FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients screened had type 2 diabetes were treated with basal insulin for at least 6 months, receiving a stable daily dose of between 15 and 40 U alone or combined with 1 or 2 OADs (metformin or a sulfonylurea or a glinide or a SGLT-2 inhibitor or a DPP-4 inhibitor), had an HbA1c between 7.5% and 10% (mean HbA1c of 8.5% at screening) and a FPG less than or equal to 10.0 mmol/L or 11.1 mmol/L depending on their previous anti-diabetic treatment.
Danish: De screenede patienter havde type 2-diabetes, blev behandlet med basalinsulin i mindst 6 måneder med en stabil dosis på 15-40 enheder alene eller kombineret med et eller to orale antidiabetika (metformin, sulfonylurinstof, et glinid, en SGLT-2-hæmmer eller en DPP-4-hæmmer) og havde HbA1c 7,5 %-10 % (gennemsnitlig HbA1c 8,5 % ved screening) og FPG ≤ 10,0 mmol/l eller 11,1 mmol/l afhængigt af deres tidligere antidiabetiske behandling.
English: Hepatic dysfunction is not expected to affect the pharmacokinetics of lixisenatide.
Danish: Nedsat leverfunktion forventes ikke at påvirke farmakokinetikken for lixisenatid.
English: Only in this case, it is okay to inject a partial dose of less than 30 dose steps.
Danish: Det er kun i dette tilfælde, at det er tilladt at injicere en delt dosis på under 30 dosistrin.
English: Based on these results, no dose adjustment for digoxin is required when co-administered with lixisenatide.
Danish: Baseret på disse resultater er dosisjustering af digoxin ikke nødvendigved administration sammen med lixisenatid.
English: Administration of Suliqua may cause formation of antibodies against insulin glargine and/or lixisenatide.
Danish: Immunogenicitet Administration af Suliqua kan medføre dannelse af antistoffer mod insulin glargin og/eller lixisenatid.
English: D. Pull off the inner needle cap and throw away.
Danish: D. Tag den inderste nålehætte af, og kasser den.
English: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Danish: Lixisenatid-induceret forsinkelse af ventrikeltømning kan reducere absorptionshastigheden for oralt administrerede lægemidler.
English: Hyperglycaemia (high blood sugar levels)
Danish: Hyperglykæmi (for højt blodsukker)
English: Suliqua (30-60) pen contains insulin glargine and lixisenatide.
Danish: Suliqua (30-60) pen indeholder insulin glargin og lixisenatid.
English: In the Add-on to metformin clinical study the treatment was started at 10 dose steps (10 units insulin glargine and 5 mcg lixisenatide).
Danish: I det kliniske studie med insulinnaive patienter blev behandlingen initieret med 10 dosistrin (10 enheder insulin glargin og 5 mikrog lixisenatid).
English: In the switch from basal insulin clinical study the starting dose was 20 dose steps (20 units insulin glargine and 10 mcg lixisenatide) or 30 dose steps, (30 units insulin glargine and 10 mcg lixisenatide), see section 4.2, depending on the previous insulin dose.
Danish: I det kliniske studie med skift fra basalinsulin var startdosis 20 dosistrin (20 enheder insulin glargin og 10 mikrog lixisenatid) eller 30 dosistrin, (30 enheder insulin glargin og 10 mikrog lixisenatid), se pkt.
English: • Do not touch the injection button yet.
Danish: Tryk ikke på injektionsknappen endnu.
English: 10 dose steps (10 units/5 mcg)*
Danish: 10 dosistrin (10 enheder/ 5 mikrog)*
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device; healthcare professionals must never use a syringe to withdraw insulin glargine/lixisenatide from a pre filled pen or dosing errors and serious harm can result.
Danish: • Suliqua fås i en fyldt pen og må kun anvendes sammen med denne pen; læger eller sundhedspersonale må aldrig anvende en sprøjte til at udtrække insulin glargin/lixisenatid fra en fyldt pen, da det kan medføre doseringsfejl og alvorlige skader.
English: • If you think your pen is damaged, do not use it. Get a new one.
Danish: • Hvis du tror, at din pen er beskadiget, må du ikke bruge den.
English: In the event of blocked needles patients must follow the instructions described in the “Instructions for Use” accompanying the package leaflet.
Danish: Hvis en nål er blokeret, skal patienten følge instruktionerne, der er beskrevet i brugervejledningen, som følger med indlægssedlen.
English: Reasons why hyperglycaemia may happen:
Danish: Årsager til hyperglykæmi:
English: • you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended.
Danish: • hvis du har en alvorlig nyresygdom, eller hvis du er i dialysebehandling, da Suliqua ikke anbefales til dig.
English: 20 dose steps (20 units/10 mcg)*
Danish: 20 dosistrin (20 enheder/ 10 mikrog)*
English: The combination of insulin glargine and lixisenatide has no impact on the pharmacodynamics of of insulin glargine.
Danish: Kombinationen af insulin glargin og lixisenatid påvirker ikke insulin glargins farmakodynamik.
English: Effect of gastric emptying on oral medicinal products The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Danish: Påvirkning af ventrikeltømning på orale lægemidler Lixisenatid forsinker ventrikeltømningen, hvilket kan reducere absorptionshastigheden af oralt administrerede lægemidler.
English: Hypoglycaemia (low blood sugar levels)
Danish: Hypoglykæmi (for lavt blodsukker)
English: • Add-on to metformin [insulin naïve]
Danish: • Tillægsbehandling til metformin [insulinnaive patienter]
English: In the event of blocked needles, patients must follow the instructions described in the Instructions for Use accompanying the package leaflet (see section 6.6).
Danish: Hvis nålen blokeres, skal patienten følge instruktionerne i brugervejledningen, som udleveres sammen med indlægssedlen (se pkt.
English: • Take care when handling needles to prevent needle injury and cross-infection.
Danish: • Vær forsigtig ved håndtering af nåle for at forhindre uheld og overførsel af en infektion.
English: Suliqua (10-40) pen contains insulin glargine and lixisenatide.
Danish: Suliqua (10-40) pen indeholder insulin glargin og lixisenatid.
English: Hypoglycaemia and gastrointestinal adverse reactions may develop if a patient is dosed with more Suliqua than required.
Danish: Der kan opstå hypoglykæmi og gastrointestinale bivirkninger, hvis der administreres højere doser af Suliqua end nødvendigt.
English: • Protease inhibitors, for HIV.
Danish: • Proteasehæmmere, til behandling af hiv.
English: • Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Danish: • Hvis du ikke selv kan håndtere pennen (hvis du f.eks. har problemer med synet), skal du bede om hjælp fra en anden person.
English: Mean body weight (kg) Baseline (mean)
Danish: Gennemsnitlig kropsvægt (kg) Baseline (gennemsnit)
English: It is not known if Suliqua harms your unborn child. Suliqua should not be used if breast-feeding.
Danish: Det vides ikke, om Suliqua kan skade dit ufødte barn.
English: Nasopharyngitis Upper respiratory tract infection
Danish: Nasofaryngitis Øvre luftvejsinfektion
English: • Always perform a safety test. See STEP 3.
Danish: • Udfør altid en sikkerhedstest.
English: Patients must be instructed to always check the pen label before each injection to avoid accidental mix-ups between the two different strengths of Suliqua and mix-ups with other injectable diabetes medicinal products.
Danish: Patienten skal instrueres i altid at kontrollere etiketten på pennen før hver injektion for at undgå forveksling mellem de to styrker af Suliqua og med andre injicerbare antidiabetika.
English: • The time you eat meals and use your medicine.
Danish: • Tidspunkter for måltider og injektioner.
English: Any other OADs were discontinued.
Danish: Alle andre orale antidiabetika blev seponeret.
English: • The other ingredients are: glycerol 85%, methionine, metacresol, zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.
Danish: • Øvrige indholdsstoffer: glycerol 85 %, methionin, metacresol, zinkchlorid, koncentreret saltsyre og natriumhydroxid (til pH-justering) og vand til injektionsvæsker.
English: Lixisenatide Suliqua Insulin glargine
Danish: Skift fra basalinsulin Suliqua Insulin glargin Lixisenatid Suliqua Insulin glargin
English: Insulin glargine has not been studied in diabetes patients with hepatic impairment.
Danish: Insulin glargin er ikke blevet undersøgt hos diabetikere med nedsat leverfunktion.
English: Suliqua is to be injected subcutaneously in the abdomen, deltoid, or thigh.
Danish: Suliqua indgives som subkutan injektion i abdomen, deltamuskel eller lår.
English: Warning signs of hypoglycaemia
Danish: Advarselstegn på hypoglykæmi
English: LIST OF EXCIPIENTS glycerol 85%, methionine, metacresol (see leaflet for further information), zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Danish: LISTE OVER HJÆLPESTOFFER glycerol 85 %, methionin, metacresol (se indlægssedlen for yderligere oplysninger), zinkchlorid, koncentreret saltsyre og natriumhydroxid (til pH-justering), vand til injektionsvæsker.
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on OAD treatment A total of 1170 patients with type 2 diabetes were randomised in an open label, 30-week, activecontrolled study to evaluate the efficacy and safety of Suliqua compared to the individual components, insulin glargine (100 units/ml) and lixisenatide (20 mcg).
Danish: I alt 1.170 patienter med type 2-diabetes blev randomiseret i et åbent, aktivt kontrolleret studie af 30 ugers varighed for at undersøge Suliquas virkning og sikkerhed sammenlignet de enkelte komponenter, insulin glargin (100 enheder/ml) og lixisenatid (20 mikrog).
English: • If you have poor eyesight, please see section 3.
Danish: • Hvis du har dårligt syn.
English: AUC was comparable while there was a small decrease in Cmax of lixisenatide of 22-34% compared with separate simultaneous administration of insulin glargine and lixisenatide, which is not likely to be clinically significant.
Danish: Sammenlignet med separat, samtidigt administreret insulin glargin og lixisenatid var AUC sammenlignelige, omend der var en lille reduktion i Cmax for lixisenatid på 22-34 %, hvilket ikke anses for klinisk signifikant.
English: Hypoglycaemia may occur if the dose of Suliqua is higher than required.
Danish: Hypoglykæmi kan opstå, hvis der anvendes en for høj dosis af Suliqua.
English: The dose of Suliqua must be individualised based on clinical response and is titrated based on the patient's need for insulin (see section 4.2).
Danish: Dosis skal tilpasses individuelt, baseret på klinisk respons, og titreres ud fra patientens insulinbehov (se pkt.
English: Baseline (mean) End of study (mean) LS change from baseline
Danish: Baseline (gennemsnit) Ved afslutning af studie (gennemsnit) LS-ændring fra baseline
English: You should check your blood sugar level more often.
Danish: Du skal derfor kontrollere dit blodsukker oftere end normalt.
English: Read the Package Leaflet and these Instructions for Use first
Danish: Læs indlægssedlen og denne brugervejledning før du bruger pennen første gang
English: Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin (see section 4.4 and 5.1 for available data on the different combinations).
Danish: Suliqua er i kombination med metformin indiceret til behandling af voksne med type 2-diabetes mellitus for at forbedre den glykæmiske kontrol, når metformin alene eller i kombination med et andet oralt glucosesænkende lægemiddel eller basalinsulin ikke giver tilstrækkelig glykæmisk kontrol (se pkt.
English: Suliqua is not recommended in women of childbearing potential not using contraception.
Danish: Kvinder i den fertile alder Suliqua bør ikke anvendes til kvinder i den fertile alder, som ikke anvender kontraception.
English: If your blood sugar is too high, follow the guidance for hyperglycaemia (see information in the box at the end of this leaflet).
Danish: Hvis dit blodsukker er for højt, skal du følge vejledningen vedrørende hyperglykæmi (se det indrammede afsnit sidst i denne indlægsseddel).
English: Dyspepsia Abdominal pain
Danish: Dyspepsi Abdominalsmerter
English: Ask your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: • To prevent infection being passed from one person to another, pens should never be used for more than one person, even when the needle is changed
Danish: • For at undgå overførsel af sygdomme må pennen kun anvendes af den samme patient, også selvom nålen skiftes.
English: Check your blood sugar and eat more food to prevent your blood sugar getting too low (hypoglycaemia).
Danish: Du skal kontrollere dit blodsukker og spise mere mad for at undgå, at dit blodsukker bliver for lavt.
English: 30-60 dose steps (1 dose step = 1 unit of insulin glargine + 0.33 micrograms of lixisenatide)
Danish: 30-60 dosistrin (1 dosistrin = 1 enhed insulin glargin + 0,33 mikrogram lixisenatid)
English: The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.
Danish: Maksimal daglig dosis er 60 enheder insulin glargin og 20 mikrog lixisenatid svarende til 60 dosistrin.
English: Insulin glargine daily dose Baseline (mean) Endpoint (mean) LS insulin dose change at week 30 (mean) *Not included in the pre-specified step-down testing procedure **2 hour PPG minus the pre-meal glucose value
Danish: LS-ændring i insulindosis ved uge 30 (gennemsnit) *Ikke inkluderet i den præ-specificerede testprocedure med trinvis reduktion **2 timer PPG minus plasma-glucose før måltid
English: Other medicines and Suliqua
Danish: Brug af anden medicin sammen med Suliqua
English: 10-40 dose steps (1 dose step = 1 unit of insulin glargine + 0.5 micrograms of lixisenatide)
Danish: 10-40 dosistrin (1 dosistrin = 1 enhed insulin glargin + 0,5 mikrogram lixisenatid)
English: If you do, you might not get your full dose (underdosing) or get too much (overdosing) as the needle could block.
Danish: Hvis du genbruger nålen, kan den blive blokeret, og du får måske ikke hele din dosis (underdosering), eller du får måske for meget (overdosering).
English: Handle your pen with care • If you think that your pen may be damaged, do not try to fix it. Use a new one.
Danish: • Hvis du mener, at din pen kan være beskadiget, skal du ikke forsøge at reparere den.
English: • Suliqua is available in two pre-filled pens containing two different strengths of lixisenatide, and different dose ranges: Both pre-filled pens contain insulin glargine in a strength of 100 units/ml Suliqua 10-40 pen allows daily doses between 10 and 40 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 50 mcg/ml; dose range: 10 to 40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide) Suliqua 30-60 pen allows daily doses between 30 and 60 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 33 mcg/ml; dose range: 30 to 60 units insulin glargine in combination with 10 to 20 mcg lixisenatide)
Danish: • Suliqua fås i to forskellige fyldte penne med hver deres styrke af lixisenatid og forskellige dosisintervaller: Begge fyldte penne indeholder insulin glargin i en styrke på 100 enheder/ml Suliqua 10-40 pennen giver daglige doser på 10-40 dosistrin (styrke: insulin glargin 100 enheder/ml og lixisenatid 50 mikrog/ml; dosisinterval: 10-40 enheder insulin glargin i kombination med 5-20 mikrog lixisenatid) Suliqua 30-60 pennen giver daglige doser på 30-60 dosistrin (styrke: insulin glargin 100 enheder/ml og lixisenatid 33 mikrog/ml; dosisinterval: 30-60 enheder insulin glargin i kombination med 10-20 mikrog lixisenatid)
English: • You lose carbohydrates from being sick (vomiting) or diarrhoea.
Danish: • Du mister kulhydrater, når du kaster op eller har diarré.
English: Warning signs of hyperglycaemia
Danish: Advarselssymptomer på hyperglykæmi
English: Reasons why hypoglycaemia may happen:
Danish: Årsager til hypoglykæmi:
English: Always use another Suliqua (10-40) pen to complete your dose and no other pen.
Danish: Anvend altid en Suliqua (10-40) pen til at injicere resten af din dosis.
English: The differentiation between the pen strengths is based on the dose range of the pen.
Danish: Forskellen på de to penne er pennenes dosisintervaller.
English: Then push firmly on.
Danish: Tryk den godt fast.
English: The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine and lixisenatide in Suliqua.
Danish: Insulin glargin:lixisenatid-forholdet har ingen relevant indvirkning på farmakokinetikken af insulin glargin og lixisenatid i Suliqua.
English: • Never use a syringe to remove medicine product from your pen.
Danish: • Brug aldrig en sprøjte til at udtage lægemiddel fra pennen.
English: • A reminder on the need to report all medication errors with Suliqua will be part of patient guide.
Danish: • Patientguiden vil også indeholde en påmindelse om at indberette alle medicineringsfejl med Suliqua.
English: What Suliqua contains
Danish: Suliqua indeholder:
English: The apparent volume of distribution of lixisenatide after subcutaneous administration of insulin glargine/lixisenatide combinations (Vz/F) is approximately 100 L. The apparent volume of distribution of insulin glargine after subcutaneous administration of the insulin glargine/lixisenatide combinations (Vss/F) is approximately 1700 L.
Danish: Det tilsyneladende fordelingsvolumen for lixisenatid efter subkutan administration af insulin glargin/lixisenatidkombinationen (Vz/F) er ca. 100 liter.
English: If a dose lower than 30 dose steps is needed, use the Suliqua 100units/ml + 50 micrograms pre-filled pen (Suliqua (10-40) pen.
Danish: Hvis du har brug for en dosis, der er under 30 dosistrin, skal du tage Suliqua 100 enheder/ml + 50 mikrogram lixisenatid (10-40) SoloStar fyldt pen.
English: Do not store with attached needle.
Danish: Må ikke opbevares med påsat nål.
English: A. Take a new needle and peel off the protective seal.
Danish: A. Fjern folieforseglingen fra en ny nål.
English: Age has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Danish: Alder har ingen klinisk relevant effekt på farmakokinetikken for lixisenatid.
English: • Throw away the used needle in a sharps container, or as told by your pharmacist or local authority.
Danish: • Du skal kassere de brugte nåle i en kanylebeholder eller efter apotekspersonalets anvisninger.
English: • You are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: • Du tager eller har taget bestemte andre lægemidler (se punkt 2, ”Brug af anden medicin sammen med Suliqua”).
English: Always use another Suliqua (30- 60) pen to complete your dose and no other pen.
Danish: Anvend altid en Suliqua (30-60) pen til at injicere resten af din dosis.
English: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Danish: Hos patienter med nedsat leverfunktion kan insulinbehovet være reduceret på grund af nedsat evne til glukoneogenese og nedsat insulinmetabolisme.
English: • This pen provides a dose of 10 to 40 dose steps in one injection, in steps of 1 dose step.
Danish: • Denne pen giver en dosis på 10 til 40 dosistrin i en injektion.
English: • Diuretics, for high blood pressure or fluid retention.
Danish: • Vanddrivende medicin, til behandling af højt blodtryk eller væskeophobning.
English: • The needle can puncture the cap if it is recapped at an angle.
Danish: • Nålen kan stikke hul i hætten, hvis den sættes skævt på.
English: • This pen provides a dose of 30 to 60 dose steps in one injection, in steps of 1 dose step.
Danish: • Denne pen giver en dosis på 30 til 60 dosistrin i en injektion.
English: • Make sure you have the correct medicine.
Danish: Du skal sikre dig, at du har den rigtige medicin.
English: Do not inject Suliqua.
Danish: Du må ikke injicere Suliqua:
English: Switch from basal insulin
Danish: Skift fra basalinsulin
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, skal du læse det indrammede afsnit sidst i indlægssedlen.
English: Plunger* Dose window Dose pointer
Danish: Stempel* Dosis vindue Dosistæller
English: A new needle must always be attached before each use.
Danish: Der skal altid påsættes en ny nål før hver injektion.
English: For lixisenatide no dose adjustment is required based on age.
Danish: Dosisændring på grund af alder er ikke nødvendig for lixisenatid.
English: • A reminder on the need to report all medication errors with Suliqua will be part of the healthcare professional guide.
Danish: • Guiden til læger og sundhedspersonalet vil også indeholde en påmindelse om at indberette alle medicineringsfejl med Suliqua.
English: When to inject Suliqua
Danish: Hvornår skal du injicere Suliqua
English: Turn the dose selector until the dose pointer lines up with your dose.
Danish: B. Drej dosisvælgeren, indtil dosistælleren er ud for din dosis.
English: Baseline (mean; post run-in phase) End of treatment (mean)
Danish: Baseline (gennemsnit; efter indkøringsfasen)
English: • Do not reuse needles.
Danish: • Du må ikke genbruge nålen.
English: The Outcome Reduction with Initial Glargine Intervention trial (i.e., ORIGIN) was an open-label, randomised, 12,537 patient study that compared LANTUS to standard care on the time to first occurrence of a major adverse cardiovascular event (MACE).
Danish: ORIGIN (Outcome Reduction with Initial Glargine Intervention)-studiet var et åbent randomiseret studie med 12.537 patienter.
English: • Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates
Danish: • Smertestillende og febernedsættende medicin som f.eks. pentoxifyllin, propoxyphen og salicylater (såsom acetylsalicylsyre).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Suliqua if
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Suliqua:
English: [1.4 to 2.6]
Danish: 4.2 og 5.2).
English: If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet).
Danish: Hvis du får symptomer på for lavt blodsukker (hypoglykæmi), skal du straks gøre noget for at øge dit blodsukker (se det indrammede afsnit sidst i indlægssedlen).
English: Gender has no clinically relevant effect on the pharmacokinetics of lixisenatide
Danish: Køn har ingen klinisk relevant effekt på farmakokinetikken for lixisenatid.
English: Do not inject a dose lower than 30 dose steps.
Danish: Du må ikke injicere en dosis, der er under 30 dosistrin.
English: Product name
Danish: Præparatnavn
English: • Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine in combination with 5-20 mcg lixisenatide (Suliqua (10-40) pen).
Danish: • Suliqua 100 enheder/ml + 50 mikrog/ml fyldt pen frigiver dosistrin på 10-40 enheder insulin glargin kombineret med 5-20 mikrog lixisenatid (Suliqua (10-40) pen).
English: If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
Danish: Hvis dit blodsukker er for lavt, skal du følge vejledningen vedrørende hypoglykæmi (se det indrammede afsnit sidst i denne indlægsseddel).
English: Each Suliqua pen contains 3 ml of solution
Danish: En Suliqua pen indeholder 3 ml injektionsvæske.
English: Add-on to metformin [insulin naïve]
Danish: Tillægsbehandling til metformin [insulinnaive patienter]
English: Scale
Danish: Dosisskala
English: Please see the information regarding medicines that should not stay too long in your stomach in the section Other medicines and Suliqua.
Danish: Se Brug af anden medicin sammen med Suliqua for oplysninger om medicin, som ikke må være for længe i maven.