natgillin/translations-raw huggingface dataset:
Yderligere oplysninger om lægemidler til sjældne sygdomme findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Further information on the orphan designation can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Det aktive stof i Opsumit, macitentan, virker ved at blokere endothelin-receptorerne. 
The active substance in Opsumit, macitentan, works by blocking endothelin receptors.
Patienterne i forsøget fik enten Opsumit eller placebo (ikke-aktivt stof) som tillæg til andre PAH-lægemidler i gennemsnitligt 2 år. 
Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years.
PAH er en sygdom, hvor blodtrykket i lungerne er unormalt højt, hvilket giver symptomer som f.eks. åndenød og træthed. 
PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.
Opsumit må heller ikke anvendes hos patienter, der har svært nedsat leverfunktion eller forhøjede mængder af leverenzymer i blodet. 
It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood.
Opsumit må derfor ikke anvendes hos kvinder, der er gravide eller ammer, eller hos kvinder, der kan blive gravide, og som ikke anvender sikker prævention. 
Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception.
Hvordan anvendes Opsumit? 
How is Opsumit used?
Patientkortet skal indeholde en advarsel om, at lægemidlet aldrig må anvendes hos gravide kvinder, og at kvinder, der kan blive gravide, skal anvende sikker prævention og bør have taget en graviditetstest en gang om måneden. 
Patients' reminder cards will include a warning that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests.
Ved PAH sker der en forsnævring af arterierne i lungerne. 
In PAH there is severe narrowing of the arteries of the lungs.
Hvilke fordele viser studierne, at der er ved Opsumit? 
What benefits of Opsumit have been shown in studies?
Den fuldstændige liste over indberettede bivirkninger ved Opsumit fremgår af indlægssedlen. 
For the full list of side effects reported with Opsumit, see the package leaflet.
Da det er påvist i dyrestudier, at Opsumit har en negativ indvirkning på fosterudviklingen, må lægemidlet ikke anvendes hos gravide kvinder eller kvinder, der kan blive gravide, og som ikke anvender sikker prævention. 
However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.
Opsumit kan anvendes alene eller i kombination med andre PAH-lægemidler. 
Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Opsumit. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opsumit have also been included in the summary of product characteristics and the package leaflet.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCPCh den 23. februar 2005. 
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005.
Katten bør revaccineres for alle komponenter ét år efter det første vaccinationsforløb, derefter hvert år for klamydia, og hvert tredje år for rhinotracheitis, calicivirose og panleukopeni. 
The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax RCPCh overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Purevax RCPCh. 
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation.
Når en kat får vaccinen, opfatter immunsystemet de svækkede eller dræbte virus og de svækkede bakterier som "fremmede" og danner antistoffer mod dem. 
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Det vigtigste mål for effektiviteten var blodets indhold af antistoffer mod virus og bakterier i vaccinen. 
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Hvis der alligevel sker selvinjektion hos sådanne personer, skal lægen have at vide, at der er sket selvinjektion med en levende klamydiavaccine. 
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Purevax RCPCh anvendes til at vaccinere katte fra 8-ugers alderen mod følgende sygdomme: 
Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Feltundersøgelserne af Purevax RCPCh vedrørte basisvaccinationsplanen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen. 
In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
Purevax RCPCh bør ikke anvendes hos drægtige katte. 
Purevax RCPCh should not be used in pregnant cats.
Purevax RCPCh leveres som et lyofilisat (en frysetørret pellet) med opløsningsvæske (solvens), der benyttes til at fremstille en suspension til indsprøjtning. 
Purevax RCPCh is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Effektiviteten af Purevax RCPCh er undersøgt under laboratorieforhold i flere undersøgelser, hvor kattene blev vaccineret og inficeret med herpesvirus, calicivirus, C. felis eller parvovirus. 
The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus.
Purevax RCPCh er en vaccine. 
Purevax RCPCh is a vaccine.
Purevax RCPCh er en veterinær vaccine, der indeholder: 
Purevax RCPCh is a veterinary vaccine that contains:
Andre oplysninger om Purevax RCPCh: 
Other information about Purevax RCPCh:
Den fuldstændige liste over indberettede bivirkninger med Purevax RCPCh fremgår af indlægssedlen. 
For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet.
Purevax RCPCh er påvist at beskytte mod ovennævnte sygdomme under laboratoriebetingelser. 
In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
Purevax RCPCh indeholder små mængder svækkede eller dræbte virus og bakterier, der forårsager felin rhinotracheitis, calicivirose, klamydia og panleukopeni. 
Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Felin viral rhinotracheitis-, felin klamydia-, felin panleukopeni- (levende, svækket) og felin calicivirose- (inaktiveret) vaccine 
Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Hvilken risiko er der forbundet med Purevax RCPCh? 
What is the risk associated with Purevax RCPCh?
Hvorfor blev Purevax RCPCh godkendt? 
Why has Purevax RCPCh been approved?
Hvad er Purevax RCPCh? 
What is Purevax RCPCh?
Hvordan blev Purevax RCPCh undersøgt? 
How has Purevax RCPCh been studied?
Hvad anvendes Purevax RCPCh til? 
What is Purevax RCPCh used for?
Hvordan virker Purevax RCPCh? 
How does Purevax RCPCh work?
Hvilken fordel viser undersøgelserne, at der er ved Purevax RCPCh? 
What benefit has Purevax RCPCh shown during the studies?
Der blev udført en yderligere undersøgelse af 15 kvindelige patienter. 
A further study was carried out in 15 female patients.
Da virksomheden havde fremlagt de yderligere oplysninger, som man havde anmodet om, blev de ”særlige omstændigheder” ophævet den 20. juli 2015. 
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Replagal den 3. august 2001. 
The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Virkningen af ugentlige doser snarere end doser givet hver anden uge blev også undersøgt. 
The effect of giving doses weekly rather than every two weeks was also investigated.
Andre oplysninger om Replagal 
Other information about Replagal
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Replagal. 
This is a summary of the European public assessment report (EPAR) for Replagal.
Den fuldstændige EPAR for Replagal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Replagal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Replagal er også blevet evalueret i yderligere undersøgelser, der omfattede 38 børn i alderen 7 år og opefter. 
Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Replagal indgives som en infusion i løbet af 40 minutter én gang hver anden uge i doser på 0,2 mg pr. kilogram kropsvægt. 
Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes.
Disse omfatter kulderystelser, hovedpine, kvalme, pyreksi (feber), smerter og ubehag, rødmen og træthed, og de er sjældent alvorlige. 
These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Hvis du ønsker yderligere oplysninger om behandling med Replagal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hos børn, som modtog Replagal, var der ingen uventet forøgelse af hjertets masse, og Gb3-niveauerne i blodet blev formindsket. 
Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced.
De hyppigste bivirkninger ved Replagal (som optræder hos flere end 1 ud af 10 patienter) er infusionsrelaterede reaktioner. 
The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Replagal blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet kun forelå sparsomme oplysninger som følge af sygdommens sjældenhed. 
Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Replagal skal anvendes. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Replagal.
Replagal reducerede den venstre ventrikelmasse med gennemsnitlig 11,5 g, mens patienter, som modtog placebo, oplevede en stigning i venstre ventrikelmasse på 21,8 g. Virkningerne hos kvindelige patienter viste sig at være sammenlignelige med resultaterne hos mandlige patienter, og der var ingen fordele forbundet med ugentlige doseringer frem for med standarddoseringer. 
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Det aktive stof i Replagal, agalsidase alfa, er en kopi af det humane enzym og er fremstillet ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi", dvs. det fremstilles af celler, som har modtaget et gen (DNA), der sætter dem i stand til at producere enzymet. 
The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Replagal blev sammenlignet med placebo (en uvirksom behandling) i to hovedundersøgelser, der omfattede i alt 40 mandlige patienter. 
Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Personer med Fabrys sygdom kan have en lang række tegn og symptomer, herunder alvorlige lidelser såsom nyresvigt, hjerteproblemer og slagtilfælde. 
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
CHMP besluttede, at fordelene ved Replagal opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse. 
The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Replagal er et lægemiddel, der indeholder det aktive stof agalsidase alfa. 
Replagal is medicine that contains the active substance agalsidase alfa.
Patienter med Fabrys sygdom mangler enzymet alfa-galactosidase A. Dette enzym nedbryder normalt et fedtstof, som hedder globotriaosylceramid (Gb3 eller GL-3). 
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Efter seks måneders behandling nedsatte Replagal patienternes smerter i væsentlig grad sammenlignet med placebo. 
After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Replagal er designet til at erstatte det humane enzym alfa-galactosidase A, som personer med Fabrys sygdom mangler. 
Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
CHMP besluttede, at for patienter med Fabrys sygdom kan behandling med Replagal give kliniske fordele på lang sigt. 
The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
I den første undersøgelse målte man Replagals effekt på smerter, og i den anden undersøgelse målte man effekten på den venstre ventrikelmasse (hjertemusklen), et mål for mængden af Gb3 i hjertecellerne. 
The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
Den fuldstændige liste over bivirkninger og begrænsninger ved Replagal fremgår af indlægssedlen. 
For the full list of all side effects and restrictions with Replagal, see the package leaflet.
Substitutionsenzymet hjælper med at nedbryde Gb3 og forhindrer det i at hobe sig op i cellerne. 
The replacement enzyme helps to break down the Gb3 and stops it building up in the cells.
Hvilken risiko er der forbundet med Replagal? 
What is the risk associated with Replagal?
Hvorfor blev Replagal godkendt? 
Why has Replagal been approved?
Replagal er en enzymsubstitutionsbehandling. 
Replagal is an enzyme replacement therapy.
Det fås som et koncentrat til fremstilling af en opløsning til infusion (drop i en vene). 
It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Hvis enzymet mangler, kan Gb3 ikke nedbrydes, og det hober sig op i cellerne, f.eks. nyrecellerne. 
If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Replagal bør kun gives af en læge med erfaring i behandling af patienter med Fabrys sygdom eller andre arvelige stofskiftesygdomme. 
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Hvordan blev Replagal undersøgt? 
How has Replagal been studied?
Hvad er Replagal? 
What is Replagal?
Replagal anvendes til behandling af patienter, som lider af Fabrys sygdom, en sjælden arvelig sygdom. 
Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Hvilken fordel viser undersøgelserne, at der er ved Replagal? 
What benefit has Replagal shown during the studies?
Hvad anvendes Replagal til? 
What is Replagal used for?
Hvordan anvendes Replagal? 
How is Replagal used?
Hvordan virker Replagal? 
How does Replagal work?
Indhold (koncentrati on 
Content (concentrati on)
Da der ikke kunne opnås enighed, indbragte CMD(h) sagen for CHMP. 
Because consensus could not be reached, the CMD(h) referred the procedure to the CHMP.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF BLEOMYCIN PHARMACHEMIE OG TILKNYTTEDE NAVNE (SE BILAG I) 
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BLEOMYCIN PHARMACHEMIE AND ASSOCIATED NAMES (SEE ANNEX I)
I Nederlandene er bleomycin på nuværende tidspunkt godkendt til følgende indikationer: 
In the Netherlands bleomycin is currently approved for the following indications:
CHMP vurderede de fremlagte oplysninger for at fastslå, hvorvidt de to indikationer kan understøttes. 
The CHMP assessed the available data in order to establish whether the two indications can be supported.
Sluttelig konkluderede CHMP, at virkningen opvejer produktets toksicitet, og at benefit/risk-forholdet er positivt. 
In conclusion, the CHMP considered that this efficacy outweighs the toxicity of the product, and that the benefit/risk balance is positive.
Ansøgningen for Bleomycin Pharmachemie er indsendt som generisk ansøgning på baggrund af den markedsføringstilladelse, der blev udstedt for referenceproduktet i Nederlandene den 18. november 1997. 
The Application for Bleomycin Pharmachemie was submitted as a generic application based on the marketing authorisation granted for the reference product in the Netherlands on 18 November 1997.
Medlemsstat Indehaver af markedsførings tilladelse 
Marketing Authorisation Holder
BEGRUNDELSE FOR UDTALELSE 
GROUNDS FOR OPINION
CHMP bemærkede, at bleomycin har været anvendt klinisk siden 1960'erne, hvilket forklarer det manglende kliniske udviklingsprogram. 
The CHMP noted that bleomycin is in clinical use since the 1960ies, thereby explaining the lack of a clinical development programme.
Det samme gælder for indikationen peniscancer, hvor indikationen understøttes af rapporter, der antyder en beskeden virkning for denne sygdom. 
The same is applicable for the indication penile cancer; the indication is supported by reports suggesting a modest efficacy for this disease.
CMPH vurderer derfor, at indikationen er acceptabel. 
The CHMP therefore considered the indication to be acceptable.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJE, ANSØGERE, I MEDLEMSSTATERNE 
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Da vurderingen af benefit/risk-forholdet ved disse indikationer var negativ for det oprindelige produkt, og da indikationerne som følge heraf blev fjernet fra listen over indikationer for alle bleomycinprodukter i Tyskland, blev indikationerne betragtet som nye indikationer, og Tyskland skønnede, at de forelagte oplysninger var utilstrækkelige til, at der kunne udstedes en markedsføringstilladelse for de foreslåede nye indikationer. 
Because the benefit/risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
CMPH bemærkede, at bleomycin stadig anvendes og også nævnes i aktuelle behandlingsvejledninger i Europa og Nordamerika, eksempelvis i forbindelse med pladecellekarcinomer i hoved og hals: "Practice Guidelines in Oncology", v. 2, 2008 (HCCN, USA), "CCO (Cancer Care Ontario) Formulary", revideret i 2006/2007, samt "Guidelines on penile cancer" (marts 2004) fra European Association of Urology. 
The CHMP also noted that bleomycin is still in use and also mentioned in current treatment guidelines in Europe and North America, such as the SCCHN: Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), the CCO (Cancer Care Ontario) Formulary, revised 2006/2007, and the Guidelines on penile cancer (March 2004) of the European Association of Urology.
Behandling med bleomycin finder næsten altid sted i kombination med andre cytostatiske midler og/eller strålebehandling. 
The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/or radiation therapy.
Den gældende tekst til produktresume, etikettering og indlægsseddel er de endelige versioner der er fastlagt ved behandling i koordinationsgruppen. 
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Bleomycin påvirker desuden i mindre grad RNA- og proteinsyntese. 
In a lower degree bleomycin also affects the RNA and protein synthesis.
Selv om ansøgeren var villig til at fjerne de indikationer, der blev gjort indsigelser mod af den berørte medlemsstat, ønskede referencemedlemsstaten og andre positive berørte medlemsstater at bevare de pågældende indikationer. 
Although the applicant was willing to remove the indications objected to by the objecting CMS, the RMS and the other positive CMSs were in favour of retaining these indications.
CMPH mener derfor, at bleomycin stadig er et værdifuldt kemoterapeutisk lægemiddel, og vedtog samtlige foreslåede indikationer for Bleomycin Pharmachemie: 
Therefore the CHMP is of the opinion that bleomycin is still a valuable chemotherapeutic drug, and adopted the totality of the proposed indications, for Bleomycin Pharmachemie:
Bleomycins virkning ligger i indskydningen i enkelte og dobbelte DNA-strenge, således at der opstår sprængninger i disse strenge, hvilket hæmmer celledeling, vækst og DNA-syntese. 
The effect of bleomycin rests on intercalation with single and double strands of DNA, resulting in single and double strand ruptures, which inhibit cell division, growth and DNA synthesis.
Kombinationen af bleomycin, vindesin, mitomycin C og cisplatin hos patienter med tilbagevendende og/eller metastatiske pladecellekarcinomer i livmoderhalsen er for nyligt blevet påvist at have en positiv virkning på overlevelse, og en fase II-undersøgelse påviste bleomycin som en del af et klinisk relevant alternativt behandlingsregime til cisplatin hos patienter med tilbagevendende livmoderhalskræft. 
The combination of bleomycin, vindesine, mitomycin C and cisplatin in patients with recurrent and/or metastatic squamous cell carcinoma of the cervix was recently shown to be of benefit with regards to survival and a phase II study showed bleomycin to be part of a clinically relevant alternative treatment regimen for cisplatin, in patients with recurrent cervical cancer.