FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission clarified on 30 July 2009 that prudent use warnings already contained in the product literature of the concerned products could be maintained even if they were not an exact reproduction of the CVMP recommendation provided that they convey the same key messages.
Slovenian: Evropska komisija je dne 30. julija 2009 pojasnila, da se lahko opozorila, ki so že v dokumentaciji zadevnih zdravil, ohranijo, čeprav niso točna reprodukcija priporočil CVMP, če izražajo enako ključno sporočilo.
English: 05-651 Drwalew POLAND
Slovenian: 05-651 Drwalew POLJSKA
English: 59439 Holzwickede
Slovenian: 59439 Holzwickede NEMČIJA
English: 1495-131 Algés PORTUGAL
Slovenian: 1495-131 Algés
English: Hungary Abo-Mix Co. Ltd. Simai u. 6
Slovenian: Madžarska Abo-Mix Co. Ltd. Simai u. 6
English: Via Piave 120 - Torreselle 35017 Piombino Dese (PD) ITALY
Slovenian: Via Piave 120 - Torreselle 35017 Piombino Dese (PD) ITALIJA
English: Viale Certosa, 130 20156 Milano ITALY
Slovenian: Viale Certosa, 130 20156 Milano ITALIJA
English: Animalcare Ltd Common Road Dunnington York
Slovenian: Animalcare Ltd Common Road Dunnington
English: Calier Portugal-Medicamentos e Produtos Veterinários SA R Pé Mouro Edifício C - Linhó 2710-335 Sintra PORTUGAL
Slovenian: Portugalska Calier Portugal-Medicamentos e Produtos Veterinários SA R Pé Mouro Edifício C - Linhó 2710-335 Sintra
English: S.P.A. via della Libertà 1
Slovenian: via della Libertà 1
English: 8501 Novo mesto SLOVENIA
Slovenian: 8501 Novo mesto SLOVENIJA
English: 1049-045 Lisboa PORTUGAL
Slovenian: 1049-045 Lisboa
English: 43330 Riudoms (Tarragona) SPAIN
Slovenian: 43330 Riudoms (Tarragona) ŠPANIJA
English: 4002 Stavanger NORWAY
Slovenian: 4002 Stavanger
English: 2909 LD Capelle a/d Ijssel THE NETHRLANDS
Slovenian: 2909 LD Capelle a/d Ijssel NIZOZEMSKA
English: 105b 06406 Bernburg
Slovenian: 105b 06406 Bernburg NEMČIJA
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien AUSTRIA
Slovenian: Bayer Austria GmbH Herbststraße 6-10 1160 Wien AVSTRIJA
English: In order to evaluate the situation concerning the existing prudent use warnings in the concerned products the CVMP agreed to define the following groups: Group 1.
Slovenian: Za oceno stanja v zvezi z obstoječimi opozorili o preudarni rabi pri zadevnih zdravilih je CVMP opredelil naslednje skupine: Skupina 1.
English: Virbac S.A. via dei Gracchi, 30 20146 Milano (MI) ITALY
Slovenian: Virbac S.A. via dei Gracchi, 30 20146 Milano (MI) ITALIJA
English: de Castellvell nº 24 43206 Reus (Tarragona) SPAIN
Slovenian: de Castellvell nº 24 43206 Reus (Tarragona) ŠPANIJA
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.
Slovenian: Pri 83 zdravilih v povzetkih glavnih značilnosti zdravila ni bilo opozoril o preudarni rabi, zato so potrebni dodatni ukrepi, da se zagotovi vključitev zadostnih opozoril o preudarni rabi v skladu s priporočili Odbora.
English: 08620 San Vicens del Horts SPAIN
Slovenian: 08620 San Vicens del Horts ŠPANIJA
English: 1854 47020 Longiano (FC) ITALY
Slovenian: 1854 47020 Longiano (FC) ITALIJA
English: Esteve Farma, Lda Av. Do Forte, 3 - Edifício Suécia II, Piso 4A 2794-044 Carnaxide PORTUGAL
Slovenian: Portugalska Esteve Farma, Lda Av. Do Forte, 3 - Edifício Suécia II, Piso 4A 2794-044 Carnaxide PORTUGALSKA
English: The warnings to be included in the Summary of the Product Characteristics and Package Leaflet should be reviewed to reflect the text set out in Annex III.
Slovenian: Opozorila, ki se vključijo v povzetek glavnih značilnosti zdravil in navodila za uporabo, je treba popraviti tako, da odražajo besedilo v Dodatku III.
English: Germany Medistar Arzneimittel-Vertrieb GmbH
Slovenian: Medistar Arzneimittel-Vertrieb GmbH
English: 949 01 Nitra SLOVAK REPUBLIC
Slovenian: 949 01 Nitra SLOVAŠKA
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.
Slovenian: Kinoloni, vključno s fluorokinoloni, so zelo močne protimikrobne snovi, ki se uporabljajo v humani in veterinarski medicini in imajo edinstven mehanizem delovanja, ki ga ne najdemo pri običajnih protimikrobnih snoveh.
English: Applicant/ Marketing Authorisation Holder
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom
English: Pfizer Hellas SA Mesogeion Av 243 15451 N.Psihiko Athens GREECE
Slovenian: Pfizer Hellas SA Mesogeion Av 243 15451 N.Psihiko Athens GRČIJA
English: 08503 Gurb-Vic (Barcelona) SPAIN
Slovenian: 08503 Gurb-Vic (Barcelona) ŠPANIJA
English: Hungary Swifts Pharma Kft. Kossuth u. 25.
Slovenian: Madžarska Swifts Pharma Kft. Kossuth u. 25.
English: 011322 Bucharest ROMANIA
Slovenian: 011322 Bucharest ROMUNIJA
English: 10785 Berlin
Slovenian: 10785 Berlin NEMČIJA
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.
Slovenian: CVMP je dne 15. februarja 2007 sprejel „Javno izjavo o uporabi (fluoro)kinolonov pri živalih za proizvodnjo živil v Evropski uniji: pojav odpornosti in vpliv na zdravje ljudi“ (EMEA/SAGAM/184651/2005), katere zaključek je, da je uporaba (fluoro)kinolonov pri živalih selekcionirala odpornost pri povzročiteljih bolezni pri živalih in zoonotskih bolezenskih povzročiteljih, ki se prenašajo s hrano, zato so potrebni ukrepi za obvladovanje tveganja.
English: Romania S.C. ROMVAC COMPANY S.A. Şos.
Slovenian: Romunija S.C. ROMVAC COMPANY S.A. Şos.
English: 15123 Marousi Attikis GREECE
Slovenian: 15123 Marousi Attikis GRČIJA
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;
Slovenian: • kinoloni, vključno s fluorokinoloni, so ključne, učinkovite in pomembne protimikrobne snovi za živali, saj so pri nekaterih resnih indikacijah pri živalih fluorokinoloni edino razpoložljivo učinkovito zdravilo;
English: The referral procedure involved 696 veterinary products containing (fluoro)quinolones as identified by the Member States (see Annex I).
Slovenian: Postopek napotitve je zajel 696 veterinarskih zdravil, za katere so države članice ugotovile, da vsebujejo (fluoro)kinolone.
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;
Slovenian: • vključitev specifičnih opozoril v povzetek glavnih značilnosti zdravila in navodilo za uporabo zadevnih zdravil naj bi spodbudilo preudarno rabo ter pripomoglo k ohranitvi pozitivnega razmerja med koristmi in tveganji, povezanimi s (fluoro)kinoloni;
English: 17170 Amer (Girona) SPAIN
Slovenian: 17170 Amer (Girona) ŠPANIJA
English: Hungary Ceva-Phylaxia Co. Ltd. Szállás u. 5.
Slovenian: Madžarska Ceva-Phylaxia Co. Ltd. Szállás u. 5.
English: Scan Vet Poland Sp. z o.o.
Slovenian: Scan Vet POLJSKA Sp. z o.o.
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.
Slovenian: Pri 163 zdravilih opozorila v povzetkih glavnih značilnosti zdravila niso bila zadostna, ker v 4. poglavju ni bilo vseh opozoril o preudarni rabi ali pa ker so bila uporabljena opozorila za fluorokinolone namesto za kinolone ali obratno.
English: Hungary Orion Corporation Orionintie 1A
Slovenian: Madžarska Orion Corporation Orionintie 1A
English: IBERIL - Soc. Comercial de Produtos Agro-Pecuários, Lda Praça Dr. Francisco Sá Carneiro, n.º 7-5º esquerdo 1000-159 Lisboa PORTUGAL
Slovenian: Portugalska IBERIL - Soc. Comercial de Produtos Agro-Pecuários, Lda Praça Dr. Francisco Sá Carneiro, n.º 7-5º esquerdo 1000-159 Lisboa
English: 88212 Ravensburg
Slovenian: 88212 Ravensburg NEMČIJA
English: Active substance(s)
Slovenian: Zdravilna(e) učinkovina(e)
English: 7323 Brande
Slovenian: 7323 Brande DANSKA
English: 28031 Madrid SPAIN
Slovenian: 28031 Madrid ŠPANIJA
English: 06516 Carros Cedex FRANCE
Slovenian: 06516 Carros Cedex FRANCIJA
English: La Selva 135 17170 Amer (Girona) SPAIN
Slovenian: La Selva 135 17170 Amer (Girona) ŠPANIJA
English: Romania S.C. CRIDA PHARM S.R.L.
Slovenian: Romunija S.C. CRIDA PHARM S.R.L.
English: 33500 Libourne FRANCE
Slovenian: 33500 Libourne FRANCIJA
English: Romania Orion Corporation Orionintie 1A
Slovenian: Romunija Orion Corporation Orionintie 1A
English: Vetlima - Soc. Distribuidora de Pro. Agro-Pecuários, Lda Avenida 5 Outubro 35, 3°-E 1050-047 Lisboa PORTUGAL
Slovenian: Portugalska Vetlima - Soc. Distribuidora de Pro. Agro-Pecuários, Lda Avenida 5 Outubro 35, 3°-E 1050-047 Lisboa
English: 831 02 Bratislava SLOVAK REPUBLIC
Slovenian: 831 02 Bratislava SLOVAŠKA
English: 08950 Esplugues de Llobregat SPAIN
Slovenian: 08950 Esplugues de Llobregat ŠPANIJA
English: 3421 GW Oudewater NETHERLANDS
Slovenian: 3421 GW Oudewater NIZOZEMSKA
English: 08228 Tarrasa SPAIN
Slovenian: 08228 Tarrasa ŠPANIJA
English: A. For products listed in Annex I containing fluoroquinolones (enrofloxacin, marbofloxacin, danofloxacin and difloxacin):
Slovenian: A. Za zdravila, navedena v Dodatku I, ki vsebujejo fluorokinolone (enrofloksacin, marbofloksacin, danofloksacin in difloksacin):
English: Laboratoires Biové 3 Rue de Lorraine, BP 45 62510 Arques FRANCE
Slovenian: Laboratoires Biové 3 Rue de Lorraine, BP 45 62510 Arques FRANCIJA
English: Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCE
Slovenian: Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCIJA
English: (MI) ITALY
Slovenian: (MI) ITALIJA
English: Hungary Bayer Hungária Kft. Alkotás u. 50.
Slovenian: Madžarska Bayer Hungária Kft. Alkotás u. 50.
English: • the use of (fluoro)quinolones in animals has selected for antimicrobial resistance in animal pathogens and food borne zoonotic pathogens;
Slovenian: • uporaba (fluoro)kinolonov pri živalih je selekcionirala protimikrobno odpornost pri povzročiteljih bolezni živali in zoonotskih bolezenskih povzročiteljih, ki se prenašajo s hrano;
English: 24-100 Puławy POLAND
Slovenian: 24-100 Puławy POLJSKA
English: 96-100 Skierniewice POLAND
Slovenian: 96-100 Skierniewice POLJSKA
English: Naquilene 500 MP Premix For Medicated Feeding Stuff
Slovenian: Naquilene 500 MP Premix For Medicated Feeding Stuff flumekvin
English: The fluoroquinolone products concerned contain the active substances enrofloxacin, marbofloxacin, danofloxacin and difloxacin, and the quinolone products contain flumequine and oxolinic acid.
Slovenian: Zadevna zdravila s fluorokinoloni vsebujejo zdravilne učinkovine enrofloksacin, marbofloksacin, danofloksacin in difloksacin, zdravila s kinoloni pa flumekvin in oksolinsko kislino.
English: Bovine
Slovenian: govedo
English: 7 44153 Ancenis Cedex FRANCE
Slovenian: 7 44153 Ancenis Cedex FRANCIJA
English: 88326 Aulendorf GERMANY
Slovenian: 6 - 8 88326 Aulendorf NEMČIJA
English: 400064 Ozzano Emilia (BO) ITALY
Slovenian: 400064 Ozzano Emilia (BO) ITALIJA
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:
Slovenian: Po sestanku ciljne skupine s CVMP in zainteresiranimi stranmi in državami članicami je CVMP sprejel razpravni dokument o uporabi fluorokinolonov pri živalih za proizvodnjo živil - previdnostni ukrepi v povzetku glavnih značilnosti zdravila s priporočili za preudarno rabo (EMEA/CVMP/416168/2006), ki vsebujejo podrobne previdnostne stavke, ki se vključijo v povzetek glavnih značilnosti zdravila, kakor sledi:
English: Romania Pharmaqua-D. Kokkoris and Bros
Slovenian: Romunija Pharmaqua-D. Kokkoris and Bros
English: Germany Albrecht GmbH Hauptstr.
Slovenian: Albrecht GmbH Hauptstr.
English: 66-400 Gorzów Wielkopolski POLAND
Slovenian: 66-400 Gorzów Wielkopolski POLJSKA
English: Germany Vétoquinol Verwaltungs GmbH Parkstr.
Slovenian: Vétoquinol Verwaltungs GmbH Parkstr.
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.
Slovenian: CVMP je menil, da je treba skozi priporočila v povzetkih glavnih značilnosti zdravil strogo priporočati preudarno rabo kinolonov in da so potrebna usklajena navodila za preudarno rabo v literaturi za omenjena zdravila.
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.
Slovenian: Zato je zaradi interesa Skupnosti Evropska komisija vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, za uporabo pri živalskih vrstah za proizvodnjo živil napotila na agencijo, da se zagotovi, da so opozorila o preudarni rabi, ki so vključena v povzetek glavnih značilnosti zdravila, usklajena med zdravili te skupine ter v skladu s priporočili razpravnega dokumenta CVMP.
English: Solution Acide Oxolinique 5% Volailles Deltavit
Slovenian: Solution Acide Oxolinique 5% Volailles Deltavit oksolinska kislina
English: Amendments to be included in the relevant sections of the summary of product characteristics
Slovenian: Dopolnila, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila
English: 1050 Brussels BELGIUM
Slovenian: 1050 Brussels BELGIJA
English: 228.4 mg/ml (equivalent to 180 mg/ml Danofloxacin)
Slovenian: 228,4 mg/ml (enakovredno 180 mg/ml danofloksacina)
English: 70204 Lure cedex FRANCE
Slovenian: 70204 Lure cedex FRANCIJA
English: Euro-Quin 10 % Powder for Oral Solution
Slovenian: Euro-Quin 10 % Powder for Oral Solution flumekvin
English: Germany Pfizer GmbH Linkstr.
Slovenian: Pfizer GmbH Linkstr.
English: Dzierżoniowska 21 58-260 Bielawa POLAND
Slovenian: 58-260 Bielawa POLJSKA
English: Flumequina 10%powder flumechina 10g/100g powder for use in drinking water
Slovenian: Flumequina 10%powder flumechina 10g/100g powder for use in drinking water flumekvin
English: Flumiquil Comprimes De 1,010 g
Slovenian: Flumiquil Comprimes De 1,010 g flumekvin
English: Romania Pfizer Animal Health Ramsgate Road
Slovenian: Romunija Pfizer Animal Health Ramsgate Road
English: Romania Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
Slovenian: Romunija Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
English: Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat SPAIN
Slovenian: Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat ŠPANIJA
English: Flumequina 10%solution flumechina 10g/100g oral solution
Slovenian: Flumequina 10%solution flumechina 10g/100g oral solution flumekvin
English: Scientific conclusions and grounds for amendment of the summary of product characteristics and package leaflet
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
English: Norway
Slovenian: NORVEŠKA
English: Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS
Slovenian: Maagdenburgstraat 38 7421 ZE Deventer NIZOZEMSKA
English: 3641 RT Mijdrecht THE NETHRLANDS
Slovenian: 3641 RT Mijdrecht NIZOZEMSKA
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:
Slovenian: V zvezi z oceno vseh informacij, ki jih je glede vključitve opozoril o preudarni rabi v povzetek glavnih značilnosti zdravila prejel Odbor, so bili sprejeti naslednji zaključki:
English: Amoxicillin Flumequine per 100 g:
Slovenian: amoksicilin flumekvin na 100 g:
English: Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN
Slovenian: Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) ŠPANIJA
English: 62-200 Gniezno POLAND
Slovenian: 62-200 Gniezno POLJSKA
English: Flumeq 50-S 500 mg/g Powder for use in drinking water /milk for cattle and chicken
Slovenian: Flumeq 50-S 500 mg/g Powder for use in drinking water /milk for cattle and chicken flumekvin
English: Flumexil 5% Suspension For Injection
Slovenian: Flumexil 5% Suspension For Injection flumekvin
English: 300 mg/tablet
Slovenian: 300 mg/tableto tablete teleta
English: REAGRO - Importação e Exportação, S.A Avenida de Roma, n.º 15 2º esq.
Slovenian: Avenida de Roma, n.º 15 2º esq.
English: 14451 Metamorfosi Attikis GREECE
Slovenian: 14451 Metamorfosi Attikis GRČIJA
English: Flumix Flumequine 160 Salmonides
Slovenian: Flumix Flumequine 160 Salmonides flumekvin
English: Romania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Slovenian: Romunija Industrial Veterinaria S.A. Esmeralda, 19 - 4º
English: Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona SPAIN
Slovenian: Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona ŠPANIJA
English: 1130 Brussels
Slovenian: 1130 Brussels BELGIJA
English: Denmark Ceva Santé Animale Zone Industrielle La Ballastiere
Slovenian: Portugalska Ceva Santé Animale Zone Industrielle La Ballastiere
English: Flumival 10% Solution Orale Pour Volailles et Veaux
Slovenian: Flumival 10% Solution Orale Pour Volailles et Veaux flumekvin
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.
Slovenian: Odbor je ugotovil tudi, da vsa v EGP-EU odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, niso bila vključena v obseg napotitve, saj pristojni nacionalni organi agenciji niso prijavili določenih zdravil ali pa informacije niso bile prejete pravočasno za vključitev omenjenih zdravil v napotitev.
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.
Slovenian: Za 132 zdravil predlagatelji/imetniki dovoljenj za promet z zdravilom ali pristojni nacionalni organi niso predložili podatkov, zato ni bila možna ocena zadevnih povzetkov glavnih značilnosti zdravila.
English: 288 02 Nymburk CZECH REPUBLIC
Slovenian: Zámečnícka 411 288 02 Nymburk ČEŠKA
English: ROMANIA
Slovenian: ROMUNIJA
English: Imequyl 10% 100mg/g powder for use in drinking water/milk for cattle, chicken and tureky
Slovenian: Imequyl 10% 100mg/g powder for use in drinking water/milk for cattle, chicken and tureky flumekvin
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;
Slovenian: • previdnostni stavki v zvezi z uporabo (fluoro)kinolonov pri živalih za proizvodnjo živil v povzetkih glavnih značilnosti 163 zdravil niso zadostno odražali priporočil CVMP;
English: HIPRALONA ENRO-I, injekcinis tirpalas galvijams ir kiaulėms
Slovenian: HIPRALONA ENRO-I, injekcinis tirpalas galvijams ir kiaulėms govedo prašiči intramuskular no
English: Diflocin 10 % oral solution
Slovenian: Diflocin 10 % oral solution difloksacin
English: Flumix Flumequine 24 Lapin-Volaille
Slovenian: Flumix Flumequine 24 Lapin-Volaille flumekvin
English: ACROLIN 10, solução oral para frangos de carne
Slovenian: ACROLIN 10, solução oral para frangos de carne peroralna raztopina piščanci
English: Bayer B.V.
Slovenian: Nizozemska Bayer B.V.
English: 5531 BK Bladel NETHERLAND
Slovenian: 5531 BK Bladel
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.
Slovenian: Poleg tega je Odbor ugotovil, da seznam zdravil v Dodatku I ne vključuje vseh v EGP-EU odobrenih zdravil za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, saj pristojni nacionalni organi agenciji določenih zdravil niso prijavili ali pa informacije niso bile prejete pravočasno za vključitev omenjenih zdravil v to napotitev.
English: JORDANIA
Slovenian: JORDANIJA
English: Quinolone products1 (e.g. flumequine, oxolinic acid)
Slovenian: Zdravila s kinoloni1 (npr. flumekvin, oksolinska kislina)
English: VIRBAC ESPAÑA, S.A. Angel Guimera, 179-181 08950 Esplugues de Llobregat SPAIN
Slovenian: Angel Guimera, 179-181 08950 Esplugues de Llobregat ŠPANIJA
English: Camí Pedra Estela S/N 43205 Reus SPAIN
Slovenian: Camí Pedra Estela S/N 43205 Reus ŠPANIJA
English: Flumiquil 50% oral powder for chicken, tureky, pig, cattle, sheep, trout and eel
Slovenian: Flumiquil 50% oral powder for chicken, tureky, pig, cattle, sheep, trout and eel flumekvin
English: Pfizer Ltd Ramsgate Road Sandwich Kent
Slovenian: Bolgarija Pfizer Ltd Ramsgate Road Sandwich
English: Laboratorios Syva, S.A. Parroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN
Slovenian: Laboratorios Syva, S.A. Parroco Pablo Diez, 49-57 24010 Trobajo Del Camino ŠPANIJA
English: 4941 VX Raamsdonksveer NETHERLANDS
Slovenian: 4941 VX Raamsdonksveer NIZOZEMSKA
English: Lithuania Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Slovenian: Bolgarija Industrial Veterinaria S.A. Esmeralda, 19 - 4º
English: Flumix Flumequine 48 Porc
Slovenian: Flumix Flumequine 48 Porc flumekvin
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;
Slovenian: • primerni previdnostni stavki v zvezi z uporabo (fluoro)kinolonov pri živalih za prehrano ljudi so bili v povzetkih glavnih značilnosti 318 zdravil, ki bili so zajeti v to napotitev;
English: Box 40261 6302 Larnaca
Slovenian: Industrial Area Aradippou 7100 P.O. Box 40261 6302 Larnaca
English: T. Skretting A/S P.O.
Slovenian: Norveška T. Skretting A/S P.O. Box 319
English: Flubactin 20%, 200mg/ml oral solution for cattle, sheep, chicken, pig, mink, coypu and rabbit
Slovenian: Flubactin 20%, 200mg/ml oral solution for cattle, sheep, chicken, pig, mink, coypu and rabbit flumekvin
English: Enrofloxacin Colistin sulphate Vitamin C
Slovenian: Enrocol enrofloksacin kolistin sulfat vitamin C
English: SLOVENIA
Slovenian: SLOVENIJA
English: Romania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Slovenian: Romunija CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Advocine Poudre Orale Danofloxacin 0.1667 g
Slovenian: Advocine Poudre Orale danofloksacin 0,1667 g peroralni prašek piščanci pitovni piščanci
English: Germany Calluna Pharma bvba Lindendreef 16 box 4
Slovenian: Calluna Pharma bvba Lindendreef 16 box 4 2320 Hoogstraten BELGIJA