FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Danish: Brug af GLP-1-receptoragonister er blevet associeret med risikoen for at udvikle akut pancreatitis.
English: Similar results for SBP and DBP were demonstrated at the final 26 week time point of the study.
Danish: Der blev påvist lignende resultater for SBP og DBP på studiets finale tidspunkt efter 26 uger.
English: It should not be administered intravenously or intramuscularly.
Danish: Det må ikke administreres intravenøst eller intramuskulært.
English: I heard more than two clicks during my injection - two louder clicks and a soft one.
Danish: Jeg hørte mere end to klik under injektionen - to høje klik og et lavt klik.
English: Of these, 1,206 were ≥ 65 years of which 119 were ≥ 75 years.
Danish: Ud af disse patienter var 1.206 ≥ 65 år, hvoraf 119 var ≥ 75 år.
English: Use a new pen for your injection.
Danish: Brug en ny pen til din injektion.
English: Your doctor may need to change your dose of these other medicines to reduce this risk.
Danish: Det kan være nødvendigt for din læge at nedsætte dosis af disse andre lægemidler for at sænke risikoen.
English: Prepare from the refrigerator.
Danish: Gør dig klar af køleskabet.
English: Do not remove the pen from your skin until you hear the second louder click.
Danish: Fjern ikke pennen fra huden, før du hører det andet høje klik.
English: While metoprolol tmax was delayed by 1 hour, this change was not statistically significant.
Danish: Selvom tmax af metoprolol var forsinket med 1 time, var denne ændring ikke statistisk signifikant.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR's for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Trulicity that has been frozen must not be used.
Danish: Trulicity, der har været nedfrosset, må ikke anvendes.
English: 3 PRESS AND HOLD
Danish: 3 TRYK OG HOLD
English: Some patients may hear a soft click right before the second loud click.
Danish: Nogle personer kan høre et lavt klik lige inden det andet høje klik.
English: Insert the needle into your skin at about a 45-degree angle.
Danish: Stik nålen ind i huden i en vinkel på 45 grader.
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Danish: Tal med lægen om, hvordan du bedst kan kontrollere dine blodsukkerniveauer, mens du er gravid.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Danish: Patienterne skal informeres om de karakteristiske symptomer på akut pancreatitis.
English: The directions regarding syringe handling and disposal are not intended to replace local or institutional policies.
Danish: De anviste retningslinjer for håndtering og bortskaffelse af injektionssprøjten erstatter ikke lokale eller institutionelle retningslinjer.
English: CHOOSE YOUR INJECTION SITE
Danish: VÆLG DIT INJEKTIONSSTED
English: ^ Patients who withdrew from randomized treatment before 24 weeks were considered as not meeting the target
Danish: ^ Patienter, som ophørte med den randomiserede behandling før 24 uger, blev betragtet som, at de ikke opnåede målet.
English: Date of latest renewal: 23 August 2019
Danish: Dato for første markedsføringstilladelse: 21. november 2014 Dato for seneste fornyelse: 23. august 2019
English: What if I cannot push in the plunger?
Danish: Hvad nu hvis jeg ikke kan trykke stemplet ind?
English: Your doctor should tell you how to treat low blood sugar.
Danish: Din læge vil fortælle dig, hvordan lavt blodsukker behandles.
English: • Trulicity is administered once a week.
Danish: • Trulicity tages én gang om ugen.
English: *Produced in CHO cells by recombinant DNA technology.
Danish: *Fremstillet i CHO-celler ved rekombinant DNA-teknologi.
English: In general these reactions were mild or moderate in severity and transient in nature.
Danish: Disse reaktioner var generelt af let eller moderat sværhedsgrad og forbigående.
English: Do I need to hold the injection button down until the injection is complete?
Danish: Skal jeg holde injektionsknappen nede, indtil injektionen er afsluttet?
English: There are no or limited amount of data from the use of dulaglutide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af dulaglutid til gravide kvinder.
English: In each case, patients can then resume their regular once weekly dosing schedule.
Danish: I begge tilfælde kan patienterne herefter genoptage deres regelmæssige doseringsplan med én ugentlig administration.
English: STORAGE AND HANDLING
Danish: OPBEVARING OG HÅNDTERING
English: Results from the long-term cardiovascular outcome study with 4949 patients randomised to dulaglutide and followed for a median of 5.4 years were consistent with these findings.
Danish: Resultaterne fra det langsigtede studie med kardiovaskulært endepunkt med 4.949 patienter randomiseret til dulaglutid og fulgt i en mediantid på 5,4 år var i overensstemmelse med disse observationer.
English: The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been established.
Danish: Dulaglutids sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Also contact your local Lilly office listed in the Information for the patient for further instructions.
Danish: Kontakt også det lokale Lilly-kontor angivet i indlægssedlen for yderligere instrukser.
English: Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy.
Danish: Fortæl det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, da Trulicity ikke bør anvendes under graviditeten.
English: IMPORTANT INFORMATION
Danish: VIGTIGE OPLYSNINGER
English: - you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis).
Danish: - du har alvorlige problemer med fordøjelsen eller med føde, der bliver i maven længere end normalt (herunder lammelse af mavesækken (gastroparese)).
English: What if there is a drop of liquid or blood on my skin after my injection?
Danish: Hvad nu hvis der er en dråbe væske eller blod på min hud efter injektionen?
English: AUCINR increased by 2 %, which is unlikely to be clinically significant, and there was no effect on maximum international normalised ratio response (INRmax).
Danish: AUCINR steg med 2 %, hvilket sandsynligvis er uden klinisk betydning, og der var ingen indvirkning på den maksimale internationale normaliserede ratio (INRmax).
English: You can also change the day of the week on which you inject Trulicity if necessary, as long as it has been at least 3 days since your last dose of Trulicity.
Danish: Om nødvendigt kan du også ændre den ugedag, hvor du indsprøjter Trulicity, så længe at det er mindst 3 dage siden, at du tog den sidste dosis Trulicity.
English: Trulicity is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients.
Danish: Det frarådes at bruge Trulicity til børn og unge under 18 år, da det ikke er blevet undersøgt i denne aldersgruppe.
English: Frequencies for events have been calculated based on their incidence in the phase II and phase III registration studies.
Danish: Hyppigheder for bivirkninger er blevet beregnet på baggrund af deres hyppighed i fase II og fase III-registreringsstudier.
English: How can I tell if I have completed my injection?
Danish: Hvordan ved jeg, om jeg har afsluttet injektionen?
English: These engineering features result in a soluble formulation and a prolonged half-life of 4.7 days, which makes it suitable for once-weekly subcutaneous administration.
Danish: Disse tekniske egenskaber resulterer i en opløselig formulering og en forlænget halveringstid på 4,7 dage, hvilket gør lægemidlet egnet til subkutan administration én gang om ugen.
English: These other medicines may be medicines taken by mouth and/or insulin given by injection.
Danish: Disse andre lægemidler kan være medicin, du tager gennem munden, og/eller insulin, som du får via injektion (indsprøjtning).
English: In addition, the dulaglutide molecule was engineered to prevent the Fcγ receptor-dependent immune response and to reduce its immunogenic potential.
Danish: Derudover er dulaglutid-molekylet konstrueret til at forebygge Fcγ-receptor-afhængigt immunrespons og til at reducere dets immunogene potentiale.
English: If you stop using Trulicity, your blood sugar levels can increase.
Danish: Hvis du stopper med at bruge Trulicity, kan dit blodsukker stige.
English: The mean age was 66.2 years, the mean BMI was 32.3 kg/m², and 46.3 % of patients were female.
Danish: Gennemsnitsalderen var 66,2 år, det gennemsnitlige BMI var 32,3 kg/m², og 46,3% af patienterne var kvinder.
English: In a 6-month carcinogenicity study in transgenic mice, there was no tumorigenic response.
Danish: I et 6-måneders karcinogenicitetsstudie af transgenetiske mus blev der ikke set noget tumorigent respons.
English: The effect of dulaglutide on fertility in humans is unknown.
Danish: Dulaglutids virkning på fertiliteten hos mennesker er ukendt.
English: Press and hold the green injection button; you will hear a loud click.
Danish: Tryk på den grønne injektionsknap og hold den nede; du vil høre et højt klik.
English: Trulicity was superior in preventing MACE compared to placebo (Figure 1).
Danish: Trulicity var overlegen i forebyggelse af MACE sammenlignet med placebo (figur 1).
English: Do not stop using Trulicity without talking with your doctor.
Danish: Du må ikke stoppe med at bruge Trulicity uden at tale med lægen.
English: Change (rotate) your injection site each week.
Danish: Skift injektionssted hver uge.
English: However, for patients receiving oral medicinal products requiring rapid gastrointestinal absorption or prolonged release formulations the potential for altered drug exposure should be considered.
Danish: For patienter, der modtager orale lægemidler, der kræver hurtig gastrointestinal absorption eller formuleringer med forlænget frigivelse, skal muligheden for ændret lægemiddeleksponering overvejes.
English: Trulicity has no or negligible influence on the ability to drive or use machines.
Danish: Trulicity påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: 104 weeks
Danish: 104 uger
English: You may use the same area of your body, but be sure to choose a different injection site in that area.
Danish: Du kan bruge samme kropsdel, men sørg for at vælge et nyt injektionssted på den kropsdel.
English: the pen.
Danish: pennen.
English: This change is not expected to have clinical consequences.
Danish: Denne ændring forventes ikke at have kliniske konsekvenser.
English: The effect of dulaglutide on blood pressure as assessed by Ambulatory Blood Pressure Monitoring was evaluated in a study of 755 patients with type 2 diabetes.
Danish: Dulaglutids virkning på blodtrykket blev vurderet ved hjælp af ambulant blodtryksmonitorering i et studie med 755 patienter med type 2-diabetes.
English: SCAN THIS CODE TO LAUNCH www.trulicity.eu
Danish: SCAN DENNE KODE FOR AT ÅBNE www.trulicity.eu
English: Figure 2: Forest plot of analyses of individual cardiovascular event types, all cause death, and consistency of effect across subgroups for the primary endpoint
Danish: Figur 2: Forest plot af analyser af individuelle kardiovaskulære hændelser, alle dødstilfælde samt overensstemmelse af virkning på tværs af undergrupper for det primære endepunkt.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeat-dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi eller toksicitet efter gentagne doser.
English: Your doctor may want to lower the dose of these other medicines to prevent you from getting low blood sugar levels (hypoglycaemia).
Danish: Din læge vil eventuelt nedsætte dosen af disse andre lægemidler for at forhindre, at du får lave blodsukkerniveauer (hypoglykæmi).
English: In the completed phase II and phase III initial registration studies, 4,006 patients were exposed to dulaglutide alone or in combination with other glucose lowering medicinal products.
Danish: I de initialt udførte fase II- og fase III-registreringsstudier blev 4.006 patienter eksponeret for dulaglutid alene eller i kombination med andre glucosesænkende lægemidler.
English: Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Dulaglutid bør ikke anvendes til patienter med type 1-diabetes mellitus eller til behandling af diabetisk ketoacidose.
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Danish: • som monoterapi, hvor behandling med metformin ikke er tilrådelig pga. intolerans eller kontraindikationer.
English: You may want to mark your calendar to remind you when to inject your next dose.
Danish: Du kan eventuelt skrive en påmindelse i din kalender, så du kan huske, hvornår du skal indsprøjte din næste dosis.
English: Contact your doctor if you have any questions or concerns.
Danish: Tal med din læge hvis du har spørgsmål eller er i tvivl.
English: The GLP-1 analog portion of dulaglutide is approximately 90 % homologous to native human GLP-1 (7-37).
Danish: Den GLP-1-analoge del af dulaglutid er cirka 90 % homolog med naturligt humant GLP-1 (7-37).
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Danish: Type 2-diabetes er en tilstand, hvor kroppen ikke danner nok insulin, og det insulin, som kroppen danner, virker ikke så godt, som det burde.
English: Hypersensitivity Anaphylactic reaction#
Danish: Overfølsomhed Anafylaktisk reaktion#
English: Place the clear base flat and firmly against your skin at the injection site.
Danish: Placer den klare base fladt og fast mod din hud på injektionsstedet.
English: Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been reported in patients treated with dulaglutide, especially at the initiation of treatment.
Danish: Dehydrering, som nogle gange fører til akut nyresvigt eller forværret nedsat nyrefunktion, er blevet rapporteret hos patienter i behandling med dulaglutid, især ved behandlingsstart.
English: This clinical study did not include patients with end stage renal disease.
Danish: Dette kliniske studie inkluderede ikke patienter med nyresygdom i slutstadiet.
English: • When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.
Danish: • Når du trykker på den grønne injektionsknap, vil pennen automatisk stikke nålen ind i din hud, sprøjte medicinen ind og trække nålen tilbage, når injektionen er færdig.
English: Sitagliptin can produce up to 80 % inhibition of DPP-4 over a 24-hour period.
Danish: Sitagliptin kan medføre en hæmning på op til 80 % af DPP-4 over en 24-timers periode.
English: WHERE TO LEARN MORE
Danish: DU KAN LÆRE MERE HER
English: The safety and efficacy of dulaglutide were evaluated in nine randomised, controlled, phase III trials involving 6,193 patients with type 2 diabetes.
Danish: Sikkerheden og virkningen af dulaglutid er blevet evalueret i ni randomiserede, kontrollerede fase IIIstudier med 6.193 patienter med type 2-diabetes.
English: If pancreatitis is confirmed, dulaglutide should not be restarted.
Danish: Hvis pancreatitis bliver bekræftet, må dulaglutidbehandlingen ikke genoptages.
English: The initial insulin glargine doses in patients with HbA1c <8.0% were reduced by 20%.
Danish: Den initielle dosis af insulin glargin hos patienter med HbA1c < 8,0 % blev reduceret med 20 %.
English: To optimise the insulin glargine dose, both groups were titrated to a target fasting serum glucose of <5.6 mmol/L.
Danish: For at optimere insulin glargindosen, blev begge grupper titreret til et fastende serumglucosemål på <5.6 mmol/l.
English: Angioedema#
Danish: Angioødem#
English: This is not unusual and will not affect your dose.
Danish: Det er ikke usædvanligt og påvirker ikke din dosis.
English: Name and address of the manufacturers of the biological active substance Eli Lilly Kinsale Limited
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Eli Lilly Kinsale Limited
English: Inject your next dose on your regular scheduled day.
Danish: Indsprøjt den næste dosis på den sædvanlige dag.
English: The Trulicity long-term cardiovascular outcome study was a placebo-controlled, double-blind clinical trial.
Danish: Det langsigtede Trulicity-studie med kardiovaskulært endepunkt var et placebokontrolleret, dobbeltblindet klinisk studie.
English: In certain situations, for example if you are 75 years or older, your doctor may recommend a starting dose of 0.75 mg once a week.
Danish: I visse tilfælde, f.eks. hvis du er over 75 år, kan din læge anbefale en startdosis på 0,75 mg en gang om ugen.
English: For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.
Danish: Hos potentielt sårbare populationer kan 0,75 mg ugentligt overvejes som startdosis.
English: In contrast to native GLP-1, dulaglutide is resistant to degradation by DPP-4, and has a large size that slows absorption and reduces renal clearance.
Danish: I modsætning til naturligt GLP-1 er dulaglutid modstandsdygtigt over for nedbrydning via DPP-4 og har en stor størrelse, som sinker absorptionen og reducerer den renale clearance.
English: Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
Danish: Trulicity er indiceret til behandling af voksne med utilstrækkeligt kontrolleret type 2-diabetes mellitus som supplement til diæt og motion
English: They are most common when first starting dulaglutide but decrease over time in most patients.
Danish: De er mest almindelige i starten af behandlingen med dulaglutid men aftager over tid hos de fleste.
English: Leave the Base Cap on until you are ready to inject.
Danish: Behold den grå fod på indtil du er klar til at indsprøjte.
English: • Store your pen in the refrigerator.
Danish: • Opbevar din pen i køleskabet.
English: The dose can be administered at any time of day, with or without meals.
Danish: Dosen kan administreres på et hvilket som helst tidspunkt af dagen uafhængigt af måltider.
English: Dulaglutide is not a substitute for insulin.
Danish: Dulaglutid er ikke en erstatning for insulin.
English: The molecule consists of 2 identical disulfide-linked chains, each containing a modified human GLP-1 analogue sequence covalently linked to a modified human immunoglobulin G4 (IgG4) heavy chain fragment (Fc) by a small peptide linker.
Danish: Molekylet består af 2 identiske disulfid-forbundne kæder, der hver indeholder en modificeret human GLP-1-analog sekvens, der er kovalent forbundet til et modificeret humant immunglobulin G4 (IgG4)-tungkædefragment (Fc) via en lille peptidbinder.
English: Trulicity contains sodium
Danish: Trulicity indeholder natrium
English: The clinical relevance of these findings is currently unknown.
Danish: Den kliniske relevans af disse fund kendes ikke på nuværende tidspunkt.
English: Continue holding the clear base firmly against your skin until you hear a second click.
Danish: Fortsæt med at holde den klare base godt fast mod huden, indtil du hører et klik mere.
English: Native GLP-1 has a half-life of 1.5-2 minutes due to degradation by DPP-4 and renal clearance.
Danish: Naturligt GLP-1 har en halveringstid på 1,5-2 minutter som følge af nedbrydning via DPP-4 og renal clearance.
English: Fasting blood glucose
Danish: Fastende blodglucose
English: - Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.
Danish: - Symptomerne på lavt blodsukker kan være hovedpine, døsighed, svaghed, svimmelhed, sult, forvirring, irritabilitet, hurtigt hjerteslag og svedtendens.
English: These were typically mild or moderate in severity and were reported to peak during the first 2 weeks of treatment and rapidly declined over the next 4 weeks, after which the rate remained relatively constant.
Danish: Disse bivirkninger var typisk af let eller moderat sværhedsgrad, og ifølge indberetningerne toppede de i de 2 første uger af behandlingen, hvorefter de hurtigt aftog over de følgende 4 uger, hvorefter raten forblev relativt konstant.
English: - you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Danish: - du har diabetisk ketoacidose (en komplikation ved diabetes, som opstår, hvis kroppen ikke er i stand til at nedbryde glukose, fordi der ikke er nok insulin).
English: Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak plasma concentrations in 48 hours.
Danish: Efter subkutan administration til patienter med type 2-diabetes nås de maksimale plasmakoncentrationer af dulaglutid i løbet af 48 timer.
English: Patients with dulaglutide anti-drug antibodies generally had low titres, and although the number of patients developing dulaglutide anti-drug antibodies was low, examination of the phase III data revealed no clear impact of dulaglutide anti-drug antibodies on changes in HbA1c.
Danish: Generelt havde patienter med antistoffer mod dulaglutid lave titre, og selvom antallet af patienter, som udviklede antistoffer mod dulaglutid, var lavt, viste en undersøgelse af fase III resultaterne ikke en klar indvirkning af dulaglutid-antistoffer på ændringer i HbA1c.
English: Slowly push the plunger all the way in until all the medicine is injected.
Danish: Tryk forsigtigt stemplet hele vejen ind, indtil al medicinen er sprøjtet ind.
English: Do not recycle the filled sharps container.
Danish: Genbrug ikke den fyldte kanylebeholder.
English: Especially tell your doctor: - if you are using other medicines that lower the amount of sugar in your blood, such as insulin or a medicine containing sulphonylurea.
Danish: Det er særligt vigtigt, at du fortæller det til lægen: - hvis du bruger andre lægemidler, der nedsætter mængden af sukker i dit blod, såsom insulin eller et lægemiddel, der indeholder et sulfonylurinstof.
English: Until then, store your pen safely to avoid an accidental needle stick injury.
Danish: I mellemtiden skal du opbevare pennen sikkert for at undgå nålestikskader.
English: In clinical pharmacology studies conducted in patients with type 2 diabetes mellitus up to 6 weeks, the majority of gastrointestinal events were reported during the first 2-3 days after the initial dose and declined with subsequent doses.
Danish: I kliniske farmakologistudier af op til 6 ugers varighed med patienter med type 2-diabetes mellitus blev størstedelen af de gastrointestinale hændelser indberettet i de første 2-3 dage efter den første dosis og aftog med efterfølgende doser.
English: Change in body weight
Danish: Ændring i legemsvægt
English: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000 and not known: cannot be estimated from available data).
Danish: < 1/10; ikke almindelig: ≥ 1/1.000 til < 1/100; sjælden: ≥ 1/10.000 til < 1/1.000; meget sjælden: < 1/10.000 og ikke kendt: kan ikke estimeres ud fra forhåndenværende data).
English: - you have type 1 diabetes (the type when your body does not produce any insulin) as this medicine may not be right for you.
Danish: - du har type 1-diabetes (den type hvor kroppen ikke danner noget insulin), da dette lægemiddel i så fald kan være uegnet til dig.
English: 1500-2000 mg/day (n=268)
Danish: 1500-2000 mg/dag (n=268)