FrancophonIA/ELRC3.0 huggingface dataset:
English: An intermediate phase follows, with a half-life on average of 30 minutes coinciding with loss of the pharmacodynamic effect.
Danish: En efterfølgende mellemliggende fase, med en gennemsnitlig halveringstid på 30 minutter, sammenfalder med tabet af farmakodynamisk virkning.
English: Measurement of FFR
Danish: Måling af FFR
English: Very common Electrocardiogram ST segment changes Common
Danish: Meget almindelig Elektrokardiogram-ST-segmentændringer Almindelig
English: Assessment of adverse reactions for regadenoson is based on safety data from clinical studies and postmarketing experience.
Danish: Vurderingen af bivirkninger for regadenoson er baseret på sikkerhedsdata fra kliniske studier og erfaring efter markedsføring.
English: • if you have any heart or blood vessel condition, particularly one that gets worse when your blood pressure decreases.
Danish: • hvis du har en sygdom i hjertet eller blodårerne, især en som bliver værre, når dit blodtryk falder.
English: Therefore, regadenoson would be expected to have no or negligible influence on the ability to drive or use machines once treatment has been completed and these reactions have resolved.
Danish: Derfor kan det forventes, at regadenoson ikke eller i ubetydelig grad påvirker evnen til at føre motorkøretøj eller betjene maskiner, efter behandlingen er gennemført, og disse reaktioner er forsvundet.
English: Particular care should be taken with the following medicines:
Danish: Vær især forsigtig med at bruge følgende medicin
English: Hyperaemia may fluctuate between sub-maximum and maximum until it slowly vanishes.
Danish: Hyperæmi kan variere mellem submaksimum- og maksimumniveauer, indtil det langsomt forsvinder.
English: Like all medicines, Rapiscan can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The doctor can then see if the heart muscles are getting enough blood flow when it is under stress.
Danish: Lægen kan så se, om hjertemuskulaturen har tilstrækkelig blodgennemstrømning, når den udsættes for stress.
English: There is no adequate information on the use of Rapiscan in pregnant women.
Danish: Der er ikke tilstrækkelig information om anvendelse af Rapiscan til gravide kvinder.
English: Regadenoson causes a rapid increase in CBF which is sustained for a short duration.
Danish: Regadenoson forårsager en hurtig stigning i CBF, som opretholdes i et kort stykke tid.
English: The radiopharmaceutical may be injected directly into the same catheter as Rapiscan.
Danish: Det radioaktive lægemiddel kan injiceres direkte i det samme kateter som Rapiscan.
English: • Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning artificial pacemaker.
Danish: • 2. eller 3. grads atrioventrikulært (AV) blok eller sinusknudedysfunktion, med mindre disse patienter har en velfungerende kunstig pacemaker.
English: In the pooled study population, 68% of patients had 0-1 segments showing reversible defects on the initial scan, 24% had 2-4 segments, and 9% had ≥ 5 segments.
Danish: I den samlede undersøgelsespopulation havde 68% af patienterne 0-1 segmenter med reversible defekter i den indledende skanning, 24% havde 2-4 segmenter og 9% havde ≥ 5 segmenter.
English: Rapiscan may make you feel dizzy.
Danish: Rapiscan kan føre til, at du føler dig svimmel.
English: These images show how well blood flows to the muscles of the heart.
Danish: Disse billeder viser, hvor godt blodet løber til hjertets muskulatur.
English: • if you have high blood pressure that is not controlled, especially if this has been accompanied by recent episodes of nose bleed, headache or blurred or double vision.
Danish: • hvis du har højt blodtryk, der ikke er kontrolleret, især hvis du i den forbindelse for nylig har oplevet tilfælde af næseblod, hovedpine, synsforstyrrelser eller dobbeltsyn
English: Respiratory effects
Danish: Respiratoriske virkninger
English: You should avoid breast-feeding for at least 10 hours after you are given Rapiscan.
Danish: Du bør undgå at amme i mindst 10 timer efter, du har fået Rapiscan.
English: A relationship between increased severity of disease and the increased incidence of dyspnoea was apparent in patients with asthma, but not in patients with COPD.
Danish: Sammenhængen mellem øget sygdomssværhedsgrad og øget forekomst af dyspnø var tydelig hos patienter med astma, men ikke hos patienter med COPD.
English: The majority of patients experience a rapid increase in heart rate.
Danish: Størstedelen af patienterne får en hurtig forhøjelse af hjertefrekvensen.
English: The scan uses a radioactive substance called a ‘radiopharmaceutical' to create images.
Danish: Ved skanningen anvendes et radioaktivt stof, som kaldes ‘radioaktiv medicin', til at danne billeder.
English: The regadenoson plasma concentration-time profile in healthy volunteers is multi-exponential in nature and best characterised by 3-compartment model.
Danish: Tidsprofilen for plasmakoncentrationen af regadenoson hos raske frivillige er af en multieksponentiel karakter og kan bedst karakteriseres ved en 3-delt model.
English: Rate Difference (regadenoson - Adenosine) (± 95% Confidence Interval
Danish: Forskel i frekvens (regadenoson - adenosin) (± SE) 95% konfidensinterval
English: It may cause other symptoms (headache or shortness of breath) that could affect your ability to drive or use machinery.
Danish: Det kan forårsage andre symptomer (hovedpine eller stakåndethed), som kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: The pharmacokinetic parameters of regadenoson have not yet been studied in the paediatric population (< 18 years).
Danish: Regadenosons farmakokinetiske parametre er endnu ikke blevet undersøgt i den pædiatriske population (< 18 år).
English: • if you have asthma or lung disease.
Danish: • hvis du har astma eller en lungesygdom.
English: FFR was measured after IV infusion of adenosine and IV injection of regadenoson (400 μg).
Danish: FFR blev målt efter IV infusion af adenosin og IV injektion af regadenoson (400 μg).
English: • FFR should be measured as the lowest value of Pd/Pa achieved during steady state hyperemia.
Danish: • FFR bør måles som den laveste værdi af Pd/Pa opnået under steady state hyperæmi
English: AndersonBrecon (UK) Ltd Wye Valley Business Park Hay-on-Wye, Hereford HR3 5PG, United Kingdom
Danish: AndersonBrecon (UK) Limited Wye Valley Business Park Hay-on-Wye, Hereford HR3 5PG
English: The images from MPI 1 and MPI 2 were compared for presence or absence of perfusion defects.
Danish: Billederne fra MPI 1 og MPI 2 blev sammenlignet for forekomst eller mangel på perfusionsdefekter.
English: If regadenoson is administered, the woman should not breast-feed for at least 10 hours (that is, at least 5 times the plasma elimination half-life) following regadenoson administration.
Danish: Hvis regadenoson indgives, bør kvinden ikke amme i mindst 10 timer (dvs. mindst 5 gange eliminationshalveringstiden i plasma) efter indgivelsen af regadenoson.
English: Rapiscan is injected by a healthcare professional (a doctor, nurse or medical technician) in a medical facility where your heart and blood pressure can be monitored.
Danish: Rapiscan injiceres af sundhedspersonalet (en læge, sygeplejerske eller medicotekniker) på et sygehus eller en klinik, hvor dit hjerte og dit blodtryk kan overvåges.
English: Rarely, Rapiscan can cause a stroke (also known as a cerebrovascular accident).
Danish: Rapiscan kan i sjældne tilfælde medføre et slagtilfælde (også kaldet en cerebrovaskulær hændelse).
English: Multiple injections
Danish: Flere injektioner
English: When you are given Rapiscan, your heart rate will increase quickly.
Danish: Når du får Rapiscan, vil din puls hurtigt forøges.
English: Headache was reported by 27% of subjects who received regadenoson in clinical trials.
Danish: Hovedpine blev rapporteret af 27% af forsøgspersonerne, som fik regadenoson i kliniske studier.
English: Animal studies on pre- and post-natal development have not been conducted.
Danish: Der er ikke blevet udført dyreforsøg af præ- og postnatal udvikling.
English: There are no adequate data from the use of regadenoson in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelsen af regadenoson til gravide kvinder.
English: There was no statistical difference between 200 mg and 400 mg caffeine with regadenoson .
Danish: Der var ingen statistisk forskel på 200 mg og 400 mg caffein i forbindelse med regadenoson.
English: The incidence of a FEV1 reduction > 15% from baseline after regadenoson administration was assessed in three randomised, controlled clinical studies.
Danish: Forekomst af FEV1-reduktion > 15% fra baseline efter indgivelse af regadenoson blev vurderet i tre randomiserede, kontrollerede kliniske studier.
English: A scan of your heart will be made after enough time has passed to allow the radiopharmaceutical to reach the heart muscle.
Danish: Der vil blive foretaget en skanning af dit hjerte, når der er gået tid nok til, at den radioaktive medicin er nået frem til hjertemuskulaturen.
English: Patients who did not achieve ≥ 85% maximum predicted heart rate (MPHR) and/or ≥ 5 METS (metabolic equivalents), transitioned into a 3-5 minutes walking recovery where during the first 3 minutes of recovery, patients were randomized 1:1.
Danish: Patienter, der ikke opnåede ≥ 85% af maksimal forudset hjertefrekvens (MPHR) og / eller ≥ 5 METS (metaboliske ækvivalenter), overgik til 3-5 minutters periode med restitution ved gang, og i løbet af de 3 første minutter med restitution blev patienterne randomiseret 1:1.
English: Do not drive or operate machinery until these effects have improved.
Danish: Kør ikke bil eller motorcykel og lad være med at betjene maskiner, indtil disse virkninger er aftaget.
English: All 1404 patients initially had a baseline MPI scan at rest in accordance with ASNC 2009 guidelines.
Danish: Alle 1404 patienter havde en MPI-scanning i hvile i henhold til ASNC 2009-retningslinjerne ved baseline.
English: Standard catheterisation and FFR measurement techniques are to be followed, and FFR should be measured as the lowest value of Pd/Pa achieved during steady state maximum hyperemia.
Danish: Standardkateterisering og FFR målingsteknikker skal følges, og FFR bør måles som den laveste værdi af Pd/Pa opnået under steady state maximum hyperæmi.
English: Your doctor may then give you an injection of a medicine called aminophylline that reduces these effects.
Danish: Din læge kan så give dig en injektion med en form for medicin, som hedder aminophyllin, der dæmper disse virkninger.
English: Repeat dosing within 10 minutes - except in patients where the duration of hyperaemia lasted for more than 10 minutes - caused a similar effect on peak and duration of maximum hyperaemia.
Danish: Gentagen dosering inden for 10 minutter, undtagen hos patienter, hvor hyperæmi blev opretholdt i mere end 10 minutter, havde en tilsvarende virkning på maxværdien og varigheden af hyperæmi.
English: Mean APV increased to greater than twice baseline by 30 seconds and decreased to less than half of the maximal effect within 10 minutes (see section 5.2).
Danish: Gennemsnitlig APV var forøget til over det dobbelte af baseline efter 30 sekunder og reduceret til under det halve af den maksimale virkning i løbet af 10 minutter (se pkt.
English: It is unknown whether regadenoson is excreted in human breast milk.
Danish: Det er ukendt, om regadenoson udskilles i human mælk.
English: Fertility and pre- and post-natal studies have not been conducted.
Danish: Der er hverken foretaget fertilitetsstudier eller præ- og postnatale studier.
English: The baseline MPI scans at rest and those without exercise at 1-14 days later from both groups, constituted the MPI 2 phase.
Danish: Baseline MPI scanningsresultaterne i hvile, og dem uden træning 1-14 dage senere for begge grupper, udgjorde MPI fase 2.
English: (n = 1,871)
Danish: Kombinerede studier (n = 1.871)
English: Fetal toxicity was noted following repeated daily administration of regadenoson, but at doses sufficiently in excess of the recommended human dose.
Danish: Fostertoksicitet blev bemærket efter gentagen daglig indgivelse af regadenoson, men ved doser, der i tilstrækkelig grad var over den anbefalede dosis til mennesker.
English: Age, gender, and race have minimal effects on the pharmacokinetics of regadenoson.
Danish: Alder, køn og race har minimale virkninger på regadenosons farmakokinetik.
English: For two patients from the exercise with regadenoson group, a serious cardiac adverse reaction was reported.
Danish: Hos to patienter i gruppen træning med regadenoson-gruppen blev der rapporteret om en alvorlig hjertebivirkning.
English: In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at regadenoson doses greater than 0.02 mg/kg.
Danish: I et studie med raske frivillige blev symptomer som rødmen, svimmelhed og forhøjet hjertefrekvens vurderet som intolerable ved doser af regadenoson større end 0,02 mg/kg.
English: • Unstable angina that has not been stabilised with medical therapy.
Danish: • Ustabil angina pectoris, der ikke er stabiliseret med medicinsk behandling.
English: • discomfort in the bones and muscles
Danish: • ubehag i knogler og muskler
English: Up to three consecutive injections of regadenoson (100 and 200 μg) have been tested in healthy volunteers, and two consecutive doses of 400 μg in healthy volunteers, as well as in patients assessed for FFR.
Danish: Op til tre på hinanden følgende injektioner af regadenoson (100 og 200 μg) er blevet testet hos raske frivillige og to på hinanden følgende doser på 400 μg hos raske frivillige såvel som hos patienter vurderet for FFR.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, or embryo-fetal development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkelte og gentagne doser, genotoksicitet eller embryoføtal udvikling.
English: Dipyridamole increases blood adenosine levels and the response to regadenoson may be altered when blood adenosine levels are increased.
Danish: Dipyridamol forhøjer niveauet af adenosin i blodet og responsen på regadenoson kan ændres, når niveauet af adenosin i blodet er forhøjet.
English: A number of patients took cardioactive medicinal products on the day of the scan, including β-blockers (18%), calcium channel blockers (9%), and nitrates (6%).
Danish: En del patienter fik kardioaktive lægemidler på skanningsdagen, herunder β-blokkere (18%), calciumkanalblokkere (9%) og nitrater (6%).
English: Some people have had flushing, dizziness and increased heart rate when they have been given too much Rapiscan.
Danish: Nogle personer har oplevet rødmen, svimmelhed og forøget puls, når de har fået for meget Rapiscan.
English: In post- marketing experience there have been cases of worsening or recurrence of atrial fibrillation after administration of regadenoson.
Danish: Efter markedsføring har der været tilfælde af forværring eller recidiv af atrieflimren efter administration af regadenoson.
English: In in vitro studies, regadenoson has been shown to have little binding affinity for the A2B and A3 adenosine receptors.
Danish: I in vitro-studier er det vist, at regadenoson har en lille bindingsaffinitet til A2B- og A3-adenosinreceptorerne.
English: Elevated blood pressure
Danish: Forhøjet blodtryk
English: If your doctor thinks that you are having severe side effects, or the effects of Rapiscan are lasting too long, they may give you an injection of a medicine called aminophylline that reduces these effects.
Danish: Hvis din læge mener, at du har alvorlige bivirkninger, eller hvis virkningen af Rapiscan varer for længe, kan du få en injektion med en form for medicin, som hedder aminophyllin, der dæmper disse virkninger.
English: • pain in the back, arms, legs, neck or jaw
Danish: • smerter i ryggen, armene, benene, nakken eller kæben
English: Rapiscan contains the active substance regadenoson.
Danish: Rapiscan indeholder det aktive stof regadenoson.
English: The plasma concentration-time profiles were not significantly altered in the early stages after dosing when most pharmacologic effects are observed.
Danish: Tidsprofilerne for plasmakoncentration var ikke signifikant ændret i de tidlige stadier efter indgivelse, hvor de fleste farmakologiske virkninger observeres.
English: Activation of the A2A adenosine receptor produces coronary vasodilation and increases coronary blood flow (CBF).
Danish: Aktivering af A2A-adenosinreceptoren medfører koronar vasodilatation og forøger den koronare blodgennemstrømning (coronary blood flow, CBF).
English: The mean duration of hyperaemic plateau was 163 (±169) seconds and maximum hyperaemia lasted at least 19 seconds in 90% of patients, however, in the individual patient the duration of hyperaemia varied between 10 seconds to more than 10 minutes.
Danish: Den gennemsnitlige varighed af det hyperæmiske plateau var 163 (± 169) sekunder, og den maksimale hyperæmi varede mindst 19 sekunder hos 90% af patienterne, men varigheden af hyperæmi varierede mellem 10 sekunder og mere end 10 minutter hos den enkelte patient.
English: • if you are allergic to regadenoson or any of the other ingredients of Rapiscan listed in section 6 of this leaflet.
Danish: • hvis du er allergisk over for regadenoson eller et af de øvrige indholdsstoffer i Rapiscan (angivet i punkt 6).
English: Because regadenoson increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, regadenoson causes relatively less uptake of the radiopharmaceutical in vascular territories supplied by stenotic arteries.
Danish: Da regadenoson forøger blodgennemstrømningen i normale kranspulsårer, med en ringe eller ikke eksisterende forøgelse i de stenotiske arterier, forårsager regadenoson en relativt mindre optagelse af det radioaktive middel i karområder, som forsynes af stenotiske arterier.
English: The use of bronchodilator therapy for symptoms was not different between regadenoson and placebo.
Danish: Brugen af bronkodilatator til behandling af symptomer var den samme for regadenoson og placebo.
English: In the measurement of FFR, the time to peak maximum hyperaemia was 30±13 seconds.
Danish: Ved måling af FFR var tiden til at nå den maksimale hyperæmi 30 ± 13 sekunder.
English: The metabolism of regadenoson is unknown in humans.
Danish: Regadenosons metabolisme er ukendt hos mennesker.
English: The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection of regadenoson and parallels the onset of the pharmacodynamic response (see section 5.1).
Danish: Den maksimale plasmakoncentration af regadenoson opnås i løbet af 1 til 4 minutter efter injektion af regadenoson og er parallel med begyndelsen på den farmakodynamiske respons (se pkt.
English: Millmount Healthcare Limited, Block 7, City North Business Campus, Stamullen, Co Meath, K32 YD60 Ireland
Danish: Millmount Healthcare Limited, Block 7, City North Business Campus, Stamullen, Co Meath, K32 YD60, Irland.
English: Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for:
Danish: Rapiscan er en selektiv koronar vasodilatator til opnåelse af farmakologisk stress hos voksne ved:
English: Subsequentially, patients from both groups, returned 1-14 days later, to undergo a second stress MPI regadenoson study without exercise.
Danish: Patienterne fra begge grupper kom tilbage 1-14 dage senere for at gennemgå et efterfølgende stressMPI regadenoson-studie uden træning.
English: Cerebrovascular accident
Danish: Cerebrovaskulær hændelse
English: Consideration should be given to delaying regadenoson administration until blood pressure is well controlled
Danish: Det bør overvejes at forsinke indgiften af Regadenoson, indtil blodtrykket er under kontrol.
English: In a patient with a long QT syndrome, sympathetic stimulation can result in less shortening of the QT interval than is normal and may even cause a paradoxical increase in the QT interval.
Danish: Hos en patient med et forlænget QT-interval, kan sympatisk stimulering resultere i en mindre forkortelse af QT-intervallet end normalt, og den kan endda medføre en paradoks forlængelse af QT-intervallet.
English: Greater than 55% of the regadenoson dose is excreted unchanged in the urine and factors that decrease clearance do not affect the plasma concentration in the early stages after dosing when clinically meaningful pharmacologic effects are observed.
Danish: Over 55% af regadenoson-dosen udskilles uændret i urinen, og faktorer, som reducerer clearance, påvirker ikke plasmakoncentrationen i de tidlige stadier efter indgivelse, hvor klinisk betydningsfulde farmakologiske virkninger blev observeret.
English: If you are unable to exercise enough to reach sufficient stress to the heart, Rapiscan will be injected to provide a stress of similar amplitude to the heart to increase the blood flow.
Danish: Hvis du ikke er i stand til at motionere nok til at opnå tilstrækkelig belastning af hjertet, vil Rapiscan injiceres for at give en tilsvarende påvirkning/belastning af hjertet for at øge blodgennemstrømningen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre præparater.
English: Your heart rate and blood pressure will be monitored.
Danish: Din puls og dit blodtryk vil blive overvåget.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB21
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, andre hjertemidler, ATC-kode: C01EB21
English: The greatest mean change from baseline (21 bpm) occurs approximately 1 minute after administration of regadenoson.
Danish: Den største gennemsnitlige ændring fra baseline (21 slag pr. minut) forekommer ca. 1 minut efter indgivelse af regadenoson.
English: Signs of maternal and fetal toxicity were seen in rats and rabbits (reduced fetal weights, delays in ossification [rats], reduced litter size and number of live fetuses [rabbits]), but not teratogenicity.
Danish: Tegn på toksicitet hos moder og foster blev observeret hos rotter og kaniner (reduceret fostervægt, forsinket ossifikation [rotter], nedsat kuldstørrelse og reduceret antal levende fostre [kaniner]), men ikke på teratogenicitet.
English: This medicinal product should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Dette lægemiddel skal inspiceres visuelt for partikler og misfarvning før indgivelse.
English: Patients who have had any symptoms or signs suggestive of acute myocardial ischaemia during exercise or recovery are likely to be at especially high risk of serious adverse reactions.
Danish: Patienter, der har haft symptomer eller tegn på akut myokardieiskæmi under fysisk aktivitet eller restituering, har sandsynligvis en større risiko for alvorlige bivirkninger.
English: For FFR measurement, a diagnosis of inducible ischemia was made according to the measurement of FFR of 0.8 (>0.8 represents the absence of inducible ischemia vs ≤ 0.8 representing the presence of inducible ischemia).
Danish: I forbindelse med FFR målinger blev der stillet en diagnose for inducerbar iskæmi afhængigt af om FFR nåede 0,8 (> 0,8 repræsenterer fravær af inducerbar iskæmi vs ≤ 0,8, der indikerer tilstedeværelse af inducerbar iskæmi).
English: • if you have chest pain that occurs unpredictably (unstable angina) and that has not improved after treatment.
Danish: • hvis du har brystsmerter, der kommer uforudsigeligt, (ustabil angina pectoris) og ikke er blevet bedre efter behandling.
English: Cardioactive medicinal products
Danish: Kardioaktive lægemidler
English: Methylxanthines
Danish: Methylxanthiner