FrancophonIA/ELRC3.0 huggingface dataset:
English: These clumps could clog the needle when you take the injection (see question 7).
Danish: Disse klumper kan tilstoppe kanylen, når du tager indsprøjtningen (se spørgsmål nr. 7).
English: All randomised patients who received at least one dose of study medication.
Danish: Alle randomiserede patienter, som fik mindst én dosis studiemedicin.
English: CV-related death
Danish: CV-relateret dødsfald
English: To take the correct dose, read each section so that you do every step in order.
Danish: For at få den korrekte dosis skal du læse alle afsnit, så du udfører hvert enkelt trin i rækkefølge.
English: The pen contains an integrated needle.
Danish: Pennen indeholder en integreret nål.
English: 24-Week Study
Danish: 24-ugers studie
English: (This question relates to step 4a.)
Danish: (Dette spørgsmål vedrører trin 4a.)
English: Weight loss was sustained over 7 years in these patients.
Danish: Vægttabet blev opretholdt over 7 år hos disse patienter.
English: It is not known if this medicine may harm your unborn child, therefore you should not use it during pregnancy and for at least 3 months before a planned pregnancy.
Danish: Det vides ikke, om dette lægemiddel kan skade dit ufødte barn, og derfor må du ikke anvende det under graviditeten og i mindst 3 måneder før en planlagt graviditet.
English: Months from Randomization
Danish: Måneder fra randomisering
English: See question number:
Danish: Se spørgsmål nr.:
English: Before You Begin
Danish: Før du går i gang
English: All-cause death
Danish: Dødsfald af alle årsager
English: International normalised ratio increased
Danish: Stigning i international normaliseret ratio
English: Patients were followed as in routine clinical practice for a median of 38.7 months with a median treatment duration of 27.8 months.
Danish: Patienterne blev fulgt som i klinisk rutinepraksis i mediant 38,7 måneder med en gennemsnitlig behandlingsvarighed på 27,8 måneder.
English: These medical conditions can increase the risk of getting pancreatitis, or getting it again, whether or not you are taking this medicine.
Danish: Disse sygdomstilstande kan forhøje risikoen for at få pancreatitis eller for at få det igen, uanset om du får dette lægemiddel eller ej.
English: The difference between the two treatment groups was not significant.
Danish: Forskellen mellem de to behandlede grupper var ikke signifikant.
English: Prolonged-release exenatide should be administered once a week on the same day each week.
Danish: Depotformulering af exenatid skal administreres én gang om ugen på samme dag hver uge.
English: Your doctor should tell you how to treat low blood sugar.
Danish: Din læge bør fortælle dig, hvordan et lavt blodsukkerniveau skal behandles.
English: C. Check the suspension.
Danish: C. Kontroller suspensionen.
English: C. Disposal.
Danish: C. Bortskaffelse.
English: See the Common Questions & Answers for what to do if you do not see the orange rod in the window after injection.
Danish: Se de generelle spørgsmål og svar for hvad du skal gøre, hvis du ikke ser den orange stempel i vinduet efter injektion.
English: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Ireland
Danish: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Irland
English: I am having trouble mixing my dose.
Danish: Jeg har problemer med at blande min dosis.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Danish: I tilfælde af overdosering bør passende understøttende behandling iværksættes i henhold til patientens kliniske tegn og symptomer.
English: Locked Position
Danish: Låst position
English: • is large enough to hold the entire pen,
Danish: • er stor nok til at kunne opbevare hele pennen
English: • Bydureon BCise pen should not be used by people who are blind or cannot see well, unless another person who is trained to use this device can help.
Danish: • Bydureon BCise pen må ikke bruges af blinde eller svagtseende personer, med mindre en anden person, som er trænet i brugen af dette hjælpemiddel, kan hjælpe.
English: 1a Take a single-dose kit from the refrigerator.
Danish: 1a Tag et enkeltdosissæt ud af køleskabet.
English: Beta-cell function
Danish: Beta-cellefunktionen
English: D. Compare both sides of the mixing window to the photos below,
Danish: D. Sammenlign begge sider af blandingsvinduet med billederne nedenfor,
English: The mean BMI was 32.7 kg/m2 and the mean duration of diabetes was 13.1 years.
Danish: Det gennemsnitlige BMI var 32,7 kg/m2, og den gennemsnitlige varighed af diabetes var 13,1 år.
English: • Do not use the pen if any parts look to be broken or damaged.
Danish: • Brug ikke pennen, hvis nogen af delene ser ud til at være i stykker eller beskadiget.
English: The black dashed Dose Line shows the correct dose.
Danish: Den sorte stiplede doseringslinje viser den korrekte dosis.
English: The medicine should look even throughout (see pictures in Figure G and Figure H, Step 2C).
Danish: Lægemidlet skal se ensartet ud (se billeder i figur G og figur H, trin 2C).
English: It's OK to see bubbles
Danish: Det er OK at se bobler
English: C. Check the liquid, inside the inspection window.
Danish: C. Kontroller væsken, i inspektionsvinduet.
English: 30-Week Study
Danish: 30-ugers studie
English: You do not have to save any parts.
Danish: Du skal ikke gemme nogen af delene.
English: Subsequent injections should use a different site of injection each week.
Danish: Ved efterfølgende injektioner bør et nyt indstikssted benyttes hver uge.
English: Needle (monoject)
Danish: Kanyle (monoject)
English: Read and follow each step in these instructions carefully every time you take Bydureon.
Danish: Læs og følg hvert trin i denne vejledning omhyggeligt, hver gang du tager din dosis af Bydureon.
English: If you need to give yourself both at the same time, use two separate injections.
Danish: Hvis du skal tage begge dele samtidig, skal du bruge to forskellige injektioner.
English: You should use contraception if you could potentially become pregnant during treatment with this medicine.
Danish: Du skal bruge prævention, hvis det er muligt, at du kunne blive gravid under behandlingen med dette lægemiddel.
English: If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection.
Danish: Hvis toppen af stemplet er trykket ned forbi linjen, skal du fortsætte fra trin 4d og tage indsprøjtningen.
English: The follow-up and extension phases of studies are included in the pool.
Danish: Opfølgningen og forlængelsesfasen af studierne er inkluderet i data pool.
English: White to off-white opaque suspension.
Danish: Hvid til offwhite uklar suspension.
English: Digoxin and lisinopril
Danish: Digoxin og lisinopril
English: Supplies needed to give your injection:
Danish: Hjælpemidler, som er nødvendige for at give dig indsprøjtning:
English: After you receive your injection, you will see an orange rod in the window.
Danish: Når du har fået din injektion, vil du se et orange stempel i vinduet.
English: Bydureon only needs to be taken once a week.
Danish: Bydureon skal kun tages én gang om ugen.
English: B. Check the expiration date (labelled EXP) printed on the pen label.
Danish: B. Tjek udløbsdatoen (EXP), som er trykt på pennens etiket.
English: The results of the primary composite and secondary cardiovascular endpoints are shown in Figure 2.
Danish: Resultaterne af det primære sammensatte og sekundære kardiovaskulære endepunkt er vist i figur 2.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Danish: Patienterne skal informeres om de karakteristiske symptomer på akut pancreatitis: vedvarende, kraftige abdominalsmerter.
English: Pay attention to the bottom surface.
Danish: Læg mærke til bundens overflade.
English: • A green shield will pop up after the cap is removed.
Danish: • Et grønt skjold kommer op, når hætten er fjernet.
English: Each week you can use the same area of your body.
Danish: Du kan bruge det samme område af kroppen hver uge.
English: Lift here for a closer look at the parts
Danish: Løft her for at se nærmere på sættets dele
English: Each single-dose kit has everything you need for your weekly dose of Bydureon.
Danish: Hvert enkeltdosissæt har alt det, du skal bruge til din ugentlige dosis af Bydureon.
English: Paediatric population Interaction studies with exenatide have only been performed in adults.
Danish: Pædiatrisk population Interaktionsstudier med exenatid er kun udført hos voksne.
English: Gender, race and body weight Gender, race and body weight have no clinically relevant influence on exenatide pharmacokinetics.
Danish: Køn, race og legemsvægt Køn, race og legemsvægt har ingen klinisk relevant betydning for farmakokinetikken for exenatid.
English: − Comes in the locked position before you use it. Do not unlock the pen until you are ready to inject it.
Danish: - Leveres i en låst position før du bruger den. Du må ikke låse pennen op, før du er klar til at indsprøjte medicinen.
English: If not mixed well, repeat Step 2 and check again.
Danish: Hvis det ikke er helt blandet, gentag trin 2 og tjek igen.
English: Weight loss of this rate may have harmful consequences.
Danish: Vægttab med denne hastighed kan have skadelige konsekvenser.
English: No predetermined dose adjustment is required; however, lipid profiles should be monitored as appropriate.
Danish: Der er ikke behov for en forud fastlagt justering af dosis, men lipidprofilerne bør overvåges efter behov.
English: If you don't see clumps you are ready to inject.
Danish: Hvis du ikke kan se klumper, er du klar til indsprøjtning.
English: Tap the vial several times against a hard surface to loosen the powder.
Danish: Bank hætteglasset flere gange mod en hård overflade for at løsne pulveret.
English: Figure 2: Forest Plot: Analysis of Primary and Secondary Endpoints (intent to treat patients)
Danish: Figur 2: Forest Plot: Analyse af primære og sekundære endepunkter (intent to treat-patienter)
English: • dehydration, sometimes with a decrease in kidney function
Danish: • dehydrering, sommetider med nedsat nyrefunktion
English: The active substance in this medicine slows stomach emptying so food passes more slowly through your stomach.
Danish: Det aktive stof i dette lægemiddel nedsætter hastigheden af mavetømning, så maden passerer langsommere gennem maven.
English: Once absorbed into the circulation, exenatide is distributed and eliminated according to its known systemic pharmacokinetic properties (as described in this section).
Danish: Når exenatid er absorberet i kredsløbet, distribueres og elimineres det i overensstemmelse med dets kendte farmakokinetiske egenskaber (som beskrevet i dette afsnit).
English: • Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides.
Danish: • Fortæl det til din læge, hvis du har lidt af pancreatitis, galdesten eller alkoholisme eller har haft et meget højt niveau af triglycerider.
English: No clinically relevant effects on Cmax or AUC were observed.
Danish: Der blev ikke observeret nogen klinisk relevante virkninger på Cmax eller AUC.
English: The needle is now prepared.
Danish: Kanylen er nu klar.
English: Overall, 26.9% of patients did not have any prior CV event, 73.1% had at least one prior CV event.
Danish: Samlet set havde 26,9 % af patienterne ikke haft nogen tidligere CV-hændelser, 73,1 % havde haft mindst én tidligere CV-hændelse.
English: Not known (frequency cannot be estimated from the available data) In addition some other side effects have been reported .
Danish: Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data) Derudover er der indberettet andre bivirkninger.
English: The mean apparent volume of distribution of exenatide following subcutaneous administration of a single dose of exenatide is 28 l.
Danish: Det gennemsnitlige tilsyneladende distributionsvolumen for exenatid efter subkutan administration af en enkelt dosis exenatid er 28 l.
English: Never mix insulin and Bydureon together in the same injection.
Danish: Du må aldrig blande insulin og Bydureon sammen i den samme injektion.
English: No dose adjustment is required based on age.
Danish: Justering af dosis på baggrund af alder er ikke nødvendigt.
English: It may also help to tap the mixing window on both sides against your palm.
Danish: Det kan også hjælpe at slå blandingsvinduet på begge sider mod din håndflade.
English: You should inject this medicine once a week, at any time of day, with or without meals.
Danish: Du skal indsprøjte dette lægemiddel én gang om ugen på et vilkårligt tidspunkt af dagen med eller uden et måltid.
English: It is normal to see a few drops of medicine inside the orange cap after you unscrew it.
Danish: Det er normalt at se et par dråber medicin inde i den orange hætte, når du har skruet den af.
English: Do not worry that the vial might come off.
Danish: Du skal ikke være bekymret for, om hætteglasset kan falde af.
English: The vital status was known at the end of the study for 98.9% and 98.8% of the patients in the prolonged-release exenatide and placebo group, respectively.
Danish: Vitalstatus var ved afslutning af studiet kendt for henholdsvis 98,9 % og 98,8 % af patienterne i gruppen med depotformulering af exenatid og placebo.
English: You can re-mix your medicine if your pen is in the locked position.
Danish: Du kan blande din medicin igen, hvis din pen er i låst stilling.
English: It is unknown whether exenatide is excreted in human milk.
Danish: Det er ukendt, om exenatid udskilles i human mælk.
English: Do not take two doses of Bydureon within 3 days of each other.
Danish: Tag ikke to doser af Bydureon indenfor 3 dage.
English: Gently clean the area with soap and water or an alcohol swab.
Danish: Vask området forsigtigt med sæbe og vand eller med en alkoholserviet.
English: The medicine is mixed well when the liquid looks cloudy from both sides of the window.
Danish: Medicinen er blandet tilstrækkeligt, når væsken ser uklar ud fra begge sider af vinduet.
English: Based on hypoglycaemic events that 1.
Danish: Baseret på hypoglykæmiske hændelser, som 1.
English: DO NOT push the injection button yet.
Danish: Tryk IKKE injektionsknappen ind endnu.
English: The green shield hides the needle.
Danish: Det grønne skjold skjuler nålen.
English: Shake for at least 15 seconds.
Danish: Ryst i mindst 15 sekunder.
English: The presence of antibodies (high or low titres) is not predictive of glycaemic control for an individual patient.
Danish: Forekomsten af antistoffer (høje eller lave titre) er ikke prædiktiv for den glykæmiske kontrol hos den enkelte patient.
English: The effect on HbA1c remained clinically significant over 52 weeks but partially diminished over time in the group that had initially received Bydureon BCise.
Danish: Virkningen på HbA1c forblev klinisk signifikant gennem 52 uger, men aftog delvist over tid hos gruppen, som initielt havde modtaget Bydureon BCise.
English: Hypoglycaemia may reduce your ability to concentrate.
Danish: Hypoglykæmi kan nedsætte din koncentrationsevne.
English: Thereafter, patients can resume their usual once weekly dosing schedule.
Danish: Derefter kan patienten genoptage den sædvanlige dosering én gang om ugen.
English: Shake vigorously like you would shake a bottle of oil-and-vinegar salad dressing.
Danish: Ryst kraftigt, som du for eksempel ryster en flaske med olie-eddike-dressing.
English: Administration of exenatide has been shown to reduce food intake, due to decreased appetite and increased satiety.
Danish: Administration af exenatid har vist sig at nedsætte indtagelsen af mad på grund af nedsat appetit og øget mæthed.
English: Data in elderly are limited, but suggest no marked changes in exenatide exposure with increased age up to about 75 years old.
Danish: Data vedrørende anvendelse til ældre patienter er begrænsede, men tyder på, at der ikke er nogen udtalte ændringer i eksponeringen for exenatid i takt med en stigende alder og op til cirka 75 år.
English: - If you have type 1 diabetes or diabetic ketoacidosis, as this medicine should not be used.
Danish: - Hvis du har type 1-diabetes eller diabetisk ketoacidose, da dette lægemiddel ikke må anvendes.
English: Interaction with warfarin
Danish: Interaktion med warfarin
English: Prolonged-release exenatide that has been frozen must not be used.
Danish: Depotformulering af exenatid, der har været nedfrosset, må ikke anvendes.
English: Please see the package leaflet and “Instructions for the User” for additional information on suspension and administration.
Danish: Se indlægssedlen og "Brugervejledning" for yderligere oplysninger om suspension og administration.
English: Exenatide has been shown to bind to and activate the known human GLP-1 receptor in vitro, its mechanism of action mediated by cyclic AMP and/or other intracellular signalling pathways.
Danish: Exenatid har vist sig at binde til og aktivere den kendte humane GLP-1-receptor in vitro, idet dens virkningsmekanisme medieres af cyklisk AMP og/eller andre intracellulære signalbaner.
English: Do not touch the orange connector inside.
Danish: Rør ikke ved det orange forbindingsled indeni.
English: DO NOT use your pen or needle if any parts are broken or missing.
Danish: Brug IKKE pennen eller kanylen, hvis nogle dele mangler eller er gået i stykker.
English: HR=hazard ratio, CI=confidence interval
Danish: HR=hazard ratio, CI=konfidensinterval
English: HR (active/placebo) and CI are based on Cox proportional hazards regression model, stratified by prior CV event, with treatment group only as explanatory variable.
Danish: HR (aktiv/placebo) og CI er baseret på Cox proportional hazards-regressionsmodel, stratificeret af tidligere CV-hændelse kun med behandlingsgruppen som forklarende variabel.
English: • STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).
Danish: • STOP med at tage dette lægemiddel og kontakt din læge omgående, hvis du får kraftige og vedvarende mavesmerter med eller uden opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pancreatitis).
English: The suspension must be mixed by shaking hard for at least 15 seconds.
Danish: Suspensionen skal blandes ved at ryste kraftigt i mindst 15 sekunder.
English: The mean age at study entry was 62 years (with 8.5% of the patients ≥75 years).
Danish: Den gennemsnitlige alder ved studiets start var 62 år (hvor 8,5 % af patienterne var ≥75 år).
English: All patients with missing endpoint data are imputed as non-responders.
Danish: Alle patienter med manglende endepunktdata registreres som non-respondenter.
English: This will allow enough time for all the medicine to go from the pen to under your skin.
Danish: Dette vil give tilstrækkelig tid til, at hele medicinen kan passere fra pennen til under huden.
English: Pens stored vertically (with the needle up or down) are more difficult to mix.
Danish: Autoinjektorer opbevaret lodret (med nålen op eller ned) er vanskeligere at blande.
English: Patients with an Event (%)
Danish: Patienter med en hændelse (%)
English: This medicine should be discontinued at least 3 months before a planned pregnancy.
Danish: Dette lægemiddel skal seponeres mindst 3 måneder inden en planlagt graviditet.
English: - If you have ever had inflammation of the pancreas (pancreatitis) (see section 4).
Danish: - Hvis du nogensinde har haft betændelse i bugspytkirtlen (pancreatitis) (se punkt 4).
English: Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Danish: Ikke-kliniske studier har vist, at exenatid fortrinsvis elimineres ved glomerulær filtration med efterfølgende proteolytisk nedbrydning.
English: Why do I need to hold the pen upright while removing the orange cap?
Danish: Hvorfor skal jeg holde pennen lodret, mens jeg fjerner den orange hætte?
English: The percentage of these subjects with positive antibody titres, in particular high titres, peaked at approximately weeks 8 to 16 of dosing and then diminished over time.
Danish: Procentdelen af disse forsøgspersoner med positive antistoftitre, især høje titre, toppede ved ca. 8 til 16 ugers behandling, som derefter formindskedes over tid.
English: • skin reactions at the injection site following injection of exenatide.
Danish: • hudreaktioner på indstiksstedet efter injektion af exenatid.
English: Your doctor is now prescribing this medicine as an additional medicine to help control your blood sugar.
Danish: Din læge har ordineret dette lægemiddel som et ekstra lægemiddel til kontrol af dit blodsukker.
English: The mean apparent clearance of exenatide is 9 l/h.
Danish: Den gennemsnitlige tilsyneladende clearance af exenatid er 9 l/t.
English: PUSH & HOLD
Danish: TRYK & HOLD
English: You may give both injections in the same body area (for example, your stomach area), but you should not give the injections next to each other.
Danish: Du kan tage begge injektioner i samme område på kroppen (for eksempel maveområdet), men du må ikke tage injektionerne direkte ved siden af hinanden.
English: After removing the needle, look for the orange rod in the window as a way to tell that the dose has been given.
Danish: Når du har fjernet nålen, skal du kigge efter det orange stempel i vinduet, som er en måde at vise, at dosis er blevet givet.
English: You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or your body is not able to use the insulin properly.
Danish: Du har diabetes, fordi din krop ikke producerer tilstrækkelig insulin til at kontrollere niveauet af sukker i blodet, eller fordi din krop ikke kan bruge insulinet ordentligt.
English: Air bubbles are not a problem with this type of injection.
Danish: Luftbobler giver ingen problemer med denne form for indsprøjtning.
English: If you do not inject Bydureon immediately, the medicine will start to form small clumps in the syringe.
Danish: Hvis du ikke indsprøjter Bydureon med det samme, vil medicinen begynde at danne små klumper i sprøjten.
English: Prolonged-release exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Depotformulering af exenatid bør ikke anvendes til patienter med type 1-diabetes mellitus eller til behandling af diabetisk ketoacidose.
English: Approximately 62% of the patients were male.
Danish: Ca. 62 % af patienterne var af hankøn.
English: • Store in packaging provided to protect from light until you are ready to prepare and use your dose.
Danish: • Opbevares i den originale yderpakning for at beskytte mod lys indtil du er klar til at forberede og tage din dosis.
English: You will not need the cap and can throw it away.
Danish: Du skal ikke bruge hætten og kan derfor smide den ud.
English: Name and address of the manufacturers responsible for batch release AstraZeneca AB
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse AstraZeneca AB
English: Fertility No fertility studies in humans have been conducted.
Danish: Fertilitet Der er ikke udført fertilitetsstudier på mennesker.
English: • Hypersensitivity (rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat)
Danish: • Overfølsomhed (udslæt, kløe og hurtig hævelse af huden i hals, ansigt, mund eller svælg)
English: Result in loss of consciousness, seizure, or coma which resolves after administration of glucagon or glucose OR 2.
Danish: Resulterer i tab af bevidsthed, kramper eller koma, der bliver løst efter administration af glucagon eller glucose ELLER 2.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to  1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres således: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).