natgillin/translations-raw huggingface dataset:
Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible.
Zdravila, za katera predlagatelji/imetniki dovoljenj za promet z zdravilom ali pristojni nacionalni organi niso predložili podatkov, zato ni bila možna ocena obstoječih opozoril v povzetku glavnih značilnosti zdravila.
Baytril piglet 25 mg/ml
Baytril piglet 25 mg/ml prašiči intramuskular no
Enrofloxacin No information available
Floxabactin enrofloksacin ni razpoložljivih podatkov ni razpoložljivih podatkov ni razpoložljivih podatkov ni razpoložljivih podatkov
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.
Predlagatelji/imetniki dovoljenj za promet z zdravilom in pristojni nacionalni organi so predložili povzetke glavnih značilnosti zdravila za 564 od 696 zdravil, vključenih v napotitev.
Hungary S.P. Veterinaria S.A. Ctra.
Madžarska S.P. Veterinaria S.A. Ctra.
Poultry (chickens and turkeys)
peroralna raztopina perutnina (piščanci in purani)
HUNGARY
Madžarska
Bulgaria
BOLGARIJA
UNISOL 2.5% oral solution for calves
UNISOL 2.5% oral solution for calves peroralna raztopina teleta
No information available
prašiči govedo ni razpoložljivih podatkov
Oxomid Acide Oxolinique 240 Salmonides
Oxomid Acide Oxolinique 240 Salmonides oksolinska kislina
Marbocyl 2% w/v Solution for Injection
Marbocyl 2% w/v Solution for Injection marbofloksacin 2 %
Zámečnícka 411
Bruistensingel 310
Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, tureky and pigeons
Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, tureky and pigeons peroralna raztopina govedo prašiči psi piščanci golobi purani
FLUMECHINA 50 %, geriamasis tirpalas
FLUMECHINA 50 %, geriamasis tirpalas flumekvin
Floxavex 100 mg/ml Concentrado Para Solucion oral pollos Y pavos
Floxavex 100 mg/ml Concentrado Para Solucion oral pollos Y pavos koncentrat za peroralno raztopino perutnina, purani
08028 Barcelona SPAIN
08028 Barcelona ŠPANIJA
FLUBACTIN sol
FLUBACTIN sol flumekvin
KARIFLOX 5 mg/ml oral solution for piglets
KARIFLOX 5 mg/ml oral solution for piglets peroralna raztopina pujski
Flumix Poudre A 3 % Flumequine
Flumix Poudre A 3 % flumekvin
Cofoxyl Liquide
Cofoxyl Liquide oksolinska kislina
Laboratorios Syva, S.A. arroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN
Laboratorios Syva, S.A. arroco Pablo Diez, 49-57 24010
Inoxyl Solution Buvable Oxolinic acid 50 mg
Inoxyl Solution Buvable oksolinska kislina
Marbocyl 10% Marbofloxacin 10%
Marbocyl 10% marbofloksacin 10 %
Baytril 100 mg/ml Lösung zum Eingeben für Hühner und Puten
Baytril 100 mg/ml Lösung zum Eingeben für Hühner und Puten peroralna raztopina piščanci purani
Marbocyl 10% Marbofloxacin per ml: marbofloxacin
Marbocyl 10% marbofloksacin v vsakem ml: marbofloksacin
DIFLOCIN 10% oral sol
DIFLOCIN 10% oral sol difloksacinijev klorid
Powerflox Max 100mg/ml solução injectável para bovinos
Powerflox Max 100mg/ml solução injectável para bovinos govedo subkutano
Concentrat Vo69 Acide Oxolinique 80 Porc
Concentrat Vo69 Acide Oxolinique 80 Porc oksolinska kislina
Concentrat Vo69 Acide Oxolinique 40 Volaille
Concentrat Vo69 Acide Oxolinique 40 Volaille oksolinska kislina
Baytril 5 mg/mlLösung zum Eingeben für Schweine
Baytril 5 mg/mlLösung zum Eingeben für Schweine peroralna raztopina prašiči
Flumexil 1.5% Flumequine
Flumexil 1.5% flumekvin
Biofloxavet 10% Oral Solution
Biofloxavet 10% Oral Solution peroralna raztopina perutnina
Flumesyva Liquid 20% Flumequine
Flumesyva Liquid 20% flumekvin
Inoxyl suspensão oral
Inoxyl suspensão oral oksolinska kislina
Romania Lavet Gyógyszergyártó Kft. Ottó u. 14
Romunija Lavet Gyógyszergyártó Kft. Ottó u. 14
Pre-ruminant Cattle
peroralna raztopina govedo
Inoxyl Pate Orale
Inoxyl Pate Orale oksolinska kislina
Baytril Max 10% Solution for Injection
Baytril Max 10% Solution for Injection govedo
GANADEXIL ENROFLOXACINA 5 %, injekcinis tirpalas
GANADEXIL ENROFLOXACINA 5 %, injekcinis tirpalas teleta subkutano
KARIFLOX 25 mg/ml oral solution for calves
KARIFLOX 25 mg/ml oral solution for calves peroralna raztopina teleta
Romania Bayer HealthCare AG Animal Health Division 51368 Leverkusen
Romunija Bayer HealthCare AG Animal Health Division 51368 Leverkusen
Hungary Lavet Gyógyszergyártó Kft. Ottó u. 14
Madžarska Lavet Gyógyszergyártó Kft. Ottó u. 14
Flumiquil Suspension Injectable
Flumiquil Suspension Injectable flumekvin
Subcutaneous, intraveneous
govedo subkutano, intravensko
Enrocare 5% Solution for Injection for Cattle, Pigs, Dogs and Cats
Enrocare 5% Solution for Injection for cattle, pigs, dogs and cats enrofloksacin 5 %
Veterinary medicinal products that do not contain prudent use warnings in section 4 of the SPC
Zdravila za uporabo v veterinarski medicini, ki ne vsebujejo opozoril o preudarni rabi v 4. poglavju povzetka glavnih značilnosti zdravila.
ENROXIL 5g/100g, vaistinis premiksas, milteliai
ENROXIL 5g/100g, vaistinis premiksas, milteliai enrofloksacin 5 g/100 g peroralni prašek perutnina prašiči
Oxolinic acid 100% Medicated premix Fish
Oxolinic Acid oksolinska kislina predmešanica za pripravo zdravilne krmne mešanice ribe
Flubactin solution
Flubactin solution flumekvin
Enroxil Oral Solution 100mg/ml for Chickens and Turkeys
Enroxil Oral Solution 100mg/ml for Chickens and Turkeys enrofloksacin 10 %
Ceva Hellas S.A. Ag. Nikolaou 15
Ceva Hellas S.A. Ag. Nikolaou 15 17455 Alimos Attikis GRČIJA
Flumiquil Poudre A 3 % Flumequine
Flumiquil Poudre A 3 % flumekvin
Enrox 100 mg/ml Lösung zum Eingeben für Hühner und Puten
Enrox 100 mg/ml Lösung zum Eingeben für Hühner und Puten peroralna raztopina piščanci purani
BAYTRIL 5% (w/v) injekční roztok
BAYTRIL 5% (w/v) injekční roztok teleta prašiči psi subkutano, intramuskular no
25.82 g amoxicillin trihydrate 15 g flumequine
25,82 g amoksicilin trihidrata 15 g flumekvina topni prašek prašiči pitovni piščanci purani
Oxolinic acid, sodium salt
Oxomid oksolinska kislina, natrijeva sol
4941 VX Raamsdonksveer THE NETHRLANDS
4941 VX Raamsdonksveer NIZOZEMSKAS
Hungary Laboratorios Karizoo, S.A. Polg.
Madžarska Laboratorios Karizoo, S.A. Polg.
Baytril Piglet Doser 0.5% Oral Solution
Baytril Piglet Doser 0.5% Oral Solution peroralna raztopina pujski
Enrocoli oral solution Enrofloxacin Colistin sulphate
Enrocoli oral solution enrofloksacin kolistin sulfat
Enroflocyna iNJ 100 mg/ml solution for injection for cattle, pig, dog, cat
Enroflocyna iNJ 100 mg/ml solution for injection for cattle, pig, dog, cat govedo prašiči psi mačke intramuskular no, subkutano
Enrocare 10% Solution for Injection for Cattle and Pigs
Enrocare 10% Solution for Injection for Cattle and Pigs enrofloksacin 10 %
Quinoex 10% Inyectable
Quinoex 10% Inyectable govedo prašiči subkutano, intramuskular no
Ganadexil enrofloxacina oral solution
Ganadexil enrofloxacina oral solution peroralna raztopina piščanci
Inoxyl solução oral
Inoxyl solução oral oksolinska kislina
FLUMISOL 36% Flumequine
FLUMISOL 36% flumekvin
Cafmix Acide Oxolinique 80 Porc
Cafmix Acide Oxolinique 80 Porc oksolinska kislina
Baytril oral solution Enrofloxacin 5 mg/ml
Baytril oral solution enrofloksacin 5 mg/ml peroralna raztopina pujski
K-FLOX 100 mg/ml solução oral para frangos de carne e coelhos
K-FLOX 100 mg/ml solução oral para frangos de carne e coelhos peroralna raztopina perutnina kunci
DIFLOCIN 10 %, geriamasis tirpalas
DIFLOCIN 10 %, geriamasis tirpalas difloksacin
Romania Vétoquinol Biowet Sp. z o.o.
Romunija Vétoquinol Biowet Sp. z o.o.
Leijsendwarsstraat 26 4901 PG Oosterhout THE NETHRLANDS
4901 PG Oosterhout NIZOZEMSKA
UNISOL 0.5% oral solution for piglets
UNISOL 0.5% oral solution for piglets peroralna raztopina pujski
Enroxil 10% perorální rostok
Enroxil 10% perorální rostok peroralna raztopina piščanci
Roxacin 10% oral solution, enrofloksacyna 100mg/ml, oral solution for chicken
Roxacin 10% oral solution, enrofloksacyna 100mg/ml, oral solution for chicken peroralna raztopina piščanci
MARBOCYL BOLUS 50 MG comprimidos para vitelos
MARBOCYL BOLUS 50 MG comprimidos para vitelos marbofloksacin 50 mg tablete govedo
Bayer HealthCare AG Animal Health Division 51368 Leverkusen GERMANY
Bayer HealthCare AG Animal Health Division 51368 Leverkusen NEMČIJA
Quinoex-10, 100mg/ml oral solution for chicken and tureky
Quinoex-10, 100mg/ml oral solution for chicken and tureky peroralna raztopina piščanci purani
Baytril One - 100 mg/ml solução injectável para bovinos
Baytril One - 100 mg/ml solução injectável para bovinos govedo subkutano, intravensko
Cafmix Acide Oxolinique 40 Volaille
Cafmix Acide Oxolinique 40 Volaille oksolinska kislina
Inoxyl pó solúvel
Inoxyl pó solúvel oksolinska kislina, natrijeva sol
Flumiquil 50 % powder Flumequine
Flumiquil 50 % powder flumekvin
Enroxil Solution for Injection 50 mg/ml for claves, pigs and dogs
Enroxil Solution for Injection 50 mg/ml for claves, pigs and dogs enrofloksacin 5 %
Fluquick Liquido
Fluquick Liquido flumekvin
Hungary Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
Madžarska Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
VETAFLOX 100 mg/ml solução oral para frangos de engorda e coelhos
VETAFLOX 100 mg/ml solução oral para frangos de engorda e coelhos peroralna raztopina pitovni piščanci kunci
Cofamix Acide Oxolinique 80 Porc
Cofamix Acide Oxolinique 80 Porc oksolinska kislina
Flumequine 10% pulvis Flumequine
Flumequine 10% pulvis flumekvin
MARBOCYL S 100 mg/ml injekční roztok
MARBOCYL S 100 mg/ml injekční roztok marbofloksacin 100 mg/ml govedo intramuskular no
Romania Laboratorios Karizoo, S.A. Polg.
Romunija Laboratorios Karizoo, S.A. Polg.
Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen
Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen govedo prašiči psi mačke subkutano, intramuskular no
Lanflox 2,5% Enrofloxacin 25 mg/ml
Lanflox 2,5% enrofloksacin 25 mg/ml peroralna raztopina teleta (neprežvekovalci)
Marbofloxacin 10%
marbofloksacin 10 %
Cattle (calves) Pigs
govedo (teleta) prašiči intramuskular no
Bayer Portugal SA Rua Quinta do Pinheiro, 5 2794-003 Carnaxide PORTUGAL
Portugalska Bayer Portugal SA Rua Quinta do Pinheiro, 5
Laboratórios Pfizer Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo PORTUGAL
Portugalska Laboratórios Pfizer Lda Lagoas Park, Edifício 10
Danofloxacin 180 mg
danofloksacin 180 mg govedo subkutano
Mayflus Suspension Oral
Mayflus Suspension Oral flumekvin
Box 17020
Postboks 2090
Romania Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
Romunija Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49
Cofamix Acide Oxolinique 40 Volaille
Cofamix Acide Oxolinique 40 Volaille oksolinska kislina
Colistin sulphate Oxolinic acid
Oxolipra oksolinska kislina
Enrofloksacyna 10% liquid, enrofloksacyna 100mg/ml oral solution for chicken
Enrofloksacyna 10% liquid, enrofloksacyna 100mg/ml oral solution for chicken peroralna raztopina piščanci
Enroxil Max 100 mg/ml injection
Enroxil Max 100 mg/ml injection govedo
Romania Laboratorios Hipra, S.A. Avda.
Romunija Laboratorios Hipra, S.A. Avda.
BAYTRIL Oplossing 2,5% Oraal
BAYTRIL Oplossing 2,5% Oraal peroralna raztopina govedo
VETAFLUMINA 5% Flumequine
VETAFLUMINA 5% flumekvin
Difloxy 10 % oral solution for chicken and turkey
Difloxy 10 % oral solution for chicken and turkey difloksacinijev klorid
EFRION 100 mg/ml Oral Solution for Chickens and Turkeys
EFRION 100 mg/ml Oral Solution for Chickens and Turkeys peroralna raztopina piščanci purani
Flumequinorom 10% Flumequine
Flumequinorom 10% flumekvin
Hungary Vétoquinol Biowet Sp. z o.o.
Madžarska Vétoquinol Biowet Sp. z o.o.
Baytril 2,5 % Injection Enrofloxacin 25 mg/ml
Baytril 2,5 % Solution Injectable enrofloksacin 25 mg pujski intramuskular no
50 mg/ml enrofloxacin 500 000 IU/ml colistin sulphate
50 mg/ml enrofloksacina 500.000 i.e. kolistin sulfata peroralna raztopina piščanci
Enroxil Max 100 mg/ml, injekční roztok pro skot
Enroxil Max 100 mg/ml, injekční roztok pro skot govedo subkutano
Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.
Portugalska Ceva Saúde Animal - Produtos Farmacêuticos e
Cattle Pigs Dogs Cats
govedo prašiči psi mačke intramuskular no
Hungary Laboratorios Hipra, S.A. Avda.
Madžarska Laboratorios Hipra, S.A. Avda.
Bayer Animal Health GmbH 51368 Leverkusen GERMANY
Bayer Animal Health GmbH 51368 Leverkusen NEMČIJA
• Fluoroquinolone products “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones 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 fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.”
• Zdravila s fluorokinoloni „Pri uporabi zdravila morate upoštevati uradne in lokalne doktrine protimikrobnega zdravljenja.“ „Fluorokinolone je treba prihraniti za zdravljenje kliničnih stanj, ki so se odzvala slabo, oz. tistih, pri katerih se pričakuje slab odziv na druge skupine protimikrobnih snovi.“ „Kadar je mogoče, uporabite fluorokinolone na podlagi testa občutljivosti.“ „Uporaba zdravila, ki ne sledi navodilom v povzetku glavnih značilnosti zdravila, lahko zviša pogostnost proti fluorokinolonom odpornih bakterij ter lahko zmanjša učinkovitost zdravljenja z drugimi kinoloni zaradi možnosti navzkrižne odpornosti.“
Diflocin 10%
Diflocin 10% difloksacin
Baytril 5% inj enrofloksacyna 50 mg/ml solution for injection for cattle and pig
Baytril 5% inj enrofloksacyna 50 mg/ml solution for injection for cattle and pig govedo prašiči intramuskular no, subkutano
Pfizer Animal Health Dúbravská cesta 2
Pfizer Animal Health Dúbravská cesta 2 841 01 Bratislava SLOVAŠKA
Marbocyl 50mg Bolus Marbofloxacin 50 mg
Marbocyl 50mg Bolus marbofloksacin 50 mg tablete govedo
Flumechina 50% Flumequine
Flumechina 50% flumekvin
Inoxyl Premix
Inoxyl Premix oksolinska kislina
100 g/1000 g Oral powder
1000 mg/g peroralni prašek ribe
Roxacin Inyectable Enrofloxacin 100 mg/ml
Roxacin Inyectable enrofloksacin 100 mg/ml prašiči intramuskular no
Lanflox 10% Oral Solution for Chickens and Turkeys
Lanflox 10% Oral Solution for Chickens and Turkeys peroralna raztopina piščanci purani
Solution for injection No information available
Flumisol flumekvin ni razpoložljivih podatkov ni razpoložljivih podatkov ni razpoložljivih podatkov ni razpoložljivih podatkov
Flumequine 10% WSP Flumequine
Flumequine 10% WSP flumekvin
Marbocyl - Tabletten für Kälber
Marbocyl - Tabletten für Kälber marbofloksacin 50 mg tablete teleta
100 mg/ml enrofloxacin 109 IU colistin sulphate
100 mg/ml enrofloksacina 109 i.e. kolistin sulfata peroralna raztopina piščanci purani
Danofloxacin 180 mg/ml
danofloksacin 180 mg/ml govedo subkutano
BAYTRIL Oplossing 0,5% Oraal
BAYTRIL Oplossing 0,5% Oraal peroralna raztopina prašiči
Inoxyl Poudre Orale Oxolinic acid 100 mg
Inoxyl Poudre Orale oksolinska kislina
Baytriluno 100 mg/ml Solucion Inyectable para Bovino
Baytriluno 100 mg/ml Solucion Inyectable para Bovino govedo subkutano, intravensko
Hipralona Enro-S Oral Solution
Hipralona Enro-S Oral Solution peroralna raztopina piščanci
Oxolinic Acid
Oxomid oksolinska kislina
Syvaquinol-10% Oral
Syvaquinol-10% Oral peroralna raztopina perutnina
Enroxil Max 100 mg/ml Solution for Injection for Cattle
Enroxil Max 100 mg/ml solution for injection for cattle govedo
ROXACIN, injekcinis tirpalas
ROXACIN, injekcinis tirpalas prašiči govedo intramuskular no
Premix for medicated feeding stuff
Predmešanica za pripravo zdravilne krmne mešanice postrvi
Enrocin 5% inj., enrofloksacyna 50mg/ml solution for injection for cattle and pig
Enrocin 5% inj., enrofloksacyna 50mg/ml solution for injection for cattle and pig govedo prašiči intramuskular no, subkutano
Roxacin injectável
Roxacin injectável prašiči intramuskular no
Hipralona Enro-I Injection
Hipralona Enro-I Injection govedo prašiči intramuskular no
Poultry (excluding laying)
peroralna raztopina perutnina (razen kokoši nesnic)
Romania Dopharma Research BV Zalmweg 24
Romunija Dopharma Research BV Zalmweg 24
40% Enrofloxacin 400 mg/g
40% enrofloksacin 400 mg/g prašek perutnina prašiči
ENROBIOFLOX 5 %, injekcinis tirpalas
ENROBIOFLOX 5 %, injekcinis tirpalas govedo prašiči subkutano, intramuskular no
Enrobioflox 10 % oral solution
Baytril 10% Oral Solution enrofloksacin 10 %
2160 Wommelgem BELGIUM
Lt. Caluwaertstraat 1 2160 Wommelgem BELGIJA
KARIFLOX 10% Oral Solution for Chickens and Turkeys
KARIFLOX 10% Oral Solution for Chickens and Turkeys peroralna raztopina piščanci purani
11.5 g/100 g Oral powder
5 g/100 g peroralni prašek govedo prašiči
Subcutaneous, Intravenous, intramuscular
govedo prašiči subkutano, intravensko, intramuskular no
Flumequine 50% WSP Flumequine
Flumequine 50% WSP flumekvin
Flumequine 50 % WSP Flumequine
Flumequine 50 % WSP flumekvin
Romania Vétoquinol S. A. Magny Vernois
Romunija Vétoquinol S. A. Magny Vernois
Oxomid Premix
Oxomid Premix oksolinska kislina
Alsir 10% Solucion Oral Enrofloxacin 100 mg/ml
Alsir 10% Solucion Oral enrofloksacin 100 mg/ml peroralna raztopina perutnina
Oxolinsyre vet
Oxolinsyre vet oksolinska kislina
ENRO-K 10% perorální roztok
ENRO-K 10% perorální roztok peroralna raztopina piščanci purani
Hungary Vétoquinol S. A. Magny Vernois
Madžarska Vétoquinol S. A. Magny Vernois
Enrobioflox 10% 100mg/ml oral solution for chicken, cattle, pig, dog, cat and pigeons
Enrobioflox 10% 100mg/ml oral solution for chicken, cattle, pig, dog, cat and pigeons enrofloksacin 10 g/100 ml peroralna raztopina piščanci govedo psi mačke golobi
FLUMEXIL 5% Flumequine
FLUMEXIL 5% flumekvin
Enroxil Solution for Injection 100mg/ml for Cattle and Pigs
Enroxil Solution for Injection 100mg/ml for Cattle and Pigs enrofloksacin 10 %
Advocid 2,5 % Danofloxacin 25 mg/ml
Advocid 2,5 % danofloksacin 25 mg/ml govedo prašiči intramuskular no, intravensko
Solution for injection Cattle Piglets
Injektionslösung für Rinder danofloksacin mesilat
Subcutaneous intravenous
govedo subkutano
Syvaquinol 10% Enrofloxacin 100 mg/ml
Syvaquinol 10% enrofloksacin 100 mg/ml peroralna raztopina perutnina
Marbocyl S, 10% Marbofloxacin 100 mg/ml
Marbocyl S, 10% marbofloksacin 100 mg/ml govedo intramuskular no
Grounds for amendment of the summary of product characeristics and package leaflet
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
Marbokem 100 mg/ml Solution Injectable Pour Bovins
Marbokem 100 mg/ml solução injectável govedo intramuskular no
ENTERFLUME 50% Flumequine
ENTERFLUME 50 % flumekvin
Amoxicillin Flumequine amoxicillin 22,5g/100g flumequine15g/ 100g
amoksicilin flumekvin amoksicilin 22,5 g/100 g flumekvin 15 g/100 g prašek za peroralno raztopino prašiči pitovni piščanci purani
Broiler chickens Breeding hens Turkeys
Floxavex peroralna raztopina pitovni piščanci purani
• 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).
Odbor priporoča spremembo pogojev dovoljenj za promet z zdravili za živali za proizvodnjo živil, ki vsebujejo kinolone, vključno s fluorokinoloni, in so navedena v Dodatku I, da se dopolnijo povzetki glavnih značilnosti zdravil in navodila za uporabo, ki niso skladna z razpravnim dokumentom CVMP (EMEA/CVMP/416168/2006).
HIPRALONA ENRO-I inj Enrofloxacin 50 mg/ml
HIPRALONA ENRO-I inj enrofloksacin 50 mg/ml govedo prašiči intramuskular no
Enrofloxacyna 5% iniekcja, enrofloksacyna 5 mg/100 solution for injection for cattle, pig, dog and cat
Enrofloxacyna 5% iniekcja, enrofloksacyna 5 mg/100 solution for injection for cattle, pig, dog and cat enrofloksacin 5 g/100 ml govedo prašiči psi mačke intramuskular no, subkutano
Denmark Bayer Animal Health GmbH 51368 Leverkusen
Švedska Bayer Animal Health GmbH 51368 Leverkusen
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.
Zdravila za uporabo v veterinarski medicini, ki vsebujejo vsa pravilna opozorila o preudarni rabi v 4. poglavju povzetka glavnih značilnosti zdravila, ki natančno posnemajo priporočila CVMP, in veterinarska zdravila, ki vsebujejo vsa opozorila o preudarni rabi v 4. poglavju povzetka glavnih značilnosti zdravila, vendar ne posnemajo natančno priporočenega besedila CVMP, vsekakor pa izražajo enaka ključna sporočila.
Flumequine Amoxicillin trihydrate
flumekvin amoksicilin trihidrat
Enrofloxacyna 10% iniekcja, enrofloksacyna 10 mg/100 solution for injection for cattle, pig, dog and cat
Enrofloxacyna 10% iniekcja, enrofloksacyna 10 mg/100 solution for injection for cattle, pig, dog and cat enrofloksacin 10 g/100 ml govedo prašiči psi mačke intramuskular no, subkutano
Fattening Chickens Fattening Turkeys
peroralna raztopina pitovni piščanci purani
Poultry Pigs Dogs Cats
peroralna raztopina perutnina teleta psi mačke
HIPRALONA ENRO-S, geriamasis tirpalas
HIPRALONA ENRO-S, geriamasis tirpalas peroralna raztopina pitovni piščanci
Flumesyva Polvo
Flumesyva Polvo flumekvin
Baytril 25 mg/ml Injektionslösung für Tiere
Baytril 25 mg/ml Injektionslösung für Tiere prašiči kunci intramuskular no, subkutano
Young poultry (chickens and turkeys)
Enroxil peroralna raztopina mlada perutnina (piščanci in purani)
50 g/500 g
50 g/500 g prašek piščanci
Enrokarizoo 10% Enrofloxacin 10 g/100 ml
Enrokarizoo 10% enrofloksacin 10 g/100 ml peroralna raztopina perutnina
Advocin 180 mg/ml injekční roztok
Advocin 180 mg/ml injekční roztok danofloksacin 180 mg/ml govedo subkutano, intravensko
Ganadexil Enrofloxacina
Ganadexil Enrofloxacina peroralna raztopina perutnina
C-Enrox 10% Enrofloxacin 100 mg/ml
C-Enrox 10% enrofloksacin 100 mg/ml peroralna raztopina perutnina
Quinocol Oral Solution Enrofloxacin Colistin sulphate
Quinocol oral solution enrofloksacin kolistin sulfat
Quinocol oral solution Enrofloxacin Colistin sulphate
Quinocol Oral Solution enrofloksacin kolistin sulfat
Romania Krka, d. d., Novo mesto Šmarješka cesta 6
Romunija Krka, d. d., Novo mesto Šmarješka cesta 6
Flumisol 10 % Flumequine
Flumisol 10 % flumekvin
Flumesol 10% Flumequine
Flumesol 10% flumekvin
Difloxacin
Diflocin difloksacin
Advocid 25 mg/ml Injektionslösung für Rinder und Schweine
Advovet soluzione iniettabile danofloksacin 25 mg/ml govedo prašiči intramuskular no (govedo in prašiči), intravensko (govedo)
Marbofloxacin 2%
Marbocyl marbofloksacin 2 %
Enrofloksacyna 10% inj, 100mg/ml solution for injection for cattle
Enrofloksacyna 10% inj, 100mg/ml solution for injection for cattle enrofloksacin 10 g/100 ml govedo subkutano
Hungary Krka, d. d., Novo mesto Šmarješka cesta 6
Madžarska Krka, d. d., Novo mesto Šmarješka cesta 6