FrancophonIA/ELRC3.0 huggingface dataset:
English: The product is indicated for the treatment of endo- and ectoparasitic infections in horses, particularly gastrointestinal nematodes, dermal nematodes, lung nematodes and bots.
Danish: Erklæringen ‘Behandlingen af gastrointestinale endoparasit-infektioner hos heste' antyder, at alle gastrointestinale endoparasit-infektioner hos heste behandles med dette produkt; ‘især' antyder, at produktet har en særlig virkemåde mod de angivne arter.
English: The ground for the referral was the substantiation of the bioavailability/bioequivalence of Equimectin in comparison to Eqvalan.
Danish: Det vides, at der er en potentiel akkumulering af resistens over for ivermectin i Parascaris equorum.
English: The CVMP during its meeting of May 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended.
Danish: De relative fald i antal æg pr. gram fæces for testproduktet blev beregnet til at være 88,2% i forhold til æg af Strongylus-typen på dag 3 og 88,2% på dag 8.
English: Outcome of a procedure under Article 107 of Directive 2001/83/EC
Danish: Resultat af en procedure i henhold til artikel 107 i direktiv 2001/83/EF
English: The European Commission issued a decision on this opinion on 29 November 2010.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 29. november 2010.
English: What are the recommendations for patients and healthcare professionals?
Danish: Hvilke anbefalinger gives der til patienter og sundhedspersonale?
English: They should also wash their hands carefully after each application of ketoprofen.
Danish: De skal ligeledes vaske hænderne grundigt efter hver påføring af ketoprofen.
English: They may be obtained with or without a prescription.
Danish: Lægemidlerne udleveres med eller uden recept.
English: Topical ketoprofen-containing medicines have been available in all Member States except for the Netherlands since 1978.
Danish: Topiske lægemidler, der indeholder ketoprofen, har kunnet fås i alle medlemsstaterne undtagen Nederlandene siden 1978.
English: What is ketoprofen?
Danish: Hvad er ketoprofen?
English: Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Ketoprofen er et non-steroidt, antiinflammatorisk lægemiddel (NSAID).
English: Finally, the CHMP agreed to review the effectiveness of these risk minimization measures in three years time.
Danish: Endelig besluttede CHMP at foretage en revurdering af disse risikominimeringsforanstaltningers effektivitet om tre år.
English: In addition, new skin reactions have been reported following use of products containing octocrylene.
Danish: Desuden blev der indberettet nye hudreaktioner efter anvendelsen af produkter, der indeholder octocrylen.
English: The CHMP looked into all the available safety data, including data from member states' databases and data provided by the companies marketing topical ketoprofen in the EU.
Danish: CHMP så på alle de tilgængelige sikkerhedsdata, herunder data fra medlemsstaternes databaser og data fremsendt af de virksomheder, der markedsfører topisk ketoprofen i EU.
English: Prostaglandins are messengers in the development of inflammation.
Danish: Prostaglandiner er signalstoffer i forbindelse med udviklingen af betændelse.
English: Why was topical ketoprofen reviewed?
Danish: Hvorfor blev topisk ketoprofen vurderet igen?
English: • Patients who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter, som har spørgsmål, skal henvende sig til deres læge eller på apoteket.
English: • these medicines should no longer be available over the counter but should only be obtained with a prescription from a doctor;
Danish: • disse lægemidler skal ikke længere kunne fås i håndkøb, men kun udleveres efter recept fra en læge;
English: As required by Article 107, the French agency informed the CHMP of its actions so that the Committee could prepare an opinion on whether the marketing authorisations for topical products containing ketoprofen 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 topiske lægemidler, der indeholder ketoprofen, burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: Blocking their production helps to reduce the signs of inflammation.
Danish: At blokere dannelsen af dem er med til at mindske betændelsessymptomerne.
English: As a result, measures to reduce harm were implemented in France, such as the inclusion of warnings and precautions in the French product information, a pictogram on the packaging and dissemination of letters to healthcare professionals.
Danish: Som et resultat heraf blev der truffet skadesbegrænsende foranstaltninger i Frankrig, såsom medtagelsen af advarsler og forsigtighedsregler i den franske produktinformation, et piktogram på emballagen og udsendelsen af breve til sundhedspersonale.
English: • Patients should make sure that the treated areas are protected from sunlight during the whole period of ketoprofen treatment and the two weeks after stopping the treatment.
Danish: • Patienter skal sørge for, at de behandlede områder er beskyttet mod sollys i hele den periode, hvor der behandles med ketoprofen, og i to uger efter behandlingens afslutning.
English: In particular, the Committee considered the responses given by the companies to a list of questions on photosensitivity reactions, including photoallergy, in patients using these medicines.
Danish: Udvalget tog navnlig de svar i betragtning, som virksomhederne havde givet på en liste med spørgsmål om lysfølsomhedsreaktioner, herunder fotoallergi, hos patienter, der bruger disse lægemidler.
English: • the risks of photoallergy with topical ketoprofen and the way to prevent it should be clearly communicated to healthcare professionals and to patients.
Danish: • risiciene for fotoallergi med topisk ketoprofen og den måde, det kan forebygges på, skal kommunikeres klart ud til fagfolk inden for sundhedssektoren og patienter.
English: The Committee also noted that, although alternative topical NSAIDs are available in the EU, ketoprofen is the only topical NSAID authorised for the treatment of acute lowback pain.
Danish: Udvalget bemærkede ligeledes, at selv om alternative topiske NSAID'er er tilgængelige i EU, er ketoprofen det eneste topiske NSAID, der er godkendt til behandling af akutte nedre rygsmerter.
English: In spite of these measures, new cases of photoallergy have been reported, which occurred even in cases of exposure to dim sunlight.
Danish: På trods af disse foranstaltninger blev der indberettet nye tilfælde af fotoallergi, selv når der var tale om eksponering for svagt sollys.
English: • Doctors, pharmacists and patients should be aware of the risk of photoallergy with topical ketoprofen.
Danish: • Læger, apotekere og patienter skal være klar over risikoen for fotoallergi med topisk ketoprofen.
English: NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Danish: NSAID'er virker ved at blokere et enzym kaldet cyclooxygenase, som er med til at danne prostaglandiner.
English: • strengthened warnings on sun exposure should be included in the product information, as well as advice to stop using topical ketoprofen if any skin reactions develop, including when using ketoprofen together with octocrylene;
Danish: • der skal medtages tydeligere advarsler om eksponering for sollys i produktinformationen samt anbefaling om at stoppe anvendelsen af topisk ketoprofen, hvis der opstår hudreaktioner, også når ketoprofen anvendes sammen med octocrylen;
English: Octocrylene is a chemical sunscreen found in several cosmetics and care products such as shampoo, skin creams, anti-ageing creams, make-up removers and hair sprays.
Danish: Octocrylen er et kemisk solfilter, som findes i mange kosmetikog plejeprodukter såsom shampoo, hudcremer, antirynkecremer, makeupfjernere og hårspray.
English: The European Medicines Agency has completed a review of the safety and effectiveness of ketoprofencontaining medicines used topically (on the skin).
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af sikkerhed og virkning af lægemidler indeholdende ketoprofen til topisk brug (på huden).
English: In December 2009, after re-assessing these medicines, the French agency considered that their benefit-risk balance was no longer positive and decided to suspend the marketing authorisations of all topical medicines containing ketoprofen in France.
Danish: I december 2009 var den franske lægemiddelkontrolmyndighed af den opfattelse - efter at have revurderet disse lægemidler - at deres benefit/risk-forhold ikke længere var positivt, og den besluttede derfor at suspendere markedsføringstilladelserne for alle topiske lægemidler, der indeholder ketoprofen, i Frankrig.
English: The CHMP noted that the number of reports of adverse skin reactions including photoallergy is low throughout the EU and that the risk of these side effects could potentially be reduced using appropriate minimisation measures.
Danish: CHMP bemærkede, at antallet af indberetninger af bivirkninger, der vedrører huden, herunder fotoallergi, er lavt i hele EU, og at risikoen for disse bivirkninger potentielt kunne reduceres ved at anvende passende risikominimeringsforanstaltninger.
English: Since their marketing authorisation, the French medicines regulatory agency (Afssaps) has reviewed the safety of topical ketoprofen-containing medicines several times because of reports of photoallergy (allergic reactions to a medicine following exposure to sunlight) in patients using these medicines.
Danish: Efter deres markedsføringstilladelse har Frankrigs lægemiddelkontrolmyndighed (Afssaps) gennemgået sikkerheden af topiske lægemidler, der indeholder ketoprofen, adskillige gange, eftersom der var indberetninger om fotoallergi (allergiske reaktioner over for et lægemiddel efter eksponering for sollys) hos patienter, som bruger disse lægemidler.
English: Topical formulations of ketoprofen are used to treat the symptoms of pain and inflammation in conditions such as minor trauma (sprains, bruising), tendonitis (inflammation of a tendon), small-joint osteoarthritis (swelling and pain in the small joints), acute low-back pain and phlebitis (inflammation of a vein).
Danish: Topiske ketoprofenformuleringer anvendes til at behandle smerte- og betændelsessymptomerne ved tilstande såsom mindre traumer (forstuvninger og blå mærker), tendonitis (betændelse i en sene), osteoarthritis i små led (hævelse og smerter i små led), akutte nedre rygsmerter og flebitis (årebetændelse).
English: Company responses provided on: 5 January 2010, 26 February 2010 and 7 June 2010 Opinion date:
Danish: 5. januar 2010, 26. februar 2010 og 7. juni 2010
English: • Patients should discontinue treatment immediately if they develop any skin reaction after application of these medicines, and seek their doctor's advice.
Danish: • Patienter skal straks afbryde behandlingen, hvis de udvikler nogen hudreaktioner efter påføringen af disse lægemidler, og kontakte deres læge.
English: They may be available as creams, gels, solutions, sprays and plasters under various trade names and as generics.
Danish: De fås som creme, gel, opløsning, spray og plastre under forskellige særnavne og som generiske lægemidler.
English: The CHMP concluded that the benefits of topical ketoprofen-containing medicines continue to outweigh their risks but recommended the following risk minimisation measures:
Danish: CHMP konkluderede, at fordelene ved topiske lægemidler, der indeholder ketoprofen, fortsat opvejer risiciene, men anbefalede følgende risikominimeringsforanstaltninger:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of topical ketoprofen continue to outweigh its risks, but that further measures should be put in place to minimise the risk of adverse skin reactions.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved topisk ketoprofen fortsat opvejer risiciene, men at der bør træffes yderligere foranstaltninger for at minimere risikoen for bivirkninger, der vedrører huden.
English: • Doctors should tell their patients how to use topical ketoprofen-containing medicines appropriately.
Danish: • Læger skal rådgive deres patienter om den korrekte brug af lægemidler, der indeholder ketoprofen.
English: The European Commission issued a decision on 13 September 2011.
Danish: Europa-Kommissionen traf en afgørelse den 13. september 2011.
English: • Patients who have any questions should speak to their doctor.
Danish: • Patienter, som har spørgsmål, skal henvende sig til deres læge.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF med senere ændringer
English: Medicines containing dexrazoxane are authorised for the prevention of cardiotoxic effects in Austria, Czech Republic, Germany, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia Spain and the United Kingdom under the following invented names: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar and Procard.
Danish: Lægemidler, som indeholder dexrazoxan, er godkendt til forebyggelse af kardiotoksiske virkninger i Østrig, Den Tjekkiske Republik, Tyskland, Danmark, Finland, Frankrig, Grækenland, Ungarn, Irland, Italien, Litauen, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Spanien og Det Forenede Kongerige under følgende særnavne: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar og Procard.
English: EMA/CHMP/485343/2011 rev.1 EMEA/H/A-31/1275
Danish: EMA/773267/2011 rev.1 EMEA/H/A-31/1275
English: What is dexrazoxane?
Danish: Hvad er dexrazoxan?
English: There was also an increased risk of severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells) and severe infection.
Danish: Der var også en øget risiko for svær myelosuppression (en tilstand, hvor knoglemarven ikke producerer nok blodceller) og alvorlig infektion.
English: The Committee also reviewed all available data on the safety and effectiveness of dexrazoxane, including published studies and data submitted by the companies that market the medicines.
Danish: Udvalget gennemgik endvidere alle tilgængelige data om dexrazoxans sikkerhed og virkning, herunder publicerede undersøgelser og data indleveret af de virksomheder, der markedsfører lægemidlerne.
English: whether the marketing authorisations for products containing dexrazoxane should be maintained, varied, suspended or withdrawn across the European Union.
Danish: afgive udtalelse om, hvorvidt markedsføringstilladelserne for dexrazozanholdige lægemidler burde fastholdes, ændres, suspenderes eller trækkes tilbage i hele EU.
English: • Information on recommended dosing and additional information on the risks associated with dexrazoxane can be found in the updated prescribing information.
Danish: • Oplysninger om anbefalet dosering og yderligere oplysninger om risici i forbindelse med dexrazoxan fremgår af de opdaterede ordinationsoplysninger.
English: Why was dexrazoxane reviewed?
Danish: Hvorfor blev dexrazoxan vurderet igen?
English: Studies showed a three-fold increase in the risk of new cancers such as AML and MDS.
Danish: Undersøgelserne viste en tre gange så høj stigning i risikoen for nye kræftsygdomme, såsom AML og MDS.
English: In addition to the restriction in the medicine's use, the CHMP has recommended a reduced dose ratio of 10:1 with doxorubicin (the dose ratio remains 10:1 for epirubicin) in adults and has included in the SmPCs more information on what is currently known about the risks of dexrazoxane-containing medicine.
Danish: Ud over begrænsningen i anvendelsen af lægemidlet har CHMP anbefalet et reduceret dosisforhold på 10:1 med doxorubicin (dosisforholdet er fortsat 10:1 for epirubicin) hos voksne og har indført flere oplysninger om den aktuelle viden om risiciene i forbindelse med dexrazoxanholdige lægemidler i produktresuméerne.
English: • When deciding whether to use dexrazoxane prescribers should consider the short- and long-term risks associated with this product (e.g. myelosuppression and the potential for AML), alongside possible benefits in relation to protection of the heart.
Danish: • Når en ordinerende læge skal beslutte, om der skal anvendes dexrazoxan, skal denne overveje de kort- og langsigtede risici i forbindelse med lægemidlet (f.eks. myelosuppression og risiko for AML) sammen med de mulige fordele i forhold til beskyttelse af hjertet.
English: The Committee also noted that in one study in breast cancer patients, dexrazoxane was associated with worsened response to cancer therapy while other studies showed an increased risk of dying in the first few months of treatment with dexrazoxane at a dose ratio of 20: 1 (20 parts dexrazoxane for 1 part of doxorubicin).
Danish: Udvalget bemærkede også, at dexrazoxan i en undersøgelse af brystkræftpatienter var forbundet med forværret respons på kræftbehandlingen, mens andre undersøgelser viste en øget risiko for at dø under de første måneders behandling med dexrazoxan med dosisforhold 20:1 (20 dele dexrazoxan til 1 del doxorubicin).
English: The UK medicines regulatory agency also shared these concerns and asked the CHMP to carry out a full assessment of the benefit-risk balance of dexrazoxane and to issue an opinion on
Danish: Den britiske lægemiddelkontrolmyndighed delte disse betænkeligheder og anmodede CHMP om at gennemføre en fuldstændig vurdering af risk/benefit-forholdet for dexrazoxan og om at
English: The Committee noted that there was evidence of serious harm in children receiving dexrazoxane.
Danish: Udvalget bemærkede, at der var dokumentation for alvorlige skader hos børn, som modtog behandling med dexrazoxan.
English: The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines toxic to the heart muscle.
Danish: Det er ikke helt klart, hvordan dexrazoxan beskytter hjertet, men det kan skyldes måden, hvorpå lægemidlet binder sig til ladede jernpartikler, som er medvirkende til de processer, der gør anthracykliner toksiske for hjertemusklen.
English: The French medicines regulatory agency raised concerns that dexrazoxane could be linked to an increased risk of two cancers: acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
Danish: Den franske lægemiddelkontrolmyndighed var bekymret for, at dexrazoxan kunne være forbundet med en øget risiko for to kræfttyper: akut myeloid leukæmi (AML) og myelodysplastisk syndrom (MDS).
English: The CHMP concluded that the benefits of dexrazoxanecontaining medicines do not outweigh its risk in children and adolescents, and the medicine should not be used in these age-groups.
Danish: CHMP konkluderede, at fordelene ved dexrazoxanholdige lægemidler ikke opvejer risiciene hos børn og unge, og at lægemidlet ikke bør anvendes til disse aldersgrupper.
English: The European Medicines Agency has completed a review of the safety and effectiveness of dexrazoxane.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af sikkerhed og virkning for dexrazoxan.
English: The use of dexrazoxane should be contraindicated in children and adolescents.
Danish: Anvendelse af dexrazoxan bør være kontraindiceret hos børn og unge.
English: • Dexrazoxane should only be used in adult patients who have already received a minimum cumulative anthracycline dose of 300 mg/m2 of doxorubicin, or 540 mg/m2 of epirubicin.
Danish: • Dexrazoxan bør kun anvendes til voksne patienter, som allerede har modtaget en vis mindste mængde kumulativ anthracyklindosis på 300 mg/m2 doxorubicin eller 540 mg/m2 epirubicin.
English: These concerns were based on studies in the United States reporting cases of AML and MDS in children with Hodgkin's disease as well as cases of AML reported in breast cancer patients receiving dexrazoxane.
Danish: Disse bekymringer var baseret på undersøgelser i USA, der berettede om tilfælde af AML og MDS hos børn med Hodgkins sygdom samt tilfælde af AML hos brystkræftpatienter, som blev behandlet med dexrazoxan.
English: • Dexrazoxane should only be used in adult patients with advanced or metastatic breast cancer.
Danish: • Dexrazoxan bør kun anvendes til voksne patienter med fremskreden eller metastatisk brystkræft.
English: The CHMP reviewed reports on AML and MDS in patients receiving dexrazoxane.
Danish: CHMP gennemgik rapporter om AML og MDS hos patienter, som modtog dexrazoxan.
English: Dexrazoxane is used in patients with cancer to prevent long-tem toxic effects on the heart caused by treatment with the anticancer medicines doxorubicin and epirubicin.
Danish: Dexrazoxan anvendes til patienter med kræft for at forhindre langsigtede toksiske virkninger på hjertet forårsaget af behandling med lægemidlerne mod kræft doxorubicin og epirubicin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that dexrazoxane should not be used in children and adolescents.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) er af den opfattelse, at dexrazoxan ikke bør anvendes til børn og unge.
English: The benefits of dexrazoxane do not outweigh its risks in children and adolescents.
Danish: Fordelene ved dexrazoxan opvejer ikke risiciene hos børn og unge.
English: The Committee has also made recommendations for changes to the summaries of product characteristics (SmPCs) for dexrazoxanecontaining medicines.
Danish: Udvalget har også fremsat anbefalinger om ændringer i produktresuméerne for dexrazoxanholdige lægemidler.
English: The use of dexrazoxane should be restricted to adult patients with advanced or metastatic breast cancer who have already received a certain amount of doxorubicin and epirubicin.
Danish: Anvendelse af dexrazoxan bør begrænses til voksne patienter med fremskreden eller metastatisk brystkræft, som allerede har modtaget en vis mængde doxorubicin og epirubicin.
English: Additional information on special populations:
Danish: Yderligere information om specielle populationer:
English: very rare not known cannot be estimated from the available data
Danish: Meget sjælden Ikke kendt kan ikke estimeres ud fra forhåndenværende data
English: You may become sleepy and could lose consciousness.
Danish: De bliver måske søvnig og kan miste bevidstheden.
English: Steady state was achieved within 13 days.
Danish: Steady-state blev opnået i løbet af 13 dage.
English: • live in a place or are on holiday in a place where the weather is warm.
Danish: • De bor et sted eller er på ferie på et sted, hvor det er varmt i vejret.
English: In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Danish: Yderligere er der indhentet omfattende erfaringer siden markedsføringen af zonisamid i Japan i 1989 og i USA i 2000.
English: • have thoughts of harming or killing yourself.
Danish: • har tanker om at skade Dem selv eller begå selvmord.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Zonegran.
Danish: Mekanismen for denne risiko er ikke kendt, og de tilgængelige data udelukker ikke muligheden for en øget risiko ved Zonegran.
English: • Zonegran capsules must be swallowed whole with water.
Danish: • Zonegran kapsler skal synkes hele med vand.
English: Do not reduce your dose or stop your medicine unless your doctor tells you to.
Danish: De må ikke mindske Deres dosis eller ophøre med medicinen, medmindre Deres læge siger det til Dem.
English: • if you are allergic to other sulphonamide medicines.
Danish: • hvis De er allergisk over for andre sulfonamid-lægemidler.
English: Symptoms may occur within hours to weeks of initiating therapy.
Danish: Symptomerne kan opstå inden for timer til uger efter behandlingsstart.