FrancophonIA/ELRC3.0 huggingface dataset:
English: • Difficulty sleeping (insomnia).
Danish: • Søvnbesvær (insomni).
English: Pancreatitis*** Delayed gastric emptying****
Danish: Pankreatitis*** Forsinket ventrikeltømning****
English: Few patients treated with liraglutide reported at least one episode of severe diarrhoea.
Danish: Enkelte patienter behandlet med liraglutid rapporterede om mindst én episode med svær diarré.
English: Placebo Liraglutide
Danish: Placebo Liraglutid
English: Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of
Danish: Saxenda er indiceret som et supplement til en kaloriefattig kost og øget fysisk aktivitet til vægtkontrol hos voksne patienter med et start-BMI (Body Mass Index) på
English: Liraglutide should therefore be used with caution in patients with thyroid disease.
Danish: Liraglutid skal derfor anvendes med forsigtighed hos patienter med thyroidea-relateret sygdom.
English: If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Saxenda.
Danish: Hvis du ikke kontrollerer gennemløbet af en ny pen før den første injektion med den, får du måske ikke den ordinerede dosis og den tilsigtede virkning af Saxenda.
English: • you are taking warfarin or other medicines by mouth that reduce your blood clotting (anticoagulants).
Danish: • du tager warfarin eller andre lægemidler gennem munden, som virker blodfortyndende (antikoagulanter).
English: However, dizziness can be experienced mainly during the first 3 months of treatment with Saxenda.
Danish: Svimmelhed kan dog opleves, hovedsageligt under de første 3 måneder ved behandling med Saxenda.
English: Cumulative Frequency (%)
Danish: Akkumuleret hyppighed (%)
English: Liraglutide exposure was not studied in patients with body weight >234 kg.
Danish: Eksponeringen af liraglutid blev ikke undersøgt hos patienter med en legemsvægt >234 kg.
English: Talk to your doctor if you have or have had a disease of the pancreas.
Danish: Tal med lægen, hvis du har eller har haft en sygdom i bugspytkirtlen (pankreas).
English: When starting treatment with Saxenda, you may lose body fluid or become dehydrated.
Danish: Når du starter behandling med Saxenda, kan du miste kropsvæske og blive dehydreret.
English: Using the wrong medicine could be harmful to your health.
Danish: Det kan skade dit helbred at bruge forkert medicin.
English: Heart rate should be monitored at regular intervals consistent with usual clinical practice.
Danish: Hjertefrekvensen skal måles regelmæssigt i overensstemmelse med almindelig klinisk praksis.
English: If you adjust your insulin dose your doctor may recommend you to monitor your blood sugar more frequently.
Danish: Hvis du justerer din insulindosis, vil din læge muligvis anbefale dig at kontrollere dit blodsukker oftere.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke laves nogen anbefaling om dosering.
English: Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.
Danish: Den absolutte biotilgængelighed af liraglutid er ca. 55% efter subkutan administration.
English: • Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Danish: • Omsorgspersoner skal håndtere brugte nåle meget forsigtigt - for at undgå stikuheld og overførsel af infektioner.
English: In the 160-weeks part of trial 1, the weight loss occurred mainly in the first year and was sustained throughout 160 weeks.
Danish: I 160 ugers behandlingsperioden af Studie 1 forekom vægttabet primært i det første år, og det blev fastholdt gennem 160 uger.
English: If you have diabetes, do not use Saxenda as a replacement for insulin.
Danish: Hvis du har diabetes, må du ikke anvende Saxenda som erstatning for insulin.
English: Diarrhoea may affect the absorption of concomitant oral medicinal products.
Danish: Diarré kan påvirke absorptionen af samtidigt indgivne orale lægemidler.
English: Non-lethal thyroid C-cell tumours were seen in two-year carcinogenicity studies in rats and mice.
Danish: Der blev konstateret ikke-dødelige C-celletumorer i thyroidea under 2-årige karcinogenicitetsstudier med rotter og mus.
English: Change in Body Weight (%)
Danish: Ændring i legemsvægt (%)
English: If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible.
Danish: Hvis en dosis glemmes inden for 12 timer fra det tidspunkt, hvor den normalt tages, skal patienten tage dosis hurtigst muligt.
English: These reactions were usually mild and transitory and the majority disappeared during continued treatment.
Danish: Sædvanligvis var disse reaktioner lette og forbigående, og størstedelen forsvandt under fortsat behandling.
English: The use of Saxenda is not recommended if you have severe heart failure.
Danish: Saxenda anbefales ikke, hvis du har alvorligt hjertesvigt.
English: Saxenda is for subcutaneous use only.
Danish: Saxenda er kun til subkutan anvendelse.
English: The liraglutide exposure in adolescents (age 12-17 years) was similar to that in adults with obesity.
Danish: Eksponeringen af liraglutid hos unge (i alderen 12-17 år) var tilsvarende med den for overvægtige voksne.
English: The dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one week intervals to improve gastro-intestinal tolerability (see table 1).
Danish: Dosis bør øges til 3,0 mg én gang dagligt ved stigninger á 0,6 mg med mindst en uges mellemrum for at forbedre den gastrointestinale tolerabilitet (se tabel 1).
English: Use in these patients is not recommended (see section 4.2).
Danish: Brug hos disse patienter anbefales derfor ikke (se pkt.
English: All 3,731 patients were randomised to 56 weeks of treatment and the 2,254 patients with pre-diabetes at screening were randomised to 160 weeks of treatment.
Danish: Alle 3.731 patienter blev randomiseret til 56 ugers behandling, og de 2.254 patienter med prædiabetes ved screening blev randomiseret til 160 ugers behandling.
English: Events reported included severe nausea and severe vomiting which are also the expected symptoms of an overdose with liraglutide.
Danish: De rapporterede tilfælde inkluderede svær kvalme og alvorlig opkastning, hvilket også er de forventede symptomer ved en overdosis med liraglutid.
English: Saxenda is used for weight loss in addition to diet and exercise in adults aged 18 and above who have
Danish: Saxenda anvendes til at opnå vægttab sammen med diæt og motion hos voksne på 18 år og derover, som har
English: Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis.
Danish: Patienter skal informeres om de karakteristiske symptomer på cholelithiasis og cholecystitis.
English: • In this case - you have not received any medicine - even though the dose counter has moved from the original dose that you have set.
Danish: • I så fald har du ikke injiceret noget medicin, heller ikke selv om dosistælleren har bevæget sig fra den oprindelige dosis, du valgte.
English: Liraglutide exposure increased proportionally with dose.
Danish: Eksponeringen af liraglutid steg proportionalt med dosis.
English: Interaction studies have been performed with 1.8 mg liraglutide.
Danish: Der er udført interaktionsstudier med 1,8 mg liraglutid.
English: Baseline Change Baseline Change Apnoea-Hypopnoea Index, events/hour 49.0 -12.2 49.3 -6.1 -6.1* (-11.0; -1.2) Full Analysis Set.
Danish: Apnø-hypopnø-indeks, hændelser/time 49,0 -12,2 49,3 -6,1 -6,1* (-11,0; -1,2) Fuldt analysesæt.
English: Liraglutide lowers body weight in humans mainly through loss of fat mass with relative reductions in visceral fat being greater than for subcutaneous fat loss.
Danish: Liraglutid nedsætter legemsvægten hos mennesker, hovedsageligt via tab af fedtmasse, hvor den relative reduktion i visceralt fedt er større end reduktionen i subkutant fedt.
English: Last observation carried forward.
Danish: Fremskrivning af sidste observation.
English: Patients were randomly allocated to either liraglutide on a daily dose of up to 1.8 mg (4,668) or placebo (4,672), both on a background of standard of care.
Danish: Patienter blev randomiseret til enten liraglutid med en daglig dosis på op til 1,8 mg (4.668) eller placebo (4.672), begge som supplement til standardbehandling.
English: Saxenda works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry.
Danish: Saxenda virker ved at påvirke receptorer i hjernen, der styrer appetitten, så du føler dig mere mæt og mindre sulten.
English: If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment.
Danish: Hvis stigningen til det næste dosistrin ikke tolereres i to på hinanden følgende uger, skal det overvejes at seponere behandlingen.
English: Saxenda is available in pack sizes containing 1, 3 or 5 pens.
Danish: Saxenda fås i pakningsstørrelser med 1, 3 eller 5 penne.
English: Saxenda pre-filled pen and needle (example)
Danish: Saxenda fyldt pen og nål (eksempel)
English: If it shows 3.0, at least 3.0 mg are left in your pen.
Danish: Hvis den viser 3,0, er der mindst 3,0 mg tilbage i pennen.
English: Gastrointestinal disorders were the most frequently reported adverse events in two dose escalation studies completed so far.
Danish: Gastro-intestinale forstyrrelser var de hyppigst rapporterede bivirkninger i to dosisoptrapningsstudier, der ind til videre er afsluttede.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Saxenda in one or more subsets of the paediatric population in the treatment of obesity and in the treatment of Prader-Willi Syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Saxenda i en eller flere undergrupper af den pædiatriske population til behandling af adipositas og til behandling af Prader-Willis syndrom (se pkt.
English: Change in Body Weight (%) Saxenda Placebo
Danish: Ændring i legemsvægt (%) Saxenda Placebo
English: Weight loss response after 12 weeks with liraglutide (3.0 mg) treatment
Danish: Vægttabsreaktion efter 12 ugers behandling med liraglutid (3,0 mg)
English: • Changed sense of taste
Danish: • Ændret smagssans
English: The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results (LEADER) trial included 9,340 patients with insufficiently controlled type 2 diabetes.
Danish: LEADER-studiet (The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results (vurdering af liraglutids effekt på kardiovaskulære endepunkter i diabetes)) inkluderede 9.340 patienter med utilstrækkeligt kontrolleret type 2-diabetes.
English: • Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation - these usually go away after a few days or weeks.
Danish: • Kvalme, opkastning, diarré, forstoppelse - disse bivirkninger forsvinder som regel efter nogle få dage eller uger.
English: The exposure of liraglutide decreases with an increase in baseline body weight.
Danish: Eksponeringen af liraglutid falder med stigende baseline-legemsvægt.
English: • When you first start using Saxenda, the starting dose is 0.6 mg once a day, for at least one week.
Danish: • Når du begynder at bruge Saxenda, er startdosis 0,6 mg én gang dagligt i mindst én uge.
English: Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10);
Danish: Hyppighedskategorierne er defineret som følger: meget almindelig (≥1/10), almindelig
English: Based on the results of population pharmacokinetic analysis, females have 24% lower weight adjusted clearance of liraglutide compared to males.
Danish: Baseret på resultaterne fra en farmakokinetisk populationsanalyse har kvinder 24% lavere vægtjusteret liraglutid-clearance sammenlignet med mænd.
English: Specific data on weight loss, responders, time course and cumulative distribution of weight change (%) for trials 1-4 are presented in tables 3-7 and figures 1, 2 and 3.
Danish: Specifikke data vedrørende vægttab, patienter med effekt, tidsforløb og kumulativ fordeling af vægtændring (%) for studie 1-4 er vist i tabel 3-7 og figur 1, 2 og 3.
English: You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.
Danish: Du skal straks gå til lægen, hvis du får symptomer som åndedrætsbesvær, hævelse af ansigt og hals, og hurtig hjerterytme (puls).
English: - if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for liraglutid eller et af de øvrige indholdsstoffer i Saxenda (angivet i punkt 6).
English: Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment (see section ‘Possible side effects').
Danish: Nogle patienter kan opleve svimmelhed, når de tager Saxenda, hovedsageligt under de første 3 måneder af behandlingen (Se under ”Bivirkninger”).
English: The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea.
Danish: Risikoen for hypoglykæmi kan mindskes ved at reducere dosis af insulin og/eller sulfonylurinstof.
English: Patients ≥65 years of age may experience more gastrointestinal effects when treated with Saxenda.
Danish: Patienter ≥65 år kan hyppigere få gastrointestinale bivirkninger ved behandling med Saxenda.
English: The urine and faeces radioactivity was mainly excreted during the first 6-8 days and corresponded to three minor metabolites, respectively.
Danish: Radioaktiviteten i urin og fæces blev hovedsageligt udskilt i løbet af de første 6-8 dage og hidrører fra tre metabolitter.
English: The predicted mean weight loss in early responders who complete 1 year of treatment is 11.2% of their baseline body weight (9.7% for males and 11.6% for females).
Danish: Det forventede gennemsnitlige vægttab hos dem, der tidligt opnår en effekt, og som gennemfører 1 års behandling, er 11,2% af legemsvægten ved baseline (9,7% for mænd og 11,6% for kvinder).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDET ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Cardiometabolic risk factors
Danish: Kardiometaboliske risikofaktorer
English: Pack sizes of 1, 3 or 5 pre-filled pens.
Danish: Pakningsstørrelser med 1, 3 eller 5 fyldte penne.
English: If your pen is already in use, go to step 3 ‘Select your dose'.
Danish: Hvis din pen allerede er i brug, kan du gå direkte til trin 3 ‘Indstilling af dosis'.
English: The 3.0 mg daily dose of liraglutide provided adequate systemic exposures over the body weight range of 60-234 kg evaluated for exposure response in the clinical trials.
Danish: En dosis på 3,0 mg liraglutid daglig sikrede tilstrækkelig systemisk eksponering i vægtintervallet 60-234 kg vurderet ud fra eksponeringsrespons i kliniske studier.
English: The pen can dial up to a maximum of 3.0 mg.
Danish: Pennen kan indstilles til højst 3,0 mg.
English: How and when to use Saxenda
Danish: Hvordan og hvornår skal du bruge Saxenda
English: Most episodes of gastrointestinal events were mild to moderate, transient and the majority did not lead to discontinuation of therapy.
Danish: De fleste tilfælde af gastrointestinale bivirkninger var lette til moderate og forbigående, og størstedelen førte ikke til seponering af behandlingen.
English: If a patient wishes to become pregnant or pregnancy occurs, treatment with liraglutide should be discontinued.
Danish: Hvis en patient ønsker at blive gravid eller graviditet konstateres, skal liraglutid seponeres.
English: Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure).
Danish: Der blev fundet to metabolitter (≤9% og ≤5% af den samlede eksponering for radioaktivitet) i plasma.
English: Please read these instructions carefully before using your Saxenda pre-filled pen.
Danish: Læs denne vejledning grundigt, inden du bruger den fyldte Saxenda pen.
English: This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
Danish: Dette lægemiddel anbefales ikke, hvis du har alvorlige mave- eller tarmproblemer som forsinket tømning af mavesækken (gastroparese), eller hvis du har en betændelsessygdom i tarmene.
English: • Allergic reactions including skin rash
Danish: • Allergiske reaktioner, herunder udslæt
English: Liraglutide lowered ethinylestradiol and levonorgestrel Cmax by 12% and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Danish: Liraglutid sænkede Cmaks for ethinylestradiol og levonorgestrel med henholdsvis 12 % og 13 % efter administration af en enkelt dosis af et oralt kontraceptionsmiddel.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen.
Danish: Saxenda leveres som en klar og farveløs eller næsten farveløs injektionsvæske, opløsning, i en fyldt pen.
English: If the dose counter stops before 3.0 mg, there is not enough solution left for a full dose of 3.0 mg.
Danish: Hvis dosisvælgeren stopper før 3,0 mg, er der ikke tilstrækkeligt med opløsning tilbage til en fuld dosis på 3,0 mg.
English: This is normal, but you must still check the flow if you use a new pen for the first time.
Danish: Dette er normalt, men du skal alligevel kontrollere gennemløbet, når du tager en ny pen i brug.
English: Pancreatitis is a serious, potentially life-threatening medical condition.
Danish: Pankreatitis er en alvorlig tilstand, der kan være livstruende.
English: Use a calculator to plan the doses as instructed by your doctor or nurse.
Danish: Brug en regnemaskine til at beregne doserne, som lægen eller sygeplejersken har instrueret dig i.
English: A small drop may remain at the needle tip, but it will not be injected.
Danish: Der kan stadig være en lille dråbe tilbage på nålens spids, men den injiceres ikke.
English: • However, if more than 12 hours have passed since you should have used Saxenda, skip the missed dose and inject your next dose the following day at the usual time.
Danish: • Hvis der er gået mere end 12 timer, siden du skulle have taget Saxenda, skal du dog springe den glemte dosis over og injicere den næste dosis den følgende dag på det sædvanlige tidspunkt.
English: If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
Danish: Hvis du taber den eller har mistanke om et problem, skal du sætte en ny nål på og klargøre pennen, før du injicerer.
English: Only the dose counter and dose pointer will show how many mg you select per dose.
Danish: Kun dosistælleren og dosismarkøren viser, hvor mange mg du vælger per dosis.
English: Talk to your doctor, pharmacist or nurse before using Saxenda.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du bruger Saxenda.
English: Both treatment periods were followed by a 12-week off drug/placebo observational follow-up period.
Danish: Begge behandlingsperioder blev efterfulgt af en 12-ugers opfølgende observationsperiode, der var enten behandlingsfri eller med placebo.
English: Table 2 lists adverse reactions reported.
Danish: Tabel 2 viser bivirkninger, der blev rapporteret.
English: Once you start using the pen:
Danish: Efter ibrugtagning af pennen:
English: Pharmacokinetic properties were assessed in clinical pharmacology studies in the paediatric population with obesity aged 12-17 years (14 patients, body weight 80-122 kg) and 7-11 years (16 patients, body weight 45-87 kg) respectively.
Danish: Farmakokinetiske egenskaber blev vurderet i kliniske farmakologi-studier hos den overvægtige pædiatriske population i alderen hhv. 12-17 år (14 patienter, legemsvægt 80-122 kg) og 7-11 år (16 patienter, legemsvægt 45-87 kg).
English: During 24 hours following administration of a single [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide.
Danish: I 24 timer efter administration af en enkelt dosis [3H]-liraglutid til raske forsøgspersoner var den primære bestanddel i plasma uomdannet liraglutid.
English: The primary endpoint was the time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Danish: Det primære endepunkt var tiden fra randomisering til første forekomst af en større kardiovaskulær hændelse (MACE): kardiovaskulær død, ikke-fatal myokardie-infarkt eller ikke-fatal apopleksi.
English: • Do not inject into a vein or muscle.
Danish: • Injicér ikke i en blodåre eller muskel.
English: • If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember.
Danish: • Hvis du har glemt at tage en dosis, og husker det inden for 12 timer, fra det tidspunkt du normalt tager din dosis, skal du injicere den, så snart du kommer i tanke om det.
English: The fact that substantial weight loss can increase the risk of cholelithiasis and thereby cholecystitis only partially explained the higher rate with liraglutide.
Danish: Den kendsgerning, at omfattende vægttab kan øge risikoen for cholelithiasis og dermed cholecystitis, kunne kun delvist forklare den højere forekomst ved behandling med liraglutid.
English: A majority of the reported events occurred in patients who had experienced nausea, vomiting or diarrhoea leading to volume depletion (see section 4.4).
Danish: Størstedelen af de rapporterede hændelser forekom hos patienter, der havde oplevet kvalme, opkastning eller diarré med deraf følgende volumendepletion (se pkt.
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 rådgives om den potentielle risiko for dehydrering i relation til gastrintestinale bivirkninger og tage forholdsregler for at undgå væskedepletion.
English: Because of lack of experience, Saxenda should not be used during breast-feeding.
Danish: På grund af den manglende erfaring bør Saxenda ikke anvendes under amning.
English: • Do not use a double dose or increase the dose on the following day to make up for the missed dose.
Danish: • Du må ikke tage en dobbeltdosis eller øge dosis den følgende dag som erstatning for den glemte dosis.
English: It should be injected in the abdomen, thigh or upper arm.
Danish: Det skal injiceres i abdomen, i låret eller i overarmen.
English: *human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
Danish: *human GLP-1-analog (glucagon-lignende peptid 1) fremstillet ved rekombinant DNA-teknologi i Saccharomyces cerevisiae.
English: Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy.
Danish: Cholelithiasis og cholecystitis kan føre til hospitalsindlæggelse og cholecystektomi.
English: What Saxenda is used for
Danish: Hvad anvendes Saxenda til
English: There is little experience with this medicine in patients of 75 years and older.
Danish: Der er begrænset erfaring med dette lægemiddel hos patienter på 75 år og derover.
English: The efficacy and safety of liraglutide for weight management in conjunction with reduced calorie intake and increased physical activity were studied in four phase 3 randomised, double-blind, placebocontrolled trials which included a total of 5,358 patients.
Danish: Virkningen og sikkerheden af liraglutid til vægtkontrol kombineret med nedsat kalorieindtag og øget fysisk aktivitet blev undersøgt i fire randomiserede, dobbeltblindede, placebokontrollerede fase 3studier, som i alt omfattede 5.358 patienter.