FrancophonIA/ELRC3.0 huggingface dataset:
English: The pen must not be stored with the needle attached.
Danish: Pennen må ikke opbevares med påsat nål.
English: Weight loss of 2.6 kg from a baseline of 89.9 kg was observed with immediate-release exenatide whereas a weight gain of 1.9 kg from a baseline of 89.3 kg was observed with insulin lispro.
Danish: Der blev observeret et vægttab på 2,6 kg fra en baseline på 89,9 kg med exenatid opløsning til injektion, hvorimod der blev observeret en vægtstigning på 1,9 kg fra en baseline på 89,3 kg med insulin lispro.
English: If you lose weight too quickly (more than 1.5 kg per week) talk to your doctor about it since this may cause problems such as gallstones.
Danish: Tal med din læge, hvis du taber dig for hurtigt (mere end 1,5 kg pr uge), da det kan give problemer såsom galdesten.
English: Weight loss of 1.8 kg from a baseline of 95 kg was observed with immediate-release exenatide whereas a weight gain of 1.0 kg from a baseline of 94 kg was observed with placebo.
Danish: Vægttab på 1,8 kg fra et baselineniveau på 95 kg blev observeret med exenatid opløsning til injektion, hvorimod en vægtøgning på 1,0 kg fra et baseline-niveau på 94 kg blev observeret med placebo.
English: In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin or metformin plus thiazolidinedione the incidence of patients with at least one minor hypoglycaemic episode was 18% and 9% respectively and one patient reported major hypoglycaemia.
Danish: I et studie af 24 ugers varighed, hvor enten insulin lispro protamin suspension eller insulin glargin blev føjet til den eksisterende behandling med exenatid opløsning til injektion og metformin eller metformin plus thiazolidindion, havde henholdsvis 18 % og 9 % af patienterne mindst en let hypoglykæmisk episode, og en patient indberettede svær hypoglykæmi.
English: Exenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Danish: Exenatid fører til langsommere ventrikeltømning og reducerer dermed den hastighed, hvormed glucose fra måltider kommer ud i kredsløbet.
English: When immediate-release exenatide is 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: Når exenatid opløsning til injektion føjes til sulfonylurinstof-behandling, skal dosisreduktion af sulfonylurinstof overvejes for at nedsætte risikoen for hypoglykæmi (se pkt.
English: Your Byetta pen is suitable for use with Becton, Dickinson and Company pen injection needles.
Danish: Byetta-pennen er egnet til brug sammen med injektionsnåle fra Becton, Dickinson and Company (BDnåle).
English: Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
Danish: Bemærk: Hvis du efter 4 gentagelser ikke ser væske, der kommer ud fra nålespidsen, så se Spørgsmål og svar, nummer 3, i afsnit 4 i denne brugsanvisning.
English: In three insulin-comparator controlled trials (n=790) comparable efficacy and adverse events were observed in immediate-release exenatide-treated patients regardless of antibody titre.
Danish: I tre insulin-komparatorkontrollerede studier (n=790), blev der observeret sammenlignelig effekt og sammenlignelige bivirkninger hos patienter behandlet med exenatid opløsning til injektion med og uden antistof-titre.
English: Injection needles are not included.
Danish: Injektionsnåle til pennen er ikke inkluderet.
English: STEP 6 Remove and Dispose of the Needle
Danish: TRIN 6 Fjern og kasser nålen
English: Immediate-release exenatide-treated patients in the open-label extension studies at 82 weeks experienced similar types of adverse events observed in the controlled trials.
Danish: De patienter, der blev behandlet med exenatid opløsning til injektion i de åbne, opfølgningsfaser på op til 82 uger, havde bivirkninger der var sammenlignelige med dem, der blev observeret i de kontrollerede studier.
English: Set up your new pen just before you use it for the first time.
Danish: Pennen skal klargøres lige før, du skal bruge den for første gang.
English: Do not use Byetta:
Danish: Tag ikke Byetta
English: Immediate-release exenatide improves glycaemic control through the immediate and sustained effects of lowering both postprandial and fasting glucose concentrations in patients with type 2 diabetes.
Danish: Den øjeblikkelige og længerevarende effekt af exenatid opløsning til injektion på nedsættelsen af både postprandiale og fastende glucosekoncentrationer forbedrer den glykæmiske kontrol hos patienter med type 2-diabetes.
English: Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 9, Section 4 of this user manual.
Danish: Bemærk: Hvis du ikke kan dreje doseringsknappen, så se Spørgsmål og svar, nummer 9, afsnit 4 i denne brugsanvisning.
English: • decreased in kidney function
Danish: • nedsat nyrefunktion
English: Immediate-release exenatide lowered HbA1c by 1.1% from a baseline of 8.3% and insulin lispro lowered HbA1c by 1.1% from a baseline of 8.2% and noninferiority of immediate-release exenatide to titrated lispro was demonstrated.
Danish: Exenatid opløsning til injektion reducerede HbA1c med 1,1% fra en baseline på 8,3 %, og insulin lispro reducerede HbA1c med 1,1 % fra en baseline på 8,2 %, og noninferioritet af exenatid opløsning til injektion til titreret lispro blev påvist.
English: Therefore, the use of exenatide is not recommended in patients with severe gastrointestinal disease.
Danish: Exenatid bør derfor ikke bruges til patienter med alvorlig mave-tarmsygdom.
English: Similar exposure is achieved with subcutaneous administration of exenatide in the abdomen, thigh, or arm.
Danish: Ens eksponeringer opnås med subkutan indgift af exenatid i mave, lår eller arm.
English: In a 30-week, open-label, active comparator-controlled, noninferiority study, the safety and efficacy of immediate-release exenatide (n=315) versus titrated insulin lispro three times daily (n=312) on a background of optimized basal insulin glargine and metformin in patients with type 2 diabetes was evaluated.
Danish: Sikkerhed og virkning for exenatid opløsning til injektion (n=315) versus titreret insulin lispro tre gange dagligt (n=312) blev evalueret i et 30-ugers åbent, aktiv komparatorkontrolleret, noninferioritetsstudie hos patienter med type 2-diabetes med optimeret insulin glargin og metformin som baggrundsbehandling.
English: See Commonly Asked Question 4.
Danish: Se i Spørgsmål og Svar, nummer 4.
English: Please see the accompanying Package Leaflet.
Danish: Se venligst den medfølgende indlægsseddel.
English: Pharmacotherapeutic group: Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ01.
Danish: Farmakoterapeutisk klassifikation: Glucagon-lignende peptid-1 receptor (GLP-1) analoger.
English: Also read the Byetta Package leaflet that comes with the Byetta pen carton.
Danish: Læs også den medfølgende indlægsseddel for Byetta, som ligger i æsken til Byetta-pennen.
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with exenatide should be discontinued.
Danish: Kvinder i den fertile alder Behandlingen med exenatid skal ophøre, hvis en patient ønsker at blive gravid eller bliver gravid.
English: - Each dose of Byetta 10micrograms solution for injection (injection) contains 10micrograms exenatide in 40 microlitre.
Danish: - Hver dosis af Byetta 10 mikrogram injektionsvæske, opløsning (injektion) indeholder 10 mikrogram exenatid i 40 mikroliter.
English: In patients with end-stage renal disease receiving dialysis, single doses of immediate-release exenatide 5 mcg increased frequency and severity of gastrointestinal adverse reactions.
Danish: Hos dialysepatienter med terminal nyresygdom, gav enkeltdoser af exenatid opløsning til injektion 5 μg flere og værre gastrointestinale bivirkninger.
English: Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres (mcl), (0.25 mg exenatide per ml).
Danish: Hver dosis indeholder 10 mikrogram (μg) exenatid i 40 mikroliter (μl) (0,25 mg exenatid pr. ml).
English: If you are having problems using your Byetta pen, contact your healthcare professional.
Danish: Hvis du har problemer med at bruge din Byetta-pen, skal du kontakte din læge eller diabetessygeplejerske.
English: • Pull off inner needle shield and throw away.
Danish: • Træk den indre nålehætte af, og smid den væk.
English: Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres (mcl), (0.25 mg exenatide per ml).
Danish: Hver dosis indeholder 5 mikrogram (μg) exenatid i 20 mikroliter (μl) (0,25 mg exenatid pr. ml).
English: In insulin-comparator studies immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) in combination with metformin and sulphonylurea significantly (statistically and clinically) improved glycaemic control, as measured by decrease in HbA1c.
Danish: I insulin-komparator studier forbedrede exenatid opløsning til injektion (5 µg to gange dagligt i 4 uger, efterfulgt af 10 µg to gange dagligt) i kombination med metformin og sulfonylurinstof den glykæmiske kontrol signifikant (statistisk og klinisk), målt i reduktion af HbA1c.
English: This symbol means the dose knob is pushed in and the pen is ready to reset.
Danish: at doseringsknappen er skubbet ind, og at pennen er klar til nulstilling.
English: Exenatide increases, on a glucose-dependent basis, the secretion of insulin from pancreatic beta cells.
Danish: Exenatid øger sekretionen af insulin fra pankreatiske betaceller på et glucoseafhængigt grundlag.
English: One to deliver doses of 5micrograms and one 10micrograms.
Danish: Den ene pen giver doser på 5 mikrogram, og den anden giver doser på 10 mikrogram.
English: - Each dose of Byetta 5 micrograms solution for injection (injection) contains 5 micrograms exenatide in 20 microlitre.
Danish: - Hver dosis af Byetta 5 mikrogram injektionsvæske, opløsning (injektion) indeholder 5 mikrogram exenatid i 20 mikroliter.
English: DOSE WINDOW SYMBOLS
Danish: SYMBOLER I DOSERINGSVINDUET
English: • The pen is now ready to reset.
Danish: • Pennen er nu klar til nulstilling.
English: 10 mcg: Each pre-filled pen contains 60 doses (approximately 2.4 ml of solution).
Danish: 10 mikrogram: Hver fyldt pen indeholder 60 doser (indeholdende ca. 2,4 ml opløsning).
English: Once in use, keep your pen below 25 ºC for 30 days.
Danish: Når en pen er taget i brug, skal den opbevares ved temperaturer under 25 ºC i 30 dage.
English: Section 1.
Danish: Afsnit 1.
English: • Pull the dose knob out until appears.
Danish: • Træk doseringsknappen helt ud, indtil kommer frem.
English: Immediate-release exenatide should not be administered after a meal.
Danish: Exenatid opløsning til injektion må ikke indgives efter et måltid.
English: Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
Danish: Stik nålen ind i huden ved brug af den hygiejniske injektionsteknik, som din læge eller diabetessygeplejerske har anbefalet.
English: • Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5 in order to get a full dose.
Danish: • Brug tommelfingeren til at trykke injektionsknappen ind, indtil den stopper, og fortsæt med at holde injektionsknappen inde og tæl langsomt til 5 for at få hele dosen.
English: STEP B Attach the Needle
Danish: TRIN B Påsætning af nål
English: If the needle is left on, medicine may leak from the Byetta pen or air bubbles may form in the cartridge.
Danish: Hvis nålen efterlades påsat, kan der løbe medicin ud af Byetta-pennen, eller der kan dannes luftbobler i cylinderampullen.
English: When immediate-release exenatide was used in combination with a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo in combination with a sulphonylurea.
Danish: Når exenatid opløsning til injektion blev anvendt i kombination med sulfonylurinstof, var forekomsten af hypoglykæmi højere end for placebo i kombination med sulfonylurinstof.
English: Hepatic impairment No dosage adjustment is necessary in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Der er ikke behov for dosisjustering til patienter med nedsat leverfunktion (se pkt.
English: • Use thumb to firmly push the injection button in until it stops, then continue holding the injection button in while slowly counting to 5.
Danish: • Brug tommelfingeren til at trykke injektionsknappen ind, indtil den stopper, og fortsæt med at holde injektionsknappen inde, og tæl langsomt til 5.
English: Replace the cap on the pen in order to protect from light.
Danish: Sæt penhætten tilbage på pennen for at beskytte mod lys.
English: If is in the dose window and the dose knob will not turn:
Danish: Hvis er i doseringsvinduet, og doseringsknappen ikke kan drejes:
English: • Follow Section 2 only to set up a new pen before first use.
Danish: • Følg kun afsnit 2, når du skal i gang med en ny pen.
English: No adjustment to paracetamol dosing is required based on these study results.
Danish: På baggrund af disse studieresultater er der ingen grund til dosisjustering af paracetamol.
English: If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge.
Danish: Hvis nåles efterlades påsat, kan der løbe medicin ud af pennen, eller der kan dannes luftbobler i cylinderampullen.
English: • Carefully put the outer needle shield back over the needle.
Danish: • Sæt forsigtigt den ydre nålehætte på nålen igen.
English: You do not have to measure any doses, the pen measures each dose for you.
Danish: Du behøver ikke at udmåle din dosis, det gør pennen for dig.
English: Injection Button
Danish: Injektionsknap
English: Special populations
Danish: USSærlige populationer
English: Please see the accompanying Byetta Package Leaflet.
Danish: Se den medfølgende Byetta-indlægsseddel.
English: Immediate-release exenatide reduced HbA1c and body weight in patients treated for 30 weeks in three placebo-controlled studies, whether the immediate-release exenatide was added to metformin, a sulphonylurea or a combination of both.
Danish: I tre 30-ugers placebokontrollerede studier, reducerede exenatid opløsning til injektion HbA1c og legemsvægt hos patienterne, uanset om exenatid opløsning til injektion blev givet i tillæg til metformin, sulfonylurinstof eller en kombination af begge.
English: Byetta 10 mcg injection exenatide
Danish: Byetta 10 µg, injektion exenatid
English: Immediate-release exenatide is available as either a 5 mcg or a 10 mcg exenatide per dose pre-filled pen.
Danish: Exenatid opløsning til injektion er tilgængelig som fyldte penne med enten 5 μg eller 10 μg exenatid pr. dosis.
English: If it is not, do not use.
Danish: Hvis ikke, må pennen ikke anvendes.
English: Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. Immediate-release exenatide and basal insulin must be administered as two separate injections.
Danish: Exenatid opløsning til injektion og basal insulin skal administreres som to adskilte injektioner.
English: Byetta 5 mcg injection exenatide
Danish: Byetta 5 µg, injektion exenatid
English: These medicinal products should be taken in a standardised way in relation to immediate-release exenatide injection.
Danish: Disse lægemidler bør tages på faste tidspunkter i forhold til, hvornår exenatid opløsning til injektion injiceres.
English: Continue turning the dose knob clockwise until is in the centre of the dose window.
Danish: Fortsæt med at dreje knappen med uret, indtil er i midten af doseringsvinduet.
English: Section 4.
Danish: Afsnit 4.
English: The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
Danish: svimmelhed, forvirring, irritabilitet, sult, hjertebanken, svedtendens og nervøsitet.
English: Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min).
Danish: Exenatid bør ikke bruges til patienter med terminal nyresygdom eller svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min).
English: Fasting lipids
Danish: Faste-lipider
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, diabetessygeplejerske eller apoteket.
English: Following subcutaneous administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2 h. Mean peak exenatide concentration (Cmax) was 211 pg/ml and overall mean area under the curve (AUC0-inf) was 1036 pg h/ml following subcutaneous administration of a 10 mcg dose of exenatide.
Danish: Den gennemsnitlige maksimale koncentration for exenatid (Cmax) var 211 pg/ml, og det samlede gennemsnitlige område under kurven (AUC0-inf) var 1036 pg •t/ml efter subkutan indgift af en 10 μg dosis exenatid.
English: STEP 3 Dial the Dose
Danish: TRIN 3 Indstilling af dosis
English: BYETTA PEN PARTS
Danish: Byetta-pennens dele
English: Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller din diabetessygeplejerskes anvisning.
English: Once in use: Store below 25 ºC for 30 days.
Danish: Efter ibrugtagning: Kan opbevares i op til 30 dage ved temperaturer under 25 ºC.
English: • Do not throw away the pen with a needle attached.
Danish: • Bortskaf ikke en pen med påsat nål.
English: Exenatide should not be used if breast-feeding.
Danish: Exenatid bør ikke anvendes til kvinder, der ammer.
English: Byetta contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: 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: Exenatid anbefales ikke til patienter med terminal nyresygdom eller svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min) (se pkt.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan ske hos op til 1 ud af 100 patienter):
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan ske hos op til 1 ud af 10 patienter):
English: Check with your doctor, pharmacist, or diabetes nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller din diabetessygeplejerske, hvis der er noget, du er i tvivl om.
English: INR should be closely monitored during initiation and dose increase of immediate-release exenatide therapy in patients on warfarin and/or cumarol derivatives (see section 4.8).
Danish: Hos patienter, der er i behandling med warfarin og/eller cumarolderivater, skal INR overvåges nøje ved initiering og ved dosisøgning af exenatid opløsning til injektion (se pkt.
English: For instructions for using the pen, see section 6.6 and the user manual included with the leaflet.
Danish: 6.6 samt brugsanvisningen, som er inkluderet i indlægssedlen for instruktion i brug af pennen.
English: Studies of immediate-release exenatide in combination with basal insulin In a 30-week study, either immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) or a placebo was added to insulin glargine (with or without metformin, pioglitazone or both).
Danish: Studier af exenatid opløsning til injektion i kombination med basal insulin I et studie af 30 ugers varighed blev enten exenatid opløsning til injektion (5 µg to gange dagligt i 4 uger efterfulgt af 10 µg to gange dagligt) eller placebo føjet til insulin glargin-behandlingen.
English: When 1000 mg paracetamol was given with 10 mcg immediate-release exenatide (0 h) and 1 h, 2 h and 4 h after immediate-release exenatide injection, paracetamol AUCs were decreased by 21%, 23%, 24% and 14% respectively; Cmax was decreased by 37%, 56%, 54% and 41%, respectively; tmax was increased from 0.6 h in the control period to 0.9 h, 4.2 h, 3.3 h, and 1.6 h, respectively.
Danish: Når der blev givet 1000 mg paracetamol sammen med 10 μg exenatid opløsning til injektion (til tiden 0), blev AUC for paracetamol til tiden 0, 1 time, 2 timer og 4 timer efter injektionen med exenatid opløsning til injektion formindsket med henholdsvis 21 %, 23 %, 24 % og 14 %.
English: Follow the steps next to the matching symbol.
Danish: Kontrollér symbolet i doseringsvinduet, og følg trinnene ud for det tilsvarende symbol.
English: Throw away any Byetta pen that has been frozen.
Danish: Hvis en Byetta-pen har været frosset, skal den altid kasseres.
English: • Replace the cap on the pen in order to protect from light.
Danish: • Sæt den blå hætte på pennen for at beskytte den mod lys.
English: Studies of immediate-release exenatide with metformin, a thiazolidinedione or both as background therapy
Danish: Studier af exenatid opløsning til injektion i kombination med metformin, et thiazolidindion eller begge som eksisterende behandling
English: Do not use an extra dose or increase the amount of your next dose to make up for the one you missed.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: In the immediate-release exenatide arm the insulin dose increased by 13 units/day compared to 20 units/day on the placebo arm. Immediate-release exenatide reduced fasting serum glucose by 1.3 mmol/l and placebo by 0.9 mmol/l.
Danish: Exenatid opløsning til injektion og placebo sænkede faste serumglucose med henholdsvis 1,3 mmol/l og 0,9 mmol/l.
English: • Once in use, your Byettapen should be kept below 25ºC.
Danish: • Efter Byetta-pennen er taget i brug, skal den opbevares ved temperaturer under 25
English: • Check Byetta in the cartridge.
Danish: • Kontroller Byetta i cylinderampullen.
English: Specific recommendations regarding intake of such medicinal products in relation to immediate-release exenatide is given in section 4.5.
Danish: Der er anført specifikke anbefalinger for indtagelse af sådanne lægemidler i forbindelse med exenatid opløsning til injektion under pkt.
English: STEP 2 Attach the Needle
Danish: TRIN 2 Påsætning af nål
English: Studies of immediate-release exenatide with metformin, a sulphonylurea or both as background therapy
Danish: Studier af exenatid opløsning til injektion i kombination med metformin, et sulfonylurinstof eller begge som eksisterende behandling
English: If not, turn dose knob clockwise until it stops and the is in the dose window.
Danish: Hvis ikke, skal du dreje doseringsknappen med uret, indtil den stopper, og fremkommer i doseringsvinduet.
English: Note: If you see several drops of Byetta leaking from the needle after the injection, the injection button was not pushed in all the way.
Danish: Bemærk: Hvis adskillige dråber af Byetta siver ud fra nålen efter injektionen, har injektionsknappen ikke været trykket helt ind. Se Spørgsmål og svar, nummer 5, i afsnit 4 i denne brugsanvisning.
English: • pain in the stomacharea
Danish: • smerter i maveregionen
English: • Check that the is in the dose window.
Danish: • Kontroller, at fremkommer i doseringsvinduet.
English: • Throw away needles in a puncture-resistant container or as recommended by your healthcare professional.
Danish: • Kassér nålen i en egnet beholder til spidse genstande, eller som anbefalet af din læge eller diabetessygeplejerske.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Hyperhidrose Alopeci
English: - If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller din diabetessygeplejerske.
English: STEP C Dial the Dose
Danish: TRIN C Indstilling af dosis
English: There were no clinically significant differences in the incidence of hypoglycaemic episodes in the immediate-release exenatide compared to the placebo group (25% and 29% respectively).
Danish: Der var ikke klinisk signifikante forskelle i forekomsten af hypoglykæmiske episoder i gruppen, der fik exenatid opløsning til injektion, sammenlignet med placebo-gruppen