FrancophonIA/ELRC3.0 huggingface dataset:
English: Fablyn has been shown to reduce fractures in the spine and elsewhere in the body, but not in the hip.
Danish: Det er påvist, at Fablyn reducerer forekomsten af frakturer i rygraden og andre steder i kroppen, men ikke i hoften.
English: Two doses of Fablyn (250 and 500 micrograms once a day) have been compared with placebo (a dummy treatment) in one main study involving almost 9,000 postmenopausal women with osteoporosis aged 60 to 80 years.
Danish: To doser af Fablyn (250 og 500 mikrogram en gang dagligt) er blevet sammenlignet med placebo (en virkningsløs behandling) i en hovedundersøgelse med deltagelse af næsten 9 000 kvinder med postmenopausal osteoporose i alderen 60 til 80 år.
English: Fablyn is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant, or women who are pregnant or breastfeeding.
Danish: Fablyn er kun beregnet til kvinder, der har været gennem overgangsalderen, og må derfor ikke anvendes til kvinder, som kan blive gravide eller til kvinder, som er gravide eller som ammer.
English: Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Fablyn is intended for long-term use.
Danish: Patienterne kan også få calcium- og vitamin D-tilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
English: Fablyn is a medicine that contains the active substance lasofoxifene.
Danish: Fablyn er et lægemiddel, der indeholder det aktive stof lasofoxifen.
English: It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Danish: Det må ikke anvendes til patienter, der har haft problemer med venøs tromboemboli, herunder dyb venetrombose (DVT), lungeemboli (blodprop i lungen) og retinal venetrombose (blodprop i den bageste del af øjet).
English: The active substance in Fablyn, lasofoxifene, is a selective oestrogen receptor modulator (SERM).
Danish: Det aktive stof i Fablyn, lasofoxifen, er en selektiv østrogen receptor modulator (SERM).
English: What measures are being taken to ensure the safe use of Fablyn?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Fablyn?
English: Lasofoxifene has the same effect as oestrogen in the bone.
Danish: Lasofoxifen har samme effekt som østrogen i knoglerne.
English: Fewer women taking the higher dose had a fracture outside the spine and there were greater increases in bone density.
Danish: Færre kvinder, som fik den høje dosis, fik brud uden for rygsøjlen, og der var større forøgelser af knogletætheden.
English: The programme will include information about the risk of venous thromboembolism, changes in the womb that may occur when taking the medicine, and the need to investigate unexplained bleeding from the womb.
Danish: Programmet skal omfatte oplysninger om risikoen for venøs tromboemboli, forandringer i livmoderen, som kan opstå ved brug af lægemidlet, og behovet for at undersøge uforklarlige blødninger fra livmoderen.
English: When deciding whether to prescribe Fablyn or other treatments, doctors should consider whether the patient has any symptoms of the menopause, and the possible effects of treatment on the womb, the breast, and the heart and blood vessels.
Danish: Inden lægen træffer beslutning om at ordinere Fablyn eller andre behandlinger, bør der tages hensyn til, om patienten har symptomer på overgangsalder, og hvilke virkninger behandlingen kan have på livmoderen, brystet, hjertet og blodkarrene.
English: Fablyn must not be used in people who are hypersensitive (allergic) to lasofoxifene or any of the other ingredients.
Danish: Fablyn må ikke anvendes til personer, som er overfølsomme (allergiske) over for lasofoxifen eller nogen af indholdsstofferne.
English: The most common side effect with Fablyn (seen in more than 1 patient in 10) is muscle cramps.
Danish: Den hyppigste bivirkning ved Fablyn (som optræder hos flere end 1 ud af 10 patienter) er muskelkramper.
English: Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who have been through the menopause).
Danish: Fablyn anvendes til behandling af osteoporose (en sygdom, der gør knoglerne skøre) hos postmenopausale kvinder (kvinder, der har været gennem overgangsalderen).
English: The main measure of effectiveness was the number of women who had a new fracture in the spine as seen on X-rays.
Danish: Virkningen blev hovedsagelig bedømt på antallet af kvinder, som fik et nyt brud på rygsøjlen, vurderet ud fra røntgenbilleder.
English: The company that makes Fablyn will make sure that an educational programme is available in all Member States for all healthcare workers who will prescribe Fablyn or order pelvic ultrasound scans for women taking the medicine.
Danish: Virksomheden, der fremstiller Fablyn, skal sørge for, at alle medlemsstater får stillet et oplysningsprogram til rådighed for det medicinske personale, der skal ordinere Fablyn eller henvise kvinder, som tager lægemidlet, til ultralydsskanning af underlivet.
English: What is the risk associated with Fablyn?
Danish: Hvilken risiko er der forbundet med Fablyn?
English: Lasofoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Danish: Lasofoxifen virker som en østrogenreceptor “agonist” (et stof, som stimulerer østrogenreceptoren) i visse former for kropsvæv.
English: For the full list of all side effects reported with Fablyn, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Fablyn fremgår af indlægssedlen.
English: Why has Fablyn been approved?
Danish: Hvorfor blev Fablyn godkendt?
English: Fablyn should be used with caution in women with severe liver or kidney problems.
Danish: Fablyn bør anvendes med forsigtighed til kvinder med svær lever- eller nyresygdom.
English: What is Fablyn?
Danish: Hvad er Fablyn?
English: What is Fablyn used for?
Danish: Hvad anvendes Fablyn til?
English: How has Fablyn been studied?
Danish: Hvordan blev Fablyn undersøgt?
English: How is Fablyn used?
Danish: Hvordan anvendes Fablyn?
English: What benefit has Fablyn shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fablyn?
English: How does Fablyn work?
Danish: Hvordan virker Fablyn?
English: SI-1000 Ljubljana SLOVENIA
Danish: SI-1000 Ljubljana SLOVENIEN
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: Granules for Suspension
Danish: Granulat til suspension
English: Middlesex UB6 0NN UNITED KINGDOM
Danish: Middlesex UB6 0NN STORBRITANNIEN
English: GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA
Danish: GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIEN
English: GlaxoSmithKline 100, route de Versailles78163 Marly-le-Roi Cedex FRANCE
Danish: Laboratoire GlaxoSmithKline 100, route de Versailles78163 Marly-le-Roi Cedex FRANKRIG
English: GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovak Republic
Danish: GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava Slovakiet
English: GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND
Danish: GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRLAND
English: A. Goštauto g. 40A, LT-01112 Vilnius, LITHUANIA
Danish: UAB „GlaxoSmithKline Lietuva“, A. Goštauto g. 40A, LT-01112 Vilnius, LITAUEN
English: GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001
Danish: GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 LETLAND
English: Nykaer 68, 2605
Danish: Kifissias 266,
English: 980 Great West Road Brentford, Middlesex, TW8 9GS
Danish: GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS STORBRITANNIEN
English: Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)
Danish: Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPANIEN
English: Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
Danish: Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPANIEN
English: Wellcome Farmacéutica, S.A. .- Parque Tecnológico de MadridC/Severo Ochoa, 2 28760 Tres Cantos (Madrid)
Danish: Wellcome Farmacéutica, S.A. .Parque Tecnológico de MadridC/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPANIEN
English: Allen Farmacéutica, S.A. Parque Tecnológico de Madrid
Danish: Allen Farmacéutica, S.A. Parque Tecnológico de Madrid C/ Severo Ochoa, 2
English: Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM
Danish: Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, STORBRITANNIEN
English: Granules for Oral Suspension in sachet
Danish: Granulat i breve til oral suspension
English: Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,
Danish: Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, STORBRITANNIEN
English: Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN
Danish: Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN STORBRITANNIEN
English: Zinnat 250 mg apvalkotās tabletes 250mg Film-coated Tablets
Danish: Zinnat 250 mg apvalkotās tabletes
English: Glaxo Wellcome House Berkeley avenue Greenford, Middlesex United Kingdom UB6 0NN
Danish: Glaxo Wellcome UK Limited Glaxo Wellcome House Berkeley avenue Greenford, Middlesex Storbritannien UB6 0NN
English: C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPAIN
Danish: 28760 Tres Cantos (Madrid)
English: GlaxoSmithKline Export Ltd
Danish: GlaxoSmithKline GmbH & Co.
English: GlaxoSmithKline, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)
Danish: Wellcome Farmacéutica, S.A. Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) SPANIEN
English: Zinnat 500 mg apvalkotās tabletes 500mg Film-coated Tablets
Danish: Zinnat 500 mg apvalkotās tabletes
English: However, there were insufficient data on their effectiveness.
Danish: Der var dog utilstrækkelige data om deres virkning.
English: London, 14 June 2010 Doc.
Danish: London, den 14. juni 2010 Dok.
English: Because of this, a number of Member States have carried out safety reviews of this combination, but these have led to different conclusions.
Danish: Derfor har en række medlemsstater foretaget sikkerhedsvurderinger af denne kombination, men de førte til forskellige konklusioner.
English: The Committee recommended that the withdrawals and suspensions should be gradual in line with national recommendations.
Danish: Udvalget anbefalede, at tilbagetrækningerne og suspenderingerne skete gradvist, i tråd med de nationale anbefalinger.
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Danish: 1 Artikel 31 i direktiv 2001/83/EF, med senere ændringer, indbringelse af interesse for Fællesskabet.
English: This means that the difference between the dose needed to treat the patient and the dose that could harm the patient is small.
Danish: Det betyder, at forskellen mellem den dosis, der er nødvendig for at behandle patienten, og den dosis, der kan være skadelig for patienten, er lille.
English: Medicines containing dextropropoxyphene on its own are authorised in 10 Member States (Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden) and medicines containing dextropropoxyphene combined with paracetamol (sometimes with caffeine) are authorised in six Member States (Belgium, Cyprus, France, Luxembourg, Malta and Portugal) as well as Norway.
Danish: Lægemidler, der indeholder dextropropoxyphen alene, er tilladt i 10 medlemsstater (Belgien, Danmark, Finland, Frankrig, Grækenland, Italien, Luxembourg, Nederlandene, Spanien og Sverige), og lægemidler, der indeholder dextropropoxyphen i kombination med paracetamol (og undertiden med koffein), er tilladt i seks medlemsstater (Belgien, Cypern, Frankrig, Luxembourg, Malta og Portugal) samt i Norge.
English: What happened during the re-examination?
Danish: Hvad skete der under revurderingen?
English: In the United Kingdom and Sweden, the marketing authorisations for these medicines were withdrawn from 2005.
Danish: I Det Forenede Kongerige og Sverige blev markedsføringstilladelserne for disse lægemidler trukket tilbage i 2005.
English: Proposed activities to reduce this risk, such as including further warnings or restrictions, or limiting the size of packs, were not considered to be adequate to protect public health.
Danish: De foreslåede foranstaltninger for at mindske denne risiko, f.eks. en medtagelse af yderligere advarsler eller begrænsninger, blev ikke betragtet som tilstrækkelige til at beskytte folkesundheden.
English: At the request of the marketing authorisation holders, the CHMP re-examined its opinion.
Danish: Efter anmodning fra indehaverne af markedsføringstilladelserne revurderede CHMP sin udtalelse.
English: The CHMP also considered the views received from patient organisations.
Danish: CHMP tog ligeledes højde for de udtalelser, det havde modtaget fra patientorganisationerne.
English: It will be the responsibility of each Member State to set the timeframe for this withdrawal and assess the need for other activities such as recommendations for prescribers and patients on safe and effective pain relief.
Danish: Det vil være de enkelte medlemsstaters ansvar at fastsætte tidsplanen for denne tilbagetrækning og vurdere nødvendigheden af andre foranstaltninger såsom anbefalinger til ordinerende læger og patienter om sikker og effektiv smertelindring.
English: To ensure prescribers have enough time to determine the most appropriate treatments for individual patients, the Committee recommended that the withdrawal of the medicines from the market be carried out gradually.
Danish: For at sikre, at de ordinerende læger har tid nok til at fastlægge den mest velegnede behandling til de enkelte patienter, anbefalede udvalget, at tilbagetrækningen af lægemidlerne fra markedet bliver foretaget gradvist.
English: Therefore, the Committee recommended that the marketing authorisations for these medicines be withdrawn across the EU.
Danish: Derfor anbefalede udvalget en tilbagetrækning af markedsføringstilladelserne for disse lægemidler i hele EU.
English: Quite often, the patients had taken medicines prescribed for someone else.
Danish: Tit havde patienterne taget medicin, der var ordineret til andre end dem selv.
English: Dextropropoxyphene is a painkiller that is used to treat short- and long-term (chronic) pain.
Danish: Dextropropoxyphen er et smertestillende middel, der anvendes til behandling af kort- og langvarige (kroniske) smerter.
English: In terms of safety, the major concern of the Committee was the ‘narrow therapeutic index' of dextropropoxyphene.
Danish: Med hensyn til sikkerheden var udvalgets største betænkelighed dextropropoxyphens "snævre terapeutiske indeks".
English: On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines.
Danish: Den 25. juni 2009 afsluttede Det Europæiske Lægemiddelagentur en vurdering af sikkerhed og virkning for lægemidler indeholdende dextropropoxyphen.
English: Patients may easily take too much dextropropoxyphene and risk a fatal overdose, as dextropropoxyphene can be rapidly fatal.
Danish: Patienterne kan nemt komme til at tage for meget dextropropoxyphen og risikere en dødelig overdosis, eftersom dextropropoxyphen hurtigt kan være dødeligt.
English: Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af markedsføringstilladelserne for lægemidler indeholdende dextropropoxyphen
English: It has been available as a prescription-only medicine for about 40 years, both on its own and in combination, as tablets, capsules, suppositories and solutions for injection.
Danish: Det har kunnet fås som receptpligtig medicin i ca. 40 år, både alene og som kombination, i form af tabletter, kapsler, suppositorier og injektionsvæske, opløsning.
English: What is dextropropoxyphene?
Danish: Hvad er dextropropoxyphen?
English: The Committee also reviewed data from published literature including analyses comparing the results of different studies (meta-analyses) in short-term pain relief.
Danish: Udvalget vurderede ligeledes data fra den offentliggjorte litteratur, herunder analyser, der sammenlignede resultaterne af forskellige undersøgelser (metaanalyser) af lindringen af kortvarige smerter.
English: There have been concerns for some years over the risk of death from overdose - both intentional and accidental - in patients taking medicines containing dextropropoxyphene and paracetamol.
Danish: Der har i nogle år været betænkeligheder med hensyn til risikoen for at dø af en overdosis - både forsætligt og uforsætligt - hos patienter, som tager lægemidler, der indeholder dextropropoxyphen og paracetamol.
English: The review was carried out under an ‘Article 31' referral1.
Danish: Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 311.
English: Why was dextropropoxyphene reviewed?
Danish: Hvorfor blev dextropropoxyphen vurderet?
English: In November 2007, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of combination products containing dextropropoxyphene and paracetamol and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Danish: I november 2007 bad Kommissionen CHMP om at foretage en fuldstændig vurdering af benefit/riskforholdet for kombinationslægemidler, der indeholder dextropropoxyphen og paracetamol, og om at afgive udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør fastholdes, ændres, suspenderes eller trækkes tilbage i hele EU.
English: The Committee acknowledged that it is important that patients continue to receive adequate pain relief, and that it is necessary to allow for those who currently take dextropropoxyphene-containing medicines to be transferred to alternative treatments.
Danish: Udvalget anerkendte vigtigheden af, at patienter fortsat kan få tilstrækkelig smertelindring, og at det er nødvendigt at give mulighed for, at de patienter, der i øjeblikket tager lægemidler indeholdende dextropropoxyphen, bliver overført til alternativ behandling.
English: It is a weak opioid (opioids are medicines related to morphine) that relieves pain by acting on receptors in the brain and spinal cord.
Danish: Det er et svagt opioid (opioider er morfin og morfinlignende lægemidler), som virker smertestillende ved at påvirke receptorer i hjernen og rygmarven.
English: In light of differences between Member States in terms of the number of fatal overdoses reported, the Committee also sought data from other sources available in Member States, including case reports of fatal overdose, data from poison centres, data from coroners' services, hospital statistics, national mortality statistics, and toxicology data from forensic services, from both published and unpublished research.
Danish: I lyset af forskellene mellem medlemsstaterne, hvad angår antallet af indberettede dødelige overdoser, indhentede udvalget ligeledes data fra andre tilgængelige kilder i medlemsstaterne, herunder caserapporter om dødelig overdosis, data fra giftinformationscentraler, data fra lægers undersøgelser af dødsfald, hospitalsstatistikker, nationale dødsstatistikker og retsmedicinske toksikologidata fra både offentliggjorte og ikke-offentliggjorte undersøgelser.
English: The CHMP noted that safety was less of a concern for the parenteral form, because these medicines are only given in a hospital setting where there is a lower risk of overdose.
Danish: CHMP bemærkede, at der ikke var så store betænkeligheder med hensyn til sikkerheden for den parenterale forms vedkommende, eftersom disse lægemidler udelukkende gives i hospitalsregi, hvor der er lavere risiko for en overdosis.
English: Data assessed by the Committee highlighted that many of the cases of fatal overdoses seen have been accidental.
Danish: De data, som udvalget vurderede, viste, at mange af tilfældene af dødelig overdosis var utilsigtede.
English: Because the Committee was also concerned about the safety of medicines containing only dextropropoxyphene, in March 2009, the assessment was widened, in agreement with the Commission, to include all dextropropoxyphene-containing medicines, either on its own or in combination.
Danish: Eftersom udvalget også havde betænkeligheder med hensyn til sikkerheden af lægemidler, der udelukkende indeholder dextropropoxyphen, blev vurderingen i marts 2009 efter aftale med Kommissionen udvidet til at omfatte alle lægemidler, der indeholder dextropropoxyphen, enten alene eller som kombination.
English: For long-term pain, the Committee noted that there is no evidence that dextropropoxyphene and paracetamol is more effective than alternative painkillers.
Danish: Ved langvarige smerter bemærkede udvalget, at der ikke er nogen dokumentation for, at dextropropoxyphen og paracetamol er mere effektivt end alternative smertestillende midler.
English: On 21 October 2009, the Committee confirmed its original recommendation that the marketing authorisations for the non-parenteral (tablets, capsules and suppositories) forms of dextropropoxyphene-containing medicines should be withdrawn.
Danish: Den 21. oktober 2009 bekræftede udvalget sin oprindelige anbefaling af, at markedsføringstilladelserne for ikke-parenterale former for lægemidler indeholdende dextropropoxyphen (tabletter, kapsler og suppositorier) blev trukket tilbage.
English: The available evidence suggests that the combination of dextropropoxyphene and paracetamol is no more effective than paracetamol on its own, or ibuprofen, for short-term pain.
Danish: Den tilgængelige dokumentation tyder på, at kombinationen af dextropropoxyphen og paracetamol ikke er mere effektiv end paracetamol eller ibuprofen alene ved kortvarige smerter.
English: However, for the parenteral form (solution for injection), the CHMP recommended that the marketing authorisations be suspended until further data are available.
Danish: Hvad angår den parenterale form (injektionsvæske, opløsning), anbefalede CHMP en suspendering af markedsføringstilladelserne, indtil der forelå yderligere data.
English: In the meantime, it is recommended that no new patients are started on dextropropoxyphene-containing medicines.
Danish: I mellemtiden anbefales det, at ingen nye patienter indleder behandling med lægemidler, der indeholder dextropropoxyphen.
English: • Prescribers should be aware that the availability of dextropropoxyphene-containing medicines will decrease as the withdrawal takes place according to national timeframes.
Danish: • De ordinerende læger skal være opmærksomme på, at tilgængeligheden af lægemidler, der indeholder dextropropoxyphen, vil blive mindre, efterhånden som tilbagetrækningerne sker i henhold til de nationale tidsplaner.
English: The CHMP therefore recommended that the marketing authorisations for the parenteral form of dextropropoxyphene-containing medicines be suspended until further data are available to show that the benefits outweigh the risks.
Danish: Derfor anbefalede CHMP, at markedsføringstilladelserne for den parenterale form for lægemidler indeholdende dextropropoxyphen blev suspenderet, indtil der foreligger yderligere data, som viser, at fordelene opvejer risiciene.
English: What are the recommendations for prescribers?
Danish: Hvilke anbefalinger gives der til de ordinerende læger?