FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use Lyxumia after the expiry date which is stated on the label and on the carton.
Danish: • Tag ikke Lyxumia efter den udløbsdato, der står på etiketten og på æsken.
English: You should seek immediate medical attention if you experience symptoms like swelling of the face, tongue or throat which causes difficulty with breathing.
Danish: Du skal omgående kontakte en læge, hvis du oplever symptomer som hævelse i ansigtet, tungen eller halsen, som giver åndedrætsbesvær.
English: This effect on post-prandial glucose was confirmed in a 4-week study versus liraglutide 1.8 mg once a day in combination with metformin.
Danish: Denne virkning på postprandial glucose blev bekræftet i et 4-ugers studie versus liraglutid 1,8 mg én gang dagligt i kombination med metformin.
English: The tmax of ramipril and ramiprilat were delayed by approximately 2.5 hours.
Danish: tmax for ramipril og ramiprilat forsinkedes cirka 2,5 time.
English: Do not stop using Lyxumia without talking with your doctor.
Danish: Hold ikke op med at tage Lyxumia uden at tale med lægen om det.
English: This is because low blood sugar (hypoglycaemia) can occur.
Danish: Dette skyldes, at der kan forekomme lavt blodsukker (hypoglykæmi).
English: There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients.
Danish: Der foreligger ingen terapeutisk erfaring med lixisenatid til patienter med type 1 diabetes mellitus, og det bør ikke anvendes til disse patienter.
English: • Always use the pen as described in the “Instructions for Use”.
Danish: • Brug altid pennen som beskrevet i ”Brugsanvisningen”.
English: Section 4 - MOVING TO THE PURPLE PEN Completed use of the green 10 microgram pen
Danish: Afsnit 4 - SKIFT TIL DEN LILLA PEN Afsluttet brug af den grønne 10 mikrogram pen
English: • Cardiovascular evaluation
Danish: • Kardiovaskulær evaluering
English: • Only use needles that are compatible for use with Lyxumia pen (see “Instructions for Use”).
Danish: • Brug kun nåle, der er kompatible til brug med Lyxumia-pennen (se ”Brugsanvisning”).
English: Throw away a pen 14 days after activation.
Danish: Kasser en pen 14 dage efter aktivering.
English: The majority of reactions were mild in intensity and usually did not result in discontinuation of the treatment.
Danish: Hovedparten af reaktionerne var af mild intensitet og resulterede som regel ikke i behandlingsophør.
English: Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 only.
Danish: Tag nålen af pennen, sæt en ny på og gentag Trin 4 og 5, men kun dem.
English: No related effect on spermatogenesis was seen in healthy men.
Danish: Der sås ingen påvirkning af spermatogenesen hos raske mænd.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.
Danish: Patienter bør informeres om de karakteristiske symptomer på akut pancreatitis: Vedvarende svære mavesmerter.
English: Paracetamol was used as a model medicinal product to evaluate the effect of lixisenatide on gastric emptying.
Danish: Paracetamol blev anvendt som model-lægemiddel til evaluering af effekten af lixisenatid på gastrisk tømning.
English: When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged.
Danish: Når Lyxumia tilføjes til igangværende metforminbehandling, kan den aktuelle metformindosis fortsættes uændret.
English: Before first use Store in a refrigerator.
Danish: Før anbrud Opbevares i køleskab.
English: Lixisenatide is a selective GLP-1 receptor agonist.
Danish: Lixisenatid er en selektiv GLP-1 receptoragonist.
English: Allergic reactions have been reported in 0.4% of Lyxumia patients.
Danish: Allergiske reaktioner er rapporteret hos 0,4 % af Lyxumia-patienterne.
English: About Your Treatment Initiation pack
Danish: Om din behandlingsopstartspakning
English: • Always read the "Instructions for Use" provided in the box.
Danish: • Læs altid ”Brugsanvisningen”, der medfølger i æsken.
English: Table of activation and disposal
Danish: Tabel over aktivering og bortskaffelse
English: • Do not repeat the activation process or you will not obtain 14 doses from your Lyxumia pen.
Danish: • Gentag ikke aktiveringsprocessen for så får du ikke 14 doser ud af din Lyxumia-pen.
English: Ninety-six percent of the patients in both treatment groups completed the study in accordance with the protocol and the vital status was known at the end of the study for 99.0% and 98.6% of the patients in the lixisenatide and placebo group, respectively.
Danish: 96 % af patienterne i begge behandlingsgrupper gennemførte studiet i overensstemmelse med protokollen og den vitale status var kendt i afslutningen af studiet for 99,0 % og 98,6 % af patienterne i hhv. lixisenatid- og placebogruppen.
English: Do not share them with anyone else.
Danish: Del dem ikke med andre.
English: Other side effects include
Danish: Andre bivirkninger omfatter:
English: Check the liquid.
Danish: Kontroller væsken.
English: Following subcutaneous administration to patients with type 2 diabetes, the rate of lixisenatide absorption is rapid and not influenced by the dose administered.
Danish: Efter subkutan administration til patienter med type 2-diabetes er hastigheden af lixisenatidabsorption hurtig og påvirkes ikke af den administrerede dosis.
English: As opposed to both insulin glulisine treatment regimens, lixisenatide reduced body weight (table 5).
Danish: I modsætning til de 2 behandlingsregimer med insulin glulisin reducerede lixisenatid legemsvægten (tabel 5).
English: Irrespective of the dose and whether lixisenatide was administered as single or multiple doses, the median tmax is 1 to 3.5 hours in patients with type 2 diabetes.
Danish: Uanset dosis og hvorvidt lixisenatid blev administreret som enkelt eller multiple doser, er middel tmax på 1 til 3,5 timer hos patienter med type 2diabetes.
English: Keep it straight as you screw it on.
Danish: Hold den lige, når du skruer den på.
English: • oral antidiabetics (such as metformin, pioglitazone, sulphonylurea medicines) and/ or ,
Danish: • orale antidiabetika (så som metformin, pioglitazon, sulfonylurinstof-medicin) og/eller
English: The body weight reduction is independent from the occurrence of nausea and vomiting.
Danish: Reduktionen af legemsvægt er uafhængig af forekomsten af kvalme og opkastning.
English: In case of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms and the lixisenatide dose should be reduced to the prescribed dose.
Danish: I tilfælde af overdosering bør der indledes passende understøttende behandling svarende til patientens kliniske symptomer, og lixisenatiddosis bør reduceres til den ordinerede dosis.
English: An increased incidence of gastrointestinal disorders was observed.
Danish: Der observeredes en øget forekomst af gastrointestinale gener.
English: As a peptide, lixisenatide is eliminated through glomerular filtration, followed by tubular reabsorption and subsequent metabolic degradation, resulting in smaller peptides and amino acids, which are reintroduced in the protein metabolism.
Danish: Som peptid udskilles lixisenatid ved glomerulær filtration fulgt af tubulær reabsorption og efterfølgende metabolisk nedbrydning, hvilket resulterer i mindre peptider og aminosyrer, der reintroduceres i proteinstofskiftet.
English: No dose adjustment is required based on age.
Danish: Dosisjustering på grund af alder er ikke nødvendig.
English: If pancreatitis is suspected, lixisenatide should be discontinued ; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Danish: Hvis der er mistanke om pancreatitis, bør lixisenatid seponeres og hvis akut pancreatitis bekræftes, må lixisenatidbehandling ikke genoptages.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology and toxicology.
Danish: Prækliniske data viser ingen særlige risici for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksikologi.
English: • Only use needles that are approved for use with Lyxumia.
Danish: • Brug kun nåle, der er godkendt til brug sammen med Lyxumia.
English: Step 5 The pen is now activated.
Danish: Trin 5 Pennen er nu aktiveret.
English: The Lyxumia Treatment Initiation pack includes two different coloured pens.
Danish: Lyxumia behandlingsopstartspakningen indeholder to forskelligt farvede penne.
English: • This pen is only for one person.
Danish: • Denne pen er kun beregnet til en person.
English: CV: cardiovascular, MI: myocardial infarction, HF: hospitalization for heart failure, Revasc: coronary revascularization procedure, HR: hazard ratio, CI: confidence interval.
Danish: CV: kardiovaskulær, MI: myokardieinfarkt, HF: Indlæggelse for hjertesvigt, Revasc: koronar revaskulariseringsprocedure, HR: risikoratio, KI: konfidensinterval.
English: Dizziness Somnolence
Danish: Svimmelhed Somnolens
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Danish: Fertilitet Dyrestudier indikerer ingen direkte skadelige virkninger med hensyn til fertilitet.
English: In patients newly started on insulin, body weight remained almost unchanged in the lixisenatide group while an increase was shown in the placebo group.
Danish: Hos patienter nyligt startet med insulin forblev legemsvægten næsten uændret i lixisenatidgruppen, hvorimod der sås en øgning i placebogruppen.
English: An attached needle might lead to contamination and possible intake of air which might impact the dose accuracy.
Danish: En påsat nål kan medføre kontaminering og måske suge luft ind, hvilket kan påvirke dosisnøjagtigheden.
English: After multiple dose administration in patients with type 2 diabetes, mean terminal half-life was approximately 3 hours and the mean apparent clearance (CL/F) about 35 L/h.
Danish: Efter multipel dosisadministration til patienter med type 2-diabetes var den gennemsnitlige halveringstid cirka 3 timer, og den gennemsnitlige clearance (CL/F) omkring 35 l/h.
English: (0.095 to 0.328)
Danish: (0,095 til 0,328)
English: Pull the injection button out firmly until it stops.
Danish: Træk injektionsknappen fast ud, til den stopper.
English: Specific recommendations regarding intake of such medicinal products are given in section 4.5.
Danish: Særlige anbefalinger vedrørende indtagelse af sådanne lægemidler er givet i pkt.
English: (-0.170 to 0.064)
Danish: (-0,170 til 0,064)
English: (-2.257 to -1.062)
Danish: (-2,257 til -1,062)
English: Reversible testicular and epididymal lesions were seen in dogs treated with lixisenatide.
Danish: Reversible testikulære og epididymale skader sås hos hunde som blev behandlet med lixisenatid.
English: Patients with type 2 diabetes with basal insulin combined with 1-3 oral anti-diabetic agents were enrolled in an open-label randomised study for insulin intensification.
Danish: Patienter med type 2-diabetes, der tager basalinsulin kombineret med 1-3 orale antidiabetika, blev inkluderet i et åbent randomiseret studie for intensivering af insulin.
English: • Low blood sugar (when Lyxumia is taken with metformin)
Danish: • Lavt blodsukker (når Lyxumia tages sammen med metformin)
English: • Activation is done to make sure that the pen is working correctly and that the dose for your first injection is correct.
Danish: • Aktivering sker for at sikre, at pennen fungerer korrekt, og at dosis til din første injektion er korrekt.
English: Your doctor may want to control your blood sugar level and then, decide to reduce your dose of basal insulin or sulphonylurea.
Danish: Din læge kan ønske at kontrollere dit blodsukkerniveau og derefter beslutte at reducere din dosis af basalinsulin eller sulfonylurinstof.
English: Clinical studies with Lyxumia indicate improved beta-cell function as measured by the homeostasis model assessment for beta-cell function (HOMA-β).
Danish: Kliniske studier med Lyxumia indikerer forbedret betacelle-funktion ved brug af Homeostasis Model Assessment for β-celle-funktion (HOMA-β).
English: Most of these reported allergic reactions were mild in severity.
Danish: De fleste af de rapporterede allergiske reaktioner var af mild intensitet.
English: The results of the primary and secondary composite efficacy endpoints, and the results of all the individual components of the composite endpoints are shown in Figure 1.
Danish: Resultaterne af de primære og sekundære sammensatte endepunkter for virkningen, og resultaterne af alle de individuelle komponenter af de sammensatte endepunkter, er vist i Figur 1.
English: What if I forget to activate the Lyxumia pen or inject myself before activation?
Danish: Spørgsmål og svar Hvad nu hvis jeg glemmer at aktivere Lyxumia-pennen eller injicerer mig før aktivering?
English: As lixisenatide is cleared primarily by the kidney, no pharmacokinetic study has been performed in patients with acute or chronic hepatic impairment.
Danish: Da lixisenatid primært udskilles via nyrerne, er der ikke udført et farmakokinetisk studium på patienter med akut eller kronisk nedsat leverfunktion.
English: Nausea and vomiting were the most frequently reported adverse reactions during the main 24-week treatment period.
Danish: Kvalme og opkastning var de hyppigst rapporterede bivirkninger under den 24-ugers behandlingsperiode.
English: • You must activate your Lyxumia pen before you use it for the first time.
Danish: • Du skal aktivere din Lyxumia-pen, før du bruger den første gang.
English: • Once your Lyxumia pen is activated it can be used for up to 14 days.
Danish: • Når Lyxumia-pennen er aktiveret, kan den bruges i op til 14 dage.
English: 10 microgram ___ / ___ / ___ ___ / ___ / ___ 20 microgram ___ / ___ / ___ ___ / ___ / ___
Danish: Aktiveringsdato Dato for bortskaffelse 10 mikrogram ___ / ___ / ___ ___ / ___ / ___ 20 mikrogram ___ / ___ / ___ ___ / ___ / ___
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of lixisenatide based on the results of pharmacokinetic studies in Caucasian, Japanese and Chinese subjects.
Danish: Etnisk oprindelse havde ingen klinisk relevant indvirkning på farmakokinetikken for lixisenatid baseret på resultaterne af farmakokinetiske studier af kaukasiske, japanske og kinesiske forsøgspersoner.
English: In 2-year subcutaneous carcinogenicity studies, non-lethal C-cell thyroid tumours were seen in rats and mice and are considered to be caused by a non-genotoxic GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Danish: I 2-årige subkutane karcinogenicitetsstudier blev ikke-dødelige C-celle-thyroideakarcinomer set hos rotter og mus, og anses at være forårsaget af en ikke-genotoksisk GLP-1 receptor-medieret mekanisme, som gnavere er specielt følsomme overfor.
English: The effect of some medicines you swallow might be affected by Lyxumia.
Danish: Virkningen af visse lægemidler, der indtages gennem munden, kan påvirkes af Lyxumia.
English: Store away from the freezer compartment.
Danish: Opbevares på afstand af fryseelementer.
English: The reduction in Cmax is of limited clinical relevance and no dose adjustment for oral contraceptives is required.
Danish: Reduktionen af Cmax har begrænset klinisk relevans, og dosisjustering for orale kontraceptiva er ikke påkrævet.
English: Overall, 6068 patients were randomized 1:1 to either placebo or lixisenatide 20 mcg (following a starting dose of 10 mcg during the first 2 weeks).
Danish: Totalt blev 6068 patienter randomiseret 1:1 til enten placebo eller lixisenatid 20 µg (efter en startdosis på 10 µg i løbet af de første 2 uger).
English: Lyxumia contains the active substance lixisenatide.
Danish: Lyxumia indeholder det aktive stof lixisenatid.
English: Always use a new needle for activation.
Danish: Brug altid en ny nål til aktivering.
English: Lixisenatide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio.
Danish: Lixisenatid bør anvendes med forsigtighed til patienter, som får orale lægemidler, der kræver hurtig gastrointestinal absorption eller kræver omhyggelig klinisk monitorering eller har et smalt terapeutisk indeks.
English: Each pen contains a different strength of Lyxumia.
Danish: Pennene indeholder hver sin styrke af Lyxumia.
English: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis.
Danish: Brug af glucagon-lignende peptid-1 (GLP-1)-receptoragonister har været forbundet med risiko for at udvikle akut pancreatitis.
English: Do not share it with anyone else.
Danish: Del den ikke med andre.
English: Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely, especially at the time of initiation of lixisenatide treatment.
Danish: Patienter som får lægemidler med et smalt terapeutisk indeks eller lægemidler som kræver omhyggelig klinisk monitorering, bør følges tæt, særligt ved opstart af lixisenatidbehandling.
English: Attach a new needle and repeat Steps D and E only.
Danish: Sæt en ny nål på og gentag Trin D og E, men kun dem.
English: This medicine contains metacresol which may cause allergic reactions.
Danish: Dette lægemiddel indeholder metacresol, som kan forårsage allergiske reaktioner.
English: Hospitalization for unstable angina
Danish: Indlæggelse for ustabil angina
English: The most frequent side effects reported with Lyxumia that may affect more than 1 in 10 users (frequency very common) were nausea (feeling sick) and vomiting.
Danish: De hyppigst rapporterede bivirkninger for Lyxumia, der kan forekomme hos flere end 1 ud af 10 patienter (frekvens meget almindelig), var kvalme (utilpashed) og opkastning.
English: Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia.
Danish: Lixisenatid stimulerer insulinsekretionen, når blodglucose er forhøjet, men ikke ved normoglykæmi, hvilket begrænser risikoen for hypoglykæmi.
English: Lixisenatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of lixisenatide is not recommended in these patients.
Danish: Lixisenatid er ikke undersøgt hos patienter med svær gastrointestinal sygdom, herunder svær gastroparese, og derfor anbefales brug af lixisenatid ikke til disse patienter.
English: No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively.
Danish: Ingen sådan forøgelse af tmax observeredes, når atorvastatin blev administreret om aftenen og lixisenatid om morgenen, men AUC og Cmax for atorvastatin øgedes med henholdsvis 27 % og 66 %.
English: • These pens are only for one person.
Danish: • Disse penne er kun beregnet til en person.
English: Follow all steps in Section
Danish: Følg alle trinene i Afsnit 2.
English: This was also confirmed in an 8-week study versus liraglutide, administered before breakfast, in combination with insulin glargine with or without metformin.
Danish: Dette blev også bekræftet i et 8-ugers studie versus liraglutid administreret før morgenmaden, i kombination med insulin glargin med eller uden metformin.
English: The table also includes adverse reactions with a frequency ≥1% in the Lyxumia group if the frequency was greater than 2 times the frequency for all comparators group.
Danish: Tabellen omfatter også bivirkninger med en frekvens på ≥ 1 % i Lyxumia-gruppen, dersom frekvensen var større end to gange frekvensen for gruppen af alle komparatorpræparater.
English: How to activate your new Lyxumia pen Step 1 Pull off the pen cap and check the pen
Danish: Sådan aktiverer du din nye Lyxumia-pen Trin 1 Tag pennens hætte af og kontroller pennen
English: In the completed Phase III studies, it was observed that approximately 90% of the patients were able to remain on the once daily maintenance dose of 20 mcg Lyxumia at the end of the main 24-week treatment period.
Danish: I de afsluttede fase III-studier observeredes det, at omtrent 90 % af patienterne kunne forblive på vedligeholdelsesdosis 20 µg Lyxumia én gang dagligt ved afslutning af den 24-ugers behandlingsperiode.
English: Frequencies of adverse reactions are defined as: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).
Danish: Bivirkningsfrekvenserne er defineret som: meget almindelig: ≥ 1/10; almindelig: ≥ 1/100 til <1/10; ikke almindelig: ≥ 1/1.000 til < 1/100; sjælden: ≥ 1/10.000 til < 1/1.000; meget sjælden: < 1/10.000).
English: Pharmacotherapeutic group: Drugs used in Diabetes, Glucagon-like peptide-1 (GLP-1) analogues , ATC code: A10BJ03.
Danish: Farmakoterapeutisk klassifikation: Lægemidler anvendt i diabetes, glucagon-lignende peptid-1 (GLP1) analog, ATC-kode: A10BJ03.
English: Throw away a used Lyxumia pen after 14 days.
Danish: En brugt Lyxumia-pen skal kasseres efter 14 dage.
English: In mice, these effects occurred at exposure ratio above 9.3-fold when compared to human exposure at the therapeutic dose.
Danish: Hos mus forekom disse hændelser med en eksponeringsratio på mere end 9,3 fold sammenlignet med human eksponering ved terapeutiske doser.
English: Based on these results, no dose adjustment for warfarin is required when co-administered with lixisenatide; however, frequent monitoring of INR in patients on warfarin and/or coumarin derivatives is recommended at the time of initiation or ending of lixisenatide treatment.
Danish: Baseret på disse resultater kræves der ingen dosisjustering for warfarin ved administration samtidig med lixisenatid, men hyppig monitorering af INR hos patienter i behandling med warfarin og/eller coumarin-derivater anbefales ved initiering eller ophør af lixisenatidbehandlingen.
English: If not, do not use this Treatment Initiation pack.
Danish: Er den ikke det, må denne behandlingsopstartspakning ikke bruges.
English: Median treatment duration was 22.4 months in the lixisenatide group and 23.3 months in the placebo group, and the median duration of study follow-up was 25.8 and 25.7 months, respectively.
Danish: Gennemsnitlig behandlingsvarighed var 22,4 måneder i lixisenatidgruppen og 23,3 måneder i placebogruppen, og gennemsnitlig varighed af studieopfølgning var henholdsvis 25,8 og 25,7 måneder.
English: Keep the outer needle cap - you will need it to remove the needle later.
Danish: Gem det ydre nålehylster - du skal bruge den til at fjerne nålen senere.
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Danish: Brug af GLP-1 receptoragonister kan være forbundet med gastrointestinale bivirkninger.
English: Some severe allergic reactions (such as anaphylaxis) have been reported uncommonly in patients receiving Lyxumia.
Danish: Nogle alvorlige allergiske reaktioner (så som anafylaksi) er i usædvanlige tilfælde rapporteret hos patienter, der fik Lyxumia.
English: Adverse reactions reported from placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
Danish: Bivirkninger rapporteret fra placebo- og aktivt-kontrollerede fase III-studier over hele behandlingsperioden er præsenteret i Tabel 1.
English: Following administration of a single dose of paracetamol 1,000 mg, paracetamol AUC and t1/2 were unchanged whatever the timing of its administration (before or after the lixisenatide injection).
Danish: Efter administration af en enkelt dosis paracetamol 1.000 mg, var paracetamol AUC og t1/2 uændrede uanset tidspunktet for administrationen (før eller efter lixisenatidinjektionen).
English: During the 12-week run-in period, addition and titration of insulin glargine resulted approximately in an HbA1c decrease of 1%.
Danish: I løbet af den 12-ugers run-in periode medførte tillæg og titrering af insulin glargin en omtrentlig HbA1c reduktion på 1 %.