natgillin/translations-raw huggingface dataset:
-Anbefalinger om lægelig overvågning af brysterne og intermitterende doseringsplan (20 dage efterfulgt af 10 dage uden behandling) for at mindske risikoen for hyperprolaktinæmi med henblik på at øge sikkerheden for brysterne (det vides dog ikke, om denne foranstaltning har nogen virkning på det iagttagne bivirkningsmønster knyttet til hyperprolaktinæmi, således mammahypertrofi, galaktorré og risici for patienter med prolaktinafhængige tumorer som f.eks. hypofyse-prolaktinom og brystcancer). 
-Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
Desuden var undersøgelserne for kortvarige til at give tilstrækkelig mulighed for at vurdere, om virkningen vedblev. 
In addition, the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Den foreslåede intermitterende behandling på 20 dage efterfulgt af en 10-dages behandlingsfri periode kan muligvis dæmpe effekten på prolaktinindholdet, men det vides ikke, om den vil få indflydelse på bivirkningsmønsteret. 
The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
CHMP noterede sig de forslag til begrænsning af sådanne risici, der var stillet af indehaveren af markedsføringstilladelsen, og hvoraf nogle allerede var indført i nogle stater, således: 
The CHMP took note of the MAH's proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
Indehaver af markedsføringstilladelse Særnavn 
Member State Marketing Authorisation Holder
• udvalget konkluderede på baggrund af de foreliggende data, at risiciene ved anvendelse af veraliprid til behandling af hedeture i forbindelse med menopausen opvejer de begrænsede fordele. 
• The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
På baggrund af de foreliggende kliniske data konkluderede CHMP, at de risici, der er forbundet med anvendelse af veraliprid til behandling af hedeture forbundet med menopausen, især de neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson-syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), opvejer de begrænsede fordele. 
In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Veraliprid er kontraindiceret ved prolaktinafhængige tumorer som f.eks. prolaktinomer i hypofysen samt brystkræft. 
Veralipride treatment is contra-indicated in patients with prolactindependent tumours such as pituitary gland prolactinoma and breast cancer.
-Indførelse af advarsler om neuroleptikas klassevirkninger (malignt neuroleptikasyndrom, QTforlængelse, tardiv dyskinesi) og abstinenssymptomer som angst og depressivt syndrom. 
-Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
For at undgå psykiske bivirkninger, ekstrapyramidale symptomer og tardiv dyskinesi foreslog indehaveren af markedsføringstilladelsen, at den tilladte behandlingsvarighed med veraliprid begrænses til 3 måneder. 
In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAH proposed a maximally allowed duration of 3 months veralipride treatment.
(Der blev således som regel ikke angivet baseline-værdier, hvorfor fyldestgørende vurdering af den observerede bedring ikke er mulig, og hverken den statistiske signifikans eller kliniske betydning af virkningen kan kvantificeres nøjagtigt, da den statistiske plan var uklar eller helt manglede, og da beskrivelsen af resultaterne var mangelfuld.) 
The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Desuden kan virkningens størrelse ikke bestemmes nøjagtigt, da undersøgelserne var for kortvarige til at muliggøre en fyldestgørende vurdering af, om virkningen vedblev. 
In addition, the effect size cannot be accurately quantified due to methodological shortcomings and the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
I forbindelse med anvendelse af veraliprid er beskrevet tilfælde af uforudsigelig og potentielt irreversibel tardiv dyskinesi samt tidlige ekstrapyramidale symptomer, depression, angst og abstinenssyndrom; sammen med risikoen for hyperprolaktinæmi og for QT-forlængelse, der er en klasseeffekt, findes disse risici at give anledning til betænkelighed. 
Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QTprolongation are considered a concern.
Veraliprid er et neuroleptikum i benzamidgruppen, som er indiceret til behandling af vasomotoriske symptomer knyttet til menopausen. 
Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
CHMP konkluderede, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af vasomotoriske symptomer knyttet til menopausen. 
The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
• udvalget tog i betragtning, at der i forbindelse med anvendelse af veraliprid er beskrevet neurologiske reaktioner (dyskinesi, ekstrapyramidale lidelser, Parkinson-syndrom) og psykiske reaktioner (depression, angst, abstinenssyndrom), herunder potentielt irreversibel tardiv dyskinesi. 
• The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
Det må her bemærkes, at det ikke altid klart fremgår, hvordan årsagssammenhængen med veraliprid er blevet vurderet. 
It should be noted that in the evaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride is not always clear.
De forelagte oplysninger synes at vise, at veraliprid har virkning på vasomotoriske symptomer knyttet til menopausen. 
Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
• udvalget fandt, at de forelagte data kun viser begrænset virkning af veraliprid til behandling af hedeture knyttet til menopausen 
• The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause;
Desuden er der i forbindelse med veraliprid beskrevet psykiske bivirkninger, hovedsagelig depression og angst. 
Psychiatric adverse events mainly referred to depressive and anxiety states have also been reported with veralipride.
• CHMP konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser anbefalede CHMP tilbagekaldelse af markedsføringstilladelserne for de i bilag I omhandlede lægemidler indeholdende veraliprid. 
• The Committee, as a consequence, concluded that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
BEGRUNDELSE FOR TILBAGEKALDELSEN AF MARKEDSFØRINGSTILLADELSEN 
GROUNDS FOR THE WITHDRAWAL OF THE MA
De neurologiske bivirkninger vedrørte ekstrapyramidale symptomer, specielt er der beskrevet tardiv dyskinesi. 
Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesias have been reported with veralipride and represent a real concern due to their potential seriousness and irreversibility.
• Risikoen for infektioner, inklusive opportunistiske infektioner samt kontraindikation for anvendelse 
• The risk of infections, including opportunistic infections, and the contraindication for use in
Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Leflunomid Teva forsynes med informationsmateriale til lægerne, indeholdende følgende: 
The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide Teva with a physician educational pack containing the following:
Læger og patienter skal gøres opmærksomme på, at at der findes en ad hocinformationsservice, som rådgiver i forbindelse med laboratorietests af leflunomid i plasma. 
Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory
Informationen i folderen bør oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure. 
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of
• Information om den identificerede risiko for synergistisk hepato- eller hæmatotoksicitet forbundet med kombinationsbehandling med andre DMARDs (Disease-Modifying Antirheumatic Drugs) 
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
• At der er risiko for alvorlig leverskade, og det derfor er vigtigt med regelmæssige målinger af ALAT for at overvåge leverfunktionen. 
• That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
• Behovet for rådgivning af patienter om vigtige risici i forbindelse med behandling med leflunomid 
• The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Ansøgningen blev trukket tilbage inden ”dag 120”. 
The application was withdrawn before ‘day 120'.
Behandlingen varede mellem seks måneder og et år. 
Treatment lasted between six months and a year.
Muligvis blokerer de også formeringen af virus. 
They may also block the multiplication of viruses.
Virkningerne af Joulferon blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Joulferon were first tested in experimental models before being studied in humans.
Hvad er Joulferon? 
What is Joulferon?
Virksomheden meddelte CHMP, at tilbagetrækningen ikke får nogen konsekvenser for igangværende kliniske undersøgelser, og at den fortsat vil gøre Joulferon tilgængelig for patienter, der deltager i sådanne undersøgelser. 
The company informed the CHMP that the withdrawal has no impact on ongoing clinical trials, and that it will continue to make Joulferon available to patients enrolled in these trials.
Virksomheden fremlagde resultaterne af to hovedundersøgelser af i alt 2 255 voksne smittet med hepatitis C, som ikke tidligere var blevet behandlet. 
The company presented the results of two main studies involving a total of 2,255 adults with hepatitis C infection who had not previously been treated.
Interferoner er naturlige stoffer, der dannes af kroppen, og som er med til at bekæmpe angreb mod kroppen såsom infektioner forårsaget af vira. 
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Den 16. april 2010 meddelte Novartis Europharm Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Joulferon til behandling af hepatitis C-smitte tilbage. 
On 16 April 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joulferon, for the treatment of hepatitis C infection.
Det vides endnu ikke med nøjagtighed, hvordan interferoner virker mod virussygdomme, men det formodes, at de fungerer som immunomodulatorer (stoffer, der ændrer den måde, hvorpå immunsystemet fungerer). 
The exact way that they work in treating viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Da CHMP var i færd med at vurdere den dokumentation, som virksomheden oprindelig havde fremlagt, var der endnu ikke fremsat nogen anbefalinger. 
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Det betyder, at CHMP stadig var i færd med at vurdere den dokumentation, som virksomheden oprindelig havde fremlagt. 
This means that the CHMP was still evaluating the initial documentation provided by the company.
Behandlingens virkning blev hovedsageligt bedømt på grundlag af den mængde hepatitis C-virus, der cirkulerede i blodet seks måneder efter endt behandling. 
The main measure of effectiveness was based on the level of hepatitis C virus circulating in the blood six months after the end of treatment.
Hvad forventedes Joulferon anvendt til? 
What was Joulferon expected to be used for?
Joulferon er et pulver og en solvens, der blandes til en opløsning til injektion. 
Joulferon is a powder and solvent to be made up into a solution for injection.
Hvordan forventes Joulferon at virke? 
How is Joulferon expected to work?
Albinterferon alfa-2b er et ”fusionsprotein”, som består af interferon alfa-2b, der allerede findes i antivirale lægemidler i EU, og som er bundet til et protein kaldet albumin. 
Albinterferon alfa-2b is a ‘fusion protein' made up of interferon alfa-2b, which is already available in antiviral medicines in the European Union (EU), attached to a protein called albumin.
Det skulle have været brugt til voksne, hvis lever var beskadiget, og som ikke tidligere havde været behandlet med interferon alfa (et andet lægemiddel til behandling af hepatitis C). 
It was to be used in adults whose liver was damaged and who had not previously been treated with interferon alfa (another medicine for hepatitis C).
Når interferon bindes til albumin, forlænges dets virkning mod hepatitis C-virus efter hver injektion. 
Attaching the interferon to albumin helps to prolong its action against the hepatitis C virus after each injection.
Det skulle have været leveret som injektionspen og hætteglas. 
It was to be available as an injection pen and as vials.
Det indeholder det aktive stof albinterferon alfa-2b. 
It contains the active substance albinterferon alfa-2b.
Det aktive stof i Joulferon, albinterferon alfa-2b, hører til gruppen af ”interferoner”. 
The active substance in Joulferon, albinterferon alfa-2b, belongs to the group ‘interferons'.
Begge patientgrupper fik også ribavirin (et andet lægemiddel til behandling af hepatitis C). 
Both groups of patients also took ribavirin (another medicine used in hepatitis C).
Undersøgelserne sammenlignede Joulferon med peginterferon alfa-2a (et andet lægemiddel til behandling af hepatitis C). 
The studies compared Joulferon with peginterferon alfa2a (another medicine used to treat hepatitis C).
Joulferon forventedes anvendt til behandling af voksne patienter med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus). 
Joulferon was expected to be used to treat adults with long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Joulferon fremstilles ved hjælp af en metode kaldet ”rekombinant dna-teknologi”": Det fremstilles af en gærcelle, som har modtaget et gen (dna), der sætter den i stand til at producere albinterferon alfa-2b. 
The albinterferon alfa-2b in Joulferon is produced by a method known as ‘recombinant DNA technology': it is made by a yeast that has received a gene (DNA), which makes it able to produce albinterferon alfa2b.
En stigende andel vil herefter vende tilbage til normalfunktion. 
An increasing proportion will return to normal function after this time.
ATCvet-kode: QG03XA91. 
ATCvet code: QG03XA91.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 11/05/2009 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/05/ 2009
Dyrenes almene sundhed blev ikke påvirket. 
The general health of the animals was not affected.
I et lille antal dyr indtraf døden efter reaktionen, men de fleste dyr kom sig uden behandling og syntes ikke at reagere på de efterfølgende vaccinationer. 
In a small number of animals death occurred following the reaction, however most animals recovered without treatment and did not appear to react to subsequent vaccinations.
De lokale reaktioner forsvinder gradvist, men hos 20-30 % af dyrene kan de vare i mere end 42 dage. 
A gradual resolution of the local reactions occurs, but in 20-30% of the animals these may persist for more than 42 days.
Veterinærlægemidlet må ikke administreres af gravide kvinder eller kvinder, der kan være gravide. 
The veterinary medicinal product must not be administered by pregnant women or those who may be pregnant.
Råd til brugeren i tilfælde af utilsigtet selvinjektion: 
Advice to the user in the event of accidental self-injection:
Kun raske dyr bør immuniseres. 
Only healthy animals should be immunised.
Administreres som subkutan injektion i nakken, lige bag øret, under anvendelse af en sikkerhedsvaccinator. 
Administer by subcutaneous injection in the neck, immediately behind the ear, using a safety vaccinator.
Hjælpestofferne (inklusive adjuvanser) anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EC) nr. 470/2009, når de anvendes i dette veterinærlægemiddel. 
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Afhængig af typen af sikkerhedsvaccinator, vil der også kunne udløses et tryk mod huden og skubbe kanylen nogle få millimeter dybere ind i vævet. 
Depending on the type of safety vaccinator, pressure may also be put on the skin and push the needle a few millimetres deeper into the tissue.
Råd til lægen: 
Advice to the physician:
Søg omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tag indlægssedlen med dig. 
Seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Dato for seneste fornyelse af markedsføringstilladelse: 10/04/2014 
Date of last renewal: 10/04/2014
Da skatolniveauet ikke er fuldstændig afhængigt af seksualstatus, er både fodermæssige og hygiejniske kontrolprocedurer til reduktion af skatolniveauer ligeledes vigtige. 
As skatole levels are not fully dependent on sexual status, both dietary and hygiene management procedures to reduce skatole levels are also important.
Undgå at vaccinere grise, som er våde og snavsede. 
Avoid injecting pigs that are wet and dirty.
Bemærk, at hvis der anvendes en sikkerhedsvaccinator, vil en del af kanylen være dækket af kanylebeskytter og vil ikke penetrere grisen. 
Note that when using a safety vaccinator part of the needle will be covered by the needle guard and will not penetrate the pig.
Dette afspejler den tid, der er nødvendig for clearance af ornelugtfremkaldende stoffer, der allerede er til stede på vaccinationstidspunktet samt variabiliteten i respons mellem de enkelte dyr. 
This reflects the time needed for clearance of boar taint compounds already present at the time of vaccination as well as the variability of response between individual animals.
Dette medfører nedsat produktion og koncentration af testosteron og andre testikelsteroider, herunder androstenon, en af de hovedsubstanser, der er ansvarlige for ornelugt. 
This leads to reduced production and concentration of testosterone and other testicular steroids, including androstenone, one of the main substances responsible for boar taint.
Ved hudkontakt afvaskes straks med sæbe og vand. 
In case of skin contact, wash immediately with soap and water.
Efter første anbrud med en steril nål skal flasken stilles i køleskab. 
After first broaching with a sterile needle, the container should be returned to the refrigerator.
Hvis der er mistanke om selvinjektion med Improvac, skal reproduktionsfysiologien overvåges ved målinger af testosteron- eller østrogenniveauer (efter omstændighederne). 
If self-injection with Improvac is suspected, reproductive physiology should be monitored by assay of testosterone or oestrogen levels (as appropriate).
Endvidere udvikler fuldt immuniserede orner metaboliske karakteristika, der er typiske for kirurgisk kastrerede dyr herunder reducerede koncentrationer af skatol, der er en anden nøglesubstans for ornelugt. 
Moreover, fully immunised boars develop metabolic characteristics typical of surgically castrated animals, including reduced concentrations of skatole, another key contributor to boar taint.
Beslutning om at anvende denne vaccine før eller efter et andet veterinært lægemiddel skal derfor foretages fra gang til gang. 
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Den største reaktion blev set ca. 7 dage efter administration med en maksimal størrelse på 13 ×7 cm. To uger efter administrationen var den maksimale størrelse aftaget til 8 ×4 cm, og der sås en gradvis reduktion af de lokale reaktioner. 
The largest reactions were seen around 7 days post administration when the maximum size was 13 x 7 cm. By two weeks post administration the maximum size had decreased to 8 x 4 cm, showing a gradual resolution of the local reactions.
For at undgå intramuskulær aflejring og læsioner, anbefales det at anvende en kortere kanyle for at opnå en penetration på 5 mm til 9 mm hos meget små grise og grise, der er yngre end 16 uger. 
To avoid intramuscular deposition and lesions, it is recommended to use a shorter needle to give 5 mm to 9 mm penetration in undersized pigs and pigs younger than 16 weeks of age.
Ved utilsigtet selvinjektion skal skadestedet vaskes grundigt med rent, rindende vand. 
In the event of accidental self-injection, wash the injury thoroughly with clean running water.
Immunisering med Improvac medfører et immunrespons mod endogen gonadotropin-releasing factor (GnRF), en faktor som kontrollerer testikelfunktion via de gonadotrope hormoner LH og FSH. 
Immunisation with Improvac induces an immune response against endogenous gonadotrophin releasing factor (GnRF), a factor that controls testicular function via the gonadotropic hormones LH and FSH.