FrancophonIA/ELRC3.0 huggingface dataset:
English: Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients.
Danish: I den første undersøgelse blev det sammenlignet med placebo (en virkningsløs behandling) hos 701 patienter, og i den anden med glipizid (et sulfonylurinstof) hos 1 172 patienter.
English: How is Ristfor used?
Danish: Hvordan anvendes Ristfor?
English: How does Ristfor work?
Danish: Hvordan virker Ristfor?
English: EMA/622300/2010 EMEA/V/C/002230
Danish: EMA/CVMP/622300/2010 EMEA/V/C/002230
English: This summary was last updated in February 2013.
Danish: Dette sammendrag blev sidst ajourført i 02-2013.
English: The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Danish: Det Europæiske Lægemiddelagentur (EMA) gennemgik de supplerende oplysninger, som blev fremsendt i henhold til en aftalt tidsplan, om vaccinens kvalitet, sikkerhed og virkning.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for BTVPUR AlSap 1 on 17 December 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BTVPUR AlSap 1 den 17. december 2010.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Danish: Vaccinen indeholder desuden "adjuvanser" (aluminiumhydroxid og saponin) for at forstærke immunresponsen.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes og kødet og mælken kan anvendes til menneskeligt konsum.
English: There can be a slight rise in body temperature, usually no more than 1 °C, in the 24 hours following vaccination.
Danish: Let forhøjelse af dyrets kropstemperatur, der normalt ikke overstiger et gennemsnit på 1 °C, kan forekomme inden for 24 timer efter vaccinationen.
English: The benefitrisk balance may be found in the scientific discussion module of this EPAR.
Danish: Risk-benefit-forholdet fremgår af den videnskabelige drøftelse i denne EPAR.
English: BTVPUR AlSap 1 was initially authorised under ‘exceptional circumstances'.
Danish: BTVPUR AlSap 1 blev oprindeligt godkendt under "særlige omstændigheder".
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) og til at reducere symptomerne på sygdommen.
English: In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly.
Danish: Hvis dyrene senere udsættes for bluetonguevirus, vil immunsystemet hurtigere kunne producere antistoffer.
English: The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal's mother is already immune to the disease.
Danish: Den første injektion gives fra 1månedsalderen hos dyr, som ikke tidligere har været eksponeret for sygdommen, og fra 2,5månedsalderen, hvis dyret er født af et moderfår, der allerede er immunt over for sygdommen.
English: The withdrawal period for BTVPUR AlSap 1 for meat and milk for cattle and sheep is zero days.
Danish: Tilbageholdelsestiden for BTVPUR AlSap 1 er nul dage hvad angår kød og mælk, både for kvæg og får.
English: The studies also showed that the vaccine can be used in pregnant sheep and cattle as well as lactating cattle.
Danish: Undersøgelserne viste også, at vaccinen kan anvendes til behandling af drægtige får og kvæg samt lakterende kvæg.
English: When it is given to sheep and cattle, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them.
Danish: Når vaccinen gives til får og kvæg, registrerer dyrets immunsystem virus som "fremmed" og reagerer ved at danne antistoffer imod den.
English: This means that it was not possible to obtain complete information about BTVPUR AlSap 1 at the time of the initial authorisation.
Danish: Det betyder, at det ikke var muligt at indhente fyldestgørende oplysninger om BTVPUR AlSap 1, da den oprindelige markedsføringstilladelse blev udstedt.
English: Two studies were conducted in sheep and cattle to establish the period of protection provided by the vaccine.
Danish: Der blev gennemført to undersøgelser hos får og kvæg for at fastlægge, hvor længe vaccinen opretholder sin beskyttende virkning.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 1 to convert to a normal status.
Danish: I 2013 konkluderede CVMP, at de indsendte oplysninger var tilstrækkelige til, at godkendelsen kunne overgå til normal status.
English: The CVMP concluded that the benefits of BTVPUR AlSap 1 exceed the risks for active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotype 1, and recommended that BTVPUR AlSap 1 be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved BTVPUR AlSap 1 er større end risiciene med hensyn til aktiv immunisering af får og kvæg for at forebygge infektion, viræmi og kliniske symptomer forårsaget af bluetonguevirus serotype 1, og anbefalede udstedelse af markedsføringstilladelse for BTVPUR AlSap 1.
English: BTVPUR AlSap 1 is a vaccine.
Danish: BTVPUR AlSap 1 er en vaccine.
English: Inactivated adjuvanted vaccine against bluetongue disease virus serotype 1
Danish: Inaktiveret, adjuveret vaccine mod bluetonguevirus serotype 1
English: The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotype 1.
Danish: Undersøgelserne viste, at vaccinen er sikker for får og kvæg, og at den reducerer symptomerne på sygdommen og forebygger viræmi hos dyr fra 1-månedsalderen, som smittes med bluetonguevirus serotype 1.
English: The company also presented results from a series of trials conducted with vaccines of similar composition but including different serotypes from the one in BTVPUR AlSap 1 in order to extrapolate further conclusions on the effectiveness of the vaccine.
Danish: Virksomheden fremlagde også resultaterne af en række undersøgelser gennemført med vacciner med en tilsvarende sammensætning, men som omfattede andre serotyper end den, der indgår i BTVPUR AlSap 1, for at ekstrapolere yderligere konklusioner med hensyn til vaccinens virkning.
English: The effectiveness of the vaccine was studied in three main laboratory trials using a vaccine with bluetongue serotype 1 in sheep and cattle of young age.
Danish: Vaccinens virkning blev undersøgt i tre hovedlaboratorieundersøgelser med en vaccine indeholdende bluetongue serotype 1 hos får og kvæg i en ung alder.
English: BTVPUR AlSap 1 contains bluetongue virus of one types (‘serotype 1').
Danish: BTVPUR AlSap 1 indeholder én type bluetonguevirus ("serotype 1").
English: BTVPUR AlSap 1 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Danish: BTVPUR AlSap 1 indeholder en bluetonguevirus, som er blevet inaktiveret, så den ikke kan fremkalde sygdommen.
English: Results also from a series of laboratory safety trials performed with vaccines of similar composition but including different bluetongue serotypes (including studies in pregnant ewes and cows) were presented in order to extrapolate safety conclusions.
Danish: Der blev endvidere fremlagt resultater fra en række sikkerhedsundersøgelser i laboratorium gennemført med vacciner med tilsvarende sammensætning, men med andre bluetongue-serotyper (herunder undersøgelser af drægtige får og køer), for at ekstrapolere konklusioner med hensyn til vaccinens sikkerhed.
English: BTVPUR AlSap 1 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges..
Danish: BTVPUR AlSap 1 anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, som er en infektion, der forårsages af bluetonguevirus, der overføres af mitter.
English: It contains inactivated (killed) bluetongue serotype 1 virus.
Danish: Det indeholder inaktiveret (dræbt) bluetonguevirus serotype 1.
English: The safety of the vaccine was studied in two main overdose laboratory safety studies carried out in sheep and cattle.
Danish: Vaccinens sikkerhed blev undersøgt i to hovedsikkerhedsundersøgelser i laboratorium gennemført med en overdosis af BTVPUR AlSap 1 hos får og kvæg.
English: Other information about BTVPUR AlSap 1:
Danish: Andre oplysninger om BTVPUR AlSap 1:
English: What is the risk associated with BTVPUR AlSap 1?
Danish: Hvilken risiko er der forbundet med BTVPUR AlSap 1?
English: BTVPUR AlSap 1 is a vaccinethat is available as a suspension for injection.
Danish: BTVPUR AlSap 1 er en vaccine, der fås som en injektionsvæske, suspension.
English: Why has BTVPUR AlSap 1 been approved?
Danish: Hvorfor blev BTVPUR AlSap 1 godkendt?
English: The duration of protection of the vaccine in both sheep and cattle was found to be 12 months.
Danish: Endelig viste undersøgelserne, at vaccinen opretholder sin beskyttende virkning i 12 måneder hos både får og kvæg.
English: What is BTVPUR AlSap 1?
Danish: Hvad er BTVPUR AlSap 1?
English: How has BTVPUR AlSap 1 been studied?
Danish: Hvordan blev BTVPUR AlSap 1 undersøgt?
English: What benefit has BTVPUR AlSap 1 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved BTVPUR AlSap 1?
English: What is BTVPUR AlSap 1 used for?
Danish: Hvad anvendes BTVPUR AlSap 1 til?
English: How does BTVPUR AlSap 1 work?
Danish: Hvordan virker BTVPUR AlSap 1?
English: The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.
Danish: Immunogeniciteten af den aktuelle formulering af vaccinen blev bekræftet hos 15 føl.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te on 6 March 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ProteqFlu-Te den 6. marts 2003.
English: Other information about ProteqFlu-Te:
Danish: Andre oplysninger om ProteqFlu-Te:
English: The withdrawal period for ProtequFlu-Te for meat and milk is zero days.
Danish: Tilbageholdelsestiden for ProteqFlu-Te for kød og mælk er nul dage.
English: The muscle stiffness usually starts from the jaw and neck, then affects the whole body.
Danish: Muskelstivheden begynder normalt i kæben og nakken og påvirker derefter hele kroppen.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner virker ved at »lære« immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod en sygdom.
English: The effectiveness of ProteqFlu-Te was first assessed in several laboratory and field studies.
Danish: Virkningen af ProteqFlu-Te blev først analyseret i flere laboratorie- og feltundersøgelser.
English: Horses are among the most susceptible species to tetanus.
Danish: Heste er én af de arter, der er følsomme over for tetanus.
English: This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted in to the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains.
Danish: Det betyder, at et gen fra to forskellige hesteinfluenzastammer (A/eq/Ohio/03 og A/eq/Richmond/1/07) blev indsat i hver sin levende canarypox-vektorvirus, som ikke fremkalder sygdomme hos heste, hvilket sætter vektoren i stand til at producere specifikke proteiner fra disse influenzastammer.
English: ProteqFlu-Te contains an adjuvant (carbomer) to enhance the immune response.
Danish: ProteqFlu-Te indeholder et adjuvans (carbomer) til at forstærke immunresponsen.
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 consumption or milk used for consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til konsum.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu-Te exceed the risks for the approved indication and recommended that ProteqFlu-Te be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved ProteqFlu-Te opvejer risiciene, når det anvendes ved den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for ProteqFlu-Te.
English: The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Danish: Sygdommen, der som regel stammer fra forurenede sår, er karakteriseret ved generel stivhed og krampeagtige spasmer i musklerne.
English: In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitive product).
Danish: Ved laboratorieundersøgelser blev heste udsat for (inficeret med) hesteinfluenzavirus, og de kliniske symptomer og udskillelsen af influenzavirus efter inficeringen blev sammenlignet mellem vaccinerede dyr og kontroldyr (ikkevaccinerede dyr eller dyr vaccineret med et konkurrerende produkt).
English: ProteqFlu-Te is a vaccine which was produced with the use of recombinant DNA technology.
Danish: ProteqFlu-Te er en vaccine, der er fremstillet ved hjælp af rekombinant DNA-teknologi.
English: What is the risk associated with ProteqFlu-Te?
Danish: Hvilken risiko er der forbundet med ProteqFlu-Te?
English: ProteqFlu-Te is a vaccine for use in horses.
Danish: ProteqFlu-Te er en vaccine til heste.
English: The vaccine also stimulates protection against tetanus to prevent mortality.
Danish: Vaccinen stimulerer også beskyttelse mod stivkrampe for at forebygge dødelighed.
English: Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart.
Danish: Heste bør have en basisvaccination ved 5-6 måneders alderen bestående af to vaccinationer med 4-6 ugers mellemrum.
English: Why has ProteqFlu-Te been approved?
Danish: Hvorfor blev ProteqFlu-Te godkendt?
English: ProteqFlu-Te is available as a suspension for injection.
Danish: ProteqFlu-Te fås som en suspension til injektion.
English: The vaccine also contains a tetanus toxoid which is a tetanus toxin processed in order to decrease its toxic effect, but retain its antigenic power.
Danish: Vaccinen indeholder også tetanustoksoid, dvs. et tetanustoksin, som er behandlet på en sådan måde, at dets toksiske virkning er reduceret, samtidig med at det bevarer sin antigene effekt.
English: Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani.
Danish: Stivkrampe er en akut, ofte dødelig sygdom, der skyldes et neurotoksin (gift), som dannes af bakterien Clostridium tetani.
English: This should be followed by revaccination 5 months later, and afterwards by booster vaccinations every two years for protection against tetanus or for protection against influenza vaccination every year alternating with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum two years for tetanus.
Danish: Basisvaccinationen bør følges op af en revaccination 5 måneder senere og derefter af boostervaccinationer hver andet år til beskyttelse mod stivkrampe eller hvert år til beskyttelse mod influenza, hvor der skiftevist anvendes ProteqFlu eller ProteqFlu-Te, dog med et mellemrum på højst to år for stivkrampe.
English: The studies showed that ProteqFlu-Te was effective in reducing clinical signs and virus excretion after infection with equine influenza, and against tetanus to prevent mortality from 14 days after primary vaccination.
Danish: Undersøgelserne viste, at ProteqFlu-Te er effektivt med hensyn til at nedsætte kliniske symptomer og virusudskillelse efter infektion med hesteinfluenza samt mod tetanus for at forebygge dødelighed, 14 dage efter den første vaccination.
English: The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium.
Danish: Derefter vil immunsystemet fremover kunne danne disse antistoffer hurtigere, når dyret udsættes for hesteinfluenzavirussen og tetanusbakterien.
English: The current formulation of ProteqFlu-Te produced similar antibody responses against the two flu strains and tetanus toxoid included in the vaccine to those seen in the main studies.
Danish: Den aktuelle formulering af ProteqFlu-Te dannede den samme mængde antistoffer mod de to influenzastrenge og tetanustoksoid, der indgår i vaccinen, som dem, der sås i hovedundersøgelserne.
English: When ProteqFlu-Te is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains and the tetanus toxoid as ‘foreign' and makes antibodies against them.
Danish: Når hestene vaccineres med ProteqFlu-Te, opfatter immunsystemet disse specifikke proteiner fra stammerne fra hesteinfluenza og tetanustoksoid som »fremmede« og producerer antistoffer mod dem.
English: The duration of protection was 5 months after primary vaccination and one year for the equine influenza and two years for the tetanus after the third vaccination.
Danish: Den beskyttende effekt holdt i 5 måneder efter basisvaccination og et år for hesteinfluenza og to år for stivkrampe efter tredje vaccination.
English: It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium).
Danish: Den indeholder dele af to hesteinfluenzastammer, der er indsat i hver sin vektorvirus (bærervirus), som hedder canarypox og tetanustoksoid (kemisk svækkede toksiner fra tetanusbakterien).
English: This will help to protect against equine influenza and tetanus.
Danish: Dette er med til at beskytte mod hesteinfluenza og tetanus.
English: A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days.
Danish: diameter på 5 cm), som fortager sig i løbet af 4 dage.
English: ProteqFlu-Te is used to vaccinate horses from 4 months of age against equine influenza and tetanus.
Danish: ProteqFlu-Te anvendes til vaccination af heste, fra de er fire måneder, mod hesteinfluenza og tetanus (stivkrampe).
English: The measure of effectiveness in all studies was antibody levels of against the two influenza vaccine strains and against tetanus toxoid.
Danish: Behandlingens virkning blev i alle undersøgelserne hovedsagelig bedømt på mængden af beskyttende antistoffer mod de to influenzavaccinestammer og mod tetanustoksoid.
English: What is ProteqFlu-Te used for?
Danish: Hvad anvendes ProteqFlu-Te til?
English: How has ProteqFlu-Te been studied?
Danish: Hvordan blev ProteqFlu-Te undersøgt?
English: Equine influenza and tetanus vaccine
Danish: Vaccine mod hesteinfluenza og stivkrampe
English: What benefit has ProteqFlu-Te shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ProteqFlu-Te?
English: How does ProteqFlu-Te work?
Danish: Hvordan virker ProteqFlu-Te?
English: What is ProteqFlu-Te?
Danish: Hvad er ProteqFlu-Te?
English: It may request a reexamination of the opinion within 15 days of receipt of notification of this negative opinion.
Danish: Virksomheden kan anmode om, at udtalelsen bliver revurderet, inden for 15 dage efter modtagelsen af meddelelsen om denne negative udtalelse.
English: The company presented the results of 4 main studies involving a total of 588 patients.
Danish: Virksomheden fremlagde resultaterne fra 4 hovedundersøgelser af i alt 588 patienter.
English: The company that applied for authorisation is Renable Pharma Limited.
Danish: Den virksomhed, der har indgivet ansøgningen, er Renable Pharma Limited.
English: It was to be available as capsules to be taken by mouth.
Danish: Det skulle leveres som kapsler, der tages gennem munden.
English: Overweight men with hypogonadotropic hypogonadism produce too much of the hormone oestrogen.
Danish: Overvægtige mænd med hypogonadotrop hypogonadisme producerer for meget af hormonet østrogen.
English: On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product EnCyzix, intended for the treatment of hypogonadotropic hypogonadism in men.
Danish: Den 25. januar 2018 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet EnCyzix, der er beregnet til behandling af hypogonadotrop hypogonadisme hos mænd.
English: The main measures of effectiveness were the amount of sperm produced and testosterone levels.
Danish: De primære mål for virkning var antal producerede sædceller og testosteronniveau.
English: Refusal of the marketing authorisation for EnCyzix (enclomifene)
Danish: Afslag på ansøgningen om markedsføringstilladelse for EnCyzix (enclomifen)
English: EnCyzix is a medicine that contains the active substance enclomifene.
Danish: EnCyzix er et lægemiddel, der indeholder det aktive stof enclomifen.
English: This stops the release of other hormones called gonadotrophins, which are needed for the testes to produce testosterone and to work normally.
Danish: Dette standser frigivelsen af andre hormoner, der kaldes gonadotropiner, og som testiklerne skal bruge for at kunne producere testosteron og fungere normalt.
English: EnCyzix was to be used in overweight men with a body mass index (BMI) of at least 25 kg/m2.
Danish: EnCyzix skulle anvendes til overvægtige mænd med et BMI på mindst 25 kg/m2.
English: Refusal of the marketing authorisation for EnCyzix (enclomifene) EMA/CHMP/54473/2018
Danish: Afslag på ansøgningen om markedsføringstilladelse for EnCyzix (enclomifen) EMA/CHMP/54473/2018
English: Therefore, the CHMP was of the opinion that the benefits of EnCyzix did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved EnCyzix ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: What was EnCyzix expected to be used for?
Danish: Hvad forventedes EnCyzix anvendt til?
English: What is EnCyzix?
Danish: Hvad er EnCyzix?
English: EnCyzix was expected to be used to treat hypogonadotropic hypogonadism in men.
Danish: EnCyzix skulle anvendes til behandling af hypogonadotrop hypogonadisme hos mænd.
English: In this condition, the sex organs (the testes in men) do not work properly resulting in symptoms such as infertility, low libido, impotence, weakened bones and weight gain.
Danish: Ved denne lidelse fungerer kønsorganerne (testiklerne hos mænd) ikke ordentligt, og det giver symptomer som ufrugtbarhed, lav libido, impotens, svækkede knogler og vægtøgning.
English: The CHMP noted that although the studies showed an increase in testosterone levels with EnCyzix, they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido.
Danish: CHMP bemærkede, at selvom undersøgelserne viste en stigning i testosteronniveauet ved brug af EnCyzix, havde de ikke fokus på, om EnCyzix medførte en bedring af symptomer som knoglesvækkelse, vægtøgning, impotens og nedsat libido.