FrancophonIA/ELRC3.0 huggingface dataset:
English: A reduction in HbA1c was observed over the course of the trial with an overall treatment difference of -0.53% (prolonged-release exenatide vs. placebo).
Danish: Der blev observeret en reduktion i HbA1c i løbet af studiet med en samlet behandlingsforskel på -0,53 % (depotformulering af exenatid vs. placebo).
English: General disorders and administration site conditions Injection site pruritus
Danish: Almene symptomer og reaktioner på administrationsstedet Pruritus på injektionsstedet
English: IMPORTANT Once the medicine is mixed well, you must inject the dose immediately.
Danish: VIGTIGT Når medicinen er blandet godt, skal du straks indsprøjte din dosis.
English: Removed Cap
Danish: Fjernet hætte
English: Mixing the medicine and filling the syringe
Danish: Blanding af medicinen og påfyldning af sprøjten
English: How do I know that the medicine is mixed well?
Danish: Hvordan ved jeg, at medicinen er blandet godt nok?
English: - The other ingredients are: poly (D,L-lactide-co-glycolide), sucrose and medium chain triglyceride.
Danish: - Øvrige indholdsstoffer: poly (D,L-laktid-coglycolid), saccharose og triglycerider af middelkædelængde.
English: NOT Mixed Well
Danish: IKKE helt blandet
English: Steady-state exenatide concentrations are maintained during the one-week interval between doses with minimal peak to trough fluctuation from this average therapeutic concentration.
Danish: Steady state-koncentrationerne af exenatid opretholdes i intervallet på 1 uge mellem doserne med et minimalt udsving fra maksimum til minimum i forhold til denne gennemsnitlige terapeutiske koncentration.
English: How do I know if the medicine is fully mixed?
Danish: Hvordan ved jeg om medicinen er helt blandet?
English: But be sure to choose a different injection site in that area.
Danish: Men husk at vælge et nyt indsprøjtningssted i det pågældende område.
English: Press the top of the vial firmly into the orange connector.
Danish: Tryk toppen af hætteglasset godt fast ind i det orange forbindingsled.
English: You should not use this medicine while breast-feeding.
Danish: Du må ikke tage dette lægemiddel mens du ammer.
English: • Hives and difficulty with breathing
Danish: • Nældefeber og åndedrætsbesvær
English: The most frequently reported adverse reaction was nausea.
Danish: Den hyppigst indberettede bivirkning var kvalme.
English: The incidence of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea (24.0% versus 5.4%) (see section 4.4).
Danish: Forekomsten af hypoglykæmi steg, når depotformulering af exenatid blev brugt i kombination med et sulfonylurea-præparat (24,0 % vs. 5,4 %) (se pkt.
English: Each single-dose pre-filled pen is provided with one custom needle.
Danish: Hver fyldt pen med enkeltdosis er forsynet med en egnet kanyle.
English: Throw away any Bydureon kit that has been frozen.
Danish: Kasser alle Bydureon-sæt, som har været nedfrosset.
English: During these next steps, you will be mixing the medicine and filling the syringe.
Danish: De næste trin i proceduren handler om at blande medicinen og fylde sprøjten.
English: You can also change your chosen injection day, as long as your last dose was given 3 or more days before.
Danish: Du kan også ændre den valgte indsprøjtningsdag, så længe det er 3 dage eller mere siden sidste dosis.
English: Safety findings at 156 weeks were consistent with those reported at 26 weeks.
Danish: De sikkerhedsmæssige fund efter 156 uger var i overensstemmelse med dem, der blev rapporteret efter 26 uger.
English: Your doctor or diabetes nurse should teach you how to inject this medicine before you use it for the first time.
Danish: Din læge eller diabetessygeplejerske skal vise dig, hvordan du indsprøjter dette lægemiddel, inden du bruger det den første gang.
English: Both prolonged-release and immediate-release exenatide patients achieved a reduction in weight compared to baseline, although the difference between the two treatment arms was not significant.
Danish: Både patienter på exenatid depotformulering og opløsning til injektion opnåede en reduktion af vægten sammenligned med baseline, selvom forskellen mellem de to behandlingsarme ikke var signifikant.
English: During the controlled period of the clinical studies, injection site reactions were observed more frequently in patients treated with Bydureon BCise versus comparator-treated patients (24% versus 4% with immediate-release exenatide).
Danish: I de kliniske studiers kontrolfase blev der oftere observeret reaktioner på injektionsstedet hos de patienter, der blev behandlet med Bydureon BCise, end hos de patienter, som blev behandlet med komparator (24 % versus 4 % opløsning til injektion).
English: 2 Connecting the parts 3 Mixing the medicine and filling the syringe 4 Injecting the medicine
Danish: 3 Blanding af medicinen og påfyldning af sprøjten 4 Indsprøjtning af medicinen
English: I'm ready to inject my dose.
Danish: Jeg er klar til at tage min dosis.
English: No pharmacokinetics study of prolonged-release exenatide has been conducted in the paediatric population.
Danish: Der er ikke udført farmakokinetiske studier af depotformulering af exenatid i en pædiatrisk population.
English: Check that the liquid in the syringe is clear and free of particles before you begin.
Danish: Kontrollér, at væsken i sprøjten er klar og fri for partikler, inden du går i gang.
English: It is normal to see a few air bubbles in the mixture.
Danish: Det er normalt, at der er nogle få luftbobler i blandingen.
English: Prolonged-release exenatide is for self-administration by the patient.
Danish: Depotformulering af exenatid er beregnet til at blive administreret af patienten selv.
English: Placebo + Insulin glargine
Danish: Placebo + Insulin glargin
English: In clinical studies of prolonged-release exenatide, approximately 45% of patients had low titre antibodies to exenatide at study endpoint.
Danish: I kliniske studier med depotformulering af exenatid havde cirka 45 % af patienterne lave antistoftitre mod exenatid ved studiets afslutning.
English: Remove the syringe.
Danish: Tag sprøjten ud.
English: Mean body weight (kg)
Danish: Gennemsnitlig kropsvægt (kg)
English: A clinically relevant effect of prolonged-release exenatide and immediate-release exenatide treated subjects was observed on HbA1c, regardless of the background anti-diabetic therapy in both studies.
Danish: Der var en klinisk relevant effekt af depotformulering af exenatid og exenatid opløsning til injektion på HbA1c, uanset den antidiabetiske baggrundsbehandling i begge studier.
English: DO NOT try to recap or reuse the needle.
Danish: Forsøg IKKE at sætte hætten på igen eller at genbruge kanylen.
English: Important: After the medicine is fully mixed, you must complete the preparation steps right away, and inject to get the full dose.
Danish: Vigtigt: Når medicinen er helt blandet, skal du straks fuldføre alle trin af indsprøjtningen for at få den fulde dosis.
English: Patients switching between the prolonged-release exenatide products (Bydureon or Bydureon BCise) may do so, with no expected relevant effect on blood glucose concentrations.
Danish: Patienter, der skifter mellem depotformuleringer af exenatid (Bydureon eller Bydureon BCise), kan gøre det uden forventet relevant indvirkning på blodglucosekoncentrationerne.
English: The incidence of withdrawal due to adverse events during the 30-week controlled study was 6% for prolonged-release exenatide treated patients, 5% for immediate-release exenatide treated patients.
Danish: Antallet af patienter der udgik af behandling på grund af bivirkninger i det 30-ugers kontrollerede studie var 6 % for patienter, der blev behandlet med depotformulering af exenatid, og 5 % for patienter, der blev behandlet med exenatid opløsning til injektion.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter blanding af lægemidlet, se pkt.
English: Least squares means.
Danish: Mindste kvadraters metode.
English: Also read the Package Leaflet in your carton.
Danish: Læs også indlægssedlen, som du finder i kartonen.
English: How do I dispose of my Bydureon pen?
Danish: Hvordan kasserer jeg min Bydureon pen?
English: Hold the pen up to the light and look through both sides and the bottom of the window.
Danish: Hold pennen op mod lyset og se fra begge sider og bunden af vinduet.
English: Powder: white to off-white powder.
Danish: Pulveret er hvidt til offwhite.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with prolonged-release exenatide formulations in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med exenatid depotformuleringer i en eller flere undergrupper af den pædiatriske population i type 2 diabetes mellitus (se pkt.
English: There were no episodes of major hypoglycaemia in the prolonged-release exenatide with insulin group.
Danish: Der var ingen episoder med alvorlig hypoglykæmi i gruppen, som fik depotformulering af exenatid sammen med insulin.
English: If you use more of this medicine than you should, please consult your doctor first as you may need medical treatment.
Danish: Hvis du har brugt for meget af dette lægemiddel, kontakt først din læge, da du kan have brug for medicinsk behandling.
English: B. Open the tray,
Danish: B. Åbn indpakningen,
English: The need for additional antihyperglycaemic medication was reduced by 33% with the prolongedrelease exenatide group (exposure-adjusted incidence of 10.5 per 100 pt-year) compared to the placebo group (exposure-adjusted incidence of 15.7 per 100 pt-year).
Danish: Behovet for yderligere antihyperglykæmisk medicin blev reduceret med 33 % i gruppen med depotformulering af exenatid (eksponeringsjusteret incidens på 10,5 pr. 100 patientår) sammenlignet med placebogruppen (eksponeringsjusteret incidens på 15,7 pr. 100 patientår).
English: • You will probably need less time as you get used to giving yourself injections.
Danish: • Efterhånden som du bliver vant til at give dig selv indsprøjtningerne, vil du sikkert ikke skulle bruge nær så meget tid.
English: Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ01.
Danish: Farmakoterapeutisk klassifikation: Lægemidler til brug mod diabetes, glucagon-lignende peptid 1 receptor (GLP-1) analoger, ATC-kode: A10BJ01.
English: Following weekly administration of 2 mg prolonged-release exenatide, mean exenatide concentrations exceeded minimal efficacious concentrations (~ 50 pg/ml) in 2 weeks with gradual increase in the average plasma exenatide concentration over 6 to 7 weeks.
Danish: Efter ugentlig administration af 2 mg depotformulering af exenatid 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 i løbet af 6 til 7 uger.
English: You will need a puncture-resistant container that is large enough to hold the entire pen with a used needle attached.
Danish: Du har brug for en beholder til spidse genstande, som er stor nok til at rumme hele pennen med den brugte kanyle påsat.
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1.
Danish: For studieresultater omhandlende kombinationer, indvirkninger på glykæmisk kontrol og kardiovaskulære hændelser, og for de undersøgte populationer, se pkt.
English: If you are not sure you have taken the full dose of Bydureon If you are not sure if you have taken all of your dose, do not inject another dose of this medicine, just take it next week as planned.
Danish: Hvis du er i tvivl om, du har fået hele din dosis Bydureon Hvis du er i tvivl om, hvorvidt du har fået hele din dosis, må du ikke indsprøjte en ny dosis af dette lægemiddel.
English: Once you mix the medicine, you must inject it immediately.
Danish: Når du har blandet medicinen, skal den straks indsprøjtes.
English: It's normal if you see air bubbles in the liquid, and they will cause no harm.
Danish: Det er normalt at kunne se luftbobler i væsken, og de er uskadelige.
English: Fasting lipids Prolonged-release exenatide has shown no negative effects on lipid parameters.
Danish: Fastende lipider Depotformulering af exenatid har ikke vist nogen negative virkninger på lipidparametrene.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 bruger ud af 10)
English: Prior to initiation of prolonged-release exenatide, it is strongly recommended that patients and caregivers be trained by their healthcare professional.
Danish: Før behandlingsstart af exenatid i depotformulering, anbefales det kraftigt, at patienter og plejere instrueres af sundhedsfaglige personer.
English: - The other ingredients are: - In the powder: poly (D,L-lactide-co-glycolide) and sucrose.
Danish: - Øvrige indholdsstoffer: - I pulveret: poly (D,L-laktid-coglycolid) og saccharose.
English: • The pen must be stored flat.
Danish: • Pennen skal opbevares liggende.
English: How do I know I gave myself the full dose of medicine?
Danish: Hvordan ved jeg, at jeg har fået den fulde dosis medicin?
English: A. Unlock the pen.
Danish: A. Lås pennen op.
English: Increased INR has been spontaneously reported during concomitant use of warfarin and prolonged-release exenatide.
Danish: Der er spontant indberettet forhøjet INR i forbindelse med samtidig anvendelse af warfarin og depotformulering af exenatid.
English: Each dose should be administered in the abdomen, thigh, or the back of the upper arm as a subcutaneous injection immediately after suspension of the powder in the solvent.
Danish: Hver dosis skal administreres i abdomen, lår eller bagsiden af overarmen som en subkutan injektion, umiddelbart efter opløsning af pulveret i solvensen.
English: Rate based on prolonged-release exenatide spontaneous reports data (unknown denominator).
Danish: Hyppighed baseret på data fra spontane indberetninger af depotformulering af exenatid (ukendt denominator).
English: In patients treated with prolonged-release exenatide, generally 20% reported at least one episode of nausea compared to 34% of immediate-release exenatide patients.
Danish: Generelt indberettede 20 % af de patienter, som blev behandlet med depotformulering af exenatid, mindst én episode med kvalme sammenlignet med 34 % af patienterne, der fik exenatid opløsning til injektion.
English: Remove the needle from your skin and replace it with the spare needle from the carton.
Danish: Tag kanylen ud af huden og erstat den med reservekanylen fra æsken.
English: To get your full dose the medicine must be mixed well.
Danish: For at få din fulde dosis, skal medicinen blandes tilstrækkeligt.
English: Where to learn more about Bydureon
Danish: Her kan du få mere at vide om Bydureon
English: Most episodes of nausea were mild to moderate.
Danish: De fleste episoder med kvalme var lette til moderate.
English: The most frequent adverse reactions were mainly gastrointestinal related (nausea which was the most frequent reaction and associated with the initiation of treatment and decreased over time, and diarrhoea).
Danish: De hyppigste bivirkninger var fortrinsvis relateret til mave-tarm-kanalen (kvalme, som var den hyppigste bivirkning og forbundet med igangsættelse af behandlingen og som aftog med tiden, og diaré).
English: with the needle attached, in a puncture-resistant container.
Danish: med kanylen påsat i en beholder til spidse genstande.
English: To get a full dose, the medicine must be mixed well and look cloudy.
Danish: For at få en fuld dosis, skal medicinen blandes godt og se uklar ud.
English: Ask your pharmacist how to safely throw away the container with used pens and needles.
Danish: Spørg på apoteket, hvordan beholderen med brugte penne og kanyler skal bortskaffes.
English: However, as renal function generally declines with age, consideration should be given to the patient's renal function (see Renal impairment).
Danish: Da nyrefunktionen generelt forringes med alderen, skal der tages hensyn til patientens nyrefunktion (se ”Nedsat nyrefunktion”) (se pkt.
English: Exenatide suppresses glucagon secretion which is known to be inappropriately elevated in patients with type 2 diabetes.
Danish: Exenatid undertrykker glukagonudskillelse, som vides at være uhensigtsmæssigt forhøjet hos patienter med type 2-diabetes.
English: Be careful not to push in the plunger.
Danish: Vær forsigtig med ikke at skubbe stemplet ind.
English: If you use more of this medicine than you should, please consult with your doctor first as you may need medical treatment.
Danish: Hvis du har brugt for meget af dette lægemiddel, skal du først kontakte lægen, da du kan have brug for medicinsk behandling.
English: The suspension should only be used if it is evenly mixed, white to off-white and cloudy, with no white medicine seen along the side, bottom or top of the pen window.
Danish: Suspensionen bør kun anvendes, hvis den er helt blandet, hvid til offwhite og uklar, uden synlige hvide partikler langs siden, bunden eller toppen af penvinduet.
English: Withdrawal due to nausea or vomiting each occurred in < 1% for prolonged-release exenatide treated patients and 1% for immediate-release exenatide treated patients.
Danish: Seponering på grund af kvalme eller opkastning forekom for < 1 % af de patienter, der blev behandlet med depotformulering af exenatid, og for 1 % af de patienter, som fik exenatid opløsning til injektion.
English: What should I do if I have trouble attaching the needle?
Danish: Hvad skal jeg gøre, hvis jeg har svært ved at sætte kanylen på?
English: Intestinal obstruction Skin and subcutaneous tissue disorders Urticaria
Danish: Tarmobstruktion Hud og subkutane væv Urticaria
English: Single-dose pre-filled pen
Danish: Enkeltddosis fyldt pen
English: This medicine is used in combination with the following diabetes medicines: metformin, sulphonylureas, thiazolidinediones, SGLT2 inhibitors and/or a long-acting insulin.
Danish: Dette lægemiddel bruges sammen med følgende typer diabetesmedicin: metformin, sulfonylurinstoffer, thiazolidindioner, SGLT2-hæmmere og/eller en langtidsvirkende insulin.
English: This reduction in body weight was seen irrespective of the occurrence of nausea although the reduction was larger in the group with nausea (mean reduction of -1.9 kg to -5.2 kg with nausea versus -1.0 kg to -2.9 kg without nausea).
Danish: Reduktionen i legemsvægt blev set uanset tilstedeværelsen af kvalme, selvom reduktionen var større i gruppen med kvalme (gennemsnitlig reduktion på -1,9 kg til -5,2 kg med kvalme versus -1,0 kg til -2,9 kg uden kvalme).
English: The suspension is packaged in a 2-ml Type I glass cartridge, sealed at one end with a (bromobutyl) rubber seal/cap combination (combiseal), and at the other end with a (bromobuty) rubber plunger.
Danish: Suspensionen er pakket i et 2 ml Type I glashætteglas, forseglet i den ene ende med en (bromobutyl) gummitætning/prop (kombineret) og i den anden ende med et (bromobutyl) gummistempel.
English: Rapid weight loss at a rate of >1.5 kg per week has been reported in patients treated with exenatide.
Danish: Der er observeret hurtigt vægttab i størrelsesordenen > 1,5 kg om ugen hos patienter, der blev behandlet med exenatid.
English: Rapid weight loss at a rate of > 1.5 kg per week has been reported in patients treated with exenatide.
Danish: Der er observeret hurtigt vægttab i størrelsesordenen >1,5 kg om ugen hos patienter, der blev behandlet med exenatid.
English: The patient should be instructed to discard the pen safely after each injection.
Danish: Patienten skal instrueres i at kassere pennen sikkert efter hver injektion.
English: The liquid in the syringe should be clear and free of particles.
Danish: Væsken i sprøjten skal være klar og fri for partikler.
English: A. Let your pen come to room temperature.
Danish: A. Lad din pen varme op til stuetemperatur.
English: The reactions are listed below as MedDRA preferred term by system organ class and absolute frequency.
Danish: Bivirkningerne er angivet nedenfor i henhold til MedDRA-konventionen, inddelt efter systemorganklasse og absolut hyppighed.
English: A reduction in body weight compared to baseline has been observed in all prolonged-release exenatide studies.
Danish: Der er observeret fald i legemsvægt sammenlignet med baseline i alle studier med depotformulering af exenatid.
English: Concomitant medicinal products
Danish: Samtidig anvendelse af andre lægemidler
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRE OG/ELLER ADMINISTRATIONSVEJ(E)
English: The pre-filled pen must be stored flat.
Danish: Den fyldte pen skal opbevares liggende.
English: Follow the “Instructions for the User” provided in the carton to inject Bydureon BCise
Danish: Følg “Brugervejledning”, som er vedlagt i æsken til Bydureon BCise
English: The following interaction studies have been conducted using 10 mcg immediate-release exenatide but not prolonged-release exenatide formulations:
Danish: Nedenstående interaktionsstudier er udført med anvendelse af 10 mikrog exenatid opløsning til injektion, men ikke med depotformulering af exenatid.
English: - If you lose weight too quickly (more than 1.5kg per week)talk to your doctor about it since this may cause problems such as gallstones.
Danish: - Du skal tale med din læge, hvis du taber dig for hurtigt (mere end 1,5 kg om ugen), da dette kan give dig problemer, såsom galdesten.
English: What you need to know before you use Bydureon
Danish: Det skal du vide, før du begynder at bruge Bydureon
English: How soon to inject after mixing Mixing the medicine
Danish: Hvor hurtigt skal man indsprøjte efter blanding Blanding af medicinen
English: The European Medicines Agency has deferred the obligation to submit the results of studies with prolonged-release exenatide in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med depotformulering af exenatid i en eller flere undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: Mean HbA1c (%) Baseline
Danish: Gennemsnitlig HbA1c (%) Baseline
English: Rate based on twelve prolonged-release exenatide completed long-term efficacy and safety studies n = 2868 total.
Danish: Rate baseret på tolv exenatid i depotformulering afsluttede langtidssikkerheds- og effektstudier n = 2868 i alt.
English: You should not see any white medicine along the bottom, top, or sides.
Danish: Du må ikke kunne se nogen hvide partikler langs bund, top eller sider.
English: Follow the “Instructions for the User” provided in the carton to inject Bydureon
Danish: Følg den “Brugervejledning”, som er vedlagt i æsken, når Bydureon skal indsprøjtes
English: A mean increase in heart rate (HR) of 2.6 beats per minute (bpm) from baseline (74 bpm) was observed in pooled prolonged-release exenatide clinical studies.
Danish: En gennemsnitlig øgning af hjertefrekvensen (HR) på 2,6 slag pr. minut (bpm) fra baseline (74 bpm) blev fundet i poolede kliniske data fra studier med depotformulering af exenatid.
English: If you have questions about taking Bydureon
Danish: Hvis du har spørgsmål vedrørende brug af Bydureon
English: If you lose weight too quickly (more than 1.5 kg per week) talk to your doctor about it since this may cause problems such as gallstones.
Danish: Tal med din læge, hvis du taber dig for hurtigt (mere end 1,5 kg pr. uge), da det kan give dig problemer, såsom galdesten.
English: Therefore, the use of prolonged-release exenatide is not recommended in patients with severe gastrointestinal disease.
Danish: Anvendelse af depotformulering af exenatid anbefales derfor ikke til patienter med alvorlig gastrointestinal sygdom.
English: Patients on pioglitazone gained weight (Table 4).
Danish: Patienterne i behandling med pioglitazon tog på i vægt (tabel 4).
English: Minutes
Danish: Minutter