FrancophonIA/ELRC3.0 huggingface dataset:
English: Have what you need ready in order to safely dispose of used needles and syringes.
Danish: Hav de nødvendige ting klar til at kassere brugte kanyler og sprøjter på en forsvarlig måde.
English: Treatment with prolonged-release exenatide and dapagliflozin combination at Week 28 resulted in a significant mean change reduction of -4.3±0.8 mmHg in systolic blood pressure compared to prolonged-release exenatide alone of -1.2±0.8 mmHg (p<0.01) or to dapagliflozin alone of -1.8±0.8 mmHg (p<0.05).
Danish: Behandling med kombination af exenatid depotformulering og dapagliflozin resulterede ved uge 28 i en signifikant gennemsnitlig reduktion på -4,3±0,8 mmHg i det systoliske blodtryk sammenlignet med exenatid depotformulering alene på -1,2±0,8 mmHg (p<0,01) eller for dapagliflozin alene på -1,8±0,8 mmHg (p<0,05).
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 bruger ud af 10)
English: Compared with insulin glargine treatment, prolonged-release exenatide demonstrated a superior change in HbA1c, significantly lowered mean body weight and was associated with fewer hypoglycaemic events (Table 5).
Danish: Sammenlignet med insulin glargin-behandling viste exenatid depotformulering overlegen ændring i HbA1c, signifikant nedsat gennemsnitslegemsvægt og var associeret med færre hypoglykæmiske episoder (tabel 5).
English: In the 30-week immediate-release exenatide comparator study both prolonged-release and immediate-release exenatide significantly reduced systolic blood pressure from baseline (4.7±1.1 mmHg and 3.4±1.1 mmHg, respectively); the difference between the treatments was not significant.
Danish: I 30-ugers sammenligningsstudiet med exenatid opløsning til injektion reducerede både exenatid depotformulering og exenatid opløsning til injektion det systoliske blotryk signifikant fra baseline (henholdsvis 4,7±1,1 mmHg og 3,4±1,1 mmHg), og forskellen mellem behandlingerne var ikke signifikant.
English: The tapping helps the medicine drip down along the sides of the vial.
Danish: Når du banker på hætteglasset, begynder medicinen at dryppe ned langs siden af hætteglasset.
English: Put it down for later.
Danish: Stil det til side til senere brug.
English: The powder is white to off-white and the solvent is a clear, colourless to pale yellow to pale brown solution.
Danish: Pulver: hvidt til offwhite pulver Solvens: klar, farveløs til svagt gul til svagt brun opløsning.
English: How do I dispose of my Bydureon BCise pen?
Danish: Hvordan bortskaffer jeg Bydureon BCise pen?
English: Prolonged-release exenatide resulted in a statistically significant reduction in HbA1c compared to patients receiving immediate-release exenatide (Table 2).
Danish: Depotformulering af exenatid medførte en statistisk signifikant reduktion i HbA1c sammenlignet med patienter, der fik exenatid opløsning til injektion (tabel 2).
English: Skin and subcutaneous tissue disorders Macular and papular rash
Danish: Hud og subkutane væv Makuløst og papuløst udslæt
English: Use only the supplied custom needles with the pen.
Danish: Anvend kun de vedlagte kanyler til pennen.
English: Pick up the vial connector package and peel off the paper cover.
Danish: Tag pakningen med forbindingsleddet ud og træk papirslåget af.
English: In a 26-week double-blind study prolonged-release exenatide was compared to maximum daily doses of sitagliptin and pioglitazone in subjects also using metformin.
Danish: I et 26-ugers dobbeltblindet studie blev exenatid depotformulering sammenlignet med maksimal daglig dosis af sitagliptin og pioglitazon hos patienter, der også fik metformin.
English: CARTON (PACK OF 4 SINGLE-DOSE PRE-FILLED PENS)
Danish: KARTON (pakning med 4 fyldte penne med enkeltdosis)
English: − Is a single use, fixed dose pen that automatically injects your medicine.
Danish: Bydureon BCise pennen: - Er en fast-doserende pen til engangsbrug, som automatisk indsprøjter din medicin.
English: Use a new injection needle for each injection and dispose of it safely after each use as instructed by your doctor or diabetes nurse.
Danish: Brug en ny kanyle til hver indsprøjtning og kassér kanylen sikkert efter hver brug, som din læge eller diabetessygeplejerske har fortalt dig.
English: In two studies prolonged-release exenatide 2 mg once weekly has been compared to immediate-release exenatide 5 mcg given twice daily for 4 weeks followed by immediate-release exenatide 10 mcg given twice daily.
Danish: I to studier er exenatid depotformulering 2 mg en gang ugentlig blevet sammenligned med exenatid opløsning til injektion 5 mikrog 2 gange dagligt i 4 uger efterfulgt af exenatid opløsning til injektion 10 mikrog to gange dagligt.
English: 1 pre-filled syringe of 0.65 ml solvent 1 vial connector
Danish: 1 fyldt injektionssprøjte med 0,65 ml solvens 1 forbindingsled til hætteglasset
English: • Keep the pen clean and away from spills.
Danish: • Hold pennen ren, og læg den på et rent sted.
English: If a dose is missed, it should be administered as soon as practical, provided the next regularly scheduled dose is due in 3 days or more.
Danish: Hvis en dosis glemmes, skal den tages så snart, det er muligt, hvis der er tre dage eller mere til næste planlagte dosis.
English: In a single-dose pharmacokinetic study of immediate-release exenatide in 13 patients with type 2 diabetes and between the ages of 12 and 16 years, administration of exenatide (5 mcg) resulted in slightly lower mean AUC (16% lower) and Cmax (25% lower) compared to those observed in adults.
Danish: I et farmakokinetisk enkeltdosisstudie med exenatid opløsning til injektion til 13 patienter med type 2diabetes i alderen 12 til 16 år resulterede administration af exenatid (5 mikrog) i et lettere reduceret gennemsnitligt AUC (16 % lavere) og Cmax (25 % lavere) sammenlignet med de værdier, der ses hos voksne.
English: Prolonged-release exenatide resulted in a statistically significant reduction in HbA1c compared to patients receiving immediate-release exenatide (Table 4).
Danish: Exenatid depotformulering resulterede i en statistisk signifikant reduktion i HbA1c sammenligned med patienter, der modtog exenatid opløsning til injektion (tabel 4).
English: For all patients completing the uncontrolled study extension of 7 years (n = 122 of 258 patients included in the extension phase), HbA1c gradually increased over time from week 52 onwards, but was still reduced compared to baseline after 7 years -1.5%).
Danish: Hos alle patienter, der fuldførte det ikke-kontrollerede forlængelsesstudie på 7 år (n=122 af 258 patienter, der var inkluderet i forlængelsesfasen), øgedes HbA1c gradvist over tid fra uge 52 og fremad, men var stadig reduceret i forhold til baseline efter 7 år -1,5 %).
English: Vial connector
Danish: Hætteglasforbindingsled (vial connector)
English: The patient should be instructed to discard the pen safely, with the needle still attached, after each injection.
Danish: Patienten skal instrueres i sikker bortskaffelse af pennen stadig med kanylen påsat efter hver injektion.
English: The risk of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea in clinical studies.
Danish: Kliniske studier har vist øget risiko for hypoglykæmi, når depotformulering af exenatid blev anvendt i kombination med sulfonylurea.
English: When 1,000 mg paracetamol tablets were administered, either with or without a meal, following 14 weeks of prolonged-release exenatide therapy, no significant changes in paracetamol AUC were observed compared to the control period.
Danish: Der blev ikke observeret nogen signifikante ændringer i AUC for paracetamol sammenlignet med kontrolperioden efter administration af 1000 mg paracetamol-tabletter, hverken med eller uden et måltid, efter 14 ugers behandling med depotformulering af exenatid.
English: Peel back the cover to open.
Danish: Træk låget tilbage for at åbne.
English: Analyses exclude measurements post rescue therapy and post premature discontinuation of study medication.
Danish: Analyser udelukker målinger efter redningsterapi og efter for tidlig seponering af studielægemiddel.
English: Mean difference in change from baseline versus placebo (95% CI)
Danish: Gennemsnitlig ændring fra baseline versus placebo (95 % CI)
English: Step 3: Inject your dose
Danish: Trin 3: Indsprøjt dosen
English: If a different glucose-lowering treatment is started after the discontinuation of prolonged-release exenatide, consideration should be given to the prolonged release of the medicinal product (see section
Danish: Hvis en anden glucosesænkende behandling iværksættes efter seponering af depotformulering af exenatid, skal der tages hensyn til den langsomme frigivelse af lægemidlet (se pkt.
English: Uneven mix White medicine on bottom, top, or sides
Danish: Hvide partikler på bunden, toppen, eller siderne
English: If you miss a dose and there are only 1 or 2 days until your next dose is due, skip the missed dose and take the next one as usual, on the day it is due.
Danish: Hvis du glemmer en dosis, og der kun er 1 eller 2 dage indtil næste dosis, skal du springe den glemte dosis over og tage den næste som normalt på den planlagte dag.
English: • injection site reactions
Danish: • reaktioner på indstiksstedet
English: After suspension The suspension must be injected immediately after mixing the powder and the solvent.
Danish: Efter suspension Suspensionen skal injiceres umiddelbart efter blanding af pulver og solvens.
English: Look
Danish: Se
English: Now, hold the vial so the syringe is pointing up.
Danish: Hold derefter på hætteglasset, så sprøjten peger opad.
English: Prolonged-release exenatide 2 mg QW
Danish: Exenatid depotformulering 2 mg QW
English: The pens must be stored flat.
Danish: Pennen skal opbevares liggende.
English: For all patients completing the uncontrolled study extension of 7 years (n = 122 of 258 patients included in the extension phase), HbA1c gradually increased over time from Week 52 onwards, but was still reduced compared to baseline after 7 years (-1.5%).
Danish: For alle patienter, der fuldførte den ukontrollerede forlængelse af studiet på 7 år (n=122 ud af 258 patienter i forlængelsesfasen), steg HbA1c gradvist over tid fra uge 52 og fremover, men var efter 7 år stadig nedsat i forhold til baseline (-1,5 %).
English: If you use this medicine in combination with a sulphonylurea, low blood sugar (hypoglycaemia) can occur.
Danish: Hvis du bruger dette lægemiddel i kombination med et sulfonylurea-produkt, kan der opstå for lavt blodsukker (hypoglykæmi).
English: After suspension, the delivered dose is 2 mg/0.65 ml.
Danish: Efter suspension er den afgivne dosis 2 mg/0,65 ml.
English: Twist the orange connector onto the syringe until snug.
Danish: Drej det orange forbindingsled fast på sprøjten, indtil den sidder helt tæt.
English: Other medicines and Bydureon Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly: - other medicines that are used to treat type 2 diabetes, such as medicines that work like Bydureon (for example: liraglutide or other exenatide containing products, as taking these medicines with Bydureon is not recommended.
Danish: Brug af anden medicin sammen med Bydureon Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, især: - anden medicin mod type 2-diabetes, såsom medicin, der virker ligesom Bydureon (f.eks. liraglutid eller andre produkter, der indeholder exenatid), da det frarådes at tage disse lægemidler sammen med Bydureon.
English: Background therapies included diet and exercise alone or with metformin, a sulphonylurea, a thiazolidinedione or a combination of oral glucose-lowering medicinal products.
Danish: Baggrundsbehandlinger omfattede kost og motion alene eller med metformin, et sulfonylurinstof, en thiazolidindion eller en kombination af orale glucosesænkende lægemidler.
English: in either your stomach, thigh, or back of the arm. Each week you can use the same area of your body but choose a different injection site in that area.
Danish: Du kan bruge samme område på kroppen hver uge, men vælg forskellige injektionssteder i det pågældende område.
English: Green cap
Danish: Grøn hætte
English: Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Danish: Patienter (%), der opnåede HbA1c ≤7 % Gennemsnitlig legemsvægt (kg) Baseline
English: If a different glucose-lowering treatment is started after the discontinuation of prolonged-release exenatide, consideration should be given to the prolonged release of the product (see section 5.2).
Danish: Hvis en anden glucosesænkende behandling iværksættes efter seponering af depotformulering af exenatid, skal der tages hensyn til den langsomme frigivelse af produktet (se pkt.
English: 4 single-dose pre-filled pens (BCise).
Danish: 4 fyldte penne med enkeltdosis (BCise).
English: Keep pushing on the plunger with your thumb while shaking.
Danish: Bliv ved med at trykke stemplet ned med tommelfingeren, mens du ryster.
English: QW=once weekly, QD=once daily, SE = standard error, CI= confidence interval, N=number of patients.
Danish: QW=en gang ugentlig, QD=en gang daglig, SE = standardafvigelse, CI= konfidensinterval, N=antal af patienter.
English: Injection site erythema
Danish: Erytem på injektionsstedet
English: Part of a multi-pack of 3 x (4 single dose kits).
Danish: Del af en multipakning med 3 x (4 enkeltdosissæt).
English: STEP 4: Inject the Dose
Danish: Trin 4: Indsprøjt dosis
English: Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI) Change from baseline in 2-hour postprandial plasma glucose (mmol/l) (± SE)
Danish: Ændring fra baseline (± SE) Gennemsnitlig forskel i ændring fra baseline mellem behandlingerne (95 % CI) Ændring fra baseline i 2-timers postprandial plasmaglucose (mmol/l) (± SE)
English: Table 3: Results of one 28-week study of Bydureon BCise versus sitagliptin and placebo in combination with metformin (modified intent to treat patients
Danish: Tabel 3: Resultater af et 28-ugers studie af Bydureon BCise versus sitagliptin og placebo i kombination med metformin (modificeret intent to treat-patienter
English: Insulin glargine was dosed to a target glucose concentration of 4.0 to 5.5 mmol/l (72 to 100 mg/dl).
Danish: Insulin glargin blev doseret til en target glucosekoncentration på 4,0 til 5,5 mmol/l (72 til 100 mg/dl).
English: Shake Hard
Danish: Ryst kraftigt
English: The effect on beta-cell function was sustained through 52 weeks.
Danish: Virkningen på betacelle-funktionen blev opretholdt i 52 uger.
English: Clinical experience in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min) is limited (see section 5.2).
Danish: Den kliniske erfaring med patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/min) er begrænset (se pkt.
English: When I inject, what should I do if I cannot push the plunger all the way down?
Danish: Hvad skal jeg gøre, hvis jeg ikke kan trykke stemplet helt i bund, når jeg skal indsprøjte?
English: Step 2: Mix your dose
Danish: Trin 2: Bland din dosis
English: Hold Upright
Danish: Holdes lodret
English: Properly dispose of your pen right away after use, as instructed by your doctor, pharmacist or diabetes nurse.
Danish: Rigtig bortskaffelse af pennen lige efter brug, som din læge, apotekspersonalet eller diabetessygeplejerske har fortalt dig.
English: Mean HbA1c (%)
Danish: Gennemsnitlig HbA1c (%)
English: QW = once weekly, BID = twice daily, N = number of patients per treatment group, SE = standard error, CI = confidence interval.
Danish: QW = en gang ugentlig, BID = to gange daglig, N = antal patienter i behandlingsgruppen, SE = standardafvigelse, CI = konfidensinterval.
English: After I mix the medicine, how long can I wait before taking the injection?
Danish: Hvor længe kan jeg vente med at tage indsprøjtningen, efter at medicinen er blandet?
English: You should inject this medicine immediately after mixing the powder and the solvent.
Danish: Du skal indsprøjte dette lægemiddel straks efter blanding af pulver og opløsningsmiddel.
English: Bydureon 2 mg powder for injection exenatide
Danish: Bydureon 2 mg pulver til injektion exenatid s.c.
English: Bydureon must be injected immediately after mixing.
Danish: Bydureon skal indsprøjtes umiddelbart efter blanding.
English: Prolonged-release suspension for injection
Danish: Depotinjektionsvæske, suspension
English: Acute pancreatitis (see section 4.4)
Danish: Akut pancreatitis (se pkt.
English: In clinical studies of Bydureon BCise, acute pancreatitis occurred in 0.4% of patients.
Danish: Der forekom akut pancreatitis hos 0,4% af patienterne i kliniske studier med Bydureon BCise.
English: Change in fasting serum glucose (mmol/l) (± SE)
Danish: Ændring i fastende serumglucose (mmol/l) (±SE)
English: 9 (see section
Danish: 9 (se pkt.
English: Keep pushing on the plunger with your thumb to keep the plunger in place.
Danish: Bliv ved med at trykke på stemplet med tommelfingeren for at holde det på plads.
English: Ask your pharmacist how to safely throw it away.
Danish: Spørg dit apotek, hvordan du sikkert bortskaffer den. Smid ikke beholderen i husholdningsaffaldet.
English: Insert the needle into your skin (subcutaneously).
Danish: Stik kanylen ind i huden (subkutant).
English: If you forget to use Bydureon You might like to choose a day that you always plan to make your Bydureon injection.
Danish: Det er en god idé at vælge en bestemt ugedag, hvor du altid giver dig selv indsprøjtningen med Bydureon.
English: The concurrent use of prolonged-release and immediate-release exenatide has not been studied and is not recommended.
Danish: Samtidig anvendelse af depotformulering af exenatid og exenatid opløsning til injektion er ikke undersøgt og anbefales ikke.
English: Both Bydureon BCise and immediate-release exenatide patients achieved a reduction in weight at Week 28 compared to baseline (Table 2).
Danish: Både de patienter, som fik Bydureon BCise og exenatid opløsning til injektion opnåede en vægtreduktion ved uge 28 sammenlignet med baseline (tabel 2).
English: Hold the vial connector package.
Danish: Hold på pakningen med forbindingsleddet.
English: Multi-pack of 3 x (4 single dose kits).
Danish: Multipakning med 3 x (4 enkeltdosissæt).
English: In a pharmacokinetic study of immediate-release exenatide in patients with type 2 diabetes, administration of exenatide (10 mcg) resulted in a mean increase of exenatide AUC by 36% in 15 elderly subjects aged 75 to 85 years compared to 15 subjects aged 45 to 65 years likely related to reduced renal function in the older age group (see section 4.2).
Danish: I et farmakokinetisk studie med exenatid opløsning til injektion til patienter med type 2-diabetes resulterede administration af exenatid (10 mikrog) i en gennemsnitlig stigning i AUC for exenatid på 36 % hos 15 ældre forsøgsdeltagere i alderen 75-85 år sammenlignet med 15 forsøgsdeltagere i alderen 45-65 år.
English: • has a lid,
Danish: • har et låg
English: C. Remove the needle cover,
Danish: C. Fjern kanylehætten,
English: While holding the pen upright with the needle cover uppermost, slowly turn the knob anticlockwise.
Danish: Mens du holder pennen lodret med kanylehætten øverst, skal du dreje håndtaget langsomt mod uret.
English: The prolonged-release exenatide and dapagliflozin treatment group showed superior reductions in HbA1c from baseline compared to prolonged-release exenatide alone and dapagliflozin alone (Table 5).
Danish: Gruppen behandlet med depotformulering af exenatid og dapagliflozin udviste superioritet for reduktion af HbA1c fra baseline sammenlignet med depotformulering af exenatid alene og dapagliflozin alene (tabel 5).
English: If you get any side effects, talk to your doctor, pharmacist or diabetes nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Remove the needle and replace it with the spare needle from your kit.
Danish: Tag kanylen ud og brug i stedet reservekanylen fra sættet.
English: • hypoglycaemia (low blood sugar) when this medicine is used with a medicine that does not contain a sulphonylurea
Danish: • hypoglykæmi (lavt blodsukker) når det tages med medicin som ikke indeholder sulfonylurinstof
English: Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or < 7 % in the two studies (p <0.05 and p ≤0.0001, respectively).
Danish: Der var klinisk og statistisk signifikant flere patienter på depotformulering af exenatid end på exenatid opløsning til injektion, som opnåede et fald i HbA1c på ≤ 7 % eller < 7 % i de to studier (henholdsvis p < 0,05 og p ≤ 0,0001).
English: See Description of selected adverse reactions section, below.
Danish: Se nedenstående beskrivelse af udvalgte bivirkninger.
English: DO NOT use a pen past its expiration date.
Danish: Brug IKKE en pen, der har overskredet holdbarhedsdatoen.
English: Patients switching from immediate-release exenatide (Byetta) to prolonged-release exenatide (Bydureon or Bydureon BCise) may experience transient elevations in blood glucose concentrations, which generally improve within the first four weeks after initiation of therapy.
Danish: Patienter, der skifter fra exenatid opløsning til injektion (Byetta) til depotformulering af exenatid (Bydureon eller Bydureon BCise), kan opleve forbigående øgning i koncentrationen af blodglucose, hvilket generelt bedres inden for de første fire uger efter opstart af behandlingen.
English: In the placebo-controlled study with insulin glargine, the change from baseline to Week 28 in fasting plasma glucose was -0.7 mmol/l for the prolonged-release exenatide group and -0.1 mmol/l for the placebo group.
Danish: I det placebokontrollerede studie med insulin glargin var ændringen fra baseline til uge 28 i fastende plasmaglucose -0,7 mmol/l for gruppen med depotformulering af exenatid og -0,1 mmol/l for placebogruppen.
English: Both Bydureon BCise and sitagliptin patients achieved a reduction in weight at Week 28 compared to baseline (Table 3).
Danish: Patienter, som fik Bydureon BCise, og patienter, som fik sitagliptin, opnåede en reduktion af vægten ved uge 28 sammenlignet med baseline (tabel 3).
English: Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly (may affect up to 1 in 100 people ) in patients receiving this medicine.
Danish: Tilfælde af betændelse i bugspytkirtlen (pancreatitis) er indberettet for patienter, der fik dette lægemiddel med hyppigheden ikke almindelig (kan forekomme hos op til 1 bruger ud af 100).
English: Check with your doctor, pharmacist, or diabetes nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller diabetessygeplejersken, hvis der er noget, du er i tvivl om.
English: Just like you might break a stick, you are breaking off the cap.
Danish: Bræk hætten af på samme måde, som hvis du ville knække en gren.
English: What Bydureon contains - The active substance is exenatide.
Danish: Bydureon indeholder: - Aktivt stof: exenatid.
English: - a medicine that contains a sulphonylurea, as low blood sugar (hypoglycaemia) can occur when combined with Bydureon.
Danish: - et lægemiddel, der indeholder en sulfonylurinstof, da lavt blodsukker (hypoglykæmi) kan opstå, når det kombineres med Bydureon.
English: The concurrent use of a formulation of prolonged-release and immediate-release exenatide has not been studied and is not recommended.
Danish: Samtidig anvendelse af depotformulering og opløsning til injektion af exenatid er ikke undersøgt og anbefales ikke.
English: • Refer to the Common questions and answers
Danish: • Læs Almindelige spørgsmål og svar
English: Prepare to safely dispose of used needles and syringes.
Danish: Gør klar til at kassere brugte kanyler og sprøjter på en forsvarlig måde.
English: Insulin glargine was dosed targeting a fasting plasma glucose of 4.0 to 5.5 mmol/l (72 to 99 mg/dl).
Danish: Insulin glargin blev doseret rettet mod en fastende plasmaglucose på 4,0 til 5,5 mmol/l (72 til 99 mg/dl).