natgillin/translations-raw huggingface dataset:
Den aktuelle videnskabelige litteratur støtter ikke brugen af colistinkombinationspræparater hos føl, da de kan forstyrre den gastrointestinale mikroflora, medførende en velkendt fatal antibiotikarelateret colitis, typisk associeret med Clostridium difficile.
The current scientific literature does not support the use of colistin combination products in foals as its use could disrupt the gastrointestinal microflora balance, leading to a well-recognised fatal antimicrobial-associated colitis, typically associated with Clostridium difficile.
VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A. Centro Empresarial da Rainha, Lote 27
VETLIMA-Sociedade Distribuidora de Produtos AgroPecuários, S.A.
Litauen COOPHAVET S.A.S.
Lithuania COOPHAVET S.A.S.
En nylig stigning i gramnegative bakterier i humanmedicinen med multiresistens (MDR), ekstensiv antibiotikaresistens (XDR) og ekstrem resistens (PDR)
A recent global increase in Gram-negative bacteria in human medicine that are multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR)
Koncepter med synergi af kombinationsprodukter, der indeholder colistin har større relevans i humanmedicinen, hvor der injiceres lave doser af colistin parenteralt sammen med andre antimikrobielle stoffer for at undgå toksicitet.
Concepts of colistin combination synergy are more relevant in human medicine since low doses of colistin are injected parenterally with other antimicrobials in order to avoid toxicity.
Svin, kyllinger (bortset fra høns, der producerer æg til konsum)
Pigs, chickens (except hens producing eggs for human consumption)
Samme overvejelser som de, der gjorde sig gældende for produkter til colistin-monoterapi, gælder også for produkter med colistin i kombination med andre antimikrobielle stoffer.
The same considerations taken for the colistin monotherapy products also apply to products containing colistin in combination with other antimicrobial substances.
6 Desuden mangler colistin terapeutisk virkning mod naturligt resistente arter, herunder Serratia, Stenotrophomonas og Proteus.
In addition, colistin lacks therapeutic activity against inherently resistant species, including the genera Serratia, Stenotrophomonas and Proteus
2 (europæisk overvågning af salget af antimikrobielle stoffer til dyr), antallet af markedsføringstilladelser pr. farmaceutisk form/administrationsvej og anvendelsernes art var det kun produkter, der indeholder colistin og er til oral administration (gruppebehandling), der blev anset for at være en prioritet.
antimicrobials, the number of marketing authorisations per pharmaceutical form/route of administration and types of use, the products containing colistin only and administered orally (group treatment) were considered a priority.
Der kunne imidlertid ikke påvises nogen fordel ved brug af kombinationsprodukter, der indeholder colistin frem for monoterapi, og der kunne ikke fastlægges realistiske afbødende foranstaltninger over for den konstaterede risiko for menneskers sundhed, da selv begrænset anvendelse af kombinationsprodukter, der indeholder colistin ansås for at være unødig brug af colistin.
However, no benefit could be demonstrated of using colistin combination products over monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even a limited use of colistin combination products was considered an unnecessary use of colistin.
har tvunget klinikerne til at genindføre den toksiske behandling med systemisk colistin i form af dets mindre toksiske inaktive prodrug colistinmethansulfonat som sidste antimikrobielle udvej til behandling af sådanne bakterier, der ofte er årsag til sygehusinfektioner
has forced clinicians to reintroduce toxic systemic colistin treatment in the form of its less toxic inactive prodrug, colistin methanesulfonate, as a last-resort antimicrobial for infections with such bacteria, which are frequently the cause of healthcare-associated infections
Denne nye forekomst af MCR-1 hos dyre- og menneskerelaterede bakterier indvarsler, at der er åbnet op for plasmidmedieret resistensoverførsel for den sidste gruppe antibiotika, polymyxiner.
This emergence of MCR-1 in animals and human-related bacteria heralds the breach of the last group of antibiotics, polymyxins, by plasmid-mediated transferable resistance.
Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf European Medicines Agency, European Surveillance of Veterinary Antimicrobial Consumption.
B.P. 7 Saint Herblon 44153 ANCENIS Cedex France
7 Saint Herblon 44153 ANCENIS Cedex
CVMP konkluderede derfor, at der ikke var grundlag for gastrointestinale indikationer for kombinationsprodukter med colistin.
Therefore, the CVMP concluded that no gastrointestinal indications could be supported for colistin combination products.
Den bredspektrede aktivitet af colistin over for gramnegative bakterier involverer binding til lipid A, der er anker for lipopolysakkarid og hovedbestanddelen i cellemembranen af mange bakterier
The broad-spectrum activity of colistin against Gram-negative bacteria involves binding to lipid A, the anchor for lipopolysaccharide and the main constituent of the outer membrane of many bacteria
Polymikrobielle gastrointestinale infektioner blev ikke nævnt af markedsføringstilladelsesindehaverne i forbindelse med de måldyrearter og indikationer, der er opført for deres produkter.
Polymicrobial gastrointestinal infections were not identified by the MAHs for the animal species and indications listed for their products.
Der blev ikke forelagt specifikke kliniske undersøgelser vedrørende invasive E. coli-infektioner, som var sekundære til mavetarmsygdom.
No specific clinical studies were provided for invasive E. coli secondary to gastrointestinal disease.
Som nævnt har dette ingen klinisk relevans for kombinationsprodukter med colistin, da colistin ikke optages fra mave-tarmkanalen og således aldrig vil medvirke til at nedkæmpe polymikrobielle infektioner i andre målvæv.
As stated previously, this has no clinical relevance for colistin combination products, since colistin is not absorbed from the gastrointestinal tract and thus will never participate in combating polymicrobial infections in other target tissues.
Spanien CENAVISA, S.A. Camí Pedra Estela s/n.
CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona)
Der blev imidlertid rejst betænkeligheder ved, om der er begrundelse for gastrointestinale indikationer for kombinationsprodukter, der indeholder colistin, når det vil være mere forsvarligt at anvende et monoterapiprodukt.
However, concerns were raised whether gastrointestinal indications for colistin combinations products are justified when it would be more prudent to use a monotherapy product.
Samtidige gastrointestinale sygdomme forbundet med E. coli (f.eks. septikæmi) blev af markedsføringstilladelsesindehaverne betegnet som komplikationer af den oprindelige mavetarmsygdom, enten gennem systemisk spredning eller immunsuppression.
Concurrent E. coli related gastrointestinal diseases (e.g. septicaemia) were identified by MAHs as occurring as complications from the original gastrointestinal disease through either direct systemic spread or immunosuppression.
Veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration til fødevareproducerende arter repræsenterer antimikrobielle stoffer med udbredt anvendelse i veterinærmedicinen.
Veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species represent commonly used antimicrobials in veterinary medicine.
Til anvendelse i foder
In feed use
Colistin er et kationisk antibakterielt flerkomponentmiddel af lipopeptidtypen, der fremstilles af kulturer af Bacillus polymyxa-var colistinus.
Colistin is a cationic, multicomponent lipopeptide antibacterial agent produced by cultures of Bacillus polymyxa var. colistinus.
Begrebet colibacillose anvendes ikke i hestemedicin, men i forbindelse med svin, fjerkræ og drøvtyggere.
Colibacillosis is not a term used in equine medicine, but a term used for pigs, poultry and ruminants.
Samme konklusion blev nået i den nylige artikel 35indbringelsesprocedure vedrørende orale produkter til monoterapi med colistin.
The same conclusion was reached in the recent Article 35 referral procedure on oral colistin monotherapy products.
Polymyxiner har ingen klinisk nyttig aktivitet mod grampositive bakterier, gramnegative kokker, anaerobe bakterier eller Mollicutes, herunder Mycoplasma spp.
Polymyxins have no clinically useful activity against Gram-positive bacteria, Gram-negative cocci, anaerobes and Mollicutes including Mycoplasma spp.
ENTEROGEL 30 Colistinsulfat
ENTEROGEL 30 Colistin sulphate
Som konklusion er kombinationsprodukter med colistin beregnet til at opfylde andre kliniske behov end monoterapiprodukter.
In conclusion, colistin combination products are intended to address different clinical needs to monotherapy products.
Begrundelse for at inddrage markedsføringstilladelserne
Grounds for withdrawal of the marketing authorisations
Anvendelse af colistin hos føl anses således for at udgøre en alvorlig risiko for måldyreartens sikkerhed, og føl kan ikke støttes som måldyreart for kombinationsprodukter med colistin.
Thus, the use of colistin in foals is considered to present a serious risk in relation to target animal safety and foals cannot be supported as a target animal species for colistin combination products.
Oral indgivelse, enkeltvis
Oral administration individually
For ikke-gastrointestinale indikationer er der betænkelighed ved den manglende begrundelse for kombinationsprodukter, der indeholder colistin.
For non-gastrointestinal indications there are concerns of lack of justification for colistin combination products.
De fleste kliniske undersøgelser, der er fremlagt ved denne artikel 35-indbringelsesprocedure, har vist, at monoterapiprodukter havde samme virkning som kombinationsprodukter med colistin.
Most clinical studies provided in this Article 35 referral procedure demonstrated that monotherapy products shared the same efficacy as colistin combination products.
Desuden er den kliniske relevans af synergi for kombinationer med colistin højst tvivlsom, fordi koncentrationen i kolon af colistin ved monoterapi er så meget højere end MIC-værdien (f.eks. 20 gange højere end MIC-værdien) for E. coli og andre bakterier, hvorfor der ikke er nogen klinisk merværdi ved in vitro-synergi af kombinationer med colistin.
Also, the clinical relevance of synergy with colistin combinations is highly doubtful for the reason that colonic concentrations of colistin alone are so much higher than the MIC (e.g. 20 times more than the MIC) for E. coli and other bacteria, as a monotherapy, hence there is no clinical added value for an in vitro synergy of colistin combinations.
Med den fornyede anvendelse af colistin i humanmedicinen, navnlig som sidste behandlingsmulighed for infektioner forårsaget af multiresistente (MDR), ekstensivt medicinresistene (XDR) og ekstremt resistente (PDR) laktosefermenterende og ikkefermenterende gramnegative stave, herunder Pseudomonas aeruginosa og Acinetobacter baumannii, er der betænkelighed ved de potentielle problemer for den offentlige sundhed som følge af stoffets fortsatte veterinære anvendelse.
With the renewed use of colistin use in human medicine, particularly as a last-resort therapeutic option to treat infections due to multidrugresistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR), lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii, then there are potential public health concerns with continued veterinary use of the substance.
I denne sammenhæng opfylder brug af kombinationsprodukter, der indeholder colistin ikke principperne for forsvarlig brug, og produkterne opfylder ikke godkendelseskriterierne i henhold til retningslinjerne for faste kombinationsprodukter.
In this context, colistin combination products are not utilised under prudent use principles nor fulfil the criteria outlined in the fixed combinations guideline for the approval of these products.
For gastrointestinale indikationer er der desuden betænkelighed ved, hvorvidt kombinationsprodukter med colistin er nødvendige frem for monoterapi.
For gastrointestinal indications, there are also concerns if colistin combinations products are necessary over monotherapy.
Svin, kyllinger Til anvendelse i drikkevandet
Pigs, chickens In drinking water use
Frankrig VETOQUINOL Magny Vernois 70200 Lure
VETOQUINOL Magny Vernois 70200 Lure France
Ved denne procedure blev CVMP anmodet om at gennemgå markedsføringstilladelserne for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration til fødevareproducerende arter med henblik på at sikre forsvarlig brug af stoffet til beskyttelse af dyrs sundhed og begrænse muligheden for fremtidig risiko for den offentlige sundhed.
In this procedure the CVMP was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Biofilm er beskyttende lag omkring bakterierne, der f.eks. dannes i fordøjelseskanalen som slimhindesamfund
Biofilms are protective layers around bacteria that are formed, for example, in the
Administreres oralt, godt blandet i solidt foder.
Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.
På disse punkter er der ikke forelagt overbevisende data af markedsføringstilladelsesindehaverne i form af kliniske undersøgelser eller andre videnskabeligt acceptable undersøgelser, der vedrører kliniske scenarier, hvor kombinationsprodukter med colistin har væsentlig betydning for fødevareproducerende dyr i EU i forhold til monoterapiprodukter.
On these points, no convincing data were provided by the MAHs, in terms of clinical trials or other scientifically acceptable studies, as to clinical scenarios where colistin combination products are essential for food-producing animals in the EU compared to monotherapy products.
Lægemiddelovervågningsdata har desuden ikke vist indberetninger om manglende virkning af kombinationsprodukter, der indeholder colistin.
Additionally, pharmacovigilance data have revealed no reports of lack of efficacy for colistin combination products.
Flere markedsføringstilladelsesindehavere fandt, at antimikrobiel synergi in vitro underbygges af videnskabelige publikationer, baseret dels på en reduktion af MIC-værdierne for målpatogenerne i tilstedeværelse af kombinationen med colistin, dels en reduktion af den relative inhibitoriske koncentration (FIC-kvotienten).
In vitro antimicrobial synergy was identified by several MAHs and backed up by scientific publications, based on both a reduction of the MIC for target pathogens in the presence of the colistin combination and a reduction in the fractional inhibitory concentration index.
Begrundelse for kombinationsprodukter, der indeholder colistin
Justification of colistin combination products
Gastrointestinal infektion forårsaget af E. coli (colibacillose) er ikke en anerkendt klinisk sygdom hos føl eller voksne heste, og der er ikke forelagt data til støtte for anvendelsen af colistin hos føl.
Gastrointestinal infection caused by E. coli (colibacillosis) is not a recognised clinical disease in foals or adult horses and no data were provided to support the use of colistin in foals, therefore this target species should be removed.
Svin, kaniner Oral
Pigs, rabbits Oral
• CVMP fandt, at markedsføringstilladelsesindehaverne ikke har forelagt overbevisende data i form af kliniske undersøgelser eller andre videnskabeligt acceptable undersøgelser vedrørende kliniske scenarier, hvor kombinationsprodukter med colistin har væsentlig betydning for fødevareproducerende dyr i EU i forhold til monoterapiprodukter,
• the CVMP considered that no convincing data were provided by the MAHs, in terms of clinical trials or other scientifically acceptable studies, as to clinical scenarios where colistin combination products are essential for food-producing animals in the EU compared to monotherapy products;
• CVMP konkluderede, at benefit/risk-vurderingen er negativ for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration, og at produkterne kan udgøre en potentiel risiko for menneskers helbred,
• the CVMP concluded that the benefit-risk assessment for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally is negative and that the products could pose a potential risk to human health;
Colistinsulfat g/100 g
Colistin sulphate g/100 g
Efter gennemgang af alle de skriftligt indsendte data konkluderede CVMP, at benefit/risk-forholdet er negativt for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration til fødevareproducerende arter, dels som følge af den manglende kliniske relevans, dels på baggrund af, at overeksponering for colistin kan udgøre en potentiel risiko for dyrs og menneskers sundhed ved at fremskynde forekomsten af resistens mod colistin.
Having considered all data submitted in writing, the CVMP concluded that the benefit-risk balance for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Praceta Jaime Cortesão, Nº 1 - R/C Loja Esq. 2625-170 Póvoa de Santa Iria
Praceta Jaime Cortesão, Nº 1 - R/C Loja Esq.
Denne mcr-1-overførsel hos isolater af E. coli blev desuden fundet i 78 (15 %) af 523 prøver af rå kødprodukter og hos 166 (21 %) af 804 dyr, fra hvilke der var udtaget prøver i 2011-14.
During a routine surveillance project on antimicrobial resistance in commensal E. coli from food animals in China, polymyxin resistance was shown to be singularly due to the plasmid-mediated mcr-1 gene Furthermore, this mcr-1 carriage in E. coli isolates was also found in 78 (15%) of 523 samples of raw meat products and 166 (21%) of 804 animals sampled during 2011-14.
På baggrund af oplysningerne i rapporterne fra EMA's European
In view of the information available in the reports of the EMA European Surveillance of Veterinary Antimicrobial Consumption
Колитетравит / COLI
Колитетравит / COLI - TETRAVIT
Frankrig QALIAN 34 rue Jean Monnet ZI D'Etiché
34 rue Jean Monnet ZI D'Etiché BP20341
Colistin er således vendt tilbage som sidste behandlingsmulighed for infektioner forårsaget af MDR, XDR og PDR laktosefermenterende og ikke-fermenterende gramnegative stave, herunder Pseudomonas aeruginosa og Acinetobacter baumannii.
Thus, colistin has re-emerged as a last-resort therapeutic option to treat infections due to MDR, XDR and PDR, lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii.
Scopolamin
Scopolamine
MICROAMOX COLI
STABOX COLI
CVMP anbefalede inddragelse af markedsføringstilladelserne for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration som anført i bilag I.
the CVMP has recommended the withdrawal of the marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally as referred in Annex I.
F.eks. er den nuværende status for relevante gramnegative gastrointestinale patogener (f.eks. E. coli) i EU, at MIC-værdierne for colistin er meget lave, og koncentrationerne af colistin i colon er meget høje (f.eks. 20 gange større end MIC-værdien), hvorfor et monoterapiprodukt kan være tilstrækkeligt til disse indikationer.
For example, the current status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs to colistin are very low and colistin colonic concentrations are very high (e.g. 20 times more than the MIC) such that a monotherapy product could suffice for these indications.
Pulver til oral suspension til brug i drikkevand
Powder for oral suspension for administration in drinking water
På baggrund af ovennævnte betænkeligheder og i overensstemmelse med de nævnte anbefalinger i EMA/CVMP/CHMP's videnskabelige rådgivning til Europa-Kommissionen blev udvalget som næste skridt anmodet om at gennemgå markedsføringstilladelserne for alle veterinærlægemidler, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration til fødevareproducerende dyr.
In view of the concerns above and in line with the aforementioned recommendations from the EMA/CVMP/CHMP scientific advice to the European Commission, as a second step, the Committee was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Oral, i drikkevandet
Oral, via drinking water
GALIPROTECT C Oxytetracyclinhydrochlori
GALIPROTECT C Oxytetracycline hydrochloride
Oral opløsning Kyllinger og svin
Oral solution Chickens and pigs
Den nuværende status for relevante gramnegative gastrointestinale patogener (f.eks. E. coli) i EU er, at MIC-værdierne for colistin er meget lave, og at koncentrationen af colistin i colon er meget høj (f.eks. 20 gange MIC-værdien), hvorfor et monoterapiprodukt vil være tilstrækkeligt til disse indikationer.
Currently the status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs of colistin are very low and colistin colonic concentrations are very high (e.g. 20 times above the MIC) such that a monotherapy product will suffice for these indications.
CVMP anbefalede derfor at inddrage markedsføringstilladelserne for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration.
Therefore, the CVMP recommended the withdrawal of the marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Colistinsulfat mg/ml
Colistin sulphate mg/ml
Pulver til opløsning i drikkevand eller mælk
Powder for administration in drinking water or milk
MIU/100
MIU/100 g
Rumænien Lavet Pharmecuticals LTD. Otto u.14.
Lithuania Lavet Pharmaceuticals Ltd. Ottó u. 14.
Til anvendelse i drikkevandet
In drinking water use
COLIDIARYL Colistinsulfat Erythromycinestolat
Colistin sulphate Erythromycin estolate
Opblandet i foder
Mixed in feeding stuffs
Frankrig MERIAL 29 avenue Tony Garnier 69007 LYON France
29 avenue Tony Garnier
COLIDIARYL Erythromycinestolat
Erythromycin estolate
MIU/tabl et g/tablet
MIU/tablet 1 g/tablet
Indehaver af markedsføringstilladels en
Marketing authorisation holder
Letland Ceva Santé Animale 10 Avenue de la
Ceva Santé Animale 10 Avenue de la Ballastière 33500 Libourne France
Premix til foderlægemiddel
Premix for medicated feedingstuff
Oralt gennem drikkevandet
Oral administration via drinking water
Oxytetracyclinhydrochlori
Oxytetracycline hydrochloride
4941 VX Raamsdonksveer The Netherlands
Raamsdonksveer The Netherlands