FrancophonIA/ELRC3.0 huggingface dataset:
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 7).
Danish: Gruppen, der blev behandlet med exenatid depotformulering og dapagliflozin, viste overlegen reduktion i HbA1c fra baseline sammenlignet med exenatid depotformulering alene og dapagliflozin alene (tabel 7).
English: Each pre-filled pen delivers 2 mg of exenatide in a volume of 0.85 ml.
Danish: Hver fyldt pen giver 2 mg exenatid i et volumen på 0,85 ml.
English: If pancreatitis is suspected, prolonged-release exenatide should be discontinued; if acute pancreatitis is confirmed, prolonged-release exenatide should not be restarted.
Danish: Hvis akut pancreatitis bliver bekræftet, må behandlingen med depotformulering af exenatid ikke genoptages.
English: When this medicine is used with a medicine that contains a sulphonylurea, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur.
Danish: Hvis dette lægemiddel bruges samtidig med medicin, som indeholder et sulfonylurea, kan der opstå episoder med lavt blodsukker (hypoglykæmi, som oftest er let til moderat).
English: In the placebo-controlled study with insulin glargine, the change from baseline to Week 28 in systolic blood pressure was -2.6 mmHg for the prolonged-release exenatide group and -0.7 mmHg for the placebo group.
Danish: I det placebokontrollerede studie med insulin glargin var ændringen fra baseline til uge 28 i systolisk blodtryk -2,6 mmHg for gruppen med depotformulering af exenatid og -0,7 mmHg for placebogruppen.
English: Bydureon must be injected immediately after mixing and preparation.
Danish: Bydureon skal indsprøjtes umiddelbart efter blanding og klargøring.
English: Slowly push
Danish: Tryk langsomt
English: Be sure to choose a different injection site in that area.
Danish: Du skal sørge for at vælge et andet sted til indsprøjtningen i området.
English: Vehicle Medium chain triglycerides
Danish: Vehikel Triglycerider, middelkædelængde
English: QW = once weekly, QD = once daily, N = number of patients per treatment group, SE = standard error, CI = confidence interval.
Danish: QW = en gang ugentlig, QD = en gang daglig, N = antal patienter i behandlingsgruppen, SE = standardafvigelse, CI = konfidensinterval.
English: The combination of prolonged-release exenatide and dapagliflozin demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 7).
Danish: Kombinationen af exenatid depotformulering og dapagliflozin viste signifikant større vægtreduktion sammenlignet med de individuelle lægemidler alene (tabel 7).
English: D. Peel off the paper tab,
Danish: D. Træk papirfligen,
English: E. Properly dispose of your pen,
Danish: E. Kasser pennen korrekt,
English: DO NOT remove the needle cover yet.
Danish: Tag ikke kanylehætten af endnu.
English: Patients switching from immediate-release (Byetta) to prolonged-release (Bydureon or Bydureon BCise) exenatide may experience transient elevations in blood glucose concentrations, which generally improve within the first two 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 to uger efter opstart af behandlingen.
English: Prolonged-release exenatide should not be used during breast-feeding.
Danish: Depotformulering af exenatid må ikke anvendes under amning.
English: For instructions on the preparation of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.
Danish: For instruktioner om tilberedning af lægemidlet før administration, se pkt.
English: Rare side effects • feeling jittery
Danish: Sjældne bivirkninger • nervøsitet
English: What Bydureon BCise pen contains - The active substance is exenatide.
Danish: Bydureon BCise pen indeholder: - Aktivt stof: exenatid.
English: The combination of prolonged-release exenatide and dapagliflozin demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 5).
Danish: Kombinationen af depotformulering af exenatid og dapagliflozin gav signifikant større vægttab end lægemidlerne hver for sig (tabel 5).
English: Prolonged-release exenatide must be injected immediately after suspension of the powder in the solvent.
Danish: Depotformulering af exenatid skal injiceres umiddelbart efter suspension af pulveret i solvensen.
English: The dose of a sulphonylurea may require adjustment due to the increased risk of hypoglycaemia associated with sulphonylurea therapy (see sections 4.2 and 4.4).
Danish: Det kan være nødvendigt at justere dosis af sulfonylurinstof på grund af øget risiko for hypoglykæmi relateret til sulfonylurinstof-behandlingen (se pkt.
English: If pancreatitis is suspected, the use of this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Danish: Hvis akut pancreatitis bliver bekræftet, må behandlingen ikke genoptages.
English: • Store flat in the refrigerator between 2°C to 8°C.
Danish: • Opbevares liggende i køleskab mellem 2°C og 8°C.
English: Do not remove the needle cover yet.
Danish: Fjern IKKE kanylehætten endnu.
English: Gently tap the vial with the other hand.
Danish: Bank forsigtigt på hætteglasset med den anden hånd.
English: Patients (%) achieving HbA1c 7%
Danish: Patienter (%), der opnåede HbA1c  7 % 45
English: Renal and urinary disorders Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine (see section
Danish: Ændret nyrefunktion, herunder akut nyresvigt, forværret kronisk nyresvigt, nedsat nyrefunktion, øget serumkreatinin (se pkt.
English: Shake vigorously again until well mixed.
Danish: Ryst kraftigt igen, indtil det er blandet godt nok.
English: Remember: You must take your injection of Bydureon immediately after mixing it.
Danish: Husk at du skal tage Bydureon-indsprøjtningen straks efter blanding.
English: Each single-dose kit contains one vial of 2 mg exenatide, one pre-filled syringe of 0.65 ml solvent, one vial connector, and two injection needles (one spare).
Danish: Hvert enkeltdosissæt indeholder ét hætteglas med 2 mg exenatid, én fyldt injektionssprøjte med 0,65 ml solvens, ét forbindingsled til hætteglasset og to injektionskanyler (hvoraf den ene er en reservekanyle).
English: Most adverse reactions were mild to moderate in intensity.
Danish: De fleste bivirkninger var lette til moderate i styrke.
English: Clinical studies with prolonged-release exenatide formulations have indicated improved beta-cell function, using measures such as the homeostasis model assessments (HOMA-B).
Danish: Kliniske studier med exenatid depotformuleringer har ved brug af Homeostasis Model Assessment (HOMA-B) indikeret forbedret beta-cellefunktion.Virkningen på beta-cellefunktionen var vedvarende gennem 52 uger.
English: Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI) Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Danish: Ændring fra baseline (±SE) Gennemsnitlig ændring fra baseline mellem behandlingerne (95% CI) Patienter (%), der opnåede HbA1c < 7 % Gennemsnitlig legemsvægt (kg) Baseline
English: - If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller diabetessygeplejersken.
English: Bydureon BCise demonstrated superiority to both sitagliptin and placebo in reducing HbA1c from baseline to Week 28 (Table 3).
Danish: Bydureon BCise viste superioritet overfor både sitagliptin og placebo til reduktion af HbA1c fra baseline til uge 28 (tabel 3).
English: When added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Ved tilføjelse til behandling med sulfonylurea, bør det overvejes at nedsætte sulfonylureadosis for at reducere risikoen for hypoglykæmi (se pkt.
English: • Talk with your doctor, pharmacist or diabetes nurse • Read the Package Leaflet carefully
Danish: • Spørg din læge, apotekspersonalet eller diabetessygeplejersken • Læs indlægssedlen grundigt
English: If you stop using this medicine this can affect your blood sugar levels.
Danish: Det kan påvirke dit blodsukkerniveau, hvis du holder op med at bruge dette lægemiddel.
English: Mixing window
Danish: Blandingsvindue
English: The expiration date is labelled EXP.
Danish: Den står på pakningen efter EXP.
English: You must take your injection of Bydureon immediately after mixing it.
Danish: Du skal tage din indsprøjtning med Bydureon straks efter blanding.
English: • intestinal obstruction (blockage in intestine)
Danish: • forstoppelse i tarmen (tarmobstruktion)
English: • hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea.
Danish: • hypoglykæmi (lavt blodsukker) ved indtagelse sammen med et lægemiddel, der indeholder et sulfonylurinstof
English: Both treatment groups had a reduction in HbA1c compared to baseline.
Danish: Begge behandlingsgrupper havde en reduktion i HbA1c sammenligned med baseline.
English: Fifteen percent of prolonged-release exenatide treated patients had mean increases in HR of ≥ 10 bpm; approximately 5% to 10% of subjects within the other treatment groups had mean increases in HR of ≥ 10 bpm.
Danish: Cirka 5 % -10 % af forsøgspersonerne i de andre behandlingsgrupper havde en gennemsnitlig øgning af HR på ≥ 10 bpm.
English: Table 2: Results of one 28-week study of Bydureon BCise versus immediate-release exenatide with diet and exercise alone or with a stable regimen of oral glucose-lowering medicinal products (modified intent to treat patients
Danish: Tabel 2: Resultater af et 28-ugers studie med Bydureon BCise versus exenatid opløsning til injektion i kombination med diæt og motion alene eller med et stabilt regime af orale glukosenedsættende midler (intent to treat-patienter
English: You must inject your dose right after mixing it.
Danish: Du skal indsprøjte dosen med det samme, når du har blandet den.
English: Dispose of the syringe with the needle still attached as instructed by your doctor or diabetes nurse.
Danish: Kassér sprøjten, mens kanylen endnu er påsat, som din læge eller diabetessygeplejerske har fortalt dig.
English: Remove 1 pen from the refrigerator and rest it flat for 15 minutes.
Danish: Tag en pen ud af køleskabet og lad den ligge vandret i 15 minutter.
English: Pull the plunger down beyond the black dashed Dose Line.
Danish: Træk stemplet tilbage forbi den sorte stiplede doseringslinje.
English: Prolonged-release exenatide was superior to placebo in reducing body weight at Week 28 (Table 8).
Danish: Exenatid depotformulering var overlegen overfor placebo i reduktion af legemsvægt ved uge 28 (tabel 8).
English: With the other hand, twist the orange connector to remove.
Danish: Drej det orange forbindingsled med den anden hånd for at fjerne forbindingsleddet.
English: Review how to attach the needle.
Danish: Læs igen, hvordan man sætter kanylen på.
English: How to use Bydureon
Danish: Sådan skal du bruge Bydureon
English: Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.
Danish: Det er især vigtigt, hvis du også bruger et sulfonylurea-produkt.
English: Prolonged-release exenatide must be injected subcutaneously immediately after mixing of the powder and the solvent.
Danish: Depotformulering af exenatid skal injiceres subkutant umiddelbart efter blanding af pulver og solvens.
English: In a 28-week, double-blind study, the combination of prolonged-release exenatide and dapagliflozin was compared to prolonged-release exenatide alone and dapagliflozin alone in subjects also using metformin.
Danish: I et 28-ugers dobbeltblindet studie blev kombinationen af depotformulering af exenatid og dapagliflozin sammenlignet med henholdsvis depotformulering af exenatid alene og dapagliflozin alene hos forsøgsdeltagere, som også fik metformin.
English: You should dispose of the pen safely after each use, as instructed by your doctor or diabetes nurse.
Danish: Du skal kassere pennen sikkert efter hver injektion, som anvist af lægen eller diabetessygeplejersken.
English: Each single-dose kit consists of one vial containing 2 mg exenatide powder, one pre-filled syringe containing 0.65 ml solvent, one vial connector, and two injection needles.
Danish: Hvert enkeltdosissæt indeholder ét hætteglas med 2 mg exenatidpulver, én fyldt injektionssprøjte med 0,65 ml solvens, ét forbindelsesled til hætteglasset og to kanyler.
English: Injection site reactions were observed more frequently in prolonged-release exenatide treated patients versus comparator-treated patients (16% versus range of 2-7%) during the 6-month controlled phase of studies.
Danish: I de kliniske studiers kontrolfase på 6 måneder blev der oftere observeret reaktioner på injektionsstedet hos de patienter, der blev behandlet med depotformulering af exenatid, end hos de patienter, som blev behandlet med komparator (16 % vs. 2-7 %).
English: 1 vial of 2 mg exenatide
Danish: 1 hætteglas med 2 mg exenatid
English: Prolonged-release suspension for injection Multipack: 12 (3 packs of 4) single-dose pre-filled pens (BCise) BCise
Danish: Multipakning: 12 (3 pakninger a 4) fyldte penne med enkeltdosis (BCise) BCise
English: In a proportion of these the glycaemic response to prolonged-release exenatide was absent at the end of the controlled period of studies; 2.6% of patients showed no glucose improvement with higher titre antibodies whereas 1.6% showed no improvement while antibody negative.
Danish: Manglende forbedring af blodglucose blev observeret hos 2,6 % af patienterne med højere antistoftitre og hos 1,6 % af patienterne, som var antistof-negative.
English: This medicine is available in pack sizes of 4 single-dose kits and 3 packs of 4 single-dose kits.
Danish: Produktet fås i pakningsstørrelser med 4 enkeltdosissæt og pakninger med 3 gange 4 enkeltdosissæt.
English: Animal studies with exenatide did not indicate harmful effects with respect to fertility; high doses of exenatide caused skeletal effects and reduced foetal and neonatal growth.
Danish: Høje exenatiddoser påvirkede skelettet og medførte nedsat fostervækst og neonatal vækst.
English: If you miss a dose and there are 3 days or more until your next dose is due, then take the missed dose as soon as it is possible to do so. For your next injection you can return to your chosen injection day.
Danish: Hvis du glemmer en dosis, og der er 3 dage eller mere indtil næste dosis, skal du tage den glemte dosis så snart, det er muligt.
English: In the uncontrolled study extension, evaluable patients who switched from immediate release to prolonged-release exenatide at Week 30 (n = 121), achieved the same improvement in HbA1c of -2.0% at Week 52 compared to baseline as patients treated with prolonged-release exenatide.
Danish: I den ukontrollerede studieforlængelse opnåede de evaluerbare patienter, der skiftede fra exenatid opløsning til injektion til depotformulering af exenatid i uge 30 (n=121), den samme forbedring i HbA1c på -2,0 % i uge 52 sammenlignet med baseline som patienter, der blev behandlet med depotformulering af exenatid.
English: To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered.
Danish: I forbindelse med anvendelsen af sulfonylurea bør nedsættelse af sulfonylureadosis overvejes for at reducere risikoen for hypoglykæmi.
English: Prolonged-release exenatide 2 mg
Danish: Depotformulering af exenatid 2 mg
English: How to use Bydureon pre-filled pen
Danish: Sådan bruger du Bydureon fyldt pen
English: SN: NN:
Danish: PC: SN:
English: Mean difference in change from baseline versus sitagliptin (95% CI)
Danish: Gennemsnitlig ændring fra baseline versus sitagliptin (95 % CI)
English: Remove one pen from the refrigerator and let it stand at room temperature for at least 15 minutes.
Danish: Tag en pen ud af køleskabet og lad den stå ved stuetemperatur i mindst 15 minutter.
English: Prolonged-release exenatide was superior to placebo in reducing body weight at Week 28 (Table 6).
Danish: Depotformulering af exenatid var bedre end placebo til at reducere legemsvægten ved uge 28 (tabel 6).
English: All treatment groups had a significant reduction in HbA1c compared to baseline.
Danish: Alle behandlingsgrupper havde en signifikant reduktion i HbA1c sammenlignet med baseline.
English: In the prolonged-release exenatide clinical studies, background therapies included diet and exercise, metformin, a sulphonylurea, a thiazolidinedione, a combination of oral glucose-lowering medicinal products or a basal insulin.
Danish: Baggrundsbehandlingen i de kliniske studier med depotformulering af exenatid bestod af diæt og motion, metformin, et sulfonylurea-præparat, et thiazolidindion-præparat, en kombination af orale glucosesænkende lægemidler eller en basal insulin.
English: After mixing the liquid with the powder, use the suspension only if the mixture is white to off white and cloudy.
Danish: Efter blanding af pulver og opløsningsmiddel må suspensionen kun bruges, hvis blandingen er hvid til offwhite og uklar.
English: Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller diabetessygeplejerskens anvisning.
English: As blood glucose concentrations decrease, insulin secretion subsides.
Danish: Udskillelsen af insulin aftager, efterhånden som blodglucosekoncentrationen falder.
English: Immediaterelease exenatide 10 mcg twice daily
Danish: Exenatid opløsning til injektion 10 mikrog to gange daglig
English: Table 4: Results of two studies of prolonged-release versus immediate-release exenatide in combination with diet and exercise alone, metformin and/or sulphonylurea and metformin and/or thiazolidinedione (intent to treat patients)
Danish: Tabel 4: Resultater af to studier med exenatid depotformulering versus opløsning til injektion i kombination med diæt og motion alene, metformin og/eller sulfonylurinstof og metformin og/eller thiazolidindion (intent to treat-patienter)
English: Change from baseline in 2-hour postprandial plasma glucose (mmol/l) (± SE)
Danish: Gennemsnitlig ændring fra baseline i 2timers postprandial serumglucose (mmol/l) (± SE)
English: Table 2: Results of two studies of prolonged-release versus immediate-release exenatide in combination with diet and exercise alone, metformin and/or sulphonylurea and metformin and/or thiazolidinedione (intent to treat patients)
Danish: Tabel 2: Resultater af to studier med depotformulering af exenatid versus exenatid opløsning til injektion i kombination med diæt og motion alene, metformin og/eller sulfonylurea og metformin og/eller thiazolidindion (intent to treat-patienter)
English: Paper cover
Danish: Papirslåg
English: Each pre-filled pen delivers a dose of 2 mg of exenatide in 0.85 ml.
Danish: Hver fyldt pen afgiver en dosis exenatid på 2 mg/0,85 ml.
English: Green shield pops up
Danish: Grønt skjold skyder op
English: • pain in the stomach area
Danish: • luft i maven (luftafgang fra tarmen)
English: What Bydureon is and what it is used for What you need to know before you use Bydureon How to use Bydureon
Danish: Det skal du vide, før du begynder at tage Bydureon Sådan skal du bruge Bydureon Bivirkninger
English: INSTRUCTIONS FOR THE USER
Danish: BRUGERVEJLEDNING
English: • Store in a refrigerator (2°C to 8°C).
Danish: • Opbevares liggende i køleskab (2 °C til 8 °C).
English: In clinical studies of prolonged-release exenatide, acute pancreatitis occurred in 0.3% of patients.
Danish: Der forekom akut pancreatitis hos 0,3% af patienterne i kliniske studier med depotformulering af exenatid.
English: Pick up the syringe.
Danish: Tag hætteglasset op.
English: Prolonged-release exenatide
Danish: Exenatid i depotformulering
English: All treatment groups had a reduction in HbA1c compared to baseline.
Danish: Alle behandlingsgrupper havde en reduktion i HbA1c sammenlignet med baseline.
English: Prolongedrelease exenatide 2 mg
Danish: Exenatid depotformulering 2 mg
English: Mean difference in change from baseline between combination and single active medicinal product (95% CI)
Danish: Gennemsnitlig ændring fra baseline mellem kombination og ét aktivt lægemiddel (95 %
English: Prolonged-release exenatide demonstrated superiority to placebo in reducing HbA1c from baseline to Week 28 (Table 8).
Danish: Exenatid depotformulering viste superioritet overfor placebo i reduktion af HbA1c fra baseline til uge 28 (tabel 8).
English: Prolonged-release exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
Danish: Depotformulering af exenatid anbefales ikke til patienter med terminal nyresygdom eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) (se pkt.
English: Adjusted LS means and treatment group difference(s) in the change from baseline values at Week 28 are modeled using a mixed model with repeated measures (MMRM) including treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), baseline SU-use stratum (yes vs. no), week, and treatment by week interaction as fixed factors, and baseline value as a covariate.
Danish: Justeret LS means og behandlingsgruppeforskelle(ne) for ændringen fra baselineværdier i uge 28 er modelleret med en MMRM-metode (mixed model repeated measures), som inkluderer behandling, region, baseline HbA1c stratum (<9,0 % eller ≥9,0 %), baseline SU-behandling stratum (ja vs. nej), uge og behandlingens ugentlige interaktion som faste faktorer og baselineværdi som kovariat.
English: Solvent: clear, colourless to pale yellow to pale brown solution.
Danish: Opløsningsmidlet er en klar, farveløs til svagt gul til svagt brun opløsning.
English: It is normal for air bubbles to be in the syringe.
Danish: Det er normalt, at der er luftbobler i sprøjten.
English: Bydureon BCise demonstrated superiority to immediate-release exenatide in reducing HbA1c from baseline to Week 28 (Table 2).
Danish: Bydureon BCise viste overlegenhed i forhold til exenatid opløsning til injektion til reduktion af HbA1c fra baseline til uge 28 (tabel 2).
English: A reduction in systolic blood pressure was observed in the 4 comparator-controlled prolonged-release exenatide studies (2.9 mmHg to 4.7 mmHg).
Danish: De 4 komparatorkontrollerede studier med depotformulering af exenatid har vist et fald i det systoliske blodtryk (2,9 - 4,7 mmHg).
English: Table 4: Results of one 26-week study of prolonged-release exenatide versus sitagliptin and versus pioglitazone in combination with metformin (intent to treat patients)
Danish: Tabel 4: Resultater af et 26-ugers studie med depotformulering af exenatid versus sitagliptin og versus pioglitazon i kombination med metformin (intent to treat-patienter)
English: Twist the needle onto the syringe until snug.
Danish: Drej kanylen fast på sprøjten, indtil den sidder helt tæt.
English: Mean difference change from baseline between treatments (95% CI) versus pioglitazone
Danish: Gennemsnitlig ændring fra baseline mellem behandlinger (95 % CI) versus pioglitazon
English: Table 6: Results of one 26-week study of prolonged-release exenatide versus sitagliptin and versus pioglitazone in combination with metformin (intent to treat patients)
Danish: Tabel 6: Resultat af et 26-ugers studie med exenatid depotformulering versus sitagliptin og versus pioglitazon i kombination med metformin (intent to treat-patienter)
English: Each pre-filled pen contains 2 mg exenatide.
Danish: Hvert fyldt pen indeholder 2 mg exenatid.
English: Mean difference in change from baseline between combination and single active medicinal product (95%CI)
Danish: Gennemsnitlig ændring fra baseline mellem kombinationen og hver enkelt aktivt lægemiddel (95 % CI)
English: • The pen may be kept for up to 4 weeks below 30°C prior to use.
Danish: • Pennen kan opbevares i op til 4 uger ved temperaturer under 30 ºC før brug.
English: Orange Cap
Danish: Orange hætte