FrancophonIA/ELRC3.0 huggingface dataset:
English: • when to check your blood sugar level and if you need a higher or lower dose.
Danish: • hvornår dit blodsukkerniveau skal kontrolleres, og om du har behov for en højere eller lavere dosis.
English: 52 weeks of treatment
Danish: 52 ugers behandling
English: Primary analysis (3-point MACE) CV Death
Danish: Primæranalyse (3-punkts MACE) CV Død
English: Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimesters.
Danish: Insulinbehovet falder normalt i første trimester og stiger siden i løbet af andet og tredje trimester.
English: If in doubt, take the full dose with a new pen.
Danish: Hvis du er i tvivl, skal du tage den fulde dosis med en ny pen.
English: Insulins and analogues for injection, long-acting.
Danish: Insuliner og analoger til injektion, langtidsvirkende.
English: Paediatric population The European Medicines Agency has waived the obligation to submit the results of trials with Tresiba in:
Danish: Pædiatrisk population Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Tresiba hos:
English: *Produced in Saccharomyces cerevisiae by recombinant DNA technology.
Danish: *Fremstillet i Saccharomyces cerevisiae ved rekombinant DNA-teknologi.
English: You should therefore monitor your blood sugar level more often than usual.
Danish: Du skal derfor kontrollere dit blodsukkerniveau oftere end normalt.
English: Safety and efficacy have been demonstrated in a long term trial in children aged 1 to less than 18 years.
Danish: Sikkerhed og virkning er blevet vist i et langtidsstudie hos børn i alderen fra 1 til under 18 år.
English: If you drink alcohol, your need for insulin may change.
Danish: Hvis du drikker alkohol, kan dit behov for insulin ændres.
English: Dose counter stopped: 52 units left
Danish: Eksempel Dosistæller stoppet: 52 enheder tilbage
English: This is normal, but you must still check the insulin flow.
Danish: Det er normalt, men du skal stadig kontrollere insulingennemløbet.
English: This should be kept in mind if treatment with the combination of pioglitazone and Tresiba is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Tresiba overvejes.
English: This could interrupt the injection.
Danish: Det kan afbryde injektionen.
English: Stop using Tresiba and see a doctor straight away if the reactions become serious.
Danish: Hold op med at bruge Tresiba, og søg straks læge, hvis reaktionerne bliver alvorlige.
English: Date of latest renewal: 21 September 2017
Danish: Dato for første markedsføringstilladelse: 21. januar 2013 Dato for seneste fornyelser: 21. september 2017
English: See your doctor if they do not disappear after a few weeks.
Danish: Kontakt din læge, hvis reaktionerne ikke er forsvundet efter nogle uger.
English: However, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia.
Danish: Patientens evne til at koncentrere sig og reagere kan dog være svækket på grund af hypoglykæmi.
English: Do not stop using your insulin without talking to your doctor.
Danish: Du må ikke holde op med at tage insulin uden først at have talt med din læge om det.
English: • If you do not respond to a glucagon injection, you will have to be treated in a hospital.
Danish: • Hvis du ikke reagerer på glucagoninjektionen, skal du behandles på hospitalet.
English: This can only be given by someone who knows how to use it.
Danish: Det kan kun gives af en person, der er instrueret i, hvordan det anvendes.
English: Gender There is no gender difference in the pharmacokinetic properties of this medicinal product.
Danish: Køn Der er ikke nogen kønsforskelle i de farmakokinetiske egenskaber af dette lægemiddel.
English: • On occasions when it is not possible to take Tresiba at the same time of the day, it can be taken at a different time of day.
Danish: • I situationer, hvor det ikke er muligt at tage Tresiba på det sædvanlige tidspunkt, kan du tage det på et andet tidspunkt af dagen.
English: Tresiba is to be dosed in accordance with the individual patient's needs.
Danish: Tresiba skal doseres i overensstemmelse med patientens individuelle behov.
English: The recommended daily starting dose is 10 units followed by individual dosage adjustments.
Danish: Den anbefalede daglige startdosis er 10 enheder efterfulgt af individuelle dosisjusteringer.
English: • sulfonamides, for infections
Danish: • sulfonamider, mod infektioner
English: 26 weeks of treatment
Danish: 26 ugers behandling
English: Then carry on with your insulin as usual.
Danish: Derefter kan du fortsætte med insulin som sædvanlig.
English: Your medicine might be harmful to their health.
Danish: Din medicin kan være skadelig for andre.
English: • Get medical help straight away.
Danish: • Søg straks lægehjælp.
English: The ratio between AUCGIR,0-12h,SS and AUCGIR,τ,SS was 0.5.
Danish: Forholdet mellem AUCGIR,0-12h,SS og AUCGIR,τ,SS var 0,5.
English: Patients should be instructed to always use a new needle.
Danish: Patienter skal instrueres i altid at bruge en ny nål.
English: Tresiba helps your body reduce your blood sugar level.
Danish: Tresiba hjælper kroppen med at sænke blodsukkerniveauet.
English: Use in elderly (≥65 years old)
Danish: Brug til ældre (≥65 år)
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: - på anmodning fra Det Europæiske Lægemiddelagentur - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: OTHER Novo Nordisk A/S
Danish: ANDET Novo Nordisk A/S
English: Clear, colourless, neutral solution.
Danish: Klar, farveløs, neutral opløsning.
English: • you have had too low blood sugar a few times recently.
Danish: • du har haft for lavt blodsukker nogle gange på det seneste.
English: Elderly (≥65 years old)
Danish: Ældre (≥65 år)
English: The half-life of Tresiba is approximately 25 hours independent of dose.
Danish: Halveringstiden af Tresiba er ca. 25 timer uafhængigt af dosis.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstillerene af det biologisk aktive stof
English: With insulin preparations, allergic reactions may occur.
Danish: Med insulinpræparater kan der forekomme allergiske reaktioner.
English: MI: Myocardial infarction.
Danish: MI: myokardieinfarkt.
English: This medicinal product must not be administered intramuscularly as it may change the absorption.
Danish: Dette lægemiddel må ikke administreres intramuskulært, da det kan ændre absorptionen.
English: Tresiba can be used in elderly.
Danish: Tresiba kan anvendes til ældre.
English: This means that the medicine is essentially ‘sodium-free'.
Danish: Det betyder, at lægemidlet stort set er natriumfrit.
English: This medicinal product is for use by one person only.
Danish: Dette lægemiddel er kun beregnet til én person.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Danish: Justering af dosis kan blive nødvendig, hvis patienter udøver øget fysisk aktivitet, ændrer deres kostvaner eller under samtidig sygdom.
English: Patients in the Tresiba arm included 43 children aged 1-5 years, 70 children aged 6-11 years and 61 adolescents aged 12-17 years.
Danish: Patienter i armen med Tresiba inkluderede 43 børn i alderen 1 til 5 år, 70 børn i alderen 6 til 11 år og 61 unge i alderen 12 til 17 år.
English: Avoidance of medication errors
Danish: Forebyggelse af medicineringsfejl
English: Steady state will occur after 2-3 days of dose administration.
Danish: Steady state forekommer efter 2-3 dages dosering.
English: • Use Tresiba once each day, preferably at the same time every day.
Danish: • Tag Tresiba én gang om dagen, fortrinsvis samme tidspunkt hver dag.
English: A minimum of 8 hours between injections should always be ensured.
Danish: Der skal altid gå mindst 8 timer mellem injektionerne.
English: Swelling around your joints: When you first start using your medicine, your body may keep more water than it should.
Danish: Hævelse omkring leddene: Når du påbegynder behandling med lægemidlet, kan kroppen tilbageholde mere vand, end den skal.
English: • you have used an injection of glucagon
Danish: • du har brugt en glucagoninjektion
English: 6 The ratio is for Tresiba Flex/Tresiba.
Danish: 6 Ratioen er for Tresiba Flex/Tresiba.
English: • Tresiba is given as an injection under the skin (subcutaneous injection).
Danish: • Tresiba gives som en injektion under huden (subkutan injektion).
English: CV: Cardiovascular.
Danish: CV: Kardiovaskulær.
English: Caution: One step equals 2 units - the pen shows the dose
Danish: Forsigtig: Et trin svarer til 2 enheder - pennen viser dosis
English: No safety issues were identified with Tresiba with respect to adverse events and standard safety parameters.
Danish: Der blev ikke identificeret sikkerhedsmæssige problemer ved Tresiba for så vidt angår bivirkninger og standard-sikkerhedsparametre.
English: It may even cause death.
Danish: Det kan i værste fald medføre døden.
English: • Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting (see section 4).
Danish: • Skift sted inden for det område, hvor du injicerer hver dag, for at nedsætte risikoen for at få fortykkelser, knuder og huller i huden (se punkt 4).
English: • anabolic steroids, such as testosterone
Danish: • anabolske steroider, f.eks. testosteron
English: Patients must be advised to take precautions to avoid hypoglycaemia while driving.
Danish: Patienter skal informeres om at tage forholdsregler for at undgå hypoglykæmi, når de kører bil.
English: Do not inject it into a vein or muscle.
Danish: Du må ikke injicere i en vene eller en muskel.
English: In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Danish: Intensiveret blodglucosekontrol og monitorering af gravide kvinder med diabetes anbefales gennem hele graviditeten, og når graviditet påtænkes.
English: Cardiovascular evaluation
Danish: Kardiovaskulær evaluering
English: Subsequently, dosage should be adjusted individually.
Danish: Dosis skal efterfølgende justeres individuelt.
English: Important information Pay special attention to these notes as they are important for correct use of the pen.
Danish: Vær særligt opmærksom på denne information, da den er vigtig for at kunne anvende pennen korrekt.
English: • acetylsalicylic acid (and other salicylates), for pain and mild fever
Danish: • acetylsalicylsyre (og andre salicylater), mod smerter og let feber
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Det er især vigtigt for personer, som har nedsat eller manglende fornemmelse af advarselssymptomerne på hypoglykæmi eller hyppige episoder med hypoglykæmi.
English: • growth hormone, for growth hormone deficiency
Danish: • væksthormon, mod mangel på væksthormon
English: Tresiba has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2).
Danish: Tresiba har været administreret til børn og unge op til 18 år med henblik på undersøgelse af de farmakokinetiske egenskaber (se pkt.
English: • If severe low blood sugar is not treated over time, it can cause brain damage.
Danish: • Hvis alvorligt lavt blodsukker ikke behandles inden for en vis tid, kan det medføre hjerneskade.
English: • Pioglitazone used together with insulin, see ‘Pioglitazone' below.
Danish: • Brug af Pioglitazon sammen med insulin, se ”Pioglitazon” nedenfor.
English: Hyperglycaemia Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia.
Danish: Hyperglykæmi Administration af hurtigtvirkende insulin anbefales i situationer med alvorlig hyperglykæmi.
English: A small air bubble may remain at the needle tip, but it will not be injected.
Danish: Der kan forblive en lille luftboble ved nålespidsen, men den injiceres ikke.
English: It is therefore recommended that the patient always carries glucose-containing products.
Danish: Det anbefales derfor, at patienten altid bærer sukkerholdige produkter på sig.
English: Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone (acromegaly).
Danish: Octreotid og lanreotid: til behandling af en sjælden lidelse med for meget væksthormon (akromegali).
English: Tresiba must not be administered intravenously as it may result in severe hypoglycaemia.
Danish: Tresiba må ikke administreres intravenøst, da det kan resultere i alvorlig hypoglykæmi.
English: EXP After first opening: Use within 8 weeks
Danish: EXP Under brug: Anvendes inden 8 uger
English: Total exposure after a single dose was, however, higher in children and adolescents than in adults with type 1 diabetes mellitus.
Danish: Den totale eksponering efter en enkelt dosis var dog højere hos børn og unge end hos voksne med type 1-diabetes mellitus.
English: If there is still no drop, change the needle and repeat steps 2A to 2C once more.
Danish: Hvis der stadig ikke kommer nogen dråbe til syne, skiftes nålen, og trin 2A til 2C gentages en gang mere.
English: Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Organ Class.
Danish: Bivirkningerne anført nedenfor er baseret på data fra kliniske studier og klassificeret efter MedDRAsystemorganklasse.
English: The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a patient to a new strength.
Danish: Dosistælleren viser antallet af enheder, uanset hvilken styrke der anvendes, og dosis skal ikke omregnes, når patienten skifter til en ny styrke.
English: • you suddenly feel unwell with sweating
Danish: • du føler dig dårlig og sveder
English: Tap the top of the pen gently a few times to let any air bubbles rise to the top.
Danish: Bank let på toppen af pennen nogle gange, så eventuelle luftbobler stiger op til toppen af pennen.
English: At baseline, HbA1c was 8.4% in both treatment groups and after 2 years HbA1c was 7.5% both with Tresiba and insulin glargine.
Danish: Ved baseline var HbA1c 8,4% i begge behandlingsgrupper, og efter 2 år var HbA1c 7,5% for både Tresiba og insulin glargin.
English: The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions' below).
Danish: Den hyppigst rapporterede bivirkning under behandling er hypoglykæmi (se afsnittet "Beskrivelse af udvalgte bivirkninger" nedenfor).
English: Tresiba must not be used if the solution does not appear clear and colourless.
Danish: Tresiba må ikke anvendes, hvis opløsningen ikke er klar og farveløs.
English: Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy.
Danish: Injektionsstederne skal altid varieres inden for samme område for at nedsætte risikoen for lipodystrofi.
English: Warning signs of too low blood sugar - these may come on suddenly:
Danish: Advarselssignalerne på for lavt blodsukker - de kan komme pludseligt:
English: Results from subgroup analyses (e.g. sex, diabetes duration, CV risk group and previous insulin regimen) was aligned with the primary analysis.
Danish: Resultater fra analyse af undergrupper (f.eks. køn, varighed af diabetes, CV risikogruppe og tidligere insulin regime) var i tråd med primæranalysen.
English: • other medicines for diabetes (oral and injectable)
Danish: • andre lægemidler til behandling af sukkersyge (oralt og som injektioner)
English: 1 Prepare your pen
Danish: 1 Klargør pennen
English: They may increase or decrease your blood sugar level.
Danish: De kan enten øge eller reducere dit blodsukkerniveau.
English: Linearity Dose proportionality in total exposure is observed after subcutaneous administration within the therapeutic dose range.
Danish: Dosisproportionalitet i total eksponering observeres efter subkutan administration inden for det terapeutiske dosisinterval.
English: OTHER SPECIAL WARNINGS, IF NECESSARY Use only clear, colourless solution Single patient use only
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Brug kun en klar, farveløs opløsning Kun til individuel brug
English: Examples
Danish: Eksempler
English: You will need it after the injection to correctly remove the needle from the pen.
Danish: Du skal bruge den efter injektionen, når du skal fjerne nålen korrekt fra pennen.
English: In both treatment arms, children aged 6-11 years had a numerically higher rate of confirmed hypoglycaemia than in the other age groups.
Danish: I begge behandlingsarme havde børn i alderen 6 til 11 år en numerisk højere hyppighed af bekræftet natlig hypoglykæmi end de andre aldersgrupper.
English: Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
Danish: Patienter, som glemmer en dosis, rådes til at tage den, når de opdager forglemmelsen, og derefter genoptage deres sædvanlige doseringsplan med dosering en gang dagligt.
English: If you drop it or suspect a problem, attach a new needle and check the insulin flow before you inject.
Danish: Hvis du taber den eller har mistanke om et problem, skal du sætte en ny nål på og kontrollere insulingennemløbet, før du injicerer.
English: Steady-state serum concentration is reached after 2-3 days of daily Tresiba administration.
Danish: Steady state-serumkoncentration nås efter 2-3 dages daglig administration af Tresiba.
English: 2 dots indicates 2 units per step
Danish: 2 prikker indikerer 2 enheder per trin
English: There is no clinical experience with the use of this medicinal product in children below the age of 1 year.
Danish: Der er ingen klinisk erfaring med brugen af dette lægemiddel i børn under 1 år.
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S
Danish: Indehaver af markedsføringstilladelsen og fremstiller Novo Nordisk A/S
English: Hazard Ratio (95% CI)
Danish: Hazardratio (95% CI)
English: Avoiding too low blood sugar (hypoglycaemia) is particularly important for the health of your baby.
Danish: Forebyggelse af lavt blodsukker (hypoglykæmi) er især vigtigt for dit barns helbred.
English: Your blood sugar level may either rise or fall.
Danish: Dit blodsukkerniveau kan enten stige eller falde.
English: The total glucose-lowering effect of Tresiba increases linearly with increasing doses.
Danish: Den samlede glucosesænkende effekt af Tresiba stiger lineært med stigende doser.
English: If you try to put it back on, you may accidentally stick yourself with the needle.
Danish: Hvis du forsøger at sætte den på igen, kan du komme til at stikke dig på nålen.
English: Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Danish: Patienter, der er blinde eller har nedsat syn, skal have besked på altid at få hjælp/assistance fra en anden person med et normalt syn og som har fået undervisning i brug af insulinpennen.
English: • Do not expose your pen to dust, dirt or liquid.
Danish: • Udsæt ikke din pen for støv, snavs eller væske.
English: Important information about some of the ingredients of Tresiba This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Vigtig information om nogle af indholdsstofferne i Tresiba Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: Tresiba can be used in elderly, but if you are elderly, you may need to check your blood sugar level more often.
Danish: Tresiba kan bruges til ældre, men det kan være nødvendigt at kontrollere blodsukkerniveauet oftere.
English: There is no clinically relevant difference in the pharmacodynamics of this medicinal product between elderly and younger adult patients.
Danish: Der er ingen klinisk relevant forskel i farmakodynamiken af dette lægemiddel hos ældre og yngre voksne patienter.
English: • Do not try to repair your pen or pull it apart.
Danish: • Forsøg ikke at reparere din pen eller skille den ad.
English: This medicinal product has no or negligible influence on the ability to drive and use machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Do not withdraw solution from the pen
Danish: Udtag ikke opløsning fra pennen
English: The primary analysis was time from randomisation to first occurrence of a 3-component major adverse cardiovascular event (MACE) defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Danish: Den primære analyse var tiden fra randomisering til første forekomst af en 3-komponent større kardiovaskulær hændelse (MACE), defineret som kardiovaskulær død, ikke-fatal myokardieinfarkt eller ikke-fatal apopleksi.
English: Needles must not be re-used.
Danish: Nåle må ikke genbruges.
English: Patients whose blood glucose control is greatly improved (e.g. by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycaemia and must be advised accordingly.
Danish: Patienter, hvis blodglucosekontrol er væsentligt forbedret (f.eks. ved intensiveret insulinbehandling), kan opleve ændringer i deres sædvanlige advarselssymptomer på hypoglykæmi og skal orienteres herom.
English: After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
Danish: Efter fødslen vil insulinbehovet normalt hurtigt vende tilbage til behovet før graviditeten.
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: 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 er stort set natriumfrit.
English: This medicinal product can be used in adolescents and children from the age of 1 year (see section 5.1).
Danish: Dette lægemiddel kan anvendes til unge og børn fra 1 år (se pkt.
English: Patients must visually verify the dialled units on the dose counter of the pen.
Danish: Patienterne skal visuelt kontrollere de indstillede enheder på pennens dosistæller.
English: Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Danish: Fortæl det straks til din læge, hvis du oplever tegn på hjertesvigt såsom usædvanlig kortåndethed, hurtig vægtstigning eller lokale væskeansamlinger (ødem).
English: Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen.
Danish: Derfor er kravet til patienter, der selvinjicerer, at de kan aflæse dosistælleren på pennen.
English: %: Percentage of subjects with a first EAC confirmed event relative to the number of randomised subjects.
Danish: %: Procent personer med et førstegangstilfælde bekræftet via afgørelse fra en hændelseskommite i forhold til antallet af randomiserede personer.
English: • Too high blood sugar (hyperglycaemia)
Danish: • For højt blodsukker (hyperglykæmi)
English: This medicinal product is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day.
Danish: Dette lægemiddel er en basalinsulin til subkutan indgivelse én gang dagligt på et hvilket som helst tidspunkt af dagen, fortrinsvis samme tidspunkt hver dag.