FrancophonIA/ELRC3.0 huggingface dataset:
English: As a peptide, lixisenatide is eliminated through glomerular filtration, followed by tubular reabsorption and subsequent metabolic degradation, resulting in smaller peptides and amino acids, which are reintroduced in the protein metabolism.
Danish: Som et peptid elimineres lixisenatid ved glomerulær filtration fulgt af tubulær reabsorption og efterfølgende metabolisk nedbrydning, hvilket resulterer i mindre peptider og aminosyrer, der reintroduceres i proteinmetabolismen.
English: Switch from GLP-1 receptor agonist has not been studied.
Danish: Skift fra en GLP-1-receptoragonist er ikke blevet undersøgt.
English: Many factors may affect your blood sugar level.
Danish: Mange faktorer kan påvirke dit blodsukker.
English: Learn to inject:
Danish: Du skal lære selv at injicere:
English: • you have a severe stomach or gut problem such as a disease of the muscles of the stomach called “gastroparesis” which results in delayed stomach emptying.
Danish: • hvis du har alvorlige problemer med maven eller tarmene som f.eks. en sygdom i mavesækkens muskler kaldet ”gastroparese”, som medfører forsinket tømning af maven.
English: • If no medicine comes out after the third time, the needle may be blocked.
Danish: • Hvis der ikke kommer væske ud efter tredje forsøg, kan nålen være tilstoppet.
English: If no liquid appears:
Danish: Hvis der ikke kommer væske ud:
English: The MAH shall ensure that, in each Member State where Suliqua is marketed, all healthcare professionals who are expected to prescribe, dispense and patients who are expected to use Suliqua, have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at i alle lande, hvor Suliqua markedsføres, skal alle sundhedspersoner, som forventes at ordinere eller udlevere Suliqua, og alle patienter, som forventes at anvende Suliqua, have adgang til/få udleveret følgende uddannelsespakke:
English: Therefore Suliqua should not be given in combination with a sulfonylurea.
Danish: Derfor må Suliqua ikke anvendes i kombination med et sulfonylurinstof.
English: Starting dose and pen
Danish: Startdosis og pen
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: • If the patient has been transferred from a different pre filled pen device, highlight the differences in design between the two devices (focus on colour differentiation, warning statements on carton/label and other safety design features such as tactile elements on the prefilled pen).
Danish: • Hvis patienten er skiftet fra en anden fyldt pen, skal du fremhæve forskellene i designet mellem de to penne (især farveforskelle, advarsler på æsken/etiketten og andre sikkerhedsmæssige designtræk som f.eks. elementer på den fyldte pen, som føles forskellige).
English: • Information so that others know you have diabetes.
Danish: • Et kort eller lignende, som fortæller andre, at du har diabetes.
English: In both studies the dose was titrated once weekly, based on fasting self-measured plasma glucose values.
Danish: I begge studier blev dosis titreret en gang ugentligt baseret på selvmålt fasteplasmaglucose.
English: To avoid medication errors, the prescriber must make sure that the correct strength and number of dose steps is stated in the prescription (see section 4.4).
Danish: For at undgå medicineringsfejl skal den ordinerende læge sikre, at den korrekte styrke og antal dosistrin er angivet på recepten (se pkt.
English: Metformin was a mandatory background therapy and 58% of patients received a second OAD at screening, being a sulfonylurea in 54% of patients.
Danish: Metformin var en obligatorisk baggrundsbehandling, og 58 % af patienterne fik ved screening et andet oralt antidiabetikum, som var et sulfonylurinstof for 54 % af patienterne.
English: In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin.
Danish: Hos ca. 93 % af patienterne viste antistofferne mod insulin glargin krydsreaktivitet over for human insulin.
English: • You have an injury, infection or fever or have had an operation.
Danish: • Du har været ude for et uheld, har en infektion eller har feber, eller hvis du er blevet opereret.
English: The main reasons for not entering the randomized phase were FPG value >13.9 mmol/L and HbA1c value <7% or >10% at the end of the run-in phase
Danish: Hovedårsagen til ikke at indgå i den randomiserede fase var faste-plasmaglucose (FPG) >13,9 mmol/l og HbA1c <7 % eller >10 % ved slutningen af indkøringsfasen.
English: C-cell hyperplasia and adenoma were seen at all doses in rats and a no observed adverse effect level (NOAEL) could be not defined.
Danish: C-celle-hyperplasi og Ccelle-adenom blev set hos rotter og mus uanset dosisniveau, og niveauet for ingen observerede bivirkninger (NOAEL) kunne ikke defineres.
English: Before using Suliqua, the instructions for use included in the package leaflet must be read carefully.
Danish: Før anvendelse af Suliqua skal brugervejledningen, som følger med indlægssedlen, læses grundigt.
English: Prior to launch of Suliqua in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials for Suliqua, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før lancering af Suliqua i hvert enkelt medlemsland skal indehaveren af markedsføringstilladelsen og den nationale lægemiddelmyndighed blive enige om indholdet og udformningen af uddannelsesmaterialet for Suliqua, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: STEP 5: Inject the dose
Danish: TRIN 5: Injektion af dosis
English: Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Danish: Vedvarende indtagelse af kulhydrater og overvågning kan være nødvendig, fordi hypoglykæmien kan vende tilbage efter tilsyneladende klinisk bedring.
English: Suliqua with alcohol
Danish: Brug af Suliqua sammen med alkohol
English: If you see air bubbles • You may see air bubbles in the medicine.
Danish: Hvis du ser luftbobler • Der kan være luftbobler i injektionsvæsken.
English: If you have kidney or liver problems If you have kidney or liver problems, talk to your doctor as you may need a lower dose.
Danish: Hvis du har nyre- eller leverproblemer Hvis du har nyre- eller leverproblemer, så tal med din læge, da du muligvis skal have en lavere dosis.
English: However, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Danish: Imidlertid kan patientens koncentrations- og reaktionsevne nedsættes som følge af hypoglykæmi eller hyperglykæmi eller f.eks. på grund af nedsat syn.
English: • Isoniazid, for tuberculosis.
Danish: • Isoniazid, til behandling af tuberkulose.
English: Based on these results, no dose adjustment for warfarin is required when co-administered with lixisenatide; however, frequent monitoring of INR in patients on warfarin and/or coumarin derivatives is recommended at the time of initiation or ending of lixisenatide treatment.
Danish: Baseret på disse resultater er dosisjustering af warfarin ikke nødvendig ved administration sammen med lixisenatid, dog anbefales hyppig monitorering af INR hos patienter i behandling med warfarin og/eller coumarinderivater ved initiering eller ophør af lixisenatid-behandlingen.
English: The reduction in Cmax is of limited clinical relevance and no dose adjustment for oral contraceptives is required.
Danish: Reduktionen i Cmax har begrænset klinisk relevans, og dosisjustering af orale kontraceptiva er ikke nødvendig.
English: • If you cannot select your full prescribed dose, use a new pen or inject the remaining dose steps and use a new pen to complete your dose.
Danish: Hvis du ikke kan vælge hele din dosis, skal du bruge en ny pen eller injicere de resterende dosistrin og bruge en ny pen til resten af din dosis.
English: • Keep new pens in the refrigerator between 2°C to 8°C.
Danish: • Opbevar nye penne i køleskab ved 2 °C til 8 °C.
English: The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section 'Description of selected adverse reactions' below).
Danish: De hyppigst rapporterede bivirkninger under behandling med Suliqua var hypoglykæmi og gastrointestinale bivirkninger (se afsnittet ”Beskrivelse af udvalgte bivirkninger” nedenfor).
English: • talk to your doctor, pharmacist or nurse if you think you have a problem with your pen.
Danish: • Tal med din læge, apotekspersonalet eller sundhedspersonalet, hvis du mener, der er et problem med pennen.
English: • you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to use glucose because there is not enough insulin) since this medicine will not be right for you.
Danish: • hvis du har diabetisk ketoacidose (en komplikation ved diabetes, der optræder, når kroppen ikke kan nedbryde glucose på grund af for lidt insulin), da Suliqua ikke er velegnet til dig.
English: • Changes where the injection is given: If you inject Suliqua too often in the same place, you may develop dents at the site, caused by a loss of fat under the skin (lipoatrophy) or you may develop lumps, caused by a build up of fat under the skin (lipohypertrophy).
Danish: • Hudforandringer på injektionsstedet: Hvis du for ofte injicerer Suliqua på samme sted i huden, kan fedtvævet under huden på dette sted svinde ind (lipoatrofi), eller du kan få knuder under huden på grund af ophobning af fedtvæv under huden (lipohypertrofi).
English: Hypoglycaemia can be very serious and is very common with medicines containing insulin (may affect more than 1 in 10 people).
Danish: Hypoglykæmi kan være meget alvorligt og er meget almindeligt ved insulinbehandling (kan forekomme hos flere end 1 ud af 10 personer).
English: Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely, especially at the time of initiation of lixisenatide treatment.
Danish: Patienter, som får lægemidler med et smalt terapeutisk indeks eller lægemidler, som kræver omhyggelig klinisk monitorering, skal følges tæt, særligt ved opstart af lixisenatid-behandling.
English: • throw the pen away and use a new one.
Danish: • Kassér pennen, og brug en ny.
English: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis.
Danish: Brug af glucagon-lignende peptid-1 (GLP-1)-receptoragonister er blevet forbundet med risiko for udvikling af akut pancreatitis.
English: Suliqua is to be dosed in accordance with the individual patient's need for insulin.
Danish: Suliqua skal doseres i forhold til den enkelte patients behov for insulin.
English: Suliqua should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio.
Danish: Suliqua bør anvendes med forsigtighed hos patienter, som får orale lægemidler, der kræver hurtig gastrointestinal absorption, kræver omhyggelig klinisk monitorering eller har et smalt terapeutisk indeks.
English: The following table describes the rate of documented symptomatic hypoglycaemia (≤3.9 mmol/L) and severe hypoglycaemia for both Suliqua and the comparator.
Danish: Nedenstående tabel viser hyppigheden af dokumenteret symptomatisk hypoglykæmi (≤3,9 mmol/l) og svær hypoglykæmi for både Suliqua og komparator.
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Danish: Hos ældre kan en fremadskridende forværring af nyrefunktionen føre til en stadig nedsættelse af insulinbehovet.
English: • Your medicine has become less effective - for example because it was not stored properly.
Danish: • Din medicin har mistet noget af sin virkning, f.eks. på grund af forkert opbevaring.
English: • Change the needle (see STEP 6 Remove the needle and STEP 2 Attach a new needle) then do a safety test (see STEP 3).
Danish: • Udskift nålen (se TRIN 6 Fjern nålen og TRIN 2 Påsæt en ny nål), og foretag en ny sikkerhedstest (se TRIN 3).
English: Suliqua has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of Suliqua is not recommended in these patients.
Danish: Suliqua er ikke undersøgt hos patienter med svær gastrointestinal sygdom, herunder svær gastroparese, og derfor anbefales Suliqua ikke til disse patienter.
English: If blood sugar remains very low for too long it may cause brain damage and may be life-threatening.
Danish: Hvis dit blodsukker er meget lavt i for lang kan det give hjerneskade og være livstruende.
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of lixisenatide based on the results of pharmacokinetic studies in Caucasian, Japanese and Chinese subjects.
Danish: Etnisk oprindelse havde ingen klinisk relevant effekt på farmakokinetikken for lixisenatid baseret på resultaterne af farmakokinetiske studier af kaukasiske, japanske og kinesiske forsøgspersoner.
English: Reversible testicular and epididymal lesions were seen in dogs treated with lixisenatide.
Danish: Reversible testikulære og epididymale skader sås hos hunde, der fik lixisenatid.
English: The incidence of the primary endpoint was similar in the lixisenatide (13.4%) and placebo (13.2%) groups: the hazard ratio (HR) for lixisenatide versus placebo was 1.017, with an associated 2-sided 95% confidence interval (CI) of 0.886 to 1.168.
Danish: Incidensen af det primære endepunkt var sammenlignelig for lixisenatid-gruppen (13,4 %) og placebogruppen (13,2 %): hazard ratio (HR) for lixisenatid versus placebo var 1,017 med et associeret tosidigt 95 % konfidensinterval (KI) på 0,886-1,168.
English: Your doctor may tell you to use Suliqua with other medicines for high blood sugar.
Danish: Din læge vil muligvis give dig besked på at tage Suliqua sammen med anden medicin mod for højt blodsukker.
English: Following administration of a single dose of paracetamol 1000 mg, paracetamol AUC and t1/2 were unchanged whatever the timing of its administration (before or after the lixisenatide injection).
Danish: Efter administration af en enkelt dosis paracetamol 1000 mg var paracetamol-AUC og -t1/2 uændrede uanset tidspunktet for administrationen (før eller efter lixisenatid-injektion).
English: In 2-year subcutaneous carcinogenicity study in mice, 3 cases of adenocarcinoma in the endometrium were seen in the mid dose group with a statistically significant increase, corresponding to an exposure ratio of 97-fold.
Danish: I 2-årige karcinogenicitetsstudier med subkutan administration hos mus sås 3 tilfælde af adenokarcinom i endometriet i middeldosis-gruppen med en statistisk signifikant stigning, svarende til en eksponeringsratio på 97-fold.
English: Pharmacists should also check that patients have been trained on how to use the pen.
Danish: Apotekspersonalet skal også spørge patienten, om han/hun er blevet instrueret i at anvende pennen.
English: Results at 30 weeks -Study Type 2 Diabetes Uncontrolled on Basal Insulin mITT population Suliqua
Danish: Resultater ved uge 30 -Studie: Type 2-diabetes ukontrolleret med basalinsulin - mITT population Suliqua
English: In 2-year subcutaneous carcinogenicity studies, non-lethal C-cell thyroid tumors were seen in rats and mice and are considered to be caused by a non-genotoxic GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Danish: I 2-årige karcinogenicitetsstudier med subkutan administration blev ikke-dødelige C-cellethyroideakarcinomer set hos rotter og mus; disse anses for at være forårsaget af en ikke-genotoksisk GLP-1-receptor-medieret mekanisme, som gnavere er specielt følsomme for.
English: You can select your dose in steps of 1 dose step.
Danish: Du kan vælge din dosis i trin på 1 enhed.
English: Paediatric population No studies have been performed with Suliqua in children and adolescents below 18 years of age.
Danish: Pædiatrisk population Der er ikke udført studier med Suliqua hos børn og unge under 18 år.
English: In case of gastrointestinal adverse reactions, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Danish: I tilfælde af gastrointestinale bivirkninger iværksættes passende understøttende behandling ud fra patientens kliniske symptomer.
English: At screening 64.4% of patients were receiving insulin glargine as basal insulin and 95.0% received at least 1 concomitant OAD.
Danish: På screeningtidspunktet fik 64,4 % af patienterne insulin glargin som basalinsulin, og 95,0 % fik samtidigt mindst et oralt antidiabetikum.
English: • Test your blood sugar level and, if it is high, as agreed with your doctor or nurse, test your urine for ketones as soon as you notice any of the above signs
Danish: • Kontroller dit blodsukker, og hvis det er for højt, skal du som aftalt med lægen eller sundhedspersonalet, undersøge urinen for ketonstoffer, så snart du får nogen af ovennævnte symptomer
English: In a pharmacokinetic study in elderly non-diabetic subjects, administration of lixisenatide 20 mcg resulted in a mean increase of lixisenatide AUC by 29% in the elderly population (11 subjects aged 65 to 74 years and 7 subjects aged ≥75 years) compared to 18 subjects aged 18 to 45 years, likely related to reduced renal function in the older age group.
Danish: I et farmakokinetisk studie med ældre ikke-diabetiske forsøgspersoner medførte administration af 20 mikrog lixisenatid en gennemsnitlig øgning af lixisenatid-AUC på 29 % i den ældre population (11 forsøgspersoner mellem 65 og 74 år og 7 forsøgspersoner i alderen ≥ 75 år) sammenlignet med 18 forsøgspersoner i alderen 18 til 45 år, sandsynligvis relateret til nedsat nyrefunktion i den ældre aldersgruppe.
English: • Do not select a dose or press the injection button without a needle attached.
Danish: • Vælg aldrig en dosis og tryk ikke på injektionsknappen uden påsat nål.
English: During this run-in phase metformin treatment was optimised and any other OADs were discontinued.
Danish: I løbet af denne indkøringsfase blev metformin-behandlingen optimeret og alle andre orale antidiabetika seponeret.
English: Always do a safety test before each injection to:
Danish: Udfør altid en sikkerhedstest før hver injektion for at:
English: • Lithium salts, for mental health problems.
Danish: • Lithiumsalte, til behandling af psykiske problemer.
English: Your healthcare professional will give you this information.
Danish: Det vil din læge eller sundhedspersonalet fortælle dig.
English: Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.
Danish: Kontakt omgående en læge, hvis du ikke kan få kontrol med din hypoglykæmi, eller hvis den kommer igen.
English: • You are recovering from an injury, operation or other stress.
Danish: • Du er ved at komme dig efter en skade, en operation eller andre former for stress.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, insuliner og analoger til injektion, langtidsvirkende.
English: It is unknown whether insulin glargine or lixisenatide is excreted in human milk.
Danish: Det vides ikke, om insulin glargin eller lixisenatid udskilles i human mælk.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) with insulin glargine indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Danish: En stor mængde data fra gravide kvinder (mere end 1000 graviditeter) viser ingen specifikke skadelige virkninger af insulin glargin på graviditet og ingen specifikke misdannelser eller føtal/neonatal toksicitet.
English: This type 2 diabetes population had the following characteristics: Mean age was 60.0 years with the majority (56.3%) being aged of 50 to 64 years, and 53.3 percent were female.
Danish: Denne population med type 2-diabetes havde følgende karakteristika: Gennemsnitsalderen var 60,0 år, størstedelen (56,3 %) af patienterne var i alderen 50-64 år, og 53,3 % var kvinder.
English: * Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of ≤3.9 mmol/L.
Danish: * Dokumenteret symptomatisk hypoglykæmi var en hændelse, hvor de typiske symptomer på hypoglykæmi var ledsaget af plasmaglucose på ≤3,9 mmol/l (målt).
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Danish: Patienter skal rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel eller betjening af maskiner.
English: • Glucagon, for very low blood sugar.
Danish: • Glucagon, til behandling af meget lavt blodsukker.
English: *Not included in the pre-specified step-down testing procedure **2 hour PPG minus the pre-meal glucose value
Danish: *Ikke inkluderet i den præ-specificerede testprocedure med trinvis reduktion **2 timer PPG minus plasma-glucose før måltid
English: You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low.
Danish: Du skal være bekendt med disse faktorer for at kunne gøre det rigtige, hvis dit blodsukker ændrer sig, og for at forhindre, at det bliver for højt eller for lavt.
English: Insulin naïve patients
Danish: Insulinnaive patienter
English: The safety and effectiveness of Suliqua on glycaemic control were evaluated in two randomised clinical studies in patients with type 2 diabetes mellitus:
Danish: Suliquas sikkerhed og virkning på glykæmisk kontrol blev undersøgt i to randomiserede, kliniske studier med patienter med type 2-diabetes mellitus:
English: Following a standardised labelled test meal, in the study referred to above, it was confirmed that lixisenatide slows gastric emptying, thereby reducing the rate of postprandial glucose absorption.
Danish: Efter et standardiseret, mærket testmåltid i ovennævnte studie blev det bekræftet, at lixisenatid nedsætter ventrikeltømningshastigheden og derved reducerer hastigheden for postprandial glucoseabsorption.
English: Severe hypoglycaemia**
Danish: Svær hypoglykæmi**
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på kartonen og pennens etiket efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Gastro-resistant formulations containing substances sensitive to stomach degradation, should be administered 1 hour before or 4 hours after lixisenatide injection.
Danish: Gastroresistente formuleringer, der indeholder stoffer, som er følsomme for nedbrydning i mavesækken, bør administreres 1 time før eller 4 timer efter injektion af lixisenatid.
English: Tell your doctor if you are taking warfarin or other anticoagulants (medicines used to prevent clotting of the blood) as you might need to have more frequent blood tests (called ‘International Normalised Ratio' or INR test) to check your blood clotting.
Danish: Du skal fortælle det til lægen, hvis du tager warfarin eller andre blodfortyndende lægemidler (antikoagulantia - medicin til at forebygge blodpropper), da du muligvis skal have taget blodprøver oftere for at få målt, hvordan dit blod størkner (kaldet ‘International Normaliseret Ratio' eller INRtest).
English: At the end of the run-in period, patients who remained inadequately controlled (HbA1c between 7% and 10%) were randomised to either Suliqua, insulin glargine or lixisenatide.
Danish: Ved slutningen af indkøringsfasen blev de patienter, der stadig var utilstrækkeligt kontrolleret (HbA1c mellem 7 % og 10 %) randomiseret til enten Suliqua, insulin glargin eller lixisenatid.