FrancophonIA/ELRC3.0 huggingface dataset:
English: Opinion following an Article 6(12)
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 6, stk. 12,
English: The product is indicated for finishing pigs from 1 week of age.
Danish: Lægemidlet er indiceret til slagtesvin fra 1-uges-alderen.
English: The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr A.M. Brady as co-rapporteur.
Danish: Udvalget udpegede dr. C. Rubio Montejano som rapportør og dr. A.M. Brady som medrapportør.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended Summary of Product Characteristics and package leaflet in the Annex III.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og det ændrede produktresumé og den ændrede indlægsseddel af bilag III.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis M Hyo satisfies the criteria for approval.
Danish: På baggrund af rapportørernes vurdering af de aktuelt tilgængelige data vedtog CVMP den 19. maj 2010 en udtalelse, hvor udvalget anbefalede, at ansøgningen om en ændring for lægemidlet til dyr Porcilis M Hyo opfylder godkendelseskriterierne.
English: During the procedure Dr C. Muñoz Madero replaced Dr C. Rubio Montejano as rapporteur.
Danish: Under proceduren erstattede dr. C. Muñoz Madero dr. C. Rubio Montejano som rapportør.
English: On 2 October 2009 the United Kingdom on behalf of France, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality, safety and efficacy of the simultaneous administration of Porcilis M Hyo with Porcilis PRRS.
Danish: Den 2. oktober 2009 indbragte Det Forenede Kongerige på vegne af Frankrig sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 39 i direktiv 2001/82/EF, med senere ændringer, under henvisning til artikel 6, stk. 12, i forordning (EF) nr. 1084/2003 som følge af de betænkeligheder, Spanien havde givet udtryk for med hensyn til kvaliteten, sikkerheden og virkningen af samtidig indgivelse af Porcilis M Hyo og Porcilis PRRS.
English: The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis M Hyo concerning simultaneous administration with Porcilis PRRS.
Danish: Indehaveren af markedsføringstilladelsen, Intervet International B.V., indsendte i henhold til den gensidige anerkendelsesprocedure en ansøgning om en type II-ændring for Porcilis M Hyo, som vedrørte samtidig indgivelse med Porcilis PRRS.
English: referral for Porcilis M
Danish: om Porcilis M Hyo
English: Opinion following an Article 6(12)F F referral for Porcilis M Hyo EMA/345914/2010
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 6, stk. 12,F F om Porcilis M Hyo
English: The assessment in phase II was required.
Danish: Der krævedes fase II-vurdering.
English: The reference Member State (RMS) is the Czech Republic and 10 concerned Member States (CMS) are involved: Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom.
Danish: Referencemedlemsstaten er Tjekkiet, og de 10 berørte medlemsstater er: Østrig, Danmark, Frankrig, Tyskland, Irland, Italien, Nederlandene, Portugal, Spanien og Det Forenede Kongerige
English: The Committee considered whether the environmental risk assessment can be completed based on the information available, or further data needs to be provided.
Danish: Udvalget vurderede, om miljørisikovurderingen kan afsluttes på grundlag af de foreliggende oplysninger, eller om der er behov for yderligere oplysninger.
English: Having considered all data submitted the CVMP concluded that:
Danish: Efter gennemgang af alle de forelagte oplysninger konkluderede CVMP, at:
English: The combination of active substances is included in veterinary medicinal products currently authorised in the European Union for use in cattle, pigs, dogs and cats.
Danish: Denne kombination af aktive stoffer indgår i veterinærlægemidler, der er godkendt i EU til anvendelse hos kvæg, svin, hunde og katte.
English: and gastrointestinal infections caused by Clostridium spp., E. coli and Salmonella spp.
Danish: samt gastrointestinale infektioner forårsaget af Clostridium spp., E. coli og Salmonella spp.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from the Czech Republic.
Danish: Efter gennemgang af de forelagte oplysninger konkluderede udvalget følgende vedrørende de spørgsmål, der var rejst i meddelelsen fra Tjekkiet:
English: The applicant did not propose any risk mitigation measures, because they did not identify any environmental risks.
Danish: Ansøgeren foreslog ingen afhjælpende foranstaltninger, da der ikke var blevet konstateret nogen miljørisici.
English: Further assessment was required for algae, hence the applicant submitted advanced models for PECs in surfacewater (FOCUS).
Danish: For alger krævedes yderligere vurdering, hvorfor ansøgeren forelagde avancerede modeller til beregning af PEC-værdier i overfladevand (FOCUS).
English: According to the guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) the Environmental Risk Assessment targets at effects of the combination product.
Danish: I henhold til vejledningen om faste kombinationsprodukter af lægemidler (EMEA/CVMP/83804/2005) omfatter miljørisikovurderingen virkningerne af kombinationsproduktet.
English: Based on the PECsoil values the PECgroundwater and PECsurfacewater were calculated.
Danish: På grundlag af PECjord-værdierne beregnedes værdierne af PECgrundvand og PECoverfladevand.
English: • The ERA can be completed and the product poses no unacceptable risk to the environment.
Danish: • miljørisikovurderingen kan afsluttes, og produktet udgør ikke en uacceptabel risiko for miljøet.
English: Treatment of weaner pigs was considered to be the worst case scenario.
Danish: Behandling af fravænnede grise blev anset for det værst tænkelige scenarie.
English: The provided study on soil degradation of amoxicillin is considered acceptable even though nonlabelled material was used and the extraction efficiencies were slightly below those recommended in the OECD guideline 307.
Danish: Den forelagte undersøgelse af nedbrydning af amoxicillin i jord blev anset for acceptabel, skønt den var foretaget med umærket materiale og med en lidt lavere ekstraktionsgrad end den, der anbefales i OECD's vejledning 307.
English: The data collected from different public sources on metabolites indicate that there are no environmental risks (according to current ERA methodology).
Danish: Dataene fra forskellige offentligt tilgængelige kilder vedrørende metabolitter viser, at der ikke er nogen miljørisici (i henhold til gældende metoder til miljørisikovurdering).
English: Water
Danish: Vand
English: Amoxicillin is a semi-synthetic aminopenicillin with broad-spectrum bactericidal activity.
Danish: Amoxicillin er et halvsyntetisk aminopenicillin med bredspektret baktericid virkning.
English: Environmental risk
Danish: Miljørisiko
English: Hence the applicant used advanced models for PEC calculation in groundwater (FOCUS), as described in the CVMP guideline on environmental impact assessment for veterinary medicinal products (EMEA/CVMP/ERA/418282/2005-Rev.1).
Danish: Ansøgeren anvendte derfor avancerede modeller til beregning af PEC i grundvand (FOCUS) som beskrevet i CVMP's retningslinjer for miljøkonsekvensvurdering for veterinærlægemidler (EMEA/CVMP/ERA/418282/2005-Rev.1).
English: The metabolites of amoxicillin are not considered to pose a higher risk than the parent compound, therefore the presented ERA is considered the worst case scenario and is acceptable, despite the fact that it does not take into account the transformation products of the active substance.
Danish: Metabolitterne af amoxicillin regnes ikke for at udgøre en større risiko end moderstoffet, hvorfor den forelagte miljørisikovurdering anses for at være det værst tænkelige scenarie og kan godtages, selv om den ikke omfatter omdannelsesprodukterne at det aktive stof.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: De gældende tekster til produktresuméet, etiketteringen og indlægssedlen er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen.
English: Environmental risk assessment of the product
Danish: Miljørisikovurdering af produktet
English: Advanced models for PECs in groundwater with the lowest KOC value (40.4 ml/g) as the worst case confirm that predicted environmental concentrations in all scenarios were below the trigger value of 0.1 μg/l and the product does not pose any risk to groundwater.
Danish: Avancerede modeller for PEC i grundvand med den laveste værdi af adsorptionskoefficienten KOC (40,4 ml/g) som værste tilfælde bekræfter, at de forventede koncentrationer i miljøet i alle scenarier var under tærskelværdien 0,1 μg/l, og at produktet ikke udgør en risiko for grundvandet.
English: This value was subsequently used in calculations of RQs for aquatic organisms.
Danish: Denne værdi blev efterfølgende anvendt til beregning af risikoforholdene for akvatiske organismer.
English: Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding lack of data on the degradation in soil of amoxicillin and clavulanic acid and the adsorption/desorption of amoxicillin in soil, due to which the environmental risk assessment (ERA) could not be completed.
Danish: Under den decentrale procedure påpegede Nederlandene og Det Forenede Kongerige potentielle alvorlige risici som følge af manglende oplysninger om nedbrydning i jord af amoxicillin og clavulansyre og adsorption/desorption i jord af amoxicillin, hvorfor miljørisikovurderingen ikke kunne afsluttes.
English: It can be concluded that the product in not expected to pose a risk to the environment when used according to the recommendations in the SPC.
Danish: Det kan konkluderes, at produktet ikke forventes at udgøre en risiko for miljøet, når det anvendes i henhold til anbefalingerne i produktresuméet.
English: The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 11 July 2012.
Danish: Sagen blev derfor indbragt for CVMP den 11. juli 2012.
English: The refined RQ of 0.7 is below the trigger value of 1, hence the product does not pose a risk for the aquatic environment - surface water.
Danish: Det mere præcise risikoforhold RQ på 0,7 er under tærskelværdien 1, hvorfor produktet ikke udgør en risiko for det akvatiske miljø - overfladevand.
English: • The publicly available scientific literature demonstrates that metabolites of amoxicillin wouldn't pose a higher risk than the parent compound, and using amoxicillin in the environmental impact assessment is justified;
Danish: • den publicerede videnskabelige litteratur viser, at metabolitterne af amoxicillin ikke vil udgøre en større risiko end moderstoffet, hvorfor det er berettiget at lade miljørisikovurderingen gælde amoxicillin, og
English: The risk quotients (RQs) calculated for terrestrial plants and earthworms were below the trigger value of 1 and the product can be considered as safe for terrestrial organisms.
Danish: De beregnede risikoforhold (RQ) for terrestriske planter og regnorme var under tærskelværdien på 1, hvorfor produktet kan anses for at være sikkert for terrestriske organismer.
English: Terrestrial effects studies
Danish: Undersøgelse af virkningerne på terrestriske organismer
English: The environmental risk assessment indicates that the product will not pose an unacceptable risk for the environment when used in accordance with the proposed SPC.
Danish: Miljørisikovurderingen viser, at produktet ikke vil udgøre en uacceptabel risiko for miljøet, når det anvendes i overensstemmelse med det ansøgte produktresumé.
English: • The studies on the degradation in soil of amoxicillin and clavulanic acid and the adsorption/desorption of amoxicillin in soil provided by the applicant are acceptable;
Danish: • de er ansøgeren forelagte undersøgelser om nedbrydning i jorden af amoxicillin og clavulansyre og adsorption /desorption af amoxicillin i jord kan godtages,
English: The product containing amoxicillin and clavulanic acid (in the form of the potassium salt) at a ratio 4:1 is indicated for treatment of infections caused by microorganisms in intensively reared pigs including respiratory diseases.
Danish: Produktet, der indeholder amoxicillin og clavulansyre (som kaliumsaltet) i forholdet 4:1, er indiceret til behandling af infektioner forårsaget af mikroorganismer hos intensivt opdrættede svin, herunder luftvejssygdomme.
English: Overall, the data package submitted by the applicant regarding environmental risk assessment is considered sufficient taking into account the nature of this application for marketing authorisation (generic application).
Danish: Som helhed fandtes ansøgningens dokumentation vedrørende miljørisikovurdering tilstrækkelig i betragtning af ansøgningens art (generisk ansøgning).
English: Quality, Target animal safety, User safety, Residues, Resistance and Efficacy were not assessed in this referral procedure.
Danish: Denne henvisningsprocedure omfatter ikke kvalitet, sikkerhed for måldyrearten, brugersikkerhed, restkoncentrationer, resistens eller virkning.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of STRENZEN 500/125 mg/g powder for use in drinking water for pigs due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the product.
Danish: Indbringelsen i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF fandt sted på grund af betænkelighed ved, at ansøgeren ikke på tilfredsstillende vis havde påvist miljøsikkerheden for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, da der manglede afgørende oplysninger, uden hvilke der ikke kunne drages konklusioner om produktets miljøsikkerhed.
English: The PECsurfacewater was calculated to be 31.80 μg/l for amoxicillin and 1.09 μg/l for clavulanic acid.
Danish: PECoverfladevand blev beregnet til 31,80 μg/l for amoxicillin og 1,09 μg/l for clavulansyre.
English: Therefore, the CVMP recommended the granting of the marketing authorisation for the veterinary medicinal products referred to in annex I for which the valid Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in annex III.
Danish: CHMP anbefalede derfor udstedelse af markedsføringstilladelse for de i bilag I anførte lægemidler, for hvilke det gældende produktresumé og den gældende etikettering og indlægsseddel fortsat er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III.
English: The PECgroundwater for both compounds was above the trigger value 0.1 μg/l (PECgroundwater for amoxicillin was 95.40 μg/l and for clavulanic acid 3.27 μg/l).
Danish: PECgrundvand for begge stoffer var over tærskelværdien 0,1 μg/l (PECgrundvand var 95,40 μg/l for amoxicillin og 3,27 μg/l for clavulansyre).
English: The exposure to the environment will be via slurry application onto land.
Danish: Eksponeringen af miljøet sker via spredning af gylle på jorden.
English: Czech Republic Novartis Animal Health Inc. Schwarzwaldallee 215
Danish: Storbritannien Novartis Animal Health Inc.
English: PECsoil values for clavulanic acid administered in weaner pigs and fattening pigs exceeded the trigger value 100 μg/kg.
Danish: PECjord-værdierne for clavulansyre ved administration til fravænnede grise og slagtegrise oversteg tærskelværdien 100 μg/kg.
English: Switzerland
Danish: Schweiz
English: Having considered all the overall submitted data in writing and in the oral explanation the CVMP concluded the data package regarding environmental risk assessment submitted by the applicant is considered sufficient and the overall benefit-risk balance of the product is positive.
Danish: Efter gennemgang af alle oplysninger fra den skriftlige og mundtlige fremlæggelse konkluderede CVMP, at ansøgningens dokumentation vedrørende miljørisikovurdering anses for tilstrækkelig, og at produktets overordnede benefit/risk-forhold er positivt.
English: Based on the revised ERA and considering additional information from peer-reviewed scientific literature, no serious risk for the environment was identified and the risk can be properly managed by the proposed conditions for use of the product as per the currently proposed SPC.
Danish: På grundlag af den reviderede miljørisikovurdering og på baggrund af supplerende oplysninger i litteraturen fra peer-review-evaluerede videnskabelige undersøgelser fandtes der ingen alvorlig miljørisiko, og risikoen kan håndteres tilfredsstillende med de påtænkte anvendelsesbetingelser for produktet i overensstemmelse med det ansøgte produktresumé.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), Styrke(r), indgivelsesvej(e), ansøger(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Danish: Clavulansyre er en naturligt forekommende beta-lactamasehæmmer, der virker kemisk synergistisk med amoxicillin.
English: Strength Animal species
Danish: Lægemiddelform Styrke Dyrearter Indgivelsessvej
English: The PECsoil value 217 μg/kg was used in the subsequent assessment.
Danish: I den efterfølgende vurdering anvendtes PECjord-værdien 217 μg/kg.
English: The target species are treated by 20 mg/kg bw of amoxicillin and 5 mg/kg bw of clavulanic acid for 5 consecutive days.
Danish: Måldyrearten behandles med amoxicillin, 20 mg/kg kropsvægt, og clavulansyre, 5 mg/kg kropsvægt, i 5 på hinanden følgende dage.
English: Considering the total evidence presented in the dossier and the data available in the public domain, the absence of the data concerning metabolites does not affect the positive benefit-risk ratio of the product.
Danish: På baggrund af en samlet vurdering af den forelagte dokumentation og de offentligt tilgængelige oplysninger anses de manglende data om metabolitter for at være uden betydning for det positive benefit/risk-forhold for produktet.
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Danish: Denne indbringelsesprocedure giver ikke anledning til krav om yderligere foranstaltninger til risikohåndtering eller risikonedsættelse.
English: PECgroundwater (combination) was 98.67 μg/l.
Danish: PECgrundvand (kombination) var 98,67 μg/l.
English: The PECsurfacewater (combination) was 32.89 μg/l.
Danish: PECoverfladevand (kombination) var 32,89 μg/l.
English: The RQs for daphnids and fish were below the trigger value of 1 but for algae the RQ was above the trigger value.
Danish: Risikoforholdet for dafnier og fisk var under tærskelværdien 1, men for alger var det over tærskelværdien.
English: PECsoil (combination) was 1086 μg/kg.
Danish: PECjord-værdien (kombination) var 1 086 μg/kg.
English: The PECsoil value 869 μg/kg was used in the subsequent assessment.
Danish: I den efterfølgende vurdering anvendtes PECjord-værdien 869 μg/kg.
English: Aquatic environment
Danish: Vandmiljøet
English: In order to address the concerns raised by the referral, the applicant provided an adapted ERA for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and further information on the degradation in soil and sorption to soil.
Danish: Til imødekommelse af de betænkeligheder, der var rejst ved indbringelsen, fremlagde ansøgeren en modificeret miljørisikovurdering for STRENZEN, pulver til opløsning drikkevand, 500/125 mg/g, til svin, samt supplerende oplysninger om nedbrydning i jord og adsorption til jord.
English: The refined PECsurfacewater value was used for recalculation of RQ for algae.
Danish: Denne mere præcise PECoverfladevand blev anvendt til fornyet beregning af risikoforholdet for alger.
English: Therefore, the CVMP recommended the granting of the marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III of the CVMP Opinion.
Danish: CHMP anbefalede derfor udstedelse af markedsføringstilladelse for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, og relaterede navne, for hvilke produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III til CVMP's udtalelse.
English: The application in question, submitted via the decentralised procedure, is a generic application according to Art. 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water registered in the Czech Republic (No.96/069/98-C).
Danish: Ansøgningen er indgivet via den decentrale procedure som en generisk ansøgning i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, som ændret, der henviser til referenceproduktet Amoksiklav, pulver til opløsning i drikkevand, 500/125 mg/g, som er godkendt i Tjekkiet (nr. 96/069/98-C).
English: The proposed indications for STRENZEN 500/125 mg/g powder for use in drinking water for pigs are treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Danish: De ansøgte indikationer for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, er behandling af luftvejsinfektioner forårsaget af mikroorganismer, der er følsomme for kombinationen af amoxicillin og clavulansyre, dvs. Actinobacillus pleuropneumoniae, Pasteurella spp.
English: Soil
Danish: Jord
English: The applicant submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Danish: Ansøgeren indgav en ansøgning via den decentrale procedure for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, som ændret, med henvisning til referenceproduktet Amoksiklav, pulver til opløsning i drikkevand, 500/125 mg/g, der er godkendt i Tjekkiet (markedsføringstilladelse nr. 96/069/98-C).
English: The benefit of STRENZEN 500/125 mg/g powder for use in drinking water for pigs is that treatment of infections caused by microorganisms in intensively reared pigs including respiratory diseases can be treated.
Danish: Fordelen ved STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, er muligheden for at behandle infektioner forårsaget af mikroorganismer hos intensivt opdrættede svin, herunder luftvejssygdomme.
English: The worst case scenario was also considered the treatment of weaner pigs.
Danish: Også her blev behandling af fravænnede grise anset for at være det værst tænkelige scenarie.
English: These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the CMD(v) was started.
Danish: Disse spørgsmål forblev uafklarede, hvorfor der blev indledt en indbringelsesprocedure i henhold til artikel 33, stk. 1, i direktiv 2001/82/EF, for CMD(v) (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale godkendelsesprocedurer - veterinær).