FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 2-year rat carcinogenicity study with prolonged-release exenatide, an increased incidence of C-cell adenomas and C-cell carcinomas was observed at doses ≥ 2-fold the human systemic exposure based on AUC.
Danish: I et 2-årigt carcinogenicitetsstudie med rotter, som fik exenatid som depotformulering, blev der observeret en øget forekomst af C-celleadenomer og C-cellecarcinomer ved doser ≥ 2 gange den humane systemiske eksponering baseret på AUC.
English: Fasting lipids The prolonged-release exenatide formulations have shown no negative effects on lipid parameters.
Danish: Fastende lipider Exenatid depotformuleringerne har ikke vist uønskede virkninger på lipidparametre.
English: B. Firmly tap the pen to mix.
Danish: B. Slå hårdt på pennen for at blande medicinen.
English: In interaction studies of the effect of immediate-release exenatide on digoxin and lisinopril there were no clinical relevant effects on Cmax or AUC, however, a delay in tmax of about 2 h was observed.
Danish: I interaktionsstudier af virkningen af exenatid opløsning til injektion på digoxin og lisinopril var der ingen klinisk relevante effekter på Cmax eller AUC.
English: #nominal p-value <0.05,
Danish: #nominel p-værdi < 0,05,
English: Prolonged-release exenatide demonstrated significantly greater weight reductions compared to sitagliptin.
Danish: Depotformulering af exenatid udviste betydeligt større vægttab end sitagliptin.
English: • hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea 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: • hypoglykæmi (lavt blodsukker) ved indtagelse sammen med et lægemiddel, der indeholder et sulfonylurinstof 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: Place the needle, vial connector package, vial, and syringe on a clean, flat surface.
Danish: Anbring kanylen, pakningen med forbindingsleddet til hætteglasset og sprøjten på en ren og plan overflade.
English: If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well.
Danish: Hvis du kan se klumper af tørt pulver på siderne eller bunden af hætteglasset, betyder det, at medicinen IKKE er blandet godt nok.
English: Needle Top of pen
Danish: Kanyle Pennens top
English: Lift the vial with the orange connector now attached out of its package.
Danish: Tag hætteglasset med det orange forbindingsled påsat ud af dets indpakning.
English: It is not known if exenatide passes into your milk.
Danish: Det vides ikke, om exenatid udskilles i modermælken.
English: Most adverse reactions associated with prolonged-release exenatide were mild to moderate in intensity.
Danish: De fleste bivirkninger forbundet med depotformulering af exenatid var lette til moderate i styrke.
English: STEP 2: Mix the medicine
Danish: TRIN 2: Bland medicinen
English: Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Justering af dosis er ikke nødvendig for patienter med nedsat leverfunktion (se pkt.
English: Includes acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine.
Danish: Inkluderer akut nyresvigt, forværret kronisk nyresvigt, nedsat nyrefunktion, forhøjet serumkreatinin.
English: When it is time for your next weekly dose, start again at step 1.
Danish: Start forfra med trin 1, når det er tid til din næste ugentlige dosis.
English: Dose Line
Danish: Doseringslinje
English: One study was of 24 weeks in duration (n = 252) and the other of 30 weeks (n = 295) followed by an open labelled extension where all patients were treated with prolonged-release exenatide 2 mg once weekly, for a further 7 years (n = 258).
Danish: Det ene studie forløb over 24 uger (n=252) og det andet over 30 uger (n=295) efterfulgt af et open-label forlængelsesstudie, hvor alle patienter blev behandlet med exenatid depotformulering 2 mg en gang ugentligt i yderligere 7 år (n=258).
English: You should inject this medicine into the skin (subcutaneous injection) of your stomach area (abdomen), upper leg (thigh), or the back of your upper arm. Do not inject into a vein or muscle.
Danish: Du skal sprøjte dette lægemiddel ind under huden (subkutan injektion) på maveområdet, øverst på benene (lårene) eller på bagsiden af overarmen.
English: This draws the medicine from the vial into the syringe.
Danish: Hermed trækkes medicinen fra hætteglasset og ind i sprøjten.
English: Review the Instructions for the User Step 3 to confirm the order of operations, then contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country).
Danish: Gennemgå brugervejledningens trin 3 for at bekræfte rækkefølgen af trinene, og kontakt venligst den lokale repræsentant for indehaveren af markedsføringstilladelsen (se afsnit 6 i indlægssedlen for en liste over kontaktinformation for hvert land).
English: Keep pushing on the plunger with your thumb until it stops, and hold it in place.
Danish: Bliv ved med at trykke på stemplet med tommelfingeren, indtil det standser, og hold det på plads.
English: The medicine is injected into your skin (subcutaneously).
Danish: Medicinen indsprøjtes i huden (subkutant).
English: §nominal p-value <0.001.
Danish: §nominel p-værdi < 0,001.
English: The improvement in fasting plasma glucose concentrations was durable through 52 weeks.
Danish: Forbedringen i koncentrationen af fastende plasmaglucose varede ved i 52 uger.
English: D. Choose your injection site.
Danish: D. Vælg et indsprøjtningområde.
English: It is okay if there are air bubbles.
Danish: Det gør ikke noget, hvis der er luftbobler i.
English: When prolonged-release exenatide is used in combination with a sulphonylurea, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Danish: Hvis depotformulering af exenatid anvendes i kombination med et sulfonylurea-produkt, skal patienterne rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel og brug af maskiner.
English: Based on hypoglycaemic events that have symptoms consistent with hypoglycaemia with a concomitant glucose value of <54 mg/dl (3 mmol/l) prior to treatment.
Danish: Baseret på hypoglykæmiske hændelser, der har symptomer i overensstemmelse med hypoglykæmi med en samtidig glukoseværdi på <54 mg/dl (3 mmol/l) før behandling.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, or genotoxicity conducted with immediate-release exenatide or prolonged-release exenatide.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet, der er udført med exenatid opløsning til injektion eller depotformulering af exenatid.
English: Put the covered needle down.
Danish: Sæt den tildækkede kanyle fra dig.
English: The LS means change in mean daily insulin dose was 1.6 units for the prolonged-release exenatide group and 3.5 units for the placebo group.
Danish: Ændringen i LS metode i gennemsnitlig daglig insulindosis var 1,6 enheder i gruppen med exenatid depotformulering og 3,5 enheder i placebogruppen.
English: The results of two studies with Bydureon BCise and six long-term clinical studies of prolonged-release exenatide are presented below; these studies comprised 1766 subjects (556 treated with Bydureon BCise), 53% men and 47% women, 304 subjects (17%) were ≥ 65 years of age.
Danish: Disse studier omfattede 1766 forsøgsdeltagere (556 behandlet med Bydureon BCise), 53 % mænd og 47 % kvinder; 304 forsøgsdeltagere (17 %) var ≥ 65 år.
English: If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose, but instead resume prolonged-release exenatide on the next regularly scheduled dosing day.
Danish: Hvis en dosis glemmes, og den næste planlagte dosis skal tages om 1-2 dage, skal patienten springe den glemte dosis over og i stedet for genoptage depotformulering af exenatid på den næste planlagte dag.
English: The pen must be removed from the refrigerator for at least 15 minutes prior to injection.
Danish: Pennen skal tages ud af køleskabet mindst 15 minutter før injektionen.
English: What should I do if I see air bubbles in the syringe?
Danish: Hvad skal jeg gøre, hvis der er luftbobler i sprøjten?
English: Prolonged-release exenatide demonstrated superiority to both sitagliptin and pioglitazone with respect to change in HbA1c from baseline.
Danish: Depotformulering af exenatid udviste superioritet i forhold til både sitagliptin og pioglitazon, hvad angår ændringen i HbA1c fra baseline.
English: Population pharmacokinetic analysis of renal impaired patients receiving 2 mg prolonged-release exenatide indicate that there may be an increase in systemic exposure of approximately 74% and 23% (median prediction in each group) in moderate (N = 10) and mild (N = 56) renal impaired patients, respectively as compared to normal (N = 84) renal function patients.
Danish: En farmakokinetisk populationsanalyse af patienter med nedsat nyrefunktion, der fik 2 mg depotformulering af exenatid, viser, at der kan være en stigning i den systemiske eksponering på ca. 74 % og 23 % (median forudsigelse i hver gruppe) hos patienter med henholdsvis moderat nedsat nyrefunktion (N=10) og let nedsat nyrefunktion (N=56) sammenlignet med patienter med normal nyrefunktion (N=84).
English: If you do see any dry powder, shake vigorously while continuing to push down on the plunger with your thumb.
Danish: Hvis du kan se noget tørt pulver, skal du ryste kraftigt, mens du
English: When the medicine is mixed well, it should look cloudy.
Danish: Når medicinen er blandet godt, skal den se uklar ud.
English: Each dual-chamber pen contains exenatide powder and solvent in a Type 1 glass cartridge sealed at one end with a chlorobutyl rubber stopper and an aluminium seal, and at the other end with a chlorobutyl rubber piston.
Danish: Hver to-kammerpen indeholder exenatidpulver og solvens i en cylinderampul (type 1-glas) forseglet med en chlorbutylgummiprop og aluminiumsforsegling i den ene ende og med et chlorbutylgummistempel i den anden ende.
English: The concurrent use of prolonged-release exenatide formulations with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied.
Danish: Samtidig anvendelse af depotformulering af exenatid og D-phenylalanin-derivater (meglitinider), alfaglucosidase-hæmmere, dipeptidylpeptidase-4-hæmmere eller andre GLP-1-receptoragonister er ikke undersøgt.
English: In a 28-week open-label study, Bydureon BCise was compared to immediate-release exenatide in subjects on a diet and exercise programme alone or with a stable regimen of oral glucose-lowering medicinal products.
Danish: I et 28-ugers open-label studie blev Bydureon BCise sammenlignet med exenatid opløsning til injektion hos patienter på et diæt- og motionsprogram alene eller med stabilt regime af orale glukosenedsættende lægemidler.
English: The powder (2 mg) in one chamber, is white to off-white and the solvent (0.65 ml) in the other chamber, is a clear, colourless to pale yellow to pale brown solution.
Danish: I pennen er der 2 kamre, hvor der i det ene kammer er et hvidt til offwhite pulver (2 mg), og i det andet kammer er der 0,65 ml opløsningsmiddel, som er en klar, farveløs til svagt gullig til svagt brunlig opløsning.
English: Prolonged-release exenatide 2 mg + Insulin glargine
Danish: Depotformulering af exenatid 2 mg + Insulin glargin
English: Result in symptoms consistent with hypoglycaemia with a concomitant glucose <54 mg/dL (3 mmol/L) prior to treatment.
Danish: Resulterer i symptomer i overensstemmelse med hypoglykæmi med en samtidig glukoseværdi <54 mg/dl (3 mmol/l) før behandling.
English: Striped Label
Danish: Stribet mærkat
English: The orange connector will keep it attached to the syringe.
Danish: Det orange forbindingsled sørger for, at det bliver siddende på sprøjten.
English: When used in combination with a sulphonylurea, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Danish: Hvis exenatid anvendes i kombination med et sulfonylurea-produkt, skal patienterne rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel og brug af maskiner.
English: There have been uncommon events of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring haemodialysis.
Danish: Der har været ikke almindelige hændelser med påvirkning af nyrefunktionen i forbindelse med brug af exenatid, herunder forhøjet serumkreatinin, nedsat nyrefunktion, forværret kronisk nyresvigt samt akut nyresvigt, hvor hæmodialyse sommetider var påkrævet.
English: Prolonged-release suspension for injection 4 single-dose pre-filled pens (BCise) BCise
Danish: Depotinjektionsvæske, suspension 4 fyldte penne med enkeltdosis (BCise) BCise
English: Each carton also contains one spare needle.
Danish: Hver pakning indeholder også en ekstra kanyle i tillæg.
English: Rate based on twelve prolonged-release exenatide completed long-term efficacy and safety studies n = 2868 total (patients on sulphonylurea n = 1002).
Danish: Hyppighed baseret på tolv fuldførte langtidseffekt- og sikkerhedsstudier med depotformulering af exenatid n=2868 i alt (patienter på sulfonylurinstof n=1002).
English: To prevent a clogged needle, always mix the medicine very well, and inject immediately after mixing.
Danish: Bland altid medicinen rigtig grundigt for at forhindre tilstopning af kanylen, og tag indsprøjtningen umiddelbart efter blanding.
English: Immune system disorders Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with a sulphonylurea)
Danish: Immunsystemet Anafylaktisk reaktion Metabolisme og ernæring Hypoglykæmi (med et sulfonylurinstof) Hypoglykæmi (med insulin)
English: No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 ml/min).
Danish: Justering af dosis er ikke nødvendig for patienter med let nedsat nyrefunktion (kreatininclearance 50-80 ml/min).
English: Bydureon must be injected immediately after suspension of the powder in the solvent.
Danish: Bydureon skal indsprøjtes umiddelbart efter suspension af pulveret i solvensen.
English: Seconds
Danish: sekunder
English: Shake well before use.
Danish: Omrystes kraftigt før brug
English: In postmarketing experiences, cases with injection site abscesses and cellulitis have been reported.
Danish: I forbindelse med brug efter markedsføringen er der indberettet tilfælde af abscesser og cellulitis på injektionsstedet.
English: After suspension, each pen delivers a dose of 2 mg in 0.65 ml.
Danish: Efter suspension afgiver hver pen en dosis på 2 mg i 0,65 ml.
English: • hypoglycaemia (low blood sugar) when taken with an insulin
Danish: • hypoglykæmi (lavt blodsukker) når det tages med insulin
English: One study was of 24 weeks in duration (n = 252) and the other of 30 weeks (n = 295) followed by an open-labelled extension where all patients were treated with prolonged-release exenatide 2 mg once weekly for a further 7 years (n = 258).
Danish: Det ene studie varede 24 uger (n=252), og det andet 30 uger (n=295) efterfulgt af en ublindet forlængelse på 7 år, hvor alle patienter blev behandlet med depotformulering af exenatid 2 mg én gang ugentligt (n=258).
English: Green label
Danish: Grøn mærkat
English: The “Instructions for the User”, provided in the carton, must be followed carefully.
Danish: Emballagen er vedlagt en “Brugervejledning”, som skal følges nøje.
English: The results of long-term clinical studies of prolonged-release exenatide are presented below; these studies comprised 1356 subjects treated with prolonged-release exenatide, 52% men and 48% women; 230 subjects (17%) were ≥ 65 years of age.
Danish: Disse studier omfattede 1356 forsøgsdeltagere behandlet med depotformulering af exenatid, 52 % mænd og 48 % kvinder; 230 forsøgsdeltagere (17 %) var ≥ 65 år.
English: In a 28-week double-blind study, prolonged-release exenatide added to insulin glargine alone or with metformin was compared to placebo added to insulin glargine alone or with metformin.
Danish: I et 28-ugers dobbeltblindet studie blev exenatid depotformulering tilføjet til insulin glargin alene eller med metformin sammenlignet med placebo tilføjet til insulin glargin alene eller med metformin.
English: Frequency reported from the 28-week controlled treatment period of the prolonged-release exenatide as add on to insulin glargine study (N=231).
Danish: Frekvens rapporteret fra 28-ugers kontrolleret behandlingsperiode med exenatid i depotformulering som supplement til insulin glargin-studie (N = 231).
English: Patients (%) achieving HbA1c ≤ 7% 62
Danish: Patienter (%), der opnåede HbA1c ≤ 7 % 62
English: Exenatide increases, on a glucose-dependent basis, the secretion of insulin from pancreatic beta cells.
Danish: Exenatid øger udskillelsen af insulin fra betaceller i pancreas på glucoseafhængig basis.
English: Event Rate n (%)
Danish: Antal hændelser n (%)
English: B. Twist knob to release injection button.
Danish: B. Drej håndtaget for at frigive injektionsknappen.
English: In the 4 comparator-controlled studies, this reduction in body weight was seen in patients treated with prolonged-release exenatide irrespective of the occurrence of nausea although the reduction was larger in the group with nausea (mean reduction of -2.9 kg to -5.2 kg with nausea versus -2.2 kg to -2.9 kg without nausea).
Danish: I de 4 komparatorkontrollerede studier er dette vægttab set hos patienter, der blev behandlet med depotformulering af exenatid, uanset forekomsten af kvalme, omend vægttabet var større i gruppen med kvalme (gennemsnitligt vægttab på -2,9 kg til -5,2 kg med kvalme vs. -2,2 kg til -2,9 kg uden kvalme).
English: Use only the supplied needles with the pen.
Danish: Brug kun de vedlagte kanyler sammen med pennen.
English: The solution should have NO CLUMPS and be uniformly cloudy.
Danish: Der må IKKE VÆRE KLUMPER i injektionsvæsken, og den skal være ensartet uklar.
English: Common Questions and Answers
Danish: Almindelige spørgsmål og svar
English: *p-value < 0.01.
Danish: *p-værdi < 0,01.
English: Prior to use of the pen, it is recommended that you should be trained by a doctor or diabetes nurse on its proper use.
Danish: Det anbefales, at du trænes af en læge eller diabetessygeplejerske i korrekt brug inden brug af pennen.
English: In a 30-week study, approximately 3% (n = 4/148) of prolonged-release exenatide treated patients experienced at least one-time period of rapid weight loss (recorded body weight loss between two consecutive study visits of greater than 1.5 kg/week).
Danish: I et 30-ugers studie havde cirka 3 % (n=4/148) af de patienter, som blev behandlet med depotformulering af exenatid, mindst én periode med hurtigt vægttab (registreret fald i legemsvægt på mere end 1,5 kg/uge mellem to studiebesøg i træk).
English: The powder is packaged in a 3 ml Type I glass vial sealed with a chlorobutyl rubber stopper and an aluminium seal with a plastic flip-off cap.
Danish: Pulveret er pakket i et 3 ml hætteglas af type I-glas, der er forseglet med en gummiprop af chlorbutyl og en aluminiumforsegling med en flipoff-hætte af plast.
English: INR should be monitored during initiation of prolonged-release exenatide therapy in patients on warfarin and/or cumarol derivatives (see sections 4.4 and 4.8).
Danish: INR bør monitoreres i starten af behandling med depotformulering af exenatid hos patienter, der får warfarin og/eller coumarolderivater (se pkt.
English: Injection site abscesses and cellulitis
Danish: Absces og cellulitis ved injektionsstedet
English: For single-use only
Danish: Kun til engangsbrug
English: Follow the instructions for the user to prepare and inject your dose.
Danish: Følg brugervejledningen til at fremstille og indsprøjte din dosis.
English: How to Store Bydureon BCise pen
Danish: Hvordan opbevares Bydureon BCise pen
English: Prolonged-release suspension for injection in pre-filled pen (BCise).
Danish: Depotinjektionsvæske, suspension i fyldt pen (BCise).
English: Hold the syringe near the black dashed Dose Line.
Danish: Hold på sprøjten tæt på den sorte stiplede doseringslinje.
English: Abdominal distension Abdominal pain
Danish: Gastroøsofageal reflukssygdom Abdominal distension Abdominalsmerte Flatulens
English: It is normal for air bubbles to be in the pen.
Danish: Det er normalt, at der er luftbobler i pennen.
English: In postmarketing experience with prolonged-release exenatide, cases with injection site abscesses and cellulitis have been reported.
Danish: I forbindelse med brug efter markedsføringen af exenatid depotformulering er der indberettet tilfælde af abscesser og cellulitis på injektionsstedet.
English: This is what the vial should now look like.
Danish: Sådan skal hætteglasset nu se ud.
English: With one hand, hold the syringe near the black dashed Dose Line.
Danish: Hold sprøjten med den ene hånd tæt på den sorte stiplede doseringslinje.
English: Clinical experience in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min) is limited.
Danish: Den kliniske erfaring med patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/min) er begrænset.
English: *p-value <0.05, **p-value < 0.01,
Danish: *p-værdi < 0,05, **p-værdi < 0,01,
English: The solvent is packaged in a 1.5 ml Type 1 glass pre-filled syringe sealed with a bromobutyl rubber cap and a rubber plunger.
Danish: Solvensen er pakket i en 1,5 ml fyldt sprøjte af type I-glas, der er forseglet med en gummihætte af brombutyl og et gummistempel.
English: It's normal if you see air bubbles in the liquid.
Danish: Det er normalt, at du kan se luftbobler i væsken.
English: Keep pushing down on the plunger with your thumb and shake vigorously.
Danish: Bliv ved med at trykke stemplet ned med tommelfingeren og ryst kraftigt.
English: The BCise pen must be removed from the refrigerator and rested flat for at least 15 minutes prior to injection.
Danish: BCise-pennen skal tages ud af køleskabet og ligge vandret i mindst 15 minutter før injektionen.
English: B. While still holding the pen straight up, firmly unscrew the orange cap.
Danish: B. Mens du stadig holder pennen lodret, løsn den orange hætte med et fast greb.
English: Approximately 49.3% had mild renal impairment (estimated glomerular filtration rate [eGFR] ≥60 to ≤89 mL/min/1.73 m2) and 21.6% had moderate renal impairment (eGFR
Danish: Ca. 49,3 % havde led nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] ≥60 til ≤89 ml/min/1,73 m2) og 21,6 % havde moderat nedsat nyrefunktion (eGFR ≥30 til ≤59 ml/min/1,73 m2).
English: Frequency reported from the 28-week controlled treatment period of the prolonged-release exenatide as add-on to insulin glargine study (N=231).
Danish: Hyppighed rapporteret fra studiet med den kontrollerede behandlingsperiode på 28 uger med depotformulering af exenatid som tillægsbehandling til insulin glargin (N=231).
English: There is one needle supplied per pen.
Danish: Der er en injektionskanyle per pen.
English: Now, pick up the vial with the orange connector attached.
Danish: Tag nu fat i hætteglasset med det orange forbindingsled påsat.
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 3).
Danish: Sammenlignet med behandling med insulin glargin viste depotformulering af exenatid en større ændring i HbA1c, signifikant reduceret gennemsnitlig legemsvægt og var forbundet med færre hypoglykæmiske hændelser (tabel 3).
English: Do not save it to use later.
Danish: Du må ikke gemme den til senere brug.