FrancophonIA/ELRC3.0 huggingface dataset:
English: At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value <0.0001) compared to the individual components.
Danish: Ved uge 30 gav Suliqua statistisk signifikant forbedret HbA1c (p <0,0001) sammenlignet med de to indholdsstoffer enkeltvist.
English: • For Suliqua, one dose step always contains one unit of insulin, regardless of the Suliqua pre-filled pen being used (10-40 pen or 30-60 pen).
Danish: • For Suliqua gælder det, at et dosistrin altid indeholder en insulinenhed, uanset, hvilken Suliqua fyldt pen der anvendes (10-40 pennen eller 30-60 pennen).
English: After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours.
Danish: Efter samtidig administration af warfarin 25 mg og gentagen dosering af lixisenatid 20 mikrog var der ingen indvirkninger på AUC eller INR (International Normaliseret Ratio), mens Cmax blev reduceret med 19 % og tmax forsinket med 7 timer.
English: B. Pull off the pen cap.
Danish: B. Tag hætten af pennen.
English: Insulin glargine daily dose LS insulin dose at week 30 (mean)
Danish: Daglig dosis insulin glargin Insulindosis ved uge 30 (gennemsnit)
English: • For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Danish: • Du kan finde oplysninger om behandling af hyperglykæmi i det indrammede afsnit sidst i indlægssedlen.
English: These factors include: - change in the injection area - improved insulin sensitivity (e.g. by removal of stress factors) - unaccustomed, increased or prolonged physical activity - intercurrent illness (e.g. vomiting, diarrhoea) - inadequate food intake - missed meals - alcohol consumption - certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency) - concomitant treatment with certain other medicinal products (see section 4.5).
Danish: Disse faktorer inkluderer: - skift til andet injektionsområde - forbedret insulinfølsomhed (f.eks. reduktion af stressfaktorer) - uvant, øget eller længerevarende fysisk aktivitet - anden samtidig sygdom (f.eks. opkastning, diarré) - utilstrækkelig fødeindtagelse - oversprungne måltider - alkoholindtagelse - visse ukompenserede endokrine forstyrrelser (f.eks. i hypofyseforlappen, hypotyroidisme eller binyrebarkinsufficiens) - samtidig behandling med visse andre lægemidler (se pkt.
English: • Always follow the “Instructions for use” that come with this package leaflet.
Danish: • Du skal altid følge brugervejledningen, som er en del af denne indlægsseddel.
English: The pen may be stored for a maximum of 28 days out of the refrigerator, but below 25°C.
Danish: Efter åbning, eller hvis pennen medbringes som reserve Pennen kan opbevares uden for køleskab i højst 28 dage ved temperaturer under 25 °C.
English: Examples include:
Danish: Hvis for eksempel:
English: Tell your doctor, pharmacist or nurse if you are using have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Needles must not be re-used.
Danish: Nålen må ikke genbruges.
English: Administration of the oral contraceptive 1 hour or 4 hours after lixisenatide did not affect AUC and t1/2 of ethinylestradiol and levonorgestrel, whereas Cmax of ethinylestradiol was decreased by 52% and 39%, respectively and Cmax of levonorgestrel was decreased by 46% and 20%, respectively and median tmax was delayed by 1 to 3 hours.
Danish: Administration af det orale kontraceptivum 1 time før eller 4 timer efter lixisenatid påvirkede ikke AUC og t1/2 for ethinylestradiol og levonorgestrel, mens Cmax for ethinylestradiol faldt med henholdsvis 52 % og 39 %, og Cmax for levonorgestrel faldt med henholdsvis 46 % og 20 %, og median-tmax blev forsinket med 1-3 timer.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (very common: ≥1/10; common: ≥1/100 to <1/10;
Danish: Nedenstående behandlingsrelaterede bivirkninger fra kliniske studier er opstillet efter systemorganklasse og efter faldende hyppighed (meget almindelig: ≥1/10; almindelig: >1/100 til <1/10; ikke almindelig: ≥1/1.000 til <1/100; sjælden: ≥1/10.000 til <1/1.000; meget sjælden:
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
Danish: Stoffer, som kan reducere den blodglucosesænkende effekt, omfatter kortikosteroider, danazol, diazoxid, diuretika, glucagon, isoniazid, østrogener og gestagener, phenthiazinderivater, somatropin, sympatomimetika (f.eks. adrenalin, salbutamol, terbutalin), thyreoideahormoner, atypiske antipsykotiske lægemidler (f.eks. clozapin og olanzapin) og proteasehæmmere.
English: • Diazoxide, for high blood pressure.
Danish: • Diazoxid, til behandling af for højt blodtryk.
English: B. Push the needle into your skin as shown by your healthcare provider.
Danish: B. Tryk nålen ind i huden som din læge, apoteket eller sundhedspersonalet har vist dig.
English: This can help to spot mild hypoglycaemic episodes.
Danish: Det kan hjælpe dig med at opdage lette tilfælde af hypoglykæmi.
English: • Only use needles that are compatible with Suliqua pen (see “Instructions for Use”).
Danish: • Du må kun anvende nåle, der passer til Suliqua pennen (se brugervejledningen).
English: Body weight has no clinically relevant effect on lixisenatide AUC.
Danish: Kropsvægt har ingen klinisk relevant effekt på AUC for lixisenatid.
English: Your blood sugar level may either rise or fall if you take:
Danish: Dit blodsukker kan enten stige eller falde, hvis du tager:
English: If your blood sugar level falls too much you may pass out (become unconscious).
Danish: Hvis dit blodsukker falder for meget, kan du besvime (blive bevidstløs).
English: Hypoglycaemia is also more likely to happen if:
Danish: Hypoglykæmi opstår oftere, hvis:
English: After concomitant administration of lixisenatide 20 mcg and ramipril 5 mg during 6 days, the AUC of ramipril was increased by 21% while the Cmax was decreased by 63%.
Danish: Efter samtidig administration af lixisenatid 20 mikrog og ramipril 5 mg i 6 dage øgedes AUC for ramipril med 21 %, mens Cmax faldt med 63 %.
English: The injection sites should be rotated within the same region (abdomen, deltoid, or thigh) from one injection to the next to reduce the risk of lipodystrophy (see section 4.8).
Danish: Injektionsstedet skal skiftes inden for det enkelte område (abdomen, deltamuskel eller lår) mellem injektionerne for at reducere risikoen for lipodystrofi (se pkt.
English: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution.
Danish: Cylinderampul af type 1 farveløst glas med et sort stempel (brombutylgummi) og en hætte (aluminium) med indsatte laminerede tætningsskiver (brombutylgummi på medicinsiden og polyisopren på ydersiden).
English: The pen cap must be put back on the pen after each injection in order to protect from light.
Danish: Hætten skal sættes på pennen efter hver injektion for at beskytte mod lys.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Some medicines such as antibiotics, oral contraceptives, statins (medicines like atorvastatin to lower cholesterol), acidresistant tablets or capsules that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Suliqua injection.
Danish: Visse lægemidler, som f.eks. antibiotika, oral prævention (f.eks. p-piller), statiner (f.eks. atorvastatin mod forhøjet kolesterol), mavesyre-resistente tabletter eller kapsler, som ikke må være for længe i maven, skal muligvis tages mindst 1 time før eller 4 timer efter injektionen med Suliqua.
English: If you stop using Suliqua
Danish: Hvis du holder op med at tage Suliqua
English: • Throw away your used pen as instructed by your pharmacist or local authority.
Danish: • Pennen skal bortskaffes i overensstemmelse med apotekets eller kommunens anvisninger.
English: The dose must be individualised based on clinical response and is titrated based on the patient's need for insulin.
Danish: Dosis skal tilpasses individuelt i henhold til klinisk respons og titreres ud fra patientens insulinbehov.
English: Lixisenatide is a peptide and is not metabolised by cytochrome P450.
Danish: Lixisenatid er et peptid og metaboliseres ikke af CYP-enzymer.
English: • Too low blood sugar (hypoglycaemia).
Danish: • For lavt blodsukker (hypoglykæmi).
English: • Disopyramide, for some heart problems.
Danish: • Disopyramid, til behandling af bestemte hjertesygdomme.
English: You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins.
Danish: Du skal altid kontrollere pennens etiket før hver injektion for at undgå forveksling mellem Suliqua og andre insuliner.
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 potensere den blodglucosesænkende effekt, og som kan øge risikoen for hypoglykæmi, omfatter orale antidiabetika, ACE (angiotensinkonverterende enzym)-hæmmere, disopyramid, fibrater, fluoxetin, monoaminoxidase (MAO)-hæmmere, pentoxifyllin, propoxyphen, salicylater og sulfonamidantibiotika.
English: If your blood sugar falls too low, you may pass out (become unconscious).
Danish: Hvis dit blodsukker bliver for lavt, kan du besvime (miste bevidstheden).
English: When administered 1 or 4 hours after 10 mcg lixisenatide, Cmax of paracetamol was decreased by 29% and 31%, respectively and median tmax was delayed by 2.0 and 1.75 hours, respectively.
Danish: Ved administration 1 eller 4 timer efter 10 mikrog lixisenatid faldt Cmax for paracetamol med henholdsvis 29 % og 31 %, og median-tmax var forsinket med henholdsvis 2,0 og 1,75 timer.
English: Insulin glargine (100 units/ml)** ≥30 to ≤60 units
Danish: Insulin glargin (100 enheder/ml)** ≥30 til ≤60 enheder
English: Always use a new needle.
Danish: Brug altid en ny nål.
English: The combination of medicinal products in this pen is for the daily injection of 10 to 40 dose steps of Suliqua.
Danish: Kombinationen af de to lægemidler i denne pen er til daglig injektion af 10-40 dosistrin Suliqua.
English: Patients with type 2 diabetes, treated with metformin alone or metformin and a second OAD treatment that could be a sulfonylurea or a glinide or a sodium-glucose co-transporter-2 (SGLT-2) inhibitor or a dipeptidyl peptidase-4 (DPP-4) inhibitor, and who were not adequately controlled with this treatment (HbA1c range 7.5% to 10% for patients previously treated with metformin alone and 7.0% to 9% for patients previously treated with metformin and a second oral anti-diabetic treatment) entered a run-in period for 4 weeks.
Danish: Patienter med type 2-diabetes, som blev behandlet med metformin alene eller metformin plus et andet oralt antidiabetikum som f.eks. et sulfonylurinstof, et glinid, en natrium-glucose-co- transportør-2 (SGLT-2)-hæmmer eller en dipeptidylpeptidase-4 (DPP-4)-hæmmer, og som ikke var tilstrækkeligt kontrolleret med denne behandling (HbA1c-inteval 7,5 %-10 % for patienter, der tidligere blev behandlet med metformin alene, og 7,0 %-9 % for patienter, der tidligere blev behandlet med metformin og et andet oralt antidiabetikum) indgik i en indkøringsfase på 4 uger.
English: D. Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.
Danish: D. Hold injektionsknappen inde, og begynd at tælle langsomt til 10, når du ser ”0” i dosisvinduet.
English: Since Suliqua may cause stomach side effects, the medicine has not been studied in patients with severe stomach or gut problems.
Danish: Suliqua kan give gener i maven og er derfor ikke blevet undersøgt hos patienter med alvorlige problemer med maven eller tarmene.
English: Medicine that may reduce warning signs of low blood sugar Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine - for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia).
Danish: Medicin, der kan sløre symptomerne på for lavt blodsukker Betablokkere og anden medicin (f.eks. clonidin, guanethidin, reserpin - mod for højt blodtryk) kan gøre det sværere at genkende advarselstegnene på for lavt blodsukker (hypoglykæmi).
English: No dose adjustment of lixisenatide is needed in patients with hepatic impairment (see section 5.2).
Danish: Dosisjustering af lixisenatid er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: • Your healthcare professional will explain the design and features of your Suliqua pen, including how the dose counter of the pre-filled pen device shows the number of dose steps to be injected.
Danish: • Lægen eller sundhedspersonalet vil forklare Suliqua-pennens design og funktioner for dig, herunder hvordan dosistælleren på den fyldte pen viser, hvor mange dosistrin du skal injicere.
English: Do not soak, wash or lubricate the pen.
Danish: Pennen må aldrig skylles, vaskes eller smøres.
English: The combination of medicinal products in this pen is for the daily injection of 30 to 60 dose steps Suliqua.
Danish: Kombinationen af de to lægemidler i denne pen er til daglig injektion af 30-60 dosistrin Suliqua.
English: • Fibrates, for lowering high levels of blood fats.
Danish: • Fibrater, til at nedsætte et højt indhold af fedtstof i blodet.
English: It is preferable that the prandial injection is performed before the same meal every day, when the most convenient meal has been chosen.
Danish: Suliqua bør injiceres før det samme måltid hver dag, når først det mest hensigtsmæssige måltid er valgt.
English: • Keep your pen at room temperature, below 25°C
Danish: • Opbevar pennen ved stuetemperatur under 25 °C
English: • Oestrogens and progestogens, such as in the contraceptive pill for birth control control or use of oestrogens for bone loss (osteoporosis).
Danish: • Østrogener og gestagener, findes f.eks. i p-piller til forebyggelse af graviditet, eller østrogen til behandling af knogleskørhed (osteoporose).
English: • Switch from basal insulin
Danish: • Skift fra basalinsulin
English: When lixisenatide 20 mcg and atorvastatin 40 mg were co-administered in the morning for 6 days, the exposure to atorvastatin was not affected, while Cmax was decreased by 31% and tmax was delayed by 3.25 hours.
Danish: Når lixisenatid 20 mikrog og atorvastatin 40 mg blev indgivet samtidig om morgenen i 6 dage, påvirkede det ikke eksponeringen for atorvastatin, mens Cmax faldt med 31 %, og tmax forsinkedes med 3,25 timer.
English: STEP 6: Remove the needle
Danish: TRIN 6: Fjernelse og bortskaffelse af nålen
English: Nausea Diarrhoea Vomiting
Danish: Kvalme Diarré Opkastning
English: • Lixisenatide: a “GLP-1 analogue” that helps the body produce its own additional insulin in response to increases in blood sugar, and slows the absorption of sugar from foods.
Danish: • lixisenatid: en såkaldt ”GLP-1-analog”, der hjælper kroppen med at danne sit eget supplerende insulin, når blodsukkeret bliver for højt.
English: If you have injected too much of this medicine, your blood sugar level may become too low (hypoglycaemia).
Danish: Hvis du har injiceret for meget Suliqua, kan dit blodsukker blive for lavt (hypoglykæmi).
English: Insulin glargine has not been studied in patients with renal impairment.
Danish: Insulin glargin er ikke blevet undersøgt hos patienter med nedsat nyrefunktion.
English: Only in this case, it is okay to inject a partial dose of less than 10 dose steps.
Danish: Det er kun i dette tilfælde, at det er tilladt at injicere en delt dosis på under 10 dosistrin.
English: After screening, eligible patients (n=1018) entered a 6 week run-in phase where patients remained on or switched to insulin glargine, in case they took another basal insulin, and had their insulin dose titrated/stabilised while continuing metformin (if previously taken).
Danish: Efter screening indgik egnede patienter (n=1.018) i en 6 ugers indkøringsperiode, hvor patienterne forblev på eller blev skiftet til insulin glargin, hvis de anvendte et andet basalinsulin.
English: - Never use a syringe to remove medicine from your pen.
Danish: - Brug aldrig en sprøjte til at trække medicinen op fra pennen.
English: What to do if you experience hypoglycaemia?
Danish: Hvad skal du gøre, hvis du får hypoglykæmi?
English: The solution should be clear, colourless and water-like.
Danish: Injektionsvæsken skal være klar, farveløs og ligne vand.
English: • During the switch to this type of combination medicine and in the weeks after the switch you should measure your blood sugar levels more frequently.
Danish: • Du skal måle dit blodsukker oftere i forbindelse med, at du skifter fra en anden medicin til denne type kombinationsmedicin og i ugerne efter skiftet.
English: There is no clinical data on exposed pregnancies from controlled clinical studies with use of Suliqua, insulin glargine, or lixisenatide.
Danish: Der foreligger ikke data fra kontrollerede kliniske studier om eksponering for Suliqua, insulin glargin eller lixisenatid under graviditet.
English: • Beta-blockers or clonidine, for high blood pressure.
Danish: • Betablokkere eller clonidin, til behandling af for højt blodtryk.
English: Suliqua must not be drawn from the cartridge of the pre-filled pen into a syringe to avoid dosing errors and potential overdose (see section 4.4).
Danish: Suliqua må ikke udtrækkes i en sprøjte fra cylinderampullen i den fyldte pen, da det kan resultere i doseringsfejl og potentiel overdosering (se pkt.
English: 30-60 dose steps SoloStar
Danish: 30-60 dosistrin SoloStar
English: What Suliqua looks like and contents of the pack Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a SoloStar pre-filled pen.
Danish: Suliqua er en klar og farveløs injektionsvæske (injektion) i en cylinderampul af glas placeret i en SoloStar fyldt pen.
English: - Never re-use needles.
Danish: - Du må aldrig genbruge nålen.
English: In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Danish: Under behandling med sympatolytika som f.eks. betablokkere, clonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulering ligeledes være reduceret eller helt mangle.
English: Press the injection button all the way in.
Danish: Tryk derefter injektionsknappen helt ind og hold den inde.
English: • Do not use your pen if there is still no medicine coming out of the needle tip.
Danish: • Brug ikke din pen, hvis der stadig ikke kommer væske ud af nålespidsen.
English: Use only clear, colourless solution.
Danish: Anvend kun en klar og farveløs injektionsvæske.
English: The cardiovascular safety of insulin glargine and lixisenatide has been established in the ORIGIN and ELIXA clinical trials, respectively.
Danish: Insulin glargins og lixisenatids kardiovaskulære sikkerhed er blevet undersøgt i 2 kliniske studier, henholdsvis ORIGIN og ELIXA.
English: 10-40 dose steps SoloStar
Danish: 10-40 dosistrin SoloStar
English: Never use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.
Danish: Brug aldrig en sprøjte til at trække injektionsvæsken op fra cylinderampullen i pennen, da det kan resultere i doseringsfejl og muligvis overdosering.
English: The label must always be checked before each injection to avoid medication errors between Suliqua and other injectable anti-diabetic medicinal products, including the 2 different pens of Suliqua (see section 4.4).
Danish: Etiketten på pennen skal altid kontrolleres før hver injektion for at undgå forveksling mellem Suliqua og andre injicerbare antidiabetika, herunder de to forskellige Suliqua-penne (se pkt.
English: Based on these results, no dose adjustment for ramipril is required when co-administered with lixisenatide.
Danish: Baseret på disse resultater er dosisjustering af ramipril ikke nødvendig ved administration sammen med lixisenatid.
English: How to read the dose window
Danish: Sådan læses dosisvinduet
English: Number (%) of patients achieving HbA1c< 7.0% with no body weight gain at week 30
Danish: Antal (%) patienter, der opnåede HbA1c <7,0 % uden vægtstigning ved uge 30
English: In patients with mild to moderate renal impairment using Suliqua, frequent glucose monitoring and dose adjustment may be necessary.
Danish: Hos patienter med let til moderat nedsat nyrefunktion kan hyppig glucosemonitorering og dosisjustering af Suliqua være nødvendig.
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device; patients, carers and 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; patienter, omsorgspersoner, læger og andre sundhedspersoner må aldrig anvende en sprøjte til at udtrække insulin glargin/lixisenatid fra en fyldt pen, da det kan medføre doseringsfejl og alvorlige skader.
English: Animal data do not indicate reproductive toxicity with insulin glargine.
Danish: Dyrestudier har ikke påvist reproduktionstoksicitet for insulin glargin.
English: STEP 4: Select the dose
Danish: TRIN 4: Indstilling af dosis
English: Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and urine test showing glucose and ketone bodies.
Danish: Tørst, øget vandladning, træthed, tør hud, ansigtsrødme, nedsat appetit, lavt blodtryk, hurtig hjerterytme (puls) og urinprøver, der er positive for sukker og ketonstoffer.
English: What to do if you experience hyperglycaemia
Danish: Hvad skal du gøre, hvis du får hyperglykæmi
English: • One dose step contains one unit of insulin glargine plus a fixed amount of lixisenatide.
Danish: • Et dosistrin indeholder en enhed insulin glargin plus en fast mængde lixisenatid.
English: Before injecting Suliqua
Danish: Før du injicerer Suliqua
English: You might then need to eat something (such as bread or pasta) that will raise your blood sugar over a longer time, especially if your next meal is not due.
Danish: Spis herefter mad, som får dit blodsukker til at stige over en længere periode (f.eks. brød eller pasta), især hvis det ikke snart er tid til dit næste måltid.
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on basal insulin A total of 736 patients with type 2 diabetes participated in a randomised, 30-week, active-controlled, open-label, 2-treatment arm, parallel-group, multicenter study to evaluate the efficacy and safety of Suliqua compared to insulin glargine (100 units/ml).
Danish: Klinisk studie hos patienter med type 2-diabetes utilstrækkeligt kontrolleret med basalinsulin I alt 736 patienter med type 2-diabetes deltog i et randomiseret, aktivt kontrolleret, åbent, 2-armet multicenter studie med parallelle grupper af 30 ugers varighed, der undersøgte Suliquas sikkerhed og virkning sammenlignet med sikkerheden og virkningen af insulin glargin (100 enheder/ml).