FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that Betavert N is similar to a ‘reference medicine' already authorised in the European Union (EU) called Betaserc 8.
Danish: Det betyder, at Betavert N er identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union, i dette tilfælde Betaserc 8.
English: The grounds for the referral were concerns expressed by the Czech Republic that Betavert N had not been shown to be bioequivalent to Betaserc 8.
Danish: Begrundelsen for indbringelsen var Den Tjekkiske Republiks betænkeligheder ved, at det ikke var påvist, at Betavert N var bioækvivalent med Betaserc 8.
English: The CHMP therefore concluded that Betavert N could be considered a generic medicine of Betaserc 8, and the marketing authorisation for Betavert N should be granted in all concerned Member States.
Danish: CHMP konkluderede derfor, at Betavert N kan betragtes som et generisk lægemiddel, da det er identisk med Betaserc 8, og at der bør udstedes markedsføringstilladelse for Betavert N i all de berørte medlemsstater.
English: Hennig Arzneimittel GmbH & Co. KG submitted Betavert N for mutual recognition on the basis of the initial authorisation granted by Germany on 18 April 2007.
Danish: KG indgav en ansøgning om gensidig anerkendelse af Betavert N på grundlag af en oprindelig markedsføringstilladelse udstedt af Tyskland den 18. april 2007.
English: This allows a dilation of the blood vessels in the inner ear, thus helping the pressure to drop and relieving the symptoms of the disease.
Danish: På denne måde udvider blodkarrene i det indre øre sig, hvorved trykket falder og symptomerne på sygdommen lindres.
English: Menière's disease is a disease where an accumulation of fluid in the inner ear causes a build-up of pressure.
Danish: Menières sygdom består i, at der sker en ophobning af væske i det indre øre, hvorved trykket forøges.
English: Company responses provided on: 11 February 2009 Opinion date:
Danish: Dato for virksomhedens svar:
English: especially children.
Danish: især børn.
English: You may then hear or feel a click.
Danish: Du kan eventuelt høre eller mærke et klik.
English: Observed values for patients completing each scheduled visit
Danish: Observerede værdier for patienter, der fuldførte hvert planlagt besøg
English: Your doctor will tell you how much Saxenda to use each week.
Danish: Din læge vil fortælle dig, hvor meget Saxenda du skal bruge hver uge.
English: The duration of exposure was between 3.5 and 5 years.
Danish: Eksponeringsvarigheden var mellem 3,5 og 5 år.
English: Your doctor will assess your treatment on a regular basis.
Danish: Din læge vil jævnligt vurdere din behandling.
English: Be very careful to calculate correctly.
Danish: Vær omhyggelig med at regne rigtigt.
English: This may help you eat less food and reduce your body weight.
Danish: Det kan hjælpe dig til at spise mindre mad og sænke din legemsvægt.
English: If you need more medicine than what is left in your pen
Danish: Hvis du har brug for mere medicin, end der er tilbage i pennen
English: Look through the pen window.
Danish: Kig igennem vinduet i pennen.
English: This is because the effects and safety of this medicine have not been studied in this age group.
Danish: Det skyldes, at virkningen og sikkerheden af lægemidlet ikke er undersøgt hos denne aldersgruppe.
English: ****From controlled phase 2, 3a and 3b clinical trials.
Danish: ****Fra kontrollerede fase 2, 3a og 3b kliniske studier.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, skal navnet og batchnummeret på det administrerede produkt tydeligt registreres.
English: Usually, you will be told to follow the table below.
Danish: Normalt vil du få besked på at følge nedenstående tabel.
English: Summary of the safety profile:
Danish: Opsummering af sikkerhedsprofilen:
English: 1 pen 3 pens 5 pens
Danish: 1 pen 3 penne 5 penne
English: Consult your doctor before you continue.
Danish: Kontakt din læge før du fortsætter.
English: Do not increase your dose further.
Danish: Du må ikke øge din dosis yderligere.
English: BMI (Body Mass Index) is a measure of your weight in relation to your height.
Danish: BMI (Body Mass Index) er et mål for din vægt i forhold til din højde.
English: 30 months After first use: 1 month
Danish: 30 måneder Efter ibrugtagning: 1 måned
English: The following effects may happen:
Danish: Der kan opstå følgende bivirkninger:
English: Time from randomization (months)
Danish: Tid efter randomisering (måneder)
English: The pain may be felt through to your back or right shoulder.
Danish: Smerten kan stråle ud mod din ryg eller højre skulder.
English: Figure 4 Kaplan Meier plot of time to first MACE - FAS population
Danish: Figur 4: Kaplan Meier plot af tiden til første MACE - FAS-population
English: • You can use Saxenda at any time of the day, with or without food and drink.
Danish: • Du kan bruge Saxenda på et vilkårligt tidspunkt på dagen, med eller uden mad og drikke.
English: Saxenda is administered once daily at any time, independent of meals.
Danish: Saxenda administreres én gang dagligt på et vilkårligt tidspunkt uafhængigt af måltider.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Danish: I tilfælde af overdosering skal der initieres passende understøttende behandling baseret på patientens kliniske tegn og symptomer.
English: It also ensures that the dosing is accurate.
Danish: Det sikrer også, at doseringen er nøjagtig.
English: Your treatment will start at a low dose which will be gradually increased over the first five weeks of treatment.
Danish: Din behandling starter med en lav dosis, som gradvist øges i løbet af de første fem ugers behandling.
English: Your doctor will start you on a diet and exercise programme.
Danish: Din læge vil fastlægge et diæt- og motionsprogram for dig.
English: SD=standard deviation.
Danish: SD=standardafvigelse.
English: People with diabetes
Danish: Personer med diabetes
English: • Before you use the pen for the first time, your doctor or nurse will show you how to use the pen.
Danish: • Inden du anvender pennen første gang, vil din læge eller sygeplejerske vise dig, hvordan pennen bruges.
English: Tell your doctor if you have diabetes.
Danish: Fortæl det til lægen, hvis du har diabetes.
English: Full Analysis Set.
Danish: Fuldt analysesæt.
English: Insomnia**
Danish: Insomni**
English: **Insomnia was mainly seen during the first 3 months of treatment.
Danish: **Insomni blev hovedsageligt observeret i de første 3 behandlingsmåneder.
English: GLP-1 is a physiological regulator of appetite and food intake, but the exact mechanism of action is not entirely clear.
Danish: GLP-1 er en fysiologisk regulator af appetit og fødeindtag, men den eksakte virkningsmekanisme er ikke fuldt klarlagt.
English: Please see section ‘Description of selected adverse reactions' for further information.
Danish: Se punktet ‘Beskrivelse af udvalgte bivirkninger' for yderligere oplysninger.
English: HR: 0.87 95% CI 0.78; 0.97 p<0.001 for non-inferiority p=0.005 for superiority
Danish: HR: 0,87 95% CI 0,78; 0,97 p<0,001 for non-inferioritet p=0,005 for superioritet
English: The vast majority of these had established cardiovascular disease.
Danish: Størstedelen af disse havde allerede kardiovaskulær sygdom.
English: The majority of events were mild or moderate.
Danish: Størstedelen af hændelserne var lette eller moderate.
English: No other treatment-related tumours have been found.
Danish: Der er ikke konstateret andre behandlingsrelaterede tumorer.
English: • Use Saxenda at about the same time each day - choose a time of the day that works best for you.
Danish: • Brug Saxenda på omtrent samme tidspunkt hver dag - vælg et tidspunkt på dagen, der passer dig.
English: • Faster pulse.
Danish: • Hurtigere puls.
English: EXP Discard pen 1 month after first use
Danish: EXP Pennen skal bortskaffes 1 måned efter første anvendelse
English: Before first use:
Danish: Før brug:
English: The majority of events were mild.
Danish: Størstedelen af hændelserne var lette.
English: Apnoea-Hypopnoea Index (AHI)
Danish: Apnø-hypopnø-indeks (AHI)
English: Stay on this programme while you are using Saxenda.
Danish: Hold dig til dette program, mens du bruger Saxenda.
English: Liraglutide binds to and activates the GLP-1 receptor (GLP-1R).
Danish: Liraglutid bindes til og aktiverer GLP-1receptoren (GLP-1R).
English: Liraglutide should not be used during pregnancy.
Danish: Liraglutid må ikke anvendes under graviditeten.
English: Adverse reactions are listed by system organ class and frequency.
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed.
English: The dose selector clicks differently when turned forward, backwards or past the number of mg left.
Danish: Dosisvælgeren klikker forskelligt, når den drejes frem, tilbage eller forbi det antal mg, der er tilbage.
English: Stop taking Saxenda and contact a doctor immediately if you notice any of the following serious side effects:
Danish: Stop med at tage Saxenda, og kontakt straks en læge, hvis du bemærker nogen af følgende alvorlige bivirkninger:
English: Increased lipase
Danish: Forhøjet lipase
English: These findings in rodents are caused by a non-genotoxic, specific GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Danish: Resultaterne hos gnaverne skyldes en ikke-genotoksisk, specifik GLP-1receptormedieret mekanisme, som gnavere er særligt følsomme for.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, bør dette lægemiddel ikke opblandes med andre lægemidler.
English: Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs
Danish: Din læge vil fortælle dig, hvordan du kan behandle lavt blodsukker, og hvad du skal gøre, hvis du bemærker et eller flere af disse advarselssignaler
English: Patients with heart failure
Danish: Patienter med hjerteinsufficiens
English: If you do that, you may not get the intended effect of this medicine.
Danish: opnår du muligvis ikke den tilsigtede virkning af medicinen.
English: Saxenda is given as an injection under the skin (subcutaneous injection).
Danish: Saxenda gives som en injektion under huden (subkutan injektion).
English: Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination.
Danish: Liraglutid metaboliseres endogent på samme måde som store proteiner uden et bestemt organ som den væsentligste elimineringsvej.
English: If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.
Danish: Hvis du vælger den forkerte dosis, kan du dreje dosisvælgeren frem eller tilbage til den rigtige dosis.
English: Missing post-baseline values were imputed using the last observation carried forward.
Danish: Manglende værdier efter baseline blev beregnet via fremskrivning af den sidste observation.
English: Do not use Saxenda after the expiry date which is stated on the pen label and carton after ‘EXP'.
Danish: Brug ikke Saxenda efter den udløbsdato, der står på pennen og på pakningen efter 'EXP'.
English: GLP-1 receptors are also expressed in specific locations in the heart, vasculature, immune system and kidneys.
Danish: GLP-1-receptorer udtrykkes også specifikke steder i hjertet, vaskulaturen, immunsystemet og nyrerne.
English: Exposure was significantly lower (44%) in patients with severe hepatic impairment (Child Pugh score >9).
Danish: Eksponeringen var signifikant lavere (44 %) hos patienter med svært nedsat leverfunktion (Child Pugh-score > 9).
English: However, it is preferable that Saxenda is injected around the same time of the day, when the most convenient time of the day has been chosen.
Danish: Det anbefales dog at Saxenda injiceres på cirka samme tidspunkt hver dag, når det mest passende tidspunkt i løbet af dagen er valgt.
English: Liraglutide is extensively bound to plasma protein (>98%).
Danish: Liraglutid bindes i udstrakt grad til plasmaprotein (>98%).
English: There was no clinically relevant effect on the overall exposure of either ethinylestradiol or levonorgestrel.
Danish: Der var ingen klinisk relevant virkning på den overordnede eksponering af hverken ethinylestradiol eller levonorgestrel.
English: Before week 0 patients were only treated with low-calorie diet and exercise.
Danish: Før uge 0 blev patienterne kun behandlet med kaloriefattig kost og motion.
English: There is no clinical experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
Danish: Der er ingen klinisk erfaring hos patienter med kongestiv hjerteinsufficiens i NYHA-klasse IV (New York Heart Association), og liraglutid anbefales derfor ikke til brug hos disse patienter.
English: You can select up to 3.0 mg per dose.
Danish: Du kan vælge op til 3,0 mg per dosis.
English: Time in weeks
Danish: Tid i uger
English: • increase of pancreatic enzymes, such as lipase and amylase.
Danish: • Forhøjet niveau af enzymer i bugspytkirtlen, såsom lipase og amylase.
English: If you feel dizziness be extra careful while driving or using machines.
Danish: Hvis du føler dig svimmel, skal du være ekstra forsigtig, når du fører motorkøretøj eller betjener maskiner.
English: Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required.
Danish: Interaktionsstudier har ikke påvist nogen klinisk relevant forsinkelse i absorptionen, og derfor er det ikke nødvendigt at justere dosis.
English: The heart rate peaked after approximately 6 weeks.
Danish: Hjertefrekvensen var højest efter ca. 6 uger.
English: A clinically relevant interaction with active substances with poor solubility or narrow therapeutic index such as warfarin cannot be excluded.
Danish: En klinisk relevant interaktion med aktive stoffer med lav opløselighed eller et snævert terapeutisk indeks, såsom warfarin, kan ikke udelukkes.
English: Table 2 Adverse reactions reported MedDRA system organ classes
Danish: Tabel 2 Bivirkninger rapporteret MedDRA systemorganklasser
English: It is not known whether liraglutide is excreted in human milk.
Danish: Det er ikke kendt, om liraglutid udskilles i human mælk.
English: Animal studies did not indicate direct harmful effects with respect to fertility but slightly increased early embryonic deaths at the highest dose.
Danish: Dyrestudier har ikke indikeret direkte skadelige virkninger på fertiliteten, men en let øget incidens af tidlig embryonal død ved den højeste dosis.
English: Saxenda should not be used if it has been frozen.
Danish: Saxenda må ikke anvendes, hvis det har været frosset.
English: Important information about some of the ingredients of Saxenda
Danish: Vigtig information om nogle af indholdsstofferne i Saxenda
English: None of the reports included severe hypoglycaemia.
Danish: Ingen af de rapporterede tilfælde inkluderede alvorlig hypoglykæmi.
English: • Feeling weak or tired
Danish: • Svaghed eller træthed
English: Saxenda is not recommended for use in paediatric patients.
Danish: Saxenda anbefales ikke til brug hos pædiatriske patienter.
English: It only shows approximately how much solution is left in your pen.
Danish: Den viser kun, hvor meget opløsning der cirka er tilbage i pennen.
English: Change the needle as described in step 5 ‘After your injection' and repeat all steps starting with step 1 ‘Prepare your pen with a new needle'.
Danish: Udskift nålen som beskrevet i trin 5 ‘Efter injektionen' og gentag alle trin med start fra trin 1 ‘Klargøring af pennen med en ny nål'.
English: In rats, a no observed adverse effect level (NOAEL) was not observed.
Danish: Hos rotter blev et ‘ikke observeret bivirkningsniveau' (NOAEL - no observed adverse effect level) ikke observeret.
English: If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.
Danish: Hvis du ikke er sikker på, hvordan du skal opdele din dosis, når du bruger to penne, skal du vælge og injicere den dosis, du har brug for, med en ny pen.
English: Example 0.6 mg selected
Danish: Eksempel 0,6 mg valgt
English: This usually occurs the first 3 months of treatment
Danish: Dette forekommer normalt i de 3 første måneder af behandlingen
English: Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility (see section 5.3).
Danish: Ud over et let fald i antallet af levedygtige implantationer, indikerede dyrestudier ikke nogen skadelige virkninger hvad angår fertilitet (se pkt.
English: Dose escalation 4 weeks
Danish: Dosisstigning 4 uger
English: Only if trained or advised by your doctor or nurse, you may split your dose between your current pen and a new pen.
Danish: Kun hvis din læge eller sygeplejerske har instrueret dig i eller rådet dig til det, kan du dele dosis mellem den aktuelle pen og en ny pen.
English: The reactions usually occurred during the first weeks of treatment and diminished within a few days or weeks on continued treatment.
Danish: Bivirkningerne forekom som regel i de første uger af behandlingen og aftog inden for få dage eller uger under fortsat behandling.
English: These tumours were not seen in monkeys treated for 20 months.
Danish: Tilsvarende tumorer blev ikke fundet hos aber, der blev behandlet i 20 måneder.
English: The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose.
Danish: Den valgte dosis skal være nøjagtigt ud for dosismarkøren for at sikre, at du får en korrekt dosis.
English: Daily doses higher than 3.0 mg are not recommended.
Danish: En daglig dosis på over 3,0 mg anbefales ikke.
English: The long-term clinical impact of this mean increase in heart rate has not been established.
Danish: Den langtidsvarende kliniske virkning af denne gennemsnitlige stigning i hjertefrekvensen er ikke klarlagt.
English: • You doctor will instruct you to gradually increase your dose by 0.6 mg usually each week until you reach the recommended dose of 3.0 mg once a day.
Danish: • Din læge vil instruere dig i gradvis at øge din dosis med 0,6 mg, normalt hver uge, indtil du er nået op på den anbefalede dosis på 3,0 mg én gang dagligt.
English: • Do not inject Saxenda which has been frozen.
Danish: • Du må ikke injicere Saxenda, som har været frosset.
English: Get help from a person with good eyesight who is trained to use the Saxenda pre-filled pen.
Danish: Få hjælp af en person med godt syn, som har fået undervisning i at bruge den fyldte Saxenda pen.
English: At week 0 patients were randomised to receive either Saxenda or placebo.
Danish: Ved uge 0 blev patienterne randomiseret til at få enten Saxenda eller placebo.
English: The mean apparent volume of distribution after subcutaneous administration is 20-25 L (for a person weighing approximately 100 kg).
Danish: Det gennemsnitlige tilsyneladende fordelingsvolumen efter subkutan administration er 20-25 l (for en person, der vejer ca. 100 kg).
English: There are limited data from the use of liraglutide in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af liraglutid til gravide kvinder.
English: The patient should be observed for clinical signs of dehydration and blood glucose should be monitored.
Danish: Patienten bør observeres for kliniske tegn på dehydrering, og blodglucose bør monitoreres.
English: Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends.
Danish: Når du er nået op på den anbefalede dosis på 3,0 mg i behandlingens 5. uge, skal du fastholde denne dosis, indtil din behandlingsperiode slutter.
English: The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick,
Danish: Advarselssignalerne for lavt blodsukker kan komme pludseligt og kan omfatte: Koldsved, kold bleg hud, hovedpine, hurtige hjerteslag (puls), kvalme,
English: Novo Nordisk A/S Hallas Allé 4400 Kalundborg Denmark
Danish: Novo Nordisk A/S Hallas Allé 4400 Kalundborg Danmark
English: In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 (CYP) and plasma protein binding.
Danish: In vitro har liraglutid udvist meget lavt potentiale for involvering i farmakokinetisk interaktion med andre aktive stoffer relateret til cytochrom P450 (CYP) og plasmaproteinbinding.
English: More frequent blood testing to determine the ability of your blood to clot may be required.
Danish: Det kan være nødvendigt at tage hyppigere blodprøver for at bestemme blodets evne til at størkne.
English: Saxenda should not be used in children and adolescents under 18 years of age.
Danish: Saxenda må ikke anvendes til børn og unge under 18 år.
English: It is unknown whether the reduced pup growth is caused by reduced pup milk intake due to a direct GLP-1 effect or reduced maternal milk production due to decreased caloric intake.
Danish: Det er ukendt, hvorvidt ungernes reducerede vækst skyldes nedsat mælkeindtag på grund af en direkte virkning af GLP-1 eller reduceret mælkeproduktion hos moderen på grund af nedsat kalorieindtag.
English: See section 4 for the warning signs of low blood sugar.
Danish: Se advarselssignalerne for lavt blodsukker under punkt 4.
English: Lifestyle intervention in the form of an energy-restricted diet and exercise counselling was background therapy for all patients.
Danish: Livsstilsændringer i form af energibegrænset kost og motionsrådgivning var baggrundsbehandling for alle patienter.
English: Do not store the pen with a needle attached For use by one person only
Danish: Opbevar ikke pennen med påsat nål Må kun anvendes af én person
English: The safety and efficacy of Saxenda in children and adolescents below 18 years of age have not yet been established.
Danish: Sikkerheden og virkningen af Saxenda hos børn og unge under 18 år er endnu ikke klarlagt.
English: The dose selector changes the dose.
Danish: Dosisvælgeren ændrer dosis.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: (≥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: Patients with an event (%)
Danish: Patienter med en hændelse %)
English: Driving or use of machines should be exercised with caution if dizziness occurs.
Danish: At føre motorkøretøj eller betjene maskiner bør udføres med forsigtighed, hvis svimmelhed forekommer.
English: • Low blood sugar (hypoglycaemia).
Danish: • Lavt blodsukker (hypoglykæmi).
English: From clinical trials and post-marketing use of liraglutide overdoses have been reported up to 72 mg (24 times the recommended dose for weight management).
Danish: Fra kliniske studier og ved brug af liraglutid efter markedsføring er der blevet rapporteret om overdosering med op til 72 mg (24 gange den anbefalede dosis til vægtkontrol).
English: It is not recommended if you are 75 years or older.
Danish: Lægemidlet anbefales ikke, hvis du er fyldt 75 år.
English: Events were isolated and the majority resolved during continued treatment with Saxenda.
Danish: Hændelserne var isolerede, og størstedelen forsvandt under fortsat behandling med Saxenda.
English: Upon initiation of liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of International Normalised Ratio (INR) is recommended.
Danish: Ved initiering af behandling med liraglutid hos patienter i behandling med warfarin eller andre coumarinderivater anbefales hyppigere overvågning af INR (International Normaliseret Ratio).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Danish: Prækliniske data viser ingen specielle risici for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.