natgillin/translations-raw huggingface dataset:
Oversigt over indlægssedlen Gefitinib Mylans virkning og anvendelse Det skal du vide, før du begynder at tage Gefitinib Mylan Sådan skal du tage Gefitinib Mylan Bivirkninger 
What you need to know before you take Gefitinib Mylan 3.
Det var hensigten, at det skulle leveres som 300 mg tabletter. 
It was to be available as 300 mg tablets.
Corluxin blev ikke sammenlignet med noget andet lægemiddel. 
Corluxin was not compared with any other medicine.
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes strategiske forretningsmæssige årsager. 
In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was due to strategic business reasons.
Hvad er Corluxin? 
What is Corluxin?
21. maj 2015 EMA/386100/2015 EMEA/H/C/002830 
EMA/261739/2015 EMEA/H/C/002830
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og udarbejdet en liste med spørgsmål. 
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Corluxin er et lægemiddel, der indeholder det aktive stof mifepriston. 
Corluxin is a medicine containing the active substance mifepristone.
Den 23. marts 2015 meddelte FGK Representative Service GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Corluxin til behandling af Cushings syndrom. 
On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Corluxin (mifepriston) 
Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Ansøgeren fremlagde data fra en hovedundersøgelse med 50 patienter med Cushings syndrom, som havde sukkersyge og/eller højt blodtryk, der er to almindelige kendetegn ved sygdommen. 
The applicant submitted data from a main study involving 50 patients with Cushing's syndrome who had diabetes and/or high blood pressure, two common features of the condition.
Hvad forventedes Corluxin anvendt til? 
What was Corluxin expected to be used for?
I undersøgelsen blev blodsukkeret og blodtrykket registreret efter 24-ugers behandling med Corluxin. 
The study looked at improvements in blood sugar levels and blood pressure following 24 weeks of Corluxin treatment.
CHMP havde betænkeligheder vedrørende lægemidlets fremstilling, herunder kontrol med urenheder og testning af det færdige præparat. 
The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product.
Ved at blokere disse receptorer forventes mifepriston at mindske virkningerne af forhøjet indhold af kortisol i kroppen og derved at lette sygdomssymptomerne. 
By blocking these receptors, mifepristone is expected to reduce the effects of the excess cortisol circulating in the body, thereby alleviating the symptoms of the disease.
CHMP havde desuden betænkeligheder ved hovedundersøgelsen og henviste blandt andet til, at der ikke var anvendt et sammenligningslægemiddel. 
The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.
Hvordan forventes Corluxin at virke? 
How is Corluxin expected to work?
Patienter med Cushings syndrom kan få vægtøgning, der omfatter ansigtet og kroppen, men ikke lemmerne ("central" vægtøgning), øget fedtlag over kravebenet og nakken, afrundet ansigtsform, tendens til blå mærker, stærk behåring i ansigtet, svækkelse af muskler og knogler, depression, sukkersyge og forhøjet blodtryk. 
Patients with Cushing's syndrome can have ‘central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.
Cushings syndrom er en sygdom, der kendetegnes af for stor produktion af hormonet kortisol fra binyrerne, som er to kirtler, der ligger over nyerne. 
Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
På tidspunktet for tilbagetrækningen af ansøgningen var CHMP var af den foreløbige opfattelse, at Corluxin ikke kunne godkendes til den brede indikation, som virksomheden havde ansøgt om, dvs. "behandling af voksne patienter med endogent Cushings syndrom, hos hvem operation ikke er mulig eller ikke har virket." 
At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Corluxin ikke opvejede risiciene. 
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.
Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser med Corluxin eller programmer for anvendelse med særlig udleveringstilladelse. 
The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Corluxin (mifepriston) EMA/386100/2015 
Withdrawal of the marketing authorisation application for Corluxin (mifepristone) EMA/261739/2015
Det aktive stof i Corluxin, mifepriston, blokerer receptorerne for kortisol (glukokortikoidreceptorer GRII). 
The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Corluxin eller i programmer for anvendelse af Corluxin med særlig udleveringstilladelse? 
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Dette gjaldt bivirkninger forårsaget af den nedsatte aktivitet af cirkulerende kortisol, forstyrrelser i væske- og mineralbalancen (navnlig nedsat kaliumindhold i blodet og øget blodtryk hos nogle patienter) samt fortykkelse af livmoderen hos nogle kvindelige patienter. 
On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Det var hensigten, at Corluxin skulle anvendes til behandling af Cushings syndrom, når operation ikke er mulig eller ikke har virket. 
Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Kommunikationsplan 
Communication Plan
Den harmoniserede dato for offentliggørelsen af brevet er 15 arbejdsdage efter Europa-Kommissionens afgørelse. 
The harmonised date for release of the letter is of 15 working days following the European Commission decision.
Indehaverne af markedsføringstilladelserne skal informere fagfolkene inden for sundhedssektoren om resultaterne af denne gennemgang af nimesulid via et ”Direct Healthcare Professional Communication” (DHPC) efter aftale med CHMP. 
The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) as agreed by the CHMP.
BETINGELSER FOR MARKEDSFØRINGSTILLADELSERNE De kompetente nationale myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelserne: 
CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Bilag IV Betingelser for markedsføringstilladelserne 
Condition of the marketing authorisations
EMEA/457286/2008-DA 
EMEA/457286/2008-EN
De fastsatte tilbageholdelsestider er sikre og kan bibeholdes. 
The established withdrawal periods are safe and can be retained.
Efter vurdering af svarene konkluderede CVMP, at: 
Having assessed the responses, the CVMP concluded that:
o Periodiske, opdaterede sikkerhedsberetninger for mindst de sidste 3 år. 
o The Periodic Safety Update Reports for at least the last 3 years.
CVMP vedtog sin udtalelse den 12. december 2007, og Kommissionen vedtog den efterfølgende beslutning den 11. marts 2008. 
The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
Der kunne ikke fastsættes en dosis til behandling af salmonellose. 
No dose could be established for the treatment of salmonellosis.
CVMP indledte indbringelsesproceduren på mødet den 10.-12. juli 2007. 
The CVMP started the referral procedure during its meeting of 10-12 July 2007.
Efter Frankrigs opfattelse er dosisregimet for dette produkt ikke korrekt. 
France considered that the dosing regime of the product is not correct.
Indehaverne af markedsføringstilladelsen blev på en liste med spørgsmål anmodet om at fremkomme med: 
The Marketing Authorisation Holders were requested in a list of questions to provide:
Brugen af produktet bør baseres på følsomhedstest og tage højde for officielle og lokale antimikrobielle politikker. 
The use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
• Begrundelse for tilbageholdelsestiden, hvis den anbefalede dosis skal øges. 
• Justification of the withdrawal period, in case the recommended dose should increase.
Hverken produkternes periodiske, opdaterede sikkerhedsberetninger eller den fremlagte litteratur omfattede beretninger om manglende virkning på området. 
Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
CVMP anbefalede en ændring af markedsføringstilladelserne for de berørte veterinærlægemidler i overensstemmelse med konklusionerne efter relevans. 
The CVMP recommended varying the Marketing Authorisations of the concerned veterinary medicinal products in accordance with the conclusions where applicable.
UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 35 VEDRØRENDE VETERINÆRLÆGEMIDLER, SOM INDEHOLDER DE AKTIVE STOFFER TRIMETHOPRIM OG SULFADIAZIN 
OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR VETERINARY MEDICINAL PRODUCTS WHICH CONTAIN THE ACTIVE SUBSTANCES TRIMETHOPRIM AND SULFADIAZINE
I henhold til artikel 35 i direktiv 2001/82/EF, med senere ændringer, indbragte Frankrig den 11. juli 2007 en sag for EMEA, som vedrørte Tribrissen oral pasta til heste (inklusive tilknyttede navne) og godkendte produkter, for hvilke dette produkt tjener som referenceprodukt, indeholdende trimethoprim og sulfadiazin som aktive stoffer. 
On 11 July 2007, France presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning Tribrissen Oral Paste for Horses (including associated names) and authorised products for which this product served as a reference product, containing trimethoprim and sulfadiazine as active ingredient.
Der foreligger ingen dokumentation for problemer i forbindelse med manglende virkning eller en eventuel ændring i resistenssituationen for de relevante målpatogener, som ville udgøre et problem med henblik på dyrs eller menneskers sundhed. 
There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
Virkningen af en dosis på 1 x 30 mg/kg kropsvægt pr. dag til indgivelse i højst 5 dage er dokumenteret for alle indikationer, undtagen for salmonellose. 
The efficacy of a dose of 1x30 mg/kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis.
• Begrundelse for den anbefalede dosis for hver angiven indikation med hensyn til virkning og potentiel selektion af bakterier, der er resistente over for antimikrobielle stoffer. 
• Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
Opfattelsen var, at dette kan føre til manglende effektivitet og fremme resistensudviklingen i målpatogener, som muligvis kan medføre risici for menneskers sundhed for så vidt angår zoonotiske bakterier. 
It considered that this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Indehaverne af markedsføringstilladelsen fremsendte skriftlige svar, der forsvarede den godkendte dosis på 1 x 30 mg/kg kropsvægt pr. dag for alle indikationer, men med forslag om, at en højere dosis kan være nødvendig i tilfælde af salmonellose. 
Marketing Authorisation Holders submitted written responses, defending the authorised dose of 1x30 mg/kg body weight per day for all indications but suggesting a higher dose may be required in the case of salmonellosis.
o Hvis relevant, del IV Oplysninger om virkning, herunder oplysninger om farmakokinetik, farmakodynamik samt data om antimikrobiel resistens. 
o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
Behandlingen fortsatte i op til to år. 
Treatment continued for up to two years.
Injektionsstedet bør skiftes hver uge. 
The site of injection should be changed each week.
Virksomheden har ikke gennemført formelle studier af patienter under 16 år. 
The company has not carried out any formal studies of patients under 16 years of age.
Bivirkningerne er de samme hos voksne og børn. 
The side effects are similar in adults and in children.
Avonex fik en markedsføringstilladelse med gyldighed i hele EU den 13. marts 1997. 
Avonex received a marketing authorisation valid throughout the EU on 13 March 1997.
Det primære mål for virkning var antallet af patienter, hvis invaliditet blev værre. 
The main measure of effectiveness was the number of patients whose disability got worse.
Yderligere information om Avonex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/avonex. 
Further information on Avonex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/avonex.
• patienter, der har haft et enkelt attak af demyelinisering, når dette er alvorligt nok til at nødvendiggøre behandling med injicerede kortikosteroider (antiinflammatoriske lægemidler). 
• patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines).
Hyppigheden af disse bivirkninger falder ved fortsat behandling. 
These side effects decrease with continued treatment.
Som for alle lægemidler bliver data vedrørende brugen af Avonex løbende overvåget. 
As for all medicines, data on the use of Avonex are continuously monitored.
Andre oplysninger om Avonex 
Other information about Avonex
For at hjælpe patienterne med at vænne sig til behandlingen kan lægen anbefale, at patienterne starter på en lavere dosis én gang om ugen, før de når op på fuld dosis. 
To help patients adjust to treatment, the doctor may recommend that patients start with a lower dose once a week before increasing to the full dose.
Avonex blev sammenlignet med placebo (en uvirksom behandling) i to hovedstudier. 
Avonex has been compared with placebo (a dummy treatment) in two main studies.
Avonex er et lægemiddel til behandling af: 
Avonex is a medicine used to treat:
• patienter med recidiverende multipel sklerose. 
• patients with relapsing multiple sclerosis (MS).
Hos voksne i alderen 18 år eller derover er den anbefalede dosis Avonex 30 mikrogram givet ved injektion i en muskel én gang om ugen. 
In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
De indberettede bivirkninger ved Avonex vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.
Den fremlagde imidlertid oplysninger fra offentliggjorte studier af brugen af Avonex hos patienter i alderen 12-18 år, som viste, at de havde oplevet et fald i hyppigheden af recidiver, muligvis på grund af Avonex-behandlingen. 
However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years, which showed that they had a decrease in the rate of relapse, possibly due to Avonex treatment.
Efter to år oplevede 22 % af de patienter, der fik Avonex, og 35 % af de patienter, der fik placebo, en forværring af invaliditeten. 
After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Avonex? 
What measures are being taken to ensure the safe and effective use of Avonex?
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Avonex opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.
Den skønnede risiko ved at få et nyt attak af demyelinisering var lavere hos de patienter, der fik Avonex, end hos de patienter, der fik placebo: Med Avonex var risikoen 21 % i to år og 35 % i tre år, mens risikoen ved placebo var 39 % i to år og 50 % i tre år. 
The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
De hyppigste bivirkninger ved Avonex (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, influenzalignende symptomer, feber, kulderystelser og svedtendens. 
The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Det første studie omfattede 301 patienter i alderen 16 år og derover med recidiverende multipel sklerose, som havde oplevet mindst to recidiver i de forgangne tre år eller mindst ét recidiv pr. år, hvis de havde haft sygdommen i mindre end tre år. 
The first study involved 301 patients aged 16 years and older with relapsing MS who had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Multipel sklerose er en sygdom, hvor en betændelsesreaktion (inflammation) skader den beskyttende isolering omkring nerverne (demyelinisering) samt nerverne selv. 
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Avonex må ikke anvendes hos patienter, der har svær depression eller selvmordstanker. 
Avonex must not be used in patients who have severe depression or have thoughts of suicide.
Det andet studie omfattede 383 voksne, som havde oplevet ét attak af demyelinisering, og i studiet sammenlignedes Avonex' og placebos evne til at reducere risikoen for et nyt attak. 
The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack.
En oversigt over Avonex, og hvorfor det er godkendt i EU 
An overview of Avonex and why it is authorised in the EU
Hvis du ønsker mere information om anvendelsen af Avonex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet. 
For more information about using Avonex, see the package leaflet or contact your doctor or pharmacist.
Behandlingen med Avonex bør ophøre hos patienter, der udvikler progressiv (forværret) multipel sklerose. 
Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
Hver sprøjte eller pen indeholder 30 mikrogram interferon beta-1a. 
Each syringe and pen contains 30 micrograms of interferon beta-1a.
Hvorfor er Avonex godkendt i EU? 
Why is Avonex authorised in the EU?
Ved recidiverende multipel sklerose oplever patienten attakker (recidiver) mellem perioder uden symptomer. 
In relapsing MS, the patient has attacks (relapses) between periods with no symptoms.
Avonex forsinker de invaliderende virkninger og reducerer antallet af attakker 
Avonex slows the progression of disability and reduces the number of relapses;
Avonex fås kun på recept, og behandlingen bør indledes af en læge med erfaring i behandling af multipel sklerose. 
Avonex can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Hvad er Avonex, og hvad anvendes det til? 
What is Avonex and what is it used for?
Det kan kun gøres med den fyldte sprøjte, når et særligt udstyr er fastgjort til sprøjten, som gør det muligt kun at injicere den lavere dosis. 
This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.
Det aktive stof i Avonex er proteinet interferon beta-1a, der tilhører en gruppe interferoner, som dannes naturligt i kroppen for at hjælpe den med at bekæmpe bl.a. virusser. 
The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Ved multipel sklerose opstår der fejl i immunsystemet (kroppens naturlige forsvar), som angriber dele af centralnervesystemet (hjernen, rygmarven og synsnerven), og det medfører betændelse, der beskadiger nerverne og det beskyttende lag omkring dem. 
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Avonex fås som injektionsvæske i fyldte sprøjter eller fyldte penne. 
Avonex is available as a solution for injection in a pre-filled syringe or pre-filled pen.
Hvilke risici er der forbundet med Avonex? 
What are the risks associated with Avonex?
Det vides endnu ikke, præcist hvordan Avonex virker ved multipel sklerose, men det aktive stof, interferon beta-1a, synes at berolige immunsystemet og forebygger recidiver af multipel sklerose. 
The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Den fuldstændige liste over bivirkninger og begrænsninger ved Avonex fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Avonex, see the package leaflet.
Avonex indeholder det aktive stof interferon beta-1a. 
Avonex contains the active substance interferon beta-1a.