natgillin/translations-raw huggingface dataset:
The following test species were used: Cucumis sativus (cucumber), Lactuca sativa (lettuce), Phaseolus aureus (mung bean), Avena sativa (oat), Triticum aestivum (wheat) and Secale cereale (rye).
Uporabili so naslednje preskusne vrste: Cucumis sativus (kumara), Lactuca sativa (zelena solata), Phaseolus aureus (fižol), Avena sativa (oves), Triticum aestivum (pšenica) in Secale cereale (rž).
The CVMP agrees that the applicant has met all the requirements for the plant toxicity evaluation, i.e. new toxicity data and the use of the PECsoil-plateau based on new degradation studies.
CVMP se strinja, da je predlagatelj izpolnil vse zahteve za vrednotenje toksičnosti za rastline, tj. nove podatke o toksičnosti in uporabo vrednosti PKOzemlja-plato na podlagi novih študij razkroja.
Enro-K 10% Oral Solution contains 100 mg enrofloxacin as active ingredient per 1 ml product.
Enro-K 10 % peroralna raztopina vsebuje 100 mg enrofloksacina kot zdravilne učinkovine na 1 ml zdravila.
As ciprofloxacin represents only 2% of the total outcome of the enrofloxacin metabolism in chickens it is assumed that any potential risk of metabolites is encompassed by using the total residue approach assuming that the total dose is excreted as parent compound or as metabolites with a toxicity that is similar to the parent compound.
Ker predstavlja ciprofloksacin le 2 % skupne presnove enrofloksacina pri kokoših, se šteje, da so vsa možna tveganja presnovkov zajeta s pristopom vseh ostankov pri predpostavki, da se celotni odmerek izloči kot izhodna spojina ali kot presnovki s toksičnostjo, podobno izhodni spojini.
The applicant provided an environmental risk assessment for Enro-K 10% Oral Solution that followed in general the established guidelines and recommendations.
Predlagatelj je predložil oceno tveganja zdravila Enro-K 10 % peroralna raztopina za okolje, v katerem je na splošno upošteval uveljavljene smernice in priporočila.
The CVMP concludes from the new studies provided that the applicant has met the requirements for the plant toxicity evaluation.
CVMP na podlagi predloženih novih študij zaključi, da je predlagatelj izpolnil zahteve za vrednotenje toksičnosti za rastline.
For all species tested a clear concentration dependent effect occurred and EC50 and NOEC values were found in the range of 124 to 435 and less than 10 to 100 mg/kg, respectively.
Pri vseh preskušanih vrstah se je pojavil jasen, od koncentracije odvisen učinek, vrednost EC50 je bila določena v razponu od 124 do 435 mg/kg, vrednost NOEC pa v razponu od manj kot 10 do 100 mg/kg.
From this data it can be concluded that there would be no risk at environmental concentrations 10 times the PECsoil value established above (542.9 µg/kg).
Iz teh podatkov je mogoče zaključiti, da pri okoljskih koncentracijah 10-kratnika zgoraj določene vrednosti PKOprst (542,9 µg/kg) tveganja ni.
A study taken from the open literature, Knapp et al (2005)4, indicated that exposure is very low.
Študija Knapp et al. (2005)4iz dostopne literature kaže, da je izpostavljenost zelo majhna.
The EC50 for nitrogen transformation was estimated to be above 29 mg/kg soil.
Vrednost EC50 za preobrazbo dušika je bila ocenjena na nad 29 mg/kg prsti.
However, the data for the test on cyanobacteria Microcystis aeruginosa does not meet validity criteria required in OECD guideline 201.
Vendar podatki preskusa na cianobakteriji Microcystis aeruginosa ne izpolnjujejo meril veljavnosti, ki jih predpisuje smernica OECD 201, saj ni prikazan koeficient variacije (KV).
Enro-K 10% Oral Solution
Enro-K 10 % peroralna raztopina Peroralna raztopina
Using the current guidelines the calculated PECsoil-plateau is 542.9 µg/kg.
Če uporabimo trenutne smernice, je izračunana vrednost PKOzemlja-plato 542,9 µg/kg.
During the decentralised procedure concerns were raised that Enro-K 10% Oral Solution may present a potential serious risk to the environment regarding risk to blue-green algae and to terrestrial plants.
Med decentraliziranim postopkom so se pojavili zadržki, da bi lahko zdravilo Enro-K 10 % peroralna raztopina lahko pomenila resno tveganje za okolje glede na modrozelene alge in kopenske rastline.
A study, taken from the open literature, Boxall et al (2006)3, was also provided.
Predložena je bila tudi študija Boxalla et al. (2006)3 iz dostopne literature.
The effect of enrofloxacin on nitrogen transformation by soil organisms was investigated according to OECD guidelines 216 and EU Test Method C.21.
Učinek enrofloksacina na preobrazbo dušika z organizmi v zemlji so raziskali v skladu s smernico OECD 216 in preskusno metodo EU C.21.
The CVMP therefore concludes that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the dossier as submitted in the referral procedure fulfils the necessary requirements with regards to the risk assessment for cyanobacteria (blue-green algae) and terrestrial plants.
CVMP zato meni, da zadržki, ki jih je sprožila Nemčija, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom ter da dokumentacija, predložena v napotitvenem postopku, izpolnjuje potrebne zahteve glede ocene tveganja za cianobakterije (modrozelene alge) ter kopenske rastline.
The proposed NOEC values are acceptable and can be used to derive a PNEC value of 100 mg/kg (100,000 µg/kg).
Predlagane vrednosti NOEC so sprejemljive in se lahko uporabijo za določitev vrednosti PKBU 100 mg/kg (100 000 µg/kg).
Consequently no risk quotient (PEC/PNEC) is derived for cyanobacteria.
Posledično za cianobakterije ni izpeljanega količnika tveganja (PKO/PKBU).
Overall, the CVMP agreed that enrofloxacin is unlikely to pose any significant risk to ground water.
Na splošno se CVMP strinja, da enrofloksacin verjetno ne predstavlja bistvenega tveganja za podtalnico.
The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Enro-K 10% Oral Solution for broiler chickens (10 mg/kg bw/day, for 5 days) above 100 µg/kg, thus requiring a Phase II assessment.
V I. fazi ocene tveganja za okolje na podlagi smernic VICH so dobljene koncentracije v okolju (PKO) v prsti za zdravilo Enro-K 10 %, peroralna raztopina, pri brojlerjih (10 mg/kg telesne mase /dan, 5 dni) nad 100 µg/kg, kar pomeni, da je potrebna ocena faze II.
Rye was the most sensitive species, with an EC50 of 124 mg/kg.
Najobčutljivejša vrsta je bila rž z vrednostjo EC50 124 mg/kg.
The geometric mean concentration during exposure was used to estimate a more realistic effect-measure compared to the nominal concentrations as also suggested in OECD 201.
Za bolj realno oceno mere učinka v primerjavi z nazivnimi koncentracijami je bilo uporabljeno geometrično povprečje koncentracij med izpostavljenostjo, kar priporoča tudi OECD 201.
2.3.Effect studies and calculation of PNEC values
Študije učinka in izračun vrednosti PKBU
The NOEC for the tested loamy sand field soil was found to be 2.9 mg enrofloxacin per kg soil (dry mass).
Vrednost NOEC za preskušano zemljo iz ilovnatega peska je bila 2,9 mg enrofloksacina na kg prsti (suha masa).
The application of an assessment factor of 100 leads to a PNEC value of 0.49 µg/l for algae.
Če uporabimo faktor ocenjevanja 100, dobimo vrednost PKBU za alge 0,49 µg/l.
The proposed EC50 values are acceptable and can be used to derive a PNEC value of 1.24 mg/kg (1240 µg/kg).
Predlagane vrednosti EC50 so sprejemljive in se lahko uporabijo za določitev vrednosti PKBU 1,24 mg/kg (1 240 µg/kg).
If the geometric mean of DT50 values from the four soils is used, the PECsoil-plateau is 506 µg/kg.
Če uporabimo geometrično povprečje vrednosti DT50 štirih prsti, je PKOprst-plato 506 µg/kg.
2.1.2 Soil adsorption and desorption A study, published in the peer-reviewed and open literature (Nowara et al 1997)1 indicated that enrofloxacin and other fluoroquinolones are strongly adsorbed to soils with high content in clay minerals of montmorillonite and kaolinite, basically through electrostatic interactions between ionized carboxylated groups of fluoroquinolones and exchangeable cations within clay layers.
V študiji, ki je bila objavljena v recenzirani in dostopni literaturi (Nowara et al 1997)1, ugotavljajo, da se enrofloksacin in drugi fluorokinoloni močno vežejo na zemljo z visoko vsebnostjo glinenih mineralov montmorilonita in kaolinita, predvsem z elektrostatskimi interakcijami med ioniziranimi karboksiliranimi skupinami fluorokinolonov ter zamenljivimi kationi v glinenih plasteh.
The coefficient of variation (CoV) was not provided, however the relatively narrow span of the 95% confidence interval around the estimated EC50 values qualitatively indicates an acceptable variation in data.
Kljub temu sorazmerno ozek razpon 95-odstotnega intervala zaupanja okoli ocenjene vrednosti EC50 kvalitativno kaže na sprejemljivo variabilnost podatkov.
Environmental fate studies
Študije usode v okolju
There was no concentration dependent effect on seedling emergence due to enrofloxacin up to the highest concentration tested.
Niso opazili od koncentracije enrofloksacina odvisnega učinka na kalitev semen do najvišje preskusne koncentracije.
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,