FrancophonIA/ELRC3.0 huggingface dataset:
English: • Immunogenicity
Danish: • Immunogenicitet
English: The most frequently reported adverse reactions during clinical trials were gastrointestinal disorders: nausea and diarrhoea were very common, whereas vomiting, constipation, abdominal pain, and dyspepsia were common.
Danish: De hyppigst rapporterede bivirkninger under de kliniske studier var gastrointestinale forstyrrelser: Kvalme og diarré var meget almindelige, mens opkastning, konstipation, abdominalsmerter og dyspepsi var almindelige.
English: To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily.
Danish: For at forbedre den gastrointestinale tolerance er startdosis 0,6 mg liraglutid dagligt.
English: The analysis of time to first microvascular event for liraglutide vs placebo had a HR of 0.84 [0.73, 0.97].
Danish: Analysen af tiden til første mikrovaskulære hændelse for liraglutid i forhold til placebo havde en HR på 0,84 [0,73; 0,97].
English: Liraglutide lowered ethinyloestradiol and levonorgestrel Cmax by 12 and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Danish: Liraglutid sænkede Cmax for ethinylestradiol og levonorgestrel med henholdsvis 12% og 13% efter administration af én dosis af et oralt kontraceptionsmiddel.
English: A stepwise approach to insulin dose reduction is recommended.
Danish: En gradvis reduktion af insulindosen anbefales.
English: MARKETING AUTHORISATION NUMBERS
Danish: MARKEDSFØRINGSTILLADELSESNUMMER
English: A large cardiovascular outcomes trial (the LEADER trial) was also conducted with liraglutide in 9,340 patients with type 2 diabetes mellitus at high cardiovascular risk.
Danish: Der blev også udført et stort kardiovaskulært endepunktsstudie (LEADER-studiet) med liraglutid, der inkluderede 9.340 patienter med type 2-diabetes mellitus og høj kardiovaskulær risiko.
English: When the pen is empty, carefully dispose of it without a needle attached.
Danish: Når pennen er tom, skal den smides omhyggeligt ud uden en nål påsat.
English: Use in patients with renal impairment
Danish: Brug hos patienter med nedsat nyrefunktion
English: During the 26 weeks, there were 12 serious events in 235 patients (5.1%) using liraglutide, whereas there were 6 serious adverse events in 232 patients (2.6%) using exenatide.
Danish: I løbet af de 26 uger var der 12 alvorlige bivirkninger ud af 235 patienter (5,1%), der fik liraglutid, og 6 alvorlige bivirkninger ud af 232 patienter (2,6%), der fik exenatid.
English: When you have found the most convenient time of the day it is preferred that you inject Victoza around the same time of the day.
Danish: Når du har fundet det tidspunkt på dagen, der passer dig bedst, er det at foretrække, at du injicerer Victoza på omtrent samme tidspunkt hver dag.
English: Victoza is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen.
Danish: Victoza leveres som en klar og farveløs eller næsten farveløs, opløsning i en fyldt pen.
English: This is more likely to happen if you also take a sulfonylurea or insulin.
Danish: Der er større sandsynlighed for, at dette sker, hvis du også tager sulfonylurinstof eller insulin.
English: Treatment with liraglutide produced clinically and statistically significant improvements in glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose and postprandial glucose compared with placebo.
Danish: Behandling med liraglutid gav klinisk og statistisk signifikante forbedringer af glykosyleret hæmoglobin A1c (HbA1c), fasteplasmaglucose og postprandial glucose sammenlignet med placebo.
English: There was a small increase in the rate of minor hypoglycaemic episodes (0.23 versus 0.03 events per patient years).
Danish: Der var en mindre stigning i hyppigheden af mindre hypoglykæmiske episoder (0,23 versus 0,03 hændelser per patientår).
English: Patients with mild and moderate renal impairment (creatinine clearance 60-90 ml/min and 3059 ml/min, respectively) may experience more gastrointestinal effects when treated with liraglutide.
Danish: Patienter med let og moderat nedsat nyrefunktion (kreatinin-clearance henholdsvis 60-90 ml/min og 30-59 ml/min) kan opleve flere gastrointestinale bivirkninger, når de behandles med liraglutid.
English: Common • Vomiting.
Danish: Almindelige • Opkastning.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre præparater.
English: Liraglutide has 24-hour duration of action and improves glycaemic control by lowering fasting and postprandial blood glucose in patients with type 2 diabetes mellitus.
Danish: Liraglutid har en virkningsvarighed på 24 timer og forbedrer den glykæmiske kontrol ved at sænke fasteglucose i blodet og den postprandiale glucose i blodet hos patienter med type 2-diabetes mellitus.
English: • Cardiovascular evaluation
Danish: • Kardiovaskulær vurdering
English: • Do not try to wash, soak or lubricate it - this can harm the pen.
Danish: • Pennen må ikke vaskes, lægges i blød eller smøres, da dette kan beskadige den.
English: Non-clinical studies have shown a treatment-related reduction of neonatal growth in suckling rat pups (see section 5.3).
Danish: Ikkekliniske undersøgelser har påvist en behandlingsrelateret reduktion af neonatal vækst hos diende rotteunger (se pkt.
English: In the LEADER trial, microvascular events comprised nephropathy and retinopathy outcomes.
Danish: I LEADER-studiet omfattede de mikrovaskulære hændelser resultater for nefropati og retinopati.
English: The mean clearance following subcutaneous administration of a single dose liraglutide is approximately 1.2 l/h with an elimination half-life of approximately 13 hours.
Danish: Middel-clearance efter subkutan administration af én dosis liraglutid er cirka 1,2 l/time med en halveringstid på cirka 13 timer.
English: The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
Danish: De bedste steder til injektion er forrest på låret, maveskindet eller overarmen.
English: For patients treated with premix insulin at baseline and at least for the following 26 weeks, the rate of severe hypoglycaemia for both liraglutide and placebo was 2.2 events per 100 patient years.
Danish: For patienter behandlet med forblandet insulin ved baseline, og som minimum i de efterfølgende 26 uger, var forekomsten af alvorlig hypoglykæmi for både liraglutid og placebo 2,2 hændelser pr. 100 patientår.
English: • Injection site reactions (such as bruising, pain, irritation, itching and rash)
Danish: • Reaktioner på injektionsstedet (såsom blå mærker, smerte, irritation, kløe og udslæt)
English: When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea or insulin.
Danish: Når du begynder at bruge disse lægemidler samtidig, vil din læge muligvis bede dig om at nedsætte dosis af sulfonylurinstoffet eller insulinet.
English: The intra-subject coefficient of variation for liraglutide AUC was 11% following single dose administration.
Danish: Den intraindividuelle variationskoefficient for liraglutids AUC var 11% efter administration af én dosis.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polyolefin and polyacetal.
Danish: Cylinderampul (type 1-glas) med stempel (brombutyl) og en lamineret gummiplade (brombutyl/polyisopren) i en fyldt engangspen til flergangsbrug (polyolefin og polyacetal).
English: Screw the needle straight and tightly onto your pen.
Danish: Skru nålen lige og stramt på pennen.
English: Victoza contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Danish: Victoza indeholder mindre end 1 mmol (23 mg) natrium per dosis, hvilket betyder, at lægemidlet stort set er 'natriumfrit'.
English: Liraglutide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in cyclic adenosine monophosphate (cAMP).
Danish: Virkningen af liraglutid medieres via en specifik interaktion med GLP-1-receptorerne, hvilket fører til en stigning i cAMP (cyklisk adenosinmonofosfat).
English: Thyroid disease
Danish: Thyroidea-relateret sygdom
English: Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of Victoza.
Danish: Få tilfælde af anafylaktiske reaktioner med yderligere symptomer som hypotension, palpitationer, dyspnø og ødem er blevet rapporteret ved brug af Victoza efter markedsføring.
English: Victoza should not be used if it does not appear clear and colourless or almost colourless.
Danish: Victoza må ikke anvendes, hvis det ikke er klart og farveløst eller næsten farveløst.
English: Simultaneously, liraglutide lowers inappropriately high glucagon secretion, also in a glucose-dependent manner.
Danish: Samtidig sænker liraglutid en uhensigtsmæssigt høj glukagonsekretion, ligeledes glucoseafhængigt.
English: Furthermore, hypoglycaemia was common, and very common when liraglutide is used in combination with a sulfonylurea.
Danish: Hypoglykæmi var endvidere almindelig, og meget almindelig ved brug af liraglutid i kombination med sulfonylurinstof.
English: • Body weight
Danish: • Legemsvægt
English: Clinical trials with liraglutide indicate improved beta-cell function based on measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Danish: Kliniske studier med liraglutid indikerer en forbedring af betacellefunktionen baseret på målinger såsom homeostasemodelvurdering for betacellefunktion (HOMA-B) og proinsulin/insulin-ratio.
English: • Bronchitis
Danish: • Bronkitis
English: Victoza pen is designed to be used with NovoFine or NovoTwist disposable needles.
Danish: Victoza pen er udviklet til brug med NovoFine eller NovoTwist engangsnåle.
English: Then prepare a new pen for injection and inject the remaining number of mg to complete your dose.
Danish: Klargør derefter en ny pen til injektion, og injicér de manglende milligram, så du får en fuld dosis.
English: Antibody formation has not been associated with reduced efficacy of liraglutide.
Danish: Dannelse af antistoffer er ikke blevet forbundet med nedsat virkning af liraglutid.
English: Always remove the needle after each injection, and store your pen without a needle attached.
Danish: Fjern altid nålen efter hver injektion, og opbevar pennen uden nålen påsat.
English: Non-fatal myocardial infarction Expanded MACE
Danish: Kardiovaskulær død Ikke-fatal apopleksi Ikke-fatal myokardieinfarkt Udvidet MACE
English: Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza.
Danish: Selv-monitorering af glucose i blodet er ikke nødvendig for at justere patientens dosis af Victoza.
English: You can keep the pen for 1 month when stored at a temperature below 30˚C or in a refrigerator (2˚C8˚C), away from the freezer compartment.
Danish: Du kan opbevare pennen i 1 måned, hvis den opbevares ved temperaturer under 30°C eller i køleskab (2°C-8°C) på afstand af køleelementet.
English: STATEMENT OF ACTIVE SUBSTANCE
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: • before using Victoza.
Danish: • før du bruger Victoza.
English: The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.
Danish: De hyppigst rapporterede bivirkninger var gastrointestinale sygdomme, infektioner og parasitære sygdomme.
English: The incidence of withdrawal due to adverse reactions was 7.8% for liraglutide-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer).
Danish: Forekomsten af seponering på grund af bivirkninger var 7,8% for patienter behandlet med liraglutid og 3,4% for komparatorbehandlede patienter i de langvarige, kontrollerede studier (26 uger eller længere).
English: The study population included patients ≥65 years (n=4,329) and ≥75 years (n=836) and patients with mild (n=3,907), moderate (n=1,934) or severe (n=224) renal impairment.
Danish: Studiepopulationen omfattede patienter ≥65 år (n=4.329) og ≥75 år (n=836), og patienter med let (n=3.907), moderat (n=1.934) eller svært (n=224) nedsat nyrefunktion.
English: Do not inject it into a vein or muscle.
Danish: Injicér ikke lægemidlet i en blodåre eller muskel.
English: Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Danish: Patienter der behandles med liraglutid, skal informeres om den potentielle risiko for dehydrering i relation til bivirkninger fra mave-tarm-kanalen og tage forholdsregler for at undgå væskemangel.
English: Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Victoza.
Danish: Der er rapporteret om få tilfælde (0,05%) af angioødem under alle langvarige kliniske forsøg med Victoza.
English: Victoza is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Danish: Victoza anbefales ikke til brug hos patienter med svært nedsat leverfunktion (se pkt.
English: Insert the needle into your skin using the injection technique shown by your doctor or nurse.
Danish: Stik nålen ind i huden på den måde, som lægen eller sygeplejersken har vist dig.
English: This will make any air bubbles collect at the top of the cartridge.
Danish: Herved stiger eventuelle luftbobler op til toppen af cylinderampullen.
English: When combining liraglutide with metformin, 20.7% of patients reported at least one episode of nausea, and 12.6% of patients reported at least one episode of diarrhoea.
Danish: Ved brug af liraglutid i kombination med metformin rapporterede 20,7% af patienterne om mindst én episode med kvalme, mens 12,6% af patienterne rapporterede om mindst én episode med diarré.
English: Talk to your doctor, pharmacist or nurse:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken:
English: Pull off the outer needle cap and keep it for later.
Danish: Fjern den ydre nålehætte og gem den til senere brug.
English: Nasopharyngitis Bronchitis
Danish: Nasofaryngitis Bronkitis
English: No dose adjustment of lisinopril is required based on these results.
Danish: Baseret på disse resultater er dosisjustering af lisinopril ikke nødvendig.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: It is not known whether liraglutide is excreted in human milk.
Danish: Det vides ikke, om liraglutid udskilles i modermælken.
English: Liraglutide did not change the overall exposure of paracetamol following a single dose of 1000 mg. Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.
Danish: Liraglutid ændrede ikke den overordnede eksponering for paracetamol efter én dosis på 1.000 mg. Paracetamols Cmax blev reduceret med 31%, og medianværdien for tmax blev forsinket med op til 15 min. Dosisjustering ved samtidig brug af paracetamol er ikke nødvendig.
English: Do not store the pen with a needle attached.
Danish: Opbevar ikke pennen med påsat nål.
English: • Wind (flatulence)
Danish: • Luft i maven (flatulens)
English: Acute pancreatitis
Danish: Akut pankreatitis
English: The pen is designed to be used with NovoFine or NovoTwist disposable injection needles up to a length of 8 mm and as thin as 32G (0.25/0.23 mm).
Danish: Pennen er udviklet til brug sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm og så tynde som 32G (0,25/0,23 mm).
English: The HR for liraglutide vs placebo was 0.78 [0.67, 0.92] for time to first nephropathy event and 1.15 [0.87, 1.52] for time to first retinopathy event.
Danish: HR for liraglutid versus placebo var 0,78 [0,67; 0,92] for tiden til første nefropatihændelse og 1,15 [0,87; 1,52] for tiden til første retinopati-hændelse.
English: The risk of hypoglycaemia is low with combined use of basal insulin and liraglutide (1.0 events per patient year, see section 5.1).
Danish: Risikoen for hypoglykæmi er lav ved kombineret brug af basalinsulin og liraglutid (1,0 hændelser per patientår, se pkt.
English: Liraglutide also significantly reduced the risk of expanded MACE (primary MACE, unstable angina pectoris leading to hospitalisation, coronary revascularisation, or hospitalisation due to heart failure) and other secondary endpoints (Figure 2).
Danish: Liraglutid reducerede også risikoen for udvidet MACE (primær MACE, ustabil angina pectoris, der medførte indlæggelse, koronar revaskularisering eller indlæggelse på grund af hjertesvigt) og andre sekundære endepunkter betydeligt (Figur 2).
English: Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Victoza therapy is started and insulin is reduced.
Danish: Selv-monitorering af glucoseniveauet i blodet er nødvendig for at tilpasse dosis af sulfonylurinstof og insulin, især når behandlingen med Victoza påbegyndes, og insulindosen reduceres.
English: Body weight loss was observed in both treatment arms (-4.3 kg with liraglutide and -3.7 kg with lixisenatide).
Danish: Reduktion i kropsvægt blev observeret i begge behandlingsarme (-4,3 kg med liraglutid og -3,7 kg med lixisenatid).
English: When initiating treatment with Victoza, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea.
Danish: Når du påbegynder behandling med Victoza, kan du i nogle tilfælde opleve væskemangel/dehydrering f.eks. ved opkastning, kvalme eller diarré.
English: N Mean baseline HbA1c (%)
Danish: N Middel baseline HbA1c (%)
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for destruktion og anden håndtering
English: When combining liraglutide with a sulfonylurea, 9.1% of patients reported at least one episode of nausea and 7.9% of patients reported at least one episode of diarrhoea.
Danish: Ved brug af liraglutid i kombination med sulfonylurinstof rapporterede 9,1% af patienterne om mindst én episode med kvalme, mens 7,9% af patienterne rapporterede om mindst én episode med diarré.
English: Liraglutide exposure was decreased by 13-23% in patients with mild to moderate hepatic impairment compared to healthy subjects.
Danish: Eksponeringen for liraglutid var reduceret med 13-23% hos patienter med let til moderat nedsat leverfunktion sammenlignet med raske forsøgspersoner.
English: Mean HbA1c change from baseline (%)
Danish: HbA1c ændring fra baseline (%)
English: You may experience nausea, vomiting or diarrhoea.
Danish: Du kan få kvalme, opkastning eller diarré.
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and insulin detemir when administering a single dose of insulin detemir 0.5 U/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Danish: Der blev ikke observeret farmakokinetiske eller farmakodynamiske interaktioner mellem liraglutid og insulin detemir, når en enkelt dosis insulin detemir 0,5 E/kg blev administreret sammen med liraglutid 1,8 mg ved staedy state hos patienter med type 2-diabetes.
English: The rate of hypoglycaemic episodes (per patient year of exposure) was statistically significantly lower when adding liraglutide compared to adding a single dose of insulin aspart (1.0 vs 8.15; ratio: 0.13; 95% CI: 0.08 to 0.21).
Danish: Hyppigheden af hypoglykæmiske episoder (per eksponeringsår) var statistisk signifikant lavere når liraglutid blev givet i tillæg, i forhold til når en enkelt dosis insulin aspart blev tilføjet (1,0 versus 8,15; ratio: 0,13; 95% CI: 0,08 til 0,21).
English: The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic impairment in a single-dose trial.
Danish: Farmakokinetikken af liraglutid blev vurderet hos patienter med varierende grader af nedsat leverfunktion i et enkeltdosisstudie.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Liraglutide did not change the overall exposure of atorvastatin to a clinically relevant degree following single dose administration of atorvastatin 40 mg.
Danish: Liraglutid ændrede ikke den overordnede eksponering for atorvastatin i klinisk relevant grad efter administration af én dosis på 40 mg atorvastatin.
English: Because of lack of experience, Victoza should not be used during breast-feeding.
Danish: På grund af den manglende erfaring må Victoza ikke anvendes under amning.
English: Very common Common Uncommon Rare
Danish: Meget almindelig Almindelig
English: If pancreatitis is suspected, liraglutide should be discontinued; if acute pancreatitis is confirmed, liraglutide should not be restarted (see sections 4.8 and 5.1).
Danish: Hvis der er mistanke om pankreatitis, skal liraglutid seponeres; og hvis akut pankreatitis bekræftes, må behandling med liraglutid ikke påbegyndes igen (se pkt.
English: Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea.
Danish: Svær hypoglykæmi blev primært observeret ved kombination med sulfonylurinstof.
English: The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea or insulin.
Danish: Risikoen for hypoglykæmi kan mindskes ved at reducere patientens dosis af sulfonylurinstof eller insulin.
English: Liraglutide exposure was lowered by 33%, 14%, 27% and 26% in patients with mild (creatinine clearance, CrCl 50-80 ml/min), moderate (CrCl 30-50 ml/min), and severe (CrCl <30 ml/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Danish: Eksponeringen for liraglutid var reduceret med 33%, 14%, 27% og 26% hos patienter med henholdsvis let (kreatinin-clearance (CrCl) 50-80 ml/min), moderat (CrCl 30-50 ml/min) og svært (CrCl <30 ml/min) nedsat nyrefunktion samt dialysekrævende terminal nyreinsufficiens.
English: Few cases of cholelithiasis (0.4%) and cholecystitis (0.1%) have been reported during long-term, controlled phase 3a clinical trials with liraglutide.
Danish: Der er rapporteret om få tilfælde af cholelithiasis (0,4%) og cholecystitis (0,1%) under langvarige, kontrollerede kliniske fase 3a-forsøg med liraglutid.
English: Contents of the pack and other information What Victoza contains
Danish: Pakningsstørrelser og yderligere oplysninger Victoza indeholder
English: Addition of liraglutide resulted in a statistically significantly greater reduction of HbA1c (-0.73% for liraglutide vs -0.40% for comparator) and body weight (-3.03 vs 0.72 kg).
Danish: Tillæg af liraglutid resulterede i en statistisk signifikant større reduktion af HbA1c (-0,73% for liraglutid versus -0,40% for komparator) og legemsvægt (-3,03 kg versus 0,72 kg).
English: Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
Danish: Victoza er indiceret som et supplement til kost og motion til voksne, unge og børn i alderen 10 år og derover med type 2-diabetes mellitus, som ikke er tilstrækkeligt kontrolleret
English: Additional trials were conducted with liraglutide that included 1,901 patients in four unblinded, randomised, controlled clinical trials (including 464, 658, 323 and 177 patients per trial) and one double-blind, randomised, controlled clinical trial in patients with type 2 diabetes mellitus and moderate renal impairment (279 patients).
Danish: Yderligere studier, som inkluderede 1.901 patienter, blev udført med liraglutid: Fire ikke-blindede, randomiserede, kontrollerede kliniske studier (som inkluderede henholdsvis 464, 658, 323 og 177 patienter) og ét dobbeltblindet, randomiseret, kontrolleret klinisk studie med patienter med type 2diabetes mellitus og moderat nedsat nyrefunktion (279 patienter).