FrancophonIA/ELRC3.0 huggingface dataset:
English: It makes the heart arteries expand and heart rate increase.
Croatian: Proširuje arterije u srcu i ubrzava otkucaje srca.
English: These images show how well blood flows to the muscles of the heart.
Croatian: Te slike nam pokazuju u kojoj mjeri krv dotiče u srčani mišić.
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).
Croatian: Metilksantini (npr. kofein i teofilin) su nespecifični antagonisti adenozinskih receptora i mogu interferirati s vazodilatacijskim djelovanjem regadenosona (vidjeti dio 5.1).
English: • low blood pressure which may result in fainting or mini strokes (including weakness of the face or an inability to speak).
Croatian: • niski krvni tlak koji može imati za posljedicu gubitak svijesti ili manji moždani udar (uključujući slabost lica ili nemogućnost govora).
English: Comparison of the images obtained with regadenoson to those obtained with adenosine was performed as follows.
Croatian: Uspoređivanje snimaka dobivenih uz primjenu regadenosona i snimaka uz primjenu adenozina učinjeno je kako slijedi.
English: Animal studies on pre- and post-natal development have not been conducted.
Croatian: Ispitivanja utjecaja na prenatalni i postnatalni razvoj u životinja nisu provedena.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama RMP-a, dokumenti mogu biti podneseni istodobno.
English: Based on a population pharmacokinetic analysis, age has a minor influence on the pharmacokinetics of regadenoson.
Croatian: Na temelju analize populacijske farmakokinetike, dob ima malo utjecaja na farmakokinetiku regadenosona.
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.
Croatian: U zdravih dobrovoljaca, 57% doze regadenosona izlučuje se nepromijenjeno urinom (raspon 19-77%), s prosječnim bubrežnim klirensom plazme od oko 450 ml/min, tj. većim od brzine glomerularne filtracije.
English: In post- marketing experience there have been cases of worsening or recurrence of atrial fibrillation after administration of regadenoson.
Croatian: Nakon stavljanja lijeka u promet bilo je slučajeva pogoršanja ili ponovne pojave fibrilacije atrija nakon primjene regadenosona.
English: (n = 758)
Croatian: (n = 1113) (n = 758)
English: The headache was considered severe in 3% of subjects.
Croatian: Smatrana je jakom kod 3% ispitanika.
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.
Croatian: Razina podudarnosti očitanja između MPI 1 (vježbanje s regadenosonom) i MPI 2 bila je slična razini podudarnosti između očitanja MPI 1 (samo s regadenosonom) i MPI 2.
English: There is no adequate information on the use of Rapiscan in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni Rapiscana u trudnica.
English: Signs of hypersensitivity (rash, urticaria, angioedema, anaphylaxis and/or throat tightness) may be immediate or delayed onset.
Croatian: Znakovi preosjetljivosti (osip, urtikarija, angioedem, anafilaksija i/ili stezanje u grlu) mogu se javiti odmah ili odgođeno.
English: Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence
Croatian: Manje često konvulzije, sinkopa, tranzitorna ishemijska ataka, odsustvo reakcije na podražaje, smanjena razina svijesti, tremor, somnolencija
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).
Croatian: Ipak, tzv. "post hoc" analiza podataka dobivenih u dva klinička ispitivanja faze 3 pokazala je da farmakokinetika regadenosona nije bila promijenjena u maloj podskupini bolesnika s laboratorijskim vrijednostima koji govore u prilog oštećenja funkcije jetre (2,5-erostruki porast transaminaza ili 1,5-erostruko povećanje serumskog bilirubina ili protrombinskog vremena).
English: Sinoatrial and atrioventricular nodal block
Croatian: Sinoatrijski i atrioventrikularni nodalni blok
English: The greatest mean change from baseline (21 bpm) occurs approximately 1 minute after administration of regadenoson.
Croatian: Najveća srednja vrijednost promjene u donosu na početne vrijednosti (21/min) događa se oko 1 minute nakon primjene regadenosona.
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.
Croatian: Regadenoson može imati umjeren inhibitorni učinak na aktivni bubrežni transporter, OCT2, te je utvrđeno da je vjerojatno supstrat za transport posredovan s BCRP, ENT1 ili ENT2.
English: In in vitro studies, regadenoson has been shown to have little binding affinity for the A2B and A3 adenosine receptors.
Croatian: U ispitivanjima in vitro regadenoson je pokazao slab afinitet vezivanja na A2B i A3 adenozinske receptore.
English: Paraesthesia, hypoaesthesia, dysgeusia
Croatian: Često parestezija, hipoestezija, disgeuzija
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).
Croatian: U nekih bolesnika primijećen je porast krvnog tlaka (maksimalni sistolički krvni tlak od 240 mm Hg i maksimalni dijastolički krvni tlak od 138 mm Hg).
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.
Croatian: Korištenjem modela 17 segmenata izračunat je broj segmenata koji prikazuju reverzibilni defekt perfuzije za inicijalno ispitivanje dobivenih uz primjenu adenozina i za randomizirano ispitivanje dobivenih uz primjenu regadenosona ili adenozina.
English: • if you are allergic to regadenoson or any of the other ingredients of Rapiscan listed in section 6 of this leaflet.
Croatian: - ako ste alergični na regadenoson ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Consideration should be given to delaying regadenoson administration until blood pressure is well controlled
Croatian: Potrebno je uzeti u obzir odgodu primjene Rapiscana dok krvni tlak ne bude dobro reguliran.
English: Mean plasma concentrations increased in a dose-related manner and by successive doses as observed in healthy volunteers.
Croatian: Prosječne vrijednosti koncentracija u plazmi povećavale su se vezano uz dozu i ponavljanjem doza, što je uočeno kod zdravih dobrovoljaca.
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).
Croatian: Ovo uključuje smanjen volumen krvi (uzrokovan primjerice jakim proljevom, dehidracijom ili uzimanjem tableta za mokrenje), upalu srčane ovojnice (perikarditis) i neke oblike bolesti srčanog zaliska ili aorte (primjerice aortalna ili mitralna stenoza).
English: Incubation with rat, dog, and human liver microsomes as well as human hepatocytes produced no detectable metabolites of regadenoson.
Croatian: Inkubacija s mikrosomima jetre štakora, psa i čovjeka, kao i s hepatocitima čovjeka nije pokazala prepoznatljive metabolite regadenosona.
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.
Croatian: U kliničkim ispitivanjima regadenoson je primjenjivan u bolesnika koji su uzimali druge kardioaktivne lijekove (npr. β-blokatore, blokatore kalcijevih kanala, ACE-inhibitore, nitrate, kardijalne glikozide i blokatore angiotenzinskih receptora) bez očitih učinaka na profil sigurnosti i djelotvornosti regadenosona.
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).
Croatian: Stoga je 1147 bolesnika randomizirano u dvije skupine: 578 bolesnika u skupinu koja je vježbala s regadenosonom (regadenoson primijenjen nakon 3 minute oporavka) i 569 bolesnika u skupinu samo s regadenosonom (regadenoson primijenjen u mirovanju nakon 1 sata).
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).
Croatian: U trećem ispitivanju dispneja je prijavljena češće nakon primjene regadenosona (18% bolesnika s KOPB; 11% bolesnika s astmom) nego placeba, ali s manjom stopom prijava nego tijekom kliničkog razvoja lijeka (vidjeti dio 4.8).
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.
Croatian: Aminofilin se smije primijeniti u dozama od 50 mg do 250 mg u obliku spore intravenske injekcije (50 mg do 100 mg kroz 30-60 sekundi) za ublažavanje teških i/ili dugotrajnih nuspojava regadenosona, ali se ne smije koristiti isključivo u svrhu zaustavljanja konvulzija izazvanih regadenosonom.
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.
Croatian: U ispitivanju provedenom na zdravim dobrovoljcima, simptomi naleta crvenila, omaglice i povećane frekvencije srca ocijenjeni su kao nepodnošljivi pri dozama regadenosona većim od 0,02 mg/kg.
English: Caution should be used when administering regadenoson to patients with a history of seizures or other risk factors for seizures, including the concomitant administration of medicinal products that lower seizure threshold (e.g. antipsychotics, antidepressants, theophyllines, tramadol, systemic steroids and quinolones).
Croatian: Potreban je oprez kada se regadenoson primjenjuje u bolesnika s ranije poznatim konvulzijama ili čimbenicima rizika za konvulzije, uključujući istodobnu primjenu lijekova koji smanjuju prag konvulzija (npr. antipsihotici, antidepresivi, teofilini, tramadol, sistemski steroidi, kinoloni).
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.
Croatian: Regadenoson je agonist (Ki ≈ 1,3 µM) A2A adenozinskih receptora niskog afiniteta, s najmanje 10 puta nižim afinitetom za A1 adenozinske receptore (Ki > 16,5 µM), i vrlo niskim ili bez afiniteta za A2B i A3 adenozinske receptore.
English: Regadenoson has the potential to cause serious and life-threatening reactions, including those listed below (see also section 4.8).
Croatian: Regadenoson može izazvati ozbiljne i po život opasne reakcije, uključujući i one navedene u nastavku (vidjeti također dio 4.8).
English: The excretion of regadenoson in milk has not been studied in animals.
Croatian: Izlučivanje regadenosona u mlijeko nije ispitano na životinjama.
English: More serious side effects include:
Croatian: Teže nuspojave uključuju:
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.
Croatian: Preporučena doza je jedna injekcija regadenosona od 400 mikrograma (5 ml) u perifernu venu, bez potrebe prilagođavanja doze prema tjelesnoj težini.
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.
Croatian: Rapiscan se koristi i tijekom kateterizacije i snimanja arterija srca (invazivna koronarna angiografija) kako bi se proširile srčane arterije te izmjerila razlika u tlaku, uzrokovana sužavanjem jedne ili više arterija.
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.
Croatian: Bolesnici iz obje skupine (vježbanje s regadenosonom i samo regadenoson) su podvrgnuti SPECT snimanju perfuzije miokarda (MPI) 60-90 minuta nakon primjene regadenosona.
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.
Croatian: U ovih bolesnika pojavljuje se R na T fenomen, pri čemu ventrikulska ekstrasistola prekida T val prethodnog otkucaja, što povećava rizik za nastanak ventrikularne tahiaritmije.
English: Rapiscan is supplied in a carton containing a single use 5 ml glass vial with a rubber stopper and aluminium sealed cap.
Croatian: Rapiscan se isporučuje u kutijama koje sadrže jednokratnu staklenu bočicu od 5 ml s gumenim čepom i aluminijskim zaštitnim zatvaračem.
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).
Croatian: U ispitivanju na odraslim bolesnicima koji će se podvrgnuti farmakološkom stresu primjenom regadenosona radi MPI pomoću radionuklida, u kojem su ispitanici randomizirani u skupinu koja prima placebo (n=66) ili skupinu koja prima kofein (200 mg, n=70 ili 400 mg, n=71) 90 minuta prije testiranja, kofein je kompromitirao dijagnostičku preciznost utvrđivanja reverzibilnih defekata perfuzije (p<0,001).
English: Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2015.
English: Coronary blood flow
Croatian: Koronarni protok krvi
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).
Croatian: Regadenoson može uzrokovati ishemiju miokarda (potencijalno povezanu s fatalnim srčanim zastojem, po život opasnim ventrikularnim aritmijama i infarktom miokarda), hipotenziju koja može dovesti do sinkope i tranzitornih ishemičkih ataka (TIA), povišen krvni tlak koji dovodi do hipertenzije i hipertenzivnih kriza i bloka SA/AV čvora koji može dovesti do AV bloka prvog, drugog ili trećeg stupnja, ili sinus bradikardije koja zahtijeva intervenciju (vidjeti dio 4.4).
English: Cardioactive medicinal products
Croatian: Kardioaktivni lijekovi
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: Ovo treba uzeti u obzir kod bolesnika na dijeti s kontroliranom količinom natrija.
English: Suboptimal Exercise Stress Test
Croatian: Test suboptimalnog opterećenja tjelesnim naporom
English: The use of bronchodilator therapy for symptoms was not different between regadenoson and placebo.
Croatian: Nije bilo razlike u uporabi bronhodilatatora za liječenje simptoma između skupina koje su primile regadenoson i skupina koje su primile placebo.
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).
Croatian: Pogoršanjem bubrežne funkcije, od blage (CLcr 50 do < 80 ml/min) do umjerene (CLcr 30 do < 50 ml/min) i do teške (CLcr < 30 ml/min), udio regadenosona koji se izlučuje nepromijenjen urinom i klirens bubrega su opadali, imajući za posljedicu porast poluživota eliminacije i vrijednosti AUC, u usporedbi sa zdravim ispitanicima (CLcr ml/min).
English: The disposition of regadenoson was studied in 18 subjects with various degrees of renal function and in 6 healthy subjects.
Croatian: Raspoloživost regadenosona ispitivana je na 18 ispitanika s različitim stupnjevima poremećaja bubrežne funkcije i 6 zdravih ispitanika.
English: Atrial fibrillation or flutter
Croatian: Fibrilacija ili undulacija atrija
English: Combination with exercise
Croatian: Kombinacija s tjelesnim naporom
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog grupiranja po učestalosti nuspojave se navode prema svojoj ozbiljnosti, od ozbiljnih prema manje ozbiljnima.
English: Angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged
Croatian: Često angina pektoris, atrioventrikularni blok, tahikardija, palpitacije, drugi poremećaji u EKG-u uključujući produženi korigirani QT interval na elektrokardiogramu
English: Cardiac resuscitation equipment and trained staff should be available before administering regadenoson (see section 4.4).
Croatian: Oprema za reanimaciju i stručno osoblje trebaju biti na raspolaganju prije primjene regadenosona (vidjeti dio 4.4).
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.
Croatian: Kod svakog bolesnika učinjen je inicijalni sken pod stresom primjenom adenozina (6minutna infuzija doze od 0,14 mg/kg/min, u mirovanju/ne pod naporom) pomoću radionuklida prema protokolu snimanja kompjutoriziranom tomografijom emisijom pojedinačnog fotona (SPECT - single photon emission computed tomography).
English: • Decompensated states of heart failure.
Croatian: • Dekompenzacija srca.
English: Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).
Croatian: Svaka bočica od 5 ml sadrži 400 mikrograma regadenosona (80 mikrograma/ml).
English: Keep out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: 5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over-seal.
Croatian: 5 ml otopine u jednokratnoj staklenoj bočici (staklo tipa 1) sa čepom od (butil)gume i aluminijskim zaštitnim zatvaračem.
English: Myocardial radiopharmaceutical uptake after regadenoson administration is therefore greater in areas perfused by normal relative to stenosed arteries.
Croatian: Preuzimanje radiofarmaceutika u miokard nakon primjene regadenosona je stoga veće u područjima irigiranim normalnim arterijama u odnosu na područja irigirana stenoziranim arterijama.
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.
Croatian: Stopa podudarnosti za regadenoson i adenozin izračunata je kao prosječna stopa podudarnosti svih triju kategorija određeno prema inicijalnoj snimci.
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.
Croatian: • ako imate visoki krvni tlak koji nije reguliran, naročito ako je popraćen nedavnim krvarenjem iz nosa,
English: Patients should avoid consumption of any products containing methylxanthines (e.g. caffeine) as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration (see section 4.5).
Croatian: Bolesnici trebaju izbjegavati konzumaciju proizvoda koji sadrže metilksantine (npr. kofein) kao i bilo koji lijek koji sadrži teofilin najmanje 12 sati prije primjene Rapiscana (vidjeti dio 4.5).
English: Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome.
Croatian: Regadenoson stimulira simpatički autonomni sustav i može povećati rizik pojave ventrikularnih tahiaritmija u bolesnika sa sindromom produženog QT intervala.
English: Heart rate returns to baseline within 10 minutes.
Croatian: Srčana se frekvencija vraća na početne vrijednosti unutar 10 minuta.
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.
Croatian: Pokazalo se da aminofilin (100 mg, primijenjen sporom intravenskom injekcijom kroz 60 sekundi) injiciran 1 minutu nakon injekcije 400 mikrograma regadenosona u bolesnika koji će biti podvrgnuti kateterizaciji srca, skraćuje trajanje odgovora koronarnog protoka krvi na regadenoson, mjereno pomoću pulsne Dopplerultrasonografije.
English: All adverse reactions are presented in the table below and are listed by system organ class and frequency.
Croatian: Sve nuspojave prikazane su u tablici u nastavku i navedene su prema klasifikaciji organskih sustava i učestalosti.
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.
Croatian: U zdravih dobrovoljaca ispitane su do tri uzastopne injekcije regadenosona (100 i 200 μg) i dvije uzastopne doze od 400 μg, kao i kod bolesnika kod kojih se procjenjivao FFR.
English: Use product only in medical facilities with cardiac monitoring and resuscitation equipment.
Croatian: Lijek koristiti samo u medicinskim ustanovama u kojima postoji kardiološki monitoring i oprema za reanimaciju.
English: This medicine is for diagnostic use only.
Croatian: Ovaj lijek se koristi samo u dijagnostičke svrhe.
English: These findings indicate that metabolism of regadenoson does not play a major role in the elimination of regadenoson.
Croatian: Ovi nalazi ukazuju da metaboliziranje regadenosona igra malu ulogu u njegovoj eliminaciji.
English: Regadenoson should be used with caution in patients with recent myocardial infarction.
Croatian: Regadenoson treba primjenjivati s oprezom u bolesnika s nedavnim infarktom miokarda.
English: • pins and needles, reduced sensation, taste changes
Croatian: • osjećaj mravinjanja i bockanja, oslabljen osjet, promjene okusa
English: Rapiscan contains the active substance regadenoson.
Croatian: Rapiscan sadrži djelatnu tvar regadenoson.
English: Clinical trials for the measurement of FFR excluded patients with an acute myocardial infarction, or within 5 days of an acute myocardial infarction.
Croatian: Klinička ispitivanja mjerenja FFR-a nisu uključivala bolesnike s akutnim infarktom miokarda ili unutar 5 dana od akutnog infarkta miokarda.