FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of E. coli, the PK/PD analysis was only favourable for strains with MICs equal to or below 4.44 µg/ml.
Danish: Ved E. coli var den farmakokinetiske/farmakodynamiske analyse kun favorabel for stammer med en MIC-værdi på 4,44 µg/ml eller derunder.
English: Finally the PK/PD model does not allow justifying the duration of treatment.
Danish: Endelig kan den farmakokinetiske/farmakodynamiske model ikke godtgøre behandlingsvarigheden.
English: • To provide adequate clinical data in support of an indication against colibacillosis at the recommended dose and duration of treatment.
Danish: • Fremskaffe relevante kliniske data til understøttelse af indikationen behandling af colibacillose ved den anbefalede dosis og behandlingsvarighed.
English: The CVMP was requested to review all available pre-clinical, clinical and residue depletion data for veterinary medicinal products containing paromomycin to be administered parenterally to pigs and recommend appropriate indications, dosing recommendations and withdrawal periods.
Danish: CVMP blev anmodet om at gennemgå alle tilgængelige prækliniske/kliniske data og restkoncentrationsdata for paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, og anbefale relevante indikationer, doseringer og tilbageholdelsestider.
English: The same marketing authorisation holder provided data in order to justify the use of ‘Gabbrovet solution injectable' in pigs at a dose of 14 mg paromomycin base/kg bodyweight for 5 consecutive days.
Danish: Samme indehaver af markedsføringstilladelse fremlagde data for at understøtte anvendelse af "Gabbrovet solution injectable" hos svin i en dosis på 14 mg paromomycinbase/kg kropsvægt i 5 dage i træk.
English: The CVMP was also asked to recommend whether in view of the elements described in the referral notification the marketing authorisations for the veterinary medicinal products concerned should be maintained, varied, suspended, or withdrawn.
Danish: På baggrund af de forhold, der er beskrevet i indbringelsesanmeldelsen, blev CVMP også anmodet om at anbefale, hvorvidt markedsføringstilladelserne til de pågældende veterinærlægemidler bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: However, the deficiencies noted in the study (absence of data on storage stability, the wide recovery rates in muscle samples and the absence of ring sample in the sampling of the injection site) cannot be covered by any safety span.
Danish: De mangler, der er bemærket i studiet (fravær af data om opbevaringsstabilitet, det brede interval af restkoncentration fundet i muskelprøver og fravær af en ringprøve i forbindelse med prøvetagning fra injektionsstedet), kan imidlertid ikke omfattes af en sikkerhedsmargin.
English: • To provide adequate clinical data (including GCP, randomised, blinded field study) in support of the treatment of pleuropneumonia caused by Actinobacillus pleuropneumoniae at the recommended dose and duration of treatment.
Danish: • Fremskaffe relevante kliniske data (der omfatter et randomiseret, blindet GCP-feltstudie) til understøttelse af behandling af pleuropneumoni forårsaget af Actinobacillus pleuropneumoniae ved den anbefalede dosis og behandlingsvarighed.
English: While target animal safety was not in the scope of this referral, there are no known adverse events in pigs.
Danish: Denne indbringelsesprocedure omfatter ikke sikkerhed for måldyrearten, men der er ingen kendte bivirkninger hos svin.
English: However, a number of deficiencies in the study were noted related to the storage of the samples, the stability of the residues in storage conditions, the wide range of recovery in muscle and the absence of a ring-shaped control surrounding the excised injection site core sample.
Danish: Der blev imidlertid bemærket en række mangler i studiet, hvad angår opbevaring af prøver, stabilitet af restkoncentrationer under opbevaring, det brede interval af restkoncentration fundet i muskelvævet og fravær af en ringformet kontrolprøve fra vævet omkring den eksciderede prøve fra injektionsstedets kerne.
English: Furthermore, neither dose determination, nor dose confirmation studies have been made available to confirm the results of the PK/PD analysis and no field trial was made available.
Danish: Derudover er der ikke fremlagt studier til dosisbestemmelse eller dosisbekræftelse for at stadfæste resultaterne af den farmakokinetiske/farmakodynamiske analyse, ligesom der ikke foreligger noget feltstudie.
English: • the CVMP considered that the use of veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not supported by pre-clinical, clinical and residue depletion data and the currently recommended indications, dosing regimens and withdrawal period could pose a potential risk to animal and human health;
Danish: • CVMP vurderer, at anvendelse af paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, ikke er understøttet af prækliniske/kliniske data og restkoncentrationsdata, og at de aktuelt anbefalede indikationer, doseringsregimer og tilbageholdelsestider kan udgøre en potentiel risiko for dyrs og menneskers sundhed.
English: Evaluation and conclusions on the benefit-risk balance Therefore, the Committee considers that in the absence of adequate pre-clinical, clinical and residue depletion data and because the use of these medicinal products could pose a potential risk to animal and human health, the benefit-risk balance for the concerned veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not favourable.
Danish: Vurdering af benefit/risk-forholdet og konklusioner Da der ikke foreligger relevante prækliniske/kliniske data og restkoncentrationsdata, og da anvendelse af disse lægemidler kan medføre en potentiel risiko for dyrs og menneskers sundhed, vurderer udvalget følgelig, at benefit/risk-forholdet for de pågældende paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, er ugunstigt.
English: This result, however is likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against E. coli.
Danish: Dette resultat kan imidlertid føre til en overvurdering af paromomycins effekt ved den anbefalede dosis, da paromomycins procentvise binding til plasmaproteiner ikke blev klarlagt, hvilket kan reducere mængden af paromomycin i plasma, der kan være virksom mod E. coli.
English: The residue depletion study was performed in pigs with the intramuscular administration of the maximum recommended dose of 14 mg paromomycin/kg bodyweight/day for 5 consecutive days.
Danish: Der blev gennemført et restkoncentrationsstudie hos svin med intramuskulær administration af den maksimale anbefalede dosis på 14 mg paromomycin/kg kropsvægt/dag i 5 dage i træk.
English: This already poor result is in addition likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against A. pleuropneumoniae.
Danish: Desuden vil dette allerede ringe resultat sandsynligvis føre til overvurdering af paromomycins effekt i den anbefalede dosis, da paromomycins procentvise binding til plasmaproteiner ikke blev klarlagt, hvilket vil reducere mængden af paromomycin i plasma, der kan være virksom mod A. pleuropneumoniae.
English: The withdrawal period should be based on robust and complete data (animal phase and validation of the analytical method) in accordance with the guidelines in force.
Danish: • Et nyt restkoncentrationsstudie er påkrævet, uanset om doseringsregimet er ændret eller ej. Tilbageholdelsestiden bør baseres på robuste og komplette data (dyreforsøgsfase og validering af analysemetode) i overensstemmelse med gældende retningslinjer.
English: In the absence of adequate data to support indications and posology, there is a risk that product administration at the currently recommended dose and duration of treatment will lead to ineffective treatment and a potential unnecessary suffering in the treated animals.
Danish: I fravær af tilstrækkelige data til at understøtte indikationerne og doseringen er der en risiko for, at administration af produktet i den aktuelt anbefalede dosis og behandlingsvarighed vil føre til ineffektiv behandling og mulig unødig lidelse hos de behandlede dyr.
English: A pharmacokinetic study was carried out in target animals at the recommended dose (14 mg/kg bodyweight of paromomycin).
Danish: Der blev gennemført et farmakokinetisk studie hos måldyrearter under anvendelse af den anbefalede dosis (14 mg paromomycin/kg kropsvægt).
English: In the absence of adequate data to support indications and posology, there is a risk that product administration at the currently recommended dose will lead to ineffective treatment and a potential unnecessary suffering in the treated animals.
Danish: I fravær af relevante data til at understøtte indikationerne og doseringen er der en risiko for, at administration af produktet i den aktuelt anbefalede dosis vil føre til ineffektiv behandling og mulig unødig lidelse hos de behandlede dyr.
English: The currently authorised indications are unspecific and no specific pathogens are mentioned, i.e. for the treatment of bacterial infections caused by pathogens which are susceptible to paromomycin or for bacterial infections of the respiratory tract, uro-genital tract, mastitis, enteritis, abscess, wounds, canine leishmaniosis and surgery.
Danish: De aktuelt godkendte indikationer er uspecifikke, idet der ikke nævnes nogen specifikke patogener, f.eks. hvad angår behandling af bakterieinfektioner forårsaget af patogener, der er følsomme over for paromomycin, eller bakterieinfektioner i luftveje, det urogenitale system, mastitis, enteritis, abscesser, sår, hunde-leishmaniasis og kirurgi.
English: o Potential effect(s) on the user safety;
Danish: o Vurdering af indvirkningen på miljøet o Potentiel indvirkning på brugersikkerheden o Potentiel indvirkning på tolerabiliteten hos måldyrearten.
English: • Treatment of E. coli involved in swine colibacillosis (neonatal diarrhoea, post-weaning diarrhoea, oedema disease) and against Actinobacillus pleuropneumoniae strains with a
Danish: • Behandling af E. coli ved svine-colibacillose (neonatal diarré, diarré efter fravænning,
English: The Netherlands Huvepharma NV Uitbreidingstraat 80
Danish: Nederlandene Huvepharma NV Uitbreidingstraat 80
English: As no adequate data are available to support indications, posology and withdrawal periods, the CVMP is not able to recommend any appropriate indications, dosage and withdrawal periods for the concerned veterinary medicinal products.
Danish: Risikostyring og risikominimerende foranstaltninger Da der ikke foreligger tilstrækkelige data til understøttelse af indikationer, doseringer og tilbageholdelsestider, kan CVMP ikke anbefale nogen relevante indikationer, doseringer eller tilbageholdelsestider for de pågældende veterinærlægemidler.
English: One of the marketing authorisation holders proposed a withdrawal time of 16 days based on a linear regression with kidney as limiting tissue, and 16 days with muscle of injection site by using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Danish: En af indehaverne af markedsføringstilladelse foreslog en tilbageholdelsestid på 16 dage ud fra en lineær regressionsmodel med nyrerne som begrænsende væv, og 16 dage for muskelvæv ved injektionsstedet under anvendelse af den "alternative" metode i overensstemmelse med CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95).
English: Grounds for suspension of the marketing authorisations
Danish: Begrundelser for suspendering af markedsføringstilladelserne
English: Belgium Huvepharma NV Uitbreidingstraat 80
Danish: Grækenland Huvepharma NV Uitbreidingstraat 80
English: The statistical evaluation to establish withdrawal period was carried out following the CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Danish: Den statistiske evaluering til fastsættelse af tilbageholdelsestiden blev gennemført i henhold til CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95)1.
English: Parofor 175 mg/ml
Danish: Parofor 175 mg/ml Paromomycin 175 mg/ml
English: • the CVMP concluded that the benefit-risk assessment for veterinary medicinal products containing paromomycin to be administered parenterally to pigs is negative because there were inadequate data to support efficacy of these veterinary medicinal products for the proposed indications at the recommended treatment dose and that this deficiency poses a risk of ineffective treatment and antimicrobial resistance development; the CVMP has recommended the suspension of the marketing authorisations for veterinary medicinal products containing paromomycin to be administered parenterally to pigs as referred in Annex I. The conditions to lift the suspension of the marketing authorisations are set out in Annex III.
Danish: • CVMP er af den opfattelse, at benefit/risk-forholdet for paromomycin-holdige veterinærlægemidler, der administreres parenteralt til svin, er negativt, fordi der ikke foreligger relevante data til understøttelse af disse veterinærlægemidlers effekt i de foreslåede indikationer i den anbefalede behandlingsdosis, og at denne mangel udgør en risiko for ineffektiv behandling og udvikling af antimikrobiel resistens.
English: For injection site, a rounded withdrawal period of 16 days was calculated using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Danish: Hvad angår injektionsstedet, blev der fastsat en tilbageholdelsestid, som blev afrundet til 16 dage under anvendelse af den "alternative" metode i overensstemmelse med CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95).
English: Benefit-risk assessment
Danish: Vurdering af fordele og risici
English: For kidney, a withdrawal time rounded to 16 days was determined based on linear regression using the ‘statistical' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Danish: Hvad angår nyrerne, blev der fastsat en tilbageholdelsestid, som blev afrundet til 16 dage ud fra en lineær regressionsmodel under anvendelse af den "statistiske" metode, jf. CVMP's vejledning i metoder til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95).
English: 28 June 2012
Danish: Den 28. juni 2012
English: The European Commission issued a decision on 28 June 2012.
Danish: Europa-Kommissionen traf en afgørelse den 28. juni 2012.
English: However, the Member States were not able to reach an agreement and the UK referred the matter to the CHMP for arbitration on 22 December 2011.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongerige henviste sagen til CHMP med henblik på voldgift den 22. december 2011.
English: In the light of this The Netherlands questioned the long-term efficacy of this product in respect of asthma control.
Danish: På denne baggrund betvivlede Nederlandene den langsigtede virkning af produktet til astmakontrol.
English: EMA/264710/2012 Rev.1 EMEA/H/A-29/001326 EMEA/H/A-29/001327
Danish: EMA/264710/2012 rev.1 EMEA/H/A-29/001326
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Flutiform and Iffeza and associated names.
Danish: Den 19. april 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af Flutiform og Iffeza og relaterede navne.
English: What are Flutiform and Iffeza?
Danish: Hvad er Flutiform og Iffeza?
English: The CHMP looked at all the available evidence on the benefits and risks of the medicine in the treatment of asthma and concluded that the questions raised over its long-term effectiveness had been adequately addressed.
Danish: CHMP gennemgik al foreliggende dokumentation om fordele og risici ved lægemidlet til behandling af astma og konkluderede, at de rejste spørgsmål vedrørende dets langsigtede virkning er tilfredsstillende belyst.
English: Flutiform will also be marketed as Flofera and Flutiformo.
Danish: Flutiform vil desuden blive markedsført under navnene Flofera og Flutiformo.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden).
Danish: re. Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Det Forenede Kongerige) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de "berørte medlemsstater", her Belgien, Bulgarien, Cypern, Danmark, Finland, Frankrig, Island, Irland, Italien, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Sverige, Tjekkiet, Tyskland og Østrig).
English: Therefore, the Committee concluded that the benefits of Flutiform and Iffeza outweigh the risks and that marketing authorisation should be granted in all concerned Member States.
Danish: Udvalget konkluderede derfor, at fordelene ved Flutiform og Iffeza overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i alle de berørte medlemsstater.
English: Why were Flutiform and Iffeza reviewed?
Danish: Hvorfor blev Flutiform og Iffeza vurderet igen?
English: Napp Pharmaceuticals Ltd submitted marketing authorisation applications for Flutiform and Iffeza and associated names to the UK medicines regulatory agency under the decentralised procedure.
Danish: Napp Pharmaceuticals Ltd indgav ansøgninger om markedsføringstilladelse for Flutiform og Iffeza og relaterede navne til Det Forenede Kongeriges lægemiddelstyrelse i henhold til den decentrale procedu
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Flutiform and Iffeza outweigh the risks, and that the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Flutiform og Iffeza er større end risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i følgende EU-medlemsstater: Belgien, Bulgarien, Cypern, Danmark, Finland, Frankrig, Island, Irland, Italien, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Sverige, Tjekkiet, Tyskland og Østrig.
English: Flutiform and Iffeza are asthma medicines containing two active substances, fluticasone propionate and formoterol fumarate.
Danish: Flutiform og Iffeza er astmalægemidler, der indeholder de to aktive stoffer fluticasonpropionat og formoterolfumarat.
English: Fluticasone propionate is an inhaled corticosteroid with high local anti-inflammatory activity and has been shown to reduce symptoms of asthma and reduce exacerbations of asthma.
Danish: Fluticasonpropionat er et inhalationsglukokortikosteroid med høj lokal antiinflammatorisk virkning og er påvist at nedsætte symptomerne på astma og at reducere anfald med forværring af astma.
English: The grounds for the referral were concerns raised by The Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate a lower amount of fluticasone propionate being deposited in the lungs.
Danish: Begrundelsen for indbringelsen var betænkeligheder, der var rejst af Nederlandene vedrørende data, der viser, at indgift af Flutiform og Iffeza giver lavere indhold af fluticasonpropionat i blodet end indgift af fluticasonpropionat alene, hvilket kan betyde, at der afsættes mindre fluticasonpropionat i lungerne.
English: They are to be used for the treatment of asthma in situations where the combination of an inhaled corticosteroid (such as fluticasone propionate) and a long-acting beta 2 agonist (such as formoterol fumarate) is appropriate.
Danish: Det anvendes til behandling af astma i situationer, hvor kombination af inhalationskortikosteroid (her fluticasonpropionat) og en langtidsvirkende beta 2-agonist (her formoterolfumarat) er hensigtsmæssig.
English: The selective long-acting beta 2 agonist formoterol fumarate exerts an effect on beta 2 receptors on the smooth muscle in the lung to produce relaxation of the airways and bronchodilatation.
Danish: Den selektive langtidsvirkende beta 2-agonist formoterolfumarat virker på beta 2-receptorerne i glat muskulatur i lungerne, så luftvejene afslappes, og bronkierne udvides.
English: Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EMA/550822/2012
Danish: Spørgsmål og svar om Flutiform og Iffeza (fluticasonpropionat/formoterolfumarat,inhalationsspray, suspension, 50/5, 125/5 og 250/10 µg) EMA/264710/2012
English: When inhaled, formoterol fumarate helps to keep the airways open allowing the patient to breathe more easily.
Danish: Når formoterolfumarat inhaleres, holder det luftvejene åbne, så patienten får lettere ved at trække vejret.
English: Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension)
Danish: Spørgsmål og svar om Flutiform og Iffeza (fluticasonpropionat/formoterolfumarat, inhalationsspray, suspension, 50/5, 125/5 og 250/10 µg)
English: • the new additional risk minimisation measures.
Danish: • de nye supplerende risikominimeringsforanstaltninger
English: The MAHs are strongly encouraged to collaborate to perform a joint study.
Danish: Indehaverne af markedsføringstilladelse opfordres kraftigt til at samarbejde om udførelse af et fælles studie.
English: Each marketing authorisation holder shall complete the below conditions, within the stated timeframe, and the competent authorities shall ensure that the following is fulfilled:
Danish: Hver indehaver af markedsføringstilladelse skal opfylde nedenstående betingelser inden for den angivne tidsfrist, og de kompetente myndigheder skal sikre, at følgende er opfyldt:
English: The final study report shall be submitted for assessment by the PRAC:
Danish: Den endelige studierapport forelægges til PRAC's vurdering:
English: Protocol to be submitted for assessment by the PRAC:
Danish: Protokol, der forelægges til PRAC's vurdering:
English: Each MAH shall develop training materials according to the following core elements:
Danish: Hver indehaver af markedsføringstilladelse udarbejder oplysningsmateriale i overensstemmelse med følgende kerneelementer:
English: • a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information
Danish: • en påmindelse om indikation, dosis, behandlingsvarighed,
English: • the risks related to the use of HES solutions for infusion outside the terms of the MA
Danish: • risiciene ved at bruge HES-infusionsvæske, opløsning, uden for betingelserne i markedsføringstilladelsen