natgillin/translations-raw huggingface dataset:
Vasculitis, including leukocytoclastic vasculitis
uključujući leukocitoklastični vaskulitis
• problems with your digestive system such as indigestion, diarrhoea, nausea, vomiting and stomach pain,
• problemi s probavnim sustavom, kao što su probavne smetnje, proljev, mučnina, povraćanje i bolovi u želucu,
Patients ranged in age from 27 to 96 years, 68% were more than 65 years old.
Dob bolesnika se kretala u rasponu od 27 do 96 godina, 68% ih je bilo starije od 65 godina.
In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
U bolesnika s umjerenim oštećenjem jetrene funkcije izloženost nevezanom dronedaronu je dvostruko viša.
In clinical studies, premature discontinuation due to adverse reactions occurred in 11.8% of the dronedarone-treated patients and in 7.7% in the placebo-treated group.
U kliničkim je ispitivanjima do prijevremenog prekida liječenja zbog nuspojava došlo u 11,8% bolesnika liječenih dronedaronom te u 7,7% bolesnika koji su primali placebo.
In clinical studies, increased levels of digitalis and/or gastrointestinal disorders indicating digitalis toxicity were observed when dronedarone was co-administered with digitalis.
U kliničkim su ispitivanjima kod istodobne primjene dronedarona i digitalisa primijećene povišene koncentracije digitalisa i/ili gastrointestinalni poremećaji koji upućuju na toksičnost digitalisa.
Lower starting dose and maintenance doses of statins should be considered according to the statin label recommendations and patients monitored for clinical signs of muscular toxicity (see section 4.4).
Treba razmotriti nižu početnu dozu i niže doze održavanja statina u skladu s preporukama za doziranje pojedinog statina, a bolesnike treba nadzirati kako bi se uočili mogući klinički znakovi mišićne toksičnosti (vidjeti dio 4.4).
Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure.
Ponovljene doze ketokonazola od 200 mg na dan dovele su do 17 puta veće izloženosti dronedaronu.
If you stop taking MULTAQ Do not stop taking this medicine without first talking to your doctor or pharmacist.
Nemojte prestati uzimati ovaj lijek bez prethodnog savjetovanja s liječnikom ili ljekarnikom.
In an in vitro study MAO contributed to the metabolism of the active metabolite of dronedarone.
U jednom in vitro ispitivanju monoaminooksidaza je pridonijela metabolizmu aktivnog metabolita dronedarona.
The other ingredients in the tablet coat are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).
Pomoćne tvari u ovojnici tablete su: hipromeloza (E464), makrogol 6000, titanijev dioksid (E171), karnauba vosak (E903).
The other ingredients in the tablet core are hypromellose (E464), maize starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (see section 2 under ‘MULTAQ contains lactose'), colloidal anhydrous silica, magnesium stearate (E572).
Pomoćne tvari u jezgri tablete su: hipromeloza (E464), kukuruzni škrob, krospovidon (E1202), poloksamer 407, laktoza hidrat (vidjeti dio 2 'MULTAQ sadrži laktozu'), bezvodni koloidni silicijev dioksid, magnezijev stearat (E572).
Some adverse reactions were also identified during post-marketing surveillance.
Neke nuspojave bile su identificirane tijekom praćenja nakon stavljanja lijeka u promet.
In patients with coronary artery disease, clinical signs of heart failure and ECG should be regularly monitored to detect early signs of heart failure.
Potrebno je redovito pratiti kliničke znakove zatajenja srca i EKG u bolesnika s bolešću koronarnih arterija, kako bi se otkrili rani znakovi zatajenja srca.
Patients should be appropriately anti-coagulated as per clinical AF guidelines.
Bolesnici moraju primati odgovarajuću antikoagulantnu terapiju u skladu s kliničkim smjernicama za liječenje fibrilacije atrija.
Tell your doctor, he/she will check your lung.
Obavijestite svog liječnika, koji će Vam pregledati pluća.
Rifampicin (600 mg once daily) decreased dronedarone exposure by 80% with no major change on its active metabolite exposure.
Induktori CYP3A4 Primjena rifampicina (u dozi od 600 mg jedanput dnevno) dovela je do smanjenja izloženosti dronedaronu za 80%, ali nije značajno utjecala na izloženost aktivnom metabolitu.
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.
Smanjenje rizika hospitalizacije povezane s fibrilacijom atrija Djelotvornost dronedarona u smanjivanju rizika hospitalizacije povezane s fibrilacijom atrija dokazana je u bolesnika s trenutnom ili u anamnezi prisutnom FA te dodatnim faktorima rizika u sklopu multicentričnog, međunarodnog, dvostruko slijepog i randomiziranog, placebom kontroliranog ispitivanja
The interaction of dronedarone on calcium antagonists is described above (see section 4.4).
Antagonisti kalcija Interakcija dronedarona i antagonista kalcija opisana je prethodno (vidjeti dio 4.4).
Do not use this medicine after the expiry date, which is stated on the blister and carton after “EXP.” The expiry date refers to the last day of that month.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i na kutiji iza oznake "EXP".
However, ability to drive and use machines may be affected by adverse reactions such as fatigue.
Međutim, na sposobnost upravljanja vozilima i rada sa strojevima mogu utjecati nuspojave poput umora.
Cases of CHF have also been reported in post-marketing experience (frequency not known) (see section 4.4).
Slučajevi kongestivnog zatajenja srca prijavljeni su i nakon stavljanja lijeka u promet (učestalost nepoznata) (vidjeti dio 4.4).
Grapefruit juice (CYP 3A4 inhibitor)
Sok od grejpa (inhibitor CYP3A4)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of dronedarone (as hydrochloride).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 400 mg dronedarona (u obliku dronedaronklorida).
Your doctor may recommend that you use a medicine against blood clot formation according to your condition.
Ovisno o Vašem zdravstvenom stanju, liječnik Vam može preporučiti uzimanje lijekova protiv zgrušavanja krvi.
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%).
primali dronedaron u dozi od 400 mg dvaput na dan (2301 bolesnik) ili placebo (2327 bolesnika) kao dodatak standardnoj terapiji koja je uključivala beta-blokatore (71%), ACE inhibitore ili antagoniste receptora angiotenzina II (69%), digitalis (14%), antagoniste kalcija (14%), statine (39%), oralne antikoagulanse (60%), kroničnu terapiju antitromboticima (6%) i/ili diuretike (54%).
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).
Nakon što je randomizirano 3149 bolesnika (placebo=1577; dronedaron=1572), ispitivanje je prijevremeno prekinuto zbog značajnog povećanja broja slučajeva zatajenja srca (placebo=33; dronedaron=80; HR=2,49 (1,66-3,74)], moždanog udara [placebo=8;
What MULTAQ looks like and content of the pack MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and “4142” on the other side.
MULTAQ tableta je bijela, ovalna, filmom obložena tableta (tableta) s dvostrukom valovitom oznakom na jednoj i oznakom “4142” na drugoj strani.
• sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant),
• sirolimus i takrolimus, everolimus i ciklosporin (primjenjuju se nakon presađivanja organa), • Gospinu travu - biljni lijek za depresiju,
The majority had hypertension (86%) and structural heart disease (60%) (including coronary artery disease: 30%; congestive heart failure (CHF): 30%; LVEF<45%: 12%).
Većina je imala hipertenziju (86%) i strukturnu bolest srca (60%) (uključujući bolest koronarnih arterija:
MULTAQ contains lactose
MULTAQ sadrži laktozu
If heart failure develops, treatment with dronedarone should be discontinued.
Razvije li se zatajenje srca, liječenje dronedaronom mora se prekinuti.
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.
Bolesnici su morali imati barem jedan faktor rizika (uključujući dob, hipertenziju, dijabetes, pretrpljen cerebrovaskularni incident, promjer lijevog atrija ≥ 50 mm ili ejekcijsku frakciju lijeve klijetke (LVEF)
If QTc Bazett interval is ≥500 milliseconds, dronedarone should be stopped (see section 4.3).
≥ 500 milisekundi, mora se prekinuti primjena dronedarona (vidjeti dio 4.3).
Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers
Interakcija s lijekovima koji se metaboliziraju pomoću CYP2D6
- if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
• Tegoba kod koje srce ne može pumpati krv tijelom onako kako bi trebalo (kongestivno zatajenje srca).
The pharmacokinetics of dronedarone in patients with AF is consistent with that in healthy subjects.
Farmakokinetika dronedarona u bolesnika s fibrilacijom atrija dosljedna je onoj u zdravih ispitanika.
Therefore, co-administration of rifampicin and other potent CYP 3A4 inducers such as phenobarbital, carbamazepine, phenytoin or St John's Wort is not recommended as they decrease dronedarone exposure.
Stoga se ne preporučuje istodobna primjena rifampicina i drugih potentnih induktora CYP3A4, poput fenobarbitala, karbamazepina, fenitoina ili Gospine trave, jer ti lijekovi smanjuju izloženost dronedaronu.
If alanine aminotransferase (ALT) levels are elevated ≥3 × upper limit of normal (ULN), ALT levels should be re-measured within 48 to 72 hours.
Ako su razine alanin aminotransferaze (ALT) povišene ≥ 3 puta iznad gornje granice normale (GGN),
The steady state mean dronedarone Cmax is 84-147 ng/ml and the exposure of the main N-debutyl metabolite is similar to that of the parent compound.
Srednji Cmax dronedarona u stanju dinamičke ravnoteže iznosi 84-147 ng/ml, a izloženost glavnom
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).
Ne očekuje se da će oštećenje bubrežne funkcije izmijeniti farmakokinetiku dronedarona jer se mokraćom ne izlučuje spoj u neizmijenjenu obliku, a svega 6% doze izlučuje se mokraćom u obliku metabolita
Dronedarone is contraindicated in patients with severe hepatic impairment because of the absence of data (see sections 4.3 and 4.4).
Zbog nedostatka podataka dronedaron je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.3 i 4.4).
Moreover, beta-blockers have the potential to interact with dronedarone from a pharmacodynamic point of view.
Osim toga, beta-blokatori mogu stupiti i u farmakodinamičku interakciju s dronedaronom.
No dose adjustment is required in other patients with renal impairment (see sections 4.4 and 5.2).
U ostalih bolesnika s oštećenjem bubrežne funkcije nije potrebno prilagođavati dozu (vidjeti dio 4.4 i 5.2).
You must not take any of the following with MULTAQ:
Sljedeće lijekove ne smijete uzimati s lijekom MULTAQ:
Statins
Statini
MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
MULTAQ se ne smije davati bolesnicima sa sistoličkom disfunkcijom lijeve klijetke ni bolesnicima koji boluju ili su bolovali od zatajenja srca.
• feeling tired,
• umor,
• Liver problems including life threatening liver failure.
• Tegobe s jetrom uključujući po život opasno zatajenje jetre.
Dronedarone 400 mg twice daily does not increase the steady state theophylline exposure.
Dronedaron u dozi od 400 mg dvaput na dan ne povećava izloženost teofilinu u stanju dinamičke ravnoteže.
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.
Nema primjetan utjecaj na QTc-interval ili ga samo neznatno produljuje, a ne utječe ni na HV- ni QRS-interval.
The major metabolic pathway includes N-debutylation to form the main circulating active metabolite followed by oxidation, oxidative deamination to form the inactive propanoic acid metabolite, followed by oxidation, and direct oxidation.
Nakon toga slijedi oksidacija i oksidativna deaminacija kojom nastaje neaktivni metabolit propionska kiselina, a zatim nastupaju oksidacija i izravna oksidacija.
• skin problems such as rash or itching,
• kožne tegobe poput osipa ili svrbeža,
Dronedarone is extensively metabolised, mainly by CYP 3A4 (see section 4.5).
Biotransformacija Dronedaron se u velikoj mjeri metabolizira, prvenstveno posredstvom CYP3A4 (vidjeti dio 4.5).
• Permanent AF with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician
• primjena u permanentnoj fibrilaciji atrija definiranoj kao trajanje fibrilacije atrija ≥6 mjeseci (ili je trajanje nepoznato) i kada liječnik više ne pokušava vratiti sinusni ritam
If left ventricular systolic dysfunction develops, treatment with dronedarone should be discontinued.
Razvije li se sistolička disfunkcija lijeve klijetke, liječenje dronedaronom mora se prekinuti.
Other antiarrhythmic medicinal products had to be withdrawn for at least 5 plasma half-lives prior to the first administration.
Bolji placebo primjenu drugih antiaritmika trebalo je prekinuti tijekom razdoblja koje odgovara razdoblju od najmanje 5 poluvjekova lijeka u plazmi.
Dronedarone had no genotoxic effects, based on one in vivo micronucleus test in mice and four in vitro tests.
Prema rezultatima jednog mikronukleusnog testa na miševima in vivo i četiri istraživanja in vitro,
However, spontaneously reported cases of rhabdomyolysis when dronedarone was given in combination with a statin (simvastatin in particular) have been reported, and, therefore, concomitant use of statins should be undertaken with caution.
Međutim, zabilježeni su spontano prijavljeni slučajevi rabdomiolize kada se dronedaron davao u kombinaciji sa statinima
Liver function
Oštećenje funkcije jetre
Abdominal pain Dyspepsia
bol u abdomenu, dispepsija
This will give you more details on exactly what medicines you cannot take with MULTAQ), - if you have a severe liver problem, - if you have a severe kidney problem, - if you take dabigatran (see section below on “Other medicines and MULTAQ”).
- ako imate teške probleme s jetrom, - ako imate teške probleme s bubrezima, - ako uzimate dabigatran (pogledajte dio "Drugi lijekovi i MULTAQ" u nastavku).
Potent CYP3A4 inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin or St John's Wort are not recommended.
Ne preporučuje se primjena potentnih induktora CYP3A4 poput rifampicina, fenobarbitala, karbamazepina, fenitoina ili Gospine trave.
Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, certain oral macrolides (such as erythromycin), terfenadine and Class I and III antiarrhythmics are contraindicated because of the potential risk of proarrhythmia (see section 4.3).
• Lijekovi koji induciraju torsades de pointes, poput fenotiazina, cisaprida, bepridila, tricikličkih antidepresiva, terfenadina i nekih peroralnih makrolida (poput eritromicina), antiaritmika skupine I i III (vidjeti dio 4.5)
MULTAQ 400 mg film-coated tablets dronedarone
MULTAQ 400 mg filmom obložene tablete dronedaron
Rare (1/10,000 to disorders test abnormalities liver injury, including life-threatening acute liver failure (see section 4.4)
Poremećaji jetre i žuči poremećene vrijednosti testova jetrene funkcije hepatocelularno oštećenje jetre, uključujući po život opasno akutno zatajenje jetre (vidjeti dio 4.4)
• Severe renal impairment (CrCl <30 ml/min)
• Teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min) • Istodobna primjena s dabigatranom
This rate should be considered in the context of the underlying elevated incidence of CHF in AF patients.
Tu stopu treba razmatrati u kontekstu već postojeće povećane incidencije kongestivnog zatajenja srca u bolesnika s fibrilacijom atrija.
Potent CYP3A4 inducers
Potentni induktori CYP3A4
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).
Potrebno je redovito pratiti kliničke znakove zatajenja srca i EKG u starijih bolesnika u dobi od ≥75 godina (vidjeti dio 4.2 i 5.1).
Dronedarone is a moderate inhibitor of CYP 3A4, a mild inhibitor of CYP 2D6 and a potent inhibitor of P-glycoproteins (P-gp).
Dronedaron je umjereno snažan inhibitor CYP3A4, slab inhibitor CYP2D6 i snažan inhibitor
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
# > 450 msek u muškaraca; > 470 msek u žena (vidjeti dio 4.4) Opis odabranih nuspojava
Moreover, due to their heart rate-lowering properties, verapamil and diltiazem have the potential to interact with dronedarone from a pharmacodynamic point of view.
Osim toga, budući da utječu na usporavanje srčanog ritma, verapamil i diltiazem mogu s farmakodinamičkog stajališta ući u interakciju s dronedaronom.
Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
Jedna filmom obložena tableta sadrži 400 mg dronedarona (u obliku dronedaronklorida).
If patients treated with dronedarone develop permanent AF, treatment with dronedarone should be discontinued.
Ako se u bolesnika liječenih dronedaronom razvije permanentna fibrilacija atrija, liječenje dronedaronom mora se prekinuti.
Common (1/100 to
(≥1/1000 i <1/100)
• Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets • Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets.
• Neprozirni PVC/aluminij perforirani blister s jediničnim dozama sa 100x1 filmom obloženom tabletom
It should be taken as:
Lijek treba uzimati na sljedeći način:
• changes in your ECG (electrocardiogram) called QTc Bazett prolonged.
• promjene u nalazima jedne krvne pretrage: razina kreatinina u krvi, • promjene na EKG-u (elektrokardiogramu) koje se zovu produljenje QTc-intervala prema Bazettu.
Interaction with medicinal products metabolized by CYP 3A4 Dabigatran
Interakcija s lijekovima koji se metaboliziraju pomoću CYP3A4
Calcium antagonists also have their exposure increased by dronedarone (400 mg twice daily) (verapamil by 1.4-fold, and nisoldipine by 1.5-fold).
Dronedaron (400 mg dvaput na dan) također povećava izloženost antagonistima kalcija (1,4 puta veća izloženost verapamilu i 1,5 puta veća izloženost nisoldipinu).
Dronedarone was not shown to alter fertility in animal studies.
Ispitivanja na životinjama nisu pokazala da dronedaron utječe na plodnost.
It also inhibits the sodium currents (Class Ib) and the calcium currents (Class IV).
Također inhibira protok natrija (skupina Ib)
• bepridil for chest pain caused by heart disease,
• neke lijekove za smirenje koji se zovu fenotiazini, • bepridil, za bolove u prsištu uzrokovane bolešću srca,
Repeated doses of diltiazem (240 mg twice daily), verapamil (240 mg once daily) and nifedipine (20 mg twice daily) resulted in an increase in dronedarone exposure of 1.7-, 1.4- and 1.2-fold, respectively.
Ponovljene doze diltiazema (240 mg dvaput na dan), verapamila (240 mg jednom na dan) i nifedipina
The co-administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio-ventricular node should be undertaken with caution.
Beta-blokatori i antagonisti kalcija Potreban je oprez prilikom istodobne primjene beta-blokatora ili antagonista kalcija s depresorskim učincima na sinusni i atrioventrikularni čvor.
If a switch is envisaged, this should be done under the supervision of a specialist (see sections 4.3 and 5.1).
Ako se predviđa prelazak bolesnika na dronedaron, to se mora provesti pod nadzorom specijaliste (vidjeti dio 4.3 i
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.
400 mg dvaput na dan, AUC0-24 dabigatrana povećao se za 100%, a njegov Cmax za 70%.
There have been spontaneously reported events of new or worsening heart failure during treatment with dronedarone.
Tijekom liječenja dronedaronom spontano su prijavljeni slučajevi novonastalog ili pogoršanja postojećeg zatajenja srca.
Prevention of drug-drug interaction
- interakcije lijekova
In patients aged 65 years of age and over, dronedarone exposures are 23% higher in comparison with patients aged below 65 years of age.
U bolesnika u dobi od 65 ili više godina izloženost dronedaronu bila je 23%
No clinical data are available regarding the co-administration of these medicinal products in AF patients.
Nema kliničkih podataka o istodobnoj primjeni navedenih lijekova u bolesnika s fibrilacijom atrija.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Kako čuvati MULTAQ Lijek čuvajte izvan pogleda i dohvata djece.
MULTAQ 400 mg
16. PODACI NA BRAILLEOVOM PISMU MULTAQ 400 mg
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.
(116/2301) i onoj koja je primala placebo (139/2327).
Dronedarone (400 mg twice daily) increased simvastatin and simvastatin acid exposure by 4-fold and 2-fold respectively.
Primjena dronedarona (400 mg dvaput na dan) četverostruko je povećala izloženost simvastatinu, a dvostruko izloženost simvastatinskoj kiselini.
If ALT levels are confirmed to be ≥3 × ULN, treatment with dronedarone should be withdrawn.
Ako se potvrdi da su razine ALT-a ≥ 3 x GGN, mora se prekinuti liječenje dronedaronom.
Monitoring of their plasma concentrations and appropriate dose adjustment is recommended in case of coadministration with dronedarone.
U slučaju istodobne primjene s dronedaronom preporučuje se praćenje njihovih koncentracija u plazmi i odgovarajuća prilagodba doze.
NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg tablets dronedarone
NAZIV LIJEKA MULTAQ 400 mg tablete dronedaron
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%).
koronarnom bolešću srca u ~ 41%, pretrpljenim moždanim udarom ili tranzitornom ishemijskom atakom u ~ 27%, ejekcijskom frakcijom lijeve klijetke ≤ 40% u ~ 20,7% te dobi od ≥ 75 godina uz hipertenziju i dijabetes u ~ 18% bolesnika).
• change in how things taste.
• promjene osjeta okusa, Rijetke
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known).
Nakon stavljanja lijeka u promet prijavljeni su slučajevi intersticijske bolesti pluća, uključujući pneumonitis i plućnu fibrozu (učestalost nepoznata).