FrancophonIA/ELRC3.0 huggingface dataset:
English: Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.
Danish: Administreres oralt, godt blandet i solidt foder.
English: 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.
Danish: 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.
English: Additionally, pharmacovigilance data have revealed no reports of lack of efficacy for colistin combination products.
Danish: Lægemiddelovervågningsdata har desuden ikke vist indberetninger om manglende virkning af kombinationsprodukter, der indeholder colistin.
English: 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.
Danish: 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).
English: Justification of colistin combination products
Danish: Begrundelse for kombinationsprodukter, der indeholder colistin
English: 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.
Danish: 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.
English: Pigs, rabbits Oral
Danish: Svin, kaniner Oral
English: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf as described in the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Danish: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
English: • 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;
Danish: • 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,
English: • 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;
Danish: • 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,
English: Colistin sulphate g/100 g
Danish: Colistinsulfat g/100 g
English: 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.
Danish: 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.
English: Via Affarosa, 4 42010 - Rio Saliceto Italy
Danish: 42010 - Rio Saliceto Italy
English: Praceta Jaime Cortesão, Nº 1 - R/C Loja Esq.
Danish: Praceta Jaime Cortesão, Nº 1 - R/C Loja Esq. 2625-170 Póvoa de Santa Iria
English: 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.
Danish: 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.
English: In view of the information available in the reports of the EMA European Surveillance of Veterinary Antimicrobial Consumption
Danish: På baggrund af oplysningerne i rapporterne fra EMA's European
English: Колитетравит / COLI - TETRAVIT
Danish: Колитетравит / COLI
English: 34 rue Jean Monnet ZI D'Etiché BP20341
Danish: Frankrig QALIAN 34 rue Jean Monnet ZI D'Etiché
English: 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.
Danish: 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.
English: Scopolamine
Danish: Scopolamin
English: STABOX COLI
Danish: MICROAMOX COLI
English: For food-producing animals in the EU/EEA today, field studies have shown that it is used primarily for pigs including group treatments and prevention of diarrhoea caused by E. coli and Salmonella spp., as first-choice http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
Danish: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Powder for oral suspension for administration in drinking water
Danish: Pulver til oral suspension til brug i drikkevand
English: 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.
Danish: 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.
English: Oral, via drinking water
Danish: Oral, i drikkevandet
English: GALIPROTECT C Oxytetracycline hydrochloride
Danish: GALIPROTECT C Oxytetracyclinhydrochlori
English: Oral solution Chickens and pigs
Danish: Oral opløsning Kyllinger og svin
English: Sulfadimethoxine
Danish: Sulfadimethoxin
English: 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.
Danish: 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.
English: 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.
Danish: CVMP anbefalede derfor at inddrage markedsføringstilladelserne for alle veterinærmedicinske produkter, der indeholder colistin i kombination med andre antimikrobielle stoffer til oral administration.
English: Colistin sulphate mg/ml
Danish: Colistinsulfat mg/ml
English: Powder for administration in drinking water or milk
Danish: Pulver til opløsning i drikkevand eller mælk
English: MIU/100 g
Danish: MIU/100
English: Vodovodna 20a 10000 Zagreb Croatia
Danish: 10000 Zagreb
English: Sulfaguanidine
Danish: Sulfaguanidin
English: Sulfamethoxypyridazine
Danish: Sulfamethoxypyridazin
English: Lithuania Lavet Pharmaceuticals Ltd. Ottó u. 14.
Danish: Rumænien Lavet Pharmecuticals LTD. Otto u.14.
English: In drinking water use
Danish: Til anvendelse i drikkevandet
English: Colistin sulphate Erythromycin estolate
Danish: COLIDIARYL Colistinsulfat Erythromycinestolat
English: Mixed in feeding stuffs
Danish: Opblandet i foder
English: 29 avenue Tony Garnier
Danish: Frankrig MERIAL 29 avenue Tony Garnier 69007 LYON France
English: Erythromycin estolate
Danish: COLIDIARYL Erythromycinestolat
English: MIU/tablet 1 g/tablet
Danish: MIU/tabl et g/tablet
English: Marketing authorisation holder
Danish: Indehaver af markedsføringstilladels en
English: Ceva Santé Animale 10 Avenue de la Ballastière 33500 Libourne France
Danish: Letland Ceva Santé Animale 10 Avenue de la
English: Premix for medicated feedingstuff
Danish: Premix til foderlægemiddel
English: Oral administration via drinking water
Danish: Oralt gennem drikkevandet
English: Oxytetracycline hydrochloride
Danish: Oxytetracyclinhydrochlori
English: Raamsdonksveer The Netherlands
Danish: 4941 VX Raamsdonksveer The Netherlands
English: Colistin sulphate
Danish: Colistinsulfat
English: Oral administration in drinking water or liquid feed
Danish: Oral indgivelse i drikkevand eller flydende foder
English: More virulent strains resulting in more severe disease can further lead to septicaemia and/or immunosuppression with the result of either multi-organ disease or polymicrobial infections.
Danish: Hos produktionsdyr medfører belastninger af nyfødte dyr og belastninger ved fravænning dysbakteriose og E. coli-diarré, som fremtræder klinisk ens. Mere virulente stammer, der medfører alvorligere sygdom, kan desuden forårsage septikæmi og/eller immunsuppression med resulterende multiorgan-sygdom eller polymikrobielle infektioner.
English: Rhone Vet Kft.
Danish: Ungarn Rhone Vet Kft. Petőfi u. 9.
English: Lamb, calves Oral use
Danish: Lam, kalve Oral
English: Trimethoprim Colistin sulphate
Danish: Trimethoprim Colistinsulfat
English: Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure.
Danish: Til støtte for nogle af indikationerne for nogle af produkterne omfattet af denne artikel 35indbringelsesprocedure blev der forelagt interne data, videnskabelige henvisninger og ekspertrapporter.
English: “However, severe nosocomial infections due to multidrug-resistant (MDR) Gram-negative bacteria now account for high morbidity and mortality in man. Colistin is therefore nowadays a last resort drug in human medicine in the context of treatment of infections caused by MDR Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), for which mortality can be extremely high.”
Danish: Colistin anses derfor i dag i humanmedicinen for at være en sidste medikamentel behandlingsmulighed ved infektioner forårsaget af multiresistente (MDR) Pseudomonas aeruginosa, Acinetobacter baumannii og Enterobacteriaceae (Escherichia coli og Klebsiella pneumoniae), som kan have ekstremt høj dødelighed.”
English: The same applies for Salmonella spp.
Danish: Det samme gælder Salmonella spp.-indikationerne for kombinationsprodukter,
English: Chicken, pigs Oral use
Danish: Kyllinger, svin Oral
English: Sulfadimidine sodium Trimethoprim
Danish: Sulfadimidinnatrium Trimethoprim
English: AMOXY-COL WSP Amoxicillin trihydrate Colistin sulphate
Danish: Amoxy-col WSP Amoxicillintrihydrat Colistinsulfat
English: treatment for neonatal diarrhoea caused by E. coli in piglets 9 and veal calves as well as for the therapy of mild colibacillosis in poultry
Danish: gruppebehandling og forebyggelse af diarré forårsaget af E. coli og Salmonella spp., som førstevalgsbehandling til neonatal diarré forårsaget af E. coli hos smågrise
English: Via Piana 265 47032 Bertinoro Italy
Danish: 47032 Bertinoro Italy
English: Dopharma B.V. Zalmweg 24
Danish: Dopharma B.V.
English: Lamb, goat, calve
Danish: Lam, geder, kalve
English: Powder for oral use
Danish: Pulver til oral opløsning
English: Oral solution Chicken, turkey
Danish: Oral opløsning Kyllinger, kalkuner
English: Lamb, goat, calves, poultry
Danish: Lam, geder, kalve, fjerkræ
English: Colistin sulphate Spiramycin adipate
Danish: Colistinsulfat Spiramycinadipat
English: Colistin sulphate mg/tablet mg/tablet
Danish: Colistinsulfat mg/table mg/table
English: Pigs and chickens (except laying)
Danish: Svin, kyllinger (undtagen æglæggere)
English: Oral powder for use in drinking water or liquid feed
Danish: Oralt pulver til opløsning i drikkevand eller flydende foder
English: Doxycycline hyclate Colistin sulphate
Danish: Doxycyclinhyclat Colistinsulfat
English: Lamb, dogs, foals, calves
Danish: Lam, hunde, føl, kalve
English: Pig, calves, poultry (chicken)
Danish: Svin, kalve, fjerkræ (kyllinger)
English: Chickens, rabbits, pigs, calves and lambs
Danish: Kyllinger, kaniner, svin, kalve og lam
English: Pigs, calves Oral use
Danish: Svin, kalve Oral
English: Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens)
Danish: Kalve, får, geder, svin, ponyer, kyllinger, kalkuner (bortset fra høner)
English: Calves, pigs, chickens (other than laying hens), turkeys
Danish: Kalve, svin, kyllinger (bortset fra æglæggere), kalkuner
English: Pig, calves, poultry (chicken, turkey), pigeon
Danish: Svin, kalve, fjerkræ (kyllinger, kalkuner), duer
English: Romania Lavet Pharmecuticals LTD.
Danish: Litauen Lavet Pharmaceuticals Ltd.
English: Pigs, chickens Oral administration in drinking water
Danish: Svin, kyllinger Oralt gennem drikkevandet
English: Oral administration, after incorporation into the feed
Danish: Oralt efter iblanding i foderet
English: Spiramycin adipate
Danish: Spiramycinadipat
English: In addition, the MAHs were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Danish: Der kunne ikke fastlægges gyldige behandlingsprincipper for ikke-gastrointestinale indikationer; kombinationsprodukter frembyder derfor ingen fordel fremfor de aktive stoffer i form af enkeltstofprodukter som beskrevet i CVMP's retningslinjer for faste kombinationsprodukter af lægemidler (EMEA/CVMP/83804/2005).
English: MICROAMOX COLI Amoxicillin trihydrate Colistin sulphate
Danish: STABOX COLI Amoxicillintrihydrat Colistinsulfat
English: Powder for use in drinking water
Danish: Pulver til opløsning i drikkevand
English: Lamb, goat, rabbits, pigs, calves, poultry
Danish: Lam, geder, kaniner, svin, kalve, fjerkræ
English: 3 Rue de Lorraine 62510 Arques France
Danish: Frankrig LABORATOIRES BIOVE 3 Rue de Lorraine
English: Poultry (grouse and web-footed)
Danish: Fjerkræ (ryper og fugle med svømmefødde r)
English: Oral use
Danish: Oral indgivelse
English: Cattle, chickens, pigs
Danish: Kalve, kyllinger, svin
English: UI
Danish: Lam
English: Colistin sulphate mg/g mg/g
Danish: Amoxicillintrihydrat Colistinsulfat mg/g 4 mg/g
English: Gyógyszergyártó Kft. Ottó u. 14
Danish: Ottó u. 14
English: Amoxicillin trihydrate Colistin sulphate
Danish: Amoxicillintrihydrat Colistinsulfat
English: Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat
Danish: Kvæg (kalve), får (lam), svin, kyllinger, kaniner, geder
English: BELCOSPIRA ORAL Colistin sulphate
Danish: BELCOSPIRA ORAL
English: Amoxicillin trihydrate
Danish: Amoxicillintrihydrat
English: Ampicillin trihydrate Colistin sulphate
Danish: Ampicillintrihydrat Colistinsulfat
English: Spiracol AD
Danish: Spiracol AD Spiramycinadipat
English: Foals, calves Oral use
Danish: Kalve, lam Oral
English: Pig, chicken Oral
Danish: Oral opløsning Svin, kyllinger Oral
English: Calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)
Danish: Kalve, får, geder, svin, føl, kyllinger, kalkuner (bortset fra æglæggere)
English: Calves, lambs, kids, piglets, poultry and rabbits
Danish: Kalve, lam, gedekid, smågrise, fjerkræ og kaniner
English: Lamb, goat, piglets, foals, calves
Danish: Lam, geder smågrise, føl, kalve
English: Calves, piglets, foals, chicken
Danish: Kalve, smågrise, føl, kyllinger
English: QALIAN
Danish: Shumen
English: Route of administration
Danish: Administrationsv ej
English: Calves, lamb, kid, foals, piglets, poultry and rabbits.
Danish: Kalve, lam, gedekid, føl, smågrise, fjerkræ, kaniner.
English: BACOLAM
Danish: Colamox
English: Vetoquinol Italia S.R.L
Danish: Vetoquinol Italia S.R.L Via Piana, 265
English: Calves, lambs, kids, pigs, rabbits and poultry
Danish: Kalve, lam, gedekid, svin, kaniner, fjerkræ
English: VIRBAC
Danish: Ballastière
English: Pigs, chicken (broilers)
Danish: Svin, kyllinger (slagtekyllinge r)
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Danish: Konklusioner fremlagt af Det Europæiske Lægemiddelagentur vedrørende: • Markedsføringstilladelse under betingede omstændigheder
English: Annex IV Conclusions on the granting of the conditional marketing authorisation and presented by the European Medicines Agency
Danish: BILAG IV Konklusioner vedrørende udstedelse af markedsføringstilladelse under betingede omstændigheder fremlagt af det europæiske lægemiddelagentur
English: and Proteus mirabilis.
Danish: og Proteus mirabilis.
English: Do not use after the expiry date stated on the label.
Danish: Må ikke anvendes efter den udløbsdato, der er angivet på etiketten.
English: Date of revision of the text
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af denne markedsføringstilladelse skal underrette Europakommissionen om markedsføringsplanerne for det lægemiddel, der er godkendt ved denne beslutning.
English: Date of first authorisation/renewal of the authorisation
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Dosage (number of tablets)
Danish: Dosering (antal tabletter)
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosering bør legemsvægten fastlægges så præcist som muligt for at undgå underdosering.
English: The following dosage scheme is advised:
Danish: Det tilrådes at følge nedenstående doseringsskema:
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMA) http://www.ema.europa.eu/.
English: In most cases, a 10-day treatment course will be sufficient.
Danish: I de fleste tilfælde er en behandlingsperiode på 10 dage tilstrækkelig.
English: The duration of treatment depends on the nature and severity of the infection and on the response seen.
Danish: Behandlingens varighed afhænger af infektionens art og sværhedsgrad og af det respons, der ses.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER
English: Antagonism may be observed with nitrofurantoin.
Danish: Der kan observeres antagonisme med nitrofurantoin.
English: Do not use in dogs with a weight of less than 3 kg. Ibaflin should only be used based on susceptibility testing.
Danish: Må ikke anvendes til hunde der vejer under 3 kg. Ibaflin bør kun anvendes på basis af en resistensbestemmelse.
English: Sodium laurylsulphate Silica
Danish: Natriumlaurylsulfat Silica
English: The overall absorption was higher when administered with food.
Danish: Den samlede absorption er højere, når det gives sammen med mad.
English: Do not use during the period of growth.
Danish: Må ikke anvendes i opvækstperioden.
English: Pyoderma is mostly secondary to an underlying disease.
Danish: Pyodermi er oftest sekundær til en tilgrundliggende sygdom.