FrancophonIA/ELRC3.0 huggingface dataset:
English: It is presented as a frozen suspension to be reconstituted with diluent and injected into chickens and into eggs where chicks are developing.
Danish: Den leveres som frossen suspension, der skal rekonstitueres med et fortyndingsmiddel og injiceres i kyllinger og i æg med kyllingefostre.
English: The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.
Danish: Lægemidlet synes ikke at forstyrre antistoffer, der kommer fra moderfuglen, og produktet kan gives sikkert til daggamle kyllinger og til æg med kyllingefostre, uden at det tilsyneladende medfører noget sikkerhedsproblem eller undertrykkende virkning på immunforsvaret.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Vaxxitek HVT+IBD to Merial S.A.S.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vaxxitek HVT+IBD til Merial S.A.S.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VAXXITEK HVT+IBD EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) VAXXITEK HVT+IBD EPAR - sammendrag for offentligheden
English: Vaxxitek HVT + IBD contains vaccine strains which induce an active immunity and a serological response (detected antibodies) against the two diseases.
Danish: Vaxxitek HVT + IBD indeholder vaccinestammer, som giver aktiv immunitet og serologisk respons (påviste antistoffer) mod de to sygdomme.
English: The studies demonstrated that Vaxxitek HVT+IBD is effective in the active immunisation of chickens and chicks in the egg against Infectious Bursal disease.
Danish: Undersøgelserne viste, at Vaxxitek HVT+IBD er effektiv til aktiv immunisering af kyllinger og kyllingefostre i æg mod infektiøs bursal sygdom.
English: Vaxxitek HVT+IBD is a recombinant vaccine intended for use against Infectious Bursal Disease (also known as Gumboro Disease) and Marek's Disease in chickens.
Danish: Vaxxitek HVT+IBD er en rekombinant vaccine mod infektiøs bursal sygdom (også kaldet Gumboro) og Marek's sygdom hos kyllinger.
English: In the absence of specific studies, no other vaccine should be administered at the same time when the product is injected into eggs.
Danish: Man bør ved injektion af vaccinen i æggene ikke foretage samtidig administration af andre vacciner, da der ikke findes specifikke undersøgelser af dette.
English: Other information about Vaxxitek HVT+IBD:
Danish: Andre oplysninger om Vaxxitek HVT+IBD:
English: Vaxxitek HVT+IBD is also used to reduce mortality, clinical signs and effects of Marek's disease, a herpes virus infection of chickens.
Danish: Vaxxitek HVT+IBD anvendes også til at nedsætte dødelighed, kliniske symptomer og virkninger forårsaget af Marek's sygdom, som er en herpesvirusinfektion hos kyllinger.
English: Vaxxitek HVT+IBD is used to prevent the deaths of chickens and to reduce clinical signs and effects of Infectious Bursal disease which is a disease which damages the immune system of chickens.
Danish: Vaxxitek HVT+IBD anvendes til at forebygge dødelighed hos kyllinger og til at reducere kliniske symptomer og virkninger, der er forårsaget af infektiøs bursal sygdom, som beskadiger immunsystemet hos kyllinger.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vaxxitek HVT+IBD exceed the risks of its use in chickens and recommended that Vaxxitek HVT+IBD be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Vaxxitek HVT+IBD er større end risiciene, når det anvendes til kyllinger.
English: What is the risk associated with Vaxxitek HVT+IBD?
Danish: Hvilken risiko er der forbundet med Vaxxitek HVT+IBD?
English: Why has Vaxxitek HVT+IBD been approved?
Danish: Hvorfor blev Vaxxitek HVT+IBD godkendt?
English: What is Vaxxitek HVT+IBD?
Danish: Hvad er Vaxxitek HVT+IBD?
English: How has Vaxxitek HVT+IBD been studied?
Danish: Hvordan blev Vaxxitek HVT+IBD undersøgt?
English: What is Vaxxitek HVT+IBD used for?
Danish: Hvad anvendes Vaxxitek HVT+IBD til?
English: How does Vaxxitek HVT+IBD work?
Danish: Hvordan virker Vaxxitek HVT+IBD?
English: What benefit has Vaxxitek HVT+IBD shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vaxxitek HVT+IBD?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pritor den 11. december 1998.
English: Other information about Pritor
Danish: Andre oplysninger om Pritor
English: This is a summary of the European public assessment report (EPAR) for Pritor.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pritor.
English: A risk management plan has been developed to ensure that Pritor is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pritor anvendes så sikkert som muligt.
English: Pritor is a medicine that contains the active substance telmisartan.
Danish: Pritor er et lægemiddel, som indeholder det aktive stof telmisartan.
English: What measures are being taken to ensure the safe and effective use of Pritor?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pritor?
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 Pritor.
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 Pritor skal anvendes.
English: The doctor should monitor the patient's blood pressure closely when starting Pritor, and may decide to adjust the patient's blood pressure-lowering medication.
Danish: Lægen bør overvåge patientens blodtryk nøje, når behandlingen med Pritor påbegyndes, og kan beslutte at justere patientens blodtrykssænkende medicin.
English: Pritor must not be used in women who are more than three months pregnant.
Danish: Det må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten.
English: Pritor is used to treat essential hypertension (high blood pressure) in adults.
Danish: Pritor anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: The CHMP decided that Pritor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Pritor opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Hypotension may be more common in patients receiving Pritor to prevent cardiovascular problems.
Danish: Hypotension kan forekomme oftere hos patienter, der får Pritor for at forebygge kardiovaskulære problemer.
English: Pritor was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Danish: Pritor blev sammenlignet med ramipril (et andet lægemiddel til forebyggelse af kardiovaskulære problemer) og med kombinationen af begge lægemidler.
English: Pritor must not be used in people who have severe liver problems or bile problems.
Danish: Pritor må ikke anvendes af personer, der har alvorlige leverproblemer eller galdeproblemer.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment
Danish: Dog kan følgende bivirkninger optræde hos mellem 1 og 10 patienter ud af 1 000: infektioner i de øvre luftveje (forkølelser), herunder betændelse i hals og bihuler, urinvejsinfektioner, herunder blærebetændelse, anæmi (lavt antal røde blodlegemer), hyperkaliæmi (højt indhold af kalium i blodet), depression, søvnløshed, besvimelsesanfald, svimmelhed, bradykardi (langsom hjerterytme), hypotension (lavt blodtryk), dyspnø (vejrtrækningsbesvær), hoste, mavesmerter, diarré, dyspepsi (halsbrand), flatulens (luft i maven), opkastning, hyperhidrose (forøget svedafsondring), kløe, udslæt, myalgi (muskelsmerter), rygsmerter, muskeltrækninger, nyreproblemer (nedsat nyrefunktion), herunder pludselig nyresvigt, brystsmerter, asteni (kraftesløshed) og øget indhold af kreatinin i blodet (en markør for muskelnedbrydning).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pritor, 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 Pritor, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Various doses of Pritor were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Danish: Forskellige doseringer af Pritor blev sammenlignet med placebo (en virkningsløs behandling) og med andre lægemidler mod hypertension (atenolol, lisinopril, enalapril og amlodipin).
English: The active substance in Pritor, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Pritor, telmisartan, er en "angiotensin II-receptorantagonist", hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Pritor must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Danish: Hos patienter med type 2-diabetes eller moderat eller alvorlig nyresygdom må Pritor desuden ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension).
English: What is the risk associated with Pritor?
Danish: Hvilken risiko er der forbundet med Pritor?
English: For the treatment of essential hypertension, Pritor has been studied in 2,647 patients who took Pritor either alone or in combination with hydrochlorothiazide.
Danish: Pritor er, til behandling af essentiel hypertension, blevet undersøgt hos 2 647 patienter, der fik Pritor enten alene eller i kombination med hydrochlorothiazid.
English: Pritor is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Danish: Pritor anvendes også til at forebygge kardiovaskulære problemer (problemer med hjertet og blodkarrene) såsom hjerteanfald eller slagtilfælde.
English: For the prevention of cardiovascular problems, 80 mg Pritor once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Danish: Til forebyggelse af kardiovaskulære problemer er Pritor 80 mg én gang dagligt blevet undersøgt i en hovedundersøgelse med deltagelse af næsten 26 000 patienter i alderen 55 år eller derover, som havde hjerte- eller arteriesygdom, havde haft et slagtilfælde eller havde diabetes, og som havde stor risiko for kardiovaskulære problemer.
English: For the treatment of essential hypertension, the usual recommended dose of Pritor is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Danish: Til behandling af essentiel hypertension er den sædvanlige anbefalede dosis af Pritor 40 mg én gang dagligt, men visse patienter kan klare sig med 20 mg én gang dagligt.
English: In the treatment of essential hypertension, Pritor was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Danish: Til behandling af essentiel hypertension var Pritor mere effektivt end placebo til at nedsætte det diastoliske blodtryk, og virkningerne af Pritor svarede til virkningerne af andre lægemidler mod forhøjet blodtryk.
English: Side effects with Pritor are not common.
Danish: Almindeligvis forekommer der ikke bivirkninger ved Pritor.
English: Why has Pritor been approved?
Danish: Hvorfor blev Pritor godkendt?
English: If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Danish: Ved utilstrækkelig virkning kan dosis øges til 80 mg, eller Pritor kan anvendes i kombination med et andet lægemiddel for hypertension, for eksempel hydrochlorothiazid.
English: What is Pritor?
Danish: Hvad er Pritor?
English: In the prevention of cardiovascular problems, Pritor had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Danish: Til forebyggelse af kardiovaskulære problemer svarede virkningen af Pritor til virkningen af ramipril, idet ca. 17 % af patienterne døde, blev hospitalsindlagt som følge af kardiovaskulære problemer eller fik et hjerteanfald eller slagtilfælde.
English: For the full list of all side effects reported with Pritor, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Pritor fremgår af indlægssedlen.
English: What benefit has Pritor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pritor?
English: How has Pritor been studied?
Danish: Hvordan blev Pritor undersøgt?
English: The full EPAR for Pritor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pritor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Hvis du ønsker yderligere oplysninger om behandling med Pritor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Pritor used for?
Danish: Hvad anvendes Pritor til?
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer telmisartan hormonet i at have nogen effekt, hvorved blodkarrene udvider sig.
English: How is Pritor used?
Danish: Hvordan anvendes Pritor?
English: What is Winfuran?
Danish: Hvad er Winfuran?
English: The effects of Winfuran were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Winfuran blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Winfuran (nalfurafin) EMA/33514/2014
English: The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i symptomer, såsom kløeintensitet og søvnforstyrrelse, efter fire ugers behandling, baseret på et standardscoresystem.
English: EMA/33514/2014
Danish: Den 24. januar 2014 EMA/33514/2014
English: Winfuran is a medicine that contains the active substance nalfurafine.
Danish: Winfuran er et lægemiddel, der indeholder det aktive stof nalfurafin.
English: What was Winfuran expected to be used for?
Danish: Hvad forventedes Winfuran anvendt til?
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Winfuran (nalfurafin)
English: The main study failed to show that Winfuran was more effective than placebo at relieving itching.
Danish: Det kunne ikke påvises i hovedundersøgelsen, at Winfuran var mere effektivt end placebo til at lindre kløen.
English: Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin.
Danish: Den nøjagtige årsag til uræmisk pruritus kendes ikke, men kløen menes at hænge sammen med for stor aktivitet af visse receptorer, my-opioidreceptorer, i hjernen og i huden.
English: Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown.
Danish: En supplerende analyse viste en beskeden fordel hos en undergruppe af patienter med en svær form for uræmisk pruritus, men CHMP fandt ikke, at den kliniske betydning heraf var påvist.
English: On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Danish: Den 17. januar 2014 meddelte Toray International U.K. Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Winfuran til behandling af kløe (svær uræmisk pruritus) hos dialysepatienter med nyresygdom i slutstadiet.
English: The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis.
Danish: Winfuran blev sammenlignet med placebo (en virkningsløs behandling) i én hovedundersøgelse med deltagelse af 339 patienter, der havde uræmisk pruritus og var i regelmæssig dialysebehandling.
English: Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.
Danish: Winfuran aktiverer nogle andre receptorer, kappa-receptorerne, som blokerer aktiviteten af my-opioidreceptorerne og derved lindrer kløen hos patienter med uræmisk pruritus.
English: Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly.
Danish: Uræmisk pruritus er vedvarende kløe, der optræder hos nogle patienter, hvis nyrer ikke fungerer korrekt.
English: The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown.
Danish: CHMP's hovedbetænkelighed var, at fordelene ved Winfuran til behandling af uræmisk pruritus ikke var tilstrækkelig påvist.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Winfuran ikke opvejede risiciene, og konkluderede, at lægemidlet ikke kunne være blevet godkendt på baggrund af de oplysninger, som virksomheden havde fremlagt.
English: How is Winfuran expected to work?
Danish: Hvordan forventes Winfuran at virke?
English: Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus.
Danish: Winfuran blev udpeget som “lægemiddel til sjældne sygdomme” den 11. september 2002 til uræmisk pruritus.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran.
Danish: Virksomheden har meddelt CHMP, at der ikke er nogen igangværende kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Winfuran.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
Danish: På baggrund af gennemgangen af dataene havde CHMP afgivet en negativ udtalelse og anbefalet afslag på udstedelse af markedsføringstilladelse for Winfuran til behandling af svær uræmisk pruritus.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Danish: I sit officielle brev erklærede virksomheden, at den havde besluttet at trække ansøgningen tilbage, fordi CHMP fandt, at de forelagte data ikke gjorde det muligt for udvalget at vurdere benefit/risk-forholdet som positivt.
English: Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).
Danish: Winfuran skulle anvendes hos patienter, hvis nyrer var holdt helt op med at virke (nyresygdom i slutstadiet), og som fik dialyse for at få fjernet affaldsstoffer fra blodet.
English: It was to be available as a concentrate for solution for infusion into a vein.
Danish: Det skulle have været leveret som koncentrat til infusionsvæske, opløsning, i en vene.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Winfuran eller i programmer for anvendelse af Winfuran med særlig udleveringstilladelse?
English: Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus.
Danish: Winfuran forventedes anvendt til behandling af svær uræmisk pruritus.
English: Olysio is available as 150 mg capsules.
Danish: Olysio leveres som 150 mg kapsler.
English: This is a summary of the European public assessment report (EPAR) for Olysio.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olysio.
English: The full EPAR and risk management plan summary for Olysio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Olysio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one capsule taken once a day with food for 12 or 24 weeks.
Danish: Den normale dosis er én kapsel én gang dagligt, der tages sammen med mad, i 12 eller 24 uger.
English: What is Olysio and what is it used for?
Danish: Hvad er Olysio, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Olysio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Olysio?
English: The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Danish: Agenturet var desuden af den opfattelse, at de tilgængelige data understøtter anvendelsen af Olysio in kombination med sofosbuvir.