FrancophonIA/ELRC3.0 huggingface dataset:
English: When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Maltese: Meta mogħti ma' elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni huwa mistenni li jżid il-konċentrazzjoni ta' tenofovir.
English: GS-331007 ↔ Cmax 1.23 (1.14, 1.34)
Maltese: GS-331007 ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03)
English: Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors.
Maltese: L-għoti flimkien ma' prodotti mediċinali li jinibixxu P-gp u/jew BCRP jista' jżid il-konċentrazzjonijiet ta' ledipasvir u sofosbuvir fil-plażma mingħajr ma jżid il-konċentrazzjoni ta' GS-331007 fil-plażma;
English: If ribavirin is co-administered with Harvoni, the contraindications regarding use of ribavirin during pregnancy and breast-feeding apply (see also the Summary of Product Characteristics for ribavirin).
Maltese: Jekk ribavirin jingħata flimkien ma' Harvoni, il-kontraindikazzjonijiet dwar l-użu ta' ribavirin waqt ittqala u t-treddigħ japplikaw (ara wkoll is-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin).
English: Interactions between Harvoni and other medicinal products
Maltese: Interazzjonijiet bejn Harvoni u prodotti mediċinali oħrajn
English: ↔ indicates no clinically relevant change in the exposure of Ledipasvir.
Maltese: ↔ tindika li m'hemm l-ebda bidla klinikament rilevanti fl-esponiment għal Ledipasvir.
English: Hepatitis C is a virus that infects the liver.
Maltese: Epatite Ċ hi infezzjoni tal-fwied ikkawżata minn virus.
English: ↑ Cmin 2.63 (2.32, 2.97) Ledipasvir ↓ Cmax 0.66 (0.59, 0.75)
Maltese: Ledipasvir ↓ Cmax 0.66 (0.59, 0.75) ↓ AUC 0.66 (0.59, 0.75) ↓ Cmin 0.66 (0.57, 0.76)
English: Not interpretable a One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
Maltese: Pazjent fil-fergħa ta' kura ta' 8 ġimgħat ta' LDV/SOF ma kellhomx subtip tal-ġenotip 1 konfermat.
English: Elderly
Maltese: Ranitidinee
English: mL/min/1.
Maltese: IU/mL.
English: GS-331007 ↔ Cmax 1.14 (1.01, 1.29)
Maltese: GS-331007 ↔ Cmax 1.14 (1.01, 1.29) ↔ AUC 1.03 (0.96, 1.12)
English: SVR Outcome for patients without SVR On-treatment virologic failure
Maltese: Falliment viroloġiku waqt il-kura Rikadutab
English: Darunavir ↔ Cmax 0.97 (0.94, 1.01)
Maltese: Darunavir ↔ Cmax 0.97 (0.94, 1.01) ↔ AUC 0.97 (0.94, 1.00) ↔ Cmin 0.86 (0.78, 0.96)
English: ↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95 (0.68, 1.33)
Maltese: Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12)
English: ↔ Cmin 0.89 (0.81, 0.98)
Maltese: 92 (0.87, 0.97) ↔ AUC 0.90 (0.85, 0.94)
English: Sofosbuvir was absorbed quickly and the median peak plasma concentrations were observed ~ 1 hour post-dose.
Maltese: Sofosbuvir ġie assorbit malajr u u l-ogħla konċentrazzjonijiet medjani fil-plażma ġew osservati ~ 1 siegħa wara d-doża.
English: GS-331007 ↔ Cmax 0.86 (0.76, 0.96)
Maltese: GS-331007 ↔ Cmax 0.86 (0.76, 0.96) ↔ AUC 0.90 (0.83, 0.97) ↔ Cmin 1.07 (1.02, 1.13)
English: Other medicines and Harvoni
Maltese: Mediċini oħra u Harvoni
English: ↔ Cmin 1.07 (0.89, 1.28) Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
Maltese: Norgestrel ↔ Cmax 1.18 (0.99, 1.41) ↑ AUC 1.19 (0.98, 1.45) ↑ Cmin 1.23 (1.00, 1.51)
English: No major differences in outcomes were observed by the presence or absence of baseline NS5A RAVs.
Maltese: Ma ġew osservati l-ebda differenzi maġġuri fir-riżultati mill-preżenza jew in-nuqqas ta' NS5A RAVs fil-linja bażi.
English: In female rats, the mean number of corpora lutea and implantation sites were slightly reduced at maternal exposures 6-fold the exposure in humans at the recommended clinical dose.
Maltese: F'firien nisa, l-għadd medju ta' corpora lutea u siti ta' impjantazzjoni tnaqqas xi ftit f'esponimenti materni li huma 6 darbiet aktar mill-esponiment fil-bnedmin fid-doża klinika rakkomandata.
English: ↑ Cmin 4.25 (3.47, 5.22) Ledipasvir ↑ Cmax 1.63 (1.51, 1.75)
Maltese: Tenofovir ↑ Cmax 1.47 (1.37, 1.58) ↔ AUC 1.35 (1.29, 1.42) ↑ Cmin 1.47 (1.38, 1.57)
English: 400 micrograms
Maltese: 400 mikrogramma
English: • respiratory arrest
Maltese: • arrest respiratorju
English: Respiratory effects
Maltese: Effetti respiratorji
English: (n = 1,871)
Maltese: Studi Kombinati (n = 1,871)
English: Cardioactive medicinal products
Maltese: Prodotti mediċinali kardjoattivi
English: Pharmacologic stress radionuclide MPI
Maltese: Stress radionuclide MPI farmakoloġiku
English: Do not take Rapiscan:
Maltese: Tiħux Rapiscan:
English: NO-0485 Oslo Norway
Maltese: NO-0485
English: Millmount Healthcare Limited, Block 7, City North Business Campus, Stamullen, Co Meath, K32 YD60 Ireland
Maltese: Millmount Healthcare Limited, Block 7, City North Business Campus, Stamullen, Co Meath, K32 YD60, Irlanda
English: Regadenoson does not significantly inhibit the transporters OAT1, OAT3, OCT1, OATP1B1, OATP1B3, MATE1, MATE2-K, BCRP, P-gp, BSEP, ENT 1 or ENT2 at 1 µM.
Maltese: Regadenoson ma jinibixxix b'mod sinifikanti t-trasportaturi OAT1, OAT3, OCT1, OATP1B1, OATP1B3, MATE1, MATE2-K, BCRP, P-gp, BSEP, ENT 1 jew ENT2 f'1 µM.
English: Classification agreement Cohen's kappa
Maltese: Qbil tal-klassifikazzjoni Kappa ta' Cohen
English: Fractional flow reserve (FFR):
Maltese: Riserva tal-fluss frazjzonali (FFR):
English: Fractional Flow Reserve (FFR)
Maltese: Riserva tal-Fluss Frazzjonali (FFR)
English: AndersonBrecon (UK) Ltd Wye Valley Business Park Hay-on-Wye, Hereford HR3 5PG, United Kingdom
Maltese: AndersonBrecon (UK) Limited Wye Valley Business Park Hay-on-Wye, Hereford HR3 5PG
English: There was no statistical difference between 200 mg and 400 mg caffeine with regadenoson .
Maltese: Ma kien hemm ebda differenza statistika bejn 200 mg u 400 mg kaffeina flimkien ma' Regadenoson.
English: Sensitivity Specificity
Maltese: Sensittività Speċifiċità
English: Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
Maltese: Data tal-aħħar tiġdid: 24/04/2015
English: (n = 1,113)
Maltese: ADVANCE MPI 1 (n = 1,113)
English: Distribution Regadenoson is moderately bound to human plasma proteins (25-30%).
Maltese: Distribuzzjoni Regadenoson jeħel b'mod moderat mal-proteini fil-plażma tal-bniedem (25-30%).
English: (n = 758)
Maltese: ADVANCE MPI 2 (n = 758)
English: Repeated use
Maltese: Użu ripetut
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.
Maltese: Regadenoson ma jinibixxix il-metaboliżmu ta' substrati għal CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, jew CYP3A4 f'mikrosomi tal-fwied uman, u dan jindika li mhux mistenni li jibdel ilfarmakokinetika ta' prodotti mediċinali metabolizzati minn dawn l-enzimi ta' ċa'zimii P450.
English: Very common Gastrointestinal discomfort Common
Maltese: Komuni ħafna Skonfort gastro-intestinali Komuni
English: Patients initiated exercise using a standard or modified Bruce protocol.
Maltese: Il-pazjenti bdew eżerċizzju bl-użu ta' protokoll standard jew Bruce modifikat.
English: Myocardial ischaemia
Maltese: Iskemija mijokardijaka
English: Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).
Maltese: Kull kunjett ta' 5 ml fih 400 mikrogramma ta' regadenoson (80 mikrogramma/ml).
English: Safety and tolerability testing
Maltese: Ittestjar ta' sigurtà u tollerabilità
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) u rari (≥ 1/10,000 sa < 1/1,000).
English: The pharmacokinetic parameters of regadenoson have not yet been studied in the paediatric population (< 18 years).
Maltese: Il-parametri farmakokinetiċi ta' regadenoson s'issa ma ġasa studjati fil-popolazzjoni pedjatrika (< 18il sena).
English: Vomiting, nausea, oral discomfort
Maltese: Rimettar, nawseja, skonfort orali
English: Bronchospasm, Respiratory arrest Gastrointestinal disorders:
Maltese: Mhux magħruf Bronkospażmu, Arrest respiratorju Disturbi gastro-intestinali:
English: Common side effects (affects 1 to 10 users in 100)
Maltese: Effetti sekondarji komuni (jaffettwaw minn utent 1 sa 10 utenti minn kull 100)
English: Multiple injections
Maltese: Injezzjonijiet multipli
English: This belongs to a group of medicines called ‘coronary vasodilators'.
Maltese: Din tappartjeni għal grupp ta' mediċini msejħa ‘vasodilaturi koronarji'.
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.
Maltese: Pazjenti miż-żewġ gruppi (eżerċizzju b'regadenoson u regadenoson biss) għaddew minn SPECT Myocardial Perfusion Imaging (MPI) fil-60-90 minuta wara l-għoti ta' wara r-regadenoson.
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.
Maltese: Minkejja affinità baxxa għar-riċettur ta' adenosine A2A, regadenoson għandu potenza qawwija li jżid il-konduttanza koronarja fi qlub iżolati tal-firien u fniek tal-Indi, b'valuri EC50 ta' 6.4 nM u 6.7-18.6 nM, rispettivament.
English: Rate Difference (regadenoson - Adenosine) (± 95% Confidence Interval
Maltese: Differenza fir-Rata (Regadenoson - Adenosine) (± SE)
English: Rapiscan contains the active substance regadenoson.
Maltese: Rapiscan fih is-sustanza attiva, regadenoson.
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.
Maltese: Kull pazjent irċieva skan inizjali ta' stress bl-użu ta' adenosine (infużjoni ta' 6 minuti bl-użu ta' doża ta' 0.14 mg/kg/min, mingħajr eżerċizzju) bi protokoll ta' immaġni b'radionuclide gated SPECT (single photon emission computed tomography).
English: Radionuclide myocardial perfusion imaging (MPI):
Maltese: Immaġni ta' perfużjoni mijokardijaka radionuclide (MPI):
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.
Maltese: Fi studji kliniċi, regadenoson ingħata lil pazjenti li kienu qed jieħdu prodotti mediċinali kardjoattivi oħrajn (i.e., imblokkaturi β, imblokkaturi tal-kanal tal-calcium, inibituri ta' ACE, nitrates, glycosides kardijaċi, u imblokkaturi tar-riċettur ta' angiotensin) mingħajr effetti apparenti fuq il-profili tas-sigurtà jew tal-effikaċja ta' regadenoson.
English: Effect of caffeine
Maltese: Effett tal-kaffeina
English: Immune system disorders: Uncommon
Maltese: Disturbi fis-sistema immuni: Mhux komuni
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%).
Maltese: Numru ta' pazjenti ħadu prodotti mediċinali kardjoattivi fil-jum tal-iskan, li jinkludu imblokkaturi β (18%), imblokkaturi tal-kanal tal-calcium (9%), u nitrates (6%).
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).
Maltese: Biż-żieda ta' indeboliment tal-kliewi, minn ħafif (CLcr 50 sa < 80 ml/min) sa moderat (CLcr 30 sa < 50 ml/min) sa indeboliment tal-kliewi sever (CLcr < 30 ml/min), il-porzjon ta' regadenoson li tneħħa mhux mibdul fl-awrina u tneħħija mill-kliewi naqas, u rriżulta f'żieda fil-ħalf-lives tal-eliminazzjoni u tal-valuri tal-AUC meta mqabbla ma' persuni b'saħħithom (CLcr ≥ 80 ml/min).
English: The most common cardiovascular histories included hypertension (81%), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or stenting (51%), angina (63%), and history of myocardial infarction (41%) or arrhythmia (33%); other medical history included diabetes (32%) and COPD (5%).
Maltese: L-iktar tipi komuni ta' storja medika kardjovaskulari kienu jinkludu pressjoni għolja (81%), bypass graft tal-arterja koronarja (coronary artery bypass graft, CABG), angioplasty koronarja transluminali perkutanea (percutaneous transluminal coronary angioplasty, PTCA) jew stenting (51%), anġina (63%), u storja medika ta' infart mijokardijaku (41%) jew arritmija (33%); tipi oħra ta' storja medika kienu jinkludu dijabete (32%) u COPD (5%).
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).
Maltese: Fi studju ta' pazjenti adulti li kienu qegħdin jagħmlu MPI radjonukleidi tal-istress farmakoloġiku b'Regadenoson, randomizzati għal plaċebo (n=66) jew għal kaffeina (200 mg, n=70 jew 400 mg, n=71) mogħtija 90 minuta qabel it-test, il-kaffeina kkompromettiet il-preċiżjoni dijanjostika tal- kxif ta' difetti ta' perfużjoni riversibbli (p<0.001).
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:
Maltese: L-istudji ADVANCE MPI 1 u ADVANCE MPI 2, individwalment u kombinati, urew li Regadenoson hu simili għal adenosine fl-evalwazzjoni tal-grad ta' anormalitajiet ta' perfużjoni riversibbli:
English: Transient ischaemic attacks and cerebrovascular accident Regadenoson can cause transient ischaemic attack (see section 4.8).
Maltese: Attakki iskemiċi transitorji u aċċidenti ċerebrovaskulari Regadenoson jista' jikkawża attakk iskemiku transitorji (ara sezzjoni 4.8).
English: Activation of the A2A adenosine receptor produces coronary vasodilation and increases coronary blood flow (CBF).
Maltese: L-attivazzjoni tar-riċettur ta' adenosine A2A tipproduċi vasodilatazzjoni koronarja u żżid il-fluss tad-demm koronarju (coronary blood flow, CBF).
English: • if you have had episodes of mini strokes (called transient ischaemic attacks)
Maltese: • jekk kellek episodji ta' mini puplesiji (li jissejħu attakki iskemiċi transitorji).
English: Cerebrovascular accident
Maltese: Aċċident ċerebrovaskulari
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.
Maltese: Aminophylline jista' jingħata f'dożi li jvarjaw minn 50 mg sa 250 mg permezz ta' injezzjoni bil-mod ġod-vini (50 mg sa 100 mg fuq perijodu ta' 30-60 sekonda) biex inaqqas reazzjonijiet avversi severi u/jew persistenti għal regadenoson iżda ma għandux jintuża biss għall-għanijiet ta' terminazzjoni ta' aċċessjoni kkaġunata minn regadenoson.
English: In the third study in 1009 patients with mild or moderate asthma (n=537) and moderate or severe COPD (n=472) the incidence of FEV1 reduction >15% from baseline was 1.1% and 2.9% in patients with asthma (p=0.15) and 4.2% and 5.4% in patients with COPD (p=0.58) following regadenoson and placebo dosing, respectively.
Maltese: Fit-tielet studju f'1009 pazjent b'ażżma ħafifa jew moderata (n=537) u b'COPD moderata jew severa (n=472), l-inċidenza ta' FEV1 tnaqqis ta' > 15% mil-linja bażi kienet ta' 1.1% u 2.9% f'pazjenti bl-ażżma (p=0.15) u 4.2% u 5.4% f'pazjenti b'COPD (p=0.58) wara dożaġġ b'regadenoson u bi plaċebo, rispettivament.
English: Haemodynamic Effects
Maltese: Effetti emodinamiċi
English: Nervous system disorders:
Maltese: Ansjetà, nuqqas ta' rqad Disturbi fis-sistema nervuża:
English: Tachypnoea, wheezing
Maltese: Takipnea, tħarħir
English: The active substance in Rapiscan is regadenoson.
Maltese: Is-sustanza attiva f'Rapiscan hi regadenoson.
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).
Maltese: Ilkonċentrazzjoni massima fil-plażma ta' regadenoson tintlaħaq fi żmien minn 1 sa 4 minuti wara injezzjoni ta' Regadenoson u sseħħ mal-bidu tar- rispons farmakodinamiku (ara sezzjoni 5.1).
English: Headache was reported by 27% of subjects who received regadenoson in clinical trials.
Maltese: Uġigħ ta' ras kien irrappurtat minn 27% tal-persuni li rċivew regadenoson fl-istudji kliniċi.
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.
Maltese: Regadenoson jista' jkollu effett inibitorju modest fuq it-trasportatur renali attiv, OCT2, u nstab li huwa substrat probabbli għal trasport medjat b'BCRP, ENT1 jew ENT2.
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.
Maltese: Id-durata medja ta' plateau iperimiku kien 163 (±169) sekonda u l-iperimja massima damet tal-inqas 19-il sekonda f'90 % talpazjenti, madakollu, fil-pazjent individwali, id-durata tal-iperimja varjat bejn 10 sekondi sa aktar minn 10 minuti.
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.
Maltese: Fil-popolazzjoni tal-istudji miġbura, 68% tal-pazjenti kellhom 0-1 segmenti li kienu juru difetti riversibbli fuq l-iskan inizjali, 24% kellhom 2-4 segmenti, u 9% kellhom ≥ 5 segmenti.
English: The most common adverse reactions reported during clinical development in a total of 1,651 patients/subjects were: dyspnoea (29%), headache (27%), flushing (23%), chest pain (19%), electrocardiogram ST segment changes (18%), gastrointestinal discomfort (15%) and dizziness (11%).
Maltese: L- iktar reazzjonijiet avversi komuni rrappurtati matul l-iżvilupp kliniku f'total ta' 1,651 pazjenti/voluntiera kienu: qtugħ ta' nifs (29%), uġigħ ta' ras (27%), fwawar (23%), uġigħ fissider (19%), tibdil fis-segment ST fuq elettrokardjogramm (18%), skonfort gastro-intestinali (15%) u sturdament (11%).
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.
Maltese: Aminophylline (100 mg, amministrata b'injezzjoni bil-mod ġol-vini f 60 sekonda) injettata minuta wara 400 mikrogramma regadenoson f'individwi li jkunu għaddejjin minn kateterizzazzjoni kardijaka, intwera li jqassar it-tul tar-rispons koronarju tal-fluss tad-demm għal regadenoson kif imkejjel blultrasonografija Doppler tal-mewġ bil-pulsazzjoni.
English: Aminophylline has been used to attenuate adverse reactions to regadenoson (see section 4.4).
Maltese: Aminophylline ntuża biex itaffi r-reazzjonijiet avversi għal regadenoson (ara sezzjoni 4.4).
English: Atrial fibrillation or flutter
Maltese: Fibrillazzjoni jew palpitazzjonijiet atrijali
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB21
Maltese: Terapija kardijaka, preparazzjonijiet kardijaċi oħrajn, Kodiċi ATC:
English: Based on a population pharmacokinetic analysis, age has a minor influence on the pharmacokinetics of regadenoson.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni, l-età għandha influwenza żgħira fuq ilfarmakokinetika ta' regadenoson.
English: MPI 2
Maltese: ANNESS II
English: Hypertension, pallor, peripheral coldness Respiratory, thoracic and mediastinal disorders: Very common Dyspnoea Common
Maltese: Pressjoni għolja, sfurija, kesħa periferali Disturbi respiratorji, toraċiċi u medjastinali:
English: This medicinal product contains less than1 mmol sodium (23 mg) per dose.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża.
English: Sinoatrial and atrioventricular nodal block
Maltese: Imblokk tan-nodes sinoatrijali u atrijoventrikulari
English: • radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Maltese: • immaġni ta' perfużjoni mijokardijaka radionuclide (myocardial perfusion imaging, MPI) f'pazjenti li ma jkunux kapaċi jagħmlu eżerċizzju adegwat li jikkawża stress.
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).
Maltese: Methylxanthines (eż., kaffeina u theophylline) huma antagonisti mhux speċifiċi tar-riċettur ta' adenosine u jistgħu jinterferixxu mal-attività ta' vasodilatazzjoni ta' regadenoson (ara sezzjoni 5.1).
English: Each 5 ml vial of Rapiscan contains 400 micrograms of regadenoson.
Maltese: Kull kunjett ta' 5 ml ta' Rapiscan fih 400 mikrogramma ta' regadenoson.
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.
Maltese: Total ta' 249 pazjent li klinikament ġew indikati biex issirilhom anġjografija koronarja b'kejl invażiv tal-FFR, irċivew regadenoson, bi 88 minn dawn il-pazjenti li rċivew regadenoson darbtejn.
English: Angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged
Maltese: Anġina pectoris, imblokk atrijoventrikulari, takikardija, palpitazzjonijiet, anormalitajiet oħrajn fl-ECG li jinkludu titwil fl-intervall QT ikkoreġut fuq elettrokardjogramm
English: However, the injection of sodium chloride 9 mg/ml (0.9%) solution given after regadenoson contains 45 mg of sodium.
Maltese: Madankollu, linjezzjoni ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni mogħtija wara regadenoson fiha 45 mg ta' sodium.
English: In ADVANCE MPI 1 and ADVANCE MPI 2, the following pre-specified safety and tolerability endpoints comparing regadenoson to adenosine achieved statistical significance: (1) a summed score of both the presence and severity of the symptom groups of flushing, chest pain, and dyspnoea was lower with regadenoson (0.9 ± 0.03) than with adenosine (1.3 ± 0.05); and (2) the symptom groups of flushing (21% vs 32%), chest pain (28% vs 40%), and ‘throat, neck or jaw pain' (7% vs 13%) were less frequent with regadenoson ; the incidence of headache (25% vs 16%) was more frequent with regadenoson .
Maltese: (1) punteġġ totali kemm tal-preżenza u s-severità tal-gruppi ta' sintomi ta' fwawar, uġigħ fis-sider, u qtugħ ta' nifs kien iktar baxx b'Regadenoson (0.9 ± 0.03) milli b'adenosine (1.3 ± 0.05); u (2) il-gruppi ta' sintomi ta' fwawar (21% vs 32%), uġigħ fis-sider (28% vs 40%), u ‘uġigħ fil-gerżuma, għonq jew xedaq' (7% vs 13%) kienu inqas frekwenti b'Regadenoson; l-inċidenza ta' wġigħ ta' ras (25% vs 16%) kien iktar frekwenti b'Regadenoson.
English: Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for:
Maltese: Rapiscan hu vasodilatur koronarju selettiv għall-użu fl-adulti bħala mediċina farmakoloġika li tikkawża stress għal:
English: Radionuclide myocardial perfusion imaging (MPI)
Maltese: Immaġni ta' perfużjoni mijokardijaka radionuclide (MPI)