FrancophonIA/ELRC3.0 huggingface dataset:
English: The impact of the combination of insulin glargine and lixisenatide on the pharmacodynamics of lixisenatide has not been studied in phase 1 studies.
Danish: Påvirkningen af kombinationen insulin glargin og lixisenatid på lixisenatids farmakodynamik er ikke blevet undersøgt i fase 1-studier.
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Danish: Lette tilfælde af hypoglykæmi kan sædvanligvis behandles med indtagelse af orale kulhydrater.
English: The medicine may not work very well.
Danish: Insulinen virker måske ikke så godt.
English: To avoid mistakes, always check the medicine pack and label on the pen before each injection to make sure you have the correct pen, especially if you inject more than one medicine.
Danish: Du skal altid kontrollere lægemiddelpakningen og etiketten på pennen før hver injektion for at sikre, at du bruger den rigtige pen, især hvis du skal injicere mere end et lægemiddel.
English: What other people should do if you have hypoglycaemia
Danish: Hvad skal andre gøre, hvis du får hypoglykæmi
English: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
Danish: Der er ingen terapeutisk erfaring hos patienter med svært nedsat nyrefunktion (kreatinin-clearance under 30 ml/min.)
English: In a pre-specified analysis of this primary endpoint, the differences observed were consistent with regard to baseline HbA1c (<8% or ≥8%) or baseline OAD use (metformin alone or metformin plus second OAD).
Danish: I en præ-specificeret analyse af dette primære endepunkt var de observerede forskelle i overensstemmelse med HbA1c ved baseline (<8 % eller ≥8 %) eller oralt antidiabetikum ved baseline (metformin alene eller metformin plus et andet oralt antidiabetikum).
English: • Fluoxetine, for depression.
Danish: • Fluoxetin, til behandling af depression.
English: If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).
Danish: Det kan medføre, at dit blodsukker bliver meget højt (hyperglykæmi), og at der ophobes syre i blodet (ketoacidose).
English: • Do not use the pen if the medicine looks cloudy, coloured or contains particles.
Danish: Du må ikke bruge pennen, hvis væsken er uklar, farvet eller indeholder partikler.
English: Suliqua is not recommended in patients with severe renal impairment and end-stage renal disease as there is no sufficient therapeutic experience with use of lixisenatide.
Danish: Suliqua anbefales ikke til patienter med svært nedsat nyrefunktion og terminal nyresygdom, da der ikke foreligger tilstrækkelig terapeutisk erfaring med lixisenatid.
English: No animal studies have been conducted with the combination of insulin glargine and lixisenatide to evaluate repeated dose toxicity, carcinogenesis, genotoxicity, or toxicity to reproduction.
Danish: Der er ikke udført dyrestudier med kombinationen insulin glargin og lixisenatid for at undersøge toksicitet efter gentagne doser, karcinogenicitet, genotoksicitet eller reproduktionstoksicitet.
English: Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Danish: Mavesmerter, hurtig og dyb vejrtrækning, søvnighed og eventuelt bevidsthedstab kan være tegn på en alvorlig tilstand med syreophobning i blodet (ketoacidose), som er en følge af mangel på insulin.
English: • Do not put your pen back in the refrigerator.
Danish: • Læg aldrig pennen tilbage i køleskab.
English: C. Check that the medicine is clear.
Danish: C. Kontroller, at væsken er klar.
English: Reaching lower HbA1c levels and achieving greater HbA1c reduction did not increase rates of hypoglycaemia with combination treatment versus insulin glargine alone (see section 4.8).
Danish: Opnåelse af lavere HbA1c-niveau og større HbA1c-reduktion ved kombinationsbehandling øgede ikke hyppigheden af hypoglykæmi versus insulin glargin alene (se pkt.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af de biologisk aktive stoffer
English: Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Danish: Insulin og dets analoger nedsætter blodglucoseniveauet ved at stimulere den perifere glucoseoptagelse, især fra skeletmuskulatur og fedt, og ved at hæmme leverens glucoseproduktion.
English: Therapy with basal insulin or oral glucose lowering medicinal product other than metformin should be discontinued prior to initiation of Suliqua.
Danish: Basalinsulin eller et eventuelt andet oralt glucosesænkende lægemiddel end metformin skal seponeres før initiering af Suliqua.
English: C. Throw away the used needle in a puncture resistant container (see “Throwing your pen away” at the end of this Instructions for Use).
Danish: C. Kasser nålen i en kanylebeholder (se ”Bortskaffelse af penne” sidst i brugervejledningen).
English: Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.
Danish: Drikkevarer eller mad, der indeholder kunstige sødestoffer (f.eks. light sodavand) kan ikke anvendes til behandling af lavt blodsukker.
English: Neither status for anti-insulin glargine antibodies nor for anti-lixisenatide antibodies had a clinically relevant impact on safety or efficacy.
Danish: Hverken status for antistoffer mod insulin glargin eller mod lixisenatid havde nogen klinisk relevant effekt på sikkerhed og virkning.
English: Suliqua is available in two pens, providing different dosing options, i.e. Suliqua (10-40) pen, Suliqua (30-60) pen respectively.
Danish: Suliqua findes som to penne, hvilket giver to forskellige doseringsmuligheder, henholdsvis Suliqua (10-40) pen og Suliqua (30-60) pen.
English: In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested.
Danish: I in vitro studier påvirkede lixisenatid ikke aktiviteten af de testede CYP-isozymer og humane transportører.
English: If you use another anti-diabetic medicine, discuss with your doctor whether you should stop using that medicine when starting Suliqua.
Danish: Hvis du tager anden diabetesmedicin, skal du tale med lægen om, hvorvidt du skal stoppe med denne medicin, når du begynder at tage Suliqua.
English: Consistent with a relatively constant concentration/time profile of insulin glargine over 24 hours with no pronounced peak when administered alone, the glucose utilisation rate/time profile was similar when given in the insulin glargine/lixisenatide combination.
Danish: I overensstemmelse med en relativt konstant koncentrations/tidsprofil over 24 timer uden nogen tydelig maksimumværdi, når insulin glargin blev administreret alene, var glucoseudnyttelseshastigheds/tidsprofilen tilsvarende, når den blev fastlagt for kombinationen insulin glargin/lixisenatid.
English: • You inject too much Suliqua.
Danish: • Du tager for meget Suliqua.
English: • Angiotensin converting enzyme (ACE) inhibitors, for heart problems or high blood pressure.
Danish: • Angiotensinkonverterende enzym (ACE)-hæmmere, til behandling af hjerteproblemer eller for højt blodtryk.
English: • Tell patients to closely monitor their blood sugar levels when starting insulin glargine/lixisenatide which contains insulin glargine and a non-insulin active substance (lixisenatide).
Danish: • Fortæl patienterne, at de skal måle deres blodsukker omhyggeligt, når de begynder at tage Suliqua, som indeholder insulin glargin og et aktivt stof (lixisenatid), som ikke er et insulin.
English: • Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson´s disease.
Danish: • Monoaminoxidase (MAO)-hæmmere, til behandling af depression eller Parkinsons sygdom.
English: • Always carry a spare pen and spare needles in case they get lost or stop working.
Danish: • Du skal altid have en ekstra pen og ekstra nåle på dig i tilfælde af, at de bliver væk eller ikke virker korrekt.
English: Patients in the Suliqua group reported a statistically significantly greater decrease in the average 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 30 (-3.35 mmol/L) compared to patients in the insulin glargine group (-2.66 mmol/L; difference -0.69 mmol/L) and patients in the lixisenatide group (-1.95 mmol/L; difference -1.40 mmol/L) (p<0.0001 for both comparisons).
Danish: Patienterne i Suliqua-gruppen rapporterede statistisk signifikant større reduktion i den gennemsnitlige selvmonitorerede plasmaglucoseprofil (SMPG-profil) med 7 daglige målinger fra baseline til uge 30 (3,35 mmol/l) sammenlignet med patienterne i insulin glargin-gruppen (-2,66 mmol/l; forskel -0,69 mmol/l) og patienterne i lixisenatid-gruppen (-1,95 mmol/l; forskel -1,40 mmol/l) (p<0,0001 for begge sammenligninger).
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Danish: Betablokkere, clonidin, lithiumsalte og alkohol kan enten øge eller hæmme insulins blodglucosesænkende effekt.
English: • Always use needles that are compatible for use with Suliqua pen.
Danish: • Anvend altid kun nåle, der passer til Suliqua-pennen.
English: Following administration of a single dose of an oral contraceptive medicinal product (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) 1 hour before or 11 hours after 10 mcg lixisenatide, the Cmax, AUC, t1/2 and tmax of ethinylestradiol and levonorgestrel were unchanged.
Danish: Efter administration af en enkelt dosis af et oralt kontraceptivum (ethinylestradiol 0,03 mg/levonorgestrel 0,15 mg) 1 time før eller 11 timer efter 10 mikrog lixisenatid var Cmax, AUC, t1/2 og tmax for ethinylestradiol og levonorgestrel uændrede.
English: Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Danish: Faktorer, der øger risikoen for hypoglykæmi, kræver nøje kontrol, og dosisjustering kan være nødvendig.
English: The mean BMI at baseline was 31.1 kg/m2 with 57.3% of patients having a BMI ≥30 kg/m2.
Danish: Uge ved baseline var 31,1 kg/m2, 57,3 % af patienterne havde et BMI ≥30 kg/m2.
English: • Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline, for asthma.
Danish: • Sympatomimetika som f.eks. adrenalin, salbutamol og terbutalin, til behandling af astma.
English: A. Select 2 dose steps by turning the dose selector until the dose pointer is at the 2 mark.
Danish: A. Vælg 2 dosistrin ved at dreje dosisvælgeren, indtil dosistælleren er ved mærket 2.
English: It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose (see section 5.1).
Danish: Det anbefales at optimere den glykæmiske kontrol ved hjælp af dosisjustering baseret på faste-plasmaglucose (se pkt.
English: • Make sure that you get the correct dose.
Danish: • Sikre, at du får den korrekte dosis.
English: The ELIXA study was a randomised, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients (n=6068) with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Danish: ELIXA-studiet var et randomiseret, dobbeltblindt, placebokontrolleret, multinationalt studie, der evaluerede kardiovaskulære (CV) udfald under behandling med lixisenatid hos type 2-diabetikere (n=6.068) med et nyligt akut koronarsyndrom.
English: No dose adjustment is required for lixisenatide in patients with mild or moderate renal impairment.
Danish: Dosisjustering af lixisenatid er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: • You have severe kidney or liver disease, or some other disease such as hypothyroidism.
Danish: • Du har en alvorlig nyre- eller leversygdom eller anden sygdom som f.eks. nedsat stofskifte.
English: Results at 30 weeks - Add-on to metformin clinical study (mITT population) Suliqua
Danish: Resultater ved uge 30 - Klinisk studie: Tillægsbehandling til metformin (mITT-population) Suliqua
English: Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Danish: Insulin hæmmer lipolyse og proteolyse og øger proteinsyntesen.
English: With Suliqua, it may take longer to recover from low blood sugar because it contains a long-acting insulin (insulin glargine).
Danish: Med Suliqua kan det tage lidt længere tid, før hypoglykæmien forsvinder, da det indeholder langtidsvirkende insulin (insulin glargin).
English: At the end of the run-in period, patients with an HbA1c between 7 and 10% , FPG ≤7.77 mmol/L and insulin glargine daily dose of 20 to 50 units, were randomised to either Suliqua (n=367) or insulin glargine (n=369).
Danish: I slutningen af indkøringsfasen blev patienter med HbA1c 7-10 %, FPG ≤7,77 mmol/l og en daglig dosis insulin glargin på 20-50 enheder randomiseret til enten Suliqua (n=367) eller insulin glargin (n=369).
English: Dispose of the needle safely after each use.
Danish: Kasser altid nålen på sikker vis efter brug.
English: The dose window on the pen shows the number of dose steps.
Danish: Dosisvinduet på pennen viser antallet af dosistrin.
English: Always use a new needle
Danish: Anvend altid en ny nål
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using insulin glargine/lixisenatide pen device.
Danish: • Blinde patienter og patienter med dårligt syn skal informeres om, at de altid skal have hjælp fra en person med normalt syn, som er instrueret i at anvende insulin glargin/lixisenatid pennen.
English: Non-clinical data for insulin glargine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Prækliniske data for insulin glargin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionstoksicitet.
English: There are no clinically relevant differences in the rate of absorption when lixisenatide as monotherapy is administered subcutaneously in the abdomen, deltoid, or thigh.
Danish: Der er ingen klinisk relevante forskelle i absorptionshastigheden, når lixisenatid som monoterapi administreres subkutant i abdomen, deltamuskel eller låret.
English: Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations.
Danish: Tegn på, at dit blodsukker falder for meget eller for hurtigt, kan være: Svedtendens, fugtig hud, ængstelse, hurtig eller uregelmæssig puls, højt blodtryk, hjertebanken.
English: At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value <0.0001) compared to insulin glargine.
Danish: Ved uge 30 gav Suliqua statistisk signifikant forbedret HbA1c (p <0,0001) sammenlignet med insulin glargin.
English: Studies with lixisenatide in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet (se pkt.
English: • Check your pen and the needle to make sure they are working properly
Danish: • Kontrollere, at pennen og nålen virker korrekt
English: • If you find it hard to press the injection button in, do not force it as this may break your pen.
Danish: • Hvis du har svært ved at trykke injektionsknappen ind, må du ikke bruge magt, da du kan komme til at ødelægge pennen.
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 medføre for lavt blodsukker.
English: Your dose of Suliqua is administered as ‘dose steps'.
Danish: Din Suliqua-dosis gives som ‘dosistrin'.
English: No C-cell carcinoma was observed in mice and C-cell carcinoma occurred in rats with an exposure ratio relative to exposure at human therapeutic dose of about 900-fold.
Danish: Der sås ingen C-celle-karcinomer hos mus, og C-celle-karcinomer forekom hos rotter ved en eksponering på ca. 900 gange den humane eksponering ved terapeutisk dosis.
English: These other medicines may include oral anti-diabetics (such as metformin, sulfonylurea medicines) or insulin.
Danish: Disse andre lægemidler kan f.eks. være oral diabetesmedicin (der indtages gennem munden), som f.eks. metformin og sulfonylurinstof, eller insulin.
English: • The active substances are insulin glargine and lixisenatide.
Danish: • Aktive stoffer: insulin glargin og lixisenatid.
English: • Pharmacists are encouraged to check that patients and caretakers are able to read the strength of Suliqua, the dose range of the pre filled pen and the dose counter of the pre filled pen before dispensing insulin glargine/lixisenatide.
Danish: • Apotekspersonalet opfordres til at kontrollere, at patienter og deres omsorgspersoner er i stand til at læse styrken på Suliqua, dosisintervallet på den fyldte pen og dosistælleren på den fyldte pen, før de udleverer insulin glargin/lixisenatid.
English: • Too high blood sugar (hyperglycaemia).
Danish: • For højt blodsukker (hyperglykæmi).
English: A number of substances affect glucose metabolism and may require dose adjustment of Suliqua.
Danish: En række stoffer har indflydelse på glucosemetabolismen og kan nødvendiggøre dosisjustering af Suliqua.
English: Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with Suliqua (see section 4.8).
Danish: Hypoglykæmi var den hyppigst observerede bivirkning under behandling med Suliqua (se pkt.
English: Other signs 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: Andre tegn kan være: Hovedpine, udtalt sultfornemmelse, kvalme, opkastning, træthed, søvnighed, rastløshed, søvnforstyrrelser, aggressiv adfærd, koncentrationsbesvær, nedsat reaktionsevne, depression, forvirring, taleforstyrrelser (til tider fuldstændigt tab af talens brug), synsforstyrrelser, rysten, lammelser (paralyse), prikkende og stikkende fornemmelse i hænder eller arme, følelsesløshed og prikken omkring munden, svimmelhed, manglende selvbeherskelse, hjælpeløshed, kramper, bevidsthedstab.
English: • Explain to your patient that: You are prescribing a number of dose steps which corresponds to a set number of units of insulin plus a fixed amount lixisenatide 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) The dose counter of the pen device shows the number of dose steps to be injected,
Danish: • Du skal forklare patienten, at: Du ordinerer et antal dosistrin, som svarer til samme antal insulin-enheder plus en fast mængde lixisenatid 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) Dosistælleren på pennen viser det antal dosistrin, der skal injiceres,
English: • If the patient starts with the Suliqua (10-40) pen, the dose may be titrated up to 40 dose steps with this pen.
Danish: • Hvis patienten starter med Suliqua (10-40) pen, kan dosis titreres op til 40 dosistrin med denne pen.
English: Concentrated hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Danish: Koncentreret saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: After subcutaneous administration of insulin glargine/lixisenatide combinations to patients with type 1 diabetes, the median tmax of lixisenatide was in the range of 2.5 to 3.0 hours.
Danish: Efter subkutan administration af insulin glargin/lixisenatid-kombinationen til patienter med type 1diabetes lå median-tmax af lixisenatid i intervallet 2,5-3,0 timer.
English: Do not use Suliqua:
Danish: Tag ikke Suliqua:
English: Insulin glargine (100 units/ml)** ≥20 to <30 units
Danish: Insulin glargin (100 enheder/ml)**≥20 til <30 enheder
English: Effect of age, race, and gender on the pharmacokinetics of insulin glargine has not been evaluated.
Danish: Indvirkningen af alder, race og køn på farmakokinetikken for insulin glargin er ikke blevet undersøgt.
English: Use Suliqua once a day, within 1 hour before a meal.
Danish: Du skal injicere Suliqua en gang dagligt inden for en time før et måltid.
English: Suliqua should be injected once a day within one hour prior to a meal.
Danish: Suliqua injiceres én gang dagligt inden for en time før et vilkårligt måltid.
English: • Change the place within the area you inject each day.
Danish: • Du skal skifte til et nyt injektionssted hver dag inden for det bestemte hudområde, som du bruger.
English: • Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).
Danish: • Du skal injicere i huden forrest på låret, på overarmen eller på din mave (abdomen).
English: • Read all of these instructions before using your pen.
Danish: • Læs hele brugervejledningen, før du bruger pennen.
English: • If the patient starts with the Suliqua (30-60) pen, the dose may be titrated up to 60 dose steps with this pen.
Danish: • Hvis patienten starter med Suliqua (30-60) pen, kan dosis titreres op til 60 dosistrin med denne pen.
English: The mean BMI at baseline was 31.7 kg/m2 with 63.4% of patients having a BMI ≥30 kg/m2.
Danish: Gennemsnitlig BMI ved baseline var 31,7 kg/m2, 63,4 % havde BMI ≥30 kg/m2.
English: What you need to know before you use Suliqua Do not use Suliqua:
Danish: Det skal du vide, før du begynder at tage Suliqua Tag ikke Suliqua:
English: • If you still find it hard to press in, get a new pen.
Danish: • Hvis du stadig har svært ved at trykke injektionsknappen ind, skal du tage en ny pen.
English: • The prescription should mention the pre-filled pen type you need (Suliqua 10-40 pen or 30-60 pen) and the number of dose steps to be injected.
Danish: • Det skal stå på recepten, hvilken fyldt pen du skal bruge (Suliqua 10-40 pennen eller 30-60 pennen), og hvor mange dosistrin, du skal injicere.
English: No pharmacokinetic interactions are known for insulin glargine.
Danish: Der er ikke kendskab til farmakokinetiske interaktioner for insulin glargin.
English: The incidence of MACE was similar between LANTUS and standard care in ORIGIN [Hazard Ratio (95% CI) for MACE; 1.02 (0.94, 1.11)].
Danish: Forekomsten af MACE var sammenlignelig for LANTUS og standardbehandling i ORIGIN [Hazard ratio (95 % KI) for MACE:
English: • You are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Suliqua").
Danish: • Du tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Suliqua”).
English: A postprandial injection of Lixisenatide also slows gastric emptying thereby reducing the rate at which meal-derived glucose is absorbed and appears in the circulation.
Danish: En postprandial injektion af lixisenatid forsinker ligeledes ventrikeltømningen og reducerer dermed den hastighed, hvormed måltidsrelateret glucose absorberes og forekommer i kredsløbet.
English: After subcutaneous administration of insulin glargine/lixisenatide combinations to patients with type 1 diabetes, insulin glargine showed no pronounced peak.
Danish: Efter subkutan administration af insulin glargin/lixisenatid-kombinationen til patienter med type 1diabetes viste insulin glargin ikke nogen udtalt maksimumkoncentration.
English: If you forget to use Suliqua
Danish: Hvis du har glemt at tage Suliqua