natgillin/translations-raw huggingface dataset:
Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien 
United Kingdom Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
• En 240 ml brun PET-flaske med børnesikret lukning til opblanding af suspensionen. 
• a 240 ml amber polyethylene terephthalate (PET) bottle with polypropylene child resistant closure for mixing the suspension,
Cozaar og tilhørende navne (Se bilag I) 2,5 mg/ml pulver og solvens til oral suspension [Se bilag 1 - Udfyldes nationalt] 
COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension [See Annex I - To be completed nationally]
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien 
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
I gentagne dosistoksicitetsundersøgelser inducerede administration af losartan et fald i de røde blodcelleparametre (erytrocytter, hæmoglobin, hæmatokrit), en stigning i urinstof-N i serum og lejlighedsvise stigninger i serumkreatinin, fald i hjertevægt (uden histologisk korrelat) og gastrointestinale forandringer (læsion af slimhindemembranen, mavesår, erosioner, blødninger). 
haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Hypertension og type 2-diabetes med nyresygdom I en kontrolleret klinisk undersøgelse med 1.513 type 2-diabetikere i alderen 31 år og ældre med proteinuri (RENAAL-undersøgelse, se pkt. 
Hypertension and type 2 diabetes with renal disease In a controlled clinical trial in 1513 type 2 diabetic patients 31 years of age and older with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse reactions which were reported for losartan are as follows:
Hvert brev indeholder 500 mg losartankaliumpulver. 
Each sachet contains 500 mg of losartan potassium powder.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET POWDER LABEL
SÅDAN SKAL DE TAGE COZAAR 
HOW TO TAKE COZAAR
Sæt sprøjten i flaskens tilpasningsstykke, indtil sprøjten og tilpasningsstykket slutter helt tæt. 
Insert the dispenser into the adapter on the medication bottle until a tight seal is made between the bottle and the adapter.
Forekommer hos færre end 1 ud af 10.000 patienter 
affects less than 1 user in 10000
For rekonstitution se pkt. 
For reconstitution see section 6.6.
Hvert brev med pulver til oral suspension giver 500 mg losartan (som kaliumsalt). 
Each sachet of powder for oral suspension delivers 500 mg of losartan potassium.
Sæt skruelåget på flasken og ryst indholdet omhyggeligt for at opløse pulveret. 
Place the screw cap on the bottle and shake the contents well to disperse.
Vær ekstra forsigtig med at tage Cozaar Tal med lægen, inden De tager Cozaar: 
It is important to tell your doctor before taking COZAAR:
Fjern sprøjten fra tilpasningsstykket og indtag medicinen. 
Remove the syringe and take the medicine.
Sæt den originale hætte tilbage på flasken. 
Replace the original cap onto the bottle.
Fjern skruelåget og placer push-in tilpasningsstykket på flaskens hals. 
Remove the screw cap, place the push-in bottle neck adaptor on the bottle, and re-cap the bottle.
Sæt hætten på flasken og ryst indholdet omhyggeligt for at opløse pulveret. 
Place the cap on the bottle and shake the contents well to disperse.
Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig. 
Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Tilsæt omhyggeligt alt indholdet i brevet til PET-flasken med solvensen. 
Carefully add the complete contents of the sachet into the PET container bottle containing the solvent, tapping the side of the sachet and inverting as necessary.
Anvendelse til pædiatriske patienter med nyreinsufficiens Losartan bør ikke gives til børn med glomerulær filtrationshastighed <30 ml/min/1,73m2, da der ikke findes dokumentation herfor (se pkt. 
Losartan is not recommended in children with glomerular filtration rate < 30 ml/ min/1.73 m2as no data are available (see section 4.2).
Indehaveren af markedsføringstilladelsen Fremstiller 
Marketing Authorisation Holder and Manufacturer
Den anbefalede startdosis er 0,7 mg/kg én gang dagligt til patienter >20 til <50 kg (op til 25 mg totalt). 
The recommended starting dose in patients >20 to <50 kg is 0.7 mg/kg once daily (up to 25 mg total, in exceptional cases where target doses above 25 mg are required, the maximal dose is 50 mg).
Almindelig: Svimmelhed, vertigo. 
Nervous system disorders: Common: dizziness, vertigo
Målet med undersøgelsen var at vise losartankaliums nyrebeskyttende virkning ud over dets gavnlige indvirkning på blodtrykket. 
751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of lowering blood pressure.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml suspension indeholder 2,5 mg losartankalium. 
STATEMENT OF ACTIVE SUBSTANCE(S) One ml suspension contains 2.5 mg of losartan potassium.
Efter rekonstitution indeholder hver ml suspension 2,5 mg losartankalium. 
After reconstitution, each ml suspension contains 2.5 mg of losartan potassium.
DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD month YYYY}> [To be completed nationally]
Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Brussels, Belgien 
Luxembourg Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Knogler, led, muskler og bindevæv Ikke kendt: Myalgi, artralgi. 
Muscoskeletal and connective tissue disorders: not known: myalgia, arthralgia
Det materiale, som brevet er lavet af, består af følgende materialer (fra ydersiden til indersiden til det materiale, der er i kontakt med pulveret): PET/ blæk/ lim/ folie/ lim/ PE. 
• A single aluminum foil sachet filled with powder containing 500 mg losartan potassium The sachet material consists of the following materials, from outside to inside and product contact layer: PET/Ink/ Adhesive/ Foil/ Adhesive/PE
Klargjort suspension: Opbevares i køleskab (2°C - 8°C). 
Store the prepared suspension in a refrigerator at 2-8°C.
Fjern hætten og placer push-in tilpasningsstykket på flaskens hals. 
Remove the cap, place the push-in bottle neck adaptor on the bottle, and re-cap the bottle.
• Et foliebrev med pulver svarende til 500 mg losartankalium 
• One foil sachet filled with powder equal to 500 mg losartan potassium
• Et foliebrev med 500 mg losartankaliumpulver 
• One foil sachet filled with 500 mg losartan potassium powder
• at behandle voksne samt børn og unge i alderen 6-16 år med forhøjet blodtryk (hypertension); 
• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6 - 16 years of age.
Oral anvendelse N/A 
Oral use
Filmovertrukken tablet Oral anvendelse N/A 
Filmcoated tablet Oral use
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Cozaar og tilhørende navne (se bilag I) 2,5 mg/ml pulver og solvens til oral suspension Losartankalium Oral anvendelse. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium.
Cozaar 12,5 mg + 50 mg filmdragerade tabletter mg 
Cozaar 12,5 mg + 50 mg filmdragerade tabletter
Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Bruxelles, Belgien 
Belgium Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Mave-tarm-kanalen Ikke kendt: Diarré. 
Gastrointestinal disorders: not known: diarrhoea
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Asteni, træthed, ødemer 
General disorders and administration site conditions: Uncommon: asthenia, fatigue, oedema
Cozaar er en råhvid væske efter suspension i solvensen. 
After suspension in solvent, COZAAR is an offwhite liquid.
Tag ikke Cozaar 
BEFORE YOU TAKE COZAAR
Ikke almindelig: Diarré, kvalme, opkastning. 
Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Sjælden: Hypersensitivitet: Anafylaktiske reaktioner, angioødem inklusive hævelse af larynx og glottis, som medfører luftvejsobstruktion og/eller hævelse af ansigt, læber, svælg og/eller tunge. 
Immune system disorders: rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schönlein purpura.
Methylhydroxybenzoat (E218) 
Methylhydroxybenzoate and propylhydroxybenzoate.
Cozaar og tilhørende navne (se bilag I) 2,5 mg/ml pulver og solvens til oral suspension losartankalium 
COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium
En ml opløsning indeholder 2,5 mg losartankalium. 
One ml of suspension contains 2.5 mg of losartan potassium.
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, Holland 
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
1 ml solvens indeholder 0,296 mg methylhydroxybenzoat; 0,041 mg propylhydroxybenzoat og 50,6 mg sorbitol. 
One ml solvent contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, and 50.6 mg sorbitol.
Hvis De har taget for meget Cozaar 
If you take more COZAAR than you should
• Amning (se pkt. 
• Lactation (see section 4.6).
Filmtabletten 
Film-coated tablets
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, P.O. Box 581, 2003 PC Haarlem, Holland 
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem P.O.
LORTAAN IC 12,5 mg Filmovertrukken tablet Oral anvendelse N/A 
LORTAAN IC 12,5 mg Film-coated tabletOral use
LOORTAN 12,50 mg12,5mg Filmovertrukken tablet Oral anvendelse N/A 
LOORTAN 12,50 mg12,5mg Film-coated tabletOral use
Medlemsstat Indehaver af markedsføringstilladelse 
MARKETING AUTHORISATION HOLDER
Opbevar Cozaar i den originale yderpakning. 
Store in the original container.
Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, Holland 
Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, The Netherlands
Hver ml suspension indeholder 0,296 mg methylhydroxybenzoat; 0,041 mg propylhydroxybenzoat; 50,6 mg sorbitol og 1,275 mg lactose. 
Each ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol, and 1.275 mg lactose.
Cozaar 12,5 mg Inicio 12,5 mg Filmovertrukken tablet Oral anvendelse N/A 
Cozaar 12,5 mg Inicio 12,5 mg Film-coated tabletOral use
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien 
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon,
De skal derfor være opmærksom på, hvordan medicinen påvirker Dem. 
These measures will help to protect the environment.
Meget almindelig: Forekommer hos flere end 1 ud af 10 patienter Almindelig: 
affects more than 1 user in 10
12,5 mg Tabletter filmovertrukne Oral anvendelse N/A 
12,5 mg film-coated tablet oral use
- Losartan bør ikke gives til børn med leverinsufficiens (se ogå pkt. 
Losartan is not recommended in children with hepatic impairment (see section 4.2).
4.2, 4.3 Losartan bør heller ikke gives til børn med leverinsufficiens (se pkt. 
-Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
100 mg Tabletter filmovertrukne Oral anvendelse N/A 
100 mg Filmcoated tablet Oral use
Sæt det originale skruelåg tilbage på flasken. 
Replace the screw cap onto the bottle.
Efter markedsføring Følgende bivirkninger er blevet rapporteret efter markedsføring: 
The following adverse events have been reported in post-marketing experience: Blood and lymphatic system disorders:
Derfor bør losartan ikke gives til patienter med svær leverinsufficiens (se pkt. 
Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
6.6 Regler for destruktion 
6.6 Special precautions for disposal and other handling
LISTE OVER HJÆLPESTOFFER 1 ml suspension indeholder 0,296 mg methylhydroxybenzoat; 0,041 mg propylhydroxybenzoat; 50,6 mg sorbitol og 1,275 mg lactose. 
One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol and 1.275 mg lactose.
LOORTAN 100 mg 100 mg Filmovertrukken tablet Oral anvendelse N/A 
LOORTAN 100 mg 100 mg Film-coated tabletOral use
50 mg Tabletter filmovertrukne Oral anvendelse N/A 
50 mg film-coated tablet oral use
Cozaar 12,5 mg 12,5mg Filmovertrukken tablet Oral anvendelse N/A 
Cozaar 12,5 mg 12,5mg Film-coated tabletOral use
COZAAR 12,5 mg 12,5 mg Filmovertrukken tablet Oral anvendelse N/A 
COZAAR 12,5 mg 12,5 mg Film-coated tabletOral use
LÆGEMIDLETS NAVN Cozaar og tilhørende navne (se bilag I) 2,5 mg/ml pulver og solvens til oral suspension Losartankalium ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev med pulver til oral suspension indeholder 500 mg losartankalium. 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR SOLVENT BOTTLE NAME OF THE MEDICINAL PRODUCT Solvent for Cozaar and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium STATEMENT OF ACTIVE SUBSTANCE(S)
RP*≥ 1 (*Relativ Potens genom att en muspotenstest jämfördes med ett referensvaccin, som visat effekt till får) 
RP*>-1 (Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep)
Subkutan Type I hætteglas af glas med butylprop og aluminiumsh ætte 
Type I glass vials with chlorobutyl stopper and aluminium seal
Særnavn Styrke Lægemiddel form 
Pharma ceutical Form
Indgivelse svej 
Strength
Extavia fik en markedsføringstilladelse med gyldighed i hele EU den 20. maj 2008. 
Extavia received a marketing authorisation valid throughout the EU on 20 May 2008.
Yderligere information om Extavia findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/extavia. 
Further information on Extavia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/extavia.
Extavia anvendes hos patienter: 
Extavia is used in patients:
Andre oplysninger om Extavia 
Other information about Extavia
I det andet studie sås der ingen forsinkelse i tiden til progression af invaliditet. 
In the second study, no delay in the time to disability progression was seen.
Som for alle lægemidler bliver data vedrørende brugen af Extavia løbende overvåget. 
As for all medicines, data on the use of Extavia are continuously monitored.
Hvad er Extavia, og hvad anvendes det til? 
What is Extavia and what is it used for?
Extavia gives ved indsprøjtning under huden. 
It is given by injection under the skin.
Den virksomhed, der fremstiller Betaferon, er indforstået med, at dens videnskabelige data anvendes i forbindelse med Extavia. 
The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Extavia? 
What measures are being taken to ensure the safe and effective use of Extavia?
Hvorfor er Extavia godkendt i EU? 
Why is Extavia authorised in the EU?
Patienterne kan godt selv indsprøjte Extavia, når de er blevet instrueret i det. 
The patients can inject Extavia themselves once they have been trained.
En oversigt over Extavia, og hvorfor det er godkendt i EU 
An overview of Extavia and why it is authorised in the EU
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Extavia opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Extavia's benefits are greater than its risks and it can be authorised for use in the EU.
• der har oplevet tegn på multipel sklerose for første gang, og når disse tegn er alvorlige nok til at nødvendiggøre behandling med injicerede kortikosteroider (antiinflammatoriske lægemidler). 
• who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
De indberettede bivirkninger ved Extavia vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Extavia are carefully evaluated and any necessary action taken to protect patients.
Behandling med Extavia bør ophøre hos patienter, hvis tilstand ikke bliver bedre. 
Extavia treatment should be stopped in patients whose condition does not improve.
I ét af de to studier blev der påvist en signifikant forsinkelse i tiden til progression af invaliditet (31 % reduktion af risikoen på grund af Extavia) og i tiden til afhængighed af kørestol (39 %). 
One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%).
Hvis du ønsker mere information om anvendelsen af Extavia, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet. 
For more information about using Extavia, see the package leaflet or contact your doctor or pharmacist.
Extavia må ikke anvendes hos patienter, der har alvorlig depression eller selvmordstanker. 
Extavia must not be used in patients who have severe depression or have thoughts of suicide.
Extavia fås som pulver og solvens, der blandes til en opløsning, som giver en dosis på 250 mikrogram. 
Extavia is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
• der har multipel sklerose af den type, der kaldes 'recidiverende-remitterende', når patienten har attakker (recidiver) mellem perioder uden symptomer og har haft mindst to tilbagefald (recidiver) inden for de sidste to år 
• who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), and with at least two relapses within the last two years;
Extavia må ikke anvendes hos patienter, der har dekompenseret leversygdom (når leveren er beskadiget og ikke længere fungerer normalt). 
Extavia must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Hvilke risici er der forbundet med Extavia? 
What are the risks associated with Extavia?
Extavia var mere effektivt end placebo til at reducere antallet af tilbagefald pr. år: Patienter, der fik lægemidlet, havde i gennemsnit 0,84 tilbagefald pr. år, mens patienter på placebo havde 1,27. 
Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
De hyppigste bivirkninger ved Extavia er influenzalignende symptomer (herunder feber, kulderystelser, ledsmerter, utilpashed, svedtendens, hovedpine og muskelsmerter) og reaktioner på injektionsstedet. 
The most frequent side effects with Extavia are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
I begge studier medførte Extavia en reduktion på 30 % i antallet af kliniske tilbagefald. 
In both studies, Extavia showed a reduction in the number (30%) of clinical relapses.
• der har sekundær progressiv multipel sklerose (den type multipel sklerose, der kommer efter recidiverende-remitterende multipel sklerose), når deres sygdom er aktiv. 
• who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Multipel sklerose er en sygdom, hvor en betændelsesreaktion 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.
Extavia er et lægemiddel til behandling af voksne, der har multipel sklerose. 
Extavia is a medicine used to treat adults who have multiple sclerosis (MS).
Extavia er også blevet undersøgt hos 1.657 patienter i to studier af sekundær progressiv multipel sklerose, som var i stand til at gå, hvor det blev sammenlignet med placebo. 
Extavia has also been studied in 1,657 patients in two studies involving secondary progressive MS patients who were able to walk, where it was compared with placebo.
Extavia fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af multipel sklerose. 
Extavia can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Den fuldstændige liste over bivirkninger og begrænsninger ved Extavia fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Extavia, see the package leaflet.
Det aktive stof i Extavia er proteinet interferon beta-1b, der tilhører en gruppe interferoner, som dannes naturligt i kroppen for at hjælpe den med at bekæmpe bl.a. virusser. 
The active substance in Extavia is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Det vides endnu ikke præcist, hvordan Extavia virker ved multipel sklerose, men det aktive stof, interferon beta-1b, synes at berolige immunsystemet og forebygger tilbagefald af multipel sklerose. 
The exact way that Extavia works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Extavia blev undersøgt over en to-årig periode hos 338 patienter med recidiverende-remitterende multipel sklerose, der var i stand til at gå uden hjælp, og dets virkning blev sammenlignet med placebo (ikke-aktivt stof). 
Extavia was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Hvilke fordele viser studierne, at der er ved Extavia? 
What benefits of Extavia have been shown in studies?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Extavia. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Extavia have been included in the summary of product characteristics and the package leaflet.
Før anvendelse af Extavia skal lægen udelukke andre årsager til symptomerne 
It is used when the patient is considered to be at high risk of developing MS. Before using Extavia, doctors need to exclude other causes for the symptoms;
Hvordan anvendes Extavia? 
How is Extavia used?
Hvordan virker Extavia? 
How does Extavia work?
I et studie af 487 patienter med et enkelt tilfælde af demyelinisering blev det påvist, at behandling med Extavia i to år reducerede risikoen for udvikling af klinisk definitiv multipel sklerose. 
In a study involving 487 patients with a single demyelinating event, treatment with Extavia for two years was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Extavia developed MS, compared with 45% of those who received placebo.
Extavia indeholder det aktive stof interferon beta-1b. Lægemidlet er identisk med Betaferon, som allerede er godkendt i EU. 
Extavia contains the active substance interferon beta-1b.
Da virksomheden havde fremlagt de ønskede yderligere oplysninger, som man havde anmodet om, blev de "særlige omstændigheder" ophævet 22. marts 2017. 
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 March 2017