FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a modified insulin, very similar to human insulin.
Danish: Dette er et modificeret insulin, der ligner human insulin meget.
English: Results from a study on progression of diabetic retinopathy
Danish: Resultater fra et studie om progression af diabetisk retinopati
English: A Make sure a needle is attached and the dose is set to ‘0'.
Danish: A Sørg for en nål er påsat, og at dosis er indstillet til ”0”.
English: DoubleStar) are not bioequivalent and are therefore not interchangeable without dose adjustment.
Danish: DoubleStar) ikke er bioækvivalente og derfor ikke kan erstatte hinanden uden dosisjustering.
English: These cases did not contain confounders and have a compatible time to onset.
Danish: Disse tilfælde var uden konfunderende faktorer og havde en kompatibel tid til indtræden.
English: Please refer to the prescribing information of the medicinal product to which the patient is switching.
Danish: Der henvises til ordinationsoplysningerne om det præparat, som patienten skifter til.
English: • Patient/carer guide (patient brochure)
Danish: • Patient/omsorgsperson vejledning (patientbrochure)
English: In most cases you will need to talk to a doctor.
Danish: I de fleste tilfælde vil du have behov for, at kontakte en læge.
English: • If you cannot select your full prescribed dose, split the dose into two injections or use a new pen.
Danish: • Hvis du ikke kan vælge hele din dosis, kan du dele dosis i to injektioner eller bruge en ny pen.
English: Antibody development was sparse and had no clinical impact.
Danish: Udviklingen af antistoffer var sparsom og havde ingen klinisk indflydelse.
English: Do not stop using this medicine without talking to your doctor.
Danish: Afbryd ikke behandlingen uden at tale med din læge.
English: If you have poor eyesight, please see section 3.
Danish: Hvis du har dårligt syn, skal du læse punkt 3.
English: Toujeo DoubleStar 24 months.
Danish: Toujeo DoubleStar 24 måneder.
English: See also section 4.2 under “Method of administration”.
Danish: 4.2 under ”Administration”.
English: It can even hide or stop the first signs that your blood sugar is too low.
Danish: Det kan endda skjule eller stoppe de første tegn på, at dit blodsukker bliver for lavt.
English: If they don't, the full dose might not be delivered.
Danish: Hvis ikke dette gøres, kan den fulde dosis muligvis ikke leveres.
English: Needles must be discarded immediately after use.
Danish: Nåle skal kasseres umiddelbart efter brug.
English: If you find it hard to press the injection button in, do not force it as this may break your pen.
Danish: Hvis du har svært ved at trykke dosisknappen ind, må du ikke tvinge den, da det kan knække din pen.
English: Patients must also be instructed to not re-use needles.
Danish: Patienterne skal også instrueres om ikke at genbruge nåle.
English: If the hypoglycaemia comes back again, take another 10 to 20 grams of sugar.
Danish: Hvis du igen får hypoglykæmi, skal du indtage endnu 10-20 g sukker.
English: The educational materials for healthcare professionals shall contain the following key elements:
Danish: Undervisningsmaterialerne til sundhedspersonale skal indeholde følgende hovedelementer:
English: This should be kept in mind if treatment with the combination of pioglitazone and Toujeo is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Toujeo overvejes.
English: No safety issues were identified with Toujeo with respect to adverse events and standard safety parameters.
Danish: Der blev ikke identificeret nogle sikkerhedsproblemer med Toujeo med hensyn til bivirkninger og standard sikkerhedsparametre.
English: Patients must visually verify the number of selected units on the dose counter of the pen.
Danish: Patienter skal visuelt kontrollere antallet af valgte enheder på pennens dosistæller.
English: • If you are ill or have a major injury.
Danish: • hvis du bliver syg eller kommer alvorligt til skade.
English: Get help from a person with good eye sight who is trained in using the pen.
Danish: Få hjælp fra en person med godt syn, der er uddannet i at bruge pennen.
English: • Instructions on how to report medication errors or adverse events: Details for national reporting added at country level.
Danish: • Instruktioner om indberetning af medicineringsfejl eller andre bivirkninger: Detaljer om national indberetning tilføjes på lande niveau.
English: Protect your pen from dust and dirt
Danish: Beskyt din pen mod støv og snavs.
English: This is because there is no experience with Toujeo in this age group.
Danish: Dette skyldes, at der ikke er nogen erfaring med anvendelse af Toujeo til denne aldersgruppe.
English: Long term efficacy and safety outcome study
Danish: Studie af langsigtet effekt og sikkerhedsresultat
English: As a consequence, exposure (AUC) in pediatric patients is slightly lower as compared to adult patients when receiving the same body weight adjusted dose.
Danish: Som konsekvens er eksponering (AUC) hos pædiatriske patienter en smule lavere sammenlignet med voksne patienter, når de fik den samme legemsvægtjusterede dosis.
English: Glycaemic control was similar when Toujeo was administered once daily in the morning or in the evening.
Danish: Glykæmisk kontrol var identisk, når Toujeo blev indgivet en gang daglig om morgenen eller om aftenen.
English: Patients who are blind or have poor vision should be instructed to 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 instrueres i at få hjælp/assistance fra en anden person, der har et godt syn og som er uddannet i at bruge insulinpennen.
English: Pharmacokinetic profiles were consistent with the pharmacodynamic activity of Toujeo.
Danish: Farmakokinetiske profiler var i overensstemmelse med Toujeos farmakodynamiske aktivitet.
English: The strength“300” is highlighted in honey gold on the label (see section 4.4).
Danish: Styrken på ”300” er fremhævet med honningguld på etiketten (se pkt.4.4).
English: • If you are blind or have poor eye sight, do not use the pre-filled pen without help.
Danish: • Hvis du er blind eller har dårligt syn, må du ikke bruge den fyldte pen uden assistance.
English: This will reduce the risk of skin shrinking or thickening (for more information, see “Other side effects” in section 4).
Danish: Dette vil mindske risikoen for krympning eller fortykkelse af huden (se ”Andre bivirkninger” i punkt 4 for mere information).
English: If you do you will get too much insulin.
Danish: Hvis du gør, vil du få for meget insulin.
English: • If you turn past your dose, you can turn back down.
Danish: • Hvis du drejer forbi din dosis kan du dreje tilbage igen.
English: Since Toujeo is a clear solution, it does not require resuspension before use.
Danish: Da Toujeo er en klar opløsning, er resuspension ikke nødvendig før brug.
English: This may cause too low blood sugar which is sometimes followed by too high blood sugar.
Danish: Dette kan forårsage for lavt blodsukker som undertiden efterfølges af for højt blodsukker.
English: Patients who forget a dose, should be advised to check their blood sugar and then resume their usual once-daily dosing schedule.
Danish: Patienter, der glemmer en dosis, rådes til at kontrollere deres blodsukker og derefter genoptage deres sædvanlige dosering en gang daglig.
English: Toujeo is available in two pre-filled pens.
Danish: Toujeo er tilgængelig i to fyldte penne.
English: Tell a doctor straight away if you notice signs of a severe allergic reaction.
Danish: Du skal straks kontakte lægen, hvis du får symptomer på alvorlige allergiske reaktioner.
English: • Do not drop your pen or knock it against hard surfaces.
Danish: • Tab ikke din pen og undgå at banke den mod hårde overflader.
English: The half-life of Toujeo after subcutaneous injection is 18-19 hours independent of dose.
Danish: Halveringstiden af Toujeo efter subkutan injektion er 18-19 timer uafhængigt af dosis.
English: • You can clean the outside of your pen by wiping it with a damp cloth.
Danish: • Du kan rengøre ydersiden af pennen ved at tørre den af med en fugtig klud.
English: • Keep eating enough carbohydrates.
Danish: • Fortsæt med at få tilstrækkeligt med kulhydrater.
English: 450 units per pen (SoloStar pen) 900 units per pen (DoubleStar pen)
Danish: 450 enheder per pen (SoloStar pen) 900 enheder per pen (DoubleStar pen)
English: B Keep the needle straight and screw it onto the pen until fixed.
Danish: B Hold nålen lige, og skru den på pennen indtil den sidder fast.
English: • You may need to repeat this step up to 3 times before seeing insulin.
Danish: • Det kan være nødvendigt at gentage dette trin op til 3 gange, før insulinet kommer ud.
English: - That they should report medication errors or any side effects.
Danish: - Indberetning af medicineringsfejl eller andre bivirkninger.
English: These signs often develop before the signs of a low sugar level in the brain.
Danish: Disse symptomer går ofte forud for symptomerne på lavt blodsukker i hjernen.
English: • If you switch from another type, brand or manufacturer of insulin your insulin dose may need to be changed.
Danish: • Hvis du skifter fra en anden type, mærke eller producent af insulin, skal din insulindosis muligvis ændres.
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: Frekvensen, typen og sværhedsgraden af bivirkninger hos den pædiatriske population indikerer ikke forskelle til det, der ses hos den generelle diabetespopulation (se pk. 5.1).
English: The cumulative review of cutaneous amyloidosis included 29 cases of which 15 were well documented cases in which the event was confirmed with histopathology.
Danish: Den samlende vurdering af kutan amyloidose inkluderede 29 tilfælde, hvoraf 15 var veldokumenterede tilfælde hvor bivirkningen var bekræftet med histopatologi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: De ikke-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogent potentiale og toksicitet i forbindelse med reproduktion.
English: Before first use, the pen must be stored at room temperature at least 1 hour before use.
Danish: Før første anvendelse skal pennen opbevares ved stuetemperatur i mindst 1 time.
English: • Always check the number in the dose window to make sure you dialled the correct dose
Danish: • Kontroller altid tallet i dosisvinduet for at sikre at du har indstillet den rigtige dosis.
English: • Pioglitazone.
Danish: • Pioglitazon.
English: If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Danish: Såfremt normale eller nedsatte værdier af glykosyleret hæmoglobin observeres, skal muligheden for tilbagevendende, ikke-erkendte (især natlige) hypoglykæmiske anfald overvejes.
English: • Keep new pens in a fridge, at 2°C to 8°C.
Danish: • Opbevar nye penne i køleskab ved 2°C til 8°C.
English: • This pen is not recommended for use by people who are blind or have visual impairments without the assistance of a person trained in the proper use of the product.
Danish: • Det anbefales ikke at denne pen bruges af personer, som er blinde eller har nedsat syn uden at disse får hjælp fra en person, som er tærnet i korrekt brug af produktet.
English: Check your blood sugar and eat more food to prevent you blood sugar getting too low.
Danish: Kontrollér dit blodsukker, og indtag mere mad for at forebygge at dit blodsukker bliver for lavt.
English: Administration with a flexible dosing time had no effect on glycaemic control and the incidence of hypoglycaemia.
Danish: Administration med en fleksibel doseringstid havde ingen virkning på glykæmisk kontrol og forekomsten af hypoglykæmi.
English: Type 2 diabetic patients (n=194) received Toujeo once daily in the evening, either at the same time of the day (fixed time of administration) or within 3 hours before or after the usual time of administration (flexible dosing time).
Danish: Type 2-diabetikere (n = 194) fik Toujeo en gang daglig om aftenen, enten på samme tidspunkt af døgnet (fast administrationstidspunkt) eller indenfor 3 timer før eller efter det sædvanlige tidspunkt for administration (fleksibel doseringstid).
English: • Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis.
Danish: - Kontakt straks din læge, hvis du får alvorlig hyperglykæmi og ketoacidose.
English: This is to avoid dosing errors and potential overdose which may lead to low blood sugar.
Danish: Dette er for at undgå doseringsfejl og potentiel overdosis, som kan medføre lavt blodsukker.
English: The educational material for patient/carer guide (patient brochure) shall contain the following key elements:
Danish: Undervisningsmaterialet til patient/omsorgsperson vejledningen (patientbrochure) skal indeholde følgende hovedelementer:
English: STEP 3: Do a safety test Always do a safety test before each injection - this is to:
Danish: TRIN 3: Udfør en sikkerhedstest Udfør altid en sikkerhedstest før hver injektion - dette er for at:
English: Body weight affects the clearance of Toujeo in a nonlinear way.
Danish: Legemsvægten påvirker clearance af Toujeo på en ikke-lineær måde.
English: b Confirmed hypoglycaemia: Any severe hypoglycaemia and/or hypoglycaemia confirmed by plasma glucose value ≤3.9 mmol/l.
Danish: b Bekræftet hypoglykæmi: Enhver alvorlig hypoglykæmi og/eller hypoglykæmi bekræftet af plasmagluxoseværdi ≤3.9 mmol/l.
English: * Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Danish: *Insulin glargin er fremstillet ved rekombinant DNA-teknologi i Escherichia coli.
English: Pregnancy There is no clinical experience with use of Toujeo in pregnant women.
Danish: Graviditet Der er ingen klinisk erfaring med brug af Toujeo hos gravide kvinder.
English: Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data).
Danish: Følgende relaterede bivirkninger, forekommet i kliniske studier, er nedenfor opstillet efter organsystem og faldende hyppighed (meget almindelig: >1/10; almindelig: >1/100 til <1/10; ikke almindelig: >1/1.000 til <1/100; sjælden: >1/10.000 til <1/1.000; meget sjælden: <1/10.000); ikke kendt: kan ikke estimeres ud fra forhåndenværende data).
English: Clinical study safety data are not available for children under 6 years.
Danish: Kliniske sikkerhedsdata er ikke tilgængelige for børn under 6 år.
English: The MAH shall agree the final text and the context of the educational material for HCPs and patients together with a communication plan, with the National Competent Authority in each Member State prior to launch of the medicinal product.
Danish: Indehaveren af markedsføringstilladelsen skal aftale den endelige tekst og indholdet af undervisningsmaterialet til HCP'er og patienter sammen med en kommunikationsplan, med den nationale kompetente myndighed i hver medlemsstat før lancering af lægemidlet.
English: The pen is recommended for patient who need at least 20 units of insulin per day (see also section 2).
Danish: Pennen anbefales til patienter, som har brug for mindst 20 enheder insulin om dagen (se punkt 2).
English: The dose regimen (dose and timing) should be adjusted according to individual response.
Danish: Dosisregimet (dosering og tidspunkt for dosering) skal tilpasses individuelt.
English: • Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Danish: • Følg de anbefalede retningslinjer for fjernelse og kassering af nåle (kontakt din læge, apotekspersonale eller sygeplejerske) for at reducere risikoen for skader med nålen ved uheld og overførsel af infektionssygdomme.
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Danish: Omskiftning fra en insulinbehandling til en anden kræver recept, lægetilsyn og blodsukkerovervågning.
English: • Swelling in the calves and ankles, caused by temporary build-up of water in the body.
Danish: • Hævelser i lægge og ankler, forårsaget af væskeophobning i kroppen.
English: You should check your blood sugar level more than usual.
Danish: Du skal kontrollere dit blodsukker mere end normalt.
English: • For all injections, if no insulin comes out, the needle may be blocked.
Danish: • For alle injektioner, hvis der ikke kommer insulin ud, så kan nålen være blokeret.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Also lumps under the skin caused by build-up of a protein called amyloid may occur (cutaneous amyloidosis, how often they occur is not known).
Danish: Derudover kan der forekomme knuder under huden, forårsaget af ophobning af et protein kaldet amyloid (kutan amyloidose, hyppigheden er ikke kendt).
English: If you do not perform the safety test before each injection, you may get too little insulin.
Danish: Hvis du ikke udfører sikkerhedstesten før hver injektion, kan du få for lidt insulin.
English: Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Danish: Stadig skift af injektionssted, indenfor et givet injektionsområde, kan mindske eller forhindre disse reaktioner.
English: STEP 5: Inject your dose
Danish: TRIN 5: Injektion af dosis
English: • Do not use the pen if the insulin looks cloudy, coloured or contains particles.
Danish: • Anvend ikke pennen, hvis insulinet er uklart, farvet eller indeholder partikler.
English: Results support the use of Toujeo in paediatric patients with type 2 diabetes mellitus.
Danish: Resultaterne støtter brugen af Toujeo hos pædiatriske patienter med type 2 diabetes mellitus.
English: Toujeo is for subcutaneous use only.
Danish: Toujeo er kun til subkutan brug.
English: o To reduce potential underdose, Toujeo DoubleStar is recommended for patients requiring at least 20 units per day.
Danish: o For at reducere potentiel underdosering anbefales Toujeo DoubleStar til patienter som kræver mindst 20 enheder om dagen..
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Toujeo.
Danish: Hvis noget af ovenstående gælder for dig (eller du ikke er sikker), så tal med din læge, apotekspersonalet eller sygeplejersken, inden du tager Toujeo.
English: Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
Danish: Intravenøs administration af den sædvanlige subkutane dosis kan føre til alvorlig hypoglykæmi.
English: Together with the available evidence from literature and text books, this signal contains sufficient evidence to establish an association between insulin glargine and cutaneous amyloidosis.
Danish: Sammen med tilgængelig evidens fra litteratur og lærebøger, indeholdt dette signal tilstrækkelig evidens til at etablere en sammenhæng mellem insulin glargin og kutan amyloidose.
English: Hypoglycaemia can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Danish: Hypoglykæmi (lavt blodsukker) kan være meget alvorligt og er meget almindeligt ved insulinbehandling (kan forekomme hos flere end 1 ud af 10 patienter).
English: At the end of these treat-to-target trials, depending on the patient population and concomitant therapy, a 10-18% higher dose was observed in the Toujeo group than in the comparator group (Table 1 and
Danish: Ved afslutningen af disse treat-to-target studier, afhængigt af patientpopulationen og anden medicinsk behandling, blev en 10-18% højere dosis observeret i Toujeo-gruppen end i sammenligningsgruppen (tabel 1 og 2).
English: Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique, as discussed with your doctor.
Danish: Overhold nøje anvisningerne vedrørende dosering, kontrollerne (blod- og urinprøver), kostplan, fysisk aktivitet (fysisk arbejde og motion) og injektionsteknik, som er aftalt med lægen.
English: Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.
Danish: Søg omgående læge, hvis du ikke kan få kontrol over din hypoglykæmi, eller hvis tilstanden kommer igen.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Danish: Opløsningen må kun anvendes, såfremt den er klar, farveløs, uden synlige faste partikler, og har et vandlignende udseende.
English: Switching a patient between another type or brand of insulin and Toujeo should be done under strict medical supervision.
Danish: Omstilling af en patient til en anden type eller mærke af insulin til Toujeo skal ske under nøje medicinsk overvågning.
English: C Check that the insulin is clear.
Danish: C Tjek at insulinet er klart.
English: If you re-use a needle this increases the risk of it becoming blocked and of you getting too much or too little insulin.
Danish: Hvis du genbruger en nål øges risikoen for, at den bliver blokeret, og for at du får for meget eller for lidt insulin.
English: If you do you might not get your dose (underdosing) or get too much (overdosing) as the needle could block.
Danish: Hvis du gør, får du måske ikke din dosis (underdosering) eller du får for meget (overdosering), da nålen kan blive blokeret.
English: The safety and efficacy of Toujeo administered with a fixed or flexible dosing time were also evaluated in 2 randomized, open-label clinical studies for 3 months.
Danish: Sikkerheden og effekten af Toujeo administreret med en fast eller fleksibel doseringstid blev også vurderet i 2 randomiserede, kliniske open-label studier i 3 måneder.
English: If you use more than one insulin always ensure you use the right insulin by checking the insulin label before each injection.
Danish: Hvis du bruger mere end en insulin skal du altid sikre dig, at det er den rigtige insulin ved at tjekke etiketten før hver injektion.
English: • Eye reactions: A big change in your blood sugar control (getting better or worse) can disturb your vision.
Danish: • Øjenreaktioner: En markant ændring (forbedring eller forværring) af din blodsukkerkontrol kan forårsage en midlertidig forstyrrelse af dit syn.
English: *GIR: Glucose infusion rate: determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values).
Danish: *GIR: Glucoseinfusionshastighed: bestemmes som mængden af glucose infunderet for at holde konstant plasmaglucosekoncentration (timemiddelværdier).
English: Patients with type 2 diabetes mellitus The recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments.
Danish: Patienter med type 2-diabetes mellitus Den anbefalede daglige startdosis er 0,2 enheder/kg efterfulgt af individuelle dosisjusteringer.
English: Toujeo DoubleStar is made to deliver the number of insulin units that your doctor prescribed.
Danish: Toujeo DoubleStar er lavet til at give det antal enheder insulin, som din læge har ordineret.