FrancophonIA/ELRC3.0 huggingface dataset:
English: More severe episodes of hypoglycaemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Danish: Sværere tilfælde af hypoglykæmi med koma, kramper eller neurologisk svækkelse kan behandles med intramuskulær/subkutan glucagon eller koncentreret intravenøs glucose.
English: As lixisenatide is cleared primarily by the kidney, no pharmacokinetic study has been performed in patients with acute or chronic hepatic impairment.
Danish: Da lixisenatid primært udskilles via nyrerne, er der ikke udført farmakokinetiske studier hos patienter med akut eller kronisk nedsat leverfunktion.
English: In each of the active-controlled trials, treatment with Suliqua produced clinically and statistically significant improvements in hemoglobin A1c (HbA1c).
Danish: I begge de aktivt-kontrollerede studier gav behandling med Suliqua klinisk og statistisk signifikante forbedringer af hæmoglobin A1c (HbA1c).
English: In rare cases, the presence of such antibodies may necessitate adjustment of the Suliqua dose in order to correct a tendency for hyperglycaemia or hypoglycaemia.
Danish: I sjældne tilfælde kræver forekomst af sådanne insulinantistoffer justering af Suliqua-dosis for at korrigere for tendensen til hyperglykæmi eller hypoglykæmi.
English: The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with insulin glargine is principally based on exposure to M1.
Danish: De farmakokinetiske og farmakodynamiske fund indikerer, at effekten af en subkutan injektion af insulin glargin hovedsageligt skyldes eksponering for M1.
English: The primary composite efficacy endpoint was the time to the first occurrence of any of the following events: Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for unstable angina.
Danish: Det sammensatte primære effektmål var tiden til første forekomst af enhver af følgende hændelser: Kardiovaskulær død, ikke-dødeligt myokardieinfarkt, ikke-dødelig apopleksi eller hospitalsindlæggelse på grund af ustabil angina pectoris.
English: A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
Danish: Yderligere forsinkelse af tmax og reduceret Cmax for paracetamol forudses for 20 mikrog lixisenatid-vedligeholdelsesdosis.
English: Injecting cold medicine is more painful.
Danish: Det er mere smertefuldt at injicere kold injektionsvæske.
English: This pen is peach coloured with an orange injection button.
Danish: Denne pen er ferskenfarvet med en orange injektionsknap.
English: Cardiovascular outcome studies
Danish: Studier med kardiovaskulære endepunkter
English: This pen is olive coloured with a brown injection button.
Danish: Denne pen er olivengrøn med en brun injektionsknap.
English: In a 28-day placebo-controlled study in patients with type 2 diabetes 5 to 20 mcg lixisenatide resulted in a statistically significant decreases in postprandial blood glucose after breakfast, lunch and dinner.
Danish: I et placebokontrolleret studie af 28 dages varighed med patienter med type 2-diabetes medførte 520 mikrog lixisenatid statistisk signifikante fald i postprandial blodglucose efter morgenmad, frokost og aftensmad.
English: Increase in heart rate has been reported with GLP1RA use and a transient increase was also observed in some studies with lixisenatide.
Danish: Der er rapporteret om øget hjertefrekvens ved GLP-1- receptoragonister, og en forbigående stigning er også observeret i en række studier med lixisenatid.
English: • Do not take two injections per day
Danish: • Du må ikke tage to injektioner på samme dag.
English: • Your pen contains a total of 300 dose steps.
Danish: • Pennen indeholder i alt 300 dosistrin.
English: • A safety test must be performed before each injection.
Danish: • Du skal lave en sikkerhedstest før hver injektion.
English: No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively.
Danish: Denne forsinkelse i tmax observeredes ikke, når atorvastatin blev administreret om aftenen og lixisenatid om morgenen, men AUC og Cmax for atorvastatin øgedes med henholdsvis 27 % og 66 %.
English: After multiple-dose administration in patients with type2 diabetes, mean terminal half-life was approximately 3 hours and the mean apparent clearance (CL/F) about 35 L/h.
Danish: Efter gentagen dosering til patienter med type 2-diabetes var den gennemsnitlige terminale halveringstid cirka 3 timer, og den gennemsnitlige tilsyneladende clearance (CL/F) omkring 35 l/time.
English: • If there are not enough dose steps left in your pen for your dose, the dose selector will stop at the number of dose steps left.
Danish: Hvis der ikke er nok dosistrin tilbage i din pen til den næste dosis, vil dosisvælgeren stoppe ved det antal dosistrin, der er tilbage.
English: You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.
Danish: Du skal kontrollere dit blodsukker lige efter, du har taget glucose for at se, om du virkelig havde hypoglykæmi.
English: • Sulfonamide antibiotics, to treat infections.
Danish: • Antibiotika af typen sulfonamider, til behandling af infektioner.
English: If necessary, you might need to test your blood sugar more often.
Danish: Det kan være, at du bliver nødt til at kontrollere dit blodsukker hyppigere.
English: If you use insulin, you should always carry the following things with you:
Danish: Du skal altid have følgende ting på dig, hvis du tager insulin:
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from beta cells and suppresses glucagon from alpha cells in the pancreas.
Danish: GLP-1-receptoren er mål for naturligt forekommende GLP-1, et endogent inkretinhormon, som potenserer glucose-afhængig insulinsekretion fra betaceller i pancreas og undertrykker glucagonsekretion fra alfaceller i pancreas.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Suliqua in all subsets of the paediatric population for treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Suliqua i alle undergrupper af den pædiatriske population ved behandling af type 2-diabetes mellitus (se pkt.
English: • For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% to choose the Suliqua starting dose.
Danish: • Ved to gange dagligt basalinsulin eller insulin glargin (300 enheder/ml) skal den totale daglige dosis reduceres med 20 % for at fastlægge Suliqua startdosis.
English: *You will not see the plunger until you have injected a few doses
Danish: *Stemplet kan først ses, når du har injiceret et par doser.
English: • Explain what the patient should anticipate regarding dysglycemia and potential adverse reactions.
Danish: • Du skal forklare patienten, hvad han/hun kan forvente med hensyn til dysglykæmi og mulige bivirkninger.
English: Exposure to insulin glargine following administration of the insulin glargine/lixisenatide combination was 86-88 % compared to administration of separate simultaneous injections of insulin glargine and lixisenatide.
Danish: Eksponering for insulin glargin efter administration af insulin glargin/lixisenatid-kombinationen var 86-88 % sammenlignet med administration af separate, samtidige injektioner med insulin glargin og lixisenatid.
English: At all time points, 30-week mean plasma glucose values were lower in the Suliqua group than in both the insulin glargine group and the lixisenatide group, with the only exception of the pre-breakfast value which was similar between the Suliqua group and the insulin glargine group.
Danish: På alle tidspunkter var de gennemsnitlige plasmaglucoseværdier ved uge 30 lavere i Suliqua-gruppen end i både insulin glargin-gruppen og lixisenatid-gruppen med eneste undtagelse af værdien før morgenmad, som var sammenlignelig i Suliqua-gruppen og insulin glargingruppen.
English: In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
Danish: I embryo-føtale udviklingsstudier sås misdannelser, væksthæmning, forsinket ossifikation og skeletale påvirkninger hos rotter ved alle doser af lixisenatid (5 gange eksponeringsratio sammenlignet med human eksponering) og hos kaniner ved høje doser (32 gange eksponeringsratio sammenlignet med human eksponering).
English: In clinical studies with insulin glargine (100 units/ml) the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as that for human insulin.
Danish: I kliniske studier med insulin glargin (100 enheder/ml) er den glucosesænkende effekt på molær basis (dvs. ved indgivelse af de samme doser) af intravenøst insulin glargin nogenlunde den samme som for human insulin.
English: Lixisenatide is a glucagon-like peptide (GLP1) receptor agonist.
Danish: Lixisenatid er en glucagonlignende peptid (GLP-1)-receptoragonist.
English: The dose should be adjusted on an individual basis, based on glucose monitoring.
Danish: Dosis skal justeres individuelt baseret på glucosemonitorering.
English: • For doses >40 dose steps/day titration must be continued with Suliqua (30-60) pen.
Danish: • For doser >40 dosistrin/dag skal titrering fortsættes med Suliqua (30-60) pen.
English: Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver ml indeholder 2,7 mg metacresol.
English: The Patient Guide shall contain the following key messages:
Danish: Patientguiden skal indeholde følgende hovedelementer:
English: In mice, these effects occurred at exposure ratio above 9.3-fold when compared to human exposure at the therapeutic dose.
Danish: Hos mus optrådte dette ved en eksponering på mere end 9,3 gange den humane eksponering ved terapeutisk dosis.
English: The randomised type 2 diabetes population had the following characteristics: Mean age was 58.4 years with the majority (57.1%) being aged of 50 to 64 years, and 50.6 percent were male.
Danish: Den randomiserede population med type 2-diabetes havde følgende karakteristika: Gennemsnitsalderen var 58,4 år, hvoraf størstedelen (57,1 %) var i alderen 50-64 år, og 50,6 % var mænd.
English: • Ensure that your patients and their caretakers are adequately informed on how to use insulin glargine/lixisenatide.
Danish: • Sikre at patienter og deres omsorgspersoner i tilstrækkelig grad informeres om, hvordan insulin glargin/lixisenatid anvendes.
English: No effects on paracetamol Cmax and tmax were observed when paracetamol was administered 1 hour before lixisenatide.
Danish: Der observeredes ingen indvirkninger på Cmax og tmax for paracetamol, når paracetamol blev administreret 1 time før lixisenatid.
English: In controlled clinical trials in adults with insulin glargine (100 units/ml), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy.
Danish: I kontrollerede kliniske studier med voksne, der fik insulin glargin (100 enheder/ml), viste analyser af undergrupperne alder, race og køn ingen forskelle i sikkerhed og virkning.
English: Get to know your pen
Danish: Lær din pen at kende
English: Cases of generalised allergic reaction including anaphylactic reaction and angioedema have been reported during marketed use of insulin glargine and lixisenatide.
Danish: Der er rapporteret tilfælde af generaliserede allergiske reaktioner, herunder anafylaktisk reaktion og angioødem, efter markedsføring af insulin glargin og lixisenatid.
English: Your doctor may tell you to use a different dose of Suliqua compared to your previous insulin dose.
Danish: Lægen vil muligvis give dig besked på at tage en Suliqua-dosis, der er forskellig fra din tidligere insulindosis.
English: This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er af særlig betydning for patienter med nedsat eller manglende evne til at mærke advarselssymptomer på hypoglykæmi, og hos patienter, som har hyppige tilfælde af hypoglykæmi.
English: • For any other basal insulin the same rule as for insulin glargine (100 units/ml) should be applied
Danish: • For alle andre basalinsuliner gælder samme retningslinjer som for insulin glargin (100 enheder/ml)
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Danish: Efter samtidig administration af lixisenatid 20 mikrog og digoxin 0,25 mg ved steady state påvirkedes AUC for digoxin ikke.
English: A metabolism study in diabetic patients who received insulin glargine alone indicates that insulin glargine is rapidly metabolised at the carboxyl terminus of the B chain to form two active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Danish: Et metabolismestudie hos diabetikere, som fik insulin glargin alene viser, at insulin glargin hurtigt metaboliseres ved carboxylenden af betakæden under dannelse af to aktive metabolitter M1 (21A-Glyinsulin) og M2 (21A-Gly-des-30B-Thr-insulin).
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Danish: Den primære virkning af insulin, herunder insulin glargin, er regulering af glucosemetabolismen.
English: Suliqua must not be mixed with any other insulin or diluted.
Danish: Suliqua må ikke blandes med andet insulin og må ikke fortyndes.
English: • Clozapine, olanzapine and phenothiazine derivatives, for mental health problems.
Danish: • Clozapin, olanzapin og phenthiazinderivater, til behandling af psykiske sygdomme.
English: Suliqua has not been studied in combination with DPP-4 inhibitors, sulfonylureas, glinides, pioglitazone and SGLT-2 inhibitors.
Danish: Suliqua er ikke blevet undersøgt i kombination med DPP-4-hæmmere, sulfonylurinstoffer, glinider, pioglitazon og SGLT-2-hæmmere.
English: There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established.
Danish: Der har været enkelte rapporter om akut pancreatitis i forbindelse med lixisenatid, men en kausal sammenhæng er ikke påvist.
English: • Healthcare Professional Guide;
Danish: • Guide til læger og sundhedspersonale; • Patientguide.
English: • insulin glargine: a long-acting type of insulin which helps control blood sugar (glucose)
Danish: • insulin glargin: en langtidsvirkende insulin, der hjælper med at kontrollere blodsukkeret (glucose)
English: Keep the needle straight and screw it onto the pen until fixed.
Danish: B. Hold nålen vandret, og skru den på pennen, indtil den sidder fast.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med din læge, apotekspersonalet eller sundhedspersonalet, før du tager denne medicin.
English: Suliqua combines two active substances with complementary mechanisms of action to improve glycaemic control: insulin glargine, a basal insulin analog (mainly targeting fasting plasma glucose), and lixisenatide, a GLP-1 receptor agonist (mainly targeting postprandial glucose).
Danish: Suliqua kombinerer to aktive stoffer med komplementerende virkningsmekanismer til at forbedre den glykæmiske kontrol: insulin glargin, en basal-insulinanalog (hovedsageligt rettet mod fasteplasmaglucose) og lixisenatid, en GLP-1-receptoragonist (hovedsageligt rettet mod postprandial glucose).
English: Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
Danish: Fortæl familie, venner og kollegaer, at de straks skal tilkalde lægehjælp, hvis du ikke kan synke, eller hvis du besvimer.
English: Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility.
Danish: Dyrestudier med lixisenatid eller insulin glargin indikerer ingen direkte skadelige virkninger med hensyn til fertilitet.
English: You should learn to recognise the signs when your blood sugar is falling - so you can take action to stop it getting worse.
Danish: Du skal lære at genkende tegnene på, at dit blodsukker falder for meget, så du kan tage de rigtige forholdsregler, så det ikke bliver værre.
English: Patients treated with Suliqua should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Danish: Patienterer i behandling med Suliqua skal informeres om den potentielle risiko for dehydrering i forbindelse med gastrointestinale bivirkninger og træffe foranstaltninger for at undgå væskemangel.
English: The re-use of needles increases the risk of blocked needles which may cause under- or overdosing.
Danish: Genbrug af nåle øger risikoen for blokerede nåle, som kan forårsage underdosering eller overdosering.
English: Neonatal growth was reduced in male rats exposed to high doses of lixisenatide during late gestation and lactation, with a slightly increased pup mortality observed.
Danish: Den neonatale vækst var reduceret hos hanrotter, der blev eksponeret for høje doser lixisenatid i den sene gestationsperiode og under diegivningen, og der observeredes en let øget mortalitet blandt ungerne.
English: It is not known if Suliqua passes into your milk.
Danish: Det vides ikke, om Suliqua udskilles i mælken.
English: Figure: Mean HbA1c(%) at start of screening, randomization point and Each Time Point (Completers) and at Week 30 - mITT population
Danish: Figur: Gennemsnitlig HbA1c (%) ved start på screening, ved randomiseringstidspunkt og ved hvert tidspunkt (deltagere, der fuldførte) og ved uge 30 - mITT-population
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Danish: Pennen må kun anvendes, såfremt injektionsvæsken er klar, farveløs, uden synlige faste partikler og har et vandlignende udseende.
English: Gastrointestinal adverse reactions were mostly mild and transient in nature.
Danish: De gastrointestinale bivirkninger var som oftest lette og forbigående.
English: • Foods containing sugar, such as dextrose tablets or a sugary drink (at least 20 grams).
Danish: • Mad, der indeholder sukker, som f.eks. druesukker-tabletter eller en sukkerholdig drik (mindst 20 gram sukker).
English: • Talk with your healthcare provider about how to inject, before using your pen.
Danish: • Tal med sundhedspersonalet om, hvad du skal gøre, før du bruger din pen.
English: Having too low or too high blood sugar (see information in the box at the end of this leaflet)can affect your ability to drive and use tools or machines.
Danish: For lavt eller for højt blodsukker (se det indrammede afsnit sidst i indlægssedlen) kan påvirke din evne til at køre bil eller motorcykel og bruge værktøj eller maskiner.
English: Documented symptomatic or severe hypoglycaemic adverse reactions
Danish: Dokumenterede symptomatiske eller svære hypoglykæmiske bivirkninger
English: • Provide patients with the patient guide prior to prescribing or dispensing Suliqua.
Danish: • Patientguiden skal udleveres til patienten før ordination eller udlevering af Suliqua.
English: To avoid dosing errors and potential overdose, neither the patients nor healthcare professionals should ever use a syringe to draw the medicinal product from the cartridge in the pre-filled pen into a syringe.
Danish: For at undgå doseringsfejl og potentiel overdosering må patienten eller sundhedspersonalet aldrig anvende en sprøjte til at udtrække lægemidlet fra cylinderampullen i den fyldte pen.
English: The tmax of digoxin was delayed by 1.5 hour and the Cmax was reduced by
Danish: Tmax for digoxin blev forsinket 1,5 time og Cmax reduceret med 26 %.
English: • Corticosteroids such as cortisone and prednisolone, for inflammation.
Danish: • Kortikosteroider såsom cortison og prednisolon, til behandling af inflammation
English: • Pentamidine, for some parasite infections.
Danish: • Pentamidin, til behandling af visse infektioner forårsaget af parasitter.
English: Patients adjusting the amount or timing of dosing should only do so under medical supervision with appropriate glucose monitoring (see section 4.4).
Danish: Patienter, der justerer dosis eller doseringstidspunkt, bør kun gøre dette under tæt lægekontrol med passende glucosemonitorering (se pkt.
English: • Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Danish: • Hudreaktioner og allergiske reaktioner på injektionsstedet: Symptomerne kan omfatte rødme, usædvanligt stærke smerter, når der injiceres, kløe, udslæt, hævelse eller betændelseslignende reaktioner (inflammation).
English: • You miss meals or delay them.
Danish: • Du springer måltider over eller spiser senere.
English: Based on these results, no dose adjustment for paracetamol is required but the delayed tmax observed when paracetamol is administered 1-4 hours after lixisenatide should be taken into account when a rapid onset of action is required for efficacy.
Danish: Baseret på disse resultater er dosisjustering af paracetamol ikke nødvendig, men den forsinkede tmax, som blev observeret, når paracetamol blev administreret 1-4 timer efter lixisenatid, skal tages i betragtning, når der er behov for en hurtigt indsættende virkning.
English: MACE was defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke.
Danish: MACE blev defineret som kardiovaskulær død, ikke-dødeligt myokardieinfarkt og ikke-dødelig apopleksi.
English: So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take.
Danish: Før du begynder at tage et lægemiddel, skal du spørge lægen, om det kan påvirke dit blodsukker, og hvilke forholdsregler du eventuelt skal tage.
English: Your thumb could block the dose selector from turning.
Danish: Tommelfingeren kan i så fald forhindre dosisvælgeren i at dreje.
English: • Read the instructions in your package leaflet carefully before using Suliqua.
Danish: • Læs omhyggeligt vejledningen i indlægssedlen, før du tager Suliqua.
English: • Do not use your pen after the expiry date.
Danish: Du må ikke bruge pennen efter udløbsdatoen.
English: SoloStar Clear colourless solution.
Danish: SoloStar Klar, farveløs opløsning.
English: The Healthcare Professional Guide shall contain the following key messages:
Danish: Uddannelsesmaterialet til læger og sundhedspersonale skal indeholde følgende hovedelementer:
English: These changes are not clinically relevant and, therefore, no dose adjustment for atorvastatin is required when co-administered with lixisenatide.
Danish: Disse ændringer er ikke klinisk relevante, og derfor er dosisjustering af atorvastatin ikke nødvendig ved administration sammen med lixisenatid.
English: For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before or 4 hours after lixisenatide injection.
Danish: Ved behandling med orale lægemidler, hvis virkning er særligt afhængig af tærskelkoncentrationer, såsom antibiotika, skal patienterne rådes til at tage disse lægemidler mindst 1 time før eller 4 timer efter injektion af lixisenatid.