FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up.
Danish: I undersøgelsen i Bangladesh var Dukorals beskyttende virkning 85 % i løbet af de første seks måneders opfølgning.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort.
Danish: Almindeligvis forekommer der ikke bivirkninger ved Dukoral, men følgende bivirkninger ses dog hos mellem 1 og 10 patienter ud af 1 000: hovedpine, diarré og mavepine, mavekramper, skvulpen i maven (luft i maven) eller ubehag i maven.
English: For the full list of side effects reported with Dukoral, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Dukoral fremgår af indlægssedlen.
English: In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up.
Danish: I den første af de to undersøgelser i Peru var Dukorals beskyttende virkning 85 % under de første fem måneders opfølgning.
English: The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%.
Danish: Den anden undersøgelse i Peru viste, at Dukorals beskyttende virkning efter en boosterdosis under det andet års opfølgning var 61 %.
English: What is Dukoral?
Danish: Hvad er Dukoral?
English: The length of protection was different for adults and children, lasting for six months in children and for two years in adults.
Danish: Varigheden af beskyttelsen var forskellig for voksne og børn.
English: What is Dukoral used for?
Danish: Hvad anvendes Dukoral til?
English: What benefit has Dukoral shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dukoral?
English: Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease.
Danish: Der bør tages hensyn til, hvor kolera findes, og risikoen for at få sygdommen.
English: How has Dukoral been studied?
Danish: Hvordan blev Dukoral undersøgt?
English: How is Dukoral used?
Danish: Hvordan anvendes Dukoral?
English: In all three studies, the main measure of effectiveness was the ‘protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo.
Danish: Den blev beregnet ved at sammenligne antallet af deltagere i undersøgelsen, som udviklede kolera efter at have fået Dukoral og efter at have fået placebo.
English: How does Dukoral work?
Danish: Hvordan virker Dukoral?
English: Further information on Brinavess can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/brinavess.
Danish: Yderligere information om Brinavess findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/brinavess.
English: The dose of Brinavess depends on the patient's body weight.
Danish: Dosen af Brinavess afhænger af patientens legemsvægt.
English: As for all medicines, data on the use of Brinavess are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Brinavess løbende overvåget.
English: Brinavess received a marketing authorisation valid throughout the European Union on 01 September
Danish: Brinavess fik en markedsføringstilladelse med gyldighed i hele EU den 1. september 2010.
English: The healthcare professional should monitor the patient's blood pressure and heart rate while the medicine is being given and for at least 15 minutes afterwards.
Danish: Sundhedspersonalet bør overvåge patientens blodtryk og hjerterytme, mens lægemidlet gives og i mindst 15 minutter derefter.
English: What measures are being taken to ensure the safe and effective use of Brinavess?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Brinavess?
English: If the blood pressure or heart rate suddenly decreases the infusion should be stopped immediately.
Danish: Hvis blodtrykket eller hjertefrekvensen pludselig falder, bør infusionen stoppes øjeblikkeligt.
English: The European Medicines Agency decided that Brinavess's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Brinavess opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Brinavess
Danish: Andre oplysninger om Brinavess
English: An overview of Brinavess and why it is authorised in the EU
Danish: En oversigt over Brinavess, og hvorfor det er godkendt i EU
English: Why has Brinavess been authorised in the EU?
Danish: Hvorfor er Brinavess godkendt i EU?
English: If the heart rhythm has not returned to normal 15 minutes after the end of the first infusion, a second, smaller dose may be given.
Danish: Hvis hjerterytmen ikke er faldet til et normalt niveau 15 minutter efter, at den første infusion er blevet givet, kan der gives en anden mindre dosis.
English: What is Brinavess and what is it used for?
Danish: Hvad er Brinavess, og hvad anvendes det til?
English: Patients on Brinavess must not be given medicines called ‘class I and III anti-arrhythmics' intravenously during the four hours before or after their Brinavess infusion.
Danish: Patienter, der tager Brinavess må ikke få lægemidler kaldet "klasse I- og III-antiarytmika" intravenøst i løbet af fire timer før eller efter deres infusion med Brinavess.
English: Side effects reported with Brinavess are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Brinavess vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The company that markets Brinavess will ensure that healthcare professionals expected to use the medicine are provided with educational material explaining how the medicine should be used.
Danish: Virksomheden, der markedsfører Brinavess, vil sikre, at sundhedspersonale, som forventes at anvende lægemidlet, får udleveret informationsmateriale om, hvordan lægemidlet bør anvendes.
English: Brinavess must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate.
Danish: Brinavess må ikke anvendes til patienter med svær aortastenose (forsnævring af hovedpulsåren), lavt systolisk blodtryk (blodtrykket, når hjertet trækker sig sammen), fremskredent hjertesvigt (når hjertet ikke pumper tilstrækkeligt blod rundt i kroppen), visse typer af ændret elektrisk aktivitet i hjertet eller meget langsom hjerterytme.
English: For more information about using Brinavess, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Brinavess, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation.
Danish: Ved at blokere disse kanaler kan vernakalant forebygge anormal elektrisk aktivitet, der kan medføre atrieflimren.
English: Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).
Danish: Vernakalant virker hovedsagelig i atrierne frem for i ventriklerne (hjertets nedre kamre).
English: Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks).
Danish: Brinavess må ikke gives inden for 30 dage efter akut koronarsyndrom (en gruppe af hjerteproblemer, der omfatter ustabil angina og hjerteanfald).
English: Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes.
Danish: Brinavess er en opløsning, som gives ved infusion (drop) i en vene i løbet af 10 minutter.
English: It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria.
Danish: Det genopretter en normal hjerterytme ved at blokere de kanaler, hvorigennem ladede partikler af kalium og natrium bevæger sig ind og ud af muskelcellerne i de øvre atrier.
English: Brinavess contains the active substance vernakalant hydrochloride.
Danish: Brinavess indeholder det aktive stof vernakalanthydrochlorid.
English: What are the risks associated with Brinavess?
Danish: Hvilke risici er der forbundet med Brinavess?
English: Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic.
Danish: Brinavess indeholder vernakalant, en type stof, der kaldes et antiarytmika.
English: The most common side effects with Brinavess (which may affect more than 1 person in 10) are dysgeusia (taste disturbances) and sneezing.
Danish: De hyppigste bivirkninger ved Brinavess (som optræder hos flere end 1 ud af 10 patienter) er dysgeusi (smagsforstyrrelser) og nysen.
English: Brinavess is to be used for atrial fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery.
Danish: Brinavess skal anvendes til behandling af flimren, som er startet inden for de seneste syv dage, eller inden for de seneste tre dage, hvis patienten for nylig har gennemgået en hjerteoperation.
English: Brinavess can only be obtained with a prescription and should be given by a qualified healthcare professional in a setting where the patient's heart can be properly monitored.
Danish: Brinavess udleveres kun på recept og skal administreres af kvalificeret sundhedspersonale i behandlingsfaciliteter, hvor patientens hjerte kan overvåges på en korrekt måde.
English: Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation.
Danish: Brinavess er et lægemiddel, der anvendes til hurtigt at genetablere normal hjerterytme hos voksne patienter, der for nylig er begyndt at have atrieflimren.
English: In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo.
Danish: I de to første studier blandt de patienter, som for nylig var begyndt at lide af atrieflimren, blev hjerterytmen normal igen hos 51 % af de patienter, der blev behandlet med Brinavess (118 ud af 231), sammenlignet med 4 % (6 ud af 159) af de patienter, der fik placebo.
English: Patients should not be given more than 5 mg of Brinavess per kg body weight within any 24-hour period, or a maximum of 565 mg in patients weighing more than 113 kg.
Danish: Der bør højst gives 565 mg til patienter, der vejer over 113 kg.
English: In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.
Danish: I det tredje studie blev hjerterytmen normal igen hos 47 % af de patienter, der blev behandlet med Brinavess, sammenlignet med 14 % af placebo-patienterne.
English: Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation.
Danish: Brinavess var mere effektivt end placebo til behandling af patienter, som for nylig var begyndt at lide af atrieflimren.
English: The main measure of effectiveness was the proportion of patients whose heart rhythm returned to normal.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, hvis hjerterytme blev normal igen.
English: A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery.
Danish: I et tredje hovedstudie blev Brinavess sammenlignet med placebo hos 161 voksne, som havde haft atrieflimren efter en hjerteoperation.
English: Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm.
Danish: Atrieflimren forekommer, når atrierne (hjertes forkamre) trækker sig hurtigt og uregelmæssigt sammen og medfører en abnorm hjerterytme.
English: How is Brinavess used?
Danish: Hvordan anvendes Brinavess?
English: For the full list of side effects of Brinavess, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Brinavess fremgår af indlægssedlen.
English: What benefits of Brinavess have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Brinavess?
English: How does Brinavess work?
Danish: Hvordan virker Brinavess?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brinavess have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Brinavess.
English: In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment).
Danish: Brinavess blev sammenlignet med placebo (en virkningsløs behandling) i to hovedstudier, der omfattede 596 voksne med atrieflimren.
English: Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Indgivelsesvej
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mysimba on 26 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Mysimba den 26. marts 2015.
English: Mysimba naltrexone / bupropion
Danish: Mysimba naltrexon / bupropion
English: This is a summary of the European public assessment report (EPAR) for Mysimba.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mysimba.
English: The full EPAR and risk management plan summary for Mysimba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Mysimba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Mysimba
Danish: Andre oplysninger om Mysimba
English: A risk management plan has been developed to ensure that Mysimba is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Mysimba anvendes så sikkert som muligt.
English: Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Danish: Patienterne i undersøgelserne fik lægemidlet som et led i et vægttabsprogram, hvor de fik rådgivning om diæt og motion.
English: Mysimba should also be stopped if patients have not lost at least 5% of their initial body weight after 4 months of treatment.
Danish: Behandlingen med Mysimba bør ligeledes standses, hvis patienten ikke har tabt mindst 5 % af sin oprindelige legemsvægt efter fire måneders behandling.
English: Mysimba is a medicine used along with diet and exercise to help manage weight in adults:
Danish: Mysimba er et lægemiddel, der sammen med diæt og motion anvendes til vægtkontrol hos voksne:
English: Prolonged-release means that naltrexone and bupropion are released slowly from the tablet over a few hours.
Danish: At det er depottabletter, betyder, at naltrexon og bupropion frigives langsomt fra tabletten i løbet af nogle timer.
English: Mysimba contains the active substances naltrexone and bupropion, which are licensed individually in the EU for other uses.
Danish: Mysimba indeholder de aktive stoffer naltrexon og bupropion, der hver for sig er godkendt i EU til andre anvendelser.
English: • who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, or high blood pressure.
Danish: • som er overvægtige (BMI mellem 27 og 30) og har vægtrelaterede komplikationer såsom sukkersyge, abnormt højt fedtindhold i blodet eller for højt blodtryk.
English: Mysimba is available as prolonged-release tablets containing 7.2 mg naltrexone and 78 mg bupropion and can only be obtained with a prescription.
Danish: Mysimba leveres som depottabletter med 7,2 mg naltrexon og 78 mg bupropion og udleveres kun efter recept.
English: In the other study, in which patient counselling was also more intensive, the overall weight loss was greater over the study period: 8.1% with Mysimba and 4.9% with placebo.
Danish: I den anden undersøgelse, hvor patientrådgivningen også var mere intensiv, var det overordnede vægttab større i løbet af undersøgelsen: 8,1 % med Mysimba, og 4,9 % med placebo.
English: What measures are being taken to ensure the safe and effective use of Mysimba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mysimba?
English: The exact way that Mysimba works is not fully understood, but the two active substances, naltrexone and bupropion, act on the parts of the brain that control food intake and energy balance, as well as reducing the effect of the part of the brain that controls the pleasure associated with eating food.
Danish: Det vides ikke nøjagtigt, hvordan Mysimba virker, men de to aktive stoffer, naltrexon og bupropion, virker på de dele af hjernen, der styrer fødeindtagelsen og energibalancen, og nedsætter virkningen på de dele af hjernen, der styrer tilfredshedsfølelsen ved fødeindtagelse.
English: What is Mysimba and what is it used for?
Danish: Hvad er Mysimba, og hvad anvendes det til?
English: The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea and vomiting (feeling and being sick) and constipation; dizziness and dry mouth were also common (seen in up to 1 patient in 10).
Danish: De hyppigste bivirkninger med Mysimba (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme, opkastning og forstoppelse; svimmelhed og mundtørhed var også almindelige (forekommer hos op til 1 ud af hver 10 patienter).
English: The treatment effect was more marked in patients who completed 56 weeks of treatment, or who had lost at least 5% of their original body weight by 4 months.
Danish: Virkningen af behandlingen var mere markant hos patienter, der gennemførte 56 ugers behandling eller havde tabt mindst 5 % af deres oprindelige legemsvægt efter 4 måneder.
English: Interim data from an ongoing study of cardiovascular outcomes were reviewed during the assessment although the CHMP also recommended ongoing monitoring of the medicine's cardiovascular effects.
Danish: Under vurderingen blev der gennemgået en igangværende undersøgelse af hjerte-karudfald, men CHMP anbefalede også løbende overvågning af lægemidlets hjertekarvirkninger.
English: Why is Mysimba approved?
Danish: Hvorfor er Mysimba blevet godkendt?
English: What are the risks associated with Mysimba?
Danish: Hvilke risici er der forbundet med Mysimba?
English: Regarding safety, although the CHMP had some concerns about possible effects on the heart and blood vessels (cardiovascular outcomes) and a slightly increased risk of seizures (fits), the most common side effects were largely manageable, as patients could stop taking the medicine if they were bothersome.
Danish: Vedrørende sikkerheden havde CHMP visse betænkeligheder ved de mulige hjerte-karvirkninger (kardiovaskulære udfald) og en let forhøjet risiko for krampeanfald; i hovedsagen kunne de fleste bivirkninger dog håndteres, da patienten kunne holde op med at tage lægemidlet, hvis bivirkningerne var belastende.
English: It is not intended to provide practical advice on how to use Mysimba.
Danish: Det er ikke en praktisk vejledning i, hvordan Mysimba bør anvendes.
English: In addition, the company that markets Mysimba will produce an information pack for doctors prescribing the medicine, including guidance on stopping treatment in patients who do not respond or if there are concerns about side effects.
Danish: Desuden skal den virksomhed, der markedsfører Mysimba, udarbejde en informationspakke til de læger, der udskriver lægemidlet, herunder vejledning om at standse behandlingen ved manglende virkning eller ved betænkelighed ved bivirkningerne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mysimba, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Mysimba, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: On the balance of the available evidence the CHMP decided that Mysimba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Mysimba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: For more information about treatment with Mysimba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mysimba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The effects of Mysimba in reducing body weight have been shown in 4 main studies involving around 4,500 obese or overweight patients, in which Mysimba was compared with placebo (a dummy treatment).
Danish: Mysimbas evne til at bevirke vægttab er påvist i 4 hovedundersøgelser med deltagelse af ca. 4 500 svært overvægtige eller overvægtige patienter, hvor Mysimba blev sammenlignet med virkningsløs behandling (placebo).
English: When given together, their actions reduce appetite and the amount that patients eat, and increase energy expenditure, helping them to stick to a calorie-controlled diet and to reduce their body weight.
Danish: Når de to stoffer gives sammen, nedsætter de appetitten og patientens fødeindtagelse og øger samtidig energiforbruget, så patienten lettere kan overholde sin kaloriefattige diæt og tabe sig i vægt.
English: The degree of improvement with Mysimba over placebo was similar using different methods of analysis, although the benefits were smallest with the most conservative methods that assumed patients who did not complete the study would not have seen any improvement.
Danish: Der var bedring med Mysimba i forhold til placebo uanset analysemetoden, men fordelen var mindre med den mest forsigtige beregningsmetode, der forudsatte, at der ikke ville være bedring hos de patienter, der ikke gennemførte undersøgelsen.
English: Treatment with Mysimba is started with a single tablet each morning, with the dose gradually increased over 4 weeks to the recommended dose of two tablets twice a day, preferably taken with food.
Danish: Derefter sættes dosis i løbet af fire uger gradvis op til den anbefalede dosis, dvs. to tabletter to gange dagligt, fortrinsvis sammen med et måltid.
English: For the full list of all side effects reported with Mysimba, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Mysimba fremgår af indlægssedlen.
English: It will also carry out a further study to assess the effect of the medicine on the heart and blood vessels.
Danish: Virksomheden skal derudover udføre en yderligere undersøgelse af lægemidlets hjerte-karvirkninger.
English: Some 46% and 30% of patients given Mysimba achieved 5 and 10% weight reductions respectively, compared with 34% and 17% respectively with placebo.
Danish: Godt 46 % og 30 % af de patienter, der fik Mysimba, opnåede et vægttab på hhv. 5 og 10 %, sammenholdt med hhv. 34 % og 17 % med placebo.