FrancophonIA/ELRC3.0 huggingface dataset:
English: I'm ready to take the injection.
Danish: Jeg er klar til at tage indsprøjtningen.
English: A. Combine the medicine.
Danish: A. Kombiner din medicin.
English: In most patients who develop antibodies, antibody titres diminish over time.
Danish: Hos de fleste patienter, der udvikler antistoffer, mindskes antistoftitrene med tiden.
English: Patients with rapid weight loss should be monitored for signs and symptoms of cholelithiasis.
Danish: Patienter med hurtigt vægttab bør monitoreres for tegn og symptomer på cholelithiasis.
English: Back of upper arm
Danish: Bagsiden af overarmen
English: The 28-week comparator-controlled period of the study was followed by a 24-week extension period during which all participating subjects received treatment with this medicinal product.
Danish: De kontrollerede 28-ugers sammenligningsstudie blev efterfulgt af en 24-ugers opfølgningsperiode, hvor alle deltagende patienter modtog behandling med dette lægemiddel.
English: Resolution of pancreatitis has been observed with supportive treatment, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Danish: Det er observeret, at pancreatitis kan forsvinde ved støttende behandling, men meget sjældne tilfælde af nekrotiserende eller hæmoragisk pancreatitis og/eller død er rapporteret.
English: • Remove the needle cover and give the injection, see steps 4e to 4g
Danish: • Tager kanylehætten af og tager indsprøjtningen - se trin 4e til 4g
English: Do not throw away the pen in your household waste.
Danish: Smid ikke pennen i dit husholdningsaffald.
English: Figure 1: Time to First Adjudicated MACE (intent to treat patients)
Danish: Figur 1: Tid til første vurderede MACE (intent to treat-patienter)
English: • Remove the blue cap of the needle, see step 1d
Danish: • Tager den blå hætte af kanylen - se trin 1d
English: Do not use tools or try to force the cap off.
Danish: Brug ikke værktøj eller forsøg at tvinge hætten af.
English: Bydureon BCise pen can be kept at room temperature for up to 4 weeks.
Danish: Bydureon BCise pen kan opbevares ved stuetemperatur i op til 4 uger.
English: The patient does not need to save any part of the single-use kit.
Danish: Patienten skal ikke gemme nogen dele af sættet til engangsbrug.
English: by pushing and screwing it onto the top of the pen until it is tight.
Danish: ved at skubbe og skrue den på pennens top, indtil den sidder stramt på.
English: Do not skip steps.
Danish: Spring ikke trin over.
English: The needle is attached to the pen and covered by the orange cap.
Danish: Nålen er fastgjort til pennen og dækket af den orange hætte.
English: Use your thumb to remove the green cap.
Danish: Brug tommelfingeren til at fjerne den grønne hætte.
English: After you lift the pen from your skin, the green shield will move back up to lock over the needle.
Danish: Når du flytter pennen fra din hud, vil det grønne skjold bevæge sig tilbage for at låse over nålen.
English: If you see any clumps, keep tapping.
Danish: Hvis du ser nogen klumper, skal du blive ved med at slå.
English: Prolonged-release exenatide can be administered at any time of day, with or without meals.
Danish: Depotformulering af exenatid kan administreres på et hvilket som helst tidspunkt på dagen uden eller i forbindelse med et måltid.
English: Needles (2)
Danish: Nåle (2)
English: You must not save the mixed medicine to inject at a later time.
Danish: Du må ikke gemme den blandede medicin til indsprøjtning på et senere tidspunkt.
English: Using too much of this medicine can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).
Danish: For meget af dette lægemiddel kan medføre kvalme, opkastning, svimmelhed eller symptomer på lavt blodsukker (se punkt 4).
English: Clean the area with an alcohol swab.
Danish: Rens området med en spritserviet.
English: It is important to stop pushing at this point, or you will waste your medicine and you will not get the correct dose.
Danish: Det er vigtigt, at du holder op med at trykke nu, da du ellers vil spilde medicin og ikke få den korrekte dosis.
English: The mean HbA1c was 8.1%.
Danish: Det gennemsnitlige HbA1c var 8,1 %.
English: INSTRUCTIONS FOR THE USER Read these instructions carefully before use
Danish: BRUGERVEJLEDNING Læs disse instruktioner omhyggeligt inden brug
English: The two chambers are separated by a second chlorobutyl rubber piston.
Danish: De to kamre er separeret med yderligere et chlorbutylgummistempel.
English: Bydureon BCise pen should be stored as follows:
Danish: Bydureon BCise pen skal opbevares som følger:
English: • Tap the prefilled pen firmly until a uniformly cloudy suspension with no clumps is obtained.
Danish: • Slå hårdt på den fyldte pen, indtil der opnås en ensartet uklar suspension uden klumper.
English: There were no events of major hypoglycaemia with Bydureon BCise.
Danish: Der var ingen forekomst af episoder med alvorlig hypoglykæmi med Bydureon BCise.
English: This means the needle has become clogged.
Danish: Det betyder, at kanylen er blevet tilstoppet.
English: If you still cannot push the button in, this may mean that the needle is clogged.
Danish: Hvis du stadig ikke kan trykke knappen ind, kan det betyde, at kanylen er tilstoppet.
English: D. Inject the medicine.
Danish: D. Indsprøjt medicinen.
English: The day of weekly administration can be changed if necessary as long as the last dose was administered at least three days before.
Danish: Dagen for den ugentlige administration kan om nødvendigt ændres, så længe den sidste dosis blev administreret mindst tre dage forinden.
English: The amino acid sequence of exenatide partially overlaps that of human GLP-1.
Danish: Aminosyresekvensen af exenatid overlapper delvist den humane GLP-1.
English: The pooled clinical studies data set for Bydureon BCise comprises two phase 3 comparator-controlled studies of 6 to 12 months duration.
Danish: Det samlede kliniske studiedatasæt for Bydureon BCise omfatter to fase 3 komparator-kontrollerede studier af 6 til 12 måneders varighed.
English: After a standard meal tolerance test.
Danish: Efter en tolerancetest med et standardmåltid.
English: Prolonged-release exenatide has minor influence on the ability to drive and use machines.
Danish: Depotformulering af exenatid påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: It may help to hold the pen up to the light to see in the window.
Danish: Det kan hjælpe at holde pennen op mod lyset, når du kigger i vinduet.
English: Hold for 10 seconds to make sure you get the full dose.
Danish: Hold den sådan i 10 sekunder for at være sikker på, at du får hele dosis.
English: UNIQUE IDENTIFIER -2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Most individual nodules were asymptomatic, did not interfere with study participation and resolved over 4 to 8 weeks.
Danish: De fleste enkelte noduli var asymptomatiske, havde ingen betydning for deltagelsen i studiet og forsvandt inden for 4-8 uger.
English: Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/or diarrhoea and/or receiving medicinal products known to affect renal function/hydration status.
Danish: Nogle af disse hændelser opstod hos patienter, der havde symptomer, som kan påvirke hydreringsgraden, herunder kvalme, opkastning og/eller diaré, og/eller som fik lægemidler, der vides at påvirke nyrefunktionen/hydreringsstatus.
English: Unlike native GLP-1, prolongedrelease exenatide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once weekly administration.
Danish: I modsætning til naturligt GLP-1 har depotformulering af exenatid en farmakokinetisk og farmakodynamisk profil hos mennesker, der er egnet til administration én gang ugentlig.
English: Overall, 9.3% of patients treated with Bydureon BCise reported nausea during the controlled period of both clinical studies.
Danish: Samlet set rapporterede 9,3 % af patienterne, der blev behandlet med Bydureon BCise, kvalme i den kontrollerede periode i begge kliniske studier.
English: A. Let your pen warm up.
Danish: A. Lad pennen varme op.
English: • WITHOUT twisting the knob, ROTATE the pen every few taps.
Danish: • UDEN at dreje på håndtaget skal pennen DREJES, hver gang du har slået nogle få gange.
English: Make a note that you have taken your Bydureon today and mark your calendar for when you are due for your next injection.
Danish: Skriv ned, at du har taget din dosis af Bydureon i dag og markér datoen for næste indsprøjtning i din kalender.
English: However, exenatide does not impair the normal glucagon response and other hormone responses to hypoglycaemia.
Danish: Exenatid forringer dog ikke det normale glukagonrespons og andre hormoners respons på hypoglykæmi.
English: A delay in tmax of about 2 h was observed when warfarin was administered 35 min after immediate-release exenatide.
Danish: Der blev observeret en forsinkelse i tmax på cirka 2 timer, når warfarin blev administreret 35 minutter efter exenatid opløsning til injektion.
English: The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
Danish: Tegnene og symptomerne på lavt blodsukker kan være hovedpine, døsighed, svækkelse, svimmelhed, forvirring, irritabilitet, sult, hurtig hjerterytme, øget svedafsondring og en følelse af nervøsitet.
English: What should I do if I cannot push the injection button all the way in when trying to inject my dose?
Danish: Hvad skal jeg gøre, hvis jeg ikke kan trykke injektionsknappen helt ind, når jeg prøver at indsprøjte min dosis?
English: ACS=acute coronary syndrome; CI=confidence interval; CV=cardiovascular; HF=heart failure; HR=hazard ratio; MACE=major adverse cardiac event; MI=myocardial infarction; n=number of patients with an event; N=number of patients in treatment group.
Danish: ACS=akut koronart syndrom; CI=konfidensinterval; CV=kardiovaskulær; HF=hjertesvigt; HR=hazard ratio; MACE=alvorlig hjerte-kar-relateret hændelse; MI=myokardieinfarkt; n=antal patienter med en hændelse; N=antal patienter i behandlingsgruppen.
English: The reduction in Cmax is of limited clinical relevance and no adjustment of dosing of oral contraceptives is required.
Danish: Faldet i Cmax er af begrænset klinisk relevans, og der er ikke behov for justeringer af doserne af orale kontraceptiva.
English: • Read the Package Leaflet carefully.
Danish: • Læs indlægssedlen omhyggeligt.
English: These include: cavity containing pus (abscess) and swollen, or red area of skin that feels hot and tender (cellulitis).
Danish: De omfatter: pus i hulrum (bylder) og hævede eller røde områder på huden, der føles varme og ømme (cellulitis).
English: There is little experience with this medicine in patients with kidney problems.
Danish: Der er kun ringe erfaring med anvendelse af dette lægemiddel til patienter med nyreproblemer.
English: You will need a puncture-resistant container that:
Danish: Du har brug for en punkteringsfri beholder som:
English: The overall incidence of minor hypoglycaemia was 6.3%.
Danish: Den samlede forekomst af ikke alvorlige tilfælde af hypoglykæmi var (6,3 %).
English: Pioglitazone 45 mg
Danish: Pioglitazon 45 mg
English: - If you have severe problems with your stomach emptying (including gastroparesis) or food digestion, as the use of this medicine is not recommended.
Danish: - Hvis du har alvorlige problemer med tømning af din mave (herunder også gastroparese) eller med at fordøje maden, da anvendelse af dette lægemiddel frarådes.
English: There are no adequate data from the use of prolonged-release exenatide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af depotformulering af exenatid til gravide kvinder.
English: 1 Getting started
Danish: 1 Kom godt i gang
English: Examination of antibody-positive specimens revealed no significant cross-reactivity with similar endogenous peptides (glucagon or GLP-1).
Danish: Undersøgelse af antistof-positive prøver viste ingen signifikant krydsreaktivitet med tilsvarende endogene peptider (glucagon eller GLP-1).
English: DO NOT proceed unless your medicine is mixed well
Danish: FORTSÆT IKKE, med mindre din medicin er blandet godt.
English: BCise is the name of the pre-filled pen device used to inject your Bydureon medicine.
Danish: BCise er navnet på den fyldte penenhed, som bruges til injektion af din Bydureon-medicin.
English: If you have an injection site reaction (redness, rash, or itching) you may like to ask your doctor for something to help relieve any signs or symptoms.
Danish: Hvis du får en reaktion på indstiksstedet (rødme, udslæt eller kløe) kan du spørge lægen, om du kan få noget til at afhjælpe symptomerne.
English: During the controlled period of the clinical study comparing Bydureon BCise with immediate-release exenatide, nausea was reported in 9.6% and 20.5% of patients in each group.
Danish: I den kontrollerede periode i det kliniske studie, der sammenlignede Bydureon BCise med exenatid opløsning til injektion, blev der rapporteret kvalme hos 9,6 % og 20,5 % af patienterne i hver gruppe.
English: by holding the pen against the page.
Danish: ved at holde pennen op mod papiret.
English: Subsequently, exenatide concentrations of approximately 153-208 pg/ml were maintained, indicating that steady state was achieved.
Danish: Efterfølgende blev koncentrationer af exenatid på cirka 153-208 pg/ml opretholdt, hvilket tyder på, at steady state blev opnået.
English: Be sure you are holding the pen at the end with the knob and the orange label.
Danish: Vær sikker på, at du holder pennen i enden med håndtaget og den orange mærkat.
English: • Swelling of the face, tongue or throat (angioedema)
Danish: • Hævelse af ansigt, tunge eller hals (angioødem)
English: What if the device malfunctions and I cannot unlock it?
Danish: Hvad hvis pennen ikke fungerer, og jeg kan ikke låse den op?
English: The suspension should be visually inspected prior to use.
Danish: Suspensionen skal inspiceres visuelt inden brug.
English: Patients and caregivers should be trained by their healthcare professional.
Danish: Patienter og omsorgspersoner skal trænes af sundhedspersonale eller lægen.
English: With one hand, hold the plunger in place so it does not move.
Danish: Hold stemplet på plads med den ene hånd, så det ikke flytter sig.
English: After the click, continue to hold the needle in your skin for 10 seconds.
Danish: Efter klikket skal du stadig holde kanylen inde i huden i 10 sekunder.
English: C. Check the mix.
Danish: C. Tjek blandingen.
English: What should I do if the top of the plunger has been pushed past the black dashed Dose Line?
Danish: Hvad skal jeg gøre, hvis toppen af stemplet er trykket ned forbi den sorte stiplede doseringslinje?
English: While patients with high titre antibodies at the last visit had an attenuated HbA1c response, HbA1c reductions in these patients were clinically relevant (-0.6% to -0.7%).
Danish: Mens patienter med høje antistoftitre ved det sidste besøg havde et svækket HbA1c respons, var HbA1c reduktioner i disse patienter klinisk relevante (-0,6 % til -0,7 %).
English: When prolonged-release exenatide was added to basal insulin, no initial dose adjustment of insulin was required.
Danish: Når depotformulering af exenatid blev anvendt som tillæg til basal insulin, var der ikke behov for nogen indledende dosisjustering af insulin.
English: Prolonged-release exenatide is not recommended in these patients.
Danish: Depotformulering af exenatid anbefales ikke til disse patienter.
English: The absolute change in 2-hour postprandial plasma glucose at Week 28 is modeled similarly using ANCOVA.
Danish: Den absolutte ændring i 2-timers postprandial plasmaglucose i uge 28 er modelleret på samme måde med ANCOVA.
English: Patients may be treated to relieve symptoms, while continuing treatment.
Danish: Man kan forsøge at symptomlindre, mens behandlingen fortsætter.
English: The absorption properties of exenatide reflect the extended release properties of the prolonged-release exenatide formulation.
Danish: Absorptionen af exenatid afspejler egenskaberne ved den forlængede frigivelse fra depotformuleringen af exenatid.
English: Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.
Danish: 3) med information om, hvad du skal gøre, hvis du er usikker på, om du har fået en hel dosis.
English: Subsequently, exenatide concentrations of approximately 151-265 pg/ml were maintained indicating that steady state was achieved.
Danish: Efterfølgende blev koncentrationer af exenatid på cirka 151-265 pg/ml opretholdt, hvilket tyder på, at steady state blev opnået.
English: The top of the plunger must stay lined up with the black dashed Dose Line as you go through the next steps.
Danish: Toppen af stemplet skal forblive på linje med den sorte stiplede doseringslinje, når du gennemfører de næste trin i proceduren.
English: Hold the pen up straight with the orange cap toward the ceiling.
Danish: Hold pennen lodret med den orange hætte op mod loftet.
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop antibodies to exenatide following treatment with prolonged-release exenatide.
Danish: Svarende til de potentielt immunogene egenskaber for protein- og peptidholdige lægemidler kan patienterne udvikle antistoffer mod exenatid efter behandling med depotformulering af exenatid.
English: On average in the phase 3 studies, 12% of the patients had higher titre antibodies.
Danish: I fase 3-studierne havde 12 % af patienterne i gennemsnit højere antistoftitre.
English: Air bubbles will not harm you or affect your dose with this type of injection.
Danish: Luftbobler vil ikke skade dig eller påvirke din dosis ved denne type indsprøjtning.
English: Keep shaking until the liquid and powder are mixed well.
Danish: Bliv ved med at ryste, indtil væsken og pulveret er blandet grundigt.
English: What should I do if I see air bubbles in the pen?
Danish: Hvad skal jeg gøre, hvis jeg ser luftbobler i pennen?
English: It will be easier to mix the medicine if the pen is at room temperature.
Danish: Det er lettere at blande medicinen, hvis pennen har stuetemperatur.
English: When you unscrew the orange cap, the green shield keeps the needle covered until you inject.
Danish: Når du skruer den orange hætte af, holder det grønne skjold nålen dækket, indtil du indsprøjter.
English: Pull the needle cover straight off. Do not twist it. (This question relates to step 4f.)
Danish: Drej ikke på den. (Dette spørgsmål vedrører trin 4f.)
English: Treatment with prolonged-release exenatide resulted in significant reductions in fasting plasma/serum glucose concentrations, these reductions were observed as early as 4 weeks.
Danish: Behandling med exenatid depotformulering resulterede i signifikant reduktion i fastende plasma/serumglucosekoncentrationerne; disse reduktioner blev set allerede efter 4 uger.
English: If you do not inject your medicine right away after mixing, the medicine may separate, and you will not get your full dose.
Danish: Hvis du ikke indsprøjter din medicin straks efter blanding, kan medicinen skille, og du får ikke din fulde dosis.
English: • Keep the pen, and all medicines, out of the reach of children.
Danish: • Opbevar pennen og al medicin utilgængeligt for børn.
English: A pharmacodynamic study with exenatide demonstrated in patients with type 2 diabetes (n = 13) a restoration of first phase insulin secretion and improved second phase insulin secretion in response to an intravenous bolus of glucose.
Danish: Et farmakodynamisk studie med exenatid viste blandt patienter med type 2-diabetes (n=13) en genoprettelse af insulinudskillelsens første fase og forbedret insulinudskillelse i anden fase som reaktion på en intravenøs glucosebolus.
English: The dose of your sulphonylurea medicine may need to be reduced while you use this medicine.
Danish: Dosis af sulfonylurinstof-medicinen skal muligvis nedsættes, mens du bruger dette lægemiddel.
English: With your other hand, firmly hold the 2 grey squares on the white cap.
Danish: Hold med din anden hånd godt fast i de to grå firkanter på den hvide hætte.
English: If not mixed well, continue to shake hard.
Danish: Hvis den ikke er helt blandet, så fortsæt med at ryste kraftigt.
English: There should not be any dry powder on the sides or bottom of the vial.
Danish: Der må ikke være noget tørt pulver tilbage på siderne eller bunden af hætteglasset.
English: Plasma/serum glucose
Danish: Plasma/serumglucose
English: Exenatide vs Placebo: HR (95% CI)
Danish: Exenatid vs. placebo: HR (95 % CI)
English: This medicine helps your body to increase the production of insulin when your blood sugar is high.
Danish: Dette lægemiddel hjælper kroppen med at lave mere insulin, når dit blodsukker bliver for højt.
English: Connecting the parts
Danish: Samling af delene
English: You should not see any clumps in the liquid.
Danish: Der må ikke være nogen klumper i væsken.
English: This medicine is provided as a powder and solvent (liquid) for suspension for injection in a pre-filled pen.
Danish: Dette lægemiddel udleveres som pulver og opløsningsmiddel (væske) til suspension til injektion i en fyldt pen.
English: Test your blood glucose levels regularly.
Danish: Kontrollér jævnligt dine blodsukkerniveauer.
English: Ask your doctor, pharmacist, or diabetes nurse if you are not sure if any of your other medicines contain a sulphonylurea.
Danish: Spørg lægen, apotekspersonalet eller diabetessygeplejersken, hvis du er i tvivl om, hvorvidt din anden medicin indeholder et sulfonylurea-produkt.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: A little bit of liquid may cling to the sides of the vial.
Danish: Der kan være en lille smule væske, der klæber til hætteglassets sider.
English: The single-dose kit has a spare needle (not shown) in case you need it.
Danish: Engangssættet indeholder en ekstra kanyle (ikke vist), hvis du får brug for en.
English: Prolonged-release exenatide should not be used during pregnancy and the use of insulin is recommended.
Danish: Depotformulering af exenatid bør ikke anvendes under graviditet, og anvendelse af insulin anbefales.
English: − Needle is hidden.
Danish: - Nålen er skjult.
English: Prolonged-release exenatide is not a substitute for insulin.
Danish: Depotformuleringen af exenatid er ikke en erstatning for insulin.
English: You may see air bubbles.
Danish: Du vil muligvis kunne se luftbobler.
English: Keep this flap open so you can refer to it as you go through the steps
Danish: Hold denne flap åben, så du kan se på sættets dele, efterhånden som du når gennem proceduren
English: The solvent should be visually inspected prior to use.
Danish: Solvensen skal kontrolleres visuelt inden brug.
English: To be sure you get your full dose, press and hold the pen against your skin.
Danish: For at være sikker på at du har fået den fulde dosis, skal du trykke og holde pennen mod din hud.
English: Continue to follow your food and exercise plan.
Danish: Du skal fortsætte med at følge din diæt og motionsplan.
English: Rate based on completed long-term safety and efficacy studies (n = 526), unless other indicated.
Danish: 4.4) Rate baseret på gennemført langsigtede sikkerheds- og effektstudier (n = 526) med mindre andet er anført.
English: • Push the pen against your skin.
Danish: • Pres pennen mod huden.
English: Overall, the level of glycaemic control (HbA1c) in patients treated with Bydureon BCise with low titre antibodies at the last visit (-1.1% to -1.5%) was comparable to that observed in those without antibody titres (-1.1% to -1.4%).
Danish: Samlet set var niveauet for glykæmisk kontrol (HbA1c) hos patienter behandlet med Bydureon BCisemed lave antistoftitre ved det sidste besøg (-1,1 % til -1,5 %) sammenligneligt med det, der observeredes hos dem uden antistoftitre (-1,1 % til -1,4 % ).
English: Pre-filled pen is for single-use only.
Danish: Den fyldte pen er kun til engangsbrug.