natgillin/translations-raw huggingface dataset:
Den leveres som infusionsvæske, suspension. 
It is available as a suspension for injection.
West Nile virus er en infektion, der overføres af myg og kan medføre svær sygdom og dødelig hjernebetændelse hos heste. 
West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Laboratorieundersøgelserne viste, at hestene opnåede beskyttelse to uger efter den indledende (primære) vaccination. 
The laboratory studies showed that horses developed protection two weeks after primary vaccination.
Forholdet mellem fordele og risici fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR. 
The benefit - risk balance may be found in the scientific discussion module of this EPAR.
Undersøgelserne hos drægtige hopper viste, at 89 % af de vaccinerede hopper af blandet race og 95 % af de vaccinerede fuldblodshopper dannede beskyttende mængder antistoffer. 
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.
Equilis West Nile blev desuden undersøgt i tre feltundersøgelser. 
Equilis West Nile was also studied in three field studies.
Equilis West Nile anvendes til vaccination af heste fra 6-måneders alderen mod West Nile virus. 
Equilis West Nile is used to vaccinate horses from six months of age against West Nile virus.
Equilis West Nile indeholder små mængder af West Nile virus, der er "inaktiveret" (dræbt), så det ikke længere kan forårsage sygdom. 
Equilis West Nile contains small amounts of West Nile virus that has been inactivated (killed) so that it can no longer cause disease.
Tilbageholdelsestiden for Equilis West Nile er 0 dage. 
The withdrawal period for Equilis West Nile is zero days.
Når Equilis West Nile gives til heste, opfatter dyrets immunsystem virus i vaccinen som “fremmed” og danner antistoffer til forsvar mod det. 
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.
Equilis West Nile er en veterinær vaccine, der indeholder inaktiveret (dræbt) West Nile virus. 
Equilis West Nile is a veterinary vaccine that contains inactivated (killed) West Nile virus.
Andre oplysninger om Equilis West Nile: 
Other information about Equilis West Nile:
I feltundersøgelserne blev virkningen bedømt på det antal heste, der dannede beskyttende mængder antistoffer mod West Nile virus. 
The measure of effectiveness in all the field studies was the number of horses which developed protective antibody levels against West Nile virus.
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. 
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.
På injektionsstedet kan der komme kortvarig let hævelse, der svinder efter 1-5 dage. 
A mild short-lived swelling may develop at the injection site which resolves in one to five days.
Equilis West Nile indeholder et adjuvans, dvs. et stof, der forstærker immunreaktionen. 
Equilis West Nile contains an adjuvant to enhance the immune response.
Virus i vaccinen er af stammen Yellow Fever-West Nile (YF-WN). 
It contains a strain called Yellow Fever-West Nile (YF-WN).
Vaccinationen gentages hvert år med en enkelt injektion af en “boosterdosis”. 
After this a single injection should be given each year as a booster.
Hvilken risiko er der forbundet med Equilis West Nile? 
What is the risk associated with Equilis West Nile?
Hvorfor blev Equilis West Nile godkendt? 
Why has Equilis West Nile been approved?
Hvad er Equilis West Nile? 
What is Equilis West Nile?
Hvordan blev Equilis West Nile undersøgt? 
How has Equilis West Nile been studied?
Vaccination med Equilis West Nile blev her sammenlignet med placebo (en virkningsløs injektion). 
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).
Hvordan virker Equilis West Nile? 
How does Equilis West Nile work?
Hvilken fordel viser undersøgelserne, at der er ved Equilis West Nile? 
What benefit has Equilis West Nile shown during the studies?
Hvad anvendes Equilis West Nile til? 
What is Equilis West Nile used for?
EMEA/H/C/002609 
EMA/CHMP/800908/2012 EMEA/H/C/002609
Det vil sige, at det var hensigten, at skulle svare til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU). 
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).
Det var hensigten, at det skulle leveres som injektionsvæske, suspension. 
It was to be available as a suspension for injection.
Hvad er Combimarv? 
What is Combimarv?
De fundne mangler var af en sådan karakter, at virksomhedens oplysninger ikke kunne anvendes til vurdering af ansøgningen om markedsføringstilladelse. 
The failures identified were such that the data provided by the company could not be used to evaluate the marketing authorisation application.
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. 
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.
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. 
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.
CHMP konstaterede desuden problemer med virksomhedens undersøgelsesresultater, herunder statistiske fejl og manglende oplysninger. 
The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Den 13. december 2012 EMA/130437/2013 
13 December 2012
Mens CHMP afventede virksomhedens besvarelse af spørgsmålene, anmodede det om en inspektion af det center, hvor undersøgelserne med lægemidlet havde fundet sted. 
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.
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål. 
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
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. 
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.
Combimarv blev udviklet som et biosimilært lægemiddel. 
Combimarv was developed as a biosimilar medicine.
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). 
The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Efter den indledende vurdering havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Combimarv ikke kunne godkendes. 
After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var patienter, som blev behandlet med Combimarv i kliniske undersøgelser 
The company informed the CHMP that at the time of the withdrawal no patients were receiving Combimarv in clinical trials.
De indledende betænkeligheder vedrørte hovedsagelig fremstillingen af lægemidlet, og hvorvidt Combimarv tilstrækkeligt svarede til referencelægemidlet. 
The initial concerns related mainly to the manufacture of the medicine and whether Combimarv was sufficiently similar to its reference medicine.
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. 
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.
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. 
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.
Der var blandt andet tale om undersøgelser af, hvordan kroppen håndterer Combimarv sammenlignet med Humulin M3, og hvordan disse insuliner påvirker blodsukkeret. 
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.
Hvad forventedes Combimarv anvendt til? 
What was Combimarv expected to be used for?
Ved sukkersyge producerer kroppen enten ikke nok insulin til at regulere blodsukkeret, eller også er den ikke i stand til at udnytte insulinet effektivt. 
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.
Virksomheden fremlagde resultaterne af undersøgelser, der skulle vise, at Combimarv svarer til referencelægemidlet Humulin M3 hvad angår struktur, biologisk aktivitet og kliniske virkninger. 
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.
Combimarv er et lægemiddel, der indeholder det aktive stof insulin, humant. 
Combimarv is a medicine that contains the active substance human insulin.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Combimarv? 
What consequences does this withdrawal have for patients in clinical trials?
Hvordan forventes Combimarv at virke? 
How is Combimarv expected to work?
Combimarv forventedes anvendt til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret. 
Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Det var hensigten, at Combimarv skulle være et erstatningsinsulin, der stærkt ligner det insulin, som kroppen producerer. 
Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
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. 
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.
Referencelægemidlet for Combimarv i denne ansøgning var Humulin M3. 
The reference medicine for Combimarv in this application was Humulin M3. For more information on biosimilar medicines, see the questions-and-answers document here.
London, den 19. november 2009 Dok. 
London, 19 November 2009 Doc.
Der manglede ligeledes data om langtidsvirkningerne hos en europæisk population. 
There was also a lack of data on the long-term effects in a European population.
Ansøgeren anmodede om en revurdering af udtalelsen. 
The applicant requested a re-examination of the opinion.
Det var meningen, at det skulle kunne fås som kapsler. 
It was to be available as capsules.
Årsagen til fibromyalgi er ukendt. 
The cause of fibromyalgia is not known.
CHMP var af den opfattelse, at lægemidlets virkning var marginal. 
The CHMP was of the opinion that the effect of the medicine was marginal.
Neurotransmittere er kemikalier, som sætter nervecellerne i stand til at kommunikere med hinanden. 
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
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. 
The main measures of effectiveness were based on the patients perceived improvement in symptoms, particularly pain levels and their overall wellbeing.
Virksomheden, som ansøgte om tilladelse, er Pierre Fabre Medicament. 
The company that applied for authorisation is Pierre Fabre Medicament.
Fibromyalgi kan også give andre symptomer såsom ømhed, stivhed, træthed, angst og ændringer i patientens søvn, følelser og tanker. 
Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
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. 
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.
Ved at blokere deres genoptagelse forventedes milnacipran at øge kommunikationsniveauet mellem disse nerveceller. 
By blocking their re-uptake, milnacipran was expected to increase the level of communication between these nerve cells.
Eftersom disse neurotransmittere er med til at reducere smertefornemmelsen, forventedes det, at en blokering af deres genoptagelse i nervecellerne ville forbedre symptomerne på fibromyalgi. 
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.
Det forventedes at virke ved at forhindre neurotransmitterne 5hydroxytryptamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nervecellerne i hjernen og rygmarven. 
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.
Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse? 
What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
CHMP bekræftede anbefalingen af afslag efter at have revurderet den. 
The CHMP refusal was confirmed after re-examination.
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. 
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.
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. 
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.
Virkningerne af Milnacipran Pierre Fabre Médicament/Impulsor blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
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. 
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.
Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om markedsføringstilladelse for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran 
Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
På daværende tidspunkt var CHMP således af den opfattelse, at fordelene ved Milnacipran Pierre Fabre Médicament/Impulsor til behandling af fibromyalgi ikke opvejer risiciene. 
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.
Milnacipran Pierre Fabre Médicament/Impulsor er et lægemiddel, der indeholder det aktive stof milnacipran. 
Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Virksomheden informerede CHMP om, at der ikke er nogen igangværende kliniske undersøgelser af Milnacipran Pierre Fabre Médicament/Impulsor i Europa anvendt til behandling af fibromyalgi. 
The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Det aktive stof i Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, er en "serotoninnoradrenalin genoptagelseshæmmer". 
The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Hvad er Milnacipran Pierre Fabre Médicament/Impulsor? 
What is Milnacipran Pierre Fabre Médicament/Impulsor?
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Milnacipran Pierre Fabre Médicament/Impulsor eller i programmer for anvendelse af Milnacipran Pierre Fabre Médicament/Impulsor med særlig udleveringstilladelse? 
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Hvad forventedes Milnacipran Pierre Fabre Médicament/Impulsor anvendt til? 
What was Milnacipran Pierre Fabre Médicament/Impulsor expected to be used for?
CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Milnacipran Pierre Fabre Médicament/Impulsor. 
Hence, the CHMP recommended that Milnacipran Pierre Fabre Médicament/Impulsor be refused marketing authorisation.
Hvordan forventedes Milnacipran Pierre Fabre Médicament/Impulsor at virke? 
How was Milnacipran Pierre Fabre Médicament/Impulsor expected to work?
Responsraten i disse patienter var cirka 52%. 
The response rate in these patients was about 52%.
Sådanne rapporter har dog været sjældent forekommende. 
However, such reports have been infrequent.
Uåbnet flaske: 3 år. 
Unopened bottle: 3 years.
Følgende responsrater blev observeret: 
The following response rates were observed:
Din læge vil kontrollere dette og tage alle de nødvendige forholdsregler. 
Your doctor will monitor this and take any necessary measures.
Voksne og ældre 
Adults and older people
• på anmodning fra Det Europæiske Lægemiddelagentur 
• At the request of the European Medicines Agency,
Tid i studiet (uger) 
Time on study (weeks)
Må ikke sælges enkeltvis. 
Not to be sold separately.
Åbnes her 
Please open here
Enhver SRE (+TIH) 
Any SRE (+TIH)
Patienter i alderen 65 år og derover 
Patients aged 65 years and over
De fleste tilfælde har ikke krævet speciel behandling, og symptomerne er forsvundet efter kort tid (nogle timer eller dage). 
In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Brug hele indeholdet. 
Use the entire contents.
Vær derfor særlig opmærksom når du kører bil, betjener maskiner eller udfører andre opgaver, der kræver din fulde opmærksomhed. 
You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Brug ikke Zometa efter den udløbsdato, der står på pakningen. 
Do not use Zometa after the expiry date stated on the pack.
Følg nøje alle instruktioner, som du har fået af din læge. 
Follow carefully all instructions given to you by your doctor.
De mest almindelige bivirkninger er normalt milde og vil sandsynligvis forsvinde efter kort tid. 
The most common ones are usually mild and will probably disappear after a short time.
Mutagenicitet og cancerogent potentiale 
Mutagenicity and carcinogenic potential
I nogle tilfælde kan hypokalcæmien være livstruende. 
In some instances the hypocalcaemia may be life-threatening.
Zometa bør ikke anvendes under graviditet. 
Zometa should not be used during pregnancy.
Børn og unge Zometa bør ikke bruges til børn og teenagere under 18 år. 
Children and adolescents Zometa is not recommended for use in adolescents and children below the age of 18 years.
Det bruges til: 
It is used:
Hvis du har fået mere Zometa, end du skulle have haft Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge. 
If you are given more Zometa than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Mediantid til normo kalcæmi var 4 dage. 
Median time to normocalcaemia was 4 days.
Der var ingen statistisk signifikante forskelle mellem de to zoledronsyredoser. 
There were no statistically significant differences between the two zoledronic acid doses.
Tidsrummet til forekomst af symptomer varierede fra én dag til flere måneder efter behandlingsstart. 
The time to onset of symptoms varied from one day to several months after starting treatment.
Der sås i særdeleshed ikke noget klart bevis for effekt på hyppigheden af fraktur eller på smerte. 
In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Zometa kan gives til patienter i alderen 65 år og derover. 
Zometa can be given to people aged 65 years and over.
NA Ikke relevant (Not Applicable) 
NA Not Applicable
Reduktion i risiko for gentagne hændelser** 
Risk reduction of suffering from multiple events** (%)
• At nedsætte mængden af calcium i blodet hos voksne, hvor det er for højt som følge af tilstedeværelsen af en tumor. 
• To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Opmærksomheden henledes endvidere på muligheden for udvikling af hypomagnesiæmi under behandlingen. 
Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Klinisk erfaring med akut overdosis af Zometa er begrænset. 
Clinical experience with acute overdose of Zometa is limited.