FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent adverse reactions during the clinical studies were gastrointestinal-related (mainly nausea (8 %), which tended to dissipate with continued treatment), headache (4 %) and injection site reactions, such as injection site pruritus (3 %) and injection site erythema (2 %).
Danish: De hyppigste bivirkninger i de kliniske studier var relateret til mave-tarm-kanalen (primært kvalme (8 %), som dog aftog med tiden ved fortsat behandling), hovedpine (4 %) og reaktioner på injektionsstedet, såsom pruritus på injektionsstedet (3 %) og erytem på injektionsstedet (2 %).
English: Overall, the percentage of antibody positive patients was consistent across clinical studies.
Danish: Generelt var procentdelen af antistofpositive patienter ens på tværs af de kliniske studier.
English: After shaking the pen, look through both sides of the window.
Danish: Efter at have rystet pennen skal du kigge gennem begge sider af vinduet.
English: This incidence was increased when it was used in combination with a sulphonylurea (26.1 %) compared to no sulphonylurea (0.9%) (see section 4.4).
Danish: Denne forkomst steg, når exenatid blev brugt i kombination med et sulfonylurea-præparat (26,1 %) sammenlignet med ingen sulfonylurea (0,9 %) (se pkt.
English: Thyroid tumours have been observed in rats and mice with long acting GLP-1 receptor agonists.
Danish: Hos rotter og mus er der observeret tumorer i thyroidea med langtidsvirkende GLP-1receptoragonister.
English: Then, take your thumb off the plunger.
Danish: Fjern derefter tommelfingeren fra stemplet.
English: Slowly push in the plunger so the top of the plunger lines up with the black dashed Dose Line.
Danish: Tryk langsomt stemplet ind, så toppen af stemplet er på linje med den sorte stiplede doseringslinje.
English: Therefore, the use of this medicinal product is not recommended in patients with severe gastrointestinal disease.
Danish: Anvendelse af dette lægemiddel anbefales derfor ikke til patienter med alvorlig gastrointestinal sygdom.
English: When prolonged-release exenatide is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued.
Danish: Hvis depotformulering af exenatid føjes til en eksisterende behandling med metformin og/eller thiazolidindion, kan den aktuelle dosis af metformin og/eller thiazolidindion fortsætte.
English: In both studies, decreases in HbA1c were evident in both treatment groups as early as the first post-treatment HbA1c measurement (Weeks 4 or
Danish: I begge studier var reduktionen i HbA1c tydelig i begge behandlingsgrupper så tidligt som i første efterbehandlingsmåling af HbA1c (uge 4 eller 6).
English: After discontinuation, the effect of prolonged-release exenatide may continue as plasma levels of exenatide decline over 10 weeks.
Danish: Virkningen af depotformulering af exenatid kan fortsætte efter seponering, da plasmaniveauet af exenatid falder over 10 uger.
English: In the 4 comparator-controlled studies, the proportion of patients who had both a reduction in weight and HbA1c ranged from 70 to 79% (the proportion of patients who had a reduction of HbA1c ranged from 88 to 96%).
Danish: I de 4 komparatorkontrollerede studier varierede andelen af patienter, der oplevede fald i både legemsvægt og HbA1c, fra 70 til 79 % (andelen af patienter, der havde fald i HbA1c, varierede fra 88 til
English: The clinical experience in patients with moderate renal impairment is limited and the use of prolonged-release exenatide is not recommended.
Danish: Den kliniske erfaring med patienter med moderat nedsat nyrefunktion er begrænset, og depotformulering af exenatid anbefales ikke til disse patienter.
English: Lower glucagon concentrations lead to decreased hepatic glucose output.
Danish: Lavere glukagonkoncentration fører til nedsat produktion af glucose i leveren.
English: A reduction in systolic blood pressure was observed in the studies with prolonged-release exenatide formulations (0.8 mmHg to 4.7 mmHg).
Danish: En reduktion i det systoliske blodtryk blev observeret i studierne med exenatid depotformuleringer (0,8 mmHg til 4,7 mmHg).
English: There is a spare needle in case you need it.
Danish: Der er også en ekstra kanyle, hvis du får brug for det.
English: Vehicle Medium chain triglycerides (MCT)
Danish: Vehikel Mellemkædede triglycerider (MCT)
English: To mix, shake the pen hard until the white medicine is no longer on the bottom, top, or sides.
Danish: For at blande, ryst pennen kraftigt, indtil de hvide partikler ikke længere er på bunden, toppen eller siderne.
English: Small subcutaneous injection site nodules were observed very frequently in clinical studies, consistent with the known properties of poly (D,L-lactide co-glycolide) polymer microsphere formulations.
Danish: I kliniske studier blev der meget hyppigt observeret mindre subkutane noduli på injektionsstedet, hvilket stemmer overens med de kendte egenskaber for formuleringen af poly (D,L-laktid-coglycolid)polymermikrokugler.
English: *p <0.01, **p < 0.001. p-values are all adjusted p-values for multiplicity.
Danish: *p < 0,01, **p < 0,001. p-værdier er alle justerede p-værdier for multiplicitet.
English: After the suspension is fully mixed, the preparation steps must be completed immediately and the suspension injected subcutaneously.
Danish: Når suspensionen er helt blandet, skal forberedelsestrinene straks udføres, og suspensionen injiceres subkutant.
English: Back
Danish: Bagfra
English: You may see white medicine along the sides, bottom or top.
Danish: Du kan måske se hvide partikler langs siderne, bunden eller toppen.
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Danish: Administration af et oralt kontraceptivum som kombinationsbehandling (30 mikrogram ethinylestradiol plus 150 mikrogram levonorgestrel) 1 time inden exenatid opløsning til injektion ændrede ikke AUC, Cmax eller Cmin for hverken ethinylestradiol eller levonorgestrel.
English: SOLVENT LABEL
Danish: ETIKET TIL SOLVENS
English: Overall, the level of glycaemic control (HbA1c) was comparable to that observed in those without antibody titres.
Danish: Generelt var niveauet af glykæmisk kontrol (HbA1c) sammenligneligt med det niveau, der ses hos patienter uden antistoftitre.
English: These reactions were less commonly observed in antibody-negative patients (4%) compared with antibody-positive patients (13%), with a greater incidence in those with higher titre antibodies.
Danish: Disse reaktioner blev observeret mindre hyppigt hos antistof-negative patienter (4 %) sammenlignet med de antistof-positive patienter (13 %) og med øget forekomst hos patienter med højere antistoftitre.
English: Prolonged-release exenatide has not been studied in patients with severe gastrointestinal disease, including gastroparesis.
Danish: Depotformulering af exenatid er ikke undersøgt hos patienter med alvorlig gastrointestinal sygdom, herunder gastroparese.
English: It is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus.
Danish: Medicinen er til indsprøjtning og bruges til at forbedre blodsukkerkontrollen hos voksne med type 2-diabetes mellitus.
English: This helps you get the correct dose of medicine.
Danish: Det er med til at sikre, at du får den rigtige dosis af medicinen.
English: Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.
Danish: Læs omhyggeligt instruktionerne i trin 3a til 4h igen, inden din næste indsprøjtning den efterfølgende uge.
English: Each pen can only be used by one person and is for single use.
Danish: Hver pen må kun anvendes af samme person og er kun beregnet til engangsbrug.
English: A container is not included in the carton.
Danish: Der medfølger ikke nogen beholder i kartonen.
English: Paracetamol Cmax decreased by 16% (fasting) and 5% (fed) and tmax was increased from approximately 1 hour in the control period to 1.4 hours (fasting) and 1.3 hours (fed).
Danish: Cmax for paracetamol faldt med 16 % (fastende) og 5 % (mæt), og tmax steg fra cirka 1 time i kontrolperioden til 1,4 timer (fastende) og 1,3 timer (mæt).
English: Patients who developed antibodies to exenatide tend to have more injection site reactions (for example: redness of skin and itching), but otherwise similar rates and types of adverse events as those with no antibodies to exenatide.
Danish: Patienter, der udviklede antistoffer mod exenatid, var tilbøjelige til at få flere reaktioner på injektionsstedet (for eksempel rødme og kløe i huden), men havde ellers samme hyppighed og type af bivirkninger, som patienter uden antistoffer mod exenatid.
English: What should I do if I have trouble removing the needle cover?
Danish: Hvad skal jeg gøre, hvis jeg har svært ved at fjerne kanylehætten?
English: Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: Natriumindhold: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: • Attach the needle, see step 4a
Danish: • Sætter kanylen på - se trin 4a
English: A study of 26-week duration has been conducted, in which prolonged-release exenatide 2 mg is compared to insulin glargine once daily.
Danish: Der er udført et studie af 26 ugers varighed, hvor depotformulering af exenatid 2 mg er sammenlignet med insulin glargin en gang dagligt.
English: No clinically meaningful differences were observed in steady state exenatide concentrations or tolerability in patients with mild to moderate renal impairment (eGFR 30 to 89 ml/min/1.73m receiving Bydureon BCise, compared to those with normal renal function.
Danish: Der blev ikke observeret nogen klinisk signifikante forskelle i steady state-exenatidkoncentrationer eller tolerabilitet hos patienter med let til moderat nedsat nyrefunktion (eGFR 30 til 89 ml/min/1,73 m2), der modtog Bydureon BCise, sammenlignet med patienter med normal nyrefunktion.
English: (see section 5.2).
Danish: (angivet i punkt 6).
English: - How to inject this medicine.
Danish: - Hvordan lægemidlet skal injiceres.
English: No pharmacokinetic study has been performed in patients with hepatic insufficiency.
Danish: Der er ikke udført noget farmakokinetisk studie af patienter med leverinsufficiens.
English: Event Rate HR (95% CI)1
Danish: Antal hændelser HR (95 % CI)1
English: • Continue holding the pen upright to prevent the medicine from accidently leaking.
Danish: • Fortsæt med at holde pennen lodret for at undgå at medicinen løber ud.
English: For prolonged-release exenatide treated patients, the incidence of potentially immunogenic injection site reactions (most commonly pruritus with or without erythema) during the 30-week and the two 26-week studies was 9%.
Danish: For patienter, der blev behandlet med depotformulering af exenatid, var forekomsten af potentielt immunogene reaktioner på injektionsstedet (oftest pruritus med eller uden erytem) i 30-ugers- og de to 26-ugersstudier på 9 %.
English: Hydroxy methyl glutaryl coenzyme A reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and tmax was delayed about 4 h when immediate-release exenatide was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
Danish: Hydroxymethylglutaryl co-enzym A-reduktasehæmmere Sammenlignet med lovastatin administreret alene faldt AUC og Cmax for lovastatin med henholdsvis omkring 40 % og 28 %, og tmax var forsinket med cirka 4 timer, når exenatid opløsning til injektion blev administreret samtidig med en enkelt dosis lovastatin (40 mg).
English: Orange Label
Danish: Orange mærkat
English: Exenatide improves glycaemic control through the sustained effects of lowering both postprandial and fasting glucose concentrations in patients with type 2 diabetes.
Danish: Exenatid forbedrer den glykæmiske kontrol gennem en vedvarende sænkning af både den postprandiale og fastende glucosekoncentration hos patienter med type 2-diabetes.
English: • changes in INR (measurement of blood thinning) have been reported when used together with warfarin
Danish: • der er indberettet ændringer i INR (måling af blodfortynding) i forbindelse med anvendelse samtidig med warfarin
English: These reactions were less commonly observed in antibody-negative patients (16%) and patients with low titre antibodies (16%) compared with those with high titre antibodies (27%).
Danish: Disse reaktioner blev observeret mindre hyppigt hos antistofnegative patienter (16 %) og patienter med lave antistoftitre (16 %) sammenlignet patienter med højere antistoftitre (27 %).
English: Approximately 10 weeks after discontinuation of prolonged-release exenatide therapy, mean plasma exenatide concentrations fell below minimal detectable concentrations.
Danish: Cirka 10 uger efter seponering af behandling med depotformulering af exenatid faldt de gennemsnitlige plasmakoncentrationer af exenatid til under de målbare minimumskoncentrationer.
English: A mean increase in heart rate (HR) of 2.4 beats per minute (bpm) from baseline (74 bpm) was observed in the controlled period of the Bydureon BCise clinical studies.
Danish: En gennemsnitlig øgning af hjertefrekvensen (HR) på 2,4 slag pr. minut (bpm) fra baseline (74 bpm) blev fundet i den kontrollerede periode med Bydureon BCise i de kliniske studier.
English: In addition, injection site reactions (pruritus, nodules, erythema), hypoglycaemia (with a sulphonylurea), and headache occurred.
Danish: Desuden forekom der reaktioner på injektionsstedet (pruritus, noduli, erytem), hypoglykæmi (i forbindelse med et sulfonylurea) samt hovedpine.
English: Air bubbles in syringe
Danish: Luftbobler i sprøjten
English: Each kit should be used by one person only and is for single use.
Danish: Hvert sæt må kun anvendes af samme person og er kun beregnet til engangsbrug.
English: You can inject each dose of the medicine in your stomach area (abdomen), your thigh, or the back of your upper arm.
Danish: Du kan indsprøjte hver dosis af medicinen i din mave, et lår eller bagsiden af overarmen.
English: To be sure you get your full dose, press the injection button with your thumb until you hear a click.
Danish: For at være sikker på at du får hele din dosis, skal du trykke på injektionsknappen med din tommelfinger, indtil du hører et klik.
English: Holding the pen with the orange cap straight up helps prevent the medicine from leaking.
Danish: Ved at holde pennen med den orange hætte lodret, forhindres medicinen i at løbe ud.
English: Areas on body for injection
Danish: Indsprøjtningsområder på kroppen
English: When exenatide was used in combination with metformin and/or a thiazolidinedione, no increase in the incidence of hypoglycaemia was observed over that of placebo in combination with metformin and/or a thiazolidinedione which may be due to this glucose-dependent insulinotropic mechanism (see section
Danish: Når exenatid blev brugt i kombination med metformin og/eller et thiazolidindion, blev der ikke observeret nogen stigning i forekomsten af hypoglykæmi i forhold til placebo kombineret med metformin og/eller et thiazolidindion, hvilket kan skyldes denne glucoseafhængige insulinotropiske mekanisme (se pkt.
English: If you stop using Bydureon
Danish: Hvis du holder op med at bruge Bydureon
English: Hold the pen up to the light and look through both sides of the mixing window.
Danish: Hold pennen op mod lyset og se gennem begge sider af blandingsvinduet.
English: N=number of patients in each treatment group, SE = standard error, CI= confidence interval, *p-value <0.001 (adjusted for multiplicity).
Danish: N=antal patienter i hver behandlingsgruppe, SE = standardafvigelse, CI= konfidensinterval, *p-værdi <0,001 (justeret for multiplicitet).
English: Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that exhibits several antihyperglycaemic actions of glucagon-like peptide-1 (GLP-1).
Danish: Exenatid er en glucagon-lignende peptid-1 (GLP-1)-receptoragonist, der har adskillige antihyperglykæmiske egenskaber som glucagon-lignende peptid-1 (GLP-1).
English: Do not go to the next step unless your medicine is mixed well.
Danish: Gå ikke videre til næste trin, hvis medicinen ikke er helt blandet.
English: Pick up the needle, and twist off the blue cap.
Danish: Tag fat i kanylen og drej den blå hætte af.
English: In 30-week placebo-controlled clinical studies with immediate-release exenatide, concomitant use of exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Danish: I de 30-ugers placebokontrollerede kliniske studier med exenatid opløsning til injektion var samtidig anvendelse af exenatid og HMG CoA-reduktasehæmmere ikke forbundet med konsistente ændringer i lipidprofilerne (se pkt.
English: At the study endpoint, approximately 43% of patients had low titre antibodies to exenatide and 14% of patients had high titre antibodies.
Danish: Ved studiets afslutning havde ca. 43 % af patienterne lave antistoftitre mod exenatid, og 14 % af patienterne havde høje antistoftitre.
English: Check that the liquid in the pen is clear and free of particles before you begin.
Danish: Kontrollér, at væsken i pennen er klar og fri for partikler, inden du går i gang.
English: Do not use the pen past the expiration date.
Danish: Brug ikke pennen efter udløbsdatoen.
English: Change from baseline (± SE)
Danish: Ændring fra baseline (±SE)
English: Change from baseline (±SE)
Danish: Ændring fra baseline (± SE)
English: Concomitant medicinal products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, non-steroidal anti-inflammatory medicinal products and diuretics.
Danish: Samtidige lægemidler omfattede ACE-hæmmere, angiotensin-II-antagonister, nonsteroide antiinflammatoriske midler og diuretika.
English: Review the Instructions for the User Step 3 to confirm the order of operations, also confirm that the knob is fully in the unlocked position, then contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country).
Danish: Gennemgå brugervejledningens trin 3 for at bekræfte rækkefølgen af trin, og bekræft også, at knappen er helt i ulåst position, og kontakt derefter den lokale repræsentant for indehaveren af markedsføringstilladelsen (se afsnit 6 i indlægssedlen for en liste over kontaktinformation for hvert land).
English: You may use a biohazard container, another hard plastic container, or a metal container.
Danish: Du kan bruge en beholder til farligt affald, en anden hård plastikbeholder eller en metalbeholder.
English: Prolonged-release exenatide did not increase the cardiovascular risk in patients with type 2 diabetes mellitus compared to placebo when added to current usual care (HR:0.91; 95% CI: 0.832, 1.004; P<0.001 for non-inferiority) see Figure1.
Danish: Depotformulering af exenatid forøgede ikke den kardiovaskulære risiko hos patienter med type 2-diabetes mellitus sammenlignet med placebo, når det blev tilføjet til den nuværende sædvanlige pleje (HR: 0,91; 95 % CI: 0,832, 1,004; P<0,001 for noninferioritet) se figur 1.
English: If the orange rod does not appear, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country).
Danish: Hvis det orange stempel ikke vises, skal du kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen (se afsnit 6 i indlægssedlen for en liste over kontaktinformation for hvert land).
English: If it's not mixed well, tap longer and more firmly.
Danish: Hvis den ikke er blandet godt, skal du slå hårdere og i længere tid.
English: STEP 3: Prepare the Pen
Danish: TRIN 3: Klargør pennen
English: Treatment with prolonged-release exenatide persistently significantly improved glycaemic control and weight control, compared to the insulin glargine treatment.
Danish: Behandling med exenatid depotformulering forbedrede vedvarende og signifikant glykæmisk kontrol og vægtkontrol, sammenlignet med insulin glargin-behandling.
English: Bydureon is injected into your skin (subcutaneously).
Danish: Bydureon indsprøjtes i huden (subkutant).
English: This is what the broken-off cap looks like.
Danish: Sådan ser den afbrækkede hætte ud.
English: Do not use this medicine after the expiry date, which is stated on the label and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: If you see clumps of dry powder on the sides of the pen, the medicine is NOT mixed well.
Danish: Hvis du kan se klumper af tørt pulver på siderne af pennen, betyder det, at medicinen IKKE er blandet godt nok.
English: In a 28-week open-label study (oral medication-blinded), Bydureon BCise was compared to sitagliptin and placebo in subjects also using metformin ≥ 1,500 mg daily.
Danish: I et 28-ugers open-label studie (oral studiemedicin-blindet) blev Bydureon BCise sammenlignet med sitagliptin og placebo hos patienter, der også brugte metformin ≥1.500 mg dagligt.
English: Furthermore, in the clinical studies, patients on a sulphonylurea combination with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Danish: Derudover har kliniske studier vist, at patienter i sulfonylurea kombinationsbehandling med let nedsat nyrefunktion har en øget forekomst af hypoglykæmisammenlignet med patienter med normal nyrefunktion.
English: There have been spontaneously reported cases of increased INR (International Normalized Ratio), sometimes associated with bleeding, with concomitant use of warfarin and exenatide (see section 4.5).
Danish: Der er spontant indberettede tilfælde af forhøjet INR (international normaliseret ratio), nogle gange forbundet med blødning, i forbindelse med samtidig anvendelse af warfarin og exenatid (se pkt.
English: You cannot save it for later use.
Danish: Du kan ikke gemme den til senere brug.
English: 1 single-dose kit contains:
Danish: 1 enkeltdosissæt indeholder:
English: NAME AND ADDRESS OF THE MARKETINGAUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control.
Danish: Bydureon er indiceret til behandling af type 2-diabetes mellitus hos voksne på 18 år og derover for at forbedre den glykæmiske kontrol ved kombination med andre glukosesænkende lægemidler, herunder basal insulin, når disse kombineret med diæt og motion ikke giver tilstrækkelig glykæmisk kontrol.
English: Patients on pioglitazone gained weight (Table 6).
Danish: Patienter på pioglitazon steg i vægt (tabel 6).
English: The results of a study using paracetamol as a marker of gastric emptying suggest that the effect of prolonged-release exenatide to slow gastric emptying is minor and not expected to cause clinically significant reductions in the rate and extent of absorption of concomitantly administered oral medicinal products.
Danish: Resultaterne af et studie, hvor paracetamol blev brugt som markør for ventrikeltømning, tyder på, at exenatids effekt i depotformulering på forsinkelsen af ventrikeltømning er lille og det forventes ikke at medføre klinisk signifikante nedsættelser i hastigheden og omfanget af absorptionen for samtidigt anvendte orale lægemidler.
English: Following weekly administration of 2 mg Bydureon BCise, mean exenatide concentrations exceeded minimal efficacious concentrations (~ 50 pg/ml) in 2 weeks with gradual increase in the average plasma exenatide concentration up to Week 8.
Danish: Efter ugentlig administration af 2 mg Bydureon BCise oversteg de gennemsnitlige koncentrationer af exenatid de effektive minimumskoncentrationer (~ 50 pg/ml) på 2 uger med en gradvis stigning i den gennemsnitlige plasmakoncentration af exenatid op til uge 8.