FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid dosing errors and potential overdose, the patients must be instructed to never use a syringe to remove Toujeo (insulin glargine 300 units/ml) from the Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen (see section 4.9 and 6.6).
Danish: For at undgå doseringsfejl og potentiel overdosis skal patienterne instrueres i aldrig at bruge en sprøjte til at fjerne Toujeo (insulin glargin 300 enheder/ml) fra den fyldte Toujeo SoloStar-pen eller den fyldte Toujeo DoubleStar-pen (se pkt.
English: Please, see also section 3.
Danish: Se også punkt 3.
English: Please, see also section 2.
Danish: Se også punkt 2.
English: If you have missed a dose of Toujeo or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):
Danish: Hvis du har sprunget en dosis Toujeo over, eller hvis du ikke har injiceret nok insulin, kan blodsukkeret blive for højt (hyperglykæmi).
English: Always perform a safety test before you use a new pen for the first time until you see insulin coming out of the needle tip (see STEP 3).
Danish: Udfør altid en sikkerhedstest før en ny pen bruges første gang indtil der kommer insulin ud af nålespidsen (se trin 3).
English: A Choose a place to inject as shown in the picture B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
Danish: A Vælg et injektionssted som vist på billedet B Tryk nålen ind under huden, som vist af din læge, apoteket eller sygeplejersken.
English: • Use Toujeo once a day, preferably at the same time every day.
Danish: Fleksibilitet i administrationstid - Brug Toujeo en gang om dagen, helst på samme tidspunkt hver dag.
English: The prolonged effect of insulin glargine may delay recovery from hypoglycaemia.
Danish: Den forlængede virkning af subkutan insulin glargin kan forsinke hypoglykæmiens ophør.
English: The overall efficacy and safety of Toujeo (insulin glargine 300 units/ml) once-daily on glycaemic control was compared to that of once-daily insulin glargine 100 units/ml in open-label, randomised, active-control, parallel studies of up to 26 weeks of duration, including 546 patients with type 1 diabetes mellitus and 2,474 patients with type 2 diabetes mellitus (Table 1 and 2).
Danish: Den samlede effekt og sikkerhed af Toujeo (insulin glargin 300 enheder/ml) en gang daglig på glykæmisk kontrol blev sammenlignet med behandlingen med insulin glargin 100 enheder/ml en gang daglig i open label, randomiserede, parallelle studier med aktiv kontrol på op til 26 ugers varighed, der inkluderede 546 patienter med type 1-diabetes mellitus og 2474 patienter med type 2-diabetes mellitus (Tabel 1 og 2).
English: Switch between insulin glargine 100 units/ml and Toujeo Since insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not interchangeable, switching may result in the need for a change in dose and should only be done under strict medical supervision (see section 4.2).
Danish: Skift mellem insulin glargin 100 enheder/ml og Toujeo Da insulin glargin 100 enheder/ml og Toujeo ikke er bioækvivalente og derfor ikke direkte udskiftelige, kan skift resultere i behov for at ændre dosis og bør kun gøres under nøje medicinsk overvågning (se pkt.
English: - When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit-to-unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels.
Danish: - Ved skift fra insulin glargin 100 enheder/ml til Toujeo gøres dette på enhed-til-enhed basis men en højere dosis af Toujeo (cirka 10-18 %) kan være nødvendig for at opnå det ønskede målområde for plasmaglucoseniveauet.
English: Patients should be informed that the dose counter of Toujeo SoloStar or Toujeo DoubleStar pre-filled pen shows the number of units of Toujeo to be injected.
Danish: Patienter skal informeres om, at dosistælleren i Toujeo SoloStar eller Toujeo DoubleStar fyldte penne viser det antal enheder af Toujeo som skal injiceres.
English: At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine 100 units/ml group and a mean decrease of 0.8 kg in the standard care group.
Danish: Ved det sidste besøg i behandlingsperioden var der en gennemsnitlig vægtstigning fra baseline på 1,4 kg i insulin glargin 100 enheder/ml-armen og et gennemsnitligt vægttab på 0,8 kg i standardbehandlings-armen.
English: • Do not inject a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis, som erstatning for en glemt dosis.
English: c Nocturnal hypoglycaemia: Episode that occurred between 00:00 and 05:59 hours d 6-month treatment period
Danish: c Natlig hypoglykæmi: Episode, der fandt sted mellem 0:00 og 5:59 d 6-måneders behandlingsperiode *RR: anslået risikoforhold; [95 % konfidensinterval]
English: To prevent the possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed.
Danish: For at forebygge mulig overførsel af sygdom må insulinpenne aldrig bruges af mere end en person, selv hvis nålen skiftes (se pkt.
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine 100 units/ml and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine 100 units/ml and 2.44 for standard care group.
Danish: Forekomsten af alvorlig hypoglykæmi (antal påvirkede patienter pr. 100 patientår) var 1,05 i insulin glargin 100 enheder/ml-armen og 0,30 i standardbehandlings-armen, og forekomsten af bekræftet ikke-alvorlig hypoglykæmi var 7,71 for insulin glargin 100 enheder/ml og 2,44 for standardbehandling.
English: D Keep the injection button held in and when you see "0" in the dose window, slowly count to
Danish: D Hold dosisknappen inde, og tæl langsom til 5, når du ser ”0” i dosisdisplayet.
English: This will change the way it works and may cause your blood sugar to become too low.
Danish: Dette vil ændre dets virkning, og kan forårsage for lavt blodsukker.
English: Packs of 1, 3, 5 and 10 pre-filled pens.
Danish: Pakninger med 1, 3, 5 og 10 fyldte penne.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Kontakt din læge eller apotekspersonalet, hvis du får nogen af følgende bivirkninger:
English: Packs of 1, 3, 5 and 10 pens are available.
Danish: Pakninger med 1, 3, 5 og 10 penne er tilgængelige.
English: These include patients: - in whom glycaemic control is markedly improved, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
Danish: Disse omfatter: - patienter, hvor den glykæmiske kontrol er forbedret betydeligt, - patienter, hvor hypoglykæmi udvikles gradvist, - ældre patienter, - efter skift fra animalsk insulin til human insulin, - patienter, som lider af autonom neuropati, - patienter med en lang diabetes-anamnese, - patienter, som har en psykisk lidelse, - patienter, som er i samtidig behandling med visse andre lægemidler (se pkt.
English: Toujeo must not be mixed or diluted with any other insulin or other medicinal products.
Danish: Toujeo må ikke blandes med andre insuliner eller fortyndes.
English: B Turn the dose selector until the dose pointer lines up with your dose.
Danish: B Drej dosisvælgeren, indtil dosisviseren er ud for din dosis.
English: Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing.
Danish: Genbrug af nåle øger risikoen for blokerede nåle, som kan forårsage underdosering eller overdosering.
English: This may lead to you getting too much insulin or not enough insulin.
Danish: Dette kan føre til at du får enten for meget eller lidt insulin.
English: Plasma glucose reductions at the end of the trial with Toujeo were similar to insulin glargine 100 units/ml with a more gradual reduction during the titration period with Toujeo.
Danish: Reduktioner i plasmaglucose med Toujeo ved studiets afslutning svarede til insulin glargin 100 enheder/ml med en mere gradvis reduktion i titreringsperioden med Toujeo.
English: B Press the injection button all the way in.
Danish: B Tryk dosisknappen helt i bund.
English: Special populations
Danish: Særlig population
English: The percentage of patients with hyperglycaemic episodes with ketosis was lower for Toujeo versus insulin glargine 100 units/mL, 6.4% and 11.8%, respectively.
Danish: Procentdelen af patienter med hyperglykæmiske episoder med ketose var lavere for Toujeo gruppen versus insulin glargin 100 enheder/ml gruppen, henholdsvis 6,4 % og 11,8.
English: Before using Toujeo SoloStar or Toujeo DoubleStar pre-filled pen, the Instructions for Use included in the package leaflet must be read carefully.
Danish: Før anvendelse af Toujeo SoloStar eller Toujeo DoubleStar fyldt pen skal brugsanvisningen, som er inkluderet i indlægssedlen, læses grundigt.
English: In the event of blocked needle, the patients must follow the instructions described in Step 3 of the Instructions for Use accompanying the package leaflet (see section 6.6).
Danish: I tilfælde af blokeret nål skal patienterne følge anvisningerne beskrevet i Trin 3 i brugsanvisningen, der følger med indlægssedlen (se pkt.
English: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism (see section 4.8).
Danish: Hos patienter med nedsat nyrefunktion kan insulinbehovet være reduceret på grund af nedsat insulinmetabolisme (se pkt.
English: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Danish: Kombinationsbehandling med Toujeo og pioglitazon Der er indrapporteret tilfælde af hjertesvigt ved anvendelse af pioglitazon i kombination med insulin, særligt hos patienter med risikofaktorer for udvikling af hjertesvigt.
English: • Perform a safety test as described in Step 3 of the Instructions for Use.
Danish: - Udfør sikkerhedstesten som beskrevet i trin 3 i brugsanvisningen.
English: 0.04 [-0.098 to 0.185]
Danish: 0,04 [-0,098 til 0,185]
English: If you experience signs of heart failure such as unusual shortness of breath, a rapid increase in weight or localised swelling (oedema).
Danish: Hvis du oplever tegn på hjertesvigt såsom unormal åndenød, hurtig vægtstigning eller ophobning af væske (ødemer), skal du kontakte din læge så hurtigt som muligt.
English: • Too low blood sugar (hypoglycaemia).
Danish: • Lavt blodsukker (hypoglykæmi).
English: • Other: The Guide for healthcare professionals is also highlighting the distinction between the different Toujeo presentations: That insulin glargine 300 units/ml is available in two different presentations: Toujeo SoloStar (1.5 mL prefilled pen/450 units) and Toujeo DoubleStar (3 mL prefilled pen/900 units).
Danish: • Andet: Vejledningen til sundhedspersonalet understreger også forskellen mellem de forskellige Toujeo præsentationer: - At insulin glargin 300 enheder/ml er tilgængelig i to forskellige præsentationer: Toujeo SoloStar (1,5 mL fyldt pen/450 enheder) og Toujeo DoubleStar (3 mL fyldt pen/900 enheder).
English: Results from all clinical trials with Toujeo indicated that reductions in HbA1c from baseline to end of trial were non-inferior to insulin glargine 100 units/ml.
Danish: Resultater fra alle kliniske studier med Toujeo viste, at reduktioner i HbA1c fra baseline til slutningen af studiet var sammenlignelig med insulin glargin 100 enheder/ml.
English: Signs in your brain include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.
Danish: Eksempler på symptomerne på lavt blodsukker i hjernen er: Hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, søvnforstyrrelser, rastløshed, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, konfusion, taleforstyrrelser (til tider fuldstændig tab af talens brug), synsforstyrrelser, rysten, lammelser, prikkende og stikkende fornemmelse (paræstesi), følelsesløshed og prikken og stikken omkring munden, svimmelhed, manglende selvbeherskelse, hjælpeløshed, kramper, bevidstløshed.
English: • Talk to your doctor, pharmacist or nurse if you think you have problem with your pen.
Danish: - Få det undersøgt hos din læge, på apoteket eller af din sygeplejerske, hvis du mener, der er et problem med pennen.
English: Toujeo is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh.
Danish: Toujeo indgives som subkutan injektion i bugvæggen, deltamusklen eller låret.
English: Results from clinical trials demonstrated that the incidence of confirmed hypoglycaemia (at any time of the day and nocturnal) was lower in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients, in patients with type 2 diabetes treated in combination with either non-insulin anti-hyperglycaemic medicinal product or mealtime insulin.
Danish: Resultater fra kliniske studier viste, at forekomsten af bekræftet hypoglykæmi (på hvilket som helst tidspunkt på dagen og natten) var lavere hos patienter behandlet med Toujeo sammenlignet med patienter behandlet med insulin glargin 100 enheder/ml, hos patienter med type 2-diabetes behandlet i kombination med enten antidiabetika uden insulin eller måltidsinsulin.
English: EU/1/00/133/039 6 pens (2 packs of 3) EU/1/00/133/040 9 pens (3 packs of 3)
Danish: EU/1/00/133/040 9 penne (3 pakker af 3)
English: For storage conditions after first opening of this medicinal product, see section 6.3.
Danish: Efter første anvendelse eller hvis taget med i reserve For opbevaringsforhold efter første anvendelse af dette lægemiddel, se pkt.
English: Injection sites must be rotated within a given injection area from one injection to the next (see section 4.8).
Danish: Injektionsstedet skal skiftes inden for det enkelte injektionsområde mellem injektionerne (se pkt.
English: Multipack: 6 (2 packs of 3) pens
Danish: Multipakke: 6 (2 pakker af 3) penne
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box
Danish: INDRE KARTON uden blå boks
English: As observed in euglycaemic clamp studies in patients with type 1 diabetes, the glucose lowering effect of Toujeo was more stable and prolonged in comparison with insulin glargine 100 units/ml after subcutaneous injection.
Danish: Som observeret i euglykæmiske clamp-studier hos patienter med type 1-diabetes, var Toujeos glucosesænkende virkning mere stabil og langvarig sammenlignet med insulin glargin 100 enheder/ml (Lantus) efter subkutan injektion.
English: Number of subjects treated (mITTa)
Danish: Antal behandlede personer (mITTa) HbA1c
English: • For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Danish: - Information om behandling af hyperglykæmi findes i det indrammede afsnit sidst i indlægssedlen.
English: To ensure the pen and needle are working, always perform the safety test until you see insulin coming out the needle tip before each injection (see STEP 3).
Danish: For at sikre at pennen og nålen virker skal en sikkerhedstest altid udføres før hver injektion indtil der kommer insulin ud af nålespidsen (se trin 3).
English: Medication errors due to mix-up between insulins, particularly between long-acting insulins and rapid-acting insulins have been reported.
Danish: Medicineringsfejl som følge af forveksling mellem insuliner, især mellem langtidsvirkende insuliner og hurtigtvirkende insuliner, er blevet rapporteret.
English: • Disopyramide - for some heart problems.
Danish: - disopyramid (anvendes til behandling af visse hjertesygdomme).
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Danish: Nogle patienter med årelang type 2-diabetes mellitus og hjertesygdom eller tidligere slagtilfælde, der var i behandling med pioglitazon (oral antidiabetikum, der anvendes til behandling af type 2-diabetes mellitus) og insulin, udviklede hjertesvigt.
English: • Throw away your used pen as told by your pharmacist or local authority.
Danish: • Pennen skal bortskaffes i overensstemmelse med apotekets eller kommunens anvisninger.
English: Each ml contains 300 units (10.91 mg) insulin glargine.
Danish: Hver ml indeholder 300 enheder (10,91 mg) insulin glargin.
English: Basal insulin dosec (U/kg)
Danish: Basalinsulin dosisc (U/kg)
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Danish: Stoffer, som kan forstærke den blodsukkersænkende effekt, og som kan øge risikoen for hypoglykæmi, omfatter orale antidiabetika, ACE (angiotensin converting enzyme)-hæmmere, disopyramid, fibrater, fluoxetin, monoaminoxidase (MAO)-hæmmere, pentoxifyllin, propoxyphen, salicylater og sulfonamidantibiotika.
English: Then eat something (such as bread or pasta) that will raise your blood sugar over a longer time.
Danish: Spis herefter madvarer med langsomt optagelige kulhydrater (såsom brød eller pasta) for at normalisere dit blodsukker.
English: Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pens are available.
Danish: Pakninger med 1, 3, 6 (2 pakker med 3), 9 (3 pakker med 3) og 10 penne er tilgængelige.
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy,
Danish: Fysiologiske koncentrationer af endogen IGF-1 aktiverer måske den mitogen-proliferative mekanisme.
English: - Switching from once-daily basal insulins to once-daily Toujeo can be done unit-to-unit based on the previous basal insulin dose.
Danish: - Skift fra basalinsulin, der skal tages en gang daglig, til Toujeo en gang daglig kan gøres enhed-til-enhed baseret på den tidligere dosis basalinsulin.
English: In patients with type 1 diabetes, the incidence of hypoglycaemia was similar in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients (Table 3).
Danish: Hos patienter med type 1-diabetes var forekomsten af hypoglykæmi den samme hos patienter behandlet med Toujeo sammenlignet med patienter behandlet med insulin glargin 100 enheder/ml (Tabel 3).
English: Odd numbers are shown as a line between even numbers:
Danish: 30 enheder valgt Ulige numre er vist som en linje mellem tallene:
English: Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day.
Danish: En fyldt Toujeo Doublestar-pen anbefales til patienter der kræver mindst 20 enheder om dagen (se pkt.
English: Body weightd (kg)
Danish: Kropsvægtd (kg)
English: Multipack: 9 (3 packs of 3) pens
Danish: Multipakke: 9 (3 pakker af 3) penne
English: Severe allergic reactions may become life-threatening.
Danish: Alvorlige allergiske reaktioner over for insulin kan være livstruende.
English: The dose delivered is the one shown in the dose window.
Danish: Dosen der indgives vises i dosisvinduet.
English: • The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 “Important information about some of the ingredients of Toujeo”) and hydrochloric acid (for pH adjustment).
Danish: - Øvrige indholdsstoffer: Zinkchlorid, metacresol, glycerol, vand til injektionsvæsker, natriumhydroxid (se punkt 2 ”Toujeo indeholder natrium”) og saltsyre (til pH-justering).
English: When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Toujeo, a change of the dose of the basal insulin may be required and the concomitant anti-hyperglycaemic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of non-insulin anti-hyperglycaemic medicinal products).
Danish: Ved skift fra behandling med middellangt eller langtidsvirkende insulin til behandling med Toujeo kan det blive nødvendigt at ændre dosis af basalinsulin og at justere anden samtidig antidiabetisk behandling (dosis og tidspunkt for anden regulær insulin eller insulin-analoger med hurtigt indsættende virkning eller dosis af ikke-insulinbaserede antidiabetika).
English: • Information so that others know you have diabetes.
Danish: - Information hvoraf det fremgår, at du er diabetiker.
English: Figure 1 shows results from a cross-over study in 18 patients with type 1 diabetes conducted for a maximum of 36 hours after injection.The effect of Toujeo was beyond 24 hours (up to 36 hours) at clinically relevant doses.
Danish: Figur 1 viser resultater fra et cross-over studie hos 18 patienter med type 1-diabetes, der blev foretaget højst 36 timer efter injektion.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger: kan forekomme hos op til 1 ud af 10 patienter
English: A new sterile needle must be attached before each injection.
Danish: En ny steril nål skal påsættes før hver injektion.
English: If this occurs, you should increase the frequency of checking your blood sugar level and might need to administer additional insulin.
Danish: Hvis dette sker bør du tjekke dit blodsukkernivau lidt oftere samt du kan have brug for at indgive ekstra insulin.
English: The product may be stored for a maximum of 6 weeks below 30°C.
Danish: Efter anbrud kan pennen opbevares i maksimalt 6 uger ved temperaturer under 30°C.
English: This must always be treated by a doctor, normally in a hospital.
Danish: Alvorlig hyperglykæmi eller ketoacidose skal altid behandles af en læge, og foregår normalt under hospitalsindlæggelse.
English: Improvement in HbA1C was not affected by, gender, ethnicity, age, diabetes duration (<10 years and ≥10 years), HbA1c value at baseline (<8% or ≥8%) or baseline body mass index (BMI).
Danish: HbA1c-værdi ved baseline (<8 % eller ≥8 %) eller body mass index (BMI).
English: • Never use a syringe to remove Toujeo from your DoubleStar pen.
Danish: • Brug aldrig en sprøjte til at fjerne Toujeo fra din DoubleStar pen.
English: Rarely, insulin may cause oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Danish: Dette ses især hvis en tidligere dårlig metabolisk kontrol forbedres ved en intensiveret insulinbehandling.
English: You will require an injection of glucose or glucagon (a medicine which increases blood sugar).
Danish: Hvis du ikke er i stand til at synke, eller hvis du er bevidstløs, skal du have en injektion med sukker (glucose) eller glucagon (et lægemiddel, der øger blodsukkeret).
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne bivirkninger: kan forekomme hos op til 1 ud af 1.000 patienter
English: If your blood sugar gets too low, see the advice in the box at the end of this leaflet.
Danish: Hvis dit blodsukker bliver for lavt, se da det indrammede afsnit sidst i indlægssedlen.
English: If you are breast-feeding, talk to your doctor, as your insulin doses and your diet might need to be changed.
Danish: Kontakt din læge, hvis du ammer, da det kan være nødvendigt at justere din insulindosis og diæt.
English: Very rare: may affect up to 1 in 10,000 people
Danish: Meget sjældne bivirkninger: kan forekomme hos op til 1 ud af 10.000 patienter
English: Warning signs of hypoglycaemia
Danish: Advarselssymptomer på hypoglykæmi