natgillin/translations-raw huggingface dataset:
• Ustabil hæmodynamisk tilstand 
• Patients in unstable hemodynamic conditions
Farmakodynamisk virkning 
Pharmacodynamic properties
Ageusi 
Ageusia
4.3, 4.4 og 5.1) Dosisjustering anses ikke for nødvendig, selvom et farmakokinetisk studie udført med raske individer viste øget plasmakoncentration hos ældre kvinder (se pkt. 
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).
• visse typer kolesterolsænkende medicin (såsom simvastatin, lovastatin, atorvastatin eller rosuvastatin), 
• some medicines for reducing the cholesterol in your blood (such as simvastatin, lovastatin,
Moderate/svage CYP3A4-inhibitorer: Calciumantagonister 
Moderate/weak CYP 3A4 inhibitors
Hos ældre patienter ≥75 år med multiple komorbiditeter skal kliniske tegn på hjerteinsufficiens og EKG 
In elderly patients ≥75 years with multiple co-morbidities, clinical signs of heart failure and ECG should be monitored on a regular basis (see sections 4.2 and 5.1).
Desuden kan verapamil og diltiazem ud fra et farmakodynamisk synspunkt potentielt interagere med dronedaron, på grund af deres evne til at nedsætte hjertefrekvensen. 
Moreover, due to their heart rate-lowering properties, verapamil and diltiazem have the potential to interact with dronedarone from a pharmacodynamic point of view.
Ikke almindelig (≥ 1/1.000 to < 1/100) 
Uncommon (1/1,000 to
Ved administration sammen med dronedaron anbefales monitorering af disse stoffers plasmakoncentration og passende dosisjustering. 
Monitoring of their plasma concentrations and appropriate dose adjustment is recommended in case of coadministration with dronedarone.
ACE eller AII receptor-antagonister Ja 
Losartan and other Angiotensin II Receptor Antagonists (AIIRAs)
• Screening af patienter før behandlingsstart - kontra indikation ved permanent atrieflimmer - kontra indikation ved tidligere eller nuværende hjertesvigt eller venstre ventrikel systolisk dysfunktion (LVSD) - forebyggelse af lægemiddelinteraktioner - lever, lunge og renal sikkerhed ved anvendelse. 
Screen patients before treatment initiation Contra indication of Permanent Atrial fibrillation Contra indication of history, or current heart failure or left ventricular systolic dysfunction (LVSD)
Bradykardi (se pkt. 
Bradycardia (see sections 4.3 and
4.4) # > 450 millisekunder for mænd, > 470 millisekunder for kvinder (se pkt. 
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
Opkastning Kvalme 
Fatigue Asthenia
LÆGEMIDLETS NAVN MULTAQ 400 mg filmovertrukne tabletter dronedaron 
NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets dronedarone
20 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100x1 filmovertrukne tabletter 
100x1 film-coated tablets
Sjælden (forekommer hos 1 til 10 patienter ud af 10.000) 
Rare (may affect up to 1 in 1,000 people)
Almindelig (forekommer hos 1 til 10 patienter ud af 100) 
Uncommon (may affect up to 1 in 100 people)
Det skal du vide, før du begynder at tage MULTAQ Sådan skal du tage MULTAQ Bivirkninger 
What MULTAQ is and what it is used for What you need to know before you take MULTAQ How to take MULTAQ
Hos patienter, der allerede er i behandling med calciumantagonister på det tidspunkt, hvor dronedaronbehandling påbegyndes, bør der udføres ekg, og calciumantagonist-dosis bør justeres om nødvendigt (se pkt. 
In patients already on calcium antagonists at time of dronedarone initiation, an ECG should be performed and the calcium antagonist dose should be adjusted if needed (see section 4.4).
der havde eller tidligere havde haft AF med yderligere risikofaktorer i ATHENA, der er et multicenter-, 
The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study.
Der bør tages ekg på patienter i behandling med calciumantagonister eller betablokkere, når dronedaron initieres, og dosis bør om nødvendigt justeres. 
In patients already on calcium antagonists or beta blockers at time of dronedarone initiation, an ECG should be performed and the dose should be adjusted if needed.
INFORMATION I BRAILLESKRIFT MULTAQ 400 mg 
MULTAQ 400 mg
Hos patienter der allerede er i behandling med betablokkere ved påbegyndelse af behandling med dronedaron, bør der udføres ekg, og dosis af betablokkeren bør justeres om nødvendigt (se pkt. 
In patients already taking beta-blockers at time of dronedarone initiation, an ECG should be performed and the betablocker dose should be adjusted if needed (see section 4.4).
• Lægemidler, der inducerer torsades de pointes såsom phenothiaziner, cisaprid, bepridil, tricykliske antidepressiva, terfenadin og visse orale makrolider såsom erythromycin, antiarytmika af klasse I og 
tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), Class I
Hvis du har taget for meget MULTAQ 
If you take more MULTAQ than you should
Træthed Asteni 
Renal impairment
Eesti sanofi-aventis Estonia OÜ 
France sanofi-aventis France
Calciumantagonister 
Tablet coat
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe 
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
• perikon - naturlægemiddel mod depression, 
• St John's Wort - a herbal medicine for depression,
MULTAQ indeholder: - Aktivt stof: dronedaron. 
The active substance is dronedarone.
Tlf.: +45 45 16 70 00 
Danmark Sanofi A/S Tlf: +45 45 16 70 00
Dronedaron kan øge plasmakoncentrationen af betablokkere, der metaboliseres af CYP2D6. 
Beta-blockers that are metabolised by CYP 2D6 can have their exposure increased by dronedarone.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 400 mg dronedaron (som hydrochlorid) Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 41,65 mg lactose (som monohydrat) Alle hjælpestoffer er anført under pkt. 
Each tablet also contains 41.65 mg of lactose (as monohydrate).
Mand 
MULTAQ.
Fra et farmakodynamisk synspunkt kan betablokkere desuden potentielt interagere med dronedaron. 
Moreover, beta-blockers have the potential to interact with dronedarone from a pharmacodynamic point of view.
Plasmakoncentrationen af ubundet dronedraron var fordoblet hos forsøgspersoner med moderat nedsat leverfunktion. 
In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
I kliniske studier blev denne bivirkning set med samme hyppighed hos de patienter, der fik MULTAQ, og de patienter, der fik uvirksom medicin (placebo). 
• Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving MULTAQ and in patients receiving placebo.
Tabel 1: Bivirkninger Systemorganklasse Meget almindelig 
System organ class
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 
PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets
Mave-tarm-kanalen 
Tablet core
Frankrig 
Malta
Strukturel hjertesygdom Ja 
Cardiac clinical symptoms
Den 16. December 2011 
16 December 2011
Europa-Kommissionen traf en afgørelse den 16. december 2011. 
The European Commission issued a decision on 16 December 2011.
Hvad er baggrunden for den aktuelle undersøgelse? 
What is the background to the current investigation?
Hvilke produkter berøres af gennemgangen? 
Which products are affected by the review?
Den irske lægemiddelstyrelse vil inspicere anlægget igen i oktober 2011, hvorefter anlægget vil gennemgå en 12-måneders “rekvalificeringsperiode”, hvor det regelmæssigt overvåges og produkterne nøje testes. 
The Irish medicines agency will inspect the plant again in October 2011 after which it will go through a 12-month ‘requalification period' where the plant will be carefully monitored and the products will undergo rigorous testing.
• Patienter, der ønsker yderligere oplysninger, bør kontakte lægen for at drøfte deres behandling. 
• Patients who have any questions should contact their doctors to discuss their treatment.
Udvalget vedtog desuden en strategi, der skal sikre tilstrækkelige forsyninger af produkter i EU, hvis problemerne gentager sig. 
The Committee also adopted a strategy to ensure adequate supply of products in the EU should problems reoccur in the future.
Udvalget tilsigtede imidlertid at mindske afhængigheden af anlægget og afgav derfor i januar 2011 anbefalinger for anvendelse af produkter importeret fra fire produktionsanlæg uden for EU (i Canada, USA, Singapore og Tyrkiet). 
However the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey).
Hvad er risikoen ved at blive udsat for endotoksiner? 
What are the risks of exposure to endotoxins?
Forbedringerne vedrører anlæggets konstruktion, nye rengøringsprocedurer og bedre testmetoder. 
These include changes to the design of the plant, new cleaning regimens and the introduction of improved testing methods.
Endotoksiner er skadelige stoffer (toksiner), der afgives fra bakterier, efter at de er døde. 
Endotoxins are harmful substances (toxins) released from bacteria after they have died.
Hvis en patient får medicin, der indeholder endotoksiner, er der risiko for at immunsystemet, kroppens forsvarssystem, reagerer mod endotoksinerne, så der opstår inflammation. 
If a patient receives a medicine that contains endotoxins, there is a risk that the immune system, the body's defence mechanism, will react against the endotoxins and cause inflammation.
De korrigerende foranstaltninger, der indføres i Castlebar, vil også blive indført på Baxters øvrige fremstillingssteder. 
The corrective measures being made at Castlebar will also be applied to Baxter's other manufacturing sites.
CHMP konkluderede, at den tilgrundliggende årsag til tilstedeværelsen af endotoksiner i de pågældende produktionslinjer var en kombination af flere forskellige faktorer: Uopdagede revner i udstyret kan have givet mulighed for bakterievækst, samtidig med at anlæggets konstruktion og de anvendte rengøringsmetoder kan have tilladt forureningen at sprede sig. 
The CHMP concluded that the root cause of the presence of endotoxins in the affected production lines was a combination of factors: undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread.
• De relevante sundhedspersoner skal fortsat overvåge dialysepatienter for alle bivirkninger, herunder aseptisk peritonitis, og indberette alle formodede tilfælde til virksomheden ved hjælp af indberetningsformularer udleveret af Baxter. 
• Healthcare professionals should continue to monitor dialysis patients for any adverse events including aseptic peritonitis and report any suspected cases to the company using the reporting forms that will be provided by Baxter.
Det Europæiske Lægemiddelagentur har foretaget en undersøgelse af fremstillingsprocesserne på Baxters anlæg i Castlebar, Irland. 
The European Medicines Agency has completed an investigation into the production processes at Baxter's manufacturing plant in Castlebar, Ireland.
Til sidst blev alle de berørte produkter fra Castlebar trin for trin tilbagekaldt i hele EU. 
All affected products from Castlebar were eventually recalled in stages across the EU.
Som led i den fremtidige risikostyringsplan vedtog udvalget, at nye produkter fra CastleBar skal underkastes intensiv overvågning af indberetninger om aseptisk peritonitis i de første måneder efter at være bragt på markedet. 
As part of the future risk management plan the Committee adopted proposals for a period of intense monitoring of any reports of aseptic peritonitis during the initial months of marketing new products from CastleBar.
Virksomheden rensede desuden de øvrige tanke og rørsystemer i produktionen. 
It also cleaned the other tanks and pipework involved in the production.
Det blev antaget, at endotoksinerne blev produceret af “biofilm” (lag af indbyrdes sammenhængende bakterier), som er meget modstandsdygtige mod rengøringsprocesser. 
It was believed that the endotoxins were being produced by ‘biofilms' (layers of bacteria that adhere to each other), which are very resistant to cleaning processes.
Det drejer sig om følgende: Dianeal, Extraneal og Nutrineal, peritonealdialysevæske, Monosol og en natriumchloridopløsning til hæmodialyse. 
These include: Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; Monosol and a sodium chloride solution for haemodialysis.
CHMP har iværksat denne gennemgang for at undersøge endotoksinforureningen til bunds og fremsætte anbefalinger til beskyttelse af folkesundheden og sikring af forsyningerne i fremtiden. 
The CHMP started the current review to investigate fully the issues related to the endotoxin contamination and to make recommendations to help protect public health and to prevent future supply shortages.
Til dette formål havde CHMP tidligere i løbet af undersøgelsen anbefalet, at de europæiske markedsføringstilladelser for produkterne blev ændret med formel tilføjelse af fremstillingsstederne i Canada, USA, Tyrkiet og Polen. 
In order to facilitate this, the CHMP had earlier during the investigation made recommendations to formally include the production sites in Canada, USA, Turkey and Poland in the products' marketing authorisations in Europe.
Dialysevæsker anvendes hos patienter med nyreproblemer til at rense blodet for affaldsstoffer (såsom urinstof). 
Dialysis solutions are used in patients with kidney problems to help clear waste substances (such as urea) from the blood.
Agenturet blev i december 2010 gjort opmærksom på tilstedeværelsen af endotoksiner i batcher af Dianeal, Extraneal og Nutrineal fremstillet på anlægget i Castlebar. 
The Agency was made aware of the presence of endotoxins in batches of Dianeal, Extraneal and Nutrineal made in the Castlebar plant in December 2010.
Agenturets udvalg for lægemidler til mennesker (CHMP) har udarbejdet anbefalinger, der skal sikre tilstrækkelige leverancer af sådanne dialysevæsker i EU, så længe man i Castlebar er i færd med at indføre foranstaltninger til at fremstille endotoksinfrie væsker. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised recommendations to ensure the adequate supply of these dialysis solutions in the EU while measures are being put in place at Castlebar to enable the production of endotoxin-free solutions.
CHMP konstaterede, at der på anlægget i Castlebar er ved at blive indført forbedringer for at sikre endotoksinfrie dialysevæsker. 
The CHMP noted that improvements are being made to Castlebar plant to ensure future production of endotoxin-free dialysis solutions.
Symptomerne på aseptisk peritonitis er uklar væske i dialyseposen, mavesmerter, kvalme, opkastning og undertiden feber. 
Symptoms of aseptic peritonitis include cloudy effluent (the solution in the drainage bag), abdominal pain, nausea (feeling sick), vomiting and sometimes fever.
Forud for undersøgelsen blev der i december 2010 fundet endotoksiner i dialysevæsker fremstillet på anlægget. 
The investigation follows the detection in December 2010 of endotoxins in dialysis solutions produced at the plant.
Trods disse foranstaltninger blev der igen fundet endotoksiner i nye batcher af væsker, der var fremstillet på anlægget. 
Despite these measures, endotoxins were still detected in new batches of solutions produced at the plant, causing the manufacture of these solutions to be shut down at the plant.
Denne gennemgang berører nogle at de dialysevæsker, der fremstilles på Baxters anlæg i Castlebar. 
The products affected by this review are some of the dialysis solutions produced at Baxter's Castlebar plant.
• Patienterne skal kontakte lægen, hvis de har mistanke om at have aseptisk peritonitis eller bemærker relevante symptomer (uklar væske i dialyseposen efter endt dialyse, mavesmerter, 
• Patients who suspect they have aseptic peritonitis or notice any relevant symptoms (cloudy effluent in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and fever) should contact their doctor.
Derfor kunne CHMP på daværende tidspunkt ikke tilbagekalde alle de pågældende produkter fra anlægget i Castlebar. 
Due to the lack of sufficient alternative sources for dialysis solutions, the CHMP could not recall all affected products from the Castlebar plant at that time.
Herved forstås inflammation af bughinden (peritoneum), som kan påvirke bughindens evne til at filtrere blodet. 
In particular, endotoxins in solutions used in peritoneal dialysis can cause ‘aseptic peritonitis', an inflammation of the peritoneum that may affect the way it filters the blood.
Det kan være nødvendigt at standse dialysen, indtil den aseptiske peritonitis er svundet. 
Aseptic peritonitis can force the patient to stop dialysis until it is resolved.
Dengang konstaterede virksomheden, at den tilgrundliggende årsag til problemet var endotoksinproducerende bakterier i to tanke. 
At the time, the company identified endotoxin-producing bacteria in two tanks as the root cause of the problem and removed the tanks from the production line.
Virksomheden gennemfører desuden et observationsstudie af lægemidlets langsigtede sikkerhed. 
The company is also carrying out an observational study on the long-term safety of the medicine.
Daxas fik en markedsføringstilladelse med gyldighed i hele EU den 5. juli 2010. 
Daxas received a marketing authorisation valid throughout the EU on 5 July 2010.
Denne fordel sås i tillæg til virkningen af de behandlinger, som patienterne i forvejen fik. 
This benefit was seen on top of the effects of the treatments that the patients were already receiving.
Tabletterne skal tages på samme klokkeslæt hver dag. 
The tablets should be taken at the same time each day.
Yderligere information om Daxas findes på agenturets websted under: ema.europa/Find medicine/Human medicine/European public assessment reports. 
Further information on Daxas can be found on the Agency's website: ema.europa/Find medicine/Human medicine/European public assessment reports.
Ved begyndelsen af undersøgelserne havde begge patientgrupper et FEV1 på ca. 1 liter (1 000 ml). 
At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Patienter, der var begyndt med lavere dosis, fik færre bivirkninger. 
Patients started on the lower dose had fewer side effects.
Patienterne kunne fortsætte behandlingen med en bronkodilator i studiets varighed. 
The patients could continue to receive treatment with a bronchodilator during the study.
Daxas indeholder det aktive stof roflumilast. 
Daxas contains the active substance roflumilast.
Som for alle lægemidler, er data vedrørende brug af Daxas løbende overvåget. 
As for all medicines, data on the use of Daxas are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Daxas? 
What measures are being taken to ensure the safe and effective use of Daxas?
For mere information om brug af Daxas, se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Daxas, see the package leaflet or contact your doctor or pharmacist.
En oversigt over Daxas, og hvorfor det er godkendt i EU 
An overview of Daxas and why it is authorised in the EU
Patienterne vil muligvis skulle tage Daxas 500 µg i flere uger, før det begynder at virke. 
Patients may need to take Daxas 500 micrograms for several weeks before it starts to have an effect.
Lægen kan afbryde behandlingen med Daxas, hvis patienten får for stort vægttab. 
The doctor may stop treatment with Daxas if the patient loses too much weight.
Studierne omfattede over 3.000 voksne med svær KOL, som havde haft mindst én episode af forværring af sygdommen i det forløbne år. 
These involved over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
På baggrund af alle foreliggende data om lægemidlets virkninger konkluderede agenturet, at fordelene ved Daxas opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
After considering all of the available data on the effects of the medicine, the Agency decided that Daxas's benefits are greater than its risks and it can be authorised for use in the EU.
Bivirkninger rapporteret for Daxas vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Daxas are carefully evaluated and any necessary action taken to protect patients.
Daxas må ikke anvendes hos patienter med moderate eller svære leverproblemer. 
Daxas must not be used in patients who have moderate or severe problems with their liver.
Ved at blokere virkningen af PDE4 nedsætter roflumilast inflammationen i lungerne, hvilket mindsker patientens symptomer eller forhindrer forværring af dem. 
By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.
Virksomheden, der fremstiller Daxas, skal sikre, at sundhedspersoner, der ordinerer lægemidlet i alle EU's medlemsstater, får udleveret uddannelsesmateriale, der indeholder oplysninger om lægemidlets bivirkninger og om, hvordan det skal bruges. 
The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Andre oplysninger om Daxas 
Other information about Daxas:
Daxas (500 µg) er påvist at være mere effektivt end placebo (en uvirksom behandling) til behandling af KOL i to hovedstudier. 
Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies.
Det Europæiske Lægemiddelagentur bemærkede, at der er behov for nye typer behandling af KOL, og at hovedstudierne viste en beskeden fordel af ved Daxas 500 µg hos patienter med svær KOL. 
The European Medicines Agency noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD.
Ca. 18 % (81 af 441 patienter) af de patienter, der begyndte med 250 µg dagligt, udgik af studiet sammenlignet med 25 % (109 af 443) af de patienter, der begyndte med 500 µg dagligt. 
Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily.
Det blokerer virkningen af enzymet PDE4, som medvirker til den inflammationsproces, der fører til KOL. 
It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD.
De hyppigste bivirkninger ved Daxas (som optræder hos mellem 1 og 10 ud af 100 patienter) er vægttab, nedsat appetit, søvnbesvær, hovedpine, diarré, kvalme og mavesmerter. 
The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Hvorfor blev Daxas godkendt i EU? 
Why is Daxas authorised in the EU?
Fordelene i form af forbedret FEV1 var ens i begge grupper i slutningen af studiet, men patienter, der ikke kunne tage 500 µg dagligt, og som da kun fik 250 µg dagligt, udviste ingen bedring i lungefunktionen. 
The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.
Daxas fås som tabletter (250 µg og 500 µg) og udleveres kun efter recept. 
Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.
Hvad er Daxas, og hvad anvendes det til? 
What is Daxas and what is it used for?