FrancophonIA/ELRC3.0 huggingface dataset:
English: The PALLAS study was a randomised placebo-controlled study investigating the clinical benefit of dronedarone 400 mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors (patients with congestive heart failure ~ 69%, coronary heart disease ~ 41%, prior stroke or TIA ~ 27%; LVEF ≤40% ~ 20.7% and patients ≥75 years with hypertension and diabetes ~ 18%).
Maltese: L-istudju PALLAS kien studju kkontrollat bil-plaċebo u magħmul b'mod arbitrarju li investiga lbenefiċċju kliniku ta' dronedarone 400 mg BID meta jingħata mat-terapija standard f'pazjenti b'fibrillazzjoni atrijali permanenti u b'fatturi ta' riskju oħra (pazjenti b'insuffiċjenza konġestiva talqalb ~ 69%, mard koronarju tal-qalb ~ 41%, puplesija preċedenti or TIA ~ 27%; LVEF ≤ 40% ~ 20.7 % u pazjenti ≥ 75 senabl-ipertensjoni u d-dijabete ~ 18%).
English: • some medicines for depression called tricyclic antidepressants,
Maltese: • xi mediċini għad-depressjoni, imsejħa antidepressanti triċikliċi,
English: Four thousand six hundred and twenty eight (4,628) patients were randomised and treated for up to 30 months maximum (median follow-up: 22 months) with either dronedarone 400 mg twice daily (2,301 patients) or placebo (2,327 patients), in addition to conventional therapy including beta-blockers (71%), ACE inhibitors or AIIRAs (69%) digitalis (14%), calcium antagonists (14%), statins (39%), oral anticoagulants (60%), chronic antiplatelet therapy (6%) and/or diuretics (54%).
Maltese: Erbat elef sitt mija u tmienja u għoxrin (4628) pazjent ġew magħżula b'mod arbitrarju u kkurati sa massimu ta' 30 xahar (il-medjan sat-tieni viżta: 22 xahar) b'jew dronedarone 400 mg darbtejn kuljum (2301 pazjent) jew plaċebo (2327 pazjent) flimkien ma' terapija konvenzjonali li tinkludi imblokkaturi tar-riċetturi beta (71 %), inibituri ta' ACE jew AIIRAs (69 %), digitalis (14 %), antagonisti tal-calcium (14 %), statins (39 %), antikoagulanti orali (60 %), terapija kronika kontra l-plejtlits (6 %) u/jew dijuretiċi (54 %).
English: Dronedarone could increase plasma concentrations of immunosupressants (tacrolimus, sirolimus, everolimus and cyclosporine).
Maltese: Dronedarone jista' jżid il-konċentrazzjonijiet fil-plażma ta' sustanzi li jnaqqsu l-attività immunitarja (tacrolimus, sirolimus, everolimus u cyclosporine).
English: Interstitial lung disease including pneumonitis and pulmonary fibrosis
Maltese: Mard tal-interstizju tal-pulmun inkluż pnewmonite u fibrożi tal-pulmun
English: Rashes (including generalised, macular, maculo-papular) Pruritus
Maltese: Raxx (li jinkludi makulari, papulo-makulari, ġeneralizzat)
English: When dabigatran etexilate 150 mg once daily was co-administered with dronedarone 400 mg twice daily, the dabigatran AUC0-24, and Cmax were increased by 100% and 70%, respectively.
Maltese: Meta dabigatran etexilate 150 mg darba kuljum ingħata flimkien ma' dronedarone 400 mg darbtejn kuljum, l-AUC0-24 u s-Cmax ta' dabigatran żdiedu b'100% u 70%, rispettivament.
English: During the course of the study, the number of deaths from any cause was comparable between the dronedarone (116/2,301) and placebo (139/2,327) groups.
Maltese: Matul l-istudju, in-numru ta' mwiet minn kwalunkwe kawża kien komparabbli bejn il-gruppi ta' dronedarone (116/2,301) u plaċebo (139/2,327).
English: Dronedarone is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min) (see section 4.3).
Maltese: Dronedarone huwa kontraindikat f'pazjenti b'indeboliment renali sever (b'tneħħija tal-kreatinina (CrCl) <30 ml/min) (ara sezzjoni 4.3).
English: In EURIDIS and ADONIS, a total of 1,237 patients with a prior episode of AF or AFL were randomised in an outpatient setting and treated with either dronedarone 400 mg twice daily (n = 828) or placebo (n = 409) on top of conventional therapies (including oral anticoagulants, beta-blockers, ACE inhibitors or AIIRAs, chronic antiplatelet agents, diuretics, statins, digitalis, and calcium antagonists).
Maltese: F'EURIDES u ADONIS, f'ambjent barra mill-isptar, total ta' 1,237 pazjent b'episodju preċedenti ta' FA/TA ġew magħżula b'mod arbitrarju għall-kura jew b'dronedarone 400 mg darbtejn kuljum (n = 828) jew plaċebo (n = 409) minbarra t-terapiji konvenzjonali (li jinkludu antikoagulanti orali, imblokkaturi tar-riċetturi beta, inibituri ACE jew AIIRAs, sustanzi kontra l-plejtlits għal tul ta' żmien, dijuretiċi, statins, digitalis, u antagonisti tal-calcium).
English: After intravenous administration the plasma clearance of dronedarone ranges from 130 to 150 L/h.
Maltese: Wara t-teħid minn ġol-vini, it-tneħħija mill-plażma ta' dronedarone tvarja minn 130 sa 150 L/siegħa.
English: Repeated doses of erythromycin (500 mg three times a day for 10 days) resulted in an increase in steady state dronedarone exposure of 3.8-fold.
Maltese: Dożi ripetuti ta' erythromycin (500 mg tliet darbiet kuljum għal 10 ijiem) irriżulta f'żieda fl-espożizzjoni ta' dronedarone fl-istat fiss ta' 3.8 darbiet.
English: Interaction with warfarin and losartan (CYP 2C9 substrates) Warfarin and other vitamin K antagonists
Maltese: Interazzjoni ma' warfarin u losartan (sustrati ta' CYP 2C9)
English: In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo.
Maltese: Fil-5 studji kkontrollati bil-plaċebo, 0.6 % tal-pazjenti fil-grupp ta' dronedarone kellhom avvenimenti pulmonarji kontra 0.8 % tal-pazjenti li rċevew plaċebo.
English: • Co-administration with dabigatran
Maltese: • It-teħid flimkien ma' dabigatran
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għallgalactose, in-nuqqas totali ta' lactase jew disturbi fl-assorbiment ta' glucose-galactose, m'għandhomx jieħdu dan il-prodott mediċinali.
English: PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 20 pillola miksija b'rita
English: Lactose is a type of sugar.
Maltese: Lactose huwa tip ta' zokkor.
English: MULTAQ contains lactose
Maltese: MULTAQ fih il-lactose
English: In clinical studies, 13% of patients received calcium antagonists concomitantly with dronedarone.
Maltese: Flistudji kliniċi, 13 % mill-pazjenti rċevew l-antagonisti tal-calcium flimkien ma' dronedarone.
English: There was a weak interaction between dronedarone and statins transported by OATP, such as rosuvastatin (which resulted in a mean 1.4-fold increase in rosuvastatin exposure).
Maltese: Kien hemm interazzjoni dgħajfa bejn dronedarone u statins ittrasportati minn OATP, bħal rosuvastatin (li rriżulta f'żieda medja ta' 1.4 darbiet fl-espożizzjoni ta' rosuvastatin).
English: MULTAQ film-coated tablets are supplied in packs of 20, 50, 60 tablets in opaque PVC and aluminium blisters and 100x1 tablets in opaque PVC and aluminium perforated unit dose blisters.
Maltese: Il-pilloli MULTAQ miksijin b'rita jiġu f'pakketti ta' 20, 50, 60 pillola f'folji opaki tal-PVC u aluminju u ta' 100 x 1 pilloli f'folji opaki mtaqqbin tal-PVC u aluminju u li jagħtu doża waħda.
English: • some tranquilising medicines called phenothiazines,
Maltese: • xi kalmanti msejħa phenothiazines,
English: The effect of severe hepatic impairment on the pharmacokinetics of dronedarone was not assessed (see section 4.3).
Maltese: L-effett ta' indeboliment epatiku sever fuq il-farmakokinetika ta' dronedarone ma ġietx evalwata (ara sezzjoni 4.3).
English: Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below).
Maltese: Waqt it-teħid ta' dronedarone, huwa rrakkomandat li wieħed joqgħod attent ħafna permezz ta' assessjar regolari tal-funzjoni kardijaka, epatika u pulmonarja (ara taħt).
English: If you have had a pacemaker fitted for this problem, you can use MULTAQ, - if you have a very slow heart beat (less than 50 beats a minute), - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds), - if you have a type of atrial fibrillation called permanent atrial fibrillation (AF).
Maltese: Jekk għandek pacemaker minħabba din ilproblema, tista' tuża MULTAQ, - qalbek tħabbat bil-mod ħafna (anqas minn 50 taħbita fil-minuta), - jekk l-ECG (elettrokardjogramma) tiegħek, turi problema fil-qalb imsejħa “intervall QT ikkoreġut imtawwal” (dan l-intervall ikun aktar minn 500 millisekonda), - għandek tip ta' fibrillazzjoni atrijali li tissejjaħ fibrillazzjoni atrijali (FA) permanenti.
English: Therefore, inhibitors and inducers of CYP 3A4 have the potential to interact on dronedarone.
Maltese: Wisq probabbli, inibituri moderati oħra ta' CYP3A4 ukoll iżidu l-espożizzjoni ta' dronedarone.
English: The study was prematurely stopped after randomization of 3,149 patients (placebo = 1,577; dronedarone = 1,572) due to the significant increase in heart failure (placebo = 33; dronedarone = 80; HR = 2.49 (1.66-3.74)]; stroke [placebo = 8; dronedarone = 17; HR = 2.14 (0.92-4.96)] and cardiovascular death [placebo = 6; dronedarone = 15; HR = 2.53 (0.98-6.53)] (see sections 4.3 and 4.4).
Maltese: L-istudju twaqqaf qabel iż-żmien wara li b'mod arbitrarju kien ntagħżlu 3,149 pazjent (plaċebo = 1,577; dronedarone = 1,572) minħabba żżieda sinifikanti fl-insuffiċjenza tal-qalb (plaċebo = 33; dronedarone = 80;
English: Medicinal products inducing torsades de pointes
Maltese: Prodotti mediċinali li jikkawżaw torsades de pointes
English: A clinical study in patients with permanent AF (AF duration for at least 6 months) and cardiovascular risk factors was stopped early due to an excess of cardiovascular death, stroke and heart failure in patients receiving dronedarone (see section 5.1).
Maltese: Studju kliniku f'pazjenti b'FA permanenti (FA li tkun ilha għallinqas 6 xhur) u fatturi ta' riskju kardjovaskulari kellu jitwaqqaf kmieni minħabba numru kbir ta' mwiet kardjovaskulari, puplesiji u insuffiċjenzi kardijaċi f'pazjenti li kienu qed jirċievu dronedarone (ara sezzjoni 5.1).
English: If alanine aminotransferase (ALT) levels are elevated ≥3 × upper limit of normal (ULN), ALT levels should be re-measured within 48 to 72 hours.
Maltese: Jekk il-livelli tal-ALT (alanine aminotransferase) huma għoljin ≥ 3 × l-ogħla limitu tan-normal (ULN), il-livelli tal-ALT għandhom jerġgħu jittieħdu fi żmien 48 sa 72 siegħa.
English: You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around, - if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction), - if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems, - if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and MULTAQ”.
Maltese: Jista' jkollok saqajk jew riġlejk minfuħin, tbati biex tieħu nifs meta tkun mimdud/a jew rieqed/rieqda, jew qtugħ ta' nifs meta tiċċaqlaq minn post għall-ieħor, - il-persentaġġ tad-demm li joħroġ mill-qalb kull darba li tħabbat ikun baxx wisq (kundizzjoni li tissejjaħ disfunzjoni tal-ventriklu tax-xellug) - ħadt l-amiodarone (mediċina antiarritmika oħra) qabel u kellek problemi fil-pulmun jew filfwied - tieħu mediċini għall-infezzjoni (fosthom infezzjoni tal-fungu jew AIDS), allerġiji, problemi fittaħbit tal-qalb, depressjoni, wara trapjant (ara s-sezzjoni ta' hawn taħt “Mediċini oħra u MULTAQ”.
English: Dronedarone 800 mg daily increased metoprolol exposure by 1.6-fold and propranolol exposure by 1.3-fold (i.e. much below the 6-fold differences observed between poor and extensive CYP 2D6 metabolisers).
Maltese: Donedarone 800 mg żied lespożizzjoni ta' metoprolol b'1.6 darbiet u l-espożizzjoni ta' propranolol b'1.3 darbiet (jiġifieri ħafna inqas mis-6 darbiet differenza osservat bejn dawk il-metabolizzanti dgħajfa u dawk estensivi ta' CYP 2D6).
English: Pantoprazole (40 mg once daily), a medicinal product which increases gastric pH without any effect on cytochrome P450, did not interact significantly on dronedarone pharmacokinetics.
Maltese: Pantoprazole (40 mg darba kuljum), prodott mediċinali li jżid il-pH gastriku mingħajr ebda effett fuq iċ-ċitokromu P450, ma kellu ebda interazzjoni sinifikanti fuq il-farmakokinetika ta' dronedarone.
English: Dronedarone is a multichannel blocker inhibiting the potassium currents (including IK(Ach), IKur, IKr, IKs) and thus prolonging cardiac action potential and refractory periods (Class III).
Maltese: Dronedarone huwa mblokkatur ta' ħafna kanali u jinibixxi l-kurrenti ta' potassium (li jinkludu IK (Ach), IKur, IKr, IKs) u għalhekk itawwal l-attività elettrokimika tal-qalb u l-perijodi refrattarji (Klassi
English: A total of 504 patients with documented AF were randomised, 249 received dronedarone and 255 received amiodarone.
Maltese: Minn total ta' 504 pazjenti b'FA dokumentat, 249 ġew magħżula b'mod arbitrarju biex jirċievu dronedarone u 255 biex jirċievu amiodarone.
English: Dronedarone is contraindicated in patients with severe hepatic impairment because of the absence of data (see sections 4.3 and 4.4).
Maltese: Dronedarone huwa kontraindikat f'pazjenti b'indeboliment epatiku sever minħabba n-nuqqas ta' dejta (ara sezzjonijiet 4.3 u 4.4).
English: After intravenous administration the volume of distribution at steady state (Vss) ranges from 1,200 to 1,400 L.
Maltese: Wara tteħid minn ġol-vini, il-volum ta' distribuzzjoni fl-istat fiss ivarja minn 1,200 sa 1,400 L.
English: The pharmacokinetics of dronedarone and its N-debutyl metabolite both deviate moderately from dose proportionality: a 2-fold increase in dose results in an approximate 2.5- to 3.0-fold increase with respect to Cmax and AUC.
Maltese: Il-farmakokinetika ta' kemm dronedarone u kemm tal-metabolit tiegħu N-debutyl tvarja b'mod moderat mill-proporzjonalità fid-doża: żieda doppja fid-doża tirriżulta f'kważi żieda ta' 2.5 sa 3.0-darbiet f'dak li għandu x'jaqsam Cmax u AUC.
English: Blood creatinine increased* QTc Bazett prolonged # * ≥10% five days after treatment initiation (see section 4.4) # >450 msec in male >470 msec in female (see section 4.4) Description of selected adverse reactions
Maltese: * ≥10% ħamest ijiem wara li tinbeda l-kura (ara sezzjoni 4.4) # >450 msec fl-irġiel >470 msec fin-nisa (ara sezzjoni 4.4)
English: The most frequent adverse reactions observed with dronedarone 400 mg twice daily in the 5 studies were diarrhoea (9%), nausea (5%) and vomiting (2%), fatigue and asthenia (7%).
Maltese: Fil-5 studji, l-aktar reazzjonijiet avversi frekwenti li ġew osservati b'dronedarone 400 mg darbtejn kuljum kienu dijarea (9%), dardir (5%) u rimettar (2%), għeja u astenja (7%).
English: The safety profile of dronedarone 400 mg twice daily in patients with atrial fibrillation (AF) or atrial flutter (AFL) is based on 5 placebo controlled studies, in which a total of 6,285 patients were randomised (3,282 patients received dronedarone 400 mg twice daily, and 2,875 received placebo).
Maltese: Il-profil ta' sigurtà ta' dronedarone 400 mg darbtejn kuljum f'pazjenti b'fibrillazzjoni atrijali (FA) jew b'tferfir atrijali (TA) huwa bbażat fuq 5 studji kkontrollati bil-plaċebo, fejn total ta' 6285 pazjent ġew magħżula b'mod arbitrarju biex jieħdu jew dronedarone 400 mg darbtejn kuljum (3282 pazjent) jew plaċebo (2875 pazjent).
English: It is recommended to perform ECGs serially, at least every 6 months.
Maltese: Huwa rrakkomandat li jsiru ECG's b'mod regolari, għallinqas kull 6 xhur.
English: 100x1 film-coated tablets
Maltese: 100 x 1 pilloli miksijin b'rita
English: • dabigatran (a medicine for prevention of blood clot formation).
Maltese: • dabigatrin (mediċina għall-prevenzjoni ta' formazzjoni ta' ċapep fid-demm).
English: MULTAQ 400 mg film-coated tablets dronedarone
Maltese: MULTAQ 400 mg pilloli dronedarone ISEM
English: The most common reasons for discontinuation of therapy with dronedarone were gastrointestinal disorders (3.2% of patients versus 1.8% in the placebo group).
Maltese: (3.2 % tal-pazjenti kontra 1.8 % fil-grupp tal-plaċebo).
English: Grapefruit juice (CYP 3A4 inhibitor)
Maltese: Il-Meraq tal-grejpfrut (inibitur ta' CYP 3A4)
English: Gender
Maltese: Femminili
English: Dronedarone does not affect the pharmacokinetics of omeprazole, a CYP 2C19 substrate.
Maltese: Dronedarone m'għandux effett fuq il-farmakokinetika ta' omeprazole, sustrat ta' CYP 2C19
English: In the 5 placebo controlled studies, CHF occurred in the dronedarone group with rates comparable with placebo (very commonly, 11.2% versus 10.9%).
Maltese: Fil-5 studji kkontrollati bil-plaċebo, CHF seħħ b'rati li huma komparabbli bejn il-grupp ta' dronedarone u dak ta' plaċebo (b'mod komuni ħafna, 11.2% kontra 10.9%).
English: Other antiarrhythmic medicinal products had to be withdrawn for at least 5 plasma half-lives prior to the first administration.
Maltese: Prodotti mediċinali antiarritmiċi oħra kellhom jitwaqqfu minn għallinqas 5 plażma half-lives qabel ma tingħata l-ewwel doża.
English: However due to presystemic first pass metabolism, the absolute bioavailability of dronedarone (given with food) is 15%.
Maltese: Iżda minħabba l-ewwel passaġġ presistemiku ta' metaboliżmu, il-bijodisponibilità assoluta ta' dronedarone (mal-ikel) hi ta' 15 %.
English: CYP 3A4 inducers
Maltese: Indutturi ta' CYP 3A4
English: The study was stopped prematurely due to an observed imbalance of deaths in the dronedarone group [n = 25 versus 12 (placebo), p = 0.027] (see sections 4.3 and 4.4).
Maltese: L-istudju twaqqaf qabel iżżmien minħabba li ġie osservat żbilanċ fl-imwiet fil-grupp ta' dronedarone [n = 25 kontra 12 (plaċebo), p = 0.027] (ara sezzjonijiet 4.3 u 4.4).
English: Dronedarone has, therefore, the potential to interact on medicinal products substrates of P-glycoproteins, CYP 3A4 or CYP 2D6.
Maltese: Għalhekk, dronedarone, għandu l-potenzjal li jkollu interazzjoni ma' prodotti mediċinali li huma sustrati tal-glikoproteini-P, CYP 3A4 jew CYP 2D6.
English: • other medicines for high blood pressure, for chest pain caused by heart disease, or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin,
Maltese: • mediċini oħra għall-pressjoni għolja, għall-uġigħ fis-sider ikkawżat minn mard tal-qalb, jew problemi oħra fil-qalb, bħal verapamil, diltiazem, nifedipine, metoprolol, propranolol jew digoxin,
English: Also contains: lactose.
Maltese: TA' EĊĊIPJENTI Fih ukoll: lactose.
English: Rifampicin (600 mg once daily) decreased dronedarone exposure by 80% with no major change on its active metabolite exposure.
Maltese: Rifampicin (600 mg darba kuljum) naqqas l-espożizzjoni ta' dronedarone b'80% mingħajr ebda tibdil kbir fuq l-espożizzjoni tal-metabolit attiv tiegħu.
English: Of the total number of subjects in clinical studies of dronedarone, 73% were 65 years of age and over and 34% were 75 years of age and over.
Maltese: Mit-total tas-suġġetti fl-istudji kliniċi ta' dronedarone, 73 % kellhom 65 sena jew iżjed u 34 % kellhom 75 sena jew iżjed.
English: In an in vitro study MAO contributed to the metabolism of the active metabolite of dronedarone.
Maltese: F'studju in vitro, MAO kellhom effett fuq il-metaboliżmu tal-metabolit attiv ta' dronedarone.
English: Electrolytes imbalance
Maltese: Żbilanċ fl-elettroliti
English: Dronedarone reduced the incidence of cardiovascular hospitalisation or death from any cause by 24.2% when compared to placebo (p<0.0001).
Maltese: Dronedarone naqqas l-inċidenza li jkollok tmur l-isptar minħabba xi mard kardjovaskulari jew mewt minn kwalunkwe kawża b'24.2 % meta mqabbel ma' plaċebo (p<0.0001).
English: Liver function tests should be performed prior to initiation of treatment with dronedarone, after one week and after one month following initiation of treatment and then repeated monthly for six months, at months 9 and 12, and periodically thereafter.
Maltese: Għandhom isiru testijiet tal-funzjoni tal-fwied qabel ma tinbeda l-kura b'dronedarone, wara ġimgħa, wara xahar li jinbeda t-trattament u mbagħad ripetuti kull xahar għal 6 xhur, fid-9 u fit-12-il xahar u mbagħad kull tant żmien.
English: The digoxin dose should be reduced by approximately 50%, serum levels of digoxin should be closely monitored and clinical and ECG monitoring is recommended.
Maltese: Id-doża ta' digoxin għandha titnaqqas bi kważi 50 %, il-livelli ta' digoxin fis-serum għandhom jiġu mmonitorjati sew u huwa rrakkomandat il-monitoraġġ kliniku u tal-ECG.
English: The pharmacological action of dronedarone may induce a moderate QTc Bazett prolongation (about 10 msec), related to prolonged repolarisation.
Maltese: L-azzjoni farmakoloġika ta' dronedarone tista' tikkawża żieda moderata fil-QTc Bazett (xi 10 msek), minħabba ħin itwal biex issir polarizzazzjoni mill-ġdid.
English: The reduction in cardiovascular hospitalisation or death from any cause was consistent in all subgroups, irrespective of baseline characteristics or medicinal products (ACE inhibitors or AIIRAs; beta-blockers, digitalis, statins, calcium antagonists, diuretics) (see figure 1).
Maltese: It-tnaqqis kemm fil-bżonn li tmur l-isptar minħabba mard kardjovaskulari u kemm f'mewt minn kwalunkwe kawża kien konsistenti fis-sottogruppi kollha, irrispettivament mill-karatteristiċi fil-linja bażi jew mill-prodotti mediċinali (inibituri ACE jew AIIRAs; beta blokkanti, diġitalis, statins, antagonisti tal-kalċju, dijuretiċi) (ara figura 1).
English: In chronic toxicity studies, slight and reversible phospholipidosis (accumulation of foamy macrophages) was observed in mesenteric lymph nodes mainly in the rat.
Maltese: F'studji kroniċi ta' tossiċità, ġiet osservata fosfolipidożi ( ġabra ta' makrofaġi li jkunu mimlija billipidi ragħwin) fin-nodi limfatiċi mesenteriċi, l-iżjed fil-firien.
English: In clinical studies, bradycardia was more frequently observed when dronedarone was given in combination with beta-blockers.
Maltese: F'studji kliniċi, bradikardija ġiet osservata b'mod aktar frekwenti meta dronedarone ingħata flimkien mal-imblokkaturi tar-riċetturi beta
English: There is limited information on the optimal timing to switch from amiodarone to dronedarone.
Maltese: M'hemmx biżżejjed informazzjoni dwar l-aħjar żmien biex taqleb minn amiodarone għal dronedarone.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: The clinical relevance of this observation is not known (see sections 4.4 and 5.2).
Maltese: Irrilevanza klinika ta' din l-osservazzjoni mhijiex magħrufa (ara sezzjonijiet 4.4 u 5.2).
English: It non-competitively antagonises adrenergic activities (Class II).
Maltese: B'mod mhux kompetittiv jantagonizza l-attivitajiet adrinerġiċi (Klassi
English: The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study.
Maltese: L-effikaċja ta' dronedarone fit-tnaqqis tar-riskju li jkollok tmur l-isptar minħabba FA ġiet murija f'pazjenti b'FA jew b'passat mediku ta' FA u fatturi ta' riskju addizzjonali fl-istudju ATHENA magħmul b'mod arbitrarju, ikkontrollat bil-plaċebo u double-blind u li sar f'ħafna ċentri u f'pajjiżi differenti.