FrancophonIA/ELRC3.0 huggingface dataset:
English: On 15 February 2007 the CVMP adopted a “Public Statement on the use of (fluoro)quinolones in foodproducing animals in the European Union: Development of Resistance and Impact on Human Health” (EMEA/SAGAM/184651/2005) concluding that the use of (fluoro)quinolones in animals has selected for resistance in animal pathogens and food borne zoonotic pathogens and that there was a need for risk management interventions.
Estonian: 15. veebruaril 2007 võttis veterinaarravimite komitee vastu dokumendi “Public Statement on the use of (fluoro)quinolones in food-producing animals in the European Union: Development of Resistance and Impact on Human Health” (Avalik teatis (fluoro)kinoloonide kasutamise kohta toiduloomadel Euroopa Liidus: resistentsuse teke ja mõju inimeste tervisele) (EMEA/SAGAM/184651/2005), milles järeldati, et (fluoro)kinoloonide kasutamine loomadel on soodustanud selektsiooni resistentsete loompatogeenide ja toiduga levivate zoonootiliste patogeenide tekke suunas ning on vaja võtta riskihaldusmeetmeid.
English: • quinolones including fluoroquinolones are critical, efficient and valuable antimicrobials for animals and for some serious animal indications, fluoroquinolones are the only effective treatment available;
Estonian: • kinoloonid, sealhulgas fluorokinoloonid, on loomadel kasutatavad olulised, efektiivsed ja väärtuslikud antimikroobsed ühendid ning mõnede raskete loomsete näidustuste korral on fluorokinoloonid ainsad olemasolevad efektiivsed ravimid;
English: Zone Industrielle des Touches 200, avenue de Mayenne B.P.
Estonian: Prantsusmaa Sogeval Zone Industrielle des Touches 200, avenue de Mayenne B.P. 2227
English: Laboratorios e Industrias Iven, S.A.
Estonian: Hispaania Laboratorios e Industrias Iven, S.A.
English: The referral procedure involved 696 veterinary products containing (fluoro)quinolones as identified by the Member States (see Annex I).
Estonian: Esildismenetlus hõlmas 696 (fluoro)kinoloone sisaldavat veterinaarravimit, mille kohta olid liikmesriigid esitanud andmed (vt I lisa) .
English: Exotic Animals (small mammals, reptiles, avian species)
Estonian: Eksootilised loomad (väiksed imetajad, roomajad, linnud)
English: Quimica Farmaceutica Bayer, S.L.
Estonian: Hispaania Quimica Farmaceutica Bayer, S.L.
English: • the use of (fluoro)quinolones in animals has selected for antimicrobial resistance in animal pathogens and food borne zoonotic pathogens;
Estonian: • (fluoro)kinoloonide kasutamine loomadel on soodustanud selektsiooni antimikroobsete ühendite suhtes resistentsete loompatogeenide ja toiduga levivate zoonootiliste patogeenide tekke suunas;
English: 2821 Gyermely
Estonian: 2821 Gyermely HUNGARY
English: 28031 Madrid SPAIN
Estonian: 28031 Madrid
English: In addition, for 83 products no prudent use warnings are included in the Summary of the Product Characteristics and therefore further action is required in order to ensure that adequate prudent use warnings in line with the recommendations from the Committee are included.
Estonian: Mõistliku kasutamise hoiatused puuduvad ravimi omaduste kokkuvõttest veel 83 ravimil , mistõttu on vajalikud täiendavad meetmed, et tagada komitee soovitustele vastavate täielike mõistliku kasutamise hoiatuste lisamine.
English: For 163 products the SPC warnings were not adequate because they do not contain all the prudent use warnings in section 4 of the SPC or warnings for fluoroquinolone were used instead of quinolone warnings, or vice versa.
Estonian: 163 ravimil ei olnud hoiatused ravimi omaduste kokkuvõttes täielikud, sest 4. lõigus ei olnud kõiki mõistliku kasutamise hoiatusi või fluorokinoloonide hoiatuste asemel kasutati kinoloonide hoiatusi või vastupidi.
English: Hungary Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park
Estonian: Prantsusmaa Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park
English: A. For products listed in Annex I containing fluoroquinolones (enrofloxacin, marbofloxacin, danofloxacin and difloxacin):
Estonian: A. I lisas loetletud ravimid, mis sisaldavad fluorokinoloone (enrofloksatsiin, marbofloksatsiin, danofloksatsiin ja difloksatsiin):
English: Romania S.C. CRIDA PHARM S.R.L.
Estonian: Rumeenia S.C. CRIDA PHARM S.R.L.
English: 08228 Tarrasa SPAIN
Estonian: 08228 Tarrasa
English: Bayer Santé 13 rue Jean Jaures 92807 Puteaux FRANCE
Estonian: Prantsusmaa Bayer Santé 13 rue Jean Jaures 92807 Puteaux FRANCE
English: Vetoquinol Especialidades Veterinarias, S.A.
Estonian: Hispaania Vetoquinol Especialidades Veterinarias, S.A.
English: Amendments to be included in the relevant sections of the package leaflet
Estonian: Muudatused, mis tuleb lisada pakendi infolehe asjakohastesse lõikudesse
English: Moreover the indications for use of the products are not the same in all countries and marketing authorisations can differ between countries.
Estonian: Lisaks sellele varieeruvad riigiti ravimite näidustused ja müügiloa tingimused.
English: 7323 Brande
Estonian: 7323 Brande DENMARK
English: Scan Vet Poland Sp. z o.o.
Estonian: Scan Vet Poola Sp. z o.o.
English: Subsequently, the European Commission invoked Community interest and referred all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species to the Agency in order to ensure that the warnings on prudent use included in the Summary of the Product Characteristics for these classes of products were harmonised in line with those recommended in the CVMP Reflection paper.
Estonian: Järgnevalt tugines Euroopa Komisjon ühenduse huvidele ja tegi Euroopa Ravimiametile esildise kõigi veterinaarravimite kohta, mis sisaldavad kinoloone, sealhulgas fluorokinoloone, ja on ette nähtud kasutamiseks toiduloomadel, et tagada nimetatud tooteklasside ravimite ravimi omaduste kokkuvõttesse lisatud mõistliku kasutamise hoiatuste ühtlustamine vastavalt veterinaarravimite komitee aruteludokumendi soovitustele.
English: Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCE
Estonian: Prantsusmaa Franvet Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCE
English: Quinolones including fluoroquinolones are very potent antimicrobials used in human and veterinary medicine which have a unique mechanism of action not related to conventional antimicrobials.
Estonian: Kinoloonid, sealhulgas fluorokinoloonid, on inim- ja veterinaarravimitena kasutatavad tugevatoimelised antimikroobsed ühendid, millel on ainulaadne toimemehhanism, mis erineb tavapäraste antimikroobsete ühendite omast.
English: Germany Albrecht GmbH Hauptstr.
Estonian: Saksamaa Albrecht GmbH Hauptstr.
English: Fatro Uriach Veterinaria, S.L.
Estonian: Hispaania Fatro Uriach Veterinaria, S.L.
English: With regard to 132 products no information was submitted by the Applicants/Marketing Authorisation Holders or competent national authorities and therefore an assessment of the concerned Summary of the Product Characteristics could not be made.
Estonian: 132 ravimi kohta müügiloa taotleja/hoidja või liikmesriikide pädevad asutused infot ei esitanud, mistõttu nende ravimi omaduste kokkuvõtte asjassepuutuvaid hoiatusi hinnata ei saanud.
English: Laboratorio Jaer S.A. Barcelona, 411
Estonian: Hispaania Laboratorio Jaer S.A. Barcelona, 411
English: Romania Pharmaqua-D. Kokkoris and Bros
Estonian: Rumeenia Pharmaqua-D. Kokkoris and Bros
English: Denmark Ceva Santé Animale Zone Industrielle La Ballastiere
Estonian: Prantsusmaa Ceva Santé Animale Zone Industrielle La Ballastiere
English: 040185 Bucharest
Estonian: 040185 Bucharest ROMANIA
English: Germany Pfizer GmbH Linkstr.
Estonian: Saksamaa Pfizer GmbH Linkstr.
English: Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS
Estonian: Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS
English: • the inclusion of specific warnings in the Summary of the Product Characteristics and Package Leaflet of the concerned products is intended to encourage prudent use and help maintain the positive benefit:risk balance for (fluoro)quinolone products;
Estonian: • erihoiatuste lisamisega asjaomaste ravimite ravimi omaduste kokkuvõttesse ja pakendi infolehte soovitakse edendada fluorokinoloonide mõistlikku kasutamist ja aidata säilitada kasulikkuse ja riski positiivset suhet;
English: • there is a need for risk management interventions regarding the use of (fluoro)quinolones for humans and animals;
Estonian: • esineb vajadus rakendada meetmeid inimestel ja loomadel (fluoro)kinoloonide kasutamisega kaasnevate riskide maandamiseks;
English: Rabbits
Estonian: Küülikud
English: Romania Pfizer Animal Health Ramsgate Road
Estonian: Rumeenia Pfizer Animal Health Ramsgate Road
English: Following a focus group meeting of the CVMP with Interested Parties and Member States, the CVMP adopted a Reflection paper on the use of Fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006) detailing the precautionary phrases to be included in the Summary of the Product Characteristics, as follows:
Estonian: Pärast veterinaarravimite komitee sihtrühma ning huvitatud poolte ja liikmesriikide esindajate koosolekut võttis veterinaarravimite komitee vastu aruteludokumendi fluorokinoloonide kasutamise kohta toiduloomadel - kasutamise ettevaatusabinõud, mis lisatakse ravimi omaduste kokkuvõttesse mõistliku kasutamise juhisesse (EMEA/CVMP/416168/2006), täpsustades hoiatuslaused järgmiselt:
English: Poligono Industrial el Segre, Parcela 409-410
Estonian: Hispaania MEVET, S. A. Poligono Industrial el Segre, Parcela 409-410
English: • for 132 the products identified by the Member States no or insufficient information was made available to the CVMP by the Applicants/Marketing Authorisation Holders or national authorities and therefore no conclusion on the availability or assessment the adequacy of precautionary phrases in the Summary of the Product Characteristics was possible; the Committee recommends the variation of the terms of the marketing authorisations of products containing quinolones including fluoroquinolones intended for food producing species as referred in Annex I in order to amend the Summary of the Product Characteristics and Package Leaflets in those cases where there are not in line with the CVMP Reflection Paper (EMEA/CVMP/416168/2006).
Estonian: • liikmesriikide tuvastatud 132 ravimi kohta ei esitanud müügiloa taotlejad/hoidjad või liikmesriikide pädevad asutused veterinaarravimite komiteele infot või esitasid puuduliku info, mistõttu ei olnud võimalik teha järeldusi nende ravimi omaduste kokkuvõtetes sisalduvate hoiatuslausete olemasolu kohta ega hinnata nende täielikkust, soovitab komitee muuta müügiloa tingimusi kinoloone, sealhulgas fluorokinoloone sisaldavatel ja toiduloomadel kasutamiseks ette nähtud ravimitel, mis on loetletud I lisas, et muuta nende ravimi omaduste kokkuvõtteid ja pakendi infolehti juhtudel, kus need ei ole kooskõlas veterinaarravimite komitee aruteludokumendiga (EMEA/CVMP/416168/2006).
English: Further to the evaluation of all information made available to the Committee the following conclusions were made concerning the inclusion of prudent use warnings in the Summary of the Product Characteristics of the concerned products:
Estonian: Pärast komiteele esitatud info hindamist tehti asjaomaste ravimite ravimi omaduste kokkuvõtetesse mõistliku kasutamise hoiatuste lisamise kohta järgmised järeldused: Rühm
English: Pfizer Animal Health Dúbravská cesta 2
Estonian: Slovakkia Pfizer Animal Health Dúbravská cesta 2
English: Oxolinic acid 100% Medicated premix Fish
Estonian: Oksoliinhape 100% Ravimsööda eelsegu Kalad
English: Germany Vétoquinol Verwaltungs GmbH Parkstr.
Estonian: Saksamaa Vétoquinol Verwaltungs GmbH Parkstr.
English: Amendments to be included in the relevant sections of the summary of product characteristics
Estonian: Muudatused, mis tuleb lisada ravimi omaduste kokkuvõtte asjakohastesse lõikudesse
English: 1130 Brussels
Estonian: 1130 Brussels BELGIUM
English: Germany Virbac S.A. 1ere Avenue 2065 M LID B.P.
Estonian: Saksamaa Virbac S.A. 1ere Avenue 2065 M LID B.P. 27
English: 5 mg/tablet
Estonian: 5 mg/tablett
English: Scientific conclusions and grounds for amendment of the summary of product characteristics and package leaflet
Estonian: Teaduslikud järeldused ning ravimi omaduste kokkuvõtte ja pakendi infolehe muutmise alused
English: 300 mg/tablet
Estonian: 300 mg/tablett Tabletid
English: Quinolone products1 (e.g. flumequine, oxolinic acid)
Estonian: Kinoloone sisaldavad tooted1 (nt flumekiin, oksoliinhape)
English: Inoxyl Solution Buvable Oxolinic acid 50 mg
Estonian: Inoxyl Solution Buvable Oksoliinhape 50 mg
English: 15451 N.Psihiko Athens GREECE
Estonian: 15451 N.Psihiko Atkanad GREECE
English: 5531 BK Bladel NETHERLAND
Estonian: 5531 BK Bladel
English: Veterinary medicinal products containing all the correct prudent use warnings in section 4 o f the SPC, exactly as the CVMP recommendation and Veterinary medicinal products containing all the prudent use warnings in section 4 of the SPC, which are however not exactly the text recommended by the CVMP, but conveys the same key messages Veterinary medicinal products that contain prudent use warnings in section 4 of the SPC but which do not adequately reflect the CVMP recommendations Veterinary medicinal products that do not contain the prudent use warnings in of section 4 of the SPC Veterinary medicinal products for which no information was submitted by the Applicants/Marketing Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible Total The (fluoro)quinolone SPC warnings were satisfactory for 318 products, and therefore no further action needs to be taken for these products.
Estonian: Veterinaarravimid, mille ravimi omaduste kokkuvõtte 4. lõik sisaldab kõiki õigeid mõistliku kasutamise hoiatusi, mis vastavad täpselt veterinaarravimite komitee soovitustele, ja veterinaarravimid, mille ravimi omaduste kokkuvõtte 4. lõik sisaldab kõiki mõistliku kasutamise hoiatusi, mille sõnastus ei vasta küll täpselt veterinaarravimite komitee soovitustele, kuid edastab sama põhisõnumit Veterinaarravimid, mille ravimi omaduste kokkuvõtte 4. lõik sisaldab mõistliku kasutamise hoiatusi, kuid mis ei väljenda täielikult veterinaarravimite komitee soovitusi Veterinaarravimid, mille ravimi omaduste kokkuvõtte 4. lõik ei sisalda mõistliku kasutamise hoiatusi Veterinaarravimid, mille kohta müügiloa taotleja/hoidja või liikmesriikide pädevad asutused infot ei esitanud ja mille ravimi omaduste kokkuvõtte hoiatusi seetõttu hinnata ei saa Kokku (Fluoro)kinoloonide ravimi omaduste kokkuvõtte hoiatused olid 318 ravimil rahuldavad ja seetõttu ei ole nende suhtes edasised meetmed vajalikud.
English: Laboratorios Serra Pamies, S.A.
Estonian: Hispaania Laboratorios Serra Pamies, S.A.
English: Rodents (rabbit, guinea pigs, mice, hamsters) Hunting birds Exotic birds Dogs
Estonian: Küülikud Närilised (küülikud, merisead, hiired, hamstrid) Röövlinnud Eksootilised linnud Koerad Kassid
English: Pfizer Ltd Ramsgate Road Sandwich Kent
Estonian: Bulgaaria Pfizer Ltd Ramsgate Road Sandwich
English: Bruistensingel 310 5232 AE Den Bosch THE NETHRLANDS
Estonian: 5232 AE Den Bosch THE NETHRLANDS
English: Intramuscular (cattle and pig), intravenous (cattle)
Estonian: Intramuskulaarne (veised ja sead), intravenoosne (veised)
English: Flumequine Durden Flumequine
Estonian: Flumequine Durden Flumekiin
English: 1MUI/g Colistin sulphate 200mg/g oxolinic acid
Estonian: 1MUI/g kolistiinsulfaati 200mg/g oksoliinhapet
English: The CVMP suggested that prudent use of fuoroquinolones should be strongly promoted through recommendations in the SPC and that there was a need to harmonise the prudent use instructions in the product literature of these products.
Estonian: Veterinaarravimite komitee soovitas fluorokinoloonide mõistliku kasutamise igakülgseks edendamiseks lisada ravimi omaduste kokkuvõttesse sellekohased soovitused ning leidis, et ravimidokumentides tuleks ühtlustada mõistliku kasutamise juhiseid.
English: Summary of Product Characteristics concerning 564 products of the 696 included in the referral were submitted by the Applicant/Marketing Authorisation Holders and competent national authorities to the CVMP for review.
Estonian: Müügiloa taotlejad/hoidjad ja liikmesriikide pädevad asutused esitasid veterinaarravimite komiteele läbivaatamiseks esildismenetlusse kaasatud 696 ravimist 564 kohta ravimi omaduste kokkuvõtted.
English: 11.5 g/100 g Oral powder
Estonian: 11.5 g/100 g Suukaudne pulber
English: Cattle Exotic animals
Estonian: Veised Eksootilised loomad
English: Fish
Estonian: Kalad
English: Laboratorios Ovejero, S. A. Ctra.
Estonian: Hispaania Laboratorios Ovejero, S. A. Ctra.
English: Danofloxacin 31.73 mg/ml (equivalent to
Estonian: Danofloksatsiin 31,73 mg/ml (vastab
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.
Estonian: Lisaks märgib komisjon, et I lisas esitatud ravimite nimekirjas ei ole kõik kinoloone, sealhulgas fluorokinoloone sisaldavad veterinaarravimid, millel on müügiluba Euroopa Majanduspiirkonna ja Euroopa Liidu liikmesriikides, sest mõnedest ravimitest liikmesriikide pädevad asutused Euroopa Ravimiametit ei teavitanud või jõudis info nende ravimite esildismenetlusse kaasamiseks liiga hilja kohale.
English: Turkeys Fish (trout)
Estonian: Kalkunid Kalad (forell)
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.
Estonian: Komisjon märkis ka seda, et kõiki kinoloone, sealhulgas fluorokinoloone sisaldavaid veterinaarravimeid, millel on müügiluba Euroopa Majanduspiirkonna ja Euroopa Liidu liikmesriikides, ei ole esildismenetlusse kaasatud kas seetõttu, et liikmesriikide pädevad asutused ei teavitanud Euroopa Ravimiametit mõnedest ravimitest või jõudis info nende kaasamiseks esildismenetlusse liiga hilja kohale.
English: Romania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Estonian: Rumeenia CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Pleinlaan 17
Estonian: Bleijenhoek 17
English: Intrauterine
Estonian: Intrauteriinne
English: Noe S.A.S.
Estonian: Prantsusmaa Noe S.A.S.
English: Drinkmix flumequine Flumequine
Estonian: Drinkmix flumequine Flumekiin
English: Fluyesyva Inyectable Flumequine
Estonian: Fluyesyva Inyectable Flumekiin
English: Marbocyl 50mg Bolus Marbofloxacin 50 mg
Estonian: Marbocyl 50mg Bolus Marbofloksatsiin 50 mg
English: Romania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Estonian: Rumeenia Industrial Veterinaria S.A. Esmeralda, 19 - 4º
English: Inoxyl Poudre Orale Oxolinic acid 100 mg
Estonian: Inoxyl Poudre Orale Oksoliinhape 100 mg
English: Intrauterine tablet
Estonian: Intrauteriintablett
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;
Estonian: • täielikud hoiatuslaused toiduloomadel ette nähtud (fluoro)kinoloonide kasutamise kohta on lisatud ravimi omaduste kokkuvõttesse käesoleva esildismenetluse 318 ravimil;
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi (Barcelona)
Estonian: 08970 Sant Joan Despi (Barcelona)
English: de Castellvell nº 24 43206 Reus (Tarragona) SPAIN
Estonian: 43206 Reus (Tarragona) SPAIN
English: 5531 AE Bladel THE NETHERLANDS
Estonian: 5531 AE Bladel
English: Flumesyva Oral paste Flumequine
Estonian: Flumesyva Oral paste Flumekiin
English: 2630 Aartselaar BELGIUM
Estonian: Kontichsesteenweg 42 2630 Aartselaar BELGIUM
English: Biovet AD 39 Petar Rakov Str. 4550 Peshtera BULGARIA
Estonian: Bulgaaria Biovet AD 39 Petar Rakov Str.
English: 100 g/1000 g Oral powder
Estonian: 100 g/1000 g Suukaudne pulber
English: Romania Ascor Chimici S.r.l.
Estonian: Rumeenia Ascor Chimici S.r.l.
English: 50 mg/ml enrofloxacin 500 000 IU/ml colistin sulphate
Estonian: 50 mg/ml enrofloksatsiini 500 000 IU/ml kolistiinsulfaati
English: Marbofloxacin 10% w/v
Estonian: Marbofloksatsiin 10% w/v
English: Rabbits Fur animals
Estonian: Küülikud Karusloomad
English: Flumequine
Estonian: Flumekiin
English: Lithuania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Estonian: Hispaania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Danofloxacin mesilate per ml: danofloxacin mesylate 31,73 mg equivalent to danofloxacin 25 mg
Estonian: 1 ml kohta: 31,73 mg danofloksatsiin mesülaati vastab 25 mg danofloksatsiinil e
English: Intravenous
Estonian: Intravenoosne
English: Lithuania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Estonian: Hispaania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
English: Gran Via Carlos III, 98 7ªEdificio Trade
Estonian: Hispaania Chemo Iberica, S.A. Gran Via Carlos III, 98 7ªEdificio Trade
English: 1093 Budapest
Estonian: 1093 Budapest HUNGARY
English: Danofloxacin mesilate
Estonian: Danofloksatsiin mesülaat
English: ICC-O-Flu 50% Flumequine
Estonian: ICC-O-Flu 50% Flumekiin
English: Baytril oral solution Enrofloxacin 5 mg/ml
Estonian: Baytril oral solution Enrofloksatsiin 5 mg/ml
English: 100 mg/ml enrofloxacin 109 IU colistin sulphate
Estonian: 100 mg/ml enrofloksatsiini 109 IU kolistiinsulfaati
English: Flumix 50% super WO Flumequine
Estonian: Flumix 50% super WO Flumekiin
English: Intramuscular
Estonian: Intramuskulaarne
English: Enrofloxacin Colistin sulphate Vitamin C
Estonian: Enrofloksatsiin Kolistiinsulfaat C-vitamiin
English: Romania Divasa-Farmavic S.A. Ctra San Hipolito km 71
Estonian: Rumeenia Divasa-Farmavic S.A. Ctra San Hipolito km 71
English: Broilers, Turkeys, Cattle
Estonian: Broilerid, Kalkunid, Veised
English: Birds
Estonian: Linnud
English: Flumesyva Premezcla Flumequine
Estonian: Flumesyva Premezcla Flumekiin
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;
Estonian: • käesoleva esildismenetluse 163 ravimil on lisatud ravimi omaduste kokkuvõttesse toiduloomadel ette nähtud (fluoro)kinoloonide kasutamise kohta hoiatuslaused, mis siiski ei väljenda täielikult veterinaarravimite komitee soovitusi;
English: Oxolinic acid 274 mg
Estonian: Oksoliinhape 274 mg
English: Bayer B.V.
Estonian: Madalmaad Bayer B.V.
English: Marbocyl 10% Marbofloxacin 10%
Estonian: Marbocyl 10% Marbofloksatsiin 10%
English: Pigs
Estonian: Põrsad
English: Animal species Route(s) of administration
Estonian: Ravimvorm Loomaliigid Manustamistee(d)
English: 841 01 Bratislava SLOVAK REPUBLIC
Estonian: 841 01 Bratislava
English: Leijsendwarsstraat 26 4901 PG Oosterhout THE NETHRLANDS
Estonian: 4901 PG Oosterhout THE NETHRLANDS
English: 1107 Budapest
Estonian: 1107 Budapest HUNGARY
English: Cattle (non ruminating) Hens (non laying)
Estonian: Veised (mittelakteeriva d lehmad) Kanad (mittemunevad)
English: Marbocyl 2 % Marbofloxacin 2%
Estonian: Marbocyl 2 % Marbofloksatsiin 2%
English: Marbofloxacin 2% w/v
Estonian: Marbofloksatsiin 2% w/v
English: Oxolinic acid 24 g
Estonian: Oksoliinhape 24 g
English: Vétoquinol B.V.
Estonian: Vétoquinol N.V.
English: Enrofloxacin 0.10 g
Estonian: Enrofloksatsiin 0,10 g
English: Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible.
Estonian: 4. rühm ravimid, mille kohta müügiloa taotleja/hoidja või liikmesriikide pädevad asutused infot ei esitanud ja mille ravimi omaduste kokkuvõtte hoiatusi seetõttu hinnata ei saa.
English: Romania Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
Estonian: Rumeenia Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona