FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Klinično študijo pri bolnikih s permanentno AF (trajanje AF vsaj 6 mesecev) in kardiovaskularnimi dejavniki tveganja so predčasno končali zaradi presežka kardiovaskularnih smrti, možganskih kapi in srčnega popuščanja, med bolniki, ki so prejemali dronedaron (glejte poglavje 5.1).
English: The in vitro plasma protein binding of dronedarone and its N-debutyl metabolite is 99.7% and 98.5% respectively and is not saturable.
Slovenian: In vitro je vezava dronedarona na beljakovine v plazmi 99,7 %, vezava njegovega N-debutilnega presnovka pa 98,5 %; vezava ni saturabilna.
English: Liver, pulmonary, coagulation and renal function tests Counsel patients about its use
Slovenian: Preverjanje delovanja jeter, pljuč, ledvic in koagulacije Svetovanje bolnikom o uporabi zdravila
English: It is recommended to measure plasma creatinine values prior to and 7 days after initiation of dronedarone.
Slovenian: Kreatinin v plazmi je priporočljivo izmeriti pred uvedbo dronedarona in 7 dni po njegovi uvedbi.
English: Calcium antagonists
Slovenian: Kalcijevi antagonisti
English: Dronedarone and/or its metabolites also have been shown to inhibit transport proteins of the Organic Anion Transporter (OAT), Organic Anion Transporting Polypeptide (OATP) and Organic Cation Transporter (OCT) families in vitro.
Slovenian: Ugotovljeno je tudi, da dronedaron in/ali njegovi presnovki in vitro zavirajo transportne beljakovine družin transporterja organskih anionov (OAT), transportnega polipeptida organskih anionov (OATP) in transporterja organskih kationov (OCT).
English: Monitor patients during treatment and discontinue dronedarone when required ECG
Slovenian: Spremljanje bolnikov med zdravljenjem in prekinitev uporabe dronedarona, kadar je to potrebno EKG
English: • Inflammation of the lungs (including scarring and thickening of the lungs).
Slovenian: • Vnetje pljuč (vključno z brazgotinjenjem in zadebelitvijo pljučnega tkiva).
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).
Slovenian: Zmanjšanje kardiovaskularnih hospitalizacij ali smrti zaradi kateregakoli vzroka je bilo konsistentno v vseh podskupinah, ne glede na izhodiščne značilnosti ali zdravila (zaviralci ACE ali antagonisti receptorjev angiotenzina II, zaviralci beta, digitalis, statini, kalcijevi antagonisti, diuretiki) (glejte sliko 1).
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.
Slovenian: Bolnike z boleznijo koronarnih arterij je treba redno spremljati glede kliničnih znakov srčnega popuščanja in jim redno kontrolirati EKG, da bi odkrili zgodnje znake srčnega popuščanja.
English: There are no or limited amount of data from the use of dronedarone in pregnant women.
Slovenian: O uporabi dronedarona pri nosečnicah podatkov ni ali jih je malo.
English: Effect of other medicinal products on dronedarone
Slovenian: Vpliv drugih zdravil na dronedaron
English: Take the next dose when you are normally due to take it.
Slovenian: Naslednji odmerek vzemite ob naslednjem običajno predvidenem času zanj.
English: What MULTAQ is and what it is used for What you need to know before you take MULTAQ How to take MULTAQ
Slovenian: Kaj je zdravilo MULTAQ in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo MULTAQ Kako jemati zdravilo MULTAQ Možni neželeni učinki
English: 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.
Slovenian: Povprečni Cmax dronedarona v stanju dinamičnega ravnovesja je od 84 do 147 ng/ml in izpostavljenost glavnemu N-debutilnemu presnovku je podobna izpostavljenosti matični spojini.
English: As compared to placebo, dronedarone lowered the risk of first AF/AFL recurrence during the 12-month study period by 25% (p = 0.00007).
Slovenian: Dronedaron je v primerjavi s placebom zmanjšal tveganje za prvo ponovitev AF/AU med 12-mesečnim obdobjem študije za 25 % (p = 0,00007).
English: White, oblong shaped tablets, engraved with a double wave marking on one side and “4142”code on the other side.
Slovenian: Bele tablete podolgovate oblike z vrezano oznako dvojnega vala na eni strani in kodo "4142" na drugi strani.
English: Patients should be appropriately anti-coagulated as per clinical AF guidelines.
Slovenian: Bolniki morajo prejemati ustrezno antikoagulantno zaščito po kliničnih smernicah za AF.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: In ESC and ACC/AHA/HRS guidelines dronedarone has a class IA recommendation in patients with paroxysmal/persistent AF and coronary artery disease.
Slovenian: V smernicah ESC in ACC/AHA/HRS ima dronedaron pri bolnikih s paroksizmalno/perzistentno AF in boleznijo koronarnih arterij priporočilo skupine IA.
English: There was a weak interaction between dronedarone and atorvastatin (which resulted in a mean 1.7-fold increase in atorvastatin exposure).
Slovenian: Obstajalo je šibko medsebojno delovanje med dronedaronom in atorvastatinom (ki je povzročilo povprečno 1,7-kratno povečanje izpostavljenosti atorvastatinu).
English: In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
Slovenian: Pri osebah z zmerno okvaro jeter se izpostavljenost nevezanemu dronedaronu poveča za 2-krat.
English: However, proarrhythmic effects may occur in particular situations such as concomitant use with medicinal products favouring arrhythmia and/or electrolytic disorders (see sections 4.4 and 4.5).
Slovenian: Vendar se lahko proaritmični učinki pojavijo v posebnih okoliščinah, npr. med sočasno uporabo z zdravili, ki povečujejo nagnjenost k motnjam srčnega ritma in/ali elektrolitskim motnjam (glejte poglavji 4.4 in 4.5).
English: Dronedarone has vasodilatory properties, in coronary arteries (related to the activation of the nitric oxide pathway) and in peripheral arteries.
Slovenian: Dronedaron deluje vazodilatacijsko na koronarne arterije (povezano z aktivacijo poti dušikovega oksida) in na periferne arterije.
English: 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.
Slovenian: Glavne presnovne poti so N-debutilacija, s katero nastane glavni aktivni presnovek v obtoku in ji sledi oksidacija, oksidativna deaminacija, s katero nastane neaktivni presnovek propanojska kislina in ji sledi oksidacija, ter neposredna oksidacija.
English: Do not drink grapefruit juice while taking MULTAQ.
Slovenian: Med jemanjem zdravila MULTAQ ne pijte grenivkinega soka.
English: Concomitant intake of food increases dronedarone bioavailability by on average 2- to 4-fold.
Slovenian: Sočasno uživanje hrane zmanjša biološko uporabnost dronedarona za povprečno 2- do 4-krat.
English: • one tablet during your evening meal.
Slovenian: • eno tableto med večernim obrokom.
English: MULTAQ prevents repetition of your problem of irregular heart rhythm.
Slovenian: Zdravilo MULTAQ prepreči ponovitev težav z nerednim bitjem srca.
English: If you think that your medicine is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom ali s farmacevtom.
English: In clinical studies, bradycardia was more frequently observed when dronedarone was given in combination with beta-blockers.
Slovenian: V kliničnih študijah je bila bradikardija pogostejša, če je bil dronedaron uporabljen v kombinaciji z zaviralci beta.
English: These medicinal products should be initiated at low dose and up titration should be done only after ECG assessment.
Slovenian: Ta zdravila je treba uvesti v majhnem odmerku, njihov odmerek pa povečati šele po ovrednotenju EKG.
English: • Diarrhoea, vomiting when excessive as it can lead to kidney problems.
Slovenian: • Driska ali prekomerno bruhanje, ker lahko povzročita težave z ledvicami.
English: Dronedarone does not affect the pharmacokinetics of clopidogrel and its active metabolite.
Slovenian: Dronedaron ne vpliva na farmakokinetiko klopidogrela in njegovega aktivnega presnovka.
English: Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below).
Slovenian: Med uporabo dronedarona so priporočljive natančne kontrole z rednim spremljanjem delovanja srca, jeter in pljuč (glejte spodaj).
English: Dronedarone can increase exposure of statins that are substrates of CYP 3A4 and/or P-gp substrates.
Slovenian: Dronedaron lahko poveča izpostavljenost statinom, ki so substrati CYP 3A4 in/ali substrati P-gp.
English: Your doctor may recommend that you use a medicine against blood clot formation according to your condition.
Slovenian: Zdravnik vam lahko glede na vaše stanje svetuje uporabo zdravila proti nastajanju krvnih strdkov.
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).
Slovenian: Na podlagi kliničnih izkušenj ima dronedaron majhen proaritmičen učinek in je v študiji ATHENA pokazal zmanjšanje smrti zaradi motenj srčnega ritma (glejte poglavje 5.1).
English: It can increase the blood levels of dronedarone and may increase your chance of getting side effects.
Slovenian: Ta lahko zviša koncentracijo dronedarona v krvi in poveča verjetnost, da se vam pojavijo neželeni učinki
English: Although plasma exposure in elderly females was increased in a pharmacokinetic study conducted in healthy subjects, dose adjustments are not considered necessary (see sections 5.1 and 5.2).
Slovenian: Farmakokinetična študija pri zdravih preiskovancih je sicer pokazala večjo izpostavljenost pri starejših ženskah, vendar prilagoditve odmerka niso potrebne (glejte poglavji 5.1 in 5.2).
English: Dronedarone is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min) (see section 4.3).
Slovenian: Dronedaron je kontraindiciran pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min (glejte poglavje 4.3).
English: • terfenadine (a medicine for allergies),
Slovenian: • terfenadina (zdraviloza alergije),
English: Medicinal products inducing torsades de pointes
Slovenian: Zdravila, ki inducirajo torsades de pointes
English: The usual dose is one 400 mg tablet twice a day.
Slovenian: Običajen odmerek je ena 400-mg tableta dvakrat na dan. Vzemite:
English: Vasculitis, including leukocytoclastic vasculitis
Slovenian: Vaskulitis, vključno z levkocitoklastičnim vaskulitisom
English: It also inhibits the sodium currents (Class Ib) and the calcium currents (Class IV).
Slovenian: Zavira tudi tok natrija (skupina Ib) in kalcija (skupina IV).
English: Cases of CHF have also been reported in post-marketing experience (frequency not known) (see section 4.4).
Slovenian: Primeri kongestivnega srčnega popuščanja so bili opisani tudi med postmarketinškim obdobjem (pogostnost neznana) (glejte poglavje 4.4).
English: Dronedarone reduced the incidence of cardiovascular hospitalisation or death from any cause by 24.2% when compared to placebo (p<0.0001).
Slovenian: Dronedaron je v primerjavi s placebom zmanjšal incidenco kardiovaskularnih hospitalizacij ali smrti zaradi kateregakoli vzroka za 24,2 % (p < 0,0001).
English: 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.
Slovenian: Vendar so v primeru jemanja dronedarona v kombinaciji s statini (predvsem s simvastatinom) poročali o spontano poročanih primerih rabdomiolize, zato je pri sočasnem jemanju statinov potrebna previdnost.
English: Liver, lung and renal safety of use.
Slovenian: Jetrna, pljučna in ledvična varnost uporabe.
English: It is unknown whether dronedarone and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se dronedaron in njegovi presnovki pri človeku izločajo v materinem mleku.
English: This reduction was driven by the occurrence of significantly fewer thyroid and neurological events and a trend for less skin or ocular events, and fewer premature study drug discontinuations compared to the amiodarone group.
Slovenian: To zmanjšanje je šlo na račun bistveno manjšega pojavljanja ščitničnih in nevroloških učinkov, trenda k manjšemu pojavljanju kožnih in očesnih učinkov ter manjšega števila predčasnega prenehanja uporabe raziskovanega zdravila v primerjavi s skupino, ki je uporabljala amiodaron.
English: Follow up, including ECG (electrocardiogram), is recommended during treatment.
Slovenian: Med zdravljenjem je priporočljivo spremljanje, vključno z EKG (elektrokardiogramom).
English: Each tablet also contains 41.65 mg of lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 41,65 mg laktoze (v obliki monohidrata).
English: • inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).
Slovenian: • vnetje krvnih žil (vaskulitis, vključno z levkocitoklastičnim vaskulitisom).
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov proizvajalcev, odgovornih za sproščanje serij
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).
Slovenian: Dronedaron v odmerku 800 mg na dan je povečal izpostavljenost metoprololu za 1,6-krat in izpostavljenost propranololu za 1,3-krat (tj. veliko pod 6-kratno razliko, ugotovljeno med slabimi in močnimi metabolizatorji s CYP 2D6).
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.
Slovenian: Pri bolnicah je bila izpostavljenost dronedaronu in njegovemu N-debutilnemu presnovku povprečno od 1,3- do 1,9-krat večja kot pri bolnikih.
English: Interstitial lung disease including pneumonitis and pulmonary fibrosis (see below)
Slovenian: Intersticijska bolezen pljuč, vključno s pnevmonitisom in pljučno fibrozo (glejte spodaj)
English: Patients ranged in age from 23 to 97 years and 42% were over 75 years old.
Slovenian: Bolniki so bili stari od 23 do 97 let in 42 % je bilo starejših od 75 let.
English: • nefazodone (a medicine for depression),
Slovenian: • nefazodona (zdravilo za depresijo),
English: 5 How to store MULTAQ Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila MULTAQ Vsebina pakiranja in dodatne informacije
English: In clinical trials, there was no evidence of safety concerns when dronedarone was co-administered with statins metabolised by CYP 3A4.
Slovenian: V kliničnih preskušanjih niso ugotovili težav z varnostjo, če je bil dronedaron uporabljen sočasno s statini, ki se presnovijo s CYP 3A4.
English: The following side effects have been reported with this medicine:
Slovenian: Med uporabo tega zdravila so bili opisani naslednji neželeni učinki:
English: In chronic toxicity studies, slight and reversible phospholipidosis (accumulation of foamy macrophages) was observed in mesenteric lymph nodes mainly in the rat.
Slovenian: V študijah kronične toksičnosti so opazili rahlo in reverzibilno fosfolipidozo (kopičenje mehurčastih makrofagov) v mezenteričnih bezgavkah, predvsem pri podganah.
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.
Slovenian: V kliničnih študijah dronedarona je bilo 73 % vseh preiskovancev starih 65 let in več, 34 % pa 75 let in več.
English: Common (1/100 to
Slovenian: Pogosti ( 1/100 do
English: Dronedarone (600 mg twice daily) increased by 1.2-fold S-warfarin with no change in R-warfarin and only a 1.07 increase in International Normalised Ratio (INR).
Slovenian: Dronedaron (600 mg dvakrat na dan) je zvišal S-varfarin za 1,2-krat, ni spremenil R-varfarina in je povečal internacionalno normalizirano razmerje (INR) le za 1,07.
English: Women of child bearing potential and pregnancy
Slovenian: Ženske v rodni dobi in nosečnost
English: MULTAQ contains an active substance named dronedarone.
Slovenian: Zdravilo MULTAQ vsebuje zdravilno učinkovino, imenovano dronedaron.
English: This metabolite contributes to the pharmacological activity of dronedarone in humans.
Slovenian: Ta presnovek pripomore k farmakološkemu delovanju dronedarona pri človeku.
English: The effect of severe hepatic impairment on the pharmacokinetics of dronedarone was not assessed (see section 4.3).
Slovenian: Vpliv hude okvare jeter na farmakokinetiko dronedarona ni ocenjen (glejte poglavje 4.3).
English: However, ability to drive and use machines may be affected by adverse reactions such as fatigue.
Slovenian: Vendar lahko na sposobnost vožnje in upravljanja s stroji vplivajo neželeni učinki, kot je utrujenost.
English: No clinical data are available regarding the co-administration of these medicinal products in AF patients.
Slovenian: Klinični podatki o sočasnem jemanju teh zdravil pri bolnikih z atrijsko fibrilacijo niso na voljo.
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).
Slovenian: Študija se je končala predčasno, po randomizaciji 3.149 bolnikov (placebo = 1.577, dronedaron = 1.572), zaradi pomembnega porasta srčnega popuščanja [placebo = 33, dronedaron = 80, razmerje ogroženosti [ROg] = 2,49 (1,66-3,74)], možganske kapi [placebo = 8, dronedaron = 17, ROg = 2,14 (0,92-4,96)] in kardiovaskularnih smrti [placebo = 6, dronedaron = 15, ROg = 2,53 (0,98-6,53)] (glejte poglavji 4.3 in 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%).
Slovenian: Najpogostejši neželeni učinki med uporabo 400 mg dronedarona dvakrat na dan v teh 5 študijah so bili driska (9%), navzea (5%) in bruhanje (2%), utrujenost in astenija (7%).
English: Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure.
Slovenian: Ponavljajoči se odmerki 200 mg ketokonazola na dan so povzročili 17-kratno povečanje izpostavljenosti dronedaronu.
English: • Permanent AF with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician
Slovenian: • Permanentna (trajna) AF ki traja 6 mesecev ali dlje (ali njeno trajanje ni znano) in zdravnik ne predvideva več poskusov za obnovitev sinusnega ritma.
English: Erythromycin, an oral macrolide, may induce torsades de pointes and, as such, is contraindicated (see section 4.3).
Slovenian: Eritromicin, peroralen makrolid, lahko povzroči torsades de pointes in je zato kontraindiciran (glejte poglavje 4.3).
English: 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.
Slovenian: Ponavljajoči se odmerki diltiazema (240 mg dvakrat na dan), verapamila (240 mg enkrat na dan) in nifedipina (20 mg dvakrat na dan) so povzročili povečanje izpostavljenosti dronedaronu (diltiazem za 1,7-krat, verapamil za 1,4-krat in nifedipin za 1,2-krat).
English: Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved (see section 4.4).
Slovenian: Priporočljivi so kliničen nadzor, nadzor EKG in biološki nadzor, odmerek digoksina pa je treba prepoloviti (glejte poglavje 4.4).
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
Slovenian: EU/1/09/591/001 - škatla z 20 filmsko obloženimi tabletami EU/1/09/591/002 - škatla z 50 filmsko obloženimi tabletami EU/1/09/591/003 - škatla z 60 filmsko obloženimi tabletami EU/1/09/591/004 - škatla s 100 x 1 filmsko obloženo tableto
English: Liver injury
Slovenian: Poškodba jeter
English: Patients should be advised to consult a physician if they develop or experience signs or symptoms of heart failure, such as weight gain, dependent oedema, or increased dyspnoea.
Slovenian: Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom, če se jim pojavijo znaki ali simptomi srčnega popuščanja, npr. če opazijo povečanje telesne mase, hipostatske edeme ali izrazitejše težko dihanje.
English: Dronedarone has, therefore, the potential to interact on medicinal products substrates of P-glycoproteins, CYP 3A4 or CYP 2D6.
Slovenian: Zato lahko dronedaron medsebojno deluje z zdravili, ki so substrati P-glikoproteinov, CYP 3A4 ali CYP 2D6.
English: The interaction of dronedarone on calcium antagonists is described above (see section 4.4).
Slovenian: Kalcijevi antagonisti Medsebojna delovanja dronedarona s kalcijevimi antagonisti so opisana zgoraj (glejte poglavje 4.4).
English: No interaction was observed between dronedarone and metformin, an OCT1 and OCT2 substrate.
Slovenian: Medsebojno delovanje z metforminom (substrat OCT1 in OCT2) Medsebojnega delovanja med dronedaronom in metforminom, substratoma OCT1 in OCT2, niso opazili.
English: This problem should be corrected before starting treatment with MULTAQ,
Slovenian: To težavo morate odpraviti, preden začnete zdravljenje z zdravilom MULTAQ.
English: MULTAQ is used if you have a problem with your heart rhythm (your heart beats out of time - atrial fibrillation) and spontaneously, or through a treatment called cardioversion has changed your heartbeat back to normal rhythm.
Slovenian: Zdravilo MULTAQ se uporablja, če imate moteno bitje srca (srce vam bije neredno - atrijska fibrilacija) in je zdravljenje, ki ga imenujemo kardioverzija, vaš srčni utrip spontano ali v toku zdravljenja znova vrnilo v normalen ritem.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: This rate should be considered in the context of the underlying elevated incidence of CHF in AF patients.
Slovenian: To pogostnost je treba ocenjevati v okviru osnovno povečane incidence kongestivnega srčnega popuščanja pri bolnikih z AF.
English: Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved.
Slovenian: Priporočljivo je klinično, elektrokardiografsko in biološko nadziranje; odmerek digoksina je treba prepoloviti.
English: Lower starting dose and maintenance doses of statins should be considered and patients monitored for clinical signs of muscular toxicity.
Slovenian: V poštev pridejo manjši začetni odmerek in manjši vzdrževalni odmerki statinov, bolnike pa je treba kontrolirati glede kliničnih znakov toksičnih učinkov na mišice.
English: After oral administration in fed conditions, peak plasma concentrations of dronedarone and the main circulating active metabolite (N-debutyl metabolite) are reached within 3 to 6 hours.
Slovenian: Po peroralni uporabi na poln želodec sta največja koncentracija dronedarona in njegovega glavnega aktivnega presnovka v obtoku (N-debutilnega presnovka) doseženi v 3 do 6 urah.