FrancophonIA/ELRC3.0 huggingface dataset:
English: Heart Failure (including use in patients with unstable hemodynamic conditions with history of, or current heart failure or left ventricular systolic dysfunction, and pre-renal azotemia) Use in Permanent atrial fibrillation defined as an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician Pulmonary-interstitial lung disease (ILD)
Maltese: • Jiċċekkja l-pazjenti qabel ma jibda t-trattament - Il-kontra-indikazzjoni ta' Fibrillazzjoni Atrijali permanenti - Il-kontra-indikazzjoni ta' passat mediku jew kurrenti ta' insuffiċjenza tal-qalb jew li tkun kurrenti jew disfunzjoni sistolika tal-ventriklu tax-xellug (LVSD) - Il-prevenzjoni ta' interazzjoni bejn mediċina u mediċina - L-użu sikur fil-fwied, fil-pulmun u fil-kliewi.
English: Therefore, concomitant use of ketoconazole as well as other potent CYP 3A4 inhibitors such as itraconazole, voriconazole, pozaconazole, ritonavir, telithromycin, clarithromycin or nefazodone is contraindicated (see section 4.3).
Maltese: Għalhekk l-użu fl-istess ħin ta' ketoconazole kif ukoll inibituri qawwijin oħra ta' CYP 3A4 bħal itraconazole, voriconazole, pozaconazole, ritonavir, telithromycin, clarithromycin jew nefazodone huwa kontra-indikat (ara sezzjoni 4.3).
English: The incidence of the primary efficacy endpoint defined as first recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy at 12 months was 75% in the dronedarone group and 59% in the amiodarone group (hazard ratio = 1.59, log-rank p-value <0.0001).
Maltese: L-inċidenza tal-għan ewlieni ta' effikaċja ddefinit bħal l-ewwel rikorrenza ta' FA jew it-twaqqif qabel iż-żmien tal-mediċina taħt studju minħabba li ma ġietx ittollerata tajjeb jew minħabba n-nuqqas ta' effikaċja wara 12-il xahar kien ta' 75 % fil-grupp ta' dronedarone u ta' 59 % fil-grupp ta' amiodarone (hazard ratio=1.59, log-rank p-value <0.
English: There was a weak interaction between dronedarone and atorvastatin (which resulted in a mean 1.7-fold increase in atorvastatin exposure).
Maltese: Kien hemm interazzjoni dgħajfa bejn dronedarone u atorvastatin ( li rriżulta f'żieda medja ta' 1.7 darbiet flespożizzjoni ta' atorvastatin).
English: Children and adolescents MULTAQ is not recommended in children and adolescents below 18 years of age.
Maltese: Tfal u adolexxenti MULTAQ mhuwiex irrakkomandat fit-tfal u fl-adolexxenti taħt it-18-il sena.
English: MULTAQ prevents repetition of your problem of irregular heart rhythm.
Maltese: MULTAQ jipprevjeni ripetizzjoni tal-problema tiegħek ta' ritmu irregolari tal-qalb.
English: Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
Maltese: Kull pillola fiha 400 mg ta' dronedarone (bħala hydrochloride).
English: Repeated doses of 300 ml of grapefruit juice three times daily resulted in a 3-fold increase in dronedarone exposure.
Maltese: Dożi ripetuti ta' 300 ml ta' meraq tal-grejpfrut tliet darbiet kuljum irriżulta f'żieda ta' 3 darbiet flespożizzjoni ta' dronedarone.
English: In such cases dronedarone should be stopped (see sections 4.3 and 4.4).
Maltese: F'dawn il-każijiet dronedarone għandu jitwaqqaf (ara sezzjonijiet 4.3 u 4.4).
English: • Liver problems including life threatening liver failure.
Maltese: • Dijarea, rimettar meta jkunu eċċessivi għax jistgħu jwaslu għal problemi fil-kliewi.
English: Other medicines and MULTAQ
Maltese: Kif taħżen MULTAQ
English: Interaction with medicinal products metabolized by CYP 3A4 Dabigatran
Maltese: Interazzjoni ma' prodotti mediċinali mmetabolizzati minn CYP 3A4
English: Renal impairment is not expected to modify the pharmacokinetics of dronedarone because no unchanged compound was excreted in urine and only approximately 6% of the dose was excreted in urine as metabolites (see section 4.2).
Maltese: L-indeboliment renali mhux mistenni li jbiddel il-farmakokinetika ta' dronedarone minħabba li fl-awrina ma tiġix imneħħija s-sustanza oriġinali u kwazi 6 % tad-doża biss tiġi mneħħija bħala metaboliti (ara sezzjoni 4.2).
English: It increases effective refractory periods (ERP) of the atrium, atrio-ventricular node, and ventricular ERP was slightly prolonged with a minimal degree of reverse frequency dependency.
Maltese: Iżid il-perijodi refrattarji effettivi (PRE) talatriju, tan-nodu atrijo-ventrikulari u l-PRE ventrikulari ġie miżjud bi ftit b'kemm kemm ta' dipendenza fuq il-frekwenza inversa.
English: In female patients, dronedarone exposures and its N-debutyl metabolite exposure are on average 1.3- to 1.9-fold higher as compared to male patients.
Maltese: F'pazjenti nisa, bħala medja, l-espożizzjonijiet ta' dronedarone u l-metabolit tiegħu N-debutyl huma 1.3 sa 1.9 darbiet ogħla meta mqabbla mal-pazjenti irġiel.
English: No interaction was observed between dronedarone and losartan and an interaction between dronedarone and other AIIRAs is not expected.
Maltese: Ebda interazzjoni ma ġiet osservata bejn dronedarone u losartan u mhux mistenni li jkun hemm interazzjoni bejn dronedarone u AIIRAs oħra.
English: Sotalol must be stopped before starting dronedarone (see sections 4.2 and 4.3).
Maltese: Sotalol irid jitwaqqaf qabel ma jinbeda dronedarone (ara sezzjonijiet 4.2 u 4.3).
English: itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir (see section 4.5)
Maltese: • It-teħid flimkien ma' inibituri qawwijin taċ-ċitokromu P 450 (CYP) 3A4 bħal ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone u ritonavir (ara sezzjoni 4.5)
English: Erythromycin, an oral macrolide, may induce torsades de pointes and, as such, is contraindicated (see section 4.3).
Maltese: Erythromycin, makrolidu orali, jista' jikkawża torsades de pointes u minħabba f'hekk huwa kontraindikat (ara sezzjoni 4.3).
English: The pharmacokinetics of dronedarone in patients with AF is consistent with that in healthy subjects.
Maltese: Il-farmakokinetika ta' dronedarone f'pazjenti b'FA hija konsistenti ma' dik f'suġġetti b'saħħithom.
English: a Determined from Cox regression model b P-value of interaction between baseline characteristics and treatment based on Cox regression model c Calcium antagonists with heart rate lowering effects restricted to diltiazem, verapamil and bepridil
Maltese: DronedaroneA]jar Placebo A]jar a Iddeterminat mill-mudell ta' rigressjoni Cox b Il-valur P ta' interazzjoni bejn il-karatteristiċi fil-linja bażi u l-kura bbażata fuq il-mudell ta' rigressjoni Cox c Antagonisti tal-kalċju b'effetti li jbaxxu r-rata ta' tħabbit tal-qalb limitati għal diltiazem, verapamil u bepridil
English: Effect of other medicinal products on dronedarone
Maltese: L-effett ta' prodotti mediċinali oħra fuq dronedarone
English: No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives.
Maltese: Ma ġie osservat ebda tnaqqis f'ethinylestradiol u levonorgestrel f'suġġetti b'saħħithom li kienu qed jirċievu dronedarone (800 mg darbtejn kuljum) flimkien ma' kontraċettivi orali.
English: Other moderate/weak CYP 3A4 Inhibitors
Maltese: Inibituri moderati/dgħajfa oħra ta' CYP 3A4
English: This metabolite contributes to the pharmacological activity of dronedarone in humans.
Maltese: Fl-umani, dan il-metabolit għandu sehem fl-attività farmakoloġika ta' dronedarone.
English: Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved (see section 4.4).
Maltese: Hija rrakkomandata sorveljanza klinika, tal-ECG u bijoloġika, u d-doża ta' digoxin għandha titnaqqas bin-nofs (ara sezzjoni 4.4)
English: • changes in your ECG (electrocardiogram) called QTc Bazett prolonged.
Maltese: • tibdil fl-ECG (elettrokardjogramma) tiegħek li tissejjaħ QTc Bazett imtawwal,
English: Overall, due to the pharmacokinetic interaction and possible pharmacodynamic interaction, calcium antagonists with depressant effects on sinus and atrio-ventricular node such as verapamil and diltiazem should be used with caution when associated with dronedarone.
Maltese: Fuq kollox, minħabba l-interazzjoni farmakokinetika u l-possibbiltà ta' interazzjoni farmakodinamika, lantagonisti tal-kalċju, b'effetti dipressivi fuq in-nodu sinoatrijali u atrijo-ventrikulari bħal verapamil u diltiazem, għandhom jintużaw b'kawtela meta jkunu assoċjati ma' dronedarone.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk.
Maltese: Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' dronedarone u l-metaboliti tiegħu fil-ħalib tas-sider.
English: • Inflammation of the lungs (including scarring and thickening of the lungs).
Maltese: • Infjammazzjoni tal-pulmun ( fosthom li l-pulmuni jiħxienu u jrabbu qoxra).
English: Beta-blockers that are metabolised by CYP 2D6 can have their exposure increased by dronedarone.
Maltese: Imblokkaturi tarriċetturi beta li huma mmetabolizzati minn CYP 2D6 jista' jkollhom l-espożizzjoni tagħhom miżjuda minn dronedarone.
English: If a switch is envisaged, this should be done under the supervision of a specialist (see sections 4.3 and 5.1).
Maltese: Jekk tkun se ssir xi bidla, din għandha ssir taħt is-superviżjoni ta' speċjalista (ara sezzjonijiet 4.3 u 5.1).
English: Figure 1 - Relative risk (dronedarone 400 mg twice daily versus placebo) - first cardiovascular hospitalisation or death from any cause.
Maltese: Figura 1 -Riskju relattiv (dronedarone 400 mg darbtejn kuljum kontra plaċebo) - żmien salewwel bżonn ta' sptar minħabba mard kardjovaskulari jew mewt minn kwalunkwe kawża.
English: Patients ranged in age from 20 to 88 years, with the majority being Caucasian (97%), male (69%) patients.
Maltese: L-età tal-pazjenti kienet tvarja minn 20 sa 88 sena, bil-parti l-kbira jkunu pazjenti Kawkasi (97 %), irġiel (69 %).
English: • Your doctor may look at your heart's electrical activity using an ECG (electrocardiogram)
Maltese: • It-tabib tiegħek jista' josserva l-attività elettrika ta' qalbek permezz ta' ECG (elettrokardjogramma).
English: White, oblong shaped tablets, engraved with a double wave marking on one side and “4142”code on the other side.
Maltese: Pilloli bojod b'forma oblunga, fuq naħa waħda mnaqqxa b'disinn ta' mewġa doppja u fuq in-naħa loħra bil-kodiċi “4142”.
English: Potent CYP3A4 inducers
Maltese: Indutturi qawwija ta' CYP3A4
English: Ageusia
Maltese: Anzjani
English: MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF).
Maltese: MULTAQ hu indikat għall-manteniment tar-ritmu tas-sinus wara li tirnexxi konverżjoni tar-ritmu kardijaku f'pazjenti adulti klinikament stabbli li kellhom attakk paroximali jew persistenti ta' fibrillazzjoni atrijali (FA).
English: Calcium antagonists also have their exposure increased by dronedarone (400 mg twice daily) (verapamil by 1.4-fold, and nisoldipine by 1.5-fold).
Maltese: L-antagonisti tal-kalċju wkoll kellhom l-espożizzjoni tagħhom miżjud minħabba dronedarone (400 mg darbtejn kuljum) (verapamil b'1.4-, darbiet u nisodipine b'1.5-, darbiet).
English: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known).
Maltese: Mard interstizjali tal-pulmun fosthom pnewmonite u fibrożi pulmunarja (ara taħt)
English: Moderate/weak CYP 3A4 inhibitors
Maltese: Inibituri moderati/dgħajfa ta' CYP 3A4 Erythromycin
English: In clinical studies, increased levels of digitalis and/or gastrointestinal disorders indicating digitalis toxicity were observed when dronedarone was co-administered with digitalis.
Maltese: Fi studji kliniċi, livelli aktar għolja ta' diġitalis u/jew disturbi gastrointestinali li jindikaw tossiċità b'diġitalis ġew osservati meta dronedarone ġie mogħti flimkien ma' digitalis.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In animals, dronedarone prevents atrial fibrillation or restores normal sinus rhythm depending on the model used.
Maltese: Fl-annimali, dronedarone jimpedixxi l-fibrillazzjoni atrijali jew jerga' jġib għan-normal ir-ritmu sinoatrijali skont il-mudell użat.
English: • Permanent AF with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician
Maltese: • FA permanenti b'FA li ddum ≥ 6 xhur (jew dewmien mhux magħruf) u mhux ikkunsidrati aktar tentattivi mill-ispeċjalista biex jerġa' jġib lura r-ritmu sinoatrijali
English: The recommended dose is 400 mg twice daily in adults.
Maltese: Id-doża rakkomandata hi ta' 400 mg darbtejn kuljum fl-adulti.
English: • skin problems such as rash or itching,
Maltese: • problemi fil-ġilda bħal raxx jew ħakk,
English: Dysgeusia
Maltese: L-Ungerija
English: Elderly
Maltese: Dabigatran
English: No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment moderat jew ħafif (ara sezzjoni 5.2).
English: In patients ≥75years old, clinical signs of heart failure and ECG should be monitored on a regular basis when co-morbidities are present (see sections 4.3, 4.4 and 5.1).
Maltese: F'pazjenti ≥75 sena, is-sinjali kliniċi ta' insuffiċjenza tal-qalb u l-ECG għandhom jiġu sorveljati fuq bażi regolari meta jkollhom mard ieħor fl-istess ħin (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: EU/1/09/591/001 - cartons of 20 film-coated tablets EU/1/09/591/002 - cartons of 50 film-coated tablets EU/1/09/591/003 - cartons of 60 film-coated tablets EU/1/09/591/004 - cartons of 100 x 1 film-coated tablets
Maltese: EU/1/09/591/002 - kaxex ta' 50 pillola miksija b'rita.
English: • inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).
Maltese: • infjammazzjoni tal-vini u tal-arterji (vaskulite fosthom vaskulite lewkoċitoklastika).
English: Vasculitis, including leukocytoclastic vasculitis
Maltese: Dan il-prodott mediċinali fih il-lactose.
English: Due to its safety profile (see sections 4.3 and 4.4), MULTAQ should only be prescribed after alternative treatment options have been considered.
Maltese: Minħabba l-profil tas-sigurtà tiegħu (ara sezzjonijiet 4.3 u 4.4), Multaq għandu jiġi ordnat biss wara li ġew ikkunsidrati għażliet alternattivi ta' kura.
English: Monitoring of co-administered medicinal products like digoxin and anti-coagulants is necessary.
Maltese: Ikun hemm bżonn ta' monitoraġġ meta jittieħdu fl-istess żmien prodotti mediċinali bħal digoxin u anti-koagulanti.
English: An increase in plasma creatinine (mean increase 10 μmol/L) has been observed with dronedarone 400 mg twice daily in healthy subjects and in patients.
Maltese: Ġiet osservata żieda fil-livell tal-kreatinina fil-plażma (żieda medja ta' 10 µmol/L) b'dronedarone 400 mg darbtejn kuljum f'suġġetti b'saħħithom u f'pazjenti.
English: In patients aged 65 years of age and over, dronedarone exposures are 23% higher in comparison with patients aged below 65 years of age.
Maltese: F'pazjenti li kellhom 65 sena jew iżjed, l-espożizzjonijiet ta' dronedarone kienu 23 % ogħla meta mqabbla ma' pazjenti li kellhom inqas minn 65 sena.
English: The incidence of the main safety endpoint defined as the occurrence of thyroid, hepatic, pulmonary, neurological, skin, eye or gastrointestinal specific events or premature study drug discontinuation following any adverse event was reduced by 20% in the dronedarone group compared to the amiodarone group (p = 0.129).
Maltese: Il-frekwenza tal-għan ewlieni tas-sigurtà ddefinit bħala l-inċidenza ta' ġrajjiet speċifiċi tat-tirojde, epatiċi, pulmunarji, newroloġiċi, tal-ġilda, tal-għajnejn jew gastrointestinali jew it-twaqqif qabel iż-żmien tal-mediċina taħt studju minħabba xi avveniment avvers tnaqqas b'20 % fil-grupp ta' dronedarone meta mqabbel mal-grupp ta' amiodarone (p = 0.129).
English: Based on clinical experience, dronedarone has a low pro-arrhythmic effect and has shown a decrease in arrhythmic death in the ATHENA study (see section 5.1).
Maltese: Ibbażat fuq l-esperjenza klinika, dronedarone għandu effett pro-arritmiku baxx u fl-istudju ATHENA wera tnaqqis fil-mewt kawża ta' arritmija (ara sezzjoni 5.1).
English: Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting.
Maltese: Mill-esperjenza wara li l-prodott tqiegħed fis-suq, ġew irrapportati każijiet ta' mard interstizjali talpulmun fosthom pnewmonite u fibrożi pulmunarja.
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg tablets dronedarone
Maltese: MULTAQ 400 mg pilloli miksijin b'rita dronedarone
English: The following side effects have been reported with this medicine:
Maltese: Il-mediċini li ġejjin ma jistawx jittieħdu ma' MULTAQ:
English: QT prolongation
Maltese: Żieda fil-QT
English: MULTAQ is used only in adults.
Maltese: MULTAQ jintuża biss fl-adulti.
English: Dronedarone 400 mg twice daily does not increase the steady state theophylline exposure.
Maltese: Dronedarone 400 mg darbtejn kuljum ma jżidx l-espożizzjoni ta' theophylline fl-istat fiss.
English: The interaction of dronedarone on calcium antagonists is described above (see section 4.4).
Maltese: L-interazzjoni ta' dronedarone fuq l-antagonisti tal-kalċju ġie deskritt aktar 'il fuq (ara sezzjoni 4.4).
English: Moreover, due to their heart rate-lowering properties, verapamil and diltiazem have the potential to interact with dronedarone from a pharmacodynamic point of view.
Maltese: Barra minn hekk, diġitalis għandu l-potenzjal li jkollu interazzjoni ma' dronedarone mil-lat farmakodinamiku.
English: Observations were increased incidence of mammary gland tumors in female mice, histiocytic sarcomas in mice and hemangiomas at the mesenteric lymph node level in rats, all at the highest tested dose only (corresponding to an exposure of 5 to 10 times that of the human therapeutic dose).
Maltese: L-osservazzjonijiet kienu- żieda fl-inċidenza ta' tumuri fil-glandola mammarja fil-ġrieden nisa, sarkomas istjosistiċi fil-ġrieden u emanġjomas fil-livell tan-nodu limfatiku mesenteriku fil-firien u dawn kollha biss fl-ogħla doża ttestjata (li tikkorrispondi ma' espożizzjoni ta' 5 sa 10 darbiet id-doża terapewtika fl-umani).
English: Hepatobiliary
Maltese: FARMAĊEWTIKU
English: Patients were to have at least one risk factor (including age, hypertension, diabetes, prior cerebrovascular accident, left atrium diameter ≥50 mm or LVEF <0.40) together with AF/AFL and sinus rhythm both documented within the last 6 months.
Maltese: Il-pazjenti ried ikollhom għallinqas fattur wieħed ta' riskju (li jinkludi l-età, l-ipertensjoni, id-dijabete, inċident ċerebro-vaskulari preċedenti, dijametru tal-atriju tax-xellug ≥ 50 mm jew LVEF < 0.40) flimkien ma' FA/TA u ritmu sinoatrijali, it-tnejn li huma ddokumentati fl-aħħar 6 xhur.
English: Dronedarone has vasodilatory properties, in coronary arteries (related to the activation of the nitric oxide pathway) and in peripheral arteries.
Maltese: Dronedarone għandu karatteristiċi vasodilatatorji, fl-arterji tal-qalb (permezz tal-attivazzjoni talpassaġġ metaboliku ta' nitric oxide) u fl-arterji periferiċi.
English: It is predicted that dronedarone could also increase the exposure of lovastatin within the same range as simvastatin acid.
Maltese: Huwa maħsub li dronedarone jista' wkoll iżid lespożizzjonijiet ta' lovastatin u atorvastatin bl-istess ammont tal-aċidu simvastatin.
English: Dronedarone does not affect the pharmacokinetics of clopidogrel and its active metabolite.
Maltese: Dronedarone m'għandux effett fuq il-farmakokinetika ta' clopidogrel u l-metaboliti attivi tiegħu.
English: In patients with coronary artery disease, clinical signs of heart failure and ECG should be regularly monitored to detect early signs of heart failure.
Maltese: F'pazjenti b'mard koronarju arterjali, sinjali kliniċi ta' insuffiċjenza tal-qalb u l-ECG għandhom jiġu sorveljati b'mod regolari biex jiġu nnutati sinjali bikrija ta'ta' insuffiċjenza tal-qalb.
English: Adverse reactions are presented by system organ class.
Maltese: Ir-reazzjonijiet avversi huma mniżżla skont is-sistema tal-klassifika tal-organi.
English: quinidine, disopyramide, dofetilide, sotalol, amiodarone,
Maltese: • mediċini oħra li jintużaw biex jikkontrollaw taħbit tal-qalb irregolari jew mgħaġġel bħal flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
English: In 2-year oral carcinogenicity studies, the highest dronedarone dose administered for 24 months was 70 mg/kg/day in rats and 300 mg/kg/day in mice.
Maltese: F'studji ta' karċinogeniċità li damu sentejn u fejn dronedarone ttieħed b'mod orali, l-ogħla doża ta' dronedarone li ngħatat għal 24 xahar kienet ta' 70 mg/kg/jum fil-firien u ta' 300 mg/kg/jum filġrieden.
English: Following oral administration in fed condition, dronedarone is well absorbed (at least 70%).
Maltese: Dronedarone jiġi assorbit tajjeb (għallinqas 70 %) wara t-teħid b'mod orali wara li wieħed ikun kiel.
English: • problems with your digestive system such as indigestion, diarrhoea, nausea, vomiting and stomach pain,
Maltese: • problemi bis-sistema diġestiva bħal indiġestjoni, dijarea, tqalligħ, rimettar u uġigħ fl-istonku,
English: In ESC and ACC/AHA/HRS guidelines dronedarone has a class IA recommendation in patients with paroxysmal/persistent AF and coronary artery disease.
Maltese: Aqra sew dan il-fuljett kollu qabel tibda tieħu din il-mediċina peress li fih informazzjoni importanti għalik.
English: Due to the pharmacokinetic interaction and possible pharmacodynamic interaction, beta-blockers should be used with caution concomitantly with dronedarone.
Maltese: Minħabba l-interazzjoni farmakokinetika u l-possibbiltà ta' interazzjoni farmakodinamika, l-użu flimkien ta' dronedarone u l-imblokkaturi tar-riċetturi beta għandu jsir b'kawtela.
English: It prolongs Wenckebach cycle length and AH-, PQ-, QT- intervals; with no marked effect or weak increase on QTc-intervals, and with no change in HV- and QRS- intervals.
Maltese: Itawwal iċ-ċiklu ta' Wenckebach u l-intervalli -AH, -PQ, -QT; mingħajr ebda effett sinifikanti jew żieda żgħira flintervalli-QTc u mingħajr tibdil fl-intervalli-HV u -QRS.
English: In ATHENA study, the maximum follow-up was 30 months.
Maltese: Fl-istudju ATHENA, l-aktar żmien kemm pazjent dam għat-tieni viżta kien ta' 30 xahar.
English: • tell your doctor immediately if you develop any of these signs and symptoms of liver problems: stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching,
Maltese: • b'mod immedjat għid lit-tabib tiegħek jekk jiżviluppawlek xi sinjali jew sintomi ta' problemi filfwied: uġigħ jew dwejjaq madwar l-istonku (addominali), nuqqas ta' aptit, dardir, rimettar, il-ġilda jew l-abjad tal-għajnejn jisfaru (suffejra), l-awrina b'mod mhux normali tkun skura, għeja ( speċjalment flimkien mas-sintomi l-oħra mniżżla hawn fuq), ħakk.
English: Dronedarone is contraindicated in patients in unstable hemodynamic conditions, with history of, or current heart failure or left ventricular systolic dysfunction (see section 4.3).
Maltese: Dronedarone huwa kontraindikat f'pazjenti b'kundizzjonijiet emodinamiċi li mhumiex stabbli, b'insuffiċjenza tal-qalb kurrenti jew preċedenti jew b'disfunzjoni sistolika tal-ventriklu tax-xellug.(ara sezzjoni4.3).
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq sanofi-aventis groupe