FrancophonIA/ELRC3.0 huggingface dataset:
English: In the measurement of FFR, the time to peak maximum hyperaemia was 30±13 seconds.
Slovenian: Pri merjenju FFR je čas, po katerem je prišlo do najizrazitejše hiperemije, znašal 30 ± 13 sekund.
English: Also, there was no apparent effect of 200 mg or 400 mg of caffeine on regadenoson plasma concentrations.
Slovenian: Poleg tega ni bilo opaznih vplivov 200 mg ali 400 mg kofeina na plazemske koncentracije regadenozona.
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.
Slovenian: V študiji z zdravimi prostovoljci so le ti simptome vročinskih valov, omotice in hitrejšega srčnega utripa ocenili kot nevzdržne pri odmerkih regadenozona, večjih od 0,02 mg/kg.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z regadenozonom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Repeated use
Slovenian: Ponavljajoča se uporaba
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.
Slovenian: Obdobje hiperemije je v povprečju trajalo 163 (± 169) sekund, najizrazitejša hiperemija je pri 90 % bolnikov trajala vsaj 19 sekund, vendar pa je pri posameznih bolnikih obdobje hiperemije trajalo od 10 sekund do več kot 10 minut.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek.
English: LABELLING
Slovenian: A. OZNAČEVANJE
English: What you need to know before you are given Rapiscan
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Rapiscan
English: Regadenoson does not inhibit the metabolism of substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in human liver microsomes, indicating that it is unlikely to alter the pharmacokinetics of medicinal products metabolised by these cytochrome P450 enzymes.
Slovenian: Regadenozon ne zavira presnove substratov za CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4 v mikrosomih človeških jeter, kar kaže, da ni verjetno, da bi vplival na farmakokinetiko zdravil, ki jih presnavljajo ti encimi citokroma P450.
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).
Slovenian: Največja koncentracija regadenozona v plazmi se doseže v 1 do 4 minutah po injiciranju regadenozona in ustreza nastopu farmakodinamičnega odziva (glejte poglavje 5.1).
English: • low blood pressure which may result in fainting or mini strokes (including weakness of the face or an inability to speak).
Slovenian: • nizek krvni tlak, ki lahko povzroči omedlevico ali majhne kapi (vključno z oslabelostjo obraza ali nezmožnostjo govoriti).
English: These images show how well blood flows to the muscles of the heart.
Slovenian: Posnetek prikazuje, kako dobro kri priteka v srčne mišice.
English: A scan of your heart will be made after enough time has passed to allow the radiopharmaceutical to reach the heart muscle.
Slovenian: Vaše srce bodo slikali, ko mine dovolj časa, da radiofarmacevtski izdelek doseže srčno mišico.
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).
Slovenian: Pri meritvi FFR je bila diagnoza inducibilne ishemije določena glede na izmerjeno FFR v vrednosti 0,8 (> 0,8 predstavlja odsotnost inducibilne ishemije, ≤ 0,8 pa predstavlja prisotnost inducibilne ishemije).
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.
Slovenian: Pri zdravih prostovoljcih se je 57% odmerka regadenozona nespremenjenega izločilo v urinu (razpon 19-77%), s povprečnim ledvičnim očistkom v plazmi približno 450 ml/min, tj. več kot je stopnja glomerularne filtracije.
English: In postmarketing experience, syncope and transient ischaemic attacks have been reported.
Slovenian: V izkušnjah po začetku trženja so poročali o sinkopi in tranzitornih ishemičnih atakah.
English: • if you have a condition that causes fits (seizures), such as epilepsy, or if you have ever had fits.
Slovenian: • ali imate bolezen, ki povzroča napade, kot je epilepsija, ali če ste kdaj imeli napade,
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).
Slovenian: Zato so 1147 bolnikov randomizirali v dve skupini: 578 bolnikov v skupino vadbe z regadenozonom in 569 v skupino samo z regadenozonom, z uporabo regadenozona bodisi 3 minute po začetku okrevanja (za skupino vadbe z regadenozonom) ali v mirovanju 1 uro pozneje (za skupino samo regadenozon).
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.
Slovenian: Pri bolnikih s sindromom podaljšanega intervala QT lahko simpatična stimulacija povzroči manjše skrajšanje intervala QT kot je normalno in povzroči celo paradoksalno zvišanje intervala QT.
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.
Slovenian: Pri zdravih prostovoljcih so preizkušali do tri zaporedna injiciranja regadenozona (100 in 200 μg), dva zaporedna 400 μg odmerka pa so preizkušali pri zdravih prostovoljcih, pa tudi pri bolnikih, pri katerih so izvedli meritev FFR.
English: Regadenoson may cause clinically significant increases in blood pressure, which in some patients can lead to hypertensive crisis (see section 4.8).
Slovenian: Regadenozon lahko povzroči klinično pomembna zvišanja krvnega tlaka, ki lahko pri nekaterih bolnikih pripeljejo do hipertenzivne krize (glejte poglavje 4.8).
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:
Slovenian: Študiji ADVANCE MPI 1 in ADVANCE MPI 2 sta posamično in kombinirano pokazali, da je regadenozon podobno adenozinu pri ocenjevanju obsega reverzibilnih perfuzijskih abnormalnosti:
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: Mean plasma concentrations increased in a dose-related manner and by successive doses as observed in healthy volunteers.
Slovenian: Povprečne koncentracije v plazmi so se povečevale sorazmerno z odmerkom in z zaporednimi odmerki, kot so opažali pri zdravih prostovoljcih.
English: The headache was considered severe in 3% of subjects.
Slovenian: Glavobol je bil pri 3% oseb hud.
English: • pain in the back, arms, legs, neck or jaw
Slovenian: • bolečina v hrbtu, rokah, nogah, vratu ali čeljusti
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB21
Slovenian: Farmakoterapevtska skupina: zdravljenje srca, druga zdravila za bolezni srca, oznaka ATC: C01EB21
English: • if you have chest pain that occurs unpredictably (unstable angina) and that has not improved after treatment.
Slovenian: • če imate bolečino v prsih, ki je ni mogoče napovedati (nestabilno angino pektoris), in če se stanje po zdravljenju ni izboljšalo,
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).
Slovenian: • meritvi funkcionalne pretočne rezerve (FFR - fractional flow reserve) stenoze edine koronarne arterije med invazivno koronarno angiografijo, kadar ne pričakujemo ponovnih meritev FFR (glejte poglavji 4.2 in 5.1).
English: Your doctor will only give you Rapiscan if it is clearly necessary.
Slovenian: Zdravnik vam bo dal zdravilo Rapiscan le, če je to nujno potrebno.
English: Rapiscan solution for injection is a clear, colourless solution with no particles visible.
Slovenian: Zdravilo Rapiscan raztopina za injiciranje je bistra, brezbarvna raztopina brez vidnih delcev.
English: Safety and tolerability testing
Slovenian: Preskušanje varnosti in prenašanja
English: Pack size of 1.
Slovenian: Velikost pakiranja 1.
English: The scan uses a radioactive substance called a ‘radiopharmaceutical' to create images.
Slovenian: Pri slikanju se uporablja radioaktivna snov, imenovana "radiofarmacevtski izdelek", ki omogoči nastanek posnetka.
English: • if you have had a recent serious heart problem (for example a heart attack or abnormal heart rhythms).
Slovenian: • ali ste imeli nedavne hude težave s srcem (na primer srčni infarkt ali nenormalen srčni ritem),
English: • Decompensated states of heart failure.
Slovenian: • dekompenzirana stanja srčnega popuščanja.
English: • if you have a heart rhythm disorder called long QT syndrome.
Slovenian: • ali imate motnjo srčnega ritma, imenovano sindrom podaljšanega intervala QT,
English: • discomfort in the mouth
Slovenian: • nelagodje v ustih
English: Do not use Rapiscan after the expiry date which is stated on the vial and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
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.
Slovenian: Ker regadenozon zvišuje krvni pretok v normalnih koronarnih arterijah, v stenotičnih arterijah pa ga zviša le malo ali sploh ne, povzroča regadenozon relativno manj privzema radiofarmacevtskega izdelka v predelih ožilja, ki jih oskrbujejo stenotične arterije.
English: Using the 17-segment model, the number of segments showing a reversible perfusion defect was calculated for the initial adenosine study and for the randomised study obtained using regadenoson or adenosine.
Slovenian: Na modelu s 17 segmenti je bilo število segmentov, ki kažejo reverzibilno perfuzijsko okvaro, izračunano za začetno študijo z adenozinom in za randomizirano študijo z uporabo regadenozona ali adenozina.
English: • FFR should be measured as the lowest value of Pd/Pa achieved during steady state hyperemia.
Slovenian: • FFR je treba meriti kot najnižjo vrednost Pd/Pa, doseženo med hiperemijo v ravnovesnem stanju.
English: Multiple injections
Slovenian: Večkratna injiciranja
English: Fetal toxicity was noted following repeated daily administration of regadenoson, but at doses sufficiently in excess of the recommended human dose.
Slovenian: Fetotoksičnost so opazili po ponavljajočih se dnevnih odmerkih regadenozona, vendar v odmerkih, ki so veliko večji od priporočenega odmerka pri ljudeh.
English: This indicates that renal tubular secretion plays a role in regadenoson elimination.
Slovenian: To kaže, da ima renalna tubularna sekrecija vlogo pri izločanju regadenozona.
English: Elevated blood pressure
Slovenian: Povišan krvni tlak
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.
Slovenian: Po injiciranju zdravila Rapiscan morate sedeti ali ležati, da se vaš srčni utrip in krvni tlak vrneta na vaši običajni ravni.
English: Incubation with rat, dog, and human liver microsomes as well as human hepatocytes produced no detectable metabolites of regadenoson.
Slovenian: Inkubacija z jetrnimi mikrosomi podgan, psov in človeka ter s človeškimi hepatociti ni pokazala zaznavnih presnovkov regadenozona.
English: Therefore administration of aminophylline solely for the purpose of terminating a seizure induced by regadenoson is not recommended.
Slovenian: Zato uporaba aminofilina izključno za namen ustavitve napada, ki ga sproži regadenozon, ni priporočljiva.
English: It makes the heart arteries expand and heart rate increase.
Slovenian: Zdravilo razširi srčne arterije in poveča srčni utrip.
English: Coronary blood flow
Slovenian: Koronarni krvni pretok
English: To be taken into consideration if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: The doctor can then see if the heart muscles are getting enough blood flow when it is under stress.
Slovenian: Nato lahko zdravnik vidi, če v srčne mišice pod obremenitvijo priteka zadostna količina krvi.
English: • pain or discomfort around the area injected, body pain
Slovenian: • bolečina ali nelagodje okoli mesta injiciranja, splošne telesne bolečine
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).
Slovenian: Vendar pa analiza post-hoc na podlagi podatkov iz dveh kliničnih preskušanj 3. faze kaže, da farmakokinetika regadenozona ni bila prizadeta v majhni podskupini bolnikov z laboratorijskimi vrednostmi, ki kažejo na okvaro jeter (2,5kratni zvečanje transaminaze ali 1,5-kratni zvečanje serumskega bilirubina ali protrombinskega časa).
English: • if you are allergic to regadenoson or any of the other ingredients of Rapiscan listed in section 6 of this leaflet.
Slovenian: • če ste alergični na regadenozon ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
English: In post- marketing experience there have been cases of worsening or recurrence of atrial fibrillation after administration of regadenoson.
Slovenian: V obdobju trženja zdravila so bili primeri poslabšanja ali ponovitve atrijske fibrilacije po dajanju regadenozona.
English: The A2B and A3 adenosine receptors have been implicated in the pathophysiology of bronchoconstriction in susceptible individuals (i.e., asthmatics).
Slovenian: Receptorja adenozina A2B in A3 sta bila vpletena v patofiziologijo bronhokonstrikcije pri občutljivih posameznikih (tj. astmatikih).
English: However, most adverse reactions are mild and transient, resolving within 30 minutes after receiving regadenoson.
Slovenian: Vendar pa je večina neželenih učinkov blagih in prehodnih ter izzvenijo v 30 minutah po uporabi regadenozona.
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%).
Slovenian: Pri starejših bolnikih (≥ 75 let; n = 321) je bil profil neželenih učinkov podoben kot pri mlajših bolnikih (< 65 let; n = 1.016), vendar je bila incidenca hipotenzije višja (2% v primerjavi z < 1%).
English: • Severe hypotension.
Slovenian: • huda hipotenzija,
English: Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence
Slovenian: Občasni konvulzije, sinkopa, tranzitorne ishemične atake, neodzivnost na spodbude, zmanjšana raven zavedanja, tremor, zaspanost
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.
Slovenian: Aminofilin se lahko daje v odmerkih v razponu od 50 mg do 250 mg v obliki počasnega intravenskega injiciranja (50 mg do 100 mg v 30-60 sekundah) za ublažitev hudih in/ali trdovratnih neželenih učinkov na regadenozon, vendar se ne sme uporabiti izključno za ustavitev epileptičnega napada, ki ga sproži regadenozon.
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).
Slovenian: Metilksantini (npr. kofein in teofilin) so nespecifični antagonisti receptorja adenozina in lahko medsebojno delujejo z vazodilatacijsko aktivnostjo regadenozona (glejte poglavje 5.1).
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.
Slovenian: Analiza populacijske farmakokinetike, ki vključuje podatke prostovoljcev in bolnikov, je pokazala, da očistek regadenozona pada vzporedno z manjšanjem očistka kreatinina in se viša z naraščanjem telesne mase.
English: These findings indicate that metabolism of regadenoson does not play a major role in the elimination of regadenoson.
Slovenian: Ti izsledki kažejo na to, da presnova regadenozona ne igra velike vloge pri izločanju regadenozona.
English: Based on a population pharmacokinetic analysis, age has a minor influence on the pharmacokinetics of regadenoson.
Slovenian: Na podlagi farmakokinetične analize populacije ima starost le manjši vpliv na farmakokinetiko regadenozona.
English: In the third study dyspnoea was reported more frequently following regadenoson (18% for patients with COPD; 11% for patients with asthma) than placebo, but at a lower rate than reported during clinical development (see Section 4.8).
Slovenian: V tretji študiji so o dispneji pogosteje poročali po dajanju regadenozona (18% za bolnike s KOPB, 11% za bolnike z astmo) kot pri placebu, vendar pri nižji stopnji, kot je bila poročana med kliničnim razvojem (glejte poglavje 4.8).
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.
Slovenian: Pri dajanju regadenozona je treba prenehati z dojenjem za vsaj 10 ur (to je vsaj 5-kratna razpolovna doba v plazmi) po odmerjanju regadenozona.
English: For use in radionuclide MPI: This product is to be administered only once within a 24 hour period.
Slovenian: Pri uporabi za radionuklidno slikanje miokardne perfuzije: To zdravilo se lahko uporabi samo enkrat v 24-urnem obdobju.
English: The majority of patients experience a rapid increase in heart rate.
Slovenian: Pri večini bolnikov se je srčni utrip hitro zvišal.
English: There is no adequate information on the use of Rapiscan in pregnant women.
Slovenian: Ustreznih informacij o uporabi zdravila Rapiscan pri nosečnicah ni.
English: • if you have episodes of heart block (which can slow the heart down) or a very slow heart rate.
Slovenian: • ali imate epizode srčnega bloka (ki lahko upočasni srce) ali zelo počasen srčni utrip,
English: Rapiscan is used in a type of heart scan in adults called ‘myocardial perfusion imaging'.
Slovenian: Zdravilo Rapiscan se uporablja pri odraslih za določeno vrsto slikanja srca, ki se imenuje "perfuzijska scintigrafija miokarda".
English: In postmarketing experience, third degree heart block and asystole have been reported within minutes of regadenoson administration.
Slovenian: V izkušnjah po začetku trženja so poročali o tretji stopnji srčnega bloka in asistoliji, ki sta se pojavili v nekaj minutah po dajanju regadenozona.
English: During cardiac catheterisation, a long thin tube called a catheter is inserted either through your femoral or radial artery and threaded through your blood vessels to your heart.
Slovenian: Med kateterizacijo srca se dolga tanka cevka, ki se imenuje kateter, vstavi bodisi preko femoralne ali radialne arterije in skozi krvne žile potisne do srca.
English: Fractional flow reserve (FFR):
Slovenian: Funkcionalna pretočna rezerva (FFR):
English: There are no adequate data from the use of regadenoson in pregnant women.
Slovenian: Zadostnih podatkov o uporabi regadenozona pri nosečnicah ni.
English: The dose injected does not depend on your weight.
Slovenian: Injicirani odmerek ni odvisen od vaše telesne mase.
English: Suboptimal Exercise Stress Test
Slovenian: Preizkus s suboptimalno telesno obremenitvijo
English: Paediatric population The European Medicines Agency has deferred the obligation to submit the results of studies with regadenoson in one or more subsets of the paediatric population with myocardial perfusion disturbances (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z regadenozonom za eno ali več podskupin pediatrične populacije z motnjami miokardne perfuzije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In in vitro studies, regadenoson has been shown to have little binding affinity for the A2B and A3 adenosine receptors.
Slovenian: V študijah in vitro se je pokazalo, da ima regadenozon majhno afiniteto za vezavo receptorjev adenozina A2B in A3.
English: Long QT syndrome
Slovenian: Sindrom podaljšanega intervala QT
English: Combination with exercise
Slovenian: Kombinacija s telesno vadbo
English: Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).
Slovenian: Ena 5 ml viala vsebuje 400 mikrogramov regadenozona (80 mikrogramov/ml).
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.
Slovenian: 10 sekund trajajoče obdobje enakomerne hiperemije je lahko za obsežne meritve upada pritiska pri ocenjevanju kompleksne ali difuzne koronarne arterijske bolezni prekratko.
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.
Slovenian: Stopnje ujemanja za regadenozon in adenozin so bile izračunane kot povprečje stopenj ujemanja za vse tri kategorije, ugotovljene z začetnim slikanjem.
English: The agreement rate for the image obtained with regadenoson or adenosine relative to the initial adenosine image was calculated by determining how frequently the patients assigned to each initial adenosine category (0-1, 2-4, 5-17 reversible segments) were placed in the same category with the randomised scan.
Slovenian: Stopnja ujemanja za posnetke, pridobljene z regadenozonom ali z adenozinom v primerjavi z začetnim posnetkom z adenozinom, je bila izračunana tako, da se je ugotovilo, kako pogosto so bili bolniki, ki so bili uvrščeni v začetno kategorijo adenozina (0-1, 2-4, 5-17 reverzibilni segmenti) z randomiziranim slikanjem uvrščeni v enako kategorijo.
English: • if you have had episodes of mini strokes (called transient ischaemic attacks)
Slovenian: • če ste imeli epizode mini možganske kapi (kar se imenuje prehodni ishemični napad),
English: Other medicines and Rapiscan
Slovenian: Druga zdravila in zdravilo Rapiscan
English: The level of agreement between the MPI 1 (exercise with regadenoson) and the MPI 2 reads was similar to the level of agreement between MPI 1 (regadenoson only) and MPI 2 reads.
Slovenian: Stopnja ujemanja med slikami MPI 1 (vadba z regadenozonom) in MPI 2 je bila podobna stopnji ujemanja med slikami MPI 1 (samo regadenozon) in MPI 2.