FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg or 10 ml of COZAAR suspension).
Danish: Den anbefalede startdosis er 0,7 mg losartan/kg én gang dagligt til patienter, der vejer 20 - 50 kg (op til 25 mg eller 10 ml Cozaar suspension).
English: Losartan may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Danish: Losartan kan administreres sammen med andre antihypertensiva (f.eks. diuretika, calciumkanalblokkere, alfa- eller betablokkere samt centralt virkende lægemidler) såvel som med insulin og andre almindeligt anvendte hypoglykæmiske lægemidler (f.eks. sulfonylurinstoffer, glitazoner og glucosidasehæmmere).
English: Use in children and adolescents (6 to 16 years old)
Danish: Anvendelse til børn og unge i alderen 6-16 år
English: The sachet should not be rinsed.
Danish: Brevet bør ikke skylles.
English: The sachet should NOT be rinsed.
Danish: Brevet bør IKKE skylles.
English: Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Danish: Losartan kan gives sammen med anden blodtrykssænkende medicin (f.eks. diuretika, kalciumkanalblokkere, alfa- eller beta-blokkere og centralt virkende lægemidler) og også sammen med insulin og anden medicin, som bruges til at nedsætte blodglucosen (f.eks. sulfonylurinstoffer, glitazoner og glucosidasehæmmere).
English: No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
Danish: Patienter med nyreinsufficiens og patienter i hæmodialyse Initial dosisjustering er ikke nødvendig hos patienter med nyreinsufficiens og patienter i hæmodialyse.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 500 mg losartan potassium
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Indeholder 500 mg losartankalium ANDET
English: Taking with food and drink COZAAR may be taken with or without food.
Danish: Brug af Cozaar sammen med mad og drikke De kan tage Cozaar i forbindelse med et måltid, men det er ikke nødvendigt.
English: One bottle of reconstituted suspension (200 ml) contains 500 mg of losartan potassium.
Danish: En flaske med rekonstitueret suspension (200 ml) indeholder 500 mg losartankalium.
English: With the syringe, adapter, and bottle attached, turn the entire assembly upside down.
Danish: Efter at sprøjte, tilpasningsstykke og flaske er samlet, vendes hele anordningen på hovedet.
English: Renal clearance of losartan and its active metabolite is about 74 ml/min and 26 ml/min, respectively.
Danish: Losartans og dets aktive metabolits plasmaclearance er henholdsvis ca. 600 ml/min og 50 ml/ min. Losartans og dets aktive metabolits renalclearance er henholdsvis ca. 74 ml/min og 26 ml/min.
English: Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Danish: Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Bruxelles, Belgien
English: affects 1 to 10 users in 1000
Danish: Forekommer hos 1 ud af 10.000 til 1 ud af 1.000 patienter
English: United Kingdom Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Danish: Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
English: • a 240 ml amber polyethylene terephthalate (PET) bottle with polypropylene child resistant closure for mixing the suspension,
Danish: • En 240 ml brun PET-flaske med børnesikret lukning til opblanding af suspensionen.
English: COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension [See Annex I - To be completed nationally]
Danish: Cozaar og tilhørende navne (Se bilag I) 2,5 mg/ml pulver og solvens til oral suspension [Se bilag 1 - Udfyldes nationalt]
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Danish: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
English: 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).
Danish: 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).
English: 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:
Danish: 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.
English: Each sachet contains 500 mg of losartan potassium powder.
Danish: Hvert brev indeholder 500 mg losartankaliumpulver.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET POWDER LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: HOW TO TAKE COZAAR
Danish: SÅDAN SKAL DE TAGE COZAAR
English: Insert the dispenser into the adapter on the medication bottle until a tight seal is made between the bottle and the adapter.
Danish: Sæt sprøjten i flaskens tilpasningsstykke, indtil sprøjten og tilpasningsstykket slutter helt tæt.
English: affects less than 1 user in 10000
Danish: Forekommer hos færre end 1 ud af 10.000 patienter
English: For reconstitution see section 6.6.
Danish: For rekonstitution se pkt.
English: Each sachet of powder for oral suspension delivers 500 mg of losartan potassium.
Danish: Hvert brev med pulver til oral suspension giver 500 mg losartan (som kaliumsalt).
English: Place the screw cap on the bottle and shake the contents well to disperse.
Danish: Sæt skruelåget på flasken og ryst indholdet omhyggeligt for at opløse pulveret.
English: It is important to tell your doctor before taking COZAAR:
Danish: Vær ekstra forsigtig med at tage Cozaar Tal med lægen, inden De tager Cozaar:
English: Remove the syringe and take the medicine.
Danish: Fjern sprøjten fra tilpasningsstykket og indtag medicinen.
English: Replace the original cap onto the bottle.
Danish: Sæt den originale hætte tilbage på flasken.
English: Remove the screw cap, place the push-in bottle neck adaptor on the bottle, and re-cap the bottle.
Danish: Fjern skruelåget og placer push-in tilpasningsstykket på flaskens hals.
English: Place the cap on the bottle and shake the contents well to disperse.
Danish: Sæt hætten på flasken og ryst indholdet omhyggeligt for at opløse pulveret.
English: 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.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: 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.
Danish: Tilsæt omhyggeligt alt indholdet i brevet til PET-flasken med solvensen.
English: Losartan is not recommended in children with glomerular filtration rate < 30 ml/ min/1.73 m2as no data are available (see section 4.2).
Danish: 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.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaveren af markedsføringstilladelsen Fremstiller
English: 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).
Danish: Den anbefalede startdosis er 0,7 mg/kg én gang dagligt til patienter >20 til <50 kg (op til 25 mg totalt).
English: Nervous system disorders: Common: dizziness, vertigo
Danish: Almindelig: Svimmelhed, vertigo.
English: 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.
Danish: Målet med undersøgelsen var at vise losartankaliums nyrebeskyttende virkning ud over dets gavnlige indvirkning på blodtrykket.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml suspension contains 2.5 mg of losartan potassium.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml suspension indeholder 2,5 mg losartankalium.
English: After reconstitution, each ml suspension contains 2.5 mg of losartan potassium.
Danish: Efter rekonstitution indeholder hver ml suspension 2,5 mg losartankalium.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD month YYYY}> [To be completed nationally]
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Luxembourg Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Danish: Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Brussels, Belgien
English: Muscoskeletal and connective tissue disorders: not known: myalgia, arthralgia
Danish: Knogler, led, muskler og bindevæv Ikke kendt: Myalgi, artralgi.
English: • 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
Danish: 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.
English: Store the prepared suspension in a refrigerator at 2-8°C.
Danish: Klargjort suspension: Opbevares i køleskab (2°C - 8°C).
English: Remove the cap, place the push-in bottle neck adaptor on the bottle, and re-cap the bottle.
Danish: Fjern hætten og placer push-in tilpasningsstykket på flaskens hals.
English: • One foil sachet filled with powder equal to 500 mg losartan potassium
Danish: • Et foliebrev med pulver svarende til 500 mg losartankalium
English: • One foil sachet filled with 500 mg losartan potassium powder
Danish: • Et foliebrev med 500 mg losartankaliumpulver
English: • to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6 - 16 years of age.
Danish: • at behandle voksne samt børn og unge i alderen 6-16 år med forhøjet blodtryk (hypertension);
English: Oral use
Danish: Oral anvendelse N/A
English: Filmcoated tablet Oral use
Danish: Filmovertrukken tablet Oral anvendelse N/A
English: 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.
Danish: 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.
English: Cozaar 12,5 mg + 50 mg filmdragerade tabletter
Danish: Cozaar 12,5 mg + 50 mg filmdragerade tabletter mg
English: Belgium Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Danish: Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Bruxelles, Belgien
English: Gastrointestinal disorders: not known: diarrhoea
Danish: Mave-tarm-kanalen Ikke kendt: Diarré.
English: General disorders and administration site conditions: Uncommon: asthenia, fatigue, oedema
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Asteni, træthed, ødemer
English: After suspension in solvent, COZAAR is an offwhite liquid.
Danish: Cozaar er en råhvid væske efter suspension i solvensen.
English: BEFORE YOU TAKE COZAAR
Danish: Tag ikke Cozaar
English: Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Danish: Ikke almindelig: Diarré, kvalme, opkastning.
English: 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.
Danish: Sjælden: Hypersensitivitet: Anafylaktiske reaktioner, angioødem inklusive hævelse af larynx og glottis, som medfører luftvejsobstruktion og/eller hævelse af ansigt, læber, svælg og/eller tunge.
English: Methylhydroxybenzoate and propylhydroxybenzoate.
Danish: Methylhydroxybenzoat (E218)
English: COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium
Danish: Cozaar og tilhørende navne (se bilag I) 2,5 mg/ml pulver og solvens til oral suspension losartankalium
English: One ml of suspension contains 2.5 mg of losartan potassium.
Danish: En ml opløsning indeholder 2,5 mg losartankalium.
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Danish: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, Holland
English: One ml solvent contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, and 50.6 mg sorbitol.
Danish: 1 ml solvens indeholder 0,296 mg methylhydroxybenzoat; 0,041 mg propylhydroxybenzoat og 50,6 mg sorbitol.
English: If you take more COZAAR than you should
Danish: Hvis De har taget for meget Cozaar
English: • Lactation (see section 4.6).
Danish: • Amning (se pkt.
English: Film-coated tablets
Danish: Filmtabletten
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem P.O.
Danish: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, P.O. Box 581, 2003 PC Haarlem, Holland
English: LORTAAN IC 12,5 mg Film-coated tabletOral use
Danish: LORTAAN IC 12,5 mg Filmovertrukken tablet Oral anvendelse N/A
English: LOORTAN 12,50 mg12,5mg Film-coated tabletOral use
Danish: LOORTAN 12,50 mg12,5mg Filmovertrukken tablet Oral anvendelse N/A
English: MARKETING AUTHORISATION HOLDER
Danish: Medlemsstat Indehaver af markedsføringstilladelse
English: Store in the original container.
Danish: Opbevar Cozaar i den originale yderpakning.
English: Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, The Netherlands
Danish: Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, Holland
English: Each ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol, and 1.275 mg lactose.
Danish: Hver ml suspension indeholder 0,296 mg methylhydroxybenzoat; 0,041 mg propylhydroxybenzoat; 50,6 mg sorbitol og 1,275 mg lactose.
English: Cozaar 12,5 mg Inicio 12,5 mg Film-coated tabletOral use
Danish: Cozaar 12,5 mg Inicio 12,5 mg Filmovertrukken tablet Oral anvendelse N/A
English: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon,
Danish: Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien
English: These measures will help to protect the environment.
Danish: De skal derfor være opmærksom på, hvordan medicinen påvirker Dem.
English: affects more than 1 user in 10
Danish: Meget almindelig: Forekommer hos flere end 1 ud af 10 patienter Almindelig:
English: 12,5 mg film-coated tablet oral use
Danish: 12,5 mg Tabletter filmovertrukne Oral anvendelse N/A
English: OTHER
Danish: Lot
English: Losartan is not recommended in children with hepatic impairment (see section 4.2).
Danish: - Losartan bør ikke gives til børn med leverinsufficiens (se ogå pkt.
English: -Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
Danish: 4.2, 4.3 Losartan bør heller ikke gives til børn med leverinsufficiens (se pkt.
English: 100 mg Filmcoated tablet Oral use
Danish: 100 mg Tabletter filmovertrukne Oral anvendelse N/A
English: Replace the screw cap onto the bottle.
Danish: Sæt det originale skruelåg tilbage på flasken.
English: The following adverse events have been reported in post-marketing experience: Blood and lymphatic system disorders:
Danish: Efter markedsføring Følgende bivirkninger er blevet rapporteret efter markedsføring:
English: Therefore losartan must not be administered in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Danish: Derfor bør losartan ikke gives til patienter med svær leverinsufficiens (se pkt.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for destruktion
English: One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol and 1.275 mg lactose.
Danish: LISTE OVER HJÆLPESTOFFER 1 ml suspension indeholder 0,296 mg methylhydroxybenzoat; 0,041 mg propylhydroxybenzoat; 50,6 mg sorbitol og 1,275 mg lactose.
English: LOORTAN 100 mg 100 mg Film-coated tabletOral use
Danish: LOORTAN 100 mg 100 mg Filmovertrukken tablet Oral anvendelse N/A
English: 50 mg film-coated tablet oral use
Danish: 50 mg Tabletter filmovertrukne Oral anvendelse N/A
English: Cozaar 12,5 mg 12,5mg Film-coated tabletOral use
Danish: Cozaar 12,5 mg 12,5mg Filmovertrukken tablet Oral anvendelse N/A
English: COZAAR 12,5 mg 12,5 mg Film-coated tabletOral use
Danish: COZAAR 12,5 mg 12,5 mg Filmovertrukken tablet Oral anvendelse N/A
English: 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)
Danish: 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.
English: RP*>-1 (Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep)
Danish: RP*≥ 1 (*Relativ Potens genom att en muspotenstest jämfördes med ett referensvaccin, som visat effekt till får)
English: Type I glass vials with chlorobutyl stopper and aluminium seal
Danish: Subkutan Type I hætteglas af glas med butylprop og aluminiumsh ætte
English: Pharma ceutical Form
Danish: Særnavn Styrke Lægemiddel form
English: Strength
Danish: Indgivelse svej
English: Extavia received a marketing authorisation valid throughout the EU on 20 May 2008.
Danish: Extavia fik en markedsføringstilladelse med gyldighed i hele EU den 20. maj 2008.
English: Further information on Extavia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/extavia.
Danish: Yderligere information om Extavia findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/extavia.
English: Extavia is used in patients:
Danish: Extavia anvendes hos patienter:
English: Other information about Extavia
Danish: Andre oplysninger om Extavia
English: In the second study, no delay in the time to disability progression was seen.
Danish: I det andet studie sås der ingen forsinkelse i tiden til progression af invaliditet.
English: As for all medicines, data on the use of Extavia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Extavia løbende overvåget.
English: What is Extavia and what is it used for?
Danish: Hvad er Extavia, og hvad anvendes det til?
English: It is given by injection under the skin.
Danish: Extavia gives ved indsprøjtning under huden.
English: The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Danish: Den virksomhed, der fremstiller Betaferon, er indforstået med, at dens videnskabelige data anvendes i forbindelse med Extavia.
English: What measures are being taken to ensure the safe and effective use of Extavia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Extavia?
English: Why is Extavia authorised in the EU?
Danish: Hvorfor er Extavia godkendt i EU?
English: The patients can inject Extavia themselves once they have been trained.
Danish: Patienterne kan godt selv indsprøjte Extavia, når de er blevet instrueret i det.
English: An overview of Extavia and why it is authorised in the EU
Danish: En oversigt over Extavia, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Extavia's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Extavia opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: • 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).
Danish: • 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).
English: Side effects reported with Extavia are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Extavia vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Extavia treatment should be stopped in patients whose condition does not improve.
Danish: Behandling med Extavia bør ophøre hos patienter, hvis tilstand ikke bliver bedre.
English: 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%).
Danish: 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 %).
English: For more information about using Extavia, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Extavia, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Extavia must not be used in patients who have severe depression or have thoughts of suicide.
Danish: Extavia må ikke anvendes hos patienter, der har alvorlig depression eller selvmordstanker.
English: Extavia is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Danish: Extavia fås som pulver og solvens, der blandes til en opløsning, som giver en dosis på 250 mikrogram.
English: • 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;
Danish: • 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
English: Extavia must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Danish: Extavia må ikke anvendes hos patienter, der har dekompenseret leversygdom (når leveren er beskadiget og ikke længere fungerer normalt).
English: What are the risks associated with Extavia?
Danish: Hvilke risici er der forbundet med Extavia?