FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Če pri vas ni mogoče doseči fizične obremenitve, ki bi predstavljala zadosten stres za srce, boste v obliki injekcije prejeli zdravilo Rapiscan, da bo na srcu prišlo do stresa podobnega obsega in se bo zaradi njega pretok krvi povečal.
English: • feeling unwell or weak
Slovenian: • slabo počutje ali šibkost
English: When you are given Rapiscan, your heart rate will increase quickly.
Slovenian: Ko boste dobili zdravilo Rapiscan, se bo srčni utrip naglo povečal.
English: Studies
Slovenian: Študija
English: Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome.
Slovenian: Regadenozon stimulira simpatični iztis in lahko poveča tveganje za ventrikularne tahiaritmije pri bolnikih s sindromom podaljšanega intervala QT.
English: Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for:
Slovenian: Zdravilo Rapiscan je selektivni koronarni vazodilatator, ki se pri odraslih uporablja kot zdravilo za farmakološko obremenitev pri:
English: Regadenoson is a low affinity agonist (Ki ≈ 1.3 µM) for the A2A adenosine receptor, with at least 10fold lower affinity for the A1 adenosine receptor (Ki > 16.5 µM), and very low, if any, affinity for the A2B and A3 adenosine receptors.
Slovenian: Regadenozon je agonist z nizko afinititeto (Ki ≈ 1,3 µM) za receptor adonezina A2A, z vsaj 10-krat nižjo afiniteto za receptor adenozina A1 (Ki > 16,5 µM), in zelo nizko (če sploh kakšno) afiniteto za receptorja adenozina A2B in A3.
English: For two patients from the exercise with regadenoson group, a serious cardiac adverse reaction was reported.
Slovenian: Pri dveh bolnikih iz skupine vadbe z regadenozonom so poročali o resnih neželenih učinkih na srce.
English: The pharmacokinetic parameters of regadenoson have not been specifically evaluated in those with varying degrees of hepatic impairment.
Slovenian: Farmakokinetičnih parametrov regadenozona niso posebej ocenili pri osebah s spremenljivimi stopnjami okvare jeter.
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.
Slovenian: Regadenozon je prejelo skupno 249 bolnikov, pri katerih je bila klinično indicirana izvedba koronarne angiografije z invazivnim merjenjem FFR, 88 izmed teh bolnikov pa je regadenozon prejelo dvakrat.
English: Regadenoson may cause bronchoconstriction and respiratory arrest (see section 4.8) , especially in patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD) or asthma.
Slovenian: Regadenozon lahko povzroči bronhokonstrikcijo in respiratorni zastoj (glejte poglavje 4.8), zlasti pri bolnikih z znano bronhokonstriktivno boleznijo ali sumom nanjo, s kronično obstruktivno pljučno boleznijo (KOPB) ali astmo.
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.
Slovenian: Pri teh bolnikih se lahko pojavi fenomen sindroma R-na-T, pri čemer val T prejšnjega utripa prekine dodatni utrip, kar zviša tveganje ventrikularne tahiaritmije.
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).
Slovenian: V študiji odraslih bolnikov, ki so bili podvrženi radionuklidnemu slikanju miokardne perfuzije pod farmakološko obremenitvijo z regadenozonom, randomiziranimi za placebo (n=66) ali kofein (200 mg, n=70, ali 400 mg, n=71), ki sta bila dana 90 minut pred testiranjem, je kofein zmanjšal diagnostično točnost zaznavanja reverzibilnih perfuzijskih okvar (p<0,001).
English: Upon case review, both patients, experienced ischemic symptoms and ECG changes during exercise or recovery prior to regadenoson administration.
Slovenian: Po pregledu primera sta oba bolnika doživela ishemične simptome in spremembe EKG med vadbo ali okrevanjem pred dajanjem regadenozona.
English: Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without prescription.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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.
Slovenian: Po uporabi vsakega odmerka regadenozona je prišlo do prehodnega, od odmerka odvisnega povečanja frekvence srčnega utripa, niso pa opazili nobenega doslednega vpliva na sistolični krvni tlak.
English: • radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Slovenian: • radionuklidnem slikanju miokardne perfuzije pri bolnikih, ki niso zmožni obremenitve z vadbo.
English: Aminophylline should be used with caution in patients with a history of seizures or who have other risk factors for seizures as it may prolong a seizure or cause multiple seizures because of its proconvulsant effect.
Slovenian: Aminofilin je treba previdno uporabljati pri bolnikih z anamnezo epileptičnih napadov ali tistih, ki imajo druge dejavnike tveganja za epileptične napade, saj lahko zaradi svojega prokonvulzivnega učinka podaljša epileptični napad ali povzroči več napadov.
English: The greatest mean change from baseline (21 bpm) occurs approximately 1 minute after administration of regadenoson.
Slovenian: Največja srednja sprememba od izhodišča (21 utripov/minuto) se pojavi približno 1 minuto po dajanju regadenozona.
English: Clinical studies have demonstrated the efficacy and safety of regadenoson in patients indicated for pharmacologic stress radionuclide MPI and for the measurement of FFR.
Slovenian: Klinične študije so pokazale učinkovitost in varnost regadenozona pri bolnikih, pri katerih je obstajala indikacija za radionuklidno slikanje miokardne perfuzije pod farmakološko obremenitvijo in za merjenje FFR.
English: For intravenous use.
Slovenian: Način uporabe Za intravensko uporabo.
English: The plasma concentration-time profiles were not significantly altered in the early stages after dosing when most pharmacologic effects are observed.
Slovenian: Profili plazemske koncentracije v odvisnosti od časa se niso značilno spremenili v zgodnjih stopnjah po odmerjanju, ko so opazili večino farmakoloških učinkov.
English: Regadenoson increases sympathetic tone, which causes an increase in heart rate and a shortening of the QT interval.
Slovenian: Regadenozon zvišuje tonus simpatikus, kar povzroči zvišanje srčnega utripa in skrajšanje intervala QT.
English: This medicine is for diagnostic use only.
Slovenian: Zdravilo je samo za diagnostične namene.
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).
Slovenian: V preskušanju EXERRT je bila ovrednotena varnost in učinkovitost regadenozona pri bolnikih s suboptimalno telesno obremenitvijo v odprti, randomizirani, multicentrični študiji neinferiornosti z uporabo regadenozona 3 minute po začetku okrevanja (vadba z regadenozonom) ali v mirovanju 1 uro pozneje (samo regadenozon).
English: • respiratory arrest
Slovenian: • respiratorni zastoj
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).
Slovenian: Mednje sodijo nizek krvni volumen (ki ga lahko denimo povzročita huda driska ali dehidracija ali jemanje tablet za odvajanje vode), vnetje okoli srca (perikarditis) in nekatere oblike bolezni srčne zaklopke ali arterij (na primer stenoza aorte ali mitralna stenoza),
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.
Slovenian: Pri bolnikih, ki imajo med telesno vadbo ali okrevanjem kakršne koli simptome ali znake, ki kažejo na akutno miokardno ishemijo, je tveganje za resne neželene učinke verjetno posebej visoko.
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%).
Slovenian: Številni bolniki so na dan slikanja uporabili zdravila za bolezni srca vključno z zaviralci adrenergičnih receptorjev beta (18%), zaviralci kalcijevih kanalčkov (9%) in nitrati (6%).
English: • pins and needles, reduced sensation, taste changes
Slovenian: • zbadanje in mrtvičenje, zmanjšan občutek, spremembe v okusu
English: Transient ischaemic attacks and cerebrovascular accident Regadenoson can cause transient ischaemic attack (see section 4.8).
Slovenian: Prehodni ishemični napadi in cerebrovaskularni inzult Regadenozon lahko povzroči prehodni ishemični napad (glejte poglavje 4.8).
English: The pharmacokinetics of regadenoson in patients on dialysis has not been assessed.
Slovenian: Farmakokinetike regadenozona pri bolnikih na dializi niso ocenjevali.
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.
Slovenian: Vsak bolnik je bil na začetku izpostavljen slikanju pod obremenitvijo z uporabo adenozina (6-minutno infundiranje z odmerkom 0,14 mg/kg/min, brez vadbe) po radionuklidnem G-SPECT (gated single photon emission computed tomography) protokolu slikanja.
English: Aminophylline may be used to attenuate severe or persistent adverse reactions to regadenoson.
Slovenian: Aminofilin se lahko uporabi za ublažitev hudih ali trdovratnih neželenih učinkov na regadenozon.
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.
Slovenian: V kliničnih študijah so regadenozon dajali bolnikom, ki so uporabljali druga zdravila za bolezni srca (tj. zaviralce adrenergičnih receptorjev beta, zaviralce kalcijevih kanalčkov, inhibitorje ACE, nitrate, kardiotonične glikozide in zaviralce receptorjev angiotenzina) brez vidnih učinkov na profil varnosti in učinkovitosti regadenozona.
English: Paraesthesia, hypoaesthesia, dysgeusia
Slovenian: Pogosti parestezija, hipoestezija, disgevzija
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.
Slovenian: Regadenozon ima morda zmerno inhibitorno delovanje na aktivni renalni prenašalec, OCT2, ugotovili so tudi, da je verjeten substrat za transport, pri katerem posredujejo BCRP, ENT1 ali ENT2.
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.
Slovenian: Bolniki iz obeh skupin (vadba z regadenozonom in samo regadenozon) so opravili slikanje miokardne perfuzije SPECT (MPI- Myocardial Perfusion Imaging) v času 60-90 minut po uporabi regadenozona.
English: (n = 1,113)
Slovenian: ADVANCE MPI 1 (n = 1.113)
English: It is unknown whether regadenoson is excreted in human breast milk.
Slovenian: Ni znano, ali se regadenozon izloča v materino mleko.
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.
Slovenian: Zdravilo se injicira neposredno v veno v obliki enkratnega odmerka 400 mikrogramov v 5-ml raztopini - injiciranje traja približno 10 sekund.
English: Like all medicines, Rapiscan can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Slovenian: Pri podganah in kuncih so videli znake toksičnosti za brejo samico in plod (zmanjšana telesna masa fetusa, zakasnjena osifikacija [podgane], manjše število legla in število živih fetusov [kunci]), vendar niso opazili teratogenosti.
English: Intravenous use.
Slovenian: Intravenska uporaba.
English: Activation of the A2A adenosine receptor produces coronary vasodilation and increases coronary blood flow (CBF).
Slovenian: Aktiviranje receptorja adenozina A2A povzroči koronarno vazodilatacijo in zviša koronarni krvni pretok.
English: Regadenoson has the potential to cause serious and life-threatening reactions, including those listed below (see also section 4.8).
Slovenian: Regadenozon lahko povzroči resne ali življenjsko nevarne učinke, vključno s spodaj naštetimi (glejte tudi poglavje 4.8).
English: Use of regadenoson involving exercise has been associated with serious adverse reactions including hypotension, hypertension, syncope and cardiac arrest.
Slovenian: Uporaba regadenozona v kombinaciji s telesno vadbo je bila povezana z resnimi neželenimi učinki, vključno s hipotenzijo, hipertenzijo, sinkopo in srčnim zastojem.
English: • Unstable angina that has not been stabilised with medical therapy.
Slovenian: • nestabilna angina pektoris, ki ni uravnana z zdravili,
English: Regadenoson may cause myocardial ischaemia (potentially associated with fatal cardiac arrest, lifethreatening ventricular arrhythmias, and myocardial infarction), hypotension leading to syncope and transient ischaemic attacks, elevated blood pressure leading to hypertension and hypertensive crises, and SA/AV node block leading to first, second or third degree AV block, or sinus bradycardia requiring intervention (see section 4.4).
Slovenian: Regadenozon lahko povzroči miokardno ishemijo (potencialno povezano s srčnim zastojem s smrtnim izidom, življenje ogrožajoče ventrikularne aritmije in miokardni infarkt), hipotenzijo, ki povzroči sinkopo in tranzitorne ishemične atake, povišan krvni tlak, ki povzroči hipertenzijo in hipertenzivne krize, ter blok SA/AV vozlov, ki povzroči AV blok prve, druge ali tretje stopnje ali sinusno bradikardijo, zaradi katere je potrebno posredovanje (glejte poglavje 4.4).
English: The recommended dose is a single injection of 400 micrograms regadenoson (5 ml) into a peripheral vein, with no dose adjustment necessary for body weight.
Slovenian: Priporočeni odmerek je 400 mikrogramov regadenozona (5 ml) v enkratnem odmerku injiciran v periferno veno, pri čemer prilagajanje odmerka na telesno maso ni potrebno.
English: You will also be given an injection of sodium chloride 9 mg/ml (0.9%) solution (5 ml), and an injection of a small amount of a radioactive substance (radiopharmaceutical).
Slovenian: Dobili boste tudi injekcijo 0,9% (9 mg/ml) raztopine natrijevega klorida (5 ml) in injekcijo majhne količine radioaktivne snovi (radiofarmacevtskega izdelka).
English: Adenosine was administered first, followed by regadenoson as its hyperaemia may last unpredictably and the measured FFR values were compared.
Slovenian: Najprej so aplicirali adenozin, nato regadenozon, saj je trajanje z njim povzročene hiperemije lahko nepredvidljivo, izmerjene vrednosti FFR pa so primerjali.
English: Aminophylline (100 mg, administered by slow intravenous injection over 60 seconds) injected 1 minute after 400 micrograms regadenoson in subjects undergoing cardiac catheterisation, was shown to shorten the duration of the coronary blood flow response to regadenoson as measured by pulsed- wave Doppler ultrasonography.
Slovenian: Aminofilin (100 mg, ki ga dajemo s počasnim intravenskim injiciranjem v 60 sekundah), injiciran 1 minuto po uporabi 400 mikrogramov regadenozona pri osebah mad kateterizacijo srca, je pokazal, da skrajša trajanje odziva koronarnega krvnega pretoka na regadenozon, izmerjeno s pulznim doplerjem.
English: • if you have slow heart rate (high degree heart block or sinus node disease), and don't have a pacemaker fitted.
Slovenian: • če imate počasen utrip srca (srčni blok visoke stopnje ali bolezen sinusnega vozla) in nimate nameščenega srčnega spodbujevalnika,
English: • redness of the skin
Slovenian: • pordelost kože
English: An increase in blood pressure has been observed in some patients (maximum systolic blood pressure of 240 mm Hg and maximum diastolic blood pressure of 138 mm Hg).
Slovenian: Pri nekaterih bolnikih so opazili zvišanje krvnega tlaka (največji sistolični krvni tlak 240 mm Hg in največji diastolični krvni tlak 138 mm Hg).
English: The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency.
Slovenian: Tveganje hude hipotenzije je lahko večje pri bolnikih z avtonomno disfunkcijo, hipovolemijo, stenozo v glavnem deblu leve koronarne arterije, stenotično boleznijo srčne zaklopke, perikarditisom ali perikardno efuzijo ali stenotično boleznijo karotidne arterije s cerebrovaskularno insuficienco.
English: (n = 758)
Slovenian: ADVANCE MPI 2 (n = 758)
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.
Slovenian: V prvi in drugi študiji so poročali o dispneji kot o neželenem učinku po dajanju regadenozona (61% za bolnike s KOPB; 34% za bolnike z astmo), pri bolnikih, ki so prejeli placebo, pa ni bilo primerov dispneje.
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
English: Fertility and pre- and post-natal studies have not been conducted.
Slovenian: Študij vpliva na razmnoževanje ter prenatalnih in postnatalnih študij niso izvajali.
English: In the second study in 48 patients with mild to moderate asthma who had previously been shown to have bronchoconstrictive reactions to adenosine monophosphate, the rate of FEV1 reduction > 15% from baseline was the same (4%) following both regadenoson and placebo dosing.
Slovenian: V drugi študiji z 48 bolniki z blago do zmerno astmo, pri katerih se je že prej pokazala bronhokonstrikcijska reakcija na adenozin monofosfat, je bila stopnja zmanjšanja FEV1 > 15% od izhodišča enaka (4%) po dajanju regadenozona in placeba.
English: Continuous ECG monitoring should be performed and vital signs should be monitored at frequent intervals until the ECG parameters, heart rate and blood pressure have returned to pre-dose levels.
Slovenian: Potreben je stalen nadzor EKG in preverjanje življenjskih znakov v pogostih časovnih presledkih, dokler se parametri EKG, srčnega utripa in krvnega tlaka ne vrnejo na vrednosti pred odmerjanjem.
English: Do not take Rapiscan:
Slovenian: Ne jemljite zdravila Rapiscan
English: Vomiting, nausea, oral discomfort
Slovenian: Pogosti bruhanje, navzea, ustno nelagodje
English: • discomfort in the stomach
Slovenian: • nelagodje v trebuhu
English: The most common cardiovascular histories included hypertension (81%), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or stenting (51%), angina (63%), and history of myocardial infarction (41%) or arrhythmia (33%); other medical history included diabetes (32%) and COPD (5%).
Slovenian: Najpogostejše kardiovaskularne anamneze so vključevale hipertenzijo (81%), obvodni presadek koronarne arterije (CABG- coronary artery bypass graft), perkutano transluminalno koronarno angioplastiko (percutaneous transluminal coronary angioplasty, PTCA) ali stentiranje (51%), angino pektoris (63%) in anamnezo miokardnega infarkta (41%) ali aritmije (33%); druge anamneze so vključevale diabetes (32%) in KOPB (5%).
English: For use in FFR: This product is to be administered no more than twice, no less than10 minutes apart, during any 24 hour period.
Slovenian: Pri uporabi za FFR: To zdravilo se sme uporabiti največ dvakrat, z vsaj 10-minutnim razmakom v 24urnem obdobju.
English: Rapiscan is also used during catheterisation and imaging arteries of the heart (invasive coronary angiography) to expand the arteries of the heart to measure the difference in pressure, caused by a narrowing within one or more arteries.
Slovenian: Zdravilo Rapiscan se uporablja tudi med kateterizacijo in slikanjem arterij v srcu (invazivna koronarna angiografija) za razširitev srčnih arterij in merjenje razlike v tlaku, do katere pride zaradi zoženja ene ali več arterij.
English: What Rapiscan looks like and contents of the pack
Slovenian: Izgled zdravila Rapiscan in vsebina pakiranja
English: Adenosine receptor agonists including regadenoson induce arterial vasodilation and hypotension.
Slovenian: Agonisti receptorjev adenozina vključno z regadenozonom inducirajo arterijsko vazodilatacijo in hipotenzijo.
English: Sinoatrial and atrioventricular nodal block
Slovenian: Blok sinoatrijskega in atrioventrikularnega vozla
English: With increasing renal impairment, from mild (CLcr 50 to < 80 ml/min) to moderate (CLcr 30 to < 50 ml/min) to severe renal impairment (CLcr < 30 ml/min), the fraction of regadenoson excreted unchanged in urine and the renal clearance decreased, resulting in increased elimination halflives and AUC values compared to healthy subjects (CLcr ml/min).
Slovenian: Z večanjem okvare ledvic, od blage (očistek kreatinina 50 to < 80 ml/min) do zmerne (očistek kreatinina 30 do < 50 ml/min) in hude okvare ledvic (očistek kreatinina < 30 ml/min), se je frakcija regadenozona nespremenjena izločala v urinu in ledvični očistek se je manjšal, kar je povzročilo podaljšanje razpolovnih časov izločanja in vrednosti AUC v primerjavi z zdravimi osebami (očistek kreatinina ≥ 80 ml/min).
English: • an allergic reaction which can cause rash, wheals/weals, swelling under the skin near the eyes or throat, throat tightness, difficulty breathing
Slovenian: • alergijska reakcija, ki lahko povzroči izpuščaje, izbočene lise, podkožno oteklino blizu oči ali grla, stiskanje v grlu in težave z dihanjem
English: 5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over-seal.
Slovenian: 5 ml raztopine v stekleni viali (tipa 1) za enkratno uporabo z (butilnim) gumijastim zamaškom in aluminijasto vrhnjo zaporko.
English: This medicinal product should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: To zdravilo je treba pred uporabo vizualno pregledati glede delcev in obarvanja.