FrancophonIA/ELRC3.0 huggingface dataset:
English: the CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Durogesic and associated names.
Danish: • udvalget vedtog en harmoniseret sammenfatning af produktresuméet og indlægssedlen for Durogesic og relaterede navne anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægssedler fremgår af bilag III for Durogesic og relaterede navne konkluderede CHMP, at benefit/risk-forholdet for Durogesic og relaterede navne fortsat er positivt under forudsætning af de vedtagne ændringer af produktinformationen.
English: The fourth injection is given four months after the third.
Danish: Den fjerde injektion gives fire måneder efter den tredje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fendrix on 2 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fendrix den 2. februar 2005.
English: The full EPAR for Fendrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Fendrix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There should be a gap of one month between the first and second, and between the second and third injections.
Danish: Der skal gå en måned mellem den første og anden injektion og en måned mellem den anden og tredje injektion.
English: The vaccine is injected into the shoulder muscle.
Danish: Vaccinen indsprøjtes i skuldermusklen.
English: This is a summary of the European public assessment report (EPAR) for Fendrix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fendrix.
English: Other information about Fendrix
Danish: Andre oplysninger om Fendrix
English: The recommended vaccination schedule for Fendrix is four doses.
Danish: Det anbefalede vaccinationsprogram for Fendrix er fire doser.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner fungerer ved at lære kroppens immunsystem (det naturlige forsvar), hvordan det forsvarer sig mod en sygdom.
English: For more information about treatment with Fendrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fendrix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Fendrix has been available in other vaccines that have been authorised in the European Union (EU) for a number of years.
Danish: Det aktive stof i Fendrix har i en årrække været anvendt i andre vacciner, der er godkendt i Den Europæiske Union (EU).
English: A booster dose of Fendrix may be given, according to official recommendations.
Danish: Der kan gives en boosterdosis Fendrix i overensstemmelse med officielle anbefalinger.
English: This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.
Danish: Dette system øger immunsystemets reaktion, hvilket kan være en fordel, når vacciner anvendes til patienter med mindre reaktion, f.eks. patienter med nyreproblemer.
English: The company also presented information on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment of the vaccine.
Danish: Virksomheden fremlagde også oplysninger om anvendelsen af Fendrix til levertransplanterede patienter, men trak ansøgningen om anvendelse af Fendrix til disse patienter tilbage under vurderingen af vaccinen.
English: Fendrix is a vaccine.
Danish: Fendrix er en vaccine.
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 Fendrix.
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 Fendrix skal anvendes.
English: Because the active substance in Fendrix has been available in the EU in other vaccines, some of the information used to support the use of the other vaccines was used to support the use of Fendrix.
Danish: Da det aktive stof i Fendrix har været på markedet i EU i andre vacciner, er nogle af de oplysninger, der er blevet brugt til at understøtte anvendelsen af de andre vacciner, også brugt til at understøtte anvendelsen af Fendrix.
English: Fendrix was as effective as a double dose of the comparator vaccine.
Danish: Fendrix var ligeså effektiv som en dobbeltdosis af sammenligningsvaccinen.
English: The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Fendrix (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, smerte, rødme, hævelse på injektionsstedet og træthed.
English: Fendrix hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Danish: Fendrix hepatitis B (rDNA) vaccine (adjuveret, adsorberet)
English: The surface antigens are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Danish: Overfladeantigenerne fremstilles ved hjælp af en metode kaldet rekombinant dna-teknologi: De produceres af en gærart, der har fået indsat et gen (dna), som sætter den i stand til at producere proteinerne.
English: It contains parts of the hepatitis B virus as the active substance.
Danish: Den indeholder dele af hepatitis Bvirusset som det aktive stof.
English: The CHMP decided that Fendrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Fendrix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Fendrix.
English: Fendrix has also been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Danish: Fendrix er også blevet undersøgt i en hovedundersøgelse med 165 patienter på 15 år og derover, der havde nyreproblemer og behov for hæmodialyse.
English: It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique used in patients with kidney disease).
Danish: Det kan anvendes til patienter på 15 år og derover, herunder patienter, der har behov for hæmodialyse (en blodrensningsteknik, der anvendes hos patienter med nyresygdom).
English: When a patient is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
Danish: Når en patient bliver vaccineret, opfatter immunsystemet overfladeantigenerne som fremmede og danner antistoffer mod dem.
English: It is recommended that individuals who receive the first dose should complete the course with Fendrix.
Danish: Det anbefales, at personer, som får den første dosis, gennemfører hele Fendrix-programmet.
English: The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
Danish: Virkningen af Fendrix varede længere end virkningen af sammenligningsvaccinen: 80 % af de patienter, som fik Fendrix, opretholdt beskyttende niveauer af antistoffer i op til tre år sammenlignet med 51 % af de patienter, som fik sammenligningsvaccinen.
English: Fendrix is a vaccine, which is available as a suspension for injection.
Danish: Fendrix er en vaccine, der fås som en suspension til injektion.
English: One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against the hepatitis B virus, compared with 84% of those receiving the comparator.
Danish: Én måned efter den sidste dosis havde 91 % af de patienter, som fik Fendrix, beskyttende niveauer af antistoffer mod hepatitis B-virussen sammenlignet med 84 % af de patienter, der fik sammenligningsvaccinen.
English: The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies against the hepatitis B virus.
Danish: Det primære mål for virkningen var andelen af patienter, som udviklede beskyttende niveauer af antistoffer mod hepatitis B-virusset.
English: Fendrix was compared with a double dose of Engerix B (another hepatitis B vaccine).
Danish: Fendrix blev sammenlignet med en dobbeltdosis af Engerix-B (en anden hepatitis B-vaccine).
English: In Fendrix, it is used with an ‘adjuvant system' which contains ‘MPL', a purified fat from bacteria, and an aluminium compound.
Danish: I Fendrix anvendes det med et adjuverende system (hjælpesystem), der indeholder MPL, som er et renset fedtstof fra bakterier, og en aluminiumsforbindelse.
English: Fendrix is used to protect patients with kidney problems against hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Danish: Fendrix anvendes til at beskytte patienter med nyreproblemer mod hepatitis B (en nyresygdom, som skyldes infektion med hepatitis B-virus).
English: What is the risk associated with Fendrix?
Danish: Hvilken risiko er der forbundet med Fendrix?
English: For the full list of side effects reported with Fendrix, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Fendrix fremgår af indlægssedlen.
English: Why has Fendrix been approved?
Danish: Hvorfor blev Fendrix godkendt?
English: Fendrix contains small amounts of the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Danish: Fendrix indeholder små mængder proteiner fra hepatitis Bvirussets overflade (‘overfladeantigen').
English: Fendrix must not be used in people who are hypersensitive (allergic) to the active substance or any of the other ingredients or have had an allergic reaction after being given a hepatitis B vaccine.
Danish: Fendrix må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne, eller der har haft en overfølsomhedsreaktion, efter de har fået en vaccine mod hepatitis B. Fendrix må heller ikke gives til patienter, der har fået pludselig høj feber.
English: What is Fendrix?
Danish: Hvad er Fendrix?
English: How has Fendrix been studied?
Danish: Hvordan blev Fendrix undersøgt?
English: What is Fendrix used for?
Danish: Hvad anvendes Fendrix til?
English: What benefit has Fendrix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fendrix?
English: In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus.
Danish: Når immunsystemet efterfølgende udsættes for hepatitis B-virusset, vil det være i stand til hurtigere at producere antistoffer mod det. Antistofferne hjælper med at beskytte mod den sygdom, der fremkaldes af virusset.
English: How is Fendrix used?
Danish: Hvordan anvendes Fendrix?
English: How does Fendrix work?
Danish: Hvordan virker Fendrix?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Higher doses were no more effective than this dose.
Danish: Højere doser var ikke mere effektive end denne dosis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Luveris to Merck Serono Europe Limited on 29 November 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Luveris til Merck Serono Europe Limited den 29. november 2000.
English: The full EPAR for Luveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Luveris findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: If the powder and solvent are used, they should be mixed together just before use.
Danish: Hvis der anvendes pulver og solvens, skal de blandes sammen inden brug.
English: Because the number of patients with this condition is low, Luveris was not compared with any other medicines.
Danish: Da der kun findes få patienter med denne tilstand, blev Luveris ikke sammenlignet med noget andet lægemiddel.
English: Doses of FSH are adjusted according to the response, and treatment may continue for up to five weeks.
Danish: FSH-doserne korrigeres i forhold til behandlingens virkning, og behandlingen kan fortsætte i op til 5 uger.
English: The patient may carry out the injection herself if she is well-motivated, has been adequately trained and has access to expert advice.
Danish: Patienten kan selv foretage injektionen, hvis hun er motiveret for det, har fået den nødvendige instruktion og har adgang til ekspertrådgivning.
English: Other information about Luveris
Danish: Andre oplysninger om Luveris
English: Luveris is given by injection under the skin.
Danish: Luveris gives ved injektion under huden.
English: This is a summary of the European public assessment report (EPAR) for Luveris.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Luveris.
English: In the main study, 67% of the women who received the approved dose of Luveris (75 International Units) together with FSH produced functional follicles (6 out of 9).
Danish: I hovedundersøgelsen dannede 67 % af de kvinder, der fik den godkendte dosis Luveris (75 internationale enheder) sammen med FSH, funktionelle follikler (6 ud af 9).
English: Lutropin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human LH.
Danish: Lutropin alfa fremstilles via en metode, der er kendt som ‘rekombinant DNA-teknologi': Det fremstilles af en celle, der har fået indsat et gen (DNA), som sætter den i stand til at danne humant LH.
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 Luveris.
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 anvendelsesbetingelserne for Luveris.
English: Luveris is given once a day together with FSH.
Danish: Luveris gives en gang dagligt sammen med FSH.
English: For more information about treatment with Luveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Luveris, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness was the number of women who produced functional follicles (eggs in the ovaries that are ready for release).
Danish: Det primære effektmål var antallet af kvinder, som dannede funktionelle follikler (æg i æggestokkene, som er klar til ægløsning).
English: FSH, which is used together with Luveris, also stimulates ovulation.
Danish: FSH, som anvendes sammen med Luveris, stimulerer også ægløsningen.
English: The patient's response to treatment is monitored to check how the egg development in the ovary is progressing.
Danish: Patientens reaktion på behandlingen overvåges for at kontrollere ægmodningen i æggestokkene.
English: It must also not be used when there is enlargement of the ovaries or cysts that are not related to polycystic ovarian disease and are of unknown origin, or unexplained bleeding from the vagina.
Danish: Det må heller ikke anvendes, når der er forstørrelse af ovarierne eller cyster, som ikke skyldes polycystisk ovariesyndrom og er af ukendt oprindelse, eller når der forekommer blødning fra vagina af ukendt årsag.
English: The CHMP decided that Luveris's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP fandt, at fordelene ved Luveris opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse herfor.
English: The active substance in Luveris, lutropin alfa, is a copy of the natural hormone LH.
Danish: Det aktive stof i Luveris, lutropin alfa, er en kopi af det naturlige LH-hormon.
English: Luveris, given together with FSH, has been studied in one main study involving 38 women with severe LH and FSH deficiency.
Danish: Luveris givet sammen med FSH blev undersøgt i en hovedundersøgelse, som omfattede 38 kvinder med svær mangel på LH og FSH.
English: EPAR summary for the public lutropin alfa
Danish: EPAR - sammendrag for offentligheden lutropin alfa
English: Treatment with Luveris should be carried out by a doctor who has experience in the treatment of fertility problems.
Danish: Behandling med Luveris bør udføres af en læge med erfaring i fertilitetsbehandling.
English: Luveris is a medicine that contains the active substance lutropin alfa.
Danish: Luveris er et lægemiddel, der indeholder det aktive stof lutropin alfa.
English: Luveris should not be used in people who may be hypersensitive (allergic) to LH, FSH or any of the other ingredients.
Danish: Luveris bør ikke anvendes hos personer, der kan være overfølsomme (allergiske) over for LH, FSH eller andre af indholdsstofferne.
English: The most common side effects with Luveris (seen in between 1 and 10 patients in 100) are reactions at the injection site (pain, redness, bruising or swelling), headache,, nausea (feeling sick), vomiting, diarrhoea, abdominal pain and discomfort, pelvic (lower abdominal) pain, mild to moderate ovarian hyperstimulation syndrome, ovarian cyst (development of a fluid-filled cavity in the ovary) and breast pain.
Danish: De hyppigste bivirkninger (som optræder hos mellem 1 og 10 ud af 100 patienter) er reaktioner på injektionsstedet (smerte, rødme, blå mærker eller hævelse), hovedpine, kvalme, opkastning, diarré, smerter og gener i mave, smerter i underliv, mild til moderat overstimulering af æggestokkene, cyster i æggestokkene (dannelse af væskefyldte hulrum i æggestokken) og smerter i brysterne.
English: The resulting solution can be mixed with FSH in the same syringe.
Danish: Den heraf følgende opløsning kan blandes med FSH i samme injektionssprøjte.
English: Luveris is a fertility treatment.
Danish: Luveris er et middel til fertilitetsbehandling.
English: Ovarian hyperstimulation syndrome occurs when the ovaries over respond to treatment, especially when medicines to trigger ovulation have been used, and can cause nausea, weight gain and diarrhoea.
Danish: Overstimulering af æggestokkene opstår, når æggestokkene overreagerer på behandlingen, især når der er anvendt ægløsningsstimulerende lægemidler, og kan fremkalde kvalme, vægtforøgelse og diarré.
English: What is the risk associated with Luveris?
Danish: Hvilken risiko er der forbundet med Luveris?
English: It is used with follicle stimulating hormone (FSH) to stimulate the development of eggs in the ovaries of adult women who have severe deficiency (very low levels) of luteinising hormone (LH) and FSH.
Danish: Det anvendes sammen med et follikelstimulerende hormon (FSH) til at stimulere ægmodningen i æggestokkene hos voksne kvinder, der lider af svær mangel på luteiniserende hormon (LH) og FSH.
English: It must not be used in women who have tumours of the pituitary gland, hypothalamus (a region of the brain), breast, womb or ovary.
Danish: Det må ikke anvendes til kvinder, der har tumorer i hypofysen, hypothalamus (et område af hjernen), brystet, livmoderen eller æggestokkene.
English: In the body, LH causes the release of eggs (ovulation) during the menstrual cycle.
Danish: LH fremkalder i kroppen ægløsning (ovulation) som led i menstruationscyklussen.
English: For the full list of all side effects reported with Luveris, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Luveris fremgår af indlægssedlen.
English: Why has Luveris been approved?
Danish: Hvorfor blev Luveris godkendt?
English: It is available as a powder and solvent that are made up into a solution for injection, and as a solution for injection in a pre-filled pen.
Danish: Det fås som pulver og solvens, der blandes til en injektionsvæske, opløsning, og som en injektionsvæske, opløsning, i en fyldt pen.
English: What is Luveris?
Danish: Hvad er Luveris?
English: What is Luveris used for?
Danish: Hvad anvendes Luveris til?
English: How has Luveris been studied?
Danish: Hvordan blev Luveris undersøgt?
English: What benefit has Luveris shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Luveris?
English: How is Luveris used?
Danish: Hvordan anvendes Luveris?
English: The dose is then increased every two weeks until the appropriate dose for the individual patient is established.
Danish: Dosen øges derefter hver anden uge, indtil den korrekte dosis for den enkelte patient er fastlagt.
English: The maximum dose should not exceed 2.5 mg three times a day.
Danish: Den maksimale dosis bør ikke overstige 2,5 mg tre gange dagligt.
English: It also noted that no other medicines have been authorised for CTEPH.
Danish: Det bemærkede også, at der ikke er blevet godkendt andre lægemidler til CTEPH.
English: Adempas received a marketing authorisation valid throughout the European Union on 27 March 2014.
Danish: Adempas fik en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 27. marts
English: Adempas is available as tablets (0.5, 1, 1.5, 2 and 2.5 mg).
Danish: Adempas fås som tabletter (0,5, 1, 1,5, 2 og 2,5 mg).
English: The usual recommended starting dose is 1 mg three times a day (approximately 6 to 8 hours apart) for two weeks.
Danish: Den sædvanlige anbefalede startdosis er 1 mg tre gange dagligt (med ca. 6-8 timers mellemrum) i to uger.
English: Other information about Adempas
Danish: Andre oplysninger om Adempas
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Danish: "Klassen" afspejler sygdommens sværhedsgrad: "Klasse II" omfatter lettere begrænsning af fysisk aktivitet, og "klasse III" omfatter markant begrænsning af fysisk aktivitet.
English: An overview of Adempas and why it is authorised in the EU
Danish: En oversigt over Adempas, og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Adempas are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Adempas løbende overvåget.
English: • The medicine was also compared with placebo in another main study in 445 patients with PAH.
Danish: • Lægemidlet blev også sammenlignet med placebo i et andet hovedstudie med 445 patienter med PAH.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
English: What is Adempas and what is it used for?
Danish: Hvad er Adempas, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Adempas?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Adempas?
English: Side effects reported with Adempas are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Adempas vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.