FrancophonIA/ELRC3.0 huggingface dataset:
English: IGlar: Insulin glargine 100 units/ml a Severe hypoglycaemia: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Danish: IGlar: Insulin glargin 100 enheder/ml a Alvorlig hypoglykæmi: Episode, der kræver assistance fra en anden person for aktivt at administrere kulhydrat, glucagon eller andre genoplivningshandlinger.
English: However, only very rarely, this will require a change to your insulin dose.
Danish: Dette vil imidlertid meget sjældent medføre behov for at ændre din insulindosis.
English: • a new sterile needle (see STEP 2).
Danish: • En ny steril nål (se TRIN 2).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for insulin glargine, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for insulin glargin er CHMP nået frem til følgende videnskabelige konklusioner:
English: The use of Toujeo may be considered during pregnancy, if clinically needed.
Danish: Anvendelsen af Toujeo til gravide kan overvejes, hvis det behandlingsmæssigt er nødvendigt.
English: 900 units per pen
Danish: 900 enheder per pen
English: In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening.
Danish: I sådanne tilfælde kan du udvikle alvorlig hypoglykæmi (og endda besvime), før du selv bliver klar over problemet.
English: • Check your blood sugar and then inject your next dose at the usual time.
Danish: - Tjek dit blodsukker og tag derefter den næste dosis på det sædvanlige tidspunkt.
English: The dose-response analysis showed that following the initial titration phase, the body weight adjusted doses in pediatric patients are higher than in adult patients at steady state.
Danish: Dosisresponsanalysen viste, at de legemsvægtjusterede doser, efter den initiale titreringsfase, er højere hos pædiatriske patienter end hos voksne patienter ved steady state.
English: Patients should be informed not to inject a double dose to make up for a forgotten dose.
Danish: Patienterne skal informeres om aldrig at tage en dobbelt dosis for at kompensere for den glemte dosis.
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin).
Danish: Insulinbehandling kan få kroppen til at producere antistoffer mod insulin (stoffer der reagerer mod insulin).
English: • If safety tests are not performed before the first use of a new pen, insulin underdose can occur.
Danish: • Hvis sikkerhedstestene ikke udføres inden første gang en ny pen bruges, kan underdosering af insulin forekomme.
English: The solution should be clear, colourless and water-like.
Danish: Opløsningen skal være klar, farveløs og ligne vand.
English: In most cases you will talk to a doctor.
Danish: I de fleste tilfælde skal du kontakte en læge.
English: Do not soak, wash or lubricate your pen - this may damage it.
Danish: Pennen må aldrig skylles, vaskes eller smøres - dette kan beskadige den.
English: • Set the dose by turning the dose selector to a line in the dose window.
Danish: • Indstil dosen ved at dreje dosisvælgeren til en linje i dosisvinduet.
English: • If there are particles in the insulin.
Danish: - Hvis der er partikler i insulinet.
English: Your doctor may tell you to use it with a short-acting insulin, or with other medicines for high blood sugar.
Danish: Din læge vil muligvis give dig besked på at tage det sammen med et hurtigtvirkende insulin eller med tabletter mod højt blodsukker.
English: Toujeo is a long-acting insulin.
Danish: Toujeo er et langtidsvirkende insulin.
English: Efficacy and safety data for paediatric patients with type 2 diabetes mellitus have been extrapolated from data for adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Danish: Virknings- og sikkerhedsdata for pædiatriske patienter med type 2 diabetes mellitus blev ekstrapoleret fra data for unge og voksne patienter med type 1 diabetes mellitus og voksne patienter med type 2 diabetes mellitus.
English: In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper-or hypoglycaemia.
Danish: I sjældne tilfælde kræver forekomsten af sådanne insulinantistoffer justering af insulindosis for at korrigere for tendensen til hyper- eller hypoglykæmi.
English: Used needles should be thrown away in a puncture resistant container or disposed of in accordance with local requirements.
Danish: Anvendte nåle skal kasseres i en punkteringsfri kanylebeholder eller kasseres i henhold til lokale retningslinjer.
English: Prior to launch of Toujeo 300 units/ml in each Member State the MAH must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Danish: Før markedsføring af Toujeo 300 enheder/ml i hver medlemsstat skal indehaveren af markedsføringstilladelsen aftale indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionskanaler og alle andre aspekter, med den nationale kompetente myndighed.
English: You should know these factors so that you can take the right action if your blood sugar level changes and help step it becoming too high or too low.
Danish: Du bør være bekendt med disse faktorer for at kunne handle korrekt i tilfælde af ændringer i dit blodsukker og for at forhindre, at blodsukkeret bliver for højt eller for lavt.
English: Figure 1: Activity profile at steady state in patients with type 1 diabetes in a 36-hour euglycaemic clamp study
Danish: Figur 1: Aktivitetsprofil ved steady state hos patienter med type 1-diabetes i et 36-timers euglykæmisk clamp-studie
English: If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy, may affect up to 1 in 10 people).
Danish: Hvis du for ofte injicerer dit insulin på samme sted på huden kan fedtvævet under huden på dette sted svinde ind (lipoatrofi, kan forekomme hos op til 1 ud af 100 patienter) eller blive tykkere (lipohypertrofi, kan forekomme hos op til 1 ud af 10 patienter).
English: Previously insulin naive patients
Danish: Tidligere insulinnaive patienter
English: When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration (see section 5.1).
Danish: Efter behov kan patienter administrere Toujeo op til 3 timer før eller efter deres sædvanlige administrationstidspunkt (se pkt.
English: This may mean your insulin dose has to change.
Danish: Dette kan betyde, at din insulindosis skal ændres.
English: • Low blood sugar means that there is not enough sugar in your blood.
Danish: • Lavt blodsukker betyder, at der ikke er nok sukker i blodet.
English: • Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
Danish: • Tal med din læge, apoteket eller sygeplejersken om, hvordan du udfører en injektion, før du bruger pennen.
English: Paediatric population Population pharmacokinetic analysis was conducted for Toujeo based on concentration data of its main metabolite M1 using data from 75 pediatric subjects (6 to <18 years of age) with type 1 diabetes.
Danish: Der blev udført en farmakokinetisk populationsanalyse for Toujeo, baseret på koncentrationsdata af dets primære metabolit M1, ved brug af data fra 75 pædiatriske forsøgspersoner (6 til < 18 år) med type 1 diabetes.
English: This is because this medicine lowers your blood sugar over a long period of time (for more information, see section 3).
Danish: Dette skyldes, at Toujeo sænker dit blodsukker over en længere periode (for yderligere oplysninger, se punkt 3).
English: SoloStar pen1 step=1 unit DoubleStar pen 1 step=2 units
Danish: SoloStar pen 1 trin = 1 enhed DoubleStar pen 1 trin = 2 enheder
English: Diabetes mellitus is an illness where your body does not make enough insulin to control your blood sugar.
Danish: Diabetes mellitus er en sygdom, som skyldes, at kroppen ikke danner tilstrækkeligt med insulin til at holde blodsukkeret under kontrol.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, longacting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose (see section 4.2).
Danish: Ændringer i styrke, mærke (producent), type (almindelig, NPH, langsomt virkende, langtidsvirkende, osv.), oprindelse (animalsk, human, human insulin-analog) og/eller fremstillingsmetode kan resultere i et behov for en dosisændring (se pkt.
English: This could cause high blood sugar.
Danish: Dette kan forårsage højt blodsukker.
English: • This will make sure you get your full dose.
Danish: • Dette sikrer, at hele din dosis er udløst.
English: Switching from the 300 units/ml to the 100 units/ml concentration results in an increased risk of hypoglycaemic events, mainly in the first week after the switch.
Danish: - Skift fra formuleringen med 300 enheder/ml til 100 enheder/ml formuleringen resulterer i øget risiko for hypoglykæmiske hændelser, især i den første uge efter skiftet.
English: Toujeo must not be used in insulin infusion pumps.
Danish: Toujeo må ikke anvendes i insulininfusionspumper.
English: On the basis of the scientific conclusions for insulin glargine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing insulin glargine is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for insulin glargin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder insulin glargin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Toujeo is not the insulin of choice for the treatment of diabetic ketoacidosis.
Danish: Toujeo er ikke det insulinpræparat, man først skal vælge til behandling af diabetisk ketoacidose.
English: Toujeo can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients (see sections 5.1and 5.2).
Danish: Toujeo kan anvendes til unge og børn fra 6 år, baseret på de samme principper som for voksne patienter (se pkt.
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. At pH 4, insulin glargine is completely soluble.
Danish: Insulin glargin er en human insulin-analog, der er udviklet til at have lille opløselighed ved neutral pH. Ved pH 4 er insulin glargin fuldstændig opløseligt.
English: Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption.
Danish: Lipodystrofi og kutan amyloidose kan opstå på injektionsstedet og forsinke den lokale insulinabsorption.
English: EU/1/00/133/033 1 pen (SoloStar) EU/1/00/133/034 3 pens (SoloStar) EU/1/00/133/035 5 pens (SoloStar) EU/1/00/133/036 10 pens (SoloStar) EU/1/00/133/037 1 pen (DoubleStar) EU/1/00/133/038 3 pens (DoubleStar) EU/1/00/133/041 10 pens (DoubleStar)
Danish: EU/1/00/133/033 1 pen (SoloStar) EU/1/00/133/034 3 penne (SoloStar) EU/1/00/133/035 5 penne (SoloStar) EU/1/00/133/036 10 penne (SoloStar) EU/1/00/133/037 1 pen (DoubleStar) EU/1/00/133/038 3 penne (DoubleStar) EU/1/00/133/041 10 penne (DoubleStar)
English: • check your pen and the needle are working properly.
Danish: • Kontrollere at pen og nål virker korrekt.
English: • You find it hard to recognise when your blood sugar is too low.
Danish: - Du har svært ved at mærke, når dit blodsukker er for lavt.
English: 58 units selected
Danish: 58 enheder valgt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON Multipack (contains Blue Box)
Danish: OPLYSNINGER DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDREKARTON Multipakke (indeholder blå box)
English: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
Danish: Behandling af diabetes mellitus hos voksne, unge og børn fra 6 år.
English: • To reduce the risk of accidental needle injury, never replace the inner needle cap.
Danish: • For at reducere risikoen for uheld med nålen må den indre nålekapsel aldrig sættes på igen.
English: If you have kidney or liver problems, talk to your doctor as you may need a lower dose.
Danish: Hvis du har nyre- eller leverproblemer Hvis du har nyre- eller leverproblemer, så tal med din læge, da du muligvis skal have en lavere dosis.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If this occurs, patients should increase the frequency of checking their blood glucose levels and might need to administer additional insulin.
Danish: Hvis dette sker, bør patienterne øge hyppigheden hvormed de kontrollerer deres blodsukkerniveau og muligvis være nødt til at administere ekstra insulin.
English: Mean change in body weight of less than 1 kg at the end of the 6-month period was observed in Toujeo-treated patients (see Table 1 and 2).
Danish: Der blev obsereveret en gennemsnitlig ændring i legemsvægt på under 1 kg ved udgangen af 6måneders perioden hos patienter behandlet med Toujeo (se Tabel 1 og 2).
English: Toujeo must not be administered intravenously.
Danish: Toujeo må ikke indgives intravenøst.
English: • You may see air bubbles in the insulin.
Danish: Hvis du ser luftbobler • Der kan være luftbobler i insulinet.
English: Toujeo is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day.
Danish: Toujeo er en basalinsulin til administration en gang daglig, der kan gives på et hvilket som helst tidspunkt af dagen men helst på samme tid hver dag.
English: Insulin glargine 100 units/ml did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Danish: Insulin glargin 100 enheder/ml ændrede ikke den relative risiko for CV-sygdom og CV-mortalitet sammenlignet med standardbehandling.
English: You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.
Danish: Det anbefales, at blodsukkeret kontrolleres umiddelbart efter indtagelsen af sukker, for at se om du virkelig havde hypoglykæmi.
English: Although Toujeo contains the same active substance as insulin glargine 100 units/ml, these medicines are not interchangeable.
Danish: Selvom Toujeo indeholder det samme aktive stof som insulin glargin 100 enheder/ml, er disse lægemidler ikke indbyrdes udskiftelige.
English: After subcutaneous injection of insulin glargine, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Danish: Efter subkutan injektion af insulin glargin, bliver insulin glargin hurtigt metaboliseret ved carboxylenden af beta-kæden under dannelse af to aktive metabolitter M1 (21A-Gly-insulin) og M2 (21A-Gly-des-30B-Thr-insulin).
English: • a puncture resistant container for used needles and pens.
Danish: • En punkterfri beholder til bortskaffelse af brugte nåle og penne.
English: Over the course of this 6-year study, 42% of the insulin glargine 100 units/ml group did not experience any hypoglycaemia.
Danish: I løbet af dette 6-års studie oplevede 42 % af patienterne i insulin glargin 100 enheder/mlgruppen ingen hypoglykæmi.
English: Switch between other insulins and Toujeo
Danish: Skift mellem andre insuliner og Toujeo
English: These units are exclusive to Toujeo and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Danish: Disse enheder gælder udelukkende for Toujeo og er ikke det samme som IE eller enhederne, som angiver styrken på andre insulin-analoger (se pkt.
English: The MAH shall ensure that in each Member State where Toujeo 300 units/ml is marketed, all healthcare professionals (HCPs) who are expected to prescribe or dispense Toujeo 300 units/ml, as well as all patients or their carers who are expected to use Toujeo 300 units/ml, are provided with educational material to address the risk(s) of Medication error (switching between 100 units/ml and 300 units/ml without dose adjustment).
Danish: Indehaveren af markedsføringstilladelsen skal sikre sig, at i hver medlemsstat, hvor Toujeo 300 enheder/ml markedsføres, er alle sundhedspersoner (HCP'er), som forventes at ordinere eller udlevere Toujeo 300 enheder/ml, samt alle patienter eller deres omsorgspersoner, der forventes at bruge Toujeo 300 enheder/ml, forsynet med undervisningsmateriale for at imødegå risiko/risici for medicineringsfejl (skift mellem 100 enheder/ml og 300 enheder/ml uden dosisjustering).
English: Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Toujeo.
Danish: Patienter, som på grund af antistoffer mod humant insulin får høje insulindoser, kan få et bedre insulinrespons med Toujeo.
English: • Do not touch the injection button yet.
Danish: • Tryk ikke på dosisknappen endnu.
English: - That dose adjustment is needed when patients are switched from one to the other strength: After titration, on average a 10-18% higher basal insulin dose are needed to achieve target ranges for plasma glucose levels when using the 300 units/ml formulation compared to the 100 units/ml formulation.
Danish: - At dosisjustering er nødvendig, når patienter skiftes fra den ene til den anden styrke: - Efter titrering er det i gennemsnit nødvendigt med 10-18 % højere dosis basalinsulin for at opnå målområdet for plasmaglucoseniveauet, når der anvendes formuleringen med 300 enheder/ml sammenlignet med formuleringen med 100 enheder/ml.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes with a medicinal product containing insulin glargine 100 units/ml) indicate no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditeter med et lægemiddel, som indeholder insulin glargin 100 enheder/ml) viser ingen specifikke skadelige virkninger af insulin glargin på graviditet og ingen specifikke misdannelser eller føtal/neonatal toksicitet.
English: If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all.
Danish: Hvis der ikke kommer insulin ud før du tager din dose, kan du få en underdosering eller ingen insulin.
English: The half-life after subcutaneous administration of Toujeo is determined by the rate of absorption from the subcutaneous tissue.
Danish: Halveringstiden efter subkutan administration af Toujeo bestemmes af absorptionshastigheden fra det subkutane væv.
English: • Changes in taste (dysgeusia).
Danish: • Smagsforstyrrelser (dysgeusi)
English: The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor.
Danish: Den totale terapeutiske insulinkoncentration (insulin glargin og dets metabolitter) hos type 1diabetespatienter var betydeligt lavere, end hvad der ville kræves for halv maksimal mætning af IGF1-receptoren og den efterfølgende aktivering af den mitogen-proliferative mekanisme initieret af IGFreceptoren.
English: If you are 65 years or older, talk to your doctor as you may need a lower dose.
Danish: Anvendelse til ældre patienter (65 år og derover) Hvis du er 65 år eller ældre, så tal med din læge, da du muligvis skal have en lavere dosis.
English: Instruct patients to perform a safety test as described in Step 3 of the Instructions for Use.
Danish: Instruer patienter i at udføre en sikkerhedstest som beskrevet i trin 3 i brugsanvisningen.
English: The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light.
Danish: Lægemidlet kan opbevares i maksimalt 6 uger ved temperaturer under 30°C og væk fra direkte varme eller direkte lys.
English: • Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
Danish: • Udskift nålen (se TRIN 6 og TRIN 2), udfør derefter en sikkerhedstest (se TRIN 3).
English: In a clinical pharmacology study, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses.
Danish: I kliniske farmakologiforsøg har intravenøst insulin glargin og humant insulin vist sig at være equipotente, når disse blev givet i samme doser.
English: The prolonged duration of action of Toujeo is dependent on its injection into subcutaneous tissue.
Danish: Den forlængede virkningsvarighed af Toujeo afhænger af injektionen i det subkutane væv.
English: Safety and efficacy of Toujeo have been demonstrated in a study in children aged 6 to less than 18 years.
Danish: Sikkerheden og virkningen af Toujeo er blevet påvist i et studie med børn i alderen 6 til <18 år.
English: Toujeo with alcohol
Danish: Brug af Toujeo sammen med alkohol
English: With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary.
Danish: På grund af forbedret metabolisk kontrol og deraf følgende øget insulinfølsomhed, kan yderligere dosisjustering blive nødvendig.
English: Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml.
Danish: Toujeo indeholder 3 gange mere insulin i 1 milliliter (ml) end standardinsulin, som indeholder 100 enheder/ml.
English: See “Pioglitazone used together with insulin”.
Danish: Se ”Pioglitazon anvendt i kombination med insulin”.
English: IGlar: Insulin glargine 100 units/ml a mITT: Modified intention-to-treat b Treatment difference: Toujeo- insulin glargine 100 units/ml; [95% Confidence Interval] c Change from baseline to Month 6 (observed case) d Change from baseline to Last main 6-month on-treatment value
Danish: IGlar: Insulin glargin 100 enheder/ml a mITT: Modificeret intention-to-treat b Behandlingsforskel: Toujeo- insulin glargin 100 enheder/ml, [95 % konfidensinterval] c Ændring fra baseline til 6. måned (observeret case) d Ændring fra baseline til sidste primære 6-måneders behandlingsværdi
English: For single patient use only.
Danish: Samme pen må kun bruges til en patient.
English: • The Toujeo SoloStar pen contains 450 units of Toujeo.
Danish: • Toujeo SoloStar pen indeholder 450 enheder af Toujeo.
English: Dose adjustment may also be required, for example, if the patient's weight or life-style changes, if there is a change in the timing of insulin dose or if other circumstances arise that increase susceptibility to hypo-or hyperglycaemia (see section 4.4).
Danish: Dosisjustering kan også blive nødvendig, hvis f.eks. patientens vægt eller livsstil ændres, ændring af tidspunkt for insulindosis, eller hvis andre omstændigheder gør, at følsomheden for hypo- eller hyperglykæmi øges (se pkt.
English: Overall, these effects on hypoglycaemia risk were consistently observed whatever the age, gender, BMI and duration of diabetes (<10 years and ≥10 years) in Toujeo-treated patients compared to insulin glargine 100 units/ml-treated patients.
Danish: Samlet set blev disse virkninger på hypoglykæmisk risiko konsekvent overholdt uanset alder, køn, BMI og varighed af diabetes (<10 år og ≥10 år) hos Toujeo-behandlede patienter sammenlignet med patienter behandlet med insulin glargin 100 enheder/ml.
English: A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
Danish: A Sæt det ydre nålehylster tilbage på nålen og brug det til at skrue nålen af pennen.
English: Patients previously treated with basal insulin
Danish: Patienter tidligere behandlet med basalinsulin
English: Your blood sugar level may become too low (hypoglycaemia).
Danish: Dit blodsukkerniveau kan blive for lavt (hypoglykæmi).