enkelte injektionsområde reducerer risikoen for udvikling af disse reaktioner.
English: You must use the pen as described in the Instructions on how to use Actraphane 30 FlexPen.
Danish: Du skal bruge pennen som beskrevet i brugervejledningen til Actraphane 30 FlexPen.
English: It may affect less than 1 in 10,000 people.
Danish: Kan forekomme hos færre end 1 ud af 10.000 behandlede.
English: Do not freeze During use: Store below 30°C.
Danish: Må ikke fryses Under brug: Opbevares under 30°C.
English: Use the injection technique advised by your doctor or nurse.
Danish: Anvend den injektionsteknik din læge eller sygeplejerske har anbefalet.
English: Read carefully the Instructions on how to use Actraphane 30 InnoLet included in this package leaflet.
Danish: Læs omhyggeligt brugervejledningen til Actraphane 30 InnoLet, der er inkluderet i denne indlægsseddel.
English: It may affect more than 1 in 10 people.
Danish: Det kan forekomme hos flere end 1 ud af 10 behandlede.
English: • After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered.
Danish: • Efter injektion skal nålen forblive under huden i mindst 6 sekunder for at sikre korrekt injektion af hele dosis.
English: Resuspending is easier when the insulin has reached room temperature.
Danish: Det er lettere at opblande insulinet, når det har opnået stuetemperatur.
English: ► There are no restrictions on treatment with Actraphane during breast-feeding.
Danish: ► Der er ingen begrænsninger ved behandling med Actraphane under amning.
English: Always make sure that you have resuspended the insulin prior to each injection.
Danish: Kontrollér altid at du har opblandet insulinet før hver injektion.
English: MARKETING AUTHORISATION NUMBER
Danish: MARKEDSFØRINGSTILLADELSESNUMRE
English: Always make sure that a drop appears at the needle tip before you inject.
Danish: Kontrollér altid at der kommer en dråbe til syne på nålens spids før du injicerer.
English: Insert the needle into your skin.
Danish: Stik nålen ind under huden.
English: • Let the insulin reach room temperature before you use it.
Danish: • Lad insulinet opnå stuetemperatur, inden du bruger det.
English: • The movement must always be repeated until the liquid appears uniformly white and cloudy.
Danish: • Bevægelsen skal altid gentages, indtil al væsken er ensartet hvid og uklar.
English: You can clean your InnoLet by wiping it with a medicinal swab.
Danish: InnoLet kan renses udvendigt ved at tørre den med en alkoholserviet.
English: If you take the wrong type of insulin, your blood sugar level may get too high or too low.
Danish: Hvis du tager den forkerte insulintype, kan dit blodsukkerniveau blive for højt eller for lavt.
English: Store below 25°C.
Danish: Opbevares ved temperaturer under 25°C.
English: ► If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
Danish: ► Hvis cylinderampullen eller injektionssystemet indeholdende cylinderampullen tabes, beskadiges eller knuses.
English: The insulin will work more quickly if you inject into the waist (abdomen).
Danish: Insulinet har en hurtigere virkning, hvis du injicerer i maveskindet.