FrancophonIA/ELRC3.0 huggingface dataset:
English: The A2B and A3 adenosine receptors have been implicated in the pathophysiology of bronchoconstriction in susceptible individuals (i.e., asthmatics).
Maltese: Ir-riċetturi ta' adenosine A2B u A3 kienu implikati fil-patofiżjoloġija tar-restrizzjoni tal-bronki f'individwi suxxettibbli (i.e., persuni ażżmatiċi).
English: In ADVANCE MPI 1 and ADVANCE MPI 2, the Cicchetti-Allison and Fleiss-Cohen weighted kappas of the median score of three blinded readers with respect to ischaemia size category (not counting segments with normal rest uptake and mild/equivocal reduction in stress uptake as ischaemic) for the combined studies of regadenoson with the adenosine scan were moderate, 0.53 and 0.61, respectively;
Maltese: Fl-istudji ADVANCE MPI 1 u ADVANCE MPI 2, il-Cicchetti-Allison u Fleiss-Cohen weighted kappas tal-punteġġ medjan ta' tliet persuni blinded li jevalwaw il-punteġġ fir-rigward tad-daqs talkategorija tal-iskemija (mingħajr ma wieħed iqis is-segmenti b'assorbiment normali waqt is-serħan u tnaqqis ħafif/ekwivoku f'assorbiment waqt stress bħala iskemiku) għall-istudji kombinati b'regadenoson mal-iskan ta' adenosine kienu moderati, 0.53 u 0.61, rispettivament; kif kienu lweighted kappas ta' żewġ skans konsekuttivi b'adenosine, 0.50 u 0.55, rispettivament.
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).
Maltese: Żieda fil-pressjoni tad-demm kienet osservata f'xi pazjenti (pressjoni sistolika tad-demm massima ta' 240 mm Hg u pressjoni dijastolika massima tad-demm ta' 138 mm Hg).
English: In patients undergoing coronary catheterisation, pulsed-wave Doppler ultrasonography was used to measure the average peak velocity (APV) of CBF before and up to 30 minutes after administration of regadenoson (400 micrograms, intravenously).
Maltese: F'pazjenti li tkun qed issirilhom kateterizzazzjoni koronarja, intużat ultrasonografija pulsed-wave Doppler biex tkejjel ilmedja tal-veloċità massima (average peak velocity, APV) tas-CBF qabel u sa 30 minuta wara l-għoti ta' regadenoson (400 mikrogramma, minn ġol-vina).
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).
Maltese: • il-kejl ta' riserva tal-fluss frazzjonali (fractional flow reserve, FFR) ta' stenożi waħda talarterja koronarja waqt anġjografija koronarja invażiva, meta ma jiġix antiċipat kejl tal-FFR repetut (ara sezzjonijiet 4.2 u 5.1).
English: In the measurement of FFR, the time to peak maximum hyperaemia was 30±13 seconds.
Maltese: Fil-kejl tal-FFR, iż-żmien għal iperimja massima kien 30±13-il sekonda.
English: In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of regadenoson administration.
Maltese: Fi studji kliniċi, kien osservat tnaqqis fil-pressjoni sistolika tad-demm (> 35 mm Hg) f'7% tal-pazjenti u tnaqqis fil-pressjoni dijastolika tad-demm (> 25 mm Hg) kienet osservata f'4% talpazjenti fi żmien 45 minuta mill-għoti ta' regadenoson.
English: The efficacy and safety of regadenoson for pharmacologic stress radionuclide MPI were determined relative to adenosine in two randomised, double- blind studies (ADVANCE MPI 1 and ADVANCE MPI 2) in 2,015 patients with known or suspected coronary artery disease who were referred for a clinically-indicated pharmacologic stress MPI.
Maltese: L-effikaċja u s-sigurtà ta' regadenoson għal stress radionuclide MPI farmakoloġiku ġew determinati fir-rigward ta' adenosine f'żewġ studji double-blind li fihom il-parteċipanti ntgħażlu b'mod każwali (ADVANCE MPI 1 u ADVANCE MPI 2) li saru fuq 2,015 pazjent li kien magħruf li kellhom, jew li kien hemm suspett li kellhom mard tal-arterja koronarja, li kienu rriferuti għal stress MPI farmakoloġiku klinikament indikat.
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).
Maltese: Riskju ta' aċċessjonijiet Għandha tintuża kawtela meta regadenoson jingħata lil pazjenti bi storja ta' aċċessjonijiet jew b'fatturi oħra ta' riskju għal aċċessjonijiet, fosthom l-għoti konkomitanti ta' prodotti mediċinali li jbaxxu llimitu tal-aċċl-aunalitie (eż. antipsikotiċi, anti-dipressanti, theophyllines, tramadol, sterojdi sistemiċi u quinolones).
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.
Maltese: F'voluntiera b'saħħithom, 57% tad-doża ta' regadenoson titneħħa mhux mibdula fl-awrina (medda 19- 77%), b'medja ta' tneħħija fil-plażma tal-kliewi ta' madwar 450 ml/min, i.e., ogħla mir-rata ta' filtrazzjoni glomerulari.
English: The half-life of this initial phase is approximately 2 to 4 minutes.
Maltese: Il-halflife ta' din il-fażi inizjali hi madwar 2 sa 4 minuti.
English: • difficulty in breathing (bronchospasm)
Maltese: • diffikultà fit-teħid tan-nifs (bronkospażmu)
English: The most common cardiovascular conditions were patients with a medical history of hypertension, dyslipidemia / hypercholesterolemia, diabetes mellitus, smoking, prior PCI and prior MI.
Maltese: L-aktar kondizzjonijiet kardjovaskulari komuni kienu pazjenti bi storja medika ta' ipertensjoni, dislipidemija / iperkolesterolemija, dijabete melitus, tipjip, PCI preċedenti u MI preċedenti.
English: After you have been given Rapiscan, you will be given an injection of sodium chloride 9 mg/ml (0.9%) solution which contains 45 mg of sodium.
Maltese: Wara li tkun ingħatajt Rapiscan, ser tingħata injezzjoni ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni li jkun fiha 45 mg ta' sodium.
English: In clinical trials, increased systolic blood pressure (≥ 50 mm Hg) was observed in 0.7% of patients and increased diastolic blood pressure (≥ 30 mm Hg) in 0.5% of patients.
Maltese: Fi provi kliniċi, ġiet osservata pressjoni tad-demm sistolika miżjuda (≥ 50 mm Hg) f'0.7% tal-pazjenti u pressjoni tad-demm diastolika miżjuda (≥ 30 mm Hg) f'0.5% tal-pazjenti.
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.
Maltese: Regadenoson jista' jikkawża restrizzjoni tal-bronki u arrest respiratorju (ara sezzjoni 4.8), b'mod speċjali f'pazjenti b'mard magħruf jew issuspettat ta' restrizzjoni tal-bronki, mard pulmonari ostruttiv kroniku (chronic obstructive pulmonary disease, COPD) jew ażżma.
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.
Maltese: • dipyridamole, mediċina li tintuża biex jiġu evitati emboli tad-demm, m'għandhiex tintuża għal mill-inqas jumejn qabel ma tingħata Rapiscan għax tista' tibdel l-effett ta' Rapiscan.
English: • The radiopharmaceutical for the myocardial perfusion imaging agent should be administered 10-20 seconds after the sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: • Il-prodott radjofarmaċewtiku għall-aġent tal-immaġni ta' perfużjoni mijokardijaka għandu jingħata 10-20 sekonda wara sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: The other ingredients are: disodium edetate, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, water for injections.
Maltese: Is-sustanzi l-oħra huma: disodium edetate, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, ilma għall-injezzjonijiet.
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%).
Maltese: Pazjenti aktar anzjani (≥ età ta' 75 sena; n = 321) kellhom profil simili ta' reazzjonijiet avversi meta mqabbla ma' pazjenti iżgħar (< (≥ età ta' 65 sena; n = 1,016), iżda kellhom inċidenza ogħla ta' pressjoni baxxa (2% kontra < 1%).
English: • discomfort in the bones and muscles
Maltese: • skonfort fl-għadam u muskoli
English: A total of 1,871 of these patients had images considered valid for the primary efficacy evaluation, including 1,294 (69%) men and 577 (31%) women with a median age of 66 years (range 26-93 years of age).
Maltese: Total ta' 1,871 minn dawn il-pazjenti kellhom immaġni li kienu kkunsidrati li huma validi għal evalwazzjonital-effikaċja primarja, li kienu jinkludu 1,294 (69%) irġiel u 577 (31%) nisa b'medjan ta' età ta' 66 sena (medda ta' età ta' 26-93 sena).
English: In the EXERRT trial the efficacy and safety of regadenoson was evaluated in patients with suboptimal Exercise Stress in an open-label randomized, multi-center, non-inferiority study when regadenoson administered either at 3 minutes during recovery (exercise with regadenoson) or at rest 1 hour later (regadenoson only).
Maltese: Fil-prova EXERRT l-effikaċja u s-sikurezza ta' regadenoson ġew evalwati f'pazjenti b'eżerċizzju subottimali tal-Istress fi studju ‘open-label randomized', ‘multi-center', b' nuqqas ta' inferjorità meta regadenoson jingħata jew fi 3 minuti waqt l-irkupru (eżerċizzju b' regadenoson) jew waqt il-mistrieħ siegħa wara (regadenoson biss).
English: Signs of hypersensitivity (rash, urticaria, angioedema, anaphylaxis and/or throat tightness) may be immediate or delayed onset.
Maltese: Sinjali ta' sensittività eċċessiva (raxx, urtikarja, anġjoedema, anafilassi u/jew għafis fil- gerżuma) jista' jkollhom bidu immedjat jew inkella bidu mdewwem.
English: Bronchoconstriction
Maltese: Restrizzjoni tal-bronki
English: Fertility Fertility studies with regadenoson have not been performed (see section 5.3).
Maltese: Fertilità Ma sarux studji dwar il-fertilità b'regadenoson (ara sezzjoni 5.3).
English: In post-marketing experience there have also been reports of cerebrovascular accident (CVA).
Maltese: F'esperjenza ta' wara ttqegħid fis-suq kien hemm rapporti wkoll ta' aċċident ċerebrovaskulari (CVA - cerebrovascular accident).
English: In the first study in 49 patients with moderate to severe COPD, the rate of FEV1 reduction > 15% from baseline was 12% and 6% following regadenoson and placebo dosing, respectively (p=0.31).
Maltese: Fl-ewwel studju li sar fuq 49 pazjent li kellhom COPD minn moderata sa severa, ir-rata ta' FEV1 tnaqqis ta' > 15% mil-linja bażi kienet ta' 12% u 6% wara ddożaġġ b ' regadenoson u bi plaċebo, rispettivament (p = 0.31).
English: Rapiscan is injected by a healthcare professional (a doctor, nurse or medical technician) in a medical facility where your heart and blood pressure can be monitored.
Maltese: Rapiscan jiġi injettat minn professjonist fil-qasam mediku (tabib, infermiera jew tekniku mediku) f'faċilità medika fejn qalbek u l-pressjoni tad-demm jistgħu jiġu mmonitorjati.
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).
Maltese: Madankollu, analiżi post-hoc ta' dejta minn żewġ studji kliniċi ta' Fażi 3 uriet li l-farmakokinetika ta' regadenoson ma kinitx affettwata f'sottosett żgħir ta' pazjenti, b'valuri tal-laboratorju li jissuġġerixxu indeboliment fil-funzjoni tal-fwied (żieda ta' 2.5 darbiet fit-transaminase jew żieda ta' 1.5 darbiet ta' bilirubina fis-serum jew tal-ħin ta' protrombin).
English: Other medicines and Rapiscan
Maltese: X'fih Rapiscan
English: The radiopharmaceutical for the myocardial perfusion imaging agent should be administered 10-20 seconds after the sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Il-prodott radjofarmaċewtiku għall-aġent tal-immaġni ta' perfużjoni mijokardijaka għandu jingħata 10-20 sekonda wara sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
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.
Maltese: Regadenoson hu agonist b'affinità baxxa (Ki ≈ 1.3 µM) għar-riċettur ta' adenosine A2A, b'mill-inqas affinità li hi 10 darbiet iktar baxxa għar-riċettur ta' adenosine A1 (Ki > 16.5 µM), u affinità baxxa ħafna, jekk ikun hemm, għar-riċetturi ta' adenosine A2B u A3.
English: Clinical studies have demonstrated the efficacy and safety of regadenoson in patients indicated for pharmacologic stress radionuclide MPI and for the measurement of FFR.
Maltese: Studji kliniċi wrew l-effikaċja u s-sigurtà ta' regadenoson f'pazjenti li huma indikati għal stress radionuclide MPI farmakoloġiku u għall-kejl tal-FFR.
English: Regadenoson is administered by intravenous injection for pharmacologic stress radionuclide MPI.
Maltese: Regadenoson jingħata permezz ta' injezzjoni ġol-vini għal stress radionuclide MPI farmakoloġiku.
English: Rapiscan is used in a type of heart scan in adults called ‘myocardial perfusion imaging'.
Maltese: Rapiscan jintuża f'tip ta' skan tal-qalb f'persuni adulti, imsejjaħ ‘immaġni ta' perfużjoni mijokardijaka'.
English: Regadenoson shows selectivity (≥ 215-fold) for increasing coronary conductance (A2A-mediated response) relative to slowing of cardiac AV nodal conduction (A1-mediated response) as measured by AV conduction time (rat heart) or the S-H interval (guinea pig heart).
Maltese: Regadenoson juri selettività (≥ 215-il darba iżjed) biex iżid ilkonduttanza koronarja (rispons medjat minn A2A) fir-rigward tat-tnaqqis tal-konduzzjoni tan- nodes AV kardijaċi (rispons medjat minn A1), kif imkejjel mill-ħin ta' konduzzjoni AV (qalb tal- firien) jew intervall S-H (qalb tal-fniek tal-Indi).
English: In in vitro studies, regadenoson has been shown to have little binding affinity for the A2B and A3 adenosine receptors.
Maltese: Fi studji in vitro, intwera li regadenoson għandu ftit affinità li jeħel mar-riċetturi ta' adenosine A2B u A3.
English: The headache was considered severe in 3% of subjects.
Maltese: L-uġigħ ta' ras kien ikkunsidrat li kien sever fi 3% tal-persuni.
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).
Maltese: Fit-tielet studju, il-qtugħ ta' nifs ġif rrapportat b'mod aktar frekwenti wara regadenoson (18% għal pazjenti b'COPD; 11% għal pazjenti bl-ażżma) milli bi plaċebo, iżda b'rata aktar baxxa milli rrapportat matul żvilupp kliniku (ara Sezzjoni 4.8).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Radionuclide MPI clinical trials conducted with regadenoson excluded patients with recent (within 3 months) myocardial infarction.
Maltese: Provi kliniċi ta' radionuclide MPI li saru b'regadenoson eskludew pazjenti b'infart mijokardijaku riċenti (fi żmien 3 xhur).
English: They normally start soon after the Rapiscan injection and are usually over within 30 minutes.
Maltese: Normalment jibdew dritt wara l-injezzjoni ta' Rapiscan u ġeneralment jgħaddu fi żmien 30 minuta.
English: Cardiac arrest, myocardial infarction, complete AV block, bradycardia, atrial flutter, new-onset, worsening or recurrence of atrial fibrillation
Maltese: Waqfien kardijaku, infart mijokardijaku, imblokk sħiħ AV, bradikardija, palpitazzjonijiet atrijali, bidu ġdid, aggravar jew rikorrenza ta' fibrillazzjoni atrijali
English: 5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over-seal.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġe fih Soluzzjoni ta' 5 ml f'kunjett li jintuża darba biss, tal-ħġieg ta' Tip 1 b'tapp tal-lastku (butyl) u overseal tal-aluminju.
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.
Maltese: Sinjali ta' tossiċità materna u tal-fetu kienu osservati fil-firien u filfniek (tnaqqis fil-piżijiet tal-feti, dewmien fl-ossifikazzjoni [firien], numru inqas ta' frieħ u fin- numru ta' feti ħajjin [fniek]), iżda mhux teratoġeniċità.
English: Within the dose range of 0.003-0.02 mg/kg (or approximately 0.18-1.2 mg) in healthy subjects, clearance, terminal half-life or volume of distribution do not appear dependent upon the dose.
Maltese: 003-0.02 mg/kg (jew madwar 0.18-1.2 mg) f'pazjenti b'saħħithom, it-tneħħija, ilhalf-life terminali jew volum tad- distribuzzjoni ma jidhrux li huma dipendenti fuq id-doża.
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.
Maltese: Iktar minn 55% tad-doża ta' regadenoson titneħħa mhux mibdula fl-awrina u fatturi li jnaqqsu ttneħħija ma jaffettwawx il-konċentrazzjoni fil-plażma fl-istadji bikrin wara d-dożaġġ meta effetti farmakoloġiċi klinikament sinifikanti jkunu osservati.
English: • blurred vision, eye pain
Maltese: • uġigħ fis-sider
English: Rapiscan contains sodium
Maltese: Kif jidher Rapiscan u l-kontenut tal-pakkett
English: Uncommon side effects (affects 1 to 10 users in 1,000)
Maltese: Effetti sekondarji mhux komuni (jaffettwaw minn utent 1 sa 10 minn kull 1,000)
English: Studies
Maltese: LISTA
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.
Maltese: F'pazjent b'sindrome ta' QT twil, l-istimulazzjoni simpatetika tista' tirriżulta f'inqas taqsir talintervall tal-QT minn dak normali u tista' wkoll tikkawża żieda paradossali fl-intervall tal-QT.
English: Do not eat food or have drinks containing caffeine (for example, tea, coffee, cocoa, cola or chocolate) for at least 12 hours before you are given Rapiscan.
Maltese: Tikolx ikel u tixrobx xorb li jkun fihom il-kaffeina (pereżempju, te, kafe, cocoa, cola jew ċikkulata) għal mill-inqas 12-il siegħa qabel ma tingħata Rapiscan.
English: SE)
Maltese: NUMRU(I)
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).
Maltese: 8 tirrappreżenta n-nuqqas ta' iskemija induċibbli kontra ≤ 0.8 li jirrappreżenta l-preżenza ta' iskemija induċibbli).
English: Adverse reactions occurred in approximately 80% of patients.
Maltese: Reazzjonijiet avversi seħħew f'madwar 80% tal-pazjenti.
English: The pharmacokinetics of regadenoson in patients on dialysis has not been assessed.
Maltese: Il-farmakokinetika ta' regadenoson f'pazjenti fuq id-dijalisi ma ġajal evalwata.
English: • 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Maltese: • 10 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni għandha tingħata immedjatament wara l-injezzjoni ta' Rapiscan.
English: • bloating, diarrhoea, involuntary loss of faeces
Maltese: • gass żejjed, dijarea, ħruġ involontarju ta' ippurgar
English: FFR was measured after IV infusion of adenosine and IV injection of regadenoson (400 μg).
Maltese: L-FFR tkejjel wara infużjoni ġol-vini ta' adenosine u injezzjoni ġol-vini ta' regadenoson (400 μg).
English: Rapiscan 400 microgram solution for injection regadenoson
Maltese: Rapiscan 400 mikrogramma soluzzjoni għall-injezzjoni Regadenoson
English: Rapiscan 400 microgram solution for injection Regadenoson
Maltese: Rapiscan 400 mikrogramma soluzzjoni għall-injezzjoni regadenoson
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.
Maltese: Il-livell ta' qbil bejn il-qari tal-MPI 1 (eżerċizzju b'regadenoson) u l-MPI 2 kienu simili għall-livell ta' qbil bejn il-qari tal-MPI 1 (regadenoson biss) u MPI 2.
English: Safety and tolerability of repeated use of this product within 24 hours has not been characterised.
Maltese: Issigurtà u t-tollerabilità tal-użu ripetut ta' dan il-prodott f'perijodu ta' 24 siegħa ma ġewx ikkaratterizzati.
English: Arthralgia
Maltese: Iperidrosi
English: The safety and efficacy of regadenoson in children below the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' regadenoson fi tfal li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
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).
Maltese: L-Aġenzija Ewropeja għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Regadenoson f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika b'disturbi ta' perfużjoni mijokardijaka (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • changes in heart tracing tests (electrocardiogram)
Maltese: • tibdil fil-testijiet tal-intraċċar tal-qalb (elettrokardjogramm)
English: ANNEX 1
Maltese: Nycoveien 1
English: • 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Maltese: • 5 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni għandha tingħata immedjatament wara l-injezzjoni ta' Rapiscan.
English: • throat tightness, throat irritation, cough
Maltese: • dwejjaq fil-gerżuma, irritazzjoni fil-gerżuma, sogħla
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).
Maltese: Għalhekk, 1147 pazjent ġew ‘randomised' f'żewġ gruppi: 578 pazjent mill-grupp b'eżerċizzju b'regadenoson u 569 mill-grupp regadenoson biss għal irkupru ta' 3 minuti (għall-grupp b'eżerċizzju b'regadenoson) jew għall-mistrieħ siegħa wara (għall-grupp regadenoson biss ).
English: Rapiscan 400 microgram solution for injection
Maltese: Rapiscan 400 mikrogramma soluzzjoni għall-injezzjoni
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini
English: You will also be given an injection of sodium chloride 9 mg/ml (0.9%) solution (5 ml), and an injection of a small amount of a radioactive substance (radiopharmaceutical).
Maltese: Ser tingħata wkoll injezzjoni ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) (5 ml), u injezzjoni ta' ammont żgħir ta' sustanza radjuattiva (prodott radjofarmaċewtiku).