FrancophonIA/ELRC3.0 huggingface dataset:
English: After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released.
Danish: Efter injektion i subkutant væv neutraliseres den sure opløsning, og der dannes præcipitater, hvorfra små mængder insulin glargin til stadighed frigives.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia.
Danish: Det er meget vigtigt at opretholde en god metabolisk kontrol under graviditeten hos patienter med forudeksisterende eller gestational diabetes for at forebygge skadelige følgevirkninger i forbindelse med hyperglykæmi.
English: The strength “300” is highlighted in honey gold on the label of your Toujeo SoloStar pre-filled pen.
Danish: Styrken ”300” er fremhævet i ”honningguld” på etiketten på din Toujeo SoloStar fyldte pen.
English: Only use needles that are compatible for use with Toujeo (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).
Danish: Brug kun nåle, der er kompatible til anvendelse med Toujeo (f.eks. nåle fra BD, Ypsomed, Artsana eller Owen Mumford).
English: 29 units selected
Danish: 29 enheder valgt
English: C Place your thumb on the injection button.
Danish: C Placer tommelfingeren på dosisknappen.
English: Toujeo dosed once daily showed similar reduction in HbA1c and FPG from baseline to week 26 compared to insulin glargine 100 units/mL.
Danish: Toujeo doseret en gang dagligt viste en lignende reduktion i HbA1c og FPG fra baseline til uge 26 sammenlignet med insulin glargin 100 enheder/ml.
English: Use only in this pen or severe overdose can result.
Danish: Anvend kun i denne pen, da svær overdosering ellers kan opstå.
English: Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable.
Danish: Insulin glargin 100 enheder/ml og Toujeo er ikke bioækvivalente, og er ikke direkte udskiftelige.
English: Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Danish: Mavesmerter, hurtig og dyb vejrtrækning, søvnighed og eventuelt besvimelse kan være tegn på den alvorlige tilstand, ketoacidose (syreophobning i blodet), som er en følge af mangel på insulin.
English: Never re-use needles.
Danish: Genbrug aldrig nåle.
English: Never share your pen - it is only for you.
Danish: Lån ikke pennen ud til andre - den må kun bruges af dig.
English: • Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Danish: • Hud og allergiske reaktioner ved injektionsstedet: Symptomerne kan omfatte rødme, usædvanligt stærke smerter når der injiceres, kløe, udslæt, hævelse eller betændelse.
English: • When insulin comes out of the needle tip, your pen is working correctly.
Danish: • Når der kommer insulin ud af nålespidsen, fungerer pennen korrekt.
English: • If you do not follow all of these instructions, you may get too much or too little insulin.
Danish: - Hvis du ikke følger alle disse instruktioner, risikerer du at få for meget eller for lidt insulin.
English: Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenosis of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Danish: Særlig forsigtighed bør udvises og intensiveret blodglucosekontrol tilrådes til patienter, hvor hypoglykæmi kan være af særlig klinisk betydning, f.eks. hos patienter med betydende stenose i koronararterierne eller i hjernens forsyningskar (risiko for kardiale eller cerebrale hypoglykæmikomplikationer) og også til patienter med proliferativ retinopati, især hvis denne ikke er laserbehandlet (risiko for forbigående amaurose efter hypoglykæmi).
English: Only use needles that are compatible for use with Toujeo DoubleStar (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford) that are 8 mm long or shorter.
Danish: Brug kun nåle, der er kompatible til anvendelse med Toujeo DoubleStar (f.eks. nåle fra BD, Ypsomed, Artsana eller Owen Mumford) som er 8 mm eller kortere.
English: No dose re-calculation is required.
Danish: Der kræves ingen beregning af dosis.
English: Results from studies comparing Toujeo and insulin glargine 100 units/ml did not indicate any difference in term of development of anti-insulin antibodies, on efficacy, safety or dose of basal insulin between Toujeo and insulin glargine 100 units/ml.
Danish: Resultater fra studier, der sammenligner Toujeo og insulin glargin 100 enheder/ml indikerede ikke nogen forskel i forbindelse med udviklingen af insulinantistoffer, på effektivitet, sikkerhed eller dosis af basalinsulin mellem Toujeo og insulin glargin 100 enheder/ml.
English: • Muscular pain (myalgia).
Danish: • Muskelsmerter (myalgi)
English: Type 1 diabetes mellitus
Danish: Patienter med type 1-diabetes mellitus
English: The efficacy and safety of Toujeo have been studied in a 1:1 randomized controlled open label clinical trial in children and adolescents with type 1 diabetes mellitus for a period of 26 weeks (n=463).
Danish: Virkningen og sikkerheden af Toujeo er blevet undersøgt i et 1:1 randomiseret, kontrolleret, åbent klinisk studie hos børn og unge med type 1 diabetes mellitus i en periode på 26 uger (n=463).
English: • The Toujeo DoubleStar pen contains 900 units of Toujeo.
Danish: • Toujeo DoubleStar pen indeholder 900 enheder af Toujeo.
English: Pens in use must not be stored in the refrigerator.
Danish: Penne i brug må ikke opbevares i køleskab.
English: The strength is highlighted in honey gold on the label of your Toujeo DoubleStar pre-filled pen.
Danish: Styrken er fremhævet i ”honningguld” på etiketten på din Toujeo DoubleStar fyldte pen.
English: Toujeo is a clear and colourless solution.
Danish: Toujeo er en klar farveløs opløsning.
English: 1 step=2 units
Danish: 1 trin = 2 enheder
English: Mean dose of insulin glargine 100 units/ml by study end was 0.42 U/kg.
Danish: Gennemsnitsdosis af insulin glargin 100 enheder/ml ved studiets afslutning var 0,42 E/kg.
English: Never put the inner needle cap back on.
Danish: Sæt aldrig den indre nålekapsel på igen.
English: • In an insulin infusion pump.
Danish: - I en insulininfusionspumpe.
English: Talk to your doctor, pharmacist or nurse before using Toujeo.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Toujeo.
English: • To avoid an insulin underdose, perform safety tests before the first use of a new pen and also before every use of the pen (see Step 3 of the Instrucions for use).
Danish: • For at undgå underdosering af insulin skal en sikkerhedstest altid udføres før en ny pen bruges første gang, og hver gang før pennen bruges (se trin 3 i brugsanvisningen).
English: Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Danish: Hypoglykæmi, der normalt er den hyppigste bivirkning ved insulinbehandling, opstår, hvis insulindosis er for høj i forhold til insulinbehovet.
English: Always carry a spare pen and spare needles in case they get lost or stop working.
Danish: Medbring altid ekstra pen og nåle i tilfælde af, at de bliver væk eller går i stykker.
English: • Do not put the pen back in the fridge.
Danish: • Læg ikke pennen tilbage i køleskabet.
English: Overall the incidence of hypoglycaemia in patients in any category was similar in both treatment groups, with 97.9% of patients in the Toujeo group and 98.2% in the insulin glargine 100 units/mL group reporting at least one event.
Danish: Samlet set var forekomsten af hypoglykæmi hos patienter i enhver kategori sammenlignelig i begge behandlingsgrupper med 97,9 % af patienterne i Toujeo gruppen og 98,2 % i insulin glargin 100 enheder/ml gruppen, som indrapporterede mindst en bivirkning.
English: Contact a doctor as soon as you feel ill or get an injury.
Danish: Sørg for at kontakte lægen tidligt i forløbet, hvis du bliver syg eller kommer til skade.
English: Medication errors prevention
Danish: Medicineringsfejl
English: Similarly, nocturnal hypoglycaemia was comparable in the Toujeo and insulin glargine 100 units/mL treatment groups.
Danish: Tilsvarende, var natlig hypoglykæmi sammenlignelig i Toujeo og insulin glargin 100 enheder/ml behandlingsgrupperne.
English: Even numbers are shown in line with the dose pointer:
Danish: Lige numre vises på linje med dosisviseren:
English: • Your pen contains a total of 450 units of insulin.
Danish: • Pennen indeholder i alt 450 enheder insulin.
English: Toujeo can be used in elderly people, renal and hepatic impaired patients, and children and adolescents from the age of 6 years.
Danish: Toujeo kan bruges af ældre mennesker samt patient med nedsat nyre- og leverfunktion, samt unge og børn fra 6 år.
English: If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3A and STEP 3 B).
Danish: Hvis dette sker: - udskift nålen (se TRIN 6 og TRIN 2), - gentag sikkerhedstesten (TRIN 3).
English: A Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and
Danish: A Vælg 3 enheder ved at dreje dosisvælgeren indtil dosisviseren er ved mærket mellem 2 og
English: - When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia.
Danish: - Ved skift fra Toujeo til insulin glargin 100 enheder/ml bør dosis reduceres (cirka med 20 %) for at reducere risikoen for hypoglykæmi.
English: Toujeo pre-filled pens have to be used as recommended in these Instructions for Use (see section 4.2).
Danish: Toujeo fyldte penne skal anvendes som anbefalet i disse brugsanvisninger (se pkt.
English: Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heart beat, high blood pressure and palpitations.
Danish: Eksempler på symptomer på, at dit blodsukker falder for meget eller for hurtigt: Svedtendens, klam hud, ængstelse, hurtig puls, højt blodtryk, hjertebanken og uregelmæssig puls.
English: • Fluoxetine - for depression.
Danish: - fluoxetin (anvendes til behandling af depression),
English: including in Toujeo therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Danish: De terapeutiske koncentrationer ved insulinbehandling, inklusive behandling med Toujeo, er dog betydeligt lavere end den farmakologiske koncentration, som kræves for at aktivere IGF-1mekanismen.
English: If the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip.
Danish: Hvis pennen er ny må du udføre en sikkerhedstest før pennen bruges første gang indtil der kommer insulin ud af nålespidsen.
English: In patients with type 2 diabetes mellitus, Toujeo can also be given together with other anti-hyperglycaemic medicinal products.
Danish: Til patienter med type 2-diabetes mellitus kan Toujeo også administreres sammen med andre antidiabetika.
English: Many factors may affect your blood sugar level.
Danish: Mange faktorer kan påvirke blodsukkeret.
English: The safety and efficacy of Toujeo in children below 6 years of age have not been established.
Danish: Sikkerhed og virkning af Toujeo er ikke påvist hos børn under 6 år.
English: The Toujeo SoloStar and Toujeo DoubleStar pre-filled pens have been specifically designed for Toujeo and no dose re-calculation is required for either pen.
Danish: Toujeo SoloStar og Toujeo DoubleStar fyldte penne er designet specifikt til Toujeo, og der kræves ingen dosisberegning for hver pen.
English: • Details on how to minimize the safety concern addressed by the additional risk minimization measures through appropriate monitoring and management: - That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo DoubleStar) are not bioequivalent and are therefore not interchangeable without dose adjustment.
Danish: • Nærmere oplysninger om, hvordan man minimerer sikkerhedsproblemet, der er omfattet af de yderligere risikominimeringsforanstaltninger gennem passende monitorering og håndtering: - At insulin glargin 100 enheder/ml og insulin glargin 300 enheder/ml (Toujeo SoloStar og Toujeo DoubleStar) ikke er bioækvivalente og derfor ikke kan erstatte hinanden uden dosisjustering.
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Danish: Efter intravenøs administration var eliminationshalveringstiden af insulin glargin og human insulin sammenlignelig.
English: Effects of insulin glargine 100 units/ml (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Danish: Effekten af insulin glargin 100 enheder/ml (en gang dagligt) på diabetisk retinopati blev undersøgt i et 5 års open-label NPH-kontrolleret studie (NPH givet 2 gange dagligt) med 1024 patienter med type 2diabetes, i hvilket progression af retinopati med 3 eller flere trin på Early Treatment Diabetic Retinopathy Study (ETDRS) standarden, blev undersøgt ved hjælp af fundus-fotografering.
English: Adjusted mean differenceb
Danish: Justeret gennemsnitlig forskelb
English: As cutaneous amyloidosis may lead to insulin resistance due to poor absorption from the infiltrated site, health care professionals and patients should be informed of this event in the PI. Absorption of insulin could be improved by rotating the injection site.
Danish: Da kutan amyloidose kan forårsage insulin resistens grundet dårlig absorption fra den infiltrerede side bør sundhedspersoner og patienter informeres om denne bivirkning i produktinformationen.
English: Medication errors have been reported in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of long-acting insulins.
Danish: Der er indrapporteret tilfælde af medicineringsfejl, hvor andre insuliner, primært hurtigtvirkende insuliner, utilsigtet er blevet administreret i stedet for langtidsvirkende insuliner.
English: The more sustained release of insulin glargine from the Toujeo precipitate compared to insulin glargine 100 units/ml is attributable to the reduction of the injection volume by two thirds that results in a smaller precipitate surface area.
Danish: Den mere vedvarende frigivelse af insulin glargin fra Toujeo-præcipitat sammenlignet med insulin glargin 100 enheder/ml kan henføres til reduktion af injektionsvolumenet med to tredjedele, hvilket resulterer i et mindre overfladeareal med præcipitat.
English: When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to mimimize the risk of hypoglycaemia (see section 4.4).
Danish: Når der skiftes fra basal insulin til Toujeo skal dosisreduktion af basal og bolus insulin overvejes på individuelt grundlag for at minimere risikoen for hypoglykæmi (se pkt.
English: Participants were randomized (1:1) to receive insulin glargine 100 units/ml (n=6264), titrated to reach FPG ≤95 mg/dl (5.3 mM), or standard care (n=6273).
Danish: Patienterne blev randomiseret (1:1) til at få insulin glargin 100 enheder/ml (n=6.264), titreret til at opnå FPG ≤ 5,3 mM (95 mg/dl) eller standardbehandling (n=6.273).
English: A Select 4 units by turning the dose selector until the dose pointer is at the 4 mark.
Danish: A Vælg 4 enheder ved at dreje dosisvælgeren indtil dosisviseren er ved mærket 4.
English: If you use a new pen, perform a safety test (see STEP 3).
Danish: Udfør en sikkerhedstest, hvis du bruger en ny pen (se trin 3).
English: In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
Danish: Til patienter med type 1-diabetes mellitus skal Toujeo kombineres med korttids-/hurtigtvirkende insulin for at dække insulinbehov ved måltider.
English: Mixing or diluting Toujeo changes its time/action profile and mixing causes precipitation.
Danish: Blanding eller fortynding kan ændre dets tids/virknings-profil, og ved blanding kan der forekomme udfældning.
English: Switch from Toujeo to other basal insulins
Danish: Skift fra Toujeo til andre basalinsuliner
English: A Choose a place to inject as shown in the picture labelled “Places to inject” B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
Danish: A Vælg et injektionssted som vist på billedet mærket ”Injektionssteder” B Tryk nålen ind under huden, som vist af din læge, apoteket eller sygeplejersken.
English: The pen may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light.
Danish: Pennen kan opbevares i højst 6 uger ved temperaturer under 30°C væk fra direkte varme eller direkte lys.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomized, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus (treated with ≤1 antidiabetic oral agent) (88% of participants).
Danish: ORIGIN (Outcome Reduction with Initial Glargine INtervention)-studiet var et multicenter, randomiseret, 2x2 faktorielt design studie omfattende 12.537 patienter med høj kardiovaskulær (CV) risiko og enten forhøjet fasteblodsukker (IFG) eller nedsat glucosetolerance (IGT) (12 % af patienterne) eller type 2-diabetes mellitus behandlet med ≤ 1 oralt antidiabetikum (88 % af patienterne).
English: 60 units selected
Danish: 60 enheder valgt
English: Do not perform any dose re-calculation.
Danish: Foretag ikke en genberegning af dosis.
English: Based on the results from clinical studies, the safety profile of Toujeo in elderly patients and in patients with renal impairment was similar to that of the overall population (see section 5.1).
Danish: På baggrund af resultater fra kliniske studier svarede sikkerhedsprofilen for Toujeo hos ældre patienter og hos patienter med nedsat nyrefunktion til den samlede population (se pkt.
English: - That the switch from one insulin therapy to another should only be done when prescribed by their healthcare provider; - That the dose newly recommended by their healthcare provider should always be followed;
Danish: - At skiftet fra en insulinbehandling til en anden kun skal ske, når det er ordineret af deres læge; - At den dosis der nyligst er anbefalet af deres læge altid skal følges; - At blodsukkeret skal overvåges nøje under skiftet og de første uger herefter; - At de skal kontakte deres læge for yderligere informationer;
English: 1.5 ml (SoloStar) 3 ml (DoubleStar)
Danish: 3 ml (DoubleStar)
English: The superiority of Toujeo over insulin glargine 100 units/ml in lowering the risk of confirmed nocturnal hypoglycaemia was shown in patients with type 2 diabetes treated with basal insulin in combination with either non-insulin anti-hyperglycaemic medicinal product (18% risk reduction) or mealtime insulin (21% risk reduction) during the period from week 9 to end of study period.
Danish: Toujeos superioritet i forhold til insulin glargin 100 enheder/ml i forbindelse med at sænke risikoen for bekræftet natlig hypoglykæmi blev påvist hos patienter med type 2-diabetes, der blev behandlet med basalinsulin i kombination med enten antidiabetika uden insulin (18 % risikoreduktion) eller måltidsinsulin (21 % risikoreduktion) i perioden fra uge 9 til slutningen af studieperioden.
English: At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine 100 units/ml group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Danish: Ved baseline havde patienterne en gennemsnitlig HbA1c på 6,4 %, og i hele opfølgningsperioden var den gennemsnitlige HbA1c i insulin glargin 100 enheder/ml-armen mellem 5,9 % og 6,4 %, og i standardbehandlings-armen mellem 6,2 % og 6,6 % gennem hele opfølgningsperioden.
English: • Your pen contains a total of 900 units of insulin.
Danish: • Pennen indeholder i alt 900 enheder insulin.
English: • Detailed description of the modalities used for the self-administration of insulin glargine: - That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo
Danish: • Detaljeret beskrivelse af behandlingsmetoderne brugt til selvadministration af insulin-glargin: - At insulin glargin 100 enheder/ml og insulin glargin 300 enheder/ml (ToujeoSoloStar og Toujeo
English: • Take care when handling needles - this is to prevent needle injury and cross-infection.
Danish: • Vær forsigtig ved håndtering af nåle - dette er for at forhindre uheld med nålen og krydsinfektion.
English: The dose increment in Toujeo SoloStar is one unit and the dose increment in Toujeo DoubleStar is 2 units.
Danish: - Dosisforøgelsen i Toujeo SoloStar er 1 enhed og dosisforøgelsen i Toujeo DoubleStar er 2 enheder.
English: If you stop using Toujeo
Danish: Hvis du holder op med at tage Toujeo
English: After subcutaneous injection of Toujeo, the intra-subject variability, defined as the coefficient of variation for the insulin exposure during 24 hours was low at steady state (17.4%).
Danish: Toujeo viste hos forsøgspersonerne lav intern variabilitet (17.4%), defineret som variationskoefficienten for insulineksponering i 24 timer ved steady state efter subkutan injektion.
English: If the DoubleStar pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:
Danish: Hvis DoubleStar-pennen er beskadiget, ikke har været opbevaret korrekt, hvis du ikke er sikker på, at den fungerer korrekt eller du bemærker, at din blodsukkerkontrol uventet forværres: - Kassér pennen og brug en ny.
English: - Switching from twice-daily basal insulins to once-daily Toujeo, the recommended initial Toujeo dose is 80% of the total daily dose of basal insulin that is being discontinued.
Danish: - Ved skift fra basalinsulin, der skal tages 2 gange daglig, til Toujeo 1 gang daglig er den anbefalede initiale Toujeo-dosis 80 % af den totale daglige dosis af basalinsulin, der er ved at blive seponeret.
English: If you don't, your full dose will not be delivered.
Danish: Hvis du ikke gør dette, vil du ikke få den fulde dosis.
English: The MAH is therefore requested to include the event cutaneous amyloidosis in the SmPC and PIL.
Danish: Indehaveren af markedsføringstilladelsen skal derfor inkludere bivirkningen kutan amyloidose i SmPC og PIL.
English: Pioglitazone used together with insulin
Danish: Pioglitazon anvendt i kombination med insulin
English: • Ensure to use the right insulin.
Danish: • Sørg for at bruge det rigtige insulin.
English: If the SoloStar pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:
Danish: Hvis SoloStar-pennen er beskadiget, ikke har været opbevaret korrekt, hvis du ikke er sikker på, at den fungerer korrekt eller du bemærker, at din blodsukkerkontrol uventet forværres: - Kassér pennen og brug en ny.