FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: • dipiridamol, lijek koji se koristi za sprječavanje stvaranja krvnih ugrušaka, ne smije se uzeti najmanje 2 dana prije nego primite Rapiscan jer može promijeniti njegov učinak.
English: The healthcare professionals will be responsible for the storage and disposal of this medicinal product.
Croatian: Zdravstveni radnici bit će odgovorni za čuvanje i bacanje lijeka.
English: Headache was reported by 27% of subjects who received regadenoson in clinical trials.
Croatian: Glavobolja je prijavljena u 27% ispitanika koji su u kliničkom ispitivanju primili regadenoson.
English: • if you have had a recent serious heart problem (for example a heart attack or abnormal heart rhythms).
Croatian: • ako ste nedavno imali ozbiljne poteškoće sa srcem (primjerice srčani udar ili nenormalni srčani ritam).
English: Dipyridamole increases blood adenosine levels and the response to regadenoson may be altered when blood adenosine levels are increased.
Croatian: Dipiridamol povisuje razinu adenozina u krvi, a odgovor na regadenoson može biti promijenjen ako je razina adenozina u krvi povišena.
English: The pharmacokinetic parameters of regadenoson have not yet been studied in the paediatric population (< 18 years).
Croatian: Pedijatrijska populacija Farmakokinetički parametri regadenosona još nisu ispitani u pedijatrijskoj populaciji (< 18 godina).
English: C-radiolabeled regadenoson to rats and dogs, most radioactivity (85-96%) was excreted in the form of unchanged regadenoson.
Croatian: C-radioobilježenog regadenosona u štakora i pasa, najveći dio radioaktivnosti (8596%) izlučio se u obliku nepromijenjenog regadenosona.
English: • Unstable angina that has not been stabilised with medical therapy.
Croatian: • Nestabilna angina pektoris koja nije stabilizirana lijekovima.
English: Safety and tolerability of repeated use of this product within 24 hours has not been characterised.
Croatian: Sigurnost i podnošljivost ponovljene primjene unutar 24 sata nije još utvrđena.
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.
Croatian: Bolesnici koji su imali bilo kakve simptome ili znakove koji upućuju na akutnu ishemiju miokarda tijekom tjelovježbe ili oporavka imaju vjerojatno naročito visoki rizik od ozbiljnih nuspojava.
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.
Croatian: U bolesnika sa sindromom produženog QT intervala, stimulacija simpatikusa može imati za posljedicu manje skraćenje QT intervala nego li je to normalno, a može čak uzrokovati paradoksalno produženje QT intervala.
English: The baseline MPI scans at rest and those without exercise at 1-14 days later from both groups, constituted the MPI 2 phase.
Croatian: Početni MPI skenovi u mirovanju i oni bez vježbanja snimljeni 1-14 dana kasnije iz obje skupine su predstavljali MPI 2 fazu.
English: • pain in the back, arms, legs, neck or jaw
Croatian: • bol u leđima, rukama, nogama, vratu ili čeljusti
English: Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without prescription.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
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.
Croatian: U sveukupnoj populaciji ispitanika 68% bolesnika imalo je 0-1 segment koji je pokazivao reverzibilni defekt perfuzije na inicijalnoj snimci, 24% je imalo 2-4 segmenta i 9% je imalo ≥ 5 segmenata.
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.
Croatian: Prosječno trajanje hiperemijskog platoa bilo je 163 (±169) sekundi i maksimalna hiperemija trajala je barem 19 sekundi kod 90% bolesnika, no kod pojedinih bolesnika trajanje hiperemije variralo je između 10 sekundi i > 10 minuta.
English: Rapiscan solution for injection is a clear, colourless solution with no particles visible.
Croatian: Rapiscan otopina za injekciju je bistra, bezbojna otopina bez vidljivih čestica.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi.
English: Ask your doctor for advice before using any medicine.
Croatian: Obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
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.
Croatian: Bolesnici koji nisu postigli ≥ 85% najviše predviđene srčane frekvencije (engl. maximum predicted heart rate, MPHR) i/ili ≥ 5 METS (metaboličkih ekvivalenata), prebačeni su u 3-5-minutni oporavak hodanjem gdje su tijekom prve 3 minute oporavka randomizirani 1:1.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB21
Croatian: Farmakoterapijska skupina: Kardiološki lijekovi, ostali kardiološki pripravci, ATK oznaka: C01EB21
English: Regadenoson may cause clinically significant increases in blood pressure, which in some patients can lead to hypertensive crisis (see section 4.8).
Croatian: Regadenoson može uzrokovati klinički značajan porast krvnog tlaka, što kod nekih bolesnika može dovesti do hipertenzivne krize (vidjeti dio 4.8).
English: The majority of patients experience a rapid increase in heart rate.
Croatian: Većina bolesnika osjeti nagli porast srčane frekvencije.
English: The plasma concentration-time profiles were not significantly altered in the early stages after dosing when most pharmacologic effects are observed.
Croatian: Profil koncentracije u plazmi nije bio značajno promijenjen u ranijim stadijima nakon primjene doze, kada je primijećena većina farmakoloških učinaka.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
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.
Croatian: Ako se regadenoson primijeni, žena mora prestati dojiti tijekom barem 10 sati (što znači barem u trajanju 5 poluvremena eliminacije iz plazme) nakon njegove primjene.
English: For two patients from the exercise with regadenoson group, a serious cardiac adverse reaction was reported.
Croatian: Za dva bolesnika iz skupine koja je vježbala s regadenosonom prijavljene su ozbiljne srčane nuspojave.
English: There was no statistical difference between 200 mg and 400 mg caffeine with regadenoson .
Croatian: Nije bilo statističke razlike između 200 mg i 400 mg kofeina i regadenosona.
English: Long QT syndrome
Croatian: Sindrom produženog QT intervala
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.
Croatian: Regadenoson ne inhibira metabolizam supstrata za CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, ili CYP3A4 u mikrosomima ljudske jetre, što ukazuje da nije vjerojatno da će djelovati na farmakokinetiku lijekova koji se metaboliziraju pomoću enzima citokrom P450.
English: • low blood pressure
Croatian: • niski krvni tlak
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.
Croatian: 10 sekundi faze stabilne hiperemije može biti prekratak za provođenje opsežnijih pullback snimki tlaka za procjenu kompleksne ili difuzne bolesti koronarne arterije.
English: Also, there was no apparent effect of 200 mg or 400 mg of caffeine on regadenoson plasma concentrations.
Croatian: Također nije bilo očitog učinka 200 mg ili 400 mg kofeina na koncentraciju regadenosona u plazmi.
English: Despite low affinity for the A2A adenosine receptor, regadenoson has high potency for increasing coronary conductance in rat and guinea pig isolated hearts, with EC50 values of 6.4 nM and 6.7-18.6 nM, respectively.
Croatian: Unatoč niskom afinitetu za A2A adenozinske receptore, regadenoson ima visoki potencijal za povećanje koronarne provodljivosti u izoliranom srcu štakora i zamorca, s vrijednošću EC50 od 6,4 nM odnosno 6,7-18,6 nM.
English: Age, gender, and race have minimal effects on the pharmacokinetics of regadenoson.
Croatian: Dob, spol i rasa imaju minimalni utjecaj na farmakokinetiku regadenosona.
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.
Croatian: Stoga se očekuje da regadenoson ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima jednom kada se dijagnostički postupak okonča i nuspojave povuku.
English: ADVANCE ADVANCE Combined MPI 1
Croatian: ADVANCE ADVANCE Kombinirano
English: • if you have episodes of heart block (which can slow the heart down) or a very slow heart rate.
Croatian: • ako imate epizode srčanog bloka (koji mogu usporiti rad srca) ili vrlo spore srčane otkucaje.
English: The same applies to the FFR measurement where the maximal myocardial blood flow is decreased in presence of severe coronary artery stenosis.
Croatian: Isto se odnosi na mjerenje FFR-a pri čemu je maksimalni protok krvi kroz miokard smanjen u prisustvu teške stenoze koronarnih arterija.
English: The images from MPI 1 and MPI 2 were compared for presence or absence of perfusion defects.
Croatian: Snimke iz MPI 1 i MPI 2 su uspoređene za prisustvo i odsustvo defekata perfuzije.
English: Myocardial uptake of the radiopharmaceutical is proportional to CBF.
Croatian: Preuzimanje (uptake) radiofarmaceutika u miokard proporcionalno je s CBF.
English: When you are given Rapiscan, your heart rate will increase quickly.
Croatian: Nakon što primite Rapiscan otkucaji Vašeg srca naglo će se ubrzati.
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.
Croatian: Aminofilin treba primjenjivati s oprezom u bolesnika s konvulzijama u povijesti bolesti ili koji imaju druge čimbenike rizika za konvulzije, jer može produžiti konvulzije ili uzrokovati višestruke konvulzije zbog svog prokonvulzivnog učinka.
English: • Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning artificial pacemaker.
Croatian: • Atrioventrikularni (AV) blok drugog ili trećeg stupnja ili disfunkcija sinoatrijskog čvora, osim ako bolesnik nema funkcionirajući elektrostimulator srca (pacemaker).
English: The doctor can then see if the heart muscles are getting enough blood flow when it is under stress.
Croatian: Liječnik može tako vidjeti prima li srčani mišić dovoljno krvi kad je pod naporom.
English: Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for:
Croatian: Rapiscan je selektivni koronarni vazodilatator koji se koristi kod odraslih osoba kao farmakološki stresni agens pri:
English: What Rapiscan contains
Croatian: Što Rapiscan sadrži
English: The A2B and A3 adenosine receptors have been implicated in the pathophysiology of bronchoconstriction in susceptible individuals (i.e., asthmatics).
Croatian: A2B i A3 adenozinski receptori sudjeluju u patofiziologiji bronhokonstrikcije u predisponiranih pojedinaca (npr. astmatičara).
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%).
Croatian: Neki od bolesnika na dan snimanja uzeli su kardiološku terapiju, uključujući β- blokatore (18%), blokatore kalcijevih kanala (9%) i nitrate (6%).
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.
Croatian: Ukupno 249 bolesnika kojima je klinički indicirano provođenje koronarne angiografije s invazivnim mjerenjem FFR-a, primilo je regadenoson, a 88 tih bolesnika primilo je regadenoson dvaput.
English: Regadenoson causes a rapid increase in heart rate (see sections 4.4 and 5.1).
Croatian: Regadenoson uzrokuje nagli porast srčane frekvencije (vidjeti također dijelove 4.4 i 5.1).
English: • heart pain (angina), abnormal heart rhythms, rapid heart beat, feeling the heart skipping a beat,
Croatian: • bol oko srca (angina), nenormalni srčani ritam, ubrzani otkucaji srca, osjećaj da srce preskače,
English: • if you have had episodes of mini strokes (called transient ischaemic attacks)
Croatian: • ako ste imali male moždane udare (koji se nazivaju tranzitorne ishemijske atake).
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.
Croatian: Znakovi toksičnosti za majku i fetus zapaženi su u štakora i kunića (smanjena fetalna težina, zakašnjela osifikacija [štakori], smanjena veličina legla i broj živih fetusa [kunići]), ali ne i teratogenost.
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%).
Croatian: Stariji bolesnici (≥ 75 godina starosti; n = 321) imali su sličan profil nuspojava u usporedbi s mlađim bolesnicima (< 65 godina starosti; n = 1016), ali su imali veću incidenciju hipotenzije (2% naspram < 1%).
English: The incidence of a FEV1 reduction > 15% from baseline after regadenoson administration was assessed in three randomised, controlled clinical studies.
Croatian: Incidencija smanjenja FEV1 > 15% od početnih vrijednosti nakon primjene regadenosona procjenjivana je u tri randomizirana kontrolirana klinička ispitivanja.
English: Repeated use
Croatian: Ponovljena primjena
English: Adverse reactions in most patients receiving regadenoson in clinical trials were mild, transient (usually resolving within 30 minutes after receiving regadenoson) and required no medical intervention.
Croatian: Nuspojave u većine bolesnika koji su primali regadenoson tijekom kliničkih ispitivanja bile su blage, prolazne (obično su se povlačile unutar 30 minuta od primjene regadenosona), i nisu zahtijevale liječenje.
English: Transient ischaemic attacks and cerebrovascular accident Regadenoson can cause transient ischaemic attack (see section 4.8).
Croatian: Tranzitorna ishemijska ataka i cerebrovaskularni inzult Regadenoson može uzrokovati tranzitornu ishemijsku ataku (vidjeti dio 4.8).
English: Subsequentially, patients from both groups, returned 1-14 days later, to undergo a second stress MPI regadenoson study without exercise.
Croatian: Nakon toga su bolesnici iz obje skupine vraćeni 1-14 dana kasnije, kako bi se na njima provela druga studija MPI pod opterećenjem samo s regadenosonom, bez vježbanja.
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.
Croatian: Nakon injekcije Rapiscana trebat ćete sjediti ili ležati dok Vam se puls i krvni tlak ne vrate na normalne vrijednosti.
English: • discomfort in the mouth
Croatian: • neugodan osjećaj u ustima
English: No dose adjustment is needed in elderly patients.
Croatian: Nije potrebno prilagođavati dozu lijeka u starijih bolesnika.
English: Myocardial ischaemia
Croatian: Ishemija miokarda
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).
Croatian: • za mjerenje rezerve frakcijskog protoka (engl. fractional flow reserve, FFR) kod stenoze pojedinačne karotidne arterije tijekom invazivne koronarne angiografije, kada opetovana mjerenja FFR nisu očekivana (vidjeti dijelove 4.2 i 5.1).
English: In postmarketing experience, syncope and transient ischaemic attacks have been reported.
Croatian: Nakon stavljanja lijeka na tržište prijavljene su pojava sinkope i tranzitorne ishemičke atake.
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).
Croatian: Kod mjerenja FFR-a, dijagnoza inducibilne ishemije postavljena na temelju izmjerene vrijednosti FFR-a od 0.8 (>0,8 predstavlja odsustvo inducibilne ishemije naspram vrijednosti ≤ 0,8 koja predstavlja postojanje inducibilne ishemije).
English: Fetal toxicity was noted following repeated daily administration of regadenoson, but at doses sufficiently in excess of the recommended human dose.
Croatian: Fetalna toksičnost zabilježena je nakon ponovljenih dnevnih primjena regadenosona, ali u dozama koje prilično nadilaze preporučene doze za ljude.
English: Rapiscan is used in a type of heart scan in adults called ‘myocardial perfusion imaging'.
Croatian: Rapiscan se koristi u odraslih pri vrsti snimanja srca koje se naziva "snimanje perfuzije miokarda".
English: Adenosine was administered first, followed by regadenoson as its hyperaemia may last unpredictably and the measured FFR values were compared.
Croatian: Adenozin je bio primijenjen prvi, nakon čega je slijedio regadenoson jer kod njega trajanje hiperemije može biti nepredvidivo, te su se uspoređivale izmjerene vrijednosti FFR-a.
English: Measurement of FFR
Croatian: Mjerenje FFR-a
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.
Croatian: Tijekom kateterizacije srca, dugačka, tanka cjevčica koja se naziva kateter uvodi se kroz femoralnu ili radijalnu arteriju i provodi kroz krvne žile do srca.
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.
Croatian: Podaci dobiveni analizom populacijske farmakokinetike, uključujući podatke dobivene od ispitanika i bolesnika, pokazuju da klirens regadenosona pada paralelno sa smanjenjem klirensa kreatinina (CLcr), a raste s porastom tjelesne težine.
English: Upon case review, both patients, experienced ischemic symptoms and ECG changes during exercise or recovery prior to regadenoson administration.
Croatian: Nakon pregleda slučaja, oba bolesnika su iskusila ishemijske simptome i promjene na EKG-u tijekom vježbanja, ili oporavka prije primjene regadenosona.
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).
Croatian: Maksimalna koncentracija regadenosona u plazmi dostiže se unutar 1 do 4 minute od injekcije regadenosona i paralelna je s početkom farmakodinamičkog odgovora (vidjeti dio 5.1).
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.
Croatian: Više od 55% doze regadenosona izlučuje se nepromijenjeno urinom i faktor snižavanja klirensa ne utječe na njegovu koncentraciju u plazmi u ranim stadijima nakon primjene doze pri kojoj su zabilježeni klinički značajni farmakološki učinci.
English: How to store Rapiscan
Croatian: Kako čuvati Rapiscan
English: Regadenoson increases sympathetic tone, which causes an increase in heart rate and a shortening of the QT interval.
Croatian: Regadenoson povećava tonus simpatikusa, što uzrokuje porast srčane frekvencije i skraćenje QT intervala.
English: • if you have a heart rhythm where your heartbeat is very fast or uneven (atrial fibrillation or atrial flutter)
Croatian: • ako vam je ritam otkucaja srca vrlo brz ili neujednačen (fibrilacija ili undulacija atrija)
English: For use in radionuclide MPI: This product is to be administered only once within a 24 hour period.
Croatian: Za primjenu kod radionuklidnog MPI-a: Rapiscan treba primijeniti samo jedanput tijekom razdoblja od 24 sata.
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.
Croatian: Budući da regadenoson povećava protok krvi u normalnim koronarnim arterijama, a u stenoziranim arterijama ga povećava malo ili uopće ne, regadenoson uzrokuje relativno slabo preuzimanje radiofarmaceutika u vaskularnom području irigiranom stenoziranim arterijama.
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.
Croatian: Injicira se u venu kao jednokratna injekcija od 400 mikrograma u 5 ml otopine - za dovršenje injekcije trebat će oko 10 sekundi.
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.
Croatian: Regadenoson može uzrokovati bronhokonstrikciju i respiratorni zastoj (vidjeti dio 4.8), naročito u bolesnika s poznatom ili sa sumnjom na postojanje bronhokonstriktivne bolesti, kronične opstruktivne bolesti pluća (KOPB) ili astme.
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:
Croatian: Ispitivanjima ADVANCE MPI 1 i ADVANCE MPI 2, pojedinačno i kombinirano, utvrđeno je da je regadenoson sličan adenozinu za procjenu opsežnosti reverzibilnih defekata perfuzije:
English: • pain or discomfort around the area injected, body pain
Croatian: • bol ili neugodan osjećaj oko mjesta injekcije, bol u tijelu.
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.
Croatian: Ako ne možete izvesti ove tjelesne aktivnosti u mjeri koja je potrebna za postizanje dovoljne razine napora za srce, ubrizgat će Vam se Rapiscan kako bi uzrokovao sličnu razinu napora za srce koja će dovesti do povećanog protoka krvi.
English: Talk to your doctor or nurse before taking Rapiscan Your doctor needs to know before you are given Rapiscan:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Rapiscan Prije nego Vam da Rapiscan Vaš liječnik mora znati:
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja regadenosona u jednoj ili više podskupina pedijatrijske populacije sa smetnjama perfuzije miokarda (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).