FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop using it, your blood sugar levels may increase.
Danish: Hvis du holder op med at bruge lægemidlet, kan dit blodsukkerniveau stige.
English: Use a calculator to plan the doses.
Danish: Brug en regnemaskine til at planlægge dosis.
English: Liraglutide is metabolised in a similar manner to large proteins without a specific organ having been identified as major route of elimination.
Danish: Liraglutid metaboliseres på samme måde som store proteiner, uden at ét bestemt organ kan udpeges som den væsentligste elimineringsvej.
English: Victoza should not be used if it has been frozen.
Danish: Victoza må ikke anvendes, hvis det har været frosset.
English: Do not take an extra 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: The mean age was 64 years and the mean BMI was 32.5 kg/m².
Danish: Gennemsnitsalderen var 64 år, og den gennemsnitlige BMI var 32,5 kg/m².
English: Please dispose of the pen and needle in accordance with local requirements.
Danish: Kassér venligst pennen og nålen i overensstemmelse med lokale krav.
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT
English: • The starting dose is 0.6 mg once a day, for at least one week.
Danish: • Den sædvanlige startdosis er 0,6 mg én gang dagligt i mindst én uge.
English: • Keep your pen out of the reach of others, especially children.
Danish: • Opbevar pennen utilgængeligt for andre, især børn.
English: Figure 1: Kaplan Meier plot of time to first MACE - FAS population
Danish: Figur 1: Kaplan Meier plot af tiden til første MACE - FAS-population
English: Other clinical data
Danish: Andre kliniske data
English: Liraglutide should not be used during pregnancy, and the use of insulin is recommended instead.
Danish: Liraglutid må ikke anvendes under graviditet, og det anbefales at anvende insulin i stedet.
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: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Victoza should be discontinued.
Danish: Hvis en patient ønsker at blive gravid, eller der konstateres graviditet, bør Victoza seponeres.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Danish: Patienterne skal informeres om de karakteristiske symptomer på akut pankreatitis.
English: Oral contraceptives
Danish: Oral kontraception
English: Daily doses higher than 1.8 mg are not recommended.
Danish: Daglige doser på over 1,8 mg anbefales ikke.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: None of the patients reported severe hypoglycaemia.
Danish: Ingen af patienterne rapporterede alvorlig hypoglykæmi.
English: From clinical trials and marketed use, overdoses have been reported of up to 40 times (72 mg) the recommended maintenance dose.
Danish: Fra kliniske studier og ved brug efter markedsføring er der blevet rapporteret om overdosering med op til 40 gange (72 mg) den anbefalede vedligeholdelsesdosis.
English: No adjustment
Danish: Ingen justering
English: In rats, a no observed adverse effect level (NOAEL) was not observed.
Danish: Hos rotter blev et ”ikke observeret bivirkningsniveau” (no observed adverse effect level - NOAEL) ikke observeret.
English: A clinically relevant interaction with active substances with poor solubility or with narrow therapeutic index such as warfarin cannot be excluded.
Danish: En klinisk relevant interaktion med aktive stoffer med lav opløselighed eller med et snævert terapeutisk indeks, såsom warfarin, kan ikke udelukkes.
English: • Increased pulse
Danish: • Øget puls
English: Be careful not to bend or damage the needle.
Danish: Pas på ikke at bøje eller beskadige nålen.
English: Warfarin and other coumarin derivatives
Danish: Warfarin og andre coumarinderivater
English: With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Danish: Med fortsat behandling blev hyppigheden og sværhedsgraden reduceret hos de fleste patienter, der initialt havde haft kvalme.
English: Low blood sugar (hypoglycaemia) may reduce your ability to concentrate.
Danish: Lavt blodsukker (hypoglykæmi) kan reducere din koncentrationsevne.
English: Intestinal obstruction
Danish: Intestinal obstruktion
English: Do not use the pen if a drop of liraglutide still does not appear.
Danish: Brug ikke pennen, hvis en dråbe liraglutid stadig ikke kommer til syne.
English: The CHMP recommends that the terms of the marketing authorisation should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen ændres.
English: Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility.
Danish: Udover et let fald i antallet af levedygtige implantationer indikerede studier hos dyr ikke nogen skadelig effekt hvad angår fertilitet.
English: Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required.
Danish: Interaktionsundersøgelser har ikke påvist nogen klinisk relevant forsinkelse af absorptionen, og derfor er det ikke nødvendigt at justere dosis.
English: Figure 2: Forest plot of analyses of individual cardiovascular event types - FAS population
Danish: Figur 2: Forest plot af analyser af individuelle kardiovaskulære hændelsestyper - FASpopulationen
English: No data are available in children below 10 years of age.
Danish: Der er ingen tilgængelige data for børn under 10 år.
English: Detailed instructions for use are provided on the other side of this leaflet.
Danish: Der findes en detaljeret brugervejledning på den anden side af denne indlægsseddel.
English: If no drop appears, repeat steps E to G up to four times.
Danish: Hvis der ikke kommer en dråbe til syne, gentag trin E til G op til fire gange.
English: This is because it may block the injection.
Danish: Dette kan blokere injektionen.
English: Pancreatitis was also reported from marketed use.
Danish: Pankreatitis er også blevet rapporteret ved brug efter markedsføring.
English: Please see section 4 for the warning signs of low blood sugar.
Danish: Se advarselssignalerne for lavt blodsukker under punkt 4.
English: This prevents contamination, infection and leakage.
Danish: Dette forhindrer kontaminering, infektioner og lækage.
English: Primary outcome or vital status at end of trial was available for 99.7% and 99.6% of participants randomised to liraglutide and placebo, respectively.
Danish: Det primære resultat eller den vitale status ved afslutningen af studiet var til stede for 99,7% og 99,6% af deltagerne randomiseret til henholdsvis liraglutid og placebo.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: Liraglutide is extensively bound to plasma proteins (>98%).
Danish: Liraglutid bindes i udstrakt grad til plasmaproteiner (>98%).
English: If you split the dose wrong, you may inject too much or too little liraglutide.
Danish: Hvis du fordeler dosis forkert, kan du injicere for meget eller for lidt liraglutid.
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 Pughscore >9).
English: Frequencies 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); not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret som følger: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There was no clinically relevant effect on the overall exposure of either ethinyloestradiol or levonorgestrel.
Danish: Der var ingen klinisk relevant virkning på den overordnede eksponering for hverken ethinylestradiol eller levonorgestrel.
English: The numbers in the display must line up precisely with the pointer to ensure that you get the correct dose.
Danish: De viste tal skal være nøjagtigt ud for markøren for at sikre, at du får en korrekt dosis.
English: Titration of the insulin glargine dose was managed by the patient after instruction by the investigator:
Danish: Titrering af insulin glargin-dosis blev administreret af patienten efter instruktion fra investigator:
English: Elderly patients (>65 years old) No dose adjustment is required based on age (see section 5.2).
Danish: Ældre patienter (>65 år) Dosisjustering, baseret på alder, er ikke nødvendig (se pkt.
English: Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure).
Danish: Der blev konstateret to mindre plasmametabolitter (≤9% og ≤5% af den samlede plasmaeksponering for radioaktivitet).
English: There was no consistent pattern with respect to system organ class of events.
Danish: Der var ikke et konsistent mønster i bivirkningerne i forhold til systemorganklasser.
English: Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Danish: Både forbedring af glykæmisk kontrol og reduktion af kardiovaskulær morbiditet og mortalitet er en essentiel del af behandlingen af type 2-diabetes.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid denne medicin nøjagtigt efter lægens anvisning.
English: MACE: major adverse cardiovascular event %: proportion in percent of subjects with an event N: number of subjects
Danish: MACE: større kardiovaskulær hændelse %: andel i procent af forsøgspersoner med en hændelse N: antal forsøgspersoner
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 vides ikke, hvorvidt ungernes reducerede vækst skyldes nedsat indtag af modermælk på grund af en direkte virkning af GLP-1 eller reduceret mælkeproduktion hos moderen på grund af nedsat kalorieindtag.
English: Insulin glargine4
Danish: Insulin glargin4
English: Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor.
Danish: Liraglutid er en GLP-1-analog med 97% sekvenshomologi til humant GLP-1, der bindes til og aktiverer GLP-1-receptoren.
English: Patients >70 years may experience more gastrointestinal effects when treated with liraglutide.
Danish: Patienter >70 år kan få flere gastrointestinale bivirkninger ved behandling med liraglutid.
English: In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 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 og plasmaproteinbinding.
English: Both treatments resulted in mean body weight loss of approximately 3 kg.
Danish: Begge behandlinger resulterede i en gennemsnitlig reduktion i kropsvægt på ca. 3 kg.
English: - if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section
Danish: - Hvis du er allergisk over for liraglutid eller et af de øvrige indholdsstoffer i dette lægemiddel (anført under punkt 6).
English: • Diarrhoea.
Danish: • Diarré.
English: Taking into account the PRAC Assessment Report on the PSUR for liraglutide, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for liraglutid, er CHMP nået frem til følgende videnskabelige konklusioner:
English: These tumours were not seen in monkeys treated for 20 months.
Danish: Tilsvarende tumorer blev ikke konstateret hos aber, der blev behandlet i 20 måneder.
English: FAS: full analysis set
Danish: FAS: hele analysegruppen
English: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists.
Danish: Der er observeret akut pankreatitis i forbindelse med brugen af GLP-1-receptoragonister.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Danish: De ikke-kliniske data viser ingen særlige risici for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: Victoza must not be administered intravenously or intramuscularly.
Danish: Victoza må ikke administreres intravenøst eller intramuskulært.
English: Upon initiation of liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of INR (International Normalised Ratio) is recommended.
Danish: Ved initiering af behandling med liraglutid hos patienter i behandling med warfarin eller andre coumarinderivater anbefales hyppigere overvågning af INR (International Normalised Ratio).
English: Prepare your pen Check the name and coloured label of your pen to make sure that it contains liraglutide.
Danish: Klargøring af pennen Kontrollér navnet og den farvede etiket på din pen for at sikre, at den indeholder liraglutid.
English: You may stick yourself with the needle.
Danish: Du kan stikke dig selv på nålen.
English: Victoza is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm.
Danish: Victoza administreres én gang dagligt på et vilkårligt tidspunkt, der er uafhængigt af måltider, og kan injiceres subkutant i abdomen, i låret eller i overarmen.
English: Pharmacodynamic effects
Danish: Farmakodynamiske virkninger
English: Population pharmacokinetic analysis suggests that body mass index (BMI) has no significant effect on the pharmacokinetics of liraglutide.
Danish: En farmakokinetisk analyse af patientgrupperne indikerer, at body mass index (BMI) ikke har nogen signifikant virkning på farmakokinetikken af liraglutid.
English: Victoza has no or negligible influence on the ability to drive and use machines.
Danish: Victoza påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Liraglutid må ikke anvendes til patienter med type 1-diabetes mellitus eller til behandling af diabetisk ketoacidose.
English: • Blood pressure and heart rate
Danish: • Blodtryk og hjertefrekvens
English: The efficacy and safety profile of Victoza was comparable to that observed in the adult population treated with Victoza.
Danish: Virknings- og sikkerhedsprofilen for Victoza var sammenlignelig med den, som er observeret hos den voksne population i behandling med Victoza.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Danish: Bilag IV Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen
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-1-receptormedieret mekanisme, som gnavere er særligt følsomme overfor.
English: In addition, liraglutide had a beneficial effect on plasma lipids.
Danish: Liraglutid havde desuden en gavnlig virkning på plasmalipider.
English: There was a comparable risk of hypoglycaemic episodes between the two treatment groups.
Danish: Risikoen for hypoglykæmiske episoder var sammenlignelig i de to behandlingsgrupper.
English: If there is still no drop of liraglutide, change the needle and repeat steps E to G once more.
Danish: Hvis der stadig ikke er en dråbe liraglutid, skal du udskifte nålen og gentage trin E til G en gang mere.
English: It is not known if Victoza passes into breast milk, therefore do not use this medicine if you are breastfeeding.
Danish: Det vides ikke, om Victoza overføres til modermælken, brug derfor ikke dette lægemiddel, hvis du ammer.
English: Combination with insulin
Danish: Kombination med insulin
English: If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.
Danish: Hvis du har tabt pennen på en hård overflade eller har mistanke om, at der er noget galt med den, skal du altid påsætte en ny engangsnål og udføre klargøring af pennen, inden du udfører injektioner med den.
English: • Your doctor will tell you when to increase it to 1.2 mg once a day.
Danish: • Din læge vil fortælle dig, hvornår du skal øge dosis til 1,2 mg én gang dagligt.
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 er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: Combination with oral antidiabetics
Danish: Kombination med orale antidiabetika
English: Combination therapy with sulfonylurea is only valid for adult patients.
Danish: Kombinationsbehandling med sulfonylurinstof er kun begrundet til voksne patienter.
English: However, if it is more than 12 hours since you should have used Victoza, skip the missed dose.
Danish: Hvis der er gået mere end 12 timer, siden du skulle have brugt Victoza, skal den glemte dosis springes over.
English: In the LEADER trial, no long-term clinical impact of increased heart rate on the risk of cardiovascular events was observed.
Danish: I LEADER-studiet blev der ikke observeret nogen langvarig klinisk indvirkning af den øgede hjertefrekvens på risikoen for kardiovaskulære hændelser.
English: Most episodes were mild to moderate and occurred in a dose-dependent fashion.
Danish: De fleste episoder var lette til moderate og forekom dosisafhængigt.
English: Never try to put the inner needle cap back on the needle.
Danish: Forsøg aldrig at sætte den indre nålehætte på nålen igen.
English: Victoza is used on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine).
Danish: Victoza bruges alene, hvis dit blodsukker ikke er tilstrækkeligt kontrolleret med kost og motion alene, og du ikke kan bruge metformin (et andet lægemiddel mod diabetes).
English: Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or faeces (6% and 5%, respectively).
Danish: Kun en mindre del af den indgivne radioaktivitet blev udskilt som metabolitter relateret til liraglutid i urin eller fæces (henholdsvis 6% og 5%).
English: The mean HbA1c at baseline was 8.7% for liraglutide and placebo.
Danish: Middel HbA1c ved baseline var 8,7% for liraglutid og placebo.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: There is no therapeutic 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 erfaring med behandling af patienter med kongestiv hjerteinsufficiens i NYHA-klasse IV (New York Heart Association), og liraglutid anbefales derfor ikke til disse patienter.
English: INSTRUCTIONS FOR USING THE VICTOZA PEN Please read these instructions carefully before using your pen.
Danish: BRUGERVEJLEDNING TIL VICTOZA PENNEN Læs denne vejledning grundigt, inden du bruger din pen.
English: It helps your body reduce your blood sugar level only when blood sugar is too high.
Danish: Det hjælper kroppen med at sænke blodsukkerniveauet, men kun når det er for højt.
English: Overall, frequency, type and severity of adverse reactions in adolescents and children aged 10 years and above were comparable to that observed in the adult population.
Danish: Generelt var hyppigheden, typen og sværhedsgraden af bivirkninger hos unge og børn i alderen 10 år og derover sammenlignelig med det, som blev observeret hos den voksne population.
English: A mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed with liraglutide in long-term clinical trials including LEADER.
Danish: Der er observeret en gennemsnitlig stigning i hjertefrekvens fra baseline på 2 til 3 slag i minuttet med liraglutid i langvarige kliniske studier, herunder LEADER.
English: Liraglutide is not a substitute for insulin.
Danish: Liraglutid er ikke en erstatning for insulin.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: • Microvascular evaluation
Danish: • Mikrovaskulær evaluering
English: * human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
Danish: * Human GLP-1-analog (glukagon-lignende peptid-1) fremstillet ved rekombinant DNA-teknologi i Saccharomyces cerevisiae.
English: • Risk Management Plan
Danish: • Risikostyringsplan (RMP)
English: Pharmacokinetic properties were assessed in clinical studies in the paediatric population with type 2 diabetes aged 10 years and above.
Danish: Farmakokinetiske egenskaber blev vurderet i kliniske studier hos den pædiatriske population med type-2 diabetes i alderen 10 år og derover.
English: Victoza is used with other medicines for diabetes when they are not enough to control your blood sugar levels.
Danish: Victoza bruges i kombination med andre lægemidler mod diabetes, når disse ikke i tilstrækkelig grad kan kontrollere dit blodsukkerniveau.
English: Victoza can be administered with needles up to a length of 8 mm and as thin as 32G.
Danish: Victoza kan administreres med nåle med en længde på op til 8 mm og så tynde som 32G.
English: • Decreased appetite
Danish: • Nedsat appetit
English: • If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Danish: • Hvis du anvender insulin, vil din læge fortælle dig, hvordan du skal reducere insulindosen, og vil anbefale dig at overvåge dit blodsukkerniveau hyppigere med henblik på at undgå hyperglykæmi (for højt blodsukkerniveau) og diabetisk ketoacidose (en komplikation til diabetes, der forekommer, når kroppen ikke er i stand til at nedbryde glukose, fordi der ikke er nok insulin).
English: • Dehydration, sometimes with a decrease in kidney function
Danish: • Væskemangel (dehydrering), nogle gange med nedsat nyrefunktion
English: • Keep your pen away from dust, dirt and all kinds of liquids.
Danish: • Beskyt pennen mod støv, snavs og alle former for væske.
English: Keep the dose button pressed down and leave the needle under the skin for at least 6 seconds.
Danish: Hold dosisknappen trykket i bund, og lad nålen sidde under huden i mindst seks sekunder.
English: Important information about some of the ingredients of Victoza
Danish: Vigtig information om nogle af indholdsstofferne i Victoza
English: Self-measured FPG
Danish: Egen FPG-måling
English: Victoza can be used in adolescents and children aged 10 years and above.
Danish: Victoza kan anvendes til unge og børn i alderen 10 år og derover.