FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved.
Danish: Hvis der opstår hypoglykæmi, bør infusionen stoppes, indtil episoden er udredt.
English: Usually, 40-60% of the total daily dose is given as a continuous basal rate and the remaining 40-60% as boluses divided between the three main meals.
Danish: Normalt indgives 40 - 60 % af total daglig dosis ved kontinuerlig basal hastighed og de resterende 40 - 60 % som bolusdoser fordelt på tre hovedmåltider.
English: Inject the insulin straight away under the skin.
Danish: Injicér straks insulinet under huden.
English: Do not store them in or too near the freezer section or cooling element.
Danish: Opbevar dem ikke for tæt på fryseboksen eller køleelementerne.
English: Do not use Velosulin after the expiry date which is stated on the label and the carton.
Danish: Brug ikke Velosulin efter den udløbsdato, der står på pakningen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Insulin, human, rDNA (fremstillet ved rekombinant DNA-teknologi i Saccharomyces cerevisiae).
English: A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 - 6.1 mmol/l) induced by intravenous treatment with another fast acting human insulin (Actrapid) reduced mortality by 42% (8% versus 4.6%).
Danish: Et klinisk forsøg på en intensivafdeling, der behandler hyperglykæmi (blodglucose over 10 mmol/l), med 204 diabetiske og 1344 ikke-diabetiske patienter, der gennemgik større kirurgiske indgreb, viste, at normoglykæmi (blodglucose 4,4-6,1 mmol/l) induceret med intravenøs behandling med et andet hurtigtvirkende insulin (Actrapid) reducerede mortaliteten med 42% (8% mod 4,6%).
English: WHAT VELOSULIN IS AND WHAT IT IS USED FOR Velosulin is human insulin to treat diabetes.
Danish: VIRKNING AF VELOSULIN, OG HVAD DE SKAL BRUGE DET TIL Velosulin er human insulin til diabetesbehandling.
English: If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain.
Danish: Hvis Deres blodsukkerniveauer forbedres meget hurtigt, kan De få en brændende, stikkende eller elektrisk smerte.
English: Velosulin is a fast-acting insulin.
Danish: Velosulin er et hurtigtvirkende insulin.
English: Infections can be minimised by careful attention to personal hygiene of the hands and infusion site and by frequent changes of catheter (maximum usage 2 days).
Danish: Antallet af infektioner kan begrænses ved omhyggelig personlig hygiejne især på hænder og infusionssted og ved hyppigt skift af kateter (højst to dages brug).
English: The vials that are being used or about to be used is not to be kept in a refrigerator.
Danish: De hætteglas, som er taget i brug, eller som snart skal tages i brug, må ikke opbevares i køleskab.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Danish: De kan genvinde bevidstheden hurtigere, hvis De får en injektion af hormonet glucagon af en person, der er instrueret i, hvordan det anvendes.
English: The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
Danish: Det daglige insulinbehov kan blive højere hos patienter med insulinresistens (f.eks. i puberteten eller på grund af overvægt) og lavere hos patienter med reduceret insulinproduktion.
English: Administration of Velosulin is also possible by subcutaneous or intravenous injection.
Danish: Administration af Velosulin er også mulig ved subkutan eller intravenøs injektion.
English: Changing the site with each injection may help to prevent such skin changes.
Danish: Hvis man ændrer stedet i forbindelse med hver indsprøjtning, vil det eventuelt forebygge den slags ændringer i huden.
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Danish: • Mild hypoglykæmi kan behandles med oral indtagelse af glucose eller sukkerholdige produkter.
English: Upon mixing Velosulin with infusion fluids an unpredictable amount of insulin will be absorbed to the infusion material.
Danish: Ved at blande Velosulin med infusionsvæsker vil en uforudsigelig mængde insulin blive absorberet til infusionsmaterialet.
English: Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Danish: Ændringer i styrke, mærke (fremstiller), type (hurtigtvirkende, bifasisk, langtidsvirkende insulin osv.), oprindelse (animalsk insulin, human insulin eller insulinanalog) og/eller fremstillingsmetode (rekombinant DNA i modsætning til insulin af animalsk oprindelse) kan medføre et behov for ændring af dosis.
English: In general, when patients are transferred from injection to infusion therapy, it may be advisable to reduce the dosage by initiating the patient at 90% of the previous total daily dosage, with 40% as basal rate and 50% as boluses divided between the three main meals.
Danish: Når patienter overføres fra injektions- til infusionsbehandling, er det generelt tilrådeligt at reducere dosis til en initialdosis på 90 % af den tidligere totale daglige dosis med 40 % ved basal hastighed og 50 % som bolusdoser fordelt på tre hovedmåltider.
English: 6 weeks when used or stored at room temperature (below 25°C).
Danish: 6 uger hvis det bruges eller opbevares ved stuetemperatur (under 25°C).
English: If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Danish: Hvis De injicerer på samme sted for ofte kan fedtvævet under huden på dette sted skrumpe ind (lipoatrofi) eller fortykkes (lipohypertrofi).
English: Chrildren and adolescents
Danish: Børn og unge
English: An injection or infusion should be followed within 30 minutes by a meal or snack containing carbohydrates.
Danish: En insulininjektion eller -infusion bør inden for 30 minutter efterfølges af et måltid eller mellemmåltid indeholdende kulhydrater.
English: Patients using CSII may be more prone to infection at the site of infusion.
Danish: Patienter, som anvender CSII, kan være mere tilbøjelige til at få en infektion på infusionsstedet.
English: Listed below are the most common medicines which may affect your insulin treatment.
Danish: Nedenstående liste omfatter en række almindelige lægemidler, som kan påvirke Deres insulinbehandling.
English: Velosulin may cause hypoglycaemia (low blood sugar).
Danish: Velosulin kan føre til hypoglykæmi (lavt blodsukker).
English: Talk about your insulin needs with your doctor and diabetes nurse.
Danish: Tal om Deres insulinbehov med lægen og diabetessygeplejersken.
English: General disorders and administration site conditions Uncommon - Injection site reactions
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig - Reaktioner på injektionsstedet
English: Use only syringes made of polyethylene, polypropylene or glass.
Danish: Der bør kun bruges sprøjter af polyethylen, polypropylen eller glas.
English: This is part of a multipack and not for sale of individual vials
Danish: Dette er del af en multipakning og er ikke beregnet til salg enkeltvis
English: It is therefore recommended that the diabetic patients carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Danish: Det anbefales derfor, at diabetespatienterne bærer nogle sukkerknalder, slik, småkager eller
English: There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
Danish: Der er ingen begrænsninger for behandling af diabetes med insulin under graviditet, da insulin ikke
English: • If you exercise more than usual.
Danish: • Hvis De dyrker mere motion, end De plejer.
English: Read and follow carefully the instructions that accompany your insulin pump.
Danish: Læs og følg omhyggeligt instruktionerne, som følger med insulinpumpesystemet.
English: Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C May be kept in an infusion pump at up to 37°C for 6 days
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys Efter ibrugtagning: Må ikke opbevares i køleskab eller opbevares over 25°C Kan opbevares i en infusionspumpe ved højst 37°C i 6 dage
English: Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions).
Danish: Reaktioner (rødme, hævelse, kløe) på injektionsstedet kan forekomme (lokale allergiske reaktioner).
English: The patient should read and follow the instructions that accompany the infusion pump and use the correct reservoir and catheter for the pump (see section 6.6).
Danish: Patienten bør omhyggeligt læse og følge den instruktion, som følger med infusionspumpen, og anvende korrekt beholder og kateter til pumpen (se pkt.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Danish: • Svær hypoglykæmi, hvor patienten er blevet bevidstløs, kan behandles med glucagon (0,51 mg) indgivet intramuskulært eller subkutant af en instrueret person eller med glucose indgivet intravenøst af en medicinsk uddannet person.
English: Your blood sugar may get too high (this is called hyperglycaemia).
Danish: Hvis Deres blodsukker bliver for højt Deres blodsukker kan blive for højt (dette kaldes hyperglykæmi)
English: Not all packs may be marketed.
Danish: Ikke alle pakninger er nødvendigvis markedsført.
English: Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites.
Danish: Subkutan injektion i maveregionen sikrer en hurtigere optagelse end fra andre injektionsområder.
English: Side effects reported very rarely (in less than 1 patient in 10,000)
Danish: Meget sjældne bivirkninger (hos mindre end 1 patient pr. 10.000)
English: When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
Danish: Når to typer insulin blandes trækkes først mængden af hurtigtvirkende insulin efterfulgt af mængden af langtidsvirkende insulin.
English: If it isn't in perfect condition when you get the vial, return the vial to your supplier If it hasn't been stored correctly or been frozen (see 6 How to store Velosulin) If it does not appear water clear and colourless.
Danish: Hvis den er løs eller mangler, når De får hætteglasset, skal De returnere Hvis det ikke har været opbevaret korrekt eller har været nedfrosset (se 6 Sådan opbevarer
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Danish: Skift til en anden type eller mærke af insulin må kun foretages under tæt lægekontrol.
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, hvis blodglucosekontrol er væsentligt forbedret, f.eks ved intensiveret insulinbehandling, kan opleve ændringer i deres sædvanlige advarselssymptomer på hypoglykæmi og bør orienteres
English: If the patient suspects an interruption to insulin flow the patient should notify the health care professional.
Danish: Hvis patienten mistænker en afbrydelse af insulingennemstrømningen, bør patienten informere
English: Make sure there is no air left in the syringe: point the needle upwards and push the air out Check you have the right dose
Danish: Kontrollér, at der ikke er luft i sprøjten: Vend nålen opad og pres luften ud Kontrollér, at dosis er korrekt
English: If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Danish: Hvis der injiceres glucagon, skal De også have glucose eller et sukkerholdigt produkt at spise, så snart De er ved bevidsthed igen.
English: Velosulin may also be administered intravenously in special situations by medical professionals.
Danish: Velosulin kan også i særlige tilfælde indgives intravenøst af sundhedspersonale.
English: Insulin products should only be added to compounds with which it is known to be compatible.
Danish: Insulinprodukter må kun tilsættes komponenter, som har påvist kompatibilitet.
English: - The active substance is insulin human made by recombinant biotechnology.
Danish: - Aktivt stof: insulin (human) fremstillet ved rekombinant bioteknologi.
English: This process is influenced by several factors (e.g. insulin dosage, injection route and site, thickness of subcutaneous fat, type of diabetes).
Danish: Flere faktorer har indflydelse på denne proces (f.eks. insulindosis, injektionsmåde og -sted, tykkelsen af det subkutane fedtlag, diabetestype).
English: Patients started on CSII must receive comprehensive instruction in the use of the pump, and the necessary actions in case of illness, hypoglycaemia, hyperglycaemia or pump failure.
Danish: Patienter, som påbegynder CSII, bør have omhyggelig instruktion i anvendelsen af pumpen og nødvendige forholdsregler i tilfælde af sygdom, hypoglykæmi, hyperglykæmi eller pumpesvigt.
English: Velosulin is for injection under the skin (subcutaneously).
Danish: Velosulin er beregnet til injektion under huden (subkutan).
English: Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Danish: Alvorlige hypoglykæmiske tilfælde kan føre til bevidstløshed og/eller kramper og kan resultere i midlertidig eller permanent hjerneskade eller død.
English: Use only teflon-coated or stainless steel needles.
Danish: Der bør kun bruges nåle, som er teflonbeklædt eller af rustfrit stål.
English: Hypoglycaemia.
Danish: Hypoglykæmi
English: 10 ml glass vial (type 1) closed with a bromobutyl/polyisoprene rubber stopper and a protective tamper-proof cap.
Danish: 10 ml hætteglas (type 1) lukket med en gummiskive af brombutyl/polyisopren og en hætte, der beskytter mod utilsigtet åbning.
English: Diabetic retinopathy (eye background changes).
Danish: Diabetisk retinopati (nethindeforandringer).
English: Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Danish: Tal med Deres læge om De overhovedet kan køre eller arbejde med maskiner, hvis De har hyppige episoder med hypoglykæmi, eller hvis De har svært ved at genkende symptomerne på hypoglykæmi.
English: No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Danish: Der er ikke observeret væsentlig binding til plasmaproteiner, undtagen (eventuelle) cirkulerende
English: If an adjustment is needed when switching the patients to Velosulin, it may occur with the first dose or during the first several weeks or months.
Danish: Hvis en justering er nødvendig ved skift til Velosulin, kan det vise sig ved første dosis eller inden for
English: When combination with long-acting insulin is necessary it is only possible to mix Velosulin with isophane or premixed insulin products.
Danish: Hvis det er nødvendigt at kombinere med langtidsvirkende insulin, er det kun muligt at blande Velosulin med isophan- eller blandingsinsuliner.
English: A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
Danish: Hvis pumpen ikke fungerer, eller infusionssættet afbrydes, kan det resultere i en hurtig stigning af glucoseniveauer.
English: The infusion set should be changed every 48 hours using aseptic technique when inserting the infusion set.
Danish: Infusionssættet bør skiftes efter 48 timer samtidig med, at der anvendes aseptisk teknik, når
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: This is a multipack and not for sale of individual vials
Danish: Dette er en multipakning og er ikke beregnet til salg enkeltvis
English: As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Danish: Som ved al anden insulinbehandling, kan der opstå reaktioner på injektionsstedet og medføre smerte, kløe, udslæt, hævelse og inflammation.
English: Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Danish: Lipodystrofi kan forekomme på injektionsstedet som en konsekvens af ikke at skifte injektionssted
English: Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia.
Danish: Utilstrækkelig dosering eller afbrydelse af behandlingen, specielt hos type 1-diabetikere, kan føre til
English: The pharmacokinetic profile has been studied in a small number (n=18) of diabetic children (aged 612 years) and adolescents (aged 13-17 years) using another fast-acting human insulin, (Actrapid).
Danish: Den farmakokinetiske profil på et andet hurtigtvirkende insulin (Actrapid) er undersøgt hos en lille gruppe (n = 18) børn (6 - 12 år) og unge (13-17 år) med diabetes.
English: You can keep it in the pump reservoir for 6 days at up to 37°C (close to the body).
Danish: Kan opbevares i pumpebeholderen ved temperaturer op til 37°C (tæt på kroppen) i 6 dage.
English: • Less exercise than usual.
Danish: • Hvis De dyrker mindre motion, end De plejer.
English: It may occur if the insulin dose is too high in relation to the insulin requirement.
Danish: Den kan forekomme, når insulindosis er for høj i forhold til insulinbehovet.
English: The blood glucose lowering effect of insulin 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: Insulins blodglucosesænkende effekt skyldes den faciliterede optagelse af glucose som følge af binding til insulinreceptorer på muskel- og fedtceller samt den simultane hæmning af
English: Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Danish: Human insulin nedbrydes af insulinprotease eller insulinnedbrydende enzymer og muligvis af disulfidisomeraseproteinet.
English: If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.
Danish: Graviditet og amning Hvis De er gravid, planlægger at blive gravid eller ammer: Spørg Deres læge til råds.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter hvor alvorlige de er.
English: Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
Danish: Før en udlandsrejse bør patienten kontakte sin læge, da tidsforskellen mellem landene kan betyde, at det er nødvendigt at tage insulin og indtage måltider på andre tidspunkter end patienten plejer.
English: Velosulin is a fast-acting insulin and may be used in combination with certain long-acting insulin products.
Danish: Velosulin er et hurtigtvirkende insulin, som kan bruges i kombination med visse langtidsvirkende insulinpræparater.
English: The vials that is not being used is to be stored in a refrigerator (2°C - 8°C).
Danish: De hætteglas, som ikke er i brug, skal opbevares i køleskab (2°C - 8°C).
English: Side effects reported uncommonly (in less than 1 patient in 100)
Danish: Ikke almindelige bivirkninger (hos mindre end 1 patient pr. 100)
English: • if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.
Danish: • Hvis De pludselig føler Dem syg, og De sveder, kaster op, har åndedrætsbesvær, hurtig hjertebanken, bliver svimmel eller føler, De er ved at besvime.
English: Always keep the vial in the outer carton when you're not using it in order to protect it from light.
Danish: Opbevar hætteglasset i den ydre karton, når det ikke er i brug, for at beskytte mod lys.
English: Velosulin must be protected from excessive heat and sunlight.
Danish: Velosulin må ikke udsættes for varme og direkte sollys.
English: This phosphate-buffered soluble insulin is intended for continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps.
Danish: Denne fosfatbufferopløsning af insulin er beregnet til kontinuert subkutan insulininfusion (CSII) til brug i eksterne infusionspumpesystemer til insulin.
English: If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin
Danish: Hvis De dyrker mere motion, end De plejer, eller ønsker at ændre Deres kost Hvis De bliver syg: Fortsæt Deres insulinbehandling Hvis De har planer om at rejse til udlandet: Tidsforskellen mellem landene kan påvirke
English: If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent)
Danish: Hvis svær hypoglykæmi ikke behandles, kan det medføre midlertidig eller varig hjerneskade
English: Follow the instructions and recommendations from your doctor regarding the use of Velosulin in a pump.
Danish: Følg nøje Deres læges instruktioner og råd vedrørende anvendelse i en insulinpumpe.
English: If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away.
Danish: Hvis De oplever nogle af ovennævnte signaler, mål Deres blodsukker og kontrollér om muligt Deres urin for ketonstoffer.
English: Don't take any insulin if you feel a hypo coming on.
Danish: Tag ikke insulin, hvis De kan mærke en begyndende hypoglykæmi.
English: See 4 What to do in an emergency for more about hypos.
Danish: Se 4 Forholdsregler i nødsituationer, for yderligere oplysninger om hypoglykæmi
English: Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials.
Danish: Det leveres i pakninger med 1 eller 5 hætteglas a 10 ml eller i en multipakning med 5 x (1 x 10 ml) hætteglas.
English: Velosulin should not be mixed with insulin zinc suspensions since the phosphate buffer may interact with the zinc in the suspension and alter the timing of action of the insulin in an unpredictable way.
Danish: Velosulin må ikke blandes med insulinzinksuspensioner, idet fosfatbufferen kan reagere med zink i suspensionen og ændre insulinets
English: They must not give you any food or drink as it could choke you.
Danish: De må ikke få noget at spise eller drikke,
English: Each vial has a protective, tamper-proof plastic cap.
Danish: Hætteglasset har en beskyttende, forseglet plastikhætte.
English: Draw air into the syringe, in the same amount as the dose of insulin you need Inject the air into the vial: push the needle through the rubber stopper and press the plunger Turn the vial and syringe upside down
Danish: Træk en mængde luft ind i sprøjten svarende til den mængde insulin, De vil injicere Injicér luften i hætteglasset: Stik nålen igennem gummiskiven og tryk stemplet i bund
English: Close blood glucose monitoring is therefore recommended.
Danish: Det anbefales derfor at monitorere blodglucose ofte.
English: You get a hypo if your blood sugar gets too low.
Danish: De får hypoglykæmi, hvis blodsukkeret bliver for lavt.