FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP was asked to conclude on whether the duration of treatment with veterinary medicinal products containing tylosin beyond three weeks is justified and whether these products are still effective against swine dysentery caused by B. hyodysenteriae.
Danish: CVMP blev anmodet om at fremsætte en konklusion om, hvorvidt behandlingsvarigheden med veterinærlægemidler indeholdende tylosin ud over 3 uger er berettiget, og om disse produkter stadig er effektive mod svinedysenteri forårsaget af B. hyodysenteriae.
English: In contrast, premix formulations authorised for the treatment and prevention of ileitis (caused by Lawsonia intracellularis) most often recommend treatment for not longer than up to three weeks.
Danish: For premixformuleringer godkendt til behandling og forebyggelse af ileitis (forårsaget af Lawsonia intracellularis) anbefales derimod oftest behandling i højst tre uger.
English: To limit the selection pressure for bacteria unnecessary use should be avoided.
Danish: For at begrænse selektionstrykket på bakterierne bør unødvendig anvendelse undgås.
English: A similar treatment strategy is recommended for tylosin premix formulation for the treatment of swine dysentery where it is mentioned that treatment can be continued ‘until the end of risk', ‘as long as necessary' or ‘until slaughter'.
Danish: En tilsvarende strategi anbefales for premixformuleringer af tylosin til behandling af svinedysenteri, hvor det nævnes, at behandlingen kan fortsætte “indtil risikoen er forbi”, “så længe det er nødvendigt” eller “indtil slagtning”.
English: V. del Commercio 28/30 41012 Carpi (MO) Italy
Danish: V. del Commercio 28/30 41012 Carpi (MO) Italien
English: Via A. Gramsci, 731-733 50019 Sesto Fiorentino (IT) Italy
Danish: Via A. Gramsci, 731-733 50019 Sesto Fiorentino (IT) Italien
English: Tylosin and its phosphate and tartrate salts are used in food producing species for the treatment of conditions caused by sensitive organisms.
Danish: Tylosin og dets fosfat- og tartratsalt anvendes i fødevareproducerende arter til behandling af sygdomme forårsaget af tylosin-følsomme organismer.
English: SUPER´S DIANA, S.L.
Danish: Spanien SUPER´S DIANA, S.L.
English: These products are effective medicines for the treatment of several diseases such as respiratory disease and ileitis/porcine intestinal adenopathy (caused by Lawsonia intracellularis).
Danish: Produkterne er effektive til behandling af flere sygdomme såsom luftvejssygdomme og ileitis/intestinal adenopati hos svin (forårsaget af Lawsonia intracellularis).
English: 1ere avenue 2065 m L. I. D. 06516 Carros
Danish: Frankrig VIRBAC 1ere avenue 2065 m L. I. D. 06516 Carros
English: D-61352 Bad Homburg Germany
Danish: D-61352 Bad Homburg Tyskland
English: For products where any specific treatment duration shorter than 3 weeks is recommended this should be maintained in the product information.
Danish: For produkter med en anbefalet specifik behandlingsvarighed på mindre end 3 uger bør denne opretholdes i produktinformationen.
English: Medical Intertrade d.o.o.
Danish: Kroatien Medical Intertrade d.o.o.
English: Therefore, on 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Danish: Den 30. oktober 2013 forelagde Sverige derfor agenturet en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF for veterinærmedicinske produkter indeholdende tylosin til oral administration i foderet eller drikkevandet til svin.
English: ZONE D'ACTIVITES DU BOIS DE TEILLAY
Danish: Frankrig DELTAVIT ZONE D'ACTIVITES DU BOIS DE TEILLAY
English: LABORATORIOS CALIER, S.A. BARCELONÉS, 26.
Danish: Spanien LABORATORIOS CALIER, S.A. BARCELONÉS, 26.
English: DK-3480 Fredensborg Denmark
Danish: DK-3480 Fredensborg Danmark
English: The published scientific reports regarding the resistance situation for B. hyodysenteriae provide a discouraging picture, where tylosin resistance today is close to complete in many areas of the European Union.
Danish: De publicerede videnskabelige artikler om resistenssituationen for B. hyodysenteriae tegner et nedslående billede, hvor der i dag er tæt fuldstændig resistens over for tylosin i mange regioner i EU.
English: SC Delos Impex 96 SRLStr Horia, Closca si Crisan, Otopeni judetul Ilfov
Danish: Rumænien SC Delos Impex 96 SRLStr Horia, Closca si Crisan, Otopeni judetul Ilfov
English: LABORATOIRES BIOVE 3 RUE DE LORRAINE 62510 ARQUES France
Danish: Frankrig LABORATOIRES BIOVE 3 RUE DE LORRAINE 62510 ARQUES
English: To maintain oral tylosin as an efficacious treatment for other currently authorised indications for pigs, unnecessary exposure should be avoided.
Danish: For at bevare oralt tylosin som en effektiv behandling til andre aktuelt godkendte indikationer til svin bør unødig eksponering undgås.
English: Risk management or mitigation measures
Danish: Foranstaltninger til risikohåndtering eller -begrænsning
English: For similar reasons recommendations to reduce the initial dose for an extended treatment period are not acceptable.
Danish: Af disse grunde kan anbefalinger om at nedsætte den indledende dosis i en udvidet behandlingsperiode ikke godtages.
English: However, effective alternatives are available (e.g. pleuromutilins) and, as there are very few susceptible outbreaks, the risk for inadequate treatment is deemed to outweigh the possible benefit of an additional treatment option in the unlikely event of confirmed susceptibility.
Danish: Der findes imidlertid effektive alternativer (f.eks. pleuromutiliner) og da der er meget få udbrud med følsomme organismer, anses risikoen for inadækvat behandling for at overstige den mulige fordel ved at have en supplerende behandlingsmulighed i det usandsynlige tilfælde, hvor følsomheden bekræftes.
English: AniMed Service AG Liebochstrasse 9 8143 Dobl Austria
Danish: AniMed Service AG Liebochstrasse 9 8143 Dobl Østrig
English: With regard to respiratory disease in pigs, tylosin premix formulations are currently often authorised for treatment using a higher dose for the first two to three weeks of treatment followed by a lower dose (typically 40% of the initial dose) for an extended period of time, often stated as the ‘whole risk period'.
Danish: Til luftvejssygdom hos svin er tylosin som premix i øjeblikket ofte godkendt med højere dosis de første 2-3 uger, efterfulgt af en lavere dosis (typisk 40 % af initialdosis) i længere tid, ofte betegnet “hele risikoperioden”.
English: 1, the CVMP recommendations on macrolides state that ‘there might be a need to review certain SPCs to reduce the approved treatment duration in cases where it is found unnecessarily long in relation to the severity of the disease'.
Danish: 1 anfører CVMP om makrolider, at “der kan være behov for at gennemgå visse produktresuméer med henblik på at fastsætte en kortere godkendt behandlingsvarighed i tilfælde, hvor denne findes unødvendigt lang i forhold til sygdommens sværhed”.
English: 2320 Hoogstraten Belgium
Danish: 2320 Hoogstraten Belgien
English: Denmark ScanVet Animal Health A/S Kongevejen 66
Danish: Danmark ScanVet Animal Health A/S Kongevejen 66
English: Extended exposure of tylosin to pigs is related to risk for development of antimicrobial resistance.
Danish: Langvarig eksponering af svin for tylosin er knyttet til risiko for udvikling af antimikrobiel resistens.
English: Specific treatment recommendations shorter than 3 weeks should be maintained.
Danish: Specifikke anbefalinger om kortere behandlingstid end tre uger bibeholdes.
English: Ipswich, Suffolk, IP7 6RD United Kingdom
Danish: Ipswich, Suffolk, IP7 6RD Det Forenede Kongerige
English: 17170 Amer (Girona) Spain
Danish: 17170 Amer (Girona)
English: As macrolides are critically important antimicrobials for pigs, unnecessary exposure leading to further resistance in target animal pathogens would be a serious risk to animal health.
Danish: Makrolider er kritisk vigtige antimikrobielle stoffer til svin, hvorfor unødig eksponering og deraf følgende yderligere resistens i målpatogener vil udgøre en alvorlig risiko for dyrs helbred.
English: Since for B. hyodysenteriae the rRNA operon exists in a single copy one single base mutation is sufficient to achieve macrolide resistant clones (Zuerner and Stanton (1994)
Danish: Da rRNA-operonet hos B. hyodysenteriae kun findes som en enkelt kopi, er mutation af en enkelt base tilstrækkelig til fremkomst af makrolidresistente kloner (Zuerner og Stanton (1994)
English: Similarly, almost complete in vitro resistance was reported among 32 Brachyspira isolates from the Czech Republic (Sperling et al. (2011))
Danish: Tilsvarende blev der beskrevet næsten fuldstændig resistens in vitro af 32 isolater af Brachyspira fra Tjekkiet (Sperling et al.
English: D-30625 Hannover Germany
Danish: D-30625 Hannover Tyskland
English: Germany bioptivet Tierarzneimittel GmbH & Co.
Danish: Tyskland bioptivet Tierarzneimittel GmbH & Co.
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Danish: Tylosin er et makrolidantibiotikum, der produceres af Streptomyces fradiae.
English: Priestley Road Basingstoke, RG24 9NL United Kingdom
Danish: Priestley Road Basingstoke, RG24 9NL Det Forenede Kongerige
English: In addition, long-term exposure to low doses of tylosin is associated with an increase in the number of resistant Campylobacter coli and group medication with antibiotics is a risk factor for spread of methicillinresistant Staphylococcus aureus (MRSA) in pigs.
Danish: Desuden er langtidseksponering for lave doser af tylosin forbundet med stigning i antal resistente Campylobacter coli, og gruppemedicinering med antibiotika er en risikofaktor for udbredelse af meticillinresistente Staphylococcus aureus (MRSA) hos svin.
English: Extended and vaguely defined treatment periods present a risk from resistance perspective and would not be justifiable from a scientific point of view taking into account disease epidemiology as well as current awareness regarding the need to always combine antibiotic use with appropriate sanitary measures.
Danish: Langvarige, vagt definerede behandlingsperioder udgør en resistensmæssig risiko og er ikke videnskabeligt forsvarlige på baggrund af sygdommens epidemiologi eller den nuværende bevidsthed om, at antibiotikabehandling altid bør kombineres med passende sanitære foranstaltninger.
English: Germany aniMedica GmbH Im Südfeld 9
Danish: Tyskland aniMedica GmbH Im Südfeld 9
English: Biovet JSC 39 Petar Rakov Str 4550 Peshtera Bulgaria
Danish: Bulgarien Biovet JSC 39 Petar Rakov Str 4550 Peshtera Bulgarien
English: 18-421 Kownaty Poland
Danish: 18-421 Kownaty
English: Due to resistance development through recent decades, tylosin is however today not considered to provide sufficient efficacy against swine dysentery (B. hyodysenteriae), and the substance should thus not be used for this disease.
Danish: På grund af resistensudvikling gennem de senere tiår anses tylosin i dag ikke for at give tilstrækkelig virkning mod svinedysenteri (B. hyodysenteriae) og bør derfor ikke anvendes til denne sygdom.
English: Denmark Ceva Animal Health A/S Ladegårdsvej 2
Danish: Danmark Ceva Animal Health A/S Ladegårdsvej 2
English: 43206 Reus (Tarragona) Spain
Danish: 43206 Reus (Tarragona) Spanien
English: As previously mentioned, most oral tylosin products were authorised in the EU Member States long time ago according to marketing authorisation requirements at that time.
Danish: For størstedelen af de orale produkter indeholdende tylosin er det som nævnt lang tid siden, at de blev godkendt i EU's medlemsstater i henhold til de daværende godkendelseskrav.
English: Zavet JSC 5 Kiril i Metodii Str. Zavet
Danish: Bulgarien Zavet JSC 5 Kiril i Metodii Str. Zavet
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, and marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter og indehavere af markedsføringstilladelse i medlemsstaterne
English: 1854 - 47020 Longiano (FC) Italy
Danish: 1854 - 47020 Longiano (FC) Italien
English: Elanco Valquímica, S.A. Avda.
Danish: Spanien Elanco Valquímica, S.A. Avda.
English: Although a somewhat lower rate of resistance was noted in Swedish strains collected during 1990-2010, more than 75% of the isolates demonstrate a minimum inhibitory concentration (MIC) far above the proposed epidemiological cut-off value of >16 μg/ml (Pringle et al. (2012))
Danish: I svenske stammer indsamlet i perioden 1990-2010 var resistensandelen noget lavere, men for over 75 % af isolaterne var den mindste hæmmende koncentration (MIC) langt over den foreslåede epidemiologiske afskæringsværdi på >16 μg/ml (Pringle et al. (2012))
English: 2730 HERLEV Denmark
Danish: 2730 HERLEV Danmark
English: Additionally, recent data show that in vitro resistance to macrolides for isolates from the European Union of Brachyspira hyodysenteriae (the causative agent of swine dysentery) is very high and tylosin might no longer be effective against this pathogen.
Danish: Desuden viser nyere data, at der er meget høj in vitro-resistens mod makrolider af isolater fra EU af Brachyspira hyodysenteriae (det ætiologiske agens ved svinedysenteri), og at tylosin muligvis ikke længere er effektivt mod denne patogen.
English: It is acknowledged that many oral tylosin formulations for pigs currently available on the EU market have been authorised many years ago, according to posology justification standards regarded acceptable at that time and in the context of what was then regarded as acceptable strategies for the administration of antimicrobials.
Danish: Det vedgås, at mange af de orale formuleringer af tylosin til svin, der er på markedet i EU, blev godkendt for mange år siden i henhold til, hvad der dengang ansås for acceptable normer for begrundelse af dosering, og i forbindelse med de dengang acceptable strategier for brug af antibiotika.
English: Although the resistance situation has not been investigated in every country where tylosin is used against swine dysentery, the awareness that tylosin resistance develops quickly and the bulk of in vitro data covering many field isolates from different areas provide sufficient information to conclude that it cannot be expected that the efficacy rate is sufficient to warrant an indication for treatment and prevention of this disease.
Danish: Resistenssituationen er ikke er undersøgt i alle lande, hvor tylosin anvendes mod svinedysenteri, men den hurtige udvikling af resistens over for tylosin sammen med in vitro-data for mange feltisolater fra forskellige områder lader konkludere, at der ikke kan forventes tilstrækkelig virkning til at berettige en indikation til behandling og forebyggelse af denne sygdom.
English: To limit the administration of oral tylosin to pigs to a maximum of three weeks would reduce the risk for selection of resistance without hampering the effective use of these products against currently authorised and justifiable indications.
Danish: Begrænsning af oral anvendelse af tylosin til svin til højst tre uger vil mindske risikoen for selektion af resistente organismer uden at hindre effektiv brug af produkterne til de i dag godkendte og forsvarlige indikationer.
English: 28108 Alcobendas (Madrid) Spain
Danish: Polígono Industrial de Alcobendas 28108 Alcobendas (Madrid) Spanien
English: Delete, where applicable, any recommendation to reduce the dose after an initial treatment period with a higher dose.
Danish: Hvor det er relevant, slettes anbefalinger om dosisreduktion efter en indledende behandlingsperiode med højere dosis.
English: Crockatt Road Lady Lane Industrial Estate, Hadleigh
Danish: Rumænien Anupco LTd. Crockatt Road Lady Lane Industrial Estate, Hadleigh
English: D-48308 Senden-Bösensell Germany
Danish: D-48308 Senden-Bösensell Tyskland
English: The risk connected with delaying the initiation of effective treatment by the time required for susceptibility testing is not considered to outweigh the benefit related to the possibility to successfully use tylosin in a few cases.
Danish: Risikoen ved at udskyde initiering af effektiv behandling, indtil følsomhedsbestemmelsen foreligger, anses ikke for at opveje fordele ved muligheden for vellykket anvendelse af tylosin i enkelte tilfælde.
English: • most oral tylosin formulations for pigs are authorised with a recommendation to treat for up to three weeks, the CVMP concluded that this maximum duration of treatment would provide sufficient efficacy.
Danish: • da de fleste orale formuleringer af tylosin til svin er godkendt med en anbefaling om behandling i op til tre uger, konkluderede CVMP, at denne maksimale behandlingsperiode vil give tilstrækkelig virkning.
English: • according to recent published susceptibility data tylosin will not be sufficiently effective against B. hyodysenteriae and therefore the CVMP concluded the indication in swine dysentery can no longer be maintained;
Danish: • i henhold til nyligt publicerede følsomhedsdata vil tylosin ikke have tilstrækkelig virkning mod B. hyodysenteriae, hvorfor CVMP konkluderede, at indikationen svinedysenteri ikke længere kan opretholdes,
English: Pharma Vet 40 Otec Paisii Str. Shumen
Danish: Bulgarien Pharma Vet 40 Otec Paisii Str.
English: 66-400 Gorzów Wielkopolski Poland
Danish: Kosynierów Gdyńskich 13-14 66-400 Gorzów Wielkopolski Poland
English: The knowledge regarding antimicrobial resistance risks has increased over time, and there is also an increasing focus on accommodating dosing strategy to the double aim of administering antimicrobials as long as necessary to obtain sufficient treatment effect, but to avoid unnecessary exposure that would encourage resistance development.
Danish: Der er efterhånden større viden om risikoen for antimikrobiel resistens, og der er stigende bevidsthed om, at doseringen bør vælges med det dobbelte formål at administrere antimikrobielle stoffer længe nok til at opnå tilstrækkelig virkning, men at undgå unødvendig eksponering, der fremmer resistensudvikling.
English: Rua da Liberdade, n° 77 2050-023 Aveiras de Baixo Portugal
Danish: ZOOPAN Produtos Pecuários S.A. Rua da Liberdade, n° 77 2050-023 Aveiras de Baixo Portugal
English: In a study of antimicrobial susceptibility of B. hyodysenteriae isolated from 21 Polish farms it was concluded that the lowest antimicrobial activity was demonstrated for tylosin and lincomycin, with inhibition of bacterial growth using concentrations >128 μg/ml and 32 μg/ml, respectively (Zmudzki et al. (2012)) 7.
Danish: I en undersøgelse af den antimikrobielle følsomhed af B. hyodysenteriae isoleret fra 21 polske brug konkluderedes det, at den laveste antimikrobielle aktivitet blev påvist for tylosin og lincomycin med hæmmende koncentrationer på hhv. >128 μg/ml og 32 μg/ml, (Zmudzki et al. (2012))
English: Replace, where applicable, treatment recommendations which are extended beyond 3 weeks, or where no treatment duration recommendation is given, with the following statement: Treatment duration should not exceed 3 weeks.
Danish: Hvis der er angivet en behandlingsvarighed ud over tre uger eller der ikke er angivet behandlingsvarighed, erstattes angivelsen med følgende erklæring: Behandlingsvarigheden må ikke være over 3 uger.
English: Given the very high resistance rate it is not regarded a sufficient measure to only include warning or precaution statements indicating that treatment of swine dysentery with tylosin should always be based on susceptibility testing.
Danish: Med den meget høje resistensandel anses det ikke for tilstrækkeligt blot at indsætte advarsler eller forholdsregler om, at behandling af svinedysenteri med tylosin altid bør være baseret på følsomhedsbestemmelse.
English: Provided swine dysentery is excluded from the indications of oral tylosin formulations for pigs and the maximum treatment is restricted to three weeks, the benefit-risk balance of these products could continue to be regarded as positive.
Danish: Forudsat at svinedysenteri slettes fra indikationerne for orale formuleringer af tylosin til svin, og den maksimale behandlingsperiode indskrænkes til tre uger, kan benefit/risk-forholdet for disse produkter fortsat anses for at være positivt.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, der indeholder tylosin til oral administration gennem foderet eller drikkevandet til svin (se bilag I)
English: 20884 Sulbiate (MB) Italy
Danish: 20884 Sulbiate (MB) Italien
English: 1000 Brussel
Danish: 1000 Brussel Belgien
English: Lilly France S.A.S.
Danish: Frankrig Lilly Frankrig S.A.S.
English: Similarly, with regard to tylosin granules and powders aimed to be mixed in the drinking water for pigs the recommended treatment period is only in exceptional cases extended beyond 3 weeks independent of indication.
Danish: For granulat- og pulver af tylosin til iblanding i drikkevandet til svin er den anbefalede behandlingsperiode kun undtagelsesvis over tre uger, uanset indikationen.
English: 47032 Bertinoro (FC) Italy
Danish: 47032 Bertinoro (FC) Italien
English: LABORATORIOS HIPRA, S.A. Avda.
Danish: Spanien LABORATORIOS HIPRA, S.A. Avda.
English: Possibly in part due to this, currently for the same indication and the same oral formulation there is significant variation between products regarding the recommended treatment duration for pigs.
Danish: Måske delvis som følge heraf er der i dag betydelig variation mellem den anbefalede behandlingsvarighed for produkter til samme indikation og samme orale formulering til svin.
English: 1000 Ljubljana Slovenia
Danish: 1000 Ljubljana
English: Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Straße 2-4
Danish: Tyskland Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Straße 2-4
English: Dzierżoniowska 21 58-260 Bielawa Poland
Danish: 58-260 Bielawa
English: • the CVMP considered that the overall benefit-risk balance is positive for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs subject to amendments in the product information;
Danish: • CVMP fandt det overordnede benefit/risk-forhold positivt for veterinærlægemidler indeholdende tylosin til oral administration gennem foderet eller drikkevandet til svin under forudsætning af ændringer af produktinformationen,
English: Taking efficacy aspects as well as the risk for resistance emergence into account, a maximum treatment period of three weeks applying the same dose level throughout the treatment period is regarded appropriate independent of disease;
Danish: Ud fra hensynet dels til virkning, dels risiko for resistensudvikling, anses der for passende med en maksimal behandlingsperiode på tre uger med samme dosisniveau i hele behandlingsperioden, uanset sygdommens art,
English: "Veta" Mariusz Hołownia
Danish: "Veta" Mariusz Hołownia Kownaty 74
English: Germany Kon-Pharma GmbH Senator-Bauer-Str. 34
Danish: Tyskland Kon-Pharma GmbH Senator-Bauer-Str. 34
English: 108.18 g/110 g Powder for oral solution
Danish: 108.18 g/110 g Pulver til oral opløsning
English: ANDRES PINTALUBA, S.A. Pol. Industrial Agro-Reus c/ Prudenci Bertrana 5.
Danish: Industrial Agro-Reus c/ Prudenci Bertrana 5.
English: GENERA d.d.
Danish: Kroatien GENERA d.d.
English: Av. Infante D. Henrique nº 333-H 3º piso Esc. 41 1800-282 Lisboa Portugal
Danish: Av. Infante D. Henrique nº 333-H 3º piso Esc. 41
English: the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Danish: anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende tylosin til oral administration gennem foderet eller drikkevandet til svin (se bilag I) med henblik på de anbefalede ændringer i produktresuméerne, etiketteringen og indlægssedlerne, der fremgår af bilag III.