FrancophonIA/ELRC3.0 huggingface dataset:
English: Pre-clinical data and an isolated clinical report suggest that calcium chloride infusion may help to reverse tilmicosin induced changes in blood pressure and heart rate in humans.
Croatian: Pretklinički podaci i izolirani klinički izvještaji pokazali su da infuzija kalcijevog klorida može pomoći u reverziji promjena krvnog tlaka i srčanih otkucaja uzrokovanih tilmikozinom.
English: • May cause sensitisation by skin contact.
Croatian: • U kontaktu s kožom može uzrokovati preosjetljivost.
English: TARGET SPECIES Cattle and sheep.
Croatian: CILJANE VRSTE ŽIVOTINJA Goveda i ovce.
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Croatian: • CVMP je procijenio da je cilj upućivanja bila harmonizacija sažetka opisa svojstava lijeka, označavanja i upute o lijeku;
English: Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Croatian: Tilmikozin je makrolidni antibiotik sintetiziran od tilozina koji ima antibakterijski spektar sličan tilozinu s pojačanim djelovanjem protiv mikroba Pasteurella multocida i Mannheimia haemolytica.
English: MIC measured in these isolates did not show an increase in MIC levels for Pasteurella multocida (97% of the isolates were susceptible to tilmicosin), therefore from the data provided no trend in resistance increase could be observed for one of the major pathogens for respiratory diseases in cattle.
Croatian: MIC, minimal inhibitory concentration) izmjerena u tim izolatima nije pokazala povećane razine MIK-a za bakteriju Pasteurella multocida (97% izolata bilo je osjetljivo na tilmikozin), stoga se iz dobivenih podataka nije moglo izvesti zaključke o trendu povećanja otpornosti za jednog od glavnih patogena u bolesti dišnog sustava kod stoke.
English: Pharmacokinetic studies demonstrate that concentrations of tilmicosin in the lung can exceed 2 µg/ml for more than 3 days which would be therapeutic for M. haemolytica, Trueperella pyogenes (formerly known as Actinomyces pyogenes), Staphylococcus aureus and Mycoplasma ovipneumonia according to in vitro studies conducted in 1992.
Croatian: Ispitivanja farmakokinetike pokazala su da koncentracije tilmikozina u plućima mogu prelaziti 2 µg/ml dulje od 3 dana što bi bilo terapeutski za bakterije M. haemolytica, Trueperella pyogenes (ranije poznata kao Actinomyces pyogenes), Staphylococcus aureus i Mycoplasma ovipneumonia prema in vitro ispitivanjima provedenim 1992. godine.
English: Since the MIC values of M. haemolytica tended to increase over the last decade the MIC90 data from recently isolated European strains should be included in SPC section 5.1 Pharmacodynamic properties.
Croatian: Budući da su vrijednosti MIK-a za bakteriju M. haemolytica pokazale trend povećanja u posljednjem desetljeću, podaci za MIK90 nedavno izoliranih europskih sojeva moraju se uključiti u odlomak 5.1 Farmakodinamička svojstva unutar Sažetka opisa svojstava lijeka.
English: • Do not work alone when using “product name (to be completed nationally)”.
Croatian: • Nemojte raditi sami prilikom primjene „naziv proizvoda (popuniti lokalno)”.
English: In pigs, tilmicosin-induced lethality is potentiated by adrenalin.
Croatian: Kod svinja, smrtnost izazvana tilmikozinom potencirana je adrenalinom.
English: In milk, a concentration of tilmicosin of 1.2 µg/ml at day 3 has been measured indicating a concentration above most MIC values of the pathogens.
Croatian: U mlijeku je 3. dan izmjerena koncentracija tilmikozina od 1,2 pokazujući koncentraciju iznad MIK vrijednosti većine patogena.
English: The percentage of relapses was lowest in the 10 mg/kg body weight tilmicosin group, suggesting that this dose would be preferable.
Croatian: Postotak relapsa bio je najniži u skupini s 10 mg/kg tjelesne težine, što dovodi do zaključka da je ta doza bolja.
English: 1030 Wien
Croatian: 1030 Wien AUSTRIJA
English: NOTE TO PHYSICIAN: please see inside of label or package leaflet for details.
Croatian: NAPOMENA LIJEČNIKU: molimo pogledajte etiketu proizvoda ili uputu o VMP-u za pojedinosti.
English: Meat and offal: 42 days Milk: 18 days
Croatian: Meso i iznutrice: 42 dana Mlijeko: 18 dana
English: In pigs, intramuscular injection at 20 mg/kg body weight has caused deaths.
Croatian: Kod svinja, intramuskularna injekcija od 20 mg/kg tjelesne težine uzrokovala je smrt.
English: In a clinical field study including severe cases, treatment with tilmicosin at doses of either 5 mg/kg body weight or 10 mg/kg body weight resulted in a better cure rate as compared to the positive control group (amoxicillin 15 mg/kg body weight).
Croatian: U kliničkom terenskom ispitivanju uključujući teške slučajeve, liječenje tilmikozinom pri dozama od 5 mg/kg ili 10 mg/kg tjelesne težine dovelo je do boljeg omjera izlječenja u usporedbi s pozitivnom kontrolnom skupinom (amoksicilin 15 mg/kg tjelesne težine).
English: The Netherlands
Croatian: NIZOZEMSKA
English: • Target species;
Croatian: • Ciljanu životinjsku vrstu;
English: Eli Lilly Nederland B.V./Elanco AnimalHealth Grootslag 1-5
Croatian: Nizozemska Eli Lilly Nederland B.V./Elanco AnimalHealth Grootslag 1-5
English: In a clinical trial, treatment of Pasteurellosis was performed with a dose of 25 mg/kg body weight.
Croatian: U kliničkom ispitivanju liječenje pasteroloze provodilo se dozom od 25 mg/kg tjelesne težine.
English: The indication “as an aid in the control of outbreaks of enzootic abortion in ewes caused by Chlamydia psittaci” was only supported by positive control data.
Croatian: Indikacija "kao pomoć u kontroli pojave enzootskog pobačaja kod ovaca uzrokovanog bakterijom Chlamydia psittaci" podržana je samo podacima pozitivne kontrole.
English: Since no dose-finding studies in rabbits were provided it cannot be concluded from the data available that Pasteurellosis can be treated with the recommended tilmicosin dosage of 10 mg/kg body weight.
Croatian: S obzirom na to da nisu podastrta ispitivanja za utvrđivanje doze kod zečeva, iz dostupnih podataka nije moguće zaključiti da se pasteroloza može liječiti preporučenim doziranjem tilmikozina od 10 mg/kg tjelesne težine.
English: Withdraw the required dose from the vial and remove the syringe from the needle, leaving the needle in the vial.
Croatian: Izvucite potrebnu dozu iz bočice i uklonite štrcaljku s igle tako da igla ostane u bočici.
English: Do not administer to primates
Croatian: Ne primjenjivati na primatima
English: • Never carry a syringe loaded with “product name (to be completed nationally)” with the needle attached.
Croatian: • Nikada nemojte držati štrcaljku napunjenu „naziv proizvoda (popuniti lokalno)” s postavljenom iglom.
English: In dog studies, tilmicosin induced a negative inotropic effect with consequent tachycardia, and a reduction in systemic arterial blood pressure and arterial pulse pressure.
Croatian: U ispitivanjima na psima, tilmikozin je potaknuo inotropni učinak s posljedičnom tahikardijom i smanjenjem sistemskog arterijskog krvnog tlaka i arterijskog pulsnog tlaka.
English: Injection of the product in goats and pigs has been fatal.
Croatian: Primjena proizvoda na kozama i svinjama rezultirala je smrtnim ishodom.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally.
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Popuniti lokalno.
English: 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)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf 2 CVMP guideline on the SPC for antimicrobials (EMEA/CVMP/SAGAM/383441/2005)
Croatian: Kritički osvrt CMVP-a o uporabi makrolida, linkozamita i streptogramina (MLS) kod životinja koje se koriste za proizvodnju hrane u Europskoj uniji: razvoj otpornosti i utjecaj na zdravlje ljudi i životinja (eng. 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)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf 2 Smjernice CMVP-a za sažetak opisa svojstava lijeka za antimikrobne lijekove (eng.
English: A dose of 30 mg/kg body weight resulted in increased respiratory rate.
Croatian: Doza od 30 mg/kg tjelesne težine dovela je do ubrzanog disanja.
English: Tolerance studies clearly demonstrate that a dosage of 20 mg/kg body weight subcutaneous tilmicosin injection in lambs (7-11 kg) was toxic, leading to deaths.
Croatian: Ispitivanja podnošljivosti jasno pokazuju da je doziranje potkožnom injekcijom tilmikozina od 20 mg/kg tjelesne težine kod janjadi (7-11 kg) bilo toksično i dovodilo do ugibanja.
English: In case of self-injection SEEK IMMEDIATE MEDICAL ATTENTION and take the vial or the package leaflet with you.
Croatian: • U slučaju samo injiciranja ODMAH POTRAŽITI POMOĆ LIJEČNIKA i uzmite bočicu ili uputu o VMP-u sa sobom.
English: The recommended dose rate of 5 to 10 mg/kg body weight seems justified based on the available data, however pharmacokinetic studies combined with in vitro MIC studies imply that a dose of 10 mg/kg body weight would be preferable for curing the major pathogens in interdigital necrobacillosis in cattle.
Croatian: Preporučena doza od 5 do 10 mg/kg tjelesne težine čini se opravdanom na temelju dostupnih podataka, no ispitivanja farmakokinetike u kombinaciji s in vitro ispitivanjima MIK-a ukazuju na to da je doza od 10 mg/kg tjelesne težine bolja za liječenje glavnih patogena kod interdigitalne nekrobaciloze stoke.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnu tvar.
English: Meat and offal: 42 days
Croatian: Meso i iznutrice: 42 dana
English: The Clinical and Laboratory Standards Institute (CLSI) has set the interpretive criteria for tilmicosin against M. haemolyica of bovine origin and specifically for bovine respiratory disease, as ≤8µg/ml = susceptible, 16 µg/ml = intermediate and ≥ 32 µg/ml = resistant.
Croatian: Institut za kliničko-laboratorijske standarde (CLSI) postavio je kriterije za tumačenje tilmikozin protiv M. haemolyica goveđeg porijekla i naročito goveđe respiratorne bolesti kao ≤ 8 µg/ml = osjetljiv, 16 µg/ml = umjereno osjetljiv i ≥ 32 µg/ml = rezistentan.
English: Doses of 150 mg/kg body weight, administered subcutaneously with an interval of 72 hours caused death.
Croatian: Doze od 150 mg/kg tjelesne težine, primijenjeno supkutano u intervalu od 72 sata uzrokovale su smrt.
English: 40 kg animals 28-50 kg animals
Croatian: 40 kg težine 28-50 kg težine
English: Overall summary of the scientific evaluation of Micotil 300 mg/ml Injectie and its associated names (see annex I)
Croatian: Cjelokupni sažetak znanstvene procjene lijeka Micotil 300 mg/ml Injectie i povezanih imena (vidjeti Dodatak I)
English: The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium channel blockade.
Croatian: Ciljni sustav kod trovanja je kardiovaskularni sustav, a ono može biti uzrokovano blokadom kalcijskih kanala.
English: The CLSI at the present time have no interpretive criteria for P. multocida of bovine origin, however they have interpretive criteria for P. multocida of swine origin, specifically swine respiratory disease, as ≤16 µg/ml = susceptible and ≥ 32 µg/ml = resistant.
Croatian: CLSI danas nema kriterije za tumačenje za P. multocida goveđeg porijekla, međutim takvi kriteriji postoje za P. multocida svinjskog porijekla, specifične svinjske respiratorne bolesti kao ≤ 16 µg/ml = osjetljiv i
English: Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Croatian: Micotil 300 Injectie je otopina za injekcije koja sadrži tilmikozin jačine 300 mg po ml.
English: Bacteriology from nasal swabs and lung tissues in these studies revealed M. haemolytica and P. multocida as major causes of pneumonia in calves.
Croatian: Bakteriološkim nalazima briseva nosa i plućnog tkiva u tim ispitivanjima otkrivene su bakterije M. haemolytica i P. multocida kao glavni uzročnici upale pluća kod stoke.
English: Belgium ELI LILLY BENELUX N.V. Division Elanco Animal Health
Croatian: ELI LILLY BENELUX N.V. Division Elanco Animal Health
English: • This product should only be administered by a veterinary surgeon.
Croatian: • Ovaj proizvod smije primijeniti samo veterinar.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Popuniti lokalno
English: Regarding the treatment of acute ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae, the pathogens Staphylococcus aureus and Mycoplasma agalactiae appear to be sensitive for tilmicosin according to the measured MIC values (S. aureus MIC <0.25-1 µg/ml, M. agalactiae MIC=0.5 µg/ml).
Croatian: U pogledu liječenja akutnog ovčjeg mastitisa povezanog s bakterijama Staphylococcus aureus i Mycoplasma agalactiae, čini se da su patogeni Staphylococcus aureus i Mycoplasma agalactiae osjetljivi na tilmikozin prema izmjerenim MIK vrijednostima (S. aureus MIC <0,25-1 µg/ml, M. agalactiae MIK=0,5 µg/ml).
English: Do not administer intravenously.
Croatian: Ne primjenjivati intravenozno.
English: Pharmacokinetic data showed that tilmicosin was well distributed into the skin of sheep following subcutaneous injection at doses of 5 mg/kg body weight or 10 mg/kg body weight.
Croatian: Farmakokinetski podaci pokazali su da se tilmikozin dobro raspodjeljuje u koži ovaca nakon potkožne injekcije pri dozama od 5 mg/kg tjelesne težine ili 10 mg/kg tjelesne težine.
English: Further to the assessment of the above mentioned data and the serious concerns expressed by the CVMP about the use of the product in the target species rabbits the MAHs agreed to remove all references to rabbits from the product information.
Croatian: S obzirom na procjenu prethodno navedenih podataka i ozbiljnu zabrinutost CVMP-a u vezi s uporabom lijeka u ciljanoj vrsti zečeva, nositelji odobrenja za stavljanje u promet pristali su ukloniti sve reference na zečeve iz informacija o lijeku.
English: Sheep weighing 40 kg were more resistant and survived a subcutaneous dose of 150 mg/kg body weight, showing ataxia and lethargy.
Croatian: Ovce težine 40 kg bile su otpornije i preživjele su potkožnu dozu od 150 mg/kg tjelesne težine te su pokazivale znakove ataksije i letargije.
English: Intravenous injection of 4.5 to 5.6 mg tilmicosin/kg body weight followed by intravenous injection of 1 ml epinephrine (1/1000) 2 to 6 times resulted in death of all 6 injected pigs.
Croatian: Intravenozna injekcija 1 ml epinefrina (1/1000) 2 do 6 puta, nakon primjene intravenozne injekcije od 4,5 do 5,6 mg tilmikozina/kg tjelesne težine rezultiralo je smrću svih 6 testiranih svinja.
English: Avoid introduction of contamination into the vial during use.
Croatian: Izbjegavajte kontaminiranje bočice za vrijeme primjene.
English: OTHER INFORMATION “product name (to be completed nationally)” is contained in 25 ml, 50 ml, 100 ml or 250 ml amber glass vials (Type I or Type II) sealed with a rubber stopper and aluminium overseal.
Croatian: “naziv proizvoda (popuniti lokalno)” pakiran je u staklene bočice jantarne boje (tip I ili tip II) od 25 ml, 50 ml, 100 ml ili 250 ml, zapečaćene gumenim stoperom ili aluminijskim pečatom.
English: BELGIUM
Croatian: Belgija
English: • Posology;
Croatian: • Doziranje;
English: Furthermore, the text in the proposed indication “…and other microorganisms sensitive to tilmicosin” is not in accordance with recommendations in the CVMP reflection paper on macrolides, lincosamides and streptogramins (EMA/CVMP/SAGAM/741087/2009)1 and not in line with the CVMP guideline on the SPC for antimicrobials (EMEA/CVMP/SAGAM/383441/2005)2.
Croatian: Nadalje, tekst u predloženoj indikaciji "...i drugi mikroorganizmi osjetljivi na tilmikozin" nije u skladu s preporukama kritičkog osvrta CMVP-a o makrolidima, linkozamidima i streptograminima (EMA/CVMP/SAGAM/741087/2009)1 i nije usklađen sa smjernicom CVMP-a o sažetku opisa svojstava lijeka za antimikrobne lijekove (EMEA/CVMP/SAGAM/383441/2005)2.
English: The Netherlands referred the issue due to divergent national decisions having been taken by the EU Member States resulting in discrepancies in the product information for Micotil 300 mg/ml Injectie and its associated names.
Croatian: Nizozemska je ukazala na pitanje uslijed različitih nacionalnih odluka koje su donijele zemlje članice EU što je dovelo do neusklađenosti informacija o lijeku Micotil
English: In Staphylococcus aureus challenge study, tilmicosin treatment (10 mg/kg body weight as a single subcutaneous injection) in ewes resulted in significantly less mortality, and more normal udders at day 10 although milk samples were still bacteriologically positive in treated animals at day 10.
Croatian: U ispitivanju izazivanjem bolesti bakterijom Staphylococcus aureus, liječenje tilmikozinom (10 mg/kg tjelesne težine putem jednokratne potkožne injekcije) kod ovaca dovelo je do značajno manje smrtnosti i normalnijeg vimena 10. dan iako su uzorci mlijeka još uvijek bili bakteriološki pozitivni kod liječenih životinja i 10. dan.
English: TARGET SPECIES
Croatian: CILJANECILJANE VRSTE ŽIVOTINJA
English: In pigs, intramuscular injection of 10 mg tilmicosin/kg body weight caused increased respiration, emesis and convulsions; 20 mg/kg body weight resulted in mortality in 3 of 4 pigs, and 30 mg/kg body weight caused the death of all 4 pigs tested.
Croatian: Intramuskularna injekcija kod svinja od 10 mg tilmikozina/kg tjelesne težine uzrokovala je ubrzano disanje, emezu i konvulzije; 20 mg/kg tjelesne težine rezultiralo je smrtnošću 3 od 4 svinje, a
English: Do not administer to goats.
Croatian: Ne primjenjivati na kozama.
English: Additional operator safety warnings:
Croatian: Dodatna sigurnosna upozorenja prilikom rukovanja proizvodom:
English: Tilmicosin is a mainly bactericidal semi-synthetic antibiotic of the macrolide group.
Croatian: 5.1 Farmakodinamička svojstva Tilmikozin je prvenstveno baktericidni polusintetički antibiotik iz grupe makrolida.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Znanstveni zaključci i osnove za izmjene sažetka opisa svojstava lijeka, označavanja i upute o lijeku
English: The posology is 10 mg tilmicosin per kg body weight which corresponds to 1 ml of product per 30 kg body weight.
Croatian: Doziranje je 10 mg tilmikozina po kilogramu tjelesne težine što odgovara 1 ml lijeka po 30 kg tjelesne težine.
English: Restrain the animal and insert separate needle subcutaneously at the injection site, preferably in a skinfold over the rib cage behind the shoulder.
Croatian: Obuzdajte životinju i uvucite odvojenu iglu supkutano na mjestu injektiranja najbolje u kožni nabor grudnog koša iza lopatice.
English: Sheep have died following a single intravenous injection of 7.5 mg/kg body weight.
Croatian: Ovce su uginule nakon jednokratne intravenozne injekcije od 7,5 mg/kg tjelesne težine.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the sight and reach of children.
Croatian: I DOSEGA DJECE” Čuvati izvan dosega i pogleda djece.
English: Regarding treatment of interdigital necrobacillosis in cattle, the in vitro studies demonstrated that the MIC values (MIC50 <0.25-0.5 µg/ml) of most major pathogens strains causing interdigital necrobacillosis in cattle, with the exception of treponeme infections, can be reached in the subcutaneous fat after a single subcutaneous injection with tilmicosin at a dose of 10 mg/kg body weight.
Croatian: Što se tiče liječenja interdigitalne nekrobaciloze kod stoke, ispitivanja in vitro pokazala su da vrijednosti MIK-a (MIK50 <0,25-0,5 µg/ml) većine patogenih sojeva koji uzrokuju interdigitalnu nekrobacilozu kod stoke, osim infekcije treponemom, mogu prodrijeti u potkožno masno tkivo nakon jednokratne potkožne injekcije tilmikozina pri dozi od 10 mg/kg tjelesne težine.
English: Studies demonstrated that tilmicosin at 10 mg tilmicosin/kg body weight has efficacy against acute mastitis in sheep caused by Staphylococcus aureus and Mycoplasma agalactiae although no bacterial cure was established.
Croatian: Ispitivanja su pokazala da je tilmikozin u dozi od 10 mg/kg tjelesne težine učinkovit protiv akutnog mastitisa kod ovaca uzrokovanog bakterijama Staphylococcus aureus i Mycoplasma agalactiae iako nije ustanovljeno bakteriološko izlječenje.
English: In a field study, involving sheep with mastitis due to natural infection with Mycoplasma agalactiae, a single subcutaneous administration with tilmicosin at a dose of 10 mg/kg body weight resulted in significantly lower milkscores and overall udderscores compared to long-acting oxytetracycline.
Croatian: U terenskom ispitivanju koje je uključivalo ovce s mastitisom uslijed prirodne infekcije bakterijom Mycoplasma agalactiae, jednokratna potkožna primjena tilmikozina u dozi od 10 mg/kg tjelesne težine dovela je do znatno nižih ocjena mlijeka i sveukupnih ocjena vimena u odnosu na oksitetraciklin s dugim djelovanjem.
English: Mannheimia, Pasteurella, Actinomyces (Corynebacterium), Fusobacterium, Dichelobacter, Staphylococcus, and Mycoplasma organisms of bovine and ovine origin.
Croatian: Mannheimia, Pasteurella, Actinomyces (Corynebacterium), Fusobacterium, Dichelobacter,
English: INJECTION OF TILMICOSIN IN HUMANS CAN BE FATAL - EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW THE ADMINISTRATION INSTRUCTIONS AND THE GUIDANCE BELOW, PRECISELY
Croatian: INJEKTIRANJE TILMIKOZINA KOD LJUDI MOŽE IMATI SMRTNE POSLJEDICE - PRIMIJENITE KRAJNJI OPREZ KAKO BISTE IZBJEGLI
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTRIJEBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Restrain the sheep whilst leaning over the animal and insert a separate needle subcutaneously into the injection site, which should be in a skinfold over the rib cage behind the shoulder.
Croatian: Obuzdajte ovcu dok se naginjete nad njom i uvucite odvojenu iglu supkutano na mjesto injektiranja, odnosno u kožni nabor grudnog koša iza lopatice.
English: The Committee considered that the proposed indication “treatment of respiratory tract infections caused by M. haemolytica and P. multocida” had been sufficiently substantiated by data.
Croatian: Odbor je procijenio da je predložena indikacija, "liječenje infekcija dišnih putova uzrokovanih bakterijama M. haemolytica i P. multocida", dovoljno poduprta podacima.
English: Numerous studies revealed that 10 mg tilmicosin/kg body weight is effective against respiratory disease due to M. haemolytica and P. multocida in cattle and sheep.
Croatian: Brojna ispitivanja pokazala su da je 10 mg tilmikozina/kg tjelesne težine učinkovito protiv bolesti dišnog sustava izazvanih bakterijama M. haemolytica i P. multocida kod stoke i ovaca.
English: UNITED KINGDOM
Croatian: Ujedinjeno Kraljevstvo
English: Thus, based on the available data, the Committee considered the indication “treatment of interdigital necrobacillosis in cattle” is acceptable at the recommended dose of 10 mg/kg body weight.
Croatian: Prema tome, na temelju dostupnih podataka, Odbor je procijenio da je indikacija "liječenje interdigitalne nekrobaciloze kod stoke" prihvatljiva pri preporučenoj dozi od 10 mg/kg tjelesne težine.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only.
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA
English: Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.
Croatian: Liječenje akutnog mastitisa kod ovaca uzrokovanog Staphylococcus aureus i Mycoplasma agalactiae.