FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ambrisentan Mylan er af sammenlignelig kvalitet og er bioækvivalent med Volibris.
English: This means that Ambrisentan Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Volibris.
Danish: Det betyder, at Ambrisentan Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Volibris.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Volibris, og de behøver ikke at blive gentaget for Ambrisentan Mylan.
English: Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient.
Danish: Behandlingen indledes med en dosis på 5 mg én gang dagligt, og lægen kan øge dosis til 10 mg dagligt afhængigt af responsen og eventuelle bivirkninger.
English: When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.
Danish: Når Ambrisentan Mylan tages sammen med ciclosporin (et lægemiddel, der dæmper aktiviteten i immunsystemet), bør dosis være 5 mg dagligt, og patienten bør overvåges nøje af sin læge.
English: Ambrisentan Mylan is used in patients with class II or III disease.
Danish: Ambrisentan Mylan anvendes til patienter med sygdom i funktionsklasse II eller III.
English: Other information about Ambrisentan Mylan
Danish: Andre oplysninger om Ambrisentan Mylan
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Danish: PAH er unormalt højt blodtryk i lungearterierne.
English: As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.
Danish: følge heraf reduceres mængden af ilt, som kan komme ind i blodet i lungerne, hvilket vanskeliggør fysisk aktivitet.
English: What measures are being taken to ensure the safe and effective use of Ambrisentan Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ambrisentan Mylan?
English: An overview of Ambrisentan Mylan and why it is authorised in the EU
Danish: En oversigt over Ambrisentan Mylan og hvorfor det er godkendt i EU
English: Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Ambrisentan Mylan vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The dose is increased to 10 mg daily when the medicine is used with tadalafil (another medicine for PAH).
Danish: Dosis sættes op til 10 mg, når lægemidlet anvendes sammen med tadalafil (et andet lægemiddel til behandling af PAH).
English: Ambrisentan Mylan is effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Danish: Ambrisentan Mylan er effektivt til PAH uden nogen identificeret årsag og til PAH forårsaget af bindevævssygdom.
English: For more information about using Ambrisentan Mylan, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Ambrisentan Mylan, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: What are the benefits and risks of Ambrisentan Mylan?
Danish: Hvilke fordele og risici er der forbundet med Ambrisentan Mylan?
English: Ambrisentan Mylan can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.
Danish: Ambrisentan Mylan fås kun på recept, og behandlingen skal indledes af en læge med erfaring i behandling af PAH.
English: Ambrisentan Mylan contains the active substance ambrisentan and is a ‘generic medicine'.
Danish: Ambrisentan Mylan indeholder det aktive stof ambrisentan og er et "generisk lægemiddel".
English: The active substance in Ambrisentan Mylan, ambrisentan, blocks the receptors (targets) for a hormone called endothelin, which causes blood vessels to become narrow.
Danish: Det aktive stof i Ambrisentan Mylan, ambrisentan, blokerer receptorerne for et hormon kaldet endothelin, som får blodkarrene til at forsnævres.
English: What is Ambrisentan Mylan and what is it used for?
Danish: Hvad er Ambrisentan Mylan, og hvad anvendes det til?
English: By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.
Danish: Ved at blokere virkningen af endothelin forhindrer Ambrisentan Mylan, at karrene bliver forsnævrede, hvorved blodtrykket sænkes, og symptomerne forbedres.
English: Why is Ambrisentan Mylan authorised in the EU?
Danish: Hvorfor er Ambrisentan Mylan godkendt i EU?
English: Therefore, the Agency's view was that, as for Volibris, the benefit of Ambrisentan Mylan outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Ambrisentan Mylan opvejer de identificerede risici som for Volibris, og at det kan godkendes til anvendelse i EU.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Danish: PAH er en invaliderende sygdom med svær forsnævring af blodkarrene i lungerne.
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the
Danish: Det giver forhøjet blodtryk i de kar, der fører blodet fra hjertet til lungerne, og reducerer blodtilførslen til lungerne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.
Danish: 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 Ambrisentan Mylan.
English: How has Ambrisentan Mylan been studied?
Danish: Hvordan er Ambrisentan Mylan blevet undersøgt?
English: How is Ambrisentan Mylan used?
Danish: Hvordan anvendes Ambrisentan Mylan?
English: How does Ambrisentan Mylan work?
Danish: Hvordan virker Ambrisentan Mylan?
English: 11 October 2019
Danish: 11. oktober 2019
English: The European Commission issued a decision on 11 October 2019.
Danish: Europa-Kommissionen traf en beslutning den 11. oktober 2019.
English: What is paromomycin?
Danish: Hvad er paromomycin?
English: These included data from companies and published literature.
Danish: Dette omfattede data fra virksomheder og offentliggjort litteratur.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/129)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/129)
English: The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der mindst skal gå, før et dyr, der er behandlet med et lægemiddel, kan slagtes, og dets kød eller andre animalske produkter kan anvendes til menneskelig konsum.
English: Why were veterinary medicines containing paromomycin reviewed?
Danish: Hvorfor blev veterinærlægemidler, der indeholder paromomycin, vurderet igen?
English: The Belgian authority noted that there were different approved uses, dose schedules and withdrawal periods across the EU.
Danish: Den belgiske myndighed bemærkede, at der var forskellige godkendte anvendelser, doseringsplaner og tilbageholdelsestider i EU.
English: Therefore, the CVMP recommended suspending the marketing authorisations for these veterinary medicines until adequate data are available.
Danish: CVMP anbefalede derfor, at markedsføringstilladelserne for disse veterinærlægemidler suspenderes, indtil der foreligger tilstrækkelige data.
English: The Committee also noted the possibility that inappropriate doses could lead to bacterial resistance.
Danish: Udvalget bemærkede også muligheden for, at uhensigtsmæssige doser kan føre til bakterieresistens.
English: The CVMP reviewed available data on effectiveness and residue depletion.
Danish: CVMP gennemgik de tilgængelige data om effektivitet og restkoncentrationsnedbrydning.
English: Paromomycin is an aminoglycoside antibiotic used to treat a wide range of bacterial infections and is given to pigs by injection into a muscle.
Danish: Paromomycin er et aminoglycosid-antibiotikum, der anvendes til at behandle en lang række bakterieinfektioner, og som gives til svin ved injektion i en muskel.
English: Questions and answers on suspension of marketing authorisations for injectable veterinary medicines containing paromomycin given to pigs
Danish: Spørgsmål og svar om suspendering af markedsføringstilladelser for injicerbare veterinærlægemidler, der indeholder paromomycin og gives til svin
English: On 25 September 2018, the Belgian medicines authority requested that the CVMP review all available data on paromomycin's effectiveness and residue depletion (how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body).
Danish: Den 25. september 2018 anmodede den belgiske lægemiddelmyndighed om, at CVMP gennemgik alle tilgængelige data om paromomycins effektivitet og restkoncentrationsnedbrydning (hvor lang tid det tager, før et lægemiddel er nået ned under maksimalgrænseværdierne for restkoncentrationer i dyrets krop).
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines do not outweigh their risks because of inadequate data supporting their use in pigs and the possibility of bacterial resistance.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved disse lægemidler ikke opvejer risiciene på grund af utilstrækkelige data til støtte for deres anvendelse hos svin og muligheden for bakterieresistens.
English: On 18 July 2019, the European Medicines Agency recommended suspending the marketing authorisations for paromomycin antibiotics given to pigs by injection into a muscle.
Danish: Den 18. juli 2019 anbefalede Det Europæiske Lægemiddelagentur at suspendere markedsføringstilladelserne for paromomycin-antibiotika, der gives til svin ved injektion i en muskel.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of veterinary medicines containing paromomycin given to pigs by injection into the muscle do not outweigh their risks.
Danish: På grundlag af en evaluering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CVMP, at fordelene ved veterinærlægemidler, der indeholder paromomycin, som gives til svin ved injektion i en muskel, ikke opvejer risiciene.
English: The Committee based its opinion on the lack of adequate data on how effective these medicines are and residue depletion data.
Danish: Udvalget baserede sin udtalelse på, at der ikke forelå tilstrækkelige data om, hvor effektive disse lægemidler er, og data om restkoncentrationsnedbrydning.
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: 1045 Budapest, Hungary
Danish: 1045 Budapest, Ungarn
English: 176 74 KalitheaAthens
Danish: 176 74 Kalithea
English: GR-Greece
Danish: GR- Grækenland
English: 65926 Frankfurt am Main, Deutschland
Danish: 65926 Frankfurt am Main, Tyskland
English: Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 - Nicosia, Cyprus
Danish: Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 - Nicosia, Cypern
English: UAB “SANOFIAVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania
Danish: UAB “SANOFIAVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Litauen
English: Estonia sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonia
Danish: Estland sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estland
English: Ireland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland
Danish: Irland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Irland
English: Greece sanofi-aventis AEBE 348 Syngrou avenueBuilding A
Danish: Grækenland sanofi-aventis AEBE 348 Syngrou avenueBuilding A
English: Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris FRANCE
Danish: Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris Frankrig
English: Hungary sanofi-aventis Zrt.
Danish: Ungarn sanofi-aventis Zrt.
English: Netherlands sanofi-aventis Netherlands B.V., Kampenringweg 45 DE, 2803 PE Gouda, The Netherlands
Danish: Holland sanofi-aventis Netherlands B.V., Kampenringweg 45 DE, 2803 PE Gouda, Holland
English: Italy sanofi-aventis S.p.A. Viale Luigi Bodio 37/B 20158 Milan Italy
Danish: Viale Luigi Bodio 37/B 20158 Milan Italien
English: Belgium Sanofi-aventis Belgium
Danish: Sanofi-aventis Belgium
English: Sanofi-Avenstis Bulgaria EOOD, Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8
Danish: Bulgarien, 1303 Sofia, 103 Alexander
English: Tavanic 250 250 mg Film-coated tablets
Danish: Tavanic 250 250 mg Tablet, filmovertrukket
English: Tavanic 500mg 500 mg Film-coated tablets
Danish: Tavanic 500mg 500 mg Tablet, filmovertrukket
English: Tavanic 500 500 mg Film-coated tablets
Danish: Tavanic 500 500 mg Tablet, filmovertrukket
English: This summary was last updated in 02-2016.
Danish: Dette sammendrag blev sidst ajourført i MM-2016.
English: Other information about Zurampic
Danish: Andre oplysninger om Zurampic
English: This is a summary of the European public assessment report (EPAR) for Zurampic.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zurampic.
English: What is Zurampic and what is it used for?
Danish: Hvad er Zurampic, og hvad anvendes det til?
English: The full EPAR and risk management plan summary for Zurampic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Zurampic findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Risks such as kidney damage or heart problems are addressed in the product information.
Danish: Risici såsom nyreskade eller hjerteproblemer er omhandlet i produktinformationen.
English: A risk management plan has been developed to ensure that Zurampic is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zurampic anvendes så sikkert som muligt.
English: Patients should drink plenty of fluids throughout the day.
Danish: Patienten bør drikke rigeligt med væske dagen igennem.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zurampic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Humanmedicinske lægemidler (CHMP) konkluderede, at fordelene ved Zurampic opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Zurampic was studied in two main studies involving over 1,200 adults with gout who were previously treated with allopurinol.
Danish: Zurampic er undersøgt i to hovedundersøgelser med over 1 200 voksne med podagra, som forinden var behandlet med allopurinol.
English: This is because these disorders have occurred during treatment with Zurampic.
Danish: Dette begrundes med, at disse sygdomme har optrådt under behandling med Zurampic.
English: What measures are being taken to ensure the safe and effective use of Zurampic?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zurampic?
English: Why is Zurampic approved?
Danish: Hvorfor blev Zurampic godkendt?
English: It is not intended to provide practical advice on how to use Zurampic.
Danish: Det er ikke en praktisk vejledning i, hvordan Zurampic bør anvendes.
English: Patients with very poor kidney function or who have had a kidney transplant must also not take Zurampic.
Danish: Patienter, der har meget dårlig nyrefunktion eller har fået foretaget en nyretransplantation, må heller ikke få Zurampic.
English: Zurampic is available as 200-mg tablets.
Danish: Zurampic fås som tabletter på 200 mg.
English: Zurampic contains the active substance lesinurad.
Danish: Zurampic indeholder det aktive stof lesinurad.
English: Patients were first treated with febuxostat alone for three weeks and then with febuxostat plus either Zurampic or placebo.
Danish: Patienterne fik først febuxostat alene i tre uger og derefter febuxostat plus enten Zurampic eller placebo.
English: It does this by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Danish: Det sker ved at blokere proteinet "urinsyretransporter-1" (URAT1) i nyrerne.
English: The company that markets Zurampic will carry out a study on the risk of heart, circulation or kidney disorders in patients treated with Zurampic, particularly in those who have previously suffered from such disorders.
Danish: Den virksomhed, der markedsfører Zurampic, skal udføre en undersøgelse af risikoen for hjerte-, kredsløbs- og nyresygdomme hos de patienter, der er behandlet med Zurampic, navnlig hos dem, der tidligere har haft sådanne sygdomme.
English: What are the risks associated with Zurampic?
Danish: Hvilke risici er der forbundet med Zurampic?
English: URAT1 normally allows some uric acid to return to the blood after the kidneys have filtered it out.
Danish: URAT1 giver sædvanligvis mulighed for, at en vis mængde urinsyre returnerer til blodet, efter at nyrerne har filtreret den ud.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zurampic, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zurampic, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Looking just at patients whose blood uric acid level did not fall sufficiently on treatment with febuxostat alone, the level dropped to less than 50 mg/litre in 44% (26 of 59) patients taking Zurampic compared to 24% (12 of 51) patients taking placebo.
Danish: Hvis man kun ser på de patienter, hvis indhold i blodet af urinsyre ikke faldt tilstrækkeligt ved behandling med febuxostat alene, kom koncentrationen under 50 mg/l hos 44 % (26 af 59) af de patienter, der fik Zurampic, sammenholdt med 24 % (12 af 51) af dem, der fik placebo.
English: The patient's kidney function will be monitored regularly during treatment with Zurampic and the doctor will advise the patient to take sufficient fluid during the day and always take Zurampic with either allopurinol or febuxostat, which helps to prevent kidney damage from Zurampic.
Danish: Patientens nyrefunktion skal overvåges regelmæssigt under behandling med Zurampic, og lægen skal instruere patienten i at indtage tilstrækkelig væske i løbet af dagen og altid tage Zurampic sammen med enten allopurinol eller febuxostat, hvilket er med til at forhindre nyreskade forårsaget af Zurampic.
English: Overall, Zurampic 200 mg once daily was effective in 57% (60 of 106) patients.
Danish: I alt var Zurampic, 200 mg én gang dagligt, effektivt hos 57 % (60 af 106) af patienterne.
English: This compared with 26% (104 of 407) in patients who took placebo in addition to allopurinol.
Danish: Dette skal sammenholdes med 26 % (104 af 407) hos patienter, der fik placebo som tillægsbehandling til allopurinol.
English: If treatment with the xanthine oxidase inhibitor is interrupted, then treatment with Zurampic must also be interrupted at the same time.
Danish: Hvis behandlingen med xanthinoxidasehæmmeren afbrydes, skal behandlingen med Zurampic også afbrydes samtidigt.
English: This compared with 47% (51 of 109) patients given placebo.
Danish: Dette skal sammenholdes med 47 % (51 af 109) af dem, der fik placebo.
English: Adding Zurampic 200 mg once daily was effective in 55% (222 of 405) patients.
Danish: Tillægsbehandling med Zurampic, 200 mg én gang dagligt, var effektiv hos 55 % (222 af 405) af patienterne.
English: These studies compared the effect of adding Zurampic or placebo (a dummy treatment) to patients' allopurinol treatment.
Danish: I undersøgelserne sammenlignedes virkningen af at anvende enten Zurampic eller virkningsløs behandling (placebo) som tillægsbehandling til patienternes behandling med allopurinol.
English: Their blood level of uric acid was not sufficiently controlled with allopurinol alone and was above 60 mg/litre at the start of the study.
Danish: Deres urinsyreindhold i blodet var ikke tilfredsstillende kontrolleret med allopurinol alene og var over 60 mg/l ved begyndelsen af undersøgelsen.
English: A third main study involved 324 adults who had at least one measurable tophus (large deposit of uric acid in or around a joint or under the skin) and with high blood levels of uric acid (over 80 mg/litre without gout medicines or above 60 mg/litre despite treatment with allopurinol or febuxostat).
Danish: I en tredje hovedundersøgelse deltog 324 voksne, som havde mindst én målelig stor knude (tophus) som følge af urinsyreophobning i eller omkring et led eller under huden, og som havde højt indhold af urinsyre i blodet (over 80 mg/l uden podagramedicin, eller over 60 mg/l trods behandling med allopurinol eller febuxostat).
English: For more information about treatment with Zurampic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zurampic, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The recommended dose is 200 mg once daily, taken in the morning at the same time as a xanthine oxidase inhibitor medicine such as allopurinol or febuxostat.
Danish: Den anbefalede dosis er 200 mg én gang dagligt, der tages om morgenen samtidig med et lægemiddel af typen xanthinoxidasehæmmer, f.eks. allopurinol eller febuxostat.
English: This prevents the build-up of uric acid in joints where it can cause pain, swelling and joint damage.
Danish: Dette forhindrer ophobningen af urinsyre i leddene, hvor det kan give smerter, hævelse og ledbeskadigelser.
English: Over time, visible deposits of uric acid disappeared in increasing number of patients continuing Zurampic and febuxostat treatment, and fewer patients had recurrence of gout attacks.
Danish: Med tiden forsvandt de synlige ophobninger af urinsyre hos flere og flere af de patienter, der fortsatte med Zurampic og febuxostat, og færre af dem fik igen anfald af podagra.
English: The most common side effects with Zurampic (which may affect up to 1 in 10 people) are flu, headache, heartburn and (gastro-oesophageal reflux disease) stomach acid coming back to the mouth, and blood tests showing increased blood creatinine levels (a marker of kidney function).
Danish: De hyppigste bivirkninger med Zurampic (forekommer hos op til 1 ud af 10 personer) er influenza, hovedpine, halsbrand, tilbageløb af mavesyre til munden (gastroøsofageal reflukssygdom) og øget indhold i blodet af kreatinin, der er en markør for nyrefunktionen.