FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge.
Danish: Brug den ikke, hvis den er beskadiget, eller hvis gummistemplet er blevet trukket ud over det hvide bånd i bunden af cylinderampullen.
English: When a GLP-1 receptor agonist is added to Levemir, it is recommended to reduce the dose of Levemir by 20% to minimise the risk of hypoglycaemia.
Danish: Når en GLP-1 receptor-agonist gives i tillæg til Levemir, anbefales det at reducere dosis af Levemir med 20% for at mindske risikoen for hypoglykæmi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktionstoksicitet og udvikling.
English: ► If you are treated with Levemir Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Danish: ► Hvis du behandles med Levemir Penfill og en anden insulin Penfill cylinderampul, skal du anvende to insulindispenseringssystemer, ét dispenseringssystem til hver insulintype.
English: Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Danish: Octreotid og lanreotid (til behandling af akromegali, en sjælden hormonel sygdom, der sædvanligvis forekommer hos midaldrende voksne og skyldes, at hypofysen danner for meget væksthormon) kan enten øge eller mindske dit blodsukkerniveau.
English: Levemir must be protected from excessive heat and light.
Danish: Levemir må ikke udsættes for overdreven varme og direkte lys.
English: • Do not try to repair your pen or pull it apart.
Danish: • Forsøg ikke at reparere din pen eller at skille den ad.
English: However, when used in combination with oral antidiabetic medicinal products, three clinical studies have shown a frequency of common (2.2% of allergic reactions and potentially allergic reactions have been observed).
Danish: Dog har tre kliniske studier vist, at hyppigheden er almindelig, når Levemir bruges i kombination med orale antidiabetika (der er observeret 2,2% allergiske reaktioner og potentielt allergiske reaktioner).
English: The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Danish: Virkningsvarigheden vil variere i forhold til dosis, injektionssted, blodgennemstrømning, temperatur og fysisk aktivitet.
English: Always ensure you use the correct pen before you inject your insulin.
Danish: Du skal altid sikre dig, at du bruger den korrekte pen, før du injicerer dit insulin.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP
English: The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units.
Danish: Styrken af insulinanaloger, inklusiv insulin detemir, udtrykkes i enheder, hvorimod styrken af humaninsulin udtrykkes i internationale enheder.
English: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Danish: Hvis du har nyre- eller leverskade, eller hvis du er over 65 år, skal du kontrollere dit blodsukker mere regelmæssigt og diskutere ændringer af din insulindosis med din læge.
English: Maximum serum concentration is reached between 6 and 8 hours after administration.
Danish: Maksimal serumkoncentration opnås 6-8 timer efter injektion.
English: Mean FPG at GW 36 (mmol/l)
Danish: Middel-FPG ved GW 36 (mmol/l)
English: Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essentially ‘sodium-free'.
Danish: Levemir indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. Levemir er stort set natriumfrit.
English: On rare occasions, injection site reactions may require discontinuation of Levemir.
Danish: I sjældne tilfælde kan reaktioner på injektionsstedet nødvendiggøre ophør af behandling med Levemir.
English: Use the dose selector on your Levemir FlexTouch pen to select your dose.
Danish: Brug dosisvælgeren på din Levemir FlexTouch pen for at indstille din dosis.
English: An apparent volume of distribution for Levemir (approximately 0.1 l/kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Danish: Fordelingsvolumen af Levemir (ca. 0,1 l/kg) indikerer, at der er en høj fraktion af insulin detemir i blodbanen.
English: The insulin dose was reduced by 20% for patients with baseline HbA1c ≤8.0% in order to minimise the risk of hypoglycaemia.
Danish: Insulindosis blev reduceret med 20% hos patienter med baseline-HbA1C ≤8,0% for at mindske risikoen for hypoglykæmi.
English: Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions.
Danish: Fortsat skift af injektionsstedet inden for et givet område kan reducere eller forebygge disse reaktioner.
English: When Levemir is used in combination with oral antidiabetic medicinal products or when added to GLP-1 receptor agonists it is recommended to use Levemir once daily, initially at a dose of 0.10.2 units/kg or of 10 units in adult patients.
Danish: Når Levemir anvendes i kombination med orale antidiabetika eller som tillæg til GLP-1-receptoragonister, anbefales det at bruge Levemir én gang dagligt, initialt i doser på 0,1-0,2 enheder/kg eller 10 enheder hos voksne patienter.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Danish: Når pennen er tom kasseres den uden nålen påsat, som din læge, sygeplejerske, apoteket eller lokale myndigheder har anbefalet.
English: Important information about some of the ingredients in Levemir
Danish: Vigtig information om nogle af indholdsstofferne i Levemir
English: Less weight gain (SD score, weight corrected for gender and age) was observed with Levemir than with NPH insulin.
Danish: Der blev observeret mindre vægtstigning (SD-score, vægt korrigeret for køn og alder) med Levemir end med NPH-insulin.
English: HbA1c ≤6% targets at both GW 24 and GW
Danish: ≤6% ved både GW 24
English: The time action profile of Levemir is statistically significantly less variable and therefore more predictable than for NPH (Neutral Protamine Hagedorn) insulin as seen from the within-subject Coefficients of Variation (CV) for the total and maximum pharmacodynamic effect in Table 1.
Danish: Tidsaktionsprofilen for Levemir er statistisk set signifikant mindre variabel og derfor mere forudsigelig end for NPH-insulin (Neutral Protamin Hagedorn) ud fra den individuelle variationskoefficient (CV) for den samlede og maksimale farmakodynamiske virkning i tabel 1.
English: ► If the insulin does not appear water clear, colourless and aqueous.
Danish: ► Hvis insulinet ikke fremstår vandklart, farveløst og vandigt.
English: Animal data do not indicate reproductive toxicity (see section 5.3).
Danish: Data fra dyr indikerer ikke reproduktionstoksicitet (se pkt.
English: • your doctor has added another medicine for the treatment of diabetes, in addition to your
Danish: • lægen tilføjer et andet lægemiddel til behandling af din diabetes, i tillæg til din behandling med
English: Efficacy and safety data for adolescent patients with type 2 diabetes mellitus have been extrapolated from data for children, adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Danish: Data omkring virkning og sikkerhed hos unge patienter med type 2-diabetes mellitus er blevet ekstrapoleret fra data for børn, unge og voksne patienter med type 1-diabetes mellitus samt voksne patienter med type 2-diabetes mellitus.
English: Levemir has a long and steady blood-sugar-lowering action within 3 to 4 hours after injection.
Danish: Levemir har en lang og stabil virkning på sænkningen af blodsukkeret med virkning 3 til 4 timer efter injektion.
English: Levemir can be used alone as the basal insulin or in combination with bolus insulin.
Danish: Levemir kan bruges som basalinsulin alene eller i kombination med bolusinsulin.
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 skal orienteres herom.
English: Substances added to Levemir may cause degradation of insulin detemir, e.g. if the medicinal product contains thiols or sulphites.
Danish: Lægemidler, som tilsættes til Levemir, kan medføre nedbrydning af insulin detemir, f.eks. hvis lægemidlet indeholder thioler eller sulfitter.
English: If any of these applies, do not use Levemir.
Danish: Hvis noget af ovenstående gør sig gældende, må du ikke bruge Levemir.
English: Post-marketing data from an additional 250 outcomes from pregnant women exposed to Levemir indicate no adverse effects of insulin detemir on pregnancy and no malformative or foetal/neonatal toxicity of insulin detemir.
Danish: Udfaldet af post marketing erfaringer fra yderligere 250 gravide kvinder, der fik Levemir, indikerer ingen skadelige virkninger af insulin detemir på graviditet og ingen misdannelser eller føtal/neonatal toksicitet.
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: If the needle is blocked, you will not inject any insulin.
Danish: Hvis nålen er tilstoppet, vil du ikke injicere noget insulin.
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 skrue en ny nål på og kontrollere insulingennemløbet, før du injicerer.
English: As the pharmacokinetics of Levemir has not been studied extensively in these populations, it is advised to monitor plasma glucose closely in these populations.
Danish: Da de farmakokinetiske egenskaber af Levemir ikke er blevet grundigt undersøgt hos disse patientgrupper, anbefales omhyggelig monitorering af plasmaglucose.
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 et andet mærke af insulin må kun gøres under tæt lægekontrol.
English: Date of last renewal: 16 April 2009
Danish: Dato for første markedsføringstilladelse: 1. juni 2004 Dato for seneste opdatering: 16. april 2009
English: Lower day-to-day variability in FPG was demonstrated during treatment with Levemir compared to NPH in long-term clinical trials.
Danish: Lavere dag-til-dag variation i FPG (fastende plasmaglucose) blev påvist under behandlingen med Levemir i forhold til NPH i langvarige kliniske forsøg.
English: Otherwise the liquid may leak out which can cause inaccurate dosing.
Danish: Ellers kan væsken løbe ud, hvilket kan forårsage ukorrekt dosering.
English: Levemir + liraglutide + metformin n=160
Danish: Levemir + liraglutid + metformin n = 160
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Danish: • Alvorlig hypoglykæmi, hvor patienten er blevet bevidstløs, kan behandles med glukagon (0,5 til 1 mg) indgivet intramuskulært eller subkutant af en instrueret person, eller med glucose indgivet intravenøst af sundhedspersonale.
English: • Always carry an extra pen and new needles with you, in case of loss or damaged.
Danish: • Medbring altid en ekstra pen og nye nåle som reserve i tilfælde af, at du mister eller beskadiger den.
English: Injection site reactions are seen more frequently during treatment with Levemir than with human insulin products.
Danish: Reaktioner på injektionsstedet ses oftere under behandling med Levemir end med præparater indeholdende humaninsulin.
English: Mean change in HbA1c from baseline (%)
Danish: Middel ændring af HbA1c fra baseline (%)
English: What to do if you experience low blood sugar: ► If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice).
Danish: Hvad du skal gøre, hvis du føler, at du får lavt blodsukker: ► Hvis du føler, at du får lavt blodsukker, skal du spise glucosetabletter eller et andet produkt med et højt sukkerindhold (f.eks. slik, kiks, frugtjuice).
English: During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Danish: Under brug eller hvis medbragt som reserve: Lægemidlet må opbevares i højst 6 uger.
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 så eventuelle luftbobler kan komme op til toppen.
English: Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Danish: Synsproblemer: Når du påbegynder insulinbehandling, kan du opleve synsforstyrrelse, men forstyrrelsen er normalt midlertidig.
English: When administered twice daily, steady state serum concentrations are reached after 2-3 dose administrations.
Danish: Ved to daglige doseringer opnås steady state-serumkoncentration efter 2-3 doser.
English: 1 unit insulin detemir corresponds to 1 international unit of human insulin.
Danish: 1 enhed insulin detemir svarer til 1 international enhed af humaninsulin.
English: Make sure not to turn the dial or correct the dose when the needle is inserted in the skin.
Danish: Sørg for, at du ikke drejer dosisvælgeren eller korrigerer dosis, når nålen befinder sig under huden.
English: Mean HbA1c (%) at GW 36
Danish: Middel-HbA1c (%) ved GW 36
English: Insert the needle into your skin as your doctor or nurse has shown you.
Danish: Stik nålen ind i huden som din læge eller sygeplejerske har vist dig.
English: Results support the use of Levemir in adolescent patients with type 2 diabetes mellitus.
Danish: Resultaterne understøtter anvendelse af Levemir hos unge patienter med type 2-diabetes mellitus.
English: • Dial the number of units required by turning the dose selector clockwise (picture C).
Danish: • Indstil det ønskede antal enheder ved at dreje dosisvælgeren med uret (figur C).
English: Read carefully the instructions for use included in this package leaflet.
Danish: Læs omhyggeligt Brugervejledningen, der er inkluderet i denne indlægsseddel.
English: What to do if you experience high blood sugar: ► If you get any of above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
Danish: Hvad du skal gøre, hvis du føler, at 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: Levemir is a modern insulin (insulin analogue) with a long-acting effect.
Danish: Levemir er et moderne insulin (insulinanalog) med en langtidsvirkende effekt.
English: In trials investigating the use of oral antidiabetic medicinal products, combination therapy with Levemir resulted in a 61-65% lower risk of minor nocturnal hypoglycaemia compared to NPH insulin.
Danish: I studier, der har undersøgt anvendelsen af orale antidiabetika, resulterede kombinationsterapi med Levemir i en 61-65% lavere risiko for minor natlig hypoglykæmi sammenlignet med NPH-insulin.
English: • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.
Danish: • Hvis du pludseligt føler dig utilpas, og du begynder at svede, kaster op, får åndedrætsbesvær, får hurtig hjerterytme (puls) eller bliver svimmel.
English: This could be the result of an insulin leakage.
Danish: Dette kan være forårsaget af en udsivning af insulin.
English: In these patients, addition of liraglutide resulted in a greater decline in HbA1c compared to addition of placebo (to 6.93% vs. to 8.24%), a greater decline in fasting plasma glucose (to 7.20 mmol/l vs. to 8.13 mmol/l), and a greater decline in body weight (-3.47 kg vs. -0.43 kg).
Danish: Hos disse patienter resulterede tillæg af liraglutid i et større fald i HbA1c sammenlignet med tillæg af placebo (til 6,93% sammenlignet med 8,24%), et større fald i faste plamaglucose (til 7,20 mmol/l sammenlignet med 8,13 mmol/l), og et større fald i legemsvægt (-3,47 kg sammenlignet med -0,43 kg).
English: What you need to know before you use Levemir
Danish: Det skal du vide, før du begynder at bruge Levemir
English: D. Screw the needle straight onto the pen.
Danish: D. Skru nålen lige på pennen.
English: Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Danish: Efter at bevidstheden er genvundet, anbefales det at give patienten kulhydrater oralt for at forhindre tilbagefald.
English: In the trial comparing Levemir vs. insulin degludec, the rate of hyperglycaemic episodes with ketosis was significantly higher for Levemir, 1.09 and 0.68 episodes per patient-year of exposure, respectively.
Danish: I studiet, der sammenlignede Levemir med insulin degludec, var frekvensen af hyperglykæmiske episoder med ketose signifikant højere for Levemir, respektivt 1,09 og 0,68 episoder per patient-eksponeringsår.
English: Levemir was the basal insulin product for 33% (n=147) of the patients (97.3% using metformin).
Danish: Levemir blev givet som basalinsulin til 33% (n=147) af patienterne (heraf tog 97,3% metformin).
English: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site.
Danish: Lipodystrofi (inklusiv lipohypertrofi, lipoatrofi) kan forekomme på injektionsstedet.
English: The blood glucose lowering effect of Levemir 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 Levemir har til at sænke blodglucose, skyldes den faciliterede optagelse af glucose, efter at insulin er bundet til receptorer på muskel- og fedtceller, og den samtidige inhibering af glucosefrigivelse fra leveren.
English: Activity profiles of Levemir in patients with type 1 diabetes
Danish: Levemir aktivitetsprofiler hos patienter med type 1-diabetes.
English: Adverse reactions observed in patients using Levemir are mainly due to the pharmacologic effect of insulin.
Danish: Hos patienter, som anvender Levemir, er de observerede bivirkninger hovedsageligt forårsaget af insulins farmakologiske effekt.
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, er det viste tal, det antal enheder der er tilbage i din pen.
English: • Always keep your pen with you.
Danish: • Medbring altid din pen
English: ► In insulin infusion pumps.
Danish: ► I insulin infusionspumper.
English: NPH insulin CV (%)
Danish: NPHinsulin CV (%)
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 relateret til sukkersyge, som kan føre til tab af synet): Hvis du har diabetisk retinopati, og dine blodsukkerniveauer forbedres meget hurtigt, kan sygdommen forværres.
English: Before using Levemir
Danish: Før du bruger Levemir
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and Levemir when administering a single dose of Levemir 0.5 units/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Danish: Der blev ikke observeret farmakokinetiske eller farmakodynamiske interaktioner mellem liraglutid og Levemir, når en enkelt dosis Levemir 0,5 enheder/kg blev givet sammen med liraglutid 1,8 mg ved steady state hos patienter med type 2-diabetes.
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Danish: • Let hypoglykæmi som behandles med oral indtagelse af glucose eller sukkerholdige produkter.
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, da tidsforskellen mellem landene kan påvirke insulinbehovet og injektionstidspunktet.
English: Levemir twice daily
Danish: Levemir to gange dagligt
English: After an increase in insulin antibodies during the first year, the insulin antibodies decreased during the second year to a level slightly higher than pre-trial level.
Danish: Efter en stigning i mængden af insulinantistoffer i løbet af det første år faldt koncentrationen af insulinantistoffer i løbet af det andet behandlingsår til et niveau, der var let forhøjet i forhold til niveauet før studiet.
English: • Put the pen cap back on your InnoLet to protect the insulin from light.
Danish: • Sæt penhætten tilbage på din InnoLet, for at beskytte insulinet mod lys.
English: In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia.
Danish: Hos børn skal insulindosis (specielt ved basalbolus-regimer) omhyggeligt tilpasses indtagelse af mad og fysisk aktivitet for at minimere risikoen for hypoglykæmi.
English: Do not count the pen clicks.
Danish: Tæl ikke antal klik med pennen.
English: Keep the push-button fully depressed until the needle has been withdrawn from the skin.
Danish: Hold trykknappen helt inde indtil nålen igen er trukket ud af huden.
English: The prolonged action of Levemir is mediated by the strong self-association of insulin detemir molecules at the injection site and albumin binding via the fatty acid side-chain.
Danish: Den langtidsvirkende aktion af Levemir medieres af en kraftig association af molekylerne i insulin detemir på injektionsstedet og albuminbinding via fedtsyresidekæden.
English: (5%) for Levemir and 11 (7%) for NPH with 3 (4%) major malformations for Levemir and 3 (2%) for NPH.
Danish: Frekvensen af medfødte misdannelser var 4 (5%) for Levemir og 11 (7%) for NPH med 3 (4%) alvorlige misdannelser for Levemir og 3 (2%) for NPH.
English: No metabolic effects of ingested insulin detemir on the breast-fed newborn/infant are anticipated since insulin detemir, as a peptide, is digested into amino acids in the human gastrointestinal tract.
Danish: Der forventes ingen metabolisk effekt af insulin detemir indtaget af det ammede nyfødte/spædbarn, da insulin detemir, som et peptid, fordøjes til aminosyrer i den humane mave-tarmkanal.
English: These usually disappear after a few weeks of taking your insulin.
Danish: Disse forsvinder normalt efter få ugers insulinbehandling.
English: You can clean your InnoLet by wiping it with a medicinal swab.
Danish: Du kan rengøre din InnoLet ved at tørre den med en medicinsk serviet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E)