FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinically relevant differences in pharmacokinetic properties between young children, children, adolescents and adults.
Danish: Der var ingen klinisk relevante forskelle i de farmakokinetiske egenskaber mellem små børn, børn, unge og voksne.
English: Within-patient variation in absorption is lower for Levemir than for other basal insulin preparations.
Danish: Den enkelte patients absorptionsvariation er mindre for Levemir end for andre basale insulinpræparater.
English: An open-label randomised clinical trial in patients with type 2 diabetes not reaching target with oral antidiabetic medicinal products was conducted.
Danish: Der blev udført et åbent randomiseret klinisk studie med patienter med type 2-diabetes, som ikke nåede målet med orale antidiabetika.
English: • Always check that the push-button is fully depressed and the dose selector is set to 0.
Danish: • Kontrollér altid, at trykknappen er helt i bund, og at dosisvælgeren står på 0.
English: Concomitant antidiabetic treatment may need to be adjusted (dose and/or timing of oral antidiabetic medicinal products or concurrent short/rapid-acting insulin medicinal products).
Danish: Samtidig behandling med andre antidiabetika skal muligvis justeres (dosis og/eller tidspunkt for indgivelse af orale antidiabetika eller korttidsvirkende, hurtigtvirkende insulinpræparater).
English: This is a multipack of 10 pre-filled pens and not for sale as individual pre-filled pens
Danish: Dette er en multipakning a 10 fyldte penne og sælges ikke som individuelle fyldte penne
English: C Pull off the big outer needle cap and keep it for later.
Danish: C Fjern den store ydre nålehætte og gem den til senere.
English: The efficacy and safety of Levemir has been studied for up to 12 months, in three randomised controlled clinical trials in adolescents and children (n=1045 in total); the trials included in total 167 children aged 1-5 years.
Danish: Virkningen og sikkerheden af Levemir hos unge og børn (n=1045 totalt) er blevet undersøgt i op til 12 måneder i 3 randomiserede kontrollerede kliniske studier, hvor studierne inkluderede i alt 167 børn i alderen 1-5 år.
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 med dosistrin på 1 enhed.
English: Clinical trial data - Levemir add-on to liraglutide+metformin Study week Randomised
Danish: Data fra klinisk studie - Levemir i tillæg til liraglutid+metformin Studieuge Randomiseret
English: ► If you have such low blood sugar that makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor.
Danish: ► Hvis du får så lavt blodsukker, at du bliver bevidstløs, hvis du har haft behov for en glucagoninjektion, eller hvis du har haft gentagne tilfælde af lavt blodsukker, skal du tale med din læge.
English: When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Danish: Skift til anden type insulin, kan betyde, at de tidlige advarselssymptomer på hypoglykæmi kan ændres eller blive mindre udtalte end dem, der oplevedes med tidligere insulin.
English: To see precisely how much insulin is left use the dose counter: Turn the dose selector until the dose counter stops.
Danish: Brug dosistælleren til at se hvor meget insulin, der præcist er tilbage: Drej dosisvælgeren indtil dosistælleren stopper.
English: Subsequently, dosage should be adjusted individually.
Danish: Efterfølgende bør dosis justeres individuelt.
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 diabetes population.
Danish: Baseret på post-marketing erfaringer samt kliniske forsøg, indikerer bivirkningernes frekvens, type og alvor, observeret i den pædiatriske population ikke, at der er forskelle i forhold til den bredere erfaring i den generelle diabetes-population.
English: Insulin detemir is distributed more slowly to peripheral target tissues compared to NPH insulin.
Danish: Insulin detemir fordeles langsommere til perifere væv end NPH-insulin.
English: For patients who require twice daily dosing to optimise blood sugar control, the evening dose can be administered in the evening or at bedtime.
Danish: Hos patienter, der har behov for insulinbehandling to gange dagligt for at optimere blodsukkerkontrollen, kan aftendosis tages om aftenen eller ved sengetid.
English: These combined mechanisms of protraction provide a more reproducible absorption and action profile of insulin detemir compared to NPH insulin.
Danish: Disse mekanismer i kombination giver insulin detemir en mere reproducerbar absorption og aktionsprofil end NPH-insulin.
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 specifikke injektionsområde kan reducere risikoen for udvikling af disse reaktioner.
English: The overall rates of maternal adverse events were similar for Levemir and NPH insulin treatment groups; however, a numerically higher frequency of serious adverse events in the mothers (61 (40%) vs. 49 (31%)) and in the newborn children (36 (24%) vs. 32 (20%)) was seen for Levemir compared to NPH insulin.
Danish: De totale bivirkningsfrekvenser hos moderen var ens for grupperne behandlet med Levemir og NPHinsulin; der blev dog set en numerisk højere frekvens af alvorlige bivirkninger med Levemir sammenlignet med NPH-insulin hos mødrene (61 (40%) mod 49 (31%)) og hos de nyfødte børn (36 (24%) mod 32 (20%)).
English: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the dose and timing of administration may be necessary (see section 4.4).
Danish: Ved skift fra andre middellangt virkende eller langtidsvirkende insulinpræparater kan justering af dosis og indgivelsestidspunkt blive nødvendig (se pkt.
English: Proportions of patients achieving HbA1c <7% targets
Danish: Andele af patienter (%) der opnåede målet HbA1c <7%
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, sygeplejersken eller apotekspersonalet, hvis du bruger anden medicin, har brugt det for nylig eller kommer til at bruge det.
English: F. Turn the dose selector to select 2 units.
Danish: F. Drej dosisvælgeren for at vælge 2 enheder.
English: Subsequently, patients were allowed to up-titrate their insulin dose to no higher than the pre-randomisation dose.
Danish: Patienterne kunne efterfølgende selv optitrere deres insulindosis, dog ikke højere end til den dosis, de blev givet umiddelbart før randomisering.
English: Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions are uncommon when Levemir is used in basal-bolus regimen.
Danish: Allergiske reaktioner, potentielt allergiske reaktioner, urticaria, udslæt, eruptioner Allergiske reaktioner, potentielt allergiske reaktioner, urticaria, udslæt og eruptioner er ikke almindelige, når Levemir bruges i et basalbolus-regime.
English: • Screw the needle straight and tightly onto your InnoLet (picture A).
Danish: • Skru nålen lige og stramt på din InnoLet (figur A).
English: NPH insulin Insulin glargine
Danish: NPH insulin Insulin glargin
English: Common - Injection site reactions
Danish: Almindelig - Reaktioner på injektionsstedet
English: When changing basal insulin to Levemir, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia (see section 4.4).
Danish: Ved skift fra basalinsulin til Levemir skal dosisreduktion af basal- og bolusinsulin overvejes individuelt for at minimere risikoen for hypoglykæmi (se pkt.
English: Observed rates of minor hypoglycaemic episodes were similar and no severe hypoglycaemic episodes were observed in either group.
Danish: Der blev i begge grupper observeret lige mange milde hypoglykæmiske episoder og ingen tilfælde af alvorlige hypoglykæmiske episoder.
English: • Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
Danish: • ACE (angiotensin konverteringsenzym)-hæmmere (til behandling af visse hjertelidelser eller forhøjet blodtryk)
English: Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Danish: Levemir er indiceret til behandling af diabetes mellitus hos voksne, unge og børn i alderen fra 1 år og opefter.
English: Levemir is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region.
Danish: Levemir administreres subkutant ved injektion i abdominalvæggen, låret, overarmen, deltoideusregionen eller glutealregionen.
English: • your doctor has switched you from one type or brand of insulin to another, or
Danish: • lægen har besluttet, at du skal skifte til en anden insulintype eller et andet insulinmærke, eller
English: If not, change the needle and repeat the procedure no more than
Danish: Hvis dette ikke sker, skift nålen og gentag proceduren,
English: ► Always carry a spare Penfill cartridge in case the one in use is lost or damaged.
Danish: ► Medbring altid en ekstra Penfill cylinderampul i tilfælde af, at den der er i brug bliver væk eller beskadiges.
English: • Deliver the dose by pressing the push-button fully down (picture D).
Danish: • Injicér dosis ved at trykke trykknappen helt i bund (figur D).
English: Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed by capillary blood glucose less than 2.8 mmol/l or 3.1 mmol/l if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Danish: Undersøgelser af natlig hypoglykæmi hos patienter med type 1-diabetes viste en betydeligt lavere risiko for mindre natlig hypoglykæmi (i stand til at behandle sig selv og bekræftet ved kapillærblodglucose under 2,8 mmol/l eller 3,1 mmol/l hvis udtrykt som plasma glucose) end med NPH-insulin, hvorimod der ikke blev observeret en forskel ved type 2-diabetes.
English: Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in insulin dose.
Danish: Samtidige sygdomme i nyrer, lever eller påvirkning af binyrer, hypofyse eller thyreoidea kan nødvendiggøre ændringer i insulindosis.
English: glucose was needed.
Danish: glucose.
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 generelt hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, hjertebanken og blodtryksfald) er meget sjælden, men kan være potentielt livstruende.
English: Renal and hepatic impairment
Danish: Renale og hepatiske sygdomme
English: ► If you are allergic to insulin detemir or any of the other ingredients in this medicine, see section
Danish: ► Hvis du er overfølsom (allergisk) over for insulin detemir eller et af de øvrige indholdsstoffer i dette lægemiddel, se punkt 6, Pakningsstørrelser og yderligere oplysninger.
English: C. Take a new disposable needle and tear off the paper tab.
Danish: C. Tag en ny engangsnål og fjern papirforseglingen.
English: Can be stored in a refrigerator (2°C-8°C).
Danish: Kan opbevares i køleskab (2°C-8°C).
English: For storage conditions of the medicinal product, see section 6.3.
Danish: Opbevaringsbetingelser for lægemidlet, se pkt.
English: +8 units
Danish: +8 enheder
English: Low blood sugar may occur if you:
Danish: Lavt blodsukker kan opstå hvis du:
English: Treat your pen with care.
Danish: Din pen skal behandles med forsigtighed.
English: During use or when carried as a spare: Levemir Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: Levemir Penfill, som er taget i brug, eller som medbringes som reserve, må ikke opbevares i køleskab.
English: ► Keep the needle under your skin for at least 6 seconds.
Danish: ► Lad nålen forblive under huden i mindst 6 sekunder.
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: Baseret på post-marketing erfaringer samt kliniske forsøg, indikerer bivirkningernes frekvens, type og alvor, observeret hos ældre patienter, samt hos patienter med nedsat nyre- eller leverfunktion ikke, at der er forskelle i forhold til den bredere erfaring i den generelle patientgruppe.
English: There is no experience with the use of Levemir in children below the age of 1 year.
Danish: Der er ingen erfaring med anvendelse af Levemir til børn under 1 år.
English: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Danish: 3 ml injektionsvæske i cylinderampul (type 1 glas) med et stempel (brombutyl) og en gummiprop (brombutyl/polyisopren) i en fyldt engangspen til flergangsbrug fremstillet af polypropylen.
English: Studies in patients with type 2 diabetes treated with basal insulin in combination with oral antidiabetic medicinal products demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin glargine and associated with less weight gain, see Table 2 below.
Danish: Studier med patienter med type 2-diabetes, der blev behandlet med basalinsulin i kombination med orale antidiabetika viste, at glykæmisk kontrol (HbA1c) med Levemir er sammenlignelig med NPHinsulin og insulin glargin og er forbundet med mindre vægtforøgelse, se tabel 2 nedenstående.
English: The trials demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin degludec when given as basal-bolus therapy, using a noninferiority margin of 0.4%.
Danish: Studierne viste, at glykæmisk kontrol (HbA1c) med Levemir er sammenlignelig med den, der opnås med NPH-insulin og insulin degludec givet som basalbolus-behandling, ved brug af en non-inferioritetsmargin på 0,4%.
English: When Levemir is used in combination with tablets for diabetes and/or in combination with injectable anti-diabetic products, other than insulin, Levemir should be administered once a day.
Danish: Når Levemir anvendes sammen med tabletter mod diabetes og/eller i kombination med andre injicerbare lægemidler mod diabetes, ud over insulin, skal Levemir administreres én gang om dagen.
English: A 26-week, double blind, randomised clinical trial was conducted to investigate the efficacy and safety of adding liraglutide (1.8 mg) vs. placebo in patients with type 2 diabetes inadequately controlled on basal insulin with or without metformin.
Danish: Der blev udført et 26-ugers dobbeltblindet, randomiseret klinisk studie for at undersøge virkningen og sikkerheden af liraglutid (1,8 mg) sammenlignet med placebo hos patienter med type 2-diabetes, der var utilstrækkeligt kontrollerede på basalinsulin med eller uden metformin.
English: Patients transferred to Levemir from another type of insulin may require a change in dose from that used with their usual insulin medicinal products.
Danish: Patienter, der skifter til Levemir fra en anden type insulin, skal muligvis have ændret dosis i forhold til dosis af de sædvanlige insulinpræparater.
English: Dose proportionality in pharmacodynamic response (maximum effect, duration of action, total effect) is observed after subcutaneous administration.
Danish: Efter subkutan administration ses dosisproportionalitet i det farmakodynamiske respons (maksimal virkning, virkningsvarighed, totaleffekt).
English: If administered twice daily, steady state will occur after 2-3 dose administrations.
Danish: Ved 2 daglige doseringer opnås steady state efter 2-3 doser.
English: Keep away from the cooling element.
Danish: Ikke for tæt på køleelementet.
English: During use or when carried as a spare: Levemir InnoLet that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: Levemir InnoLet, som er taget i brug, eller medbragt som reserve, må ikke opbevares i køleskab.
English: The absolute bioavailability of insulin detemir when administered subcutaneous is approximately
Danish: Den absolutte biotilgængelighed af insulin detemir ved subkutan indgivelse er ca. 60%.
English: Dose proportionality in serum concentrations (maximum concentration, extent of absorption) is observed after subcutaneous administration in the therapeutic dose range.
Danish: Efter subkutan administration ses dosisproportionalitet i serumkoncentration (maksimumkoncentration, absorptionsomfang) inden for det terapeutiske dosisområde.
English: Levemir is for injection under the skin (subcutaneously).
Danish: Levemir er beregnet til injektion under huden (subkutant).
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Danish: • Binyrebarkhormoner (såsom 'cortison' til behandling af inflammation)
English: Levemir was non-inferior to NPH insulin as measured by HbA1c at gestational week (GW) 36, and the reduction in mean HbA1c through pregnancy was similar, see table 4.
Danish: Levemir var non-inferiørt sammenlignet med NPH-insulin målt på HbA1c i gestationsuge (GW) 36, og med sammenlignelig reduktion i middel HbA1c gennem graviditeten, se tabel 4.
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 nedsætte risikoen for at trække blod ind i nålen eller i insulinbeholderen.
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 reduces the risk of developing such skin changes.
Danish: Hvis man injicerer et nyt sted hver gang, nedsætter det risikoen for at udvikle ændringer i huden.
English: Each ml contains 100 units of insulin detemir.
Danish: 1 ml indeholder 100 enheder insulin detemir.
English: Always check the flow before you inject.
Danish: Kontrollér altid gennemløbet før du injicerer.
English: Levemir Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: Levemir Penfill er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: Do not use the pen without proper training from your doctor or nurse.
Danish: Tag ikke pennen i brug, før du er blevet instrueret af din læge eller sygeplejerske.
English: A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient's requirement are administered:
Danish: Imidlertid kan hypoglykæmi udvikle sig over følgende stadier, hvis der indgives for høje doser i forhold til patientens behov:
English: Levemir is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes).
Danish: Levemir anvendes til at sænke det høje blodsukkerniveau hos voksne, unge og børn, der er fyldt 1 år, med sukkersyge (diabetes mellitus).
English: Small amounts of air may collect in the needle and cartridge during normal use.
Danish: Der kan samle sig små luftbobler i nål og insulinbeholder under normal brug.
English: Talk to your doctor, nurse or pharmacist for advice.
Danish: Tal med din læge, sygeplejerske eller spørg på apoteket for at få råd.
English: The insulin scale shows you approximately how much insulin is left in your pen.
Danish: Insulinskalaen viser hvor meget insulin, der omtrent er tilbage i din pen.
English: leakage of insulin, blocked needles and inaccurate dosing.
Danish: udsivning af insulin, tilstoppede nåle og upræcis dosering.
English: There was no clinically relevant difference in pharmacokinetics of Levemir between patients with renal or hepatic impairment and healthy subjects.
Danish: Der er ingen klinisk relevant forskel i de farmakokinetiske egenskaber af Levemir mellem patienter med nedsat renal- eller hepatisk funktion og raske personer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (FlexTouch)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET TIL MULTIPAKNING (FlexTouch)
English: If you do not check the flow, you may get too little insulin or no insulin at all.
Danish: Hvis ikke du kontrollerer gennemløbet, kan du risikere at få for lidt insulin eller slet ingen insulin.
English: If one SMPG measurement 3.1-4.0 mmol/l (56-72 mg/dl)
Danish: I tilfælde af SMPG måling 3,1-4,0 mmol/l (56-72 mg/dl)
English: Levemir is not to be used in insulin infusion pumps.
Danish: Levemir er ikke beregnet til brug i insulininfusionspumper.
English: Needles, cartridges and pre-filled pens must not be shared.
Danish: Nåle, cylinderampuller og fyldte penne må ikke deles med andre.
English: Glycaemic control (HbA1c) with Levemir was comparable to NPH insulin, with a lower risk of nocturnal hypoglycaemia and no associated weight gain.
Danish: Den glykæmiske kontrol (HbA1c) med Levemir var sammenlignelig med NPH-insulin med mindre risiko for natlig hypoglykæmi og ikke forbundet med vægtstigning.
English: There are no clinically relevant differences between genders in pharmacokinetic properties of Levemir.
Danish: Køn Der er ingen klinisk relevant forskel mellem køn i de farmakokinetiske egenskaber af Levemir.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9).
Danish: Når patientens blodglucose er stabiliseret, skal dosisjustering overvejes (se pkt.
English: Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.
Danish: Smertefuld neuropati (smerter der skyldes beskadigede nerver): Hvis dit blodsukkerniveau forbedres meget hurtigt, kan du få nerverelaterede smerter.
English: • Caregivers must be very careful when handling used needles -to reduce the risk of needle injury and cross-infection.
Danish: • Omsorgspersoner skal håndtere brugte nåle meget forsigtigt - for at reducere risikoen for stikuheld og krydsinfektion.
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: Symptomer på lavt blodsukker: Koldsved, kold bleg hud, hovedpine, hurtig hjerterytme (puls), kvalme, usædvanlig stor sultfornemmelse, forbigående synsforstyrrelser, døsighed, unormal træthed og svaghed, nervøsitet eller rysten, indre uro, forvirring og koncentrationsbesvær.
English: Levemir can be used with meal-related rapid acting insulin medicines.
Danish: Levemir kan bruges sammen med hurtigtvirkende insulinpræparater taget i forbindelse med måltider.
English: MARKETING AUTHORISATION NUMBER EU/1/04/278/014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/278/014
English: Levemir can be used in adolescents and children from the age of 1 year (see section 5.1).
Danish: Levemir kan anvendes til unge og børn i alderen fra 1 år og opefter (se pkt.