natgillin/translations-raw huggingface dataset:
Dronedaron medførte udprægede effekter på embryo-føtal udvikling ved høje doser i rotter, såsom øget afstødning af implantater, reduceret vægt af foster og placenta, samt eksterne viscerale og skeletale misdannelser.
Dronedarone caused marked effects on embryo-foetal development at high doses in rats, such as increased post-implantation losses, reduced foetal and placental weights, and external, visceral and skeletal malformations.
- hvis du har eller har haft en lidelse, hvor hjertet ikke kan pumpe blodet rundt i kroppen, så godt som det burde (en tilstand, der kaldes hjertesvigt).
- 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).
• Du skal stoppe med at tage dine tabletter og straks tale med din læge, hvis du bliver gravid, mens du er i behandling med MULTAQ.
• Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking
Klinisk signifikante INR-stigninger (≥5), som regel inden for 1 uge efter opstart af dronedaron, blev imidlertid rapporteret hos patienter, som tog orale antikoagulantia.
However, clinically significant INR elevations (≥5) usually within 1 week after starting dronedarone were reported in patients taking oral anticoagulants.
Læs indlægssedlen for at få mere information.
See leaflet for further information.
• diarré, udtalt opkastning, da det kan føre til nyreproblemer,
• Diarrhoea, vomiting when excessive as it can lead to kidney problems.
De hyppigste årsager til ophør af behandlingen med dronedaron var gastrointestinale forstyrrelser (3,2 % af patienter mod 1,8 % i placebogruppen).
The most common reasons for discontinuation of therapy with dronedarone were gastrointestinal disorders (3.2% of patients versus 1.8% in the placebo group).
Hvis du har fået indopereret en pacemaker for dette problem, kan du anvende MULTAQ, - hvis du har meget lav puls (under 50 slag pr. minut), - hvis dit ekg (elektrokardiogram) viser et hjerteproblem, der kaldes ”forlænget QT-korrigeret interval” (intervallet er længere end 500 millisekunder), - hvis du har en type atrieflimren, der kaldes permanent atrieflimren (AF).
If you have had a pacemaker fitted for this problem, you can use MULTAQ, - if you have a very slow heart beat (less than 50 beats a minute), - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds), - if you have a type of atrial fibrillation called permanent atrial fibrillation (AF).
De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at dronedaron og dets metabolit udskilles i mælk.
Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk.
Den hyppigst observerede bivirkning ved dronedaron 400 mg to gange daglig i de 5 studier var diarré (9%), kvalme (5%) og opkastning (2%), træthed og asteni (7%).
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%).
Patienterne rangerede i alderen fra 20 til 88 år, heraf var størstedelen af kaukasisk afstamning (97%), mænd (69%).
Patients ranged in age from 20 to 88 years, with the majority being Caucasian (97%), male (69%) patients.
Dronedaron og dets N-debutylmetabolits in vitro-plasmaproteinbinding er henholdsvis 99,7 % og 98, 5 %, og er ikke mætbar.
The in vitro plasma protein binding of dronedarone and its N-debutyl metabolite is 99.7% and 98.5% respectively and is not saturable.
• Du må ikke tage MULTAQ, hvis du er kvinde i den fødedygtige alder, og du ikke anvender pålidelig prævention.
• Do not take MULTAQ if you are a woman able to have children and you are not using a reliable contraceptive method.
• ændringer i smagssansen.
• change in how things taste.
Patienter med symptomer på hjerteinsufficiens under hvile eller under minimal fysisk anstrengelse inden for den foregående måned, eller patienter der har været indlagt for hjerteinsufficiens inden for den foregående måned.
Patients with symptoms of heart failure at rest or with minimal exertion within the previous month or who were hospitalised for heart failure during the previous month
Det øger effektive refraktære perioder (ERP) af atriet, atrioventrikulæreknude-ERP, og ventrikulær ERP med minimal grad af omvendt frekvensafhængighed.
It increases effective refractory periods (ERP) of the atrium, atrio-ventricular node, and ventricular ERP was slightly prolonged with a minimal degree of reverse frequency dependency.
Nedsat nyrefunktion forventes ikke at ændre dronedarons farmakokinetik, da intet uændret stof blev udskillet i urinen, og kun ca. 6 % af dosis blev udskillet i urinen som metabolitter (se pkt.
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).
I visse tilfælde rapporteredes også forhøjet blod urea nitrogen sandsynligvis pga. hypoperfusion sekundært til udvikling af hjerteinsufficiens (præ-renal azotæmi).
Some cases also reported increases in blood urea nitrogen possibly due to hypoperfusion secondary to developing CHF (pre-renal azotaemia).
• dabigatran (medicin til forebyggelse af blodpropper).
• dabigatran (a medicine for prevention of blood clot formation).
Den farmakologiske effekt af dronedaron kan inducere en moderat forlængelse (ca. 10 millisekunder) af QTc Bazett interval, relateret til den forlængede repolarisering.
The pharmacological action of dronedarone may induce a moderate QTc Bazett prolongation (about 10 msec), related to prolonged repolarisation.
Det er ukendt, hvorvidt dronedaron og/eller dets metabolitter kan fjernes ved dialyse (hæmodialyse, peritonealdialyse eller hæmofiltrering).
It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).
Hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter, skal du tale med din læge, inden du tager dette lægemiddel.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Patienter skulle have mindst én risikofaktor (inklusive alder, hypertension, diabetes, tidligere cerebrovaskulær hændelse, diameter af venstre forkammer ≥50 mm eller LVEF < 0,40), sammen med AF/AFL og sinusrytme, begge dokumenteret inden for de sidste 6 måneder.
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.
• anden medicin mod forhøjet blodtryk, mod brystsmerter pga. hjertesygdom eller andre hjerteproblemer, såsom verapamil, diltiazem, nifedipin, metoprolol, propranol eller digoxin,
• other medicines for high blood pressure, for chest pain caused by heart disease, or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin,
Effekten af nedsat nyrefunktion på dronedarons farmakokinetik er ikke blevet undersøgt i et specifikt studie.
The effect of renal impairment on dronedarone pharmacokinetics has not been evaluated in a specific study.
Du skal fortælle det til lægen eller sige det på apoteket, hvis du tager noget af følgende medicin:
You must tell your doctor or pharmacist if you are taking any of the following medicines:
Sammenlignet med placebo sænkede dronedaron risikoen for første tilbagevenden af AF/AFL i løbet af de 12 måneder studierne varede med 25% (p= 0,00007).
As compared to placebo, dronedarone lowered the risk of first AF/AFL recurrence during the 12-month study period by 25% (p = 0.00007).
MULTAQ må ikke gives til patienter med systolisk dysfunktion af venstre ventrikel eller til patienter med eksisterende eller tidligere episoder af hjerteinsufficiens.
MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
a: Bestemt ud fra Cox regressionsmodel b: P-værdi af interaktion mellem baselinekarakteristika og behandling baseret på Cox regressionsmodel c: Calciumantagonister med nedsættende effekt på hjertefrekvensen begrænset til diltiazem, verapamil og bepridil
a Determined from Cox regression model b P-value of interaction between baseline characteristics and treatment based on Cox regression model c Calcium antagonists with heart rate lowering effects restricted to diltiazem, verapamil and bepridil
Patienter med permanent atrieflimren
Patients with permanent atrial fibrillation
Patienterne skal informeres om at kontakte en læge, hvis de udvikler eller oplever tegn eller symptomer på hjerteinsufficiens, såsom vægtøgning, behandlingsrelateret ødem eller forværret dyspnø.
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.
Der blev ikke observeret fald i ethinylestradiol og levonorgestrel hos raske forsøgspersoner, der modtog dronedaron (800 mg to gange daglig) samtidigt med orale kontraceptiva.
No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives.
En antal patienter havde tidligere været eksponeret for amiodaron (se pkt.
A number of patients had been previously exposed to amiodarone (see section 4.4).
Reduktionen i kardiovaskulær indlæggelse eller død af vilkårlig årsag var konsistent i alle undergrupper, uanset baseline-karakteristika eller lægemidler (ACE-hæmmere eller AIIRA'er; beta-blokkere, digitalis, statiner, calciumantagonister, diuretika) (se figur 1).
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).
Der var en svag interaktion mellem dronedaron og statiner transporteret af OATP, såsom rosuvastatin (hvilket resulterede i en 1,4-fold stigning i rosuvastatins plasmakoncentration).
There was a weak interaction between dronedarone and statins transported by OATP, such as rosuvastatin (which resulted in a mean 1.4-fold increase in rosuvastatin exposure).
Stigning i kreatinin bør ikke nødvendigvis føre til seponering af ACE-hæmmere eller angiotensin IIreceptorantagonister (AIIRAer).
An increase in creatininaemia should not necessarily lead to the discontinuation of treatment with ACE inhibitors or Angiotensin II Receptors Antagonists (AIIRAs).
Erythromycin, et oralt makrolid, kan inducere torsades de pointes og er derfor kontraindiceret (se pkt.
Erythromycin, an oral macrolide, may induce torsades de pointes and, as such, is contraindicated (see section 4.3).
Patienterne skal følges for udvikling af systolisk dysfunktion af venstre ventrikel under behandlingen.
Patients should be followed for the development of left ventricular systolic dysfunction during treatment.
Hos patienter i alderen 65 år eller over er plasmakoncentrationen af dronedaron 23 % højere sammenlignet med patienter under 65 år.
In patients aged 65 years of age and over, dronedarone exposures are 23% higher in comparison with patients aged below 65 years of age.
Halveringstiden for den terminale elimination af dronedaron er ca. 25-30 timer og 20-25 timer for dets N-debutylmetabolit.
The terminal elimination half-life of dronedarone is around 25-30 hours and that of its N-debutyl metabolite around 20-25 hours.
Efter intravenøs administration er plasmaclearance mellem 130 og 150 L/t.
After intravenous administration the plasma clearance of dronedarone ranges from 130 to 150 L/h.
Hos patienter med koronararteriesygdom, skal kliniske tegn på hjerteinsufficiens og EKG overvåges regelmæssigt for at påvise tidlige tegn på hjerteinsufficiens.
In patients with coronary artery disease, clinical signs of heart failure and ECG should be regularly monitored to detect early signs of heart failure.
EU/1/09/591/001 20 filmovertrukne tabletter EU/1/09/591/002 50 filmovertrukne tabletter EU/1/09/591/003 60 filmovertrukne tabletter EU/1/09/591/004 100x1 filmovertrukne tabletter
EU/1/09/591/001 20 film-coated tablets EU/1/09/591/002 50 film-coated tablets EU/1/09/591/003 60 film-coated tablets EU/1/09/591/004 100x1 film-coated tablets
Det skal besluttes, om amning eller behandling med MULTAQ skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MULTAQ therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
MULTAQ indeholder et aktivt stof, der hedder dronedaron.
MULTAQ contains an active substance named dronedarone.
Erytem (inklusive erytema og erytematøst udslæt) Eksem
Erythemas (including erythema and rash erythematous) Eczema
• anden medicin der bruges til at behandle uregelmæssige eller hurtige hjerteslag såsom flecainid,
• other medicines used to control an irregular or fast heart beat such as flecainide, propafenone,
Farmakokinetikken for dronedaron og dets Ndebutylmetabolit afviger begge moderat fra dosisproportionalitet: En fordobling af dosis resulterer i en stigning på ca. 2,5-3 gange i Cmax og AUC.
The pharmacokinetics of dronedarone and its N-debutyl metabolite both deviate moderately from dose proportionality: a 2-fold increase in dose results in an approximate 2.5- to 3.0-fold increase with respect to Cmax and AUC.
Dronedaron forebygger atrieflimren eller genskaber normal sinusrytme i dyr, afhængigt af den anvendte model.
In animals, dronedarone prevents atrial fibrillation or restores normal sinus rhythm depending on the model used.
Dronedaron besidder intet særligt potentiale til at inhibere CYP1A2, CYP2C9, CYP2C19, CYP2C8 eller CYP2B6.
Dronedarone has no significant potential to inhibit CYP 1A2, CYP 2C9, CYP 2C19, CYP 2C8 and CYP 2B6.
I et in vitro-studie bidrog MAO til metabolismen af dronedarons aktive metabolit.
In an in vitro study MAO contributed to the metabolism of the active metabolite of dronedarone.
Kongestiv hjerteinsufficiens (se nedenfor)
Cardiac disorders Congestive heart failure (see below)
Der observeredes øget forekomst af tumorer i mælkekirtler hos hunmus, histiocytiske sarkomer hos mus og hæmangiomer på mesenterial lymfeknudeniveau hos rotter, alle udelukkende ved højeste testede dosis (svarende til en plasmakoncentration på 5-10 gange terapeutisk dosis hos mennesker).
Observations were increased incidence of mammary gland tumors in female mice, histiocytic sarcomas in mice and hemangiomas at the mesenteric lymph node level in rats, all at the highest tested dose only (corresponding to an exposure of 5 to 10 times that of the human therapeutic dose).
Efter gentagen administration af 400 mg to gange daglig opnås steady-state inden for 4-8 dage, og den gennemsnitlige akkumulationsrate for dronedaron går fra 2,6 til 4,5.
After repeated administration of 400 mg twice daily, steady state is reached within 4 to 8 days of treatment and the mean accumulation ratio for dronedarone ranges from 2.6 to 4.5.
Patienter med koronararteriesygdom
Patients with coronary artery disease
I kliniske studier fik 13 % af patienterne calciumantagonister samtidigt med dronedaron.
In clinical studies, 13% of patients received calcium antagonists concomitantly with dronedarone.
Dog kan din evne til at køre bil og bruge maskiner påvirkes af bivirkninger som træthed.
However, your ability to drive and use machines may be affected by side effects such as tiredness.
Da dronedaron er en svag inhibitor af CYP2D6 i mennesker, antages dronedaron i begrænset omfang at interagere med antidepressiva der metaboliseres af CYP2D6.
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.
• visse typer medicin mod blodpropper såsom warfarin,
• some medicines against blood clot formation such as warfarin,
I studier om kronisk toksicitet, blev der observeret en mindre reversibel fosfolipidose (akkumulation af skumlignende makrofager) i mesenterale lymfeknuder, hovedsageligt i rotter.
In chronic toxicity studies, slight and reversible phospholipidosis (accumulation of foamy macrophages) was observed in mesenteric lymph nodes mainly in the rat.
Dersom lungetoksicitet bekræftes, bør behandlingen seponeres.
If pulmonary toxicity is confirmed, treatment should be discontinued.
Du skal synke tabletten hel med et glas vand i forbindelse med et måltid.
Swallow the tablet whole with a drink of water during a meal.
Der er spontant indrapporteret tilfælde af nyopstået eller forværret hjerteinsufficiens under behandling med dronedaron.
There have been spontaneously reported events of new or worsening heart failure during treatment with dronedarone.
• betændelse (inflammation) i blodkarrene (vasculitis inklusive leukocytoklastisk vasculitis).
• inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).
Pantoprazol (40 mg én gang daglig), et lægemiddel der øger pH i mavesækken uden effekt på cytokrom P450, gav ingen signifikant ændring i dronedarons farmakokinetik.
Pantoprazole (40 mg once daily), a medicinal product which increases gastric pH without any effect on cytochrome P450, did not interact significantly on dronedarone pharmacokinetics.
Vasculitis, inklusive leukocytoklastisk vasculitis.
Vasculitis, including leukocytoclastic vasculitis
Vurdering af interne faktorer såsom køn eller alder på forekomsten af spontane bivirkninger viste en øget forekomst af en hvilken som helst bivirkning og af alvorlige bivirkninger forbundet med køn (kvindelige patienter).
Assessment of intrinsic factors such as gender or age on the incidence of any treatment emergent adverse reactions showed an interaction for gender (female patients) for the incidence of any adverse reactions and for serious adverse reactions.
Dabigatran Når dabigatranetexilat 150 mg en gang daglig blev co-administreret med dronedaron 400 mg to gange daglig, blev dabigatran AUC0-24 og Cmax øget med henholdsvis 100 % og 70 %.
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.
• 2. eller 3. grads atrioventrikulær blok, komplet grenblok, distalt blok, sinusknudedysfunktion,
• Second- or third- degree atrio-ventricular block, complete bundle branch block, distal block,
Dronedaron er en moderat inhibitor af CYP3A4 og en svag inhibitor af CYP2D6 og en potent inhibitor af P-glykoproteiner (P-gp).
Dronedarone is a moderate inhibitor of CYP 3A4, a mild inhibitor of CYP 2D6 and a potent inhibitor of P-glycoproteins (P-gp).
Du skal tale med din læge og beslutte om du vil tage MULTAQ eller amme.
You and your doctor should decide if you will take MULTAQ or breastfeed.
• du har en lidelse, hvor de kar, der forsyner hjertet med blod, bliver hårde og forsnævrede (forkalkning af kranspulsårene).
• you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease).
• ritonavir (medicin mod aids),
• ritonavir (a medicine for AIDS infection),
Behandling med dronedaron kan påbegyndes hos ambulante patienter.
Treatment with dronedarone can be initiated in an outpatient setting.
ledningsdefekt i atrier eller syg sinus-syndrom (gælder ikke ved brug i forbindelse med fungerende pacemaker)
sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
Lavere start- og vedligeholdelsesdoser af statiner bør overvejes, og patienter bør monitoreres for kliniske tegn på muskeltoksicitet.
Lower starting dose and maintenance doses of statins should be considered and patients monitored for clinical signs of muscular toxicity.
Monoaminoxidaser medvirker delvist til metaboliseringen af dronedarons aktive metabolit (se pkt 4.5).
Monoamine Oxidases contribute partially to the metabolism of the active metabolite of dronedarone (see section 4.5).
EU/1/09/591/001 - pakninger med 20 filmovertrukne tabletter EU/1/09/591/002 - pakninger med 50 filmovertrukne tabletter EU/1/09/591/003 - pakninger med 60 filmovertrukne tabletter EU/1/09/591/004 - pakninger med 100x1 filmovertrukne tabletter
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
Dog kan proarytmiske effekter forekomme i særlige tilfælde, såsom ved samtidig behandling med lægemidler der begunstiger arytmi og/eller elektrolytforstyrrelser (se pkt.
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).
Antiarytmika af klasse I eller III (såsom flecainid, propafenon, quinidin, disopyramid, dofetilid, sotalol, amiodaron) skal seponeres, inden behandling med dronedaron påbegyndes.
Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone.
Du må ikke tage noget af følgende medicin sammen med MULTAQ:
You must not take any of the following with MULTAQ:
Et klinisk studie med patienter med permanent AF (AF-varighed mindst 6 måneder) og kardiovaskulære risikofaktorer blev stoppet før tid på grund af øget forekomst af kardiovaskulær død, apopleksi og hjerteinsufficiens hos de patienter, der fik dronedaron (se pkt.
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).
Hvis QTc Bazett intervallet er ≥ 500 msek., bør dronedaron seponeres (se pkt.
If QTc Bazett interval is ≥500 milliseconds, dronedarone should be stopped (see section 4.3).
Efter oral administration i ikke-fastende tilstand opnås peak plasmakoncentration af dronedaron og dets hovedmetabolit (N-debutylmetabolit) inden for 3-6 timer.
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.
Respiratoriske, torakale og mediastinale sygdomme
Respiratory, thoracic and mediastinal disorders
MULTAQ er en hvid, oval, filmovertrukket tablet (tablet) med en dobbeltbølge på den ene side, og ”4142” på den anden side.
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.
Dronedaron er kontraindiceret hos patienter med alvorlig nyreinsufficiens (kreatininclearance <30 ml/min) (se pkt.
Dronedarone is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min) (see section 4.3).
Der blev oftere observeret bradykardi i kliniske studier, når dronedaron blev givet i kombination med betablokkere.
In clinical studies, bradycardia was more frequently observed when dronedarone was given in combination with beta-blockers.
MULTAQ er indiceret til opretholdelse af sinusrytme hos voksne, klinisk stabile patienter med paroksystisk eller persisterende atrieflimren (AF) efter vellykket kardiovertering.
MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF).
Rifampicin (600 mg en gang daglig) nedsatte plasmakoncentrationen af dronedaron med 80 % uden nogen særlig ændring i plasmakoncentrationen af den aktive metabolit.
Rifampicin (600 mg once daily) decreased dronedarone exposure by 80% with no major change on its active metabolite exposure.