FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Porcilis PCV been studied?
Danish: Hvordan blev Porcilis PCV undersøgt?
English: What benefit has Porcilis PCV shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Porcilis PCV?
English: How does Porcilis PCV work?
Danish: Hvordan virker Porcilis PCV?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration
English: 3.5 mg/ml Concentrate for solution for infusion
Danish: 3,5 mg/ml Koncentrat til infusionsvæske, opløsning
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage <Indhold (Koncentration)>
English: This will help to protect against the disease.
Danish: Dette beskytter mod sygdommen.
English: This summary was last updated in April 2013.
Danish: Dette sammendrag blev sidst ajourført i 04-2013.
English: A slight increase in body temperature, by up to 1.5 °C, may occur for one or two days.
Danish: Der kan være let temperaturforhøjelse på indtil 1,5 °C i en eller to dage.
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 (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod sygdommen.
English: Flavivirus strain YF-WN
Danish: Flavivirus stamme YF-WN
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum, eller mælken fra dyret kan anvendes til menneskeligt konsum.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis West Nile on 6 June 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Equilis West Nile den 06/06/2013.
English: The effectiveness of Equilis West Nile was first studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination, and how long the protection lasted.
Danish: Virkningen af Equilis West Nile blev først undersøgt i en række laboratorieforsøg, hvor det blev undersøgt, hvor længe det tog at opnå beskyttelse efter vaccination, og hvor længe beskyttelsen varede.
English: The vaccine is initially given to horses over six months of age as two injections into the muscle, three to five weeks apart.
Danish: Indledningsvis gives vaccinationen til heste over 6 måneder som to injektioner i en muskel med tre til fem ugers mellemrum.
English: The duration of protection was 12 months after primary vaccination as well as after the yearly single booster vaccination.
Danish: Beskyttelsen varede i 12 måneder efter den primære vaccination og efter den årlige revaccination med en enkelt boosterdosis.
English: In future if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for West Nile virus, vil immunsystemet reagere hurtigere.
English: If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis West Nile exceed the risks for the treatment of the approved indication and recommended that Equilis West Nile be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Equilis West Nile overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Equilis West Nile.
English: The vaccine was also compared with placebo in two other field studies involving pregnant mares.
Danish: Vaccinen blev desuden sammenlignet med placebo i to andre feltundersøgelser med drægtige hopper.
English: The first involved 128 pregnant mares of mixed breeds and the second involved 41 pregnant thoroughbred mares.
Danish: I den første indgik 128 drægtige hopper af blandet race, i den anden 41 drægtige fuldblodshopper.
English: It is available as a suspension for injection.
Danish: Den leveres som infusionsvæske, suspension.
English: West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Danish: West Nile virus er en infektion, der overføres af myg og kan medføre svær sygdom og dødelig hjernebetændelse hos heste.
English: The laboratory studies showed that horses developed protection two weeks after primary vaccination.
Danish: Laboratorieundersøgelserne viste, at hestene opnåede beskyttelse to uger efter den indledende (primære) vaccination.
English: The benefit - risk balance may be found in the scientific discussion module of this EPAR.
Danish: Forholdet mellem fordele og risici fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR.
English: The studies in pregnant mares showed that 89% of the vaccinated mixed-breed mares and 95% of the vaccinated thoroughbred mares produced protective antibody levels.
Danish: Undersøgelserne hos drægtige hopper viste, at 89 % af de vaccinerede hopper af blandet race og 95 % af de vaccinerede fuldblodshopper dannede beskyttende mængder antistoffer.
English: Equilis West Nile was also studied in three field studies.
Danish: Equilis West Nile blev desuden undersøgt i tre feltundersøgelser.
English: Equilis West Nile is used to vaccinate horses from six months of age against West Nile virus.
Danish: Equilis West Nile anvendes til vaccination af heste fra 6-måneders alderen mod West Nile virus.
English: Equilis West Nile contains small amounts of West Nile virus that has been inactivated (killed) so that it can no longer cause disease.
Danish: Equilis West Nile indeholder små mængder af West Nile virus, der er "inaktiveret" (dræbt), så det ikke længere kan forårsage sygdom.
English: The withdrawal period for Equilis West Nile is zero days.
Danish: Tilbageholdelsestiden for Equilis West Nile er 0 dage.
English: When Equilis West Nile is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Danish: Når Equilis West Nile gives til heste, opfatter dyrets immunsystem virus i vaccinen som “fremmed” og danner antistoffer til forsvar mod det.
English: Equilis West Nile is a veterinary vaccine that contains inactivated (killed) West Nile virus.
Danish: Equilis West Nile er en veterinær vaccine, der indeholder inaktiveret (dræbt) West Nile virus.
English: Other information about Equilis West Nile:
Danish: Andre oplysninger om Equilis West Nile:
English: The measure of effectiveness in all the field studies was the number of horses which developed protective antibody levels against West Nile virus.
Danish: I feltundersøgelserne blev virkningen bedømt på det antal heste, der dannede beskyttende mængder antistoffer mod West Nile virus.
English: The main field study showed that vaccination with Equilis West Nile when given as recommended produced protective antibody levels in 94% of the vaccinated horses at day 42 of the study.
Danish: Felt-hovedundersøgelsen viste, at når Equilis West Nile blev givet i henhold til anbefalingerne, havde 94 % af de vaccinerede heste på dag 42 af undersøgelsen dannet en beskyttende mængde antistoffer.
English: A mild short-lived swelling may develop at the injection site which resolves in one to five days.
Danish: På injektionsstedet kan der komme kortvarig let hævelse, der svinder efter 1-5 dage.
English: Equilis West Nile contains an adjuvant to enhance the immune response.
Danish: Equilis West Nile indeholder et adjuvans, dvs. et stof, der forstærker immunreaktionen.
English: It contains a strain called Yellow Fever-West Nile (YF-WN).
Danish: Virus i vaccinen er af stammen Yellow Fever-West Nile (YF-WN).
English: After this a single injection should be given each year as a booster.
Danish: Vaccinationen gentages hvert år med en enkelt injektion af en “boosterdosis”.
English: What is the risk associated with Equilis West Nile?
Danish: Hvilken risiko er der forbundet med Equilis West Nile?
English: Why has Equilis West Nile been approved?
Danish: Hvorfor blev Equilis West Nile godkendt?
English: What is Equilis West Nile?
Danish: Hvad er Equilis West Nile?
English: How has Equilis West Nile been studied?
Danish: Hvordan blev Equilis West Nile undersøgt?
English: The first of these involved 173 horses at least six months of age, in which vaccination with Equilis West Nile was compared with a placebo (dummy injection).
Danish: Vaccination med Equilis West Nile blev her sammenlignet med placebo (en virkningsløs injektion).
English: How does Equilis West Nile work?
Danish: Hvordan virker Equilis West Nile?
English: What benefit has Equilis West Nile shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Equilis West Nile?
English: What is Equilis West Nile used for?
Danish: Hvad anvendes Equilis West Nile til?
English: EMA/CHMP/800908/2012 EMEA/H/C/002609
Danish: EMEA/H/C/002609
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det vil sige, at det var hensigten, at skulle svare til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
English: It was to be available as a suspension for injection.
Danish: Det var hensigten, at det skulle leveres som injektionsvæske, suspension.
English: What is Combimarv?
Danish: Hvad er Combimarv?
English: The failures identified were such that the data provided by the company could not be used to evaluate the marketing authorisation application.
Danish: De fundne mangler var af en sådan karakter, at virksomhedens oplysninger ikke kunne anvendes til vurdering af ansøgningen om markedsføringstilladelse.
English: In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Danish: Derudover fremlagde virksomheden resultaterne af en hovedundersøgelse, der omfattede 432 patienter med sukkersyge og sammenlignede sikkerheden og virkningen af de tre lægemidler fra Marvel LifeSciences med de tilsvarende referencelægemidler.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Danish: I sit officielle brev til agenturet om tilbagetrækningen af ansøgningen meddelte virksomheden, at den havde besluttet at trække ansøgningen tilbage med henblik på at gentage undersøgelserne hos en valideret kontraktforskningsorganisation og indsende supplerende oplysninger.
English: The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Danish: CHMP konstaterede desuden problemer med virksomhedens undersøgelsesresultater, herunder statistiske fejl og manglende oplysninger.
English: 13 December 2012
Danish: Den 13. december 2012 EMA/130437/2013
English: While the CHMP was awaiting the company's response to the questions, it requested an inspection of the site where studies with the medicine had taken place.
Danish: Mens CHMP afventede virksomhedens besvarelse af spørgsmålene, anmodede det om en inspektion af det center, hvor undersøgelserne med lægemidlet havde fundet sted.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Danish: Betænkelighederne vedrørende oplysningerne foranledigede, at CHMP anmodede om en inspektion af Bombay Bioresearch Centre (BBRC) i Indien, hvor der var udført undersøgelser for Marvel LifeSciences (undersøgelsernes sponsor), og af Marvel LifeSciences' afdeling i Det Forenede Kongerige.
English: Combimarv was developed as a biosimilar medicine.
Danish: Combimarv blev udviklet som et biosimilært lægemiddel.
English: The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Danish: Ansøgningen var en fælles ansøgning fra Marvel LifeSciences for Combimarv og to andre lægemidler (Solumarv og Isomarv medium, der ligeledes er udviklet som biosimilære lægemidler).
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Danish: Efter den indledende vurdering havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Combimarv ikke kunne godkendes.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Combimarv in clinical trials.
Danish: Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var patienter, som blev behandlet med Combimarv i kliniske undersøgelser
English: The initial concerns related mainly to the manufacture of the medicine and whether Combimarv was sufficiently similar to its reference medicine.
Danish: De indledende betænkeligheder vedrørte hovedsagelig fremstillingen af lægemidlet, og hvorvidt Combimarv tilstrækkeligt svarede til referencelægemidlet.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Combimarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Danish: Den 15. november 2012 meddelte Marvel LifeSciences Ltd officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Combimarv til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: The insulin in Combimarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Danish: Insulinet i Combimarv fremstilles ved "rekombinant DNA-teknologi": Det produceres af en bakterie, der har fået indsat et gen (DNA), som gør den i stand til at producere insulin.
English: Among these were results from studies that looked at how the body handles Combimarv compared with Humulin M3 and how these insulins affect blood sugar levels.
Danish: Der var blandt andet tale om undersøgelser af, hvordan kroppen håndterer Combimarv sammenlignet med Humulin M3, og hvordan disse insuliner påvirker blodsukkeret.
English: What was Combimarv expected to be used for?
Danish: Hvad forventedes Combimarv anvendt til?
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Danish: Ved sukkersyge producerer kroppen enten ikke nok insulin til at regulere blodsukkeret, eller også er den ikke i stand til at udnytte insulinet effektivt.
English: The company presented the results of studies designed to show that Combimarv is similar to its reference medicine Humulin M3 in terms of its structure, biological activity and clinical performance.
Danish: Virksomheden fremlagde resultaterne af undersøgelser, der skulle vise, at Combimarv svarer til referencelægemidlet Humulin M3 hvad angår struktur, biologisk aktivitet og kliniske virkninger.
English: Combimarv is a medicine that contains the active substance human insulin.
Danish: Combimarv er et lægemiddel, der indeholder det aktive stof insulin, humant.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Combimarv?
English: How is Combimarv expected to work?
Danish: Hvordan forventes Combimarv at virke?
English: Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Danish: Combimarv forventedes anvendt til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
Danish: Det var hensigten, at Combimarv skulle være et erstatningsinsulin, der stærkt ligner det insulin, som kroppen producerer.
English: The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice (GCP) and seriously questioned the reliability of the study data.
Danish: Der blev herunder konstateret en række kritiske og væsentlige forhold, der viste, at udførelsen af undersøgelserne ikke var i overensstemmelse med god klinisk praksis (GCP), og som rejste alvorlig tvivl om pålideligheden af undersøgelsesresultaterne.
English: The reference medicine for Combimarv in this application was Humulin M3. For more information on biosimilar medicines, see the questions-and-answers document here.
Danish: Referencelægemidlet for Combimarv i denne ansøgning var Humulin M3.
English: London, 19 November 2009 Doc.
Danish: London, den 19. november 2009 Dok.
English: There was also a lack of data on the long-term effects in a European population.
Danish: Der manglede ligeledes data om langtidsvirkningerne hos en europæisk population.
English: The applicant requested a re-examination of the opinion.
Danish: Ansøgeren anmodede om en revurdering af udtalelsen.
English: It was to be available as capsules.
Danish: Det var meningen, at det skulle kunne fås som kapsler.
English: The cause of fibromyalgia is not known.
Danish: Årsagen til fibromyalgi er ukendt.
English: The CHMP was of the opinion that the effect of the medicine was marginal.
Danish: CHMP var af den opfattelse, at lægemidlets virkning var marginal.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Danish: Neurotransmittere er kemikalier, som sætter nervecellerne i stand til at kommunikere med hinanden.
English: The main measures of effectiveness were based on the patients perceived improvement in symptoms, particularly pain levels and their overall wellbeing.
Danish: De primære effektmål var baseret på, hvor stor en forbedring der efter patienternes mening var i symptomerne, navnlig hvad angår smerteniveauerne og deres generelle velbefindende.
English: The company that applied for authorisation is Pierre Fabre Medicament.
Danish: Virksomheden, som ansøgte om tilladelse, er Pierre Fabre Medicament.
English: Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Danish: Fibromyalgi kan også give andre symptomer såsom ømhed, stivhed, træthed, angst og ændringer i patientens søvn, følelser og tanker.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.
Danish: Efter at have drøftet begrundelserne for denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 19. november 2009.
English: By blocking their re-uptake, milnacipran was expected to increase the level of communication between these nerve cells.
Danish: Ved at blokere deres genoptagelse forventedes milnacipran at øge kommunikationsniveauet mellem disse nerveceller.
English: Since these neurotransmitters are involved in reducing the sensation of pain, it was expected that blocking their re-uptake into nerve cells would improve the symptoms of fibromyalgia.
Danish: Eftersom disse neurotransmittere er med til at reducere smertefornemmelsen, forventedes det, at en blokering af deres genoptagelse i nervecellerne ville forbedre symptomerne på fibromyalgi.
English: It was expected to work by preventing the neurotransmitters 5hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det forventedes at virke ved at forhindre neurotransmitterne 5hydroxytryptamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nervecellerne i hjernen og rygmarven.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse?
English: The CHMP refusal was confirmed after re-examination.
Danish: CHMP bekræftede anbefalingen af afslag efter at have revurderet den.
English: In three main studies, 2,960 adult patients with fibromyalgia were given either Milnacipran Pierre Fabre Médicament/Impulsor or placebo (a dummy treatment) for around four to seven months.
Danish: I tre hovedundersøgelser fik 2 960 voksne patienter med fibromyalgi enten Milnacipran Pierre Fabre Médicament/Impulsor eller placebo (en virkningsløs behandling) i ca. fire til syv måneder.
English: Milnacipran Pierre Fabre Médicament/Impulsor was expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Danish: Milnacipran Pierre Fabre Médicament/Impulsor forventedes anvendt til behandling af voksne med fibromyalgi, som er en sygdom, der giver vedvarende, udbredte smerter og smertereaktioner ved berøring.
English: The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Milnacipran Pierre Fabre Médicament/Impulsor blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults.
Danish: Den 23. juli 2009 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Milnacipran Pierre Fabre Médicament/Impulsor til behandling af fibromyalgi hos voksne.
English: Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om markedsføringstilladelse for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Milnacipran Pierre Fabre Médicament/Impulsor in the treatment of fibromyalgia did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP således af den opfattelse, at fordelene ved Milnacipran Pierre Fabre Médicament/Impulsor til behandling af fibromyalgi ikke opvejer risiciene.
English: Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Danish: Milnacipran Pierre Fabre Médicament/Impulsor er et lægemiddel, der indeholder det aktive stof milnacipran.