FrancophonIA/ELRC3.0 huggingface dataset:
English: Incubation with rat, dog, and human liver microsomes as well as human hepatocytes produced no detectable metabolites of regadenoson.
Danish: Inkubation med levermikrosomer fra rotter, hunde og mennesker samt humane hepatocytter producerede ikke nogle sporbare regadenosonmetabolitter.
English: Transient dose dependent increases in heart rate occurred following administration of each dose of regadenoson, whereas no consistent dose-related effect on systolic blood pressure was observed.
Danish: Der forekom forbigående dosisafhængige stigninger i hjertefrekvens efter indgivelse af hver dosis af regadenoson, hvorimod der ikke blev observeret nogen konsistent dosisrelateret effekt på systolisk blodtryk.
English: The excretion of regadenoson in milk has not been studied in animals.
Danish: Udskillelsen af regadenoson i mælk hos dyr er ikke blevet undersøgt.
English: • low blood pressure which may result in fainting or mini strokes (including weakness of the face or an inability to speak).
Danish: • lavt blodtryk, som kan resultere i besvimelse eller mini-slagtilfælde (herunder muskelslaphed i ansigtet eller manglende evne til at tale).
English: • if you have had a recent serious heart problem (for example a heart attack or abnormal heart rhythms).
Danish: • hvis du har haft et alvorligt hjerteproblem for nyligt (for eksempel et hjerteanfald eller unormal hjerterytme).
English: Regadenoson increases sympathetic tone, which causes an increase in heart rate and a shortening of the QT interval.
Danish: Regadenoson forhøjer den sympatiske tonus, hvilket forårsager en forhøjelse af hjertefrekvensen og en forkortelse af QT-intervallet.
English: Fractional flow reserve (FFR):
Danish: Fraktioneret flowreserve (FFR):
English: Usually, exercise on a treadmill is used to put the heart under stress before a scan.
Danish: Normalt motionerer man på et løbebånd for at udsætte hjertet for en stressbelastning før en skanning.
English: A decision should be made whether to discontinue breastfeeding or to abstain from regadenoson administration taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med regadenoson skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Therefore, 1147 patients were randomized in two groups: 578 patients from the exercise with regadenoson group and 569 from the regadenoson only group to either 3 minutes recovery (for the exercise with regadenoson group) or at rest 1 hour later (for the regadenoson only group).
Danish: Dermed blev 1147 patienter randomiseret i to grupper: 578 patienter fra træning med regadenosongruppen og 569 patienter fra gruppen med regadenoson alene, til enten 3 minutters restitution (træning med regadenoson-gruppen) eller i hvile 1 time senere (gruppen med regadenoson alene).
English: as were the weighted kappas of two consecutive adenosine scans, 0.50 and 0.55, respectively.
Danish: Ligeledes var de vægtede kappa-værdier for de to på hinanden følgende adenosinskanninger, hhv. 0,50 og 0,55.
English: This indicates that renal tubular secretion plays a role in regadenoson elimination.
Danish: Dette indikerer, at renal tubulær secernering spiller en rolle i eliminationen af regadenoson.
English: A population pharmacokinetic analysis including data from subjects and patients demonstrated that regadenoson clearance decreases in parallel with a reduction in creatinine clearance (CLcr) and increases with increased body weight.
Danish: Et farmakokinetisk populationsstudie med data fra forsøgspersoner og patienter viste, at regadenosons clearance reduceres parallelt med en reduktion af kreatininclearance (CLcr) og forøges med højere legemsvægt.
English: Contents of the pack and further information
Danish: Pakningsstørrelser og yderligere oplysninger
English: The same applies to the FFR measurement where the maximal myocardial blood flow is decreased in presence of severe coronary artery stenosis.
Danish: Det samme gælder for FFR-målinger, da den maksimale myokardiale blodgennemstrømning reduceres ved alvorlig koronararteriestenose.
English: Bronchoconstriction
Danish: Bronkokonstriktion
English: The 10-second window of steady state hyperaemia can be too short for performing extensive pressure pullback recordings to assess complex or diffuse coronary artery disease.
Danish: Det 10 sekunders vindue af hyperæmi ved steady state kan være for kort til at udføre omfattende flowmålinger for at vurdere kompleks eller diffus koronararteriesygdom.
English: • difficulty in breathing (bronchospasm)
Danish: • vejrtrækningsbesvær (bronkospasme)
English: However, most adverse reactions are mild and transient, resolving within 30 minutes after receiving regadenoson.
Danish: De fleste bivirkninger er dog milde, forbigående og forsvinder i løbet af 30 minutter efter indgivelse af regadenoson.
English: After the initial scan, patients were randomised to either regadenoson or adenosine, and received a second stress scan with the same radionuclide imaging protocol as that used for the initial scan.
Danish: Efter den indledende skanning blev patienterne randomiseret til enten regadenoson eller adenosin, og de fik derpå en ny stress-skanning med den samme radionuklid-SPECT-protokol, som blev brugt til den indledende skanning.
English: Coronary blood flow
Danish: Koronar blodgennemstrømning
English: • if you have episodes of heart block (which can slow the heart down) or a very slow heart rate.
Danish: • hvis du har episoder med hjerteblok (som kan gøre dit hjerte langsommere) eller en meget langsom puls.
English: Fetotoxicity, but not teratogenicity, was noted in embryo-fetal development studies (see section 5.3).
Danish: Føtotoksicitet, men ikke teratogenicitet blev bemærket i embryoføtale udviklingsforsøg (se pkt.
English: Talk to your doctor or nurse before taking Rapiscan Your doctor needs to know before you are given Rapiscan:
Danish: Tal med din læge eller apotekspersonalet, inden du får Rapiscan Din læge skal vide det, før du får Rapiscan:
English: • pain or discomfort around the area injected, body pain
Danish: • smerter eller ubehag rundt om injektionsområdet, legemssmerter
English: After the Rapiscan injection you will need to sit or lie down until your heart rate and blood pressure return to your normal levels.
Danish: Efter injektionen med Rapiscan skal du sidde eller ligge ned, indtil din puls og dit blodtryk vender tilbage til dine normale niveauer.
English: This medicine is for diagnostic use only.
Danish: Dette lægemiddel er kun til diagnostisk brug.
English: Paraesthesia, hypoaesthesia, dysgeusia
Danish: Paræstesi, hypoæstesi, dysgeusi
English: The disposition of regadenoson was studied in 18 subjects with various degrees of renal function and in 6 healthy subjects.
Danish: Regadenosons egenskaber blev undersøgt hos 18 forsøgspersoner med forskellige grader af nyrefunktion og hos 6 raske forsøgspersoner.
English: Also, there was no apparent effect of 200 mg or 400 mg of caffeine on regadenoson plasma concentrations.
Danish: Desuden sås ingen tydelig indvirkning af 200 mg eller 400 mg caffein på regadenosons plasmakoncentration.
English: These include low blood volume (caused, for example, by severe diarrhoea or dehydration or taking water pills), inflammation around the heart (pericarditis) and some forms of heart valve or artery disease (for example, aortic or mitral stenosis).
Danish: Sådanne omfatter lavt blodvolumen (for eksempel forårsaget af alvorlig diarré eller dehydrering eller indtagelse af vanddrivende piller), betændelse rundt om hjertet (perikarditis) og nogen former for sygdom i hjerteklapperne eller arterierne (for eksempel aorta- eller mitralstenose).
English: Based on a population pharmacokinetic analysis, age has a minor influence on the pharmacokinetics of regadenoson.
Danish: Baseret på en analyse af populationsfarmakokinetik, har alder en ringe indflydelse på regadenosons farmakokinetik.
English: A total of 249 patients, who were clinically indicated to undergo coronary angiography with invasive measurement of FFR, received regadenoson, with 88 of those patients receiving regadenoson twice.
Danish: I alt fik 249 patienter, der blev klinisk indikeret til at gennemgå koronar angiografi med invasiv måling af FFR, regadenoson, hvoraf 88 af disse patienter fik regadenoson to gange.
English: Within the dose range of 0.003-0.02 mg/kg (or approximately 0.18-1.2 mg) in healthy subjects, clearance, terminal half-life or volume of distribution do not appear dependent upon the dose.
Danish: Inden for dosisintervallet på 0,003-0,02 mg/kg (eller ca. 0,18-1,2 mg) hos raske forsøgspersoner synes hverken clearance, terminal halveringstid eller fordelingsvolumen at være dosisafhængig.
English: Do not eat food or have drinks containing caffeine (for example, tea, coffee, cocoa, cola or chocolate) for at least 12 hours before you are given Rapiscan.
Danish: Lad være med at spise mad eller indtage drikke, der indeholder caffein (for eksempel te, kaffe, kakao, cola eller chokolade) i mindst 12 timer før du får Rapiscan, da caffein kan påvirke Rapiscans virkning.
English: The ADVANCE MPI 1 and ADVANCE MPI 2 studies, individually and combined, demonstrated that regadenoson is similar to adenosine in assessing the extent of reversible perfusion abnormalities:
Danish: ADVANCE MPI 1- og ADVANCE MPI 2-studierne, hver for sig og kombineret, viste, at regadenoson er sammenlignelig med adenosin til vurdering af graden af reversible perfusionsabnormiteter:
English: In post-marketing experience there have also been reports of cerebrovascular accident (CVA).
Danish: Der er efter markedsføringen rapporteret om cerebrovaskulære hændelser (CVA).
English: These findings indicate that metabolism of regadenoson does not play a major role in the elimination of regadenoson.
Danish: Disse fund indikerer, at regadenosons metabolisme ikke spiller en større rolle i udskillelsen af regadenoson.
English: Rapiscan solution for injection is a clear, colourless solution with no particles visible.
Danish: Rapiscan injektionsvæske, opløsning, er en klar, farveløs opløsning uden synlige partikler.
English: The safety and efficacy of regadenoson in children below the age of 18 years have not yet been established.
Danish: Pædiatrisk population Regadenosons sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Regadenoson has the potential to cause serious and life-threatening reactions, including those listed below (see also section 4.8).
Danish: Regadenoson kan forårsage alvorlige og livstruende reaktioner, herunder de nedenfor anførte (se også pkt.
English: Methylxanthines (e.g., caffeine and theophylline) are non-specific adenosine receptor antagonists and may interfere with the vasodilation activity of regadenoson (see section 5.1).
Danish: Methylxanthiner (f.eks. caffein og theophyllin) er uspecifikke adenosinreceptorantagonister og kan påvirke regadenosons vasodilatator-aktivitet (se pkt.
English: Each patient received an initial stress scan using adenosine (6-minute infusion using a dose of 0.14 mg/kg/min, without exercise) with a radionuclide gated SPECT (single photon emission computed tomography) imaging protocol.
Danish: Hver patient fik en indledende stressskanning med brug af adenosin (6-minutters infusion med en dosis på 0,14 mg/kg/min, uden motionsbelastning) og en radionuklear gated SPECT (single photon emission computed tomography)protokol.
English: • dipyridamole, a medicine used to prevent blood clots, must not be used for at least two days before you are given Rapiscan because it can change the effect of Rapiscan.
Danish: • dipyridamol, medicin til at forhindre blodpropper, må ikke anvendes i mindst to dage før du får Rapiscan, da det kan ændre Rapiscans virkning.
English: However, post-hoc analysis of data from the two Phase 3 clinical trials showed that the pharmacokinetics of regadenoson were not affected in a small subset of patients with laboratory values suggestive of impaired hepatic function (2.5-fold transaminase elevation or 1.5-fold elevation of serum bilirubin or prothrombin time).
Danish: Post-hocanalyse af data fra de to kliniske fase 3 studier viste imidlertid, at regadenosons farmakokinetik ikke var påvirket i en lille undergruppe af patienter med laboratorieværdier, som tyder på nedsat leverfunktion (2,5 gange forhøjet transaminase eller 1,5 gange forhøjet serum-bilirubin eller protrombintid).
English: • fits, fainting, mini strokes (including weakness of the face or an inability to speak), reduced responsiveness (which may include a comatose state), trembling, sleepiness
Danish: • anfald, besvimelse, mini-slagtilfælde (herunder muskelslaphed i ansigtet eller manglende evne til at kunne tale), nedsat reaktionsevne (som kan omfatte en komatilstand), rysten, søvnighed
English: The A2B and A3 adenosine receptors have been implicated in the pathophysiology of bronchoconstriction in susceptible individuals (i.e., asthmatics).
Danish: A2B- og A3-adenosinreceptorer har betydning for patofysiologien ved bronkokonstriktion hos udsatte personer (dvs. astmatikere).
English: Patients from both groups (exercise with regadenoson and regadenoson only) underwent a SPECT Myocardial Perfusion Imaging (MPI) at 60-90 minutes post-regadenoson administration.
Danish: Patienter fra begge grupper (træning med regadenoson og regadenoson alene) gennemgik en SPECTmyocardial perfusion Imaging (MPI) undersøgelse 60-90 minutter efter administration af regadenoson.
English: • Decompensated states of heart failure.
Danish: • Dekompenseret hjerteinsufficiens.
English: Therefore administration of aminophylline solely for the purpose of terminating a seizure induced by regadenoson is not recommended.
Danish: Det frarådes derfor at indgive aminophyllin udelukkende med henblik på at standse et krampeanfald, der er udløst af Regadenoson.
English: What you need to know before you are given Rapiscan
Danish: Det skal du vide, før du får Rapiscan
English: Adenosine was administered first, followed by regadenoson as its hyperaemia may last unpredictably and the measured FFR values were compared.
Danish: Adenosin blev først indgivet efterfulgt af regadenoson, da varigheden af dets hyperæmi er uforudsigeligt og de målte FFR-værdier blev sammenlignet.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
English: In postmarketing experience, third degree heart block and asystole have been reported within minutes of regadenoson administration.
Danish: Efter markedsføring blev der rapporteret om 3. grads hjerteblok og asystole inden for få minutter efter indgivelsen af regadenoson.
English: • discomfort in the mouth
Danish: • ubehag i munden
English: Aminophylline may be administered in doses ranging from 50 mg to 250 mg by slow intravenous injection (50 mg to 100 mg over 30-60 seconds) to attenuate severe and/or persistent adverse reactions to regadenoson but should not be used solely for the purpose of terminating a seizure induced by regadenoson.
Danish: Aminophyllin kan indgives i doser fra 50 mg til 250 mg via langsom intravenøs injektion (50 mg til 100 mg i løbet af 30-60 sekunder) for at dæmpe svære og/eller vedvarende bivirkninger udløst af regadenoson, men bør ikke bruges udelukkende med henblik på at standse et krampeanfald udløst af regadenoson.
English: • pain in the joints
Danish: • smerter i leddene
English: In the EXERRT trial the efficacy and safety of regadenoson was evaluated in patients with suboptimal Exercise Stress in an open-label randomized, multi-center, non-inferiority study when regadenoson administered either at 3 minutes during recovery (exercise with regadenoson) or at rest 1 hour later (regadenoson only).
Danish: I EXERRT-forsøget blev virkningen og sikkerheden af regadenoson undersøgt hos patienter med suboptimal stresstest ved træning i et åbent randomiseret, multicenter, non-inferioritetsstudie, hvor regadenoson blev indgivet efter 3 minutters restitution (træning med regadenoson) eller i hvile 1 time senere (kun regadenoson).
English: • theophylline, a medicine used to treat asthma and other lung diseases, must not be used for at least 12 hours before you are given Rapiscan because it can block the effect of Rapiscan.
Danish: • theophyllin, medicin til behandling af astma og andre lungesygdomme, må ikke anvendes i mindst 12 timer før du får Rapiscan, da det kan blokere Rapiscans virkning.
English: General disorders and administration site conditions: Very common Chest pain Common
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig Brystsmerter
English: • radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Danish: • radionuklear undersøgelse af myokardieperfusionen (myokardieskintigrafi) hos patienter, som ikke kan opnå tilstrækkelig fysisk stressbelastning.
English: Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).
Danish: Hvert 5 ml hætteglas indeholder 400 mikrogram regadenoson (80 mikrogram/ml).
English: In these patients, the phenomenon of R-on-T syndrome can occur, wherein an extra beat interrupts the T wave of the previous beat, and this increases the risk of a ventricular tachyarrhythmia.
Danish: Hos disse patienter kan R på T-fænomenet forekomme, hvor et ekstra hjerteslag forstyrrer T-takken fra det foregående hjerteslag, og dette forhøjer risikoen for ventrikulær takyarytmi.
English: Repeated use
Danish: Gentagen brug
English: The agreement rates for regadenoson and adenosine were calculated as the average of the agreement rates across the three categories determined by the initial scan.
Danish: Frekvenserne for overensstemmelse for regadenoson og adenosin blev beregnet som gennemsnittet af frekvenserne for overensstemmelse mellem alle tre kategorier fastlagt i den indledende skanning.
English: Myocardial uptake of the radiopharmaceutical is proportional to CBF.
Danish: Myokardiets optagelse af det radioaktive diagnostikum (isotop tracer) er proportional med CBF.
English: A total of 1,871 of these patients had images considered valid for the primary efficacy evaluation, including 1,294 (69%) men and 577 (31%) women with a median age of 66 years (range 26-93 years of age).
Danish: den primære effektevaluering, herunder 1.294 (69%) mænd og 577 (31%) kvinder med en median alder på 66 år (interval 26-93 år).
English: In a study of adult patients undergoing pharmacological stress radionuclide MPI with regadenoson , randomized to placebo (n=66) or caffeine (200 mg, n=70 or 400 mg, n=71) administered 90 minutes before the test, caffeine compromised the diagnostic accuracy of detecting reversible perfusion defects (p<0.001).
Danish: I et studie med voksne patienter, der blev udsat for farmakologisk stress i forbindelse med radionuklidMPI med regadenoson, og som var randomiseret til placebo (n = 66) eller caffein (200 mg (n = 70) eller 400 mg (n = 71)) indgivet 90 minutter før testen, kompromitterede caffein den diagnostiske præcision ved detektering af reversible perfusionsdefekter (p < 0,001).
English: Appropriate bronchodilator therapy and resuscitative measures should be available prior to regadenoson administration.
Danish: Hensigtsmæssig bronkieudvidende behandling og genoplivningsudstyr skal være tilgængeligt, før indgivelsen af regadenoson påbegyndes.
English: Regadenoson may have a modest inhibitory effect on the active renal transporter, OCT2, and has been found to be likely substrate for BCRP, ENT1 or ENT2 mediated transport.
Danish: Regadenoson kan have en beskeden hæmmende virkning på det aktive nyretransportprotein, OCT2, og det er påvist, at det er et sandsynligt substrat for BCRP-, ENT1- elle ENT2-medieret transport.
English: For diagnostic use only.
Danish: Kun til diagnostisk brug.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis.
English: No dose adjustment is needed in elderly patients.
Danish: Dosisjustering er ikke nødvendig for ældre patienter.
English: • the measurement of fractional flow reserve (FFR) of a single coronary artery stenosis during invasive coronary angiography, when repeated FFR measurements are not anticipated (see sections 4.2 and 5.1).
Danish: • måling af fraktioneret flowreserve (FFR) af en enkelt koronararteriestenose under invasiv koronarangiografi, når gentagne FFR målinger ikke forventes (se pkt.
English: Myocardial radiopharmaceutical uptake after regadenoson administration is therefore greater in areas perfused by normal relative to stenosed arteries.
Danish: Myokardiets radioaktive traceroptagelse efter indgivelse af regadenoson er derfor større i områder, der perfunderes af normale arterier sammenlignet med stenotiske arterier.
English: Older patients (≥ 75 years of age; n = 321) had a similar adverse reaction profile compared to younger patients (< 65 years of age; n = 1,016), but had a higher incidence of hypotension (2% versus < 1%).
Danish: Bivirkningsprofilen for ældre patienter (≥ 75 år; n = 321) var sammenlignelig med bivirkningsprofilen for yngre patienter (< 65 år; n = 1.016), men de ældre patienter havde en større forekomst af hypotension (2% versus < 1%).
English: It is injected directly into a vein, as a single dose of 400 micrograms in a 5 ml solution - the injection will take about 10 seconds to complete.
Danish: Det injiceres direkte ind i en vene, som en enkelt dosis på 400 mikrogram i en 5 ml opløsning - injektionen tager ca. 10 sekunder.
English: Regadenoson should be used with caution in patients with recent myocardial infarction.
Danish: Regadenoson skal anvendes med forsigtighed til patienter med nyligt myokardieinfarkt.
English: Caution should be used when administering regadenoson to patients with a history of seizures or other risk factors for seizures, including the concomitant administration of medicinal products that lower seizure threshold (e.g. antipsychotics, antidepressants, theophyllines, tramadol, systemic steroids and quinolones).
Danish: Der skal udvises forsigtighed ved administration af Regadenoson til patienter med tidligere krampeanfald eller andre risikofaktorer for krampeanfald, herunder samtidig administration af lægemidler, der sænker krampetærkslen (f.eks. antipsykotika, antidepressiva, theofylliner, tramadol, systemiske steroider og quinoloner).
English: Heart rate and blood pressure will be monitored during the entire procedure.
Danish: Hjertefrekvens og blodtryk overvåges under hele undersøgelsen.
English: In the first and second studies, dyspnoea was reported as an adverse reaction following regadenoson dosing (61% for patients with COPD; 34% for patients with asthma) while no subjects experienced dyspnoea following placebo dosing.
Danish: I det første og andet studie blev dyspnø rapporteret som en bivirkning efter indgivelse af regadenoson (61% for patienter med COPD; 34% for patienter med astma), men ingen forsøgspersoner oplevede dyspnø efter indgivelse af placebo.
English: In clinical studies, regadenoson was administered to patients taking other cardioactive medicinal products (i.e., β-blockers, calcium channel blockers, ACE inhibitors, nitrates, cardiac glycosides, and angiotensin receptor blockers) without apparent effects on the safety or efficacy profile of regadenoson.
Danish: I kliniske studier blev regadenoson indgivet til patienter, som fik andre kardioaktive lægemidler (dvs. β-blokkere, calciumkanalblokkere, ACE-hæmmere, nitrater, hjerteglykosider og angiotensinreceptorhæmmere), uden tydelig virkning på sikkerheds- og virkningsprofilen for regadenoson.
English: In healthy volunteers, 57% of the regadenoson dose is excreted unchanged in the urine (range 19-77%), with an average plasma renal clearance around 450 ml/min, i.e., in excess of the glomerular filtration rate.
Danish: Hos raske frivillige blev 57% af regadenoson-dosen udskilt i uændret form i urinen (interval 19-77%), med en gennemsnitlig renal clearance i plasma på omkring 450 ml/min, dvs. ud over den glomerulære filtrationshastighed.