natgillin/translations-raw huggingface dataset:
Bydureon skal indsprøjtes umiddelbart efter blanding og klargøring.
Bydureon must be injected immediately after mixing and preparation.
Tryk langsomt
Slowly push
Du skal sørge for at vælge et andet sted til indsprøjtningen i området.
Be sure to choose a different injection site in that area.
Vehikel Triglycerider, middelkædelængde
Vehicle Medium chain triglycerides
QW = en gang ugentlig, QD = en gang daglig, N = antal patienter i behandlingsgruppen, SE = standardafvigelse, CI = konfidensinterval.
QW = once weekly, QD = once daily, N = number of patients per treatment group, SE = standard error, CI = confidence interval.
Kombinationen af exenatid depotformulering og dapagliflozin viste signifikant større vægtreduktion sammenlignet med de individuelle lægemidler alene (tabel 7).
The combination of prolonged-release exenatide and dapagliflozin demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 7).
D. Træk papirfligen,
D. Peel off the paper tab,
E. Kasser pennen korrekt,
E. Properly dispose of your pen,
Tag ikke kanylehætten af endnu.
DO NOT remove the needle cover yet.
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.
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.
Depotformulering af exenatid må ikke anvendes under amning.
Prolonged-release exenatide should not be used during breast-feeding.
For instruktioner om tilberedning af lægemidlet før administration, se pkt.
For instructions on the preparation of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.
Sjældne bivirkninger • nervøsitet
Rare side effects • feeling jittery
Bydureon BCise pen indeholder: - Aktivt stof: exenatid.
What Bydureon BCise pen contains - The active substance is exenatide.
Kombinationen af depotformulering af exenatid og dapagliflozin gav signifikant større vægttab end lægemidlerne hver for sig (tabel 5).
The combination of prolonged-release exenatide and dapagliflozin demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 5).
Depotformulering af exenatid skal injiceres umiddelbart efter suspension af pulveret i solvensen.
Prolonged-release exenatide must be injected immediately after suspension of the powder in the solvent.
Det kan være nødvendigt at justere dosis af sulfonylurinstof på grund af øget risiko for hypoglykæmi relateret til sulfonylurinstof-behandlingen (se pkt.
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).
Hvis akut pancreatitis bliver bekræftet, må behandlingen ikke genoptages.
If pancreatitis is suspected, the use of this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
• Opbevares liggende i køleskab mellem 2°C og 8°C.
• Store flat in the refrigerator between 2°C to 8°C.
Fjern IKKE kanylehætten endnu.
Do not remove the needle cover yet.
Bank forsigtigt på hætteglasset med den anden hånd.
Gently tap the vial with the other hand.
Patienter (%), der opnåede HbA1c  7 % 45
Patients (%) achieving HbA1c 7%
Ændret nyrefunktion, herunder akut nyresvigt, forværret kronisk nyresvigt, nedsat nyrefunktion, øget serumkreatinin (se pkt.
Renal and urinary disorders Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine (see section
Ryst kraftigt igen, indtil det er blandet godt nok.
Shake vigorously again until well mixed.
Husk at du skal tage Bydureon-indsprøjtningen straks efter blanding.
Remember: You must take your injection of Bydureon immediately after mixing it.
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).
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).
De fleste bivirkninger var lette til moderate i styrke.
Most adverse reactions were mild to moderate in intensity.
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.
Clinical studies with prolonged-release exenatide formulations have indicated improved beta-cell function, using measures such as the homeostasis model assessments (HOMA-B).
Ændring fra baseline (±SE) Gennemsnitlig ændring fra baseline mellem behandlingerne (95% CI) Patienter (%), der opnåede HbA1c < 7 % Gennemsnitlig legemsvægt (kg) Baseline
Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI) Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Er du i tvivl, så spørg lægen, apotekspersonalet eller diabetessygeplejersken.
- If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
Bydureon BCise viste superioritet overfor både sitagliptin og placebo til reduktion af HbA1c fra baseline til uge 28 (tabel 3).
Bydureon BCise demonstrated superiority to both sitagliptin and placebo in reducing HbA1c from baseline to Week 28 (Table 3).
Ved tilføjelse til behandling med sulfonylurea, bør det overvejes at nedsætte sulfonylureadosis for at reducere risikoen for hypoglykæmi (se pkt.
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).
• Spørg din læge, apotekspersonalet eller diabetessygeplejersken • Læs indlægssedlen grundigt
• Talk with your doctor, pharmacist or diabetes nurse • Read the Package Leaflet carefully
Det kan påvirke dit blodsukkerniveau, hvis du holder op med at bruge dette lægemiddel.
If you stop using this medicine this can affect your blood sugar levels.
Blandingsvindue
Mixing window
Den står på pakningen efter EXP.
The expiration date is labelled EXP.
Du skal tage din indsprøjtning med Bydureon straks efter blanding.
You must take your injection of Bydureon immediately after mixing it.
• forstoppelse i tarmen (tarmobstruktion)
• intestinal obstruction (blockage in intestine)
• hypoglykæmi (lavt blodsukker) ved indtagelse sammen med et lægemiddel, der indeholder et sulfonylurinstof
• hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea.
Begge behandlingsgrupper havde en reduktion i HbA1c sammenligned med baseline.
Both treatment groups had a reduction in HbA1c compared to baseline.
Cirka 5 % -10 % af forsøgspersonerne i de andre behandlingsgrupper havde en gennemsnitlig øgning af HR på ≥ 10 bpm.
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.
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
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
Du skal indsprøjte dosen med det samme, når du har blandet den.
You must inject your dose right after mixing it.
Kassér sprøjten, mens kanylen endnu er påsat, som din læge eller diabetessygeplejerske har fortalt dig.
Dispose of the syringe with the needle still attached as instructed by your doctor or diabetes nurse.
Tag en pen ud af køleskabet og lad den ligge vandret i 15 minutter.
Remove 1 pen from the refrigerator and rest it flat for 15 minutes.
Træk stemplet tilbage forbi den sorte stiplede doseringslinje.
Pull the plunger down beyond the black dashed Dose Line.
Exenatid depotformulering var overlegen overfor placebo i reduktion af legemsvægt ved uge 28 (tabel 8).
Prolonged-release exenatide was superior to placebo in reducing body weight at Week 28 (Table 8).
Drej det orange forbindingsled med den anden hånd for at fjerne forbindingsleddet.
With the other hand, twist the orange connector to remove.
Læs igen, hvordan man sætter kanylen på.
Review how to attach the needle.
Sådan skal du bruge Bydureon
How to use Bydureon
Det er især vigtigt, hvis du også bruger et sulfonylurea-produkt.
Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.
Depotformulering af exenatid skal injiceres subkutant umiddelbart efter blanding af pulver og solvens.
Prolonged-release exenatide must be injected subcutaneously immediately after mixing of the powder and the solvent.
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.
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.
Du skal kassere pennen sikkert efter hver injektion, som anvist af lægen eller diabetessygeplejersken.
You should dispose of the pen safely after each use, as instructed by your doctor or diabetes nurse.
Hvert enkeltdosissæt indeholder ét hætteglas med 2 mg exenatidpulver, én fyldt injektionssprøjte med 0,65 ml solvens, ét forbindelsesled til hætteglasset og to kanyler.
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.
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 %).
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.
1 hætteglas med 2 mg exenatid
1 vial of 2 mg exenatide
Multipakning: 12 (3 pakninger a 4) fyldte penne med enkeltdosis (BCise) BCise
Prolonged-release suspension for injection Multipack: 12 (3 packs of 4) single-dose pre-filled pens (BCise) BCise
Manglende forbedring af blodglucose blev observeret hos 2,6 % af patienterne med højere antistoftitre og hos 1,6 % af patienterne, som var antistof-negative.
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.
Produktet fås i pakningsstørrelser med 4 enkeltdosissæt og pakninger med 3 gange 4 enkeltdosissæt.
This medicine is available in pack sizes of 4 single-dose kits and 3 packs of 4 single-dose kits.
Høje exenatiddoser påvirkede skelettet og medførte nedsat fostervækst og neonatal vækst.
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.
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.
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.
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.
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.
I forbindelse med anvendelsen af sulfonylurea bør nedsættelse af sulfonylureadosis overvejes for at reducere risikoen for hypoglykæmi.
To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered.
Depotformulering af exenatid 2 mg
Prolonged-release exenatide 2 mg
Sådan bruger du Bydureon fyldt pen
How to use Bydureon pre-filled pen
Gennemsnitlig ændring fra baseline versus sitagliptin (95 % CI)
Mean difference in change from baseline versus sitagliptin (95% CI)
Tag en pen ud af køleskabet og lad den stå ved stuetemperatur i mindst 15 minutter.
Remove one pen from the refrigerator and let it stand at room temperature for at least 15 minutes.
Depotformulering af exenatid var bedre end placebo til at reducere legemsvægten ved uge 28 (tabel 6).
Prolonged-release exenatide was superior to placebo in reducing body weight at Week 28 (Table 6).
Alle behandlingsgrupper havde en signifikant reduktion i HbA1c sammenlignet med baseline.
All treatment groups had a significant reduction in HbA1c compared to baseline.
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.
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.
Efter blanding af pulver og opløsningsmiddel må suspensionen kun bruges, hvis blandingen er hvid til offwhite og uklar.
After mixing the liquid with the powder, use the suspension only if the mixture is white to off white and cloudy.
Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller diabetessygeplejerskens anvisning.
Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you.
Udskillelsen af insulin aftager, efterhånden som blodglucosekoncentrationen falder.
As blood glucose concentrations decrease, insulin secretion subsides.
Exenatid opløsning til injektion 10 mikrog to gange daglig
Immediaterelease exenatide 10 mcg twice daily
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)
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)
Gennemsnitlig ændring fra baseline i 2timers postprandial serumglucose (mmol/l) (± SE)
Change from baseline in 2-hour postprandial plasma glucose (mmol/l) (± SE)
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)
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)
Papirslåg
Paper cover
Hver fyldt pen afgiver en dosis exenatid på 2 mg/0,85 ml.
Each pre-filled pen delivers a dose of 2 mg of exenatide in 0.85 ml.
Grønt skjold skyder op
Green shield pops up
• luft i maven (luftafgang fra tarmen)
• pain in the stomach area
Det skal du vide, før du begynder at tage Bydureon Sådan skal du bruge Bydureon Bivirkninger
What Bydureon is and what it is used for What you need to know before you use Bydureon How to use Bydureon
BRUGERVEJLEDNING
INSTRUCTIONS FOR THE USER
• Opbevares liggende i køleskab (2 °C til 8 °C).
• Store in a refrigerator (2°C to 8°C).
Der forekom akut pancreatitis hos 0,3% af patienterne i kliniske studier med depotformulering af exenatid.
In clinical studies of prolonged-release exenatide, acute pancreatitis occurred in 0.3% of patients.
Tag hætteglasset op.
Pick up the syringe.
Exenatid i depotformulering
Prolonged-release exenatide
Alle behandlingsgrupper havde en reduktion i HbA1c sammenlignet med baseline.
All treatment groups had a reduction in HbA1c compared to baseline.
Exenatid depotformulering 2 mg
Prolongedrelease exenatide 2 mg
Gennemsnitlig ændring fra baseline mellem kombination og ét aktivt lægemiddel (95 %
Mean difference in change from baseline between combination and single active medicinal product (95% CI)
Exenatid depotformulering viste superioritet overfor placebo i reduktion af HbA1c fra baseline til uge 28 (tabel 8).
Prolonged-release exenatide demonstrated superiority to placebo in reducing HbA1c from baseline to Week 28 (Table 8).
Depotformulering af exenatid anbefales ikke til patienter med terminal nyresygdom eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) (se pkt.
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).
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.
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.
Opløsningsmidlet er en klar, farveløs til svagt gul til svagt brun opløsning.
Solvent: clear, colourless to pale yellow to pale brown solution.
Det er normalt, at der er luftbobler i sprøjten.
It is normal for air bubbles to be in the syringe.
Bydureon BCise viste overlegenhed i forhold til exenatid opløsning til injektion til reduktion af HbA1c fra baseline til uge 28 (tabel 2).
Bydureon BCise demonstrated superiority to immediate-release exenatide in reducing HbA1c from baseline to Week 28 (Table 2).
De 4 komparatorkontrollerede studier med depotformulering af exenatid har vist et fald i det systoliske blodtryk (2,9 - 4,7 mmHg).
A reduction in systolic blood pressure was observed in the 4 comparator-controlled prolonged-release exenatide studies (2.9 mmHg to 4.7 mmHg).
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)
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)
Drej kanylen fast på sprøjten, indtil den sidder helt tæt.
Twist the needle onto the syringe until snug.
Gennemsnitlig ændring fra baseline mellem behandlinger (95 % CI) versus pioglitazon
Mean difference change from baseline between treatments (95% CI) versus pioglitazone
Tabel 6: Resultat af et 26-ugers studie med exenatid depotformulering versus sitagliptin og versus pioglitazon i kombination med metformin (intent to treat-patienter)
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)
Hvert fyldt pen indeholder 2 mg exenatid.
Each pre-filled pen contains 2 mg exenatide.
Gennemsnitlig ændring fra baseline mellem kombinationen og hver enkelt aktivt lægemiddel (95 % CI)
Mean difference in change from baseline between combination and single active medicinal product (95%CI)
• Pennen kan opbevares i op til 4 uger ved temperaturer under 30 ºC før brug.
• The pen may be kept for up to 4 weeks below 30°C prior to use.
Orange hætte
Orange Cap
Ydre karton, multipakning med 3 x (4 enkeltdosissæt) - inklusive blå box
OUTER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - INCLUDING THE BLUE BOX
Dette lægemiddel fås i pakningsstørrelser med 4 fyldte penne med enkeltdosis (BCise) og en multipakning indeholdende 12 (3 pakninger a 4) fyldte penne med enkeltdosis (BCise).
This medicine is available in a pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise).
Liste af bivirkninger i tabelform
Tabulated list of adverse reactions
Ændring fra baseline (± SE) Gennemsnitlig forskel i ændring fra baseline mellem behandlingerne (95 % CI)
Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI)
Tabel 8: Resultat af et 28-ugers studie af exenatid depotformulering versus placebo i kombination med insulin glargin alene eller med metformin (intent-to-treat-patienter)
Table 8: Results of one 28-week study of prolonged-release exenatide versus placebo in combination with insulin glargine alone or with metformin (intent to treat patients)
Brug tommelfingeren til at trykke stemplet ned, indtil det standser.
With your thumb, push down the plunger until it stops and hold your thumb in place.
Tabel 5: Resultatet af et 26-ugers studie af exenatid depotformulering versus insulin glargin i kombination med metformin alene eller metformin og sulfonylurinstof (intent to treat-patienter)
Table 5: Results of one 26-week study of prolonged-release exenatide versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients)
Pas på ikke at stramme for meget.
Do not over tighten.
Beholderen må ikke smides i skraldespanden.
Do not throw the container in your household waste.
Exenatid opløsning til injektion 10 mikrog BID
Immediate-release exenatide 10 mcg BID
Efter suspension må blandingen kun bruges, hvis den er hvid til offwhite og uklar.
After suspension, the mixture should only be used if it is white to off white and cloudy.
Hold på kanylehætten med den anden hånd.
In your other hand, hold the vial.
Bank!
Tap!
Justeret mindste kvadraters metode (LA Means) og behandlingsgruppers forskel(le) i ændringer fra baselineværdier ved uge 28 er fastsat ved anvendelse af blandet model med gentagne målinger (MMRM), inklusive behandling, region, baseline HbA1c strata (<0,9 % eller ≥9,0 %), uge og behandling per ugentlig interaktion som faste faktorer samt baselineværdi som kovariat.
Adjusted least squares means (LS Means) and treatment group difference(s) in the change from baseline values at Week 28 are modelled using a mixed model with repeated measures (MMRM) including treatment, region, baseline HbA1c stratum (< 9.0% or ≥ 9.0%), week, and treatment by week interaction as fixed factors, and baseline value as a covariate.
Efter opblanding må suspensionen kun bruges, hvis blandingen er hvid til offwhite og uklar.
After mixing, use the suspension only if the mixture is white to off white and cloudy.
Tabel 5: Resultater af et 28-ugers studie med depotformulering af exenatid og dapagliflozin versus depotformulering af exenatid alene og dapagliflozin alene, i kombination med metformin (intent to treat-patienter)
Table 5: Results of one 28-week study of prolonged-release exenatide and dapagliflozin versus prolonged-release exenatide alone and dapagliflozin alone, in combination with metformin (intent to treat patients)