FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) were aligned with the primary analysis.
Danish: Resultater fra analyser af undergrupper (f.eks. køn, diabetesvarighed, CV-risikogruppe og tidligere insulinregime) blev justeret i forhold til den primære analyse.
English: • Eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case).
Danish: • Spis glucosetabletter eller et andet meget sukkerholdigt produkt, såsom slik, kiks eller frugtjuice (medbring for en sikkerheds skyld altid glucosetabletter eller et meget sukkerholdigt produkt).
English: drink alcohol; use too much insulin; exercise more than usual; eat too little or miss a meal.
Danish: drikker alkohol, tager for meget insulin, motionerer mere end normalt, spiser for lidt eller springer et måltid over.
English: • Neonates and infants from birth to less than 12 months of age with type 1 diabetes mellitus.
Danish: • Nyfødte og spædbørn fra fødslen og op til 12 måneder med type 1-diabetes mellitus.
English: • Once the needle is covered, carefully push the outer needle cap completely on.
Danish: • Når nålen er dækket, skubbes den ydre nålehætte helt på.
English: Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2).
Danish: Ryzodeg har været administreret til børn og unge op til 18 år med henblik på undersøgelse af de farmakokinetiske egenskaber (se pkt.
English: Ryzodeg pre-filled pen and needle (example) (FlexTouch)
Danish: Ryzodeg fyldt pen og nål (eksempel) (FlexTouch)
English: The half-life after subcutaneous administration of Ryzodeg is determined by the rate of absorption from the subcutaneous tissue.
Danish: Halveringstiden efter subkutan administration af Ryzodeg bestemmes af absorptionshastigheden fra det subkutane væv.
English: Prandial Blood glucose Increment 90 minutes after dosing meal (Plasma) (mmol/L)
Danish: Stigning i prandial blodglucose 90 minutter efter doseringsmåltid (plasma) (mmol/l)
English: The pharmacokinetic profile for insulin aspart appears 14 minutes after injection with a peak concentration after 72 minutes.
Danish: Den farmakokinetiske profil for insulin aspart viser sig 14 min efter injektion i blodet og koncentration topper efter 72 min.
English: • if you are allergic to insulin degludec, insulin aspart or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for insulin degludec, insulin aspart eller et af de øvrige indholdsstoffer i Ryzodeg (angivet i punkt 6).
English: Before you use Ryzodeg for the first time, your doctor or nurse will show you how to use it.
Danish: Før du tager Ryzodeg første gang, viser lægen eller sygeplejersken dig, hvordan du skal bruge den.
English: Hypoglycaemia Rate (per patient year of exposure) Severe
Danish: Hyppighed af hypoglykæmi (pr. patientår med eksponering) Alvorlig
English: The cardiovascular safety of insulin degludec as compared to insulin glargine was confirmed (HR 0.91 [0.78; 1.06]) (Figure 2).
Danish: Den kardiovaskulære sikkerhed for insulin degludec sammenlignet med insulin glargin blev bekræftet (HR 0,91 [0,78; 1,06]) (figur 2).
English: eat more or exercise less than usual; drink alcohol; get an infection or a fever; have not used enough insulin; keep using less insulin than you need; forget to use your insulin or stop using insulin without talking to your doctor.
Danish: spiser mere eller dyrker mindre motion, end du plejer, drikker alkohol, får en infektion eller feber, ikke har taget tilstrækkeligt insulin, gentagne gange tager mindre insulin end nødvendigt, glemmer at tage insulin eller stopper med at tage insulin uden at tale med lægen.
English: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Danish: Insulin degludecs affinitet til serumalbumin svarer til en plasmaproteinbinding på > 99 % i humant plasma.
English: Patients switching from basal/bolus insulin therapy to Ryzodeg will need to convert their dose based on individual needs.
Danish: Patienter, som skifter fra basal-/bolusinsulinbehandling til Ryzodeg, skal konvertere deres dosis ud fra deres individuelle behov.
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: One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
Danish: En (1) enhed af denne insulin svarer til 1 international enhed human insulin, 1 enhed insulin glargin, 1 enhed insulin detemir eller 1 enhed bifasisk insulin aspart.
English: Seven multinational, randomised, controlled, open-label, treat-to-target clinical studies of between 26 and 52 weeks' duration were conducted exposing a total of 1,761 patients with diabetes mellitus (1 study involving 362 patients in type 1 diabetes mellitus and 6 studies involving 1,399 patients in type 2 diabetes mellitus) to Ryzodeg.
Danish: Der blev gennemført syv multinationale, randomiserede, kontrollerede, åbne, kliniske treat-to-targetstudier på mellem 26 og 52 ugers varighed, hvor i alt 1.761 patienter med diabetes mellitus (et studie involverede 362 patienter med type 1-diabetes mellitus og seks studier involverede 1.399 patienter med type 2-diabetes mellitus) fik Ryzodeg.
English: Detailed instructions accompanying the delivery system must be followed.
Danish: Den detaljerede vejledning, som følger med dispenseringssystemet, skal følges.
English: Figure 1: Pharmacodynamics, single dose - Mean glucose infusion rate profile - Patients with type 1 diabetes - 0.8 U/kg Ryzodeg - Trial 3539
Danish: Figur 1: Farmakodynamik, enkelt dosis - Middelglucoseinfusionsrateprofil - Patienter med type 1-diabetes - 0,8 enheder/kg Ryzodeg - Studie 3539
English: Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
Danish: Reproduktionsstudier med dyr har ikke vist nogen forskel mellem insulin degludec og humant insulin med hensyn til embryotoksicitet og teratogenicitet.
English: Patients should not take an extra dose to make up for a missed dose.
Danish: Patienterne skal ikke tage en ekstra dosis som erstatning for en glemt dosis.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Danish: I sjældne tilfælde vil tilstedeværelsen af insulinantistoffer nødvendiggøre justering af insulindosis for at korrigere en tendens til hyper- eller hypoglykæmi.
English: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: This medicinal product must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).
Danish: Dette lægemiddel må ikke udtages fra cylinderampullen tilhørende den fyldte pen og ind i en sprøjte (se punkt 4.4).
English: Dose button with 3 lines
Danish: Dosisknap med 3 linjer
English: In all trials in type 2 diabetes mellitus, oral antidiabetic drugs (OADs) were allowed.
Danish: I alle studier med type 2-diabetes mellitus var det tilladt at anvende orale antidiabetika (OAD).
English: Dose-adjustments are recommended to be based on fasting plasma glucose measurements.
Danish: Det anbefales, at dosisjusteringer baseres på målinger af faste-plasmaglucose.
English: • Wait until the signs of too low blood sugar have gone or when your blood sugar level has settled.
Danish: • Vent indtil symptomerne på for lavt blodsukker er forsvundet, eller dit blodsukker er stabiliseret.
English: Ryzodeg o.d. plus insulin aspart (IAsp) was also compared to o.d. or b.i.d.
Danish: Ryzodeg o.d. plus insulin aspart (IAsp) blev også sammenlignet med o.d. eller b.i.d.
English: Mean HbA1c (%)
Danish: Middel-HbA1c (%)
English: If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
Danish: Hvis du har symptomer på for lavt blodsukker, skal du straks sørge for at øge dit blodsukkerniveau.
English: If a dose of this medicinal product is missed, the patient can take the missed dose with the next main meal of that day and thereafter resume the usual dosing schedule.
Danish: Hvis en dosis af dette lægemiddel glemmes, kan patienten tage den glemte dosis sammen med det næste hovedmåltid samme dag og derefter genoptage sin sædvanlige doseringsplan.
English: Insulin degludec and insulin aspart bind specifically to the human insulin receptor and result in the same pharmacological effects as human insulin.
Danish: Insulin degludec og insulin aspart bindes specifikt til humaninsulinreceptoren og medfører samme farmakologiske virkninger som humant insulin.
English: • Please also read the manual that comes with your insulin delivery system.
Danish: • Læs også brugervejledningen til insulindispenseringssystemet.
English: This effect is maintained in the co-formulation with insulin aspart and does not interfere with the rapid-acting insulin aspart monomers.
Danish: Denne virkning opretholdes i den kombinerede formulering med insulin aspart og interfererer ikke med de hurtigtvirkende insulin aspart-monomerer.
English: • Ensuring you use the right type of insulin - always check the insulin label before each injection to avoid accidentally confusing Ryzodeg with other insulin products.
Danish: • Sikre dig at du anvender den rigtige type insulin - kontrollér altid insulinetiketten før hver injektion for at undgå utilsigtet forveksling af Ryzodeg og andre insulinpræparater.
English: There are no clinically relevant differences in the pharmacokinetics of Ryzodeg between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Danish: Der er ingen klinisk relevante forskelle i de farmakokinetiske egenskaber af Ryzodeg mellem ældre og yngre voksne patienter, mellem forskellige racer eller mellem raske forsøgspersoner og patienter med nedsat nyre- eller leverfunktion.
English: It helps your body reduce your blood sugar level.
Danish: Det hjælper kroppen med at sænke blodsukkerniveauet.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23mg) per dosis, hvilket betyder, at det stort set er natriumfrit.
English: After 26 weeks, the Ryzodeg dose could be split into b.i.d.
Danish: Efter 26 uger kunne dosis med Ryzodeg opdeles i dosering b.i.d.
English: What you need to know before you use Ryzodeg Do not use Ryzodeg:
Danish: Det skal du vide, før du begynder at tage Ryzodeg Tag ikke Ryzodeg:
English: The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing.
Danish: Genbrug af insulin pen engangsnåle øger risikoen for blokerede nåle, hvilket kan føre til under- eller overdosering.
English: If you forget a dose, inject the missed dose with your next large meal on that day and thereafter resume your usual dosing schedule.
Danish: Hvis du glemmer en dosis, skal du injicere den manglende dosis ved det næste store måltid samme dag og derefter genoptage din sædvanlige doseringsplan.
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 insulin degludec to insulin glargine.
Danish: Studiet blev udformet som et non-inferiort studie for at ekskludere en præspecificeret risikomargin på 1,3 for hazardratioen (HR) for MACE, hvor insulin degludec sammenlignes med insulin glargin.
English: If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Danish: Hvis dosistælleren stopper før den når 0, er den fulde dosis ikke blevet injiceret, hvilket kan føre til et for højt blodsukkerniveau.
English: was compared to biphasic insulin aspart 30 (BIAsp 30) b.i.d.
Danish: blev sammenlignet med bifasisk insulin aspart 30 (BIAsp 30) b.i.d.
English: The steady-state pharmacokinetic properties of the insulin degludec component of Ryzodeg were investigated using a population pharmacokinetic analysis in children down to 1 year of age.
Danish: De farmakokinetiske egenskaber af insulin degludec-komponenten i Ryzodeg ved steady state blev undersøgt ved en farmakokinetisk populationsanalyse hos børn ned til 1 år.
English: Total exposure of insulin degludec after single dose administration was, however, higher in children and adolescents than in adults with type 1 diabetes mellitus.
Danish: Den totale eksponering for insulin degludec efter administration af en enkelt dosis var imidlertid højere hos børn og unge end hos voksne med type 1-diabetes mellitus.
English: insulin detemir (IDet) plus IAsp in type 1 diabetes mellitus (Table 3).
Danish: insulin detemir (IDet) plus IAsp ved type 1-diabetes mellitus (tabel
English: Ryzodeg dosed once daily with the main meal plus insulin aspart for the remaining meals showed similar reduction in HbA1c at week 16 and no differences in FPG and SMPG compared to comparator insulin detemir dosed once or twice daily plus mealtime insulin aspart.
Danish: Ryzodeg doseret en gang dagligt i forbindelse med hovedmåltidet plus insulin aspart i forbindelse med de resterende måltider, viste en tilsvarende reduktion i HbA1c ved uge 16 og ingen forskel i FPG og SMPG sammenlignet med komparator, insulin detemir, doseret en eller to gange dagligt plus insulin aspart ved måltider.
English: It is not known if Ryzodeg affects the baby in pregnancy or during breast-feeding.
Danish: Det vides ikke, om Ryzodeg påvirker barnet under graviditeten eller amning.
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: The pharmacodynamic effect of Ryzodeg is distinctively separated for the two components (Figure 1), and the resulting action profile reflects the individual components, the rapid-acting insulin aspart and the basal component insulin degludec.
Danish: Den farmakodynamiske virkning af Ryzodeg er meget forskellig for de to komponenter (figur 1), og den resulterende virkningsprofil afspejler de enkelte komponenter, det hurtigtvirkende insulin aspart og basalkomponenten insulin degludec.
English: The half-life of the basal component (insulin degludec) at steady state is 25 hours independent of dose.
Danish: Basalkomponentens (insulin degludecs) halveringstid ved steady state er 25 timer uafhængigt af dosis.
English: • beta-blockers, for high blood pressure.
Danish: • betablokkere, for forhøjet blodtryk.
English: Safety and efficacy have been demonstrated in a trial in children aged 2 to less than 18 years.
Danish: Sikkerhed og virkning hos børn i alderen 2 til 18 år er blevet påvist i et studie.
English: Before you use Ryzodeg for the first time, your doctor or nurse will show you how to use the pre-filled pen.
Danish: Før du tager Ryzodeg første gang, viser lægen eller sygeplejersken dig, hvordan du skal bruge den fyldte pen.
English: Detailed instructions accompanying the pre-filled pen must be followed.
Danish: Den detaljerede vejledning, som følger med den fyldte pen, skal følges.
English: Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the thigh.
Danish: Ryzodeg administreres subkutant ved injektion i abdominalvæggen, overarmen eller låret.
English: The efficacy and safety of Ryzodeg have been studied in a randomised controlled clinical trial in children and adolescents with diabetes mellitus type 1 for a period of 16 weeks (n=362).
Danish: Virkningen og sikkerheden af Ryzodeg er blevet undersøgt i et randomiseret, kontrolleret klinisk studie hos børn og unge med type 1-diabetes mellitus over en periode på 16 uger (n=362).
English: Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s).
Danish: Ryzodeg tillader fleksibilitet med hensyn til tidspunktet for administration af insulin, når blot det doseres sammen med hovedmåltidet/-erne.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Ryzodeg and other insulin products.
Danish: Patienterne skal instrueres i altid at kontrollere insulinetiketten før hver injektion for at undgå utilsigtet forveksling af Ryzodeg og andre insulinpræparater.
English: Changing where you inject each time may reduce the risk of developing these skin changes.
Danish: Hvis du injicerer et nyt sted hver gang, kan det reducere risikoen for at udvikle disse hudforandringer.
English: Needles are not included Read the package leaflet before use.
Danish: Nåle medfølger ikke Læs indlægssedlen inden brug.
English: DEVOTE was a randomised, double-blind, and event-driven clinical trial focusing on insulin degludec, the long-acting component of Ryzodeg.
Danish: DEVOTE var et randomiseret, dobbeltblindet og hændelsesdrevet klinisk studie med fokus på insulin degludec, den langtidsvirkende komponent af Ryzodeg.
English: You can carry your Ryzodeg cartridge (Penfill) with you and keep it at room temperature (not above 30°C) for up to 4 weeks.
Danish: Du kan medbringe din Ryzodeg cylinderampul (Penfill) og opbevare den ved stuetemperatur (ikke over 30°C) i op til 4 uger.
English: This medicinal product can be used in adolescents and children from the age of 2 years (see section 5.1).
Danish: Dette lægemiddel kan anvendes til unge og børn fra 2 år (se pkt.
English: Ryzodeg may be associated with higher occurrence of severe hypoglycaemia compared to a basal-bolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 5.1).
Danish: Ryzodeg kan være forbundet med øget forekomst af alvorlig hypoglykæmi sammenlignet med basal-bolusregime hos den pædiatriske population, særligt hos børn i alderen 2 til 5 år (se pkt.
English: When changing from another insulin regimen to Ryzodeg, dose reduction of total 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 andet insulinregime til Ryzodeg skal reduktion af den totale insulindosis overvejes individuelt for at reducere risikoen for hypoglykæmi (se pkt.
English: It is unknown whether insulin degludec/insulin aspart is excreted in human milk.
Danish: Det er ukendt, om insulin degludec/insulin aspart udskilles i humant mælk.
English: If you forget to use Ryzodeg
Danish: Hvis du har glemt at tage Ryzodeg
English: The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments.
Danish: Den anbefalede samlede daglige startdosis er 10 enheder sammen med måltid/-er efterfulgt af individuelle dosisjusteringer.
English: The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg.
Danish: Den veldokumenterede hurtige absorption af insulin aspart er bevaret i Ryzodeg.
English: With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Danish: Med Ryzodeg blev overfølsomhed (manifesteret ved hævelse af tunge og læber, diarré, kvalme, træthed og kløe) og urticaria rapporteret sjældent.
English: If the insulin looks cloudy, do not use the pen.
Danish: Hvis insulinet virker uklar, må du ikke bruge pennen.
English: • Too low blood sugar (hypoglycaemia)
Danish: • For lavt blodsukker (hypoglykæmi)
English: Few severe hypoglycaemic episodes were reported in each group; the observed rate of severe hypoglycaemia within the Ryzodeg arm was higher for subjects aged 2-5 years compared to subjects aged 6-11 years or 12-17 years (0.42 vs 0.21 and 0.21 respectively).
Danish: Der blev rapporteret få episoder med alvorlig hypoglykæmi i hver gruppe; den observerede hyppighed af alvorlig hypoglykæmi i armen med Ryzodeg var højere hos forsøgspersoner i alderen 2 til 5 år sammenlignet med forsøgspersoner i alderen 6 til 11 år eller 12-17 år (0,42 versus henholdsvis 0,21 og 0,21).
English: You can carry your Ryzodeg 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 4 weeks.
Danish: Du kan medbringe din Ryzodeg fyldte pen (FlexTouch) og opbevare den ved stuetemperatur (ikke over 30°C) eller i et køleskab (2°C - 8°C) i op til 4 uger.
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, når dit blodsukker bliver for lavt.
English: Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.
Danish: Behandling af diabetes mellitus hos voksne, unge og børn fra 2 år.
English: Hypoglycaemia (too low blood sugar) may occur very commonly with insulin treatment (may affect more than 1 in 10 people).
Danish: Hypoglykæmi (for lavt blodsukker) kan forekomme med insulin behandling (kan forekomme hos flere end 1 ud af 10 behandlede).
English: 3 Select your dose • Make sure the dose counter shows 0 before you start.
Danish: 3 Indstilling af dosis • Kontrollér, at dosistælleren står på 0, før du starter.
English: Ryzodeg should be used with special caution in children 2 to 5 years old because data from the clinical trial indicate that there may be a higher risk for severe hypoglycaemia in children in this age group (see sections 4.4, 4.8 and 5.1).
Danish: Ryzodeg skal anvendes med særlig forsigtighed til børn i alderen 2 til 5 år, da data fra kliniske studier indikerer, at der kan være en øget risiko for alvorlig hypoglykæmi hos børn i denne aldersgruppe (se pkt.
English: The recommended starting dose of Ryzodeg is 60-70% of the total daily insulin requirements in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments.
Danish: Den anbefalede startdosis af Ryzodeg er 60-70 % af det samlede daglige insulinbehov i kombination med korttids-/hurtigtvirkende insulin ved de øvrige måltider efterfulgt af individuelle dosisjusteringer.
English: Frequency not known (cannot be estimated from the available data) Skin changes where you use the injection (lipodystrophy): It is not known if Ryzodeg may cause lipodystrophy but such skin changes have been seen with other types of insulin.
Danish: Hyppighed ikke kendt (kan ikke bestemmes ud fra tilgængelig data) Hudforandringer på det sted, hvor du injicerer (lipodystrofi): Det vides ikke, om Ryzodeg kan give lipodystrofi, men denne type hudforandringer er set med andre typer insulin.
English: This assessment supports the use of Ryzodeg in adolescent patients with type 2 diabetes mellitus.
Danish: Vurderingen understøtter brugen af Ryzodeg hos unge patienter med type 2-diabetes mellitus.
English: Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing.
Danish: Genbrug af nåle kan øge risikoen for blokerede nåle, hvilket kan føre til upræcis dosering.
English: An efficacy and safety evaluation for adolescent patients with type 2 diabetes mellitus has been made using data from adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Danish: Virkning og sikkerhed hos unge patienter med type 2-diabetes mellitus blev vurderet ud fra data fra unge og voksne med type 1-diabetes mellitus og voksne med type 2-diabetes mellitus.