FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Tresiba, stop using this medicine and see a doctor straight away.
Danish: Hvis du får en alvorlig allergisk reaktion (forekommer sjældent) overfor insulin eller andre af indholdsstofferne i Tresiba, skal du stoppe med at tage dette lægemiddel og straks kontakte lægen.
English: • you often get too low blood sugar
Danish: • hvis du ofte har for lavt blodsukker
English: 11 multinational clinical trials of 26 or 52 weeks' duration were conducted as controlled, open-label, randomised, parallel, treat-to-target trials exposing 4,275 patients to Tresiba (1,102 in type 1 diabetes mellitus and 3,173 in type 2 diabetes mellitus).
Danish: Der blev gennemført 11 multinationale kliniske studier af 26 eller 52 ugers varighed som kontrollerede, åbne, randomiserede, parallel-gruppe, treat-to-target-studier, hvor 4.275 patienter fik Tresiba (1.102 med type 1-diabetes mellitus og 3.173 med type 2-diabetes mellitus).
English: Elderly, race, renal and hepatic impairment
Danish: Ældre, race, nedsat nyre- og leverfunktion
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tresiba.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Tresiba.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: For patients with type 1 diabetes a dose reduction of 20% based on the previous basal insulin dose or basal component of a continuous subcutaneous insulin infusion regimen should be considered with subsequent individual dosage adjustments based on the glycaemic response.
Danish: For patienter med type 1-diabetes skal en dosisreduktion på 20% ud fra den tidligere basalinsulindosis eller basalkomponent af en kontinuerlig subkutan insulininfusionregime overvejes efterfulgt af individuelle dosisjusteringer baseret på det glykæmiske respons.
English: Approx. how much insulin is left
Danish: Ca. hvor meget insulin der er tilbage
English: Type 1 + Type 2 diabetes mellitus (pooled) Maintenance period b
Danish: Type 1 + type 2-diabetes mellitus (sammenlagt) Vedligeholdelsesperiode b
English: 5 Blood glucose (BG) confirmed symptomatic hypoglycaemia was defined as episodes confirmed by a plasma glucose value of less than 3.1 mmol/L, with symptoms consistent with hypoglycaemia.
Danish: 5 Blodglucose (BG) bekræftet symptomatisk hypoglykæmi var defineret som episoder bekræftet ved plasmaglucoseværdier mindre end 3,1 mmol/l med symptomer forenelig med hypoglykæmi.
English: Pack sizes of 5 and 10 cartridges of 3 mL.
Danish: Pakningsstørrelser med 5 og 10 cylinderampuller a 3 ml.
English: You can carry your Tresiba cartridge (Penfill) with you and keep it at room temperature (not above 30°C) for up to 8 weeks.
Danish: Du kan medbringe din Tresiba cylinderampul (Penfill) og opbevare den ved stuetemperatur (ikke over 30°C) i op til 8 uger.
English: Day-to-day variability in glucose-lowering effect during one dosing interval (AUCGIR,τ,SS) Day-to-day variability in glucose-lowering effect from 2-24 hours (AUCGIR2-24h,SS)
Danish: Dag-til-dag-variation i glucosesænkende virkning i et doseringsinterval (AUCGIR,τ,SS) Dag-til-dag-variation i glucosesænkende virkning fra 2-24 timer (AUCGIR2-24h,SS)
English: The rate of nocturnal severe hypoglycaemia was significantly lower for Tresiba compared to insulin glargine (Table 8).
Danish: Hyppigheden af natlig alvorlig hypoglykæmi var signifikant lavere for Tresiba sammenlignet med insulin glargin (Tabel 8).
English: For both, the needed dose is dialled in units.
Danish: For begge indstilles den nødvendige dosis i enheder.
English: Your pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm.
Danish: Pennen er beregnet til anvendelse sammen med NovoTwist eller NovoFine engangsnåle med en længde på op til 8 mm.
English: The insulin degludec glucose-lowering action at steady state shows four times lower day-to-day variability in terms of Coefficients of Variation (CV) for the glucose-lowering effect during 0-24 hours (AUCGIR,τ,SS) and 2-24 hours (AUCGIR2-24h,SS) as compared to insulin glargine, see Table 1.
Danish: Insulin degludecs glucosesænkende virkning ved steady state viser fire gange lavere dag-til-dagvariation med hensyn til variationskoefficienter (CV) for den glucosesænkende virkning i 0-24 timer (AUCGIR,τ,SS) og 2-24 timer (AUCGIR2-24h,SS) sammenlignet med insulin glargin, se tabel 1.
English: Injection site reactions Uncommon Peripheral oedema
Danish: Reaktioner på injektionsstedet Ikke almindelig Perifert ødem
English: After first opening or if carried as a spare
Danish: Under brug eller medbragt som reserve
English: Table 5 Results from open-label clinical trials in type 2 diabetes mellitus: left - prior basal insulin users, right - insulin naïve
Danish: Tabel 5 Resultater fra åbne kliniske studier med type 2-diabetes mellitus: venstre - tidligere basalinsulin brugere, højre - insulinnaive
English: DEVOTE was a randomised, double-blind, and event-driven clinical trial with a median duration of 2 years comparing the cardiovascular safety of Tresiba versus insulin glargine (100 units/mL) in 7,637 patients with type 2 diabetes mellitus at high risk of cardiovascular events.
Danish: DEVOTE var et randomiseret, dobbeltblindet, og event-styret klinisk studie med en gennemsnitlig varighed på 2 år, hvor den kardiovaskulære sikkerhed af Tresiba blev sammenlignet med insulin glargin (100 enheder/ml) hos 7.637 patienter med type 2-diabetes mellitus, der havde høj risiko for at få kardiovaskulære tilfælde.
English: Favours insulin glargine
Danish: Favoriserer insulin glargin
English: Always keep Tresiba Penfill in the outer carton when you are not using it in order to protect it from light.
Danish: Opbevar altid Tresiba Penfill i den ydre karton, når den ikke er i brug, for at beskytte den mod lys.
English: The reduction in hypoglycaemia was achieved at a lower average FPG level with Tresiba than with insulin glargine.
Danish: Reduktionen i hypoglykæmi blev opnået ved et lavere gennemsnitligt Faste Plasma Glucose (FPG)-niveau med Tresiba end med insulin glargin.
English: In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with Tresiba (insulin degludec) in combination with metformin achieved a target HbA1c <7.0%, and the remaining patients continued in a 26-week open-label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal).
Danish: I et 104 ugers klinisk studie opnåede 57% af de patienter med type 2-diabetes, der blev behandlet med Tresiba (insulin degludec) i kombination med metfomin, et target HbA1c på <7,0%, og de resterende patienter fortsatte i et 26 ugers åbent studie og var randomiserede til at tilføje liraglutid eller en enkelt dosis insulin aspart (i forbindelse med hovedmåltidet).
English: When changing basal insulin to Tresiba, 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
Danish: Ved skift af basalinsulin til Tresiba skal individuel dosisjustering af basal- og bolusinsulin overvejes for at mindske risikoen for hypoglykæmi (se pkt.
English: If you have a serious allergic reaction (seen rarely) to the insulin or any of the ingredients in Tresiba, stop using Tresiba and see a doctor straight away.
Danish: Hvis du får en alvorlig allergisk reaktion (forekommer sjældent) overfor insulin eller andre af indholdsstofferne i Tresiba, skal du stoppe med at tage Tresiba og straks kontakte lægen.
English: Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Danish: Resultater fra kliniske studier indikerer ikke nogen forskel i bivirkningernes frekvens, type og sværhedsgrad, observeret hos ældre samt hos patienter med nedsat nyre- eller leverfunktion, i forhold til den bredere erfaring i den generelle patientpopulation.
English: • glucocorticoids such as ‘cortisone', for inflammation
Danish: • binyrebarkhormoner som "cortison", mod betændelse
English: Too high blood sugar may happen if you: 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: For højt blodsukker kan forekomme, hvis du: 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 du har brug for, glemmer at tage insulin eller stopper med at tage insulin uden at tale med lægen.
English: After first opening: Do not store above 30°C.
Danish: Under brug: Må ikke opbevares ved temperaturer over 30°C.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Læs indlægssedlen inden brug Subkutan anvendelse
English: Having too low or too high blood sugar can affect your ability to drive or use any tools or machines.
Danish: Hvis dit blodsukker er for lavt eller for højt, kan det påvirke din evne til at køre bil eller arbejde med værktøj eller maskiner.
English: • you experience rapid heartbeat or feeling dizzy.
Danish: • du får hjertebanken og føler dig svimmel.
English: The trials evaluated the rate of hypoglycaemia upon treatment with Tresiba compared to insulin glargine (100 units/mL) (see Table 7).
Danish: Studierne vurderede hyppigheden af hypoglykæmi efter behandling med Tresiba sammenlignet med insulin glargin (100 enheder/ml) (se tabel 7).
English: However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
Danish: Hypoglykæmi kan dog udvikles over forskellige faser, hvis der administreres større doser end svarende til patientens behov:
English: • Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once, as with all basal insulin products improvement from the period of low blood sugar may be delayed.
Danish: Det kan være nødvendigt at måle dit blodsukker mere end én gang, da der som ved alle basalinsulinpræparater kan være forsinkelse på forbedringen fra perioden med lavt blodsukker.
English: 1 In a once-daily regimen + insulin aspart to cover mealtime insulin requirements 2 In a once-daily regimen ± OADs (any combination of metformin, dipeptidyl peptidase-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and sodium glucose cotransporter-2 inhibitor) 3 Per patient year of exposure
Danish: 1 I et regime med administration én gang dagligt + insulin aspart for at dække behovet for insulin ved måltiderne 2 I et regime med administration én gang dagligt ± orale antidiabetika (OADs) (enhver kombination af metformin, dipeptidyl peptidase-4-inhibitor, alpha-glucosidase-inhibitor, thiazolidinedioner og natrium-glucose cotransporter-2-inhibitor) 3 Per patientår med eksponering
English: Always dispose of the needle after each injection in an appropriate sharps container.
Danish: Kassér altid nålen efter hver injektion i en passende kanylebeholder.
English: METHOD AND ROUTE OF ADMINISTRATION Needles are not included
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Nåle medfølger ikke
English: What to do if you get too low blood sugar
Danish: Hvad du skal gøre, hvis du får for lavt blodsukker
English: In patients with type 2 diabetes mellitus, this medicinal product can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin (see section 5.1).
Danish: Hos patienter med type 2-diabetes mellitus kan dette lægemiddel administreres som monoterapi eller i kombination med orale antidiabetika, GLP-1-receptoragonister og bolusinsulin (se pkt.
English: Do not use Tresiba
Danish: Tag ikke Tresiba
English: Do not make any dose re-calculation.
Danish: Lav ikke nogen omregning af dosis.
English: Local reactions: Local reactions at the place you inject yourself may occur.
Danish: Almindelige bivirkninger (kan forekomme hos færre end 1 ud af 10 behandlede) Lokale reaktioner: Der kan forekomme lokale reaktioner på det sted, hvor du injicerer dig selv.
English: Method of administration Subcutaneous use only.
Danish: Administration Kun til subkutan anvendelse.
English: • High blood sugar (hyperglycaemia) - if your blood sugar is too high, follow the guidance for high blood sugar in section 4.
Danish: • Højt blodsukker (hyperglykæmi) - hvis dit blodsukker er for højt, følg vejledningen for højt blodsukker under punkt 4.
English: The patient brochure shall contain the following key elements: - That Tresiba is available in 2 strengths; - Key differences in the design of the packages and the pre-filled pen devices; - Always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Tresiba; - Patients who are blind or have poor vision must be instructed always to get help/assistance from another person who has good vision and is trained in using the insulin device; - Always use the dose recommended by your healthcare provider; - Always use the dose counter and the dose pointer to select the dose.
Danish: Patient-brochuren skal indeholde følgende nøgleelementer: - At Tresiba er tilgængelig i to styrker; - Nøgleforskelle i design af pakningerne og de fyldte penne; - Tjek altid insulinetiketten før hver injektion for at undgå fejltagelser mellem de to forskellige styrker af Tresiba såvel som andre insulinpræparater; - Patienter som er blinde eller har nedsat syn, skal instrueres i altid at få hjælp af en person med godt syn, som har fået undervisning i at bruge insulinenheden; - Brug altid den dosis din læge har anbefalet; - Brug altid dosistælleren og dosismarkøren til at vælge dosis.
English: Table 2 Hypoglycaemia meta-analysis outcomes
Danish: Tabel 2 Udfald af hypoglykæmisk metaanalyse
English: This makes sure that the insulin flows.
Danish: Dette sikrer gennemløb af insulinen.
English: • Low blood sugar (hypoglycaemia) - if your blood sugar is too low, follow the guidance for low blood sugar in section 4.
Danish: • Lavt blodsukker (hypoglykæmi) - hvis dit blodsukker er for lavt, følg vejledningen for lavt blodsukker under punkt 4.
English: Start by checking your pen to make sure that it contains Tresiba 200 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.
Danish: Begynd med at kontrollere pennen for at sikre dig, at den indeholder Tresiba 200 enheder/ml, og se derefter på nedenstående illustrationer, så du kan lære de forskellige dele af pennen og nålen at kende.
English: Start by checking your pen to make sure that it contains Tresiba 100 units/mL, then look at the illustrations below to get to know the different parts of your pen and needle.
Danish: Begynd med at kontrollere pennen for at sikre dig, at den indeholder Tresiba 100 enheder/ml, og se derefter på nedenstående illustrationer, så du kan lære de forskellige dele af pennen og nålen at kende.
English: The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm.
Danish: Den fyldte pen (FlexTouch) er beregnet til anvendelse sammen med NovoFine/NovoTwist engangsnåle med en længde på op til 8 mm.
English: If you take a wrong type of insulin, your blood sugar level may get too high or too low.
Danish: Hvis du tager en forkert type insulin, kan dit blodsukkerniveau blive for højt eller for lavt.
English: You can select a maximum of 80 units per dose, in steps of 1 unit.
Danish: Du kan vælge maksimum 80 enheder pr. dosis i trin af 1 enhed.
English: If you forget to use Tresiba
Danish: Hvis du har glemt at tage Tresiba
English: The MAH shall provide an educational pack prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and all pharmacists who are expected to dispense Tresiba.
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering sikre, at læger og sygeplejersker, som forventes at være involverede i behandling af personer med diabetes og alle farmaceuter, som forventes at udlevere Tresiba, er blevet forsynet med en undervisningspakke.
English: Geriatric patients ≥65 years Type 1 diabetes mellitus Maintenance period b
Danish: Ældre patienter ≥65 år Type 1-diabetes mellitus Vedligeholdelsesperiode b Type 2-diabetes mellitus Vedligeholdelsesperiode b
English: There is no experience with flexibility in dosing time of Tresiba in children and adolescents.
Danish: Der er ingen erfaring med fleksibelt doseringstidspunkt af Tresiba hos børn og unge.
English: Tresiba can be used in renal and hepatic impaired patients.
Danish: Tresiba kan anvendes til patienter med nedsat nyre- og leverfunktion.
English: You can select up to 80 units per dose.
Danish: Du kan vælge op til 80 enheder pr. dosis.
English: • danazol, for endometriosis
Danish: • danazol, lægemiddel for endometriose (livmoderslimhinden)
English: What you need to know before you use Tresiba
Danish: Det skal du vide, før du begynder at tage Tresiba
English: • you find it hard to recognise too low blood sugar.
Danish: • hvis du har svært ved at vurdere, om du har for lavt blodsukker.
English: Read the package leaflet before use Subcutaneous use
Danish: Læs indlægssedlen inden brug Subkutan anvendelse
English: Non-fatal MI
Danish: Ikke-fatal Apopleksi Ikke-fatal MI
English: You can select up to 160 units per dose.
Danish: Du kan vælge op til 160 enheder pr. dosis.
English: • The dose counter shows the dose dialled in units.
Danish: • Dosistælleren på pennen viser den valgte dosis i enheder.
English: Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.
Danish: Du må ikke bruge insulinskalaen, den viser ikke, nøjagtigt hvor meget insulin der er tilbage i pennen.
English: Favours Tresiba
Danish: Favoriserer Tresiba
English: For patients with type 2 diabetes taking once-daily basal, basal-bolus, premix or self-mixed insulin therapy, changing the basal insulin to Tresiba can be done unit-to-unit based on the previous basal insulin dose followed by individual dosage adjustments.
Danish: For patienter med type 2-diabetes, som tager basal-, basal-bolus-, blandings- eller selvblandet insulinbehandling én gang dagligt, kan skiftet til Tresiba ske enhed til enhed ud fra den tidligere basalinsulindosis efterfulgt af individuelle dosisjusteringer.
English: Table 7 Results from the double-blind, cross-over clinical trials in type 1 and type 2 diabetes mellitus
Danish: Tabel 7 Resultater fra det dobbeltblindede, cross-over kliniske studie med type 1- og type 2diabetes mellitus
English: Confirmed2
Danish: Bekræftet2
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Tresiba as well as other insulin products.
Danish: Patienterne skal instrueres i altid at kontrollere insulinetiketten før hver injektion for at undgå utilsigtet forveksling af de to styrker af Tresiba såvel som andre insulinpræparater.
English: Do not place the used needle in household waste.
Danish: Afskaf ikke brugte nåle med husholdningsaffaldet.
English: You can select a maximum of 160 units per dose, in steps of 2 units.
Danish: Du kan vælge maksimum 160 enheder pr. dosis i trin af 2 enheder.
English: If it shows 160, at least 160 units are left in your pen.
Danish: Hvis den viser 160, er der mindst 160 enheder tilbage i pennen.
English: What Tresiba contains
Danish: Tresiba indeholder:
English: • The other ingredients are glycerol, metacresol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections (see section 2).
Danish: • Øvrige indholdsstoffer: glycerol, metacresol, phenol, zinkacetat, saltsyre og natriumhydroxid (til pH-justering) og vand til injektionsvæsker (se punkt 2).
English: Confirmed hypoglycaemiaa
Danish: Bekræftet hypoglykæmia
English: • if you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for insulin degludec eller et af de øvrige indholdsstoffer i Tresiba
English: Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Danish: Hård behandling eller misbrug kan føre til upræcis dosering, hvilket kan føre til et for højt eller for lavt blodsukkerniveau.
English: In type 1 diabetes mellitus, Tresiba must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
Danish: Ved type 1-diabetes mellitus skal Tresiba kombineres med korttids-/hurtigtvirkende insulin for at dække insulinbehovet ved måltiderne.
English: Insulin glargine N (%)
Danish: Insulin glargin N (%)
English: The following substances may increase the insulin requirement Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Danish: Orale kontraceptiva, thiazider, glukokortikoider, thyreoideahormoner, sympatomimetika, væksthormon og danazol.
English: 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 2 x 3 mL
Danish: 1 x 3 ml + 7 NovoFine engangsnåle 1 x 3 ml + 7 NovoTwist enagngsnåle 2 x 3 ml
English: It is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above.
Danish: Det anvendes til at behandle sukkersyge (diabetes mellitus) hos voksne, unge og børn fra 1-års-alderen.
English: After first opening: Do not refrigerate.
Danish: Under brug: Må ikke opbevares i køleskab.
English: In a prospectively planned meta-analysis across seven open-label treat-to-target confirmatory trials in patients with type 1 and type 2 diabetes mellitus, Tresiba was superior in terms of a lower number of treatment-emergent confirmed hypoglycaemic episodes (driven by a benefit in type 2 diabetes mellitus, see Table 2) and nocturnal confirmed hypoglycaemic episodes compared to insulin glargine (100 units/ml) (administered according to label).
Danish: I en prospektivt planlagt metaanalyse over syv åbne, konfirmatoriske treat-to-target-studier med patienter med type 1- og type 2-diabetes mellitus var Tresiba bedre med hensyn til et lavere antal bekræftede behandlingsrelaterede hypoglykæmiske episoder (drevet af en fordel ved type 2-diabetes mellitus, se tabel 2) og bekræftede natlige hypoglykæmiske episoder sammenlignet med insulin glargin (100 enheder/ml) (administreret ifølge etiket).
English: 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 5 x 3 mL
Danish: 1 x 3 ml + 7 NovoFine engangsnåle 1 x 3 ml + 7 NovoTwist engangsnåle 5 x 3 ml
English: DPP-4 inhibitor 2 Flexible once-daily regimen (intervals of approximately 8-40 hours between doses) + one or two of the following oral antidiabetes agents SU, metformin or DPP-4 inhibitor 3 Once-daily regimen + one or two of the following oral antidiabetes agents: SU, metformin or DPP-4 inhibitor
Danish: 1 Regime med administration en gang dagligt (sammen med hovedmåltidet om aftenen) + et eller to af følgende orale antidiabetika: SU, metformin eller DPP-4-inhibitor 2 Fleksibelt regime med administration en gang dagligt (intervaller på ca. 8-40 timer mellem doserne) + et eller to af følgende orale antidiabetika: SU, metformin eller DPP-4-inhibitor 3 Regime med administration en gang dagligt + et eller to af følgende orale antidiabetika: SU, metformin eller DPP-4
English: If you stop using Tresiba
Danish: Hvis du holder op med at tage Tresiba
English: When your pen contains less than 160 units, the dose counter stops at the number of units left.
Danish: Når pennen indeholder mindre end 160 enheder, stopper dosistælleren ved det antal enheder, der er tilbage.