natgillin/translations-raw huggingface dataset:
White, oblong shaped tablets, engraved with a double wave marking on one side and “4142”code on the other side.
Bele tablete podolgovate oblike z vrezano oznako dvojnega vala na eni strani in kodo "4142" na drugi strani.
Patients should be appropriately anti-coagulated as per clinical AF guidelines.
Bolniki morajo prejemati ustrezno antikoagulantno zaščito po kliničnih smernicah za AF.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
In ESC and ACC/AHA/HRS guidelines dronedarone has a class IA recommendation in patients with paroxysmal/persistent AF and coronary artery disease.
V smernicah ESC in ACC/AHA/HRS ima dronedaron pri bolnikih s paroksizmalno/perzistentno AF in boleznijo koronarnih arterij priporočilo skupine IA.
There was a weak interaction between dronedarone and atorvastatin (which resulted in a mean 1.7-fold increase in atorvastatin exposure).
Obstajalo je šibko medsebojno delovanje med dronedaronom in atorvastatinom (ki je povzročilo povprečno 1,7-kratno povečanje izpostavljenosti atorvastatinu).
In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
Pri osebah z zmerno okvaro jeter se izpostavljenost nevezanemu dronedaronu poveča za 2-krat.
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).
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).
Dronedarone has vasodilatory properties, in coronary arteries (related to the activation of the nitric oxide pathway) and in peripheral arteries.
Dronedaron deluje vazodilatacijsko na koronarne arterije (povezano z aktivacijo poti dušikovega oksida) in na periferne arterije.
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.
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.
Do not drink grapefruit juice while taking MULTAQ.
Med jemanjem zdravila MULTAQ ne pijte grenivkinega soka.
Concomitant intake of food increases dronedarone bioavailability by on average 2- to 4-fold.
Sočasno uživanje hrane zmanjša biološko uporabnost dronedarona za povprečno 2- do 4-krat.
• one tablet during your evening meal.
• eno tableto med večernim obrokom.
MULTAQ prevents repetition of your problem of irregular heart rhythm.
Zdravilo MULTAQ prepreči ponovitev težav z nerednim bitjem srca.
If you think that your medicine is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom ali s farmacevtom.
In clinical studies, bradycardia was more frequently observed when dronedarone was given in combination with beta-blockers.
V kliničnih študijah je bila bradikardija pogostejša, če je bil dronedaron uporabljen v kombinaciji z zaviralci beta.
These medicinal products should be initiated at low dose and up titration should be done only after ECG assessment.
Ta zdravila je treba uvesti v majhnem odmerku, njihov odmerek pa povečati šele po ovrednotenju EKG.
• Diarrhoea, vomiting when excessive as it can lead to kidney problems.
• Driska ali prekomerno bruhanje, ker lahko povzročita težave z ledvicami.
Dronedarone does not affect the pharmacokinetics of clopidogrel and its active metabolite.
Dronedaron ne vpliva na farmakokinetiko klopidogrela in njegovega aktivnega presnovka.
Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below).
Med uporabo dronedarona so priporočljive natančne kontrole z rednim spremljanjem delovanja srca, jeter in pljuč (glejte spodaj).
Dronedarone can increase exposure of statins that are substrates of CYP 3A4 and/or P-gp substrates.
Dronedaron lahko poveča izpostavljenost statinom, ki so substrati CYP 3A4 in/ali substrati P-gp.
Your doctor may recommend that you use a medicine against blood clot formation according to your condition.
Zdravnik vam lahko glede na vaše stanje svetuje uporabo zdravila proti nastajanju krvnih strdkov.
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).
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).
It can increase the blood levels of dronedarone and may increase your chance of getting side effects.
Ta lahko zviša koncentracijo dronedarona v krvi in poveča verjetnost, da se vam pojavijo neželeni učinki
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).
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).
Dronedarone is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min) (see section 4.3).
Dronedaron je kontraindiciran pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min (glejte poglavje 4.3).
• terfenadine (a medicine for allergies),
• terfenadina (zdraviloza alergije),
Medicinal products inducing torsades de pointes
Zdravila, ki inducirajo torsades de pointes
The usual dose is one 400 mg tablet twice a day.
Običajen odmerek je ena 400-mg tableta dvakrat na dan. Vzemite:
Vasculitis, including leukocytoclastic vasculitis
Vaskulitis, vključno z levkocitoklastičnim vaskulitisom
It also inhibits the sodium currents (Class Ib) and the calcium currents (Class IV).
Zavira tudi tok natrija (skupina Ib) in kalcija (skupina IV).
Cases of CHF have also been reported in post-marketing experience (frequency not known) (see section 4.4).
Primeri kongestivnega srčnega popuščanja so bili opisani tudi med postmarketinškim obdobjem (pogostnost neznana) (glejte poglavje 4.4).
Dronedarone reduced the incidence of cardiovascular hospitalisation or death from any cause by 24.2% when compared to placebo (p<0.0001).
Dronedaron je v primerjavi s placebom zmanjšal incidenco kardiovaskularnih hospitalizacij ali smrti zaradi kateregakoli vzroka za 24,2 % (p < 0,0001).
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.
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.
Liver, lung and renal safety of use.
Jetrna, pljučna in ledvična varnost uporabe.
It is unknown whether dronedarone and its metabolites are excreted in human milk.
Ni znano, ali se dronedaron in njegovi presnovki pri človeku izločajo v materinem mleku.
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.
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.
Follow up, including ECG (electrocardiogram), is recommended during treatment.
Med zdravljenjem je priporočljivo spremljanje, vključno z EKG (elektrokardiogramom).
Each tablet also contains 41.65 mg of lactose (as monohydrate).
Ena tableta vsebuje 41,65 mg laktoze (v obliki monohidrata).
• inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).
• vnetje krvnih žil (vaskulitis, vključno z levkocitoklastičnim vaskulitisom).
Name and address of the manufacturers responsible for batch release
Ime in naslov proizvajalcev, odgovornih za sproščanje serij
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).
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).
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.
Pri bolnicah je bila izpostavljenost dronedaronu in njegovemu N-debutilnemu presnovku povprečno od 1,3- do 1,9-krat večja kot pri bolnikih.
Interstitial lung disease including pneumonitis and pulmonary fibrosis (see below)
Intersticijska bolezen pljuč, vključno s pnevmonitisom in pljučno fibrozo (glejte spodaj)
Patients ranged in age from 23 to 97 years and 42% were over 75 years old.
Bolniki so bili stari od 23 do 97 let in 42 % je bilo starejših od 75 let.
• nefazodone (a medicine for depression),
• nefazodona (zdravilo za depresijo),
5 How to store MULTAQ Contents of the pack and other information
5 Shranjevanje zdravila MULTAQ Vsebina pakiranja in dodatne informacije
In clinical trials, there was no evidence of safety concerns when dronedarone was co-administered with statins metabolised by CYP 3A4.
V kliničnih preskušanjih niso ugotovili težav z varnostjo, če je bil dronedaron uporabljen sočasno s statini, ki se presnovijo s CYP 3A4.
The following side effects have been reported with this medicine:
Med uporabo tega zdravila so bili opisani naslednji neželeni učinki:
In chronic toxicity studies, slight and reversible phospholipidosis (accumulation of foamy macrophages) was observed in mesenteric lymph nodes mainly in the rat.
V študijah kronične toksičnosti so opazili rahlo in reverzibilno fosfolipidozo (kopičenje mehurčastih makrofagov) v mezenteričnih bezgavkah, predvsem pri podganah.
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.
V kliničnih študijah dronedarona je bilo 73 % vseh preiskovancev starih 65 let in več, 34 % pa 75 let in več.
Common (1/100 to
Pogosti ( 1/100 do
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).
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.
Women of child bearing potential and pregnancy
Ženske v rodni dobi in nosečnost
MULTAQ contains an active substance named dronedarone.
Zdravilo MULTAQ vsebuje zdravilno učinkovino, imenovano dronedaron.
This metabolite contributes to the pharmacological activity of dronedarone in humans.
Ta presnovek pripomore k farmakološkemu delovanju dronedarona pri človeku.
The effect of severe hepatic impairment on the pharmacokinetics of dronedarone was not assessed (see section 4.3).
Vpliv hude okvare jeter na farmakokinetiko dronedarona ni ocenjen (glejte poglavje 4.3).
However, ability to drive and use machines may be affected by adverse reactions such as fatigue.
Vendar lahko na sposobnost vožnje in upravljanja s stroji vplivajo neželeni učinki, kot je utrujenost.
No clinical data are available regarding the co-administration of these medicinal products in AF patients.
Klinični podatki o sočasnem jemanju teh zdravil pri bolnikih z atrijsko fibrilacijo niso na voljo.
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).
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).
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%).
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%).
Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure.
Ponavljajoči se odmerki 200 mg ketokonazola na dan so povzročili 17-kratno povečanje izpostavljenosti dronedaronu.
• Permanent AF with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician
• Permanentna (trajna) AF ki traja 6 mesecev ali dlje (ali njeno trajanje ni znano) in zdravnik ne predvideva več poskusov za obnovitev sinusnega ritma.
Erythromycin, an oral macrolide, may induce torsades de pointes and, as such, is contraindicated (see section 4.3).
Eritromicin, peroralen makrolid, lahko povzroči torsades de pointes in je zato kontraindiciran (glejte poglavje 4.3).
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.
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).
Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved (see section 4.4).
Priporočljivi so kliničen nadzor, nadzor EKG in biološki nadzor, odmerek digoksina pa je treba prepoloviti (glejte poglavje 4.4).
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
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
Liver injury
Poškodba jeter
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.
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.
Dronedarone has, therefore, the potential to interact on medicinal products substrates of P-glycoproteins, CYP 3A4 or CYP 2D6.
Zato lahko dronedaron medsebojno deluje z zdravili, ki so substrati P-glikoproteinov, CYP 3A4 ali CYP 2D6.
The interaction of dronedarone on calcium antagonists is described above (see section 4.4).
Kalcijevi antagonisti Medsebojna delovanja dronedarona s kalcijevimi antagonisti so opisana zgoraj (glejte poglavje 4.4).
No interaction was observed between dronedarone and metformin, an OCT1 and OCT2 substrate.
Medsebojno delovanje z metforminom (substrat OCT1 in OCT2) Medsebojnega delovanja med dronedaronom in metforminom, substratoma OCT1 in OCT2, niso opazili.
This problem should be corrected before starting treatment with MULTAQ,
To težavo morate odpraviti, preden začnete zdravljenje z zdravilom MULTAQ.
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.
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.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
This rate should be considered in the context of the underlying elevated incidence of CHF in AF patients.
To pogostnost je treba ocenjevati v okviru osnovno povečane incidence kongestivnega srčnega popuščanja pri bolnikih z AF.
Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved.
Priporočljivo je klinično, elektrokardiografsko in biološko nadziranje; odmerek digoksina je treba prepoloviti.
Lower starting dose and maintenance doses of statins should be considered and patients monitored for clinical signs of muscular toxicity.
V poštev pridejo manjši začetni odmerek in manjši vzdrževalni odmerki statinov, bolnike pa je treba kontrolirati glede kliničnih znakov toksičnih učinkov na mišice.
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.
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.
In such cases dronedarone should be stopped (see sections 4.3 and 4.4).
V takšnih primerih je treba zdravljenje z dronedaronom prekiniti (glejte poglavji 4.3 in 4.4).
• Severe renal impairment (CrCl <30 ml/min)
• Huda okvara ledvic (očistek kreatinina < 30 ml/min).
In an in vitro study MAO contributed to the metabolism of the active metabolite of dronedarone.
V študiji in vitro je MAO pripomogla k presnovi aktivnega presnovka dronedarona.
In the 5 placebo controlled studies, CHF occurred in the dronedarone group with rates comparable with placebo (very commonly, 11.2% versus 10.9%).
V 5 s placebom kontroliranih študijah se je zastojno srčno popuščanje v skupini z dronedaronom pojavilo podobno pogosto kot v skupini s placebom (zelo pogosto, 11,2 % v primerjavi z 10,9 %).
Patients should be warned to avoid grapefruit juice beverages while taking dronedarone.
Grenivkin sok Bolnike je treba opozoriti, naj se med jemanjem dronedarona izogibajo napitkom z grenivkinim sokom.
Patients should immediately report any symptoms of potential liver injury (such as sustained new-onset abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching) to their physician.
Bolniki morajo svojega zdravnika nemudoma obvestiti o vsakem možnem simptomu okvare jeter (npr. trajajočih novonastalih bolečinah v trebuhu, anoreksiji, navzei, bruhanju, zvišani telesni temperaturi, splošnem slabem počutju, zlatenici, temnem urinu ali srbenju).
• some medicines against blood clot formation such as warfarin,
• nekatera zdravila za preprečevanje nastanka krvnih strdkov kot varfarin,
Since dronedarone is a weak inhibitor of CYP 2D6 in humans, it is predicted to have limited interaction on antidepressant medicinal products metabolised by CYP 2D6.
Dronedaron pri človeku šibko zavira CYP 2D6, zato ima predvidoma malo medsebojnih delovanj z antidepresivnimi zdravili, ki se presnovijo s CYP 2D6.
Patients should be followed for the development of left ventricular systolic dysfunction during treatment.
Bolnike je treba kontrolirati glede nastanka sistolične disfunkcije levega prekata med zdravljenjem.
Therefore, inhibitors and inducers of CYP 3A4 have the potential to interact on dronedarone.
Zaradi tega lahko zaviralci in induktorji CYP 3A4 medsebojno delujejo z dronedaronom.
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.
Ponavljajoči se odmerki eritromicina (500 mg trikrat na dan 10 dni) so povzročili 3,8-kratno povečanje izpostavljenosti dronedaronu v stanju dinamičnega ravnovesja.
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
* ≥ 10 % pet dni po začetku zdravljenja (glejte poglavje 4.4) # > 450 msec pri moških oz. > 470 msec pri ženskah (glejte poglavje 4.4)
• other skin problems such as redness of the skin or eczema (redness, itching, burning or blistering),
• druge težave s kožo, npr. pordelost kože ali ekcem (rdečina, srbenje, pekoč občutek ali nastajanje mehurjev),
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%).
Študija PALLAS je bila randomizirana, s placebom kontrolirana študija, ki je preučevala klinično korist dronedarona 400 mg dvakrat na dan poleg standardnega zdravljenja pri bolnikih s permanentno (kronično) atrijsko fibrilacijo in dodatnimi dejavniki tveganja (bolniki s kongestivnim srčnimi popuščanjem ~69 %, koronarno boleznijo srca ~41 %, predhodno možgansko kapjo ali TIA ~27 %, iztisni delež levega prekata [LVEF] ≤ 40 % ~20,7 % in bolnikih, starih 75 let ali več s hipertenzijo in sladkorno boleznijo ~18 %).
• some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin,
• nekatera zdravila za epilepsijo (fenobarbital, karbamazepin ali fenitoin),
Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - France
Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - Francija
• ritonavir (a medicine for AIDS infection),
• ritonavirja (zdravilo za aids),
Due to the pharmacokinetic interaction and possible pharmacodynamic interaction, beta-blockers should be used with caution concomitantly with dronedarone.
Zaradi farmakokinetičnih in možnih farmakodinamičnih medsebojnih delovanj je treba zaviralce beta uporabljati previdno, kadar so uporabljeni istočasno z dronedaronom.
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).
- Pomožne snovi v jedru tablete so hipromeloza (E464), koruzni škrob, krospovidon (E1202), poloksamer 407, laktoza monohidrat (glejte poglavje 2 razdelek »Zdravilo MULTAQ vsebuje laktozo«, brezvodni koloidni silicijev dioksid, magnezijev stearat (E572).
Patients ranged in age from 20 to 88 years, with the majority being Caucasian (97%), male (69%) patients.
Bolniki so bili stari od 20 do 88 let; večina je bila belcev (97 %) in moških (69 %).
• some tranquilising medicines called phenothiazines,
• nekaterih pomirjeval, imenovanih fenotiazini,
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.
Število smrti zaradi kateregakoli vzroka je bilo med potekom študije v skupini z dronedaronom (116/2301) primerljivo tistemu v skupini s placebom (139/2327).
100x1 film-coated tablets
100 x 1 filmsko obložena tableta
The active substance is dronedarone.
- Zdravilna učinkovina je dronedaron.