FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatro Uriach Veterinaria, S.L.
French: Espagne Fatro Uriach Veterinaria, S.L.
English: 96-100 Skierniewice POLAND
French: 96-100 Skierniewice POLOGNE
English: Cattle (non ruminating)
French: Bovins (non ruminants)
English: Subcutaneous,
French: Sous-cutanée,
English: 66-400 Gorzów Wielkopolski POLAND
French: 66-400 Gorzów Wielkopolski POLOGNE
English: Romania Pharmaqua-D. Kokkoris and Bros
French: Roumanie Pharmaqua-D. Kokkoris and Bros
English: Flumix Flumequine 24 Lapin-Volaille
French: Flumix Fluméquine 24 Lapin-Volaille
English: Gastroenteral solution
French: Solution gastroentérale
English: Germany Albrecht GmbH Hauptstr.
French: Allemagne Albrecht GmbH Hauptstr.
English: (MI) ITALY
French: (MI) ITALIE
English: 1050 Brussels BELGIUM
French: 1050 Brussels BELGIQUE
English: Water soluble granules
French: Granules solubles dans l'eau
English: Active substance(s)
French: Nom de fantaisie Principe(s) actif(s)
English: Fish
French: Poissons
English: Amendments to be included in the relevant sections of the summary of product characteristics
French: Modifications à inclure dans les rubriques correspondantes du résumé des caractéristiques du produit
English: 228.4 mg/ml (equivalent to 180 mg/ml Danofloxacin)
French: 228,4 mg/ml (équivalents à 180 mg/ml de danofloxacine)
English: Bayer A/S Nørgaardsvej 32 Postboks 2090 2800 KGS Lyngby DENMARK
French: Bayer A/S Nørgaardsvej 32 Postboks 2090
English: Flumix Flumequine 48 Porc
French: Flumix Fluméquine 48 Porc
English: Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN
French: Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) ESPAGNE
English: Germany Pfizer GmbH Linkstr.
French: Allemagne Pfizer GmbH Linkstr.
English: Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat SPAIN
French: Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat ESPAGNE
English: 040185 Bucharest
French: 040185 Bucharest ROUMANIE
English: Germany Vétoquinol Verwaltungs GmbH Parkstr.
French: Allemagne Vétoquinol Verwaltungs GmbH Parkstr.
English: 3641 RT Mijdrecht THE NETHRLANDS
French: 3641 RT Mijdrecht PAYS-BAS
English: In addition the Committee notes that the list of products in Annex I does not include all veterinary medicinal products containing quinolones including fluoroquinolones authorised in the EEA-EU, as either some products were not notified to the Agency by the competent national authorities or the information was not received in time to include these products in the current referral.
French: De plus, le comité fait remarquer que la liste des produits mentionnés dans l'Annexe I ne contient pas tous les médicaments vétérinaires contenant des quinolones, et notamment de fluoroquinolones, autorisés dans l'EEE-UE, car soit certains produits n'ont pas été notifiés à l'Agence par les autorités nationales compétentes, soit les informations ne sont pas parvenues à temps pour permettre l'inclusion de ces produits dans la procédure de saisine.
English: 2909 LD Capelle a/d Ijssel THE NETHRLANDS
French: Rivium Westlaan 142 2909 LD Capelle a/d Ijssel PAYS-BAS
English: 62-200 Gniezno POLAND
French: 62-200 Gniezno POLOGNE
English: Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS
French: Maagdenburgstraat 38 7421 ZE Deventer PAYS-BAS
English: 4941 VX Raamsdonksveer NETHERLANDS
French: 4941 VX Raamsdonksveer PAYS-BAS
English: The Committee also noted that not all veterinary medicinal products containing quinolones including fluoroquinolones authorised in the EEA-EU have been included in the scope of the referral as either some products were not notified to the Agency by the competent national authorities or the information was not received on time to allow the inclusion of these products in the referral procedure.
French: Le comité a également constaté que tous les médicaments vétérinaires contenant des quinolones, et notamment de fluoroquinolones, autorisés dans l'EEE-UE ont été inclus dans le champ d'application de la saisine, car soit certains produits n'ont pas été notifiés à l'Agence par les autorités nationales compétentes, soit les informations ne sont pas parvenues à temps pour permettre l'inclusion de ces produits dans la procédure de saisine.
English: Romania Pfizer Animal Health Ramsgate Road
French: Roumanie Pfizer Animal Health Ramsgate Road
English: Flumix Flumequine 160 Salmonides
French: Flumix Fluméquine 160 Saumonsides
English: • precautionary phrases related to the use of (fluoro)quinolones intended for food-producing species have been included in Summary of the Product Characteristics for 163 products which however do not adequately reflect the CVMP recommendations;
French: • des phrases de précaution relatives à l'utilisation des (fluoro)quinolones destinées aux espèces animales productrices d'aliments ont été incluses dans le RCP de 163 produits, qui ne reflètent toutefois pas de manière appropriée les recommandations du CVMP;
English: Dzierżoniowska 21 58-260 Bielawa POLAND
French: 58-260 Bielawa POLOGNE
English: Poligono Industrial el Segre, Parcela 409-410
French: Espagne MEVET, S. A. Poligono Industrial el Segre, Parcela 409-410
English: 5531 AE Bladel THE NETHERLANDS
French: 5531 AE Bladel PAYS-BAS
English: 14451 Metamorfosi Attikis GREECE
French: 14451 Metamorfosi Attikis GRÈCE
English: Imequyl 10% 100mg/g powder for use in drinking water/milk for cattle, chicken and tureky
French: Imequyl 10% 100mg/g powder for use in drinking water/milk for cattle, chicken and turkey
English: Granules for oral solution
French: Granules pour solution orale
English: Salmonids
French: Salmonidés
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien AUSTRIA
French: Bayer AUTRICHE GmbH Herbststraße 6-10
English: Veterinary medicinal products that do not contain prudent use warnings in section 4 of the SPC
French: Médicaments vétérinaires ne contenant pas d'instructions d'utilisation prudente à la rubrique 4 du RCP.
English: ROMANIA
French: ROUMANIE
English: Amendments to be included in the relevant sections of the package leaflet
French: Modifications à inclure dans les rubriques correspondantes de la notice
English: T. Skretting A/S P.O.
French: T. Skretting A/S P.O. Box 319
English: Romania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
French: Roumanie Industrial Veterinaria S.A. Esmeralda, 19 - 4º
English: Scientific conclusions and grounds for amendment of the summary of product characteristics and package leaflet
French: Conclusions scientifiques et motifs de la modification du résumé des caractéristiques du produit et de la notice
English: Flumequine 50% Liquid (Andreotti)
French: Fluméquine 50% Liquid (Andreotti)
English: Laboratorios Ovejero, S. A. Ctra.
French: Espagne Laboratorios Ovejero, S. A. Ctra.
English: Camí Pedra Estela S/N 43205 Reus SPAIN
French: Camí Pedra Estela S/N 43205 Reus ESPAGNE
English: Veterinary medicinal products that contain prudent use warnings in section 4 of the SPC but which do not adequately reflect the CVMP recommendations; Group 3.
French: Médicaments vétérinaires contenant toutes les instructions d'utilisation prudente à la rubrique 4 du RCP, mais qui ne reflètent pas de manière appropriée les recommandations du CVMP; Groupe 3.
English: Danofloxacin mesilate per ml: danofloxacin mesylate 31,73 mg equivalent to danofloxacin 25 mg
French: Danofloxacine mésylate par ml: 31,73 mg de danofloxacine mésylate équivalents à 25 mg de danofloxacine
English: SLOVENIA
French: SLOVÉNIE
English: Laboratorios Serra Pamies, S.A.
French: Espagne Laboratorios Serra Pamies, S.A.
English: Flumiquil 50% oral powder for chicken, tureky, pig, cattle, sheep, trout and eel
French: Flumiquil 50% oral powder for chicken, turkey, pig, cattle, sheep, trout and eel
English: Cattle (non ruminating) Hens (non laying)
French: Bovins (non ruminants) Poules (non pondeuses)
English: Enrofloxacin 10% Enrofloxacin 10%
French: Enrofloxacin 10% Enrofloxacine 10 %
English: Lithuania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
French: Espagne Industrial Veterinaria S.A. Esmeralda, 19 - 4º
English: Solution for injection Bovine (non milk producing)
French: Bovins (non producteurs de lait)
English: Fish (trout)
French: Poissons (truites)
English: Oral powder
French: Poudre orale
English: 11.5 g/100 g Oral powder
French: 11,5 g/100 g Poudre orale
English: Veterinary medicinal products containing all the correct prudent use warnings in section 4 of the SPC (Special precautions for use), exactly as the CVMP recommendation and veterinary medicinal products containing all the prudent use warnings in section 4 of the SPC, which is however not exactly the text recommended by the CVMP, but conveys the same key messages; Group 2.
French: Médicaments vétérinaires contenant toutes les instructions correctes d'utilisation prudente à la rubrique 4 du RCP (Précautions particulières d'emploi), exactement telles que formulées dans la recommandation du CVMP, et médicaments vétérinaires contenant toutes les instructions d'utilisation prudente à la rubrique 4 du RCP, qui ne sont toutefois pas exactement équivalentes au texte recommandé par le CVMP, mais qui véhiculent les mêmes messages clés.
English: Drinkmix flumequine Flumequine
French: Drinkmix flumequine Fluméquine
English: Romania Divasa-Farmavic S.A. Ctra San Hipolito km 71
French: Roumanie Divasa-Farmavic S.A. Ctra San Hipolito km 71
English: Danofloxacin 31.73 mg/ml (equivalent to
French: Danofloxacine 31,73 mg/ml (équivalents à
English: United Kingdom
French: ROYAUME-UNI
English: 5531 BK Bladel NETHERLAND
French: 5531 BK Bladel PAYS-BAS
English: 1MUI/g Colistin sulphate 200mg/g oxolinic acid
French: 1MUI/g de sulfate de colistine 200mg/g d'acide oxolinique
English: Oxolinic acid 50%
French: Acide oxolinique 50 %
English: Difloxacin hydrochloride
French: Difloxacine chlorhydrate
English: Fluyesyva Inyectable Flumequine
French: Fluyesyva Inyectable Fluméquine
English: Enrofloxacin Bromhexine
French: Enrofloxacine Bromhexine
English: Box 40261 6302 Larnaca
French: Industrial Area Aradippou 7100 P.O. Box 40261 6302 Larnaca
English: 841 01 Bratislava SLOVAK REPUBLIC
French: 841 01 Bratislava RÉPUBLIQUE SLOVAQUE
English: Oxolinic acid, sodium salt
French: Acide oxolinique, sel de sodium
English: 100 g/1000 g Oral powder
French: 100 g/1000 g Poudre orale
English: Romania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
French: Roumanie CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Poultry
French: Poulets
English: Hungary Divasa-Farmavic S.A. Ctra San Hipolito km 71
French: Espagne Divasa-Farmavic S.A. Ctra San Hipolito km 71
English: Romania Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
French: Roumanie Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
English: Rabbits
French: Lapins
English: Inoxyl Solution Buvable Oxolinic acid 50 mg
French: Inoxyl Solution Buvable Acide oxolinique 50 mg
English: Cattle Exotic animals
French: Bovins Animaux exotiques
English: Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible.
French: Produits pour lesquels aucune information n'a été soumise par les demandeurs/titulaires des autorisations de mise sur le marché ou les autorités nationales compétentes et pour lesquels aucune évaluation des instructions existantes dans le RCP n'a donc été possible.
English: Amoxicillin 22,5% ΚAI Flumequine 15%
French: Amoxicillin 22,5% ΚAI Fluméquine 15%
English: Enrofloxacin Colistin sulphate Vitamin C
French: Enrofloxacine Sulfate de colistine Vitamine C
English: Colistine sulphate 12 g Oxolinic acid 100g
French: Sulfate de colistine 12 g Acide oxolinique 100g
English: Lithuania Laboratorios Calier, S.A. Barcelonés, 26
French: Espagne Laboratorios Calier, S.A. Barcelonés, 26
English: Flumequine 50% Liquid (Neofarma)
French: Fluméquine 50% Liquid (Neofarma)
English: de Castellvell nº 24 43206 Reus (Tarragona) SPAIN
French: 43206 Reus (Tarragona) ESPAGNE
English: Birds
French: Oiseaux
English: 25.82 g amoxicillin trihydrate 15 g flumequine
French: Amoxicilline Fluméquine pour 100 g: 25,82 g d'amoxicilline trihydratée 15 g de fluméquine
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi (Barcelona)
French: 08970 Sant Joan Despi (Barcelona)
English: Flumesyva Oral paste Flumequine
French: Flumesyva Oral paste Fluméquine
English: Solution injectable Cattle Goat
French: Solution injectable Bovins Chèvres
English: Romania Lavet Gyógyszergyártó Kft. Ottó u. 14
French: Roumanie Lavet Gyógyszergyártó Kft. Ottó u. 14
English: Inoxyl Poudre Orale Oxolinic acid 100 mg
French: Inoxyl Poudre Orale Acide oxolinique 100 mg
English: Lithuania Codifar N.V. Lt. Caluwaertstraat 1
French: Lt. Caluwaertstraat 1
English: Birds Fish
French: Oiseaux Poissons
English: • adequate precautionary phrases related to the use of (fluoro)quinolones intended for foodproducing species have been included in Summary of the Product Characteristics for 318 products concerned by this referral;
French: • des phrases de précaution appropriées, relatives à l'utilisation des (fluoro)quinolones destinées aux espèces animales productrices d'aliments ont été incluses dans le RCP de 318 produits concernés par la présente saisine;
English: Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona SPAIN
French: Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona ESPAGNE
English: ICC-O-Flu 50% Flumequine
French: ICC-O-Flu 50% Fluméquine
English: Marbocyl 50mg Bolus Marbofloxacin 50 mg
French: Marbocyl 50mg Bolus Marbofloxacine 50 mg
English: Belgium Bayer N.V. Louizalaan 143
French: Belgique Bayer N.V.
English: • no precautionary phrases related to the use of (fluoro)quinolones intended for food-producing species have been included in Summary of the Product Characteristics of 83 products concerned by this referral;
French: • aucune phrase de précaution relative à l'utilisation des (fluoro)quinolones destinées aux espèces animales productrices d'aliments n'a été incluse dans le RCP de 83 produits concernés par la présente saisine;
English: Flumix 50% super WO Flumequine
French: Flumix 50% super WO Fluméquine
English: Lithuania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
French: Espagne CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Medicated feed
French: Aliments médicamenteux
English: 1093 Budapest
French: 1093 Budapest HONGRIE
English: Difloxacin
French: Difloxacine
English: Flumequine Amoxicillin trihydrate
French: Fluméquine Amoxicilline trihydratée
English: Baytril oral solution Enrofloxacin 5 mg/ml
French: Baytril oral solution Enrofloxacine 5 mg/ml
English: Gran Via Carlos III, 98 7ªEdificio Trade
French: Espagne Chemo Iberica, S.A. Gran Via Carlos III, 98 7ªEdificio Trade
English: Flumesyva Premezcla Flumequine
French: Flumesyva Premezcla Fluméquine
English: Flumequine
French: Fluméquine
English: Romania Ascor Chimici S.r.l.
French: Roumanie Ascor Chimici S.r.l.
English: Subcutaneous intramuscular
French: Sous-cutanée intramusculaire
English: Pre-ruminant Cattle
French: Bovins préruminants
English: Flumiquil Poudre A 3 % Flumequine
French: Flumiquil Poudre A 3 % Fluméquine
English: Premix for medicated feedingstuffs
French: Prémélange pour aliments médicamenteux
English: 100 mg/ml enrofloxacin 109 IU colistin sulphate
French: 100 mg/ml d'enrofloxacine 109 UI de sulfate de colistine
English: Eurovet Animal Health B.V. Handelsweg 25
French: Eurovet Animal Health B.V.
English: Inoxyl Acide Oxolinique 240 Salmonides
French: Inoxyl Acide Oxolinique 240 Saumonsides
English: Flumix Poudre A 3 % Flumequine
French: Flumix Poudre A 3 % Fluméquine
English: Amoxicillin 22,5% + Flumequine 15%
French: Amoxicillin 22,5% + Fluméquine 15%
English: Rodents (rabbit, guinea pigs, mice, hamsters) Hunting birds Exotic birds Dogs
French: Rongeurs (lapins, cochons d'Inde, souris, hamsters) Oiseaux de proie
English: Colistin sulphate Oxolinic acid
French: Sulfate de colistine Acide oxolinique
English: Laboratorios Dr Esteve, S.A. Avda.
French: Espagne Laboratorios Dr Esteve, S.A. Avda.
English: Oxolinic acid 100% Medicated premix Fish
French: Acide oxolinique 100 % Prémélange médicamenteux
English: Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, tureky and pigeons
French: Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, turkey and pigeons
English: Oxomid Acide Oxolinique 240 Salmonides
French: Oxomid Acide Oxolinique 240 Saumonsides
English: Labiana Life Science, S.A. Venus 26 - Can Parellada Industrial
French: Venus 26 - Can Parellada Industrial
English: 1107 Budapest
French: 1107 Budapest HONGRIE
English: Hungary S.P. Veterinaria S.A. Ctra.
French: Espagne S.P. Veterinaria S.A. Ctra.
English: 50 mg/ml enrofloxacin 500 000 IU/ml colistin sulphate
French: 50 mg/ml d'enrofloxacine 500 000 UI/ml de sulfate de colistine
English: Flumisol 100mg/ml oral solution for chicken, tureky, pig, cattle and sheep
French: Flumisol 100mg/ml oral solution for chicken, turkey, pig, cattle and sheep
English: Danofloxacin mesilate
French: Danofloxacine mésylate
English: Belgium Ceva Santé Animale N.V. Metrologielaan 6
French: Belgique Ceva Santé Animale N.V.
English: 5 mg/tablet
French: 5 mg/comprimé Comprimés
English: 08017 Barcelona SPAIN
French: 08017 Barcelona ESPAGNE
English: Quinoex-10, 100mg/ml oral solution for chicken and tureky
French: Quinoex-10, 100mg/ml oral solution for chicken and turkey
English: Oral paste
French: Pâte orale
English: Schippers Europe B.V. Bleijenhoek 17
French: Schippers Europe B.V.
English: ITALY
French: Italie
English: Oxolinic acid 24 g
French: Acide oxolinique 24 g
English: Soluble powder
French: Poudre soluble
English: 08028 Barcelona SPAIN
French: 08028 Barcelona ESPAGNE
English: 08041 Barcelona SPAIN
French: 08041 Barcelona
English: Enrofloxacin 0.10 g
French: Enrofloxacine 0,10 g
English: Amoxicillin trihydrate Flumequine
French: Amoxicilline trihydratée Fluméquine
English: Amendment to the summary of product characteristics and package leaflet
French: Modification du résumé des caractéristiques du produit et de la notice
English: Flumequine Durden Flumequine
French: Fluméquine Durden Fluméquine
English: Oral liquid
French: Liquide oral
English: Advocid 2,5 % Danofloxacin 25 mg/ml
French: Advocid 2,5 % Danofloxacine 25 mg/ml
English: Romania Vétoquinol Biowet Sp. z o.o.
French: Roumanie Vétoquinol Biowet Sp. z o.o.
English: Marbocyl 10% Marbofloxacin 10%
French: Marbocyl 10% Marbofloxacine 10 %
English: Danofloxacin 180 mg
French: Danofloxacine 180 mg
English: Romania Bayer HealthCare AG Animal Health Division 51368 Leverkusen
French: Roumanie Bayer HealthCare AG Animal Health Division 51368 Leverkusen
English: Oxolinic acid 274 mg
French: Acide oxolinique 274 mg
English: Marbocyl 2 % Marbofloxacin 2%
French: Marbocyl 2 % Marbofloxacine 2 %
English: Enrofloxacina Premix Enrofloxacin 50 mg/g
French: Enrofloxacina Premix Enrofloxacine 50 mg/g
English: Marbofloxacin 2%
French: Marbofloxacine 2 %
English: VIRBAC ESPAÑA, S.A. Angel Guimera, 179-181 08950 Esplugues de Llobregat SPAIN
French: Espagne VIRBAC ESPAÑA, S.A. Angel Guimera, 179-181
English: Flumexil 1.5% Flumequine
French: Flumexil 1.5% Fluméquine
English: Danofloxacin 25 mg
French: Danofloxacine 25 mg
English: HIPRALONA ENRO-I inj Enrofloxacin 50 mg/ml
French: HIPRALONA ENRO-I inj Enrofloxacine 50 mg/ml
English: Oxolinic acid 5 g/kg
French: Acide oxolinique 5 g/kg
English: Marbofloxacin 10%
French: Marbofloxacine 10 %
English: Belgium Dopharma Research BV Zalmweg 24
French: Belgique Dopharma Research BV Zalmweg 24
English: Oxolinic acid 1000 mg/g
French: Acide oxolinique 1000 mg/g
English: Flumesyva Liquid 20% Flumequine
French: Flumesyva Liquid 20% Fluméquine
English: ADVOCIN 2,5% Danofloxacin 25 mg/ml
French: ADVOCIN 2,5% Danofloxacine 25 mg/ml
English: Romania Dopharma Research BV Zalmweg 24
French: Roumanie Dopharma Research BV Zalmweg 24
English: Invented name
French: Nombre
English: Bayer HealthCare AG Animal Health Division 51368 Leverkusen GERMANY
French: Bayer HealthCare AG Animal Health Division 51368 Leverkusen ALLEMAGNE
English: Salmon Trout
French: Saumons Truites
English: Oxolinic acid 50 g
French: Acide oxolinique 50 g
English: Danofloxacin 25 mg/ml
French: Danofloxacine 25 mg/ml
English: Marbocyl 2% Marbofloxacin Marbofloxacin 2.0 % w/v
French: Marbocyl 2% Marbofloxacine Marbofloxacine 2,0 % m/v
English: Romania Laboratorios Karizoo, S.A. Polg.
French: Roumanie Laboratorios Karizoo, S.A. Polg.
English: 40% Enrofloxacin 400 mg/g
French: 40% Enrofloxacine 400 mg/g
English: Ceva Hellas S.A. Ag. Nikolaou 15
French: Ceva Hellas S.A. Ag. Nikolaou 15 17455 Alimos Attikis GRÈCE
English: Bayer s.r.o Litvínovská 609/3 190 21 Praha 9 CZECH REPUBLIC
French: 190 21 Praha 9
English: Subcutaneous or intraveneous or intramuscular
French: Sous-cutanée ou intraveineuse ou intramusculaire
English: Calves Poultry
French: Veaux Poulets
English: Young poultry (chickens and turkeys)
French: Jeunes volailles (poulets et dindes)
English: Marbofloxacin 10% w/v
French: Marbofloxacine 10 % m/v
English: Cattle Goats Horses Sheep
French: Bovins Chèvres Chevaux Moutons
English: 1126 Budapest
French: 1126 Budapest HONGRIE
English: Enrocoli oral solution Enrofloxacin Colistin sulphate
French: Enrocoli oral solution Enrofloxacine Sulfate de colistine
English: Danofloxacin 180 mg/ml
French: Danofloxacine 180 mg/ml
English: “Official and local antimicrobial policies should be taken into account when the product is used.” “Whenever possible, quinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the quinolones and may decrease the effectiveness of treatment with other (fluoro) quinolones due to the potential for cross resistance.” The implementation of the CVMP recommendations was foreseen to be achieved following voluntary action and collaboration between national authorities and industry.
French: «Les directives officielles locales sur l'utilisation des agents antimicrobiens doivent être prises en compte lors de l'utilisation du produit.» «Dans la mesure du possible, les fluoroquinolones ne devraient être utilisées qu'après avoir réalisé un test de sensibilité.» «Une utilisation du produit ne respectant pas les instructions du RCP est susceptible d'augmenter la prévalence des bactéries résistantes aux quinolones et de diminuer l'efficacité du traitement par d'autres (fluoro)quinolones, en raison d'une possibilité de résistance croisée.» Il était prévu que la mise en œuvre des recommandations du CVMP se fasse sur la base d'une action volontaire et d'une collaboration entre les autorités nationales compétentes et l'industrie.
English: Romania Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
French: Roumanie Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
English: Enrofloxacin 10%
French: Enrofloxacine 10 %
English: Flumechina 50% Flumequine
French: Flumechina 50% Fluméquine
English: Oxolinic acid 0.05 g
French: Acide oxolinique 0,05 g
English: FLUMISOL 36% Flumequine
French: Flumisol 36 % Fluméquine
English: Flumequinorom 10% Flumequine
French: Flumequinorom 10% Fluméquine
English: Poultry (excluding laying)
French: Volailles (sauf pondeuses)
English: Oxolinic acid 0.04 g
French: Acide oxolinique 0,04 g
English: Baytril Injection 5% Enrofloxacin 5 g/100 ml
French: Baytril Injection 5% Enrofloxacine 5 g/100 ml
English: Chicken (excluding laying hens) Turkey Rabbit
French: Poulets (sauf poules pondeuses) Dindes Lapins
English: León-Vilecha, Nº30 24192 León
French: León-Vilecha, Nº30
English: Lambs Rabbits Pigs
French: Porcs Lapins
English: Oxolinic acid 240 mg/g
French: Acide oxolinique 240 mg/g
English: Enrofloxacin 200 g/1000 ml
French: Enrofloxacine 200 g/1000 ml
English: Enrofloxacin 5%
French: Enrofloxacine 5 %
English: Marbofloxacin 2% w/v
French: Marbofloxacine 2 % m/v
English: Cattle (calves) Pigs
French: Bovins (Veaux) Porcs
English: Flumequine 10% pulvis Flumequine
French: Flumequine 10% pulvis Fluméquine
English: Goats
French: Chèvres
English: Lanflox 2,5% Enrofloxacin 25 mg/ml
French: Lanflox 2,5% Enrofloxacine 25 mg/ml
English: Oxolinic acid 0.08 g
French: Acide oxolinique 0,08 g
English: Enrofloxacin Colistin sulphate
French: Enrofloxacine Sulfate de colistine
English: Poultry Rabbits
French: Poulets Lapins
English: Flumiquil 50 % powder Flumequine
French: Flumiquil 50 % powder Fluméquine