FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Saxenda, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Saxenda, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: For more information about treatment with Saxenda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Saxenda, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Saxenda?
Danish: Hvilke risici er der forbundet med Saxenda?
English: The medicine can only be obtained with a prescription.
Danish: Lægemidlet Saxenda udleveres kun efter recept.
English: To limit these effects, when starting treatment the dose of Saxenda is slowly increased over 4 weeks.
Danish: For at begrænse disse virkninger sættes dosis af Saxenda langsomt op i løbet af de første fire uger af behandlingen.
English: Patients treated with Saxenda had a continuous decrease in body weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained.
Danish: De patienter, der blev behandlet med Saxenda, tabte sig vedholdende i vægt under de første 40 ugers behandling, hvorefter det opnåede vægttab holdt sig.
English: When the figures for the main studies were re-analysed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted.
Danish: Talmaterialet fra hovedundersøgelserne blev analyseret på ny med en mere forsigtig metode, der forudsatte, at de patienter, der ikke gennemførte undersøgelsen (ca. 30 %), ikke ville udvise nogen bedring.
English: For practical information about using Saxenda, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Saxenda, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Regarding safety, the most common side effects with Saxenda relate to the stomach and gut such as nausea.
Danish: Hvad angår sikkerheden, vedrørte de almindeligste bivirkninger ved Saxenda mave-tarmsystemet, såsom kvalme.
English: Further information on the long-term safety of liraglutide (particularly its effects on the heart and blood vessels) is expected from an ongoing study with Victoza.
Danish: En igangværende undersøgelse med Victoza forventes at give yderligere oplysninger om den langsigtede sikkerhed af liraglutid (navnlig virkningen på hjerte og blodkar).
English: Saxenda is available as a solution for injection in pre-filled pens.
Danish: Saxenda fås som injektionsvæske i fyldte penne.
English: Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment).
Danish: Saxenda har vist sig at være effektivt til at nedsætte legemsvægten i fem hovedundersøgelser, som omfattede over 5 800 meget overvægtige eller overvægtige patienter og varede op til 56 uger.
English: How is Saxenda used?
Danish: Hvordan anvendes Saxenda?
English: What benefits of Saxenda have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Saxenda?
English: The active substance in Saxenda, liraglutide, is a ‘glucagon-like peptide-1 (GLP-1) receptor agonist' that is already authorised in the EU as Victoza at lower doses (up to 1.8 mg per day) for the treatment of type 2 diabetes.
Danish: Det er under navnet Victoza i forvejen godkendt i EU i lavere doser (op til 1,8 mg dagligt) til behandling af type 2-sukkersyge.
English: For the full list of all side effects and restrictions with Saxenda, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Saxenda fremgår af indlægssedlen.
English: How does Saxenda work?
Danish: Hvordan virker Saxenda?
English: It may harm them,
Danish: Sådan skal De tage Ristfor
English: It is especially important to mention the following:
Danish: Det er især vigtigt, at De nævner følgende:
English: See section 2, Do not take Ristfor.
Danish: Se punkt 2, Tag ikke Ristfor.
English: • Take one tablet:
Danish: • Tag en tablet:
English: • twice daily by mouth
Danish: • to gange dagligt gennem munden.
English: Your doctor may ask you to stop Ristfor.
Danish: Lægen vil måske bede Dem om at stoppe med at tage Ristfor.
English: Children and adolescents below 18 years should not use this medicine.
Danish: Børn og unge under 18 år må ikke tage dette lægemiddel.
English: If you stop taking Ristfor, your blood sugar may rise again.
Danish: Hvis De holder op med at tage Ristfor, kan Deres blodsukker stige igen.
English: Very common: low blood sugar
Danish: Meget almindelig: Lavt blodsukker
English: You should not stop taking this medicine without talking to your doctor first.
Danish: De må ikke holde op med at tage lægemidlet uden at tale med lægen først.
English: Ristfor is contraindicated in patients with:
Danish: Ristfor er kontraindiceret hos patienter med:
English: Consider the benefits and risks of concomitant use.
Danish: Overvej fordele og risici ved samtidig anvendelse.
English: Ristfor should not be used during pregnancy.
Danish: Ristfor bør ikke anvendes under graviditet.
English: If you miss a dose, take it as soon as you remember.
Danish: Hvis De glemmer en dosis, så tag den så snart De kommer i tanke om det.
English: Ristfor should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Danish: Ristfor bør ikke anvendes til patienter med type 1-diabetes og må ikke anvendes til behandling af diabetisk ketoacidose.
English: Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Danish: På grund af den høje sikkerhedsmargin (19 gange på dette no-effect-niveau), anses disse neoplastiske ændringer ikke som relevante for situationen hos mennesker.
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Danish: Det er uvist, om dette lægemiddel er sikkert og effektivt hos børn og unge under 18 år.
English: p< 0.001 compared to placebo or placebo + combination treatment.
Danish: p<0,001 sammenlignet med placebo eller placebo + kombinationsbehandling.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Blodpeak er lavere end plasmapeak og fremkommer på ca. samme tidspunkt.
English: No animal studies have been conducted with Ristfor.
Danish: Der er ikke udført dyreforsøg med Ristfor.
English: Data from the 73 % of patients who were taking metformin are presented in Table 2.
Danish: Data fra 73% af de patienter, som tog metformin, fremgår af tabel 2.
English: Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar.
Danish: Fortsæt med at tage dette lægemiddel så længe Deres læge ordinerer det, så De fortsat kan få hjælp til at kontrollere Deres blodsukker.
English: - if you have type 1 diabetes.
Danish: - Hvis De har type 1-diabetes.
English: receptor antagonists)
Danish: receptorantagonister).
English: The renal clearance was approximately 350 mL/min.
Danish: Den renale clearance var ca. 350 ml/min.
English: Initial Therapy (twice daily)
Danish: Initialbehandling (to gange dagligt)
English: When this happens, sugar (glucose) builds up in the blood.
Danish: Når dette sker, øges sukkerindholdet (glukose) i blodet.
English: If a patient wishes to become pregnant or if a pregnancy occurs, treatment should be discontinued and the patient switched to insulin treatment as soon as possible.
Danish: Hvis en patient ønsker at blive gravid eller bliver gravid, bør behandlingen seponeres, og patienten bør skifte til insulinbehandling så snart som muligt.
English: • digoxin (to treat irregular heart beat and other heart problems).
Danish: • Digoxin (til behandling af uregelmæssig hjerterytme og andre hjerteproblemer).
English: If no adequate strength of Ristfor is available, individual monocomponents should be used instead of the fixed-dose combination.
Danish: Hvis der ikke findes en passende styrke af Ristfor, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Patients and/or care-givers should be informed of the risk of lactic acidosis.
Danish: Patienter og/eller omsorgspersoner skal informeres om risikoen for laktacidose.
English: After oral administration, metformin absorption is saturable and incomplete.
Danish: Efter oral administration er absorptionen af metformin mættet og ufuldstændig.
English: Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose.
Danish: Disse reaktioner startede inden for de første 3 måneder efter initiering af behandling med sitagliptin, hvor enkelte rapporter forekom efter første dosis.
English: The starting dose is at most half of the maximum dose.
Danish: Startdosis er højst halvdelen af den maksimale dosis.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30 ºC.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Lægen vil måske udskrive et lægemiddel til behandling af den allergiske reaktion og et andet lægemiddel mod Deres diabetes.
English: If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated.
Danish: Hvis acidose i en eller anden form forekommer, skal behandlingen stoppes omgående, og andre hensigtsmæssige og korrigerende handlinger initieres.
English: The safety and efficacy of Ristfor in children and adolescents from birth to < 18 years of age have not been established.
Danish: Ristfors sikkerhed og virkning hos børn og unge fra fødslen til <18 år er ikke klarlagt.
English: If you need to have major surgery you must stop taking Ristfor during and for some time after the procedure.
Danish: Hvis De skal have en større operation, skal De stoppe med at tage Ristfor under indgrebet og i nogen tid herefter.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Ristfor.
Danish: Følgende redegørelser viser de farmakokinetiske egenskaber ved de enkelte aktive substanser i Ristfor.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30 %.
Danish: Efter en oral dosis var den ikkeabsorberede fraktion i fæces 20-30%.
English: STOP taking Ristfor and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Ristfor og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger:
English: Reduction in fasting plasma glucose (FPG) was observed at 3 weeks, the first time point at which FPG was measured.
Danish: Reduktionen i faste-plasmaglucose (FPG) blev observeret efter 3 uger, det første tidspunkt hvor FPG blev målt.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres herom, og monitorering af blodglucose bør udføres hyppigere især ved start af behandling med sådanne lægemidler.
English: The clinical relevance of this decrease is unknown.
Danish: Klinisk relevans af dette fald er ukendt.
English: A limited amount of data suggests the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Danish: En begrænset mængde data antyder, at anvendelse af metformin til gravide kvinder ikke er forbundet med øget risiko for medfødte misdannelser.
English: This medicine alone is unlikely to cause abnormally low blood sugar (hypoglycaemia).
Danish: Det er ikke sandsynligt, at dette lægemiddel alene medfører unormalt lavt blodsukker (hypoglykæmi).
English: Component of a multi-pack, can't be sold separately.
Danish: Del af multipakning, som ikke kan sælges separat.
English: During treatment with Ristfor, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Ristfor vil lægen kontrollere Deres nyrefunktion mindst en gang om året eller hyppigere, hvis De er ældre, og/eller hvis Deres nyrefunktion bliver dårligere.
English: Ristfor with alcohol
Danish: Brug af Ristfor sammen med alkohol
English: This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body.
Danish: Dette lægemiddel hjælper med at øge mængden af insulin, der frigives efter et måltid, og nedsætter mængden af sukker, der dannes af kroppen.
English: • Your doctor may need to increase your dose to control your blood sugar.
Danish: • Det kan være nødvendigt, at lægen øger dosis for at kontrollere Deres blodsukker.
English: You should not take this medicine during pregnancy or if you are breast-feeding.
Danish: De må ikke tage dette lægemiddel under graviditet, eller hvis De ammer.
English: Your doctor will decide when you must stop and when to restart your treatment with Ristfor.
Danish: Lægen vil beslutte, hvornår De skal stoppe behandlingen med Ristfor, og hvornår De kan genoptage den igen.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er opnået.
English: The mean Vd ranged between 63 - 276 L.
Danish: Gennemsnitligt fordelingsvolumen (Vd) lå på 63-276 l.
English: Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
Danish: Ældre patienter (65-80 år) havde ca. 19% højere sitagliptinplasmakoncentrationer sammenlignet med yngre patienter.
English: • metformin belongs to a class of medicines called biguanides.
Danish: • Metformin tilhører en klasse af medicin, der kaldes biguanider.
English: However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin.
Danish: Ved bilkørsel og betjening af maskiner bør der dog tages hensyn til, at svimmelhed og søvnighed er rapporteret med sitagliptin.
English: For adult patients with type 2 diabetes mellitus:
Danish: Til voksne patienter med type 2-diabetes mellitus:
English: Food decreases the extent and slightly delays the absorption of metformin.
Danish: Mad mindsker graden af og forsinker i mindre grad absorptionen af metformin.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske undersøgelser: Metformin reducerer totalkolesterol, LDL-kolesterol og triglyceridniveauerne.
English: The level of digoxin in your blood may need to be checked if taking with Ristfor.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager Ristfor.
English: No studies in lactating animals have been conducted with the combined active substances of this medicinal product.
Danish: Der er ikke udført undersøgelser på diegivende dyr med de kombinerede aktive stoffer i dette lægemiddel.
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and absolute frequency (Table 1).
Danish: Bivirkningerne ses nedenfor som MedDRA termer inddelt i systemorganklasse og absolut frekvens (Tabel 1).
English: Dose reduction may be considered in relation to declining renal function.
Danish: Dosisreduktion kan overvejes i forbindelse med tiltagende nedsættelse af nyrefunktionen.
English: • dolutegravir, a medicine used to treat HIV infection
Danish: • Dolutegravir, et lægemiddel til behandling af hiv-infektion.
English: Dose-proportionality was not established for Cmax and C24hr (Cmax increased in a greater than dose-proportional manner and C24hr increased in a less than dose-proportional manner).
Danish: Dosisproportionaliteten blev ikke fastslået for Cmax og C24t (Cmax steg mere end dosisproportionalt og C24t steg mindre end dosisproportionalt).
English: If you stop taking Ristfor
Danish: Hvis De holder op med at tage Ristfor
English: • If you have reduced kidney function, your doctor may prescribe a lower dose.
Danish: • Hvis De har nedsat nyrefunktion, vil lægen eventuelt ordinere en lavere dosis.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Danish: Det stimulerer ikke insulinudskillelsen og medfører derfor ikke hypoglykæmi.
English: Plasma AUC of sitagliptin increased in a dose-proportional manner.
Danish: Sitagliptins plasma-AUC steg proportionalt med dosis.
English: Ristfor should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Ristfor bør gives to gange dagligt sammen med et måltid for at reducere de gastrointestinale bivirkninger, som metformin er forbundet med.
English: Table 3: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Danish: Tabel 3: Hyppighed af sammensatte kardiovaskulære endepunkter og vigtige sekundære endepunkter
English: The difference was mainly due to a higher percentage of patients in the placebo group experiencing 3 or more episodes of hypoglycaemia (9.1 vs. 19.8 %).
Danish: Forskellen skyldtes hovedsageligt en højere procentdel af patienter i placebogruppen, som oplevede 3 eller flere episoder med hypoglykæmi (9,1 versus 19,8%).
English: • medicines which increase urine production (diuretics)
Danish: • Medicin, som øger urinproduktionen (vanddrivende medicin).
English: Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
Danish: Der forventes derfor ingen betydende interaktioner med andre p-glykoproteinhæmmere.
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, sitagliptin may be administered with or without food.
Danish: Eftersom samtidig administration af et fedtrigt måltid sammen med sitagliptin ikke havde nogen effekt på farmakokinetikken, kan sitagliptin administreres med eller uden mad.
English: A GFR should be assessed before initiation of treatment with metformincontaining products and at least annually thereafter.
Danish: GFR skal bestemmes, inden behandling med metforminholdige præparater iværksættes og derefter mindst én gang om året.
English: If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Hvis det er nødvendigt, bør doseringen af det antihyperglykæmiske lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af dette.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any 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: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Ristfor before or at the time of the injection.
Danish: Hvis De skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i Deres blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal De stoppe med at tage Ristfor forud for eller på tidspunktet for injektionen.
English: In addition, osteoarthritis and pain in extremity were reported with frequency uncommon (> 0.5 % higher among sitagliptin users than that in the control group).
Danish: Desuden er osteoarthritis og ekstremitetssmerter rapporteret med frekvensen ikke almindelig (>0,5% højere hos de brugere, der fik sitagliptin, end i kontrolgruppen).
English: As metformin and sitagliptin are excreted by the kidney, Ristfor should be used with caution as age increases.
Danish: Da metformin og sitagliptin udskilles via nyrerne, bør Ristfor anvendes med forsigtighed efterhånden som alderen stiger.
English: Hypoglycaemia has been reported in combination with sulphonylurea (13.8%) and insulin (10.9%).
Danish: Der er blevet rapporteret om hypoglykæmi i kombination med sulfonylurinstof (13,8%) og insulin (10,9%).
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL.
Danish: Ved de normale metformindoser og doseringsregimer nås steady state plasmakoncentrationer inden for 24-48 timer og er generelt under 1 µg/ml.
English: C]sitagliptin oral dose, approximately 16 % of the radioactivity was excreted as metabolites of sitagliptin.
Danish: C] oral sitagliptin-dosis udskiltes ca. 16% af radioaktiviteten som sitagliptinmetabolitter.
English: The dose of antihyperglycaemic therapy with Ristfor should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Danish: Doseringen af antihyperglykæmisk behandling med Ristfor bør individualiseres på basis af patientens aktuelle regime, effektivitet og tolerabilitet, uden at den maksimale anbefalede daglige dosis på 100 mg sitagliptin overskrides.
English: Adults with normal renal function (GFR ≥ 90 mL/min)
Danish: Voksne med normal nyrefunktion (GFR ≥ 90 ml/min)
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Den prospektive, randomiserede undersøgelse (UKPDS) har fastslået den langvarige, gunstige effekt af intensiv blodglucosekontrol ved type 2-diabetes.
English: Ristfor may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Ristfor kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktacidose, især hvis Deres nyrer ikke fungerer korrekt.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 µg/mL, even at maximum doses.
Danish: I kontrollerede kliniske forsøg oversteg metformins maksimale plasmakoncentrationer (Cmax) ikke 5 µg/ml, selv ved maksimale doser.
English: Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.
Danish: Tæt monitorering af glykæmisk kontrol, dosisjustering inden for det anbefalede dosisområde samt ændring af diabetesbehandlingen skal overvejes, når sådanne lægemidler administreres samtidigt.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Danish: Patienterne bør informeres om det karakteristiske symptom for akut pankreatitis: vedvarende svære mavesmerter.