FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended to monitor renal function periodically and to consider further investigations as needed.
Danish: Det anbefales at monitorere nyrefunktionen regelmæssigt og overveje yderligere undersøgelser hvis nødvendigt.
English: Hepatotoxicity are concerned by the additional minimization measures.
Danish: Hepatotoksicitet er omfattet af de yderligere minimeringsforanstaltninger
English: It is recommended to perform ECGs serially, at least every 6 months.
Danish: Det anbefales af tage ekg løbende, mindst hver 6. måned.
English: MULTAQ and some other medicines can affect each other and cause serious side effects.
Danish: MULTAQ og andre typer medicin kan påvirke hinanden og medføre alvorlige bivirkninger.
English: Patients developing permanent AF during treatment
Danish: Patienter, der udvikler permanent AF under behandlingen
English: Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical assistance
Danish: Kontakt straks lægen, hvis du oplever nogle af de følgende bivirkning - du kan have brug for akut lægehjælp
English: It non-competitively antagonises adrenergic activities (Class II).
Danish: Det antagoniserer adrenerge aktiviteter non-kompetitivt (klasse II).
English: AF recurrence was 63.5% versus 42%, respectively.
Danish: Tilbagevenden af AF var henholdsvis 63,5% mod 42%.
English: The content and format of the MULTAQ Prescriber guide, together with the communication and distribution plan should be agreed with the National Competent Authority in each Member State prior to distribution.
Danish: Indholdet og formatet af MULTAQ ordinationsvejledningen samt kommunikations- og distributionsplanen skal godkendes af den relevante nationale myndighed i hver medlemsstat før distribution.
English: There was no increased risk of hypotension, bradycardia and heart failure.
Danish: Der var ingen øget risiko for hypotension, bradykardi eller hjerteinsufficiens.
English: Treatment should be supportive and based on symptoms.
Danish: Behandlingen skal være støttende og baseret på symptomer.
English: There are no or limited amount of data from the use of dronedarone in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af dronedaron til gravide kvinder.
English: Do not use this medicine if you notice any visible sign of deterioration (see section 6).
Danish: Brug ikke dette lægemiddel, hvis der er synlige tegn på nedbrydning (se punkt 6).
English: In some cases, MULTAQ treatment may need to be stopped.
Danish: I nogle tilfælde kan det være nødvendigt at stoppe behandlingen med MULTAQ.
English: Management of plasma creatinine increase
Danish: Håndtering af stigning i plasmakreatinin
English: The tablet cannot be divided into equal doses.
Danish: Tabletten kan ikke deles i to lige store doser.
English: The primary endpoint of the study was the time to first hospitalisation for cardiovascular reasons or death from any cause.
Danish: Det primære endepunkt i studiet var tiden indtil første hospitalsindlæggelse på grund af kardiovaskulære årsager, eller død af enhver årsag.
English: It is recommended to measure plasma creatinine values prior to and 7 days after initiation of dronedarone.
Danish: Det anbefales at måle plasmakreatininværdierne før og 7 dage efter initiering af dronedaron.
English: Follow up, including ECG (electrocardiogram), is recommended during treatment.
Danish: Opfølgning, inklusive ekg (elektrokardiogram) anbefales under behandling.
English: Patients who received amiodarone within 4 weeks prior to randomisation were not included.
Danish: Patienter, der har modtaget amiodaron inden for 4 uger før randomiseringen, blev ikke inkluderet.
English: 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.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterkort og pakning efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life.
Danish: Der bør tages hensyn til, at amiodaron kan have en lang virkningsvarighed efter seponering på grund af dets lange halveringstid.
English: No clinical data are available regarding the co-administration of these medicinal products in AF patients.
Danish: Der er ingen kliniske data tilgængelige vedrørende co-administrationen af disse lægemidler hos AF-patienter.
English: It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat.
Danish: Det tilhører en gruppe lægemidler, der hedder antiarytmika, som hjælper med at regulere dit hjertes slag.
English: • Your doctor may look at your heart's electrical activity using an ECG (electrocardiogram)
Danish: • Din læge kan se på hjertets elektriske aktivitet ved hjælp af ekg-udstyr (elektrokardiogram).
English: The mean exposure across studies was 13 months.
Danish: Gennemsnitseksponeringen på tværs af studierne var 13 måneder.
English: • It is not known if MULTAQ passes into your breast milk.
Danish: • Det vides ikke om MULTAQ passerer over i modermælken.
English: There is limited information on the optimal timing to switch from amiodarone to dronedarone.
Danish: Der foreligger begrænset dokumentation om optimal timing af skift fra amiodaron til dronedaron.
English: Liver function tests should be performed prior to initiation of treatment with dronedarone, after one week and after one month following initiation of treatment and then repeated monthly for six months, at months 9 and 12, and periodically thereafter.
Danish: Der bør udføres leverfunktionstest før behandling med dronedaron påbegyndes, en uge og en måned efter initiering af behandlingen og derefter hver måned i 6 måneder, i måned 9. og 12. og periodisk derefter.
English: If an increase in creatininaemia is observed, serum creatinine should be re-measured after a further 7 days.
Danish: Hvis der observeres en stigning i kreatinin, skal serumkreatinin måles efter yderligere 7 dage.
English: These changes are linked to the therapeutic effect of dronedarone and do not reflect toxicity.
Danish: Disse ændringer er forbundet med dronedarons terapeutiske effekt og afspejler ikke toksicitet.
English: • Allergic reactions, including swelling of the face, lips, mouth, tongue or throat.
Danish: • allergiske reaktioner, herunder hævelser i ansigtet, læberne, munden, tungen eller halsen.
English: These effects most likely result from its electrophysiological properties belonging to all four Vaughan-Williams classes.
Danish: Disse effekter er sandsynligvis resultatet af dets elektrofysiske egenskaber, der tilhører alle fire VaughanWilliamsklasser.
English: • Your doctor may check your lungs.
Danish: • Din læge vil måske kontrollere dine lunger.
English: • MULTAQ is not recommended if you are pregnant or you think you may be pregnant.
Danish: • MULTAQ anbefales ikke, hvis du er gravid, eller hvis du overvejer at blive gravid.
English: • you have a problem that gives you a low level of potassium or magnesium in your blood.
Danish: • du lider af en sygdom, der medfører et lavt niveau af kalium eller magnesium i dit blod.
English: Children and adolescents MULTAQ is not recommended in children and adolescents below 18 years of age.
Danish: Børn og unge MULTAQ anbefales ikke til børn og unge under 18 år.
English: • you have breathlessness or non-productive cough.
Danish: • du bliver stakåndet eller har uproduktiv hoste.
English: Anaphylactic reactions including angioedema
Danish: Anafylaktiske reaktioner, herunder angioødem
English: Dermatitis allergic Dermatitis
Danish: Dermatitis, allergisk Dermatitis
English: MULTAQ with food and drink
Danish: Brug af MULTAQ sammen med mad og drikke
English: • Bradycardia <50 beats per minute (bpm)
Danish: • Bradykardi <50 slag pr. minut
English: Lactose is a type of sugar.
Danish: Lactose er en sukkerart.
English: • rifampicin - for tuberculosis.
Danish: • rifampicin - mod tuberkulose.
English: • your atrial fibrillation becomes permanent while you are taking MULTAQ.
Danish: • din atrieflimren bliver permanent, mens du tager MULTAQ.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager, har gjort det for nylig eller måske vil tage anden medicin.
English: The results of one of the blood tests to check kidney function (blood creatinine levels) may be changed by MULTAQ.
Danish: Resultatet af en af disse blodprøver, som kontrollerer nyrefunktionen (blodkreatinin-niveauet), kan være ændret på grund af MULTAQ.
English: • Patients with liver and lung toxicity related to the previous use of amiodarone
Danish: • Patienter med lever- og lungetoksicitet relateret til tidligere anvendelse af amiodaron.
English: In the event of overdose, monitor the patient's cardiac rhythm and blood pressure.
Danish: I tilfælde af overdosering skal patientens hjerterytme og blodtryk overvåges.
English: Appropriate investigation and close observation of patients should continue until normalisation of ALT.
Danish: Der skal udføres relevante undersøgelser og tæt observation af patienten, indtil ALAT er normaliseret.
English: In the pooled data from EURIDIS and ADONIS as well as in the individual trials, dronedarone consistently delayed the time to first recurrence of AF/AFL (primary endpoint).
Danish: I de poolede data fra EURIDIS og ADONIS såvel som i de individuelle studier forsinkede dronedaron gennemgående den første tilbagevenden af AF/AFL (primært endepunkt).
English: Monitoring of co-administered medicinal products like digoxin and anti-coagulants is necessary.
Danish: Monitorering af samtidigt administrerede lægemidler såsom digoxin og antikoagulantia er påkrævet.
English: It can increase the blood levels of dronedarone and may increase your chance of getting side effects.
Danish: Det kan øge blodets indhold af dronedaron, og kan øge din risiko for at få bivirkninger.
English: If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: Hvis en dosis ikke indtages, skal patienten tage den næste dosis som planlagt og ikke fordoble dosis.
English: A total of 504 patients with documented AF were randomised, 249 received dronedarone and 255 received amiodarone.
Danish: I alt blev 504 patienter med dokumenteret AF randomiseret, 249 modtog dronedaron, og 255 modtog amiodaron.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: <1/10); ikke almindelig (>1/1.000 til <1/100), sjælden (>1/10.000 til <1/1.000); meget sjælden <1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If no further increase in creatininaemia is observed, this value should be used as the new reference baseline taking into account that this may be expected with dronedarone.
Danish: Hvis der ikke observeres yderligere stigning i kreatinin, skal denne værdi bruges som ny baseline (reference), idet dette kan forventes ved behandling med dronedaron.
English: Patients could be in AF/AFL or in sinus rhythm after spontaneous conversion or following any procedures.
Danish: Patienter kunne ved inklusionen være i AF/AFL eller i sinusrytme efter spontan konvertering eller efter en hvilken som helst procedure.
English: In ATHENA study, the maximum follow-up was 30 months.
Danish: Den maksimale follow-up var 30 måneder i ATHENA-studiet.
English: In the event of overdose, treatment should be supportive and directed toward alleviating symptoms.
Danish: I tilfælde af overdosering skal behandlingen være støttende og rettet mod at lindre symptomer.
English: Your doctor may change the dose of any other medicines you are taking.
Danish: Din læge kan ændre dosis af en hvillken som helst anden medicin du tager.
English: Your doctor will take this into account when checking your blood levels and will use another reference of the “normal” value of blood creatinine.
Danish: Din læge vil tage højde for dette i sin vurdering af blodprøven og vil bruge en anden standardværdi for blodkreatinin.
English: While you are taking MULTAQ, your doctor may perform tests to check your medical condition and how the medicine is working for you.
Danish: Mens du tager MULTAQ, vil din læge muligvis udføre nogle undersøgelser for at tjekke din sygdomstilstand og for at se, hvordan medicinen virker på dig.
English: It is unknown whether dronedarone and its metabolites are excreted in human milk.
Danish: Det er ukendt, om dronedaron og dets metabolitter udskilles i human mælk.
English: Dronedarone displays indirect antiadrenergic effects and partial antagonism to adrenergic stimulation.
Danish: Dronedaron udviser indirekte antiadrenerge effekter og delvis antagonisme mod adrenerg stimulation.
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.
Danish: Der er dog spontant blevet indrapporteret tilfælde af rabdomyolyse, når dronedaron blev givet i kombination med et statin (simvastin i særdeleshed), og derfor skal samtidig brug af statiner ske med forsigtighed.
English: If any of the above apply to you, do not take MULTAQ.
Danish: Hvis noget af det ovenstående gælder for dig, må du ikke tage MULTAQ.
English: Other antiarrhythmic medicinal products had to be withdrawn for at least 5 plasma half-lives prior to the first administration.
Danish: Andre antiarytmika skulle seponeres i mindst 5 plasmahalveringstider før første administration.
English: Administration of dronedarone to patients receiving digoxin will bring about an increase in the plasma digoxin concentration and thus precipitate symptoms and signs associated with digoxin toxicity.
Danish: Administration af dronedaron til patienter, der får digoxin, vil medføre en forhøjet digoxinplasmakoncentration og dermed fremskynde symptomer og tegn associeret med digoxin-toksicitet.
English: The Prescriber Guide should display information to help physician assess whether the patient is eligible for MULTAQ prescription and whether the patient remains within the prescribing information.
Danish: Ordinationsvejledningen skal indeholde information, som hjælper lægen til at vurdere, om patienten er berettiget til MULTAQ behandling og om patienten forbliver inden for ordinationsoplysningerne.
English: While taking MULTAQ, tell your doctor if
Danish: Mens du er i behandling med MULTAQ, fortæl din læge, hvis
English: The marketing authorisation holder shall ensure that Health care professionals who intend to prescribe or dispense MULTAQ are provided or have access to the most recent version of SmPC and MULTAQ Prescriber guide.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at læger, som vil ordinere eller udlevere MULTAQ, får eller har adgang til den seneste version af SmPC og MULTAQ ordinationsvejledning.
English: The N-debutyl metabolite exhibits pharmacodynamic activity but is 3 to 10-times less potent than dronedarone.
Danish: N-debutylmetabolitten udviser farmakodynamisk aktivitet, men er 3-10 gange mindre potent end dronedaron.
English: Patients had at least one ECG-documented AF/AFL episode during the last 3 months and were in sinus rhythm for at least one hour and were followed for 12 months.
Danish: Patienterne havde mindst én ekg-dokumenteret AF/AFL-hændelse i løbet af de sidste 3 måneder, var i sinusrytme i mindst en time, og blev fulgt gennem 12 måneder.
English: After intravenous administration the volume of distribution at steady state (Vss) ranges from 1,200 to 1,400 L.
Danish: Efter intravenøs administration er fordelingsvoluminet ved steady-state (Vss) fra 1.200 til 1.400 L.
English: Pharmacotherapeutic group: cardiac therapy, antiarrhythmics class III, ATC code: C01BD07
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, antiarytmikum klasse III, ATC-kode: C01BD07
English: Tell your doctor, he/she will check your lung.
Danish: Fortæl din læge det, han/hun vil kontrollere dine lunger.
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.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Patients should be carefully evaluated for symptoms of Congestive Heart Failure.
Danish: Patienterne bør nøje evalueres for symptomer på kongestiv hjerteinsufficiens.
English: Your doctor will consider all available treatment options before prescribing MULTAQ to you.
Danish: Din læge vil overveje alle tilgængelige behandlingsmuligheder før MULTAQ ordineres til dig.
English: It also prevents ventricular tachycardia and ventricular fibrillation in several animal models.
Danish: Det forebygger også ventrikulær takykardi og ventrikelflimren i adskillige dyremodeller.
English: Similar results were obtained on the incidence of cardiovascular hospitalisation with a risk reduction of 25.5% (p <0.0001).
Danish: Lignende resultater blev opnået på forekomsten af kardiovaskulær hospitalsindlæggelse med en risikoreduktion på 25,5% (p <0,0001).
English: • telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
Danish: • telithromycin, erythromycin eller clarithromycin (antibiotika mod infektioner),
English: Dronedarone decreases arterial blood pressure and myocardial contractility (dP/dt max) with no change in left ventricular ejection fraction and reduces myocardial oxygen consumption.
Danish: Dronedaron sænker det arterielle blodtryk, og myokardiel kontraktilitet (dP/dt max) uden ændring i venstre ventrikulær ejection fraction, og reducerer myokardiets iltforbrug.
English: • bepridil for chest pain caused by heart disease,
Danish: • bepridil mod brystsmerter pga. hjertesygdom,
English: The median time from randomised to first AF/AFL recurrence in the dronedarone group was 116 days, i.e. 2.2-fold longer than in the placebo group (53 days).
Danish: Mediantiden fra randomisering til første tilbagevenden af AF/AFL i dronedarongruppen var 116 dage, dvs. 2,2 gange længere end i placebogruppen (53 dage).
English: Dronedarone had no genotoxic effects, based on one in vivo micronucleus test in mice and four in vitro tests.
Danish: Dronedaron havde ingen genotoksisk effekt, baseret på en in vivo mikronucleustest i mus, og fire in vitro tests.
English: Adverse reactions are presented by system organ class.
Danish: Bivirkninger vises udfra systemorganklasse.
English: • Permanent AF with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician
Danish: • Permanent AF med en varighed af AF på ≥6 måneder (eller ukendt varighed) og forsøg på at genetablere sinusrytmen ikke længere overvejes af lægen.
English: Dronedarone could increase plasma concentrations of immunosupressants (tacrolimus, sirolimus, everolimus and cyclosporine).
Danish: Dronedaron kan øge plasmakoncentrationen af immunsuppressiva (tacrolimus, sirolimus, everolimus og ciclosporin).
English: It also inhibits the sodium currents (Class Ib) and the calcium currents (Class IV).
Danish: Det hæmmer også natriumstrømmen (klasse Ib), og calciumstrømmen (klasse IV).
English: In patients who were taking amiodarone, an ECG was to be performed about 4 hours after the first administration to verify good tolerability.
Danish: Hos de patienter der fik amiodaron, skulle ekg udføres ca. 4 timer efter første administration for at sikre god tolerabilitet.
English: In patients, dronedarone and its metabolite are completely eliminated from the plasma within 2 weeks after the end of a 400 mg twice daily-treatment.
Danish: Hos patienter bliver dronedaron og dets metabolitter fuldstændigt elimineret fra plasma indenfor 2 uger efter ophørt behandling med 400 mg to gange daglig.
English: The recommended dose is 400 mg twice daily in adults.
Danish: Den anbefalede dosis er 400 mg to gange daglig hos voksne.
English: Dronedarone has vasodilatory properties, in coronary arteries (related to the activation of the nitric oxide pathway) and in peripheral arteries.
Danish: Dronedaron har vasodilaterende egenskaber i koronararterierne (relateret til aktiveringen af nitrogenoxidpathway) og i perifere arterier.
English: Effect of dronedarone on other medicinal products
Danish: Dronedarons effekt på andre lægemidler
English: Onset of dyspnoea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically.
Danish: Nyopstået dyspnø eller uproduktiv hoste kan være relateret til pulmonal toksicitet, og patienterne bør nøje evalueres klinisk.
English: This problem should be corrected before starting treatment with MULTAQ,
Danish: Dette problem skal behandles, inden du begynder på behandlingen med MULTAQ,
English: It reduces alpha-adrenergic blood pressure response to epinephrine and beta1 and beta2 responses to isoproterenol.
Danish: Det nedsætter det alfaadrenerge blodtryksrespons på adrenalin, og beta1 og beta2 respons på isoprenalin.
English: If this applies to you (or you are not sure), please talk to your doctor or pharmacist before taking MULTAQ.
Danish: Hvis dette gælder for dig (eller du er i tvivl), skal du tale med din læge eller spørge på apoteket, før du tager MULTAQ.
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.
Danish: 4.3 og 4.4) bør MULTAQ kun ordineres, når alternative behandlingsmuligheder er overvejet.
English: White, oblong shaped tablets, engraved with a double wave marking on one side and “4142”code on the other side.
Danish: Hvide, aflange tabletter, præget med to bølger på den ene side og koden ”4142” på den anden side.
English: Gender, age and weight are factors that influence the pharmacokinetics of dronedarone.
Danish: Faktorer som køn, alder og vægt kan influere dronedarons farmakokinetik.
English: If you think that your medicine is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du tror, at din medicin er for kraftig eller for svag, skal du tale med din læge eller spørge på apoteket.
English: Recurrences of AF (including absence of conversion) were more frequent in the dronedarone group, whereas premature study drug discontinuations due to intolerance were more frequent in the amiodarone group.
Danish: Tilbagevenden af AF (inklusive udeblivelse af konvertering) forekom hyppigere i dronedarongruppen, hvorimod for tidlig seponering af studielægemiddel på grund af intolerance eller mangel på effekt forekom hyppigere i amiodarongruppen.
English: After oral administration, approximately 6% of the labelled dose is excreted in urine mainly as metabolites (no unchanged compound excreted in urine) and 84% are excreted in faeces mainly as metabolites.
Danish: Efter oral administration bliver ca. 6 % af den mærkede dosis udskillet i urinen, primært som metabolitter (ingen udskillelse af uomdannet stof i urinen) og 84 % bliver udskillet i fæces, primært som metabolitter.
English: The majority had hypertension (86%) and structural heart disease (60%) (including coronary artery disease: 30%; congestive heart failure (CHF): 30%; LVEF<45%: 12%).
Danish: Størstedelen havde hypertension (86 %) og strukturel hjertesygdom (60 %) (inklusive koronararteriel sygdom: 30 %; hjerteinsufficiens (CHF): 30 %; LVEF <45 %: 12 %).
English: The DIONYSOS study compared the efficacy and safety of dronedarone (400 mg twice daily) versus amiodarone (600 mg daily for 28 days, then 200 mg daily thereafter) over 6 months.
Danish: DIONYSOS-studiet sammenlignede effekten og sikkerheden af dronedaron (400 mg to gange daglig) mod amiodaron (600 mg daglig i 28 dage, derefter 200 mg daglig) over 6 måneder.