natgillin/translations-raw huggingface dataset:
• if you have had a recent serious heart problem (for example a heart attack or abnormal heart rhythms).
• ali ste imeli nedavne hude težave s srcem (na primer srčni infarkt ali nenormalen srčni ritem),
• Decompensated states of heart failure.
• dekompenzirana stanja srčnega popuščanja.
• if you have a heart rhythm disorder called long QT syndrome.
• ali imate motnjo srčnega ritma, imenovano sindrom podaljšanega intervala QT,
• discomfort in the mouth
• nelagodje v ustih
Do not use Rapiscan after the expiry date which is stated on the vial and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
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.
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.
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.
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.
• FFR should be measured as the lowest value of Pd/Pa achieved during steady state hyperemia.
• FFR je treba meriti kot najnižjo vrednost Pd/Pa, doseženo med hiperemijo v ravnovesnem stanju.
Multiple injections
Večkratna injiciranja
Fetal toxicity was noted following repeated daily administration of regadenoson, but at doses sufficiently in excess of the recommended human dose.
Fetotoksičnost so opazili po ponavljajočih se dnevnih odmerkih regadenozona, vendar v odmerkih, ki so veliko večji od priporočenega odmerka pri ljudeh.
This indicates that renal tubular secretion plays a role in regadenoson elimination.
To kaže, da ima renalna tubularna sekrecija vlogo pri izločanju regadenozona.
Elevated blood pressure
Povišan krvni tlak
After the Rapiscan injection you will need to sit or lie down until your heart rate and blood pressure return to your normal levels.
Po injiciranju zdravila Rapiscan morate sedeti ali ležati, da se vaš srčni utrip in krvni tlak vrneta na vaši običajni ravni.
Incubation with rat, dog, and human liver microsomes as well as human hepatocytes produced no detectable metabolites of regadenoson.
Inkubacija z jetrnimi mikrosomi podgan, psov in človeka ter s človeškimi hepatociti ni pokazala zaznavnih presnovkov regadenozona.
Therefore administration of aminophylline solely for the purpose of terminating a seizure induced by regadenoson is not recommended.
Zato uporaba aminofilina izključno za namen ustavitve napada, ki ga sproži regadenozon, ni priporočljiva.
It makes the heart arteries expand and heart rate increase.
Zdravilo razširi srčne arterije in poveča srčni utrip.
Coronary blood flow
Koronarni krvni pretok
To be taken into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
The doctor can then see if the heart muscles are getting enough blood flow when it is under stress.
Nato lahko zdravnik vidi, če v srčne mišice pod obremenitvijo priteka zadostna količina krvi.
• pain or discomfort around the area injected, body pain
• bolečina ali nelagodje okoli mesta injiciranja, splošne telesne bolečine
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).
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).
• if you are allergic to regadenoson or any of the other ingredients of Rapiscan listed in section 6 of this leaflet.
• če ste alergični na regadenozon ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
In post- marketing experience there have been cases of worsening or recurrence of atrial fibrillation after administration of regadenoson.
V obdobju trženja zdravila so bili primeri poslabšanja ali ponovitve atrijske fibrilacije po dajanju regadenozona.
The A2B and A3 adenosine receptors have been implicated in the pathophysiology of bronchoconstriction in susceptible individuals (i.e., asthmatics).
Receptorja adenozina A2B in A3 sta bila vpletena v patofiziologijo bronhokonstrikcije pri občutljivih posameznikih (tj. astmatikih).
However, most adverse reactions are mild and transient, resolving within 30 minutes after receiving regadenoson.
Vendar pa je večina neželenih učinkov blagih in prehodnih ter izzvenijo v 30 minutah po uporabi regadenozona.
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%).
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%).
• Severe hypotension.
• huda hipotenzija,
Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence
Občasni konvulzije, sinkopa, tranzitorne ishemične atake, neodzivnost na spodbude, zmanjšana raven zavedanja, tremor, zaspanost
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.
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.
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).
Metilksantini (npr. kofein in teofilin) so nespecifični antagonisti receptorja adenozina in lahko medsebojno delujejo z vazodilatacijsko aktivnostjo regadenozona (glejte poglavje 5.1).
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.
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.
These findings indicate that metabolism of regadenoson does not play a major role in the elimination of regadenoson.
Ti izsledki kažejo na to, da presnova regadenozona ne igra velike vloge pri izločanju regadenozona.
Based on a population pharmacokinetic analysis, age has a minor influence on the pharmacokinetics of regadenoson.
Na podlagi farmakokinetične analize populacije ima starost le manjši vpliv na farmakokinetiko regadenozona.
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).
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).
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.
Pri dajanju regadenozona je treba prenehati z dojenjem za vsaj 10 ur (to je vsaj 5-kratna razpolovna doba v plazmi) po odmerjanju regadenozona.
For use in radionuclide MPI: This product is to be administered only once within a 24 hour period.
Pri uporabi za radionuklidno slikanje miokardne perfuzije: To zdravilo se lahko uporabi samo enkrat v 24-urnem obdobju.
The majority of patients experience a rapid increase in heart rate.
Pri večini bolnikov se je srčni utrip hitro zvišal.
There is no adequate information on the use of Rapiscan in pregnant women.
Ustreznih informacij o uporabi zdravila Rapiscan pri nosečnicah ni.
• if you have episodes of heart block (which can slow the heart down) or a very slow heart rate.
• ali imate epizode srčnega bloka (ki lahko upočasni srce) ali zelo počasen srčni utrip,
Rapiscan is used in a type of heart scan in adults called ‘myocardial perfusion imaging'.
Zdravilo Rapiscan se uporablja pri odraslih za določeno vrsto slikanja srca, ki se imenuje "perfuzijska scintigrafija miokarda".
In postmarketing experience, third degree heart block and asystole have been reported within minutes of regadenoson administration.
V izkušnjah po začetku trženja so poročali o tretji stopnji srčnega bloka in asistoliji, ki sta se pojavili v nekaj minutah po dajanju regadenozona.
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.
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.
Fractional flow reserve (FFR):
Funkcionalna pretočna rezerva (FFR):
There are no adequate data from the use of regadenoson in pregnant women.
Zadostnih podatkov o uporabi regadenozona pri nosečnicah ni.
The dose injected does not depend on your weight.
Injicirani odmerek ni odvisen od vaše telesne mase.
Suboptimal Exercise Stress Test
Preizkus s suboptimalno telesno obremenitvijo
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).
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).
In in vitro studies, regadenoson has been shown to have little binding affinity for the A2B and A3 adenosine receptors.
V študijah in vitro se je pokazalo, da ima regadenozon majhno afiniteto za vezavo receptorjev adenozina A2B in A3.
Long QT syndrome
Sindrom podaljšanega intervala QT
Combination with exercise
Kombinacija s telesno vadbo
Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).
Ena 5 ml viala vsebuje 400 mikrogramov regadenozona (80 mikrogramov/ml).
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.
10 sekund trajajoče obdobje enakomerne hiperemije je lahko za obsežne meritve upada pritiska pri ocenjevanju kompleksne ali difuzne koronarne arterijske bolezni prekratko.
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.
Stopnje ujemanja za regadenozon in adenozin so bile izračunane kot povprečje stopenj ujemanja za vse tri kategorije, ugotovljene z začetnim slikanjem.
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.
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.
• if you have had episodes of mini strokes (called transient ischaemic attacks)
• če ste imeli epizode mini možganske kapi (kar se imenuje prehodni ishemični napad),
Other medicines and Rapiscan
Druga zdravila in zdravilo Rapiscan
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.
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.
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.
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.
• feeling unwell or weak
• slabo počutje ali šibkost
When you are given Rapiscan, your heart rate will increase quickly.
Ko boste dobili zdravilo Rapiscan, se bo srčni utrip naglo povečal.
Studies
Študija
Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome.
Regadenozon stimulira simpatični iztis in lahko poveča tveganje za ventrikularne tahiaritmije pri bolnikih s sindromom podaljšanega intervala QT.
Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for:
Zdravilo Rapiscan je selektivni koronarni vazodilatator, ki se pri odraslih uporablja kot zdravilo za farmakološko obremenitev pri:
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.
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.
For two patients from the exercise with regadenoson group, a serious cardiac adverse reaction was reported.
Pri dveh bolnikih iz skupine vadbe z regadenozonom so poročali o resnih neželenih učinkih na srce.
The pharmacokinetic parameters of regadenoson have not been specifically evaluated in those with varying degrees of hepatic impairment.
Farmakokinetičnih parametrov regadenozona niso posebej ocenili pri osebah s spremenljivimi stopnjami okvare jeter.
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.
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.
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.
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.
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.
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.
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).
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).
Upon case review, both patients, experienced ischemic symptoms and ECG changes during exercise or recovery prior to regadenoson administration.
Po pregledu primera sta oba bolnika doživela ishemične simptome in spremembe EKG med vadbo ali okrevanjem pred dajanjem regadenozona.
Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without prescription.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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.
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.
• radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
• radionuklidnem slikanju miokardne perfuzije pri bolnikih, ki niso zmožni obremenitve z vadbo.
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.
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.
The greatest mean change from baseline (21 bpm) occurs approximately 1 minute after administration of regadenoson.
Največja srednja sprememba od izhodišča (21 utripov/minuto) se pojavi približno 1 minuto po dajanju regadenozona.
Clinical studies have demonstrated the efficacy and safety of regadenoson in patients indicated for pharmacologic stress radionuclide MPI and for the measurement of FFR.
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.
For intravenous use.
Način uporabe Za intravensko uporabo.
The plasma concentration-time profiles were not significantly altered in the early stages after dosing when most pharmacologic effects are observed.
Profili plazemske koncentracije v odvisnosti od časa se niso značilno spremenili v zgodnjih stopnjah po odmerjanju, ko so opazili večino farmakoloških učinkov.
Regadenoson increases sympathetic tone, which causes an increase in heart rate and a shortening of the QT interval.
Regadenozon zvišuje tonus simpatikus, kar povzroči zvišanje srčnega utripa in skrajšanje intervala QT.
This medicine is for diagnostic use only.
Zdravilo je samo za diagnostične namene.
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).
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).
• respiratory arrest
• respiratorni zastoj
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).
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),
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.
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.
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%).
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%).
• pins and needles, reduced sensation, taste changes
• zbadanje in mrtvičenje, zmanjšan občutek, spremembe v okusu
Transient ischaemic attacks and cerebrovascular accident Regadenoson can cause transient ischaemic attack (see section 4.8).
Prehodni ishemični napadi in cerebrovaskularni inzult Regadenozon lahko povzroči prehodni ishemični napad (glejte poglavje 4.8).
The pharmacokinetics of regadenoson in patients on dialysis has not been assessed.
Farmakokinetike regadenozona pri bolnikih na dializi niso ocenjevali.
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.
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.
Aminophylline may be used to attenuate severe or persistent adverse reactions to regadenoson.
Aminofilin se lahko uporabi za ublažitev hudih ali trdovratnih neželenih učinkov na regadenozon.
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.
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.
Paraesthesia, hypoaesthesia, dysgeusia
Pogosti parestezija, hipoestezija, disgevzija