natgillin/translations-raw huggingface dataset:
Medicines known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin should also not be given to patients receiving Diflucan. 
Zdravila, za katera je znano, da podaljšujejo interval QT in ki se presnavljajo prek citokroma P450 (CYP) 3A4, kot so cisaprid, astemizol, pimozid, kinidin in eritromicin, se prav tako ne smejo dajati bolnikom, ki jemljejo zdravilo Diflucan.
Diflucan works by preventing the formation of ergosterol, which is an important part of fungal cell walls. 
Zdravilo Diflucan deluje tako, da preprečuje nastajanje ergosterola, ki je pomemben del glivičnih celičnih sten.
Other sections harmonised by the CHMP include sections on special warnings, side effects, interactions, pharmacological properties and quality. 
Druga poglavja, ki jih je uskladil CHMP, so poglavje s posebnimi opozorili, o neželenih učinkih, medsebojnem delovanju, farmakoloških lastnostih ter kakovosti zdravila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diflucan in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Diflucan.
Terfenadine must also not be used in patients receiving Diflucan at multiple doses of 400 mg per day or higher. 
Pri bolnikih, ki jemljejo zdravilo Diflucan z večkratnimi odmerki v količini 400 mg na dan ali več, se prav tako ne sme uporabljati terfenadin.
The CHMP agreed that Diflucan should not be used in patients who are hypersensitive (allergic) to the active substance, to related azole substances, or to any of other ingredient of the medicine. 
CHMP je potrdil, da se zdravilo Diflucan ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilno učinkovino, na sorodne azolne snovi ali katero koli drugo sestavino zdravila.
The CHMP agreed that Diflucan can be used for the following conditions: mucosal and invasive candidiasis, genital candidiasis (trush), crypotococcal meningitis, dermatomycosis, coccidiodomycosis and onychomycosis. 
CHMP je potrdil, da se zdravilo Diflucan lahko uporablja za naslednje bolezni: mukozna in invazivna kandidiaza, genitalna kandidiaza (sor), kriptokokni meningitis, dermatomikoze, kokcidiodomikoze in onihomikoze.
What is Diflucan? 
Kaj je zdravilo Diflucan?
Diflucan is used to treat various fungal infections, including candidiasis (thrush) and fungus in the nails. 
Zdravilo Diflucan se uporablja za zdravljenje različnih glivičnih okužb, vključno s kandidiazo (sor) in nohtnimi glivicami.
Diflucan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)). 
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini CMD(h) je ugotovila, da je za zdravilo Diflucan potrebno usklajevanje.
As a result of the following weaknesses identified with this study the results could not be accepted: 
Kot posledica naslednjih slabosti, ugotovljenih pri tej študiji, rezultatov niso mogli sprejeti:
• The possibility of release into the environment has not been investigated. 
• možnost sproščanja v okolje ni bila raziskana.
In the first phase the DT50 was calculated to be 4 hours, while it was 12 hours in the second phase. 
V prvi fazi je bil izračunani DT50 4 ure, medtem ko je bil v drugi fazi 12 ur.
However at the end of the study (27 days), 64% of the dose formed non-extractable residues. 
Vendar pa so ob koncu študije (27 dni) 64 % odmerka sestavljali ostanki, ki jih ni bilo mogoče ekstrahirati.
The DT50 was further recalculated in accordance with a biphasic model. 
DT50 so ponovno izračunali v skladu z bifaznim modelom.
Res Vet Sci. 1980 May;28(3):267-74. 
Res Vet Sci. 1980 maj;28(3):267-74.
Member State Applicant/Marketing Authorisation Holder 
Država članica Predlagatelj/imetnik dovoljenja za promet z zdravilom
When such specific information is not available the default values given in the guideline are applied. 
Kadar tovrstne specifične informacije niso na voljo, se uporabijo privzete vrednosti, podane v smernici.
The CVMP therefore considers that the objections raised by Germany and The Netherlands should not prevent the granting of a Marketing Authorisation. 
CVMP zato meni, da ugovori Nemčije in Nizozemske ne smejo preprečiti odobritve dovoljenja za promet z zdravilom.
It is assumed that veterinary medicinal products with limited use and limited environmental exposure will have a limited impact on the environment. 
Predpostavlja se, da bodo imela zdravila za uporabo v veterinarski medicini, ki imajo omejeno uporabo in omejeno izpostavljenost okolju, omejen vpliv na okolje.
The incidence takes into account the number of ill animals at the start of the study and all additional animals becoming ill during the observation period. 
Pri pojavnosti se upoštevajo število bolnih živali na začetku študije in vse dodatne živali, ki zbolijo v opazovanem obdobju.
The guidance document also allows for the use of alternative values if appropriately justified. 
Smernica prav tako dovoljuje uporabo drugih vrednosti, če so te primerno utemeljene.
• The nature and the biological activity of bound residues is not known, 
• vrsta in biološka aktivnost vezanih ostankov ni znana,
10000 = Area of 1 hectare [m2 .ha-1] 
10000 = Površina 1 hektar [m2 .ha-1]
Therefore it was concluded that all extractable degradation products would represent less than 5% of the dose by day 27. 
Zato so zaključili, da bodo vsi razkrojni produkti, ki jih je mogoče ekstrahirati, do 27. dne predstavljali manj kot 5 % odmerka.
OVERALL SUMMARY OF THE SCIENTIFIC CONCLUSIONS 1. 
SPLOŠNI POVZETEK ZNANSTVENIH ZAKLJUČKOV
The environmental risk assessment is carried out as a two Phase process. 
Ocena tveganja za okolje se izvede v dveh fazah.
The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination Group procedure with the following amendment: 
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, sprejete med postopkom koordinacijske skupine, z naslednjim dopolnilom:
The proportion of animals in the herd which are treated may be available from information in the dossier such as field trial data or from the scientific literature. 
Delež zdravljenih živali v čredi je lahko na voljo iz informacij v dokumentaciji, kot so podatki terenskih preskušanj ali podatki iz znanstvene literature.
The data available on BRD incidence within herds in the EU can be summarized as follows: 
Podatke, ki so na voljo o pojavnosti respiratorne bolezni goveda znotraj čred v EU, lahko povzamemo na naslednji način:
All other potential degradation products of florfenicol were below the LOD by day 2. 
Vsi drugi možni razkrojni produkti florfenikola so bili do 2. dne pod mejo zaznavnosti.
The CVMP reviewed bibliographical information on the incidence of BRD in several EU countries and on the percentage of animals that have been treated therapeutically and preventatively. 
CVMP je pregledal bibliografske podatke o pojavnosti respiratorne bolezni goveda v več državah EU in o odstotku živali, ki so jih zdravili terapevtsko in preventivno.
The incidence rate observed by Martin et al, 2007 was refined to include the animals presenting clinical signs of BRD before the study, with the result that the incidence was increased to 37.7%. 
Delež pojavnosti, kot ga je ugotovil Martin et al, 2007, so izpopolnili tako, da so vključili živali, ki so pred študijo kazale klinične znake respiratorne bolezni goveda, zaradi česar se je pojavnost povečala na 37,7 %.
United Kingdom Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park, 
Združeno kraljestvo Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park,
In relation to the proportion of a herd to be treated, it was noted that disease incidence and subsequent therapy are difficult to dissociate. 
V zvezi z deležem črede, ki bo zdravljen, so opazili, da je pojavnost bolezni in posledično zdravljenje težko ločiti.
The CVMP considers that the therapeutic indication as currently authorised in the Reference Member State does not make the limitations of the approved use clear as the existing wording could be interpreted as allowing use of the product for preventative and therapeutic treatment of all diseases caused by florfenicol susceptible bacteria. 
CVMP meni, da terapevtska indikacija, kot je trenutno odobrena v referenčni državi članici, ne določa jasno omejitve odobrene uporabe, saj bi obstoječe besedilo lahko razlagali, kot da dovoljuje uporabo zdravila za preventivno in terapevtsko zdravljenje vseh bolezni, ki jih povzročajo za florfenikol občutljive bakterije.
2.3 Degradation of residues in manure 
2.3 Razkroj ostankov v gnoju
= Depth of penetration into soil [m] 
= Globina prodiranja v tla [m]
From the above data it can be concluded that incidence of BRD within herds in the EU is generally below 50%. 
Iz zgoraj navedenih podatkov lahko zaključimo, da je pojavnost respiratorne bolezni goveda znotraj čred v EU na splošno nižja od 50 %.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES 
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA, IMETNIKOV/PREDLAGATELJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
In Phase I the calculation of the initial PEC in soil is performed when more than a “small number of animals” are treated. 
V I. fazi se izračuna začetna vrednost PKO v tleh, kadar se zdravi več kot „manjše število živali“.
• The nature of the binding is not known, 
• vrsta vezave ni znana,
If appropriate, the assessment proceeds to the second phase where the fate and effects of the product are determined and a risk assessment for the relevant environmental compartment is carried out. 
Kadar je to potrebno, se ocenjevanje nadaljuje z drugo fazo, pri kateri se določita obnašanje in vpliv zdravila ter se izvede ocena tveganja za ustrezni del okolja.
Considering the totality of the data the CVMP considered that this figure represents a conservative estimate of the overall BRD incidence rate within herds in the EU. 
Ob upoštevanju popolnosti podatkov je CVMP menil, da predstavlja to število konservativno oceno celotne pojavnosti respiratorne bolezni govedi znotraj čred v EU.
2.1 Incidence of BRD (Bovine Respiratory Disease) 
2.1 Pojavnost respiratorne bolezni goveda
PECsoil initial = Predicted Environmental Concentration in soil [μg.kg-1] D 
PKOtla začetni = Predvidena okoljska koncentracija v tleh [μg.kg-1] D
Phase I identifies veterinary medicinal products that require a more extensive environmental risk assessment. 
V I. fazi se opredelijo zdravila za uporabo v veterinarski medicini, ki zahtevajo obsežnejšo oceno tveganja za okolje.
Because Fenflor 300 mg/ml solution for injection for cattle is indicated for treatment only (i.e. it is indicated only for use in clinically ill animals not for preventative use) it was considered that, in this case, it was appropriate to use the disease incidence within the herd as the proportion of animals treated. 
Ker je zdravilo Fenflor 300 mg/ml raztopina za injiciranje za govedo indicirano le za zdravljenje (tj. indicirano je le za uporabo pri klinično bolnih živalih in ne za preventivno uporabo), se je ugotovilo, da je v tem primeru primerno uporabiti pojavnost bolezni znotraj črede kot delež živali, ki so zdravljene.
= Nitrogen produced in one year per place [kg.N. 
= Proizvodnja dušika v enem letu na mesto [kg.N.
= Daily dose of the active ingredient [mg.kgbw 
= Dnevni odmerek zdravilne učinkovine [mg.kgtm
Using the value of 38% for the proportion of treated animals in a herd, a maximum PECsoil value of 88.6 μg/kg was calculated. 
Z uporabo vrednosti 38 % kot deleža zdravljenih živali v čredi je bila izračunana najvišja vrednost PKOtla 88,6 μg/kg.
= Housing factor either 1 for animals housed throughout the year or 0.5 for animals housed for only 6 months (see Table 3 of the guideline) = Conversion factor [1000 μg.mg-1] 
= Koeficient nastanitve je 1 za živali, ki so nastanjene celo leto, ali 0,5 za živali, ki so nastanjene le po 6 mesecev (glejte razpredelnico 3 v smernici) = Faktor menjave [1000 μg.mg-1]
During the mutual recognition procedure concerns were raised that Fenflor 300 mg/ml solution for injection for cattle may present a potential serious risk to the environment. 
Med postopkom z medsebojnim priznavanjem so se pojavili zadržki, da lahko zdravilo Fenflor, 300 mg/ml raztopina za injiciranje, za pri uporabio pri govedu pomeni možno resno tveganje za okolje.
The Marketing Authorisation Holder provided a study to demonstrate that florfenicol degrades rapidly, with a DT50 of 14 hours (calculated using the Arrhenius equation to extrapolate from a DT50 of 5 hours measured at 20°C rather than at 10°C, as recommended in the CVMP guideline). 
Imetnik dovoljenja za promet z zdravilom je priložil študijo, ki dokazuje, da se florfenikol razkraja hitro, s časom razkroja DT50 14 ur (izračunanim z Arrheniusovo enačbo za ekstrapolacijo iz DT50 5 ur, merjeno pri 20 °C namesto pri 10 °C, kot priporoča smernica CVMP).
Florfenicol concentrations were below the limit of quantification (LOQ) (0.4 mg/kg) by day 2 and below the limit of detection (LOD) (0.1 mg/kg) by day 27. 
Koncentracije florfenikola so bile do 2. dne pod mejo kvantifikacije (0,4 mg/kg), do 27. dne pa pod mejo zaznavnosti (0,1 mg/kg).
2.2 PECsoil CALCULATION 
2.2 IZRAČUN PKOtla
In this instance a number of publications were provided to substantiate the proportion of animals treated for BRD within a herd. 
V tem primeru so bile predložene številne publikacije za utemeljitev deleža živali, zdravljenih zaradi respiratorne bolezni goveda znotraj črede.
Fenflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms. 
Zdravilo Fenflor vsebuje florfenikol, ki je širokospektralni, primarno bakteriostatični antibiotik s širokim spektrom delovanja, vključno naz mnogeimi gramnegativne imi in grampozitivneimi organizmei.
• Dairy calves: Sweden - 2.2-53.3% (Svensson et al 20064). 
• Teleta krav molznic: Švedska - 2,2-53,3 % (Svensson et al 20064).
The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC) provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 
Dokumentacija, predložena v napotitvenem postopku, izpolnjuje potrebne zahteve glede ocene tveganja za okolje (kot je določeno v členu 12(3)(j) Direktive 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES), ob upoštevanju, da se zdravilo uporablja le za terapevtsko zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
However, given that the CVMP considers that no Phase II environmental risk assessment is required for this application (because the calculated PECsoil values are below the trigger value), the manure degradation study is not pivotal to the environmental risk assessment. 
faza ocene tveganja za to vlogo za okolje ni potrebna za to vlogo (saj so vrednosti izračunanih PKOtla nižje od sprožitvene mejne vrednosti), pa študija razkroja v gnoju ni ključna za oceno tveganja za okolje.
place-1.y-1] (see Table 3 of the guideline) 
mesto-1.leto-1] (glejte razpredelnico 3 v smernici)
• Commercial veal unit: UK - 75% (Miller et al, 19802). 
• Teletina za prodajo: Združeno kraljestvo - 75 % (Miller et al, 19802).
To support the argument that the environmental risk assessment could be completed at Phase I, the Marketing Authorisation Holder also provided a manure degradation study, which was performed in accordance with the criteria laid out in the above mentioned CVMP guideline. 
Imetnik dovoljenja za promet z zdravilom je v podporo trditvi, da bi lahko oceno tveganja za okolje zaključili v I. fazi, prav tako predložil študijo razkroja v gnoju, ki je bila izvedena v skladu z merili, določenimi v zgoraj omenjeni smernici CVMP.
The LOQ is equal to 11% of the dose added to manure (0.4/3.6) and the LOD is equal to 2.7% (0.1/3.6) of the dose added to manure. 
Meja kvantifikacije znaša 11 % (0,4/3,6) odmerka, dodanega gnoju, meja zaznavnosti pa znaša 2,7 % (0,1/3,6) odmerka, dodanega gnoju.
• Dairy farm calves: Italy - 28.9% (Makoshey et al, 20086). 
• Teleta mlečnih kmetij: Italija - 28,9 % (Makoshey et al, 20086).
In the first phase the extent of environmental exposure is determined based on the intended use of the veterinary medicinal product. 
V prvi fazi se glede na predvideno uporabo zdravila za uporabo v veterinarski medicini določi obseg izpostavljenosti okolju.
• Veal calves: The Netherlands - 19.8%, Belgium - 13.3% (Catry et al, 20091). 
• Klavna teleta: Nizozemska - 19,8 %, Belgija - 13,3 % (Catry et al, 20091).
The CVMP concluded that adequate evidence had been provided to demonstrate that the proportion of treated animals in a herd would not be higher than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and that the data justified the use of this figure of 38% as the value for the proportion of treated animals in a herd, for use in calculating the PECsoil. 
CVMP je zaključil, da so predloženi zadostni dokazi, da delež zdravljenih živali v čredi ne bo višji od 38 % za zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni, in da podatki oupravičujejo uporabo vrednosti 38 % kot deleža zdravljenih živali v čredi za izračun PKOtla.
The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1). 
Imetnik dovoljenja za promet z zdravilom je predložil podatke, da bi dokazal, da je odstotek črednih živali, ki jih bodo zdravili zaradi respiratorne bolezni goveda, manjši od privzete vrednosti 50 %, ki je navedena v zgoraj omenjenih smernici CVMP (EMEA/CVMP/ERA/418282/2005-Rev.1).
6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves. 
Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. in Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET 
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILO ZA UPORABO
In this case a number of studies were provided to demonstrate that the proportion of treated animals in a herd would not be greater than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 
V tem primeru so predložili številne študije, da bi dokazali, da delež zdravljenih živali v čredi ne bo višji od 38 % za terapevtsko zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
The PECsoil for each cattle type (calves, dairy cows, cattle 0-1 year, cattle over 2 years) has been calculated using 38% as the proportion of the herd treated, according to the following formula (from the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1). 
PKOtla so za vsako posamezno vrsto goveda (teleta, krave molznice, govedo, staro 0-1 leta, govedo, starejše od 2 let) izračunali s pomočjo 38 % kot deleža zdravljene črede v skladu z naslednjo formulo (iz smernice CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
= Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline) = EU nitrogen spreading limit [kg N.ha-1] 
= Menjava živali na mesto in leto [mesto-1.leto-1] (glejte razpredelnico 3 v smernici) = Meja širjenja dušika v EU [kg N.ha-1]
74:162-179 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle. 
5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. in Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
= Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline) = Bulk density of dry soil [kg.m-3] 
= Delež zdravljene črede [vrednost med 0 in 1] (glejte razpredelnico 2 v smernici) = Specifična masa suhe prsti [kg.m-3]
• Beef calves: Spain - 31.5%, UK - 13-15% (Martin et al, 20073). 
• Teleta pitanci: Španija - 31,5 %, Združeno kraljestvo - 13-15 % (Martin et al, 20073).
Svensson C., Hultgren J. and Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western Sweden, and risk factors for diarrhoea and respiratory disease. 
4 Svensson C., Hultgren J. in Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western
This overall process is described in VICH Phase I and Phase II guidelines (VICH Topic GL6 (Ecotoxicity Phase I; Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL) and VICH GL 38 (Environmental impact assessment for veterinary medicinal products - Phase II (CVMP/VICH/790/03-FINAL)). 
fazi smernic VICH (predmet VICH GL6 (Ekotoksičnost faza I; Smernica o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje (PVO) - I. faza (CVMP/VICH/592/98-FINAL) in VICH GL 38 (Presoja vplivov zdravil za uporabo v veterinarski medicini na okolje - II.
Section 4.2 of the SPC and Section 4 of the Package Leaflet: 
poglavje 4.2 povzetka glavnih značilnosti zdravila in poglavje 4 navodila za uporabo:
All PECsoil values calculated are below the Phase II trigger value of 100 μg/kg, with the highest PECsoil (88.6 μg/kg) calculated for cattle of over 2 years of age. 
fazo, pri čemer je bil najvišji izračunani PKOtla (88,6 μg/kg) pri govedu, starejšem od 2 let.
The product is presented as a solution for injection containing 300 mg of florfenicol per ml solution for injection and it is intended for the therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 
Zdravilo je na voljo kot raztopina za injiciranje, ki vsebuje 300 mg florfenikola na ml raztopine za injiciranje in je namenjeno terapevtskemu zdravljenju okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.