natgillin/translations-raw huggingface dataset:
For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1-> 64 µg/ml). 
Za E. coli, Camplylobacter i enterokoka, oba tipa i divljeg i ne divljeg fenotipa su zabilježena. (MIC raspon 1->64 µg/ml).
Generally, cross-resistance between tildipirosin and other macrolides, lincosamides or streptogramins is to be expected. 
Općenito unakrižna rezistencija između tildipirosina i drugih makrolida, linkozamida ili streptogramina je očekivana.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian. 
Primijeniti samo nakon procjene odnosa koristi-rizika od strane odgovornog veterinara.
Box 
Kutija
Marketing authorisation holder: Intervet International B. V. 
Nositelj odobrenja za stavljanje u promet: Intervet International B.V.
Macrolides are characterised by their extensive partitioning into tissues. 
Makrolide odlikuje velika raspodjela u tkiva.
Resistance to macrolides generally results from three mechanisms: (1) the alteration of the ribosomal target site (methylation), often referred to as MLSB resistance as it affects macrolides, lincosamides and group B streptogramins, (2) the utilisation of active efflux mechanism; (3) the production of inactivating enzymes. 
Otpornost na makrolide općenito rezultira iz 3 mehanizma: (1) promjena ribosomskog ciljnog mjesta (metilacija), često se spominje kao rezistencija na MLSB jer utječe na makrolide, likozamide i skupinu B streptogramine, (2) korištenje aktivnog mehanizma istjecanja, (3) proizvodnja inaktivirajućih enzima.
In very rare cases, transient lethargy in piglets has been observed. 
U vrlo rijetkim slučajevima je primijećena prolazna letargija prasadi.
Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides. 
Stoga, proizvod ne treba primjenjivati s drugim antimikrobnim VMP sa sličnim načinom djelovanja kao što su makrolidi ili linkozamidi.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA)( http://www.ema.europa.eu/)
Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients. 
Ne primjenjivati u slučaju preosjetljivosti na makrolidnu skupinu antibiotika ili na bilo koju od pomoćnih tvari.
Interaction with other medicinal products and other forms of interaction: 
Interakcija sa drugim veterinarsko-medicinskim proizvodima i drugi oblici djelovanja
The following tildipirosin breakpoints have been established for bovine respiratory disease (according to CLSI Guideline VET02 A3): 
Kod respiratornih bolesti goveda ustanovljena je granična vrijednost tildipirosina (prema CLSI Smjernicama VET02 A3)::
The efficacy of metaphylactic use of Zuprevo was demonstrated in a placebo controlled multi-centre field study, when outbreak of clinical disease was confirmed (i.e. animals in at least 30% of the pens sharing the same airspace showed clinical signs of SRD, including at least 10% animals per pen within 1 day; or 20% within 2 days or 30% within 3 days). 
Učinkovitost metafilaktičke upotrebe Zupreva je dokazana u više kontroliranih placebo terenskih istraživanja, kada je klinički potvrđeno izbijanje bolesti (tj. životinje u najmanje 30% boksova u istom zračnom prostoru su pokazale kliničke znakove DBS-a, uključujući najmanje 10% životinja po boksu u 1 danu, ili 20% u roku od 2 dana ili 30% u roku od 3 dana).
The presence of the disease in the herd should be confirmed before preventive treatment. 
Prisutnost bolesti u stadu treba utvrditi prije preventivnog liječenja.
Another animal developed treatment related shock after the first administration and was euthanized on welfare grounds. 
Kod druge životinje se razvilo stanje šoka nakon prve primjene i bila je eutanazirana na osnovi dobrobit.
Recommended needle size and diameter per production stage 
Preporučene veličine igle i promjer po fazi proizvodnje:
It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. 
Preporučuje se liječenje životinja u ranijem stadiju bolesti uz provjeru stanja 48 sati nakon injiciranja.
Marker residue 
Marker rezidua
Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid (collected post mortem), which far exceed those in blood plasma. 
Akumulacija na mjestu infekcije dišnog sustava je dokazana visokom i trajnom koncentracijom tildipirosina u plućima i bronhalnoj tekućini (skupljeno post mortem), što daleko premašuje onu u krvnoj plazmi.
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. 
11. POSEBNE MJERE OPREZA ZA ČUVANJE Čuvati izvan pogleda i dosega djece.
Administer strictly intramuscularly. 
Primjenjivati isključivo intramuskularno.
The presence of the disease in the herd should be confirmed before metaphylaxis is implemented. 
Prisutnost bolesti u stadu treba biti potvrđena prije provođenja metafilakse.
Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 
Wim de Korverstraat 35 5831 AN Boxmeer
NO ENTRY Antiinfectious agents/ 
Neprimjenjivo antiinfektivne tvari/antibiotici
PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides. 
FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: antibiotici za sustavnu primjenu, makrolidi.
Recommended needle size and diameter per production stage Needle length (cm) 
Preporučene veličine igle i promjer po fazi proizvodnje: Veličina igle ( cm)
20 ml 50 ml 100 ml 250 ml 
50 ml 100 ml 250 ml
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition. 
Ne primjenjivati na gravidnim životinjama, koje su namijenjene za proizvodnju mlijeka za ljudsku uporabu, u roku od 2 mjeseca do očekivanog teljenja.
Official, national and regional antimicrobial policies should be taken into account when the product is used. 
Prilikom primjene proizvoda treba uzeti u obzir službene, nacionalne i regionalne antimikrobne odredbe.
Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs. 
Metafilaktička primjena ovog proizvoda na klinički zdravim životinjama koje su u bliskom kontaktu s bolesnim životinjama preporuča se u isto vrijeme kad se tretiraju i klinički bolesne životinje, kako bi se smanjio rizik razvoja kliničkih znakova zaraze.
180 mg. For the full list of excipients, see section 6.1. 
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
Pain on injection and injection site swellings are very common in treated animals. 
Bol od injekcije i oteklina na mjestu injiciranja vrlo su česti u tretiranih životinja.
If accidental eye exposure occurs, flush eyes immediately with clean water. 
Ako dođe do slučajnog dodira s očima odmah isprati oči s čistom vodom.
Following the maximum recommended injection site volume of 5 ml, injection site reactions resolved completely within 21 days. 
Pridržavajući se maksimalno preporučenog volumena na mjestu injekcije od 5 ml, otekline na mjestu ubrizgavanja potpuno nestanu u roku 21 dan.
In target animal safety studies, administration of the maximum recommended injection volume (5 ml) very commonly caused slight swellings at the injection site that were not painful on palpation. 
U ispitivanjima neškodljivosti kod ciljnih životinja, primjena maksimalne preporučene injekcije, volumena 5 ml vrlo često su uzrokovale male otekline na mjestu ubrizgavanja, koje nisu bile bolne na dodir.
If accidental skin exposure occurs, wash the skin immediately with soap and water. 
Ako dođe do slučajnog dodira s kožom, odmah oprati kožu sa sapunom i vodom.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin 
NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Veterinarsko - medicinski proizvod je bistra žućkasta otopina za injekcije koja sadrži 40 mg/ml tildipirosina.
Overdoses of 10 times the recommended dose as well as repeated subcutaneous administration of the veterinary medicinal product only led to transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in calves. 
Predoziranje s 10 puta većom dozom od preporučene i ponovljena potkožna primjena veterinarsko medicinskog proizvoda dovode do prolaznih kliničkih znakova kao što su nelagoda i bolne otekline na mjestu injiciranja, kod teladi.
In vitro, the effect of tildipirosin is bacteriostatic against Pasteurella multocida and B. bronchiseptica, and bactericidal for A. pleuropneumoniae and H. parasuis. 
In vitro, učinak tildipirosina je bakteriostatski na Pasteurella multocida i B. bronchiseptica, a baktericidan na A. pleuropneumoniae i H. parasuis.
Tildipirosin administered subcutaneously to cattle at a single dose of 4 mg/kg body weight resulted in rapid absorption with average peak plasma concentration of 0.7 µg/ml within 23 minutes (Tmax) and high absolute bioavailability (78.9%). 
Tildipirosin koji se kod goveda primjenjivao potkožno pri jednoj dozi od 4 mg/kg tjelesne mase bio je brzo apsorbiran dosegnuvši prosječnu koncentraciju plazme od 0,7 µm/mL unutar 23 minute (Tmax.) i visoku apsolutnu bioraspoloživost (78,9 %).
In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals. 
U teladi, jedna potkožna injekcija, 10 puta veća doza od preporučene (40 mg/kg tjelesne težine) i ponovljena potkožna primjena tildipirosina (u 3 navrata u razmaku od 7 dana) na 4, 12 i 20 mg/kg (1, 3 i 5 puta preporučena klinička doza) dobro su se tolerirale, osim prolaznih kliničkih znakova kao što su nelagodnost i bolne otekline na mjestu injiciranja kod nekih životinja.
The antimicrobial activity spectrum of tildipirosin includes: 
Antimikrobni spektar djelovanja uključuje:
Overdose (symptoms, emergency procedures, antidotes): 
Predoziranje (simptomi, hitne mjere, antidoti):
Active substance: 
Djelatnu tvar:
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. 
Kad se koristi veterinarsko medicinski proizvod treba uzeti u obzir službenu, nacionalnu i regionalnu antimikrobnu praksu.
SPECIAL WARNINGS Read the package leaflet before use. 
POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals. 
Nakon maksimalno preporučenog volumena na mjestu injekcije od 10 ml, otekline na mjestu injiciranja mogu biti, u pojedinih životinja povezane s boli na opip u trajanju od jedan dan.
Not authorised for use in lactating animals producing milk for human consumption. 
Nije odobrena primjena na životinjama u laktaciji koje proizvode mlijeko za ljudsku uporabu.
In pigs, it is postulated that the metabolism of tildipirosin proceeds by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by dihydroxylation and by S-cysteine and S-glutathione conjugation. 
Pretpostavlja se da je u svinja metabolizam tildipirosina proces redukcije i konjugacije sulfata s kasnijom hidratacijom (ili otvorenih prstena), demetilacijom, dihidroksilacijom i S-cistin i Sglutation konjugacijom.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin 
NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA ZUPREVO je bistra žućkasta otopina za injekcije koja sadrži 180 mg/ml tildipirosina.
Tildipirosin may cause sensitisation by skin contact. 
U kontaktu s kožom tildipirosin može uzrokovati preosjetljivost.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Predoziranje (simptomi, postupci u slučaju nužde, protuotrov )- ako je nužno
Tildipirosin administered intramuscularly to pigs at a single dose of 4 mg/kg body weight was rapidly absorbed reaching average peak plasma concentration of 0.9 µg/ml within 23 minutes (Tmax). 
Tildipirosin koji se kod svinja primjenjivao intramuskularno u jednoj dozi od 4 mg/kg tjelesne mase bio je brzo apsorbiran dosegnuvši prosječnu koncentraciju u plazmi od 0,9 µg/mL, unutar 23 minute
Needle length (cm) 
Veličina igle ( cm)
Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis, which are the bacterial pathogens most commonly associated with swine respiratory disease (SRD). 
Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica i Haemophilus parasuis, su bakterijski patogeni najčešće povezani sa dišnom bolesti svinja (DBS).
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD). 
Mannheimia haemolytica, Pasteurella multocida i Histophilus somni to su bakterijski patogeni često povezani sa respiratornom bolesti goveda (RBG).
At 20 mg/kg body weight one out of eight animals showed transient generalized body tremors with inability to stand after the first administration and the animal showed transient unsteadiness on its feet after the third administration. 
Pri tjelesnoj masi od 20 mg/kg, jedna od osam životinja pokazala je kratkotrajno generalizirano podrhtavanje tijela s nemogućnošću ustajanja nakon prve primjene te je pokazala kratkotrajnu slabost nogu i nakon treće primjene.
Tildipirosin Porcine 1,200 μg/kg 
Tildipirosin Tildipirosin svinja 1200
Cattle (meat and offal): 47 days. 
Govedo (meso i jestive iznutrice): 47 dana.
Intramuscular injection Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE intramuskularna injekcijaPročitati uputu o VMP prije primjene.
Do not administer simultaneously with other macrolides or lincosamides (see section 4.8) 
Ne primjenjivati istodobno sa drugim makrolidima ili linkozamidima. (vidi odjeljak 4.8)
In cattle, it is postulated that metabolism of tildipirosin proceeds by cleavage of the mycaminose sugar moiety, by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by mono- or dihydroxylation with subsequent dehydration and by S-cysteine and Sglutathione conjugation. 
Pretpostavlja se da je metabolizam tildipirosina u goveda, rezultat cijepanja mikaminoze od djela šećera, procesom redukcije i konjugacije sulfata s kasnijom hidratacijom (ili otvorenih prstena), demetilacijom, dehidrokslacijom i S-cistin i S-glutation konjugacijom.
At 20 mg/kg bodyweight one of eight animals showed transient generalized body tremors with inability to stand after the first administration and the animal showed transient unsteadiness on its feet after the third administration. 
U grupi od 20 mg/kg jedna od osam životinja pokazala je kratkotrajno generalizirano podrhtavanje tijela s nemogućnošću ustajanja nakon prve primjene i kratkotrajnu nestabilnost nogu nakon treće primjene.
Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml. 
Kutija sadrži 1 bočicu od 20 ml, 50 ml, 100 ml ili 250 ml.
Tildipirosin Bovine 400 μg/kg 
Tildipirosin Tildipirosin govedo 400
Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg BW group. 
Mišićna podrhtavanja na stražnjim nogama, uočena su nakon prvog tretmana u jedne svinje iz skupine od 12 do 20 mg/kg tjelesne mase.
Meat and offal: 9 days 
Meso i jestive iznutrice: 9 dana
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Detaljne informacije o ovom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
Special caution should be taken to avoid accidental self-injection, as toxicology studies in laboratory animals showed cardiovascular effects after intramuscular administration of tildipirosin. 
Toksikološkim ispitivanjima u laboratoriju, životinje su pokazale kardiovaskularne učinke nakon intramuskularne primjene tildipirosina.
Citric acid monohydrate Propylene glycol Water for injections 
Propilen glikol Voda za injekcije
Pathomorphological injection site reactions resolved completely within 21 days. 
Patomorfološka reakcija na mjestu ubrizgavanja završila je unutar 21 dana.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Cattle 
POJEDINOSTI KOJE SE POJAVLJUJU NA SREDNJEM PAKIRANJU Goveda
In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida. 
In vitro, učinak tildipirosina je bakteriocidni na Mannheimia haemolytica i Histophilus somni, a bakteriostatski na P. multocida..
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin. 
Za liječenje i metafilaksu dišnih bolesti svinja (DBS) povezanih s Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica i Haemophilus parasuis osjetljivih na tildipirosin.
Do not administer simultaneously with other macrolides or lincosamides (see section 12). 
Ne primjenjivati istodobno s drugim makrolidima ili linkozamidima ( vidi odjeljak 12).
If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic, and continued until clinical signs have resolved. 
Ako klinički znakovi dišnih bolesti opstanu ili se povećaju, liječenje se mora promijeniti koristeći drugi antibiotik i nastaviti se dok ne nestanu klinički znakovi.
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only. 
Primijeniti 4 mg tildipirosina/kg tjelesne mase (ekvivalent 1 ml/45 kg tjelesne mase), samo jednom.
During clinical trials, pain on injection and injection site swellings were seen very commonly in treated pigs. 
U kliničkim ispitivanjima, bolnost i otok na mjestu injiciranja su vrlo česti u tretiranih svinja.
Pathomorphological injection site reactions will largely resolve within 35 days. 
Patomorfološke reakcije na mjestu injiciranja nestat će najdulje unutar 35 dana.
4.10 Overdose (symptoms, emergency procedures, antidotes) 
4.10 Predoziranje (simptomi, postupci u slučaju nužde, protuotrovi)
INDICATION 
OZNAČAVANJE
Manufacturer for the batch release: Intervet International GmbH Feldstrasse 1 a 
Nositelj odobrenja za proizvodnju za puštanje proizvodne serije: Intervet International GmbH
Vial (100 ml, 250 ml) 
Bočica(100 ml, 250 ml)
If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic, and continued until clinical signs have resolved. 
Ako klinički znakovi dišnih bolesti i dalje traju ili se pojačavaju, ili se vrate, liječenje treba promijeniti koristeći drugi antibiotik i nastaviti sve dok ne nestanu klinički znakovi.
Meat and offal: 9 days. 
Meso i jestive iznutrice: 9 dana.
Type I amber glass vial with chlorobutyl rubber stopper and an aluminium cap. 
Jantarna staklena bočica tip I, s klorobutilnim gumenim čepom i aluminijskom kapicom.
Zone diameter (mm) MIC breakpoint (µg/ml) S 
Sastav diska Zona dijametra (mm) MIC granična vrijednost (µg/ml)
In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg bodyweight (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg bodyweight group and 2 piglets from the 20 mg/kg bodyweight group following the first or second injection. 
U prasadi intramuskularna primjena tildipirosina (u tri navrata u razmaku od 4 dana) u dozi od 8, 12 i 20 mg/kg tjelesne mase (2, 3 i 5 puta preporučena klinička doza) rezultirala je privremenim blago potištenim ponašanjem kod jednog praseta iz skupine od 8 i od 12 mg/kg tjelesne mase, u dva praseta iz skupine od 20 mg/kg tjelesne mase nakon prve ili druge aplikacije.
OTHER INFORMATION Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml. 
15. OSTALE INFORMACIJE Kutija sadrži jednu bočicu od 20 ml, 50 ml, 100 ml i 250 ml.
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only. 
Primijeniti 4 mg tildipirosina/kg tjelesne mase (ekvivalent 1ml/10 kg tjelesne mase), samo jednom.
Growing-finishing Finishing/sows/boars 
Tovna prasad/krmače/nerast
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
Needle diameter (mm) 
Promjer igle ( mm)
Vial (20 ml, 50 ml) 
Bočica (20 ml, 50 ml)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pigs 
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Svinje
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cattle 
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Govedo
MARKETING AUTHORISATION NUMBERS EU/2/11/124/005-008 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/124/005-008
The mean total excretion of the total dose administered within 14 days was about 17% in urine and 57% in faeces. 
Prosječno izlučivanje ukupne doze primijenjene unutar 14 dana bilo je 17%
Read the package leaflet before use. 
Prije upotrebe pročitati uputu.
Not for use in animals from which milk is produced for human consumption. 
Ne primjenjivati kod životinja čije je mlijeko namijenjeno za ljudsku uporabu
6.4 Special precautions for storage 
6.4 Posebne mjere opreza za čuvanje
200 μg/kg 2000 μg/kg 3000 μg/kg 
μg/kg μg/kg μg/kg μg/kg mišić koža +
MANUFACTURER'S BATCH NUMBER Batch: 
17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cattle 
PODACI NA VANJSKOM PAKOVANJU Govedo
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Učestalost štetnih nuspojava je definirana sljedećim pravilom: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojave za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).