FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
Danish: Behandling af diabetes mellitus hos voksne, unge og børn fra 1-års-alderen.
English: The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Tresiba should be provided with a patient brochure and be trained on the correct use of the pre-filled pen before prescribing or dispensing Tresiba.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sunhedspersonale er informeret om at alle patienter som får udskrevet Tresiba skal modtage en patient-brochure og trænes i korrekt brug af den fyldte pen før udskrivning eller dispensering af Tresiba.
English: Glucose Infusion Rate (mg/(kg*min))
Danish: Glucoseinfusionsrate (mg/(kg*min))
English: • If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Danish: • Hvis du vil ændre din sædvanlige kost, skal du først tale med lægen, sundhedspersonalet eller apotekspersonalet, da en kostændring kan ændre dit insulinbehov.
English: Proportions of patients with hypoglycaemia (percent of patients) Severe
Danish: Andel af patienter med hypoglykæmi (procent af patienter) Alvorlig
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 der udvises omhu, så insulindosis (specielt ved basal-bolus-behandlingsregimer) stemmer overens med fødeindtagelse og fysisk aktivitet for at mindske risikoen for hypoglykæmi.
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Danish: Intensivering af insulinbehandling med en hurtig forbedret glykæmisk kontrol kan være forbundet med en forbigående forværring af diabetisk retinopati, hvorimod forbedret glykæmisk kontrol gennem længere tid nedsætter risikoen for forværring af diabetisk retinopati.
English: The total glucose-lowering effect is comparable for Tresiba 100 units/mL and 200 units/mL after administration of the same doses of the two products.
Danish: Den samlede glucosesænkende effekt er sammenlignelig for Tresiba 100 enheder/ml og 200 enheder/ml efter administration af de samme doser af de to præparater.
English: The potency of insulin analogues, including insulin degludec, is expressed in units.
Danish: Styrken af insulinanaloger, herunder insulin degludec, udtrykkes i enheder.
English: • Always use a new needle for each injection.
Danish: • Anvend altid en ny nål ved hver injektion.
English: Tresiba in a pre-filled pen is available in two strengths.
Danish: Tresiba i fyldt pen er tilgængelig i to styrker.
English: • Test your blood sugar level.
Danish: • Mål dit blodsukkerniveau.
English: Do not count the pen clicks to select the dose; - Check how many units were selected before injecting the insulin; - The dose counter shows the number of units regardless of strength and no dose conversion should be done; - Reporting of medication errors or any side effects.
Danish: Tæl ikke pennens klik for at vælge dosis; - Tjek hvor mange enheder der er valgt, før insulinet injiceres; - Dosistælleren viser antallet af enheder uanset styrke og ingen dosis ændring skal laves; - Rapportér fejlmedicinering og alle bivirkninger.
English: Before you use Tresiba for the first time, your doctor or nurse will show you how to use the pre-filled pen.
Danish: Før du tager Tresiba første gang, viser lægen eller sygeplejersken dig, hvordan du skal bruge den fyldte pen.
English: One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir.
Danish: Én (1) enhed insulin degludec svarer til 1 international enhed humant insulin, 1 enhed insulin glargin (100 enheder/ml) eller 1 enhed insulin detemir.
English: To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen.
Danish: For at undgå doseringsfejl og potentiel overdosering, skal patienter og sundhedspersonale aldrig anvende en sprøjte til at udtage lægemidlet fra cylinderampullen i den fyldte pen.
English: In direct comparison, requirements for bioequivalence are met for Tresiba 100 units/mL and Tresiba 200 units/mL (based on AUCIDeg,τ,SS and Cmax,IDeg,SS).
Danish: Ved direkte sammenligning opfyldes kravene for bioækvivalens for Tresiba 100 enheder/ml og Tresiba 200 enheder/ml (baseret på AUCIDeg,τ,SS og Cmax, IDeg,SS).
English: See advice in ‘Too low blood sugar' below.
Danish: Se information i ”For lavt blodsukker” nedenfor.
English: • Eye disorder - fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder.
Danish: • Øjensygdom - hurtig forbedret blodsukkerkontrol kan være forbundet med en forværring af diabetisk øjensygdom, der er forbigående.
English: • Please also read the manual that comes with your insulin delivery system.
Danish: • Læs også brugsanvisningen til insulindispenseringssystemet.
English: Pregnancy There is no clinical experience with the use of Tresiba in pregnant women.
Danish: Graviditet Der foreligger ingen kliniske erfaringer med anvendelsen af Tresiba til gravide kvinder.
English: Tresiba is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall.
Danish: Tresiba administreres subkutant ved injektion i låret, overarmen eller abdominalvæggen.
English: • Pull the needle and pen straight up from your skin.
Danish: • Træk nålen og pennen lige op fra huden.
English: • in insulin infusion pumps.
Danish: • i insulininfusionspumper.
English: Figure 1 Glucose infusion rate profile, smoothed, steady state - Mean profile 0-24 hours - IDeg 100 units/mL 0.6 units/kg - Trial 1987
Danish: Figur 1 Glucoseinfusionsrateprofiler, udjævnet, steady state - Middelprofil 0-24 timerIDeg 100 enheder/ml 0,6 enheder/kg - Studie 1987
English: Patients were randomised to either Tresiba or insulin glargine (100 units/mL) followed by cross-over.
Danish: Patienterne blev randomiseret til enten Tresiba eller insulin glargin (100 enheder/ml) efterfulgt af cross-over.
English: Do not count the pen clicks.
Danish: Tæl ikke antal klik.
English: This is because the dosing or timing of your insulin injections, food or exercise may need to be changed.
Danish: Det kan nemlig være nødvendigt at ændre doseringen eller tidspunkterne for dine insulininjektioner, måltider eller motion.
English: If your blood sugar level falls too much, you may become unconscious.
Danish: Hvis dit blodsukker falder for meget, vil du besvime.
English: Any waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel, samt affald heraf, skal bortskaffes i henhold til de lokale retningslinjer.
English: There is no experience with the use of Tresiba in children below the age of 1 year.
Danish: Der er ingen erfaring med brug af Tresiba hos børn under 1 år.
English: Tresiba was superior compared to insulin glargine in terms of a lower rate of severe hypoglycaemic events and a lower proportion of subjects experiencing severe hypoglycaemia.
Danish: Tresiba var bedre i sammenligning med insulin glargin, hvad angår en lavere forekomst af alvorlige hypoglykæmiske tilfælde og en lavere andel af individer, der oplever alvorlig hypoglykæmi.
English: General effects from diabetes treatment • Too low blood sugar (hypoglycaemia)
Danish: Generelle følger af behandling af sukkersyge • For lavt blodsukker (hypoglykæmi)
English: If blood appears at the injection site, press lightly with a cotton swab.
Danish: Hvis der kommer blod til syne ved injektionsstedet, trykker du let på det med en vatpind.
English: The educational pack is aimed at increasing awareness about the introduction of a new strength of insulin in the European market and describing key differences in the design of the packages and the pre-filled pen devices to minimise the risk of medication errors and mix up between the two different strengths of Tresiba.
Danish: Undervisningspakken er beregnet til at øge opmærksomheden omkring introduktionen af en ny styrke insulin på det europæiske marked, og beskriver hovedforskellene i designet af pakningerne og den fyldte penenhed, for at minimere risikoen af fejlmedicinering og fejltagelser mellem de to forskellige styrker af Tresiba såvel som andre insulinpræparater.
English: Hold the dose button down until the dose counter returns to 0 after the injection.
Danish: Hold dosisknappen nede, indtil dosistælleren vender tilbage til 0 efter injektionen.
English: Tresiba is a basal insulin that forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect of Tresiba (see figure 1).
Danish: Tresiba er et basalinsulin, som efter subkutan injektion danner opløselige multihexamerer, hvorved der opstår et depot, hvorfra insulin degludec kontinuerligt og langsomt absorberes i kredsløbet og fører til den flade og stabile glucosesænkende virkning af Tresiba (se figur 1).
English: See your delivery system manual for further instructions.
Danish: Se brugsanvisningen til dispenseringssystemet for yderligere oplysninger.
English: The rate of hyperglycaemic episodes with ketosis was significantly lower for Tresiba versus insulin detemir, 0.68 and 1.09, respectively.
Danish: Hyppigheden af hyperglykæmiske tilfælde med ketose var signifikant lavere for Tresiba versus insulin detemir, henholdsvis 0,68 og 1,09.
English: • Pull off the outer needle cap and keep it for later.
Danish: • Fjern den ydre nålehætte og gem den til senere.
English: Get help from a person with good eyesight who is trained to use the pen.
Danish: Få hjælp af en person med godt syn, som har fået undervisning i at bruge pennen.
English: Solution for injection (FlexTouch)
Danish: Injektionsvæske, opløsning (FlexTouch)
English: After first opening: Use within 8 weeks
Danish: Under brug: Anvendes inden 8 uger
English: Furthermore, two 64-week controlled, double-blind, randomised, cross-over, treat-to-target trials were conducted in patients with at least one risk factor for hypoglycaemia and with type 1 diabetes mellitus (501 patients) or type 2 diabetes mellitus (721 patients).
Danish: Derudover blev to 64-ugers kontrollerede, dobbeltblindede, randomiserede, cross-over, treat-to-targetstudier udført hos patienter med mindst én risikofaktor for hypoglykæmi og med type 1 diabetes mellitus (501 patienter) eller type 2 diabetes mellitus (721 patienter).
English: In type 1 diabetes mellitus, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Danish: Ved type 1-diabetes mellitus fører ubehandlede hyperglykæmiske tilfælde i sidste instans til diabetisk ketoacidose, som kan være dødelig.
English: Tell them what could happen if your blood sugar gets too low, including the risk of passing out.
Danish: Fortæl dem, hvad der kan ske, herunder risikoen for, at du besvimer, hvis dit blodsukker bliver for lavt.
English: Insulin degludec monomers gradually separate from the multi-hexamers thus resulting in a slow and continuous delivery of insulin degludec into the circulation.
Danish: Insulin degludec-monomerer separeres gradvist fra multihexamererne, hvilket medfører en langsom og kontinuerlig frigivelse af insulin degludec til kredsløbet.
English: If your blood sugar is too low or too high, your ability to concentrate or react might be affected.
Danish: Hvis dit blodsukker er for lavt eller for højt, kan det påvirke din koncentrations- eller reaktionsevne.
English: This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Danish: Dette reducerer risikoen for urenheder, infektion, insulinlækage, tilstoppede nåle og upræcis dosering.
English: There is no difference in the pharmacokinetics of insulin degludec between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Danish: Der er ingen forskel i insulin degludecs farmakokinetiske egenskaber mellem ældre og yngre voksne patienter, mellem forskellige racer eller mellem raske forsøgspersoner og patienter med nedsat nyreeller leverfunktion.
English: Detailed instructions accompanying the pre-filled pen must be followed.
Danish: Den detaljerede vejledning, som er vedlagt den fyldte pen, skal følges.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes og hjertesygdom eller tidligere slagtilfælde, som er blevet behandlet med pioglitazon og insulin, oplevede hjertesvigt.
English: The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Danish: Den evne, insulin har til at sænke blodglucosen, 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: The trial was designed as a non-inferiority trial to exclude a pre-specified risk margin of 1.3 for the hazard ratio (HR) of MACE comparing Tresiba to insulin glargine.
Danish: Studiet var designet som et non-inferiort studie for at ekskludere en præspecificeret risikomargin på 1,3 for MACE hazardratioen (HR), hvor Tresiba blev sammenlignet med insulin glargin.
English: The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing.
Danish: Genbrug af nåle til insulinpenne øger risikoen for blokerede nåle, hvilket kan føre til under- eller overdosering.
English: A dose reduction of 20% based on the previous basal insulin dose followed by individual dosage adjustments should be considered when - transferring to Tresiba from twice-daily basal insulin - transferring to Tresiba from insulin glargine (300 units/mL)
Danish: En dosisreduktion på 20% i forhold til den tidligere basalinsulin dosis efterfulgt af individuelle dosisjusteringer skal overvejes, når - der skiftes til Tresiba fra basalinsulin to gange dagligt - der skiftes til Tresiba fra insulin glargin (300 enheder/ml)
English: The ratio of mitogenic relative to metabolic potency for insulin degludec is comparable to that of human insulin.
Danish: Forholdet mellem mitogenetisk og metabolisk styrke for insulin degludec er sammenligneligt med humant insulins.
English: Results support the use of Tresiba in adolescent patients with type 2 diabetes mellitus.
Danish: Resultaterne heraf understøtter brugen af Tresiba hos unge patienter med type 2-diabetes mellitus.
English: • Make sure the dose counter shows 0 before you start.
Danish: • Kontrollér, at dosistælleren står på 0, før du starter.
English: • if the pen is damaged or has not been stored correctly (see section 5).
Danish: • hvis pennen er beskadiget eller ikke har været opbevaret korrekt (se punkt 5).
English: • Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
Danish: • Før nålespidsen ind i den ydre nålehætte, mens den ligger på en plan overflade, uden at røre ved nålen eller den ydre nålehætte.
English: In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.
Danish: I tilfælde af blokerede nåle, skal patienter følge instruktionerne beskrevet i brugervejledningen, som findes sammen med indlægssedlen.
English: This helps you to ensure that you get your full insulin dose.
Danish: Det er med til at sikre, at du får hele insulindosis.
English: • beta-blockers, for high blood pressure.
Danish: • betablokkere, mod forhøjet blodtryk.
English: After subcutaneous injection, soluble and stable multi-hexamers are formed creating a depot of insulin in the subcutaneous tissue.
Danish: Efter subkutan injektion dannes der opløselige og stabile multihexamerer, hvorved der opstår et insulindepot i det subkutane væv.
English: • The active substance is insulin degludec.
Danish: • Aktivt stof: insulin degludec.
English: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Tresiba.
Danish: Reaktioner på injektionsstedet (inklusive hæmatom, smerter, hæmoragi, erytem, knuder, hævelse, misfarvning, pruritus, varme samt fortykkelse på injektionsstedet) forekom hos patienter i behandling med Tresiba.
English: • angiotensin converting enzyme (ACE) inhibitors, for some heart problems or high blood pressure.
Danish: • ACE-hæmmere (angiotensin-konverteringsenzymhæmmere), mod visse hjertelidelser eller forhøjet blodtryk.
English: The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1).
Danish: Der er ikke noget, der tyder på, at frekvensen, typen og sværhedsgraden af bivirkninger i den pædiatriske population er forskellige fra erfaringerne hos den generelle diabetespopulation (se pkt.
English: Substances added to Tresiba may cause degradation of insulin degludec.
Danish: Lægemidler, som tilsættes til Tresiba, kan medføre nedbrydning af insulin degludec.
English: Too low blood sugar may happen if you: drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.
Danish: For lavt blodsukker kan forekomme, hvis du: drikker alkohol, bruger for meget insulin, motionerer mere end normalt, spiser for lidt eller springer et måltid over.
English: Tresiba is a long-acting basal insulin called insulin degludec.
Danish: Tresiba er et langtidsvirkende basalinsulin, som kaldes insulin degludec.
English: What to do if you get too high blood sugar
Danish: Hvad du skal gøre, hvis du får for højt blodsukker
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 eller slet ikke noget 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, præcist hvor meget insulin der er tilbage: Drej dosisvælgeren, indtil dosistælleren stopper.
English: Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.
Danish: Samtidige sygdomme i nyrer, lever eller sygdomme, som påvirker binyrer, hypofyse eller thyreoidea, kan nødvendiggøre ændringer i insulindosis.
English: If not treated, this could lead to diabetic coma and eventually death.
Danish: Denne tilstand kan ubehandlet resultere i diabetisk koma og i værste fald død.
English: The rates (events per patient-year of exposure) of severe hypoglycaemia (ISPAD definition; 0.51 vs 0.33), confirmed hypoglycaemia (57.71 vs 54.05) and nocturnal confirmed hypoglycaemia (6.03 vs 7.60) were comparable with Tresiba versus insulin detemir.
Danish: Hyppighederne (tilfælde per eksponeret patientår) af alvorlig hypoglykæmi (ISPAD (International Society for Pediatric and Adolescent Diabetes)-definition; 0,51 vs 0,33), bekræftet hypoglykæmi (57,71 vs 54,05) og bekræftet natlig hypoglykæmi (6,03 vs 7,60) var sammenlignelige for Tresiba versus insulin detemir.
English: If you stop using your insulin, this could lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood), see advice in section 4 ‘Too high blood sugar'.
Danish: Hvis du holder op med at tage insulin, kan det føre til et meget højt blodsukkerniveau og ketoacidose (en tilstand, hvor der er for meget syre i blodet), se informationen i punkt 4 "For højt blodsukker".
English: The pen can dial up to a maximum of 160 units.
Danish: Pennen kan indstilles til højst 160 enheder.
English: Estimated risk ratio (Insulin degludec/Insulin glargine)
Danish: Estimeret risikorate (insulin degludec/insulin glargin)
English: Degradation of insulin degludec is similar to that of human insulin; all metabolites formed are inactive.
Danish: Biotransformation Nedbrydningen af insulin degludec ligner humant insulins; alle metabolitter, som dannes, er inaktive.
English: Rate of severe or BG confirmed symptomatic hypoglycaemia3,5 Maintenance period4
Danish: Hyppighed af alvorlig eller BG bekræftet symptomatisk hypoglykæmi3,5 Vedligeholdelsesperiode4
English: • thiazides, for high blood pressure or if your body keeps too much water (water retention).
Danish: • thiazider, mod forhøjet blodtryk eller for meget vand i kroppen (væskeophobning).
English: Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see section 5.2).
Danish: Monitorering af glucose skal intensiveres og insulindosis justeres individuelt (se pkt.
English: You can carry your Tresiba pre-filled pen (FlexTouch) with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C to 8°C) for up to 8 weeks.
Danish: Du kan medbringe din fyldte Tresiba pen (FlexTouch) og opbevare den ved stuetemperatur (ikke over 30°C) eller i et køleskab (2°C - 8°C) i op til 8 uger.
English: Make sure to have a minimum of 8 hours between the doses.
Danish: Der skal altid gå mindst 8 timer mellem doserne.
English: It delivers 1-80 units in steps of 1 unit.
Danish: Den leverer 1-80 enheder i trin af 1 enhed.
English: • The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen).
Danish: • De bedste steder til injektion er foran på låret, på overarmen eller foran på maveskindet.
English: Table 1 Day-to-day variability within-patients in glucose-lowering-effect of Tresiba and insulin glargine at steady state in patients with type 1 diabetes mellitus
Danish: Tabel 1 Dag-til-dag-variation med hensyn til den glucosesænkende virkning af Tresiba og insulin glargin ved steady state hos patienter med type 1-diabetes mellitus
English: During a period of 24 hours with once-daily treatment, the glucose-lowering effect of Tresiba, in contrast to insulin glargine, was evenly distributed between the first and second 12 hours (AUCGIR,0-12h,SS/AUCGIR,total,SS = 0.5).
Danish: I en periode på 24 timer med behandling en gang dagligt var den glucosesænkende virkning af Tresiba, i modsætning til insulin glargin, jævnt fordelt mellem den første og den anden 12-timers periode (AUCGIR,0-12h,SS/AUCGIR,total,SS
English: Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted.
Danish: Doser og tidspunkter for samtidig behandling med hurtigtvirkende eller korttidsvirkende insulinpræparater eller andre antidiabetika skal muligvis justeres.
English: • Always carry an extra pen and new needles with you in case of loss or damage.
Danish: • Medbring altid en ekstra pen og nye nåle, hvis du taber eller beskadiger pennen eller nålene.
English: A new needle must always be attached before each use.
Danish: Der skal altid påsættes en ny nål inden brug.
English: Basal only therapy in previously insulin-naïve
Danish: Kun basalbehandling hos tidligere insulinnaive
English: Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
Danish: Få hjælp af en person med godt syn, som har fået undervisning i at bruge den fyldte FlexTouch pen.
English: It delivers 2-160 units in steps of 2 units.
Danish: Den leverer 2-160 enheder i trin af 2 enheder.
English: • if the cartridge or the delivery system you are using is damaged.
Danish: • hvis cylinderampullen eller dispenseringssystemet er beskadiget.