natgillin/translations-raw huggingface dataset:
Although not following the recommended OECD guideline, the results are sufficient to demonstrate that enrofloxacin is not likely to pose any risk to fish. 
Čeprav rezultati niso upoštevali priporočene smernice OECD, so zadostni za dokaz, da enrofloksacin verjetno ne predstavlja nevarnosti za ribe.
2.4 Risk characterisation 
2.4 Opis tveganja
A study taken from the open literature, Robinson et al. (2005)2, studied the toxicity of enrofloxacin to algae Microcystis aeruginosa (cyanobacteria or blue-green algae) and Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum, green alga). 
V študiji iz dostopne literature, tj. Robinson et al. (2005)2, so proučevali toksičnost enrofloksacina za algi Microcystis aeruginosa (cianobakterije oziroma modrozelene alge) in Pseudokirchneriella subcapitata (včasih poimenovana Selenastrum capricornutum, zelena alga).
Higher tier modelling has also revealed a negligible risk for ground water contamination. 
Višjestopenjsko modeliranje je pokazalo tudi zanemarljivo tveganje za onesnaženje podtalnice.
The EC50 based on the initial exposure concentration can be estimated to be 51.45 µg/l when considering the EC50 of 49 µg/l based on the nominal start concentration (equal to 100% recovery) and an initial average recovery of 105% of the nominal concentration. 
Vrednost EC50, ki temelji na začetni koncentraciji izpostavljenosti, lahko ocenimo na 51,45 µg/l, če upoštevamo, da EC50 49 µg/l temelji na nazivni začetni koncentraciji (enaki 100-odstotnemu izkoristku) in začetnem povprečnem 105-odstotnem izkoristku nazivne koncentracije.
It can be concluded that enrofloxacin does not pose a risk to fresh water invertebrates, fish, soil microorganisms and soil invertebrates. 
Lahko se zaključi, da enrofloksacin ne predstavlja tveganja za sladkovodne nevretenčarje, ribe, mikroorganizme v prsti in nevretenčarje v prsti.
A terrestrial plant growth test according to OECD guideline 208 was provided. 
Predložen je bil preskus rasti kopenskih rastlin v skladu s smernico OECD 208.
The EC50 based on the final exposure concentration can be estimated to be 4.9 µg/l when considering the EC50 of 49 µg/l based on the nominal start concentration (equal to 100% recovery) and an average recovery of 10% of the nominal concentration (mean of the range 0 to 20%). 
Vrednost EC50, ki temelji na končni koncentraciji izpostavljenosti, lahko ocenimo na 4,9 µg/l, če upoštevamo, da EC50 49 µg/l temelji na nazivni začetni koncentraciji (enaki 100-odstotnemu izkoristku) in povprečnem 10-odstotnemu izkoristku nazivne koncentracije (povprečje razpona od 0 do 20 %).
The resulting PECgw value is 0.057 µg/l, which is below the critical trigger value of 0.1 µg/l. 
Izračunana vrednost PKOgw je 0,057 µg/l, kar je pod kritično vrednostjo 0,1 µg/l.
However, it is the view of the CVMP, that a margin of more than 800 between the estimated PECsw (0.019 µg/l) and the EC50 calculated on the basis of the data in the Robinson et al paper (15.9 µg/l) indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable. 
CVMP kljub temu meni, da meja več kot 800 med ocenjeno vrednostjo PKOsw (0,019 µg/l) in vrednostjo EC50, izračunano na podlagi podatkov iz prispevka Robinsona et al. (15,9 µg/l), kaže na zelo majhno izpostavljenost cianobakterijam, ki je posledica uporabe tega zdravila, ter zagotavlja, da je dejansko tveganje za cianobakterije sprejemljivo.
An earthworm reproduction test according to OECD guideline 222 was performed. 
Opravljen je bil preskus razmnoževanja deževnikov v skladu s smernico OECD 222.
2.2 Calculation of PEC values 
2.2 Izračun vrednosti PKO
From this data set, it is concluded that enrofloxacin, used according to the applicant's indications, does not pose a risk to fresh water invertebrates, fish, soil micro-organism, plants and soil invertebrates. 
Iz teh podatkov lahko zaključimo, da enrofloksacin pri uporabi za indikacije, ki jih navaja predlagatelj, ne predstavlja tveganja za sladkovodne nevretenčarje, ribe, mikroorganizme v prsti, rastline in nevretenčarje v prsti.
The test follows the recommended test guideline with no major deviation and was conducted in compliance with GLP. 
Preskus so izvedli ob upoštevanju priporočene smernice za testiranje brez bistvenih odstopanj in v skladu z GLP.
The plant test follows the recommended test guideline with no major deviation and was conducted in compliance with GLP. 
Preskus z rastlinami so izvedli ob upoštevanju priporočene smernice za testiranje brez bistvenih odstopanj in v skladu z GLP.
However, a margin of more than 800 between the estimated PECsw and the EC50 calculated on the basis of the data in the Robinson et al paper indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable. 
Kljub temu meja več kot 800 med ocenjeno vrednostjo PKOsw in vrednostjo EC50, izračunano na podlagi podatkov iz prispevka Robinsona et al., kaže na zelo majhno izpostavljenost cianobakterij, pri uporabi tega zdravila, ter zagotavlja, da je dejansko tveganje za cianobakterije sprejemljivo.
The effect of enrofloxacin on the emergence and growth of terrestrial plant seedlings was investigated. 
Proučili so učinek enrofloksacina na kalitev in rast semen kopenskih rastlin.
2.3.5 Plants 
2.3.5 Rastline
Although not following the recommended OECD guideline, the results are sufficient to demonstrate that enrofloxacin is not likely to pose any risk to aquatic invertebrates. 
Čeprav rezultati niso upoštevali priporočene smernice OECD, so zadostni za dokaz, da enrofloksacin verjetno ne predstavlja nevarnosti za vodne nevretenčarje.
2.3.3 Fish Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Pimephales promelas (fathead minnow). 
2.3.3 Ribe V študiji Robinsona et al. (2005)2 so proučili toksičnost enrofloksacina za Pimephales promelas
However, growth (on a fresh weight per plant basis) of all species tested was significantly inhibited by enrofloxacin. 
Vendar je enrofloksacin bistveno zavrl rast (na podlagi mase sveže rastline) vseh preskušanih vrst.
Some of the data are new studies conducted according to the recommended OECD guidelines and in compliance with GLP, those studies were performed following questions raised during the Decentralised Procedure. 
Nekateri podatki so nove študije, opravljene v skladu s priporočenimi smernicami OECD in v skladu z GLP.
The CVMP is of the opinion that the provided information on toxicity to cyanobacteria is insufficient for a full risk characterisation, as the information found in the peer reviewed paper by Robinson et al 2005, does not allow for a full assessment of e.g. the validity of data and the exposure concentration. 
CVMP meni, da predloženi podatki o toksičnosti za cianobakterije niso zadostni za popoln opis tveganja, saj podatki iz recenziranega prispevka Robinsona et al. (2005) ne omogočajo popolne ocene npr. veljavnosti podatkov in koncentracije izpostavljenosti.
The CVMP concluded that the provided information on toxicity to cyanobacteria is insufficient for a full risk characterisation, as the information found in the peer reviewed paper by Robinson et al 2005 does not allow for a full assessment of e.g. the validity of data and the exposure concentration. 
CVMP je zaključil, da predloženi podatki o toksičnosti za cianobakterije niso zadostni za popoln opis tveganja, saj podatki iz recenziranega prispevka Robinsona et al. (2005) ne omogočajo popolne ocene npr. veljavnosti podatkov in koncentracije izpostavljenosti.
2.3.6 Earthworms 
2.3.6 Deževniki
50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. 
100 mg/ml Kokoši in purani50 ml zdravila na 100 litrov vode ali 10 mg zdravilne učinkovine na kg telesne mase na dan. Zdravljenje naj traja vsaj 3 dni.
2.2.3 PECsurfacewater (PECsw) 
2.2.3 PKOpovršinska voda (PKOsw)
2.2.1 PECsoil-plateau 
2.2.1 PKOzemlja-plato
The newly performed study was preferred to assess the effect of enrofloxacin on the emergence and growth of terrestrial plants. 
Pri vrednotenju učinka enrofloksacina na kalitev in rast kopenskih rastlin je imela prednost novo izvedena študija.
2.1.1 Metabolism and excretion 
2.1.1 Presnova in izločanje
2.3.2 Aquatic invertebrates (Daphnia magna) Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Daphnia magna (waterflea). 
V študiji Robinsona et al. (2005)2 so proučili toksičnost enrofloksacina za Daphnia magna (vodno bolho).
The CVMP concludes that it is not feasible to estimate an exact PNEC value for cyanobacteria based on the study by Robinson et al 2005. 
CVMP je zaključil, da na podlagi študije Robinson et al. (2005) ni mogoče oceniti točne vrednosti PKBU za cianobakterije.
Using this PNEC value and the PECsoil established above (542.9 µg/kg) a risk quotient of 0.44 can be established for plants. 
S to vrednostjo PKBU in zgoraj določeno vrednostjo PKOprst (542,9 µg/kg) se lahko za rastline določi količnik tveganja 0,44.
Ciprofloxacin is the main metabolite of enrofloxacin. 
Glavni presnovek enrofloksacina je ciprofloksacin.
Using this PNEC value and the PECsw established above (0.019 µg/l) a risk quotient of less than 0.01 can be established for fish. 
S to vrednostjo PKBU in zgoraj določeno vrednostjo PKOsw (0,019 µg/l) se lahko za ribe določi količnik tveganja manj kot 0,01.
Using this PNEC value and the PECsw established above (0.019 µg/l) a risk quotient of less than 0.01 can be established for aquatic invertebrates. 
S to vrednostjo PKBU in zgoraj določeno vrednostjo PKOsw (0,019 µg/l) se lahko za vodne nevretenčarje določi količnik tveganja manj kot 0,01.
Using this PNEC value and the PECsoil established above (542.9 µg/kg) the risk quotient can be concluded to be far below 1 for earthworms. 
S to vrednostjo PKBU in zgoraj določeno vrednostjo PKOzemlja (542,9 µg/kg) se lahko za deževnike določi količnik tveganja precej nižje od 1.
2.1.3 Soil degradation 
2.1.3 Razpad v zemlji
2.2.2 PECgroundwater (PECgw) 
2.3.2 Vodni nevretenčarji (Daphnia magna)
These signs resolve within a few minutes. 
Ti znaki izginejo v nekaj minutah.
These measures should help to protect the environment. 
Takšni ukrepi pomagajo varovati okolje.
ATCvet code: QJ01FA94. 
ATCvet oznaka: QJ01FA94.
Wash hands after use. 
Po uporabi umijte roke.
Use only according to the benefit/risk assessment by the responsible veterinarian. 
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Cattle, pigs and sheep 
Govedo, prašiči in ovce
Draxxin should only be used if pigs are expected to develop the disease within 2-3 days. 
Draxxin se uporabi le v primeru, če se pričakuje razvoj bolezni v 2-3 dneh.
Do not use in case of hypersensitivity of the target animals to macrolide antibiotics. 
Ne uporabite v primeru preobčutljivosti ciljnih živali na makrolidne antibiotike.
The active substance in Draxxin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
Zdravilna učinkovina v Draxxino je dovoljena učinkovina so dovoljene učinkovine, kot je navedena so navedene v tabeli 1(dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010:
Muscle Skin and fat in natural proportions Liver 
Mišice Koža in maščoba v naravnih razmer-jih Jetra
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
Date of last renewal: 19/09/2008. 
Datum podaljšanja dovoljenja za promet: 19.09.2008.
Clear colourless to slightly yellow solution. 
Čista brezbarvna do rahlo rumena raztopina.
Pigs: 13 days. 
Prašiči: 13 dni.
Pigs and sheep: For intramuscular use. 
Prašiči in ovce: za intramuskularno uporabo.
Plasma protein binding was approximately 60-75%. 
Vezava na beljakovine plaze je približno 60-75 %.
They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process. 
Pri tem pospešujejo disociacijo peptidil-tRNK iz ribosomov med procesom translokacije.
Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids. 
Rezistenca je lahko kromosomska ali kodirana s plazmidi in je lahko prenosljiva, v kolikor je pridružena transposonom ali plazmidom.
The efficacy of antimicrobial treatment of foot rot might be reduced by other factors, such as wet environmental conditions, as well as inappropriate farm management. 
Učinkovitost protimikrobnega zdravljenja nalezljive šepavosti ovac je lahko manjša zaradi drugih dejavnikov kot so vlažno okolje ali neprimerno upravljanje farm.
If a hypersensitivity reaction occurs appropriate treatment should be administered without delay. 
Če se pojavi preobčutljivostna reakcija, je treba nemudoma začeti z ustreznim zdravljenjem.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
B POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Special warnings for sheep: 
Posebno opozorilo za uporabo pri ovcah:
It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipid lipoxin A4. 
Zmanjša nastajanje proinflamatornih mediatorjev, levkotriena B4 in CXCL-8 in povzroči nastajanje protivnetnega lipida lipoksina A4.
MLSB resistance may be constitutive or inducible. 
MLSB rezistenca je lahko sestavna ali pa inducirana.
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. 
V kolikor klinični znaki bolezni ne pojenjajo oziroma se okrepijo, ali pa če se pojavi recidiva, je potrebno spremeniti način zdravljenja, tako da uporabimo drugi antibiotik; zdravljenje nadaljujemo vse do odprave kliničnih znakov.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. 
Z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni, fetotoksični ali maternotoksični učinki.
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. 
Priporoča se zdravljenje živali v zgodnjih fazah bolezni ter preverjanje učinka zdravljenja 48 ur po vbrizgavanju.
Pack size: Cardboard box containing one vial. 
Velikost pakiranja: kartonska škatla z eno vialo.
Tulathromycin may cause sensitisation by skin contact. 
Tulatromicin lahko povzroči senzibilizacijo pri kožnem kontaktu.
However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. 
Vendar pa in vivo koncentracija tulatromicina na mestu infekcije v pljučih ni znana.
Manufacturers responsible for batch release: FAREVA AMBOISE 
Izdelovalec, odgovoren za sproščanje serij: FAREVA AMBOISE Zone Industrielle,
Plasma protein binding was low, approximately 40%. 
Vezava na beljakovine plazme je nizka, le okoli 40%.
For any respiratory disease, 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. 
Pri vseh respiratornih boleznih se priporoča zdravljenje živali v zgodnjih fazah bolezni ter preverjanje učinka zdravljenja 48 ur po vbrizgavanju.
Muscle Fat 
Mišice Maščoba
Cattle: 22 days. 
Govedo: 22 dni.
Sheep: 16 days. 
Ovce: 16 dni.
No such reactions have been observed in pigs and sheep after intramuscular administration. 
Teh reakcij pri prašičih in ovca po intramuskularnem dajanju ni bilo opaziti.
In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages. 
Pri obeh, govejih in prašičjih polimorfonuklearnih celicah (PMN; neutrofilci), tulatromicin spodbuja apoptozo (programirana celična smrt) in očiščenje apoptotskih celic z makrofagi.
Date of first authorisation: 11/11/2003. 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11.11.2003.
Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot. 
Draxxin je kazal omejeno učinkovitost pri ovcah s hudimi kliničnimi znaki ali pri kronični obliki nalezljive šepavosti ovac, zato ga dajemo le v zgodnjih fazah bolezni.
Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Water for injections 
Seznam pomožnih snovi monotioglicerol propilenglikol citronska kislina klorovodikova kislina natrijev hidroksid voda za injekcije
In case of accidental eye exposure, flush the eyes immediately with clean water. 
V primeru nenamernega stika očesa z zdravilom, prizadeto oko nemudoma sprati s čisto vodo.
Official, national and regional antimicrobial policies should be taken into account when the product is used. 
Uporaba zdravila naj bo v skladu z uradnimi, nacionalnimi in regionalnimi doktrinami protimikrobnega zdravljenja.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Evropske agencije za zdravila http://www.ema.europa.eu/
Pharmacotherapeutic group: Antibacterials for systemic use, macrolides. 
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, makrolidi.
To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. 
Za zagotovitev pravilnega odmerjanja je potrebno čim natančneje določiti telesno maso obolele živali, da zagotovimo zadostno odmerjanje zdravila.
Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux. 
Rezistenca na makrolide se lahko razvije zaradi mutacij genov, ki kodirajo ribosomalno RNK (rRNK) oziroma nekaterih ribosomalnih proteinov; z encimsko modifikacijo (metilacijo) 23S rRNK tarčnega mesta, kar običajno povzroči povečanje navzkrižne rezistence z likozamidi in skupino B streptogramnov (MLSB rezistenca); z encimsko inaktivacijo ali pa z izločanjem makrolidov.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and antiinflammatory actions in experimental studies. 
Tulatromicin poleg protimikrobnih lastnosti, dokazuje tudi imunomodulacijsko in protivnetno delovanje v poskusnih študijah.
Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA. 
Makrolidi so antibiotiki z bakteriostatičnim načinom delovanja, ki zavirajo sintezo nujno potrebnih proteinov s selektivno vezavo na bakterijsko ribosomalno RNK.
Tulathromycin 
tulatromicin
Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment. 
Zdravljenje zgodnjih faz nalezljive šepavosti ovac (foot rot) v povezavi z virulentno bakterijo Dichelobacter nodosus, ki zahteva sistemsko zdravljenje.
Antiinfectious agents/ Antibiotics' 
/Antibiotik
Vall de Bianya 17813 (Gerona) SPAIN 
Vall de Bianya 17813 (Girona) SPAIN
5 mg/ml For the full list of excipients, see section 6.1. 
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
500 ml vials must not be used for pigs and sheep. 
500 ml viale se ne smejo uporabljati za zdravljenje prašičev in ovca.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA
For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper. 
V kolikor zdravimo več živali se priporoča uporaba aspiracijske igle ali pa brizge za večkratno odmerjanje, da se izognemo večkratnemu prebadanju zamaška.
14R)-2-ethyl tetrahydroxy hexamethyl trideoxy-3(dimethylamin o)-ß-Dxylohexopyranosyl]oxy]-1oxa-6azacyclopentde-can-15-one expressed as tulathromycin equivalents 
14R)-2-ethyl tetrahydroxy hexamethyl trideoxy-3(dimethylamin o)-ß-D
Subcutaneous administration of Draxxin to cattle causes very commonly transient pain reactions and local swellings at the injection site that can persist for up to 30 days. 
Pri govedu podkožno vbrizgavanje Draxxina pogosto povzroči trenutno bolečino in lokalno oteklino na mestu vbrizgavanja, ki lahko vztraja tudi do 30 dni.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin. 
Zdravljenje infekcioznega govejega keratokonjuktivitisa (IBK), povzročenega z Moraxella bovis občutljivo na tulatromicin.
Interaction with other medicinal products and other forms of interaction: Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne uporabljajte hkrati z drugimi antimikrobnimi sredstvi, ki imajo podoben način delovanja, kot so drugi makrolidi in linkozamidi.
MARKETING AUTHORISATION 
IMETNIK DOVOLJENJA ZA PROMET
Vial sizes: 50, 100 and 250 ml. 
Velikost vial: 50, 100 in 250 ml.
Primary packaging: Type I glass vial with a fluoropolymer coated chlorobutyl stopper and an aluminium overseal. 
Stična ovojnina: steklena viala tipa 1 s klorobutilnim zamaškom prevlečenim s fluoropolimerom in aluminijasto zaporko.
Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides. 
Ne uporabljajte hkrati z drugimi antimikrobnimi sredstvi, ki imajo podoben način delovanja, kot so drugi makrolidi in linkozamidi.
Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product. 
Tulatromicin je polsintetično protimikrobno zdravilo iz skupine makrolidov, ki izvira iz produktov fermentacije.
In case of accidental spillage onto skin, wash the skin immediately with soap and water. 
Pri nenamernem stiku kože z zdravilom, je potrebno kožo nemudoma sprati z milom in vodo.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
DODATEK II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) D. DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours. 
Pri ovcah farmakokinetični profil tulatromicina, danega z enkratnim intramuskularnim odmerkom po 2,5 mg/kg telesne mase, doseže najvišjo koncentracijo (Cmax) v plazmi okoli 1,19 μg/ml, dosežena pa je približno 15 minutah po vnosu (Tmax) in ima polovični čas izločitve (T½) 69,7 ur.
4.2 Indications for use, specifying the target species 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Govedo
4.8 Interaction with other medicinal products and other forms of interaction 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Lahko se pojavi navzkrižna rezistenca z drugimi makrolidi.