FrancophonIA/ELRC3.0 huggingface dataset:
English: Xtandi is not for use in women and must not be given to women who are or who may be pregnant.
Danish: Xtandi er ikke beregnet til kvinder og må ikke gives til kvinder, som er eller kan være gravide.
English: The doctor may have to reduce the dose or interrupt treatment if a patient gets certain side effects.
Danish: Lægen kan være nødt til at nedsætte dosen eller afbryde behandlingen, hvis patienten får visse bivirkninger.
English: Further information on Xtandi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xtandi.
Danish: Yderligere information om Xtandi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Xtandi.
English: Xtandi (enzalutamide)
Danish: Xtandi (enzalutamid)
English: The usual dose is 160 mg once a day, at about the same time each day.
Danish: Den anbefalede dosis er 160 mg, der skal tages én gang dagligt på omtrent samme tidspunkt hver dag.
English: • treatment with docetaxel (a cancer medicine) has not worked or no longer works; or
Danish: • behandling med docetaxel (et kræftlægemiddel) ikke har virket eller ikke længere virker, eller
English: Other information about Xtandi
Danish: Andre oplysninger om Xtandi
English: In addition, seizures (fits) can occur in around 4 patients in 1,000.
Danish: Desuden kan krampeanfald forekomme hos ca. 4 ud af 1 000 patienter.
English: As for all medicines, data on the use of Xtandi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Xtandi løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Xtandi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xtandi?
English: Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription.
Danish: Xtandi fås som kapsler (40 mg) og tabletter (40 og 80 mg) og udleveres kun efter recept.
English: The medicine contains the active substance enzalutamide.
Danish: Lægemidlet indeholder det aktive stof enzalutamid.
English: For more information about using Xtandi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Xtandi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Xtandi has also been shown to delay the development of metastatic disease.
Danish: Xtandi har også vist sig at forsinke udviklingen af metastatisk sygdom.
English: An overview of Xtandi and why it is authorised in the EU
Danish: En oversigt over Xtandi, og hvorfor det er godkendt i EU
English: Other important side effects include falls, cognitive disorder (problems with thinking, learning and memory), and neutropenia (low levels of neutrophils, a type of white blood cells).
Danish: Andre væsentlige bivirkninger omfatter fald, kognitive forstyrrelser (problemer med koncentration, indlæring og hukommelse) og neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: It is used when the cancer is metastatic (has spread to other parts of the body), castration resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either:
Danish: Det anvendes, når kræften er metastatisk (har bredt sig til andre dele af kroppen), er kastrationsresistent (forværres trods behandling til nedbringelse af produktionen af testosteron eller efter kirurgisk fjernelse af testiklerne) og når enten:
English: Regarding its safety, the side effects with Xtandi were generally mild and could be managed appropriately.
Danish: Hvad angår sikkerheden, var bivirkningerne ved Xtandi generelt milde og kunne behandles tilstrækkeligt.
English: • hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not yet require chemotherapy (another type of cancer treatment).
Danish: • hormonterapi ikke har virket, og når patienten ingen symptomer har eller kun oplever milde symptomer og endnu ikke har brug for kemoterapi (en anden type kræftbehandling).
English: Side effects reported with Xtandi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Xtandi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Xtandi and what is it used for?
Danish: Hvad er Xtandi, og hvad anvendes det til?
English: The Agency therefore concluded that Xtandi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Xtandi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Xtandi authorised in the EU?
Danish: Hvorfor blev Xtandi godkendt i EU?
English: Xtandi can also be used for castration-resistant prostate cancer that is not metastatic (has not yet spread) but is at high risk of doing so.
Danish: Xtandi kan også anvendes mod kastrationsresistent prostatakræft, der ikke er metastatisk (endnu ikke har bredt sig) men har en høj risiko for at blive det.
English: Enzalutamide does this by blocking the receptors to which these hormones attach.
Danish: Enzalutamid virker mere specifikt ved at blokere for de receptorer, som disse hormoner binder sig til.
English: Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, enzalutamide slows down the growth of the prostate cancer.
Danish: Da prostatakræft har brug for testosteron og andre mandlige kønshormoner for at overleve og vokse, bremser enzalutamid væksten af prostatakræft ved at blokere for effekten af disse hormoner.
English: The company that markets Xtandi will provide the results of an ongoing study on the long-term effects of Xtandi in men with non-metastatic prostate cancer.
Danish: Virksomheden, der markedsfører Xtandi, vil fremlægge resultaterne af et igangværende studie om de langsigtede virkninger af Xtandi hos mænd med ikkemetastatisk prostatakræft.
English: What are the risks associated with Xtandi?
Danish: Hvilke risici er der forbundet med Xtandi?
English: The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, fractures (broken bones), hot flushes and hypertension (high blood pressure).
Danish: De hyppigste bivirkninger ved Xtandi (som optræder hos mere end 1 ud af 10 patienter) er træthed, knoglebrud, hedeture og forhøjet blodtryk.
English: Treatment with Xtandi should be started and monitored by a doctor who has experience in treating prostate cancer.
Danish: Behandling med Xtandi bør indledes og overvåges af en læge med erfaring i behandling for prostatakræft.
English: The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens.
Danish: Det aktive stof i Xtandi, enzalutamid, virker ved at blokere for effekten af det mandlige kønshormon testosteron og andre mandlige kønshormoner, der kaldes androgener.
English: Xtandi is a cancer medicine used to treat men with prostate cancer.
Danish: Xtandi er et kræftlægemiddel til behandling af mænd med prostatakræft.
English: The European Medicines Agency considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life for patients with metastatic disease is important for patients.
Danish: Det Europæiske Lægemiddelagentur fandt, at det var klart påvist, at Xtandi havde en kræftbekæmpende effekt, og at lægemidlets livsforlængende egenskaber var gavnlige for patienter med metastatisk sygdom.
English: Non-metastatic prostate cancer
Danish: Ikkemetastatisk prostatakræft
English: Metastatic prostate cancer
Danish: Metastatisk prostatakræft
English: Xtandi has also been compared with placebo in a second main study involving 1,717 patients with metastatic, castration-resistant prostate cancer in whom hormone therapy had failed, but who had no symptoms or mild symptoms and had not previously been treated with chemotherapy.
Danish: Xtandi er også blevet sammenlignet med placebo i et andet hovedstudie, der omfattede 1 717 patienter med metastatisk, kastrationsresistent prostatakræft, som havde oplevet behandlingssvigt ved hormonterapi, men som ingen eller kun milde symptomer havde, og som ikke tidligere havde fået kemoterapi.
English: In addition, patients treated with Xtandi lived for longer without their disease showing signs of worsening in a radiographic scan: 20 months compared with 5 months for patients treated with placebo.
Danish: De patienter, der fik Xtandi, levede desuden længere, uden at deres sygdom viste tegn på forværring på røntgenbilleder, nemlig 20 måneder sammenholdt med 5 måneder for de patienter, der fik placebo.
English: How is Xtandi used?
Danish: Hvordan anvendes Xtandi?
English: Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with metastatic, castration-resistant prostate cancer who were previously treated with docetaxel.
Danish: Xtandi er blevet sammenlignet med placebo (en uvirksom behandling) i et hovedstudie, der omfattede 1 199 patienter med metastatisk, kastrationsresistent prostatakræft, som tidligere var blevet behandlet med docetaxel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xtandi 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 Xtandi.
English: What benefits of Xtandi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xtandi?
English: Xtandi has been compared with placebo in a study involving 1,401 patients with castration-resistant prostate cancer at high risk of becoming metastatic.
Danish: Xtandi er blevet sammenlignet med placebo i et studie, der omfattede 1 401 patienter med kastrationsresistent prostatakræft, der havde en høj risiko for at blive metastatisk.
English: For the full list of side effects with Xtandi, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Xtandi fremgår af indlægssedlen.
English: How does Xtandi work?
Danish: Hvordan virker Xtandi?
English: Patients treated with Xtandi lived for an average of 37 months without their disease becoming metastatic compared with 15 months on placebo.
Danish: De patienter, som fik Xtandi, levede gennemsnitligt i 37 måneder uden sygdomsforværring sammenlignet med 15 måneder hos dem, der fik placebo.
English: The average survival of patients treated with Xtandi was around 32 months compared with 30 months for patients treated with placebo.
Danish: De patienter, der fik Xtandi, havde en gennemsnitlig overlevelse på ca. 32 måneder, mens de patienter, der fik placebo, havde en gennemsnitlig overlevelse på 30 måneder.
English: In this study, Xtandi was more effective than placebo at prolonging patients' lives: on average, patients treated with Xtandi lived for 18 months, compared with 14 months for patients given placebo.
Danish: I dette studie var Xtandi mere effektivt end placebo til at forlænge patienternes liv.
English: MA (EU) number Invented name
Danish: (Særnavn) Navn
English: EU/1/17/1217/003 Nitisinone MDK 10 mg Capsule, hard
Danish: MF (EU)-nummer
English: These member states were not able to reach an agreement.
Danish: Disse medlemsstater kunne ikke nå til enighed.
English: The European Commission issued a decision on 06 March 2009.
Danish: Europa-Kommissionen traf en afgørelse den 6. marts 2009.
English: The company wanted the authorisation to be recognised in Austria, Denmark, Germany, Greece, Hungary, Poland, Portugal and Sweden (the concerned Member States).
Danish: Virksomheden ønskede, at markedsføringstilladelsen blev anerkendt i Østrig, Danmark, Tyskland, Grækenland, Ungarn, Polen, Portugal og Sverige (de berørte medlemsstater).
English: Dr. Antonio Addis (Italy)
Danish: Dr. Antonio Addis (Italien)
English: Dr Catherine Moraiti (Greece)
Danish: Dr. Catherine Moraiti (Grækenland)
English: What is Uman Big?
Danish: Hvad er Uman Big?
English: London, 09 March 2009 Doc.
Danish: London, den 9. marts 2009 Dok.
English: Why was Uman Big reviewed?
Danish: Hvorfor blev Uman Big undersøgt?
English: Questions and answers on the referral for Uman Big
Danish: Spørgsmål og svar om indbringelsen af sagen vedrørende Uman Big
English: On 31 October 2008, the Italian medicines agency, Agenzia Italiana del Farmaco, referred the matter to the CHMP.
Danish: Den 31. oktober 2008 indbragte den italienske lægemiddelstyrelse, Agenzia Italiana del Farmaco, sagen for CHMP.
English: Immunoglobulins are blood proteins that have been extracted from donor plasma.
Danish: Immunglobuliner er blodproteiner, som er udvundet af donorplasma.
English: The grounds for the referral were concerns over the insufficiency of the clinical data submitted to establish the efficacy of the product.
Danish: Begrundelsen for indbringelsen af sagen var betænkeligheder over utilstrækkeligheden af de kliniske data, der var fremlagt for lægemidlets virkning.
English: • in haemodialysed patients (patients whose kidneys have failed and who rely on a blood purification technique called haemodialysis), until vaccination has become effective;
Danish: • til hæmolysepatienter (patienter, hvis nyrer har svigtet, og som er afhængige af en blodrensningsteknik kaldet hæmodialyse), indtil der er effekt af vaccination
English: Based on evaluation of the currently available data and the scientific discussion within the Committee and at the CHMP's Blood Products Working Party, the CHMP concluded that the benefits of Uman Big outweigh its risks, and that therefore the marketing authorisation for Uman Big should be granted in all concerned member states.
Danish: På grundlag af vurderingen af de nu foreliggende data og den faglige drøftelse i udvalget og i CHMParbejdsgruppen vedrørende blodpræparater konkluderede CHMP, at fordelene ved Uman Big opvejer risiciene, og at der derfor bør udstedes markedsføringstilladelse for Uman Big i alle de berørte medlemsstater.
English: virus; including those whose vaccination is incomplete or status unknown;
Danish: herunder personer, som ikke er færdigvaccineret, eller hvis status er ukendt
English: Uman Big is given as an intramuscular (into the muscle) injection to prevent hepatitis B in the following cases:
Danish: Uman Big gives som en intramuskulær (i musklen) injektion for at forebygge hepatitis B i følgende tilfælde:
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Uman Big 180 IU/ml, solution for injection.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en procedure for indbragte sager efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Uman Big 180 IE/ml, injektionsvæske, opløsning.
English: • in subjects who did not show an immune response after vaccination (and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
Danish: • til personer, som ikke viste nogen immunrespons efter vaccination (og for hvem en kontinuerlig forebyggelse er nødvendig som følge af en kontinuerlig risiko for at blive inficeret med hepatitis
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Uman Big outweigh its risks, and that the marketing authorisation granted in Italy can be recognised in other Member States of the European Union and the European Economic Area.
Danish: Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Uman Big opvejer risiciene, og at markedsføringstilladelsen, som er udstedt i Italien, kan anerkendes i andre medlemsstater af Den Europæiske Union og af Det Europæiske Økonomiske Samarbejdsområde.
English: In addition, the absence of product specific safety data or postmarketing safety data was raised as a concern.
Danish: Manglen på lægemiddelspecifikke sikkerhedsdata eller sikkerhedsdata indhentet efter udstedelsen af markedsføringstilladelsen vakte endvidere betænkelighed.
English: Kedrion S.p.A. submitted Uman Big for mutual recognition on the basis of the initial authorisation granted by Italy on 2 June 1979.
Danish: indgav en ansøgning om gensidig anerkendelse af Uman Big på grundlag af en oprindelig markedsføringstilladelse udstedt af Italien den 2. juni 1979.
English: Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection
Danish: Human Hepatitis B Immunglobuliner, 180 IE/ml, injektionsvæske, opløsning
English: Hepatitis B immunoglobulins contain high levels of antibodies against the hepatitis B virus.
Danish: Hepatitis B immunglobuliner indeholder store mængder antistoffer mod hepatitis B-virus.
English: • in case of accidental exposure in people who have not been vaccinated against the hepatitis B
Danish: • i tilfælde af utilsigtet kontakt hos personer, som ikke er blevet vaccineret mod hepatitis B virus,
English: • in the newborn of a hepatitis B virus carrier-mother;
Danish: • til nyfødte af en mor, som er bærer af hepatitis B-virus
English: Uman Big is a solution of human hepatitis B immunoglobulins.
Danish: Uman Big er en opløsning af human hepatitis B immunglobuliner.
English: What is Priorix?
Danish: Hvad er Priorix?
English: Priorix is marketed in all EU Member States as well as in Norway and Iceland.
Danish: Priorix markedsføres i alle EU's medlemsstater samt Norge og Island.
English: Priorix is authorised in the EU via national procedures.
Danish: Priorix blev godkendt i EU via nationale procedurer.
English: The European Commission issued a decision on 25 May 2012.
Danish: Europa-Kommissionen traf en afgørelse den 25. maj 2012.
English: It can be used in adults, adolescents and children from nine months of age.
Danish: Den kan anvendes hos voksne, unge og børn fra 9-måneders alderen.
English: On 15 March 2012, the European Medicines Agency completed a review of Priorix.
Danish: Den 15. marts 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Priorix.
English: The company that markets the medicine is GlaxoSmithKline (GSK) Biologicals.
Danish: Den virksomhed, der markedsfører lægemidlet, er GlaxoSmithKline (GSK) Biologicals.
English: Why was Priorix reviewed?
Danish: Hvorfor blev Priorix vurderet igen?
English: There was some inconsistency between EU countries regarding the use of Priorix in patients infected with HIV.
Danish: Der var nogen uoverensstemmelse mellem EU-landene hvad angår brug af Priorix hos hiv-smittede patienter.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at “lære” immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdommen.
English: The CHMP recommended that this should be harmonised to nine months of age.
Danish: CHMP anbefalede, at dette blev harmoniseret til 9-måneders alderen.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these viruses.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, når det møder sådanne virus.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Priorix in the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Priorix i Den Europæiske Union (EU).
English: There was some inconsistency between EU countries regarding the approved lower age limit for Priorix, which varied from nine months to 15 months of age.
Danish: Der var nogen uoverensstemmelse mellem de forskellige lande i EU hvad angår den godkendte nedre aldersgrænse for Priorix, der varierede fra 9 måneder til 15 måneder.
English: Priorix is also contraindicated in people with certain other conditions which severely weaken the immune system.
Danish: Priorix er desuden kontraindiceret hos personer med visse andre sygdomme, der alvorligt svækker immunsystemet.
English: The CHMP decided to contraindicate the use of Priorix in people with symptomatic, advanced HIV, since these patients have a severely weakened immune system which puts them at risk of serious health problems following vaccination with attenuated measles virus.
Danish: CHMP besluttede, at gøre Priorix kontraindiceret hos personer med symptomgivende, fremskreden hiv, da sådanne patienter har et stærkt svækket immunsystem og derfor risikerer alvorlige helbredsproblemer efter vaccination med svækkede mæslingevirus.
English: The CHMP recommended arranging this section according to the dosing recommendations for different age groups.
Danish: CHMP anbefalede, at dette afsnit blev ordnet i henhold til doseringsanbefalingerne for forskellige aldersgrupper.
English: For children between nine and 12 months old, the CHMP decided to include a recommendation to give a second dose preferably within three months of the first dose.
Danish: For børn mellem ni og tolv måneder besluttede CHMP at indsætte en anbefaling om, at der blev givet en ekstra dosis fortrinsvis inden for tre måneder efter den første dosis.
English: Due to the divergent national positions, on 20 May 2011, GlaxoSmithKline Biologicals referred the matter to the CHMP in order to harmonise the marketing authorisations for Priorix in the EU.
Danish: Den 20. maj 2011 indbragte GlaxoSmithKline Biologicals sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Priorix i EU.
English: When a person is given Priorix, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når man får Priorix, opfatter immunsystemet disse virus som “fremmede” og danner antistoffer mod dem.
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (warnings and precautions for use), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation) and 5.1 (pharmacodynamic properties).
Danish: (Særlige advarsler og forsigtighedsregler), 4.5 (Interaktion med andre lægemidler og andre former for interaktion), 4.6 (Frugtbarhed, graviditet og amning) og 5.1 (Farmakodynamiske egenskaber).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de indsendte data og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler burde harmoniseres i EU.
English: Priorix contains small amounts of attenuated (weakened) forms of the viruses that cause measles, mumps and rubella.
Danish: Priorix indeholder små mængder af en svækket form af de virus, der er årsag til mæslinger, fåresyge og røde hunde.
English: Priorix is a vaccine used to protect against measles, mumps and rubella (German measles).
Danish: Priorix er en vaccine mod mæslinger, fåresyge og røde hunde.
English: However, since a single dose of Priorix produces a lower immune response in children under 12 months old, the CHMP decided to include a reference to the other sections containing specific information on the use of Priorix in children between nine and 12 months old.
Danish: Derfor besluttede CHMP at indsætte en henvisning til de andre afsnit med særlige oplysninger om anvendelsen af Priorix hos børn mellem 9 og 12 måneder.
English: The review of Zydelig was initiated at the request of the European Commission on 17 March 2016, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Zydelig blev indledt den 17. marts 2016 på anmodning fra Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: Some changes have now been made in how the medicine is used to ensure it is given as safely as possible.
Danish: Der er foretaget nogle ændringer i, hvordan lægemidlet anvendes, for at sikre, at det anvendes så sikkert som muligt.