FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter, som har spørgsmål, bør henvende sig til deres læge eller på apoteket.
English: It also has an effect on the liver by increasing the production of glycogen (the storage form of glucose in the liver).
Danish: Det har ligeledes en virkning på leveren ved at øge produktionen af glykogen (som er den måde, glukose lagres på i leveren).
English: Alternative treatments should be used as appropriate,
Danish: Efter behov bør der anvendes andre behandlinger,
English: • Doctors should stop prescribing benfluorex.
Danish: • Læger bør ikke længere ordinere benfluorex.
English: Benfluorex works by making the cells more sensitive to insulin, which means that the body makes better use of the insulin it produces and the blood glucose is reduced.
Danish: Benfluorex virker ved at gøre cellerne mere følsomme over for insulin, hvilket betyder, at kroppen gør bedre brug af det insulin, den danner, og at blodsukkeret sænkes.
English: In November 2009, following several reports of cardiac valvulopathy (thickening of the heart valves) and pulmonary arterial hypertension (high blood pressure in the artery that leads from the heart to the lungs), the French medicines regulatory authority carried out a review of the safety of benfluorex and decided to suspend its marketing authorisation.
Danish: I november 2009, efter flere indberetninger om hjerteklapsygdom (fortykkelse af hjerteklapperne) og pulmonal arteriel hypertension (højt blodtryk i den arterie, der fører fra hjertet til lungerne), foretog den franske lægemiddelmyndighed en revurdering af benfluorex' sikkerhed og besluttede at suspendere markedsføringstilladelsen for dette
English: In addition, there is risk of valve diseases with the use of benfluorex, which was confirmed in a new study conducted in October 2009.
Danish: Desuden medfører brugen af benfluorex risiko for hjerteklapsygdomme, hvilket blev bekræftet i en ny undersøgelse, der blev foretaget i oktober 2009.
English: The review included information provided by the market leader from clinical trials, information published in scientific journals, and ‘spontaneous reports' of side effects from patients to the companies that make the medicines or health authorities.
Danish: Revurderingen omfattede information fra den markedsførende virksomhed om kliniske undersøgelser, information offentliggjort i videnskabelige tidsskrifter og "spontane indberetninger" af bivirkninger fra patienter til medicinalvirksomhederne eller sundhedsmyndighederne.
English: In 2007, a re-assessment of the benefit-risk balance led to the withdrawal of the indication for the use in patients with high blood levels of triglycerides, a type of fat.
Danish: I 2007 førte en revurdering af benefit/risk-forholdet til en tilbagetrækning af indikationen for brug til patienter med høje niveauer af triglycerider (en fedttype) i blodet.
English: As required by Article 107, the French authority informed the CHMP of its action so that the Committee could prepare an opinion on whether the marketing authorisations for products containing benfluorex should be maintained, changed, suspended or revoked across the EU.
Danish: Sådan som artikel 107 foreskriver, informerede den franske myndighed CHMP om de foranstaltninger, den havde truffet, så udvalget kunne udarbejde en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende benfluorex burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: Medicines containing benfluorex were first authorised in 1974.
Danish: Lægemidler indeholdende benfluorex blev godkendt første gang i 1974.
English: Benfluorex was used as an add-on treatment in patients with diabetes who are overweight.
Danish: Benfluorex blev anvendt som tillægsbehandling hos overvægtige diabetespatienter.
English: At the time of this review,they were available as tablets containing 150 mg benfluorex hydrochloride in France and Portugal2 under the following invented names, Mediator, Benfluorex Mylan and Benfluorex Qualimed.
Danish: På tidspunktet for denne revurdering kunne de fås i Frankrig og Portugal2 som tabletter, der indeholder 150 mg benfluorexhydrochlorid, under følgende særnavne: Mediator, Benfluorex Mylan og Benfluorex Qualimed.
English: Why was benfluorex reviewed?
Danish: Hvorfor blev benfluorex vurderet igen?
English: Shortly after, as a precautionary measure, the Portuguese medicines regulatory authority also decided to recall these medicines from the market.
Danish: Kort efter besluttede den portugisiske lægemiddelmyndighed også at tilbagekalde disse lægemidler fra markedet som en sikkerhedsforanstaltning.
English: As a result, benfluorex-containing medicines were taken off the market in France.
Danish: Som følge heraf blev lægemidler indeholdende benfluorex taget af markedet i Frankrig.
English: The CHMP noted that the available data show that the effect of benfluorex in the treatment of diabetes is only limited.
Danish: CHMP bemærkede, at de foreliggende data viser, at benfluorex kun har en begrænset virkning ved behandling af diabetes.
English: The European Medicines Agency has completed a review of the safety and effectiveness of benfluorex.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af benfluorex' sikkerhed og virkning.
English: Co-rapporteur(s):
Danish: Medrapportør(er):
English: The CHMP has reviewed available information on the safety and efficacy of benfluorex-containing medicines, particularly data on the associated risk of heart valve diseases and pulmonary arterial hypertension.
Danish: CHMP vurderede de foreliggende oplysninger om sikkerhed og virkning for lægemidler indeholdende benfluorex, navnlig data om den hermed forbundne risiko for hjerteklapsygdomme og pulmonal arteriel hypertension.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of benfluorex no longer outweigh its risks, and that all marketing authorisations for medicines containing benfluorex should be revoked throughout the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved benfluorex ikke længere opvejer risiciene, og udvalget anbefalede en tilbagetrækning af alle markedsføringstilladelser for lægemidler indeholdende benfluorex i hele EU.
English: Since its marketing authorisation, the safety of benfluorex has been reviewed several times.
Danish: Benfluorex' sikkerhed er blevet undersøgt flere gange siden markedsføringstilladelsen.
English: • Patients who are currently treated with benfluorex-containing medicines should, when convenient,
Danish: • Patienter, der i øjeblikket behandles med lægemidler indeholdende benfluorex bør, når de har mulighed for det, få en tid hos deres læge for at få ændret recepten.
English: Therefore, on the basis of the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of benfluorex-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisation of these medicines be revoked.
Danish: På basis af en vurdering af disse data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende benfluorex ikke opvejer risiciene.
English: • Patients who have been treated with these medicines in the past should mention this to their doctor, who will look for the signs and symptoms of heart valve disease.
Danish: • Patienter, der er blevet behandlet med disse lægemidler tidligere, bør nævne dette for deres læge,
English: Questions and answers on the withdrawal of medicines containing benfluorex EMA/811097/2009 Rev. 1
Danish: EMA/811097/2009 Rev. 1
English: on 2 May 2007.
Danish: den 2. maj 2007.
English: This helps to protect against the disease.
Danish: Dette er med til at beskytte mod sygdommen.
English: This summary was last updated in 06-2010.
Danish: Dette sammendrag blev sidst ajourført i 06-2010.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 12 August 2010.
Danish: Da virksomheden havde fremlagt de yderligere oplysninger, som man havde anmodet om, blev de ”særlige omstændigheder” ophævet den 12. august 2010.
English: Focetria was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Danish: Focetria blev oprindeligt godkendt under ”særlige omstændigheder”, da der af faglige årsager kun forelå begrænsede oplysninger på godkendelsestidspunktet.
English: Focetria is given according to official recommendations.
Danish: Focetria gives i overensstemmelse med de officielle anbefalinger.
English: Focetria is a vaccine.
Danish: Focetria er en vaccine.
English: This document is a summary of the European Public Assessment Report (EPAR) for Focetria.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Focetria.
English: The vaccine can only be obtained with a prescription.
Danish: Vaccinen udleveres kun efter recept.
English: The outer membranes that contain the surface antigens have then been extracted and purified.
Danish: De ydre membraner, der indeholder overfladeantigenerne, er derefter blevet ekstraheret og renset.
English: In children aged from six to 35 months of age, the use of a second dose has been shown to increase the immune response.
Danish: Hos børn i alderen seks til 35 måneder har indgivelse af en yderligere dosis vist sig at øge immunresponsen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S.r.l.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Focetria til Novartis Vaccines and Diagnostics S.r.l.
English: Other information about Focetria:
Danish: Andre oplysninger om Focetria:
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at ”lære” immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod en sygdom.
English: In both studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.
Danish: I begge undersøgelserne viste vaccinen sig at frembringe en tilstrækkelig beskyttende mængde antistoffer i overensstemmelse med de kriterier, som er fastsat af CHMP.
English: For more information about treatment with Focetria, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Focetria, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults and children and adolescents aged six months to 17 years.
Danish: CHMP bemærkede, at en enkelt dosis var i stand til at fremkalde en tilfredsstillende immunrespons hos voksne samt børn og unge i alderen seks måneder til 17 år.
English: In the elderly (over 60 years of age), the second dose must be given.
Danish: Ældre (over 60 år) må ikke få en sådan yderligere dosis.
English: Two main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response, one study in 661 healthy adults (including 251 elderly subjects over 60 years of age), and one study in 720 healthy children and adolescents (aged between six months and 17 years).
Danish: Der blev foretaget to hovedundersøgelser, hvor det blev undersøgt, med hvilken effekt et todosisprogram af vaccinen kunne fremkalde en immunrespons: én undersøgelse af 661 raske voksne (herunder 251 ældre over 60 år) og én undersøgelse af 720 raske børn og unge (i alderen seks måneder til 17 år).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Focetria.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Focetria.
English: Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Danish: Focetria må ikke gives til patienter, der har haft en anafylaktisk reaktion (alvorlig allergisk reaktion) over for nogle af vaccinens komponenter eller over for nogle af de sporstoffer, der findes i vaccinen, f.eks. ægge- eller kyllingeprotein, ovalbumin (et protein i æggehvide), kanamycin- eller neomycinsulfat (antibiotika), formaldehyd og cetyltrimethylammoniumbromid.
English: Focetria influenza vaccine (H1N1)v (surface antigen, inactivated, adjuvanted)
Danish: Focetria influenzavaccine (H1N1)v (overfladeantigen, inaktiveret, adjuveret)
English: The full EPAR for Focetria can be found here.
Danish: Den fuldstændige EPAR for Focetria findes her.
English: It contains a flu strain called A/California/7/2009 (H1N1)-derived strain NYMC X-181.
Danish: Vaccinen indeholder en influenzastamme kaldet A/California/7/2009 (H1N1)-deriveret stamme NYMC X-181.
English: The vaccine also contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Danish: Vaccinen indeholder også et ”adjuvans” (en olieholdig forbindelse), som giver en bedre immunrespons.
English: The CHMP decided that Focetria's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Focetria opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Focetria.
English: Focetria is given as one dose, injected into the muscle of the shoulder or thigh.
Danish: Focetria gives som én dosis via injektion i skulder- eller lårmusklen.
English: The most common side effects with Focetria (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of the injection (pain, hardening and redness), malaise (feeling unwell), sweating and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Focetria (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, myalgi (muskelsmerter), reaktioner på injektionsstedet (smerte, hårdhed og rødmen), utilpashed, svedtendens og træthed.
English: It is a suspension for injection that contains parts (‘surface antigens') of the influenza (flu) virus.
Danish: Det er en injektionsvæske, suspension, der indeholder dele (”overfladeantigener”) af influenzavirus.
English: Focetria was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Danish: Focetria blev oprindeligt udviklet som en pandemisk vaccine til brug under influenza A (H1N1)pandemien, som blev erklæret i juni 2009.
English: What is the risk associated with Focetria?
Danish: Hvilken risiko er der forbundet med Focetria?
English: Why has Focetria been approved?
Danish: Hvorfor blev Focetria godkendt?
English: For the full list of all side effects reported with Focetria, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Focetria fremgår af indlægssedlen.
English: Focetria is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Danish: Focetria er en vaccine til beskyttelse mod influenza, som er fremkaldt af A (H1N1)v 2009-virus.
English: A second dose may be given after an interval of at least three weeks.
Danish: Tidligst tre uger efter den første dosis kan der gives endnu en dosis.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet virusset som ”fremmed” og producerer antistoffer mod det. Immunsystemet kan således hurtigere danne antistoffer, når det udsættes for samme virus igen.
English: What is Focetria?
Danish: Hvad er Focetria?
English: Focetria contains small amounts of ‘surface antigens' (proteins on the outer membrane of the virus) of a virus called A(H1N1)v 2009.
Danish: Focetria indeholder små mængder af ”overfladeantigener” (proteiner på virussets ydre membran) fra en virus kaldet A(H1N1)v 2009, der først er blevet inaktiveret (dræbt), så den ikke længere forårsager sygdom.
English: How has Focetria been studied?
Danish: Hvordan blev Focetria undersøgt?
English: What is Focetria used for?
Danish: Hvad anvendes Focetria til?
English: What benefit has Focetria shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Focetria?
English: How is Focetria used?
Danish: Hvordan anvendes Focetria?
English: How does Focetria work?
Danish: Hvordan virker Focetria?
English: The reasons for this are not clear.
Danish: Årsagen hertil er ikke tydelig.
English: This summary was last updated in September 2016.
Danish: Dette sammendrag blev sidst ajourført i september 2016.
English: Hands should be washed after use.
Danish: Vask hænder efter brug.
English: The European Commission granted a marketing authorisation valid throughout the EU for Draxxin on 23 July 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Draxxin den 23. juli 2003.
English: The full EPAR for Draxxin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
Danish: Den fuldstændige EPAR for Draxxin findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
English: This is a summary of the European Public Assessment Report (EPAR) for Draxxin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Draxxin.
English: The main measure of effectiveness was the proportion of pigs that completed the full three or six weeks of each study without needing to be removed from the study because of SRD.
Danish: Det primære effektmål var den andel af svinene, der fuldførte alle tre eller seks uger af hver undersøgelse, uden at det var nødvendigt at trække dem ud af undersøgelsen på grund af SRD.
English: This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
Danish: Dette betyder, at antibiotikummet måske ikke længere virker mod bakterier, der kan smitte enten dyr eller mennesker.
English: The main measure of effectiveness was clinical cure rate (no SRD or mild SRD) on day 14.
Danish: Det primære effektmål var den kliniske helberedelsesrate (ingen SRD eller mild SRD) på dag 14.
English: The main measure of effectiveness was the change in symptoms over 10 days.
Danish: Det primære effektmål var ændringen i symptomer over 10 dage.
English: This means to treat at the same time both diseased animals and those clinically healthy animals in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
Danish: Dette betyder, at man på samme tid behandler både syge dyr og de klinisk raske dyr, som er i tæt kontakt med dem, for at forhindre dem i at udvikle kliniske tegn og forhindre, at sygdommen spredes yderligere.
English: If symptoms persist, get worse or come back, treatment should be changed to another antibiotic.
Danish: Hvis symptomerne ikke forsvinder, eller hvis de forværres eller vender tilbage, bør der behandles med et andet antibiotikum.
English: It works by attaching to the RNA (the molecules that instruct the cell how to make proteins) within the bacterial cells.
Danish: Det virker ved, at det binder sig til RNA (de molekyler, der instruerer cellerne i at lave proteiner) inde i bakteriecellerne.
English: For cattle the meat withdrawal period is 22 days, for pigs it is 13 days and for sheep it is 16 days.
Danish: Tilbageholdelsestiden for kød er 22 dage for kvæg, 13 dage for svin og 16 dage for får.
English: It should also not be used at the same time as other macrolide antibiotics or lincosamides (another type of antibiotic medicine).
Danish: Det bør heller ikke anvendes samtidig med andre makrolide antibiotika eller lincosamider (en anden type antibiotisk lægemiddel).
English: The main measure of effectiveness was the change in symptoms, including body temperature, breathing and recovery over a period of between two weeks and two months.
Danish: Det primære effektmål var ændringen i symptomer, herunder kropstemperatur, åndedræt og helbredelse over en periode på mellem to uger og to måneder.
English: In the treatment studies, the cattle were infected with BRD-causing bacteria, but the cattle in the prevention studies had no symptoms of the disease.
Danish: I behandlingsundersøgelserne blev kvæget smittet med bakterier, der forårsagede BRD, men kvæget i forebyggelsesundersøgelserne havde ingen symptomer på sygdommen.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Draxxin's benefits are greater than its risks and recommended that it be approved in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Draxxin opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Draxxin can cause eye irritation.
Danish: Draxxin kan forårsage øjenirritation.
English: It is also the time required after administration of a medicine before milk can be used for human consumption.
Danish: Det er også den tid, der skal gå efter administration af et lægemiddel, før mælken kan anvendes til menneskeligt konsum.
English: The main measure of effectiveness was the proportion of cattle whose disease was cured after three weeks.
Danish: Det primære effektmål var den andel af kalvene, hvis sygdom var blevet kureret efter tre uger.
English: This prevents the bacteria being able to make vital proteins and stops them growing and multiplying.
Danish: Dette forhindrer bakterierne i at kunne danne nødvendige proteiner og standser deres vækst og formering.
English: • Early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires systemic treatment (treatment with a medicine given by mouth or by injection).
Danish: • tidlige stadier af klovspalteforrådnelse hos får, der er forårsaget af Dichelobacter nodosus, som kræver systemisk behandling (behandling med et lægemiddel, der gives gennem munden eller ved injektion).
English: For the best results sheep with foot rot should be kept in a dry environment.
Danish: For at opnå de bedste resultater bør får med klovspalteforrådnelse holdes i tørre omgivelser.
English: Other types of reaction to the injection persist for about 30 days after injection in cattle and pigs.
Danish: Andre typer reaktioner over for injektionen varer i cirka 30 dage efter injektionen hos kvæg og svin.
English: Why is Draxxin approved?
Danish: Hvorfor blev Draxxin godkendt?
English: The medicine should only be used for metaphylaxis in cattle and pigs once the presence of the disease in the herd has been established, and if animals are expected to develop the disease within two to three days.
Danish: Lægemidlet bør kun anvendes til metafylakse hos kvæg og svin, når sygdommen er blevet påvist i bestanden, og hos dyr, der forventes at udvikle sygdommen inden for to til tre dage.
English: Draxxin may also cause sensitisation (redness, itching and swelling) if it comes into contact with the skin.
Danish: Draxxin kan endvidere forårsage sensibilisering (rødme, kløe og hævelse), hvis det kommer i kontakt med huden.
English: Draxxin is given as a single injection of 2.5 mg per kilogram bodyweight.
Danish: Draxxin gives som en enkelt injektion på 2,5 mg per kilogram legemsvægt.