FrancophonIA/ELRC3.0 huggingface dataset:
English: • movement disorders such as those in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.
Danish: • bevægelsesforstyrrelser såsom ved Parkinsons sygdom og andre beslægtede sygdomme, hvor tab af nerveceller fører til tremor (rysten), gangforstyrrelser (problemer med den måde, patienten går på) og muskelstivhed.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Striascan er sammenligneligt med DaTSCAN.
English: What are the benefits and risks of Striascan?
Danish: Hvilke fordele og risici er der forbundet med Striascan?
English: Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.
Danish: Der skal være genoplivningsudstyr til rådighed, før Striascan indgives, hvis patienten skulle få en allergisk reaktion.
English: As for every medicine, the company provided studies on the quality of Striascan.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Striascan.
English: Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.
Danish: Mellem 1-4 timer inden patienterne får Striascan, skal de også tage et andet lægemiddel, f.eks. jodtabletter, for at forhindre det radioaktive jod i Striascan i at trænge ind i skjoldbruskkirtlen.
English: What measures are being taken to ensure the safe and effective use of Striascan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Striascan?
English: There was no need for ‘bioequivalence' studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Striascan optages på samme måde som referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies' and Alzheimer's disease.
Danish: Striascan anvendes til at skelne mellem en type demens, der kaldes "Levy body demens" og Alzheimers sygdom.
English: In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum.
Danish: Hos patienter med Parkinsons sygdom og beslægtede sygdomme og hos patienter med Lewy body demens sker der typisk et tab af de dopamin-indeholdende nerveceller i striatum.
English: Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.
Danish: Ioflupan binder sig specifikt til strukturer i nervecelleenderne, som er ansvarlige for transporten af dopamin.
English: Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia.
Danish: Striascan udleveres kun efter recept og bør kun anvendes til patienter, der er blevet henvist af en læge med erfaring i håndtering af bevægelsesforstyrrelser eller demens.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, DaTSCAN, og det er ikke nødvendigt at gentage disse med Striascan.
English: This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
Danish: Denne ophobning kan ses ved hjælp af en billedteknik, der kaldes single photon emission computed tomography (SPECT), som opfanger det radioaktive jod-123.
English: Striascan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DaTSCAN.
Danish: Det betyder, at Striascan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder DaTSCAN.
English: Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein.
Danish: Striascan gives i en vene i en arm ved langsom injektion, der varer mindst 15-20 sekunder.
English: This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Striascan gives ved injektion i en vene, så det aktive stof ledes direkte ind i blodbanen.
English: It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of iodine.
Danish: Det indeholder et stof, der kaldes ioflupan, som er mærket med 123I (iod-123), en radioaktiv form for jod.
English: It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
Danish: Det anvendes til at påvise tab af nerveceller i et område i hjernen kaldet striatum, navnlig de celler, der udsender dopamin, et kemisk signalstof.
English: Therefore, the Agency's view was that, as for DaTSCAN, the benefit of Striascan outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Striascan opvejer de identificerede risici, som for DaTSCAN, og at det kan godkendes til anvendelse i EU.
English: This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.
Danish: Dette gør det muligt at skelne sygdomme, der ligner Parkinsons sygdom, fra essentiel tremor og skelne Lewy body demens fra Alzheimers sygdom.
English: Why is Striascan authorised in the EU?
Danish: Hvorfor blev Striascan godkendt i EU?
English: What is Striascan and what is it used for?
Danish: Hvad er Striascan, og hvad anvendes det til?
English: How has Striascan been studied?
Danish: Hvordan er Striascan blevet undersøgt?
English: How is Striascan used?
Danish: Hvordan anvendes Striascan?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Striascan 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 Striascan.
English: Striascan (ioflupane (
Danish: Striascan (ioflupan (123I))
English: I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine.
Danish: Når Striascan injiceres, fordeles ioflupan (123I) i blodet og hober sig op i striatum, hvor det bindes til de strukturer, der anvendes til transport af dopamin.
English: Annex I Scientific conclusions
Danish: Bilag I Videnskabelige konklusioner
English: It must also not be used in babies whose immune system is weakened.
Danish: Det må heller ikke gives til spædbørn, hvis immunsystem er svækket.
English: The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq on 27 June 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for RotaTeq den 27. juni 2006.
English: It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
Danish: Den indeholder fem levende rotavirusstammer, alle med forskellige antigener (G1, G2, G3, G4 og P1[8]).
English: The full EPAR for RotaTeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for RotaTeq findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European public assessment report (EPAR) for RotaTeq.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for RotaTeq.
English: RotaTeq should never be injected under any circumstances.
Danish: RotaTeq bør aldrig under nogen omstændigheder injiceres.
English: The first dose should be given six weeks after birth at the earliest.
Danish: Den første dosis bør tidligst gives seks uger efter fødslen.
English: There are various types of rotaviruses that cause gastroenteritis.
Danish: Der findes mange forskellige typer af rotavirus, som forårsager gastroenteritis.
English: An antigen is a specific structure that the body can recognise as ‘foreign' and against which the body can make an antibody, a special protein that can neutralise or destroy the antigen.
Danish: Et antigen er en bestemt struktur, som kroppen kan genkende som "fremmed", og som den kan producere et antistof mod, dvs. et bestemt protein, som kan neutralisere eller ødelægge antigenet.
English: A risk management plan has been developed to ensure that RotaTeq is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at RotaTeq anvendes så sikkert som muligt.
English: They vary in that they may carry different antigens.
Danish: De adskiller sig fra hinanden ved at have forskellige antigener.
English: Overall, the studies of RotaTeq involved over 72,000 babies, including about 2,000 premature babies.
Danish: Samlet set omfattede undersøgelserne af RotaTeq over 72 000 spædbørn, herunder cirka 2 000 for tidligt fødte spædbørn.
English: RotaTeq is given according to official recommendations.
Danish: RotaTeq gives i overensstemmelse med de officielle anbefalinger.
English: RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
Danish: RotaTeq kan gives til for tidligt fødte spædbørn, forudsat at graviditeten varede mindst 25 uger.
English: The first dose is given when the baby is between 6 and 12 weeks of age.
Danish: Første dosis gives, når barnet er mellem seks og 12 uger gammelt.
English: The contents of the tube of RotaTeq are given directly into the baby's mouth.
Danish: Indholdet i RotaTeq-tuben gives direkte i spædbarnets mund.
English: It is recommended that the last dose be given to the child by the age of 20 to 22 weeks.
Danish: Det anbefales, at den sidste dosis gives, når barnet er 20 til 22 uger gammelt.
English: RotaTeq is a vaccine that is taken by mouth.
Danish: RotaTeq er en vaccine, der indtages gennem munden.
English: When a baby is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally and carry the same or very similar antigens.
Danish: Når et spædbarn modtager vaccinen, producerer immunsystemet (det system, som bekæmper sygdomme) antistoffer mod disse antigener, hvilket bidrager til at forebygge mod infektioner forårsaget af rotavirus, som forekommer naturligt, og som har de samme eller meget lignende antigener.
English: RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between the two vaccines).
Danish: RotaTeq kan gives samtidigt med andre vaccinationer (bortset fra oral poliovaccine, hvor der kræves to ugers interval mellem de to vacciner).
English: Other information about RotaTeq:
Danish: Andre oplysninger om RotaTeq:
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 RotaTeq.
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 RotaTeq skal anvendes.
English: For more information about treatment with RotaTeq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med RotaTeq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: RotaTeq is given as three doses, with at least four weeks between each dose.
Danish: RotaTeq gives som tre doser med et interval på mindst fire uger mellem hver dosis.
English: It is available as a solution in a single-dose tube.
Danish: Den fås som en opløsning i en enkeltdosistube.
English: About half of the babies received RotaTeq, and the others received placebo (a dummy vaccine).
Danish: Omkring halvdelen af spædbørnene modtog RotaTeq, og de øvrige modtog placebo (en uvirksom behandling).
English: The main measure of effectiveness, which was studied in 6,000 babies, was the number of babies who developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
Danish: Det primære effektmål, som blev undersøgt hos 6 000 spædbørn, var antallet af spædbørn, der udviklede rotavirusforårsaget gastroenteritis i den efterfølgende rotavirussæson (dvs. den tid på året, hvor rotavirus er i omløb og forårsager infektioner, generelt i de køligere måneder, fra vinter til tidlig forår).
English: The most common side effects with RotaTeq (seen in more than 1 patient in 10) are pyrexia (fever), diarrhoea and vomiting.
Danish: De hyppigste bivirkninger ved RotaTeq (som ses hos mere end 1 ud af 10 patienter) er pyreksi (feber), diarré og opkastning.
English: RotaTeq is used in babies from 6 to 32 weeks of age to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Danish: RotaTeq anvendes til spædbørn i alderen seks til 32 uger til forebyggelse af gastroenteritis (diarré og opkastninger) forårsaget af rotavirusinfektioner.
English: RotaTeq contains viruses that carry the antigens for some of the most commonly occurring types of rotaviruses.
Danish: RotaTeq indeholder virus med antigener mod nogle af de mest almindeligt forekommende typer af rotavirus.
English: RotaTeq must not be given to babies who have had intussusception in the past or who have problems with their bowel that could put them at risk of intussusception.
Danish: RotaTeq må ikke gives til spædbørn, som tidligere har haft intussusception, eller som har problemer med tarmene, der kan give dem risiko for at få intussusception.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for RotaTeq, 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 RotaTeq, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Vaccination with RotaTeq should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Danish: Vaccination med RotaTeq bør udsættes hos spædbørn, der får pludselig høj feber, diarré eller opkastninger.
English: What measures are being taken to ensure the safe and effective use of RotaTeq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af RotaTeq?
English: The number of cases of rotavirus gastroenteritis due to viruses with the same antigens as in the vaccine decreased following vaccination with RotaTeq.
Danish: Antallet af tilfælde af rotavirusforårsaget gastroenteritis, som blev forårsaget af virus med de samme antigener som i vaccinen, faldt efter vaccination med RotaTeq.
English: RotaTeq rotavirus vaccine, live
Danish: RotaTeq rotavirusvaccine, levende
English: RotaTeq must not be used in babies who are hypersensitive (allergic) to the active substance or any of the other ingredients, or who showed signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus in the past.
Danish: RotaTeq må ikke anvendes til spædbørn, der er overfølsomme (allergiske) over for det aktive stof eller nogen af de øvrige indholdsstoffer i vaccinen, eller som har vist tegn på allergi efter tidligere at have fået en dosis af RotaTeq eller en anden vaccine mod rotavirus.
English: Among the almost 6,000 babies in whom the main measure of effectiveness was studied, 82 of the babies vaccinated with RotaTeq developed rotavirus gastroenteritis (one with severe gastroenteritis) compared with 315 of the babies who received placebo (51 severe cases).
Danish: Blandt de næsten 6 000 spædbørn, som virkningen blev undersøgt hos, udviklede 82 af de spædbørn, der blev vaccineret med RotaTeq, rotavirusforårsaget gastroenteritis (ét af dem fik svær gastroenteritis) sammenlignet med 315 af de spædbørn, der modtog placebo (51 svære tilfælde).
English: The CHMP decided that RotaTeq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved RotaTeq opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for RotaTeq.
English: For the full list of all side effects reported with RotaTeq, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved RotaTeq fremgår af indlægssedlen.
English: The study also showed that there were fewer hospital admissions or visits to emergency clinics for rotavirus gastroenteritis in babies vaccinated with RotaTeq.
Danish: Undersøgelsen viste også, at der var færre hospitalsindlæggelser og skadestuebesøg på grund af rotavirusforårsaget gastroenteritis blandt spædbørn vaccineret med RotaTeq.
English: If necessary it may be given up to the age of 32 weeks.
Danish: Hvis det er nødvendigt, kan den sidste dosis gives, når barnet er senest 32 uger gammelt.
English: What is the risk associated with RotaTeq?
Danish: Hvilken risiko er der forbundet med RotaTeq?
English: Why has RotaTeq been approved?
Danish: Hvorfor blev RotaTeq godkendt?
English: What is RotaTeq?
Danish: Hvad er RotaTeq?
English: How has RotaTeq been studied?
Danish: Hvordan blev RotaTeq undersøgt?
English: What is RotaTeq used for?
Danish: Hvad anvendes RotaTeq til?
English: What benefit has RotaTeq shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved RotaTeq?
English: How does RotaTeq work?
Danish: Hvordan virker RotaTeq?
English: How is RotaTeq used?
Danish: Hvordan anvendes RotaTeq?
English: What is DuoCover?
Danish: Hvad er DuoCover?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for DUOCOVER
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for DUOCOVER
English: On 23 May 2008, Bristol Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for DuoCover for the prevention of atherothrombotic events.
Danish: Den 23. maj 2008 meddelte virksomheden Bristol Myers Squibb Pharma EEIG officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for DuoCover til forebyggelse af aterotrombotiske hændelser.
English: What was DuoCover expected to be used for?
Danish: Hvad forventedes DuoCover anvendt til?
English: However the CHMP thought that the company could have addressed these concerns and was of the provisional opinion that DuoCover could have been approved for the prevention of atherothrombotic events.
Danish: CHMP mente dog, at virksomheden kunne have bragt disse betænkeligheder ud af verden, og var af den foreløbige opfattelse, at DuoCover kunne have været godkendt til forebyggelse af aterotrombotiske hændelser.
English: Based on the review of the data and the company's responses to the CHMP lists of questions at the time of the withdrawal, the CHMP had some concerns.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder.
English: How is DuoCover expected to work?
Danish: Hvordan forventes DuoCover at virke?
English: DuoCover is a medicine containing two active substances clopidogrel and acetylsalicylic acid in one tablet.
Danish: DuoCover er et lægemiddel, der indeholder de to aktive stoffer clopidogrel og acetylsalicylsyre i én tablet.
English: Furthermore, the studies of Iscover and Plavix used with acetylsalicylic acid as separate tablets were used to support the use of DuoCover in the same indication.
Danish: Undersøgelserne af Iscover og Plavix, anvendt sammen med acetylsalicylsyre som særskilte tabletter, blev desuden anvendt til at underbygge brugen af DuoCover til samme indikation.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DuoCover?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse med DuoCover?
English: Therefore, at the time of the withdrawal, the CHMP's view was that the company had not fully addressed their concerns and the benefit of the DuoCover combined tablet compared with the separate medicines had not been demonstrated.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at virksomheden ikke havde behandlet udvalgets betænkeligheder fuldt ud, og at fordelene ved den kombinerede DuoCover-tablet ikke var tilstrækkeligt påvist.
English: It was also expected to be used in patients who did not have this abnormal reading on the ECG, if they had unstable angina (a severe type of chest pain) or a ‘non-Q-wave' myocardial infarction and who had a stent inserted (a short tube placed in an artery to prevent it closing up).
Danish: DuoCover forventedes også anvendt til patienter, som ikke har haft en sådan unormal visning på EKG'et, patienter, der har ustabil angina (en svær form for brystsmerter) eller har haft et myokardieinfarkt uden forekomst af Q-takker (en form for slagtilfælde), og har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
English: The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoCover or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Danish: Virksomheden meddelte CHMP, at tilbagetrækningen ikke får konsekvenser for patienter, som det er planen skal deltage i kliniske undersøgelser med DuoCover, eller patienter, som allerede deltager i kliniske undersøgelser med clopidogrel og acetylsalicylsyre som særskilte lægemidler.
English: Clopidogrel on its own has been approved by the EU under the names Iscover and Plavix, for the prevention of atherothrombotic events, in combination with acetylsalicylic acid, in patients with acute coronary syndrome.
Danish: Clopidogrel er i forvejen blevet godkendt særskilt i EU under navnene Iscover og Plavix til forebyggelse af aterotrombotiske hændelser hos patienter med akut koronarsyndrom, i kombination med acetylsalicylsyre.
English: The active substances in DuoCover, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoCover to reduce the number of tablets the patients need to take every day.
Danish: Clopidogrel og acetylsalicylsyre, de aktive stoffer i DuoCover, kombineres i én tablet for at mindske det daglige antal tabletter, patienten skal tage, hvilket skulle gøre det lettere at følge behandlingen.