FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of appropriate residue depletion data, a withdrawal period for meat and offal derived from treated cattle cannot be set.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at en tilbageholdelsesperiode for kød og slagteaffald, der stammer fra behandlet kvæg, ikke kan fastsættes på grund af manglende passende data om nedbrydelse af restkoncentrationer.
English: The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Danish: CVMP anbefalede et afslag på ansøgningen om markedsføringstilladelse for målarten kvæg og ændring af de eksisterende markedsføringstilladelser, således at alle henvisninger til målarten kvæg for veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat i form af injektionsvæske, fjernes.
English: 3 Re-examination
Danish: 3 Revurdering
English: The CHMP agreed that the recommendations are applicable to all oral use formulations.
Danish: CHMP vedtog, at henstillingerne gælder alle orale formuleringer.
English: 2 Safety
Danish: 2 Sikkerhed
English: The scientific conclusions of the CHMP Opinion of 17 Decemeber 2009 were revised accordingly.
Danish: De videnskabelige konklusioner i CHMP's udtalelse af 17. december 2009 blev ændret tilsvarende.
English: The grounds for re-examination relate mainly to implementation issues rather than to scientific grounds.
Danish: Begrundelserne for revurderingen var mest gennemførelsesrelaterede frem for videnskabelige.
English: Overall Safety
Danish: Generel sikkerhed
English: The detailed grounds for the re-examination request were submitted to the Agency by 13 April 2010.
Danish: De detaljerede begrundelser for revurderingen blev fremsendt til agenturet den 13. april
English: As conclusion the recurrence prevention of mania has not been demonstrated.
Danish: Konklusionen er, at forebyggelse af tilbagevenden af mani ikke er blevet påvist.
English: Various MAHs submitted written notice to the European Medicines Agency by 27 February 2010 to request a re-examination of the Opinion.
Danish: Flere af indehaverne af markedsføringstilladelserne indsendte en skriftlig meddelelse til Det Europæiske Lægemiddelagentur den 27. februar 2010, hvori de anmodede om fornyet vurdering af udtalelsen.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALPROIC ACID/VALPROATE CONTAINING PRODUCTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN VIDENSKABELIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE VALPROINSYRE/VALPROAT (se bilag I)
English: Furthermore, the MAHs refer to the fact that syrups and oral solutions are also approved for bipolar disorder in some Member States.
Danish: De henviser desuden til, at syrup og orale opløsninger også er godkendt til bipolær lidelse i nogle medlemsstater.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER OG INDLÆGSSEDLER FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: According to the CHMP recommendation for valproate containing medicinal products the indication should be adapted as follows due to the limitations and shortcomings of the data from clinical trials as the analysis was based in relatively old clinical studies.
Danish: I overensstemmelse med CHMP's anbefaling for lægemidler indeholdende valproat skal indikationen tilpasses som følger på grund af begrænsningerne og manglerne ved dataene fra de kliniske undersøgelser, eftersom analysen var baseret på relativt gamle kliniske undersøgelser:
English: For theoretical reasons slow-release formulations could be advantageous for compliance reasons and also for avoiding high plasma peaks which may be accompanied by frequent adverse effects.
Danish: Teoretisk set kan formuleringer med langsom frigivelse være fordelagtige, når det gælder overensstemmelsen, og også når det gælder om at undgå høje plasmaniveauer, som ledsages af hyppige bivirkninger.
English: In addition, the time to recurrence of manic events has not shown statistically significant differences.
Danish: Desuden viste undersøgelsen af den tid, der går, inden en manisk episode optræder igen, ikke nogen statistisk signifikante forskelle.
English: In 2008, in light of the results of the US FDA meta-analysis of clinical trial data for antiepileptics, and in light of the spontaneous and literature reports, the Pharmacovigilance Working Party concluded that any antiepileptic drug may be associated with a low risk of suicidal thoughts and behaviour.
Danish: I lyset af resultaterne af den amerikanske Food and Drug Administrations metaanalyse af kliniske undersøgelsesdata om antiepileptiske lægemidler og i lyset af de spontane indberetninger og indberetninger omtalt i litteraturen konkluderede arbejdsgruppen vedrørende lægemiddelovervågning i 2008, at alle antiepileptiske lægemidler kan være forbundet med en lav risiko for selvmordstanker og selvmordsadfærd.
English: Therefore, in pregnant women or women envisaging a pregnancy, valproate should not be used for the treatment of manic episodes, unless safer alternatives prove to be ineffective or are not tolerated.
Danish: Derfor må valproat ikke bruges til behandling af maniske episoder hos gravide kvinder eller kvinder, der planlægger at blive gravide, medmindre sikrere alternativer viser sig at være virkningsløse eller ikke tolereres.
English: Evidence of efficacy of valproate in the prevention of mood episodes is thus not completely convincing based on the performed clinical studies.
Danish: Dokumentationen for valproats virkning til forebyggelse af humørsvingningsepisoder er således ikke helt overbevisende ud fra de gennemførte kliniske undersøgelser.
English: The MAHs should look into their respective safety databases and add the approapriate frequence of occurrence to the above additional adverse events.
Danish: Indehaverne af markedsføringstilladelsen skal konsultere deres respektive sikkerhedsdatabaser og tilføje, hvor hyppigt ovennævnte yderligere bivirkninger forekommer.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out in Annex III and in accordance to the conditions set out in Annex IV.
Danish: Som følge heraf anbefalede CHMP at opretholde markedsføringstilladelserne for de lægemidler, der er omtalt i bilag I. Ændringerne af de pågældende punkter i produktresuméerne og indlægssedlerne fremgår af bilag III og er i overensstemmelse med betingelserne i bilag IV.
English: On the basis of the evidence available to the PhVWP, it was agreed that SPCs for all antiepileptics across the European Union should be modified with regard to suicidality with the addition of a warning.
Danish: På baggrund af den dokumentation, der var tilgængelig for arbejdsgruppen vedrørende lægemiddelovervågning, blev det besluttet, at produktresuméerne for alle antiepileptiske lægemidler i hele EU skal ændres med hensyn til suicidalitet, og at der skal tilføjes en advarsel.
English: Based on the already well known safety profile for valproate, the MAHs are not in agreement with the submission of the Risk Management Plan.
Danish: Da sikkerhedsprofilen for valproat allerede er velkendt, er indehaverne af markedsføringstilladelserne ikke enige i, at der skal indsendes en risikostyringsplan.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for valproic acid/valproate containing medicinal products initiated by The Netherlands.
Danish: - CHMP behandlede den sag, der var indbragt af Nederlandene i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende valproinsyre/valproat.
English: Taking into account that in different EU member States the authorised valproate products may have or not the indication for the bipolar disorder the CHMP agreed with the following:
Danish: I betragtning af, at de godkendte valproatlægemidler i de forskellige EU-medlemsstater muligvis ikke alle omfatter indikationen "bipolær lidelse", nåede CHMP til enighed om følgende:
English: Moreover, no specific safety issues have been identified in studies in which antidepressant co-medication has been used in patients with bipolar disease.
Danish: Desuden har man ikke identificeret nogen specifikke sikkerhedsproblemer i undersøgelser, hvor der samtidig blev givet antidepressive lægemidler.
English: Whereas, in the original analysis time to recurrence of any mood episode or depressive episode, respectively was not significantly different in the three treatment groups, post-hoc analyses showed that valproate treated patients dropped out significantly less frequent than placebo treated patients due to a mood episode, whereas the respective difference was not statistically significant compared to lithium treated patients.
Danish: Mens der i den oprindelige analyse af den tid, der går, inden henholdsvis en humørsvingningsepisode eller depressiv episode finder sted igen, ikke var nogen signifikant forskel i de tre behandlingsgrupper, viste post hoc-analyserne, at patienter, der blev behandlet med valproat, udgik af undersøgelserne som følge af en humørsvingningsepisode i signifikant mindre grad end patienter, der fik placebo, mens den respektive forskel ikke var statistisk signifikant sammenlignet med de lithiumbehandlede patienter.
English: Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterium (time to recurrence of any mood episode), patients treated with valproate had better outcomes on several secondary outcome measures than those treated with lithium or placebo.
Danish: Mens Bowden-undersøgelsen, der var lithium- og placebokontrolleret, ikke påviste en statistisk signifikant forskel, når det gælder det primære effektmål (den tid, der går, inden en humørsvingningsepisode finder sted igen), havde patienter behandlet med valproat bedre resultater med hensyn til adskillige sekundære effektmål end de patienter, der fik lithium eller placebo.
English: Having considered the detailed grounds for re-examination provided by the MAH in writing, the CHMP agrees that changes related to the indication in bipolar disorders are relevant to those Marketing Authorisation Holders applying to the new or amended indication, as applicable.
Danish: Efter behandlingen af de detaljerede begrundelser, som indehaverne af markedsføringstilladelserne havde fremsendt skriftligt, nåede CHMP frem til den konklusion, at ændringer, som vedrører indikationen bipolær lidelse også er relevante for de indehavere af markedsføringstilladelser, som i givet fald ansøger om den ny eller ændrede indikation.
English: Concerns were raised by the Netherlands regarding the efficacious and safe use of valproic acid/valproate containing medicinal products in the acute treatment of manic episodes and the prevention of recurrence of mood episodes in patients with bipolar disorder.
Danish: Nederlandene gav udtryk for betænkeligheder med hensyn til en effektiv og sikker brug af lægemidler indeholdende valproinsyre/valproat til akut behandling af maniske episoder og forebyggelse af humørsvingningsepisoders tilbagevenden hos patienter med bipolær lidelse.
English: In addition, the CHMP considered the safety profile of valproic acid/valproate in this indication and recommended some amendments to the Product Information in relation to the risk of suicidal ideation and behaviour, to the use in pregnancy and to the inclusion of nausea, sedation and extrapyramidal effects as undesirable effects.
Danish: Desuden behandlede CHMP sikkerhedsprofilen for valproinsyre/valproat til denne indikation og anbefalede nogle ændringer af produktoplysningerne med hensyn til risikoen for selvmordstanker og -adfærd, brugen hos gravide og medtagelse af bivirkningerne
English: The MAHs for valproic acid/valproate authorised products applying to the new indication should submit a Risk Management Plan to the the national competent authorities (NCAs) of the respective member states.
Danish: Indehaverne af markedsføringstilladelsen for godkendte lægemidler indeholdende valproinsyre/valproat, som ansøger om den nye indikation, fremsender en risikostyringsplan til de nationale kompetente myndigheder i de respektive medlemsstater.
English: - The Committee concluded that valproic acid/valproate containing medicinal products have a positive benefit-risk ratio in the proposed amended indication “treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Danish: - CHMP konkluderede, at lægemidler indeholdende valproinsyre/valproat har et positivt benefit/risk-forhold til den foreslåede ændrede indikation "behandling af maniske episoder ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres.
English: The content, objectives and implementation of the RMP should be discussed between the relevant MAH and the NCA.
Danish: Risikostyringsplanens indhold, målsætninger og gennemførelse skal drøftes mellem de berørte indehavere af markedsføringstilladelsen og de nationale kompetente myndigheder.
English: - The Committee considered the grounds for re-examination submitted by various MAHs for valproic acid/valproate containing medicinal products on 13 April 2010 and the discussion within the Committee;
Danish: - Udvalget behandlede begrundelserne for revurdering, som var indsendt den 13. april 2010 af nogle af indehaverne af markedsføringstilladelserne for lægemidler indeholdende valproinsyre/valproat og tog hensyn til udvalgets videnskabelige drøftelse.
English: - The Committee concluded that the Product Information of all valproic acid/valproate containing medicinal products should be amended to include information on the treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristic and Package
Danish: - CHMP konkluderede, at produktoplysningerne for alle lægemidler indeholdende valproinsyre/valproat skal ændres, så der medtages oplysninger om behandling af maniske episoder ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres, og derfor anbefalede CHMP tilsvarende ændringer af de pågældende punkter i produktresuméet og indlægssedlen.
English: In the two-arm study performed by Calabrese and co-workers (2005), patients in the valproate group performed better in several efficacy parameters compared to the lithium group (in a statistically nonsignificant way), however significantly more patients in the lithium group experienced various adverse effects (tremor, polyuria, polydipsia) compared to the valproate group.
Danish: I den toarmede undersøgelse, der blev foretaget af Calabrese og medarbejdere (2005), klarede patienterne i valproatgruppen sig bedre for så vidt angik adskillige virkningsparametre sammenlignet med lithiumgruppen (på en statistisk ikke-signifikant måde).
English: Furthermore, when applying for the new indication the MAHs should submit a Risk Management Plan to the National Competent Authorities for assessment, as relevant.
Danish: Endvidere skulle indehaverne af markedsføringstilladelsen ved ansøgningen om den ny indikation, hvor dette er relevant, fremlægge en risikostyringsplan for de nationale kompetente myndigheder til vurdering.
English: - The Committee considered all the available data submitted on efficacy and the safety for valproic acid/valproate containing products, in relation to the treatment of mania in bipolar disorder as well in the prevention of recurrence of mood episodes.
Danish: - CHMP behandlede alle de foreliggende data, der var indsendt om virkning og sikkerhed for lægemidler indeholdende valproinsyre/valproat ved behandling af mani i forbindelse med bipolær lidelse og ved forebyggelse af humørsvingningsepisoders tilbagevenden.
English: It could be criticised that the latter study was not placebo-controlled; however the use of lithium in bipolar disorder, especially in the recurrence prevention is the established standard of care.
Danish: Brugen af lithium ved bipolær lidelse, navnlig til forebyggelse af tilbagevenden, er dog den etablerede behandlingsstandard.
English: All MAHs expressed their agreement with the overall recommended amendments to the SPC on the understanding that changes related to the indication in bipolar disorder are relevant to those
Danish: Alle indehaverne af markedsføringstilladelserne støttede de generelle ændringer til produktresuméet under den forudsætning, at ændringerne til indikationen bipolær lidelse er relevante for de indehavere af markedsføringstilladelser, som ansøger om den ny eller ændrede indikation.
English: The warnings in the product information remain appropriate.
Danish: Advarslerne i produktinformationen er fortsat passende.
English: The application was submitted to France as reference Member State and to Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Danish: Ansøgningen blev indgivet til Frankrig som referencemedlemsstat, og til de berørte medlemsstater Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Finland, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien og Det Forenede Kongerige.
English: The submitted studies are considered to be well conducted.
Danish: De forelagte undersøgelser anses for at være veludførte.
English: The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Danish: Ændringsproceduren (FR/V/0167/01/II/017) blev indledt den 28. januar
English: Treatment failures between Day 8 and Day 18 were considered relapses.
Danish: Behandlingssvigt mellem dag 8 og dag 18 blev anset for tilbagefald.
English: However, any use of antibiotic will lead to increase of resistance and therefore, prudent use should always be recommended.
Danish: Brug af ethvert antibiotikum vil imidlertid medføre øget resistens, hvorfor det altid bør anbefales, at det bruges forsvarligt.
English: The MIC90 of the total population of M. bovis was 4 µg/ml.
Danish: MIC90 for hele populationen af M. bovis var 4 µg/ml.
English: 49071 Beaucouzé France
Danish: 49071 Beaucouzé Frankrig
English: The follow up of animals was sufficiently long as to observe the same clinical disease progression in the control group as in the field.
Danish: Opfølgningen af dyrene var tilstrækkelig lang til at iagttage samme kliniske forløb af sygdommen i kontrolgruppen som i felten.
English: The final outcome and the risk for relapse was assessed when the antimicrobial effect of Resflor has ceased.
Danish: Det endelige resultat og risikoen for tilbagefald blev vurderet, da den antimikrobielle virkning af Resflor var ophørt.
English: Germany Intervet Deutschland GmbH Feldstraße 1a
Danish: Tyskland Intervet Deutschland GmbH Feldstraße 1a
English: This issue remained unsolved and therefore a CMDv procedure under Article 13(1) of Commission Regulation (EC) No 1234/2008 has started on 6 November 2013.
Danish: Dette spørgsmål forblev uafklaret, hvorfor der den 6. november 2013 blev indledt en CMD(v)procedure i medfør af artikel 13, stk. 1, i Kommissionens forordning (EF) nr. 1234/2008.
English: Mannheimia haemolytica was the most prevalent pathogen pre-treatment (142 isolates).
Danish: Mannheimia haemolytica var den mest udbredte patogene organisme før behandling (142 isolater).
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 24 January 2014, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No
Danish: Da referencemedlemsstaten og de berørte medlemsstater ikke var i stand til at nå til enighed om ændringen, indbragte Frankrig den 24. januar 2014 sagen for CVMP i medfør af artikel 13, stk. 2, i Kommissionens forordning (EF) nr. 1234/2008.
English: This is in line with the recommendations of the CVMP guideline on statistical principles (EMA/CVMP/EWP/81976/2010)
Danish: Dette er på linje med anbefalingerne i CVMP's retningslinjer for statistiske principper (EMA/CVMP/EWP/81976/2010)
English: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Spain
Danish: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Spanien
English: An additional statistical analysis has been carried out to demonstrate non-inferiority of florfenicol in comparison to the positive control with regards to the clinical cure rate on Day 7.
Danish: Der er udført en supplerende statistisk analyse for at påvise non-inferioritet af florfenicol i forhold til den positive kontrol hvad angår klinisk helbredelsesrate på dag 7.
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Danish: Det er indiceret til behandling af luftvejsinfektioner forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni forbundet med pyreksi.
English: The tested group was compared to two control groups, one negative control (saline) and a positive control.
Danish: Den testede gruppe blev sammenlignet med to kontrolgrupper, en negativ kontrol (saltvand) og en positiv kontrol.
English: However, it could not be used alone in this study, as this would have given an advantage to the tested product which is a combined product of florfenicol and flunixin.
Danish: Det kunne imidlertid ikke anvendes alene i denne undersøgelse, da dette ville have indebåret en fordel for den testede kombination af florfenicol og flunixin.
English: The experimental study performed in 2008 was blinded, randomised, and compliant with good clinical practice (GCP).
Danish: Den eksperimentelle undersøgelse fra 2008 var blindet, randomiseret og i overensstemmelse med god klinisk praksis (GCP).
English: Overall summary of the scientific evaluation of Resflor solution injectable and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Resflor, injektionsvæske, opløsning, og relaterede navne (se bilag I)
English: Intervet GesmbH Siemensstrasse 107 1210 Wien Austria
Danish: Intervet GesmbH Siemensstrasse 107 1210 Wien Østrig
English: The efficacy of Resflor against respiratory infection caused by M. bovis was demonstrated in two experimental models (performed in 2008 and 2012) and two clinical field trials (performed in 2004 and
Danish: Virkningen af Resflor mod luftvejsinfektioner forårsaget af M. bovis blev påvist i to forsøgsmodeller (udført i 2008 og 2012) og to kliniske feltundersøgelser (udført i 2004 og 2005).
English: • the CVMP considered that no specific risk of antimicrobial resistance has been identified with the use of this product at the recommended dose;
Danish: • CVMP fandt, at der ikke er påvist specifik risiko for antimikrobiel resistens ved anvendelse af produktet i den anbefalede dosis,
English: Mycoplasma bovis was next with 63 isolates followed by Pasteurella multocida (50 isolates).
Danish: Derefter kom Mycoplasma bovis med 63 isolater, efterfulgt af Pasteurella multocida (50 isolater).
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Danish: Fortegnelse over veterinærlægemidlets navn, lægemiddelform, styrke, dyrearter, indgivelsesvej, indehaver af markedsføringstilladelse i medlemsstaterne