FrancophonIA/ELRC3.0 huggingface dataset:
English: Kampenringweg 45 D-E Gouda Netherlands
Danish: Kampenringweg 45 D-E Gouda Holland
English: Five main studies were carried out.
Danish: Der blev gennemført fem hovedstudier.
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Danish: Hvert år gennemgår agenturet alle nye oplysninger, der måtte foreligge, og opdaterer om nødvendigt denne oversigt.
English: It is not yet known how long the protection will last.
Danish: Det vides endnu ikke, hvor længe beskyttelsen varer.
English: Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Danish: Imvanex fik en markedsføringstilladelse med gyldighed i hele EU den 31. juli 2013.
English: Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Danish: Kopper blev officielt erklæret udryddet i 1980 med det sidst kendte tilfælde af sygdommen i 1977.
English: Imvanex has been authorised under ‘exceptional circumstances'.
Danish: Imvanex er blevet godkendt under "særlige omstændigheder".
English: Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Danish: Yderligere information om Imvanex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/imvanex.
English: The vaccine can only be obtained with a prescription.
Danish: Vaccinen fås kun på recept.
English: However, the duration of protection is not known.
Danish: Det vides dog ikke, hvor længe beskyttelsen varer.
English: This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.
Danish: Denne vaccine vil blive anvendt, når det skønnes nødvendigt for at beskytte mod kopper i henhold til de officielle anbefalinger.
English: When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Danish: Når personen igen kommer i kontakt med dette eller et lignende virus, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe viraene og hjælpe med at beskytte mod sygdommen.
English: Vaccines work by ‘teaching' the immune system how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet, hvordan det skal forsvare sig mod en sygdom.
English: This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease.
Danish: Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Imvanex, fordi sygdommen er sjælden.
English: Imvanex (live modified vaccinia ankara virus)
Danish: Imvanex (levende modificeret vaccinia Ankara-virus)
English: As for all medicines, data on the use of Imvanex are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Imvanex løbende overvåget.
English: The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Danish: De hyppigste bivirkninger ved Imvanex (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, kvalme, muskelsmerter (myalgi), træthed og reaktioner på injektionsstedet (smerte, rødme, hævelse, hærdning og kløe).
English: The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Danish: Studierne omfattede over 2.000 voksne, herunder patienter med hiv og atopisk dermatitis (en kløende hudlidelse forårsaget af et overaktivt immunsystem) og personer, der tidligere var blevet vaccineret mod kopper.
English: Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
Danish: Da Imvanex er blevet godkendt under særlige omstændigheder, vil den virksomhed, der markedsfører Imvanex, fremskaffe data om vaccinens fordele og risici ved at gennemføre observationsstudier med patienter, der får vaccinen, samt hvis der skulle komme et udbrud af sygdommen i fremtiden.
English: Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
Danish: I to af studierne blev der specifikt set på effektiviteten af Imvanex som booster.
English: Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
Danish: Imvanex må ikke anvendes til patienter, der er overfølsomme (allergiske) over for det aktive stof eller et af de øvrige stoffer, der findes på sporstofniveau, såsom kyllingeprotein, benzonase og gentamicin.
English: An overview of Imvanex and why it is authorised in the EU
Danish: En oversigt over Imvanex, og hvorfor det er godkendt i EU
English: Imvanex would therefore be beneficial for people who cannot be given vaccines containing replicating viruses, such as patients with a weakened immune system.
Danish: Imvanex vil derfor være gavnligt for personer, der ikke må få vacciner med replikerende vira, f.eks. patienter med et svækket immunsystem.
English: For more information about using Imvanex, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Imvanex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet virusset i vaccinen som "fremmed" og danner antistoffer mod det.
English: Other information about Imvanex
Danish: Andre oplysninger om Imvanex
English: A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine.
Danish: I et efterfølgende studie med 433 personer, der ikke var blevet vaccineret før, blev det observeret, at niveauet af beskyttende antistoffer efter vaccination med Imvanex var mindst lige så højt som ved en traditionel koppevaccine.
English: Side effects reported with Imvanex are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Imvanex vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first.
Danish: Hvis en boosterdosis er nødvendig for personer, der tidligere er blevet vaccineret mod kopper, bør der gives en enkelt 0,5 ml-dosis, undtagen hos patienter med et svækket immunsystem (kroppens naturlige forsvar), der bør have to boosterdoser, hvor den anden dosis gives mindst 28 dage efter den første.
English: What measures are being taken to ensure the safe and effective use of Imvanex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imvanex?
English: The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines.
Danish: Vaccinia-virusset i Imvanex kan ikke replikere i humane celler og har derfor mindre sandsynlighed for at give bivirkninger end traditionelle koppevacciner.
English: Imvanex is a vaccine used to protect against smallpox in adults.
Danish: Imvanex er en vaccine, der anvendes til beskyttelse mod kopper hos voksne.
English: Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox.
Danish: Vacciner indeholdende vaccinia-vira var effektive i kampen mod kopper.
English: It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus.
Danish: Det indeholder en levende modificeret form for vaccinia-virus kaldet "vaccinia Ankara", som er i familie med koppevirus.
English: Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells.
Danish: Imvanex indeholder en modificeret form for vaccinia Ankara-virus, som ikke forårsager sygdom hos mennesker, og som ikke kan replikere (formere sig) i menneskeceller.
English: Why is Imvanex authorised in the EU?
Danish: Hvorfor er Imvanex godkendt i EU?
English: What is Imvanex and what is it used for?
Danish: Hvad er Imvanex, og hvad anvendes det til?
English: Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox.
Danish: Da dette virus ligner koppevirusset, forventes de antistoffer, der produceres mod det, også at beskytte mod kopper.
English: What information is still awaited for Imvanex?
Danish: Hvilke oplysninger afventes der stadig for Imvanex?
English: The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines.
Danish: Det Europæiske Lægemiddelagentur vurderer, at Imvanex er effektivt til at anspore til produktion af antistoffer mod kopper i et omfang, som giver en beskyttelse, der er mindst lige så høj som ved traditionelle koppevacciner.
English: What are the risks associated with Imvanex?
Danish: Hvilke risici er der forbundet med Imvanex?
English: Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox.
Danish: Det er i studier blevet påvist, at Imvanex er effektivt til at anspore produktion af antistoffer i et omfang, der forventes at yde beskyttelse mod kopper.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imvanex 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 Imvanex.
English: Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first.
Danish: Personer, der ikke tidligere er blevet vaccineret mod kopper, bør have to 0,5 ml-doser, hvor den anden dosis gives mindst 28 dage efter den første.
English: How is Imvanex used?
Danish: Hvordan anvendes Imvanex?
English: How does Imvanex work?
Danish: Hvordan virker Imvanex?
English: What benefits of Imvanex have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Imvanex?
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Danish: • Bioækvivalens med et EU-referencelægemiddel er blevet påvist på grundlag af relevante data i overensstemmelse med kravene i artikel 10 i direktiv 2001/83/EF (f.eks. en bioækvivalensundersøgelse udført med EU-referencelægemidlet).
English: Condition for lifting the suspension of the marketing authorisations
Danish: Betingelse for at ophæve suspenderingen af markedsføringstilladelserne
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s)
Danish: For at kunne ophæve suspenderingen af markedsføringstilladelserne i bilag IB skal de kompetente myndigheder i EU's medlemsstater sikre, at nedenstående betingelse er opfyldt af markedsføringstilladelsesindehaveren/-indehaverne.
English: Annex III Condition for lifting the suspension of the marketing authorisations
Danish: Bilag III Betingelse for at ophæve suspenderingen af markedsføringstilladelserne
English: It is used in addition to diet and exercise.
Danish: Det anvendes sammen med diæt og motion.
English: It is available as tablets (15, 30 and 45 mg).
Danish: Det fås som tabletter (15, 30 og 45 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sepioglin on 9 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sepioglin den 9. marts 2012.
English: The tablets should be swallowed with water.
Danish: Tabletterne sluges med vand.
English: The recommended starting dose of Sepioglin is 15 or 30 mg once a day.
Danish: Den anbefalede startdosis af Sepioglin er 15 eller 30 mg en gang dagligt.
English: The full EPAR for Sepioglin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Sepioglin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Sepioglin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sepioglin.
English: Other information about Sepioglin
Danish: Andre oplysninger om Sepioglin
English: This means that Sepioglin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Sepioglin er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
English: Treatment with Sepioglin should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Sepioglin skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke har tilstrækkelig gavn af behandlingen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sepioglin.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om hvordan Sepioglin skal anvendes.
English: For more information about treatment with Sepioglin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sepioglin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Sepioglin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Sepioglin, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Danish: Denne dosis skal muligvis øges til 45 mg en gang dagligt efter en til to uger, hvis der er behov for en bedre kontrol af glukosekoncentrationen (blodsukkerkoncentrationen) i blodet.
English: EPAR summary for the public pioglitazone
Danish: EPAR - sammendrag for offentligheden pioglitazon
English: Sepioglin is a ‘generic medicine'.
Danish: Sepioglin er et ‘generisk lægemiddel'.
English: Sepioglin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Sepioglin anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
English: What are the benefits and risks of Sepioglin?
Danish: Hvilken fordel og risiko er der forbundet med Sepioglin?
English: The Committee recommended that Sepioglin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Sepioglin.
English: The CHMP concluded that, in accordance with EU requirements, Sepioglin has been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sepioglin er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Sepioglin is a medicine that contains the active substance pioglitazone.
Danish: Sepioglin er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Danish: Lægen skal ved efterfølgende kontroller bekræfte, at patienten stadig har gavn af behandlingen.
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Actos.
English: Sepioglin should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Danish: Sepioglin bør ikke anvendes til patienter i dialyse (en blodrensningsteknik, som anvendes hos personer med nyresygdom).
English: Because Sepioglin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Sepioglin er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Sepioglin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Sepioglin er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
English: Why has Sepioglin been approved?
Danish: Hvorfor er Sepioglin blevet godkendt?
English: Sepioglin can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Sepioglin kan også anvendes sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: Sepioglin is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Sepioglin anvendes som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
English: What is Sepioglin?
Danish: Hvad er Sepioglin?
English: Sepioglin can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Danish: Sepioglin kan desuden anvendes sammen med både metformin og et sulfonylurinstof til patienter, som ikke er tilfredsstillende reguleret trods dobbeltterapi med orale lægemidler (‘tredobbelt terapi').
English: Sepioglin can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Danish: Sepioglin kan også anvendes i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), hvor metformin ikke er egnet (‘dobbeltterapi').
English: How has Sepioglin been studied?
Danish: Hvordan er Sepioglin blevet undersøgt?
English: What is Sepioglin used for?
Danish: Hvad anvendes Sepioglin til?
English: How is Sepioglin used?
Danish: Hvordan anvendes Sepioglin?
English: How does Sepioglin work?
Danish: Hvordan virker Sepioglin?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform
English: 1 pre-filled pen + 1 pre-filled pen
Danish: 1 fyldt pen + 1 fyldt pen
English: This summary was last updated in 09-2015.
Danish: Dette sammendrag blev senest ajourført i 09-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BeneFIX den 27. august 1997.
English: This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for BeneFIX.
English: The full EPAR for BeneFIX can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for BeneFIX findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: During treatment, the doctor should regularly carry out blood tests to adjust the dose to be given.
Danish: Lægen skal under behandlingen regelmæssigt tage blodprøver for at tilpasse dosen, der skal gives.
English: Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses.
Danish: Ud af 972 infusioner blev 84 % vurderet til at have en "god" eller "særdeles god" virkning.
English: In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX.
Danish: Hos de tidligere behandlede patienter forsvandt 82 % af de 693 blødningsepisoder, der blev behandlet, efter en enkelt infusion af BeneFIX.
English: A risk management plan has been developed to ensure that BeneFIX is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at BeneFIX anvendes så sikkert som muligt.
English: It has also been studied in patients who have not received any treatment for their haemophilia.
Danish: Det er også blevet undersøgt hos patienter, som ikke er blevet behandlet for deres hæmofili.
English: What measures are being taken to ensure the safe and effective use of BeneFIX?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af BeneFIX?
English: BeneFIX is used to replace the missing factor IX.
Danish: BeneFIX anvendes til at erstatte den manglende faktor IX.
English: They include angioedema (swelling of the face and limbs), burning and stinging at the injection site, chills, flushing, urticaria (itchy rash), headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (fast heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Danish: Disse omfatter angioødem (hævelse af ansigtet og lemmerne), brænden og stikken på injektionsstedet, kulderystelser, rødmen, urticaria (kløende udslæt), hovedpine, nældefeber, hypotension (for lavt blodtryk), apati, kvalme, rastløshed, takykardi (hurtig hjerterytme), trykken for brystet, snurrende fornemmelser, opkastning og hiven efter vejret.
English: The CHMP decided that BeneFIX's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved BeneFIX er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for BeneFIX.