FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pen has 60 doses to provide 30 days of twice-aday injections.
Danish: Hver pen indeholder 60 doser, som rækker til 30 dages injektion to gange dagligt.
English: Seven-point self-monitored blood glucose profiles (before and after meals and at 3 am) demonstrated significantly reduced glucose values compared to insulin in the postprandial periods after immediate-release exenatide injection.
Danish: 7-punkts selvmonitorerede blodglucoseprofiler (før og efter måltider samt kl. 3 om natten) demonstrerede signifikante reduktioner i glucoseværdier hos patienter sammenlignet med insulin i den postprandiale periode efter injektion med exenatid opløsning til injektion.
English: Administration of the oral contraceptive 30 minutes after immediate-release 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 oral kontraception 30 min. efter exenatid opløsning til injektion påvirkede ikke AUC, men resulterede i en reduktion af Cmax for ethinylestradiol med 45 %, og Cmax for levonorgestrel med 27-41 %, og en forsinkelse i tmax med 2-4 timer pga. forsinket ventrikeltømning.
English: Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine
Danish: Ændret nyrefunktion, herunder akut nyresvigt, forværring af kronisk nyresvigt, nyreinsufficiens, forhøjet serumkreatinin
English: The liquid should be clear, colourless, and free of particles.
Danish: Væsken skal være klar, farveløs og fri for partikler.
English: The concurrent use of immediate-release exenatide with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied and cannot be recommended.
Danish: Samtidig brug af exenatid opløsning til injektion og D-phenylalaninderivater (meglitinider), alfaglucosidasehæmmere, dipeptidylpeptidase-4-hæmmere eller andre GLP-1-receptoragonister er ikke undersøgt og kan ikke anbefales.
English: The incidence and type of other adverse events observed were similar to those seen in the 30-week controlled clinical trials with a sulphonylurea, metformin or both.
Danish: Incidensen og typen af andre observerede bivirkninger var sammenlignelig med dem, man så i de 30-ugers kontrollerede kliniske studier med sulfonylurinstof, metformin eller begge.
English: The 26-week study showed similar results with statistically significant reductions from baseline HbA1c compared to placebo (-0.8% versus -0.1%).
Danish: 26-ugers studiet viste lignende resultater med statistisk signifikante reduktioner af HbA1c fra baseline sammenlignet med placebo (-0,8 % versus -0,1 %).
English: The clinical experience in patients with moderate renal impairment is very limited (see section 4.2).
Danish: Den kliniske erfaring med patienter, der har moderat nedsat nyrefunktion, er meget begrænset, se pkt 4.2.
English: Gastroresistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after immediate-release exenatide injection.
Danish: Gastroresistente formuleringer, der indeholder substanser, som er følsomme over for nedbrydning i ventriklen, såsom syrepumpehæmmere, skal indtages mindst 1 time før eller mere end 4 timer efter en injektion med exenatid opløsning til injektion.
English: When immediate-release exenatide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin or pioglitazone alone.
Danish: Når exenatid opløsning til injektion føjes til eksisterende metformin- og/eller pioglitazon-behandling, kan den aktuelle dosering af metformin og/eller pioglitazon fortsættes, da der ikke forventes øget risiko for hypoglykæmi sammenlignet med metformin eller pioglitazon alene.
English: When exenatide is used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Danish: Hvis exenatid anvendes i kombination med sulfonylurinstof eller basal insulin, skal patienterne rådes til at udvise forsigtighed for at undgå hypoglykæmi under bilkørsel og ved betjening af maskiner.
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 glucagonlignende peptid-1(GLP-1)-receptoragonist, som udviser flere af de antihyperglykæmiske virkninger af glucagonlignende peptid-1 (GLP-1).
English: Byetta is a clear and colourless liquid (solution for injection) filled in a glass cartridge within a pen.
Danish: Byetta er en klar og farveløs væske (injektionsvæske) i en glascylinderampul, der er i en pen.
English: Why do I see particles in the cartridge after I finish my injection?
Danish: Hvorfor er der partikler i cylinderampullen, efter jeg har taget min injektion?
English: - If you cannot turn the dose knob, the needle may be clogged.
Danish: Hvis doseringsknappen ikke kan drejes, er nålen muligvis tilstoppet.
English: In female rats given exenatide for 2 years, an increased incidence of benign thyroid C-cell adenomas was observed at the highest dose, 250 mcg/kg/day, a dose that produced an exenatide plasma exposure 130-fold the human clinical exposure.
Danish: I hunrotter, som fik exenatid i 2 år, sås en øget incidens af godartede thyreoide C-celle adenomer ved den højeste dosis, 250 µg/kg/dag, en dosis, som gav en exenatid-plasmaeksponering på 130 gange den humane kliniske eksponering.
English: When immediate-release exenatide is used in combination with basal insulin, the dose of basal insulin should be evaluated.
Danish: Når exenatid opløsning til injektion anvendes i kombination med basal insulin, skal dosis af basal insulin vurderes.
English: Weight increase of 0.2 kg was observed for patients on insulin lispro protamine suspension and 0.6 kg for insulin glargine treated patients from a baseline of 102 kg and 103 kg respectively.
Danish: En vægtøgning på 0,2 kg blev observeret hos patienterne på insulin lispro protamin suspension og på 0,6 kg hos insulin glargin-behandlede patienter fra et baseline-niveau på henholdsvis 102 kg og 103 kg.
English: Dispose of a used pen after 30 days, even if some medicine remains in the pen.
Danish: Kassér en brugt pen efter 30 dage, selv hvis der er medicin tilbage i pennen.
English: • Injection is complete when the is in the centre of the dose window.
Danish: • Injektionen er afsluttet, når er i midten af doseringsvinduet.
English: These instructions do not take the place of talking with your healthcare professional about your medical condition or your treatment.
Danish: Denne vejledning er ikke ment som erstatning for samtaler med din læge eller diabetessygeplejerske om din sygdom eller din behandling.
English: In patients treated with 5 mcg or 10 mcg immediate-release exenatide, 36% reported at least one episode of nausea.
Danish: Af de patienter, der blev behandlet med 5 μg eller 10 μg exenatid opløsning til injektion, rapporterede 36 % mindst en episode med kvalme.
English: Doses higher than 10 mcg BID are not recommended.
Danish: Doser højere end 10 μg to gange dagligt anbefales ikke.
English: Weight loss of 2.3 kg (2.6%) was achieved with immediate-release exenatide in the 26-week study and a loss of 2.5 kg (2.7%) in a 52-week study whereas treatment with insulin was associated with weight gain.
Danish: Der blev opnået vægttab på 2,3 kg (2,6 %) med exenatid opløsning til injektion i 26-ugers studiet og et tab på 2,5 kg (2,7 %) i et 52-ugers studie, mens insulinbehandling var associeret med vægtøgning.
English: • Replace blue pen cap on pen before storage.
Danish: • Sæt den blå hætte på pennen igen før opbevaring.
English: Immediate-release exenatide must not be administered by intravenous or intramuscular injection.
Danish: Exenatid opløsning til injektion må ikke injiceres intravenøst eller intramuskulært.
English: Becton, Dickinson and Company needles are suitable to use with the Byetta pen.
Danish: Becton, Dickinson and Company-nåle (BD-nåle) er egnede til brug sammen med Byetta-pennen.
English: Table 1: Adverse reactions of immediate-release exenatide identified from clinical trials and spontaneous reports
Danish: Tabel 1: Rapporterede bivirkninger ved exenatid opløsning til injektion identificeret i kliniske studier og spontane indberetninger
English: The patient should be instructed to discard the needle after each injection.
Danish: Patienten skal instrueres i at kassere nålene efter hver injektion.
English: Proportion of patients (%) achieving HbA1c ≤ 7% (patients completing studies) Baseline weight (kg) Change of weight from baseline (kg)
Danish: Andel af patienter (%) der opnåede HbA1c ≤7 % (patienter der fuldførte studiet) Baseline vægt (kg)
English: Byetta is indicated for treatment of type 2 diabetes mellitus in combination with: - metformin - sulphonylureas - thiazolidinediones - metformin and a sulphonylurea - metformin and a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Danish: Byetta er indiceret til behandling af type 2-diabetes mellitus i kombination med: - metformin - sulfonylurinstoffer - thiazolidindioner - metformin og sulfonylurinstof - metformin og thiazolidindion til voksne, der ikke har opnået tilstrækkelig glykæmisk kontrol ved den maksimalt tolererede dosis for disse orale behandlinger.
English: Do not reuse needles.
Danish: Genbrug ikke nåle.
English: The proportion of patients achieving HbA1c < 7% and HbA1c ≤ 6.5% was 56% and 42% with immediate-release exenatide and 29% and 13% with placebo.
Danish: Andelen af patienter, som opnåede HbA1c <7 % og HbA1c ≤6,5 % var 56 % og 42 % med exenatid opløsning til injektion og 29 % og 13 % med placebo.
English: If you miss a dose of this medicine, skip that dose and use your next dose at the next prescribed time.
Danish: Hvis du glemmer at tage en dosis af dette lægemiddel, skal du springe den pågældende dosis over og blot tage den næste dosis på det ordinerede tidspunkt.
English: Long-term controlled data in elderly are limited, but suggest no marked changes in exenatide exposure with increased age up to about 75 years old.
Danish: Der er begrænsede, kontrollerede langtidsdata for ældre patienter, men for patienter op til 75 år tyder data ikke på, at der vil være en betydelig ændring i exenatid-eksponeringen.
English: During the study both treatment arms titrated insulin glargine using an algorithm reflecting current clinical practice to a target fasting plasma glucose of approximately 5.6 mmol/l.
Danish: Under studiet titrerede begge behandlingarme insulin glargin ved brug af en algoritme, som afspejlede gældende klinisk praksis, til et faste plasma-glucose-mål på ca. 5,6 mmol/l.
English: A reduction in body weight was seen in patients treated with immediate-release exenatide irrespective of the occurrence of nausea although the reduction was larger in the group with nausea (mean reduction 2.4 kg versus 1.7 kg) in the long-term controlled studies of up to 52 weeks.
Danish: Der blev set en reduktion i legemsvægt hos de patienter, som fik behandling med exenatid opløsning til injektion, uanset om de havde kvalme eller ej, selvom reduktionen var større i gruppen med kvalme (gennemsnitlig reduktion 2,4 kg mod 1,7 kg) i de kontrollerede langtidsstudier på op til 52 uger.
English: Clearance was significantly reduced by 84% in patients with end-stage renal disease receiving dialysis (see section 4.2).
Danish: Clearance var signifikant reduceret med 84 % hos patienter med terminal nyresygdom, som var i behandling med dialyse (se pkt.
English: Do I need to do the New Pen Setup before every dose?
Danish: Skal jeg udføre Klargøring af ny pen før hver dosis?
English: Consult with your healthcare professional about how to handle a partial dose.
Danish: Rådfør dig med din læge eller diabetessygeplejerske om, hvordan du håndterer en delvis givet dosis.
English: Make sure that the 5 with the line under it is in the centre of the dose window.
Danish: Vær sikker på, at 5 med stregen under er i midten af doseringsvinduet.
English: Immediate-release exenatide can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart).
Danish: Exenatid opløsning til injektion kan indgives når som helst inden for én time før morgen- og aftenmåltidet (eller to hovedmåltider på dagen, med ca. 6 timer eller mere i mellem).
English: • To prevent this, for your next dose, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).
Danish: • For at forhindre dette ved din næste dosis, skal du sørge for at trykke injektionsknappen ind og holde den inde og tælle langsomt til 5 (se afsnit 3, trin 4: Injektion af dosis).
English: Most episodes of nausea were mild to moderate and occurred in a dose-dependent fashion.
Danish: De fleste tilfælde af kvalme var milde til moderate og optrådte dosisafhængigt.
English: Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered.
Danish: Bemærk: Hvis du ikke kan dreje doseringsknappen, eller det drypper fra pennen, har du ikke fået den fulde dosis.
English: Why do I see Byetta leaking from my needle after I have finished my injection?
Danish: Hvorfor løber der Byetta ud fra nålen, efter at jeg har taget min dosis?
English: Ask your doctor, pharmacist, or diabetes nurse if you are not sure if any of your other medicines contain a sulphonylurea.
Danish: Rådfør dig med lægen, apotekspersonalet eller din diabetessygeplejerske, hvis du er usikker på, om andet af din medicin indeholder sulfonylurinstoffer.
English: Baseline HbA1c (%) HbA1c (%) change from base line
Danish: Baseline HbA1c (%)
English: The incidence of withdrawal due to adverse events was 8% for immediate-release exenatide-treated patients, 3% for placebo-treated and 1% for insulin-treated patients in the long-term controlled trials (16 weeks or longer).
Danish: Incidensen af patienter der afbrød studiet på grund af bivirkninger var 8 % for patienter behandlet med exenatid opløsning til injektion og 3 % for placebobehandlede og 1 % for insulinbehandlede patienter i kontrollerede langtidsstudier (16 uger eller længere).
English: If you forget to use Byetta
Danish: Hvis du har glemt at tage Byetta
English: • Changes in INR (measurement of blood thinning) have been reported when used together with warfarin.
Danish: • Ændringer i måling af blodets fortynding (INR), når Byetta har været anvendt samtidig med warfarin.
English: • Swelling of theface, tongue or throat(angioedema)
Danish: • hævelse af ansigt, tunge eller hals (angioødem)
English: Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal.
Danish: Type I-glascylinderampul med et (bromobutyl) gummistempel, gummiskive og aluminiumshætte.
English: If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when immediate-release exenatide is not administered.
Danish: Hvis sådanne lægemidler skal indgives sammen med føde, skal patienterne rådes til at tage dem i forbindelse med et måltid, hvor exenatid opløsning til injektion ikke indgives, hvis det er muligt.
English: - If you have ever had inflammation of the pancreas (pancreatitis) (see section 4).
Danish: - Hvis du har haft betændelse i bugspytkirtlen (pankreatitis) (se pkt.
English: Make sure needle is on straight and screwed on all the way.
Danish: Vær sikker på, at nålen er sat lige på og skruet helt fast.
English: Warnings and precautions Talk to your doctor, pharmacist, or diabetes nurse before using Byetta about the following: - Using this medicinein combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur.
Danish: Kontakt lægen, apoteketspersonalet eller din diabetessygeplejerske, før du bruger Byetta og diskuter følgende: - Anvendelse af dette lægemiddel i kombination med sulfonylurinstoffer, da det kan medføre lavt blodsukker (hypoglykæmi).
English: Patients in the immediate-release exenatide-treated group with anHbA1c 8.0% at the end of the BIO phase decreased their insulin glargine dose by at least 10%.
Danish: Patienter i behandlingsgruppen med exenatid opløsning til injektion med HbA1c 8,0 % i slutningen af BIO-fasen reducerede deres insulin glargin-dosis med mindst 10 %.
English: There have been uncommon, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Danish: Der har været ikke almindelige, spontane bivirkningsrapporter om ændret nyrefunktion, inklusive forøget serumkreatinin, nedsat nyrefunktion, forværring af kronisk nyresvigt og akut nyresvigt, der i nogle tilfælde krævede dialyse.
English: • If you repeat the New Pen Setup before each routine dose, you will not have enough Byetta for 30 days.
Danish: • Hvis du gentager ”Klargøring af ny pen” før hver rutinemæssige brug, vil du ikke have nok Byetta til 30 dages forbrug.
English: What Byetta contains
Danish: Byetta indeholder
English: Both treatment arms were titrated to achieve target fasting plasma glucose levels (see section 5.1).
Danish: Begge behandlingsarme blev titreret til at opnå de fastsatte mål for faste plasmaglucose (se pkt.
English: • Byettais injected twice a day,the pen contains enough medicine for 30 days.
Danish: • Byetta skal injiceres to gange dagligt, og pennen indeholder medicin til 30 dage.
English: If you stop using Byetta
Danish: Hvis du holder op med at tage Byetta
English: Injection site reactions have been reported in approximately 5.1% of subjects receiving immediate-release exenatide in long-term (16 weeks or longer) controlled trials.
Danish: Der blev rapporteret reaktioner på injektionsstedet hos ca. 5,1 % af de patienter, som fik behandling med exenatid opløsning til injektion i de kontrollerede langtidsstudier (16 uger eller længere).
English: • Keep the pressure on the injection button as you remove the needle from your skin, this keeps the medication in the cartridge clear.
Danish: • Hold trykket på injektionsknappen mens du tager nålen ud af huden; dette holder medicinen i cylinderampullen klar.
English: Note: A small air bubble in the cartridge is normal
Danish: Bemærk: En lille luftboble i cylinderampullen er normal.
English: • You have firmly pushed the injection button in all the way until it stops and
Danish: • Du har trykket injektionsknappen helt ind, indtil den stopper, og
English: For routine use, do not repeat the New Pen Setup.
Danish: Ved rutinemæssig brug skal klargøringen ikke gentages.
English: Table 1 lists adverse reactions reported of immediate-release exenatide from clinical trials and spontaneous reports (not observed in clinical trials, frequency not known).
Danish: Tabel 1 indeholder en liste med rapporterede bivirkninger ved exenatid opløsning til injektion fra kliniske studier og spontane rapporter (ikke observeret i kliniske studier, hyppighed ikke kendt).
English: A small amount of Byetta will always remain in the cartridge.
Danish: Der vil altid blive en lille mængde Byetta tilbage i cylinderampullen.
English: This prevents the liquid from leaking out.
Danish: Dette forebygger at medicinen siver ud.
English: See Commonly Asked Questions, numbers 5 and 9, in Section 4 of this user manual.
Danish: Se Spørgsmål og svar, nummer 5 og 9, i afsnit 4 i denne brugsanvisning.
English: keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
Danish: Dette vil forhindre udsivning af Byetta, det vil holde luftbobler ude, nedsætte hyppigheden af tilstoppede nåle, og minimere risikoen for infektion.
English: The proportion of patients achieving HbA1c < 7% was 47.9% with immediate-release exenatide and 42.8% with insulin lispro.
Danish: Andelen af patienter, der opnåede HbA1c < 7 %, var 47,9 % med exenatid opløsning til injektion og 42,8 % med insulin lispro.
English: Following a basal insulin optimization (BIO) phase, patients with HbA1c7.0% were randomized to add either immediate-release exenatide or insulin lispro to their existing regimen of insulin glargine and metformin.
Danish: Efter en basal insulin-optimeringsfase (BIO-fase) blev patienter med HbA1c7,0 % randomiseret til tillægsbehandling med enten exenatid opløsning til injektion eller insulin lispro til deres eksisterende behandling med insulin glargin og metformin.
English: All patients assigned to immediate-release exenatide initially received 5 mcg BID for four weeks.
Danish: Alle patienter, der fik tildelt exenatid opløsning til injektion, fik i første omgang 5 µg 2 gange daglig i fire uger.
English: To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered.
Danish: For at reducere risikoen for hypoglykæmi i forbindelse med brugen af sulfonylurinstof skal en dosisreduktion af sulfonylurinstof overvejes.
English: It is not known if exenatide passes into your milk.
Danish: Det vides ikke, om exenatid udskilles i mælken.
English: Treatment differences (immediate-release exenatide minus comparator) were -4.1 kg in the 26-week study and -5.4 kg in the 52-week study.
Danish: Forskel mellem behandling (exenatid opløsning til injektion minus komparator) var -4,1 kg i 26-ugers studiet og -5,4 kg i 52-ugers studiet.
English: • Follow the instructions for hygienic injection technique recommended by your healthcare professional.
Danish: • Følg instruktionerne til hygiejnisk injektionsteknik i overensstemmelse med lægens anbefalinger.
English: This treatment effect was comparable to that of insulin glargine in a 26-week study (mean insulin dose 24.9 IU/day, range 4-95 IU/day, at the end of study) and biphasic insulin aspart in a 52-week study (mean insulin dose 24.4
Danish: Denne behandlingseffekt var sammenlignelig med effekten af insulin glargin i et 26-ugers studie (gennemsnitlig insulin dosis 24,9 IE/dag, område 4-95 IE/dag, ved afslutningen af studiet) og med bifasisk insulin aspart i et 52-ugers studie (gennemsnitlig insulindosis 24,4 IE/dag, område 3-78 IE/dag, ved afslutningen af studiet).
English: Byetta 10 mcg: Each dose contains 88 mcg metacresol.
Danish: Byetta 10 mikrogram: Hver dosis indeholder 88 μg metacresol.
English: STEP 1 Check the Pen
Danish: TRIN 1 Kontrol af pennen
English: Hence, no restriction in timing of intake of these medicinal products in relation to immediate-release exenatide injection are needed.
Danish: Det er derfor ikke nødvendigt med restriktioner på tidspunktet for indtagelse af disse lægemidler i forhold til injektion af exenatid opløsning til injektion.
English: Concomitant medicinal products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, nonsteroidal anti-inflammatory medicinal products and diuretics.
Danish: Sådanne samtidige lægemidler kunne være ACE-hæmmere, angiotensin-II-antagonister, nonsteroide antiinflammatoriske midler og diuretika.
English: Immediate-release exenatide is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulphonylurea, pioglitazone and/or a basal insulin.
Danish: Exenatid opløsning til injektion anbefales til brug til patienter med type 2-diabetes, som allerede er i behandling med metformin, sulfonylurinstof, pioglitazon og/eller basal insulin.
English: How do I clean my Byetta pen?
Danish: Hvordan rengør jeg Byetta-pennen?
English: • Do not use Byettaafter the expiry date, which is stated on the label and the carton after ‘EXP'.
Danish: • Byetta må ikke anvendes efter den udløbsdato, der er trykt på etiketten efter ”EXP”.
English: The dose of exenatide can then be increased to 10 mcg BID to further improve glycaemic control.
Danish: Dosis af BYETTA kan derefter øges til 10 μg to gange dagligt for yderligere at forbedre den glykæmiske kontrol.