FrancophonIA/ELRC3.0 huggingface dataset:
English: The solvent should only be used if it is clear and free of particulate matter.
Danish: Solvensen må kun anvendes, hvis den er klar og fri for partikelstoffer.
English: Most episodes of nausea were mild to moderate, associated with the initiation of treatment and decreased over time.
Danish: De fleste episoder med kvalme var lette til moderate og var forbundet med behandlingsstart og blev reduceret med tiden.
English: What if the device malfunctions and I cannot remove the orange cap?
Danish: Hvad hvis pennen ikke fungerer, og jeg kan ikke fjerne den orange hætte?
English: This is what the syringe should now look like.
Danish: Sådan skal sprøjten nu se ud.
English: With continued therapy, the frequency decreased in most patients who initially experienced nausea.
Danish: Hyppigheden faldt i takt med den fortsatte behandling hos de fleste patienter, der i starten havde kvalme.
English: The frequency of adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports (not observed in clinical studies, frequency not known) are summarised in Table 1 below.
Danish: Hyppigheden af bivirkninger af depotformulering af exenatid identificeret i kliniske studier og spontane rapporter (ikke observeret i kliniske studier, hyppighed ikke kendt) er opsummeret i tabel 1 nedenfor.
English: Across 12 studies of prolonged-release exenatide most episodes (99.9% n = 649) of hypoglycaemia were minor, and resolved with oral administration of carbohydrate.
Danish: Samlet set for 12 studier med depotformulering af exenatid var de fleste episoder med hypoglykæmi (99,9 % n=649) milde og forsvandt efter oral administration af kulhydrater.
English: Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative medicinal products, including exenatide.
Danish: Det er observeret, at påvirkningen af nyrefunktionen var reversibel i forbindelse med understøttende behandling og ved seponering af de potentielt tilgrundliggende lægemidler, herunder exenatid.
English: EXSCEL was a pragmatic cardiovascular (CV) outcome study in patients with type 2 diabetes and any level of CV risk.
Danish: EXSCEL var et pragmatisk kardiovaskulære (CV) outcome studie med fokus på kardiovaskulære (CV) hændelser hos patienter med type 2 diabetes og ethvert niveau af CV risiko.
English: Effects of overdoses with exenatide (based on immediate-release exenatide clinical studies) included severe nausea, severe vomiting and rapidly declining blood glucose concentrations.
Danish: Virkninger af overdoser af exenatid (baseret på kliniske studier med exenatid opløsning til injektion) var kraftig kvalme, kraftig opkastning og hurtigt faldende blodglucosekoncentrationer.
English: Therefore, no dose adjustments for medicinal products sensitive to delayed gastric emptying are required.
Danish: Det er derfor ikke nødvendigt at justere dosis for lægemidler, der er sensitive over for forsinket ventrikeltømning.
English: Do not recycle the container with used pens.
Danish: Genbrug ikke beholderen med brugte penne.
English: The powder in one chamber must be mixed with the solvent in the other chamber of the pre-filled pen.
Danish: Pulveret i det ene kammer af den fyldte pen skal blandes med solvens i det andet kammer.
English: DO NOT proceed unless needle is attached
Danish: FORTSÆT IKKE, med mindre nålen er fastgjort
English: To review how to:
Danish: For at repetere, hvordan du
English: You may see a few drops of liquid on the needle or in the cover.
Danish: Det kan ske, at der er nogle få dråber væske på kanylen eller i hætten.
English: When used with insulin, prolonged-release exenatide and insulin must be administered as two separate injections.
Danish: Ved samtidig anvendelse med insulin skal depotformulering af exenatid og insulin administreres som to separate injektioner.
English: Choice of other medicinal products and dose selection should be considered accordingly, as adverse reactions may continue and efficacy may, at least partly, persist until exenatide levels decline.
Danish: Dette bør tages i betragtning ved valg og dosering af andre lægemidler, da bivirkninger kan fortsætte, og virkningen, i det mindste delvist, kan vare ved, indtil exenatidniveauet aftager.
English: Prolonged-release exenatide in combination with basal insulin showed no clinically significant differences in the incidence of hypoglycaemic episodes compared to insulin.
Danish: Depotformulering af exenatid i kombination med basal insulin udviste ingen klinisk signifikante forskelle i forekomsten af hypoglykæmiske episoder sammenlignet med insulin.
English: Only unlock the pen when you are ready to inject.
Danish: Du må først låse pennen op, når du er klar til indsprøjtning.
English: A total of 14,752 patients were randomised 1:1 to either prolonged-release exenatide 2 mg once weekly or placebo, added to the current usual care which could include SGLT2 inhibitors.
Danish: I alt 14.752 patienter blev randomiseret 1:1 til enten depotformulering af exenatid 2 mg én gang ugentligt eller placebo, som blev tilføjet til deres sædvanlige behandling, der kunne omfatte SGLT2-hæmmere.
English: Be sure to use the injection technique recommended by your doctor or diabetes nurse.
Danish: Sørg for at bruge den indsprøjtningsteknik, som din læge eller diabetessygeplejerske har anbefalet.
English: Exenatide Placebo
Danish: Exenatid Placebo
English: Frequencies reported in pooled data from the controlled periods of the two phase 3 clinical studies (n = 410).
Danish: Frekvenser rapporteret i poolede data fra de kontrollerede perioder i de to fase 3 kliniske forsøg (n =
English: The safety and efficacy of prolonged-release exenatide in children and adolescents aged under 18 years have not yet been established.
Danish: Exenatids sikkerhed og virkning i depotformuleringen er hos børn og unge under 18 år endnu ikke klarlagt .
English: WAIT
Danish: VENT
English: Table 1: Adverse reactions of Bydureon BCise identified from clinical studies
Danish: Tabel 1: Bivirkninger ved Bydureon BCise identificeret fra kliniske studier
English: Table 1: Adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports
Danish: Tabel 1: Bivirkninger ved depotformulering af exenatid identificeret fra kliniske studier og spontane indberetninger
English: Most individual nodules did not interfere with study participation and resolved over time.
Danish: De fleste enkelte noduli havde ingen betydning for deltagelsen i studiet og forsvandt over tid.
English: Also be sure you twisted the knob until it stopped, the orange label disappeared, and the injection button appears.
Danish: Kontroller også, at du har drejet håndtaget, indtil det stoppede, at den orange mærkat er forsvundet, og at injektionsknappen er kommet frem.
English: B. Make sure you received your full dose.
Danish: B. Vær sikker på, at du får den fulde dosis.
English: • Hold the pen by the end with the orange label and tap the pen firmly against the palm of your hand.
Danish: • Hold pennen i den ende, hvor der er en orange mærkat, og slå pennen hårdt mod din håndflade.
English: Posology The recommended dose is 2 mg exenatide once weekly.
Danish: Dosering Den anbefalede dosis er 2 mg exenatid én gang ugentligt.
English: Improvements in blood pressure were maintained through 52 weeks.
Danish: Forbedringerne i blodtrykket blev opretholdt gennem 52 uger.
English: - If you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.
Danish: - Hvis du har en alvorlig nyresygdom eller er i dialyse, da anvendelse af dette lægemiddel frarådes.
English: • nausea (nausea is most common when starting this medicine, but decreases over time in most patients)
Danish: • kvalme (kvalme opstår oftest, når behandling med dette lægemiddel lige er begyndt, men svinder med tiden hos de fleste patienter)
English: This is to make sure you get the full dose.
Danish: Dette er for at sikre, at du får den fulde dosis.
English: The reductions in body weight were sustained at Week 52.
Danish: Reduktionerne i legemsvægten var fortsat til stede i uge 52.
English: Approximately 42% of patients developed low titre antibodies to exenatide and 32% of patients developed high titre antibodies at any time during the studies.
Danish: Ca. 42 % af patienterne udviklede lave antistoftitre mod exenatid, og 32 % af patienterne udviklede høje antistoftitre til enhver tid i studierne.
English: Very common side effects (may affect more than 1 in 10 people) • hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 bruger ud af 10) • Hypoglykæmi (lavt blodsukker) når det tages med medicin som indeholder et sulfonylurinstof
English: • Bydureon BCise pen • Alcohol swab • A clean, flat surface • Puncture-resistant container (see “disposal” instructions at the end of these instructions) STEP 1: Prepare for injection
Danish: • Bydureon BCise pen • Spritserviet • En ren, flad overflade • Punkteringsfri beholder (se Bortskaffelsesinstruktioner i slutningen af denne vejledning)
English: These injection site reactions were generally mild and usually did not lead to withdrawal from studies.
Danish: Disse reaktioner på injektionsstedet var generelt lette og førte normalt ikke til udtrædelse af studierne.
English: Do not use Bydureon: - If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section
Danish: Brug ikke Bydureon: - Hvis du er allergisk over for exenatid eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Discontinuation of treatment
Danish: Seponering af behandlingen
English: by pulling on the corner tab.
Danish: ved at hive i hjørnefligen.
English: If you still cannot push the button all the way in, remove the needle from your skin.
Danish: Hvis du stadig ikke kan trykke knappen helt ind, skal du tage kanylen ud af huden.
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and of insulin, particularly when prolonged-release exenatide therapy is started and insulin is reduced.
Danish: Selvmonitorering af blodglucose er nødvendig for at tilpasse dosen af sulfonylurinstof og insulin, især når behandling med depotformuleringen af exenatid påbegyndes, og insulindosen reduceres.
English: Hospitalisation for HF
Danish: Hospitalsindlæggelse for ACS Hospitalsindlæggelse for HF
English: The 156-week results were consistent with those previously reported in the 26-week interim report.
Danish: Resultaterne fra uge 156 var i overensstemmelse med de tidligere rapporterede i 26-ugers interimrapporten.
English: It should be clear and free of particles.
Danish: Den skal være klar og fri for partikler.
English: If you see white medicine, it is unmixed.
Danish: Hvis du ser hvide partikler, er den ikke blandet.
English: The air bubbles will not harm you or affect your dose.
Danish: Luftboblerne er ikke skadelige for dig og har ingen betydning for din dosis.
English: Turn the knob from the Lock to the Unlock position until you hear a click.
Danish: Drej knappen fra låst til åben, indtil du hører et klik.
English: You will need a puncture-resistant container that is large enough to hold the entire pen.
Danish: Du skal bruge en punkteringsfri beholder, der er stor nok til at rumme hele pennen.
English: In addition, hypoglycaemia with a sulphonylurea occurred very commonly (see Description of selected adverse reactions, below).
Danish: Desuden opstod der hypoglykæmi i forbindelse med et sulfonylurea med hyppigheden meget almindelig (se Beskrivelse af udvalgte bivirkninger nedenfor).
English: Exenatide is cleared primarily by the kidney, therefore hepatic dysfunction is not expected to affect blood concentrations of exenatide.
Danish: Exenatid elimineres primært via nyrerne, og en leverdysfunktion forventes derfor ikke at påvirke koncentrationerne af exenatid i blodet.
English: The most common adverse events leading to withdrawal in either treatment group were nausea and vomiting.
Danish: De hyppigste bivirkninger, som i begge behandlingsgrupper førte til seponering, var kvalme og opkastning.
English: One patient was reported with major hypoglycaemia since he had a low blood glucose value (2.2 mmol/l) and requested assistance with oral carbohydrate treatment which resolved the event.
Danish: Der blev indberettet alvorlig hypoglykæmi for en enkelt patient, som havde en lav blodglucoseværdi (2,2 mmol/l) og behov for hjælp med indtagelse af kulhydrater oralt, hvilket fik hændelsen til at svinde.
English: Warnings and precautions Talk to your doctor, pharmacist, or diabetes nurse before using Bydureon about the following: - If you use this medicine in combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller diabetessygeplejersken om følgende, før du bruger Bydureon: - Hvis du bruger dette lægemiddel i kombination med et sulfonylurea-produkt, da der kan opstå for lavt blodsukker (hypoglykæmi).
English: Then choose a different injection site and finish taking the injection.
Danish: Vælg derefter et andet injektionssted og fortsæt med at tage indsprøjtningen.
English: Patients (%) achieving
Danish: Patienter (%), der opnåede
English: Hidden Needle
Danish: Skjult nål
English: This means the medicine is not mixed evenly.
Danish: Dette betyder, at medicinen ikke er helt blandet
English: There have been spontaneously reported events of acute pancreatitis with prolonged-release exenatide.
Danish: Der har været spontant indberettede tilfælde af akut pancreatitis med depotformulering af exenatid.
English: For both prolonged-release exenatide formulations, the improvement in fasting plasma glucose concentrations was sustained through 52 weeks.
Danish: For begge exenatid depotformuleringerne blev forbedringen i fastende plasmaglucosekoncentrationer opretholdt gennem 52 uger.
English: International normalised ratio increased (see section
Danish: Stigning i international normaliseret ratio (se pkt.
English: Due to the long washout period of prolonged-release exenatide, women of childbearing potential should use contraception during treatment with prolonged-release exenatide.
Danish: På grund af exenatids lange udvaskningsperiode i depotformulering skal kvinder i den fertile alder anvende kontraception, når de er i behandling med depotformulering af exenatid.
English: − if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend that you monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Danish: - hvis du anvender insulin, vil din læge fortælle dig, hvordan du skal reducere insulindosen, og vil anbefale, at du overvåger dit blodsukkerniveau hyppigere med henblik på at undgå hyperglykæmi (for højt blodsukkerniveau) og diabetisk ketoacidose (en komplikation til diabetes, der forekommer, når kroppen ikke er i stand til at nedbryde glukose, fordi der ikke er nok insulin).
English: Each carton contains 4 single-dose kits:
Danish: Hver karton indeholder 4 enkeltdosissæt:
English: One needle is a spare.
Danish: Den ene kanyle er en reservekanyle.
English: Powder poly (D,L-lactide-co-glycolide) sucrose
Danish: Pulver poly (D,L-laktid-coglycolid) saccharose
English: Solvent for Bydureon
Danish: Solvens til Bydureon
English: B. Shake the pen hard, in an up-and-down motion, until the medicine is mixed evenly and you do not see any white medicine along the sides, bottom or top.
Danish: B. Ryst pennen kraftigt i en op og nedad-gående bevægelse, indtil medicinen er helt blandet og du ikke ser flere hvide partiker langs siderne, bunden eller toppen.
English: The most frequently reported gastrointestinal adverse reaction was nausea.
Danish: Den hyppigst rapporterede gastrointestinale bivirkning var kvalme.
English: Press the injection button with your thumb until you hear a click.
Danish: Tryk på injektionsknappen med din tommelfinger, indtil du hører et klik.
English: A. Choose your injection site,
Danish: A. Vælg injektionssted,
English: Amongst patients treated with Bydureon BCise evaluable for antibodies (N = 393), the incidence of potentially immunogenic injection site reactions (most commonly injection site nodule) during the two studies was approximately 20%.
Danish: For patienter, der blev behandlet med Bydureon BCise, som kunne evalueres for antistoffer (N = 393), var forekomsten af potentielt immunogene reaktioner på injektionsstedet (oftest nodulus på injektionsstedet) i de to studier ca. 20 %.
English: The primary safety (noninferiority) and efficacy (superiority) endpoint in EXSCEL was the time to first confirmed Major Adverse Cardiac Event (MACE): cardiovascular (CV)-related death, nonfatal myocardial infarction (MI) or nonfatal stroke.
Danish: Det primære sikkerhedsendepunkt (noninferioritet) og effekt endepunkt (superioritet) i EXSCEL var tiden til første bekræftede alvorlige hjerte-kar-relaterede hændelse (MACE (Major Adverse Cardiac Event)): kardiovaskulær (CV)-relateret dødsfald, ikke-letal myokardieinfarkt (MI) eller ikke-letalt slagtilfælde.
English: • Do not use past the expiration date.
Danish: • Brug ikke lægemidlet efter udløbsdatoen.
English: Administration of the oral contraceptive 35 minutes after exenatide did not affect AUC but resulted in a reduction of the Cmax of ethinyl estradiol by 45%, and Cmax of levonorgestrel by 27-41%, and a delay in tmax by 2-4 h due to delayed gastric emptying.
Danish: Administration af det orale kontraceptivum 35 minutter efter exenatid påvirkede ikke AUC, men medførte et fald i Cmax for ethinylestradiol på 45 % og i Cmax for levonorgestrel på 27-41 % samt en forsinkelse i tmax på 2-4 timer som følge af forsinket gastrisk tømning.
English: However, after you unlock it, you must complete the preparation steps right away and inject to get the full dose.
Danish: Men efter at du har låst den op, skal du færdiggøre forberedelsestrinene med det samme og indsprøjte for at få den fulde dosis.
English: Hold the needle against your skin for 15 seconds.
Danish: Hold nålen mod huden i 15 sekunder.
English: The frequency of adverse reactions of Bydureon BCise identified from clinical studies are summarised in Table 1 below.
Danish: Hyppigheden af bivirkninger af Bydureon BCise identificeret i kliniske studier er opsummeret i tabel 1 nedenfor.
English: It should be injected into the skin and not into a vein or into the muscle.
Danish: Det skal injiceres ind i huden og ikke ind i en vene eller muskel.
English: Prolonged-release exenatide was associated with a significantly lower incidence of episodes of hypoglycaemia than basal insulin in patients also receiving metformin therapy (3% versus 19%) and in patients also receiving metformin plus sulphonylurea therapy (20% versus 42%).
Danish: Depotformulering af exenatid var forbundet med en signifikant lavere forekomst af episoder med hypoglykæmi end basal insulin hos patienter, der også fik behandling med metformin (3 % vs. 19 %), og hos patienter, der også fik behandling med metformin og sulfonylurea (20 % vs. 42 %).
English: Require third-party assistance to resolve because of impairment in consciousness or behaviour and has glucose value of <54 mg/dL (3 mmol/L) OR 3.
Danish: Kræver hjælp fra tredjepart til at løse på grund af nedsat bevidsthed eller adfærd og har en glukoseværdi på <54 mg/dl (3 mmol/l) ELLER 3.
English: The finished medicinal product is comprised of the suspension-filled cartridge assembled into the pen device.
Danish: Det færdige lægemiddel består af det fyldte hætteglas, der er samlet i penanordningen.
English: Prolonged-release exenatide must not be administered by intravenous or intramuscular injection.
Danish: Depotformulering af exenatid må ikke administreres som en intravenøs eller intramuskulær injektion.
English: For subcutaneous use only
Danish: Kun til subkutan brug
English: While holding the pen upright with the needle cover uppermost, twist the knob anticlockwise until the orange label disappears and the injection button is released.
Danish: Mens pennen holdes lodret med kanylehætten øverst, drejes håndtaget mod uret, indtil den orange mærkat forsvinder, og injektionsknappen frigives.
English: A reduction in body weight compared to baseline has been observed in studies with prolonged-release exenatide formulations.
Danish: En reduktion i legemsvægt sammenlignet med baseline er blevet observeret i studier med exenatid depotformuleringer.
English: − medicines used to thin the blood (anticoagulants), e.g. Warfarin, as you will require additional monitoring of changes in INR (measurement of blood thinning) during initiation of therapy with this medicine.
Danish: - blodfortyndende medicin (antikoagulantia), f.eks. warfarin, da du vil have brug for ekstra overvågning af ændringerne i INR (måling af blodfortynding) under behandlingsstarten med dette lægemiddel.
English: How do I know if I injected my full dose?
Danish: Hvordan ved jeg, om jeg har indsprøjtet hele dosis?
English: Its use is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhoea.
Danish: Anvendelse af præparatet er ofte forbundet med utilsigtede gastrointestinale reaktioner, herunder kvalme, opkastning og diaré.
English: If you do not inject your dose right away, small clumps of medicine may form in the pen and you may not get your full dose.
Danish: Hvis du ikke indsprøjter dosen med det samme, kan der dannes små klumper af medicin i pennen, hvilket betyder, at du måske ikke får den fulde dosis.
English: Plunger not lining up with black dashed Dose Line Being unable to push the plunger down when injecting
Danish: Stempel ikke på linje med den sorte stiplede doseringslinje 6 Kan ikke trykke stemplet ned ved indsprøjtning
English: Adverse reactions that have been observed with the prolonged-release exenatide but not in clinical studies with Bydureon BCise are also included in Table 1.
Danish: Bivirkninger, som er set med exenatid i depotformulering, men ikke i kliniske studier med Bydureon BCise er også inkluderet i tabel 1.
English: Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
Danish: Alvorlige allergiske reaktioner (anafylaksi) er blevet indberettet i sjældne tilfælde (kan påvirke op til 1 ud af 1.000 patienter).
English: The mean dose of insulin glargine at the beginning of treatment was 10.1 IU/day rising to 31.1 IU/day for insulin glargine-treated patients.
Danish: Gennemsnitlig dosis af insulin glargin i begyndelsen af behandling var 10,0 IU/dag stigende til 31,1 IU/dag hos insulin glargin-behandlede patienter.
English: Throw away any Bydureon pen that has been frozen.
Danish: Kasser alle Bydureon-penne, som har været nedfrosset.
English: Each dose should be administered in the abdomen, thigh, or the back of the upper arm as a subcutaneous injection immediately after the medicinal product is fully mixed.
Danish: Hver dosis skal administreres i abdomen, lår eller bagsiden af overarmen som en subkutan injektion, umiddelbart efter at lægemidlet er helt blandet.
English: This will let the pen warm up to room temperature.
Danish: På denne måde kan pennen varme op til stuetemperatur.
English: Why should I inject my medicine right away after mixing it?
Danish: Hvorfor skal jeg indsprøjte min medicin straks efter blanding?
English: In addition, a double-blind, placebo-controlled cardiovascular outcome study (EXSCEL) enrolled 14,752 subjects with type 2 diabetes and any level of CV risk when added to the current usual care.
Danish: Derudover omfattede et dobbeltblindet, placebokontrolleret studie med fokus på kardiovaskulære hændelser (EXSCEL) 14.752 forsøgspersoner med type 2-diabetes og ethvert niveau af CV-risiko ved tilføjelse til den nuværende sædvanlige behandling.
English: • Keep holding the pen against the skin for 15 seconds.
Danish: • Hold pennen fast mod huden i 15 sekunder.
English: Step 1: Prepare your pen
Danish: Trin 1: Klargør pennen
English: Check that you have fully screwed on the pen needle.
Danish: Tjek, at du har skruet kanylen helt på.
English: Exenatide
Danish: Exenatid