FrancophonIA/ELRC3.0 huggingface dataset:
English: Very few episodes (0.001 events/patient year) were observed with administration of liraglutide in combination with oral antidiabetics other than sulfonylureas.
Danish: Der blev observeret meget få episoder (0,001 hændelser/patientår) med administration af liraglutid i kombination med andre orale antidiabetika end sulfonylurinstoffer.
English: If you have symptoms of acute pancreatitis, such as persistent, severe stomach ache, you should consult your doctor immediately (see section 4).
Danish: Hvis du har symptomer på akut betændelse i bugspytkirtlen, såsom vedvarende stærke mavesmerter, skal du straks kontakte din læge (se punkt 4).
English: Victoza is available in packs containing 1, 2, 3, 5 or 10 pens.
Danish: Victoza fås i pakker med 1, 2, 3, 5 eller 10 penne.
English: In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following active substances:
Danish: Det er især vigtigt, at du fortæller det til lægen, apotekspersonalet eller sygeplejersken, hvis du bruger medicin, der indeholder et eller flere af følgende aktive stoffer:
English: Pull out the needle.
Danish: Træk nålen ud.
English: Animal studies did not indicate direct harmful effects with respect to fertility but slightly increased early embryonic deaths at the highest dose.
Danish: Dyreforsøg har ikke indikeret direkte skadelige effekter på fertiliteten, men en let øget incidens af tidlig fosterdødelighed ved maksimumdosis.
English: This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
Danish: Dette reducerer risikoen for urenheder, infektioner, lækage af liraglutid, blokerede nåle og unøjagtig dosering.
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, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor).
Danish: Advarselssignalerne for hypoglykæmi kan komme pludseligt og kan medføre: koldsved, kold bleg hud, hovedpine, hurtig hjertebanken, kvalme, usædvanlig stor sultfornemmelse, synsforstyrrelser, døsighed, svaghed, nervøsitet, angst, forvirring, koncentrationsbesvær og rysten.
English: Victoza contains the active substance liraglutide.
Danish: Victoza indeholder det aktive stof liraglutid.
English: After first use of the pen, store below 30°C or in a refrigerator.
Danish: Efter første anvendelse af pennen skal den opbevares ved temperaturer under 30°C eller i køleskab.
English: • Increase of pancreatic enzymes (such as lipase and amylase).
Danish: • Forhøjet niveau af enzymer i bugspytkirtlen (såsom lipase og amylase).
English: OTHER SPECIAL WARNINGS, IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: The exposure of liraglutide decreases with increasing body weight.
Danish: Eksponeringen for liraglutid aftager med stigende legemsvægt.
English: Increase in insulin glargine dose (IU)
Danish: Stigning i insulin glargin dosis (IE)
English: Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.
Danish: Den absolutte biotilgængelighed for liraglutid er cirka 55% efter subkutan administration.
English: Investigations
Danish: Undersøgelser
English: Generally, the patients reported severe nausea, vomiting and diarrhoea.
Danish: Generelt har patienterne rapporteret alvorlig kvalme, opkastning og diarré.
English: Following a [3H]-liraglutide dose, intact liraglutide was not detected in urine or faeces.
Danish: Efter en [3H]-dosis af liraglutid blev der ikke konstateret intakt liraglutid i urin eller fæces.
English: Five double-blind, randomised, controlled clinical phase 3a adult trials were conducted to evaluate the effects of liraglutide on glycaemic control (Table 2).
Danish: Der blev udført fem dobbeltblindede, randomiserede, kontrollerede kliniske fase 3a-studier hos voksne for at vurdere virkning af liraglutid på den glykæmiske kontrol (Tabel 2).
English: • Clean the pen with a cloth moistened with a mild detergent.
Danish: • Rengør pennen med en klud fugtet med et mildt rengøringsmiddel.
English: If you forget a dose, use Victoza as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, skal du bruge Victoza, så snart du kommer i tanke om det.
English: The safety profile of liraglutide was generally similar to that observed in other studies with liraglutide.
Danish: Sikkerhedsprofilen for liraglutid var generelt svarende til hvad der er observeret i andre studier med liraglutid.
English: Diarrhoea may affect the absorption of concomitant oral medicinal products.
Danish: Diarré kan påvirke absorptionen af samtidigt oralt indgivne lægemidler.
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 af svær diarré.
English: Following subcutaneous administration, the protracted action profile is based on three mechanisms: self-association, which results in slow absorption; binding to albumin; and higher enzymatic stability towards the dipeptidyl peptidase -4 (DPP-4) and neutral endopeptidase (NEP) enzymes, resulting in a long plasma half-life.
Danish: Efter subkutan administration er den langvarige virkningsprofil baseret på tre mekanismer: selvassociering, der resulterer i langsom absorption; binding til albumin; samt højere enzymstabilitet for DPP-4- og NEP-enzymerne (dipeptidylpeptidase-4 og neutral endopeptidase), hvilket resulterer i lang plasmahalveringstid.
English: Dispose of it carefully and put the pen cap back on.
Danish: Smid den omhyggeligt ud, og sæt penhætten på igen.
English: Cholelithiasis and cholecystitis
Danish: Cholelithiasis og cholecystitis
English: 9,340 patients were randomly allocated to either liraglutide (4,668) or placebo (4,672), both in addition to standards of care for HbA1c and cardiovascular (CV) risk factors.
Danish: 9.340 patienter blev randomiseret til enten liraglutid (4.668) eller placebo (4.672), begge som supplement til standardbehandling af HbA1c og kardiovaskulære risikofaktorer.
English: Liraglutide exposure increased proportionally with dose.
Danish: Eksponeringen for liraglutid steg proportionelt med dosis.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Victoza is used in combination with a sulfonylurea or insulin.
Danish: Patienterne bør rådes til at udvise forsigtighed for at undgå hypoglykæmi, mens de fører motorkøretøj eller betjener maskiner, særligt hvis Victoza anvendes i kombination med sulfonylurinstof eller insulin.
English: Dose adjustments of griseofulvin and other compounds with low solubility and high permeability are not required.
Danish: Dosisjustering for griseofulvin og andre forbindelser med lav opløselighed og høj permeabilitet er ikke nødvendig.
English: Most episodes of confirmed hypoglycaemia in clinical trials were minor.
Danish: De fleste bekræftede episoder af hypoglykæmi i de kliniske forsøg var af mindre karakter.
English: There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis.
Danish: Der er begrænset erfaring med behandling af patienter med inflammatorisk tarmsygdom og diabetisk gastroparese.
English: Pack sizes of 1, 2, 3, 5 or 10 pre-filled pens.
Danish: Pakningsstørrelser med 1, 2, 3, 5 eller 10 fyldte penne.
English: Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues.
Danish: Farmakoterapeutisk klassifikation: Lægemidler til brug ved diabetes, glukagon-lignende peptid-1 (GLP-1)-analoger.
English: Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control.
Danish: Det forventes, at nogle patienter kan have gavn af en dosisøgning fra 1,2 mg til 1,8 mg, og baseret på det kliniske respons kan dosis, efter mindst én uge, øges til 1,8 mg for yderligere at forbedre den glykæmiske kontrol.
English: The treatment difference in HbA1c was 1.3% after additional 26 weeks of open label extension, confirming the sustained glycaemic control with Victoza.
Danish: Behandlingsforskellen i HbA1C var 1,3% efter yderligere 26 ugers åben forlængelse af studiet, hvilket bekræfter den vedvarende glykæmiske kontrol med Victoza.
English: • Warfarin or other oral anti-coagulation medicines.
Danish: • Warfarin og andre orale lægemidler mod blodpropper.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Table 2 Liraglutide clinical phase 3 trials in monotherapy (52 weeks) and in combination with oral antidiabetics (26 weeks)
Danish: Tabel 2 Kliniske fase 3-studier med liraglutid som monoterapi (52 uger) og i kombination med orale antidiabetika (26 uger)
English: Do not use this medicine if the solution is not clear and colourless or almost colourless.
Danish: Brug ikke lægemidlet, hvis opløsningen ikke er klar og farveløs eller næsten farveløs.
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells.
Danish: GLP-1-receptoren er mål for det native GLP-1, et endogent inkretinhormon, der potentierer glucoseafhængig insulinsekretion fra de pankreatiske betaceller.
English: Thyroid adverse events, such as goitre, have been reported in clinical trials and in particular in patients with pre-existing thyroid disease.
Danish: Thyroidea-relaterede bivirkninger, f.eks. struma, er blevet rapporteret i kliniske studier, og særligt hos patienter med allerede eksisterende thyroideasygdom.
English: The apparent volume of distribution after subcutaneous administration is 11-17 l. The mean volume of distribution after intravenous administration of liraglutide is 0.07 l/kg.
Danish: Det tilsyneladende fordelingsvolumen efter subkutan administration er 11-17 l. Middelfordelingsvolumen efter intravenøs administration af liraglutid er 0,07 l/kg.
English: Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration.
Danish: modsætning til det native GLP-1 har liraglutid en farmakokinetisk og farmakodynamisk profil hos mennesker, der gør det egnet til dosering én gang dagligt.
English: During 24 hours following administration of a single radiolabelled [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide.
Danish: 24 timer efter administration af én radioaktivt mærket [3H]-dosis af liraglutid hos raske forsøgspersoner var den største bestanddel i plasma intakt liraglutid.
English: If you selected a wrong dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer.
Danish: Hvis du er kommet til at vælge den forkerte dosis, kan du ændre den ved at dreje dosisvælgeren frem eller tilbage, indtil den rigtige dosis er ud for markøren.
English: The urine and faeces radioactivity was mainly excreted during the first 68 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 svarer til tre mindre metabolitter.
English: Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2).
Danish: Diabetisk ketoacidose er indberettet hos insulinafhængige patienter efter hurtig seponering eller dosisreduktion af insulin (se pkt.
English: In the LEADER trial, (see subsection Cardiovascular evaluation), 873 patients were on premix insulin (with or without OAD(s)) at baseline and at least for the following 26 weeks.
Danish: I LEADER-studiet (se underafsnittet Kardiovaskulær vurdering) var 873 patienter på forblandet insulin (med eller uden orale antidiabetika) ved baseline og som minimum i de efterfølgende 26 uger.
English: Needles are not included.
Danish: Nåle medfølger ikke.
English: Liraglutide reduced postprandial glucose across all three daily meals by 31-49 mg/dl (1.682.71 mmol/l).
Danish: Liraglutid reducerede postprandial glucose for alle tre daglige måltider med 31-49 mg/dl (1,682,71 mmol/l).
English: The patient should be advised to discard the injection needle in accordance with local requirements after each injection and store the pen without an injection needle attached.
Danish: Patienten bør rådes til at bortskaffe nålen i overensstemmelse med lokale krav efter hver injektion og opbevare pennen uden påsat nål.
English: Do not stop using Victoza without talking to your doctor.
Danish: Du må ikke holde op med at bruge Victoza uden først at have talt med din læge om det.
English: On the basis of the scientific conclusions for liraglutide the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing liraglutide is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for liraglutid er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder liraglutid forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Skin and subcutaneous tissue disorder
Danish: Hud og subkutane væv
English: Dehydration
Danish: Dehydrering
English: In the LEADER study, delayed gastric emptying was reported three times more frequently in the liraglutide group compared to the placebo group.
Danish: I LEADER-studiet blev der rapporteret forsinket ventrikeltømning tre gange hyppigere end i liraglutidgruppen i sammenligning med placebogruppen.
English: Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Danish: Svære og vedvarende mavesmerter, som eventuelt kan stråle ud til ryggen, såvel som kvalme og opkastning, da dette kan være et tegn på en betændelse i bugspytkirtlen (pankreatitis).
English: Pull off the paper tab from a new disposable needle.
Danish: Fjern papirforseglingen fra en ny engangsnål.
English: In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with Victoza alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.
Danish: I fem store, langvarige kliniske fase 3a-studier blev over 2.500 voksne patienter behandlet med Victoza alene eller i kombination med metformin, sulfonylurinstof (med eller uden metformin) eller metformin med rosiglitazon.
English: Water for injections
Danish: Vand til injektionsvæsker
English: This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increase in effort to breathe).
Danish: Du må ikke bruge dette lægemiddel, hvis du lider af type 1-diabetes (når din krop ikke producerer insulin) eller diabetesrelateret syreforgiftning (diabetisk ketoacidose) (en komplikation af diabetes med højt blodsukker og anstrengelse ved vejrtrækning).
English: Injection site reactions have been reported in approximately 2% of patients receiving Victoza in longterm (26 weeks or longer) controlled trials.
Danish: Der er rapporteret om reaktioner på injektionsstedet hos ca. 2% af de patienter, der fik Victoza i de langvarige, kontrollerede studier (26 uger eller længere).
English: Use of liraglutide is not recommended in these patients since it is associated with transient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea.
Danish: Brug af liraglutid anbefales ikke til disse patienter, da det er forbundet med forbigående gastrointestinale bivirkninger, herunder kvalme, opkastning og diarré.
English: Paediatric Population
Danish: Pædiatrisk population
English: • A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc.
Danish: • En alvorlig form for allergisk reaktion (anafylaktisk reaktion) med yderligere symptomer såsom åndedrætsbesvær, hævelse af hals og ansigt, hurtig hjerterytme (puls) osv.
English: • Sulfonylurea (such as glimepiride or glibenclamide) or insulin.
Danish: • Sulfonylurinstof (såsom glimepirid eller glibenclamid) eller insulin.
English: The primary endpoint was the time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): CV 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 (major adverse cardiovascular events)): kardiovaskulær død, ikke-fatal myokardieinfarkt eller ikke-fatal apopleksi.
English: In the insulin degludec + liraglutide arm, the insulin dose was reduced by 20% in order to minimize the risk of hypoglycaemia.
Danish: I armen med insulin degludec + liraglutid blev insulindosis reduceret med 20% for at minimere risikoen for hypoglykæmi.
English: No dose adjustment is required for adolescents and children aged 10 years and above.
Danish: Dosisjustering er ikke nødvendig for unge og børn i alderen 10 år og derover.
English: This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.
Danish: Dette lægemiddel anbefales ikke, hvis du har alvorlige mave- eller tarmproblemer, som resulterer i forsinket tømning af mavesækken (gastroparese) eller betændelsessygdomme i tarmene.
English: Over the duration of the phase 3a trials, liraglutide decreased the systolic blood pressure on average of 2.3 to 6.7 mmHg from baseline and compared to active comparator the decrease was 1.9 to 4.5 mmHg.
Danish: I løbet af fase 3a-studierne reducerede liraglutid det systoliske blodtryk med gennemsnitligt 2,3 til 6,7 mmHg fra baseline, og sammenlignet med den aktive komparator var reduktionen 1,9 til 4,5 mmHg.
English: Patients at risk
Danish: Patienter i risikogruppen
English: The liraglutide exposure in adolescents and children was comparable to that observed in the adult population.
Danish: Eksponeringen for liraglutid hos børn og unge var sammenlignelig med den, som blev observeret hos den voksne population.
English: Non-cardiovascular death
Danish: Ikke-kardiovaskulær død
English: In mouse models of atherosclerosis, liraglutide prevented aortic plaque progression and reduced inflammation in the plaque.
Danish: I musemodeller af aterosklerose forhindrede liraglutid progression af aortisk plaque og reducerede inflammation i plaques.
English: Be careful not to press the dose button when turning the dose selector backwards, as liraglutide may come out.
Danish: Undgå at trykke på dosisknappen, når du drejer dosisvælgeren baglæns, da der kan komme liraglutid ud.
English: There are no adequate data from the use of liraglutide in pregnant women.
Danish: Data for anvendelse af liraglutid til gravide er utilstrækkelige.
English: Improved first and second phase insulin secretion after 52 weeks treatment with liraglutide was demonstrated in a subset of patients with type 2 diabetes (n=29).
Danish: Der blev påvist forbedret første- og andenfase-insulinsekretion efter 52 ugers behandling med liraglutid hos en undergruppe af patienter med type 2-diabetes (n=29).
English: Weight loss was sustained.
Danish: Vægttab var opretholdt.
English: This will help your doctor to decide if the dose of the sulfonylurea or insulin needs to be changed.
Danish: Dette kan hjælpe din læge til at beslutte, om din dosis af sulfonylurinstof eller insulin skal ændres.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: Treatment with liraglutide alone and in combination with one or two oral antidiabetic drugs resulted in a reduction in fasting plasma glucose of 13-43.5 mg/dl (0.72-2.42 mmol/l).
Danish: Behandling med liraglutid alene og i kombination med et eller to orale antidiabetika resulterede i en reduktion af fasteplasmaglucose på 13-43,5 mg/dl (0,72-2,42 mmol/l).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: The signs include heartburn.
Danish: Symptomerne på dette inkluderer halsbrand.
English: In a clinical trial with liraglutide as monotherapy, rates of hypoglycaemia reported with liraglutide were lower than rates reported for patients treated with active comparator (glimepiride).
Danish: I et klinisk studie med liraglutid som monoterapi var de rapporterede hypoglykæmirater for liraglutid lavere end de rapporterede rater for patienter, der blev behandlet med en aktiv komparator (glimepirid).
English: Liraglutide was superior in preventing MACE vs placebo (Figure 1).
Danish: Liraglutid var bedre end placebo til at forhindre MACE (Figur 1).
English: Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Victoza.
Danish: Allergiske reaktioner inklusive urticaria, udslæt og pruritus er blevet rapporteret ved brug af Victoza efter markedsføring
English: As there is sufficient evidence to conclude on a causal relationship between delayed gastric emptying and liraglutide, delayed gastric emptying should be included as an ADR in section 4.8 of the SmPC with a frequency allocation of ‘uncommon' and in section 4 of the Package Leaflet.
Danish: Da der er tilstrækkelige data til at træffe konklusioner angående et kausalt forhold mellem forsinket ventrikeltømning og liraglutid, skal forsinket ventrikeltømning inkluderes som bivirkning i produktresuméets punkt 4.8 med hyppigheden "ikke almindelig" og i indlægssedlens punkt 4.
English: The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results (LEADER) trial, was a multicentre, placebo-controlled, double-blind clinical trial.
Danish: LEADER-studiet (The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcome Results (vurdering af liraglutids effekt på kardiovaskulære endepunkter i diabetes)) var et klinisk, placebokontrolleret, dobbeltblindet multicenterstudie.
English: Non-lethal thyroid C-cell tumours were seen in 2-year carcinogenicity studies in rats and mice.
Danish: Der blev konstateret ikke-dødelige C-celletumorer i thyroidea under 2-årige karcinogenicitetsforsøg med rotter og mus.
English: If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose.
Danish: Hvis dosisvælgeren stopper, før den ønskede dosis er ud for markøren, er der ikke tilstrækkeligt med liraglutid tilbage til en fuld dosis.
English: Data from clinical trials showed that liraglutide is associated with delayed gastric emptying.
Danish: Data fra kliniske studier viste, at liraglutid er forbundet med forsinket ventrikeltømning.
English: Tmax was delayed by 1.5 h with liraglutide for both compounds.
Danish: Tmax blev forsinket med 1,5 time med liraglutid for begge forbindelser.
English: The mechanism of blood glucose lowering also involves a minor delay in gastric emptying.
Danish: Sænkningsmekanismen for glucose i blodet involverer desuden en mindre forsinkelse af ventrikeltømning.
English: Dosing with Victoza during mid-gestation caused a reduction in maternal weight and foetal growth with equivocal effects on ribs in rats and skeletal variation in the rabbit.
Danish: Dosering af Victoza i midten af graviditeten forårsagede en reduktion af moderens vægt og fosterets tilvækst med usikre virkninger på ribben hos rotter og skeletvariationer hos kaniner.