FrancophonIA/ELRC3.0 huggingface dataset:
English: The ability of Menveo to trigger the production of antibodies (immunogenicity) was assessed in a main study involving almost 4,000 participants aged 11 years and above and in a second main study involving almost 3,000 children between two and 10 years old.
Danish: Menveos evne til at udløse dannelse af antistoffer (immunogenicitet) blev vurderet i en hovedundersøgelse, som omfattede næsten 4 000 deltagere i alderen 11 år og derover, og i en anden hovedundersøgelse, som omfattede næsten 3 000 børn mellem to og 10 år.
English: Why has Menveo been approved?
Danish: Hvorfor blev Menveo godkendt?
English: The vaccine must not be given to anyone who has had a life-threatening reaction to a vaccine that contains similar components in the past.
Danish: Vaccinen må ikke anvendes til personer, der tidligere har haft en livstruende reaktion over for en vaccine, der indeholder lignende komponenter.
English: Menveo is used in people who are at risk of exposure to the bacterium.
Danish: Menveo anvendes til personer, som har risiko for at blive udsat for bakterien.
English: For more information about treatment with Menveo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Twynsta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Menveo must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, including diphtheria toxoid.
Danish: Menveo må ikke anvendes til personer, som er overfølsomme (allergiske) over for de aktive stoffer eller andre af indholdsstofferne, herunder difteritoksoid.
English: The number of people who had an immune response against the oligosaccharides was similar for the two vaccines.
Danish: Antallet af personer, hos hvem der blev fremkaldt en immunreaktion mod oligosaccharider, var ens for de to vacciner.
English: The Committee therefore decided that Menveo's benefits are greater than its risks in people who are at risk of exposure to N. meningitidis bacterium, and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede derfor, at fordelene ved Menveo opvejer risiciene hos personer, som har risiko for at blive udsat for N. meningitidis bakterien, og anbefalede udstedelse af markedsføringstilladelse.
English: When the person is exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Danish: Når personen eksponeres for bakterien, vil antistofferne sammen med andre komponenter i immunsystemet kunne dræbe bakterierne og derved medvirke til at beskytte mod sygdommen.
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Danish: Invasiv sygdom optræder, når bakterien spreder sig i kroppen og forårsager alvorlige infektioner såsom meningitis (betændelse i hinderne rundt om hjernen og rygmarven) og septikæmi (blodforgiftning).
English: What is Menveo?
Danish: Hvad er Menveo?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Menveo, 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 IDflu, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: For the full list of all side effects reported with Menveo, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Menveo fremgår af indlægssedlen.
English: Menveo meningococcal group A, C, W135 and Y conjugate vaccine
Danish: Menveo meningokok gruppe A, C, W135 og Y konjugeret vaccine
English: Menveo was compared with a similar conjugated vaccine against N. meningitidis.
Danish: Menveo blev sammenlignet med en tilsvarende konjugeret vaccine mod N. meningitidis.
English: The Committee noted that Menveo offers the benefits of conjugated vaccines, including producing a stronger immune response in young children.
Danish: Udvalget bemærkede, at Menveo havde fordelene ved de konjugerede vacciner, herunder evnen til at fremkalde en kraftigere immunreaktion hos mindre børn.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når en person vaccineres, opfatter immunsystemet de dele af bakterien, der er indeholdt i vaccinen, som "fremmede" og danner antistoffer mod dem.
English: Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified, then ‘conjugated' (attached) to a protein from the bacterium Corynebacterium diphtheriae.
Danish: Menveo indeholder små mængder af oligosaccharider (en form for sukker), som er udvundet af fire grupper af N. meningitidiis-bakterien: A, C, W135 og Y. Disse er blevet renset og derefter ‘konjugeret' (bundet) til et protein fra bakterien Corynebacterium diphtheriae.
English: Menveo is used to protect adults and children from the age of two against invasive disease caused by four groups of the bacterium N. meningitidis (A, C, W135, and Y).
Danish: Menveo anvendes til beskyttelse af voksne, unge og børn fra 2 årsalderen mod invasiv meningokoksygdom forårsaget af fire grupper af bakterien N. meningitidis (A, C, W-135 og Y).
English: The results of the main studies showed that Menveo was as effective as the comparator vaccine in stimulating an immune response against all four types of N. meningitidis oligosaccharides in adults and children from the age of two.
Danish: Resultaterne af hovedundersøgelserne viste, at Menveo var ligeså effektiv som sammenligningsvaccinen til at fremkalde en immunreaktion mod alle fire typer af N. meningitidis oligosaccharider hos voksne og unge og børn fra to årsalderen.
English: The CHMP noted that five N. meningitidis bacterial groups (A, B, C, W135 and Y) are responsible for invasive disease, and that Menveo provides broader protection than other available vaccines.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) bemærkede, at fem N. meningitidis bakteriegrupper (A, B, C, W135 og Y) er årsag til invasiv sygdom, og at Menveo giver en bredere beskyttelse end andre foreliggende vacciner.
English: The most common side effects with Menveo in adults and children from the age of 11 (seen in more than 1 patient in 10) are headache, nausea (feeling sick), malaise (feeling unwell), myalgia (muscle pain), as well as pain, erythema (reddening of the skin) and induration (hardening) at the site of injection.
Danish: De hyppigste bivirkninger ved Menveo hos voksne og børn fra 11 årsalderen (som optræder hos mere end 1 af 10 patienter) er hovedpine, kvalme, utilpashed, muskelsmerter og smerter, rødme og hårdhed på injektionsstedet.
English: What is Menveo used for?
Danish: Hvad anvendes Menveo til?
English: The main measure of effectiveness was whether Menveo was as good as the comparator vaccine at stimulating immune response against the four types of N. meningitidis oligosaccharides.
Danish: Virkningen blev hovedsagelig bedømt på, om Menveo var lige så god som sammenligningsvaccinen til at fremkalde immunreaktionen mod de fire typer af N. meningitidis oligosaccharider.
English: What benefit has Menveo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Menveo?
English: How has Menveo been studied?
Danish: Hvordan blev Menveo undersøgt?
English: It is available as a powder and solution that are mixed together to make a solution for injection.
Danish: Det er en pulver og solvens, som blandes til en injektionsvæske, opløsning.
English: How is Menveo used?
Danish: Hvordan anvendes Menveo?
English: How does Menveo work?
Danish: Hvordan virker Menveo?
English: The full EPAR for Lacosamide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lacosamide Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Danish: Den sædvanlige startdosis er 50 mg to gange dagligt, som kan øges hver uge indtil en maksimal dosis på 300 mg to gange dagligt, hvis det anvendes alene, eller 200 mg to gange dagligt, hvis det gives sammen med andre antiepileptiske lægemidler.
English: It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Danish: Det kan anvendes til behandling af partielle anfald med eller uden sekundær generalisering (hvor anfaldet efterfølgende spreder sig til andre dele af hjernen).
English: The medicine can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg).
Danish: Lægemidlet udleveres kun efter recept og fås som tabletter (50 mg, 100 mg, 150 mg og 200 mg).
English: This is a summary of the European public assessment report (EPAR) for Lacosamide Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lacosamide Accord.
English: This is because the active substance, lacosamide, has been shown to be highly soluble and completely absorbed, meaning that almost 100% of the substance reaches the blood when taken by mouth.
Danish: Det skyldes, at det er påvist, at det aktive stof, lacosamid, er højopløseligt og absorberes fuldstændigt, hvilket betyder, at næsten 100 % af stoffet når blodbanen, når det tages gennem munden.
English: If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced.
Danish: Hvis behandlingen med Lacosamide Accord skal afbrydes, bør dosis nedtrappes lidt efter lidt.
English: As for every medicine, the company provided studies on the quality of Lacosamide Accord.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Lacosamide Accord.
English: The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Danish: Det vides endnu ikke helt præcist, hvordan lacosamid virker, men stoffet synes at reducere aktiviteten i natriumkanalerne (porer på overfladen af nervecellerne), der gør det muligt at overføre elektriske impulser mellem nerveceller.
English: It is also thought that lacosamide might help protect nerve cells from damage.
Danish: Det menes også, at lacosamid er med til at beskytte nerveceller mod beskadigelse.
English: There was no need for ‘bioequivalence' studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalente" undersøgelser af, om Lacosamide Accord absorberes på samme måde som referencelægemidlet for at producere samme niveau af det aktive stof i blodet.
English: Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Danish: Tilsammen kan disse virkemåder forhindre, at anormal elektrisk aktivitet spredes i hjernen, og derigennem mindske risikoen for epileptiske anfald.
English: Lacosamide Accord is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 16 years or older.
Danish: Lacosamide Accord er et antiepileptisk lægemiddel til behandling af partielle anfald (epileptiske krampeanfald, der udspringer fra en bestemt del af hjernen) hos epilepsipatienter i alderen 16 år og opefter.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Accord.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Vimpat, og det er ikke nødvendigt at gentage disse med Lacosamide Accord.
English: The Agency recommended that Lacosamide Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Lacosamide Accord godkendes til anvendelse i EU.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Accord has been shown to be comparable to Vimpat.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Lacosamide Accord i overensstemmelse med EU's krav har vist sig at være sammenligneligt med Vimpat.
English: Lacosamide Accord is given on its own or combined with other medicines for epilepsy.
Danish: Lacosamide Accord gives alene eller i kombination med andre antiepileptiske lægemidler.
English: Therefore, the Agency's view was that, as for Vimpat, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Vimpat.
English: Because Lacosamide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Lacosamide Accord er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This means that Lacosamide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Vimpat.
Danish: Det betyder, at Lacosamide Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Vimpat.
English: What are the benefits and risks of Lacosamide Accord?
Danish: Hvilke fordele og risici er der forbundet med Lacosamide Accord?
English: The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine.
Danish: Det aktive stof i Lacosamide Accord, lacosamid, er et antiepileptikum.
English: What measures are being taken to ensure the safe and effective use of Lacosamide Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lacosamide Accord?
English: It is not intended to provide practical advice on how to use Lacosamide Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Lacosamide Accord bør anvendes.
English: For more information about treatment with Lacosamide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lacosamide Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Lacosamide Accord
Danish: Andre oplysninger om Lacosamide Accord
English: Lacosamide Accord contains the active substance lacosamide.
Danish: Lacosamide Accord indeholder det aktive stof lacosamid.
English: What is Lacosamide Accord and what is it used for?
Danish: Hvad er Lacosamide Accord, og hvad anvendes det til?
English: Lacosamide Accord lacosamide
Danish: Lacosamide Accord lacosamid
English: For practical information about using Lacosamide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lacosamide Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: If the doctor decides that a faster effect is needed, treatment with Lacosamide Accord may be started with a higher first dose (called a loading dose).
Danish: virkning, kan behandlingen med Lacosamide Accord indledes med en højere initialdosis (kaldet en støddosis).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide Accord have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lacosamide Accord.
English: Why is Lacosamide Accord approved?
Danish: Hvorfor blev Lacosamide Accord godkendt?
English: How is Lacosamide Accord used?
Danish: Hvordan anvendes Lacosamide Accord?
English: How has Lacosamide Accord been studied?
Danish: Hvordan blev Lacosamide Accord undersøgt?
English: How does Lacosamide Accord work?
Danish: Hvordan virker Lacosamide Accord?
English: These reactions may be severe.
Danish: Disse reaktioner kan være alvorlige.
English: In children this may affect growth and development.
Danish: Hos børn kan de påvirke vækst og udvikling.
English: No interactions were observed.
Danish: Ingen interaktioner blev observeret.
English: In addition, consideration should be given to referring the patient to a paediatric specialist.
Danish: Herudover bør det overvejes at henvise patienten til en pædiatrisk specialist.
English: if you are using the medicine for several months or longer.
Danish: • hvis du bruger medicinen i flere måneder eller længere.
English: You should avoid coming into contact with anyone who has these infections.
Danish: Du skal undgå at komme i kontakt med personer, der har disse sygdomme.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgenden opdateres efter behov af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i henhold til de procedurer, der er fastsat i direktiv 2001/83/EF afsnit III kapitel 4.
English: 4.5 Interactions with other medicaments and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Breathe out through your mouth.
Danish: Pust ud gennem munden.
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra forhåndenværende data):
English: if you have cystic fibrosis.
Danish: • du har cystisk fibrose.
English: There was no effect on fertility.
Danish: Der var ingen indvirkning på fertiliteten.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Danish: Hyppighed er defineret således: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1000 til < 1/100).
English: Please read this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: The median (50%) onset time of relief was 35.9 hours.
Danish: Median (50 %) tiden til symptomlindring var 35,9 timer.
English: Effect on Growth in Paediatric Population
Danish: Virkning på væksten i den pædiatriske population
English: Therefore, the patient should continue regular use to achieve full therapeutic benefit.
Danish: Patienten skal derfor fortsætte med regelmæssig anvendelse for at opnå den bedste terapeutiske virkning.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke bruge en dobbeltdosis som erstatning for den glemte dosis.
English: Use in children aged 3 to 11 years
Danish: Brug til børn i alderen 3 - 11 år
English: if you have any other infection.
Danish: • hvis du har anden infektion.
English: A clinical interaction study was conducted with loratadine.
Danish: Et klinisk interaktionsstudie med loratadin blev udført.
English: Do not stop your treatment even if you feel better unless told to do so by your doctor.
Danish: Stop ikke behandlingen selvom du føler dig bedre, med mindre din læge har bedt dig om det.
English: Repeat steps 3 to 6 for the other nostril (Figure 3).
Danish: Gentag trin 3 til 6 for det andet næsebor (figur 3).
English: It is very important that you use your nasal spray regularly.
Danish: Det er meget vigtigt, at du bruger næsesprayen regelmæssigt.
English: Immediate hypersensitivity (allergic) reactions may occur after use of this product.
Danish: Akutte overfølsomhedsreaktioner (allergiske) kan opstå efter brug af dette lægemiddel.
English: Do not use a larger dose or use the spray more often or for longer than your doctor tells you to.
Danish: Du må ikke tage en større dosis eller bruge næsesprayen oftere eller i længere tid end din læge har fortalt dig.
English: However, no mutagenic effects can be expected at therapeutically relevant doses.
Danish: Ingen mutagene påvirkninger kan imidlertid forventes ved terapeutisk relevante doser.
English: Non-nasal Symptoms
Danish: Ikke-nasale symptomer
English: Use in adults and children over 12 years old
Danish: Brug til voksne og børn over 12 år
English: Systemic Effects of Corticosteroids
Danish: Kortikosteroiders systemiske virkning
English: If you forget to use your nasal spray at the right time, use it as soon as you remember, then carry on as before.
Danish: Hvis du har glemt at bruge næsesprayen til rette tid, så brug den så snart du kommer i tanke om det og fortsæt som sædvanligt.
English: The incidence of all other adverse events was comparable with that of placebo.
Danish: Incidensen for alle andre bivirkninger var sammenlignelig med placebo.
English: Within each system organ class, adverse reactions are ranked by frequency.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet i henhold til hyppighed.
English: You should stop taking Nasonex and get immediate medical help if you experience symptoms such as:
Danish: Du skal holde op med at bruge Nasonex og omgående søge læge, hvis du får symptomer som:
English: if you have an untreated infection in your nose.
Danish: • hvis du har en ubehandlet infektion i næsen.
English: It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone furoate lies in its ability to inhibit the release of mediators of allergic reactions.
Danish: Sandsynligvis kan en stor del af mekanismen bag mometasonfuroats antiallergiske og antiinflammatoriske effekt tilskrives evnen til at hæmme frigørelse af mediatorer involveret i allergiske reaktioner.
English: These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Danish: Disse bivirkninger er langt mindre sandsynlige end ved behandling med orale kortikosteroider og kan variere individuelt mellem patienter og mellem forskellige kortikosteroidpræparater.
English: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Danish: Mometasonfuroat er et lokalt glukokortikoid med lokale antiinflammatoriske egenskaber ved doser, som ikke er systemisk aktive.
English: *recorded for twice daily dosing for nasal polyposis †recorded at uncommon frequency for twice daily dosing for nasal polyposis
Danish: *registreret ved dosering to gange dagligt for nasale polypper †registreret med hyppigheden ”ikke almindelig” ved dosering to gange dagligt for nasale polypper
English: Adverse reactions are listed according to MedDRA primary system organ class.
Danish: Bivirkningerne er listet i henhold til de primære MedDRA systemorganklasser.
English: If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Danish: Hvis der er evidens for anvendelse af højere doser end de anbefalede, bør supplerende systemisk kortikosteroidbehandling overvejes i perioder med stress og ved elektiv kirurgi.