FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, long-term exposure to low doses of tylosin is associated with an increase in the number of resistant Campylobacter coli and group medication with antibiotics is a risk factor for spread of methicillinresistant Staphylococcus aureus (MRSA) in pigs.
Croatian: Osim toga, dugoročno izlaganje niskim dozama tilozina povezano je s porastom u broju rezistentnih bakterija Campylobacter coli i skupina lijekova s antibioticima predstavlja čimbenik rizika za širenje meticilin rezistentnih sojeva Staphylococcus aureus (MRSA) u svinja.
English: Denmark Ceva Animal Health A/S Ladegårdsvej 2
Croatian: Ceva Animal Health A/S Ladegårdsvej 2
English: confirms this situation by reporting a 100% in vitro resistance among 78 isolates from pigs with diarrhoea.
Croatian: potvrđuje ovu situaciju prijavljivanjem 100 % rezistencije in vitro između 8 izolata svinja s proljevom.
English: The published scientific reports regarding the resistance situation for B. hyodysenteriae provide a discouraging picture, where tylosin resistance today is close to complete in many areas of the European Union.
Croatian: Objavljena znanstvena izvješća u vezi situacije s rezistencijom na B. hyodysenteriaeza obeshrabrujuća su, budući da je rezistencija na tilozin skoro potpuna na mnogim područjima Europske unije.
English: Polígono Industrial El Segre parcela 409-410.
Croatian: Španjolska MEVET, S. A.U. Polígono Industrial El Segre parcela 409-410.
English: 1854 - 47020 Longiano (FC) Italy
Croatian: 1854 - 47020 Longiano (FC) Italija
English: As previously mentioned, most oral tylosin products were authorised in the EU Member States long time ago according to marketing authorisation requirements at that time.
Croatian: Kao što je to već navedeno većina oralnih pripravaka tilozina odobrena je odavno u državama članicama EU-a u skladu s tadašnjim zahtjevima za odobravanje.
English: 24 bld Vital Bouhot CS 50004
Croatian: Francuska Lilly France S.A.S. 24 bld Vital Bouhot CS 50004
English: To limit the administration of oral tylosin to pigs to a maximum of three weeks would reduce the risk for selection of resistance without hampering the effective use of these products against currently authorised and justifiable indications.
Croatian: Ograničavanje primjene peroralnih tilozina u svinja na najviše tri tjedna smanjilo bi rizik od odabira rezistencije bez sprječavanja učinkovite uporabe ovih lijekova protiv trenutačno odobrenih i opravdanih indikacija.
English: Tylosin and its phosphate and tartrate salts are used in food producing species for the treatment of conditions caused by sensitive organisms.
Croatian: Tilozin i njegovi fosfati te tartaratne soli koriste se kod vrsta koje služe za hranu za liječenje stanja uzrokovanih osjetljivim organizmima.
English: • most oral tylosin formulations for pigs are authorised with a recommendation to treat for up to three weeks, the CVMP concluded that this maximum duration of treatment would provide sufficient efficacy.
Croatian: • većina peroralnih formulacija tilozina za primjenu na svinjama odobrena je uz preporuku liječenje do tri tjedna pa je CVMP zaključio da će najdulje trajanje liječenja osigurati dostatnu djelotvornost.
English: Av. Infante D. Henrique nº 333-H 3º piso Esc. 41 1800-282 Lisboa Portugal
Croatian: Henrique nº 333-H 3º piso Esc. 41 1800-282 Lisboa Portugal
English: Due to resistance development through recent decades, tylosin is however today not considered to provide sufficient efficacy against swine dysentery (B. hyodysenteriae), and the substance should thus not be used for this disease.
Croatian: Zbog razvoja rezistencije tijekom posljednjih nekoliko desetljeća, tilozin se danas ipak ne smatra dostatno djelotvornim protiv svinjske dizenterije (B. hyodysenteriae) i tvar stoga ne treba koristiti za liječenje te bolesti.
English: It is however acknowledged that, regardless of the indication, for most oral tylosin formulations authorised for pigs at present the maximum recommended treatment duration is three weeks, indicating that this has in many cases been concluded to be a sufficient treatment period.
Croatian: Međutim, potvrđeno je da bez obzira na indikacije, za većinu trenutno odobrenih peroralnih formulacija tilozina za svinje maksimalno preporučeno trajanje iznosi tri tjedna što ukazuje na to da je u većini slučajeva zaključeno da se radi o dostatnom razdoblju liječenja.
English: Additionally, recent data show that in vitro resistance to macrolides for isolates from the European Union of Brachyspira hyodysenteriae (the causative agent of swine dysentery) is very high and tylosin might no longer be effective against this pathogen.
Croatian: Osim toga, nedavni podaci pokazuju da je in vitro rezistencija protiv makrolida iz izolata Europske unije bakterije Brachyspira hyodysenteriae (uzročnika svinjske dizenterije) vrlo visoka i da tilozin možda više nije djelotvoran protiv ovog patogena.
English: 20884 Sulbiate (MB) Italy
Croatian: 20884 Sulbiate (MB) Italija
English: M. Rāmavas 2
Croatian: Rāmavas 2
English: LABORATORIOS HIPRA, S.A. Avda.
Croatian: Španjolska LABORATORIOS HIPRA, S.A. Avda.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsta i nositelja odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet u državama članicama
English: Given the very high resistance rate it is not regarded a sufficient measure to only include warning or precaution statements indicating that treatment of swine dysentery with tylosin should always be based on susceptibility testing.
Croatian: S obzirom na vrlo visoku stopu rezistencije smatra se da nije dovoljno samo uključiti upozorenje o mjerama opreza koje navode da liječenje svinjske dizenterije tilozinom treba uvijek temeljiti na testiranju susceptibilnosti.
English: DK-7100 Vejle
Croatian: DK-7100 Vejle Danska
English: 1000 Brussel
Croatian: 1000 Brussel Belgija
English: 20864 Agrate Brianza (MB) Italy
Croatian: 20864 Agrate Brianza (MB) Italija
English: Germany aniMedica GmbH Im Südfeld 9
Croatian: Njemačka aniMedica GmbH Im Südfeld 9
English: Germany bioptivet Tierarzneimittel GmbH & Co.
Croatian: Njemačka bioptivet Tierarzneimittel GmbH & Co.
English: Similarly, with regard to tylosin granules and powders aimed to be mixed in the drinking water for pigs the recommended treatment period is only in exceptional cases extended beyond 3 weeks independent of indication.
Croatian: Slično tome, s obzirom da su granule i prašci tilozina osmišljeni za miješanje s pitkom vodom za svinje preporučeno razdoblje liječenja je samo u iznimnim slučajevima produljeno iznad 3 tjedna neovisno o indikaciji.
English: Replace, where applicable, treatment recommendations which are extended beyond 3 weeks, or where no treatment duration recommendation is given, with the following statement: Treatment duration should not exceed 3 weeks.
Croatian: Zamijenite ako je to potrebno preporuke o liječenju koje se proteže dulje od 3 tjedna ili ako nisu dane preporuke o liječenju sa sljedećom izjavom: Liječenje ne smije trajati dulje od 3 tjedna.
English: Priestley Road Basingstoke, RG24 9NL United Kingdom
Croatian: Priestley Road Basingstoke, RG24 9NL Ujedinjena Kraljevina
English: The knowledge regarding antimicrobial resistance risks has increased over time, and there is also an increasing focus on accommodating dosing strategy to the double aim of administering antimicrobials as long as necessary to obtain sufficient treatment effect, but to avoid unnecessary exposure that would encourage resistance development.
Croatian: Saznanja o antimikrobnoj rezistenciji lijeka povećala su se s vremenom te također postoji pojačano zanimanje za prilagodbu strategije doziranja kako bi se ostvario dvostruki cilj primjene antimikrobnih lijekova sve dok je to potrebno kako bi se postigao dostatan učinak liječenja ili i da bi se izbjeglo nepotrebno izlaganje koje bi potaknulo razvoj rezistencije.
English: Thus, to state that the administration of oral tylosin for pigs should not exceed three weeks is likely to assure sufficient treatment efficacy for currently authorised indications in pigs and this measure would also satisfy the requirement to avoid unnecessary exposure and thus reduce the risk for resistance development.
Croatian: Stoga, kako bi se potvrdilo da primjena peroralnog tilozina na svinjama ne smije premašiti tri tjedna te je vjerojatno da će osigurati djelotvornost liječenja za trenutačno odobrene indikacije u svinja i ta mjera će također zadovoljiti zahtjev za izbjegavanjem nepotrebnog izlaganja i tako smanjiti rizik od razvoja rezistencije.
English: Evaluation and conclusion on the benefit-risk balance
Croatian: Procjena i zaključak o omjeru dobrobiti i rizika
English: Pharma Vet 40 Otec Paisii Str. Shumen
Croatian: Bugarska Pharma Vet 40 Otec Paisii Str.
English: PM 21 TYLOSINE 20 PORCVOLAILL E
Croatian: PM 21 TYLOSINE 20 PORCVOLAILL
English: 47032 Bertinoro (FC) Italy
Croatian: 47032 Bertinoro (FC) Italija
English: de la Industria, nº 30 Polígono Industrial de Alcobendas
Croatian: Polígono Industrial de Alcobendas
English: Delete, where applicable, any recommendation to reduce the dose after an initial treatment period with a higher dose.
Croatian: Izbrišite, ako je to primjenjivo, bilo koju preporuku za smanjivanjem doze nakon početnog liječenja s višom dozom.
English: 1000 Ljubljana Slovenia
Croatian: 1000 Ljubljana
English: Dr. Franje Tuđmana 3 10431, Sveta Nedelja Croatia
Croatian: Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 10431, Sveta Nedelja Hrvatska
English: the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Croatian: CVMP je preporučio izmjene odobrenja za stavljanje u promet veterinarsko-medicinskog proizvode koji sadrže tilozin koji se daje svinjama peroralno putem hrane ili vode za piće (vidjeti prilog I.) kako bi se promijenili sažeci opisa svojstava, označavanje i upute o VMP u skladu s preporučenim promjenama u informacijama o proizvodu kako je to opisano u prilogu III.
English: SUPER´S DIANA, S.L.
Croatian: Španjolska SUPER´S DIANA, S.L. Ctra.
English: 4.5 Special precautions for use
Croatian: 4.5. Posebne mjere pri uporabi
English: Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf requirements can be made available, that would provide convincing support for specific dosing strategies for currently accepted indications for oral tylosin formulations for pigs.
Croatian: Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf s trenutnim zahtjevima i koji bi ponudili uvjerljivu potporu za specifične strategije doziranja za trenutno prihvaćene indikacije za formulacije peroralnog tilozina za svinje.
English: 3991 RA Houten The Netherlands
Croatian: 3991 RA Houten
English: • according to recent published susceptibility data tylosin will not be sufficiently effective against B. hyodysenteriae and therefore the CVMP concluded the indication in swine dysentery can no longer be maintained;
Croatian: • u skladu s nedavno objavljenim podacima o susceptibilnosti, tilozin neće biti dostatno djelotvoran protiv bakterije B. hyodysenteriae i stoga je CVMP zaključio da indikacija tilozina za liječenje svinjske dizenterije više nije održiva;
English: Germany KLAT-Chemie GmbH Visbeker Str. 12
Croatian: Njemačka KLAT-Chemie GmbH Visbeker Str. 12
English: The CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health
Croatian: Službeni dokument CVMP-a o uporabi makrolida, linkozamida i streptogramina (MLS) kod životinja koje služe za hranu ljudima u Europskoj uniji: razvoj rezistencije i utjecaj na zdravlje ljudi i životinja
English: Pharma SIS 4 San Stefano Str. Dobrich
Croatian: Bugarska Pharma SIS 4 San Stefano Str.
English: 108.18 g/110 g Powder for oral solution
Croatian: 108.18 g/110 g Prašak za oralnu otopinu
English: Pigs and domestic birds
Croatian: Svinje i kućne ptice
English: Riudoms (Tarragona) Spain
Croatian: RIUDOMS (Tarragona) Španjolska
English: RIUDOMS (Tarragona) Spain
Croatian: Riudoms (Tarragona) Španjolska
English: Given that, as stated in the above mentioned CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009), this substance class is critically important for veterinary medicine and for human use and, furthermore, that the development of resistance is reported for veterinary pathogens as well as zoonotic pathogens such as Campylobacter spp, extended treatment of pigs beyond what can be regarded medically motivated must be avoided.
Croatian: S obzirom na prethodno navedeni službeni dokument CVMP o uporabi makrolida, linkozamida i streptogramina (MLS) kod životinja koje služe za hranu ljudima u Europskoj uniji: razvoj rezistencije i utjecaj na zdravlje ljudi i životinja (EMA/CVMP/SAGAM/741087/2009), ova klasa tvari je os kritične važnosti za veterinarsku medicinu i za uporabu kod ljudi te nadalje s obzirom da je prijavljen razvoj rezistencije na veterinarske patogene kao i na zoonotske patogene poput Campylobacter spp, produljeno liječenje svinja izvan medicinski motiviranog razdoblja mora se izbjegavati.
English: Lithuania Franvet, Zone Industrielle d'Etriché, 49500 Segré, France
Croatian: Zone Industrielle d'Etriché, 49500 Segré, Francuska
English: The risk connected with delaying the initiation of effective treatment by the time required for susceptibility testing is not considered to outweigh the benefit related to the possibility to successfully use tylosin in a few cases.
Croatian: vremena koje je potrebno za testiranje susceptibilnosti premašuje korist povezanu s mogućnosti uspješne uporabe tilozina u nekoliko slučajeva.
English: • the CVMP considered that the overall benefit-risk balance is positive for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs subject to amendments in the product information;
Croatian: • CVMP je smatrao da je ukupni omjer koristi i rizika pozitivan za veterinarsko-medicinske proizvode koji sadrže tilozin koji se primjenjuje peroralno putem krmiva ili vode za piće pod uvjetom da se ažuriraju informacije o proizvodu;
English: In the CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in foodproducing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)
Croatian: U službenom dokumentu CVMP o uporabi makrolida, linkozamida i streptogramina (MLS) kod životinja koje služe za hranu ljudima u Europskoj uniji: razvoj rezistencije i utjecaj na zdravlje ljudi i životinja (EMA/CVMP/SAGAM/741087/2009)
English: Str. Principala, nr. 944 Filipestii de Padure, Jud.
Croatian: Filipestii de Padure, Jud.
English: In a study of antimicrobial susceptibility of B. hyodysenteriae isolated from 21 Polish farms it was concluded that the lowest antimicrobial activity was demonstrated for tylosin and lincomycin, with inhibition of bacterial growth using concentrations >128 μg/ml and 32 μg/ml, respectively (Zmudzki et al. (2012)) 7.
Croatian: U ispitivanju antimikrobne susceptibilnosti sojeva bakterije B. hyodysenteriae izolirane na 21 poljoprivrednom gospodarstvu u Poljskoj zaključeno je da je najniža antimikrobna aktivnost dokazana za tilozin i linkomicin uz inhibiciju rasta bakterija uporabom koncentracija većih od 28 μg/ml odnosno 32 μg/ml (Zmudzki et al.
English: Germany Kon-Pharma GmbH Senator-Bauer-Str. 34
Croatian: Njemačka Kon-Pharma GmbH Senator-Bauer-Str. 34
English: Sintofarm Via P. Togliatti, 5 Guastalla (RE) Italy
Croatian: Togliatti, 5 Guastalla (RE) Italija
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetaka opisa svojstava, označavanja i uputa o VMP
English: Indication for treatment of swine dysentery caused by Brachyspira hyodysenteriae
Croatian: Indikacije za liječenje svinjske dizenterije uzrokovane bakterijom Brachyspira hyodysenteriae
English: E-08950 Esplugues de Llobregat, Barcelona Spain
Croatian: E-08950 Esplugues de Llobregat, Barcelona Španjolska
English: Overall summary of the scientific evaluation of veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene veterinarskomedicinskih proizvoda koji sadrže tilozin koji se daje svinjama peroralno putem krmiva ili vode za piće (vidi Prilog I.)
English: INDUSTRIAL VETERINARIA, S.A.
Croatian: Španjolska INDUSTRIAL VETERINARIA, S.A.
English: Applicant/Marketing authorisation holder
Croatian: Podnositelj zahtjeva/Nositelj odobrenja za stavljanje lijeka u promet
English: Annex I
Croatian: Dodatak I.
English: 40 000 000 IU (50g) Powder for oral solution
Croatian: 40 000 000 IU (50g) Prašak za oralnu otopinu
English: 4941 VX Raamsdonkveer The Netherlands
Croatian: 4941 VX Raamsdonkveer Nizozemska
English: Pigs and chickens (not producing eggs for human consumption)
Croatian: Svinje i pilići (koji ne nesu jaja za konzumaciju kod ljudi)
English: NL-4941 VX Raamsdonksveer The Netherlands
Croatian: NL-4941 VX Raamsdonksveer Nizozemska
English: 08520 Les Franqueses del Valles (Barcelona) Spain
Croatian: 08520 Les Franqueses del Valles (Barcelona)
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 12: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Croatian: U slučaju da indikacija(e) za određeni proizvod ne navodi(e) specifično svinjsku dizenteriju, ali ne isključuju takvu uporabu, potrebno je dodati sljedeću rečenicu u dio 12: Visoka stopa in vitro rezistencije dokazana je kod europskih sojeva bakterije Brachyspira hyodysenteriae što ukazuje da proizvod neće biti dovoljno učinkovit protiv svinjske dizenterije.
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, the following sentence should be added to section 4.5: A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Croatian: U slučaju da indikacije(a) za određeni proizvod ne navode svinjsku dizenteriju, ali ne isključuju takvu uporabu, potrebno je dodati sljedeću rečenicu u dio 4.5.: Visoka stopa in vitro rezistencije dokazana je kod europskih sojeva bakterije Brachyspira hyodysenteriae što ukazuje da proizvod neće biti dovoljno učinkovit protiv svinjske dizenterije.
English: and Hidalgo et al. (2009) 6, that 90-100% of Brachyspira isolates demonstrate in vitro resistance.
Croatian: da 90-100 % izolata bakterije Brachyspira isolates pokazuje in vitro rezistenciju.
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, a cross reference to section 4.5 should be added: For information regarding swine dysentery see section 4.5.
Croatian: U slučaju da indikacije(a) za određeni proizvod ne navode svinjsku dizenteriju, ali ne isključuju takvu uporabu, potrebno je dodati unakrsnu referencu u dio 4.5.: Za više informacija o svinjskoj dizenteriji pogledajte dio 4.5.
English: S.P. VETERINARIA, S.A. CTRA.
Croatian: Španjolska S.P. VETERINARIA, S.A. Ctra.
English: S.P. VETERINARIA, S.A. Ctra.
Croatian: Španjolska S.P. VETERINARIA, S.A. CTRA.
English: 34 RUE JEAN MONNET ZI D'ETRICHE 49500 SEGRE
Croatian: Francuska QALIAN 34 RUE JEAN MONNET ZI D'ETRICHE 49500 SEGRE
English: Elanco Valquímica, S.A. Avda.
Croatian: Španjolska Elanco Valquímica, S.A. Avda. de la Industria, nº 30
English: Ceva Salute Animale S.p.A. Viale Colleoni, 15
Croatian: Viale Colleoni, 15
English: 34 RUE JEAN MONNET ZI D'ETRICHE 49500 SEGRE France
Croatian: Francuska QALIAN 34 RUE JEAN MONNET ZI D'ETRICHE 49500 SEGRE Francuska
English: LABORATORIOS MAYMO VIA AUGUSTA 302 08017 BARCELONA Spain
Croatian: Francuska LABORATORIOS MAYMO VIA AUGUSTA 302
English: Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Straße 2-4
Croatian: Elanco Animal Health Werner-Reimers-Straße 2-4
English: TRELACON G 250 PREMEZCLA Tylosin
Croatian: TRELACON G 250 PREMEZCLA
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN/I I METODA DAVANJA
English: PRODITYL, Pó para solução oral para administração na água de bebida para suínos, frangos e perus
Croatian: Pó para solução oral para administração na água de bebida para suínos, frangos e perus
English: 100 000 000 IU/jar Granules for oral solution
Croatian: 100 000 000 IU/jar Granule za oralnu otopinu
English: Lithuania Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
Croatian: Rumunjska Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
English: TRELACON G 50 PREMEZCLA Tylosin
Croatian: TRELACON G 50 PREMEZCLA
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Markiesstraat 1
Croatian: Elanco Animal Health Markiesstraat 1
English: Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
Croatian: Mađarska Kela NV (Kela Laboratoria NV) Sint Lenaartseweg 48
English: 20 g/100 g powder Powder for oral solution
Croatian: 20 g/100 g powder Prašak za oralnu otopinu
English: In case the indication(s) for a particular product do not specify swine dysentery, but do not exclude such use, a cross reference to section 12 should be added: For information regarding swine dysentery see section 12.
Croatian: U slučaju da indikacije(a) za određeni proizvod ne navode specifično svinjsku dizenteriju, ali ne isključuju takvu uporabu, potrebno je dodati unakrsnu referencu u dio 12.:
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflets
Croatian: Razlozi za izmjenu sažetaka opisa svojstava, označavanja i uputa o VMP
English: ul.
Croatian: Str.
English: Calves, Pigs, ChickensBroilers, Turkeys (not producing eggs for human consumption)
Croatian: Telad, svinje, pilići brojleri, purice (koji ne nesu jaja za konzumaciju kod ljudi)
English: Calves, Pigs, ChickensBroilers (not producing eggs for human consumption)
Croatian: Telad, svinje, pilići brojleri (koji ne nesu jaja za konzumaciju kod ljudi)
English: Germany Dopharma Research B.V. Zalmweg 24
Croatian: Njemačka Dopharma Research B.V.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Izmjene u određenim poglavljima sažetaka opisa svojstava, označavanja i uputa o lijeku
English: Lithuania Dopharma Research B.V. Zalmweg 24, 4941 VX Raamsdonksveer, the Netherlands
Croatian: Zalmweg 24, 4941 VX Raamsdonksveer, Nizozemska
English: 20 g/100 g powder Premix for medicated feeding stuff
Croatian: 20 g/100 g powder Predmješavina za ljekovitu hranu
English: Annex III
Croatian: Prilog III.
English: Pigs, broilers
Croatian: Svinje, brojleri
English: Oral solution Calves, swine and broilers.
Croatian: Oralna otopina Telad, svinje i brojleri.