FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products(see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products authorised under Article 13 of Directive 2001/82/EC, as amended, as referred in Annex I, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Romanian: CVMP a recomandat modificări ale autorizaţiilor de punere pe piaţă pentru Baytril 2,5 % injectable, Baytril 5 % injectable, Baytril 10 % injectable şi denumirile asociate şi medicamentele de uz veterinar corelate, autorizate în temeiul articolului 13 din Directiva 2001/82/CE, astfel cum a fost modificată, menţionate în Anexa I, pentru modificarea rezumatelor caracteristicilor produselor, etichetării şi prospectelor, prevăzute în Anexa III.
English: Enrofloxacin 100 mg/ml (or 50 mg/ml)
Romanian: Enrofloxacin 100 mg/ml (sau 50
English: This is recommended as the withdrawal period for milk from cattle treated at the recommended dose of 5 mg/kg bw with the 100 mg/ml strength subcutaneously.
Romanian: Aceasta este recomandată ca perioadă de aşteptare pentru laptele de la bovinele tratate cu doza recomandată de 5 mg/kg greutate corporală cu concentraţia de 100 mg/ml administrată subcutanat.
English: - Dosage for rodents: 10 mg/kg bw, once daily by subcutaneous injection for 5-10 consecutive days
Romanian: - Doză pentru rozătoare: 10 mg/kg greutate corporală o dată pe zi, prin injectare subcutanată, timp de 5-10 zile consecutive.
English: Cattle, dogs, sheep, goats, cats, rabbits, pigs
Romanian: Bovine, câini, oi, capre, pisici, iepuri, porci
English: Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days.
Romanian: Mamita acută determinată de Escherichia coli: 5 mg enrofloxacină / kg greutate corporală, care corespunde la 1 ml/20 kg greutate corporală, prin injectare intravenoasă lentă o dată pe zi timp de două zile consecutive.
English: 20 mg/kg bw, corresponding to 0.8 ml/kg bw, once daily by intramuscular injection for 5 to 10 consecutive days.
Romanian: 20 mg / kg greutate corporală, care corespunde la 0,8 ml / kg greutate corporală, o dată pe zi prin injectare intramusculară, pentru 5 până la 10 zile consecutive.
English: Treatment of skin and wound infections caused by enrofloxacin susceptible strains of: Staphylococcus aureus.
Romanian: Tratamentul infecţiilor pielii şi plăgii determinate de tulpini sensibile la enrofloxacină ale: Staphylococcus aureus.
English: Treatment of septicaemia caused by enrofloxacin susceptible strains of E. coli.
Romanian: Tratamentul septicemiei cauzate de tulpini de E. coli sensibile la enrofloxacină.
English: Treatment of Escherichia coli infections of the alimentary tract or septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Romanian: Tratamentul infecţiilor de Escherichia coli ale tubului digestiv sau al septicemiei cauzate de tulpini de Escherichia coli sensibile la enrofloxacină.
English: Pigs and calves
Romanian: Porci şi viţei
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.
Romanian: Tratamentul infecţiilor tractului respirator determinate de tulpini sensibile la enrofloxacină ale Pasteurella multocida, Mannheimia haemolytica şi Mycoplasma spp.
English: Denmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Romanian: Danemarca Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
English: Pigs, rabbits, dogs, cats
Romanian: Porci, iepuri, câini, pisici
English: - A study described the first case of livestock-associated methicillin-resistant Staph.
Romanian: - un studiu a descris primul caz de Staph.
English: Belgium FORTE Healthcare Limited Cougar Lane
Romanian: Portugalia FORTE Healthcare Limited Cougar Lane
English: 5-10 mg/kg bw, corresponding to 0.2-0.4 ml/kg bw, once daily by intramuscular injection for 5 consecutive days.
Romanian: 5-10 mg / kg greutate corporală, care corespunde la 0,2-0,4 ml/ kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 5 zile consecutive.
English: This is recommended as the withdrawal period for cattle meat and offal for animals treated at the recommended dose of 5 mg/kg bw/day for 5 days with either the 50 mg/ml or 100 mg/ml strenghts and administered subcutaneously.
Romanian: Aceasta este recomandată ca perioadă de aşteptare pentru carnea şi organele de bovine pentru animalele tratate cu doza recomandată de 5 mg/kg greutate corporală/zi timp de 5 zile, cu concentraţia de 50 mg/ml sau cea de 100 mg/ml şi cu administrare subcutanată.
English: On the basis of the available data the CVMP considered that these indications can be accepted.
Romanian: Pe baza tuturor datelor disponibile, CVMP a considerat că aceste indicaţii pot fi acceptate.
English: 10 mg/kg bw, corresponding to 2 ml/5 kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Romanian: 10 mg / kg greutate corporală, care corespunde la 2 ml / 5 kg greutate corporală, o dată pe zi prin injectare subcutanată pentru 5 până la 10 zile consecutive.
English: The Cmax/MIC and AUC/MIC ratios for Staphylococcus spp.
Romanian: Rapoartele Cmax/CMI şi ASC/CMI pentru Staphylococcus spp. sunt, de asemenea, adecvate pentru infecţia gram-pozitivă la ambele specii.
English: Bravničarjeva 13 Ljubljana Slovenia
Romanian: Slovenia Bayer d.o.o. Bravničarjeva 13
English: Thus, a withdrawal period of 4 days is recommended for sheep meat and offal for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
Romanian: Astfel, se recomandă o perioadă de aşteptare de 4 zile pentru carnea şi organele de oaie pentru animalele tratate cu doza recomandată de 5 mg/kg greutate corporală, cu concentraţiile de 50 mg/ml şi de 100 mg/ml administrate prin injecţie subcutanată.
English: - Dosage: 5 mg/kg bw, once daily for 5 days
Romanian: - Doză: 5 mg/kg greutate corporală, o dată pe zi timp de 5 zile
English: Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Escherichia coli.
Romanian: Tratamentul mamitelor acute severe determinate de tulpini sensibile la enrofloxacină ale Escherichia coli.
English: Belgium Vetpharma Animal Health, S.L.
Romanian: Portugalia Vetpharma Animal Health, S.L.
English: Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus and Escherichia coli.
Romanian: Tratamentul mamitelor determinate de tulpini sensibile la enrofloxacină ale Staphylococcus aureus şi Escherichia coli.
English: Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd.
Romanian: Luxemburg Chanelle Pharmaceuticals Manufacturing Ltd.
English: Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Romanian: Tratamentul infecțiilor tractului urinar determinate de tulpini sensibile la enrofloxacină ale Escherichia coli.
English: On the basis of the available data the CVMP considered that this indication can be accepted.
Romanian: Pe baza tuturor datelor disponibile, CVMP a considerat că această indicaţie poate fi acceptată.
English: 10 Great North Way York Business Park Nether Poppleton York
Romanian: Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton York
English: Pigs (piglets)
Romanian: Porci (purcei)
English: Rodents, reptiles and ornamental birds (25 mg/ml strength) Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible supported by sensitive testing of the causal organism, indicates enrofloxacin as the substance of choice.
Romanian: Tratamentul infecţiilor tubului digestiv şi ale tractului respirator în care experienţa clinică, dacă este posibil susţinută de testarea sensibilităţii organismului care produce infecţia, indică enrofloxacina ca substanţă de primă opţiune.
English: Cattle, pigs, dogs,
Romanian: Bovine, porci, câini,
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida and Mannheimia haemolytica.
Romanian: Tratamentul infecţiilor tractului respirator cauzate de tulpini de Pasteurella multocida şi Mannheimia haemolytica sensibile la enrofloxacină.
English: Treatment of post-partum dysgalactiae syndrome (PDS), mastitis, metritis, agalactia (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli, Klebsiella spp.
Romanian: Tratamentul sindromului disgalactic post-partum (SDP), al sindromului mastită-metrită-agalaxie (sindromul MMA) cauzat de tulpini de Escherichia coli, Klebsiella spp. sensibile la enrofloxacină (concentraţia de 100 mg/ml)
English: Germany Chanelle Pharmaceuticals Manufacturing Ltd.
Romanian: Germania Chanelle Pharmaceuticals Manufacturing Ltd.
English: Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.
Romanian: Tratamentul infecţiilor pielii şi plăgilor cauzate de tulpini de Staphylococcus aureus sensibile la enrofloxacină.
English: Cats, dogs, sheep, cattle, pigs, goats
Romanian: Pisici, câini, oi, bovine, porci, capre
English: 10 mg/kg bw, corresponding to 0.4 ml/kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Romanian: 10 mg / kg greutate corporală, care corespunde la 0,4 ml / kg greutate corporală, o dată pe zi prin injecţie subcutanată pentru 5 până la 10 zile consecutive.
English: Luxembourg Bayer SA-NV J.E.
Romanian: Luxemburg Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem
English: Belgium Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Romanian: Ţările de Jos Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
English: 10 Great North Way York Business Park Nether Poppleton
Romanian: Ţările de Jos Animalcare Group plc. 10 Great North Way York Business Park Nether Poppleton
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Romanian: 2,5 mg enrofloxacină / kg greutate corporală, care corespunde la 0,5 ml/20 kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 3 zile.
English: Cattle, pigs, dogs, cats
Romanian: Bovine, porci, câini, pisici
English: Goats (50 mg/ml and 100 mg/ml strengths)
Romanian: Capre (concentraţii de 50 mg/ml şi 100 mg/ml)
English: Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus, Escherichia coli.
Romanian: Tratamentul mastitei cauzate de tulpini de Staphylococcus aureus, Escherichia coli sensibile la enrofloxacină.
English: 5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Romanian: 5 mg enrofloxacină/kg greutate corporală, care corespunde la 1 ml/20 kg greutate corporală, o dată pe zi, timp de 3 - 5 zile.
English: Cattle, pigs, dogs, sheep, goats
Romanian: Bovine, porci, câini, oi, capre
English: Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Romanian: Tratamentul septicemiei determinate de tulpini sensibile la enrofloxacină ale Escherichia coli.
English: Cattle, sheep, goats, pigs, dogs, cats
Romanian: Bovine, oi, capre, porci, câini, pisici
English: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by subcutaneous injection for 3 days.
Romanian: 5 mg enrofloxacină / kg greutate corporală, care corespunde la 1 ml/20 kg greutate corporală, o dată pe zi prin injectare subcutanată, timp de 3 zile.
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma spp.
Romanian: Tratamentul infecţiilor tractului respirator determinate de tulpini sensibile la enrofloxacină ale Pasteurella multocida, Mycoplasma spp. şi Actinobacillus pleuropneumoniae.
English: 5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/10 kg bw, once daily for 3-5 days.
Romanian: 5 mg enrofloxacină/kg greutate corporală, care corespunde la 1 ml/10 kg greutate corporală, o dată pe zi, timp de 3 - 5 zile.
English: Piglets (25 mg/ml strength)
Romanian: Purcei (concentraţie de 25 mg/ml)
English: Dogs, cats, exotic animals (small mammals, reptiles and birds)
Romanian: Câini, pisici, animale exotice (mamifere mici, reptile şi păsări)
English: Cattle, pigs, sheep, goats
Romanian: Bovine, porci, oi, capre
English: Dogs, pigs, cattle, cats
Romanian: Câini, porci, bovine, pisici
English: Cats, dogs, cattle, pigs
Romanian: Pisici, câini, bovine, porci
English: Cattle, dogs, pigs
Romanian: Bovine, câini, porci
English: Cattle (calves), pigs, dog
Romanian: Bovine (viţei), porci, câini
English: Enrofloxacin 100 mg/ml
Romanian: Enrofloxacin 100 mg/ml (sau
English: Dogs, cats and exotic animals (small mammals, reptiles and avian species)
Romanian: Câini, pisici şi animale exotice (mamifere mici, reptile şi specii de păsări)
English: Cattle, pigs, sheep
Romanian: Bovine, porci, oi
English: Cats, cattle, dogs, Pigs
Romanian: Pisici, bovine, câini, porci
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Romanian: 2,5 mg enrofloxacină / kg greutate corporală, care corespunde la 0,5 ml/10 kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 3 zile.
English: Cattle, pigs, dogs
Romanian: Bovine, porci, câini
English: Pigs, cattle, dogs, cats
Romanian: Porci, bovine, câini, pisici
English: Cattle, pigs, goats, sheep, dogs
Romanian: Bovine, porci, capre, oi, câini
English: Dogs, cats, exotic animals (small mammals, reptiles and avian species)
Romanian: Câini, pisici, animale exotice (mamifere mici, reptile şi specii de păsări)
English: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by subcutaneous injection for 3 days.
Romanian: 5 mg enrofloxacină / kg greutate corporală, care corespunde la 1 ml/10 kg greutate corporală, o dată pe zi prin injectare subcutanată, timp de 3 zile.
English: Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg of bw, corresponding to 2 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Romanian: Infecţii ale tractului digestiv sau septicemie determinate de Escherichia coli : 5 mg enrofloxacină / kg de greutate corporală, care corespunde la 2 ml/10 kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 3 zile.
English: Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Romanian: Tratamentul infecţiilor tractului digestiv, respirator și urogenital (inclusiv prostatita, terapia adjuvantă cu antibiotice pentru piometru ), infecţii ale pielii şi plăgii, otită ( externă / medie ), determinate de tulpini sensibile la enrofloxacină ale: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. şi Proteus spp.
English: Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp.
Romanian: Tratamentul infecţiilor tubului digestiv şi ale tractului respirator cauzate de tulpini de Escherichia coli, Pasteurella multocida şi Staphylococcus spp. sensibile la enrofloxacină.
English: Cattle, sheep, goats, pigs, dogs
Romanian: Bovine, oi, capre, porci, câini
English: Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Romanian: Infecţii ale tractului digestiv sau septicemie determinate de Escherichia coli : 5 mg enrofloxacină / kg de greutate corporală, care corespunde la 1 ml/10 kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 3 zile.
English: Dogs, cattle, poultry, cats, pigs
Romanian: Câini, bovine, păsări de curte, pisici, porci
English: Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Romanian: Infecţii ale tractului digestiv sau septicemie determinate de Escherichia coli : 5 mg enrofloxacină / kg de greutate corporală, care corespunde la 1 ml/20 kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 3 zile.
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Romanian: 2,5 mg enrofloxacină / kg greutate corporală, care corespunde la 1 ml/10 kg greutate corporală, o dată pe zi prin injectare intramusculară, timp de 3 zile.
English: 5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/5 kg bw, once daily by subcutaneous injection for up to 5 days.
Romanian: 5 mg enrofloxacină / kg greutate corporală, care corespunde la 1 ml / 5 kg greutate corporală, zilnic, prin injectare subcutanată, până la 5 zile.
English: (100 mg/ml strength)
Romanian: 50 mg/ml)
English: Calves, pigs, dogs
Romanian: Viţei, porci, câini
English: INN
Romanian: Oi
English: Goats:
Romanian: Pisici:
English: Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Romanian: Tratamentul infecţiilor tractului digestiv determinate de tulpini sensibile la enrofloxacină ale Escherichia coli.
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of: Pasteurella multocida, Mycoplasma spp.
Romanian: Tratamentul infecţiilor tractului respirator determinate de tulpini sensibile la enrofloxacină ale: Pasteurella multocida, Mycoplasma spp., Actinobacillus pleuropneumoniae.
English: Belgium SP Veterinaria SA Ctra.
Romanian: Portugalia SP Veterinaria SA Ctra.
English: Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of, e.g.: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Romanian: Tratamentul infecţiilor tractului digestiv, respirator și urogenital (ca terapie adjuvantă cu antibiotice pentru piometru ), infecţii ale pielii şi plăgii, determinate de tulpini sensibile la enrofloxacină ale, de exemplu: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. şi Proteus spp.
English: Cattle, sheep, pigs, dogs
Romanian: Bovine, oi, porci, câini
English: Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Romanian: Tratamentul infecţiilor tractului digestiv, respirator și urogenital (ca terapie adjuvantă cu antibiotice pentru piometru ), infecţii ale pielii şi plăgii, determinate de tulpini sensibile la enrofloxacină ale: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. şi Proteus spp.
English: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, daily by subcutaneous injection for up to 5 days.
Romanian: 5 mg enrofloxacină / kg greutate corporală, care corespunde la 1 ml / 10 kg greutate corporală, zilnic, prin injectare subcutanată, până la 5 zile.
English: Calves, pigs, poultry dogs, cats
Romanian: Viţei, porci, păsări de curte, câini, pisici
English: Sweden Chanelle Pharmaceuticals Manufacturing Ltd.
Romanian: Norvegia Chanelle Pharmaceuticals Manufacturing Ltd.
English: • 10% and
Romanian: • 10% şi
English: DK-2100 Köpenhamn Ö DENMARK
Romanian: DK-2100 Köpenhamn Ö Danemarca
English: 4.8 Interaction with other medicinal products and other forms of interaction
Romanian: 4.8 Interacţiune cu alte produse medicinale sau alte forme de interacţiune
English: None known
Romanian: Nu se cunosc
English: Wash contaminated skin.
Romanian: Pielea contaminată se va spăla.
English: antibacterial for systemic use
Romanian: antibacterian pentru uz sistemic
English: The target animals are:
Romanian: Animalele-ţintă sunt:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES To be completed nationally
Romanian: DECLARAREA SUBSTANŢELOR ACTIVE ŞI A ALTOR SUBSTANŢE Se va completa naţional
English: Quinta da Beloura 2710-444 Sintra PORTUGAL
Romanian: Quinta da Beloura 2710-444 Sintra
English: A minimum lethal dose has not been established in pigs.
Romanian: Nu a fost stabilită o doză minimă letală la porci.
English: Novartis Farma Produtos Farmacêuticos S.A Rua do Centro Empresarial Edifício 8
Romanian: Novartis Farma Produtos Farmacęuticos S.A Rua do Centro Empresarial Edifício 8
English: Due to the divergent national decisions taken by Member States concerning the authorisation of these products, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
Romanian: Având în vedere deciziile naţionale divergente luate de statele membre cu privire la autorizarea acestor produse, a fost sesizat în acest sens CVMP în temeiul articolului 34 alineatul (1) din Directiva 2001/82/CE, pentru a soluţiona divergenţele dintre Rezumatele caracteristicilor produsului (RCP) autorizate la nivel naţional în întreaga Uniune Europeană.
English: Mesogion Av 198, 15561 Holargos GREECE
Romanian: Mesogion Av 198 15561 Holargos Grecia
English: Indications for use;
Romanian: 1. indicaţii de utilizare;
English: Rabbits There are no pharmacokinetic data available for rabbits.
Romanian: Iepuri Nu sunt disponibile date farmacocinetice la iepuri.
English: If signs of an interaction do occur, administration of contaminated feed should be stopped immediately.
Romanian: Dacă apar semne de interacţiune, se va opri imediat administrarea furajelor contaminate.
English: Premixes with tiamulin are marketed in 20 European Member States under a variety of invented names (see Annex I).
Romanian: Premixurile cu tiamulină sunt comercializate în 20 de state membre ale Uniunii Europene sub o varietate de denumiri inventate (a se vedea anexa I).
English: The Marketing Authorisation Holders were requested:
Romanian: Deţinătorii autorizaţiilor de punere pe piaţă au fost invitaţi:
English: 1. to provide an exhaustive list of differences between the SPCs of the product authorised in the Member States; 2. to review all sections of the SPCs and to suggest appropriate changes in the text where divergences exist and to propose a harmonised Product Information (SPC and labelling), taking into account the latest guidance; 3. to provide available relevant data, in particular substantiating such proposed harmonised Product Information in relation to the discrepancies identified above.
Romanian: 1. să furnizeze o listă exhaustivă a diferenţelor dintre RCP-urile produselor autorizate în statele membre; 2. să reexamineze toate secţiunile din RCP-uri şi să sugereze modificări corespunzătoare ale textului acolo unde există divergenţe, precum şi să propună Informaţii despre produs armonizate (RCP şi etichetarea), ţinând cont de cele mai recente ghiduri; 3. să prezinte date relevante disponibile, în special în sprijinul acestor Informaţii despre produs armonizate propuse, în legătură cu discrepanţele identificate mai sus.
English: People with known hypersensitivity to tiamulin should administer the product with caution.
Romanian: Persoanele cu hipersensibilitate cunoscută la tiamulin trebuie să administreze produsul cu precauţie.